ACH Risk

Assessment

Guide

This publication has been developed to assist you in completing the required ACH Risk Assessment. Conditions of use are within the control of individual users and there is no warranty, expressed or implied, in connection with making this publication available.

Copyright 2010 ALACHA, GACHA,

SFE, SOCACHA, TACHA

1

Introduction

Definitions

2

Guide Directions

Pre-Assessment Check List

Assessment Questionnaire

3

Risk Management Systems & Controls

Section 1: Policies & Procedures

Section 2: Reporting to the Board

Section 3: Audit

4

Credit Risk

Section 4: Credit Risk Controls

Section 5: Originator Underwriting Standards

Section 6: Risk Selection

Section 7: Originator/TPS Agreements

5

High Risk Activities and Direct Access to the ACH

Operator

Section 8: High Risk Activities

Section 9: Direct Access to ACH Operator

Section 10: Third-Party Sender Relationships

6

Compliance Risk & Transactional Risk

Section 11: Compliance & Transactional Risk

7

Third-Party Service Providers

Section 12: Third-Party Service Providers

8

Information Technology & Information Security Section 13: Information Technology & Security

9

Business Continuity PlanningSection 14: Business Continuity Planning

10

ACH Risk Assessment Overall Rating

1

Introduction

Effective June 18, 2010, every financial institution is required to conduct a risk assessment of

their ACH activities in accordance with the requirements of their regulator(s). Areas of review

should include:

RISK MANAGEMENT: In recent years, the banking industry and regulators have devoted additional attention to ACH risk management. The NACHA Risk Management Strategy and the U.S. Department of the Treasury’s Office of the Comptroller of the Currency (“OCC”) Bulletin 200639 (“Bulletin”) of September 1, 2006 are two significant milestones. Codifying such practices in the Rules ties the performance of basic risk management practices into the Rules and sends a strong message to the industry about the importance of risk management.

RULES FRAMEWORK: The Rule requires all Participating DFIs to conduct a risk assessment of their ACH activities, and to implement risk management programs based on the results of such assessments, in accordance with the requirements of their regulator(s).

Examples of recent risk-management requirements and guidance by regulators include:

2

* OCC Bulletin 2006-39, Automated Clearing House Activities, September 1, 2006 http://www.occ.treas.gov/ftp/bulletin/2006-39.pdf;

* FFIEC’s BSA/AML Examination Manual, 2007 edition

http://www.ffiec.gov/bsaamlinfobase/documents/BSAAMLMan2007.pdf, pages 199 through 205;

* OCC Bulletin 2008-12, Payment Processors, April 24, 2008

http://www.occ.treas.gov/ftp/bulletin/2008-12.html;

* FDIC Financial Institution Letter 127-2008, Payment Processor Relationships, November 7, 2008 http://www.fdic.gov/news/news/financial/2008/fil08127.html 

* FFIEC Guidance on Risk Management of Remote Deposit Capture, January 14, 2009 http://www.ffiec.gov/pdf/pr011409rdcguidance.pdf.

Generally, these regulators stress the importance of 1) assessing the nature of risks associated with ACH activity; 2) performing appropriate know-your-customer due diligence; 3) establishing controls for Originators, third-parties, and direct-access to ACH Operator relationships; and 4) having adequate management, information and reporting systems to monitor and mitigate risk.

3

Guide on taxation in Australia

The aim of this guide is to provide a broad introduction to the framework of Australia’s tax system. The Australian tax system is a mix of direct and indirect taxes levied by both the Commonwealth and State governments, depending on the type of tax. The Commonwealth is Australia’s federal (or national) level government which can impose taxation on all Australian taxpayers. Within Australia however are a number of states whose ability to impose tax is limited to matters connected to the individual state in question and which are not already taxed by the Commonwealth.

1. Commonwealth taxes

Jurisdiction to tax

The Federal Government of Australia has jurisdiction to tax Australian residents on income from worldwide sources and non-residents on only Australian sourced income. Australian legislation contains specific rules relating to residency to determine whether an individual or company is a resident for tax purposes.

Australia also has a system for determining whether an income amount is sourced in Australia or another country. Generally, income is sourced in the place of employment or the fixed place of business. International transactions are often sourced according to where the relevant contract is made, although there are often variations to these broad rules depending on the circumstances.

The risk associated with the residence and source rules is that one amount of income may be taxed in two different countries. To avoid this, Australia has entered into many double tax agreements with other countries which will prevail over domestic law to ensure that taxation is only imposed once on any given amount of income.

In addition, Australia also operates a system of foreign tax credits under which tax credits are given to Australian residents who pay foreign tax on foreign income. These credits are then used to offset against Australian tax paid on the same amount, again ensuring income is only taxed once.

Taxes on income

Taxable income is generally an entity’s total assessable income less any allowable deductions. If a loss is incurred it may be carried forward to future years provided the loss carry forward tests are satisfied.

Assessable income includes items such as salaries, wages, income from business, interest, rent and dividends.

Deductions generally include expenses that have been incurred in the course of gaining or producing income, in addition to a number of specific deductions allowable under legislation. Deductions are not allowed for personal expenses or those of a capital nature. However, if certain conditions are met, it is possible for companies and individuals to set off losses against other types of income.

Taxes on capital gains (Capital Gains Tax (CGT))

CGT is imposed on gains realised from the sale of assets, with special rules applicable to the valuation of capital gains.

For taxation purposes, the assets subject to CGT are very broad and include both tangible and intangible assets. Certain assets such as motor vehicles, personal use assets and one’s main residence are subject to exemptions, while foreign residents are subject to capital gains on only a limited range of assets, such as real property.

Capital gains are included in taxpayers’ assessable income and therefore taxed at each taxpayer’s applicable income tax rate (see below, Taxation of Individuals).

If the capital asset is held for longer than 12 months, Australian residents are entitled 50% discount for taxation purposes. The CGT rules have recently been amended so that non-residents can no longer access the 50% discount.

Any capital loss incurred can be offset only against capital gains.

There are also various tax incentives for capital investment and inbound investments to Australia that may apply in certain circumstances for a limited period of time.

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2. Medicare Levy and Medicare Levy Surcharge

Medicare is Australia’s public health insurance scheme. It operates by receiving contributions through the Medicare Levy and the Medicare Levy Surcharge, which are taxes imposed on Australian residents’ taxable incomes.

The Medicare Levy is imposed at a flat rate of 1.5% of an individual’s taxable income, although exemptions may be given to low income earners and foreign residents. The Medicare Levy Surcharge is an additional flat rate of between 1-1.5% imposed on high income earners who do not have private hospital insurance.

3. Superannuation tax – the Superannuation Guarantee Charge

In Australia, every employer must pay a minimum level of superannuation (known as the superannuation guarantee) to its employees to ensure that workers have money set aside for their retirement. In the 2013-14 income tax year, the superannuation guarantee rate increased from 9% the previous year to 9.25% of each individual’s employment earnings. With amendments recently coming into effect, the minimum rate will increase progressively over the next six years until it reaches 12% from 1 July 2019 onwards.

If an employer fails to provide the minimum level of

superannuation, they become liable to pay the Superannuation Guarantee Charge (SGC) which includes the amount of the shortfall in superannuation payments plus interest and administrative charges. However, in practice, most companies will contribute the minimum level of superannuation to avoid the SGC.

Also, there are statutory limits to how much employers or employees can contribute to superannuation funds. If contributions are made in excess of these limits, a penalty charge may apply.

4. Luxury car tax

The luxury car tax is a flat rate of 33% imposed when a luxury car is sold or imported into Australia. Certain rules specify what amounts to a luxury car and under what circumstances it will attract the luxury car tax, although it generally applies to cars valued over approximately either $60,000 or $75,000, depending on the fuel consumption of the vehicle.

Other considerations when trading between Australia and other countries

1. Transfer pricing

Australia has transfer pricing rules that need to be considered where goods or services are bought or sold between Australia and other countries. The transfer pricing rules have particular relevance to transactions between related parties in a corporate group for the supply of goods, services or finance that are not priced on terms which would be comparable to those that would be charged between parties transacting at arm’s length.

If an international transaction does not occur at arm’s length or is not supported by an acceptable pricing methodology, then market prices may be substituted into the transaction for Australian taxation purposes to ensure an appropriate level of tax is paid.

For an intra-group cross-border transaction to be deemed

to have occurred at arm’s length, the Australian Taxation

Office (ATO) requires that companies appropriately document

the transaction itself and the pricing methodologies used

when entering into the transaction. Other factors that may

be taken into account by the ATO include, amongst other

things, the commercial justifications for the transaction, any

applicable review processes and whether any alternatives were

considered.

2. Customs duty

Customs duty is imposed on goods imported into Australia. The rate of customs duty is generally around 5% of the ‘customs value’ of goods, although this often changes depending on the type of good that is imported. The customs value of a good is determined as a question of law, taking into account the type of good, its country of origin and the purpose of its import into Australia.

Customs duty is payable when the relevant goods enter Australia. The specific duty rules that apply will depend on how the goods are classified by the Australian Customs Service, and may be altered by Tariff Concession Orders or Free Trade Agreements. The rules applying to customs duty in Australia are complex and importers should seek advice on a case-by-case basis.

3. Excise duty

Excise duty is imposed on alcohol, tobacco, fuel and petroleum products that are produced or manufactured in Australia. If these products are imported into Australia rather than produced or manufactured in Australia, customs duty applies to their importation at a rate comparable to the excise rate (see above, Customs duty).

Excise duty is paid by either the manufacturer or distributer at a flat rate. The applicable excise rates may increase twice a year to reflect inflationary changes.

In addition, a licence is generally required to undertake activities in relation to excisable goods

2. Administration of Australia’s taxation system

Self-assessment

Australian taxation is based on a self-assessment model, where taxpayers are responsible for lodging their own taxation returns. Individuals and companies are required to lodge an annual ‘Income Tax Return’, while companies and other entities may have further requirements for the purposes of GST and PAYG (see below, Withholding taxes).

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Not every tax return in Australia is reviewed by the ATO. Instead, each taxpayer’s assessment of his/her income is taken to be true.

However the ATO does undertake audits of individuals’ and companies’ tax returns to ensure that a taxpayer’s actual tax affairs are consistent with his/her self-assessment.

Withholding taxes

General

Withholding taxes are payable on a number of payment types at various flat rates depending on the payment in question. The purpose of Australia’s withholding tax rules is to enable the efficient and timely collection of tax revenue on an ongoing basis.

The obligation to make a withholding rests with the ‘payer’ of funds, not the recipient. Under these rules, the payer must withhold an amount from certain payments it makes and then pay that amount to the ATO, usually in regular instalments throughout the year, depending on the size of the entity.

Withholding taxes are often paid where dividends, interest or royalties are paid by an Australian resident to a foreign entity. The rate of withholding is typically set out in the relevant double tax agreement.

In addition, withholding taxes also apply in relation to the failure to quote an Australian Business Number (ABN) or a Tax File Number (TFN) in various situations in which they are required (see below, Australian Business Numbers and Tax File Numbers).

Pay-as-you-go (PAYG)

Australia also has a ‘pay-as-you-go’ (PAYG) withholding tax regime. In the most common application of PAYG withholding, a business that has employees must withhold an amount from salary or wage payments made to its employees. The amount withheld broadly represents the income tax payable on that salary or wage and must be remitted to the ATO.

Further, an amount must be withheld from payments made to another business if it has not quoted its ABN when dealing with your business (see below, Australian Business Numbers and Tax File Numbers). PAYG withholdings generally occur at a rate of 46.5% in this situation.

Australian Business Numbers and Tax File Numbers

An ABN is an identification tool used by businesses in dealings with the ATO, other business and government agencies. A business must have an ABN if it is required to register for GST (see above, Consumption taxes). All other businesses may choose whether to obtain an ABN. However, if a business does not have an ABN, withholding taxes apply in its dealings with other businesses, effectively reducing the value of receipts from their other businesses (see above, Withholding taxes: PAYG).

As a similar identification tool, TFNs are used by individuals and organisations to help the ATO administer the Australian tax system. They apply to certain types of income such as salary, wages and some forms of investment income. While it is not compulsory for an individual to have a TFN, it is highly recommended that individuals obtain a TFN because if it is not quoted where required, income tax will be withheld from income earned at the highest marginal tax rate (see above, Withholding taxes: PAYG).

3. State and Territory taxes

State jurisdiction to impose taxes and duties

States and Territories in Australia generally have jurisdiction to impose tax on various state-based transactions. To fall within a state’s jurisdiction, transactions must generally be entered into or carried out within the boarders of a particular State, or alternatively they must have a connection to the particular State wishing to impose taxation on the relevant transaction.

States and Territories most commonly impose tax on immovable property situated in that particular State, as well as on various other state-based transactions such as car registration and employment.

Many State and Territory taxes and duties are not consistent throughout Australia and therefore the laws applicable in each jurisdiction must be considered where relevant. The taxes and duties mentioned below however indicate some common forms of state taxation.

Stamp duty

Stamp duty is imposed on certain transactions such as transfers of property and dealings with shares in companies that are landholders. It is imposed on the acquirer in the relevant transaction, not the transferor.

