Senin, 08 Agustus 2022

 


MANUAL

ON

OFFICE PROCEDURE


LOK SABHA SECRETARIAT

NEW DELHI


For Official use only


MANUAL

ON

OFFICE PROCEDURE

(Third Edition)


LOK SABHA SECRETARIAT

NEW DELHI

November, 2009

Kartika, 1931 (Saka)


O & M No. 65


Third Edition, 2009


© BY LOK SABHA SECRETARIAT

Published under Rule 382 of the Rules of Procedure and Conduct of Business in Lok Sabha (Thirteenth Edition) and printed by the General Manager, Government of India Press, Minto Road, New Delhi.


PREFACE


     The Lok Sabha Secretariat since its inception has been consistently endeavouring to evolve as an organization with impeccable efficiency. In order to be able to handle its multifarious tasks with greater speed and ability, the Secretariat has been reviewing and upgrading its work methods and procedures from time to time and also bringing out revised editions of the Manual for the use of its officers and staff. The Manual was first published in 1959 as the Manual on Filing Procedure, and later on it was revised in 1992 and renamed as the Manual on Office Procedure. This is the third revised and enlarged edition of the Manual.

     The chapters in this volume have been arranged as per the established stages of the filing procedure. It inter alia contains changes that have been introduced in the filing and office procedure after the publication of the second edition. Besides, the instructions pertaining to review of performance, observance of punctuality, maintenance of proper office decorum, confidentiality and secrecy of papers, etc., which were brought out in the circulars and instructional orders issued from time to time, have been consolidated and included as new chapters in this edition. At the same time, the instructions related to specific procedure pertaining to the functioning of a few individual Branches, included in the earlier edition, have been consciously omitted to make the Manual a handbook that contains instructions on procedural matters of general applicability only.

     I am sure the Manual will serve as an invaluable Guide for the officers and staff of the Secretariat on the systematic handling, submission and maintenance of files and on other such matters.

NEW DELHI; P.D.T. ACHARY,

25 July, 2009 Secretary-General.

Sravana 3, 1931 (Saka)


(iii)


CONTENTS

PAGE

CHAPTER I Definitions  1

CHAPTER II Composition & Working of a File

Constituents of a File 3

File Register 3

Opening and Numbering of New Files 4

Working a File 5

CHAPTER III Preparation and Submission of Cases

Noting 9

Drafting 14

Arrangement of Papers in a Case 19

CHAPTER IV Security of Official Information and Documents 20

CHAPTER V Recording of Files 25

CHAPTER VI Editing and Printing of Important Files Classified under Class 'A' 27

CHAPTER VII Maintenance and Printing of Precedent Register and Preparation of Entries for Manual of Business and Procedure in Lok Sabha, Manual on Articles of the Constitution, Manual on Directions by the Speaker, Select Documents

and Journal of Parliamentary Information 29

CHAPTER VIII Collection and Printing of Departmental Decisions 31

CHAPTER IX Review and Weeding of Records 33

CHAPTER X Maintenance of research material, summaries of books, reference material,

bibliographies, etc. prepared by Committee Branches and LARRDIS 40

CHAPTER XI Review of Performance, Punctuality, Regulation of Attendance and

Observance of Proper Office Decorum 41

CHAPTER XII Instructions/guidelines for updating the Procedure & Practice Volumes of Branches, Drafting and Circulation of Orders and Writing of the Confidential

Reports 44

APPENDICES

APPENDIX I Specimen of File Register 55

APPENDIX II Specimen of Table of Contents of File Register 56

APPENDIX III Specimen of Indication Slips 57

APPENDIX IV Channel of Submission of the Administration/House Keeping/Service/Protocol

Branches 59

APPENDIX V Channel of Submission of the DRSCs, Financial and Other Comittees (Files

related to draft report, minutes and list of points)  60

(i)


(ii)

PAGE

APPENDIX VI Channel of Submission of the DRSCs, Financial and Other Committees (Files related to administrative matters such as application for leave, medical

reimbursement, vehicular advance etc.)  61

APPENDIX VII Channel of Submission of the House related Branches (LB-I & II, Table

Office and PNO) 62

APPENDIX VIII Channel of Submission of LARRDIS 63

APPENDIX IX Specimen of Register of Risographing of Secret Documents 64

APPENDIX X Specimen of Register of Spare Copies of Secret Documents 65

APPENDIX XI Specimen of Form for Sending Files to Record Room 66

APPENDIX XII Specimen for printing official receipts, issues and unofficial memoranda 67

APPENDIX XIII Specimen of Precedent Register 68

APPENDIX XIV Specimen of Entries for Precedent Register  69

APPENDIX XV Specimen of Table of Contents for Precedent Register 70

APPENDIX XVI Model Entry for the Manual of Business and Procedure in Lok Sabha 71

APPENDIX XVII Model Entry for the Manual on Articles of the Constitution 72

APPENDIX XVIII Model Entry for Select Documents 73

APPENDIX XIX Model Entry for Manual on the Directions by the Speaker 74

APPENDIX XX Model Entry for Journal of Parliamentary Information on Procedural Matters 76

APPENDIX XXI Specimen of Summary for Departmental Decisions 77

APPENDIX XXII Specimen of Form for Review and Weeding of Records 78

APPENDIX XXIII No. of copies of Govt. Bills/Private Member Bills and other documents to be

retained in the Record Room 79

APPENDIX XXIV Weeding out of Records relating to Accounts 81

APPENDIX XXV Monthly review of performance of Committee Branches 82

APPENDIX XXVI Quarterly review of performance of Committee Branches 83

APPENDIX XXVII Specimen of Preface of Procedure & Practice Manual-I 84

APPENDIX XXVIII Specimen of Preface of Procedure & Practice Manual-II 85

APPENDIX XXIX Specimen of the Instructional Orders (I &II) 86


CHAPTER I

DEFINITIONS

1.1 Special meanings to be attached to some of the terms used in the manual are defined as under:—

(1) Appendix to Correspondence—In relation to a file 'Appendix to Correspondence' means lengthy enclosures to a communication (whether receipt or issue) on the file, inclusion of which in the correspondence portion is likely to obstruct smooth reading of the correspondence or make the correspondence portion unwieldy.

(2) Appendix to Notes—In relation to a file 'Appendix to Notes' means a lengthy summary or statement containing detailed information concerning certain aspects of the question discussed on the file, incorporation of which in the main note is likely to obscure the main point or make the main note unncessarily lengthy.

(3) Branch Officer—Branch Officer (i.e., Under Secretary/officer holding equivalent rank) is incharge of the Branch(es)/Section(s) and in respect thereto exercises control both in regard to despatch of business and maintenance of discipline. Work comes to him from the Branch(es)/Section(s) under his charge.

(4) Case—Case consists of the file containing the papers under consideration and any other files and papers, books, etc., put up for reference to enable the question or questions raised to be disposed of.

(5) Classified dak—Classified dak means dak bearing a security grading.

(6) Come-back case—Come-back case means a case received back for further action such as re-examination or preparing a draft or a summary of the case.

(7) Correspondence—Correspondence is the collection of all communications (receipts) received and office copies of out-going communications (issue) consisting of —(a) Official Correspondence; (b) Demi-official Correspondence; and (c) Un-official Correspondence.

(8) Current File —Current file means a file containing a paper or papers on which action has not been finally completed.

(9) Dak—Dak includes every type of written communication such as letter, telegram, inter-departmental note, file, fax, e-mail, wireless message which is received whether by post or otherwise, in any Service/Branch/Section/Unit for its consideration.

(10) Dealing hand—Dealing hand means any functionary such as Junior Clerk, Senior Clerk, Executive Assistant, Senior Executive Assistant etc. entrusted with initial examination and noting upon cases.

(11) Demi-Official Correspondence—A Communication is demi-official when Government officers correspond with each other or with any member of the public without the formality of the prescribed procedure and with a view to inter-change or communication of opinion or information before a formal decision is taken.

(12) Divisional Officer—Divisional Officer (i.e. Director/Additional Director/Deputy Secretary/officer holding equivalent rank) is responsible for the disposal of business dealt with the Branch(es)/Section(s) under his charge.

(13) Docketing—Docketing means making of entries in the notes portion of a file about the serial number assigned to each item of correspondence (whether receipt or issue) for its identification.

(14) Draft—Draft means a rough copy prepared of a document. The word 'Drafting' when used in the Secretariat means composing of official communications, based on officers' notes or orders.


1


2

(15) File—File means a collection of papers on a specific subject-matter, assigned a number (File No.) and consisting of one or more of —(a) Correspondence; (b) Notes; (c) Appendix to Correspondence; and (d) Appendix to Notes.

(16) Filing—Filing can be defined as placing loose matter in some systematic order so that the papers wanted can be located readily.

(17) Fresh Receipt—F.R. means any subsequent receipt on a case which brings an additional information to aid the disposal of the paper under consideration.

(18) Issue—The term 'Issue' is used to signify the various stages of action after approval of a draft, namely, typing of fair copy the examination of the typed material, submission of a fair copy for signature and finally the despatch of the communication to the addressee.

(19) Messenger/Peon Book—Messenger/Peon Book means a record, maintained in form, of particulars of despatch of non-postal communications and their receipt by the addressees.

(20) Notes—Notes mean the remarks recorded on a case to facilitate its disposal. It includes a precise of previous papers, a statement or an analysis of questions requiring decision, suggestions regarding the course of action and final orders passed thereon.

(21) Official Correspondence—Means correspondence addressed by or to any Government official, public body or private individual in conformity with the prescribed form and procedure.

(22) Paper under Consideration—The Paper Under Consideration (P.U.C.) is normally a primary receipt, the consideration of which is the subject matter of the case.

(23) Receipts—All communications whether official, demi-official or un-official received in the Secretariat or by any officer of the Secretariat in the official capacity are called receipts.

(24) Recording—Recording is the process of closing a file after action on all the issues considered thereon has been completed. It includes operations like completing references, removing routine papers, revising the file title, changing the file cover and stitching the file.

(25) Referencing—Referencing is the process of putting up and referring to connected records, precedents, rules, regulations, books or any other paper having bearing on the case.

(26) Inter-departmental Correspondence—A communication through which a paper or a file or a case is forwarded to any other Department(s) for obtaining their concurrence, opinion or remarks.

(27) Urgent dak—Urgent dak means dak marked 'Immediate' or 'Priority', and includes telegrams, wireless messages, telex messages, fax, etc.


CHAPTER II

COMPOSITION & WORKING OF A FILE

1. Constituents of a File

Main File

    2.1 The two main parts of a file are (i) 'Notes' and (ii) 'Correspondence', each one of which is placed in a single cover in the left and right sides, respectively. The former contains notes recorded on a 'Paper Under Consideration' and on a 'Fresh Receipt', if any. The correspondence contains all communications received and office copies of out-going communications.

    2.2 If the issues raised in a receipt or in notes or in the orders passed thereon go beyond the original subject, relevant extracts should be taken and dealt with separately on new files.

Part File

    2.3 A part file may be opened when the main file is not likely to be available for sometime and it is necessary to process a fresh receipt or a note without waiting for its return, or when the main file has become rather bulky, in which case only the essential papers which are required for the disposal of a point should be submitted with a separate note sheet and not the whole file.

2.4 A part file will normally consist of:—

(i) the original 'Paper Under Consideration' or its copy and other essential papers on the 'Correspondence' side; and

(ii) the note or notes recorded or to be recorded on the 'Paper Under Consideration' or a copy thereof on the 'Notes' side.

    2.5 Part file should be amalgamated with the main file as soon as possible. The duplicate papers, if any, should be removed.

    2.6 When more than one part files are opened, each one of them should be given a distinct number, e.g. 5/2/2009/O&M (Part File 1), 5/2/2009/O&M (Part File II).

    2.7 The dealing hand concerned should invariably maintain a list of part files opened by him. Collection Cover

    2.8 It contains routine notes of secondary information, casual correspondence exchanged for collecting further information from various sources, reminders, acknowledgements, and other K.W. (Keep with) papers, which are not appropriate to form part of the main file. Only the gist of the material collected in the collection cover is incorporated in the main file.

    2.9 Many of the items assembled in the collection cover will be of only temporary value. At the time of recording of file, the papers which have lost their value should be destroyed under the direction of the Branch Officer.

2.10 Collection cover must not leave the Branch to which it belongs.

2. File Register

    2.11 Each branch/section/unit will open a file register. General works and General Store Branches will be responsible for printing, stock, issue, etc., of the file registers. The register will be in the form enclosed at Appendix-I and neatly bound. It will be a permanent record and therefore, will contain adequate number of sheets according to the needs of each branch/section/unit.

3


4

     2.12 As soon as a new file is opened, the number and subject allotted to it should be entered in the file Register. A record of files opened during a calendar year will be kept in the file register. Entries for the next year will be made either in a new file register or in the same register where pages will be allocated year-wise.

     2.13 The entries in the file register will be made legibly, and erasures, omissions and overwriting will be avoided. All entries will be in blue ink only.

     2.14 The file register will be placed in a central place in the branch/section/unit under the custody of a junior clerk etc. as decided by the branch/unit/section Head for reference but in no case shall it be roughly handled.

3. Opening and numbering of new files

     2.15 There should be a separate file for each distinctive subject. If the subject of a file is too wide or too general, there will be a tendency to place in it papers dealing with different aspects of the matter which apart from making the file unwieldy will impede work.

     2.16 The system of opening and numbering of new files broadly accepted for general application in the Lok Sabha Secretariat is based on subject classification. The main subjects ordinarily dealt with in a branch/ section/unit are known as 'Standard Headings'. Some subjects yield to further sub-division i.e. 'Sub-Headings'.

     To enable the files to be easily traced at a moment's notice, an alphabetical list of contents, as shown in Appendix II, will be prepared at the beginning of the file register indicating the 'Standard Headings' and 'Sub-Headings' and the pages allotted to them.

     2.17 The list will be scrutinised and brought up-to-date at the beginning of every calendar year. As far as possible the main subjects will be allotted the same standard file number year after year. A new heading may be added to the list with the approval of the Head of the branch/section/unit during the course of the year, if found necessary.

     2.18 When it is necessary to open a new file, the dealing hand will first ascertain from the list the 'Standard Heading' under which it should be opened. He will then prepare a suitable title for the new file and allot it a number (next available in the serial order in the file register) under the 'Standard Heading'.

     2.19 The title of the file should indicate the subject matter of the case in as few words as possible. The first words of the title should almost always be the main subject under which the file is being opened and the descriptive part of the title should then follow. Thus, for instance, the subject of a new file opened under the main subject 'Lok Sabha Secretariat (Recruitment and Conditions of Service) Rules' will be 'Lok Sabha Secretariat (Recruitment and Conditions of Service) Rules—Delegation of authority to impose punishment'. The title should be so framed that it would show at a glance the subject-matter dealt with and enable the file to be easily identified. The title of the file should be approved by the Head of the branch/section/unit, before it is actually opened.

     2.20 A number given to the file will consist of (i) the number allotted to the 'Standard Heading', (ii) The serial number given to the file under the 'Standard Heading', (iii) the year in which opened, and (iv) the initials or letters used for identifying the branch/section/unit. The file will bear the same number and subject as shown in the file register.

     2.21 Thus the files opened in O&M Section during the year 2009 under the Standard Heading 'Assessment of staff requirements and job analysis by O&M Section' will be numbered as follows:—

Standard Heading — 2

Main Subject — Assessment of staff requirements and job analysis of Branches by O&M Section

2/1/2009/O&M Staff requirements and job analysis of P.N.O.

2/2/2009/O&M Staff requirements and job analysis of Reporters Branch

2/3/2009/O&M Staff requirements and job analysis of LARRDIS


5

    2.22 Files may be opened under sub-heads, in case the subject yields to further sub-division. These files will be numbered as under:—

Standard Heading — 2

Main Subject — Assessment of staff requirements and job analysis of Branches by O&M Section. Sub-Heading

Staff requirements and job analysis of P.N.O. — 2/1/2009/O&M Sub-Division 

Consideration of Report on P.N.O. by Administration — 2/1(I)/2009/O&M

Implementation of recommendations of O&M by P.N.O./Administration — 2/1(II)/2009/O&M

    2.23 A policy file should bear the alphabet '(P)' after the 'Standard Heading' number under which the file is opened, in order to distinguish it from other files. Routine action taken or matters dealt with as a result of policy decision, should be on a separate file which should be closed at the end of each year.

    2.24 Papers will be dealt with and filed in a file without regard to the year to which the references in that file pertain.

    No file should ordinarily contain more that 150 sheets of notes and correspondence. On reaching the maximum limit, a new file should be opened with the same number but marked Vol. II or Vol. III, as the case may be. The previous file should be closed and marked Vol. I.

    In all subsequent files on the same subject, the previous and later references should be quoted in the space provided for this purpose.

    If the file relates to the Sessional work, it should be closed after each Session irrespective of the fact whether it contains 150 sheets or less. Similarly, a file relating to a Committee will be closed on the expiry of the term of Committee whether it contains 150 sheets or less.

4. Working a file

    2.25 When an officer passes an order requiring a file or any matter to be disposed of by a particular date, the individual who is responsible for carrying out that order must comply with it before the date specified.

    If, however, owing to any circumstances beyond the control of the individual concerned, some delay is inevitable and he finds himself unable to finish the work by the date stated in the order, he should report accordingly and submit a request for the extension of time together with full reasons which will be considered by the officer who passed the original order.

Numbering of pages

    2.26 Every page of notes and correspondence should be consequently numbered in separate series with pencil at the top right hand corner from bottom to top. Blank intervening pages, if any, should also be numbered. When there are annexures etc. to the P.U.C., these will bear the number allotted to the P.U.C. followed by alphabet e.g. 15-A, 15-B, 15-C etc.

    The idea is to distinguish the P.U.C. from an enclosure. Where, however, the enclosures to a communication received or issued consist of a large mass of material, they may be allotted consecutive page numbers, if convenient. Page numbering done in pencil should be inked at the time of recording of the file.

Serial Numbers

    2.27 Every communication, whether receipt or issue, together with its enclosures kept in the 'Correspondence' will be given a serial number in red ink in the centre of its first page. The first communication will be market 'Serial No. 1' and subsequent ones will bear consecutive numbers in a single series. To distinguish


6

'Receipt' and 'Issue' communications, the entries should be marked 'Serial No. 1(R)' and 'Serial No. 2(1)' and so on.

     2.28 The serial numbers are useful for the purpose of referring to any paper, as also for ensuring that the file is complete. The loss of a letter is at once detected by the fact that a serial number is missing. The series, therefore, must be carefully kept up.

Docketing

     2.29 Docketing is the process of making entries in the 'Notes' portion of a file about each Serial Number (Receipt or Issue) in the 'Correspondence' for its identification. A receipt will be docketed by writing in red ink, across the page, the Serial Number of the communication followed by its number and date and the designation/ name of sender [e.g. Serial No. 4 (Receipt)— No. 2/1/2009-O&M, dated 28 January, 2009 from the Secretary, Bihar Legislative Assembly]. An 'Issue' will be docketed by entering the Serial No. given to it, followed by the date of its issue and the name and designation of the addressee [e.g. Serial No. 5 (Issue) dated the 31st January, 2009 to the Secretary, Bihar Legislative Assembly].

Docketing of Part Files

2.30 Docketing in the Part Files should be done in pencil in the following manner:—

Serial Number (Receipt)

Serial Number (Issue)

     The pencil entries should be erased when amalgamating the papers with the Main File, and the revised entries made in red ink.

Referencing and use of slips

     2.31 Referencing is the process of putting up and referring to connected records, precedents, rules, regulations, books or any other paper having a bearing on a case. Reference to such paper will be made as far as possible by quoting the file number and the number of page, in the margin. When absolutely necessary flags may be used to facilitate the identification of a particular reference. While using slips it should be remembered that the slips are merely a temporary convenience for the quick identification of papers and should be removed as soon as they have served their purpose. To facilitate the identification of references after the removal of slips, it is necessary that the number of the file and the relevant page number referred to should be quoted in the body of the note e.g.:—

[F.No. 3/1/AN/2009P-3 Notes]

     2.32 Similarly a description of the Rules, Regulations, Act, etc., together with the number of the relevant paragraph or clause referred to, will always be quoted in the body of the note while the alphabetical letters of the slip and the page number will be indicated in the margin.

     2.33 Books or Rules etc., referred to need not be put up on a file if copies thereof are available with the officer to whom a case is submitted. This should, however, be indicated in the margin of the notes in pencil. Where it is found necessary to put up books to officers, clean and bound volumes should be put up.

     2.34 Whenever any reference is taken from any book, the latest edition of the original book of reference (available in the Parliament Library) should be consulted. Second hand quotations should not be relied upon, but should invariably be checked with the original.

Cross-referencing of correspondence

     2.35 In order to know at a glance the latest position in regard to any P.U.C. without going through the whole correspondence, the previous and later references on that P.U.C. will be cross-referenced by marking previous reference and later reference in margin with pencil.


7

Linking of files

     2.36 When two or more current files on which action is necessary are linked, the printed slip bearing 'please see also the linked file' should be pinned to the cover of the topmost file. The number of the linked file should be given on the slip. Linking of files should be avoided as far as possible. Ordinarily, files should be consolidated, whenever practicable, into one file by an intelligent selection and arrangement of papers. Where it is necessary to refer to another file, an extract of the relevant noting, etc. on the file should be made provided it is of reasonable length, and placed on the file for which it is required. Only in those cases where many pages have to be referred to, files should be linked. Heads of Branches should take special care to see that files are linked together only when absolutely necessary are unlinked at the earliest opportunity. If linked files are not received back in the branch within a few days of submission and they are required for the disposal of another reference, the pemission of the officer, with whom they are, should be obtained to unlink them.

Pinning together of papers

     2.37 When the papers in a file are pinned together it should be so done as not to allow the sharp point of the pin to protrude and prick the fingers of any person who handles the file. In order to prevent injuries from pins, the sharp point of the pin should be embedded under the surface of the paper at the top.

Punching of papers

     2.38 Every paper shall be punched at the left hand top corner to the correct gauge (3/4 of an inch from either side) before it is tagged to the correspondence or notes.

Flagging of papers in a file

     2.39 A flag bearing the words 'Paper Under Consideration (P.U.C.) should be attached to the receipt which is being considered. If a receipt has been disposed of and a later receipt is being dealt with on the same file, the P.U.C. slip should be removed from the old receipt and affixed to the new one. If more than one receipt are under consideration at the same time, the P.U.C. slip should be attached to each 'receipt' and numbered I, II, III and so on. The receipt should be numbered serially.

     2.40 The previous papers put on the file and the recorded proceedings should be flagged with flags bearing different letters. No two flags should be alike in the same file. The flags should be doubled over and pinned neatly to the inside of the cover page. They should not overlap each other when the papers are arranged in the file, but should be distributed along the whole width, so that they may be easily seen.

Quick movement of files

     2.41 Files disposed of by the Branches during the day must reach the respective Branch Officers the same day preferably at regular intervals.

     2.42 If a file cannot reach the officer concerned on the same day, it must reach him the following morning by 10.00 O'clock.

Movement of files

     2.43 Indication Slip showing atop the nomenclature of Branch/Section from which the file has been initiated (Appendix III) and beneath it the name of Branch/Section or abbreviated designation of an officer to whom the file is being forwarded for necessary action/approval, will be clipped on the File Cover. Indication slips of different colours may be used for identifying urgent and important items of work. For example, in Question Branch Indication Slips printed in Pink colour and Blue colour are clipped on the file covers while putting up notices of Short Notice Question and Half-an-Hour discussion respectively. The dealing hand will keep a note of the movement of file in his diary.

     2.44 Files passed by higher Officer will be sent direct by Personal Assistant/Private Secretary to the Officer to whom marked after keeping a note of the movement, in his diary.


8

Priority marking on files

     2.45 The two prescribed priority markings to be used on files and papers are 'ACTION THIS DAY' and 'IMMEDIATE'.

     2.46 The label 'ACTION THIS DAY' should be used only in cases of extraordinary urgency requiring disposal on a top priority basis like Questions, Notices of Calling Attention, Adjournment Motions, List of Business of the House or a Committee thereof, etc. In all such cases, timings of receipt and disposal should be indicated in the margin of the last note on the file.

     2.47 The label 'IMMEDIATE' should be used in cases which are assigned a priority lower than the cases referred to in the preceding para but which still require action on the same day.

     2.48 The Officers through whom a file passes should examine whether the priority marking, if any, is appropriate, and if not, should remove or change the marking.

     2.49 In no case should a file be sent to the residence of an Officer unless so directed by the Officer concerned or under the specific directions of the Branch Officer.

     2.50 Priority slips should be affixed on the top flap of a file band or file board or if there be no flap, on the file cover itself.

Use of only neat and clean file covers and file boards

     2.51 Only neat and clean file covers and file boards will be used for submitting files. The Heads of Branches will ensure that instructions in this regard are observed strictly by the staff working under them and no torn or dirty file cover or file board is used.


CHAPTER III

                       PREPARATION AND SUBMISSION OF CASES Perusal of Dak by Head of Branch and its classification

     3.1 After perusal of Dak, the Head of Branch should classify the receipts into the following three categories:—

(i) Receipts of an important nature (i.e.) receipts raising new questions of policy, modification of existing policy or orders or any other receipts which is not of a routine nature;

(ii) Receipts on which the line of action is clear; and

(iii) Receipts on which no action is called for and are for information only.

     3.2 Receipts in category (i) may be discussed by the Head of Branch with the Branch Officer at the Dak stage and the level at which action is to be initiated got settled. If action is to be initiated by a dealing hand he may discuss it with the next immediate superior officer who will have to approve the disposal under the 'Jumping level' scheme and get clear instructions regarding the line of action.

     3.3 Receipts in category (ii) may be marked by the Head of the Branch direct to the dealing hands after indicating directions on the Receipts, where necessary.

     3.4 In regard to receipts in category (iii) the Head of the Branch may give directions for the filing of such papers at the Dak stage. The PUC may then be added to the relevant file after docketing and the case need not be put up again unless the information is to be brought to the notice of higher officer.

Initial examination of receipts by dealing hands

     3.5 Soon after the receipts are made over to him, the dealing hand will read them one by one and sort them out according to priority. 'ACTION THIS DAY', and 'IMMEDIATE' receipts will be taken up first, care being taken at the same time that ordinary receipts are not left unattended to for more than a week.

Bringing a receipt on to a file

     3.6 A receipt will be brought on to a current file if it relates to a subject on which a file already exists. If not, it will be necessary to open a new file for initiating action on the receipt according to the instructions contained in Chapter II. The receipt will then be docketed and referenced in the manner described in Chapter II.

1. Noting

3.7 The objects of noting are:

(a) to state the facts clearly and concisely, drawing attention to previous decisions, precedents, correspondence or rules and orders having a bearing on the subject;

(b) to state points on which orders are required; and

      (c) to suggest action to be taken.

Scope of noting by Branch

     3.8 When the line of action on a receipt is obvious or is based on a clear precedent or practice or has been indicated by the Branch Officer, or the Divisional Officer in the directions given by him on a receipt, a draft reply, where necessary should be put up for approval without much noting. In other cases the Branch will put up a note. It will be the duty of the Branch:—

(a) to see whether all the facts so far as they are open to check are correct;

(b) to point out any mistakes or mis-statements of facts;

9


10

(c) to draw attention, where necessary, to statutory or customary procedure and to point out the law and rules and where they are to be found;

(d) to supply other relevant facts and figures available in the Secretariat and to put up precedents or papers containing previous decisions of policy;

(e) to state the question or questions for consideration and to bring out clearly the points requiring decision; and

(f) to suggest a course of action, wherever possible.

3.9 The following instructions shall be observed by branches/sections/units/offices in noting upon cases:—

(a) All notes should be clearly intelligible and couched in simple language; they should be concise and to the point. Excessive noting is an evil which should be carefully avoided.

(b) All notes should be temperately written and should be free from personal remarks. If apparent errors in the note of another Department have to be pointed out or if the opinion expressed therein has to be criticised, care should be taken that the observations are couched in courteous language. All notes should be written in third person.

(c) It is to be assumed that the 'paper under consideration' and the previous notes, if any, will be read by the officer to whom the case is submitted. The reproduction of verbatim extracts from, or paraphrasing of the PUC or of notes by other Department on the same file shall, therefore, be avoided.

(d) A precis of a single paper shall be made only when it is of great length and complexity. Such a precis or a precis of the contents or the history of a file shall not ordinarily be prepared except on the instructions of an officer.

(e) If the inclusion of any information in the note is likely to obscure the main point at issue or make the note unnecessarily lengthy, a separate statement or appendix giving the information should be placed on the file.

(f) When there are, in a single case, several points or orders which can more conveniently be dealt with separately than in a continous note, each point should be separately noted upon in 'Branch Notes'. The Branch Officer and/or higher officers will record their orders on each 'Branch Note' separately and these notes will thereafter be amalgamated to form the notes on the file for purposes of issue of orders, etc.

(g) As far as possible, one note should emanate from the Branch. In the case of difference of opinion between the dealing hand and the Head of the Branch, the matter should be settled by personal discussion and the note should only summarise the points (including the alternate suggestion on a point) for decision.

(h) The sequence of noting should ordinarily follow the sequence of the serial number in the correspondence. If there has been any interruption in the continuity of the notes occasioned by submission of a receipt independently of the file, the papers should be amalgamated with the main file at the earliest opportunity.

(i) Except in routine matters, no note should be written on the receipt itself.

(j) If any Officer has made any remarks or written his direction on the P.U.C., these should first be copied out on the notes and then only the Branch note should follow.

(k) Every note should be legibly written upon paper of foolscap folio size, with a quarter margin. All long notes should be type written in double space.

(l) Paragraphs should be numbered.


11

(m) Sufficient space should be left for noting/signatures by higher officers. Notes to be submitted to Branch Officer or higher officers should not end at the every bottom of the page. A fresh blank sheet should always be added to the notes.

(n) Whenever notices or requests are received from Members of Parliament or others on small pieces of paper, they will not be passed on as they are, because of the likelihood of their being lost in transit. The first receiving Branch will paste or clip the slip of paper, thus received, to a foolscap size white sheet before passing it on in a file cover to officer or branch concerned for disposal. The branch concerned will type out the notice or request etc., on a note sheet or white foolscap size paper, and then deal with the receipt in the usual manner.

(o) The practice of writing long notes in the margin should be avoided as far as possible. Such marginal notes, if any, should be removed before the file is submitted to higher officers.

(p) When the lines on which a reply should be sent to a letter are apparent, the dealing hand should at the time of noting submit a 'draft for approval'. In such cases it is sufficient to note 'draft reply submitted for approval'. The substance of the reply should not be written in the notes.

(q) When a note, letter, file or other communication has been received from another Department, Ministry or Office or person, noting or further noting in connection with the matter therein will not be done on the sheet or sheets containing such a note or communication but all noting in this Secretariat will be done on a fresh and separate note sheet.

(r) All Inter-departmental correspondence between this Secretariat and other Ministries or Departments should be kept separately and not mixed up with the internal notings in this Secretariat.

(s) The last paragraph of every note should invariably state precisely the question(s) for consideration or points(s) on which the orders are solicited.

(t) Notes should be recorded after careful consideration so that they are not to be rejected or re-written and erasures should be rare.

(u) If at all a note is to be rejected, it should be cut out and revised note written in continuation without pasting it.

(v) The dealing hand should append his/her initials with the date on the left hand side below his/her note. The Head of the Branch shall also likewise put his/her dated initials below the note of the dealing hand, except when disposing of a paper within the powers delegated to him/her in which case he/she will sign his/her name in full on the right hand side.

Higher officers should initial on the right hand side of notes.

(w) All markings to higher Officers should be in the margin of the note.

(x) Wherever order of H.S./H.D.S./S.G. are to be solicited, the Branch noting(s) should invariably be followed by a concise, self-contained note (typed in double space) by the Divisional Officer concerned. Notings, if any, of Joint Secretary/Additional Secretary/Secretary over the note(s) of Divisional Officer should also be typed in similar manner.

(y) Notes involving more than one Branch should be consolidated by Divisional Officer/JS/AS/Secretary concerned and points on which orders of H.S./H.D.S./S.G. are solicited should be specifically mentioned.

(z) After orders are passed by H.S./H.D.S./S.G., no signatures should be put by any officer on the right hand side of the note sheet. All marking/initials should be in the margin of the note sheet.


12

(aa) If further note is required to be put up, it should be on the new note sheet bearing the name of the Branch or Office of the officer who has initiated that note and not in continuation of the note on which H.S./H.D.S./S.G. has passed orders.

Action by Head of the Branch

    3.10 The Head of the Branch will scrutinise the note of the dealing hand. Other instructions contained in para 3.9 (g) will be followed.

    3.11 Heads of Branches are authorised and expected to dispose of the following items of work without reference to their Branch/Divisional Officer:—

(i) Grant of casual leave/compensatory leave/special leave up to three days;

(ii) Issue of reminders and acknowledgements;

(iii) Recording of files;

(iv) Issue of Office Orders, Routine Orders and Circulars of ephemeral natures;

(v) Any other case, which by a general or specific office order, Head of Branch is authorised to dispose of independently.

    3.12 The delegations under (v) above have been made vide O.O. Part I Nos. 316 and 359 dated 18th February, 1957 and 25th October, 1957, respectively.

    3.13 While signing official communications relating to matter within his own power, the Head of Branch may use his name and designation.

Authentication of Orders

    3.14 Notwithstanding the powers delegated to Heads of Branches for disposal of certain cases and issuing of communications over their signatures, all orders passed by or made in the name of the Speaker, shall be authenticated by the signature of an officer not below the rank of Under Secretary.

Noting by Branch Officer

    3.15 A Branch Officer will dispose of as many cases as possible on his own responsibility. Orders of the Divisional Officer or higher officers will be taken by him on cases which are of sufficiently important nature or those involving question of policy. He should endeavour to reduce the number of cases to be submitted formally to the Divisional Officer by taking his verbal directions.

    3.16 Where he has to pass orders or to make recommendations for the consideration of higher officers, he will confine his note to the actual points that should be dealt with by him without attempting to reiterate the ground already covered in the previous notes. When he agrees with the recommendations made in the preceding note, he will merely append his signature or indicate his agreement with a particular proposal.

    3.17 In cases where a note has been written and approved by an officer and sent to another officer or a Branch for comments or examination of the proposal or for similar purpose, an officer to whom the file is marked should invariably write the note himself. The receiving officer may ask his Branch to examine the matter or furnish factual information. In such cases the Branches should submit a separate routine note for the information of the Branch Officer who shall ultimately record his note on the file. Branches should not write notes on files disposed of at the officer level.

Notes and orders by Divisional Officer

    3.18 The Divisional Officer should, ordinarily, dispose of most of the cases coming up to him on his own responsibility. He should use his discretion in taking orders of the Joint Secretary/Additional Secretary/Secretary/ Secretary-General on the more important cases, whether orally or by submission of papers. The oral method should be adopted as far as possible. Items of work which should ordinarily be sent to Secretary-General have been incorporated in the Brochure titled "Items of work to be submitted to Secretary-General."


13

Self-contained note for H.S/H.D.S./Chairman of Parliamentary Committee

     3.19 Whenever orders of H.S./H.D.S./Chairman of Parliamentary Committee/Convenor of Sub-committee of a Parliamentary Committee are to be solicited on any matter, a self-contained note shall be submitted. The following instructions shall be observed in the preparation and submission of such self-contained notes:

(a) The note will be given a heading as follows:—

Branch

Subject......................

(b) The contents of the note should be concise and to the point and will be divided into paragraphs, each dealing with a particular aspect of the subject and each paragraph duly numbered.

(c) The note shall contain a concise background of the case and the orders relevant to the subject matter and reference to the statutory or customary procedure or previous decisions or precedents, if any. If the case is based on the provisions of any rules, regulations, statute or past precedents, action to be taken will also be suggested.

(d) If the inclusion of any information in the note is likely to obscure the main point at issue or makes the note unnecessarily lengthy, a separate statement or appendix giving the information will be placed on the file.

(e) The last paragraph of the note should invariably state precisely the question or questions for consideration or point on which the orders are solicited.

(f) The note should be neatly typed in double-spacing with a quarter margin on blue note-sheet and should not contain unnecessary erasures, omissions or additions.

(g) The self-contained note to the H.S./H.D.S./Chairman/Convenor should in the first instance be signed by the Divisional Officer and submitted through Joint Secretary, Additional Secretary, Secretary and Secretary-General.

(h) The self-contained note, together with the relevant papers that are to be put up with it to the H.S./ H.D.S./Chairman/Convenor will be submitted in a separate file cover which will bear the number and subject of the main file. After the Divisional Officer has approved it, he will return the main file to the Branch and submit the self-contained note to the Secretary-General through the Joint Secretary/Additional Secretary/Secretary.

(i) If the Divisional Officer wants to put up a note in connection with the self-contained note for the information of Joint Secretary/Additional Secretary/Secretary/Secretary-General, he will do so on a separate note sheet which will be returned to him and the self-contained note forwarded to the H.S./H.D.S./Chairman/Convenor by the Personal Staff of Secretary-General, Secretary, Additional Secretary or Joint Secretary as the case may be.

(j) When the note is received back from H.S./H.D.S./Chairman/Convenor with his orders thereon, all markings/initials should be done in the margin of the note sheet. No further noting will be done on the sheet or sheets containing the orders. All further noting will be done on a fresh and separate note sheet so that the self-contained note and H.S./H.D.S./Chairman/Convenor's orders thereon remain in the file in a separate file cover as a self-contained documents which can be utilised for further reference, if necessary.

(k) If any further information is to be submitted to H.S./H.D.S./Chairman/Convenor on the same matter or his orders thereon are to be taken again, further noting will be done on a separate note sheet in continuation of the previous self-contained note and it will not be necessary to summarise the position in a fresh self-contained note every time the file is submitted to H.S./H.D.S./Chairman/ Convenor.

(l) Highlighters should not be used for highlighting of notes.


14

3.20 When a file has to be sent to the Hon'ble Speaker, the following instructions will be observed:—

(a) It should contain only that information which is necessary to enable the Hon'ble Speaker to arrive at a decision without calling for further facts or references, and all papers which are not strictly relevant to the point at issue should be removed.

(b) Essential references contained in the filed papers should be extracted, placed in the file and referenced.

(c) All papers placed in the file should be legible. If any communication including fax communications received from Ministries/Departments, etc. are illegible, the same may be retyped.

2. Drafting

Draft—When to be prepared

     3.21 Except when the line of action on a case is obvious, a draft of the communication proposed to be sent out will be prepared after orders have been passed by the competent officer indicating the terms of the reply to be sent, where the line of reply is clear a fair letter may be put up for signature.

     3.22 A Branch Officer or a higher officer who has formulated his ideas on a case may himself prepare a draft and authorise its issue or submit it to the next higher officer for approval, as the case may be. In other cases a draft will be prepared by the Branch.

3.23 The following general instructions will be followed regarding drafting:

(a) A draft should be typed in double space, in half margin and on both sides of the paper.

(b) The number and date of the communication replied to or of the last communication in a series of correspondence on the same subject should always be referred to. Where it is necessary to refer to more than one communication or a series of communications, this should be done in the margin of the draft. The subject should be mentioned invariably in all communications including reminders.

(c) A draft should show clearly the enclosures which are to accompany the fair copy. To draw the attention of the typist, the comparers and the despatcher, a diagonal stroke should be made in the margin. The number of enclosures also be indicated at the end of the draft on the left bottom of the page thus Encls. Nos. ...'

(d) If copies of an enclosure referred to in the draft are available and have not therefore to be typed, the fact should be clearly stated in the margin of the draft for the guidance of the typist.

(e) All drafts put up on a file should bear the number of the file. When two or more letters, notifications, etc. are to issue from the same file on the same date to the same addressee the serial number should also be given in addition in order to avoid confusion in reference, thus (i) 8/5(I)/2009-O&M and (ii) 8/5(II)/2009-O&M.

(f) Where State Governments or Ministries, etc., are consulted on any matter, time limit for replies should ordinarily be specified. The officer over whose signature the communication is to issue will initial on the draft in token of his approval. His designation should invariably be indicated on the draft.

(g) A flag bearing the words 'Draft for Approval' should be attached to the draft. When more than one draft are submitted at the same time, they should be numbered I, II, III and so on.

Collection of Model Drafts

(h) In order to ensure that drafts which are prepared after great thought and careful examination are not lost in files and thus become unavailable at the time when they are required for the disposal of similar references later on, copies of all model drafts should be collected in a separate file.

(i) For quick reference, an index to the collection of model drafts will be maintained in each Branch. The subjects of the index will be arranged in alphabetical order, each page being devoted to a letter or letters as the case may be.


15

(j) In the course of day to day disposal of cases as and when important communications are drafted, the Head of the Branch concerned will have spare copies of such drafts made out and add them to the collection and index them under appropriate subjects.

(k) The collection of model drafts will be scrutinized in the beginning of every year and obsolete drafts weeded out. Draft which have subsequently been improved will be replaced by the latest drafts on the subject.

(l) A draft should convey the exact intention of the order passed. The language used should be clear, concise and incapable of misconstruction. Lengthy sentences, abruptness, redundancy, circumlocution, superlatives and repretitions (whether of words, expressions or ideas) should be avoided. Communications of some length or complexity should generally be concluded with a summary.

(m) The following general principles may be followed by all concerned:—

(i) No more words that are necessary to express one's meaning should be used. Failure to do so is likely to obscure the correct meaning and to tax the reader.

(ii) Superfluous adjectives, adverbs, and round about phrases should not be used.

(iii) Familiar words should be perferred to the far fetched as the former are more likely to be readily understood.

(iv) Words with a precise meaning should be preferred to those that are vague. This will serve to convey one's thoughts more clearly.

(v) Concrete words should be preferred to abstract words for they are more likely to have precise meaning.

(n) The use of participles is sometimes very convenient in the drafts. The following list will meet most of the cases:—

Acknowledging Communicating Notifying

Admitting Directing Proclaming

Advising Enclosing Recommending

Appealing Enquiring Reporting

Appointing Explaining Requesting

Affirming Forwarding Sanctioning

Authorising Intimating Stating

Cancelling Inviting Submitting

Confirming Nominating

(o) Some vague words and phrases have crept into official style and claim the sanction of tradition e.g., 'therein, thereon, thereof, in respect of, in regard to, as regards, in relation to, for being, do the needful, for necessary action or necessary instructions, respectively, etc.' Words such as these tend to obscure the meaning. For the words 'therein, thereon and thereof ' the simple words 'in it, on it, or of it' would have served the purpose. Likewise, 'in relation to' displaces in many cases the word 'towards'. Anxiety to avoid repetition leads to the use of 'former' and 'latter', but this places undue strain on the reader's memory. Such vague expressions should be avoided.


16

(p) A phrase which has been much overworked in official communications is 'as to'. It often appears unnecessarily along with the words 'whether, who, what etc.' For example, in the sentence "The Administrative Officer is requested to report as to whether the case has been completed", 'as to' is redundant and should be omitted.

(q) Some of the errors which are common to official writing are given below and care should be taken to avoid these mistakes:—

(i) The words 'Government', 'Secretariat', 'Branch' are sometimes used in singular and sometimes in plural. The correct procedure is to use them in the plural form, but if the singular is used, it should be constantly followed throughout the sentence and should not be changed as has been done in the following sentence:—

  "The Secretariat has considered your case carefully but have come to the conclusion."

Likewise, the mood also gets mixed up frequently. An example of change in mood is given below:—

"When I referred the matter to the Committee, it was considered by me."

The correct form should be:—

"When I referred the matter to the Committee, I considered."

It is equally important to see that tense used throughout is the same.

(ii) After 'suggest' use 'should' not 'may' (after 'request' use 'may' not 'should').

(iii) 'Point out' is a much abused phrase. It should really be used in speaking of some fact or a circumstance of which the addressee ought to have been aware from the source of information open to him. It should never be used as synonymous with 'explain' or 'inform you'.

(iv) 'However' is a word which often gets misplaced, "after careful consideration (1) of these suggestions (2) the Government of India are unable (3) to agree that". In this sentence (2) is the right place for 'however' and not (1) or (3). It should come between commas, fairly near but not too near the beginning.

(v) Wrong use of the words 'had' and 'have' is also frequent. The past perfect 'had' is to be used only to emphasise the priority of one event in the past over another e.g., it is correct to say "I had gone to Shimla when the Chairman left the place". But it is a wrong usage in the sentence "I had gone to Shimla last Friday".