The imposition of stamp duty is not consistent throughout the states, although it is generally imposed at either a fixed rate or at a rate that depends on the value of the transaction. For example, New South Wales imposes stamp duty on transfers of land according to a sliding scale that is dependent on the value of the real property. The cheapest valued properties attract stamp duty of 1.25%, with the rate progressively increasing to approximately 7% for the most expensively valued properties in New South Wales.

In a similar manner, Victoria charges duty on transfers of land on the greater of the market value of, or the consideration paid for, the property. For transfers occurring since 2008, stamp duty is then paid at a rate of 5.5% for high valued properties down to 1.4% for the cheapest valued properties.

It is important to consider stamp duty rules on a state by state basis whenever real property or business assets are acquired or transferred as rates can vary significantly, while certain transactions may receive concessions or exemptions.

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Payroll tax

Payroll tax is imposed on employers whose annual wages paid

to employees exceed a set amount determined by each state.

The tax is generally between 3% and 7%.

Payroll tax is currently payable in New South Wales at a rate of

5.45% for businesses who pay more than $750,000 in annual

wages. By comparison, Victoria sets its threshold annual

wages level at $550,000 and its rate of payroll tax at 4.9%.

Land tax

Individuals and other entities who own land in Australia over

a prescribed value are liable to pay land tax annually on the

combined value of all taxable land owned. Again, the rate

payable varies between states, while some states exempt

certain classes of land such as one’s principal place of

residence, land used for primary production (for example,

farming) and land used by charities, religions and schools.

New South Wales and Victoria use progressive scales of

taxation in relation to land tax. The minimum threshold land

values above which land tax must be paid are $406,000 and

$250,000 in New South Wales and Victoria, respectively.

Further, whilst the rate payable depends on the value of the

land owned, the range of rates is 0-2% and 0-2.25% for the

same states, respectively.

Motor vehicles duty

Motor vehicle duties are often payable where a motor vehicle

is registered in or transferred within a certain state. The

duty is paid by the purchaser with the applicable rate of duty

generally depending on the type of car and the circumstances

surrounding its transfer.

Key contacts

Anthony Bradica

Partner

T: +61 3 9603 3523

anthony.bradica@hallandwilcox.com.au

Frank Hinoporos

Senior Associate

T: +61 3 9603 3571

frank.hinoporos@hallandwilcox.com.au

Level 30, Bourke Place

600 Bourke Street, Melbourne

Victoria 3000 Australia

Phone +61 3 9603 3555 Facsimile +61 3 9670 9632 www.hallandwilcox.com.au

Disclaimer

This publication is for general information only and may not be used or relied upon by any person. Hall & Wilcox recommends that appropriate legal advice is obtained in respect of the matters set out in this publication. Hall & Wilcox disclaims any liability of any kind whatsoever to any reader of this publication who acts in reliance wholly or partly upon the content of this publication.

207_2_4400552_Aug13

FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM PROGRAM

7356.002

CHAPTER 56: DRUG QUALITY ASSURANCE

SUBJECT: DRUG

Revision Note: Program

MANUFACTURING INSPECTIONS

revised to add potential OAI reporting responsibilities and ORA agreement, Concept of Operations for Inspection.

IMPLEMENTATION DATE 10/31/2017

and to align with the CDER Facility Evaluation and

COMPLETION DATE

10/31/2020

DATA REPORTING

PRODUCT CODES

PRODUCT/ASSIGNMENT CODES

All Human Drugs

Industry codes:

50, 54-56, 59, 60-66

Domestic/Foreign surveillance inspections covered under this program, 7356.002, include inspection of any facility that does not have a specific program:

PAC Type Subject

56002 Full Drug Process Inspections (DPI)

56002H Abbreviated Drug Process Inspections (DPI)

Report coverage of the surveillance programs specified below under the following PACs:

PAC Type Subject

56002A Full DPI/Small Volume Parenterals (CPGM: Sterile Drug

Process Inspections)

56002I Abbreviated DPI/Small Volume Parenterals (CPGM: Sterile Drug

Process Inspections)

56002B Full DPI/Drug Repackers and Relabelers

56002J Abbreviated DPI/Drug Repackers and Relabelers

56002C Full DPI/Radioactive Drugs

56002K Abbreviated DPI/Radioactive Drugs

56002F Full Active Pharmaceutical Ingredient Process Inspections

56002L Abbreviated Active Pharmaceutical Ingredient Process Inspections

56002P Full Drug Process Inspections - PET Domestic (CPGM:

PET CGMP Drug Process and Pre- Approval Inspections/Investigations)

56002Q Abbreviated Drug Process Inspections - PET Domestic (CPGM:

PET CGMP Drug Process and Pre- Approval Inspections/Investigations)

Note: The following three surveillance programs are reported under single PACs; there are no full or abbreviated specific PACs:

PAC Subject

56002E DPI/Medical Gas Manufacturers (CPGM: Compressed Medical Gases)

56002M DPI/Therapeutic Biological Product Inspections (CPGM: Inspections of Licensed Biological Therapeutic Drug Products)

56002S Drug Process Inspections - Biosimilars

56843 Post Approval Inspections/Investigations

(Continued on next page)

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FIELD REPORTING REQUIREMENTS

The ORA division completes the Establishment Inspection Report (EIR), including an inspection classification consistent with Field Management Directive (FMD) 86 and FDA policies governing pharmaceutical quality including this compliance program, within ORA established timeframes. The ORA division files the inspection documents electronically no later than 45 calendar days from the close of the inspection using the specific module (eNSpect, or Compliance Management System (CMS)) accessible to both Office of Regulatory Affairs (ORA) and CDER (Center for Drug Evaluation and Research).

ORA divisions should, as soon as practical, report significant inspection issues into FACTS, as per the Investigations Operations Manual (IOM). For inspections initially classified as Official Action Indicated (OAI) due to failure to comply with Current Good Manufacturing Practice (CGMP), submit the written classification analysis and electronic documents to CDER’s Office of Compliance (OC), Office of Manufacturing Quality (OMQ) for evaluation via CMS.1

ORA divisions (e.g., Pre-Approval Program Managers (PAMs)) are responsible for timely reporting of potential OAI (pOAI) alerts into Panorama2 as per the current procedures.3 The PAM should take into consideration the following when entering a pOAI alert into Panorama:

1. For surveillance coverage that may result in an OAI status, enter a pOAI alert into Panorama, as soon as practical, but at most within 2 days of closing the inspection.

2. Enter a pOAI alert for the refusal of an inspection.4

3. If surveillance and pre-approval coverage are provided during the same inspection:

- Do not enter a pOAI alert for significant application-specific pre-approval issues which do not impact marketed product; refer to CPGM 7346.832.

- Do enter a pOAI alert for significant surveillance issues (see point 1).

The PAM must remove the pOAI alert in Panorama as soon as practical if the ORA division decides to change the initial recommendation of OAI. If CDER/OC/OMQ decides to change the initial OAI recommendation, OMQ must update or remove the pOAI alert associated with that initial classification in Panorama as soon as practical.

During an inspection, if you obtain information pertaining to inadequate adverse drug experience (ADE) reporting, unapproved drug issues, or post-approval reporting violations (failing to submit application supplements, Field Alert Reports (FARs), etc.), report in accordance with directions

1 For further information see Part V Regulatory/Administrative Strategy

2 PANORMA: CDER Time Reporting and Workflow Management System

3 Refer to Panorama Step-By-Step guides for creating, editing and closing pOAI alerts.

4 Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection. See https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm360484.pdf

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provided in the applicable compliance programs and under separate captions in the EIR. Data system information about these inspectional activities should be reported under separate Program Assignment Codes (PACs). Expansion of coverage under these programs into a CGMP inspection should be reported under this compliance program.

The ORA divisions should use this revised compliance program for all CGMP inspections satisfying the statutory obligation for periodic risk-based inspections of drug production. The instructions provided in this section and elsewhere in this program governing ORA and CDER interactions supersede the instructions in the other programs for the 5600 PACs (e.g., 7356.002A, 7356.002F, 7356.002P), with the exception of inspections reported under PAC 56843.

Note that Active Pharmaceutical Ingredient (API) and Positron Emission Tomography (PET) drug inspections are performed to verify conformance with different quality standards and have their own compliance programs. API inspections per CPGM 7356.002F are conducted to verify adherence to section 501(a)(2)(B) of the Food, Drug, and Cosmetic Act using ICH Q7 as a guideline. PET inspections per CPGM 7356.002P are conducted to verify adherence to 21 CFR Part 212.

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PART I - BACKGROUND

Until 2012, FDA was required to inspect domestic establishments that manufacture drugs marketed in the United States every 2 years, but there was no comparable requirement for inspecting foreign establishments. The Food and Drug Administration Safety and Innovation Act (FDASIA),5 which amended the FD&C Act section 510(h), eliminated this distinction, directing FDA to take a risk-based approach to inspecting both domestic and foreign drug manufacturing establishments. The selection of both domestic and foreign establishments for routine surveillance inspections is now driven by a risk-based site selection model. In 2015 the agency formalized its process for selecting establishments for inspection based on risk factors specified by section 510(h) of the Act.

This compliance program provides surveillance inspection coverage of drug manufacturing establishments complying with the requirements of CGMP as per 501(a)(2)(B) of the Act and implementing regulations. The focus of surveillance inspections is on system-wide controls that ensure manufacturing processes produce quality drugs. Systems examined during these inspections include those related to materials, quality control, production, facilities and equipment, packaging and labeling, and laboratory controls.

FDA expects that establishments that comply with CGMP are likely to operate in a state of control and consistently manufacture drug products of acceptable quality. FDA will use information gathered from surveillance inspections to, among other things, make assessments about manufacturing facilities listed in pending drug applications.

The inspectional guidance in this program is structured to provide for efficient use of resources devoted to routine surveillance coverage, recognizing that in-depth coverage of all systems and all processes is not feasible or required for all firms and inspections. It also provides guidance for conducting for-cause inspections as appropriate (see page 9 under PROGRAM MANAGEMENT INSTRUCTIONS).

5 Food and Drug Administration Safety and Innovation Act (FDASIA),

see https://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf, page 1067.

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PART II- IMPLEMENTATION

OBJECTIVES

The goal of this program's activities is to ensure that establishments consistently manufacture drug products of acceptable quality and minimize consumers' exposure to adulterated drug products. Under this program, inspections, investigations, sample collections, sample analyses, and regulatory or administrative follow-up are made in order to identify quality problems and adverse trends at establishments, so that FDA can develop strategies to mitigate them. The objectives of this program are:

* to determine whether inspected firms are operating in compliance with applicable CGMP requirements, and if not, to provide the evidence for actions to prevent adulterated products from entering the market; as appropriate, to remove adulterated products from the market, and to take action against persons responsible;

* to provide an assessment of firms’ conformance to CGMP requirements for Agency decisions;

* to provide input to firms during inspections to improve their compliance with regulations; and,

* to better understand current practices in drug manufacturing for the purpose of updating the CGMP requirements, regulatory policy, and guidance documents.

STRATEGY

A. Inspection of Manufacturing Establishments (includes repackaging, contract labs, etc.)

Drug products are manufactured using many physical operations that bring together components, and containers and closures to make a product that is released for distribution. Drug manufacturing can be organized into sets of operations and related activities, called systems. Control of all systems helps to ensure the firm will produce drugs that are safe, have the identity and strength, and meet the quality and purity characteristics as intended.

This program applies to all manufacturing operations at the establishment.

It is not practical for FDA to audit every aspect of CGMP in every manufacturing facility during every inspection visit. Profile classes generalize inspection coverage from a small number of specific products to all the products in that class. Reporting coverage for every profile class as defined in FACTS, for each inspection, provides the most broadly resource-efficient approach. This program uses a risk-based systems approach to further generalize inspection coverage from a small number of profile classes to an overall evaluation of the firm. Risk-based inspectional approaches allow updating of all profile classes.

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The inspection is defined as audit coverage of two or more systems, with mandatory coverage of the Quality System (see system definitions below). Depending on the purpose of the inspection, inspection coverage may include different numbers of systems. Inspecting the minimum number of systems, or more systems as deemed necessary by the ORA division, will provide the basis for an overall CGMP classification decision.

B. Inspection of Systems

Inspections of drug manufacturers should be made and reported using the system definitions and industry codes in this compliance program. Focusing on systems, rather than profile classes, will increase efficiency in conducting inspections because the systems are often applicable to multiple profile classes. System inspection coverage should represent all profile classes at the establishment and determine their acceptability/non-acceptability.

Coverage of a system should be sufficiently detailed, with specific examples selected, so that the system inspection outcome reflects the state of control in that system for every profile class. If a particular system is adequate, it should be adequate for all profile classes manufactured by the firm. For example, the way a firm handles "materials" (i.e., receipt, sampling, testing, acceptance, etc.), should be the same for all profile classes. An inspection does not have to include each profile class attribute when covering a given system provided that inspection coverage includes related controls for all types of drugs and operations. Likewise in the Production System, there are general requirements like SOP use, charge-in of components, equipment identification, in- process sampling and testing which can be evaluated through selection of example products in various profile classes. Under each system there may be something unique for a particular profile class: e.g., under the Materials System, the production of Water for Injection USP for use in manufacturing. Selecting unique functions within a system will be at the discretion of the lead investigator. Any given inspection need not cover every system. See Part III.