(vi) Many words are used without a proper implication of their meaning. When the Officer asks for a file and the file is lost, the dealing hand often puts up a note saying that it is 'not available'. To say that the file is not available does not mean that it is lost. It only means that the file has been kept somewhere else or sent to some other office. The use of the words 'in case', for the word ' if' and the phrase 'as well as' an equivalent of 'and' are other instances. When the dealing hand writes, "the file will be put up in case the Member does not pay the rent on the due date", he means that "the file will be put up if the Member does not pay the rent on the due date".

(vii) The words 'till' and 'all' also come in for a good deal of mishandling. When a dealing hand puts up a file to the Officer stating that no return was received till the 1st of December, it actually means that a return was received on the 1st December. But this is not what the dealing hand wants to say. What the dealing hand has in mind is that no return was received even on the 1st of December. To convey that, the word 'up to' followed by the word 'had' would have been


17

correct e.g., "up to December 1st the return had not been received". Similarly, when a dealing hand reports that "all the Junior Clerks have not passed the Senior Clerk Test", what he means is that "not a single clerk has passed the Senior Clerk Test". But what he actually conveys is that there are some Junior Clerks who have passed the Senior Clerk Test.

(viii) Omission of the article and use of the wrong preposition are also frequently met with. The following are some of the examples of wrong usage:—

Incorrect Correct

In Compliance of In compliance with

In the margin On the margin

In this behalf On his behalf

To kindly see To see kindly

Dispose it off Dispose it of

Under the circumstances In the circumstances

To thoroughly investigate To investigate thoroughly

3.24 The following words are often wrongly used:—


Acquaint

for

Inform or tell.

Advert

for

Refer.

Adumbrate

for

Sketch, outline, fore shadow.

Ameliorate

for

Better, improve.

Assist

for

Help.

Blue-print

for

Plan.

Ceiling

for

Limit.

Cross-section

for

Sample.

Commence

for

Begin.

Deem

for

Think.

Conditioned by

for

Dependent on.

Consider

for

Think.

Drive (intr.)

for

Came, originate, spring.

Develop

for

Take place, occur, happen, grow.

Entail

for

Impose, necessitate.

Envisage

for

Contemplate, face.

Eventuate

for

Come about, happen, occur, result, turn out.

Evince

for

Show, manifest, display.

Factor

for

Fact, consideration, circumstances, feature, element, constituent.


18

Function (verb) for Work, operate, act.

Inform for Tell.

In isolation for By itself.

Initiate for Begin, start.

Locality for Place.

Major for Important, chief, main, principal.

Majority, The. for Most.

Materialise for Come about, happen, occur.

Minimise for Under-estimate, disparage, belittle, make light of.

Practically for Virtually, almost, nearly, all but.

Proceed for Go.

A percentage of for Some.

A Proportion of for Some.

Purchase for Buy.

Reaction for Opinion, view.

Render for Make.

Reside for Live.

Residence for Home.

State for Say.

Stress (verb) for Emphasise.

Sufficient for Enough.

Terminate for End.

Transmit for Send, forward.

Visualise for Imagine, picture.

Record of verbal discussions, orders and instructions

    3.25 All points emerging from discussions between two or more officers and the conclusion reached should be recorded on the relevant file by the officer authorising action. Similarly, all verbal orders or instructions given by any officer and, where necessary, the circumstance leading to such orders/instructions, should be recorded on the file.

Channel of submission of cases

    3.26 The cases are put up by the dealing hand and they are processed/finalised of various levels of hierarchy. The channel of submission which is practiced in the Secretariat particularly in the LAFEAS and LARRDI Services are detailed in the charts given at appendices IV, V, VI, VII and VIII. The channel of submission of cases will also be determined by the orders issued from time to time under the jumping level scheme.


19

    3.27 Heads of Branches may be permitted to submit certain types of cases direct to Divisional Officers and the Branch Officer to the Joint Secretary/Additional Secretary/Secretary. Similarly, Divisional Officer may, in specified cases, deal direct with the Secretary-General or the Hon'ble Speaker.

    3.28 Selected dealing hands may also be authorised to submit cases direct to Branch Officer/Divisional Officer.

    3.29 After orders have been passed by a competent officer, the officer will mark the file either to the officer who put up the case to him or to an officer at an intermediate stage who should be kept informed of the decision taken.

3. Arrangement of Papers in a case

3.30 The papers of a current case will be placed in the following manner:—

(a) 'Notes' and 'Correspondence' will be kept in a single file cover, the 'Notes' portion being tagged on to the left hand side of the cover and the 'Correspondence' to the right half of the cover. 'Notes' will be filed downwards and 'Correspondence' upwards so that the latest 'Notes' and the 'Correspondence' are on the top when the file is opened.

(b) Self-contained inter-departmental references and replies thereto which are not to be returned, should be included in the correspondence portion of the file. Inter-departmental references which are to be returned in original will be noted upon, off the file without their being brought on to a file. A copy or a summary of the inter-departmental reference, together with a copy of the note recorded on the file of the originating Ministry in reply, will be retained, when necessary, and be kept in the correspondence portion.

     (c) Drafts for approval will be placed on the current file between the 'Notes' and the 'Correspondence'. Placing of more than one draft on the file

(d) Sometimes, while submitting a draft to higher officers for approval, it becomes necessary to place on the file more than one draft for the facility of comparison or explaining the changes readily. One of these drafts is the final draft and the others are first, second, revised, etc. drafts.

(e) While submitting files (to officers) containing more than one draft, the unapproved drafts should be numbered serially and following indication given in the margin of these drafts in red ink:—

'Unapproved draft Nos. I, II etc. Not to be issued.'

Other Papers

(f) Other papers referred to in the note or draft should be arranged in the same sequence in which reference to them occur in the draft or note. Books, regulations, etc. will, however, be kept at the top of the file.

    3.31 After the file is received back from officers, the Head of the Branch or the dealing hand concerned should see the file carefully and get neatly typed the finally approved draft for issue.

    While issuing the fair typed letter, the enclosures, if any, should be tagged to the draft; and an indication (issued with enclosures) should be given on the draft/office copy. The approved draft and unapproved drafts of important nature will be kept with K.W. Papers thereafter.


CHAPTER IV

SECURITY OF OFFICIAL INFORMATION AND DOCUMENTS

4.1 Rule 14 of the Lok Sabha Secretariat (Conduct) Rules, 1955 (as amended) provides as follows:—

"No officer shall, unless generally or specially permitted by the Secretary-General or in the performance in good faith of the duties assigned to him, communicate directly or indirectly any official document or any part thereof or information which has come into his possession in the course of his official duties, or has been prepared or collected by him in the course of those duties, whether from official source or otherwise, to any other officer of the Secretariat or to other Government Servant or to any private person or to the Press to whom he is not authorised to communicate such document or information."

    Under the above Rule officers of this Secretariat are prohibited from communicating to anyone (without good authority) any information acquired by them in the course of their official duties. It shall be the duty of every member of the staff to see that official information is not disclosed to anyone who is not connected officially with such matters, even through conduct in which there is no deliberately harmful intent, such as idle gossip, the desire to appear important by being 'in the know', the furtherance of communal or family interests, or the desire to gratify a person towards whom an obligation is felt.

    Particular care should be used in conversation with or in the hearing of persons who may have a motive for obtaining some particular piece of information or Press Correspondents whose business is to get and publish news.

Classification of Secret and Confidential Papers

    4.2 There are four grades of security markings, shown below and all the protected documents in this Secretariat will be classified in one of these gradings.

Top Secret

    4.3 This marking is reserved for papers containing information of such a vital nature that for reasons of national security, it must not be disclosed to any one for whom it is not essential to have knowledge of it for the proper performance of his duty.

    4.4 Such documents include references to current or future Military operations, intending movements or dispositions of armed forces, shaping of secret methods of war, matters of high international and internal political policy, cyphers and reporters derived from secret sources of intelligence.

    4.5 The distribution of papers having "Top Secret" classification must be limited to the minimum number of persons concerned, and in such cases, it will not be safer to err on the side of security.

Secret

    4.6 This marking is reserved for papers containing information, the unauthorised disclosure of which would endanger national security, cause serious injury to the interest or prestige of the nation or serious embarrassment to Government or would be of great advantage to a foreign nation.

NOTE—This classification should be used for highly important matters.


20


21

Confidential

    4.7 This marking is reserved for papers containing information, the unauthorised disclosure of which while not endangering the national security would be prejudicial to the interest of the nation, any Government activity or individual or would cause administrative embarrassment or difficulty or be of the advantage to a foreign nation.

    NOTE—Most matters will, on proper analysis, be classified no higher than "Confidential". Personal—Not for Publication

    4.8 This marking is reserved for communication to the members of the Public when it is desired to make it clear that these communications or the information contained therein should not be published.

Procedure for handling secret and confidential papers

    4.9 The following procedure will be observed with regard to the treatment and safeguarding of secret and confidential information and papers:

(1) The Branch Officer will invariably determine whether a particular document is to be classified as 'Secret' or 'Confidential'.

(2) Papers which may be secret or confidential until the occurrence of some particular event or announcement will not be treated as such afterwards.

(3) All secret and confidential papers should be typed in the presence of the official who has dictated or initiated the same. The file in any case should be retained in the official's personal custody and only such papers should be removed from the file to be given to the stenographer/typist as are essential for the typing work in hand. All drafts, rough notes and other routine papers will invariably be destroyed as soon as the fair copy of the letter, note, etc., has been issued.

The pages of stenographer's note book, in which dictation of secret and confidential papers has been taken, should be removed by the official concerned and destroyed or kept in safe custody for destruction.

(4) All secret and confidential material for risographing shall be received by the Head of the 'D' Branch who shall arrange to get them risographed/multigraphed in his presence. If, however, any such material is required to be multigraphed by any officer in his own presence, the needful shall be done without any delay. The copies made and the original copy of material shall be returned to the officer in whose presence the copies have been made. No unauthorised extra copies of such papers shall be made.

(5) Whenever copies of any of the secret papers are made, the Distribution Branch will maintain a record of the total number of copies made in a register (as shown in Appendix-IX). All entries made in this register from time to time, will be put up to the Branch Officer for his information and endorsement.

(6) Similarly, the Branches dealing with secret papers will maintain another register (as shown in Appendix-X) for recording the number of copies of such papers received from the Distribution Branch and their utilisation. This register will also be put up to the Branch Officer as soon as any entry is recorded in it, for his necessary endorsement.

(7) Papers marked secret or confidential will not pass in the ordinary course through the office but will be seen and dealt with only by persons explicitly authorised in that behalf. If not passed by hand from one authorised person to another, they will be sent in sealed covers or in the boxes provided for this purpose, which are fitted with special locks. The possession of keys for these boxes will be permitted only to persons particularly authorised and the safe custody of the keys will be a matter of great importance for which each authorised officer will be personally responsible.


22

(8) Papers marked secret or confidential will be handled by the Head of the Branch or by a thoroughly reliable dealing hand. They will be diarised or given a file No. by the person concerned without disclosing the subject.

(9) All covers marked secret or confidential, if not addressed to an officer by name, will be sent to the Branch Officer by the Receipt Clerk in 'D' Branch.

(10) No secret or confidential papers will be left lying in the Officers' Room or in the Branches where unauthorised persons might obtain access to them. Such papers will be carefully locked in secret almirahs or top secret boxes.

(11) Fair copies of secret or confidential material or floppy/disc, etc. containing secret or confidential information will be kept in the personal custody of the reliable officials particularly authorised for the safe custody of secret or confidential papers. Files in the computer containing secret or confidential information shall be given an appropriate password which is known only to the reliable officials.

(12) When sent by post, confidential or secret papers will be closed in double covers of which the inner one will be pasted or sealed and marked 'confidential' or 'secret' and superscribed with only the name of the officer by whom it is to be opened. The outer cover will bear the usual official address. Letters or packets containing confidential or secret papers sent by post will invariably be registered and those containing secret papers will also be sent "acknowledgement due".

(13) Secret and confidential files when recorded will be kept under the supervision of the Head of the Branch concerned for their safe custody. Every classified file (other than confidential) will be reviewed once in five years for declassification. A declassified file considered fit for permanent preservation will be transferred to the Parliamentary Museum and Archives.

(14) It is not necessary to use double covers for the movement in office of 'Top Secret' and 'Secret' papers by hand provided the single cover used is carefully sealed and marked with the correct name, address and security marking, and the cover is entrusted to the hand of a reliable dealing hand who can take it direct to the officer addressed. When such papers are sent by the hand of an Attendant they should be enclosed in double covers.

(15) The following instructions should be borne carefully in mind by officers and staff in regard to matters dealt with in Lok Sabha Secretariat:—

(a) Rule 383 of the Rules of Procedure and Conduct of Business in Lok Sabha provides that—

"The Secretary-General shall have custody of all records, documents and papers belonging to the House or any of its Committees or Lok Sabha Secretariat and he shall not permit any such records, documents or papers to be taken from the Parliament House without the permission of the Speaker."

This rule should be strictly complied with by all officers and members of the staff of the Lok Sabha Secretariat.

(b) In case a verbal or written communication is received from the Ministries or Departments or from anyone not connected with this Secretariat for the supply of any information directly or indirectly related to Parliament or Lok Sabha Secretariat, it should not be communicated to any one outside the Lok Sabha Secretariat without the express orders of Secretary-General.

(c) Should a verbal or written enquiry be made by a person belonging either to a Ministry or Department or by an outsider for eliciting information on any matter which may be in the know to an official of this Secretariat, the person making such an enquiry may be politely requested to contact the Branch Officer concerned. In no case should such information be furnished by any officer or member of the staff of this Secretariat unless he is satisfied that the supply of such information is definitely allowed under general or specific orders by the Secretary-General on the subject.


23

(d) In the event of a request being received in writing and the information is required immediately, it should be submitted quickly by the Branch dealing with the matter through proper channel for the orders of the Secretary-General. Till such time as the Secretary-General has passed orders on the file, no information need be furnished even though the person seeking the information be pressing for it.

(e) In cases where information is asked for by a person (whether an official of a Ministry/Department or an outsider) after normal working hours when it may be difficult to contact the Branch Officer or any higher authority, the person seeking the information may be politely asked to renew his request on the following day, when it may be possible to obtain the orders of the Branch Officer concerned.

(f) In rare cases when information immediately required beyond working hours, the Head of the Branch dealing with the matter should try to contact the Branch Officer at his residence over the telephone and if per chance the Branch Officer be not available, he should ring up Divisional Officer/Joint Secretary/Additional Secretary/Secretary/Secretary-General at residence and obtain orders.

(g) In cases where the Branch Officer himself has any doubt as to whether the information asked for should or should not be furnished, he should immediately take the orders of the higher officer(s).

(h) Every official of this Secretariat should make it a point that no person who is not an employee of the Lok Sabha Secretariat is allowed to see the files or papers without the permission of the Branch Officer or if in doubt without the express orders of Divisional Officer/Joint Secretary/ Additional Secretary/Secretary/Secretary-General.

(i) No unauthorised outsider should be allowed to watch the working of the Assistants, Clerks, etc., in the office rooms, and any official business with outsiders should be concluded quickly and they should be politely asked to leave the room after such business is concluded.

(16) Joint Secretary(S)/Additional Secretary(S) has been put in general charge of all the security arrangements in the Parliament House Complex and will act as a liaison officer in matters concerning the treatment and safeguarding of secret and confidential information and papers, between the Lok Sabha Secretariat and different security agencies like Intelligence Bureau, SPG, NSG and Delhi Police, etc.

(17) Secret documents should not be transmitted through the medium of FAX.

     4.10 While handling protected documents, other instructions for the treatment and safeguarding of such documents issued by the Lok Sabha Secretariat and supplied to officers and heads of Branches from time to time should be strictly adhered to.

Procedure for dealing with Secret/Confidential Communications received from Ministries in regard to Questions

     4.11 The following procedure will be observed for dealing with Secret/Confidential Communications received from the Ministries regarding questions:—

(a) Secret/Confidential Communications will be received by the officers concerned in whose name these have been marked.

(b) The officer concerned will deal with such cases himself. Relevant file may be called for from the Branch.


24

(c) In case the file is to be referred to other officers for obtaining his opinion, it will be marked Confidential/ Secret in red ink in bold letters and put in a special folder meant for this purpose. Such files will be transmitted from one officers to another through their P.As. The Officers concerned will ensure that the file is received back within a reasonable time.

(d) After final orders on the admissibility or otherwise of a question have been passed, the officer concerned will remove the Secret/Confidential Communication from the file and indicate the fact therein. The relevant extract of the decision will be placed on the file for further action and the file will be returned to the Branch after deleting the Secret/Confidential marking.

(e) Such Secret/Confidential Communications will be kept in the custody of the officer concerned.

     4.12 It is expected of the Officers/P.As. who handle the Secret/Confidential Communications that their contents remain sacrosanct and are not divulged to unauthorised persons.


CHAPTER V

RECORDING OF FILES

     5.1 Recording is the process of closing a file after action on all the issues under consideration thereon has been completed.Thus, when no further action is required to be taken on a file, the dealing hand will put it up to the Head of Branch for his approval for the file being recorded.

Classification of files for Recording

5.2 Files will be recorded under any one of the following classes:—

(a) Class 'A' meaning 'keep and print or microfilm'—This classification will be adopted for:

(i) files of historical importance such as papers relating to the origin of Secretariat, Committees and their functions;

(ii) files relating to major policy decisions and the implementation of a change of policy including a complete set of instructions thereunder;

(iii) files containing direct referrence to trends or developments in political, social, economic or other fields, and important aspects of scientific or technical research and development.

(iv) files providing lasting precedents for important procedure, e.g. administrative memoranda, historical reports and summaries and legal opinion on important matters;

(v) files containing rules, regulations, departmental instructions or guidelines of general application;

(vi) files relating to important litigation or 'causes celebres' in which the administration was involved;

(vii) important rulings/decisions of the Hon'ble Speaker or the Secretary-General and decisions relating to the service conditions of the staff which are not embodied in any Rules, etc.

(viii) files containing papers which are important or are likely to become important in future, however, indirectly as source of information on any aspect of history, whether political, military, social, economic etc. or which are, or may in future prove to be of biographical or antiquarian interest; and

(ix) material likely to be required frequently for reference in future.

(b) Class 'B' meaning 'keep but do not Print or Microfilm'—This class will also cover files which contain orders and instructions, etc., of permanent importance but which are not likely to be required very frequently for referernce.

(c) Class 'C' meaning 'Keep for specified period only'—This class will consist of files of secondary importance which are to be preserved for limited periods of 3, 5 or 10 years.

     5.3 No file will be included in class 'A' without the approval of the Divisional Officer. Destruction of Ephemeral Files

     5.4 Papers which are of a purely ephemeral nature, such as manuscripts, proofs, etc. of printed publications, will not be recorded but shall be filed and kept separately for one year, after which these papers would be destroyed.

Preparing a File for Record

     5.5 After a file has been marked for record, it should be arranged properly for recording. This would involve the following action:—

(a) Amendment or revision of the title of the file, where necessitated by the development of the subject matters of the case since its start.


25


26

(b) Completion of references, that is removing alphabetical slips/flags and giving permanent identification marks to the references quoted in notes and correspondence (where this has not already been done) and marking numbers of previous or later files on the subject on the cover of the file.

(c) Preparation, where necessary, of a fresh cover for the file with the revised title and details of previous and later references,etc., neatly typed.

(d) Noting in the file register the classification and date of recording.

(e) Giving indication about the life of the file on the cover.

(f) Obtaining orders of the Branch Officer whether the file is to be summarised or not for the purpose of incorporation of important decision in the Precedents Register, if not already done so and writing on the cover 'Recorded and Summarised' or 'Not summarised' as the case may be.

(g) Files recorded under class 'A' will be edited for printing by the dealing hand in accordance with the instructions given in Chapter VI.

     5.6 In all printed or bound files a coloured sheet or 'separator' should be included between the correspondence and the notes.

     Papers which are not of sufficient importance to form part of the main file, but have relation to the subject matter of the file, will be retained as 'K.W. papers' by inserting a sheet after the correspondence.

     5.7 The file will, thereafter, be made over to the Branch Daftry/Messenger, who after stitching neatly, will hand it over to the Branch Junior Clerk.

     5.8 When the file is stitched, the same will be submitted to Head of Branch for signature. Recorded files will be kept serially arranged in the Branch/Section concerned.

Custody of files

     5.9 With a view to having a permanent record about the ultimate disposal of a file, all files will be sent to the Record Room by the Clerk of the Branch concerned, who will make an entry in the relevant column of the File Register against the file concerned.

     Recorded files will be kept serially arranged in the Branch Record Room or in the Branch in case the Branch does not have separate Record Room. Normally, the files should not be kept in the Branch Record Room or Branch for more than 3 to 5 years, depending upon the requirement of a file. Thereafter, files will be transferred to main Record Room in Sales and Records Branch.

     5.10 While sending files to main Record Room, two lists will be prepared by Branches, in the form shown in Appendix XI. One copy will be retained by the Record Room and other returned to the Branch concerned.

     5.11 The Sales and Records Branch will maintain Record Review Register in which a few pages will be allotted for each future year. Class 'C' files marked for review in a particular year will be entered in the pages earmarked for that year in the register.

     5.12 When printed copies of files have been received and compared with the original, one copy will be kept in the Branch concerned and the original file along with the remaining printed copies will be sent to the Record Room.

     5.13 Recorded files which are marked secret/confidential should be retained by the Head of the Branch concerned for safe custody.


CHAPTER VI

EDITING AND PRINTING OF IMPORTANT FILES CLASSIFIED UNDER CLASS 'A'

     6.1 Recorded files classified 'A' will be carefully edited first by the dealing hand and thereafter the Head of the Branch will check whether the editing has been done properly. Careful editing of all matters sent to the printers is of the great importance. No amount of care at a later stage can redeem the waste of money involved in careless or incomplete editing.

     6.2 Those responsible for editing notes should endeavour to reduce the matter to be printed to what is absolutely essential. They should exercise what are technically described as routine notes, such as requests by the officer for further papers or information, etc. Notes—of frequent occurrence — which merely reproduce correspondence should invariably be omitted and summaries of correspondence or of other printed papers should be printed only when the length of the correspondence and the imprtance of the case render it likely that these summaries will be useful to officers in future. A common form of note is that with which office puts up a draft, with an explanation of points in the drafts: this is unnecessary, because these points are dealt with in the earlier notes of officers and in the draft itself. The note by the officers frequently is 'the draft may issue as revised'. All that need be printed in such cases is the officer's note in the form 'the draft may issue'.Notes which are clearly wrong or irrelevant or which have not been accepted by the officer passing the final orders can frequently either be exercised altogether or considerably curtailed. The editors should always remember that one of the objects of printing proceedings is to facilitate references by officers in future. It is accordingly obvious that such references will be simplified and the time of the officers saved if only essentials are printed.

     6.3 The editing of correspondence does not usually offer such large opportunities for reduction as the editing of notes. But here again a careful editor can achieve much. Letters of routine character such as reminders and acknowledgments etc., should not usually be brought into the correspondence at all, but even if they have been incorporated, they should be removed before printing. Where some mention of them is unavoidable, they can be replaced by short phrases such as:—

Serial No. 26 acknowledged receipt of serial No. 25.

Serial No. 27 reminder to the Government of Maharashtra.

Serial No. 28 reminder to the Government of Tamil Nadu.

6.4 Abbreviations should be avoided as far as possible.

     6.5 Serial Numbers must be clearly entered or written on the left hand side of the notes and correspondence and the words 'Serial No.' and the numeral will be printed in the style approved.

     6.6 Tabular statements will be avoided as much as possible.They are expensive and trouble some to print and very often the cost of printing them is out of all proportion to their usefulness. In very many cases the 'Turn on' or 'Solid' style will serve the purpose equally well.

     6.7 When a case is referred unofficially to another Ministry, the Notes of the Ministry to which it is referred will be shown thus in the middle of the page within spare brackets:—

[Notes in the Ministry of ]

     The same procedure will be observed when notes by another Ministry are amalgamated with a Branch note.

     6.8 The date on which a note is initialled or signed, will appear on the right hand side of the initials and signature and in a line with them thus:— R.A.H., 28.04.2009

     6.9 When a file is referred to one or more Branches or Ministries and no notes of importance are recorded by these Branches or Ministries, their notes with the initials and signatures will be deleted and merely

27


28

'Seen in and Branch' or Ministries as the case may be recorded in brackets. This is enough

to show that the file was seen by those particular Branches or Ministries and their consent obtained to the proposed action, if any. When a page is subjected to several corrections in editing, it should be re-typed before sending for printing.

6.10 Official receipts and issues and unofficial memoranda will be printed as shown in Appendix XII. 6.11 The number of copies to be printed will be determined in each case according to its requirement. 6.12 Before printing a file, the approval of the Divisional Officer will be obtained.

    6.13 When printed copies of files have been received and compared with the original, one copy will be kept in the Branch concerned and the original file along with the remaining printed copies will be sent to the Record Room.


CHAPTER VII

MAINTENANCE AND PRINTING OF PRECEDENT REGISTER AND PREPARATION OF ENTRIES

FOR MANUAL OF BUSINESS AND PROCEDURE IN LOK SABHA, MANUAL ON ARTICLES OF

THE CONSTITUTION, MANUAL ON DIRECTIONS BY THE SPEAKER, SELECT DOCUMENTS

AND JOURNAL OF PARLIAMENTARY INFORMATION

     7.1 In order to finding out readily references to past decisions and precedents in connection with disposal of cases, each Branch will maintain a Precedent Register containing entries relating to decisions of precedent value as shown in Appendix XIII.

     7.2 All entries in the Precedent Register will be classified under recognized headings and will be arranged alphabetically. The entries recorded in the register should be precise and clear and will be entered as shown in Appendix XIV.

     7.3 An alphabetical table of contents, as shown in Appendix XV, will be prepared indicating main heading and sub-headings and page numbers allotted to them. Sufficient space will be left between each main heading and sub-heading for inserting other entries from time to time.

     7.4 As soon as an entry under a new heading is made in the register, that heading will be shown in the table of contents at its proper place.

     7.5 Entries under each heading will be started on a fresh page and entries under that heading will be entered one after the other with sufficient space between two entries.

     7.6 As soon as a decision is taken in a file, it will be summarised and entered in the Precedent Register and shown to the Head of the Branch. The entries in the Precedent Register should also contain some background of the case or example wherever available. At the time of recording the file, a note will be recorded on the cover of the relevant file that it has been summarised and entered in the Precedent Register and the file will be submitted to the Branch Officer for information.

     7.7 If a file does not contain any important decision and is not summarised, it will still be examined so as to find out whether it has any precedent value and the dealing hand concerned will submit the file to the Branch Officer with the suggestion whether or not it should be entered in the Precedent Register.

     7.8 In every case where a file is not summarised but is entered in the Precedent Register, a note to that effect will be recorded in the relevant file.

     7.9 At the end of each year the entries in the Precedent Register will be re-examined with a view to selecting those which contain important decisions or which have any precedent value. The entries selected for retention will be typed, given continuous serial number and submitted to the Divisional Officer for final approval. The entry in the Precedent Register relating to a decision, which becomes obsolete, should be deleted.

     7.10 After the entries have been finally approved by the Divisional Officer, the headings and sub-headings will be shown in the contents pages. These will then be printed with the following title in the Branch series.

Precedent Register

of

—Branch

(containing entries upto—2009)

(Vol. I, II, III, etc.)

29


30

    7.11 At the end of every Lok Sabha, the various entries in the printed Precedent Register, will be further examined and amalgamated and reprinted in one volume. The following steps will be taken concurrently while summarising decisions taken on a file:—

(a) Preparation of entries for Manual of Business and Procedure in Lok Sabha and Manual on Articles of the Constitution

    A suitable entry will be prepared for Manual of Business and Procedure in Lok Sabha and Manual on Articles of the Constitution, where necessary. Such entries will be prepared in the forms shown at Appendices XVI and XVII and will indicate in the margin the Rules/Articles, sub-rule/Clause etc. to which the entry pertains and the exact place where it should be inserted in the printed Manual. The entries will be submitted by the Branch concerned for Joint Secretary's approval through their Branch/Divisional Officers. As soon as an entry is approved, two copies thereof will be made out by the Branch concerned, and forwarded to the Committee Branch-I.

(b) Preparation of entries for Select Documents

    In the case of Branches dealing with Committee work, an entry will be prepared for inclusion in Select Documents after summarising and editing the important observations made by Chairman, Secretary-General, Secretary or Members of the Committee on the functions, scope, procedure and the various other aspects of the Committee.

    These entries will be prepared on the model shown in Appendix XVIII and kept in folders for incorporation in the Select Documents of the Committee, to be printed from time to time.

(c) Preparation of entries for Manual on Directions by the Speaker

    A suitable entry will be prepared for the "Manual on the Directions by the Speaker", where necessary. Such entries will be prepared in the form shown at Appendix XIX and will indicate in the margin, the Directions to which the entry pertains and the exact place where it should be inserted in the printed Manual.

(d) Preparation of entries for Journal of Parliamentary Information

    Entries for short notes on important points concerning procedural matters of general interest and other parliamentary activities, such as Questions, Committee work, Privilege Issues, Conferences, etc., should be prepared, where necessary and sent to JPI Section (LARRDIS) for incorporation in the Journal of Parliamentary Information. A model entry is given in Appendix XX.

(e) Preparation of entries for Departmental Decisions

    Entries will be made for incorporation in Departmental Decisions. Detailed instructions for the maintenance of Departmental Decisions are given in Chapter VIII.


CHAPTER VIII

COLLECTION AND PRINTING OF DEPARTMENTAL DECISIONS

     8.1 All the important decisions or orders by the Speaker on the various files, will be collected by the Branches, as soon as those are taken and will be kept in the "Collection of Decisions" file, which will be maintained by each Branch, The decisions will be edited and made self-contained, so that the point for the decision is stated first, the background next, the views for and against the point and the conclusions of the competent authorities summarised thereafter. The summaries will contain the following:—

(a) Main-heading at the top;

(b) Sub-heading giving the gist of the Speaker's decision (and not the general heading of the file);

(c) Suitable catch-words of the sub-heading;

(d) The number of the file from which the decision has been extracted.

     8.2 Decisions given by Secretary-General/Secretary/Additional Secretary/Joint Secretary will also be incorporated in the collection.

Printing of Departmental Decisions

8.3 At the end of every year these decisions will be printed in three different parts under the title

"A selection from the (Departmental) Decisions Part " The nature of the decisions to be included in each

part and the Branch to be responsible for its compilation and printing will be as indicated hereunder:

Nature of Decisions Branch responsible for

compilation

Part I Decisions regarding Legislative Branch-I

Parliamentary matters

other than questions and

Committees.

Part II Decisions regarding Question Branch

Questions.

Part III Decisions regarding Committee Branch-I

Parliamentary

Committees.

     If, however, the number of decisions collected during the year are considered insufficient for the purpose of printing as a separate volume, these should be kept in manuscript and printed when sufficient material is gathered.

     8.4 After the summary has been approved, copies thereof will be prepared in the form as shown in Appendix XXI.

     8.5 Two copies of each of those approved summaries will thereafter be passed on to the compiling Branch. The third copy of the summary will be retained as office copy in the Branch concerned for their record.

     8.6 The compiling Branches will submit these decisions Branch-wise in batches of ten for approval of Secretary-General. After they have been approved by the Secretary-General all the decisions will be consolidated by the compiling Branch concerned and arranged according to alphabetical order of the main headings and sub-headings, if any.

31


32

    8.7 These decisions, when arranged, will be numbered serially. A table of contents and the index will also be prepared.

    8.8 After the compilation has thus been finalised, a preface will be prepared and the compilation will be submitted for final approval. Thereafter, the compilation will be printed in the respective (compiling) Branch Series.

    8.9 At the end of every five years, the compiling Branches will scrutinise the decisions included in their annual publications with a view to weeding out such decisions as might have become obsolete and print them in a single publication.


CHAPTER IX

REVIEW AND WEEDING OF RECORDS

Files

     9.1 No file other than ephermeral files mentioned in para 5.4 of this Manual will be weeded out without first reviewing its contents.

     9.2 Class 'C' files will be reviewed on the expiry of the specified retention period, and depending on the merits of the case, will be weeded out; or retained for a further period not exceeding 10 years from the year of its closing at the end of which it will be weeded out without any further review; or upgraded to class 'B', if so considered necessary on the merits of the case with the approval of Branch Officer.

     9.3 Class 'A' and class 'B' files will be reviewed on attaining the 25th year of their life. In these reviews, the need for revising the original classification of class 'B' files may be considered i.e. Upgradation to class 'A' or degradation to class 'C'.

     9.4 The year of review of class 'C' files be recorded with reference to the year of their closing and that for class 'A' and class 'B' files with reference to the year of their opening.

     9.5 Beginning in January each year, the record clerk in Sales and Records Branch; or the record clerk of Branch records room will send to the Branches concerned the files which became due for review in the preceding year together with a list of files, in the form given in Appendix XXII.

     9.6 Files received for review in the concerned Branches will be examined, by respective dealing hands. Files those no longer required will be marked for destruction, with the approval of Head of the Branch. Other files may be marked for further retention as prescribed in para Nos. 9.2 and 9.3 of this Chapter. For convenient retrieval, the covers of files may be stamped with the letters 'R' or 'D', to indicate whether the file should be retained or destroyed. For files which are marked for weeding out, an entry to this effect will be made in the file register against the file classification number, duly attested by Head of the Branch.

     9.7 After review, the record clerk will make entries of revised classification/retention period in the file register/file and return them to Sales and Records Branch/Branch records room along with the list (Appendix XXII) except in the case of less than 3 years old files which will be restored in the Branch as prescribed in para No 5.9 of this Manual.

     9.8 While weeding out files, great care should be taken to ensure that only those relating to unimportant matters are destroyed. The following types of cases will not be destroyed:—

(a) Important decisions of the Speaker or the Secretary General.

(b) Decisions relating to service conditions of the staff which are not embodied in any Rules, etc.

(c) Precedents relating to the position of the Secretariat vis-à-vis the Executive/Government.

(d) Important decisions on requests for any information or any other concessions.

(e) Files containing papers which are important or are likely to become important in future, however indirectly as source of information on any aspect of history, whether political, military, social, economic, etc. or which are, or may in future prove to be of biographical or antiquarian interest.

     9.9 While examining the recorded files for weeding out purposes, the following instructions should be observed:—

(a) References to earlier and later files should be indicated on the covers of the relevant files, if they are not already there.

(b) If the covers of files which are to be retained are found to be spoiled or torn they should be replaced by new ones and torn pages should be carefully repaired/pasted.

33


34

(c) Each category should be listed and the lists submitted to the Branch Officer with recommendations for preserving or weeding out, as the case may be.

(d) Thereafter, indication whether the file should be 'retained' or 'destroyed' should be given on the cover of file and in initialled by the Head of the Branch.

(e) After marking in the file register the disposal regarding files to be destroyed, the files should be returned to the Records Room.

(f) At the time of review of files for weeding out on the expiry of the specified retention period, appropriate care should be taken to ensure that important information (in the form of an O.M. or a letter or in any other form) as is likely to be used in future in the light of section 8(3) of the Right to Information Act, 2005 may be retained even after destruction of the file/record, unless such information has already been published or put on the website of Lok Sabha. The concerned Branch Officer(s)/ Divisional Officer(s) should apply their wisdom while taking decision in this regard.

Bills, Opinions on Bills and Extracts of Debates relating to Bills

     9.10 These consist ordinarily of Bills at their various stages and papers connected with that, i.e. Bills as introduced, Opinions and Precise of Opinions on Bills, Extracts from Debates relating to Bills which were circulated, Select Committee Reports, Bills as passed by Parliament etc. In order to decide which of these should be retained and which weeded out, the Legislative Branches I and II should examine their stock position and importance and prepare a comprehensive statement in two lists—one enumerating the documents which are considered of importance for the present or for future purposes, and the other those which are to be weeded out. The first list should also show how many copies of each are to be retained, excess being weeded out. The number of copies of various documents to be retained in the record room will ordinarily be as shown in Appendix-XXIII.

     9.11 The two lists with the recommendations thereon as indicated in the preceding paragraph should then be submitted to the Branch Officer for orders.

     9.12 On receipt of the orders, two copies of the lists will be sent to the Record Clerk with clear instructions for the disposal of the documents. The Record Clerk should return the duplicate copy of the statement to the Legislative Branch I or II, as the case may be after initialling it in token of having received the statement. He will also make necessary entries in the appropriate registers.

     9.13 The Legislative Branches-I and II should also maintain a complete set of important documents which may be required for reference, properly bound, with all connected documents in their correct sequence.

Manuscripts and corrected proofs of Debates

     9.14 The manuscripts and corrected proofs of Parliamentary Debates, Hindi and English versions both, will be weeded out after the printed Debates are received from printers and released for distribution.

     The original papers relating to original version of Debate such as corrections from Ministers/Members in their speeches, Division Lists and other papers from Table Office, communications from Legislative Branches I & II, Question Branch, Reporters Branch. LT Nos. from Parliament Library, corrected Question Lists and other essential papers will be preserved by the Editorial Branch till the English and Hindi Versions of Debates are printed and their release order issued. The concerned Branches shall send a copy of the release order to Editorial Branch. Thereafter, these papers would be weeded out under the orders of Branch Officer.

Shorthand notebooks of proceedings

     9.15 The Reporters will preserve their shorthand notebooks for a period of three months from the last date to which the proceedings in the notebook relate and after the said period, they may be destroyed.


35

Books, Reports, Debates, Newspapers, Journals & Periodicals in the Library

     9.16 Books, reports, pamphlets and other publications which have ceased to be of any further use will be weeded out from time to time in the Library. Proposals for weeding out shall be submitted through the Branch Officers indicating the reasons for the action proposed and denote the number of copies to be retained or weeded out and the orders of concerned Director/Joint Secretary should be sought thereon.

     9.17 The following general principles shall be followed in recommending the weeding of books etc. in the Library:—

(a) Law books will be weeded out after the newer editions of the same have been received.

(b) Only those Reports will be weeded out which are of a very temporary nature and not worth preserving as old records.

(c) Only those books and publications etc. will be weeded out which are not considered worth preserving in a library of Parliament.

(d) Debates/Acts of Parliament and other legislative bodies will not be weeded out.

     9.18 The following guidelines will be observed regarding number of copies to be retained in respect of various publications books, pamphlets, journals, periodicals, etc.:—

(a) Government Publications

Category English Version Hindi Version/

Regional Language Version of State Publications

1 2 3

(I) Central Government Publications

(i) Reports of the Committees, 5 5 Commissions, Study/Working Groups, Conferences, Seminars, Symposia, Souvenirs, Five Year Plans, National Policy Documents, General elections Reports, Law Commission Reports and White Papers

(ii) Reports of Parliamentary 5 3

Committees and other

Publications of Lok Sabha and

Rajya Sabha Secretariats

(iii) Annual Reports of main 3 2 Ministries/Departments, Reports of UPSC, UGC, Commission/Commissioner(s) of SC/ST, Election Commission, Minority Commission and

Liguistic Minorities

Commissioner, etc.

(iv) Budget Documents, Audit 3 3 Reports, Finance and

Appropriation Accounts,

Economic Survey, Currency and

Finance, Statistical Abstract of


36

1

2

3

India and Other Documents of



Statistical nature

(v) Census Documents

3

3

(vi) Ad hoc publications

3

2

(vii) Agreements

2

2

(viii) Annual Reports (other than the

main Ministries—Departments)

(ix) Reports of Universities and

other similar institutions

(x) Publications of Technical nature

(xi) Central Public Sector undertakings:

2

2

1

2

2

1

(aa) Articles & Memorandum of

3

3

Association

(bb) Annual Reports

3

2

(II) State Government Publications

(i) Reports of the Committees,

2

1

Commissions, Study/Working Groups, Conferences, Seminars, Symposia, Souvenirs, Five Year Plans, Policy Documents, Budget Documents, Audit Reports, Finance and Appropriation Accounts, Statistical Pocket Books, Economic Survey and White Papers

(ii) Reports of Legislative Committees 2 1

and State Government

Undertakings

(iii) Ad hoc Publications 1 1

(iv) Publications of Technical nature 1 1

(v) Annual Reports of Ministries/ 1 1

Departments i.e. Home, Education, Welfare Departments Such as Scheduled Castes/ Scheduled Tribes, Child and Women Development and Department for Backward Classes (Annual Reports, Audit Reports and Annual Accounts of other individual Departments need not be retained)

(III) Foreign Government Publications

(i) Reports of Committees, 1

Commissions, Study/Working Groups, Conferences, Seminars, Symposia, Souvenirs, Plan Documents, National Policy Documents, Budget Papers, Publications of statistical nature, Parliamentary Committees Reports, Other Ad hoc Publications and White Papers


37

1 2 3

(ii) Annual Reports of the 1 -

Departments of External Affairs, Commerce/Trade and Defence (Annual Reports, Audit Reports and Annual Accounts of other individual Departments need not be retained)

(iii) All publications received from the United Kingdom will continue to be retained as usual.

(IV) United Nations and its allied agencies

      All publications received from the United Nations and its Allied agencies will continue to be added to the holdings of Parliament Library as per prevailing practice.

(V) Parliamentary Debates English Version Hindi Version

5 2

(b) Books/Pamphlets

(i) Duplicate books:—only one copy of the old editions of such books, of which latest edition are available will be retained and all the earlier reprint editions will be weeded out.

(ii) Reprints:—Only latest reprint editions along with the original editions will be retained and all the earlier reprint editions will be weeded out.

(iii) Pamphlets:—All the pamphlets will be examined from time to time and only useful ones will be retained and others will be weeded out after taking orders of JS/Director.

(c) Newspapers/Journals/Periodicals

     Daily newspapers will be weeded out every three months; weekly magazine, every six months; and monthly journals and periodicals, once every year. Important periodicals, especially those relating to law & Legislation, should not be weeded out.

     In the case of annual serials also only two copies each of the earlier serials will be retained and additional copies, if any, will be weeded out. In future also two copies of the annual publications/serials will be added to the Parliament Library.

     9.19 The following procedure will be followed for retention/weeding out of Government publications/ books:—

(a) Government Publications

(i) For retention/weeding out of those publications which do not fall under any of the categories mentioned in para Nos. 9.17 and 9.18 of this chapter specific orders of the Divisional Officer/Joint Secretary shall be obtained in each case.

(ii) Annual Reports of State and Foreign Government Departments other than those mentioned at Serial Nos. (v) and (ii) of para 9.18 (II) & (III), respectively, if considered useful for reference purposes, may also be retained and the rest weeded out after taking written orders of the Divisional Officer/ Joint Secretary keeping strictly in view the guidelines.


38

(iii) Statement indicating the names of State and Foreign Government Departments (giving details of accession number, date of accession) whose annual reports have been weeded out, will be passed on to Processing Section so that all the Catalogue Cards are removed from the different card catalogue cabinets and also to make a note in the remarks column of the Accession Registers that the reports have been weeded out.

(iv) Those publication which are found to be unaccessioned/unclassified shall be listed and orders of the Divisional Officer/Joint Secretary be taken for their retention or weeding out from Parliament Library.

(b) Books

(i) The List of Books which are to be weeded out, will be put up to the Director/JS for orders periodically.

(ii) Separate registers will be maintained for weeded out books in (i) Hindi (ii) English (iii) Regional languages, and (iv) Pamphlets, and details about such books viz. author, title accession no. and call no. will be entered in the registers maintained for the said purpose.

(iii) Acquisition Section will also be intimated in writing of the books that have been weeded out, so that necessary entries are made in relevant records maintained by them.

(iv) All the Catalogue Cards of such books will be removed from different card cabinets catalogues in the Library. If only surplus copies of a particular book are to be weeded out, necessary entries will be affected in all the cards of that book. Similar corrections will be carried out in the data stored in the computer when computerized index is prepared.

(v) Such of the books in English and Hindi that are considered useful for Staff Library will be segregated and added there.

(vi) The remaining English and Hindi Books and regional languages books will be handed over to Acquisition Section, who will offer them to different educational institutions of New Delhi and ensure proper acknowledgement from them for keeping a proper record thereof. Unwanted publications will be sent to General Works Branch for sale as waste paper.

Debates, Publications and Reports etc. in Branches

     9.20 After every three years, the Branches will review the stock position of the Debates, Publications and Reports etc., with which they are concerned, and submit to their Branch Officers proposals for retention or weeding out the copies thereof. The proposals will clearly indicate the reasons for the action proposed and denote the number of copies to be retained or weeded out.

     9.21 Before weeding out the copies of the Debates, publications or reports, an enquiry will be made from the Parliament Library whether they could find any use for them or could take them over for disposal under extant Instructional Orders, etc. The copies which the Library wishes to take over, should be transferred to the Library; the others should be weeded out and disposed of according to the directions of the Branch Officer.