Complete inspection of one system may necessitate further follow up of some items within the activities of another/other system(s) to fully document the findings. However, this coverage does not constitute nor require complete coverage of these other systems.

C. A Scheme of Systems for the Manufacture of Drugs/Drug Products

The overall theme in devising the following scheme of systems was the subchapter structure of the 21 CFR 211 CGMP regulations. Every effort was made to group whole subchapters together in a rational set of six systems which incorporates the general scheme of pharmaceutical manufacturing

operations.

The organization and personnel, including appropriate qualifications and training, employed in any given system, will be evaluated as part of that system's operation. Production, control, and distribution records required to be maintained by the CGMP regulations and selected for review should be included for inspection audit within the context of each of the above systems. Inspections of contract companies should be within the system for which the product or service is contracted as well as their Quality System.

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A general scheme of systems for auditing the manufacture of drugs and drug products consists of the following:

1) Quality System. This system assures overall compliance with CGMPs and internal procedures and specifications. This system includes the quality control unit and all of its review and approval duties (e.g., change control, reprocessing, batch release, annual record review, validation protocols, and reports, etc.). It includes all product defect evaluations and evaluation of returned and salvaged drug products. See the CGMP regulations, 21 CFR 211 Subparts B, E, F, G, I, J, and K.

2) Facilities and Equipment System. This system includes the measures and activities which provide an appropriate physical environment and resources used in the production of the drugs or drug products. It includes:

a) Buildings and facilities along with maintenance;

b) Equipment qualifications (installation and operation); equipment calibration and preventative maintenance; and cleaning and validation of cleaning processes as appropriate. Process performance qualification will be evaluated as part of the inspection of the overall process validation which is done within the system where the process is employed; and,

c) Utilities that are not intended to be incorporated into the product such a HVAC, compressed gases, steam and water systems.

See the CGMP regulations, 21 CFR 211 Subparts B, C, D, and J.

3) Materials System. This system includes measures and activities to control finished products, components, including water or gases that are incorporated into the product, containers and closures. It includes validation of computerized inventory control processes, drug storage, distribution controls, and records. See the CGMP regulations, 21 CFR 211 Subparts B, E, H, and J.

4) Production System. This system includes measures and activities to control the manufacture of drugs and drug products including batch compounding, dosage form production, in-process sampling and testing, and process validation. It also includes establishing, following, and documenting performance of approved manufacturing procedures. See the CGMP regulations, 21 CFR 211 Subparts B, F, and J.

5) Packaging and Labeling System. This system includes measures and activities that control the packaging and labeling of drugs and drug products. It includes written procedures, label examination and usage, label storage and issuance, packaging and labeling operations controls, and validation of these operations. See the CGMP regulations, 21 CFR 211 Subparts B, G, and J.

6) Laboratory Control System. This system includes measures and activities related to laboratory procedures, testing, analytical methods development and validation or verification, and the stability program. See the CGMP regulations, 21 CFR 211 Subparts B, I, J, and K.

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As this program approach is implemented, the experience gained will be reviewed to make modifications to the system definitions and organization as needed.

PROGRAM MANAGEMENT INSTRUCTIONS

A. Definitions

1. Surveillance Inspections

The Full Inspection Option

The Full Inspection Option is a surveillance inspection meant to provide a broad and in-depth evaluation of the firm's conformance with CGMP requirements. A Full Inspection may change to an Abbreviated Inspection Option with concurrence of the ORA division. During the course of a Full Inspection, verification of Quality System activities may require limited coverage in other systems. The Full Inspection Option will normally include an inspection audit of at least four of the systems, one of which must be the Quality System (the system which includes the responsibility for the annual product reviews).

The Abbreviated Inspection Option

The Abbreviated Inspection Option is a surveillance inspection meant to provide an efficient updated evaluation of a firm's conformance with CGMP requirements. The abbreviated inspection will provide documentation for continuing a firm in a satisfactory CGMP compliance status. Generally this will be done when a firm has a record of satisfactory CGMP compliance, with no significant recall, or product defect or alert incidents, or with little shift in the manufacturing profiles of the firm since the last inspection. See Part III, Section B.2. An Abbreviated Inspection may change to a Full Inspection, upon findings of objectionable conditions (as listed in Part V) in one or more systems, with ORA division concurrence. The Abbreviated Inspection Option normally will include an inspection audit of at least two of the systems, one of which must be the Quality System (the system which includes the responsibility for the annual product reviews). The ORA division drug program managers should ensure that the optional systems are rotated in successive Abbreviated Inspections. During the course of an abbreviated inspection, verification of quality system activities may require limited coverage in other systems. Some firms participate in a limited part of the production of a drug or drug product, e.g., a contract laboratory. Such firms may employ only two of the systems defined. In these cases the inspection of the two systems will comprise inspection of the entire firm and will be considered the Full Inspection Option.

Selecting Systems for Coverage

The selection of the system(s) for coverage will be made by the ORA division based on the firm's specific operation, history of previous coverage, history of compliance, or other priorities determined by the ORA division.

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2. For-Cause Inspections

A for-cause inspection is defined to include: (i) Follow-up compliance inspections performed to verify corrective actions after a regulatory action has been taken; (ii) inspections performed in response to specific events or information (Field Alert Reports (FARs), Biological Product Defect Reports (BPDRs), industry complaints, recalls, and other indicators of defective products, etc.) that bring into question the compliance and/or quality of a manufacturing practice, facility, process, or drug.

For-cause inspections that are to be initiated and reported under this program include follow-up compliance inspections performed to verify corrective actions after a regulatory action has been taken. Follow-up compliance inspections provide focused coverage and include the areas of concern, the proposed corrective action plan for impacted operations, any implemented corrective actions, and/or the deficiencies noted on the FDA-483 for a previous inspection. The decision to add systems coverage is made on case-by-case basis.

For-cause inspections in response to FARs defect reports are to be initiated and performed under CPGM 7356.021.

Other for-cause inspections (e.g., industry complaints, other indicators of defective products) may be initiated as per FMD-17, but expanded to include CGMP coverage for the purpose of updating overall compliance status.

3. State of Control

A drug firm is considered to be operating in a state of control when it employs conditions and practices that assure compliance with the intent of Sections 501(a)(2)(B) of the Act and the portions of the CGMP regulations that pertain to their systems. A firm in a state of control produces finished drug products for which there is an adequate level of assurance of quality, strength, identity and purity.

A firm is out of control if any one system is out of control. A system is out of control if the quality, identity, strength and purity of the products resulting from one or more system(s) cannot be adequately assured. Documented CGMP deficiencies provide the evidence for concluding that a system is not operating in a state of control. See Part V. Regulatory/Administrative Strategy for a discussion of compliance actions based on inspection findings demonstrating out of control systems/firm.

4. Drug Process

A drug process is a related series of operations which result in the preparation of a drug or drug product. Major operations or steps in a drug process may include mixing, granulation, encapsulation, tableting, chemical synthesis, fermentation, aseptic filling, sterilization, packing, labeling, testing, etc.

5. Drug Manufacturing Inspection

A drug manufacturing inspection is an establishment inspection in which two or more systems, including the Quality System, are evaluated to determine if manufacturing is occurring in a state of control.

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B. Inspection Planning

ORA will conduct drug manufacturing inspections using a risk-based approach and maintain profiles or other monitoring systems. The ORA division is responsible for determining the depth of coverage given to each drug firm. The depth of inspection coverage should be determined by the firm's compliance history, the manufacturing technology employed, and the characteristics of the products. CGMP inspectional coverage shall be sufficient to assess the state of control and compliance for each firm.

In advance of a scheduled Surveillance Inspection, the Office of Surveillance (OS) in the Office of Pharmaceutical Quality (OPQ)/CDER prepares an up-to-date site dossier which includes but is not limited to, quality information on facility inspection history, recalls, shortages, customer complaints, foreign regulator inspection outcomes, information on submitted Field Alert Reports (FARs) or Biological Product Defect Reports (BPDRs), submitted quality metrics data if available, and a listing of all products manufactured at the site. When a system is inspected, the inspection of that system may be considered applicable to all products which use it. Investigators should select an adequate number and type of products to accomplish coverage of the system. Selection of products should be made so that coverage is representative of the firm's overall abilities in manufacturing within CGMP requirements.

Products posing special challenges, such as low dose products, narrow therapeutic range drugs, combination products,6 modified release products, biological products,and new products manufactured under recently approved drug applications, should be considered first in selecting products for coverage (refer to IOM section 5.5.1.2 – Inspectional Approach 7).

The health significance of certain CGMP deviations may be lower when the drug product involved has no major systemic health effect or no dosage limitations such as in products like calamine lotion. Such products should be given inspection coverage with appropriate priority.

Inspections for this compliance program may be performed during visits to a firm when operations are being performed for other compliance programs or other investigations.

C. Profiles

The inspection findings will be used as the basis for updating all profile classes in the profile screen of the FACTS EIR coversheet that is used to record profile/class determinations. Normally, an inspection under this risk-based systems approach will result in all profile classes being updated.

6 Combination products are subject to the CGMP requirements outlined in 21 CFR Part 4. See the FDA Guidance for Industry and Staff: Current Good Manufacturing Practice Requirements for Combination Products for more information at https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM429304.pdf.

7 Investigations Operations Manual, https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf

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PART III – INSPECTIONAL

INVESTIGATIONAL OPERATIONS

A. General

Review and use the CGMP regulations for Finished Pharmaceuticals (21 CFR 210 and 211) and related guidance for industry to evaluate manufacturing processes.

The investigator should conduct inspections according to the STRATEGY section in Part II of this compliance program. Recognizing that drug firms vary greatly in size and scope, and manufacturing systems are more or less sophisticated, the approach to inspecting each firm should be carefully planned. For example, it may be more appropriate to review the Quality System thoroughly before entering production areas in some firms; in others, the Quality System review should take place concurrently with inspection of another system or systems selected for coverage. The complexity and variability necessitate a flexible inspection approach; one which allows the investigator to choose the inspection focus and depth appropriate for a specific firm, but also one which directs the performance and reporting on the inspection within a framework which will provide for a uniform level of CGMP assessment. Furthermore, this inspection approach will provide for fast communication and evaluation of findings.

Inspectional observations noting CGMP deficiencies should be related to a requirement. CGMP requirements for manufacture of drug products (dosage forms) are in section 501(a)(2)(B) of the FD&C Act and the regulations, and are amplified by guidance, case precedents, etc. CGMP requirements apply to the manufacture of all human drugs, which include prescription and nonprescription drug products, drug products that are the subject of pending applications, drug products used in clinical trials, as well as products not requiring approval.

Active Pharmaceutical Ingredient (API) and Positron Emission Tomography (PET) drug inspections are performed to verify conformance with different quality standards than 21 CFR 210 and 211 and have their own compliance programs. API inspections are conducted under CPGM 7356.002F, which employs ICH Q7 as a quality standard, and establishes compliance to the statutory requirement of the section 501(a)(2)(B) of the FD&C Act. Firms that follow ICH Q7 generally will be considered to comply with the statutory requirement. PET inspections under CPGM 7356.002P are conducted to verify adherence to 21 CFR Part 212.

Guidance documents are not to be referred to as the justification for an inspectional observation. The justification comes from the statute and the CGMP regulations. Current Guides to Inspection and Guidance to Industry documents provide interpretations of requirements, which may assist in the evaluation of the adequacy of CGMP systems. Guidance documents do not establish requirements.

Current inspectional observation policy as stated in the IOM says that the FDA-483, when issued, should be specific and contain only significant items. For this program, inspection observations should be organized under separate captions by the systems defined in this program. List the observations in order of importance within each system. Where repeated or similar observations are made, they should be consolidated under a unified observation. A limited number of observations can

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be common to more than one system (e.g., organization and personnel including appropriate qualifications and training). In these instances, put the observation in the first system reported on the FDA-483 and in the text of the EIR, reference the applicability to other systems where appropriate. This is being done to accommodate the structure of eNSpect which allows individual citation once per FDA-483. Refrain from using unsubstantiated conclusions. Do not use the term "inadequate" without explaining why and how. Refer to policy in the IOM, Chapter 5, Section 5.2.3 – Reports of Observations for further guidance on the content of Inspectional Observations.

Specific specialized inspectional guidance may be provided as attachments to this program, or in requests for inspection, assignments, etc.

B. Inspection Approaches

This program provides two surveillance inspectional options, Full Inspection Option and the Abbreviated Inspection Option . See the definitions of the inspection options in Part II of this program.

1. Selecting the Full Inspection Option. The Full Inspection Option will include inspection of at least four of the systems listed in Part II Strategy, one of which must be the Quality System.

a) Select the Full Inspection Option for an initial FDA inspection of newly registered establishments. Inspection coverage should include all systems as appropriate to the operations. A Full Inspection may change to the Abbreviated Inspection Option, with ORA division concurrence.