Other miscellaneous papers

     9.22 The following miscellaneous papers will be weeded out after the lapse of the period mentioned against them:—

(a) Parliamentary Bulletins and One year provided that at least 10 sets of each will be preserved

Circulars for Future reference in addition to the sets maintained by Branches

(b) List of M.Ps One year, provided that 10 copies of each list will be retained in the Distribution Branch for record

(c) Beat lists of Parliamentary Two years

papers circulated to M.Ps


39

(d) Peon books Two years

(e) Attendance Register Three years

(f) Casual Leave Register Three years

(g) Casual Leave Applications One year

(h) Typist's Diary One year

(i) Precedents Register As and when revised edition is brought out

(j) Used shorthand Note-Books One year

with Stenographers/PAs

(k) Inspection Reports (In all One year after the date of next inspection Branches except O&M Section)

(l) Leave Applications Three years

(m) Computer/Typewriter/Furniture Permanent

Register [General Works,

General Procurement, General

Store and Computer (HW &

SW) Management Branches]

     9.23 In regard to weeding out of records connected with accounts, the Branches concerned will observe the instructions contained in the Appendix 13 to Rule 289 of the General Financial Rules. However, some of the miscellaneous records relating to accounts will be weeded out as per the retention schedule given in Appendix XXIV.

     9.24 The weeding of all records will be supervised by the Head of Branch and the actual disposal done in his presence.

     9.25 Each Branch will submit to the Branch Officer a weekly report of the progress made in connection with the weeding out work till the work is over.


CHAPTER X


BRANCHES CONCERNED: COMMITTEE BRANCHES AND LARRDIS

SUBJECT: Maintenance of research material, summaries of books, reference material, bibliographies, etc. prepared by Committee Branches and LARRDIS and supply of copies thereof to Parliament Library.

     10.1 As soon as the Branch concerned has prepared a research note or bibliography of permanent value, has summarised an important book, or has supplied useful material to a Member of Parliament in response to an enquiry received from him, one copy of each such work will be put up to the Divisional Officer administrative incharge of the Branch with a view to deciding whether the material should be placed in the Library for reference.

     10.2 Before sending the material to the Parliament Library the Branch concerned will prepare index cards in triplicate for distribution as under:—

(i) One copy for Parliament Library (to be supplied, along with material);

(ii) One copy for the concerned Research Wing and/or Members' Reference Wing; and

(iii) One copy to be maintained by the Branch concerned in their card-index cabinet.

     10.3 The index card will clearly indicate the subject matter of the work, the name of the Branch (abbreviated), relevant file number and Index number allotted by the Library (vide para 10.5 below). The cards will be of the same size as are used in the Parliament Library.

     10.4 Each kind of work will be serially numbered and a list thereof maintained in the Branch. For distinguishing one kind of work from another the following symbols will be used:—

Bibliographies — "BIB" [Bib-1, Bib-2 etc.]

Research Notes — "N" [N-1, N-2, N-3 and so on]

Summaries of Books — "B" [B-1, B-2, B-3 and so on]

References — "R" [R-1, R-2, etc.]

     10.5 The Library will give classification number to each work received from the Branches and inscribe the same number on the index cards received from the Branches. They will also open special folders/Cabinets for the maintenance of the material.

     10.6 In regard to reference work which is already contained in recorded files or bound volumes etc., index cards giving references to the files will be prepared and supplied to the Library.


40


CHAPTER XI

REVIEW OF PERFORMANCE, PUNCTUALITY, REGULATION OF ATTENDANCE AND

OBSERVANCE OF PROPER OFFICE DECORUM

     11.1 To ensure accountability and objectivity in the functioning of the Branches of the Secretariat, the following instructions have been laid down:—

     (a) Each Branch (other than a Committee Branch) will formulate an annual plan generally in the month of January while a Committee Branch will formulate its plan soon after selection of subjects for examination. The plan will cover only important items of work. Routine matters will not be mentioned in the plan. The plan will reflect the manner and time-frame of action with month-wise break up of targets to be achieved in respect of each of the progammes and projects to be undertaken/subjects to be examined by the Branch during the ensuing year. The plan will also reflect available manpower in the Branch and its productive utilisation throughout the year. For House related Branches emphasis will be laid on programmes for inter-session periods.

     (b) The action plan will identify the levels of accountability, both direct and supervisory, for implementation of each action point. The plan will be discussed and finalised at the meeting to be held by the Joint Secretary (JS) concerned with the Branch and copy of the approved plan sent to Secretary-General (SG).

     (c) Monthly performance report on the items of annual plan indicating details of targeted and actual performance and comments on variance, if any, will be submitted by each branch to JS concerned. The report should preferably be written by Heads of Branches and unnecessary embellishments should be avoided. Slippages in targets and problems, if any, in execution will be discussed and corrective measures be taken in the monthly review of performance by the JS concerned.

     (d) A quarterly appraisal report with reference to planned targets with comments of the JS concerned will be placed before SG for perusal.

     (e) As soon as monthly performance report/quarterly appraisal report is received back from JS/SG, the Head of the Branch will circulate it to the concerned Assistants/Clerks, etc. for taking necessary action in the light of observations made by the officers.

     (f) Model formats for quarterly/monthly review of performance of Committee Branches are given in the Appendices XXV & XXVI. Other Branches may, if considered necessary, modify the same or devise new formats to suit their special requirements.

Punctuality

     11.2 Except in Branches where shift system of duty or different duty hours are observed due to exigency of work, the normal office hours in Lok Sabha Secretariat are from 10.00 a.m. to 6.00 p.m. with half-an-hour lunch break from 1.00 p.m. to 1.30 p.m. In case of Staff Car Drivers/Van Drivers etc. the normal reporting time for duty would be 9.30 a.m. to 6.30 p.m. or as detailed by the Branch concerned. Every member of the staff is expected to be in his/her seat during prescribed office hours. 10 minutes' grace time may be allowed in respect of arrival time to cover any unforeseen contingencies. Such late coming (within the grace time) may be condoned unless it becomes a matter of frequent recurrence.

Attendance Register

     11.3 Every Branch including Reporters' Branch and Interpreters' Branch shall maintain an Attendance Register. Every member of the staff [including non-supervisory Gazetted Officers in the Branch(es)] shall enter his/her initials clearly alongwith the time of arrival. The register shall be initialled at the bottom by the Head of the Branch/Supervisory Officer (at the Branch level). The Head of the Branch will put X mark in the attendance column against those staff members who have not arrived at the prescribed time mentioned at Para 11.2 above. Thereafter the Attendance Register has to be sent to Branch Officer 10 minutes after the prescribed arrival

41


42

time. After the attendance register is initialled by the Branch Officer, the same shall be sent to be concerned Divisional Officer at 10.15 a.m. Any person arriving thereafter shall record his/her initials in the Divisional Officer's room.

11.4 Divisional Officers should be very particular in scrutinising the Attendance Registers.

     11.5 Before leaving the office, every member of the staff [including non-supervisory Gazetted Officers in the Branches] shall enter his/her initials clearly along with the time of departure.

     11.6 The attendance of the staff attached to the Chairmen of the Parliamentary Committees will be controlled by the Divisional Officers concerned, under overall guidance of respective Chairmen.

     11.7. The attendance of the staff attached to Officers will be controlled by the respective Officers. If these Officers happen to be absent for more than one week, the staff attached to such officers will report to the Officer in-charge of Administration Branch-I.

Recording of non-attendance

     11.8 The following abbreviations will be used by the Head of Branch/Supervisory Officer (at the Branch level) to denote the reasons for non-attendance:—

(i) Compensatory Holiday CH

(ii) Casual Leave CL

(iii) Restricted Holiday RH

(iv) Absent A*

(v) Earned Leave EL

(vi) Commuted Leave Comm. L

(vii) Maternity Leave ML

(viii) Paternity Leave PL

(ix) Special Casual Leave SCL

(x) Half Pay Leave HPL

(xi) Extra Ordinary Leave EOL

(xii) Study Leave SL

(xiii) Leave Not Due LND

     *[This entry should be made in pencil and when leave of any kind is sanctioned appropriate abbreviation may be used].

Late attendance

     11.9 Half-a-day's casual leave should be debited to the casual leave account of the person for each late attendance but late attendance upto an hour, but on not more than two occasions in a month, may be condoned by the Supervisory Officer, at his discretion, if this is due to unavoidable reasons. Suitable disciplinary action may be taken against the official concerned, if he/she is taking leave without prior permission except under compelling circumstances.

     11.10 The case of an employee who leaves office early without permission before the time for closing of office should also be treated like late attendance and half-a-day's casual leave should be debited to the CL account for each of such early departure from office.


43

Observance of proper decorum

     11.11 No official should play games like cricket, volleyball, cards etc. in the precincts of Parliament House Estate.

11.12 All Officers/staff shall refrain from smoking in the Parliament House Estate.

     11.13 All Officers/staff are directed to follow these instructions and observe strict punctuality and also office decorum. Any Officer/staff found violating these instructions will be liable to disciplinary action.

     11.14 Divisional Officers shall ensure that the instructions contained in this Chapter are complied with by the Officers/staff in letter and spirit. Failure in enforcing compliance of these instructions will be considered as a reflection on the supervisory abilities of the Officers concerned.

Duties of the supporting Staff

     11.15 The general duties of Messengers/Daftries/Record Sorters attached to Officers/Branches of Lok Sabha Secretariat will be as under:

(i) To see that office rooms are cleaned and opened in time; to switch off lights, fans, air-conditioners and heaters, etc., before leaving the office and to get the rooms locked by the Farrashes.

(ii) To clean and dust books, files and papers, etc., kept in the Rooms/Branches.

(iii) To arrange Papers, Orders, Reports, Bulletins, Bills, Lists, Printed Forms, Circulars, etc., in folders/ files and almirahs, etc., and to maintain sets thereof in the Branches.

(iv) To deliver files and papers, etc. to Officers and Branches and also to deliver/collect files to/from Courier Service.

(v) To distribute the receipts, papers and files to the staff concerned within the Branch.

(vi) To stitch files, etc., for recording.

(vii) To fetch Books and Publications etc. for Parliament Library and return them after use.

(viii) To bring stationery from General Store Branch.

(ix) To deliver urgent dak or other papers to Ministries/Officers, whenever called upon to do so.

(x) To wear uniform during the office hours.

(xi) To provide drinking water, etc.

(xii) To attend telephone calls in the absence of the Officers/P.As, etc.

     11.16 The above may be supplemented/modified by the Chief/Head of Service as necessary keeping in view the nature of work in a particular Branch, under the advice of Administration Branch-I/O&M Section.

     11.17 In respect of Other Group 'D' employees, the Concerned Branch will with the approval of Divisional Officer and under the advice of Administration Branch-I/O&M Section, lay down their duties and responsibilities.

     11.18 The Instructional and Office Orders affecting Group 'D' employees will be bilingual (English & Hindi) and the same will invariably be communicated to them by the Head of the Branch. The Head of the Branch will keep a record of acknowledgement by taking signature of each Group 'D' employee that such order has been explained to him/her and that he/she understands fully what his/her duties and responsibilities are under such order.

     11.19 Disciplinary action should be taken in case of not performing the prescribed duties and responsibilities properly and also for conduct against the terms and spirit of the Instructional and Office Orders that are issued pertaining to Group 'D' employees.


CHAPTER XII

INSTRUCTIONS/GUIDELINES FOR UPDATING THE PROCEDURE & PRACTICE VOLUMES OF

BRANCHES, DRAFTING & CIRCULATION OF ORDERS AND WRITING OF THE

CONFIDENTIAL REPORTS

Procedure & Practice Volumes of the Branches of Lok Sabha Secretariat

     12.1 The Procedure and Practice volume(s) of a Branch describes the procedure for disposal of work in the Branch. The following procedure/instructions will be followed by the Branches for regularly updating the Procedure and Practice volume(s).

     12.2 The source of authority (i.e. Instructional Order, Office Order Pt.-I, Routine Order, Rule of Decision of Hon'ble Speaker or Secretary-General, etc.) will be quoted within brackets at the end of each para of the Procedure and Practice volume(s).

     12.3 All procedural instructions will, in the first instance, be issued in the form of Instructional Orders, Routine Orders, etc. as hithertofore. Branches will, at regular intervals, review all Instructional Orders, Office Orders-Part I, Routine Orders, recommendation contained in O&M Reports on the working of the Branches as also other decisions on the Branch files (which have not been incorporated in Instructional Orders, etc.).

     12.4 In case the review of Instructional Orders, etc. reveals that the procedure as laid down in the Branch Procedure and Practice volume(s) has undergone considerable change necessitating wholesale amendments, a revised edition of the volume(s) will be brought out in the light of modified practices. Where, however, the extent of amendments is not considerable, correction slips (similar in form to those issued for the Manuals on Procedure and Constitution) will be issued to the Branch volume(s).

     12.5 The question whether a revised edition of the Branch volume(s) should be brought out or only correction slips need to be issued will be decided at the level of the Divisional Officer. The drafts of revised edition/ correction slips will be shown to O&M Section before issue in order to ensure uniformity of style. To avoid waste of paper and labour, the number of copies of the revised edition/correction slips will be restricted to the barest minimum and a decision regarding number of copies to be prepared/issued will be taken at the level of the Divisional Officer. In cases where a limited number of copies will suffice, the material will be got cyclostyled and circulated. In other cases, the material will be sent to Rotaprint Section/Printing Section for printing on rotaprint machines/getting the same printed from Government of India Press, Minto Road, New Delhi.

12.6 Two copies of the printed/cyclostyled revised edition/correction slips will be supplied to O&M Section.

     12.7 On amalgamation of certain Branches as a result of reorganisation, steps will be taken to bring out consolidated edition of Procedure and Practice volume(s) for the Branches as so constituted.

12.8 Similarly, new branches will urgently bring out Procedure and Practice volume(s).

     12.9 Some of the other points for observance while bringing out new/revised edition of Procedure and Practice volume(s) are enumerated below:

(a) Each major subject dealt within the Branch will constitue a separate chapter e.g. Government Bills, Resolutions, Budget, Debates, etc.

(b) Within the chapter, each successive stage of disposal will be given in a separate para.

(c) The paras will be arranged in a logical and coherent way so as to give a running description of the disposal of each stage in the order it takes place in practice.

44


45

(d) There will be no repetitions and overlapping of material. If it is required to repeat a provision for clarification of the context, a cross-reference will be given.

(e) The Procedure and Practice volume will speak as an order e.g.—

"All Notices of amendments will be time-and-date-stamped."

"The name of the Bill will be entered in the Parliamentary Bill Register.", etc.

(f) A distinct chapter will be included in the Procedure and Practice volume detailing out the various registers that are required to be maintained in the Branch.

(g) The chapters will be numbered in Roman Style in the contents page and at the top of each chapter.

(h) The paragraphs in a chapter will be numbered with chapter number in arabic numbers proceeding the number of paragraph such as 1.2 (for para 2 of the chapter I), 2.2 (for para 2 of chapter II), 3.2 (for para 2 of chapter III), etc.

(i) Cross reference to Para Nos. will be given in the appendices.

(j) In respect of Branches which have supportive documents like Instructional Orders, Officer Orders, Routine Orders, Model Drafts, etc. the Procedure and Practice volume will be published in two volumes:

(i) Volume I A narrative on Procedure and Practice.

(ii) Volume II A compilation of all supportive documents like Instructional Orders, Routine Orders, Model Drafts and other connecting directives, if any. Other Branches will have only one volume of Procedure and Practice volume.

(k) The preface of Procedure and Practice volume in respect of branches possessing supportive documents will be as per Appendix XXVII. The preface in respect of other branches will be as per Appendix XVIII.

(l) Model Drafts which have subsequently been improved further will be replaced by the latest drafts on the subject.

     12.10 The Assistants and Clerks will always study carefully the relevant chapters/paras/portions of Procedure and Practice volume(s) before submitting cases in order to ensure that they are not offending against the provisions contained in Procedure and Practice volume(s). The Assistants and Clerks will from time to time refresh their memory be glancing through the relevant portions of Branch Procedure and Practice volume(s). The Head of the Branch and Branch Officer will also go through the Branch Procedure and Practice volume(s) in order to see that the work in the Branch is progressing on scientific lines.

Classification, drafting, serial numbering, multigraphing and circulation of orders 12.11 Orders have been classified into the following four categories:—

(I) Instructional Orders;

(II) Routine Orders;

(III) Office Orders-Part I; and

(IV) Office Orders-Part II.


46

     12.12 The following procedure will, henceforth, be followed in regard to classification, drafting, serial numbering, multigraphing and circulation of orders.

I. INSTRUCTIONAL ORDERS

     12.13 Instructional Orders will contain instructions on procedural matters in this Secretariat and will be issued only when such matters pertain to all or a majority of Branches.

     12.14 The following instructions should be carefully borne in mind by the members of the staff in order to ensure that the language, expression, terminology, etc. of the Instructional Orders drafted by them are uniform and identical:

(a) Every Instructional Order will be given a brief but appropriate subject in order to show at a glance its contents. The name of the Branch from which the Instructional Order emanates will be indicated at the top within brackets below the words 'LOK SABHA SECRETARIAT'.

(b) As far as possible, the opening paragraph will be so worded as to serve as a preamble or brief introductory note.

(c) Each paragraph will deal with one point only. There will not be long paragraphs covering more than one point. When there are different aspects of the same point, the substantive paragraph will be divided into sub-paragraphs and, if necessary, those sub-paragraphs will again be split up, e.g.,

(i) The substantive paragraphs will be numbered as 1,2,3, etc.

(ii) The sub-paragraphs will be numbered as (a), (b), (c), and so on.

(iii) Further sub-divisions will be shown as (i), (ii), (iii), etc.

(d) The numbering of paragraphs will be continuous, even though the Instructional Order is divided into Parts, Chapters or Sections. If, for example, the first chapter or section ends in paragraph 4, the second chapter or section will begin with paragraph 5 and so on.

    Parts and Chapters will be marked as I, II, III, etc. and Sections will be shown as Section-1. Each part or section will be given a heading.

(e) The language will be simple, straight-forward and never involved. Long and complex sentences will be avoided as far as possible. Obscurity, expression in a round-about manner and use of rhetorics will be avoided.

(f) Brevity coupled with clarity of expression will be observed in drafting. When a paragraph deals with establishment matters or Rules governing the service conditions, etc., the language and expression to be used in the Instructional Order will be identical with the authoritative Rules and Regulations so that confusion in their interpretation may be avoided. Repetition, circumlocution and vague expression will always be avoided.

    Similarly, in matters dealing with Legislation, etc. the authoritative language of the Rules and Parliamentary Publications will be used.

(g) There will be an even flow in the language of the Instructional Order with proper sequence. Each succeeding paragraph will be a continuation of the preceding paragraph and there will not be any paragraph in between without proper relevancy with the main point on which those paragraphs are written.

    Each Section or Chapter will be self-contained incorporating all the aspects of the matter delineated therein.

(h) As far as possible, illustrations of registers, drafts, statements, charts, forms, etc. will be given in the form of Appendices in order to elucidate the description within the body of the Instructional Orders. They will not be incorporated within the body of the orders.


47

The Appendices will be shown as I, II, III and so on.

(i) The following terminology will be used in all cases:—

Lok Sabha Chamber

Rajya Sabha Chamber

Central Hall (previously known as Central Chamber/Constitution Hall)

Director(Translation) previously known as Principal Chief Editor

Director (Reporting) previously known as Principal Chief Parliamentary Reporter

Parliament ("the" not to be added before)

Parliament House

Parliament Library

Speaker.

(j) Abbreviations will always be avoided except in well-known cases, e.g. "M.P". The names of Branches will be given in full. The designation of Officers will also be quoted in full.

(k) In all cases where any authority or rule or code or reference is quoted, an indication of the source will be given.

(l) While drafting an Instructional Order on a particular subject a careful study of all previous Office Orders and Instructional Orders on that subject or related to it will be made in order to see that no contradiction of provisions or procedure already laid down is made in the draft.

(m) In all cases where any portion of the draft Instructional Order relates to procedure or to work pertaining to a Branch other than the sponsoring one, such drafts will always be shown to that Branch so as to ensure that the correct procedure is laid down in the Instructional Order.

(n) In the Appendix to the Instructional Orders the paragraph of the Instructional Orders to which it relates will invariably be quoted. Moreover, a brief description of the form, etc., shown in the Appendix will be given, where necessary., e.g.

APPENDIX I

(See paragraph ——— of I.O. No. ——)

     12.15 The numbering and issue of Instructional Orders will be centralised in the Distribution Branch. The drafting of the Instructional Orders will be the function of the Branches concerned who should have these Orders approved by the Divisional Officer concerned or the Joint Secretary, as the case may be, and after approval, pass on a fair copy of the Instructional Order to the Distribution Branch for serial numbering and issue along with a forwarding note.

     12.16 For the purpose of central numbering of Instructional Orders, the Distribution Branch will keep a separate register. The Assistant concerned in the Distribution Branch will see that uniformity of form and expression is maintained in all the Instructional Orders and that overlapping of orders is avoided.

     12.17 Instructional Orders will issue over the signature of an Officer not below the rank of Divisional Officer.

12.18 Copies of Instructional Orders will be supplied to all Officers and Branches.

     12.19 At the end of each Calendar Year, the Distribution Branch will circulate consolidated list of cancelled Instructional Orders.


48

     12.20 While issuing amendments/supplementary instructions to an existing Instructional Order, the following instructions will be followed by the Branches:—

(a) A distinctive number shall be assigned to each Instructional Order even if the Instructional Order purports to amend or be supplementary to an existing Instructional Order.

(b) The subject of the amendments/supplementary instructions to an Instructional Order will be the same as that of the original Instructional Order.

(c) A descriptive sub-heading to the main subject heading shall be given to the amendment/supplementary instructions to an existing Instructional Order, where necessary.

     12.21 The form of the amending Instructional Order or the supplementary Instructional Order shall be as indicated in Appendix XXIX to the Manual.

II. ROUTINE ORDERS

     12.22 Routine Orders will contain instructions on procedure or matters of detail when these pertain to one or a few Branches but not all Branches.

     12.23 Routine Orders, will be drafted and serial numbered by the concerned Branches themselves. As a Routine Order is meant for one or a few Branches only, copies thereof need not be circulated to all Officers and Branches. A few copies will be typed by the Branch concerned for their own use. If, however, a large number of copies are required for use within the Branch, or it is considered necessary to supply copies of a particular Routine Order to some other Branches also, a fair copy of such order will be prepared by the Branch concerned and sent to the Distribution Branch for multigraphing/risographing.

     Name of Branches and Officers to whom copies of the Routine Orders are to be supplied will invariably be indicated. The Distribution Branch will circulate copies of the Routine Orders to such Branches and Officers.

12.24 Copies of the Routine Orders should be distributed only as follows:—

(a) To the Head of the Branch issuing the Routine Order.

(b) To the Branch Officer concerned.

(c) To the Divisional Officer concerned.

(d) To Joint Secretary concerned for information.

(e) To any other Branch/Officer affected by the R.O.

(f) One copy to O&M Section.

III. OFFICE ORDERS-PART I

     12.25 Office Orders-Part I will relate to matters of General Administration, Discipline and other orders of general application but not relating to procedural matters.

     12.26 Other instructions in respect of drafting, serial numbering, multigraphing, circulation and issue of amendments of Office Orders-Part I will be the same as laid down (in respect of Instructional Orders) in Para Nos. 12.15-12.21 of this Instructional Order.

IV. OFFICE ORDERS-PART II

     12.27 Office Orders-Part II will relate to staff matters, such as pay, appointments, postings, transfers, promotions, holidays, leave, etc.

     12.28 The drafting of Office Orders-Part II will be the responsibility of the Administration Branches I & II. However, the numbering thereof will be centralised in Administration Branch-I. A fair copy of Office Order-Part II will be passed on by the Administration Branch-I/Administration Branch-II to the Distribution


49

Branch for multigraphing and circulation. Copies of such orders will not be circulated to all Officers and Branches, but only to those who are concerned as follows:—

(a) Office Orders-Part II announcing the results of Departmental Examinations

(i) To those Branches where the successful candidates are working.

(ii) As many copies as there are persons to Administration Branch-I for keeping a copy each in their personal files.

(iii) One copy each to Secretary/Principal Secretary to HS, Addl. Director (PSS)/Joint Director (PSS) to SG, PS to Additional Secretary and/or Joint Secretary (incharge of Administration), Divisional Officer and Branch Officer (incharge of Administration), and Divisional Officer and Branch Officer (incharge of Joint Recruitment Cell).

(iv) One copy to Joint Recruitment Cell.

(v) One copy to O&M Section.

(b) Office Order Part-II about transfers of the staff from one Branch to another

(i) To those Branches as are affected by these transfers as also Branch and Divisional Officers thereof.

(ii) As many copies as there are persons to Administration Branch-I and Administration Branch-II for keeping a copy each in their Personal Files and Service Books.

(iii) One copy to Administration Branch-I for keeping in the files containing orders of transfers.

(iv) One copy each to Secretary/Principal Secretary to HS, Addl. Director (PSS)/Joint Director (PSS) to SG , PS to Additional Secretary and/or Joint Secretary (incharge of Administration), and Divisional Officer and Branch Officer (incharge of Administration).

(v) One copy to O&M Section.

(c) Office Orders-Part II containing orders of appointment confirmation and promotion

(i) To the persons concerned through the Head of the Branch.

(ii) One copy to the B&P Branch to draw Salary Bills.

(iii) As many copies as the number of persons affected by these orders to Administration Branch-I and Administration Branch-II for keeping a copy each in their Personal Files and Service Books.

(iv) One copy to Pay & Accounts Officer, Lok Sabha.

(v) One copy to DGACR Concurrent Audit (P) Branch.

(vi) One copy each to Secretary/Principal Secretary to HS, Addl. Director (PSS)/Joint Director (PSS) to SG , PS to Additional Secretary and/or Joint Secretary (incharge of Administration), Divisional Officer and Branch Officer (incharge of Administration).

(vii) One copy to O&M Section.

(d) Office Orders-Part II regarding quasi-permanent appointments

(i) To the persons concerned through the Head of the Branch.

(ii) One copy to the B&P Branch to draw Salary Bills.

(iii) As many copies as the number of persons affected by these orders to Administration Branch-I and Administration Branch-II for keeping a copy each in their Personal Files and Service Books, respectively.

(iv) To DGACR Concurrent Audit (P) Branch.


50

(v) One copy each to Secretary/Principal Secretary to HS, Addl. Director (PSS)/Joint Director (PSS) to SG, PS to Additional Secretary and/or Joint Secretary (incharge of Administration), and Divisional Officer and Branch Officer (incharge of Administration).

(vi) One copy to O&M Section.

(e) Office Orders-Part II regarding leave and increments to non-gazetted officers of Lok Sabha

Secretariat

         (i) To B&P Branch (10 copies).

(ii) To PA (NGA) Branch (5 copies).

(iii) To Administration Branch-I (2 copies).

(iv) Administration Branch-II (10 copies)

(v) To persons concerned through the Head of the Branch.

         (vi) One copy to O&M Section.

Writing of the Confidential Reports

    While writing the Confidential Reports of Officers, the following instructions/guidelines shall be observed/ followed by the Reporting/Reviewing officers:

    12.29 The Confidential Report is an important document. It provides the basic and vital inputs for assessing the performance of an officer and for his/her further advancement in his/her career. The officer reported upon, the Reporting Officer and the Reviewing officer should, therefore undertake the duty of filling out the form with a high sense of responsibility.

    12.30 Performance appraisal through confidential report should be used as a tool for human resource development. Reporting Officers should realise that the objective is to develop an officer so that he/she realises his/her true potential. It is not meant to be a fault-finding process but a developmental one. In order to assess correctly, the Reviewing Officer should keep himself well informed and well acquainted with the work and qualities of the officers and staff working under him as well as their character, performance and ability. The Reporting Officer and the Reviewing officer should not shy away from reporting shortcomings in performance, attitudes or overall personality of the officer reported upon. Such entries should however be based on established facts and not on mere suspicion.

    12.31 Adverse remarks in the Confidential Reports should be made with care and responsibility. The Reporting/Reviewing Officer should make every effort to bring to the notice of the officers and staff working under him, their defects, as and when noticed, with a view to remedying them. Ordinarily, it is only when efforts so made prove of little avail, that adverse remarks should be recorded in the Confidential Reports. While doing so, the Reporting/Reviewing Officer should also indicate the efforts made by him to remedy to defects noticed by him and the result.

    12.32 The confidential reports of officers and staff of this Secretariat shall be obtained annually for the period ending 30th June. However, whenever any Reporting Officer or the officer reported upon is transferred to another post in the Secretariat or to another Branch/Section during the interval between the two annual reports, interim reports shall be obtained only when the Reporting Officer or the officer reported upon has at least 3 (three) months experience on which to base the report. Where an officer to be reported upon has taken Earned Leave for a period of more than 15 days during the period of report, the total period spent on leave shall be deducted from the total period spent on any post, for purposes of computing the period of 3 months which is relevant for writing of entries in the ACR. Leave taken for short term duration need not be treated as relevant for the porpose.

     12.33 The items should be filled with due care and attention and after devoting adequate time. Any attempt to fill the report in a casual or superficial manner will be easily discernible to the higher authorities.

    12.34 Every answer shall be given in a narrative form. The space provided indicates the desired length of the answer. Words and phrases should be chosen carefully and should accurately reflect the intention of the


51

officer recording the answer. Please use unambiguous and simple language. Please do not use omnibus expressions like 'outstanding', 'very good', 'good', 'average', 'below average' while giving your comments against any of the attributes.

     12.35 The Reporting Officer shall, in the begining of the year, assign targets to each of the officers with respect to whom he is required to report upon for completion during the year. In the case of an officer taking up a new post in the course of the reporting year, such targets/goals shall be set at the time of assumption of the new charge. The targets set should clearly be known and understood by both the officers concerned.

     12.36 Although performance appraisal is an annual exercise (June ending), in order that it may be a tool for human resource development, the Reporting Officer should at regular intervals review the performance and take necessary corrective steps by way of advice, etc.

     12.37 It should be the endeavour of each appraiser to present the truest possible picture of the appraisee's performance in regard to his/her performance, conduct, behaviour and potential.

12.38 Assessment shoud be confined to the appraisee’s performance during the period of report only.

     12.39 An officer should not be graded ‘Outstanding’ unless exceptional qualities and performance have been noticed. Grounds for giving such a grading should be clearly brought out.

     12.40 Every warning/reprimand issued in writing need not automatically find place in the Confidential Report. Only cases in which despite warning, the officer reported upon has not improved, appropriate mention of such warning may be made in the Confidential Reports.

12.41 The following procedure should be followed in filling up the column relating to integrity:—

(a) If the officer’s integrity is beyond doubt, it may be so stated.

(b) If there is any doubt or suspicion, the column should be left blank and action taken as under—

(i) A separate secret note should be recorded and followed up. A copy of the note should also be sent together with the Confidential Report to the next superior officer who will ensure that the follow-up action is taken expeditiously. Where it is not possible either to certify the integrity or to record the secret note, the Reporting Officer should state either that he had not watched the Officer’s work for sufficient time to form a definite judgement or that he had heard nothing against the officer, as the case may be.

(ii) If, as a result of the follow-up action, the doubts or suspicions are cleared, the officer’s integrity should be certified and an entry made accordingly in the Confidential Report.

(iii) If the doubts or suspicions are confirmed, this fact should also be recorded and duly communicated to the officer concerned.

(iv) If as a result of the follow-up action the doubts or suspicions are neither cleared nor confirmed, the officer’s conduct should be watched for a further period and thereafter action taken as indicated at (ii) and (iii) above.

(v) When a Reporting Officer cannot in fairness to himself and to the officer reported upon, either certify integrity or make an adverse entry or even be in possession of any information which would enable him to make a secret report to the next superior officer, i.e., when the Reporting Officer has not had occasion to watch his work closely or when the officer reported upon has worked under the Reporting Officer only for a brief period or has been on long leave etc. the Reporting officer should make an entry in the integrity column to the effect that he has not watched the work of officer reported upon for sufficient time to be able to make any definite remark or that he has heard nothing against the integrity of officer reported upon, as the case may be. This would be factual statement to which there can be no objection. But it is necessary that a superior officer should make every effort to form a definite judgement about the integrity of those working under him, as early as possible, so that he may be able to make a positive statement.


APPENDIX I

(See para 2.11 of Chapter II)

File Register

Standard Heading No.

Main Subject

File No.

Vol. No.

Subject

   Date of Commencement

Date of transfer

of file to other

Branch

Date of

recording with

classification

of records

1

2

3

4

5

6










































































































































































55


53


APPENDICES


APPENDIX II

(See para 2.16 of Chapter II)

Table of Contents of File Register

Subject

Standard

Sub-

Page No.


Heading No.

Heading No. in Register

Administrative matters relating to O&M Section

1

-

1—3

Analysis of output of staff with reference to the norms fixed

2

-

4

Annual Administrative Report—Compilation of

by O&M Section

(i) Preparation of write up relating to O&M Section

3

-

3/1

5-6

5

(ii) Co-ordination, editing and consolidation

of Annual Administrative Report of LSS


3/2

6

Assessment of staff requirements and job

analysis of Branches by O&M Section

(i) Staff requirements and job-analysis of P.N.O.

4

-

4/1

7—15

7

(ii) Staff requirements and job-analysis of


4/2

8

Legislative Branch-I

(iii) Staff requirements and job-analysis of Table Office


4/3

9

Economy Measures

5

-

16

Inspections

6

-

17—25

(i) Inspection of E&T Service


6/1

17

(ii) Inspection of LARRDIS


6/2

18

(iii) Inspection of Printing & Publications Service


6/3

19

Issue of orders of general applicability

7

-

26

Procedure and Practice volumes of Branches

8

-

27



56


APPENDIX III

(See para 2.43 of Chapter II)

Indication Slips

c?????1T ????~cq

LOK SABHA SECRETARIAT

TM

Branch

HALF-AN-HOUR DISCUSSION


QUESTION BRANCH


QUESTION BRANCH


57


ACTION THIS DAY

???????????????


????????????????

LOK SABHA SECRETARIAT

?????

——————————Branch


MOST IMMEDIATE

??????????


????????????????

LOK SABHA SECRETARIAT

??????Branch




AT ONCE

?????

????????????????

LOK SABHA SECRETARIAT

?????

——————————Branch

58


APPENDIX IV

(See para 3.26 of Chapter III)

L A F E A S

Channel of Submission of the Administration/House Keeping Service/ Protocol Branches

(i.e. Administration Branch-I, Administration Branch-II, DMCC Unit,

Confidential Cell, O & M Section, B&P Branch, MS Branch,

MSA Branch and Conference Branch etc.)

Secretary-General

Secretary/Additional Secretary

Joint Secretary

Director/Additional Director

Deputy Secretary

Under Secretary

Executive/Protocol Officer

Sr. Executive/Protocol Assistant/Executive/Protocol Assistant/Sr. Clerk & Jr. Clerk

59


APPENDIX V

(See para 3.26 of Chapter III)

L A F E A S

Channel of Submission of the DRSCs, Financial and Other Committees*

(Files related to draft report, minutes and list of points)

Secretary-General

Secretary/Additional Secretary

Joint Secretary

Director/Additional Director

Deputy Secretary

Under Secretary

Committee Officer/Senior Committee Assistant/Committee Assistant

*Other Committee Branches viz. Empowerment of Women, SCTC, Petitions, MPLADS, CB-I, CB-II and Joint Committee on Security


60


APPENDIX VI

(See para 3.26 of Chapter III)

L A F E A S

Channel of Submission of the DRSCs, Financial and Other Committees*

(Files related to administrative matters such as application for

leave, medical reimbursement, vehicular advance etc.)

Secretary-General

Secretary/Additional Secretary

Joint Secretary

Director/Additional Director

Deputy Secretary

Under Secretary

Committee Officer

Senior Committee Assistant/Committee Assistant/Senior Clerk/Junior Clerk

*Other Committee Branches viz. Empowerment of Women, SCTC, Petitions, MPLADS, CB-I, CB-II and Joint Committee on Security

61


APPENDIX VII

(See para 3.26 of Chapter III)

L A F E A S

Channel of Submission of the House related Branches (LB-I & II, Table Office, PNO)

Secretary-General

Secretary/Additional Secretary

Joint Secretary

Director/Additional Director

Deputy Secretary

Under Secretary

Legislative/Executive Officer

Senior Legislative/Executive Assistant/Legislative/Executive Assistant/Senior Clerk/Junior Clerk


62


APPENDIX VIII

(See para 3.26 of Chapter III)

L A R R DI S

Channel of Submission

Secretary-General

Secretary/Additional Secretary

Joint Secretary

Director/Additional Director

Joint Director

Deputy Director

Research/Reference Officer

Research/Reference Assistant/Senior Library Assistant/Junior Library Assistant


63


APPENDIX IX

[See para 4.9(5) of Chapter IV]

Register of Risographing of Secret Documents

(Distribution Branch)

Sl. No.

No. & Date of document

No. of pages of document

Risographed at (time)

Total number of copies made

No. of smudged copies

Disposal of smudged copies

No. of

copies

issued

No. of copies supplied to dealing Branch

Signature of Head of Distribution Branch

Signature of Head of dealing Branch (in token of receipt of spare copies and document)

1

2

3

4

5

6

7

8

9

10

11

























































APPENDIX X

[See Para 4.9 (6) of Chapter IV]

Register of Spare Copies of Secret Documents

ling Section Branch

No. & date of document and subject

Date of receipt

No. of pages in one copy of document

Branch/Office from which received

No. of copies received

Signature of Head of Branch

Date of issue

No. of

copies

issued

To whom issued

Signature of the officer to whom delivered or the No. & date of the communication with which sent

Balance

Signature of Head of Branch

1

2

3

4

5

6

7

8

9

10

11

12






























































APPENDIX XI

(See Para 5.10 of Chapter V)

Form for sending files to record room

BRANCH FORM NO.

Sl. No.

Subject

File No.

No. of

Volumes

Classification of files

Period for which to be retained

Date of destruction in the case of files classified

'C'

Reference

No. of

entries

made in

Receipt

Register

1

2

3

4

5

6

7

8











































































































































































































66


APPENDIX XII

(See Para 6.10 Chapter VI)

Specimen for printing official receipts, issues and unofficial memoranda Official receipts and issues and unofficial memoranda

(i) Letter from the Chief Secretary to the Government of Maharashtra No. 790 dated the 3rd February, 2009.

(ii) Office Memorandum from the Ministry of Home Affairs No. 790, dated the 3rd February, 2009. and not

(i) Letter No. 790, dated the 3rd February, 2009.

From

The Chief Secretary to the Government of Maharashtra.

To

The Secretary-General, Lok Sabha.

(ii) Office Memorandum No. 790 dated the 3rd February, 2009.

From

The Ministry of Home Affairs.

To

The Secretary-General, Lok Sabha.

Enclosures to letters

    From the Chief Secretary to the Government of Maharashtra to the Secretary-General, Lok Sabha No. 790, dated the 3rd February, 2009.

Demi-Official Correspondence

    Demi-official letter from Shri , Secretary, Ministry of Home Affairs, and Not 'Sir', 'Dear Sir', 'My dear', 'I have etc.', 'Yours faithfully', 'Yours sincerely' etc.

Headings to Correspondence

    Only the first page of the Correspondence in proceedings will have a heading in the following form printed on it:—

Lok Sabha Secretariat

(Branch)

File No. Serial No.

(Here give a brief subject)

Here give a more comprehensive subject.


67


APPENDIX XIII

(See Para 7.1 of Chapter VII)

Precedent Register

Decision or ruling in brief File No./LSS

Debate dated

c

68


APPENDIX XIV

(See Para 7.2 of Chapter VII)

Specimens of Entries for Precedent Register

Specimen No. 1

MOTION: Mover of motion permitted to move another motion in

substitution of the original motion:

    [On the 19th February, 1958, the Prime Minister and Minister of External Affairs and Finance moved a motion that the report of the Commission of Inquiry into the affairs of the Life Insurance Corporation of India be taken into consideration.

    After speaking on the motion the Prime Minister moved another motion in substitution of the original motion. Objection was raised that the substitute motion could not be moved unless the original motion had been withdrawn by leave of the House.

     The Speaker ruled that under Rule 342 the mover could move a substitute motion and withdrawal of original motion was not necessary. The substitute motion was then placed before the House by the Speaker.]

[L.S. Deb. (II), 19-2-1958, c.

]

Specimen No. 2

MEMBERS OF SELECT COMMITTEE MAY BE PERMITTED IN SPECIAL CASES TO SPEAK

ON THE MOTION TO REFER THE BILL TO SELECT COMMITTEE:

    [On the 14th August, 1958, in reply to a query, the Speaker observed that in the interest of proper debate even those members whose names were proposed for the Select Committee on the Banaras Hindu University (Amendment) Bill, would be called upon to take part in the discussion on the motion for reference to Select Committee.].

[L.S. Deb. (II), 14-8-1958, c. ....]


69


APPENDIX XV

(See Para 7.3 of Chapter VIIa)

Specimen of Table of contents for Precedent Register

Page(s) Serial No.

of

Precedent

ABSENCE OF MEMBERS

ADAPTATION OF RULES

OF PROCEDURE, ETC.

ADDRESS

ADJOURNMENT MOTIONS

General

Admissible

lnadmissible

Notice of

AFFIRMATION OR OATH

ALLOCATION OF BUSINESS

OF THE LOK SABHA

AMENDMENTS

General

Inadmissible

Notice of


APPENDIX XVI

[See Para 7.11 (a) of Chapter VII]

Model entry for the Manual of Business and Procedure in Lok Sabha

LEGISLATIVE BRANCH


Page 103, Rule 79, after Note IX, insert—

X. When a Bill is withdrawn on the ground that President's recommendation

required for its introduction has not been obtained, and is re-introduced with the necessary recommendation, the notices of amendments given by Members in respect of the Bill as originally introduced are treated as having been given in respect of the Bill as re-introduced.

The Indian Stamp (Amendment) Bill, 1958 was introduced on the 26 April, 1958, with the President's recommendation under article 117(1). Three lists of amendments to the Bill were circulated on the 28th and 29th April, 1958. The Bill was withdrawn on the 30th April, 1958, as President's recommendation was also required under Article 274(1). The Bill was re-introduced on the 2nd May, 1958, with the necessary recommendations of the President. The notices of amendments circulated on the 28th and 29th April, 1958, were treated as having been given in respect of the Bill as re-introduced, and members were informed accordingly through a paragraph in Bulletin Part II, dated the 2nd May, 1958.

[F. No. 1286-L/58]

[CS. No. 73, dated 15-7-58.]


71


APPENDIX XVII

[See Para 7.11 (a) of Chapter VII]

Model entry for the Manual on Articles of the Constitution

LOK SABHA SECRETARIAT

COMMITTEE BRANCH I

Entry for the Manual on Constitution


V. The Speaker is not subject to jurisdiction of any court for failure to exercise his power to regulate the proceedings of House*.

(F. No. 822-CI/58, Vol. I)

    *On the 6th August, 1956, the Orissa High Court on a petition to initiate contempt proceedings against the Speaker of the Orissa Legislative Assembly for failure on his part to intervene and prevent Shri Nabakrishna Choudhury, the then Chief Minister, from casting reflections, in the Assembly on the Orissa High Court, Observed:

    "The mere omission of the Speaker to draw the attention of the Chief Minister to the provisions of article 211 of the Constitution would not make him liable for contempt, even if it be assumed that the speech of the Chief Minister constitutes contempt of Court. In any case clause (2) of article 212 makes it absolutely clear that the Speaker is not subject to the jurisdiction of any court in respect of the exercise by him (or the failure to exercise by him) of his power to regulate the proceedings in the Assembly."


72


APPENDIX XVIII

[See Para 7.11 (b) of Chapter VII]

Model entry for Select Documents

P.A.C. BRANCH

Public Accounts Committee—Consideration of the Appropriation Accounts of Himachal Pradesh

Administration for the years 1954-55, 1955-56 and 1956-57 (pre-reorganisation)

Finance Accounts for 1955-56 and Audit Report thereon—Holding of

sittings at Simla.