For efficient use of FDA resources, before scheduling the surveillance coverage of the newly registered establishment, the ORA division should consult with CDER to determine whether it is listed in any pending application and also needs a pre-approval inspection.

b) Select the Full Inspection Option when the firm has a history of fluctuating into and out of compliance. To determine if the firm meets this criterion, the ORA division should utilize all information at its disposal, such as inspection results, results of sample analyses, complaints, DQRS and BPDR reports, recalls, etc. and the compliance actions resulting from them or from past inspections.

c) Evaluate if important changes have occurred by comparing current operations against the EIR for the previous Full Inspection. The following types of changes are typical of those that warrant the Full Inspection Option:

1) New potential for cross-contamination arising through change in process or product line.

2) Use of new technology requiring new expertise, significant new equipment, or new facilities.

d) A Full Inspection may also be conducted on a surveillance basis at the ORA division’s discretion.

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2. Selecting the Abbreviated Inspection Option. The Abbreviated Inspection Option normally will include inspection audit of at least two systems, one of which must be the Quality System. During the course of an Abbreviated Inspection, verification of quality system activities may require limited coverage in other systems

a) This option involves an inspection of the manufacturer to maintain surveillance over the firm's activities and to provide input to the firm on maintaining and improving the CGMP level of assurance of quality of its products.

b) A Full Inspection may change to the Abbreviated Inspection option, with ORA division concurrence, based on inspection history.

c) Abbreviated Inspection coverage may be changed to the Full Inspection Option at the discretion of the ORA division.

Inspection Coverage

It is not anticipated that Full Inspections (4 to 6 systems coverage) can be conducted every time. To build comprehensive information on the firm's manufacturing activities, ORA divisions should consider selecting different systems for inspection coverage during successive Abbreviated Inspections.

Follow up inspections to a Warning Letter or other significant regulatory actions are considered for-cause inspections, and as a result, the related for-cause assignments can request either full systems coverage or individual system coverage. In addition, coverage can be added on case-by-case basis at the discretion of the ORA division prior to or during the inspection.

C. System Inspection Coverage

QUALITY SYSTEM

Assessment of the Quality System is two-phased. The first phase is to evaluate whether the Quality Control Unit has fulfilled the responsibility to review and approve all procedures related to production, quality control, and quality assurance and assure the procedures are adequate for their intended use. This also includes the associated recordkeeping systems. The second phase is to assess the data collected to identify quality problems which may link to other major systems for inspectional coverage.

For each of the following, the firm should have written and approved procedures and documentation resulting therefrom. The firm's adherence to written procedures should be verified through observation whenever possible. These areas are not limited to finished products, but may also incorporate components and in-process materials. These areas may indicate deficiencies not only in this system but also in other major systems that would warrant expansion of coverage.

All areas under this system should be covered; however, the depth of coverage may vary depending upon inspectional findings.

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- Product reviews: at least annually; should include information from areas listed below as appropriate; batches reviewed, for each product, are representative of all batches manufactured; trends are identified; refer to 21 CFR 211.180(e)

- Complaint reviews (quality and medical): documented; evaluated; investigated in a timely manner; includes corrective action where appropriate

- Discrepancy and failure investigations related to manufacturing and testing: documented; evaluated; investigated in a timely manner; includes corrective action where appropriate

- Change Control: documented; evaluated; approved; need for revalidation assessed

- Product Improvement Projects: for marketed products

- Reprocess/Rework: evaluation, review and approval; impact on validation and stability

- Returns/Salvages: assessment; investigation expanded where warranted; disposition

- Rejects: investigation expanded where warranted; corrective action where appropriate

- Stability Failures: investigation expanded where warranted; need for field alerts evaluated; disposition

- Quarantine products

- Validation: status of required validation/revalidation (e.g., computer, manufacturing process, laboratory methods)

       - Training/qualification of employees in quality control unit functions FACILITIES AND EQUIPMENT SYSTEM

For each of the following, the firm should have written and approved procedures and documentation resulting therefrom. The firm's adherence to written procedures should be verified through observation whenever possible. These areas may indicate deficiencies not only in this system but also in other systems that would warrant expansion of coverage. When this system is selected for coverage in addition to the Quality System, all areas listed below should be covered; however, the depth of coverage may vary depending upon inspectional findings.

1. Facilities

- cleaning and maintenance

- facility layout and air handling systems for prevention of cross-contamination (e.g., penicillin, beta-lactams, steroids, hormones, cytotoxics)

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- specifically designed areas for the manufacturing operations performed by the firm to prevent cross-contamination or mix-ups

- general air handling systems

- control system for implementing changes in the building

- lighting, potable water, washing and toilet facilities, sewage and refuse disposal

- sanitation of the building, use of rodenticides, fungicides, insecticides, cleaning and sanitizing agents

2. Equipment

- equipment installation and operational qualification where appropriate

- adequacy of equipment design, size, and location

- equipment surfaces should not be reactive, additive, or absorptive

- appropriate use of equipment operations substances, (lubricants, coolants, refrigerants, etc.) contacting products/containers

- cleaning procedures and cleaning validation for re-usable or multi-product equipment

- controls to prevent contamination, particularly with any pesticides or any other toxic materials, or other drug or non-drug chemicals

- qualification, calibration and maintenance of storage equipment, such as refrigerators and freezers for ensuring that standards, raw materials, reagents, etc. are stored at the proper temperatures

- equipment qualification, calibration and maintenance, including computer qualification/validation and security

- control system for implementing changes in the equipment

- equipment identification practices (where appropriate)

         - documented investigation into any unexpected discrepancy

MATERIALS SYSTEM

For each of the following, the firm should have written and approved procedures and documentation resulting therefrom. The firm's adherence to written procedures should be verified through observation whenever possible. These areas are not limited to finished products, but may also

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incorporate components and in-process materials. These areas may indicate deficiencies not only in this system but also in other systems that would warrant expansion of coverage. When this system is selected for coverage in addition to the Quality System, all areas listed below should be covered; however, the depth of coverage may vary depending upon inspectional findings.

- training/qualification of personnel

- identification of components, containers, closures

- inventory of components, containers, closures

- storage conditions

- storage under quarantine until tested or examined and released

- representative samples collected, tested or examined using appropriate means

- at least one specific identity test is conducted on each lot of each component

- a visual identification is conducted on each lot of containers and closures

- testing or validation of supplier's test results for components, containers and closures

- rejection of any component, container, closure not meeting acceptance requirements

- Investigate fully the firm's procedures for verification of the source of components.

- appropriate retesting/reexamination of components, containers, closures

- first in – first out use of components, containers, closures

- quarantine of rejected materials

- water and process gas supply, design, maintenance, validation and operation

- containers and closures should not be additive, reactive, or absorptive to the drug product

- control system for implementing changes in the materials handling operations

- qualification/validation and security of computerized or automated processes

- finished product distribution records by lot

- documented investigation into any unexpected discrepancy

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PRODUCTION SYSTEM

For each of the following, the firm should have written and approved procedures and documentation resulting therefrom. The firm's adherence to written procedures should be verified through observation whenever possible. These areas are not limited to finished products, but may also incorporate components and in-process materials. These areas may indicate deficiencies not only in this system but also in other systems that would warrant expansion of coverage. When this system is selected for coverage in addition to the Quality System, all areas listed below should be covered; however, the depth of coverage may vary depending upon inspectional findings.

- training/qualification of personnel

- control system for implementing changes in processes

- adequate procedure and practice for charge-in of components

- formulation/manufacturing at not less than 100%

- identification of equipment with contents, and where appropriate phase of manufacturing and/or status

- validation and verification of cleaning/sterilization/ depyrogenation of containers and closures

- calculation and documentation of actual yields and percentage of theoretical yields

- contemporaneous and complete batch production documentation

- established time limits for completion of phases of production

- implementation and documentation of in-process controls, tests, and examinations (e.g., pH, adequacy of mix, weight variation, clarity)

- justification and consistency of in-process specifications and drug product final specifications

- prevention of objectionable microorganisms in non-sterile drug products

- adherence to preprocessing procedures (e.g., set-up, line clearance)

- equipment cleaning and use logs

- master production and control records

- batch production and control records

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- process validation, including validation and security of computerized or automated processes

- change control; the need for revalidation evaluated

     - documented investigation into any unexpected discrepancy

PACKAGING AND LABELING SYSTEM

For each of the following, the firm should have written and approved procedures and documentation resulting therefrom. The firm's adherence to written procedures should be verified through observation whenever possible. These areas are not limited only to finished products, but also incorporate components and in-process materials. These areas may indicate deficiencies not only in this system but also in other systems that would warrant expansion of coverage. When this system is selected for coverage in addition to the Quality System, all areas listed below should be covered; however, the depth of coverage may vary depending upon inspectional findings.

- training/qualification of personnel

- acceptance operations for packaging and labeling materials

- control system for implementing changes in packaging and labeling operations

- adequate storage for labels and labeling, both approved and returned after issued

- control of labels which are similar in size, shape, and color for different products

- finished product cut labels for immediate containers which are similar in appearance without some type of 100 percent electronic or visual verification system or the use of dedicated lines

- gang printing of labels is not done, unless they are differentiated by size, shape, or color

- control of filled unlabeled containers that are later labeled under multiple private labels

- adequate packaging records that will include specimens of all labels used

- control of issuance of labeling, examination of issued labels and reconciliation of used labels

- examination of the labeled finished product

- adequate inspection (proofing) of incoming labeling

- use of lot numbers, destruction of excess labeling bearing lot/control numbers

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- physical/spatial separation between different labeling and packaging lines

- monitoring of printing devices associated with manufacturing lines

- line clearance, inspection and documentation

- adequate expiration dates on the label

- conformance to tamper-resistant packaging requirements (see 21CFR 211.132 and Compliance Policy Guide, Sec. 450.500)8

- validation of packaging and labeling operations including validation and security of computerized processes

      - documented investigation into any unexpected discrepancy

LABORATORY CONTROL SYSTEM

For each of the following, the firm should have written and approved procedures and documentation resulting therefrom. The firm's adherence to written procedures should be verified through observation whenever possible. These areas are not limited only to finished products, but may also incorporate components and in-process materials. These areas may indicate

deficiencies not only in this system but also in other systems that would warrant expansion of coverage. When this system is selected for coverage in addition to the Quality System, all areas listed below should be covered; however, the depth of coverage may vary depending upon inspectional findings.

- training/qualification of personnel

- adequacy of staffing for laboratory operations

- adequacy of equipment and facility for intended use

- calibration and maintenance programs for analytical instruments and equipment

- validation and security of computerized or automated processes

- reference standards; source, purity and assay, and tests to establish equivalency to current official reference standards as appropriate

- system suitability checks on chromatographic systems (e.g., GC or HPLC)

8 CPG Sec. 450.500 Tamper-Resistant Packaging Requirements for Certain Over-the-Counter Human Drug Products. See https://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074391.htm

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- specifications, standards, and representative sampling plans

- adherence to the written methods of analysis

- validation/verification of analytical methods

- control system for implementing changes in laboratory operations

- required testing is performed on the correct samples

- documented investigation into any unexpected discrepancy

- complete analytical records from all tests and summaries of results

- quality and retention of raw data (e.g., chromatograms and spectra)

- correlation of result summaries to raw data; presence of unused data

- adherence to an adequate Out of Specification (OOS) procedure which includes timely completion of the investigation

- adequate reserve samples; documentation of reserve sample examination

- stability testing program, including demonstration of stability indicating capability of the test methods

D. Sampling

Samples of defective product constitute persuasive evidence that significant CGMP problems exist. Physical samples may be an integral part of a CGMP inspection where control deficiencies are observed. Physical samples should be correlated with observed control deficiencies. Contact program coordinator (chemistry, microbiology) in ORS/OMPTSLO identified in CONTACTS for guidance and types of samples (in process or finished product) to be collected and for appropriate servicing laboratory. Documentary samples may be submitted when the documentation illustrates the deficiencies better than a physical sample. ORA divisions may elect to collect, but not analyze, physical samples, or to collect documentary samples to document CGMP deficiencies. Physical sample analysis is not necessary to document CGMP deficiencies.

When a large number of products have been produced under deficient controls, collect physical and/or documentary samples of products which have the greatest therapeutic significance, narrow therapeutic range, or low dosage strength. Include samples of products of minimal therapeutic significance only when they illustrate highly significant CGMP deficiencies.

For sampling guidance, refer to IOM, Chapter 4 – Sampling.

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E. Inspection Teams

An inspection team (see IOM section 5.1.2.5 – Team Inspections) composed of experts from within the Division, other ORA divisions, or Headquarters is encouraged when it provides needed expertise and experience. Contact ORA/Office of Pharmaceutical Quality Operations if technical assistance is needed (see also FMD 142). ORA leads the inspection with CDER participation, when requested by ORA. Participation of an analyst (chemist or microbiologist) on an inspection team is also encouraged, especially where laboratory issues are extensive or complex. Contact your Drug Servicing Laboratory or ORA/Office of Regulatory Science. Each inspection team member is responsible for preparing for, executing, and documenting the inspection, including contributing to the establishment inspection report, which documents the items covered during the inspection, within established timeframes.

F. Reporting

If ORA observes critical conditions (e.g., which may result in an imminent health hazard), as appropriate and if feasible, they may be discussed between ORA and OMQ before the inspection closes. The ORA Director of Investigations Branch or designee, the investigator(s), and OMQ collaboratively decide whether to continue the inspection to gather additional information or to close the inspection to initiate prompt regulatory action.

The investigator will utilize IOM Subchapter 5.10 – Reporting for guidance in reporting of inspectional findings. Identify systems covered in the Summary of Findings. Identify and explain in the body of the report the rationale for inspecting the profile classes covered. Report and discuss in full any adverse findings by systems under separate captions. Add additional information as needed or desired, for example, a description of any significant changes that have occurred since previous inspections. Each report should include a description of operations, products, and controls covered during the inspection in sufficient detail to enable appropriate regulatory decision-making following the inspection and to inform future inspections.

FDA’s pharmaceutical CGMP inspection program and resulting inspection reports are of interest to counterpart inspectorates and regulators worldwide who use and rely on FDA inspections and inspection reports, as does FDA of their inspections and reports.

Reports with specific, specialized information required should be prepared as instructed within the individual assignment/attachment.

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PART IV - ANALYTICAL

ANALYZING LABORATORIES

The types of analyses that may be performed under this program include (but are not limited to);

* Routine analyses: Assay, Impurities, Dissolution, Identification

* Routine microbiological analyses: Sterility, Endotoxin, Nonsterile examination

* Other microbiological examinations

* Chemical Cross Contamination

* Antibiotics

* Bioassays

* Particulate Matter in Injectables

SERVICING LABORATORY

Contact (email) ORAHQ ORS Management <ORAORSMANAGEMENT@fda.hhs.gov> for servicing laboratory(s) for all chemical and microbiological testing. When contacting ORS for servicing laboratories provide product description, lots to be tested, analyses to be performed, and reason for the sample collection. Servicing laboratories will be identified based on lab specialization, technology and testing expertise, and laboratory capacity.

[NOTE: The Laboratory Servicing Table (LST) Dashboard is not sufficiently detailed to accurately, correctly identify laboratories and should not be used for selecting servicing laboratories under this program.]

ANALYSIS:

1. Samples are to be examined for compliance with applicable specifications as they relate to deficiencies noted during the inspection.. All analyses will be performed by the official regulatory methods, or when no official method exists, by other validated procedures identified by ORS/OMPTSLO.

2. The presence of cross-contamination must be confirmed by a mass spectroscopic method.

3. Check Analysis for dissolution rate must be performed by a second dissolution-testing laboratory.

4. Microbiological examinations should be based on appropriate sections of USP and Pharmaceutical Microbiological Manual (PMM).9

9 Pharmaceutical Microbiological Manual (PMM), ORA.007,

See https://www.fda.gov/downloads/scienceresearch/fieldscience/ucm397228.pdf

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PART V - REGULATORY/ADMINISTRATIVE STRATEGY

Inspection findings that demonstrate that a firm is not operating in a state of control may be used as evidence for taking appropriate advisory, administrative, and/or judicial actions.

The initial classification should be based on the ORA division’s assessment of the seriousness of the CGMP problem.

The endorsement of the inspection report should point out the actions by the firm that have been taken or will be taken and when. All deficiencies noted in inspections/audits under this program must be addressed by stating the firm's corrective actions, accomplished or projected, for each as established in the discussion with management at the close of the inspection.

All corrective actions proposed by firms are monitored and managed collaboratively by the ORA division and OMQ. These approaches may range from shut down of operations, recall of products, conducting testing programs, development of new procedures, modifications of plants and equipment, to simple immediate corrections of conditions. CDER OPQ sub-offices (Office of Process and Facilities (OPF) and/or OS) will also assist ORA divisions as requested.

If an inspection report documents that one or more systems at the establishment is/are out of control, the inspection should receive an initial OAI classification. Issuance of a Warning Letter or taking other regulatory or advisory actions pursuant to a surveillance inspection should result in the classification of all profile classes as unacceptable. Also, the inspection findings will be used as the basis for updating profile classes in FACTS.

FDA laboratory tests that demonstrate effects of absent or inadequate current good manufacturing practice are strong evidence for supporting regulatory actions. Such evidence development should be considered as an inspection progresses and deficiencies are found. However, the lack of violative physical samples is not a barrier to pursuing regulatory and/or administrative action provided that CGMP deficiencies have been well documented. Likewise, physical samples found to be in compliance are not a barrier to pursuing action under CGMP charges.

Evidence to support significant and/or a trend of deficiencies within a system covered could demonstrate the failure of a system and should result an OAI referral to OMQ. When deciding the type of action to recommend, the initial decision should be based on the seriousness and/or the frequency of the problems. Examples of such problems include the following:

Quality System:

1) Pattern of failure to review/approve procedures

2) Pattern of failure to document execution of operations as required

3) Pattern of failure to review documentation

4) Pattern of failure to conduct investigations and resolve discrepancies/failures/ deviations/complaints

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COMPLIANCE PROGRAM PROGRAM

7356.002

    5) Pattern of failure to assess other systems to assure compliance with CGMP and SOPs Facilities and Equipment

1) Contamination with filth, objectionable microorganisms, toxic chemicals or other drug chemicals, or a reasonable potential for contamination, with demonstrated avenues of contamination, such as airborne or through unclean equipment

2) Pattern of failure to validate cleaning procedures for non-dedicated equipment; Lack of demonstration of effectiveness of cleaning for dedicated equipment

3) Pattern of failure to document investigation of discrepancies

4) Pattern of failure to establish/follow a control system for implementing changes in the equipment

    5) Pattern of failure to qualify equipment, including computers Materials System

1) Release of materials for use or distribution that do not conform to established specifications

2) Pattern of failure to conduct one specific identity test for components

3) Pattern of failure to document investigation of discrepancies

4) Pattern of failure to establish/follow a control system for implementing changes in the materials handling operations

5) Lack of validation of water systems as required depending upon the intended use of the water

    6) Lack of validation of computerized processes

Production System

1) Pattern of failure to establish/follow a control system for implementing changes in the production system operations

2) Pattern of failure to document investigation of discrepancies

3) Lack of process validation

4) Lack of validation of computerized processes

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5) Pattern of incomplete or missing batch production records

6) Pattern of nonconformance to established in-process controls, tests, and/or specifications

Packaging and Labeling

1) Pattern of failure to establish/follow a control system for implementing changes in the packaging and/or labeling operations

2) Pattern of failure to document investigation of discrepancies

3) Lack of validation of computerized processes

4) Lack of control of packaging and labeling operations that may introduce a potential for mislabeling

    5) Lack of packaging validation

Laboratory System

1) Pattern of failure to establish/follow a control system for implementing changes in the laboratory operations

2) Pattern of failure to document investigation of discrepancies

3) Lack of validation of computerized and/or automated processes

4) Pattern of inadequate sampling practices

5) Lack of validated analytical methods

6) Pattern of failure to follow approved analytical procedures

7) Pattern of failure to follow an adequate OOS procedure

8) Pattern of failure to retain raw data

9) Lack of stability indicating methods

10) Pattern of failure to follow stability programs

Follow up to a Warning Letter or other significant regulatory action as a result of an abbreviated inspection should warrant full inspection coverage as defined in this program.

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      PART VI – REFERENCES, ATTACHMENTS, AND PROGRAM CONTACTS REFERENCES

* Federal Food, Drug, and Cosmetic Act, as amended

* Code of Federal Regulations, Title 21, Parts 4, 210 and 211, as revised

* Preamble to Code of Federal Regulations, Title 21, Parts 210 and 211 General Comments (1978)

* 21 CFR Part 11 Electronic Records: Electronic Signatures

* Inspection Operations Manual

* Regulatory Procedures Manual

* Compliance Policy Guides Manual, Chapter 4 Human Drugs

* Guidance for Industry10

* Pharmaceutical Quality/CMC 11

* Pharmaceutical Quality/Manufacturing Standards (CGMP)12

* Pharmaceutical Quality/Microbiology13

* Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug

Inspection

* Current Good Manufacturing Practice Requirements for Combination Products

* ICH Guidelines14

- Q8(R2) Pharmaceutical Development

- Q9 Quality Risk Management

- Q10 Pharmaceutical Quality System

* Inspection Guides 15

* Computerized Systems in Drug Establishments

* Guide to Inspections of Dosage Form Drug Manufacturers-CGMPs

* Guide to Inspections of Lyophilization of Parenterals

* Guide to Inspections of Pharmaceutical Quality Control Laboratories

* Guide to Inspections of High Purity Water Systems

* Guide to Inspections of Validation of Cleaning Processes

10 See https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

11 See https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064979.htm

12 See https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064971.htm

13 See https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064983.htm

14 See https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm

15 See https://www.fda.gov/ICECI/Inspections/InspectionGuides/default.htm

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ATTACHMENTS

Attachments to the Drug Process Inspection program may be issued for certain industries, dosage forms, and processes with known problems or unique drug processes. These attachments will contain the guidance needed to perform these specialized inspections.

Some of the attachments to be issued with this program may include reporting requirements specifically designed to obtain industry-wide information on certain practices to permit evaluation of the adequacy of FDA's regulatory efforts.

Attachments and/or reporting requirements will be periodically reviewed and evaluated and deleted from the program when they are no longer needed.

CONTACTS

For technical questions concerning inspections contact: Office of Regulatory Affairs (ORA)

Office of Medical Products and Tobacco Operations (OMPTO)

Division of Medical Products and Tobacco Program Operations (DMPTPO) Telephone

number: 301-796-0358

Email: ORAHQDrugInspectionPOC@fda.hhs.gov 

Office of Regulatory Science/

Office of Medical Products, Tobacco & Specialty Laboratory Operations (OMPTSLO)

Shari Kahn (Chemistry) 301-796-8154, shari.kahn@fda.hhs.gov

Angele Smith (Microbiology) 301-796-4200, Angele.smith@fda.hhs.gov

Center for Drug Evaluation and Research

CGMP or any Quality-Related Policy Questions

For CGMP or any quality-related policy question, technical or scientific questions or information needs, including questions about this program, please send an email to the following address and it will be handled as a top priority:

OPQPolicy@fda.hhs.gov

Enforcement-Related Guidance or Policy

For enforcement-related guidance or policy, including evidence need and sufficiency,

citations, and case evaluation/recommendation advice, please send an email

to the following address and it will be handled as a top priority:

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7356.002

CDER OMQ Compliance Policy 

CDEROMQCompliance@fda.hhs.gov

Labeling Requirements and Policies

Office of Unapproved Drugs and Labeling Compliance, see intranet home page for contacts [CDER | Office of Compliance | Office of Unapproved Drugs and Labeling Compliance]

Registration and Drug Listing Requirements

CDER Office of Compliance, see “CDER: Who’s the Lead” intranet page for contacts [CDER | Office of Communications | CDER: Who’s the Lead]

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PART VII - CDER AND ORA RESPONSIBILITIES OVERVIEW

CDER and ORA recently redefined their roles and responsibilities with regard to application review and inspections of human drugs facilities under the concept of operations (ConOps). 16 This ConOps operating model applies to pre- and post-approval, surveillance, and for-cause inspections. The roles and responsibilities for surveillance and surveillance related for-cause inspections subject to this Program 7356.002 are summarized below.

Surveillance Inspection Responsibilities:

OS uses a risk-based site selection model to identify facilities for inspection, and prepares an up-to-date site dossier for each of the identified facilities in advance of a scheduled surveillance inspection. ORA schedules surveillance inspections for individual sites. ORA leads surveillance facility inspections with CDER participation, when requested by ORA. ORA then conducts an on-site inspection based on the Surveillance Compliance Program and quality information summarized in the site dossier.

If the intial classification is OAI, the responsible ORA Division provides a written classification analysis, including the electronic documents, to OMQ within 45 calendar days of closing the inspection. OMQ makes a final classification with input from the Office of the Chief Counsel, if needed, and issues a decisional letter in the following 45 calendar days (90 calendar days following the inspection closing). If an inspection is classified as final OAI, OMQ, solely or in collaboration with ORA, takes an appropriate action within 90 calendar days of the decisional letter. If OMQ determines that an advisory or enforcement action is not warranted, ORA is notified of the change in classification. OMQ will then issue an FMD-145/decisional letter no later than 90 calendar days following the inspection closing.

If the facility inspection results in an ORA recommendation for an NAI or VAI classification and no further action is recommended, ORA issues an FMD-145/decisional letter within 90 calendar days following the inspection closing.

For-Cause Inspection Responsibilities:

Requests for for-cause inspections can be initiated by ORA, OPF, OS, or OC. Once the initiating office determines a for-cause inspection is warranted, the office prepares an assignment that sets forth the areas of required coverage which may or may not include surveillance program coverage. If required, ORA approves the assignment as per FMD-17, and schedules the inspection. ORA leads, and performs the inspections with CDER participation, when appropriate.