     The Public Accounts Committee of 1958-59 held their first sitting on the 14th May, 1958 to consider their future programme of work, etc. The Committee decided that they should cover the bulk of their work in hand before the commencement of the next session of Lok Sabha in August. Almost all Members of the Committee were of the view that the Appropriation Accounts and Audit Reports for three years relating to the Government of Himachal Pradesh might be taken up for examination in the first instance. They expressed the view that it would be more convenient and economical if they sat for the purpose from the 16th June, 1958 onwards for 5 days at Simla. The following reasons were adduced by the Members for holding the sittings at Simla:—

(i) The Headquarters of the Himachal Pradesh Government is located at Simla; it would be convenient

for them to lay hands on the relevant records at short notice and it would obviate the necessity of the Himachal Pradesh Government Officials moving to Delhi for attending the sittings.

(ii) The Accountant-General, Punjab, who deals with the Himachal Government's Accounts has also his Headquarters at Simla. It would, therefore, not be necessary for him and his staff to come down to Delhi for the purpose.

(iii) No extra expenditure would be involved as Members would draw the same D.A. as at Delhi except the T.A. for Railway journey which would not be much.

     This view was supported by the Deputy Comptroller and Auditor-General who was present at the above sitting of the Committee.

     2. The Chairman of the Committee wrote to the Speaker on the 15th May, 1958, apprising him about the decision of the Committee and asking for his permission to hold the sittings of the Committee at Simla as enjoined under Rule 267 of the 'Rules of Procedure and Conduct of Business in Lok Sabha'. The Speaker granted the necessary permission on the 23rd May, 1958.

     3. A Camp Office of the Lok Sabha Secretariat was set up at Gorton Castle, Simla (where the office of the A.G., Punjab is located) for functioning as the Secretariat of the Committee and the staff consisting of an Under Secretary, 1 Committee Officer, 3 Reporters, 2 Assistants and 1 Messenger comprised this Secretariat.

[F. No. 9(1)-PAC/58]


73


APPENDIX XIX

[See Para 7.11 (c) of Chapter-VII]

Model entry for Manual on the Directions by the Speaker

     119. A Minister desiring to make a statement in the House under rule 372 shall intimate in advance the date on which the statement is proposed to be made and also send a copy of the statement to the Lok Sabha Secretariat for the information of the Speaker.

     I. Intimation about a statement to be made by a Minister should be given to the Lok Sabha Secretariat at least one day in advance so that the item may be duly included in the List of Business and the statement made in the House at the appropriate time.

[LSS O.M. No. 257-T(I)/58, dt. 7-3-1958 to all Ministries and

F. No. 257-T(I)/58, Vol. XVII.]

     II. The item regarding the statement is ordinarily included in the List of Business for the date intimated by the Minister.

[LSS O.M. No. 257-T(I)/56, dt. 30-10-1956 to all Ministries and

F. No. 257-T(I)/56, Vol. XII]

     III. Ministries are also required to forward two copies of the statement in advance to this Secretariat for the information of the Speaker.

[LSS O.M. No. 257-T(I)/56, dt. 30-10-1956 to all the Ministries and

F. No. 257-T(I)/56, Vol. XII]

     IV. Even if the statement to be made by the Minister is secret in nature, a copy thereof should be supplied confidentially to the Speaker in advance.

[F. No. 257-T(I)/58, Vol. XX]

     V. Where, however, a Minister proposes to make a statement ex tempore (which is done generally in urgent cases at short notice) the requirement of supply of advance copy of the statement is not insisted upon. In such cases the item is also not included in the List of Business if notice of the Minister's intention to make the statement is received too late.

           (i) On the 23rd March, 1959, the Prime Minister made a statement ex tempore about the situation in Tibet, copies of the statement were not supplied in advance. The item had not been included in the List of Business as the intimation was received from Prime Minister only on the 23rd March, 1959.

           (ii) On the 3rd April, 1959, the Prime Minister made a statement ex tempore about crossing of the border and arrival in India of Dalai Lama of Tibet, copies of the statement were not supplied. The item was also not included in the List of Business as the Prime Minister informed about his intention to make the statement on the 3rd April, 1959 only.

74


75

     VI. Copies of the statement received from the Ministry are treated as confidential till the statement has actually been made in the House.

     VII. It is open to Ministers to alter the text of the statement before it is actually made in the House but as far as possible copies of the revised statement should be supplied before the statement is made.


APPENDIX XX

[See Para 7.11(d) of Chapter VII]

Model Entry for Journal of Parliamentary Information on Procedural Matters

LOK SABHA

Circulation of copies of Bills to Members before Introduction

    A recent development in the procedure regarding introduction of Bills in Lok Sabha is the decision that copies of Bills should be circulated to Members at least two days before the day on which they are proposed to be introduced. Appropriation Bills, Finance Bills and Secret Bills are, however, exempted from this requirement. This is provided by the following Direction from the Speaker:

"No Bill shall be included for introduction in the list of business for a day until after copies thereof have been made available for the use of Members for at least two days before the day on which the Bill is proposed to be introduced:

Provided that Appropriation Bills, Finance Bills, and such Secret Bills as are not put down in the list of business may be introduced without prior circulation of copies to members:

Provided further that in other cases, where the Minister desires that the Bills may be introduced earlier than two days after the circulation of copies or even without prior circulation, he shall give full reasons in a memorandum for the consideration of the Speaker explaining as to why the Bill is sought to be introduced without making available to Members copies thereof in advance, and if the Speaker gives permission the Bill shall be included in the list of business for the day on which the Bill is proposed to be introduced."

Before this procedure came into effect copies of Bills were circulated to members only after introduction.


76


APPENDIX XXI

(See Para 8.4 of Chapter VIII)

Specimen of Summary for Departmental Decisions

MAIN HEADING: JOINT COMMITTEE

SUBJECT: Inadmissibility of premature and conditional minutes of dissent.

Catch-words: Joint Committee—Minutes of dissent.

SUMMARY:—

     The Joint Committee on the Constitution (Fourth Amendment) Bill, concluded its deliberation at the morning session on the 30th March, 1955 and considered the draft report at the afternoon session of the same day.

     2. But a member of the Joint Committee from Rajya Sabha Shri Surendra Mohanty sent his minute of dissent to the office on 29th March (on the previous day), adding the condition that paras 3 and 4 of his minute of dissent should be omitted if industrial and commercial property were specifically enumerated in Clause 3 and a ceiling fixed on the agricultural property, in Clauses 3(c) and (d) of the Bill.

     3. Pandit Thakur Das Bhargava, who was in the Chair when the report of the Committee was presented to the House, observed that a decision from the Speaker on the matter should be taken as to whether this Minute should be appended to the Report or not.

     4. The case was submitted to the Speaker, who decided on the 2nd April, 1955, that owing to the fact that the minute of dissent was premature and conditional it could not be treated as part of the report. The member was informed accordingly.

     5. In order, however, to give this matter the force of a Direction from the Speaker the following was approved by the Speaker (Shri G.V. Mavalankar) on the 5th July, 1955:—

" A minute of Dissent shall be given only after the Draft Report has been considered and adopted by the Committee and it shall not be conditional in any respect."

[F. No. 49-CII/55, Vol. II, 36-CII/55, Vol. IV]


77


APPENDIX XXII

[See Paras 9.5. & 9.7 of Chapter IX]

Form for Review and Weeding of Records

Sl. No.

1

File No.

2

Instructions of reviewing authority

3


INSTRUCTIONS

1. The departmental record room will prepare this list in triplicate by completing columns 1 and 2 only.

2. The Section responsible for review will sign one copy of the list and return it to the departmental

record room by way of acknowledgement, retaining the other two copies.

3. After review, the section concerned will complete column 3 of the list in both the copies by indicating:

(a) the word 'keep' in the case of the files proposed to be retained indefinitely.

(b) the letter 'W' in the case of files desired to be weeded out; and

(c) the precise year of weeding, in the case of class 'C' files proposed to be retained for a further period not exceeding 10 years from the date of their closing.

4. Both the copies of the list should accompany the files returned to the departmental record room

which will sign one copy and return it to the section concerned by way of acknowledgement.

78


APPENDIX XXIII

[See Para 9.10 Chapter IX]

No. of Copies of Government Bills/Private Members' Bills and other documents to be retained

in the record room

(a) Government Bills

No. of copies


English

Hindi

(i) 

Bills as introduced

10

5

(ii) 

Papers containing opinions on Bills,

Precis of opinions on Bills and

10

5


Extracts from Debates



(iii) 

Reports of Select or Joint Committees and Bills as reported by Select or Joint

10

5


Committees



(iv) 

Bills as passed by the Council of States

10

5

(v) 

Bills as passed by Parliament

10

5

(vi) 

Bills which have lapsed or have been withdrawn or negatived

10

5


(b) Private Members' Bills No. of copies

English Hindi

(i) Private Members' Bills as introduced in 10 5 Lok Sabha

(ii) Private Members' Bills as introduced in 10 5 Rajya Sabha

(iii) Papers containing opinions on Private 10 5

Members' Bills, Precis of opinion on

Bills and Extracts from Debates

(iv) Reports of Select or Joint Committees 10 5

on Private Members' Bills and Bills as

reported by Select or Joint Committees

(v) Private Members' Bills which have lapsed 10 5 or have been withdrawn or negatived

(c) Miscellaneous papers No. of copies

(i) The Five Year Plan including the Summary All copies

(ii) Draft Report of the Planning Commission 15 copies and yearly Progress Reports of Planning

(iii) Budget sets including papers relating to 5 copies Supplementary Demands for Grants etc.

79


80

(c) Miscellaneous papers No. of copies

(iv) Annual Administrative Reports and 5 copies Summaries of such Reports

(v) Various reports on which there are 5 copies

discussions in the House i.e., the

Report on the working of the

Preventive Detention Act, the Report

of the Commissioner(s) for Scheduled

Castes/Scheduled Tribes etc.


APPENDIX XXIV

[See Para 9.23 of Chapter IX]

Weeding out of Records Relating to Accounts

     The following records relating to accounts will be weeded out after the lapse of the period mentioned against each:

(i) Contingent Bills 3 Years

(ii) TA/LTC/Medical Bills of Staff 3 Years

(iii) Salary/TA/DA & Medical Bills of MPs 5 Years

(iv) Paid Cheques* 5 Years

(v) Expenditure Control Registers and Objection Books 3 Years

(vi) Schedules/Slips of H.B. Advance, O.C. Adv., Fan 3 Years

Adv., Festival Adv., Scooter/Car Adv., GPF Adv.

and C.G.E.I.S.@

(vii) Audit Registers of Class IV staff 5 Years

* Bank Scroll & List of Payments to be retained.

@ Salary Bills to be retained.


APPENDIX XXV

[Vide Para 11.1(f) of Chapter XI]

Monthly Review of Performance of Committee Branches

COMMITTEE BRANCH

(A) Items of work allocated to Shri/Smt.

1. 

2. 

3. 

4. 

5. 

(B) Achievements/shortfalls:

Targets

Achievements

Shortfall

Remarks/Remedial

measures


























Name of Reporting Assistant/Officer to be given.


APPENDIX XXVI

[Vide Para 11.1(f) of Chapter XI]

Quarterly Review of Performance of Committee Branches

COMMITTEE BRANCH

A.

1. Ministries under the

Jurisdiction of the Committee

(Wherever applicable)

2. No. of subjects selected

3. Subjects taken up in

consultation with Chairman

4. No. of Action Taken reports

proposed to be taken up

5. No. of Bills referred to the

Committee (wherever

Applicable)

B.

1. Staff strength

2. Distribution of subjects

amongst Reporting Assistants/

Officers

C.

Quarterly targets/plan of work

Achievements

Shortfall, if any, with brief reasons




83


APPENDIX XXVII

[See Para 12.9 (k) of Chapter XII]

PREFACE

This publication explains the procedure to be followed by Branch in regard to work

done by the Branch. It is in two volumes.

     2. Volume-I is a narrative on procedure and practice which is based on — (i) Rules, Instructional Orders, Office Orders, Routine Orders; (ii) Orders passed on the files from time to time; and (iii) Other incidental directives, which have been cited at the appropriate places.

     3. Volume-II is a compilation of extracts from all the relevant Rules, Instructional Orders, Office Orders, Routine Orders, Model Drafts and other connected directives for ready reference.

     4. This publication is for departmental use only. No portion of it shall be quoted or cited in any correspondence with any outside individual/organisation.

NEW DELHI; P.D.T. ACHARY,

25 July, 2009 Secretary-General.

Sravana 3, 1931 (Saka)


84


APPENDIX XXVIII

[See Para 12.9 (k) of Chapter XII]

PREFACE

This publication explains the procedure to be followed by Branch in regard to work

done by the Branch.

    2. This publication is for departmental use only. No portion of it shall be quoted or cited in any correspondence with any outside individual/organisation.

NEW DELHI; P.D.T. ACHARY,

25 July, 2009 Secretary-General.

Sravana 3, 1931 (Saka)


85


APPENDIX XXIX

[See Para 12.21 of Chapter XII]

LOK SABHA SECRETARIAT

( Branch)

Parliament House Annexe,

New Delhi-110 001.

25th July, 2009

Sravana 3, 1931 (Saka)

I. INSTRUCTIONAL ORDER NO.

SUBJECT: Indian Parliamentary Group.

The following amendments are made to Instructional Order No.

dated the :—

For the heading "Addresses by Group" appearing on page , the

following shall be substituted:

"Addresses by distinguished foreign visitors under the auspices of the Indian Parliamentary Group—ancillary arrangements connected therewith."

    2. Substitute the following paragraphs for the existing paragraph Nos. 31 to 42 renumbering paragraph 43 as 47:—

    "31. Generally, receptions and/or parties to the Distinguished Visitors from foreign countries e.g. Prime Minister, Ministers and persons of international repute and their Addresses to Members of Parliament are arranged by the Department of Parliamentary Affairs, but when such functions are held under the auspices of the Indian Parliamentary Group, all ancillary arrangements connected therewith will be initiated by this Secretariat.

32. * * * * *"

Name & Designation of the Issuing Officer

(F.No. )


II. INSTRUCTIONAL ORDER NO.


SUBJECT: Procedure for convening meetings of the House Committee and the Accommodation Sub-Committee.

In continuation of the instructions contained in Instructional Order No. dated

the July, 2009 the following subsidiary/supplementary instructions are issued for

guidance of the Branches:—

1. 

2. 

3. 

Name & Designation of the Issuing Officer

(F.No. )


GMGIPMRND—4017LS—14-11-2009.


University of Pennsylvania

Doctoral Dissertation Manual 

Instructions for Preparing and

Filing the Dissertation


Revised October 2009

Approved by the Graduate Council of the Faculties and the Council of Graduate Deans


2

Table of Contents Page

Introduction 3

I. Preparing the Manuscript

a. Overall Appearance

b. Organization of the Manuscript

c. Margins 4

d. Line Spacing

e. Font

f. Pagination

g. Abstract

h. Title Page 6

i. Paper

j. Mixed Media

k. Copyright Notice

l. Footnotes/Endnotes 8

m. Bibliography

II. Accompanying Forms

a. Approvals

b. ProQuest Publishing Agreement

c. Using ProQuest for Copyright Registration

d. Use of Copyrighted, Previously Published or Co?authored Material

e. Patents 9

f. Request for Restriction of Publication

g. Survey of Earned Doctorates

h. PhD Exit Survey

III. Submission Procedures

a. Appointment at the Graduate Division

b. Dissertation Deposit Fee 10

c. Electronic Filing of the Dissertation

d. Hard Copy Filing

e. Open Access Publishing by ProQuest

IV. Checklist… 11

V. Transcripts and Diplomas

Appendix 1. Restriction of Publication Request Form 12

Appendix 2. Official Names of the Graduate Groups 13

Appendix 3. Certification of Dissertation 15

Appendix 4. Tips for Creating a PDF with Embedded Fonts 16

Appendix 5. Alumni Request for Posting to Scholarly Commons 17

Appendix 6. Sample Title Pages 19


3

Introduction: Writing and filing the dissertation are among the final steps leading to the award of the PhD. At the University of Pennsylvania, the student presents the dissertation publicly, defends it, and, with the approval of the dissertation committee, submits the final manuscript to the Graduate Division. The University’s publication requirement is satisfied when the Graduate Division submits the dissertation to ProQuest for unlimited distribution and to the University Library for shelving in the permanent collection. (See Section III.f. for permission for temporary delay of publication.)

The University’s requirements regarding the format for the dissertation are documented in this manual. Follow the instructions carefully and, should further questions arise, consult the Graduation Coordinator of the SAS Graduate Division Office (Suite 322A, 3401 Walnut Street/6228; phone 898-7444).

I. Preparing the Manuscript

a. Overall Appearance: The manuscript must be clear and legible, free of errors, and attractive in appearance. All pages must be printed single-sided. The manuscript should be submitted unbound in an envelope or box.

b. Organization of the Manuscript: 

Preliminary Pages, in the following order:

Title Page

Copyright Notice (optional)

Dedication (optional)

Acknowledgment (optional)

Abstract

Table of Contents

List of Tables

List of Illustrations

Preface (optional)

Main Text

Appendices (optional)

Bibliography (optional)

Index (optional except for graduate groups in Anthropology, Architecture, City & Regional Planning, Earth & Environmental Science, East Asian Languages & Civilization, Folklore & Folklife, Near Eastern Languages & Civilization, South Asia Regional Studies)


c. Margins:

Left-hand margin: 1.5 inches

Right-hand margin: 1 inch

Top and bottom margins: 1 inch

All text, including footnotes and page numbers, must be inside these boundaries. Nothing may appear in the margin area.

d. Line spacing: The text of the dissertation is double-spaced, except for footnotes, long quoted passages, and lists of tables and figures, which are single-spaced.

e. Font: Any non-italic 10- or 12- point font may be used. Headings may be larger. For enhanced screen readability, use Arial (10pt), Courier New (10pt), Georgia (11pt), Times New Roman (12 pt), or Verdana (10pt) font. For footnotes, figures, citations, charts and graphs, a font of 8 point or larger may be used. Italic type may be used for quotations, words in a foreign language, occasional emphasis, or book titles.

f. Pagination: Every page in the dissertation has a number, except for the Title Page and the copyright notice (if desired).

For the preliminary pages – dedication (optional), acknowledgements (optional), abstract, table of contents, list of tables, graphs, illustrations and preface (optional) – use small Roman numerals (i, ii, iii, iv, v, ...). These may be placed either at the top or the bottom of the page. The title page is counted as page i, and the copyright page (if there is one) as page ii, but do not print the page numbers on either of these two pages (e.g., in a dissertation with a copyright notice, the first numbered page is iii; in a dissertation without a copyright notice, the first numbered page is ii).

For the text, use Arabic numbers (1, 2, 3, 4, 5, ...) starting with page 1 (the first page of the text itself). These may be placed either at the top or the bottom of the page. If you use footnotes, it is recommended that you print page numbers at the page top. Do not print page numbers, footnotes, or anything else in the margins. Each page must be consecutively numbered, including tables, graphs, illustrations, and bibliography/index (if they are included); letter suffixes (such as 10a, 10b, ...) are not allowed.

Check pagination carefully. Do not include blank pages. All pages must have a page number and be accounted for.

g. Abstract: The Abstract is a condensed summary of the dissertation, not to exceed 350 words. All words count towards the total. The abstract, which is normally a single paragraph, consists of four parts: the statement of the problem; the procedure and methods used to investigate the problem; the results of the investigation; and the conclusions.


5

The abstract is published online by ProQuest in “Dissertation Abstracts International,” providing information to interested readers about the general content of the dissertation.

The abstract is double?spaced. Below the word "ABSTRACT" (in upper case), list the title of the dissertation (upper case), your name, and your dissertation supervisor's name.


ABSTRACT

PRACTICAL ADVICE: THE EFFECT OF "POOR RICHARD'S ALMANAC”

ON DOMESTIC LIFE IN THE AMERICAN COLONIES

Author's Name

Supervisor's Name

The same elements that transformed the political structure of the British colonies in North America, first through revolution and later through a new constitution, were also eager to

promote a similar transformation of social relations among Americans. But at the time of the Revolution, there was no widespread consensus on how Americans should act towards one another nor an official aristocracy whose manners were expected to set the tone for the larger society. Benjamin Franklin's "Poor Richard's Almanack" sought to fill this void through the means of pithy homilies issued by an "ordinary" American of the day. Examining its text, one finds both significant guidance concerning interpersonal relations in a society which officially had shed the formal class distinctions of the mother country, practical suggestions for new arrivals in the cities, and useful tips for those working the land in a country that was still largely unsettled. The book also served as the original model for a uniquely American literary form, the self-help book, which in the United States soon took the place of custom and clan as a means of providing the average individual with clues to proper behavior. Through this book, Franklin had an influence on everyday American manners that was every bit as significant as his influence on American scientific and intellectual life.


6

h. Title Page: The Title Page must contain the TITLE (in upper case); the author's name; the graduate group name (see Appendix 2 for official names); the year the degree is being granted; the name, faculty title (rank and department), and signature of the dissertation advisor (or co-advisors, if there is more than one); and the name, faculty title (rank and department), and signature of the graduate group chair. The names and faculty titles (rank and department)of the Dissertation Committee members should be listed on the Title Page (no signatures). If you want to use a format for your name that differs from the current name in the Penn In Touch System (e.g., a married name, or a full middle name rather than a middle initial), contact the Registrar’s Office and provide the necessary documentation to make that change. NOTE: The Library copy of the manuscript must be signed but no signatures are required in the pdf submitted electronically to Scholarly Commons.

The title page is understood to be page “i” for counting purposes, but no page number should be printed on the title page.

Students in the Graduate Group in Managerial Science and Applied Economics (Wharton Doctoral) also include their field of specialization above the graduate group name. See sample Title Pages in Appendix 5 (page 18).

i. Paper: The dissertation is printed single-sided on acid-free white paper, 20 lb. bond (or heavier stock), 8 1/2 x 11 inches in size.

j. Mixed Media: Supplementary files of essential supporting material may be submitted on a CD or DVD along with the core manuscript. Such “compound dissertations” will be distributed by ProQuest only as hardbound publications, with the CD or DVD sleeve on the inside of the binding. ProQuest guidelines must be satisfied, and any 3rd party software licenses necessary for the use, viewing and publication of the content on the CD or DVD must be provided.

In the case of electronic submission of the dissertation (see Section III.c.), supplementary digital files may be filed as attachments.

k. Copyright Notice: The dissertation submitted as a part of the requirements for a degree is the property of the University. However, the author of the dissertation owns and retains the copyright in the dissertation, without further registration formalities. If you choose to include a copyright notice in your manuscript, place it on a separate page immediately following the Title Page. Display the title of the dissertation, then the word “COPYRIGHT” (or symbol ©), the year of first publication, and your name. Do not print a page number on this page; it is understood to be page "ii" for counting purposes.


7

Sample

Title of the Dissertation

COPYRIGHT

Year of Publication

Author's Full Legal Name


You may elect to register the copyright in the dissertation with the U.S. Copyright Office, although this is not legally required. There are legal advantages, however, to obtaining a federal copyright registration. (See, generally, http://www.copyright.gov/circs/circ1.pdf.) You may apply to register your copyright yourself for $35 (see the Library of Congress website at http://www.copyright.gov) or you can authorize ProQuest to act as your agent and apply to register your copyright as part of the publishing process for $65 (see “Using ProQuest for Copyright Registration” below, section II.c.). Questions regarding copyright may be directed to Shawn Martin at Van Pelt Library, <repository@pobox.upenn.edu>


8

l. Footnotes/Endnotes: Notes can appear as footnotes below the text on a page, or as endnotes at the end of each chapter. Footnotes at the bottom of a page may be numbered continuously throughout the dissertation. Endnotes at the end of a chapter are numbered separately for each chapter (i.e., the first note of each chapter will always be numbered 1). A bottom-of-the-page footnote must begin on the same page as the text to which it refers, but it may continue on a following page if necessary. Nothing may appear in the margin area.

m. Bibliography: This is an alphabetical listing of all references used. It may be a single alphabetical list by chapters or an alphabetical list by authors for subject and class of publications. Page numbers in the bibliography continue the pagination of the text; do not number the bibliography separately.

II. Accompanying Forms

a. Approvals: The Certification of Dissertation form with the graduate group Chairperson's signature, must accompany the dissertation (see sample in Appendix 3).

b. ProQuest Publishing Agreement (included in the "Publishing Your Dissertation" brochure) grants ProQuest the right to reproduce and disseminate your work. If the dissertation is submitted with a CD or DVD, the following must be included:

o a Reprint Permission Letter to authorize the reproduction and dissemination of any copyrighted materials owned by a third person that you use within the body of the work, and which does not constitute a fair use;

o a description of software or other applications used to create the CD or DVD, including a list of files and file sizes and copies of licenses for third party software needed to access, display, run, or print the dissertation;

o written permission to reproduce copyrighted images, video, graphics,

animation, data, and images of individuals, where the reproduction is not a fair use.

c. Using ProQuest for Copyright Registration: If you want to authorize ProQuest to file a copyright application on your behalf, pay the copyright fee of $65 to the University. See Section I.k. for information on registering copyright on your own.

d. Use of Copyrighted, Previously Published, or Coauthored material: University of Pennsylvania policy permits dissertations based on joint work with other researchers, provided that, in such cases, a unique and separate dissertation is presented by each degree candidate. The candidate must include a concise account of his or her contribution to the whole work. Authorship of a dissertation by more than one degree candidate is not allowed.

If someone other than you owns the copyright in content in your manuscript, including appendices, and your use of that content is not a fair use of that content, ProQuest requires submission of a permission letter from the copyright holder to use that content. Attach the permission letter to your ProQuest Publishing Agreement. For general guidance on what might constitute a fair use of copyrighted materials within your manuscript, see, e.g., the U.S. Copyright Office’s guidance at: http://www.copyright.gov/fls/fl102.html 


9

Questions regarding copyright may also be directed to Shawn Martin at Van Pelt Library, <repository@pobox.upenn.edu>

e. Patents: Any inventions that you discover as part of your research for your degree and disclosed as part of your dissertation, and any patent or other intellectual property rights arising therefrom, are governed by the policies of the University of Pennsylvania, including the Patent and Tangible Research Property Policies and Procedures  http://www.med.upenn.edu/postdoc/documents/patent.policy.02.22.05.pdf and the Policy Relating to Copyrights and Commitment of Effort for Faculty. For more information, please contact the University’s Center for Technology Transfer.

f. Request for Restriction of Publication:  Publication of the dissertation is a University requirement, satisfied by shelving in the University Library and submission to ProQuest. In cases where a paper is in press or a patent application is pending, you (or the University’s Center for Technology Transfer) may request a delay of one year in the dissemination of the dissertation by Proquest and the public release of the dissertation through its availability in the University Library. (Complete the form attached as Appendix 1.)

g. Survey of Earned Doctorates: Completion of this survey is a degree requirement. The Survey should be completed online. Instructions for completing the survey will be forwarded to degree candidates by the Graduate Division.

h. PhD Exit Survey: Instructions for completing the survey online will be forwarded to degree candidates by the Graduate Division.

III. Submission Procedures:

See the Graduation and Beyond web page for registration deadlines and procedures:

http://www.sas.upenn.edu/GAS/home/grad&beyond/graduation.html 

a. Appointment at Graduate Division: The original dissertation must be suitable for publication before it can be processed by the Graduate Division Office on behalf of the Graduate Council of the Faculties. Appointments will be made on a rolling basis, but all revisions must be made before the completed dissertation is delivered to the Graduate Division Office. The manuscript(s) should be submitted unbound in a box or sealable envelope.


10

b. Dissertation Deposit Fee: A fee of $100 is payable to Trustees of the U of Pennsylvania to cover cost of processing and publication. Copyright Registration by UMI, if desired, is an additional cost of $65.

c. Electronic Filing of the Dissertation: Beginning in fall 2009, a PDF file of the dissertation may be submitted online via the Scholarly Commons@Penn portal. Submit your manuscript to Scholarly Commons in advance of your appointment at the Graduate Division. See the instructions online at: http://www.library.upenn.edu/scholcomm/dissertations.html If possible, use your Penn email account.

In addition, a single hard copy of the manuscript, with original signatures on the Title Page, is required for the Library collection. Bring this copy to your appointment.

There are several advantages to electronic submission of a pdf. Once accepted through Scholarly Commons, the dissertation will almost immediately be available for full?text searching via the internet at no cost. (This provides the same access ProQuest offers for $160 through its “Open Access Publishing” option.)

NOTE: Students who want to publish the dissertation in Open Access format should discuss this plan in advance with their adviser to ensure there are no concerns relating to copyright.

Electronic submission of a PDF file ensures the highest quality reproduction of the manuscript, with color images preserved both online and in hardcopy. Supplementary digital files can be attached, if desired. Follow instructions for embedding links provided in Appendix 4 in order to preserve all formatting and punctuation.

The University will forward the PDF file of the dissertation to ProQuest.

d. Hard Copy Filing: If you are not submitting electronically, two copies of the manuscript are submitted to the Graduate Division. (Photocopies are not

acceptable, except for the signed Title Page in the second copy.) The Graduate Division sends one manuscript to ProQuest, where it is scanned to create a PDF file.

The other (with original signatures on the Title Page) is shelved as part of the Library’s permanent collection. The Certification of Dissertation form must be included with each manuscript.

e. To choose Open Access Publishing by ProQuest, pay ProQuest the $160 fee by Cashiers check or credit card. Note: If you are submitting a pdf of your dissertation electronically, it is unnecessary to purchase this feature through ProQuest; your dissertation will be published in open access through Scholarly Commons.


IV. Checklist

1. Is every page of the dissertation correctly numbered? Are all pages included?

2. Is a bibliography and/or index required by your graduate group?

3. Does the author's name, in full, appear on the title page, the abstract, and the contract form? Is the name the same on all three? Is it in the same format as in the Penn In Touch system?

4. Is the title on the abstract and on the ProQuest Form the same, word for word, as on the dissertation?

5. Does the supervisor's name (without the faculty title) appear on the abstract? Is the name typed accurately and in the proper place, so that it is clearly indicated that s/he is the supervisor and not the author?

6. Are all charts, graphs, and other special illustrative materials perfectly legible? Are they in the correct order and position? Are they paginated?

7. If you are submitting electronically, did you embed the fonts to preserve all the formatting? (see Appendix 4)

8. Do you want ProQuest to apply to register the copyright in the dissertation with the U.S. Copyright Office? If so, payment of the $65 copyright fee must be made to the

University prior to the deposit of the dissertation. Bring proof of payment (print screen or bring a receipt from the Cashiers Office) if payment is made less than 48 prior to your appointment at the Graduate Division.

9. Have you obtained permission from the copyright owner to include any significant portion of a third person’s copyrighted work which is not a fair use? If the dissertation is submitted with a CD or DVD, have the following been included: a description of software or other applications used, including a list of files and file sizes; copies of licenses for third party software necessary to access, display, run, or print the dissertation; and written permission to reproduce copyrighted images, video, graphics, animation, data, and images of individuals, which is not a fair use?

10. Have you obtained the Certification for Dissertation (Form 153) which certifies that the dissertation is in suitable form for publication, from your graduate group? This form must be submitted along with your completed dissertation.

11. Have you completed the Survey of Earned Doctorates, the PhD Exit form, and the ProQuest Publishing Agreement? These forms are emailed to all degree candidates by the Graduate Division and must be completed on line prior to your appointment. Bring verification of completion of the two surveys to your appointment. If you have questions regarding these forms, call 215-898-7444.

V. Transcripts and Diplomas

Information on ordering transcripts is online at http://www.upenn.edu/registrar/student-services/transcripts.html 

Diplomas are mailed to the address of record by the Office of the Secretary approximately two months after each degree cycle, (e.g., in early October for August graduates, in March for December graduates, and in July for May graduates).


Appendix 1 RESTRICTION OF PUBLICATION REQUEST FORM

Publication of the dissertation is a University requirement, satisfied by shelving in the University Library and submission to ProQuest. In cases where a paper is in press or a patent application is pending, you (or the University’s Center for Technology Transfer) may request a one?year delay in the dissemination of the dissertation by ProQuest and the public release of the dissertation through its availability in the University Library.

To request restriction of your dissertation, complete the following information and submit the form at the time you deposit your dissertation.

Restrict publication online until _______(insert mo/year) MAXIMUM OF 1 YEAR

Restrict shelving in the University Library _______(insert mo/year) MAXIMUM OF 1 YEAR

AUTHOR’S NAME

Signature of Author Date

Signature of Adviser Date




Appendix 2 Official Names of Graduate Groups

Africana Studies

Ancient History

Anthropology

Applied Mathematics and Computational Science

Architecture

Art and Archaeology of the Mediterranean World

Biochemistry and Molecular Biophysics

Bioengineering

Biology

Cell and Molecular Biology

Chemical and Biomolecular Engineering

Chemistry

City and Regional Planning

Classical Studies

Communication

Comparative Literature and Literary Theory

Computer and Information Science

Criminology

Demography

Earth and Environmental Science

East Asian Languages and Civilizations

Economics

Education

Electrical and Systems Engineering

English

Epidemiology and Biostatistics


Folklore and Folklife

Genomics and Computational Biology

Germanic Languages and Literatures

History of Art

History

History and Sociology of Science

Immunology

Linguistics

Managerial Science and Applied Economics

Accounting

Applied Economics

Ethics and Legal Studies

Finance

Health Care Management & Economics

Management

Marketing

Operations and Information Management

Statistics

Materials Science and Engineering

Mathematics

Mechanical Engineering and Applied Mechanics

Music

Near Eastern Languages and Civilizations

Neuroscience

Nursing

Pharmacological Sciences

Philosophy

Physics and Astronomy

Political Science


16

Psychology

Religious Studies

Romance Languages

Sociology

Social Welfare

South Asia Regional Studies

Appendix 3. CERTIFICATION OF DISSERTATION (153 Form)

Note: Your Graduate Group Coordinator will provide you with your official form.

SAMPLE

University of Pennsylvania

 Graduate Division of Arts and Sciences

CERTIFICATION OF DISSERTATION

Instructions for Administrator: One copy of this form, signed by the Graduate Group Chair, needs to be included with the copies of the Ph.D. dissertation deposited in the Graduate Division Office, 3401 Walnut Street, Suite 322A/6228

This is to certify that the accompanying copies of the doctoral dissertation of

(Student Name)

are completed and correct copies as approved by the Dissertation Committee and are in

satisfactory form for submission.

Signature of Graduate Group Chair Date


Appendix 4.

Tips for successfully creating a PDF with all fonts embedded that will display and print correctly

See online instructions online at

http://www.sas.upenn.edu/computing/help/students/dissertation?pdf


18

Appendix 5. ALUMNI REQUEST

TO POST THE DISSERTATION IN SCHOLARLY COMMONS

In August 2009, the University of Pennsylvania began accepting PhD dissertations in digital format through Scholarly Commons, an online library resource available worldwide to internet users. This form may be used by PhD recipients who graduated before the digital option was made available and who desire “Open Access” publication of their dissertation. Instructions for posting the dissertation are available in the Dissertation Manual, online at http://www.upenn.edu/provost/dissertationmanual. Once the digital file has been submitted to Scholarly Commons, it will be processed upon receipt of this form. Send the completed form to: Graduate Division of Arts and Sciences, 322A, 3401 Walnut St., Philadelphia, PA 19104. For questions, call: 215-898-7577.

I,

(Print name)

hereby request that my dissertation be posted online in Scholarly Commons.

I certify that the digital file I submit is identical to the original dissertation that I submitted to satisfy degree requirements.

The title of my dissertation is .

My degree was conferred on .

(e.g., May 2009)

Signed,


DATE


Contact information:

Email

Phone




Form created 10/23/09


19

Appendix 6. SAMPLE TITLE PAGES

PRACTICAL ADVICE: THE IMPACT OF “POOR RICHARD’S ALMANAC”

ON DOMESTIC HABITS IN THE AMERICAN COLONIES

Author’s Name

A DISSERTATION

in

History

Presented to the Faculties of the University of Pennsylvania

in

Partial Fulfillment of the Requirements for the

Degree of Doctor of Philosophy

2009

Supervisor of Dissertation Co-Supervisor (if applicable)

Signature Signature

Typed Name Typed Name

Title (e.g. Richard Poor, Associate Professor, History) Title

Graduate Group Chairperson

____Signature

Typed Name and Title (e.g. Eric Franklin, Professor of History)

Dissertation Committee (Typed Names and title; no signatures)


20

SAMPLE TITLE PAGE FOR WHARTON DOCTORAL

PRACTICAL ADVICE: THE IMPACT OF “POOR RICHARD’S ALMANAC”

ON DOMESTIC HABITS IN THE AMERICAN COLONIES

Author’s Name

A DISSERTATION

in

Management

For the Graduate Group in Managerial Science and Applied Economics

Presented to the Faculties of the University of Pennsylvania

in

Partial Fulfillment of the Requirements for the

Degree of Doctor of Philosophy

2009

Supervisor of Dissertation

Signature

Typed Name(s) and Title: (e.g. Richard Poor, Associate Professor, Management)

Graduate Group Chairperson

Signature

Typed Name and Title (e.g. Eric Bradlow, Professor of Marketing, Statistics, and Education)

Dissertation Committee (Typed Names and title; no signatures)


THE DEPARTMENT OF BIOMEDICAL ENGINEERING THE UNIVERSITY OF MEMPHIS


BME UNDERGRADUATE ADVISING GUIDE


WELCOME! And we are delighted you have selected Biomedical Engineering as your

undergraduate major! The Biomedical Engineering degree is a wonderful program that provides graduates with unique training, skills and knowledge for a wide range of career options in medical research, development, education and regulatory oversight, and in medical and legal professions.

This advising guide provides general information about the Biomedical Engineering discipline, and the biomedical engineering program at The University of Memphis. It also provides information about how to plan, with your advisor, a curriculum to help you achieve your career goals. This document is only a guide; official policies, as updated and or augmented may be found in The University of Memphis undergraduate bulletin (http://www.memphis.edu/ugcatalog/archive/index.php).

PROGRAM EDUCATIONAL OBJECTIVES*

The Biomedical Engineering Program at the University of Memphis aims to produce graduates who

demonstrate the following within the first few years after graduation. Graduates will:

* secure employment in biomedical or related health industries or institutions,

* pursue professional studies,

* pursue opportunities for professional growth, development, and service.

*( revised 23 Feb 2015)

STUDENT OUTCOMES 

The following outcomes describe what students are expected to know and be able to do by the time of

graduation from the Biomedical Engineering undergraduate program:

(a) an ability to apply knowledge of mathematics, science, and engineering

(b) an ability to design and conduct experiments, as well as to analyze and interpret data

(c) an ability to design a system, component, or process to meet desired needs within realistic constraints such as economic, environmental, social, political, ethical, health and safety, manufacturability, and sustainability

(d) an ability to function on multidisciplinary teams

(e) an ability to identify, formulate, and solve engineering problems

(f) an understanding of professional and ethical responsibility

(g) an ability to communicate effectively

(h) the broad education necessary to understand the impact of engineering solutions in a global, economic, environmental, and societal context

(i) a recognition of the need for, and an ability to engage in life-long learning

(j) a knowledge of contemporary issues

(k) an ability to use the techniques, skills, and modern engineering tools necessary for engineering practice.

In addition students will gain experience in:

* applying principles of engineering, biology, human physiology, chemistry, calculus-based physics, mathematics (through differential equations), and statistics;

* solving bio/biomedical engineering problems, including those associated with the interaction between living and non-living systems;

* analyzing, modeling, designing and realizing bio/biomedical engineering devices, systems, components, or processes; and

* making measurements on and interpreting data from living systems

2 Revised March 2015


BIOMEDICAL ENGINEERING OVERVIEW: 

* Biomedical engineering combines biology and medicine with engineering to advance healthcare through the creation of innovative devices and procedures.

* The field encompasses many diverse areas for improving human health such as

o implant devices and biomechanics

o tissue engineering/regeneration

o biosensors

o imaging

o electrophysiological technologies

which are used for the prevention, detection, diagnosis, and treatment of diseases such as osteoporosis,

cancer and heart arrhythmia.

* All these areas are multi-disciplinary in nature and present challenges to engineers, scientists and medical professionals.

* Students who complete an undergraduate program may immediately fill positions such as R&D design engineer, research and test engineer, regulatory specialist, quality control engineer, technical support engineer or sales engineer.

* Most students continue their education, earning masters, doctoral, medical, dental, or other professional degrees including law degrees (especially in intellectual property).

* See the American Institute of Medical & Biological Engineering webpages for additional information

BIOMEDICAL ENGINEERING – THE FUTURE IS BRIGHT!

* According to the U.S. Bureau of Labor Statistics, "employment of biomedical engineers is projected to grow 27 percent from 2012 to 2022, much faster than the average for all occupations.”

o The aging of the population and a growing focus on health issues will drive demand for better medical devices and equipment designed by biomedical engineers. Along with the demand for more sophisticated medical equipment and procedures, an increased concern for cost-effectiveness will boost demand for biomedical engineers, particularly in pharmaceutical, medical device manufacturing and related industries.

* A 2014 survey by the National Association of Colleges and Employers found the average starting salary for a person with a Bachelor's degree in Biomedical Engineering to be $43,200/year, with substantial increase in starting salary to $71,600/year with MS degree in Biomedical Engineering (Jan 2015)

* In 2014 the U.S. Bureau of Labor Statistics reported the median salary of all Biomedical Engineers employed in the U.S. to be $86,960 /year.

BIOMEDICAL ENGINEERING CURRICULUM AT THE UNIVERSITY OF MEMPHIS:

* Integrates physical, chemical, mathematical, and computational sciences and engineering with biology and medicine.

* Curriculum prepares graduates for professional practice and provides a foundation for lifelong learning and professional growth.

* Curriculum includes biomedical and engineering foundation courses as well as upper level biomedical, engineering and technical electives (as noted in the typical sequence below) to allow students, with advisor’s assistance, to focus1 their curriculum to areas of interest in the larger BME discipline and its supporting fields.

* Curriculum culminates in a senior design experience in which a medical device is designed, constructed and evaluated.

3 Revised March 2015


* Curriculum flow charts and degree sheets are on the departmental website under the “Current Student” link to help you in planning and tracking your progress in the program.

1Undergraduate students may focus* their degree program in:

1] Biomaterials/Tissue Engineering;

2] Bioelectrical Devices and Systems;

3] Biomechanics;

4] BioSensor Devices and Systems;

5] Pre-medical professional studies.

*(Note focus areas are not official and students may develop curriculum to overlap/integrate one or more focus areas for their particular career goals.)

FOCUS AREAS

Biomaterials/Tissue Engineering: This area provides the student with basic knowledge and background in understanding structure, organization, and properties necessary for materials to be used in medical devices and/or for engineering tissues, to replace, augment and/or restore function of damaged or diseased tissues. This area involves the development, selection, modification and evaluation of material structure and properties and interactions with host cells/tissues.

Bioelectric & BioSensors Devices and Systems: This area trains students in the basic concepts and principles for detecting, measuring and monitoring chemical and bio-electrical phenomena in cardiovascular, neurological and musculoskeletal tissues, diagnostic interpretation via signal processing and the application of electrical simulation for tissue function.

Biomechanics: The Biomechanics focus introduces and develops students’ skills for examining forces acting upon and within biological/physiological structures and the effects produced by such forces. This includes mechanical analyses of implant devices, hard (e.g. bones) and soft (e.g. ligaments, blood vessels, lung) tissues, and blood and air flow analyses.

Pre-medical studies: This area provides students with highly recommended courses, including organic chemistry, to prepare them for pursuing medical, dental and/or related health science programs. This program will require additional hours to meet pre-medical, biology, and chemistry course requirements above and beyond the 128 hours required for the BS BME degree. Additional information and resources are available at the Pre-Health Advising Center.

Second major: Second majors provide students the opportunity to expand and build their undergraduate degree program to meet career goals. Students may obtain a second major in physics. This program requires additional hours above and beyond the 128 required semester hours. Second majors may also be obtained in other engineering departments and options should be discussed with advisor.

Pre-law studies: Biomedical engineers are in unique position to help review and litigate many legal issues in the biotechnology sector, particularly with respect to Copyright and Intellectual Property statutes and laws. Students interested in using the BS degree in biomedical engineering to pursue a legal career are encouraged to talk with their advisor and to review information and resources at the Pre-law Advising Center. This program may require additional hours above and beyond the 128 required semester hours for degree.

4 Revised March 2015


Honors in Biomedical Engineering: Biomedical Engineering Honors Program is for highly motivated and high achieving students and provides special opportunities to advance their career and professional development. The program aims to develop student talents, interests, and abilities within the curriculum and to encourage independence and creativity. Students are eligible to apply for the honors program in biomedical engineering if they have and maintain a cumulative GPA of 3.4, with at least junior standing and have received approval for department honors committee. The honors program requires a minimum of 10 hours of honors course credit in upper division biomedical engineering courses, including both BIOM 4800 BME Honors Seminar (1hr) and BIOM 4999 BME Honors Thesis (3hrs). Students that complete the honors requirements and regular B.S.B.M.E. curriculum will be recognized at the commencement ceremony by having their degree awarded “With Honors in Biomedical Engineering.” Honors designation will also appear on student’s diploma and academic transcript.

REQUIREMENTS

Admission: Admission requirements to The University of Memphis are located on the University on-line

catalogue. Once admitted to the University, students will declare their major as Engineering-Pre-Biomedical.

To be admitted to the Biomedical Engineering major, the following courses must be completed with a minimum

grade of “C” in each: 

MATH 1910 – Calculus I

BIOM 1710 – Introduction to Biomedical Engineering/Biotechnology

(or EECE1202 – Electrical and Computer Engineering Concepts or MECH 1307 – Mechanical

Engineering Computing)

BIOM 1720 – Introduction to Biomedical Engineering Tools

PHYS 2110 – Physics I for Science and Engineering/Calculus-based

ENGL 1010 – English Composition

Students’ progress/completion of above listed requirements is monitored by the Herff College of Engineering (HCoE) Academic Advisor.

Graduation Requirements: Students must satisfy all university, college and departmental degree requirement for the degree desired. University requirements may be found on University on-line catalogue.

      All students are required to complete an approved curriculum of a minimum 128 semester hours. All students must obtain a minimum 2.0 grade point average on all work completed, and obtain a minimum grade of "C-" in all engineering, mathematics, physics, biology, and chemistry courses used to satisfy degree requirements. Engineering requires that a minimum of 30 hours of the hours required by the  University  for residency be taken as upper division hours in courses in the Herff College of Engineering. Specific departmental requirements are subject to change and students should consult their advisor regularly to learn of changes that occur. Other University and HCoE requirements are located on the University on-line catalogue

Graduation:  Graduation is NOT automatic and you must file your intent to graduate by the appropriate  deadlines. Information on the dates and deadlines for filing your intent to graduate form for your intended semester of graduation are published by the University Registrar. You also need to see your advisor to file your HCoE Degree Application.

Transfer Students: A student will satisfy residence requirements for graduation by earning at least

twenty-five (25) percent of credit hours required for the degree at the University of Memphis. At least thirty (30) of the final sixty (60) hours required for the degree must be completed at the University of Memphis. A student transferring credits from a two-year college or institution must complete, as a requirement for the baccalaureate degree, a minimum of sixty semester hours in an accredited senior institution.

5 Revised March 2015


Transfer Credit: Any University of Memphis student considering taking courses at another

institution, to satisfy degree requirements, should meet with his/her academic advisor, refer to the Transfer Equivalency Table to see how those courses will transfer back to the University of Memphis, and complete a Transfer Credit Request (TCR) form. For program degree credits, please contact your advisor or Ms. Lori Stewart (ljstwart@memphis.edu), the HCoE student advisor.

OTHER ACADEMIC INFORMATION

Cooperative Education: The Cooperative (co-op) Education Program offers students a real-world

engineering dimension to their education often referred to as ‘total education.’ The Herff College of Engineering Co-op program may best be summarized as being a unique educational opportunity by which students obtain an academic education and at the same time obtain a minimum of one year of vitally needed practical experience in their chosen field of study. Co-op opportunities exist with many of the biomedical companies in the Memphis area including, Medtronic, Smith-Nephew, Wright Medical Technologies Inc., Odessey Medical Inc., Onyx, Gyrus ENT Inc., GE Medical Systems. Students interested in co-op opportunities should contact Ms. Shelia Moses, Program Services Specialist in the HCoE Dean’s office (phone 678-4933; srmoses@memphis.edu). Note, co-op course credits do not satisfy degree requirements. Grades assigned for co-op courses are used in calculating student’s GPA.

International/Study Abroad Programs: Engineering is a global industry and profession in which

engineers, scientists, and managers from diverse backgrounds and cultures must function in a dynamic international environment. Engineers may be involved with several design teams on several continents linked electronically. Engineers are often called upon daily to deal with foreign suppliers and customers. Opportunities for students to experience work and education in different countries and experience different cultures will allow them to be more competitive and successful in the international engineering and business markets and in the changing global environment. Contact The University of Memphis Study Abroad Office (http://www.memphis.edu/abroad/) to find out about different study abroad programs, requirements, and scholarships.

Overload: Students are allowed to register for a maximum of 20.5 hours each semester without prior

approval. To register for more than 20.5 hours in any one term, the student must fill the Course Overload Form with a signature from the authorized personnel for the department or college (http://www.memphis.edu/registrar/forms.htm)

To Change Major: If you have decided to change your major, contact the faculty/departmental

advisor for your NEW major.

      Withdrawing from the Current or Upcoming Term: We hope it is not necessary, but if you need to withdraw completely from the University, your first step should be to drop all of your courses online on or before the "Last Day to Drop a Class" for the term/part(s)-of-term. See the appropriate Dates & Deadlines  calendar to find this date. Do not make the mistake of thinking that you are withdrawing by simply not attending your classes. You must drop the classes you have enrolled in; otherwise, you may receive F grades and, possibly, owe the University money.

      You must have permission to drop all of your courses if you are a scholarship athlete, are under contract due to academic suspension, high school deficiencies, or remediation or are receiving a Lottery Scholarship. You will need to contact the athletic academic services, academic status and retention office and/or financial aid office to obtain permission.

6 Revised March 2015


      It is possible to withdraw from a term after the drop deadline has passed; this is a Late Withdrawal. It is even possible to withdraw from a term after it has ended and grades have been issued; this is a Retroactive Withdrawal. In either instance, however, you must apply for permission to withdraw, and your withdrawal will be permitted only if you have the proper approval. Approval is granted only in those instances in which "serious and unforeseen circumstances" prevented you from completing that term's classes. To apply for either late or retroactive withdrawal, please contact your advisor or the HCoE advisor, Ms. Lori Stewart (ljstwart@memphis.edu).

ELECTIVES 

Electives may be used to tailor program of study to match individual student’s career goals. The B.S. BME degree program has two (2) biomedical engineering (BIOM) electives, four (4) engineering electives, two (2) technical electives, and one (1) biology or engineering elective. These nine (9) electives provide much flexibility and choices in developing program of study to meet career goals.

The BIOM electives must be selected from the upper division BIOM courses. The engineering electives may be selected from upper division engineering courses in the HCoE. The technical electives may be selected from upper division courses in BIOL, CHEM, Engineering (including biomedical), MATH, PHYS and Engineering Technology (TECH). The biology-engineering elective must be from upper division courses in BIOL or Engineering. These elective courses should be chosen with permission of the advisor, the Chair or the Chair designee. Students may need to take other courses to satisfy pre-requisite requirements for upper division courses outside of the department.

The focus areas below are examples pertaining to specific areas and career paths. It is not necessary for students to select a focus area since students can be well served by choosing topics from each focus area. Not all electives have been specified for each focus area. Selection of additional electives should be done in consultation with student advisor.

a. Biomaterials/Tissue Engineering Focus

BIOM 4730 Biomaterials (4)

BIOM 4702 Biotechnology Tools of Biomedical Engineering Research (3)

BIOM 4150 Engr Tools for Medical Device Design (3)

BIOM 4750 Biomechanics (4)

(or BIOM 4205 Introduction to Biomedical or Chemical Sensors (3) or BIOM 4110

Science of Medicine (3))

MECH 3331 Fluid Mechanics (3)

(or MECH 3322 Mechanics of Materials (3)

MECH 4324 Computer Aided Design (3)

(or METH 4472 Computer Aided Drafting and Design (3))

BIOL 3130 Cell Biology (3)

(or BIOL 4094 - Biology of Stem Cells (3) or BIOL 4380 Histology (3) or BIOL 4445

Immunology (3))

CHEM 3310/3301 Foundations/Organic Chemistry (3) + Laboratory (1)

CHEM 3511/3501 Foundations/BioOrganic Chemistry (3) + Laboratory (1)

7 Revised March 2015


b. Bioelectrical Devices, Sensors and Systems Focus

BIOM 4720 Bioelectricity (4)

BIOM 4205 Introduction to Biomedical and Chemical Sensors (3) (or BIOM 4110 Science of Medicine (3))

EECE 3211 Electronics I (3)

EECE 3213 Electronics I Laboratory (1)

EECE 3240 Electromagnetic Field Theory (3)




EECE 3203 Signals and Systems I (3)

BIOL 3130 Cell Biology (3)

MATH 4391 Partial Differential Equations I

CHEM 3211/3201 Foundations/Analytical CHEM (3) + Laboratory (2)

CHEM 3411/3402 Foundations/Physical Chemistry (3) + Laboratory (2)

c. Biomechanics Focus

BIOM 4750 Biomechanics (4)

BIOM 4150 Engr Tools for Medical Device Design (3)

(or BIOM 4730 Biomaterials (4) or BIOM 4110 Science of Medicine)

BIOM 4393 Applied Finite Element Analysis (3)

MECH 3321 Mechanics of Machines (3)

MECH 3331 Fluid Mechanics (3)

(or MECH 3330 Introduction to Thermal Systems (3))

MECH 4324 Computer Methods/Design (3)

BIOL 3620 Comparative Anatomy of Vertebrates (3)

(or BIOL 4380 Histology)

MECH 2332 Dynamics (3)

MECH 3341 Numerical & Statistical Methods (3)

e. Premedical Studies

The biomedical engineering curriculum also serves as an excellent pre-medical curriculum for students interested in pursuing physician/dentist careers. Additional information on premed school preparation and activities is available at the Pre-Health Advising Center.

For Humanities electives, two of the following are suggested:

THEA 1030, COMM 1851, ART 1030 or MUS 1030

Note: PHIL 3514 Biomed Ethics is also highly recommended, but cannot be used to satisfy the

university’s general education humanities requirements.

For Two (2) Technical Electives:

CHEM 3311 and CHEM 3301 – Foundations/Organic Chemistry + Lab

CHEM 3511 and CHEM 3501 - Foundations/Bioorganic + Lab

Students should consider taking at least one additional biology course from the following:

BIOL 3072/3073 – Genetics and Lab (note student may take course without the lab)

BIOL 3610 – Vertebrate Embryology

BIOL 3620 – Comparative Anatomy

BIOL 3130 – Cell Biology

8 Revised March 2015


BIOL 4380 – Histology

BIOL 3500 – Micro I/Fundmntl Aspect

BIOL 4445 – Immunology

CHEM 4511/4512 – Biochemistry I & II

f. General list of possible technical electives ( there are other electives and they should be discussed with

advisor)

BIOL 3130 - Cell Biology (3)

BIOL 4094 - Biology of Stem Cells (3)

BIOL 4480 - Cellular/Molec Pharm (3)

BIOL 4402 – Toxicology (3)

BIOL 3072/3073 – Genetics and Laboratory (3/4)

BIOL 3620 - Comparative Anatomy of Vertebrates (3)

BIOL 4445 – Immunology (3)

BIOL 4150 - Developmental Biology (3)

BIOL 4200 - Cell and Developmental Biology Lab (3)

BIOL 4380 - Histology (3)

BIOL 3500/3505 – Microbiology I/Fundamental Aspects and Lab (3/4)

MATH 3242 – Introduction to Linear Algebra (3)

MATH 4391 – Partial Differential Equations I (3)

MATH 4721 – Numerical Analysis (3)

PHYS 2115 - Classical Physics (3)

PHYS 3010 - Modern Physics (3)

PHYS 3011 - Theoretical Physics(3)

PHYS 3211 - Electricity and Magnetism (3)

PHYS 4410 - Quantum Physics (3)

TECH 4462 - Quality Improvement (3)

TECH 4463 - Quality Systems (3)

TECH 4472 – Computer Aided Design (3)

Other CIVL, MECH, EECE upper division engineering courses

CHEM 3310/3301 – Foundations Organic Chemistry (3) + Laboratory (1)

CHEM 3511/3501 – Foundations of BioOrganic chemistry (3) = Laboratory (1)

CHEM 3211/ 3201 - Foundations/Analytical CHEM (3) + Lab (2)

CHEM 3411/3402 - Foundations/Physical Chemistry + Lab (2)

CHEM 5411 - Biochemistry I (3)

ADDITIONAL DEGREE PROGRAMS FOR BIOMEDICAL ENGINEERING STUDENTS

a. Second Major In Physics for Biomedical Engineering Students.

Physics remains a key foundation to many biomedical engineering activities including materials development, electromagnetic radiation and imaging, biomechanics and nanotechnology. Students have the opportunity to enhance and expand their biomedical engineering degree by obtaining a second major in Physics. The second major requires a total of twenty-nine (29) semester hours beyond PHYS 2110/2111 and

PHYS 2120/2121, many of which count toward the engineering degree and/or are already required by the

9 Revised March 2015


biomedical engineering degree program as outlined below. Note the second major in physics program only requires and additional 8 hours (three courses) beyond the 128 hour requirement for the B.S. degree in biomedical engineering. For details, please visit the Department of Physics web site at: http://www.memphis.edu/physics/academics_undergrad_2ndmajor.htm. Please register for the program with your advisor and HCoE Academic Advisor, Ms. Lori Stewart (ljstwart@memphis.edu),

Physics Requirements: Credits Offered Every To  Satisfy Requirement: 

2115 Classical Physics 3 Spring Take this class

3010 Modern Physics 3 Fall Take as Upper Divis techn elective

3011 Theoretical Physics 3 Spring Take as Upper Divis techn elective

3111 Mechanics 3 Take BIOM 2810 & MECH 2332

(Intro Biomech & Dynamics)

3211 Elec & Magnetism 3 Fall Take this class

3610 Exp. Techniques I 1 Take BIOM 4780 Sr. Proj.

3611 Exp. Techniques II 1 Take BIOM 4780 Sr. Proj.

4410 Quantum Physics 3 Fall Take this class

Note: check prerequisites

4510 Thermodynamics 3 Take MECH 3311 Thermodynamics

Upper Divis. Elective I 3 Take BIOM 4760

Biom. Eng. Design Principles

Upper Divis. Elective II 3 Take BIOM 4720 Bioelec. or BIOM 4730 Biomaterials or BIOM 4750

Biomechanics

b. Accelerated BS/MS Program in Biomedical Engineering

Highly qualified students are allowed to earn a Bachelor’s degree in an approved undergraduate discipline and a Master’s degree in Biomedical Engineering (BME) in five years. Students with high school advanced placement credits may require less time. Students will join research teams organized through the Joint Graduate Program in Biomedical Engineering, which is shared by the University of Memphis and The University of Tennessee Health Science Center. Students apply once they have reached sophomore standing and have completed one semester of course work. In addition to an application form, students must submit one letter of reference and a copy of their transcript to the BME department. Each applicant will be required to complete an interview with a

pre-graduate advisor in the BME department. This is a highly competitive program and admission

is limited. In order to remain in the program past the junior year, students must maintain a minimum GPA of 3.25  Students in their senior year will become eligible to apply for combination senior status, allowing them to take graduate courses in BME. Up to 9 hours of graduate course work may be applied towards B.S degree requirements; the courses that may be applied will be determined in consultation with your academic advisor. To continue in this program past the B.S., students must submit a “Change of Status” application with Graduate Admissions. Contact your advisor to find out if this option is right for you.

10 Revised March 2015


ADDITIONAL INFORMATION FOR BME AND UNIVERSITY CURRICULUM 

The only Courses that satisfy the University’s Humanities and Social/Behavioral Science elective requirements are listed below. Other courses may be taken but cannot be used to satisfy graduation requirements in the HCoE.

HUMANITIES (6 hrs.) (Select any two)

ART 1030 (1101) Introduction to Art - Fundamental principles of visual artistic expression as the basis for understanding Western and non-Western traditions.

ARTH 2010 (2101) World Art I - Development of visual arts from prehistoric times through medieval period.

ARTH 2020 (2102) World Art II - Continues World Art I; development of visual arts from medieval period through Renaissance to present.

CLAS 2481 Mythology - Thematic study of ancient myths.

COMM 1851 Introduction to Film - Film as a cultural, artistic, and social phenomenon.

Introduction to Dance - Dance as an expressive art form, a symbolic language, and an

DANC 1151

integral aspect of world cultures.

Religions of Abraham: Judaism, Christianity, Islam - Religious traditions arising from

JDST 2850

ancient Near East.

MUS 1030

(MUHL 1101) Music Appreciation - Music of various Western and non-Western cultures.

MUS 1040 Music in America - Music history, sources and current styles of American music.

Fundamental Issues in Philosophy - Critical exploration of such issues as knowledge,

PHIL 1101

reality, and the good life.

Values and the Modern World - Introduction to social and ethical issues: good and evil,

PHIL 1102

science, religion, sex, race.

Introduction to Ancient Political Thought - Fundamental questions of ancient political

POLS 1101

thought.

Introduction to Modern Political Thought - Fundamental questions of modern political

POLS 1102

thought.

Introduction to Religion - The world's major spiritual traditions from ancient times to the

RLGN 1100

present

THEA 1030 (1551) Introduction to Theatre - Experiential, conceptual, historical, and cultural study of theatre.

Hebrew and Greek Legacy - Interdisciplinary examination of major traditions of ancient

UNIV 3580

Hebraic and Greek cultures.

Faith, Reason and Imagination - Interdisciplinary examination of the religious, rationalist,

UNIV 3581

and aesthetic viewpoints as distinctive ways of understanding.

SOCIAL/BEHAVIORAL SCIENCES (select one; ECON 2110 is already required in BME curriculum)

ANTH 1100 Biological Anthropology and Prehistory- Origins of humans and human society, behavior, and culture.

ANTH 1200 Cultural Anthropology - Origins and development of human culture throughout the world.

CSED 2101 The Family in Global Perspective - Interdisciplinary overview of the family as a primary, global, social institution.

11 Revised March 2015




This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.



USER MANUAL

Version 8.0

Revised November 2013


Department of Clinical Parasitology

Hospital for Tropical Diseases

3rd Floor Mortimer Market Centre

Mortimer Market,

London

WC1E 6JB

Phone 020 3447 5418

Fax 020 7383 0041

Dx Number: DX 6640701

Exchange: TOTTENHAM CT RD 91WC

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015

Author(s): Peter Chiodini, David Manser

Page 1 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

TABLE OF CONTENTS

SECTION 1 4

INTRODUCTION - ABOUT THE DEPARTMENT OF CLINICAL PARASITOLOGY 4

SERVICES PROVIDED 4

REMIT OF THE DEPARTMENT OF CLINICAL PARASITOLOGY 4

SECTION 2 5

HOW TO USE THIS MANUAL 5

SECTION 3 6

THE DEPARTMENT OF CLINICAL PARASITOLOGY – STAFF AND

ORGANISATION 6

STAFFING: 6

CONTACTING SENIOR STAFF 6

ENQUIRIES 7

HOURS OF BUSINESS 7

EMERGENCY ON-CALL SERVICE 7

URGENT REQUESTS DURING NORMAL HOURS 7

FABRIC AND FACILITIES 7

SECTION 4 8

HOW TO USE THE DIAGNOSTIC AND ADVISORY SERVICE 8

TRANSPORT AND COLLECTION OF SPECIMENS 8

SAFETY 8

PACKAGING OF SPECIMENS 8

HAZARDOUS SPECIMENS 9

REQUEST FORMS 9

TYPES OF SPECIMENS 10

POSTAL ADDRESS 10

SECTION 5 11

Repertoire of Services offered by the Department of Clinical Parasitology 11

1. DIAGNOSIS AND IDENTIFICATION OF PARASITES IN CLINICAL MATERIAL, FOR EXAMPLE:

11

2. DIAGNOSIS OF HUMAN PARASITIC DISEASES BY IMMUNOLOGICAL METHODS. 11

3. CULTURE OF LEISHMANIA FROM CLINICAL MATERIAL BY PRIOR ARRANGEMENT. 11

4. PCR ASSAYS 11

5. ADVISORY SERVICE 12

SPECIMENS REQUIRED FOR THE DIAGNOSIS OF INDIVIDUAL PARASITIC

DISEASES 12

AMOEBIASIS (ENTAMOEBA HISTOLYTICA) 12

BABESIOSIS 13

CYCLOSPORIASIS 13

CYSTICERCOSIS (LARVAL TAENIA SOLIUM INFECTION) 13

ENTEROBIASIS 14

FASCIOLIASIS 14

FILARIASIS 14

FREE LIVING AMOEBA 15

GIARDIASIS 16

HYDATID DISEASE 16

IDENTIFICATION OF WORMS 16

INTESTINAL HELMINTHIASIS 17

INTESTINAL PROTOZOA 17

LEISHMANIASIS 17

MICROSPORIDIA 18

MALARIA 19

SCHISTOSOMIASIS 19

STRONGYLOIDES 20

TOXOCARIASIS 20

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 2

Author(s): Peter Chiodini, David Manser

Page 2 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

TOXOPLASMOSIS 22

TRICHINOSIS 22

TRYPANOSOMIASIS 22

VISCERAL LARVA MIGRANS 23

RETENTION OF SAMPLES 24

REPORTING TIMES FOR LABORATORY INVESTIGATIONS 25

SECTION 6 26

Results and advisory service 26

TELEPHONED RESULTS: 26

PARASITE SEROLOGY - NORMAL REPORTING PRACTICE 26

STORAGE OF RESULTS 27

OBTAINING RESULTS BY TELEPHONE 27

OBTAINING ADVICE AND INFORMATION 27

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 3 Author(s): Peter Chiodini, David Manser

Page 3 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Section 1

INTRODUCTION - ABOUT THE DEPARTMENT OF

CLINICAL PARASITOLOGY

SERVICES PROVIDED

The PHE National Parasitology Reference Laboratory services requests from all General practitioners, PHE and Medical Microbiology laboratories in the NHS. The Department has an international reputation and provides a parasitology service to Clinicians and Laboratories world wide.

The Department offers a wide range of investigations including diagnosis and identification of parasites in clinical material, diagnosis of human parasitic disease by immunological methods, culture and genomic detection from clinical material.

A twenty-four hour service for microscopic diagnosis of malaria is available. An advisory service on investigation of patients for parasitic disease, the appropriateness of tests, their timing and interpretation together with advice on treatment is also available. Individual tuition for technical, scientific and medical staff in faecal and blood parasitology can be provided by special arrangement.

The Department of Clinical Parasitology processes over 33,000 requests per annum.

The Department also houses the UKNEQAS (Parasitology) laboratory and the UK NEQAS-associated teaching facility

REMIT OF THE DEPARTMENT OF CLINICAL PARASITOLOGY

The remit of the Department of Clinical Parasitology is: 

1) To provide a comprehensive diagnostic, identification and advisory service on human parasites and the diseases they cause.

2) To develop, evaluate and advise on new parasite diagnostic techniques.

3) To produce epidemiological data for the PHE.

4) To liaise with other diagnostic and research parasitology laboratories in the UK and overseas, so that best practice is shared globally

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 4 Author(s): Peter Chiodini, David Manser

Page 4 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Section 2

HOW TO USE THIS MANUAL

The manual is intended to assist you in making the best use of the services offered by the Department of Clinical Parasitology. The manual is divided into six sections. If you have difficulty finding information that you think should be here, please let us know, so that we can improve the manual. (email david.manser@uclh.nhs.uk )

The page numbers on which specific items appear are listed in the Table of Contents at the front of the manual.

Section 1 of the manual provides an overview of the Department of Clinical Parasitology.

Section 2 of the manual explains how to use the manual

Section 3 of the manual provides information about the Department of Clinical Parasitology, its staff and organisation and contact details.

Section 4 of the manual provides suggestions on how to use the Diagnostic and Advisory Service.

Section 5 provides a repertoire of services available from the Department of Clinical Parasitology.

Section 6 describes how results are normally sent to you and how they can be obtained if they are required urgently.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 5 Author(s): Peter Chiodini, David Manser

Page 5 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Section 3


THE DEPARTMENT OF CLINICAL PARASITOLOGY –

STAFF AND ORGANISATION

The Department of Clinical Parasitology is a laboratory within the Specialty of Microbiology, UCLH.

The Department of Clinical Parasitology is the PHE National Parasitology Reference Laboratory.

STAFFING:

Senior staff: Professor P L Chiodini - Consultant Parasitologist Mr D W Manser - Laboratory Manager

Dr C Sutherland - Clinical Scientist Grade B

Specialist Registrar (on rotation) in Parasitology

BMS 8a: Ms P Lowe –Serology Section Head

Ms J Watson – Microscopy & PCR Section Head

Laboratory staff: BMS band 7: Dr WJ Bligh

Mr MM Suvari

Dr S Boadi

Ms K Bowers

Mrs C Fagg

Mrs R. Kinson

Ms Z Hrydziuszko

MLA: Mr A Cenizal

Ms C. Halls

CONTACTING SENIOR STAFF





Professor. P.L. Chiodini


020 3447 5418

Mr. D. W. Manser


020 3447 5411

Specialist Registrar


020 3447 5809

On-call BMS

0845

155 5000 or 020 34567890 and bleep UCH 425


Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 6 Author(s): Peter Chiodini, David Manser

Page 6 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

ENQUIRIES

For enquiries requesting information and/or advice regarding any item identified in the list of services offered by the Department of Clinical Parasitology, requests for information and/or advice regarding suitability of specimens, significance of results and treatment options.

Consultant Parasitologist 020 3447 5418

Specialist Registrar 020 3447 5809

For enquires requesting information regarding safe arrival of specimens, availability of tests, etc.

Laboratory Manager 020 3447 5411

Or appropriate section: Microscopy / PCR 020 3447 5414

Serology 020 3447 5413

HOURS OF BUSINESS

Information and advice is available from staff in the Department of Clinical Parasitology within normal working hours (0900 - 1700 Monday to Friday).

EMERGENCY ON-CALL SERVICE

A 24 hour, 7 day service is provided for urgent malaria diagnosis.

URGENT REQUESTS DURING NORMAL HOURS

Please telephone to say that an urgent sample is en route.  Contact 020 3447 5418.

A responsible person (and deputy), capable of accepting and transmitting the result(s), in the submitting organisation must be identified at this time. The results of urgent tests will be telephoned by a senior member of staff to the identified person (or deputy) in the submitting organisation as soon as the result is verified

FABRIC AND FACILITIES

The department is situated in purpose built laboratory accommodation commissioned in December 1998. There are 5 laboratories: Microscopy; Serology; Research; UK NEQAS and PCR areas.

Routine access to the laboratories is restricted to the laboratory staff, with controlled entry for visitors. Many of the specimens arrive by vacuum tube, minimising the need for non-laboratory staff to enter the department.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 7 Author(s): Peter Chiodini, David Manser

Page 7 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Section 4

HOW TO USE THE DIAGNOSTIC AND ADVISORY

SERVICE

TRANSPORT AND COLLECTION OF SPECIMENS

Specimens are received (by vacuum tube, post, DX, hospital van, taxi, or by courier) at the Specimen Reception area of the department. A regular van delivery / pickup of specimens between local centres is maintained by the UCLH Transport department.

If specimens are to be brought to the laboratory personally by medical or nursing staff they must be carried in an approved container for transport.

SAFETY

Current guidelines must be followed to avoid needle stick injuries or accidental exposure to blood and blood-contaminated body fluids of those persons taking, transporting and processing the samples.

Any accident should be reported at once to your immediate superior as urgent action may be required; please refer to your local Safety Policy/Infection Control guidelines.

Neither the request form nor the outside of the container should be contaminated with the sample.

Ensure that the container is correctly sealed. All specimens from human sources must be regarded as potentially infectious

PACKAGING OF SPECIMENS

Label all samples clearly with hospital number, name, and date of collection.

Location, consultant code/name, doctor’s name, bleep/extension and test or tests required in addition to the patient details above should be put on the request form.

The sender must be an authorised person, not a member of the public; the recipient of the results must be a recognised laboratory or medical practitioner.

Specimens MUST be packaged according to Packing Instructions P650 and UN3373 requirements. See “Transport of infectious substances - best practice guidance for

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 8 Author(s): Peter Chiodini, David Manser

Page 8 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

microbiology laboratories” available on the Department off Health website (www.dh.gov.uk)

The outside must be marked conspicuously with the following:

‘BIOLOGICAL SUBSTANCE, CATEGORY B’

It is essential that such substances are properly packed and labelled and appropriate instruction and protection provided to the carrier(s).

The sender is responsible for ensuring the health and safety of any courier or taxi service that is used to transport samples to the Parasitology laboratory.

Hazardous specimens

Any specimens from known or suspected cases of hepatitis, tuberculosis, or HIV/AIDS must be clearly identified as a ‘RISK OF INFECTION’.

Spillage of body fluids / leaking containers. - This may necessitate the rejection of the specimen. If this occurs, a member of the Department of Clinical Parasitology staff will inform a responsible person in the submitting organisation by telephone and advise that a request for a repeat sample be made.

REQUEST FORMS

Where possible, use a Parasitology request form personalised to your location. A personalised request form will have the code assigned to your laboratory or practice, this ensures speedy processing of the specimen and ensures the report is returned to the requesting address. If a laboratory would like a copy of the new parasitology request form please email the Laboratory Manager providing the laboratory address, responsible person (or deputy) to whom results are to be sent, telephone and fax numbers to: david.manser@uclh.nhs.uk

Request forms can be dispatched to you by prior arrangement. Use a separate form for each specimen type. Complete all sections of the form using a ball-point pen or ink. Mark clearly the name of the responsible person (or deputy) to whom results are to be sent.

Please give complete patient identification and relevant clinical details, including risk category and travel history. This information is needed to help determine which special precautions are required and which tests are to be done.

Processing times for different specimens vary according to clinical priority, as does the frequency of individual tests.

CLINICALLY IMPORTANT REQUESTS WILL BE GIVEN PRIORITY AND THE RESULTS TELEPHONED TO YOU BY A SENIOR MEMBER OF STAFF AT THE EARLIEST OPPORTUNITY.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 9 Author(s): Peter Chiodini, David Manser

Page 9 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

TYPES OF SPECIMENS

Confirmation of Parasitic infection can often be obtained directly following the analysis of a clinical specimen for the presence of the parasite. Indirect methods can also be used to test for evidence of a parasitic infection. Negative results do not necessarily exclude a diagnosis.

Faeces, blood and sera constitute the majority of samples received for analysis. Other samples include adhesive tape smears, urine, skin snips, biopsies, and whole organisms such as arthropods and worms for identification.

Please send separated serum rather than whole blood for serology requests (to prevent lysis of sample if delayed in post)

If you are uncertain of the type(s) of specimen(s) you should submit for analysis, telephone prior to sending the sample, in order that you can discuss the appropriateness of the specimen with a senior member of staff from the Department of Clinical Parasitology.

POSTAL ADDRESS

Send your specimens, together with an official request form or signed letter containing as much clinical information as is deemed necessary and requesting the service(s) required to:

The Department of Clinical Parasitology

The Hospital for Tropical Diseases

3rd Floor Mortimer Market Centre

Mortimer Market

London WC1E 6JB

Dx Number: DX 6640701

Exchange: TOTTENHAM CT RD 91 WC

Please Note: Specimens sent for diagnosis or further investigation to a clinical laboratory must comply with the conditions set down in the Post Office Regulations governing the transport of pathological specimens. For insurance purposes, the value of a routine specimen is not likely to exceed £1 sterling.

Specimens which are known or suspected to contain Hazard Group 4 pathogens should not be sent by post.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 10 Author(s): Peter Chiodini, David Manser

Page 10 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Section 5

Repertoire of Services offered by the Department of

Clinical Parasitology

The Department of Clinical Parasitology offers the following services:

1. Diagnosis and identification of parasites in clinical material, for example:

a) Identification or confirmation of identity of ova, cysts, larvae and worms in faeces, tissues, urine and other fluids. The department aims to provide a 24 hour turnaround time within the working week for the above-mentioned specimens. If histology is required the sample will be dealt with in conjunction with a histopathologist.

b) Speciation of malaria and filaria parasites in thick and thin blood films.

The department aims to provide a 24 hour turnaround time, within the working week, for these specimens. Communication with the laboratory before the specimen is dispatched is recommended for urgent samples.

2. Diagnosis of human parasitic diseases by immunological methods.

3. Culture of Leishmania from clinical material by prior arrangement.

Culture of Leishmania from clinical material can take up to THREE WEEKS. Prior arrangement is advised to obtain the most efficient service.

4. PCR assays

PCR assays for Leishmania, Microsporidia and the triple assay for E. histolytica, Giardia and Cryptosporidia are available on request.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 11 Author(s): Peter Chiodini, David Manser

Page 11 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

5. Advisory service

We provide an advisory service on the investigation of patients for parasitic disease, the appropriateness of tests, their timing and interpretation together with advice on treatment.

Information regarding this service can normally be provided by telephone, fax or email.

SPECIMENS REQUIRED FOR THE DIAGNOSIS OF

INDIVIDUAL PARASITIC DISEASES

Amoebiasis (Entamoeba histolytica)

Intestinal - stool samples for the detection of Entamoeba histolytica / Entamoeba dispar cysts can be sent by conventional means. Examination for trophozoites requires that the stool is examined within 30 minutes of voiding. Accordingly the laboratory must be advised in advance of submission. Microscopy of rectal scrapings must be arranged with the laboratory in advance.

The molecular test for Cryptosporidium species, Giardia intestinalis and Entamoeba histolytica offers several advantages over standard microscopy based diagnostics. The assay is significantly more sensitive (greater than ten fold improvement in the limit of detection for some species) than light microscopy. In addition the assay is semi quantitative and can therefore reveal detailed information on the response of a patient’s parasite load to subsequent drug therapy. For Entamoeba histolytica the assay also has the advantage of being specific for this pathogen, and does not pick up morphologically related but non pathogenic cysts such as Entamoeba dispar. Finally, the assay can be run on a much wider range of samples, such as biopsies and liver aspirates since it does not rely on the presence of morphologically intact parasites.

Stool samples for the molecular test must not be in any fixative as this may cause false negatives.

Amoebic serology

For such test a minimum of 0.5ml of serum is required.

The IFAT (screening titre 1/80) is an essential test in cases of suspected amoebic liver abscess (ALA). Such cases produce high titres of about 1/160-1/320, and the test is positive in over 95% of cases of ALA by the end of the first 14 days. However, it appears to give false positives in some cases of non-amoebic liver disease. Consequently it is necessary to confirm a positive result by the Cellulose Acetate Precipitin test (CAP).

The IFAT also gives very good results in cases of amoeboma. In amoebic colitis the test is positive, often at low titre, in about 75% of cases; in cyst passers it is often negative and in other cases it may be positive because of past infection. The test is therefore not suitable for the investigation of vague abdominal symptoms or as a routine check.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 12 Author(s): Peter Chiodini, David Manser

Page 12 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

However, in addition to hot stool microscopy, rectal scrapes or biopsies, a negative result should be obtained before the use of steroids or surgery for presumed ulcerative colitis or Crohn’s Disease.

A Cellulose Acetate Precipitin test (CAP) will be performed if the IFAT is positive. This test is less sensitive than the IFAT. A positive is confirmatory evidence of an active or recently treated infection. A negative CAP in the presence of a positive IFAT may suggest early infection, a treated case, past infection or occasionally, a false positive IFAT. After treatment the CAP is the first to become negative, sometimes as soon as one month but occasionally after one year.

Babesiosis

A tick borne parasitic infection diagnosed by blood film (Babesia microti and Babesia divergens) or IFAT (Babesia microti). A minimum of 2ml of EDTA anti-coagulated blood (for microscopy) and 0.5ml of serum (for serology) is required.

Microscopy of thick and thin blood films is required. Serological testing is available (Babesia microti only) on discussion with the laboratory.

Cyclosporiasis

Stool samples may be sent for microscopy. Up to three samples may be necessary due to the intermittent excretion of this parasite.

Malabsorption is a relatively common finding in patients with the recently recognised parasite Cyclospora cayetanensis.

Cysticercosis (larval Taenia solium infection)

Cysticercosis, caused by the presence of the larval stage (cysticercus) of Taenia solium in various organs, especially the CNS, is diagnosed by a variety of methods including imaging and serology. A serological service (EITB Immunoblotting) is provided. A minimum of 0.5ml of serum is required, CSF testing is also available, please provide as much CSF as you are able to spare.

The cysts may occur in almost any situation but are most likely to draw attention to their presence in the brain or eye. Any patient with ‘epilepsy’ who has resided overseas should be investigated.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 13 Author(s): Peter Chiodini, David Manser

Page 13 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Intestinal infections with Taenia solium or saginata will usually give negative results by serology

Microscopy of stools for ova is recommended in these cases but cannot differentiate to species level.

If sending segments for identification please send without fixative (see below under identification of worms). HIGH RISK stickers must be used if Taenia solium is suspected

Enterobiasis

An adhesive tape smear (Sellotape, Scotch tape (i.e. clear transparent adhesive tape)) taken first thing in the morning from the perianal skin and attached sticky side down to a microscope slide, is the appropriate specimen for detecting Enterobius vermicularis ova. While adult worms may be present in stool samples, a negative stool result for worms and ova does not exclude the diagnosis because the ova are laid on the perianal skin.

Fascioliasis

Fascioliasis is caused by Fasciola hepatica (the liver fluke of sheep and cattle). Eggs in faeces are often scanty and may not be found in up to 30% of cases. Serology can be helpful and an IFAT test for antibody is available. A minimum of 0.5ml of serum is required.

Outbreaks of infection with Fasciola hepatica (typically following consumption of infected watercress) are uncommon but have occurred in the UK. Occasional sporadic cases are encountered, usually from abroad.

Patients with upper abdominal pain, thought to be hepatic, eosinophilia and fever, should be investigated. Serology is the best method of diagnosis in the early stage of the infection.

The IFAT (screening titre 1/32) has given reliable results. It is species specific. In proven Fasciola hepatica infections the titre is in the order of 1/128.

Filariasis

The syndromes produced by the various species of filarial worms are usually associated with eosinophilia. A patient with an eosinophilia who has lived in, or visited, a filaria endemic area might reasonably be tested for filariasis.

The major human filariases are Wuchereria bancrofti, Onchocerca volvulus, Brugia malayi, and Loa loa.

With the exception of Onchocerca volvulus, a definitive diagnosis of filariasis is usually made by the demonstration of microfilariae in the peripheral blood. Onchocerca volvulus is diagnosed by demonstration of microfilariae in skin snips.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 14 Author(s): Peter Chiodini, David Manser

Page 14 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Twenty millilitres of anti-coagulated blood (citrate tube) are required so that the microfilariae can be detected by filtration. Day blood (for Loa loa) should be taken between 12noon and 2pm local time and night blood (for Wuchereria bancrofti) at 12 midnight. Samples should be kept at room temperature until processed.


PERIODICITY

COLLECTION TIME(hr/local)

Wuchereria bancrofti

Nocturnal

2400-0200

Brugia malayi

Nocturnal

2400-0200

Loa loa

Diurnal

1200-1400

Mansonella perstans

No periodicity

Anytime

Mansonella ozzardi

No periodicity

Anytime


A filaria ELISA, using Brugia pahangi as antigen is used as a “generic” screening test. A minimum of 0.5ml of serum is required. A negative result does not exclude the diagnosis and this is especially so with onchocerciasis.

The filaria ELISA is a non-specific screening test that is positive in many types of filariasis and in strongyloidiasis. It is most useful in the diagnosis of TPE (Tropical Pulmonary Eosinophilia) where high antifilarial antibody levels are required to make the diagnosis. Positive results are reported at Levels 1 to 9. Levels 1 and 2 are regarded as weak positives; Levels 5 and over are strong positives.

Reactive symptomatic cases with moderate eosinophilia tend to give high level positives. Non-reactive cases, which may be asymptomatic though microfilariae are present, give low levels of positivity and may be negative. Known causes of false positive results are Hookworm (about 50% of cases) and occasionally Ascaris infection. We are unable to speciate Filaria infections using our ELISA test. This may be done if microfilaria are seen in a blood film or by staining the microfilaria obtained by filtration.

Free Living Amoeba

A PCR is available upon discussion with the Consultant Parasitologist or SpR for the diagnosis of Naegleria fowleri, Balamuthia mandrillaris and Acanthamoeba species. The sample should be CSF or Brain/tissue and received in the laboratory as soon as possible.

Culture is available for Naegleria fowleri or Balamuthia mandrillaris on discussion with the Consultant Parasitologist or SpR. The sample should be CSF or Brain/tissue and received in the laboratory as soon as possible.

Culture for Acanthamoeba species should be referred direct to the LSHTM.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 15 Author(s): Peter Chiodini, David Manser

Page 15 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Giardiasis

(See also intestinal protozoa)

Giardia trophozoites are only detectable when stools are examined within 4 hours of voiding. Giardia cysts are frequently excreted intermittently so that a minimum of six stools may be required for microscopic exclusion. Giardia can be demonstrated in duodenal / jejunal juices if examined within 4 hours.

The molecular test for Cryptosporidium species, Giardia intestinalis and Entamoeba histolytica offers several advantages over standard microscopy based diagnostics. The assay is significantly more sensitive (greater than ten fold improvement in the limit of detection for some species) than light microscopy. In addition the assay is semi quantitative and can therefore reveal detailed information on the response of a patient’s parasite load to subsequent drug therapy.

Stool samples for the molecular test must not be in any fixative as this may cause false negatives.

Giardia serology is no longer available, please send an unfixed stool sample for microscopy and PCR.

Hydatid disease

Hydatid ELISA is performed at HTD. The diagnosis should be considered in individuals who have visited an endemic area and have a space-occupying lesion in any organ, especially the liver. The diagnosis of hydatid disease depends upon a compatible clinical picture, serology and imaging.

Serological cross-reactions, giving rise to false positives, can occur with sera from patients with other parasitic infections, notably larval cestodes and filarial worms, and with some neoplasms. False negatives may occur and are more common in the case of non-hepatic hydatid cysts.

A minimum of 0.5ml of serum is required, CSF testing is available, please provide as much CSF as you are able to spare.

Aspiration of a cyst should be considered only after taking expert advice and, if felt to be indicated, should be conducted in a centre experienced in the management of hydatid disease. If viability is required the aspirate should be kept at room temperature and reach us with 24 hours.

If you have any queries concerning the diagnosis in a suspected case of hydatid disease, please contact us for advice.

Identification of Worms

Tapeworm segments for identification – please send in saline, DO NOT send in Formalin or other fixative as this prevents identification beyond genus.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 16 Author(s): Peter Chiodini, David Manser

Page 16 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

HIGH RISK stickers must be used if Taenia solium is suspected.

Other worms, part or whole, please send as they are or in saline, DO NOT send in formalin or other fixative.

Intestinal Helminthiasis

(Excluding Enterobius infections). Stool samples should be forwarded with the minimum delay. (A minimum of two separate samples should be examined before a diagnosis is excluded.)

Serology is NOT available for Ascaris, Anisakis, Capillaria, Clonorchis, or hookworm infections.

Intestinal Protozoa

(See also Amoebiasis, Giardiasis and Microsporidia).

Stool samples for the demonstration of trophozoites, cysts and oocysts should be forwarded with the minimum of delay.

Microsporidiosis from HIV positive patients

Requests for microsporidiosis should be clearly marked

Intestinal and tissue microsporidia are found almost exclusively in immunocompromised

patients. Stool, tissue and urine samples may be sent for examination as appropriate.

PCR is the preferred diagnostic tool, please see Microsporidia below No serology is available at HTD for these parasites

Leishmaniasis

For Diagnosis and Species Determination of Leishmania, please send:

Cutaneous and Mucocutaneous Leishmaniasis

Punch Biopsy; Take from the edge of the lesion. Place in viral transport media containing antibiotics, but not antifungals, and send to Parasitology at HTD. If histology is required take second biopsy, or cut original biopsy in half vertically through the epidermis and tissue. Put half in viral transport media (as above) for Parasitology at HTD and half in formal saline for histology.

Slit skin smears; Take from the edge of the lesion, onto a slide. Air dry and then fix with methanol.

PCR can be used to detect and speciate Leishmania from cutaneous cases. Contact microscopy section of laboratory for advice.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 17 Author(s): Peter Chiodini, David Manser

Page 17 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Visceral

Bone marrow or Splenic aspirate; Please send 2 methanol fixed slides and a small

amount (less than 1ml) of sample in a sterile EDTA tube ( e.g. Vacutainer purple top).

An attempt should always be made to find Leishmania from aspirated material (bone marrow or spleen) by microscopy or PCR - contact laboratory for advice.

For all of the above conditions.

Histology Sections; Please send at least 6 normal thickness sections on slides or in a

small screw capped tube.

Please do not send samples over the weekend.

Please send a travel history with all specimens.

Serology for Leishmania

For Serology a minimum or 0.5ml of serum is required.