ORA or CDER will not issue an FMD-145 letter without the concurrence of the initiating office. For-cause inspections that result in surveillance program coverage and are initially classified OAI, will receive final classification from OMQ in 90 days following the close of the inspection; OMQ involves other offices (e.g., ORA, OPF, OS, OC) as appropriate, based on the inspection findings. In addition, the office that initiates the for-cause inspection assignment completes the final assessment in 90 days following the close of the inspection, involving other offices (e.g., ORA, OPF, OS, OC) as appropriate. Any follow-up actions are completed by CDER within 6 months post-inspection.

16 Integration Of FDA Facility Evaluation And Inspection Program For Human Drugs: A Concept Of Operations (ConOps), see

https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/UCM574362.pdf

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Medical Interface

Manual

For IPAs and medical groups and their contracted providers.

January 2019

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Table of Contents

I. Introduction 5

II. Medical Care Solutions Interface Procedures 5

A. Referral Procedures 5

B. Triage Guidelines 6

C. Covered MHSA Services 7

D. Common Interface Scenarios and Examples 10

E. Co-Management Procedures 14

F. Resolution of Disagreements 15

III. Blue Shield MHSA Interface with Primary Care Physicians 15

A. PCP Referrals 15

B. PCP Consultation Line 15

IV. Psychiatric/Medical Clinical Interface 17

A. Psychiatric Disorders with Concurrent or Co-Morbid Medical Sequelae 17

B. Circumstances That Might Warrant a Referral to a Psychiatrist or Behavioral Health Clinician by a

PCP 17

V. Frequently Asked Questions 18

VI. Laboratory Tests to Rule Out Physical Disorders and Monitor the Use of Psychotropic

Medications 21

VII. Contact Numbers for Physicians 22

VIII. Contact Numbers for Patients 22

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I. Introduction

Since significant overlap can occur between medical problems and mental health and substance abuse disorders, HAI-CA, a subsidiary of Magellan Health Services, Blue Shield of California's (Blue Shield) mental health service administrator (MHSA) wants to facilitate treatment of members that is coordinated between the behavioral health provider and the physician. The purpose of this manual is to provide IPAs and medical groups with an overview of Blue Shield and Blue Shield MHSA’s protocols developed to promote the integration of medical and behavioral health treatment.

This manual is intended as a guideline for the physician and office staff to coordinate the provision of behavioral and medical services to Blue Shield’s members and to clearly identify the responsible party for mental health and substance abuse services including mixed services.

Blue Shield’s MHSA values and promotes effective and proactive operational interactions with medical colleagues as a vital component of quality patient care. We look forward to partnering with you to improve the clinical outcomes of members.

II. Medical Care Solutions Interface Procedures

Blue Shield’s MHSA intake, care management, and after-hours staff will coordinate appropriate communication with all medical providers. The MHSA’s intake, care management, and after-hours staff will make referrals to Blue Shield’s Medical Care Solutions Department when it is determined that the primary diagnosis is medical in nature, rather than psychiatric/chemical dependency. The MHSA’s intake, care management, and after-hours staff will receive referrals when the primary diagnosis is determined to be psychiatric/chemical dependency.

If the primary diagnosis is medical in nature, Blue Shield’s Medical Care Solutions staff will notify the IPA or medical group regarding their responsibility to manage the members’ medical care based on the Division of Financial Responsibility (DOFR) in the IPA’s contract with Blue Shield.

A. Referral Procedures

Blue Shield’s MHSA will respond to requests for psychiatric services from the member, Blue Shield, the PCP, or other licensed health professional, consistent with the California Department of Managed Healthcare (DMHC) established standards for managed behavioral health organizations.

Blue Shield MHSA’s staff members have access to Blue Shield MHSA medical directors 24 hours a day, seven days a week to enable toll free access to care for Blue Shield members at all times, as follows:

1. If Blue Shield’s MHSA determines on initial contact that the diagnosis is medical in nature, the Blue Shield MHSA care advocate or intake coordinator will refer the member back to either Blue Shield Medical Care Solutions, or the member’s PCP, IPA, or medical group.

2. If the member’s PCP determines that the member is in need of psychiatric/chemical dependency evaluation/treatment and would like to make a referral for such treatment, the PCP or his/her representative should call Blue Shield MHSA at (877) 263-9952 to be connected to a licensed mental health clinician Blue Shield MHSA staff who will facilitate the request. Members can self-refer to Blue Shield’s MHSA through toll-free telephone access at (877) 263-9952 and do not need a referral from the IPA or PCP.

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II. Medical Care Solutions Interface Procedures (cont’d.)

A. Referral Procedures (cont’d.)

Requests for emergent evaluations can be made through either of the above toll-free numbers, by direct referral to an emergency room or psychiatric emergency response team, or by dialing 911.

Requests for psychiatric consultations while a patient is admitted to a medical/surgical facility can be made through either of the above toll-free numbers. Blue Shield’s MHSA will review and authorize the case according to protocols established in this manual.

B. Triage Guidelines

The Triage Guidelines are designed to clarify the lines of behavioral health care management and IPA/medical group care management for patients with complex clinical conditions, as described in the Behavioral Health Services Agreement between Blue Shield’s MHSA and Blue Shield.

The following guidelines determine the assignment of care management and financial responsibility in the majority of mixed service cases.

1. Place of service - medical / surgical v. psychiatric unit / facility

If a member receives treatment in a medical/surgical setting (ambulatory or inpatient) for detoxification, or medical issues associated with attention deficit hyperactivity disorder (ADHD), depression, etc. regardless of mental health diagnosis, then Blue Shield and the IPA/medical group will be responsible for the care management and assume financial responsibility provided to the member depending on the contract.

2. Type of treating professional (attending, consultant) primary care / medical – surgical v. psychiatric / psychological / behavioral

If a psychiatric or behavioral health consultation is required in a medical/surgical setting, Blue Shield’s MHSA requires notification and preauthorization, following which, Blue Shield’s MHSA will assume the care management and financial responsibility of the consultative service, including special procedures, and tests associated with the Blue Shield MHSA’s authorized consultative service. If the psychiatric consultant feels that the condition may have an organic component that would require formal neurological tests (EEG, MRI, CAT SCAN, EKG) these tests would continue to be the responsibility of the IPA/medical group and requires the express authorization of the member’s IPA/medical group.

3. Primary clinical condition / focus of treatment

If a member has a mild traumatic head injury with cognitive changes resulting in a psychiatric or emotional disturbance, Blue Shield’s MHSA requires notification and preauthorization, following which, Blue Shield’s MHSA will assume approved mental heatlh services (inpatient consultation, psychotherapy, biofeedback, neuropsychological testing, etc.) provided by Blue Shield MHSA psychiatrist/ psychologist/ behavioral specialist.

A psychiatric consult will determine whether a traumatic brain injury (TBI) should be classified as mild, moderate, or severe. The behavioral changes associated with a moderate or severe injury also have structural changes evident with imagery. The treatment for moderate to severe TBI must be coordinated with the neurologist since the etiology of the behavioral changes are related to structural changes in the brain.

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II. Medical Care Solutions Interface Procedures (cont’d.) C. Covered MHSA Services

The following chart provides a useful reference to covered Mental Health and Substance Abuse services. The specific clinical situation must be evaluated within the context of place of service, the attending provider’s area of specialty, and the primary diagnosis, pursuant to Section B above. Payment for services may be subject to eligibility, benefit limitations, and medical necessity requirements at the time of service. The following services and supplies are Blue Shield MHSA services only to the extent that they are for medically necessary covered services and have been authorized by Blue Shield’s MHSA.

DESCRIPTION

OF SERVICES

SERVICES INCLUDED

Emergency Room

•

Psychiatric consultations only if a mental health problem is suspected. Blue Shield MHSA will cover psychiatric emergency screening exams as required by Health & Safety Code § 1371.4. All other emergency room professional, technical, and facility charges are excluded.

* Mental health and/or substance abuse professional services

* Diagnostic assessment and outpatient treatment, including but not limited, to individual and group therapy, psychiatric consultations, and medication management

* Psychological testing

* Psychiatric/psychological consultations to evaluate a member prior to a surgical procedure

* Intensive outpatient treatment programs (I.O.P.)

* Specialized psychological treatment programs or service

* Electroconvulsive therapy (ECT) including anesthesiology

* Office-Based Opioid Treatment (OBOT) – opioid detoxification and/or maintenance therapy, takes place in a provider’s office.

* Methadone Maintenance – for heroin or other opiate addictions – treatment program - daily doses of methadone to block the euphoric and sedating effects of opiates, reduce the cravings, and relieve the symptoms associated with withdrawal

* Repetitive Transcranial Magnetic Stimulation (rTMS) - a non-invasive method of delivering electromagnetic stimulation to the brain for the treatment of severe depression

* Telehealth/telemedicine for behavioral health

* Behavioral health counseling and other behavioral services related to the care of transgender/trans-sexual population

* Authorization and medical management of Long Acting injectable psychotropic prescription medications ordered/administered by the mental health provider

* With respect to members enrolled in HMO or POS benefit plans, diagnostic tests ordered/administered by an MHSA provider without the express authorization of the member’s IPA/medical group (MHSA may require MHSA providers to be financially responsible for such costs as long as the member is held harmless)

* ICD-10 Code F98.5 (Stuttering) if billed by a licensed behavioral health clinician

* ICD-10 Code F95.8, F95.9 (Tic disorder, unspecified) if billed by a licensed behavioral health clinician

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DESCRIPTION

OF SERVICES

SERVICES INCLUDED

Outpatient Mental

•

ICD-10 Code F95.0 (Transient tic disorder) if billed by a licensed behavioral health

Health/Substance

clinician

Abuse

(cont’d.)

•

ICD-10 Code F95.1 (Chronic motor or vocal tic disorder) if billed by a licensed behavioral health clinician

•

ICD-10 Code F95.2 (Tourette’s disorder) if billed by a licensed behavioral health clinician

•

ICD-10 Code F98.4 (Stereotypic Movement Disorder) if billed by a licensed behavioral health clinician

•

ICD-10 Code O99.340, O99.341, O99.342, O99.343, O99.344, O90.6 (Mental

Health Disorder Complicating Pregnancy, Childbirth, or the Puerperium, Unspecified) if billed as a secondary diagnosis to a covered primary diagnosis

•

ICD-10 Code R159 (Incontinence of Feces - Encopresis with Constipation and

Overflow Incontinence) if billed by a licensed behavioral health clinician

Behavioral Health

Treatments (BHT)

•

Behavioral Health Treatment - professional services and treatment programs, including applied behavior analysis and evidence-based intervention programs, which

including, Applied

develop or restore, to the maximum extent practicable, the functioning of an individual

Behavior Analysis

with pervasive developmental disorder or autism

(ABA)

•

Behavioral Health Treatment is covered when prescribed by a physician or licensed psychologist and treatment is provided under a treatment plan approved by the

MHSA. BHT delivered in the home or other non-institutional setting must be obtained from MHSA Participating Providers

•

Behavioral Health Treatment used for the purposes of providing respite, day care, or educational services, or to reimburse a parent for participation in the treatment is not covered

Partial Hospital

•

Facility services

Days or Day

Treatment

•

Mental health and/or substance abuse professional services

•

All partial hospital treatment or day treatment medically necessary to prevent full-time hospitalization or to provide transition services to allow early discharge from full-time hospitalization

•

Routine diagnostic procedures and services related to the admission diagnosis

•

Neuropsychological testing related to the evaluation, treatment or differential diagnosis of a behavioral health condition vs. a medical condition

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DESCRIPTION

OF SERVICES

SERVICES INCLUDED

Residential Treatment Services

The Inpatient Residential Program is a program provided in a licensed facility that provides structured 24-hour residential services designed to promote treatment and maintain recovery

Mental Health Treatment Services

The Residential Mental Health Treatment Program is provided in a licensed facility which operates in accordance with applicable California state law and provides 24 hour residential care, pursuant to written, specific, and detailed treatment programs for full time participating clients under the direction of an administrator and physician for chronic mental health conditions.

Substance Abuse Services

The Residential Care Substance Abuse Condition Program is a program provided in a licensed facility that provides structured 24-hour residential services designed to promote treatment and maintain recovery from the recurrent use of alcohol, drugs, and/or related substances, both legal and illegal, including but not limited to: subacute detoxification (if facility is appropriately licensed), dependence, intoxication effects, biological changes, and behavioral changes.

Please consult the members’ benefit plan for detailed benefit coverage information.

Inpatient Mental Health/ Substance Abuse (Rehab)

* Facility services

* Mental health and/or substance abuse professional services

* Histories and physicals required for Blue Shield MHSA admissions

* Inpatient treatment programs and services

* Routine diagnostic procedures and services related to the admission diagnosis

* Electroconvulsive therapy (ECT) including anesthesiology medication (all routes)

Inpatient

Medical/Surgery

* Psychiatric consultations for members in medical/surgical beds

* Authorization and medical management of injectable psychotropic prescription medications ordered/administered by the mental health provider

* With respect to members enrolled in HMO or POS benefit plans, diagnostic tests ordered/administered by the MHSA provider without the express authorization of the member’s IPA/medical group (MHSA may require MHSA providers to be financially responsible for such costs as long as the member is held harmless)

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II. Medical Care Solutions Interface Procedures (cont’d.) D. Common Interface Scenarios and Examples

The following chart describes common clinical situations where medical and behavioral services overlap. Please note that the areas described below also assign care management and financial responsibility consistent with the Behavioral Health Services Agreement between Blue Shield and the MHSA.