Note: negative serology does not exclude the diagnosis of visceral leishmaniasis, particularly in sera from HIV positive patients.

Serology is not helpful in the diagnosis of cutaneous infections.

In mucocutaneous leishmaniasis serology is usually seropositive except in early cases.

A Direct Agglutination Test (DAT) for Leishmaniasis using formalinised promastigotes of Leishmania donovani stained with Coomassie blue is the standard serology test and a rapid test (rK39) antibody detection assay is also provided. The DAT is considered positive when the titre exceeds 1600 and in visceral leishmaniasis titres may rise to 51,000 or above. The rK39 test is reported as positive or negative, with no titre

available.

Microsporidia

The molecular test for microsporidial species offers several advantages over standard microscopy based diagnostics. The assay is significantly more sensitive (greater than one hundred fold improvement in the limit of detection) than light microscopy. In addition the assay is semi quantitative and can therefore reveal detailed information on the response of a patient’s parasitic load to subsequent drug therapy. Finally, the assay can differentiate between morphologically identical microsporidia, a feat only possible previously with electron microscopy. Therefore phenomena such as resistance of Enterocytozoon bieneusi to albendazole therapy can be considered in a real time process.

Stool samples for the molecular test must not be in any fixative as this may cause false negatives.

Microscopy can still be performed on corneal scrapes.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 18 Author(s): Peter Chiodini, David Manser

Page 18 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Malaria

Suspected malaria is a medical emergency.

The infection is best diagnosed by submitting a minimum of 2ml of EDTA anti-coagulated blood with the minimum of delay, so that thick and thin films can be made in the laboratory. A less satisfactory alternative is to submit stained thin blood films plus unstained thick films for examination. Delay in receipt of EDTA sample can adversely affect the integrity of the sample and consequently make accurate diagnosis difficult.

Antigen detection by immunochromatography is available on request. Malaria serology is not suitable for diagnosing current infection.

Malaria (past infection)

Serology for malaria may be requested:

1. If for some reason it is important to attempt a retrospective diagnosis.

2. For the investigation of splenomegaly or nephrotic syndrome in a patient who might have been exposed to malaria.

It is not recommended for the investigation of acute fever, as urgent blood film examination is the method of choice. An ELISA assay is performed using Plasmodium falciparum and vivax antigens. Positive results will be reported as an optical density and a cut-off point will be stated. A minimum of 0.5ml of serum or EDTA plasma is required.

Sera/plasma from suspected Tropical Splenomegaly Syndrome patients will be tested by IFAT if the ELISA is positive.

The malaria ELISA used at HTD cannot be used to speciate malaria infections.

Schistosomiasis

Definitive diagnosis is by demonstration of the characteristic ova in clinical material. For S. haematobium, a terminal urine sample (the last 10 to 20ml of urine passed) is required. Faecal samples are the best specimens for the detection of S. mansoni (and S. japonicum) but as S. mansoni and S. haematobium overlap in geographical distribution and can affect both genitourinary and alimentary systems a terminal urine sample and a minimum of three faecal samples should be sent from all patients being investigated for schistosomiasis when serology is positive. Biopsy material (unfixed) from rectum, sigmoid or bladder is valuable for the detection of ova by crush preparation and permits assessment of their viability. If biopsies are taken, fixed material should also be sent for histology. Rectal / sigmoid scrapings are also useful samples for the diagnosis of schistosomiasis. Such samples must be sent to the laboratory by prior arrangement only.

Serology:

A minimum of 0.5ml of serum is required.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 19 Author(s): Peter Chiodini, David Manser

Page 19 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

The test should be requested on patients known to have been exposed to fresh water in endemic areas. It starts to become positive approximately six weeks after exposure.

Deposition of ova commences at about this time but their first appearance (e.g. in urine) may be delayed for several months. Confirmation of the diagnosis by finding ova should be sought where possible.

The ELISA is reported to detect about 96% of Schistosoma mansoni and 92% of Schistosoma haematobium infections. The test does not distinguish active from treated infections. The actual time taken to become seronegative post treatment varies, but in some patients the test may remain positive for over two years after treatment.

Positive results are reported at Levels 1 to 6. Levels 1 and 2 are regarded as weak positives; Levels 5 and over are strong positives.

It is known that patients may become seropositive through contact with cercaria from animal species of schistosome and probably when harbouring unisexual infection with human species. The schistosomal egg antigen used in the ELISA may cross-react with the sera of trichinosis cases or with those of hepatitis cases in some instances.

Currently it is not possible to speciate using our serology ELISA test.

Strongyloides

Often associated with mild abdominal symptoms, strongyloidiasis is also an occasional cause of Loeffler’s syndrome and, in fulminating cases, may cause secondary bacterial septicaemia or meningitis.

Strongyloides is diagnosed by faecal microscopy and stool culture for the demonstration of larvae. The larvae may not be present in every specimen. Strongyloides larvae (and adults) can also be demonstrated in duodenal / jejunal aspirates. Duodenal string testing is more sensitive.

Faecal specimens should NOT be refrigerated before sending if Strongyloides culture is required.

Serology for strongyloidiasis (ELISA) is available. The test is indicated for the investigation of eosinophilia or if there is a good clinical history to suggest strongyloidiasis.

A minimum of 0.5ml of serum is required. There is known to be cross reaction between filaria and strongyloides in ELISA tests.

Toxocariasis

Serology is the method of choice for the diagnosis of toxocariasis. The ELISA is usually performed on serum, but can be undertaken on vitreous humour where appropriate. Please contact the serology section if you intend to send vitreous or aqueous fluids.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 20 Author(s): Peter Chiodini, David Manser

Page 20 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

A minimum of 0.5ml of serum is required.

The Toxocara IgG antibody ELISA test against larval excretory/secretory antigen is the most appropriate method for diagnosis. Sensitivity is 91% and specificity is 86% (with cross reactivity possible with strongyloidiasis, trichinosis, amoebiasis and fascioliasis). Results are expressed as an optical density value.

Positive ELISA tests will be confirmed using a Western blot.

A Negative ELISA on SERUM does not exclude ocular toxocariasis. Vitreous sampling may be necessary to exclude ocular toxocariasis.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 21 Author(s): Peter Chiodini, David Manser

Page 21 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Toxoplasmosis

Please refer samples to the Toxoplasma Reference Laboratory (TRL) at Singleton Hospital, Swansea. (General enquiries: 01792 285058)

Trichinosis

Crush preparations of fixed muscle biopsy specimens may reveal larvae. Biopsies should also be fixed and sent for histology. Serology is usually deployed for the diagnosis of this condition. A minimum of 0.5ml of serum is required.

Except in the rare event of an outbreak in the UK, serology is usually requested for symptoms suggestive of the stage of muscle encystment: myalgia, eosinophilia, and, in the early stages, fever. The IFAT (screening titre 1/32) has proved reliable and specific with positive titres of about 1/128.

Trypanosomiasis

African trypanosomiasis is caused by Trypanosome brucei rhodesiense or gambiense. This disease is restricted to Africa. Diagnosis is made by examining stained blood films or by antibody detection. CSF microscopy and serology may occasionally be required in cases with neurological involvement.

American trypanosomiasis (Chagas disease) is caused by Trypanosoma cruzi. Once confined entirely to the Americas it has now spread to other continents.

Diagnosis is made by examining stained blood films (taken within two months of infection the acute phase or reactivation in cases of immunosuppression) or by antibody detection at any time outside these periods.

Trypanosomes disintegrate rapidly on removal from the body, therefore it is vital that specimens for microscopy are examined rapidly. EDTA whole blood must be examined within 24 hrs and CSF within 20 minutes of taking the sample.

A minimum of 2ml of EDTA anti-coagulated blood and a minimum of 0.5ml of serum is required.

CSF testing is available, please provide as much CSF as you are able to spare.

Sera are screened by IFAT for Trypanosoma brucei. The usual titre for screening is 1/20.

An ELISA is used for screening and serodiagnosis of T. cruzi with IFAT performed on ELISA positive samples.

Please give the relevant travel history so that the appropriate species can be tested for.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 22 Author(s): Peter Chiodini, David Manser

Page 22 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Visceral Larva Migrans

Serology offers almost the only prospect of specific diagnosis. Requests should be made for tests for filariasis, strongyloidiasis and toxocariasis. A minimum of 0.5ml of serum is required.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 23 Author(s): Peter Chiodini, David Manser

Page 23 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

RETENTION OF SAMPLES

Please note that we do not keep all samples once tested so if extra tests are required please phone the laboratory at the earliest opportunity to request the additions, please see table below for approximate sample retention times:

Serum and CSF supernatant for serology tests

6 months unless specifically requested to be saved (or found to be positive)

Citrated blood for filarial microscopy

Discarded after filtration

EDTA Blood for microscopy

Forty eight hours

Body fluids inc semen

sputum

Aspirates

BAL

duodenal and jejunal

cyst fluids

stool

Urine

Perianal swab

48 hours after final report produced by Parasitology Laboratory

String test

Skin scrapes

Skin snips

Swabs

Rectal scrapes

Rectal snips

Sellotape slide

Discarded after processing and testing

Biopsies

Bone marrow

Slit skin smears

6 months (unless all sample used in testing)

Ectoparasites

Adult worms

1 year

Tapeworm Segments

48 hours after final report produced by Parasitology Laboratory

Ticks

Not kept (sent to ref lab for further ID)


Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 24 Author(s): Peter Chiodini, David Manser

Page 24 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

REPORTING TIMES FOR LABORATORY INVESTIGATIONS

The reporting time is defined as the period from the receipt and booking in of a specimen to the time the report is ISSUED to the individual requesting the test.

Clinically important requests will be given priority and the results telephoned to you at the earliest opportunity.

A table listing the range of tests for parasitic diseases that are undertaken in the Department of Clinical Parasitology is available as a separate turn around times document. Some tests are restricted to UCLH requests only.

Routine serological analyses are undertaken in batches.

The following serology tests are referred to the Mahidol University, Thailand.

* Angiostrongylus

* Paragonimus

We would hope for a 28 day turnaround from sending of a sample to another reference laboratory to receiving a result and reporting it on our computer system.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 25 Author(s): Peter Chiodini, David Manser

Page 25 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Section 6

Results and advisory service

For microscopy where possible, we aim to provide a 24-hour turnaround time, within the working week. All microscopy tests can be performed and reported by telephone within 24 hours of receiving a specimen if prior notice is given.

Telephoned results:

Results are telephoned under the following circumstances:

* If it is thought that a result might lead to an immediate change in patient management.

* If further information is required to decide whether the submitted sample should be processed further.

* If a telephoned result has been requested.

Results will usually be telephoned by the Specialist Registrar or by the individual who has performed the test, but if clinical advice is likely to be needed the call may be made by the Consultant Parasitologist or Deputy. If a telephone number, telephone extension or bleep number has been indicated on the report, the call will be made to that number.

Parasite Serology - Normal Reporting Practice

It is most economic to carry out serological tests in batches and, in general, serological tests are not necessarily performed as soon as a specimen is received. Most tests are batched weekly, thus when tests are carried out at the Department of Clinical Parasitology, written reports may not be available for eight days after the specimen has reached the laboratory. See the table published on the same web page as this manual for in laboratory turnaround times.

When several tests are to be carried out on the same specimen then reports are issued as results become available. Reports are not necessarily delayed to allow all tests to be reported at once.

If urgent results are required or if you want to know when a particular result will be available when please contact the laboratory (020 3447 5413).

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 26 Author(s): Peter Chiodini, David Manser

Page 26 of 27


This is a CONTROLLED document.

Any document appearing in paper form that is not printed on green paper is not controlled and should not be used.

Storage of Results

All records are currently maintained in the department for a minimum period of ten years.

Obtaining Results by Telephone

Although written reports are issued as soon as they are available, the laboratory is happy to make results available by telephone when these would be helpful. Users are asked to use this service only when necessary as it does delay the routine work of the laboratory.

UCLH information governance policy:

Wherever possible personal information should not be transferred by FAX. If, for reasons of urgency, it is necessary to use FAX, rather than mail or courier, the FAX should be sent to a designated Safe Haven. Therefore if we receive a request to fax results we require a safe haven fax number, and we will only fax results if a paper copy is required urgently.

Obtaining advice and information

If you need of advice on clinical interpretation of results, Professor P.L. Chiodini or the Specialist Registrar can be reached on 020 3447 5418 or 5809. If the advice relates to a particular result it is helpful if the clinical details and laboratory reference number are available.

For advice on the types of samples and containers appropriate for different tests please contact the Microscopy section on 020 3447 5414, or serology section on 020 3447 5413 or the Laboratory Manager on 020 3447 5411.

If you are unsure which of the above numbers is appropriate please telephone the laboratory general enquires number on 020 3447 5418 and the Department of Clinical Parasitology staff will put you in touch with the appropriate section.

Parasitology User Manual - Version: 8.0. Index: PARA-MM-UserManual. Printed: 04-Dec-2013 14:31

Authorised on: 03-Dec-2013. Authorised by: David Manser. Policy Unique Reference: 35-36738961. Due for review on: 10-Dec-2015 27 Author(s): Peter Chiodini, David Manser

Page 27 of 27



Milestone Systems

XProtect® VMS 2018 R2

Administrator Getting Started Guide

XProtect Professional

XProtect Express



Administrator Getting Started Guide | XProtect VMS 2018 R2

Contents

Guide contents 4

Installation 5

Getting started 6

About the Getting started page 6

Automatic configuration wizard 6

Automatic configuration wizard: First page 6

Automatic configuration wizard: Scanning options 6

Automatic configuration wizard: Select hardware manufacturers to scan for 6

Automatic configuration wizard: Scanning for hardware devices 7

Automatic configuration wizard: Continue after scan 7

Configure in Management Application 8

Licensing 8

Add hardware devices 8

Configure user access 9

Configure a Mobile server 9

Additional features 10

Upgrade from a previous version 11

Upgrade video device drivers 12

For more information 13

Index 14


ii | Contents


Administrator Getting Started Guide | XProtect VMS 2018 R2

Copyright, trademarks and disclaimer

Copyright  2018 Milestone Systems A/S

Trademarks

XProtect is a registered trademark of Milestone Systems A/S.

Microsoft and Windows are registered trademarks of Microsoft Corporation. App Store is a service mark of Apple Inc. Android is a trademark of Google Inc.

All other trademarks mentioned in this document are trademarks of their respective owners.

Disclaimer

This text is intended for general information purposes only, and due care has been taken in its preparation.

Any risk arising from the use of this information rests with the recipient, and nothing herein should be construed as constituting any kind of warranty.

Milestone Systems A/S reserves the right to make adjustments without prior notification.

All names of people and organizations used in the examples in this text are fictitious. Any resemblance to any actual organization or person, living or dead, is purely coincidental and unintended.

This product may make use of third-party software for which specific terms and conditions may apply. When that is the case, you can find more information in the file 3rd_party_software_terms_and_conditions.txt located in your Milestone system installation folder.


3 | Copyright, trademarks and disclaimer


Administrator Getting Started Guide | XProtect VMS 2018 R2

Guide contents

This guide briefly explains how to install your XProtect system as well as how to configure some of its basic features.

The guide is valid for:

* XProtect® Professional

* XProtect® Express

Check the Milestone website (http://www.milestonesys.com/downloads) for updates to make sure that you install the most recent version of your system.


4 | Guide contents


Administrator Getting Started Guide | XProtect VMS 2018 R2

Installation

Minimum system requirements

For information about system requirements for the various components of your system, read the release notes available on http://www.milestonesys.com.

Administrator rights

When you install your system, it is important that you have administrator rights on the computer that should run your system. If you only have standard user rights, you cannot configure the surveillance system.

Install the software

Prerequisites: Shut down any existing surveillance software.

1. Run the installation file. Depending on your security settings, you may receive one or more security warnings. Click the Run button if you receive a warning.

2. When the installation wizard starts, select language for the installer and then click Continue.

3. Select if you want to install a trial version of your system or indicate the location of your software license file.

4. Read and accept the license agreement, and indicate if you want to participate in the Milestone data collection program.

5. Select Typical or Custom installation. If you select Custom installation, you can select application language, which features to install and where to install them. Let the installation wizard complete.

You can now begin configuring your system through the Management Application.

If you are upgrading from a previous version, make sure you read the upgrade information in the Administrator Manual for the relevant XProtect Professional VMS product.



5 | Installation


Administrator Getting Started Guide | XProtect VMS 2018 R2

Getting started

About the Getting started page

The Getting started page is always shown when you open the Management Application. The Getting started page serves as a place of reference for users. It also provides different wizards that help to configure your surveillance system quickly. After you have run the wizards, it is likely that you need to fine-tune your system further. For more information, see the Advanced configuration chapter in the help.

Under the License heading in the bottom-left part of the page, you can get an overview of your system's hardware device licenses and your number of device changes without activation.

You can also access and view video tutorials that show and explain how to go through each step of your system's wizards. To access the video tutorials, click the View tutorials link in the bottom-right part of the page. The link takes you to an external web page with video tutorials for your system.

Automatic configuration wizard

The Automatic configuration wizard is for easy configuration for first time use of the system. Use the wizard to automatically add cameras to your system using this step-by-step procedure.

Automatic configuration wizard: First page

When you open the Management Application for the first time, the Automatic configuration wizard opens to guide you through the process of adding hardware devices to your system.

If you are new to the system, click Yes, configure to scan your network for available cameras and configure your system. To exit and use a more advanced way of adding devices to your system, click Skip to leave the wizard and go to the Management Application to get more options for setting up your system's device configuration.

Automatic configuration wizard: Scanning options

Choose where you want your system to scan for cameras and devices.

By default, the Scan local network checkbox is selected, which means that you only scan your local network for devices. However, if you know the IP address or a range of IP addresses to which cameras and devices are attached, specify these by clicking the Plus icon next to Add the IP addresses or IP ranges to be scanned. You can add more than one range of IP addresses if you need to.

Automatic configuration wizard: Select hardware manufacturers to scan for

If you know the specific manufacturer of your hardware device(s), select these in the dropdown on this page. You can select as many manufacturers as you want to.

Note: All manufacturers are selected by default. If you want to reduce the scanning time or know the specific manufacturers of your cameras, only select the checkboxes that represent these manufacturers.



6 | Getting started


Administrator Getting Started Guide | XProtect VMS 2018 R2

Automatic configuration wizard: Scanning for hardware devices

Scanning for hardware devices that match your selected manufacturers begins. A status bar indicates how far in the scan process you are. Once scanning for cameras and devices is complete, you may need to provide user name and password for your selected devices or cameras. When you have typed in the relevant credentials, click the Verify button to add the device to your system.

Note: Not all devices and cameras need a user name and password. You can add such devices to your system without any need to type in credentials.


Automatic configuration wizard: Continue after scan

Once you have added the number of devices and cameras you want to add, your system sets up storage for you. Storage is the location to which your system saves recordings. By default, your system chooses the location with most available disk space.

When the system has finished configuring storage, you are given the option to automatically add new cameras to your system as they are detected on the network. Enabling this allows you to set up your system so that any devices or cameras are automatically set up for you in the future as soon as they are connected to your network. Note that not all devices and cameras support automatic discovery.

If your device/camera does not show up automatically after you have connected it to your network, you must add it manually.

If a device/camera has been added to your system previously and you removed it, the device cannot be discovered automatically and you must add it manually.

To go directly to XProtect Smart Client once you have completed the wizard, select the check box in the bottom-left corner of the wizard page.


7 | Getting started


Administrator Getting Started Guide | XProtect VMS 2018 R2

Configure in Management Application

The Management Application is the server-side user interface. All management of your system is handled here.

Licensing

When you purchase your software and licenses, you receive:

    * An order confirmation.

    * A software license file named after your SLC (Software License Code) and with the .lic extension.

Your SLC is also printed on your order confirmation and consists of several numbers and letters grouped by hyphens like:

    * Product version 2014 or earlier: xxx-xxxx-xxxx

    * Product version 2016 or later: xxx-xxx-xxx-xx-xxxxxx

The software license file contains all information about your purchased VMS products and licenses. Milestone recommends that you store the information about your SLC and a copy of your software license file in a safe place from which you can find them again.

To get started, you download the software from our website. While you are installing the software, you are asked to provide the software license file. If you have not yet received the software license file, you can still install the software and run it for a 30-day trial period with a maximum of eight added cameras and a retention time of maximum five days. To continue using your system, you must import your software license file before the end of the trial period.

When the installation of your system is complete and you have added your cameras, encoders and other relevant hardware, you must activate your licenses. If your system is online, your licenses are activated automatically and only in a few scenarios, you need to activate them manually. If your system is offline and you have used all of your device changes without activation, you must manually activate your licenses each time you make changes that affect your use of your licenses. It is important that you activate licenses in a grace period before the grace period ends because the then unlicensed hardware stops sending data to the system.

When the installation is complete, please refer to the help for your Professional VMS product, for more information about:

    * how our license system works specific for your Professional VMS product

    * how you activate your licenses manually

    * when you need to activate your licenses manually even if your system is online

    * what device changes without activation is

    * where you see how many used and free licenses you have

Add hardware devices

To add more cameras after having run the Getting Started wizard, do the following:

    1. On the Getting started page, start the Add Hardware wizard.

    2. Select a hardware detection method, and follow the wizard.

8 | Configure in Management Application


Administrator Getting Started Guide | XProtect VMS 2018 R2

Before you add hardware devices, make sure you have configured their IP addresses, user name and passwords as described by the manufacturers.

Configure user access

To quickly and easily configure how client applications should access your system server, and which users should be able to use the client applications, start the Configure User Access wizard. Note that the wizard gives users access to all cameras on your system. If you require different rights for individual users, you should use advanced configuration instead:

* Under Advanced Configuration > Server Access, specify port number to use, whether you want clients to be able to access the system server from the Internet, how many clients you want to be able to connect simultaneously and more.

* Under Advanced Configuration > Users, configure settings and rights for client access. You can add users from Active Directory, which allows you to use your organization's existing user data.

Configure a Mobile server

A Mobile server handles log-ins when a user wants to log into his/her XProtect surveillance setup via the XProtect Web Client, or the Milestone Mobile client from a mobile device.

Upon correct login, the Mobile server distributes video streams from relevant recording servers to XProtect Web Client or Milestone Mobile client. This offers an extremely secure setup, where recording servers are never connected to the Internet. When a Mobile server receives video streams from recording servers, it also handles the complex conversion of codecs and formats allowing streaming of video on the mobile device.

Add a Mobile server:

1. Go to Servers > Mobile Servers. From the menu that appears, select Create New. Fill in/edit the needed properties.

Important: If you edit settings for Login method, All cameras view and Outputs and events, while you are connected to the Milestone Mobile client, you must restart the Milestone Mobile client for the new settings to take effect.

Delete a Mobile server:

1. Expand Servers > Mobile Servers in order to see existing servers.

2. Right-click the unwanted server and select Delete. Click Yes.

Rename a Mobile server:

1. Expand Servers > Mobile Servers in order to see existing servers.

2. Select the required Mobile server.

3. On the Info tab, which opens once the Mobile server is selected, change the name of the server by typing in the Server name and Description fields.

     4. In the lower right corner, click Apply. 9 | Configure in Management Application


Administrator Getting Started Guide | XProtect VMS 2018 R2

Additional features

XProtect Download Manager

Manage which system features your organization's users can access from a targeted welcome page on the surveillance system server. Access XProtect Download Manager from Windows' Start menu. XProtect Download Manager comes with a default configuration ensuring that users get access to the XProtect Smart Client. To make special language versions, plug-ins or similar available to users.

Matrix

The Matrix feature allows distributed viewing of live video from any camera to any Matrix recipient on a network operating with your system. A computer on which you can view Matrix-triggered video is known as a Matrix recipient. In order to become a Matrix recipient, the computer must have XProtect Smart Client installed.

Built-in help system

To access the help system from anywhere within the Management Application, click the Help button in the toolbar or press F1 on your keyboard.


10 | Additional features


Administrator Getting Started Guide | XProtect VMS 2018 R2

Upgrade from a previous version

You can upgrade your entire system configuration from one version to another. The following information applies if you upgrade from one version of a product to another version of the same product and if you upgrade to one XProtect product from another streamlined XProtect product.

When you install the new version of your system, it inherits the configuration from your previous version. Milestone recommends that you make regular backups of your server configuration as a disaster recovery measure. You should also do this when you upgrade your server. While it is rare that you lose your configuration (cameras, schedules, views, and more), it can happen under unfortunate circumstances. Fortunately, it takes only a minute to back up your existing configuration.

Back up configuration

The following describes backup of the configuration in XProtect Professional VMS 7.0 and onwards. If you need information about how to back up configuration from an earlier version, see the relevant Administrator's Manual for your XProtect product.

In the following, we assume that you have not changed the system's default configuration path, which is C:\Program Data\Milestone\Milestone Surveillance on servers running all supported operating systems. If you have changed the default configuration path, you must take your changes into consideration when using the method described in the following.

1. Make a copy of the folder C:\Program Data\Milestone\Milestone Surveillance and all of its content.

2. Open the folder C:\Program Files\Milestone\Milestone Surveillance\devices, and verify if the file devices.ini exists. If the file exists, make a copy of it. The file exists if you have configured video properties for certain types of cameras. For such cameras, changes to the properties are stored in the file rather than on the camera itself.

3. Store the copies away from the server, so that they are not affected if the server is damaged, stolen or otherwise affected.

Remember that a backup is a snapshot of your system configuration at the time of backing up. If you later change your configuration, your backup does not reflect the most recent changes. Back up your system configuration regularly.

When you back up your configuration as described, the backup includes restore points. This allows you to not only restore the backed-up configuration, but also to revert to an earlier point in that configuration if you need to.

Restore configuration

If you need to restore your system configuration, do the following:

1. Copy the content of the backed-up Milestone Surveillance folder into C:\Program Data\Milestone\Milestone Surveillance.

2. If you backed up the file devices.ini, copy the file into C:\Program Files\Milestone\Milestone Surveillance\devices.


11 | Upgrade from a previous version


Administrator Getting Started Guide | XProtect VMS 2018 R2

Upgrade video device drivers

1. On the system server on which you want to install the new video device drivers version, shut down any running surveillance software, including any running Recording Server service.

2. Run the XProtect Device Pack installation file and follow the wizard.

3. When the wizard is complete, remember to start the Recording Server service again.

Video device drivers are installed automatically during the initial installation of your system. New versions of video device drivers are collected in device packs which are released from on a regular basis and made available for free on the Milestone website (http://www.milestonesys.com) (within the same product version).

Milestone recommends that you always use the latest version of video device drivers. When you update video device drivers, you can install the latest version on top of any version you may have installed.

IMPORTANT: When you install new video device drivers, your system cannot communicate with camera devices from the moment you begin the installation until the moment installation is complete and you have restarted the Recording Server service. This process usually takes no longer than a few minutes, but Milestone recommends that you perform the update at a time when you do not expect important incidents to take place.




12 | Upgrade video device drivers


Administrator Getting Started Guide | XProtect VMS 2018 R2

For more information

For information about how to back up and upgrade your system as well as how to change advanced settings in your system, read the Administrator's Guide for your relevant XProtect product. You can always find the latest Administrator Guides at the Milestone website (http://www.milestonesys.com/support/manuals-and-guides/).


13 | For more information


Administrator Getting Started Guide | XProtect VMS 2018 R2

Index

A

About the Getting started page • 6

Add hardware devices • 8

Additional features • 11

Automatic configuration wizard • 6

Continue after scan • 7

First page • 6

Scanning for hardware devices • 7

Scanning options • 6

Select hardware manufacturers to scan for • 6

C

Configure a Mobile server • 9

Configure in Management Application • 8

Configure user access • 9

Copyright, trademarks and disclaimer • 3

F

For more information • 14

G

Getting started • 6

Guide contents • 4

I

Installation • 5

L

Licensing • 5, 8

U

Upgrade from a previous version • 12

Upgrade video device drivers • 13


14 | Index




Convercent Predictive Analytics

Innovation in User Experience for Issue Reporting & Management



SOLUTIONPERSPECTIVE

Governance, Risk Management & Compliance Insight




© 2015 GRC 20/20 Research, LLC. All Rights Reserved.

No part of this publication may be reproduced, adapted, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of GRC 20/20 Research, LLC. If you are authorized to access this publication, your use of it is subject to the Usage Guidelines established in client contract.

The information contained in this publication is believed to be accurate and has been obtained from sources believed to be reliable but cannot be guaranteed and is subject to change. GRC 20/20 accepts no liability whatever for actions taken based on information that may subsequently prove to be incorrect or errors in analysis. This research contains opinions of GRC 20/20 analysts and should not be construed as statements of fact. GRC 20/20 disclaims all warranties as to the accuracy, completeness or adequacy of such information and shall have no liability for errors, omissions or inadequacies in such information. Although GRC 20/20 may include a discussion of related legal issues, GRC 20/20 does not provide legal advice or services and its research should not be construed or used as such.

©2015 GRC 20/20 Research, LLC; Resdistribution License Granted to Convercent 2



Table of Contents

The Need for 360° Contextual Awareness of Compliance 4

Compliance & Ethics in the Past 4

Compliance Today 5

Convercent Predictive Analytics 7

Innovation in User Experience for Issue Reporting & Management 7

What the Predictive Analytics Innovation Is About 7

How Is the Predictive Analytics Innovation Different? 8

Benefits of the Predictive Analytics 8

Considerations in Context of Predictive Analytics 9

About GRC 20/20 Research, LLC 10

Research Methodology 10


TALK TO US . . .


We look forward to hearing from you and learning what you think about GRC 20/20

research. GRC 20/20 is eager to answer inquiries from organizations looking to improve GRC

related processes and utilize technology to drive GRC efficiency, effectiveness, and agility.



©2015 GRC 20/20 Research, LLC; Resdistribution License Granted to Convercent 3



Convercent Predictive Analytics

Innovation in User Experience for Issue Reporting & Management

The Need for 360° Contextual Awareness of Compliance

Compliance and ethics is not the same today as it was a few years ago, and it’s safe to say that it will continue to evolve. The trends and forces shaping transformation in compliance are likely to continue to influence the trajectory of compliance and ethics for years to come.

Compliance & Ethics in the Past

In the past, compliance and ethics were manual and disconnected. Organizations may have had a centralized compliance function to manage critical compliance issues bearing down on the organization, but compliance in reality was fragmented and distributed across the organization with highly redundant approaches taxing the business. This approach to compliance was a tactical one focused on checkboxes and rules. The mentality was, “Show me what I have to do to get by, let me check those boxes, and then give me a get-out-of-jail-free card.”

The result was a maze of disconnected processes, reporting, and information. Compliance created redundant, document-centric, and manual approaches that did not integrate well with each other and were highly inefficient for the organization. Compliance functions spent more time managing the volume of documents than it did actually managing and improving compliance. The line of business was overwhelmed with inconsistent approaches to policies and procedures, issue/incident reporting, and self-assessments.

Like the multi-headed Hydra in mythology, these redundant, manual, and document-centric approaches of the past were ineffective. As the Hydra grows more heads of regulation, ethical challenges, and obligations, scattered compliance information overwhelmed and exhausted compliance professionals as they were losing the battle against the “Hydra of Compliance.” These problems led to a reactive approach to compliance, with silos of compliance data that compliance professionals could never find the time to coordinate and link together manually. This piecemeal approach increased inefficiencies and the risk that serious matters could fall through the cracks. The redundant and inefficient processes led to overwhelming complexity that slowed the business, even as the business environment required more agility.

The document-centric, scattered, and manual processes of the past have impaled compliance with inefficiency. With reporting that is primarily comprised of emails, documents, shared files, spreadsheets, and manual processes, compliance professionals

©2015 GRC 20/20 Research, LLC; Resdistribution License Granted to Convercent 4



are spending a disproportionate amount of time collecting data, versus time spent adding strategic value to the business through analyzing and trending the data collected. Compliance departments often express to GRC 20/20 Research their frustration with the:

* Inability to gain a clear view of compliance dependencies

* High cost of consolidating silos of compliance information

* Difficulty maintaining accurate compliance information

* Failure to trend across compliance assessment/reporting periods

* Incapability of providing compliance intelligence to support business decisions and strategic planning

* Redundant approaches that limit correlation, comparison, and integration of information

* Lack of agility to respond promptly to changing regulations, laws, and situations

This antiquated approach leaves compliance teams with flat metrics that lack context and don’t help compliance professionals identify or address problematic culture or behavioral issues.

Compliance Today

Too often today, compliance and ethics efforts are reactive rather than proactive. Regulations and guidelines are designed to prevent last year’s scandal from repeating itself and compliance activities are largely reduced to confirming that they have “checked all the boxes.” Absent is a forward-looking perspective that identifies and mitigates potential ethics, compliance and reputational risks. Without this forward-looking approach, ethics and compliance efforts can never be part of the strategic planning process but will instead be derided as “corporate cop” activities.

Organizations today are distributed and dynamic. With the globalization of business, compliance and ethics have become complex, crossing jurisdictions, geographies, and cultures. This is complicated by the distributed nature of the modern organization, as it is a complex web of employees, suppliers, vendors, contractors, consultants, agents, and third parties. At the same time, organizations are constantly changing: business is dynamic. Employees, relationships, regulations, risks, economies, litigation, regulation, and legislation are constantly changing. Compliance and ethics have become moving targets. Last year’s compliance program will not work this year, and this year’s will not work next year.

Compliance and ethics today is in the midst of transformation. The pressure upon organizations is requiring them to rethink their approach to and role of compliance across the organization. Organizations are looking for greater compliance agility and effectiveness, while achieving greater efficiency with human and financial resources.

©2015 GRC 20/20 Research, LLC; Resdistribution License Granted to Convercent 5


Organizations are seeing increased scrutiny and focus on compliance and ethics activities from several sources:

* Governments worldwide are increasing their scrutiny of organizations and have become more prescriptive in their ethics and compliance standards.

* Enforcement agencies have grown more sophisticated in assessing “real” versus “paper ” ethics and compliance efforts.


* Stakeholders, including investors, activist groups, consumers, business partners, and employees, are demanding transparency and accountability.

With increased enforcement actions, organizations are seeing greater challenges to managing and monitoring their risk of compliance and ethical misconduct. There is a shift from the check-box/rule-based compliance mentality to increasing focus on compliance intelligence. Organizations want to provide 360° contextual intelligence and awareness of compliance information. Compliance is no longer the “corporate cop,” as it shifts to focus on the integrity of the organization. Compliance and ethics are becoming how we do business as opposed to obstacles to business. As a result, organizations have been integrating the role of ethics and compliance into a Chief Ethics and Compliance Officer (CECO) role that coordinates compliance and ethics across the organization.

Compliance data needs to become federated into a compliance intelligence and analytics warehouse to overcome the inefficiencies of the manual and document-centric approaches of the past. These trends point in one clear direction, toward a new ethics and compliance architecture that is dynamic, predictive, and information-based. That is, a new model for ethics and compliance that:

* Aligns with stakeholder demands for transparency and accountability

* Functions as a strategic partner with the business, executives, and the board

* Leverages emerging technologies to improve efficiency, effectiveness, and agility

* Enables ethics and compliance practitioners to better target their resources.

The result is a new approach to ethics and compliance that will not only deliver demonstrable proof of compliance, but at the same time will shift the focus of efforts from being reactive and “checking the box” to being proactive and forward-looking. This shift enables compliance organizations to have greater efficiency in processing and managing information, effectiveness in ensuring corporate integrity, and agility in addressing rapidly changing business, regulatory, legal, and reputational risks.

The bottom line: Compliance programs have been very tactical in the past in managing requirements, putting processes in place, communicating policies, conducting training, reporting and investigating incidents, and more. What compliance programs have often lacked is overall reporting and analytics that move compliance from the tactical approach to the strategic approach.

©2015 GRC 20/20 Research, LLC; Resdistribution License Granted to Convercent 6



Convercent Predictive Analytics

Innovation in User Experience for Issue Reporting & Management

Convercent’s Predictive Analytics is a GRC solution that GRC 20/20 has researched, evaluated, and reviewed with organizations that are using it in changing, distributed, and dynamic business environments. GRC 20/20 has evaluated and verified the innovation in Predictive Analytics and finds it to be a compelling compliance data analytics and reporting platform that delivers actionable insight and intelligence into compliance issues and trends enabling 360° contextual awareness of compliance. In this context, GRC 20/20 has recognized Convercent’s Predictive Analytics with a 2015 GRC Innovation Award for the best user experience in Issue Reporting & Management in 2015.

What the Predictive Analytics Innovation Is About

Convercent’s Predictive Analytics has been deployed in enterprise organizations across a range of high-risk industries. These organizations were looking to move beyond simple metrics in their tactical compliance programs of the past to take on a strategic and integrated view of compliance information through an advanced reporting and analytics platform they found in the Predictive Analytics solution.

Convercent, through the Predictive Analytics solution, has enabled the evolution of compliance reporting and analytics with a solution built specifically for compliance practitioners that provides the depth and richness executives and board members need and expect in order to fulfill their fiduciary obligations to govern compliance in the organization.

Compliance Officers have been bringing the same metrics to board meetings for years, always with the fear that they will be asked for the “why?” behind changes and trends in metrics. Predictive Analytics enables compliance professionals to report on and analyze hotline reports, disclosures, policy attestations, and training completions in an integrated environment and see links to behavior across these areas. Convercent’s Analytics platform provides compliance professionals the ability to arm themselves with the “why?” behind changes to metrics so they can answer the questions of executives and the board.

Convercent has invested in architecting a compliance data warehouse and data mart infrastructure that underpins the dashboards and reports to deliver on compliance intelligence and agility to the organization. These data structures not only support the integrated capabilities of compliance analytics and reporting, but also provide point in time slicing of the data to enable historical reporting.

GRC 20/20 finds that Convercent’s Predictive Analytics solution:

? Provides rich analytical dashboards because of the investment made in creating a fully integrated compliance platform that is further enhanced by underlying semantic technologies.

©2015 GRC 20/20 Research, LLC; Resdistribution License Granted to Convercent 7



* Enables the creation of interactive dashboards that provide insights into

correlations and causality across multiple aspects of human behavior.

* Delivers integration and insight through connectors to external business systems (e.g., human resource systems, expense management systems) to provide additional attributes that can be leveraged in compliance analytics and reporting.

How Is the Predictive Analytics Innovation Different?

With this new level of analytics and reporting, compliance professionals are able to understand and be intelligent about changes in compliance metrics by pulling together multiple layers of information from compliance data, company data, and external data to get a richer view of what is behind the behavior, compliance issues, and incidents across the organization. The combination of different data points that were trapped in silos in the past now work together to enable compliance professionals to collect the right type of data and accurately pinpoint the true cause of issues. Not only does this save a team time and effort, but decisions are made proactively instead of reactively since they can make informed decisions that targets the root cause and underlying behavioral and environmental drivers of compliance risk and misconduct.

With this level of analytics and reporting, Predictive Analytics enables compliance professionals to start slicing and dicing compliance data of conflicts disclosed, incidents involved in, training completed, policy attested to, and other employee data points to accurately pinpoint the true cause of an issue. In addition, Predictive Analytics allows compliance professionals to continue to drill down into information to be intelligent and understand the motivation behind employee behavior and non-compliance. Not only does this help compliance focus their efforts where actually needed, but also provides them correlations and guidance on what to focus on instead of blindly creating more policies and procedures.

Benefits of the Predictive Analytics

Organizations are looking for a more effective way to report on compliance programs. Stakeholders and regulators are demanding greater proof of compliance and transparency into compliance. Compliance executives are expected to bring real intelligence to demonstrate and bolster the value of compliance to business performance through reporting and analytics.

As compliance programs mature, compliance professionals need to understand that they must move beyond the basic practices of standing up a program. Implementing a hotline and monitoring the number and types of calls used to be a key element of a successful compliance program, but is no longer enough. Compliance must set up a hotline, monitor reports to ensure the hotline is being used and then take the next steps of analyzing the types of reports being made, where they are coming from, what policies and training courses they’re topically linked to and ultimately attempt to pinpoint the root cause of that report to identify any program weaknesses and be able to accurately communicate to the board of directors the true health and effectiveness of the program.

©2015 GRC 20/20 Research, LLC; Resdistribution License Granted to Convercent 8



GRC 20/20 finds that Convercent’s Predicative Analytics provides a deeper and intelligent understanding of what is happening throughout the organization in context of compliance. This delivers a 360° contextual awareness of compliance across compliance activities and employee behavior. With these analytics, compliance professionals can answer those hard questions like “What areas of our organization have elevated FCPA risk?” or “Have we been consistent in applying sanctions across the organization and its operations?” Bottom line: By having everything integrated in one Predictive Analytics platform to see correlations, patterns, and a 360° contextual awareness of compliance information and employee behavior, compliance professionals are able to make faster and better decisions to mitigate compliance and ethics risk.

Some specific benefits of this innovation include:

* Provides 360° contextual awareness of compliance that enables compliance executives with the ability to arm themselves with the answers before they go meet with the board.

* Shifts compliance reporting from being reactive to cohesive, predictive,

proactive, and preventative.

* Deep analytics and reporting that enable better compliance-informed business decisions.

* Enhanced ability to monitor and mitigate compliance risk, potentially preventing a costly instance of misconduct by understanding the correlations of information and behavior throughout the organization.

Considerations in Context of Predictive Analytics

Every solution has its strengths and weaknesses, and may not be the ideal fit for all organizations in all situations. While GRC 20/20 has identified many positive attributes of Convercent’s Predictive Analytics to enable compliance programs to be intelligent and informed about the relationships of information across the enterprise, readers should not see this as a complete and unquestionable endorsement of Convercent’s Predictive Analytics.

Overall, clients have shown a high degree of adoption and satisfaction with their use and implementation of Predictive Analytics, which has delivered on their expectations of compliance intelligence through advanced compliance analytics and reporting. Clients have a lot of positive feedback on Convercent as a company as well as the Predictive Analytics solution and find it to be an easy to use and adaptable solution for their compliance intelligence, analytics, and reporting needs.

©2015 GRC 20/20 Research, LLC; Resdistribution License Granted to Convercent 9


About GRC 20/20 Research, LLC

GRC 20/20 Research, LLC (GRC 20/20) provides clarity of insight into governance, risk management, and compliance (GRC) solutions and strategies through objective market research, benchmarking, training, and analysis. We provide objective insight into GRC market dynamics; technology trends; competitive landscape; market sizing; expenditure priorities; and mergers and acquisitions. GRC 20/20 advises the entire ecosystem of GRC solution buyers, professional service firms, and solution providers. Our research clarity is delivered through analysts with real-world expertise, independence, creativity, and objectivity that understand GRC challenges and how to solve them practically and not just theoretically. Our clients include Fortune 1000 companies, major professional service firms, and the breadth of GRC solution providers.

Research Methodology

GRC 20/20 research reports are written by experienced analysts with experience selecting and implementing GRC solutions. GRC 20/20 evaluates all GRC solution providers using consistent and objective criteria, regardless of whether or not they are a GRC 20/20 client. The findings and analysis in GRC 20/20 research reports reflect analyst experience, opinions, research into market trends, participants, expenditure patterns, and best practices. Research facts and representations are verified with client references to validate accuracy. GRC solution providers are given the opportunity to correct factual errors, but cannot influence GRC 20/20 opinion.


GRC 20/20 Research, LLC

4948 Bayfield Drive Waterford, WI 53185 USA +1.888.365.4560 info@GRC2020.com www.GRC2020.com


CLINICAL GUIDELINE




NASPGHAN Practice Guidelines: Diagnosis

and Management of Hepatitis C Infection in

Infants, Children, and Adolescents

           *Cara L. Mack, tRegino P. Gonzalez-Peralta, }+Nitika Gupta, §Daniel Leung, *Michael R. Narkewicz, llEve A. Roberts, ¶Philip Rosenthal, and #Kathleen B. Schwarz

ABSTRACT


Hepatitis C virus (HCV) is an RNA virus that affects >180 million individuals worldwide with a high propensity for chronic infection. Children with HCV infection differ from adults in several ways including some modes of transmission, rates of clearance, progression of fibrosis, and the duration of potential chronic infection when acquired at birth. Since the discovery of HCV in 1989, there have been significant advances in the understanding of the virology and natural history of chronic HCV infection in children. In addition, there are now several treatment options for children with chronic hepatitis C infection and many new therapies on the horizon. As a consequence, the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition brought together experts in pediatric hepatology to review the available data in children and provide clinicians with approaches to the diagnosis, management, and prevention of HCV infection in children and adolescents. The guideline details the epidemiology and natural history of HCV infection in children, the diagnostic workup, monitoring and treatment of disease, and provides an update on future treatment options and areas of research.

Received March 5, 2012; accepted March 7, 2012.

From the *Section of Pediatric Gastroenterology, Hepatology & Nutrition, Digestive Health Institute, Pediatric Liver Center, University of Colorado School of Medicine and Children’s Hospital Colorado, Aurora, CO, the tDivision of Pediatric Gastroenterology, Hepatology, and Nutrition, University of Florida College of Medicine and Shands Hospital for Children, Gainesville, FL, the }+Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Emory University School of Medicine and Transplant Services, Children’s Healthcare of Atlanta, Atlanta, GA, the §Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Texas Children’s Hospital, Baylor College of Medicine, Houston, TX, the llDivision of Gastroenterology, Hepatology, and Nutrition, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada, the ¶Division of Pediatric Gastroenterology, Hepatology, and Nutrition, University of California, San Francisco, CA, and the #Division of Pediatric Gastroenterology and Nutrition, Pediatric Liver Center, Johns Hopkins Children’s Center, Baltimore, MD.

Address correspondence and reprint requests to Cara L. Mack, MD, Children’s Hospital Colorado, Aurora, CO 80045 (e-mail: cara.mack@ childrenscolorado.org).

Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Website (www.jpgn.org).

The authors report no conflicts of interest.

Copyright # 2012 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition

DOI: 10.1097/MPG.0b013e318258328d 


Key Words: chronic hepatitis, infectious hepatitis, interferon therapy, pediatric liver disease

(JPGN 2012;54: 838–855)

H

epatitis C virus (HCV) is an RNA virus that affects >180 million individuals worldwide with a high propensity for chronic infection (www.who.int/immunization/topics/hepatitis). The overall prevalence of hepatitis C antibody positivity is estimated to be about 1% to 1.5% in North America (1). Recent data from NHANES3 suggest that 0.17% of 6- to 11-year-olds are HCV antibody–positive (31,000) and 0.39% of 12- to 19-year olds are positive (101,000). Chronic HCV infection (chronic hepatitis C [CHC]) is estimated to affect 0.1% to2% of children depending on the population and risk factors in the children (1), affecting an estimated 23,000 to 46,000 children in the United States (2) and 6600 in Canada (3). The prevalence of CHC in individuals older than 6 years in the United States has slightly decreased from 1.8% in 1988–1994 to 1.3% in 2007–2008 (4). Interestingly, the prevalence of CHC in Mexico appears to be lower (overall population prevalence of 0.36%), but there are no pediatric-specific data available (5). Thus, HCV infection is an important problem for pediatric gastroenterologists and hepatologists.

     Children with HCV infection differ from adults in several ways including some modes of transmission, rates of clearance, progression of fibrosis, and the duration of potential chronic infection when acquired at birth. Vertical transmission of HCV infection is the most common route of acquiring HCV in infants and children and there are approximately 7500 new cases in the United States per year from vertical transmission. There is a significant economic effect from pediatric HCV infection. Ten-year costs associated with pediatric HCV infection were recently estimated to be $199 to $336 million (2). There is also a significant effect on death with a 26-fold increased risk of liver-related death associated with CHC acquired in childhood (6). Since the discovery of HCV in 1989, there have been significant advances in the understanding of the virology and natural history of chronic HCV infection in children. In addition, several treatment options are now available for children with CHC and many new therapies on the horizon. As a consequence, the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) brought together experts in pediatric hepatology to review the available data in children and provide clinicians with approaches to the diagnosis, management, and prevention of HCV infection in children and adolescents. In addition, this group sought to identify gaps in knowledge to inform a pediatric HCV research agenda.

     These guidelines apply to children living in North America, but not necessarily to those living in other continents, particularly in


  838 JPGN • Volume 54, Number 6, June 2012 Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


JPGN • Volume 54, Number 6, June 2012 Pediatric Hepatitis C Infection


developing countries with limited resources for health care. The guidelines may need to be adapted to national health care systems because certain tests or treatment regimens may not be available and/or reimbursed by health insurance programs.

SELECTION OF TOPICS AND PATIENTS

     In 2010, NASPGHAN developed a pediatric HCV guidelines working group. Areas of interest were identified, and small groups were assigned to each area. The areas of interest included epidemiology, diagnosis, monitoring, anticipatory guidance and disclosures, treatment, side effects of treatment and monitoring for adverse events, special populations, outcome of therapy, and future therapies. There are a number of significant differences between HCV infection in the pediatric and adult populations. Perhaps one of the most important differences is the issue of maternal–fetal transmission. Although the majority of HCV-infected women do not transmit the virus to the offspring, uncertainty and guilt always surround possible transmission. The issue of whether or not to breast-feed is another concern as is the issue of disclosure. What people with whom the HCV-infected child interacts should be told about the infection? What are the legal rights of the child and caregivers in regard to disclosure? The child with CHC is frequently stigmatized; how should this issue be addressed? Can the child with CHC play sports without disclosing the HCV status? Although children with CHC generally have a mild course of liver disease during childhood, there is still concern for cirrhosis, liver transplantation, and cancer in the future. There may be age-related differences in response to treatment, as well as in compliance and tolerance to therapy. Finally, there is the worrisome question of the effect of HCV infection on the developing brain.

     Pediatric patients (age bracket: 0–18 years) with CHC or at risk for HCV infection were identified as the target population. For issues that primarily affect adults with small overlap in the adolescent population, such as the role of intravenous drug use (IVDU) and subsequent acute HCV, the committee deferred to the recently published adult guidelines of the American Association for the Study of Liver Diseases (AASLD) due to limited data in children (7). The primary target audiences for these NASPGHAN guidelines are primary care providers caring for children, pediatric gastroenterologists and hepatologists, and pediatric infectious disease specialists. The secondary target audiences for these guidelines include, but are not limited to, adult gastroenterologists and hepatologists, other pediatric and adult subspecialists with high chance for contact with patients affected by chronic viral hepatitis, nurses, and obstetricians.

LITERATURE SEARCH

     A systematic literature search was performed using accessible databases of relevance: PubMed, MEDLINE, EMBASE, Cochrane Library, Biosis Previews, EBM Reviews, ISI Web of Science, and Scopus including publications from 1990 to January 2011 by the small groups for the selected topics. The search included publications of all of the types presenting or reviewing data on HCV infection in patients younger than 18 years.

GRADES OF EVIDENCE

     Grades of evidence for each statement were based on the grading of the literature and were assigned using the AASLD Practice Guidelines method: Grading of Recommendation Assessment, Development, and Evaluation workgroup with minor modifications (8). The strength of recommendations in the Grading of Recommendation Assessment, Development, and Evaluation system was classified as outlined in Table 1. The Working Group 


also applied the grading system used by the International Maternal Pediatric Adolescent AIDS Clinical Trial group that allows a comparative ranking between adult and pediatric studies (Table 1).

EPIDEMIOLOGY

Definitions

     Nomenclature in this practice guideline conforms broadly to standard usage; however, as with other pediatric liver diseases, some definitions require additional specification and are summarized in Table 2. The liver diseases caused by HCV infection are acute hepatitis C (AHC) and CHC. Although AHC is not the subject of this practice guideline, it is relevant to neonates and individuals at risk for acute infection. Symptomatic AHC has been defined as the onset of acute hepatitis (alanine aminotransferase [ALT] >10x normal) in an individual without previously known liver disease or other reason for acute liver disease, associated with detectable HCV RNA in the first serum sample and the development of anti-HCV antibody (9). AHC is frequently asymptomatic and not perceived clinically. Neonatal hepatitis C infection is defined as detectable HCV RNA in an infant’s blood in the first 1 to 6 months of life, typically in the context of maternal-to-infant transmission of HCV infection. Resolution of neonatal HCV infection frequently occurs (10). Neonatal HCV infection must be distinguished from perinatal transient viremia in which HCV RNA is detected in peripheral blood within 0 to 5 days of birth (10); with respect to this transient viremia, detection of HCV RNA in cord blood is irrelevant. The definition of chronic HCV infection applies to adults and children: evidence of active viral infection with detectable HCV RNA for at least 6 months. The designation of CHC implies ongoing liver injury, which can be mild. The outcome variable of greatest interest in the pediatric age-bracket is resolution of infection. The definition is independent of having detectable anti-HCV antibody, which is a sentinel antibody and bears no relation to disease status. Resolution of CHC may be spontaneous or treatment-induced. Spontaneous resolution of chronic HCV infection is when an individual who had CHC loses detectable serum HCV RNA without any treatment (2 negative HCV RNA tests at least 6 months apart) (11).

Pathobiology of HCV

     HCV is an RNA virus within the Flaviviridae family, which includes yellow fever virus, West Nile virus, dengue virus, and others. It occupies its own genus (Hepacivirus) and there are 6 main types, clinically known as genotypes. The metabolic effects and susceptibility to antiviral drugs vary between genotypes (12). Approximately, 1010 to 1012 viral genomes are produced each day in a chronically infected person. The viral genome encodes only 9 proteins, including its own RNA polymerase. This RNA polymerase is greatly error prone with an error rate estimated at 2 x 10-3 base substitutions per genome site per year. Because of the high error rate of the HCV RNA polymerase, many variant viruses known as “quasispecies”are produced and confer a survival

advantage to HCV. In present usage clinically, “quasispecies”refers to the collection of variant HCVs in an individual, but it can

also refer to the individual variants themselves, similar to its original usage biochemically. Extremely young infants infected with HCV by vertical transmission show changes in the composition of the infant’s HCV quasispecies including new variants that were never found in the maternal quasispecies (13). Young children with CHC due to vertical transmission show differences in the natural history of their liver disease, which reflect changes in the composition of their quasispecies compared with the maternal quasispecies, in part because of interaction with their own host


   www.jpgn.org 839 Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


Mack et al JPGN • Volume 54, Number 6, June 2012

TABLE 1. Grading systems for recommendations

Grading of recommendations, assessment,

development and evaluation (GRADE) Criteria

Strength of recommendation

Strong [1] Factors influencing the strength of the recommendation included the quality of the evidence, presumed patient-important outcomes, and cost

Weak [2] Variability in preferences and values, or more uncertainty. Recommendation is

made with less certainty, higher cost, or resource consumption

Quality of evidence

High [A] Further research is unlikely to change confidence in the estimate of the clinical effect

Moderate [B] Further research may change confidence in the estimate of the clinical effect

Low [C] Further research is extremely likely to effect confidence on the estimate of clinical effect

IMPAACT pediatrics grading system Quality of evidence for recommendation

TABLE 2. Definitions used in practice guideline

Terminology Definition

Infection with hepatitis C Documentation of HCV RNA presence in the blood

Acute hepatitis C Development of acute infection with HCV in a patient known to be negative in the previous 6 mo and evidence for hepatitis

Chronic hepatitis C Evidence of chronic HCV infection for >6 mo with ongoing liver injury

Spontaneous resolution Individual with HCV infection loses detectable serum HCV RNA without any treatment as indicated by 2 sequential negative tests for HCV RNA at least 6 mo apart

HCV = hepatitis C virus.

  840 www.jpgn.org Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


JPGN • Volume 54, Number 6, June 2012 Pediatric Hepatitis C Infection


resolve vertical HCV infection (22). The placenta has been shown to play a protective role against HCV infection in the neonate. Various components of the innate immune system such as natural killer and g-d T cells operate within the placenta to eradicate HCV (23).

Liver Histology and Extrahepatic

Manifestations in Pediatric CHC

     CHC in children is associated with a variety of histological patterns of disease, generally not as severe as in adults. Indeed in many children, liver biopsy discloses no obvious histological changes or mild inflammation and fibrosis. Nevertheless, significant fibrosis or cirrhosis may occur (24). Children rarely require liver transplantation for CHC. Between 1988 and 2009, 133 children were transplanted for chronic liver failure due to CHC in the United States. To date, hepatocellular carcinoma appears extremely uncommon in children with CHC. Only 2 cases have been reported in children (25), but others may exist. Two further cases presented in young adults who had acquired CHC in childhood (26). Recent observations in adults with CHC indicate that hepatocellular carcinoma complicating CHC may develop in the absence of cirrhosis (27,28), a finding of potential importance to pediatric patients. Regression of cirrhosis after treatment for CHC has been reported in adult studies.

     Numerous extrahepatic disorders have been associated with CHC in adults. Glomerulonephritis, typically membranoprolifera-tive, may occur in children with CHC. Unlike in the adult population, neither cryoglobulinemia nor lymphoma has yet been reported in children. HCV infection in the central nervous system has been identified as causing cognitive impairment in some adults with CHC (29). These observations raise the issue of learning impairment in children with CHC. Impaired quality of life, potentially severe enough to have a negative effect on learning, has been reported in children with CHC. These findings include developmental delay, learning disorders, and cognitive deficits less severe than those of attention deficit hyperactivity disorder but still reflecting decreased executive function (30,31).

Epidemiology of Pediatric CHC

     HCV infection is estimated to affect 0.1% to 2% of children in the United States, with seroprevalence of HCV infection estimated at 0.2% among children and 0.4% among adolescents (32). Transmission of infection is by contaminated blood or body fluids. At one time HCV infection accounted for the majority of transfusion-associated hepatitis, but presently the risk of acquiring HCV infection by transfusion of blood or blood products is negligible (33). Presently, the primary mechanism of HCV infection in children is mother-to-infant transmission (vertical transmission). The prevalence of CHC among pregnant women, taken as being both anti–HCV- and HCV RNA–positive during pregnancy, is approximately 0.75% (0.49%–1.7%) (34–40). In one large review, the estimated risk of transmitting HCV infection from mother to child was 1.7% per pregnancy if the mother had detectable anti-HCV antibodies, 4.3% if the mother had detectable HCV RNA, and 7.1% if the mother tested positive for HCV RNA at least twice during pregnancy or around the time of delivery (41). Even with the addition of several recent studies, the estimate of risk for HCV transmission is similar, 5% to 7% per pregnancy for a mother with HCV infection without human immunodeficiency virus (HIV).

     It is not known exactly when mother-to-infant HCV transmission takes place. Several factors that affect the risk of HCV transmission have been studied. Several reports indicate that undetectable maternal HCV RNA is associated with a small risk 


of transmission (42,43), presumably because HCV RNA load can vary during pregnancy. Concomitant HIV infection increases the risk of HCV transmission 2- to 3-fold (41). Recently, this effect appears somewhat less prominent, perhaps because greatly effective antiretroviral therapy decreases HCV load during pregnancy or because infants of HIV-positive mothers may be born somewhat prematurely (43). High maternal HCV viral load (>600,000 IU/mL) appears to favor mother-to-infant HCV transmission (44–46). Internal monitoring of the fetus (“fetal scalp vein monitoring”) (10), prolonged rupture of membranes (10,43), and fetal anoxia around the time of delivery, as indicated by decreased cord blood pH (46), may enhance the risk of infection. The role of amniocentesis on the risk of mother-to-infant HCV transmission cannot be evaluated based on available data (47,48).

      Several factors previously thought to affect mother-to-infant HCV transmission have not been found to alter risk. Elective cesarean section is not required for HCV-monoinfected women because it confers no reduction in the rate of mother-to-infant HCV transmission (41,43,46,49,50). With vaginal delivery, large vaginal tears should be avoided. Breast-feeding does not promote HCV transmission from mother to infant (41,43). It is prudent to avoid breast-feeding if the nipples are bleeding, if mastitis is present, or if the mother is experiencing a flare of hepatitis with jaundice postpartum. Cost-effectiveness analysis based on available epidemiological data indicates that screening all of the asymptomatic mothers for CHC is not cost-effective (51); however, mothers at high risk for HCV should be screened for HCV.

      IVDU with sharing of contaminated needles or apparatus is a major contributor to the spread of HCV infection. Sharing of nasal straws can also transmit HCV infection. Tattooing and body piercing are potential modes of HCV transmission and have been reported as a risk for transmission in adults (52). Data regarding the risk of HCV transmission in households where 1 member has CHC are confusing. In general, there appears to be an extremely small risk (<2%) and this risk may differ in different parts of the world (53–55). No data are available regarding the risk of HCV transmission in infant day-care centers. The present consensus is that the risk of HCV transmission by sexual intercourse in stable relationships is negligible (56). Importantly, low risk of HCV transmission does not constitute grounds for sexually active adolescents to ignore safe-sex practices.

Natural History of HCV Infection in Infants

      HCV infection acquired in infancy can have several different patterns of outcome. Spontaneous resolution of infection is an important outcome, although it remains unclear whether children are more likely than adults to clear HCV infection. Some infants appear to acquire HCV infection from their chronically infected mother, but they lose all evidence of infection during early infancy (10,43,57–59). This pattern is best described as spontaneous resolution of neonatal AHC. It is not evident that it is merely transient viremia, especially if serum ALT is elevated. Little information is presently available about the long-term course of these children, who are generally regarded as having recovered from HCV-associated disease. Other infants develop CHC but achieve spontaneous resolution during the first few years of childhood, generally by 7 years or earlier. This pattern of early spontaneous resolution may occur irrespective of whether the child acquired CHC by mother-to-infant transmission or via blood transfusion (11,53,60,61). The long-term course for those who do not have spontaneous resolution of CHC from infancy has been reported as mild: children are clinically well with normal or


   www.jpgn.org 841 Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


Mack et al JPGN • Volume 54, Number 6, June 2012

Adapted from reference (73). HCV = hepatitis C virus; HIV = human immunodeficiency virus.

* All of the positive anti-HCV antibody tests should be followed up with a HCV RNA test to determine active infection.

   842 www.jpgn.org Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


JPGN • Volume 54, Number 6, June 2012 Pediatric Hepatitis C Infection


due to maternal antibody (76). There are 3 types of immunoassays: EIA, microparticle EIA, and chemiluminescence immunoassay. The third-generation EIAs can be performed in plasma or serum and use recombinant antigens from core (c22) and nonstructural proteins 3 (c33), 4 (c100), and 5. The specificity and sensitivity of the third-generation EIAs in patients with chronic liver disease due to HCV infection are >98% and >97%, respectively (77). Supplementary Table 1 (http.-//links.lww.com/MPG/A112) lists the Food and Drug Administration (FDA)–approved antibody-based assays. The first 2 are recommended for screening and use a mixture of proteins as the solid-phase agent. The third can be used for supplemental testing for detection of antibodies to individual HCV proteins. Given the ready availability of nucleic acid testing for viral RNA, the recombinant immunoblot assay is used less often than in the past when nucleic acid testing was not commonly available. One disadvantage of the antibody-based tests is that they cannot distinguish acute from chronic infection. The third-generation EIAs that detect antibodies against core protein and nonstructural proteins 3, 4, and 5 generally become positive about 6 to 8 weeks after acquisition of infection (78). Therefore, anti-HCV IgG antibodies are usually negative during the acute phase, and HCV infection during this time frame can only be determined by serum HCV RNA.

     Another antibody-based test of interest, the OraQuick HCV rapid antibody test, was approved by the FDA in June 2010. It uses whole blood samples obtained by venipuncture. The major advantage of this test is that it allows point-of-care testing in that it is portable and easy to use; it provides an answer within 40 minutes and can therefore be used for HCV screening for persons who are at risk for hepatitis, such as youths who live on the streets or are incarcerated (79,80). Further testing is necessary to confirm HCV infection if the test result is positive. Anti-HCV IgM is not useful for distinguishing between acute and chronic HCV infection and measuring HCV IgM is not recommended.

Qualitative and Quantitative HCV RNA

     Supplementary Table 2 (http.-//links.lww.com/MPG/A112) summarizes the FDA-approved qualitative and quantitative tests for HCV RNA, usually performed by RT-PCR. In the past, qualitative tests were used for diagnosis because they were more sensitive than the quantitative tests. Recently improved to be greatly sensitive, quantitative tests are now recommended for diagnosis in patients with positive anti-HCV antibody tests (81).

     If the antibody test and the HCV RNA test are positive, this result is interpreted as acute or chronic HCV depending on the clinical context. If the antibody test is positive and the HCV RNA test is negative, this result indicates resolution of HCV infection or AHC during a period of low-level viremia. If the antibody test is negative but the HCV RNA test is positive, there are 3 possible interpretations: this represents early AHC, chronic HCV infection in the setting of an immunocompromised state, or a false-positive HCV RNA test. If the HCV RNA is negative and if repeated in 6 months it remains negative, the individual does not have chronic HCV infection. HCV RNA tests can be detected in serum or plasma as early as 1 to 2 weeks after exposure to the virus and weeks before the antibody tests become positive or the liver enzymes become elevated (78).

HCV Genotypes

     HCV genotyping is useful for prediction of the likelihood of response to antiviral agents and for determining the optimal duration of therapy. The genotype assay uses subgenomic regions 


such as core/C1 or NS5B. Two HCV genotyping assays are available in the United States: the Truegene HCV Genotyping assay (Siemens) done by direct sequencing and the Versant HCV Inno-LiPA HCV II assay (reverse hybridization with genotype-specific probes). Subgenotypes such as 1a, 1b are not relevant to interferon (IFN)-a therapy but may be relevant in the future to treatment with direct-acting antiviral agents. IL28B receptor testing may be considered for children with genotype 1 before embarking on therapy because IL28B receptor variants have been quite useful for predicting response to pegylated (PEG)-IFN-a and ribavirin in adults with genotype 1 (82). Diagnostic tests suitable for future research in high-risk pediatric patients include dried blood spot testing from fingerstick or heelstick samples, salivary assays, point-of-care testing on venipuncture samples, and RT-PCR of frozen or formalin-fixed liver biopsies (83).

MONITORING AND ANTICIPATORY GUIDANCE

Monitoring of Children Who are Treatment Na?¨ve

     Children with chronic HCV infection not receiving antiviral therapy should be evaluated annually to provide ongoing education and to assess for clinical and biochemical evidence of chronic liver disease. Laboratory investigations during periodic assessments may include serum aminotransferases, bilirubin (total and direct/con-jugated), albumin, HCV RNA levels, complete blood count (with platelet count), and prothrombin time/international normalized ratio (if cirrhosis is present) (2A; BII). Liver biopsy should be generally considered only if the result will influence medical decision making. Liver biopsy may be specifically useful to investigate unexplained clinical hepatic decompensation in a previously stable patient and in children who are being considered for antiviral treatment to assess severity of liver disease. It is reasonable to forego pretreatment liver biopsy in children with HCV genotypes 2 or 3 who have a high (>80%) probability of achieving a virological cure with presently available treatments (see below) (2B; BII).

Screening for Hepatocellular Carcinoma

     As noted above, there are only a few reported cases of children with chronic HCV infection developing hepatocellular carcinoma (HCC) (25,26). In those with significant liver disease (ie, cirrhosis), abdominal ultrasonography and serum a-fetoprotein should be considered annually or biannually for surveillance of HCC (2B; BII*).

Monitoring of Children Younger Than 3 Years With HCV Infection

     Vertical transmission presently accounts for the majority of pediatric HCV infections. Children born to HCV-infected mothers should be screened for CHC with anti-HCV antibody testing at 18 months of age, when maternally derived antibodies have cleared (1B; AIII); however, sensitive nucleic amplification assays to detect HCV RNA may be useful in selected cases where the potential of having transmitted an infection results in significant maternal anxiety, despite the low risk of transmission (41) (2B; BIII). In this particular setting, the early exclusion of HCV infection is reassuring and may be worth the added expense. Of note, infants with detectable HCV RNA in infancy should be periodically monitored because spontaneous viral clearance may occur during childhood, particularly in HCV genotype 3 infections (84).


   www.jpgn.org 843 Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


Mack et al JPGN • Volume 54, Number 6, June 2012

HCV = hepatitis C virus; NSAIDs = nonsteroidal anti-inflammatory drugs.

   844 www.jpgn.org Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


JPGN • Volume 54, Number 6, June 2012 Pediatric Hepatitis C Infection


and casual dates can be a contentious and anxiety-provoking proposition. Although there likely are national and international geographic regulations with regards to this issue, there is generally no legal requirement to disclose HCV infection to casual or sexual contacts in the United States; however, the Centers for Diseases Control and Prevention and many patient advocate groups suggest revealing this information to sexual partners when appropriate (www.hcvadvocate.org; www.cdc.gov/hepatitis/hcv). This recommendation poses further ethical concerns and questions regarding the appropriate timing to disclosure this information and how it should be done. This decision should be individualized and should be arrived at only after thoroughly weighing all of the advantages and disadvantages of transmitting this information, largely based on the cognitive development of the individuals involved. Further information can be obtained from the HCV Advocate website (http://hcvadvocate.org).

TREATMENT OF HEPATITIS C

     There are several schools of thought regarding the need for treatment of children with CHC. Because CHC generally has a slow progression to fibrosis and severe disease is rare in children, follow-up without treatment until adulthood may be a valid option for many children. Treatment during childhood does not achieve increased rates of response compared with adults, and adverse events are frequent and in some cases, may be severe. Conversely, treatment may be justified because it allows definitive resolution in a subgroup of patients. Adolescence and young adulthood are associated with busy school and work demands, which may result in a lack of compliance with medical regimens and visits. All of those factors may lead to postponed treatment. Conversely, treatment of young children may be accomplished more easily given motivated caregivers and schedules, which can be more easily adjusted to therapeutic regimens than is the case for adolescents.

     Children with hepatitis C who demonstrate persistently elevated serum aminotransferases or those with progressive disease (ie fibrosis on liver histology) should be considered for treatment. Although in adults the presence of bridging fibrosis on liver biopsy is an important predictor of future progression to cirrhosis (98), this observation has not been confirmed in children (64,99,100). One can also argue that children with CHC and only mild disease (low/normal aminotransferases, minimal inflammation, or fibrosis on biopsy) could be considered for treatment given the real possibility of viral eradication and the lack of predictors of progression. The goals of treatment in the individual patients are eradicating virus infection, preventing end-stage liver disease and HCC, and removing stigma associated with HCV infection. An overall goal is 


to decrease the global burden of disease. Presently available treatments for pediatric CHC are IFN-a or PEG-IFN-a and ribavirin. The AASLD recommends the FDA-approved combination of PEG-IFN-a with ribavirin as first-line treatment for CHC in adults and children ages 3 to 17 years (81) (1A; AI). Based on multiple smaller open-labeled, uncontrolled single-center and large blinded, multicenter pediatric studies (101–109) outlined in Table 6, combination treatment with PEG-IFN-a has demonstrated superiority in achieving sustained virological response (SVR) over IFN-a alone. PEG-IFN-a also requires only once weekly dosing rather than 3 times per week dosing as is necessary for standard IFN-a. Factors predictive of a higher virological response to treatment include HCV genotypes 2 and 3 (typically >80% SVR) and a lower viral load in those with genotype I (<600,000 IU/mL or <2 x 106 copies/ mL) (101,102,105).

     IFN-a is a cytokine that has important functions in the innate antiviral immune response (110). Circulating IFN-a attaches to cell-surface receptors that signal through the system of Janus-activated kinase and signal transducers and activators of transcription, leading to the induction of multiple IFN-stimulated genes. These genes include double-stranded RNAses, inhibitors of viral protein translation, and proteins that destabilize viral messenger HCV RNA. The expression of these genes under activation of IFN-a also results in activation of natural killer cells, maturation of dendritic cells, proliferation of memory T cells, and prevention of T-cell apoptosis (111). This cytokine can be pegylated by the covalent attachment of large molecule polyethylene glycol to recombinant IFN-a. Once pegylated, recombinant IFN-a carries a longer half-life, better pharmacokinetic profile, and better rate of virological response than IFN alone (112,113).

     The addition of ribavirin to IFN-a treatment dramatically improved SVR (up to 30%–40%) and the end-of-treatment response (ETR) in adults and children (102). Combination treatment also results in a significant decrease in the relapse rate of HCV infection as compared with PEG-IFN-a monotherapy (114,115). These advantages have also been confirmed in pediatric trials (102,106). Ribavirin is an oral nucleoside analogue with broad activity against viral pathogens and has immunomodulatory effects (116). Although the mechanism of action is not entirely clear, ribavirin has been shown to have some minimal direct activity against HCV replication (117) and its use may lead to rapid and lethal mutation of virions or depletion of intracellular GTP, which is necessary for viral RNA synthesis (118). Ribavirin is presently available as 200-mg capsules (Rebetol, Ribasphere, ribavirin) or an oral suspension formulated at 40 mg/mL (Rebetol).

     Presently 2 US licensed PEG-IFNs are approved by the FDA for children with CHC. PEG-IFN-a-2b (PEGINTRON; Merck &


TABLE 6. Selected PEG-IFN/ribavirin treatment trials in children with chronic HCV infection

Author, year

No. studied

Treatment regimen

Sustained virological response* no./total (%)




All types

HCV type 1

HCV type 2/3

Christensson et al, 2000 (106)

11

IFN-2b-ribavirin

7/11 (64)

2/5(40)

5/5 (100)

Lackner et al, 2000 (107)

12

IFN-2a-ribavirin

6/12(50)

6/12(50)

N/A

Wirth et al, 2002 (103)

41

IFN-2b-ribavirin

25/41 (61)

18/34(53)

7/7 (100)

Gonza´lez-Peralta et al, 2005 (101)

118

IFN-2b-ribavirin

54/118 (46)

33/82(36)

21/25(84)

Wirth et al, 2005 (104)

62

PEG-IFN-2b-ribavirin

36/61 (59)

22/46(48)

13/13 (100)

Wirth et al, 2010 (105)

107

PEG-IFN-2b-ribavirin

70/107 (65)

38/72 (53)

28/30(93)

Schwarz et al, 2011 (102)

55

PEG-IFN-2a-ribavirin

29/55 (53)

21/45(47)

8/10(80)

HCV=hepatitis C virus; PEG-IFN = pegylated interferon.

* Undetectable serum HCV RNA 24 weeks after treatment cessation.

   www.jpgn.org 845 Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


Mack et al JPGN • Volume 54, Number 6, June 2012


Co, Inc, Whitehouse Station, NJ) contains a “linear”12-kDa PEG moiety. The optimal dose of PEG-IFN-a-2b is 60 mg • m-2 • week-1 given subcutaneously. Formulations include premeasured vials (50, 80, 120, or 150 mg/0.5 mL, Peg-Intron Kit) that require reconstitution with a diluent or ready-to-use injection pens (80, 120, or 150 mg/0.5 mL Peg-Intron Redipen) with dials that allow for dosing adjustments (Schering Corporation; Merck & Co.). PEG-IFN-a-2a (Pegasys; Genentech/Roche, San Francisco, CA) contains a larger, “branched”40-kDa PEG moiety. PEG-IFN-a-2a is given at a dose of 180 mg/1.73 m2 weekly subcutaneously and is available either as prefilled syringes or as vials (180 mg/mL and 180 mg/ 0.5 mL). PEG-IFN-a-2a does not require reconstitution with diluents. Dosing of these PEG-IFNs is different and may be differentially efficacious (119–122), although one has not conclusively and consistently demonstrated superiority. Both should be given in combination with ribavirin at a dose of 15 mg • kg-1 • day-1 PO divided twice daily. The recommended length of therapy is 48 weeks of treatment for genotypes 1 or 4 and 24-week duration of treatment for genotypes 2 or 3 in children (1A; A1*). If HCV RNA does not become undetectable by 24 weeks, there is also no evidence that prolonged treatment improves clinical outcome (ie, cirrhosis, HCC, SVR) (123).

SIDE EFFECTS OF MEDICATIONS AND

MONITORING FOR ADVERSE EVENTS

     IFN-a and ribavirin are powerful medications that are associated with multiple potential side effects and adverse events that affect quality of life (124,125). A thorough understanding of side effects is essential to intervene in a timely fashion and to avoid 


severe adverse events. Caretakers need to educate the patient and family on the necessary monitoring for side effects. Two large multicentered trials reported on adverse events due to PEG-IFN-a and ribavirin in pediatric HCV: a North American study that used PEG-IFN-a-2a in 114 patients (102) and a European/North American study that used PEG-IFN-a-2b in 107 patients (105). Furthermore, a recent study from Egypt analyzed the safety of PEG IFN-a-2a and ribavirin in the first 12 weeks of therapy in 30 pediatric patients with HCV (126). The incidence of side effects associated with PEG-IFN-a and ribavirin therapy for pediatric CHC is shown in Table 7, and recommendations on monitoring for side effects are outlined in Table 8. Constitutional symptoms are almost universal in children undergoing therapy. These symptoms include fever, fatigue, myalgias, arthralgias, headaches, and nausea. With the exception of nausea, these constitutional complaints are predominantly side effects of IFN-a. The constitutional symptoms are usually most severe within 24 hours of the IFN injection, and many symptoms will wane or resolve after the first few months of therapy (104,124).

      The pediatric population is uniquely susceptible to deficits in growth in both weight and height while receiving PEG-IFN-a and ribavirin. Both PEG-IFN-a and ribavirin can be associated with anorexia, nausea, and subsequent weight loss. In the preliminary study by Abdel-Aziz et al (126), 63% of patients showed significant reduction in body weight at weeks 4 and 12, with only 17% of patients regaining their original weight by week 12. The European study analyzed growth parameters and found that weight loss was common, with most patients experiencing compensatory weight gain after completion of treatment (105). A ribavirin dose adjustment was recommended for weight loss of >10% and


TABLE 7. Percentage of patients with adverse events during PEG-IFN/treatment

Adverse event

Schwarz et al, North America,

PEG-IFN-a-2a, RBV,

n=55 (102)

Wirth et al, Europe/United States,

PEG-IFN-a-2b, RBV,

n =107 (105)

Abdel-Aziz et al,* Egypt,

PEG-IFN-a-2a, RBV,

n=30 (126)

Constitutional




Fever, “flu-like”91


80

77

Fatigue

27

30

17

Headache

62

62

47

Anorexia

13

29

27

Myalgia/arthralgia

36

17

10

Gastrointestinal




Nausea

—t

18

27

Vomiting

—t

27

20

Decreased weight

19

76

Blood/lymphatic system




Neutropenia

27

33

56

Anemia

11

46

Neuropsychiatric




Depressed mood/depression

4

4

Irritabilityl

31

37

Insomnia/trouble sleeping

11

3

Cutaneous




Injection site reaction

45

29

Rash

20

Alopecia

17


PEG-IFN = pegylated interferon; RBV = ribavirin.

* For the present study only, the side effect profile was based on first 12 weeks of therapy.

t Gastrointestinal symptoms (nausea, emesis, diarrhea or abdominal pain): 56% in this study.

*Includes irritability, anxiety, nervousness, agitation, restlessness, mood alteration, affective lability, mood alteration.

   846 www.jpgn.org Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


JPGN • Volume 54, Number 6, June 2012 Pediatric Hepatitis C Infection


TABLE 8. Recommendations for monitoring during therapy

Laboratory test to Obtain test on following

be monitored wk of therapy

CBC with differential, 0, 1, 2, 4, 8, 12 and

absolute neutrophil count every 4–8 wk thereafter

Hepatic panel, glucose 0, 1, 2, 4, 8, 12 and

every 4–8 wk thereafter

TSH/total T4 0, 12, 24, 36, 48

Urine HCG (for female 0,24

patients 13 y or older)

Prothrombin time 0; only repeat if clinically

indicated

Urinalysis 0; only repeat if clinically

indicated

HCV RNA 0, 24, 48, 72

 CBC = complete blood cell; HCG = human chorionic gonadotropin; HCV = hepatitis C virus; TSH = thyroid-stimulating hormone.

a PEG-IFN-a adjustment for a BMI decrease of >10%. With regard to growth in height, inhibition of growth velocity was observed in 70% of patients. Growth velocity increased after treatment completion, and at 24-week follow-up, the mean height percentile of 44.3% was slightly below the baseline height percentile of 50.9%. Long-term follow-up of growth parameters is necessary to determine whether the growth inhibition is temporary or long-lasting.

     Bone marrow suppression induced by IFN-a constitutes the next most common toxicity after constitutional symptoms, occurring in approximately one third of treatment recipients (102,105). The bone marrow toxicity is associated with depressed levels of total white cell and absolute neutrophil counts, and, to a lesser extent, platelets and red cells. The neutropenia usually reaches a sustained nadir by 8 weeks of therapy and returns to baseline within weeks after cessation of therapy (102,126). In the 2 larger studies of IFN/ribavirin treatment for pediatric HCV, neutropenia was not associated with increased rates of bacterial infections. Dose reductions due to neutropenia occurred in 38% of patients in the North American study and 12% in the European study. Drug cessation due to neutropenia did not occur in either study.

     IFN-a–induced reductions in platelet counts are usually asymptomatic and manifest within the first 8 weeks of therapy. Platelet levels then stabilize at this lower level for the duration of therapy (124). The mechanisms leading to the thrombocytopenia include suppression of megakaryopoiesis, platelet sequestration in capillaries (127), and immune-mediated thrombocytopenia (128,129). In the North American study, there was no significant thrombocytopenia, and in the European study 1 patient discontinued therapy at week 42 due to thrombocytopenia (platelet count 45,000 cells/mm3).

     Ribavirin is the main contributor to the onset of hemolytic anemia that most commonly manifests in the first month of treatment, reaching a nadir by week 4 (124,126). The mechanism of ribavirin-induced anemia is thought to involve ribavirin metabolites that impair antioxidant defenses and promote red cell oxidative damage (130). Dose reductions due to ribavirin-induced anemia occurred in 25% of patients who received PEG-IFN-a-2a (102) and 7% of patients who received PEG-IFN-a-2b (103). Recommendations for dose reductions due to bone marrow suppression are outlined for both forms of PEG-IFN in Supplementary Table 3 (http://links.lww.com/MPG/A112). Dose reduction was not associated with significant decreases in SVRs (102,105).

     

Dose adjustments may be insufficient to ameliorate marrow suppression, and interventions to treat severe or symptomatic anemia or neutropenia may be necessary (131). Available agents include Epogen (epoetin alfa, Amgen Inc, Thousand Oaks, CA) for anemia, granulocyte colony stimulating factor (GCSF) for neutro-penia, and blood products. Epogen is a synthetic glycoprotein that acts similarly to endogenous erythropoietin (EPO) (132). It is a hormone produced by the kidneys that stimulates bone marrow erythropoiesis and in turn increases red cell counts, hemoglobin, and hematocrit levels (133). It has been found to be safe in the settings of cancer chemotherapy, HIV infection, and chronic renal failure (134–136). In the adult world, >85% of patients on PEG-IFN/ribavirin for HCV become anemic as endogenous EPO production is decreased (137,138); 20% to 25% of patients require dose reduction due to anemia and its symptoms (139). Interestingly, anemia is also linked to improved SVR and Epogen does not alter this phenomenon while ameliorating clinically significant anemia (135,138). This adjuvant therapy has been documented to enhance compliance to treatment regimens, improve rates of SVR, and improve quality of life (140–142); however, there is presently no approved EPO dosing for children in the context of therapy for CHC.

     GCSF is a cytokine that is naturally produced by monocytes, activated T cells, fibroblasts, and endothelial cells. GCSF stimulates myeloid progenitor cells in bone marrow to induce cell proliferation, differentiation, and selected end-cell functional activation. It is approved for use in the setting of chemotherapy, induction/ consolidation for AML, bone marrow transplantation, and severe chronic neutropenia (142). As neutropenia is the most common cause of PEG-IFN-a dose reduction (up to 25%) in adult CHC treatment, GCSF is effective in normalizing the absolute neutrophil count, is well tolerated, and improves SVR (143,144). As with Epogen, there is presently no approved GCSF dosing for children in the context of therapy for CHC. With respect to thrombocytopenia, bleeding has not been observed in patients with low platelet counts (<50,000) and dose modifications are rarely necessary. Clinical implications or advantages of platelet transfusion are both unclear (131). In the North American trial (102), hematopoietic growth factors were not allowed by the FDA and bone marrow suppression was easily managed by drug dose reduction, suggesting that such factors may not generally be necessary in treating children with CHC.

     IFN-associated neuropsychiatric complications can be the most challenging to manage during treatment for CHC. IFN-a therapy has been associated with the initiation or worsening of underlying depression, anxiety, and suicidal ideation (145). It is essential to perform a baseline neuropsychiatric evaluation and specifically to survey for signs of depression before initiation of therapy. The onset of neuropsychiatric symptoms may not occur until 3 to 6 months into therapy (124). In the pediatric trials of CHC treatment, psychiatric or adverse events were reported in approximately one third of patients. In the North American study, irritability was reported in 31% and depression in 4% of patients. One patient required discontinuation of therapy due to a suicidal gesture (102). The European analysis included reports of nervousness, agitation, aggression, mood alteration, anxiety, depression, and affective lability (105). These events did not require dose adjustments or treatment cessation. Insomnia was reported by both groups and occurred in 3% to 11% of patients. It is recommended that whenever there is a concern for major depression or other psychiatric illnesses, the child should be referred to a psychiatrist for consideration of initiating antidepressant therapy or discontinuing IFN-a therapy. Discontinuation of therapy is strongly recommended in the setting of suicidal ideations or attempted suicide.


   www.jpgn.org 847 Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited .


Mack et al JPGN • Volume 54, Number 6, June 2012


     Thyroid abnormalities are the most common endocrinological adverse effect induced by IFN-a, occurring in 1% to 6% of adults treated with IFN-a (124). Thyroid abnormalities can occur at any time during therapy. Possible mechanisms of this thyroid dysfunction include direct inhibition of thyroid synthetic functions and secretion or development of antithyroid peroxidase or antithyroglobulin auto-antibodies (146). The incidence of hypothyroidism in the pediatric CHC treatment trials was 2% to 3%, with the majority of these patients requiring thyroxine supplementation (102,105). Interestingly, the European study reported that 23% of patients had at least 1 abnormal thyroid-stimulating hormone (TSH) value during therapy. It is recommended that TSH and total T4 levels be measured every 3 months during therapy. The diagnosis of clinical hypothyroidism should be confirmed and subsequently managed by an endocrinologist. Similar to the autoimmune-mediated mechanism of thyroid injury, antibodies to the adrenal cortex or pancreatic islet cells can result in IFN-induced adrenal insufficiency or diabetes, respectively. New-onset type 1 diabetes mellitus was described in 1 patient receiving PEG-IFN-a and ribavirin (102).

     A wide variety of occular complications can occur while receiving IFN-a therapy, such as retinopathy, optic neuritis, or neuropathy. In a large ophthalmological follow-up study of adults receiving IFN-a therapy, the retinopathy did not require cessation of therapy in the majority and the retinopathy resolved in all of the affected patients after completion of therapy (147). The North American pediatric trial performed surveillance eye exams and identified lesions in 3 patients (ischemic retinopathy with cotton wool spots, uveitis, transient monocular blindness) (148). Two of these patients were taken off of therapy with resolution of lesions in all. It is recommended that visual disturbances or complaints while receiving therapy warrant expeditious evaluation by an ophthalmologist.

     Numerous cutaneous drug reactions can occur, including IFN-induced injection site reactions, dry skin, pruritus, and alopecia. Furthermore, ribavirin can induce a rash characterized by a diffuse inflammatory, erythematous, and maculopapular lesion that resolves after stopping ribavirin (149). The dry skin may mimic eczematous or psoriatic lesions (150). In the North American pediatric trial, a rash was documented in 20% of patients. The alopecia is more common in females (124) and was identified in 17% of patients in the pediatric European study. Finally, another potential complication of CHC treatment is that ribavirin (and to a lesser extent, IFN-a) is greatly teratogenic (151). Therefore, a urine human chorionic gonadotropin test is recommended for all of the females 13 years or older at baseline and should be repeated at 24 weeks of therapy. Ribavirin can cause teratogenesis when either partner is taking it. In sexually active teenagers, the use of and strict adherence to contraception is mandatory.

     In summary, conscientious and thorough monitoring for potential adverse events is essential to optimize care of pediatric patients being treated for CHC. Overall, cessation of therapy due to adverse events is rare and side effects can be managed with appropriate referral care and treatment when necessary.

SPECIAL POPULATIONS AND OUTCOMES

     Individualization of therapy warrants serious consideration under several circumstances. There is a paucity of both data and adequately powered clinical trials in these unique pediatric groups that may warrant therapy for HCV infection.

Young Age

     Children who are younger than 3 years should generally not be treated, and treatment is not approved in this age group. In young 


children, HCV infection may still spontaneously resolve and adverse effects of IFN-a in extremely young children are not well elucidated, although spastic diplegia has been reported in infants treated with IFN-a for hemangiomas (152). There are no published studies or reports of treatment in children who are younger than 3 years. The decision to treat should consider several aspects including age, severity of disease, efficacy of the chosen therapy, its adverse effects, compliance to treatment, and willingness to be treated.