Clinical Situation

Place of Service

Provider Type

Primary Diagnosis

Responsibility

Primary medical presentation in ER with secondary psychiatric considerations

Emergency room

Non-behavioral health physician

Medical/surgical or psychiatric

Blue Shield/IPA

Primary psychiatric presentation in ER with no indication for emergent medical evaluation

Emergency room

Behavioral health clinician

Psychiatric

Blue Shield MHSA is responsible for psychiatric consult only

Behavioral health Telehealth/telemedicine for homebound patient with hip replacement, complains of anxiety, restlessness after stopping pain meds

Home utilizing telehealth/ telemedicine

MHSA behavioral health clinician utilizing telehealth/telemedicine

Medical/surgical or psychiatric

Blue Shield MHSA

Transgender patient dealing with depression

Office-Based

Behavioral health clinician

Psychiatric

Blue Shield MHSA

Individual dependent on opioids

Office-Based OpioidTreatment

Behavioral Health Physician with DEA waiver to prescribe buprenorphine

Substance Abuse with or without Mental Health comorbidity

Blue Shield MHSA

Transcranial Magnetic Stimulation (TMS) which is medically necessary and for FDA approved indications.

Physician’s office

Behavioral Health

Physician with

university-based

training in TMS

Major Depressive Disorder, Severe

Blue Shield MHSA

Acute medical detoxification

Blue Shield approved detox bed or unit in a general acute care facility

Medical/surgical or psychiatrist/addiction specialist

Medical diagnosis, such as: Acute alcohol withdrawal, acute benzodiazepine withdrawal, delrrium tremens, siezures due to substance withdrawal

Blue Shield/IPA

Exception: Blue Shield MHSA approved MH services (inpatient consultation, and special procedures, and tests associated with the Blue Shield MHSA’s authorized consultative service)

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Clinical Situation

Place of Service

Provider Type

Primary Diagnosis

Responsibility

Substance Use Disorders (i.e. treatment which does not require detoxification medication protocol including oral anticonvulsants, benzodiasepines, or antihypertensives to prevent medial complications of withdrawals such as seizures, or strokes, or myocardial infarctions)

Blue Shield MHSA approved psychiatric admission in a rehab facility, inpatient psych facility, residential treatment center (RTC), partial hospitalization program (PHP), or intensive outpatient program (IOP).

Behavioral health clinician

Substance

Abuse/Mental

Health

Blue Shield MHSA

Chronic pain

Medical/surgical or structured pain program, facility, or clinic

Medical/surgical

Behavioral health clinician

Medical/surgical Medical/surgical

Blue Shield/IPA Blue Shield MHSA

Chronic pain (inpatient consultation, psychotherapy, biofeedback, psychiatric tests, etc.)

Blue Shield MHSA approved mental health services in a Medical/surgical or structured pain program, facility, or clinic

Blue Shield MHSA psychiatrist/ psychologist/ behavioral specialist

Medical/surgical or psychiatric

Blue Shield MHSA

(Pain management consultation and recommendations for alternative pain management modalities would be the responsibility of the IPA)

Psychogenic pain (inpatient consultation, psychotherapy, biofeedback, psychiatric tests, etc.)

Blue Shield MHSA approved mental health services in a Medical/surgical or structured pain program, facility, clinic or behavioral health specialist office

Blue Shield MHSA psychiatrist/ psychologist/ behavioral specialist

Psychiatric

Blue Shield MHSA

Psychogenic pain is a rule out diagnosis; tests to confirm psychogenic etiology are IPA’s responsibility

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Clinical Situation

Place of Service

Provider Type

Primary Diagnosis

Responsibility

Head injury with cognitive changes resulting in a psychiatric or emotional disturbance (consultation, psychotherapy, biofeedback, neuropsychological testing, etc.)

Head injury with cognitive changes resulting in organic impairment (i.e., speech and memory problems), but no psychiatric concern exists (Fitness for Duty evaluation and/or neuropsychological testing)

Medical facility, clinic, or behavioral health specialst office

Medical/surgical facility or clinic

Blue Shield MHSA psychiatrist/ psychologist/ behavioral specialist

Medical/surgical

Psychiatric

Medical/surgical

Blue Shield MHSA

Blue Shield/IPA

Medical management of delirium or amnesia due to medical etiology

Medical/surgical facility or clinic

Medical/surgical

Medical/surgical

Blue Shield/IPA

Psychiatric management of acute behavioral disorder due to delirium or amnesia (inpatient consultation, psychotherapy, biofeedback, neuropsychological testing, etc.)

It is the responsibility of the IPA/med group to rule out medical etiology for Delirium

Blue Shield MHSA approved mental health services in a Medical facility, clinic or behavioral health specialist office

Blue Shield MHSA psychiatrist/ psychologist/ behavioral specialist

Mental Health/ Substance Abuse

Blue Shield MHSA

Anorexia/bulimia (inpatient/outpt consultation, psychotherapy, psychiatric tests, etc.)

Blue Shield MHSA approved mental health services in a Medical/ surgical, facility, clinic or behavioral health specialist office

Blue Shield MHSA psychiatrist/ psychologist/ behavioral specialist

Psychiatric

Blue Shield MHSA

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Clinical Situation

Place of Service

Provider Type

Primary Diagnosis

Responsibility

Anorexia/bulimia – with medical complications

Medical/surgical facility or clinic

Nutritional counselor or Medical/surgical

Medical/surgical

Blue Shield/IPA

Routine pre-ECT evaluation for medical stability

Lab (CXR, ECG, blood chemistry, CBC), Anesthesia clinic (consultation)

Blue Shield MHSA psychiatrist

Psychiatric

Blue Shield MHSA

Speech Therapy Occupational Therapy

Facility,

rehabilitation clinic

Speech Language Pathologist,

Occupational Therapist

Autistic spectrum disorder

Blue Shield/IPA

Differential diagnosis of ADHD (Neurological evaluation)

Facility or clinic

Pediatric neurologist

ADHD

Blue Shield/IPA

Patient’s physical condition requires emergency transportation to an ER or medical/ surgical facility

Emergency transportation

N/A

Medical/ surgical or psychiatric

Blue Shield/IPA

Blue Shield MHSA approved transportation for direct admissions to an Psychiatric unit or facility from a medical/surgical facility

Transportation

N/A

Psychiatric

Blue Shield MHSA

Patient’s condition requires emergency transportation directly to mental health unit from community

Emergency transportation

N/A

Psychiatric

Blue Shield MHSA

Surgical prodecure that requires a Psychiatric/ psychological consultation to evaluate a member prior to a surgical procedure

Psychiatrist/psycholo gist office

Psychiatrist/ Psychologist/ Behavioral specialist

Medical

Blue Shield MHSA

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II. Medical Care Solutions Interface Procedures (cont’d.) E. Co-Management Procedures

The following procedures outline Blue Shield Medical Care Solutions and Blue Shield MHSA’s co-management of a case for a member with both a psychiatric/chemical dependency diagnosis as well as a medical diagnosis who needs assessment and treatment:

1. The Blue Shield MHSA care advocates and their Blue Shield Medical Care Solutions counterparts will contact each other as soon as a potential co-management case is identified. Contact will be guided by established workflows. Electronic communications must be transmitted on a secure website.

2. For patients with a primary medical diagnosis, Blue Shield’s MHSA will arrange for and authorize psychiatric consultations and any ongoing aspects of psychiatric management related to a psychiatric diagnosis.

3. For patients with a primary medical diagnosis who are undergoing a surgical procedure and require a psychiatric workup as part of the routine pre-surgical evaluation (e.g., gastrointestinal bypass, transplant, etc.), the IPA/medical group will arrange for Blue Shield MHSA authorization for the psychiatric consultation.

4. For patients with a primary psychiatric or substance abuse diagnosis, the Blue Shield medical case manager or PCP will arrange for and authorize medical/surgical consultations and any ongoing medical/surgical care.

5. If, during a co-managed case, transition from a medical/surgical unit of a facility to a mental health, chemical dependency unit or facility is thought to be necessary, it should be accomplished with as much advance notice as possible Any transfer to a psychiatric unit from a medical/surgical unit must be pre-authorized by a MHSA Medical Director A transfer to a medical unit from a psychiatric unit must be pre-authorized by a IPA/Blue Shield UM Medical Director

6. Certain exceptional cases may require co-funding of a hospital stay by Blue Shield’s MHSA and Blue Shield, when the psychiatric and medical diagnoses and their treatment plans are interrelated. Blue Shield’s MHSA and Blue Shield/IPA medical directors must approve such a funding arrangement.

7. Discharge treatment plans should be jointly developed as far in advance of discharge as possible.

8. Diagnostic tests ordered/administered by the mental health provider, without the express authorization of the IPA/medical group, shall be the financial responsibility of Blue Shield’s MHSA. (The mental health provider shall direct patients to preferred diagnostic centers per the patient’s IPA/medical group.)

9. All medical consultations at any level of care will be coordinated through the patient’s IPA/medical group. Failure to do so will result in Blue Shield’s MHSA being financially responsible for the consultative services. When contacted, the IPA/medical group will authorize and identify appropriate medical consultants when medically necessary. The mental health provider shall seek authorization from the IPA/ medical group for medical diagnostic evaluations prior to their ordering. If the medical consultant does not have medical staff privileges at the psychiatric or substance abuse facility, the IPA/medical group must make appropriate arrangements for a medical consult at their expense

10. Blue Shield’s MHSA administers the Blue Shield Behavioral Health Condition Management Program. This program specifically targets Blue Shield disease management programs and other referral partners for patient depression screening. Positively screened cases are referred to the Blue Shield Behavioral Health Condition Management Program for management and coordination of services and addressing identified needs.

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II. Medical Care Solutions Interface Procedures (cont’d.) F. Resolution of Disagreements

If the Blue Shield MHSA care manager and complex case manager and their Blue Shield medical counterparts cannot agree on any aspect of the procedures described above, the matter should be referred immediately for resolution, by phone contact between the appropriate Blue Shield MHSA medical director and the appropriate medical director of Blue Shield and/or the IPA, as appropriate.

III. Blue Shield MHSA Interface with Primary Care Physicians

A. PCP Referrals

Blue Shield’s MHSA will develop several processes that allow its staff to monitor and facilitate the coordination of care between the member’s primary care physician (PCP) and the behavioral health provider, with written member consent, such as:

* Blue Shield MHSA will routinely assess its provider network for coordination of care with Blue Shield’s PCPs through audits of the behavioral health network providers.

* Blue Shield MHSA will provide PCP contact information to facility providers upon member admission.

* Blue Shield’s MHSA actively coordinates the co-administration of medical/behavioral services through contact with Blue Shield Medical Care Solutions and/or the IPA/medical group case manager.

* All programs and initiatives are routinely monitored via a set of associated core metrics through Blue Shield’s Behavioral Health joint workgroup.

B. PCP Consultation Line

To further facilitate communication with our medical colleagues, Blue Shield’s MHSA provides a toll-free PCP Consultation Line at (877) 263-9870, accessible during business hours for non-urgent consultations. The toll-free number has a dedicated staff that has access to a Blue Shield MHSA medical director 24 hours a day, seven days a week.

The PCP consultation line is available for two functions. First, we expect it to further streamline the process by which a physician or designee can facilitate a referral to a Blue Shield MHSA contracted mental health clinician. After the referring physician or designee provides basic demographic and clinical information to a Blue Shield MHSA intake specialist, the intake specialist will be able to give the physician or designee the names, addresses, and phone numbers of available network clinicians in locations near the member who have the appropriate clinical expertise to match the patient’s needs. The physician or designee can then make a personal referral of specific mental health professionals for the patient. This should be particularly effective for patients needing support or assistance in pursuing mental health or substance abuse evaluations and/or treatment.

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III. Blue Shield MHSA Interface with Primary Care Physicians (cont’d.)

The second function addressed by the phone line is consultative. The consultation line is available to PCPs during business hours to initiate a prompt telephone consultation with a Blue Shield MHSA medical director, on issues such as:

* Determining when a mental health referral is appropriate for a particular patient, what such a referral could be expected to accomplish, and what particular expertise the mental health clinician receiving the referral would need.

* Questions concerning psychopharmacologic agents.

* Questions concerning management of difficult or challenging patients.

* Blue Shield’s MHSA can also facilitate integration of medical and mental health/substance abuse services for members through contact with our network providers. Upon obtaining a signed authorization for the release of information from their patients, the PCP and the mental health provider can discuss and coordinate a patient’s treatment.