History of Substance Abuse

     In general, patients are excluded from therapy if they have severe comorbid medical conditions that could compromise the tolerability of the drugs or interfere with compliance to the regimen. Adolescents and young adults with a history of substance abuse may fall into this category. There are no studies of CHC treatment in adolescents with a history of substance abuse; however, in a meta-analysis of 16 prospective studies from an adult cohort of 953 illicit drug users, it was found that they had comparable effectiveness and tolerability of therapy as to those in the general population (153). The estimated overall SVR and dropout rates in illicit drug users were 52% (95% CI 44%–60%) and 26% (95% CI 18%–35%), respectively. The rate of psychiatric severe adverse events that led to treatment discontinuation was 2% (95% CI 1%– 3%). These prevalence rates were not significantly different from those reported in registration trials of treatment of chronic HCV that excluded illicit drug users from the study population (SVR 50% [95% CI 39%–61%]; dropout rate 26% [95% CI 12%– 41%]; and psychiatric serious adverse events 2% [95% CI 0%– 6%]). By subgroup analysis, active ongoing drug use negatively affected the rate of treatment success (39% [95% CI 30%–49%] vs 55% [95% CI 45%–64%]; P 1/4 0.02) (153). Thus, adolescents with a history of substance abuse may be candidates for therapy on an individualized basis.

Psychiatric Illness

     Treatment for CHC is well known to have multiple neuro-psychiatric side effects including depression, confusion, mania, psychosis, hallucinations, and suicidal ideation. There is also risk that a patient’s known psychiatric disorder will flare or become unmanageable once therapy is initiated. Psychoeducation groups have shown promise for preparing patients with chronic medical illness to anticipate and endure intensive medical treatment that has substantial psychiatric side effects (154). The goal is to aid patients to overcome barriers to treatment, particularly psychosocial problems, because available CHC treatments have become increasingly effective. Clearance by an appropriately trained psychiatrist for therapy is advisable before commencing treatment. Ongoing psychiatric evaluation and therapy are appropriate during CHC treatment, allowing for either prompt intervention or discontinuation of treatment should severe neuropsychiatric side effects develop.

Juvenile Detention Center Resident

     Incarcerated adolescents or residents of detention centers who have CHC are another special population. Often such individuals have lifestyles and behaviors that place them at risk for HCV infection. Again, there are no trials in the medical literature addressing this special population. Arguments in favor of treatment for CHC in these individuals include prominently that the patients are a captive audience and much more likely to be


  848 www.jpgn.org Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


JPGN • Volume 54, Number 6, June 2012 Pediatric Hepatitis C Infection


compliant with medications, laboratory studies, and visits; however, these individuals are often not incarcerated for the entire length of time required for HCV treatment, and when released may not have the finances or resources to continue therapy.

Co-infection: HIV

     Limited evidence is available presently regarding the timing, efficacy, and safety of PEG-IFN-a and ribavirin in children and adolescents coinfected with HIV and HCV. We know that HIV has a negative effect on the natural history of HCV infection. Coinfected HCV/HIV patients have higher rates of viral persistence, increased viral load, and a more rapid progression to end-stage liver disease. Thus, for many clinicians, this increased progression rate supports earlier and aggressive therapy for HIV/HCV coinfected children. Restoration and maintenance of immune function by the use of greatly active antiretroviral therapy reduce the negative effect of HIV on HCV infection, but the SVR to PEG-IFN-a and ribavirin therapy is 15% to 50% lower than in HCV-monoinfected individuals (155). Although there have been substantial reductions in morbidity and mortality in HIV-infected patients using greatly active antiretroviral therapy, liver-related deaths have become the leading cause of mortality. Given this lower treatment response rate, regardless of genotype, coinfected HCV/HIV patients including children should receive at least 48 weeks of treatment (156,157). No guidelines presently exist for the optimal regimen for HCV/HIV coinfected children. (158) Limited experience in the clinical management of this group and the lack of evidence to guide policy are barriers to achieving optimal care and treatment for this special population. If therapy for CHC is initiated, extremely close monitoring for adverse events is necessary.

Co-infection: HBV

     HBV also has a negative effect on the natural history of HCV infection, as shown by adult retrospective and cross-sectional data. In a study in which the long-term outcome of infection acquired in childhood was assessed in patients coinfected with HBV and HCV after a median follow-up of 23 years, there was a low rate of progression to liver fibrosis, no liver failure, and a low development of HCC (159). If a decision is made to treat an HBV/HCV coinfected child, combination of PEG-IFN-a and ribavirin for a full course, independent of genotype, is recommended based upon adult data.

Patients With Hematological Disorders Who Have Undergone Multiple Blood Transfusions

     The majority of children in this special population will have hemolytic conditions such as sickle cell anemia and thalassemia. The risk of acquiring HCV infection is dependent upon the number of units of blood exposure; however, these risks have declined with the introduction of universal HCV screening of blood products that began in the 1990s. The risk of hemolysis due to ribavirin makes combination therapy a complicated issue. Multiple transfusions are associated with hepatic iron overload, which complicates therapy for CHC and may accelerate the progression of cirrhosis and risk for HCC. Treatment may be effective but the issues of hemolysis with ribavirin, use of injections, and iron overload all need to be considered in the decision to treat (160).

Transplantation (Renal or Liver)

     CHC remains the leading indication for liver transplantation in adults in the United States. After liver transplant, graft reinfection 


is almost universal and development of chronic HCV, cirrhosis, and death occurs in about one third of adult liver transplant recipients (161). Although rare in children, pediatric liver transplant recipients for end-stage liver disease due to CHC demonstrated patient and allograft survival rates of 72% and 55%, respectively, at 5 years. Following retransplantation, these rates decreased to 55% and 34%, respectively. Recipients were listed for retransplantation in 31%, and were retransplanted in 19% for HCV recurrence. A mean of 1.2 liver transplants was performed per patient for CHC. The median time between liver transplants for CHC was 290 days. The risk of HCV recurrence in pediatric OLT recipients is high and is associated with a high rate of retransplantation (162).

     Pediatric recipients of kidney transplants with CHC are another unique population. Again, the prevalence is rare. Data in adults suggest that kidney transplant recipients with CHC have similar graft and patient survival outcomes as do recipients who do not have CHC (163). In general, antiviral therapy after renal transplant is not considered a safe option (164). Postrenal transplant use of IFN-a has limited efficacy and high cost. It increases the risk of irreversible renal graft rejection in 15% to 64% of cases (165,166) by promoting the cytotoxic action of T lymphocytes and monocytes, cytokine, and HLA antigen production (167). If a decision is made to treat a pediatric kidney or liver transplant recipient who has CHC, extremely close monitoring is mandatory for adverse events due to intolerance of the drugs used and an increased risk for graft rejection when IFN is administered.

Renal Disease (Dialysis)

     HCV-infected hemodialysis patients have lower survival rates compared with HCV-positive patients without renal failure because they often present with comorbid diseases and co-infections. Treatment of HCV-positive hemodialysis patients is complex and difficult. Both nephrologists and hepatologists must closely monitor these patients. Patients with CHC on hemodialysis may receive standard or a reduced dose of IFN-a with or without the addition of low-dose ribavirin. IFN-a therapy is modestly effective for the treatment of CHC in patients with end-stage renal disease (168). Approximately one third of patients can achieve a SVR after conventional or PEG-IFN-a monotherapy. Treatment before renal transplantation is recommended because of the risk of increased graft rejection posttransplant.

Considerations for Patients Cirrhotic at Presentation

     A meta-analysis of 45 studies concluded that anti-HCV treatment in cirrhotic adult patients was less effective than in noncirrhotic patients (169). Viral eradication reduced the risk of liver complications and improved survival in noncirrhotic patients. Based on both effectiveness and tolerability, therapy has a significantly beneficial effect in patients with compensated cirrhosis, whereas decompensated patients must weigh the risks versus the benefits of treatment. If treatment is to be undertaken in such patients, a low accelerating dose protocol may aid in successfully treating these patients (170). Using this approach, an ETR of 46% and SVR of 24% in patients with advanced disease were achieved. Specifically, the ETR was 30% and SVR 13% in genotype 1, but 82% and 50%, respectively, in nongenotype 1.

OUTCOME OF THERAPY

     There are several possible outcomes of HCV therapy. To compare different treatment regimens, it is imperative that standard definitions of outcomes are used (Table 9). Each outcome has been


   www.jpgn.org 849 Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


Mack et al JPGN • Volume 54, Number 6, June 2012

HCV = hepatitis C virus; LDL = low-density lipoprotein; siRNA = silencing RNA.

  850 www.jpgn.org Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


JPGN • Volume 54, Number 6, June 2012 Pediatric Hepatitis C Infection


who are undergoing IFN-a–based treatment (2B; CIII). Interestingly, this polymorphism does not appear to influence the response to triple therapy with PEG-IFN-a, ribavirin, and protease inhibitors (174,175). Thus, it may not prove to be of use with the development of newer therapies.

      An important area for the prevention of HCV infection in children would be the prevention of perinatal transmission. With the development of new therapies that target HCV, it is possible that some of the therapies may prove useful in the prevention of perinatal transmission, much like the dramatic effect of azidothy-midine therapy and the perinatal transmission of HIV; however, the low rate of perinatal transmission will mandate that the therapies have an excellent safety profile. An extremely large study will be required to detect a significant reduction in the rate of perinatal transmission.

      The working group has recommended the following areas of focus for research in pediatric HCV-related disease:

1. Research focusing on the interruption of vertical transmission could effectively eliminate the majority of the pediatric cases.

2. Development of an HCV vaccine would have the potential to significantly reduce adolescent transmission. Based on the previous experience with hepatitis B vaccination, this will need to target universal vaccination to be effective.

3. There is a significant need for the development of long-term epidemiological data focused on the long-term outcome of perinatal acquisition of HCV infection.

4. With the development of direct-acting antivirals, early inclusion of children in studies of pharmacokinetics and safety is needed to allow children to have early access to effective therapies.

5. Because adolescents with high-risk behaviors are at increased risk of acquiring HCV infection, investigations of the utility of point-of-care testing in this population are needed to determine whether counseling, access to treatment, and interventions for prevention can be effective. Furthermore, there is a need for research on the most effective education and interventions targeted at the entire adolescent population to reduce risk of HCV transmission.

6. Chronic HCV infection may lead to isolation and stigmatization of children and their families. There has not been any research in the effects of disclosure or nondisclosure and their role in the potential stigmatization of children and their families.

7. One of the unique aspects of HCV infection in children relates to growth and cognitive development. Many of the present therapies may have an effect on both of these issues. Studies of CHC outcome and treatment effect must include assessments of growth and cognitive issues of CHC in children to assist in decision making on the timing of therapy.

REFERENCES

1. Armstrong GL, Wasley A, Simard EP, et al. The prevalence of hepatitis

C virus infection in the United States, 1999 through 2002. Ann Intern Med 2006;144:705–14.

2. Jhaveri R, Grant W, Kauf TL, et al. The burden of hepatitis C virus infection in children: estimated direct medical costs over a 10-year period. J Pediatr 2006;148:353–8.

3. Zou S, Tepper M, El Saadany S. Prediction of hepatitis C burden in Canada. Can J Gastroenterol 2000;14:575–80.

4. McQuillian GM, Kruszon-Moran D, Denniston MM, et al. Viral hepatitis. NCHS Data Brief 2010;27:1–8.

5. Chiquete E, Panduro A. Low prevalence of anti-hepatitis C virus antibodies in Mexico: a systematic review. Intervirology 2007;50:1–8.

6. Omland LH, Krarup H, Jepsen P, et al., DANVIR Cohort Study-Mortality in patients with chronic and cleared hepatitis C viral infection: a nationwide cohort study. J Hepatol 2010;53:36–42.

7. 

Ghany MG, Nelson DR, Strader DB, et al. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the AASLD. Hepatology 2011;54:1433–44.

8. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. Brit Med J 2008;336:924–6.

9. Gerlach JT, Diepolder HM, Zachoval R, et al. Acute hepatitis C: high rate of both spontaenous and treatment-induced viral clearance. Gastroenterology 2003;125:80–8.

10. Mast EE, Hwang LY, Seto DS, et al. Risk factors for perinatal transmission of hepatitis C virus (HCV) and the natural history of HCV infection acquired in infancy. J Infect Dis 2005;192:1880–9.

11. Yeung LT, To T, King SM, et al. Spontaneous clearance of childhood hepatitis C virus infection. J Viral Hepatol 2007;14:797–805.

12. Nainan OV, Alter MJ, Kruszon-Moran D, et al. Hepatitis C virus genotypes and viral concentrations in participants of a general population survey in the United States. Gastroenterology 2006;131:478–84.

13. Murakami J, Okamoto M, Miyata H, et al. Evolution in the hypervari-able region of hepatitis C virus in infants after vertical transmission. Pediatr Res 2000;48:450–6.

14. Farci P, Quinti I, Farci S, et al. Evolution of hepatitis C viral quasispecies and hepatic injury in perinatally infected children followed prospectively. Proc Natl Acad Sci USA 2006;103:8475–80.

15. Sullivan DG, Bruden D, Deubner H, et al. Hepatitis C virus dynamics during natural infection are associated with long-term histological outcome of chronic hepatitis C disease. J Infect Dis 2007;196:239–48.

16. Huang H, Shiffman ML, Cheung RC, et al. Identification of two gene variants associated with risk of advanced fibrosis in patients with chronic hepatitis C. Gastroenterology 2006;130:1679–87.

17. Mosbruger TL, Dugga P, Goedert JJ, et al. Large-scale candidate gene analysis of spontaneous clearance of hepatitis C virus. J Infect Dis 2010;201:1371–80.

18. Bosi I, Ancora G, Mantovani W, et al. HLA DR13 and HCV vertical infection. Pediatr Res 2002;51:746–9.

19. Martinetti M, Pacati I, Cuccia M, et al. Hierarchy of baby-linked immunogenetic risk factors in the vertical transmission of hepatitis C virus. Int J Immunopathol Pharmacol 2006;19:369–78.

20. Bevilacqua E, Fabris A, Floreano P, et al. Genetic factors in mother-to-child transmission of HCV infection. Virology 2009;390:64–70.

21. Della Bella S, Riva A, Tanzi E, et al. Hepatitis C virus-specific reactivity of CD4þ-lymphocytes in children born from HCV-infected women. J Hepatol 2005;43:394–402.

22. Ruiz-Extremera A, Munoz-Gamez JA, Salmeron-Ruiz MA, et al. Genetic variation in interleukin 28B with respect to vertical transmission of hepatitis C virus and spontaneous clearance in HCV-infected children. Hepatology 2011;53:1830–8.

23. Waasdorp Hurtado C, Golden-Mason L, Brocato M, et al. Innate immune function in placenta and cord blood of hepatitis C-seropositive mother-infant dyads. PLoS One 2010;5:e12232.

24. Rumbo C, Fawaz RL, Emre SH, et al. Hepatitis C in children: a quaternary referral center perspective. J Pediatr Gastroenterol Nutr 2006;43:209–16.

25. Gonzalez-Peralta RP, Langham MR Jr, Andres JM, et al. Hepato-cellular carcinoma in 2 young adolescents with chronic hepatitis C. J Pediatr Gastroenterol Nutr 2009;48:630–5.

26. Strickland DK, Jenkins JJ, Hudson MM. Hepatitis C infection and hepatocellular carcinoma after treatment of childhood cancer. J Pediatr Hematol Oncol 2001;23:527–9.

27. Lok AS, Seeff LB, Morgan TR, et al. Incidence of hepatocellular carcinoma and associated risk factors in hepatitis C-related advanced liver disease. Gastroenterology 2009;136:138–48.

28. Madhoun MF, Fazili J, Bright BC, et al. Hepatitis C prevalence in patients with hepatocellular carcinoma without cirrhosis. Am J Med Sci 2010;339:169–73.

29. Forton DM, Thomas HC, Murphy CA, et al. Hepatitis C and cognitive impairment in a cohort of patients with mild liver disease. Hepatology 2002;35:433–9.

30. Rodriguez JR, Balistreri W, Haber B, et al. Impact of hepatitis C virus infection on children and their caregivers: quality of life, cognitive, and emotional outcomes. J Pediatr Gastroenterol Nutr 2009;48:341–7.


   www.jpgn.org 851 Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


Mack et al JPGN • Volume 54, Number 6, June 2012


31. Nydegger A, Srivastava A, Wake M, et al. Health-related quality of life in children with hepatitis C acquired in the first year of life. J Gastroenterol Hepatol 2008;23:226–30.

32. Hepatitis C virus infection. American Academy of Pediatrics. Committee on Infectious Diseases. Pediatrics 1998;101(3 Pt 1):481–5.

33. Luban NL, Colvin CA, Mohan P, et al. The epidemiology of transfusion-associated hepatitis C in a children’s hospital. Transfusion 2007;47:615–20.

34. Moriya T, Sasaki F, Mizui M, et al. Transmission of hepatitis C virus from mothers to infants: its frequency and risk factors revisited. Biomed Pharmacother 1995;49:59–64.

35. Zanetti AR, Tanzi E, Paccagnini S, et al. Mother-to-infant transmission of hepatitis C virus. Lombardy Study Group on Vertical HCV Transmission. Lancet 1995;345:289–91.

36. Okamoto M, Nagata I, Murakami J, et al. Prospective reevaluation of risk factors in mother-to-child transmission of hepatitis C virus: high virus load, vaginal delivery, and negative anti-NS4 antibody. J Infect Dis 2000;182:1511–4.

37. Resti M, Azzari C, Mannelli F, et al. Mother to child transmission of hepatitis C virus: prospective study of risk factors and timing of infection in children born to women seronegative for HIV-1. Tuscany Study Group on Hepatitis C Virus Infection. Brit Med J 1998; 317:437–41.

38. Conte D, Fraquelli M, Prati D, Minola E, et al. Prevalence and clinical course of chronic hepatitis C virus (HCV) infection and rate of HCV vertical transmission in a cohort of 15,250 pregnant women. Hepato-logy 2000;31:751–5.

39. Claret G, Noguera A, Esteva C, et al. Fortuny C.Mother-to-child transmission of hepatitis C virus infection in Barcelona, Spain: a prospective study. Eur J Pediatr 2007;166:1297–9.

40. Mast EE. Mother-to-infant hepatitis C virus transmission and breast-feeding. Adv Exp Med Biol 2004;554:211–6.

41. Yeung LT, King SM, Roberts EA. Mother-to-infant transmission of hepatitis C virus. Hepatology 2001;34:223–9.

42. Granovsky MO, Minkoff HL, Tess BH, et al. Hepatitis C virus infection in the mothers and infants cohort study. Pediatrics 1998; 102:355–9.

43. European Paediatric Hepatitis C Virus Network. A significant sex—but not elective cesarean section—effect on mother-to-child transmission of hepatitis C virus infection. J Infect Dis 2005;192:1872–9.

44. Ohto H, Terazawa S, Sasaki N, et al. Transmission of hepatitis C virus from mothers to infants. The Vertical Transmission of Hepatitis C Virus Collaborative Study Group. N Engl J Med 1994;330:744–50.

45. Tajiri H, Miyoshi Y, Funada S, et al. Prospective study of mother-to-infant transmission of hepatitis C virus. Pediatr Infect Dis J 2001; 20:10–4.

46. Steininger C, Kundi M, Jatzko G, et al. Increased risk of mother-to-infant transmission of hepatitis C virus by intrapartum infantile exposure to maternal blood. J Infect Dis 2003;187:345–51.

47. Minola E, Maccabruni A, Pacati I, et al. Amniocentesis as a possible risk factor for mother-to-infant transmission of hepatitis C virus. Hepatol 2001;33:1341–2.

48. Ducarme G, Ceccaldi PF, Bernuau J, et al. [Amniocentesis and viral risk (hepatitis B, C virus and HIV)]. J Gynecol Obstet Biol Reprod (Paris) 2009;38:469–73.

49. Ferrero S, Lungaro P, Bruzzone BM, et al. Prospective study of mother-to-infant transmission of hepatitis C virus: a 10-year survey (1990–2000). Acta Obstet Gynecol Scand 2003;82:229–34.

50. Shiraki K, Ohto H, Inaba N, et al. Guidelines for care of pregnant women carrying hepatitis C virus and their infants. Pediatr Int 2008; 50:138–40.

51. Plunkett BA, Grobman WA. Routine hepatitis C virus screening in pregnancy: a cost-effectiveness analysis. Am J Obstet Gynecol 2005;192:1153–61.

52. Haley RW, Fischer RP. Commercial tattooing as a potentially important source of hepatitis C infection: Clinical epidemiology of 626 consecutive patients unaware of their hepatitis C serologic status. Medicine (Baltimore) 2001;80:134–51.

53. Jara P, Resti M, Hierro L, et al. Chronic hepatitis C virus infection in childhood: clinical patterns and evolution in 224 white children. Clin Infect Dis 2003;36:275–80.

54. 

Ackerman Z, Ackerman E, Paltiel O. Intrafamilial transmission of hepatitis C virus: a systematic review. J Viral Hepat 2000;7:93–103.

55. Mohamed MK, Magder LS, Abdel-Hamid M, et al. Transmission of hepatitis C virus between parents and children. Am J Trop Med Hyg 2006;75:16–20.

56. Tohme RA, Holmberg SD. Is sexual contact a major mode of hepatitis C virus transmission? Hepatology 2010;52:1497–505.

57. Ketzinel-Gilad M, Colodner SL, Hadary R, et al. Transient transmission of hepatitis C virus from mothers to newborns. Eur J Clin Microbiol Infect Dis 2000;19:267–74.

58. Ceci O, Margiotta M, Marello F, et al. Vertical transmission of hepatitis C virus in a cohort of 2,447 HIV-seronegative pregnant women: a 24-month prospective study. J Pediatr Gastroenterol Nutr 2001;33:570–5.

59. Shebl FM, El-Kamary SS, Saleh DA, et al. Prospective cohort study of mother-to-infant infection and clearance of hepatitis C in rural Egyptian villages. J Med Virol 2009;81:1024–31.

60. Rerksuppaphol S, Hardikar W, Dore GJ. Long-term outcome of vertically acquired and post-transfusion hepatitis C infection in children. J Gastroenterol Hepatol 2004;19:1357–62.

61. Bortolotti F, Verucchi G, Camma C, et al. Long-term course of chronic hepatitis C in children: from viral clearance to end-stage liver disease. Gastroenterology 2008;134:1900–7.

62. Casiraghi MA, De Paschale M, Romano L, et al. Long-term outcome (35 years) of hepatitis C after acquisition of infection through mini transfusions of blood given at birth. Hepatology 2004;39:90–6.

63. Iorio R, Giannattasio A, Sepe A, et al. Chronic hepatitis C in childhood: an 18-year experience. Clin Infect Dis 2005;41:1431–7.

64. Vogt M, Lang T, Frosner G, et al. Prevalence and clinical outcome of hepatitis C infection in children who underwent cardiac surgery before the implementation of blood-donor screening. N Engl J Med 1999; 341:866–70.

65. Delgado-Borrego A, Healey D, Negre B, et al. Influence of body mass index on outcome of pediatric chronic hepatitis C virus infection. J Pediatr Gastroenterol Nutr 2010;51:191–7.

66. Delgado-Borrego A, Jordan SH, Negre B, et al. Reduction of insulin resistance with effective clearance of hepatitis C infection: results from the HALT-C trial. Clin Gastroenterol Hepatol 2010;8:458–62.

67. Cesaro S, Bortolotti F, Petris MG, et al. An updated follow-up of chronic hepatitis C after three decades of observation in pediatric patients cured of malignancy. Pediatr Blood Cancer 2010;55:108–12.

68. Page K, Hahn JA, Evans J, et al. Acute hepatitis C virus infection in young adult injection drug users: a prospective study of incident infection, resolution, and reinfection. J Infect Dis 2009;200:1216–26.

69. Serra MA, Escudero A, Rodriguez F, et al. Effect of hepatitis C virus infection and abstinence from alcohol on survival in patients with alcoholic cirrhosis. J Clin Gastroenterol 2003;36:170–4.

70. Wise M, Finelli L, Sorvillo F. Prognostic factors associated with hepatitis C disease: a case-control study utilizing U.S. multiple-cause-of-death data. Public Health Rep 2010;125:414–22.

71. Beech BM, Myers L, Beech DJ. Hepatitis B and C infections among homeless adolescents. Fam Commun Health 2002;25:28–36.

72. Murray KF, Richardson LP, Morishima C, et al. Prevalence of hepatitis C virus infection and risk factors in an incarcerated juvenile population: a pilot study. Pediatrics 2003;111:153–7.

73. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. Centers for Disease, Control and Prevention. MMWR Recomm Rep 1998;47 (RR-19):1–39.

74. England K, Pembrey L, Tovo PA, et al. Excluding hepatitis C virus (HCV) infection by serology in young infants of HCV-infected mothers. Acta Paediatr 2005;94:444–50.

75. Polywka S, Pembrey L, Tovo PA, et al. Accuracy of HCV-RNA PCR tests for diagnosis or exclusion of vertically acquired HCV infection. J Med Virol 2006;78:305–10.

76. American Academy of Pediatrics. 2006 Report of the Committee on Infectious Diseases, 27th ed. Hepatitis C. Elk Grove Village, IL: American Academy of Pediatrics; 2006: 355–359.

77. de Leuw P, Sarrazin C, Zeuzem S. How to use virological tools for the optimal management of chronic hepatitis C. Liver Int 2011;31 suppl 1:3–12.


   852 www.jpgn.org Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


JPGN • Volume 54, Number 6, June 2012 Pediatric Hepatitis C Infection


78. Mukherjee S, Lin J, Bronze MS. Hepatitis C virus (HCV) assays are used to evaluate for HCV infection. Medscape 2011; 1996209.

79. Lee SR, Yearwood GD, Guillon GB, et al. Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection. J Clin Virol 2010;48:15–7.

80. Lee SR, Kardos KW, Schiff E, et al. Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid. J Virol Methods 2011;172:27–31.

81. Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49:1335–74.

82. Halfon P, Bourliere M, Ouzan D, et al. A single IL28B genotype SNP rs12979860 determination predicts treatment response in patients with chronic hepatitis C Genotype 1 virus. J Gastroenterol Hepatol 2011; 23:931–5.

83. Gruppioni E, Vasuri F, Fiorentino M, et al. Real-time quantitative assay for routine testing of HCV RNA in formalin-fixed, paraffin-embedded liver samples. Diag Mol Pathol 2009;18:232–323.

84. Guido M, Rugge M, Jara P, et al. Chronic hepatitis C in children: the pathological and clinical spectrum. Gastroenterology 1998;115: 1525–9.

85. Tohme RA, Holmberg SD. Is sexual contact a major mode of hepatitis

C virus transmission? Hepatology 2010;52:1497–505.

86. Larzo MR, Poe SG. Adverse consequences of tattoos and body piercings. Pediatr Ann 2006;35:187–92.

87. Daniel AR, Shehab T. Transmission of hepatitis C through swapping body jewelry. Pediatrics 2005;116:1264–5.

88. Baizhanova Z, Ignatova TM, Nekrasova TP. [Metabolic syndrome and insulin resistance in patients with chronic hepatitis C]. Terapevticheskii arkhiv 2010;82:51–6.

89. Hwang SJ, Lee SD. Hepatic steatosis and hepatitis C: Still unhappy bedfellows? J Gastroenterol Hepatol 2011;26(suppl 1):96–101.

90. Peters MG, Terrault NA. Alcohol use and hepatitis C. Hepatology 2002;36 (5 suppl 1):S220–5.

91. Rose VL. AAP releases hepatitis C screening recommendations. Amer Fam Phys 1998;58:1218.

92. Pembrey L, Newell ML, Tovo PA. European paediatric hepatitis C virus network. Antenatal hepatitis C virus screening and management of infected women and their children: policies in Europe. Eur J Pediatr 1999;158:842–6.

93. European Paediatric Hepatitis C Virus Network. Effects of mode of delivery and infant feeding on the risk of mother-to-child transmission of hepatitis C virus. Brit J Obstet Gynaecol 2001;108:371–7.

94. European Paediatric Hepatitis C Virus Network. A significant sex—but not elective cesarean section—effect on mother-to-child transmission of hepatitis C virus infection. J Inf Dis 2005; 192:1872–9.

95. Lin HH, Kao JH, Hsu HY, et al. Absence of infection in breast-fed infants born to hepatitis C virus-infected mothers. J Pediatr 1995; 126:589–91.

96. Resti M, Bortolotti F, Azzari C, et al. Transmission of hepatitis C virus from infected mother to offspring during subsequent pregnancies. J Pediatr Gastroenterol Nutr 2000;30:491–3.

97. Mok J, Pembrey L, Tovo PA, et al. When does mother to child transmission of hepatitis C virus occur? Arch Dis Child: Fetal Neonat Ed 2005;90:F156–60.

98. NIH Consensus Statement on Management of Hepatitis C: 2002. NIH Consens State Sci Statements 2002; 19:1–46.

99. Camarero C, Ramos N, Moreno A, et al. Hepatitis C virus infection acquired in childhood. Eur J Pediatr 2008;167:219–24.

100. Goodman ZD, Makhlouf HR, Liu L, et al. Pathology of chronic hepatitis C in children: liver biopsy findings in the Peds-C Trial. Hepatology 2008;47:836–43.

101. Gonzalez-Peralta RP, Kelly DA, Haber B, et al., International Pediatric Hepatitis C Therapy GroupInterferon alfa-2b in combination with ribavirin for the treatment of chronic hepatitis C in children: efficacy, safety, and pharmacokinetics. Hepatology 2005;42:1010–8.

102. Schwarz KB, Gonzalez-Peralta RP, Murray KF, et al. The combination of ribavirin and peginterferon is superior to peginterferon and placebo for children and adolescents with chronic hepatitis C. Gastroenterology 2011;140:450–8.

103. Wirth S, Lang T, Gehring S, et al. Recombinant alfa-interferon plus ribavirin therapy in children and adolescents with chronic hepatitis C. Hepatology 2002;36:1280–4.

104. 

Wirth S, Pieper-Boustani H, Lang T, et al. Peginterferon alfa-2b plus ribavirin treatment in children and adolescents with chronic hepatitis C. Hepatology 2005;41:1013–8.

105. Wirth S, Ribes-Koninckx C, Calzado MA, et al. High sustained virologic response rates in children with chronic hepatitis C receiving peginterferon alfa-2b plus ribavirin. J Hepatol 2010;52:501–7.

106. Christensson B, Wiebe T, Akesson A, et al. Interferon-alpha and ribavirin treatment of hepatitis C in children with malignancy in remission. Clin Infect Dis 2000;30:585–6.

107. Lackner H, Moser A, Deutsch J, et al. Interferon-alpha and ribavirin in treating children and young adults with chronic hepatitis C after malignancy. Pediatrics 2000;106:E53.

108. Schwarz KB, Mohan P, Narkewicz MR, et al. Safety, efficacy and pharmacokinetics of peginterferon alpha2a (40 kd) in children with chronic hepatitis C. J Pediatr Gastroenterol Nutr 2006;43:499–505.

109. Tsunoda T, Inui A, Etani Y, et al., Working Group for the Study of Pegylated Monotherapy for Children with Chronic Hepatitis C in the Japan Society of Pediatric HepatologyEfficacy of pegylated interferon-alpha2a monotherapy in Japanese children with chronic hepatitis C. Hepatol Res 2011;41:399–404.

110. Bekisz J, Schmeisser H, Hernandez J, et al. Human interferons alpha, beta and omega. Growth Factors 2004;22:243–51.

111. Feld J, Hoofnagle JH. Mechanism of action of interferon and ribavirin in treatment of hepatitis C. Nature 2005;436:967–72.

112. Zeuzem S, Feinman SV, Rasenack J, et al. Peginterferon alfa-2a in patients with chronic hepatitis C. N Engl J Med 2000;343:1666–72.

113. Lindsay KL, Trepo C, Heintges T, et al., Hepatitis Interventional Therapy GroupA randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C. Hepatology 2001;34:395–403.

114. McHutchison JG, Gordon SC, Schiff ER, et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N Engl J Med 1998;339:1485–92.

115. Poynard T, Marcellin P, Lee SS, et al. Randomized trial of interferon alpha2b plus ribavirin for 48 weeks or for 24 weeks versus interferon alpha2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. International Hepatitis Interventional Therapy Group (IHIT). Lancet 1998;352:1426–32.

116. Lau JY, Tam RC, Liang TJ, et al. Mechanism of action of ribavirin in the combination treatment of chronic HCV infection. Hepatology 2002;35:1002–9.

117. Maag D, Castro C, Hong Z, et al. Hepatitis C virus RNA-dependent RNA polymerase (NS5B) as a mediator of the antiviral activity of ribavirin. J Biol Chem 2001;276:46094–8.

118. Crotty S, Maag D, Arnold JJ, et al. The broad-spectrum antiviral ribonucleoside ribavirin is an RNA virus mutagen. Nat Med 2000;6:1375–9.

119. Ascione A, De Luca M, Tartaglione MT, et al. Peginterferon alfa-2a plus ribavirin is more effective than peginterferon alfa-2b plus ribavirin for treating chronic hepatitis C virus infection. Gastroenterology 2010;138:116–22.

120. McHutchison JG, Lawitz EJ, Shiffman ML, et al., IDEAL Study TeamPeginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med 2009;361:580–93.

121. Rumi MG, Aghemo A, Prati GM, et al. Randomized study of peginterferon-alpha2a plus ribavirin vs peginterferon-alpha2b plus ribavirin in chronic hepatitis C. Gastroenterology 2010;138:108–15.

122. Sporea I, Danila M, Sirli R, et al. Comparative study concerning the efficacy of Peg-IFN alpha-2a versus Peg-IFN alpha-2b on the early virological response (EVR) in patients with chronic viral C hepatitis. J Gastrointestin Liver Dis 2006;15:125–30.

123. Di Bisceglie AM, Shiffman ML, Everson GT, et al., HALT-C Trial InvestigatorsProlonged therapy of advanced chronic hepatitis C with low-dose peginterferon. N Engl J Med 2008;359:2429–41.

124. Sung H, Chang M, Saab S. Management of Hepatitis C antiviral therapy adverse events. Curr Hepatitis Rep 2011;10:33–40.

125. Foster GR. Quality of life considerations for patients with chronic hepatitis C. J Viral Hepat 2009;16:605–11.

126. Abdel-Aziz DH, Sabry NA, El-Sayed MH, et al. Efficacy and safety of pegylated interferon in children and adolescents infected with chronic hepatitis C: A preliminary study. J Pharm Prac 2011;24:203–10.


   www.jpgn.org 853 Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


Mack et al JPGN • Volume 54, Number 6, June 2012


127. Yamane A, Nakamura T, Suzuki H, et al. Interferon-alpha-2b-induced thrombocytopenia is caused by inhibition of platelet production but not proliferation and endomitosis in human megakaryocytes. Blood 2008;112:542–50.

128. Pockros PJ, Duchini A, McMillan R, et al. Immune thrombocytopenic purpura in patients with chronic hepatitis C virus infection. Am J Gastroenterol 2002;97:2040–5.

129. Dourakis SP, Deutsch M, Hadziyannis SJ. Immune thrombocytopenia and alpha-interferon therapy. J Hepatol 1996;25:972–5.

130. DeFranceschi L, Fattovich G, Turrini F, et al. Hemolytic anemia induced by ribavirin therapy in patients with chronic hepatitis C virus infection: role of membrane oxidative damage. Hepatology 2000; 31:997–1004.

131. Collantes RS, Younossi ZM. The use of growth factors to manage the hematologic side effects of PEG-interferon alfa and ribavirin. J Clin Gastroenterol 2005;39:S9–13.

132. Egrie JC, Dwyer E, Browne JK, et al. Darbepoetin alfa has a longer circulating half-life and greater in vivo potency than recombinant human erythropoietin. Exp Hematol 2003;31:290–9.

133. Adamson J. Erythropoietin, iron metabolism, and red blood cell production. Semin Hematol 1996;33:5–7.

134. Allon M, Kleinman K, Walczyk M, et al. Pharmacokinetics and pharmacodynamics of darbepoetin alfa and epoetin in patients undergoing dialysis. Clin Pharmacol Ther 2002;72:546–55.

135. Dieterich DT, Wasserman R, Bra¨u N, et al. Once-weekly epoetin alfa improves anemia and facilitates maintenance of ribavirin dosing in hepatitis C virus-infected patients receiving ribavirin plus interferon alfa. Am J Gastroenterol 2003;98:2491–9.

136. Sulkowski MS, Dieterich DT, Bini EJ, et al., for the HIV/HCV Coinfection Study GroupEpoetin alfa once weekly improves anemia in HIV/hepatitis C virus-coinfected patients treated with interferon/ ribavirin: a randomized controlled trial. J Acquir Immune Defic Syndr 2005;39:504–6.

137. Van Vlerken LG, Van Soest H, Janssen MP, et al. Suboptimal endogenous erythropoietin response in chronic hepatitis C patients during ribavirin and PEG interferon treatment. Eur J Gastroenterol Hepatol 2010;22:1308–15.

138. Sievert W, Dore GJ, McCaughan GW, et al., CHARIOT Study GroupVirological response is associated with decline in hemoglobin concentration during pegylated interferon and ribavirin therapy in hepatitis C virus genotype 1. Hepatology 2011;53: 1109–17.

139. Afdhal NH, Dieterich DT, Pockros PJ, et al., Proactive Study Group-Epoetin alfa maintains ribavirin dose in HCV-infected patients: a prospective, double-blind, randomized controlled study. Gastroenterology 2004;126:1302–11.

140. Pockros PJ, Shiffman ML, Schiff ER, et al., PROACTIVE Study GroupEpoetin alfa improves quality of life in anemic HCV-infected patients receiving combination therapy. Hepatol 2004;40: 1450–8.

141. Shiffman ML, Salvatore J, Hubbard S, et al. Treatment of chronic hepatitis C virus genotype 1 with peginterferon, ribavirin, and epoetin alpha. Hepatology 2007;46:371–9.

142. Cash WJ, Patterson K, Callender ME, et al. Adjuvant therapy used in conjunction with combination therapy for chronic hepatitis C improves sustained virus response rates in genotype 1 patients. J Viral Hepat 2010;17:269–73.

143. Ong JP, Younossi ZM. Managing the hematologic side effects of antiviral therapy for chronic hepatitis C: anemia, neutropenia, and thrombocytopenia. Cleve Clin J Med 2004;71:S17–21.

144. Sulkowski MS. Management of the hematologic complications of hepatitis C therapy. Clin Liver Dis 2005;9:601–16.

145. Al-Huthail YR. Neuropsychiatric side-effects of interferon alfa therapy for hepatitis C and their management: a review. Saudi J Gastroenterol 2006;12:59–67.

146. Hsieh MC, Yu ML, Chuang WL, et al. Virologic factors related to interferon-alpha-induced thyroid dysfunction in patients with chronic hepatitis C. Eur J Endocrinol 2000;142:431–7.

147. Mehta N, Murthy UK, Kaul V, et al. Outcome of retinopathy in chronic hepatitis C patients treated with peginterferon and ribavirin. Dig Dis Sci 2010;55:452–7.

148. 

Narkewicz MR, Rosenthal P, Schwarz KB, et al., PEDS-C Study GroupOphthalmologic complications in children with chronic hepatitis C treated with pegylated interferon. J Pediatr Gastroenterol Nutr 2010;51:183–6.

149. Veluru C, Atluri D, Chadalavada R, et al. Skin rash during chronic hepatitis C therapy. Gastroenterol Hepatol 2010;6:323–5.

150. Mistry N, Shapero J, Crawford RI. A review of adverse cutaneous drug reactions resulting from the use of interferon and ribavirin. Can J Gastroenterol 2009;23:677–83.

151. Ward RP, Kugelmas M. Using pegylated interferon and ribavirin to treat patients with chronic hepatitis C. Am Fam Phys 2005;72:655–62.

152. Barlow CF, Priebe CJ, Mulliken JB, et al. Spastic diplegia as a complication of interferon a-2a treatment of hemangiomas of infancy. J Pediatr 1998;132:527–30.

153. Zanini B, Covolo L, Donato F, et al. Effectiveness and tolerability of combination treatment of chronic hepatitis C in illicit drug users: meta-analysis of prospective studies. Clin Ther 2010;32:2139–59.

154. Hong BA, North CS, Pollio DE, et al. The use of psychoeducation for a patient with hepatitis C and psychiatric illness in preparation for antiviral therapy: a case report and discussion. J Clin Psychol Med Settings 2011;18:99–107.

155. Tural C, Galeras JA, Planas R, et al. Differences in virological response to pegylated interferon and ribavirin between hepatitis C virus (HCV)-monoinfected and HCV-HIV-coinfected patients. Antivir Ther 2008; 13:1047–55.

156. Mofenson LM, Brady MT, Danner SP, et al. Guidelines for the Prevention and Treatment of Opportunistic Infections among HIV-exposed and HIV-infected children: recommendations from CDC, the National Institutes of Health, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics. MMWR Recomm Rep 2009;58:1–166.

157. Soriano V, Puoti M, Sulkowski M, et al. Care of patients coinfected with HIV and hepatitis C virus: 2007 updated recommendations from the HCV-HIV International Panel. AIDS 2007;21:1073–89.

158. England K, Thorne C, Pembrey L, et al. Policies and practices for the clinical management of HIV/HCV coinfected children in Europe: an epidemiological survey. Eur J Pediatr 2009;168:915–7.

159. Zampino R, Marrone A, Merola A, et al. Long-term outcome of hepatitis B and hepatitis C virus co-infection and single HBV infection acquired in youth. J Med Virol 2009;81:2012–20.

160. Harmatz P, Jonas MM, Kwiatkowski JL, et al. Safety and efficacy of pegylated interferon alpha-2a and ribavirin for the treatment of hepatitis C in patients with thalassemia. Haematologica 2008; 93:1247–51.

161. Ferrell LD, Wright TL, Roberts J, et al. Hepatitis C viral infection in liver transplant recipients. Hepatology 1992;16:865–76.

162. Barshes NR, Udell IW, Lee TC, et al. The natural history of hepatitis C virus in pediatric liver transplant recipients. Liver Transplant 2006; 12:1119–23.

163. Arango J, Arbelaez M, Henao J, et al. Kidney graft survival in patients with hepatitis C: a single center experience. Clin Transplant 2008; 22:16–9.

164. Pereira BJ, Natov SN, Bouthot BA, et al. Effects of hepatitis C infection and renal transplantation on survival in end-stage renal disease. The New England Organ Bank Hepatitis C Study Group. Kidney Int 1998;53:1374–81.

165. Schmitz V, Kiessing A, Bahra M, et al. Peginterferon alfa-2b plus ribavirin for the treatment of hepatitis C recurrence following combined liver and kidney transplantation. Ann Transplant 2007;12:22–7.

166. Baid S, Cosimi AB, Tolkoff-Rubin N, et al. Renal disease associated with hepatitis C infection after kidney and liver transplantation. Transplantation 2000;70:255–61.

167. Baid S, Tolkoff-Rubin N, Saidman S, et al. Acute humoral rejection in hepatitis C-infected renal transplant recipients receiving antiviral therapy. Am J Transplant 2003;3:74–8.

168. Liu CH, Kao JH. Treatment of hepatitis C virus infection in patients with end-stage renal disease. J Gastroenterol Hepatol 2011;26:228– 39.

169. Vezali E, Aghemo A, Colombo M. A review of the treatment of chronic hepatitis C virus infection in cirrhosis. Clin Ther 2010;32:2117–38.


   854 www.jpgn.org Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


JPGN • Volume 54, Number 6, June 2012 Pediatric Hepatitis C Infection


170. Everson GT, Trotter J, Forman L, et al. Treatment of advanced hepatitis

C with a low accelerating dosage regimen of antiviral therapy. Hepatology 2005;42:255–62.

171. Soriano V, Vispo E, Poveda E, et al. Directly acting antivirals against hepatitis C virus. J Antimicrob Chemother 2011;66:1673–86.

172. Vermehren J, Sarrazin C. New HCV therapies on the horizon. Clin Microbiol Infect 2011;17:122–34.

173. Lemon SM, McKeating JA, Pietschmann T, et al. Development of novel therapies for hepatitis C. Antiviral Res 2010;86:79–92.

174. 

Jacobson IM, McHutchison JG, Dusheiko G, et al., ADVANCE Study TeamTelaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011;364:2405–16.

175. Poordad F, McCone J Jr, Bacon BR, et al., SPRINT-2 Investigators-Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011;364:1195–206.

176. Clark PJ, Thompson AJ, McHutchison JG. IL28B genomic-based treatment paradigms for patients with chronic hepatitis C infection: the future of personalized HCV therapies. Am J Gastroenterol 2011;106:38–45.


   www.jpgn.org 855 Copyright 2012 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited.


Tidak ada komentar:

Posting Komentar