* Blue Shield MHSA staff will only disclose protected health information relevant to the clinical consultation. Protected health information disclosed will be guided by relevant HIPAA and California legislative guidelines regarding need for a release of information.

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IV. Psychiatric/Medical Clinical Interface

The information in this section includes a list of the most common clinical situations that lie at the interface between the psychiatric disciplines and other disciplines in medicine. This list is not meant to be exhaustive, but rather to assist in the identification of members who are likely to benefit from care provided by a PCP or medical specialist and a psychiatrist.

A. Psychiatric Disorders with Concurrent or Co-Morbid Medical Sequelae

* Anorexia nervosa, bulimia, other eating disorders

* Dementia

* Other neurological degenerative diseases

* Psychological sequelae accompanying chronic pain

* Chemical detoxification

* Psychological sequelae of terminal illnesses

* Other cerebral white matter disorders

* ADHD

* Sexual dysfunction (desire, arousal, orgasmic, sexual pain, etc.)

* Intermittent explosive disorder

* Conversion, or hypochondriacal disorders

* Serious emotional disturbance (SED) of a child

* Pervasive development disorder or autism

B. Circumstances That Might Warrant a Referral to a Psychiatrist or Behavioral Health Clinician by a PCP

* Diagnostic consultation

* Evaluation for psychotherapy

* Evaluation for psychotropic medication management

* Need for ongoing psychotropic medication maintenance review

* Severe, recurrent, persistent or psychotic psychological symptoms

* Presence of complex medical/psychiatric problems

* Poor compliance with recommended medical treatment plan

* Partial response to initial treatment(s) of depression, anxiety, agitation, or sleep problems

* Evaluation for ECT

* Need for psychiatric hospitalization

* Need for involuntary commitment

* Symptom recurrence after a positive acute-phase response

* Undiagnosable, ill-defined physical complaints

* Differential diagnosis for a child behavioral disorder

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V. Frequently Asked Questions

1. In situations where a member sees a PCP for an office visit and is diagnosed and managed for a mental disorder, is the office visit reviewed under the medical or behavioral health benefit?

There should be no obstacles discouraging members from seeking assistance from their PCP. PCPs can diagnose and manage general psychiatric disorders. Blue Shield/IPA will manage all services provided by the non-psychiatric physician. Blue Shield’s MHSA will assume management of services upon transfer of care to a Blue Shield MHSA mental health provider. The MHSA has Behavioral/Developmental Pediatricians in the MHSA network. These physicians will bill and be reimbursed by the MHSA for the behavioral disorders that they treat.

2. How are emergency room visits for physical symptoms of an anxiety attack (heart palpitations, nausea, etc.) reviewed?

Because the member is presenting to the emergency room to rule out a medical condition, Blue Shield is responsible for aspects of the patient’s care. In these situations, the member typically presents at the emergency room with the intent of ruling out the presence of a potentially life-threatening medical disorder. Therefore, Blue Shield/IPA is responsible for these cases. If the emergency room physician requests a psychiatric consult, Blue Shield’s MHSA is responsible for the consultation service.

3. Are laboratory tests, to determine blood levels of psychotropic medications, covered by Blue Shield/IPA or Blue Shield’s MHSA?

Outpatient laboratory tests ordered in the interest of the psychiatrist’s management of the mental health patient, such as psychotropic medication levels without express authorization of the members’

IPA/medical group are the financial responsibility of Blue Shield’s MHSA.

Laboratory tests ordered by a psychiatrist while the patient is hospitalized in a psychiatric facility will be covered under the mental health benefit and managed by Blue Shield’s MHSA, unless the tests have been authorized by the patient’s IPA/medical group.

4. How should a dual diagnosis case (i.e., hypertension/depression, heart disease/depression, etc.) be handled?

Blue Shield Medical Care Solutions, Blue Shield’s MHSA, and the IPA/medical group will manage the care in their respective areas of specialization. Please refer to the Co-Management Procedures previously outlined in Section E.

5. Many times when individuals are hospitalized for a serious medical illness, the hospital will order a psychiatric consult to help the patient deal with the disease process. How should this be handled?

To obtain a consultation from a psychiatrist while the member is confined in a medical/surgical bed, the PCP or his/her representative should call the Blue Shield MHSA at (877) 263-9952.

6. Who will handle office visits for ADHD?

Blue Shield’s MHSA reviews and manages authorized visits to mental health clinicians for the treatment of this disorder.

7. How will anesthesia for electroconvulsive treatment be handled?

Anesthesia is routinely administered with electroconvulsive treatment. Because it is a procedure that is customarily provided with a psychiatric intervention it is covered under the mental health benefit administered by Blue Shield’s MHSA.

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V. Frequently Asked Questions (cont’d.)

8. How will examinations, x-rays, and lab procedures to rule out physical disorders with a mental health diagnosis be handled?

Blue Shield/IPA’s administer coverage for authorized medical diagnostic tests ordered with the goal of ruling out physical disorders. Blue Shield’s MHSA will recommend a medical consultant that is both part of the IPA/medical group and has or can obtain temporary staff privileges at the MHSA authorized facility or the IPA/medical group will select a consultant who does have or can obtain medical privileges at the MHSA authorized facility and then be responsible for all medical tests ordered by this consultant. Blue Shield’s MHSA refers mental health providers to the appropriate authorizing entity when they become aware of orders for medical diagnostic tests. An exception to the Blue Shield/IPA/medical group responsibility for medical diagnostic tests is when tests are ordered in the interest of a psychiatric procedure such as ECT. Failure to coordinate medical services with the appropriate IPA/medical group will result in Blue Shield’s MHSA being financially responsible for said services.

9. What if a patient is suffering from neurological disorders and is being treated at a psychiatric unit?

Blue Shield’s MHSA manages the care of patients who are being treated by a psychiatrist. Blue Shield/IPA’s provide management of the neurological and other medical/surgical disorders. In those instances, the psychiatric benefit would cover the services provided by the psychiatrist and in the psychiatric unit. The medical/surgical benefit would cover services managed by Blue Shield. The attending psychiatrist is directed to the IPA/medical group to arrange for medical/neurological consultation, when medically necessary.

10. How will patients be managed when they are admitted for anorexia and/or bulimia but may require additional days for serious medical complications?

Blue Shield’s MHSA administers the mental health benefit for these patients. If their medical condition requires services at a medical/surgical facility, then Blue Shield Medical Care Solutions/IPA will manage these services. Blue Shield’s MHSA provides management only for the psychiatric consultative services.

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V. Frequently Asked Questions (cont’d.)

11. How will neuropsychological testing be handled?

Blue Shield/IPA is responsible for examination and management of patients with pure medical diagnoses (e.g., head injury). Blue Shield MHSA’s is responsible in those circumstances in which neuropsychological testing is authorized for individuals with psychiatric diagnoses (see examples below) for whom neuropsychological testing will facilitate treatment planning, or assist in the determination of a differential diagnosis. Common reasons for considering neuropsychological testing for mental health patients include:

* Differential diagnosis of dementia

* Dementia vs. pseudodementia

* Dementia vs. other DSM diagnoses

* Sequelae of head injury vs. anxiety and/or depression

* Organic brain syndromes due to neurotoxin exposure

* Rule/Out (R/O) alcohol amnestic disorder (Korsakoff’s syndrome)

* R/O dementia associated with alcoholism

* R/O sedative or anxiolytic amnestic disorder

(In these situations testing is not useful unless six weeks have elapsed since the last exposure to the toxic substance.)

* Organic mood disorder vs. mood disorder

* Organic anxiety disorder vs. anxiety disorder

* Organic delusional disorder vs. schizophrenia or other psychotic diagnoses

12. How will psychiatric consultation, as part of a pre-surgical requirement, be handled for individuals with a primary medical diagnosis?

For members who have a primary medical diagnosis or condition, psychiatric consults as part of a routine pre-surgical work up (e.g., gastrointestinal bypass, organ transplant, etc.) will be arranged for and authorized by Blue Shield MHSA.

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VI. Laboratory Tests to Rule Out Physical Disorders and Monitor the Use of Psychotropic Medications

Mental health providers are directed to coordinate care with the patient’s IPA/medical group to identify preferred facilities for performing these tests. Psychotropic medication levels are the responsibility of Blue Shield’s MHSA. All laboratory tests to rule out the presence of a medical disorder shall be coordinated with the IPA/medical group. Failure to do so will result in Blue Shield’s MHSA being financially responsible for said tests unless said tests were ordered by a medical consultant for clarification of a medical diagnosis. In this situation, the member who is at the inpatient level of care must utilize the inpatient laboratory contracts and would be a financial responsibility of the IPA/medical group.

First Generation Antipsychotics

Mood Stabilizing Agents

Liver function tests

Lithium

CBC w/differential

Blood levels

Thyroid function tests

Electrolytes

EKG (pimozide only)

Thyroid panel

Blood levels

Creatinine clearance/BUN

Second Generation Antipsychotics

Fasting blood sugar (at initiation only)

LFTs

CBC (at initiation only)

Cholesterol

ECG (at initiation only)

Glucose

Urinalysis (at initiation only)

Prolactin levels

Tegretol

Clozapine

CBC w/differential

WBC – weekly

Platelets

Absolute neutrophil count

LFTs

EEG (w/pos. seizure history)

Blood level

Antidepressants

Lamotrigine

Tricyclics

CBC w/differential

EKG

LFTs

Blood levels

Platelets

SSRIs

Antianxiety Agents

LFTs – baseline only

LFTs

Creatinine/BUN – baseline only

Stimulants

TFTs – baseline only

CBC – baseline

SNRIs

LFTs – baseline

Cholesterol

TFTs – baseline

Wellbutrin

Stimulants

EEG – prior to initiation with history of seizure

LFTs – baseline and follow-up

MAO Inhibitors

Miscellaneous Baseline Screen

LFTs (at initiation)

Urine/blood-drug level/toxicity

Serum bilirubin

EEG

Transaminase activity

SMAC

Platelet MAO inhibition

Drug screens

Pregnancy test – prior to starting meds

Neurological exam

Thyroid function tests

MAT – naltrexone – LFT’s and acamprosate (metimes BUN/Cr)

Risperidone – prolactin level

EKG for Mellaril and Geodon and Celexa, also if QT prolonging meds are used together.

EKG for Mellaril and Geodon and Celexa, also if QT prolonging meds are used together.

CBC w/differential/Platelets for Depakote

Labs, EKG and Xrays in preparation for outpatient ECT

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VII. Contact Numbers for Physicians

Physician Contact Information

Blue Shield of California

Blue Shield MHSA

Michael Millman, PhD

Behavioral Health Director

(916) 841-0483

Toll-free Number (877) 263-9952

michael.millman@blueshieldca.com

PCP Consultation Line (877) 263-9870

VIII. Contact Numbers for Patients

Patient Contact Information

Blue Shield of California

Blue Shield MHSA

Mental Health Customer Service Number on Members’ ID Card

Toll-free Number (877) 263-9952

Implementation Date: July 2000; Revision effective dates: 3/02, 7/03, 4/04, 12/05, 7/08, 7/09, 10/11, 1/14, 1/15, 1/16, 1/18, 1/19

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RESEARCH TOOLS AND

INSTRUMENTS

PEER REVIEW MANUAL

2017-18

Research Tools and Instruments Peer Review Manual 2017-18

Foreword

This manual is designed as a guide for Selection Committee members for the Research Tools  and Instruments (RTI) program. This document outlines the activities to be undertaken by members and Chairs during each competition year, and also describes the policies, guidelines and deliverables relevant to these activities. The manual is updated annually.

Applicants who refer to this manual should note that the content is intended to guide Selection Committee members and outline principles, rather than provide them with a set of rules.

For more information regarding the RTI program, policies, and guidelines send email to resgrant@nserc-crsng.gc.ca

The evaluation of RTI applications in Subatomic Physics differs from these guidelines and is described in the current internal procedures of the Subatomic Physics Evaluation Section. For more information, contact the Subatomic Physics Program Officer.

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Contents

1. Research Tools and Instruments program 5

1.1 Program objectives 5

1.2 Program description 5

1.3 Nature of research supported 5

1.4 Eligible and ineligible expenses 6

1.5 Eligibility to apply 6

2. Membership 7

2.1 Membership selection process 7

2.2 Roles and responsibilities 7

2.2.1 Members 7

2.2.2 Chairs 8

2.2.3 NSERC staff 8

2.3 Orientation session 8

2.4 Time commitment 9

3. Review Procedures 9

3.1 Assignment of applications 9

3.1.1 Selection Committee assignment 9

3.1.2 Assignment of committee reviewers 9

3.1.3 External reviewers 10

3.2 Applications and review material 10

3.2.1 Incomplete or non-adherent application 10

3.2.2 Review materials 10

4. Evaluation of Applications 11

4.1 Selection criteria 11

4.2 Review process 12

4.2.1 Eligibility of subject matter and of the equipment 12

4.2.2 Partial funding recommendations 13

4.2.3 Implicit or unconscious biases 13

4.2.4 Deliverables 13

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4.2.5 Use of the assessment notes template 13

5. Confidentiality 14

6. Competition Results 14

6.1 Communication of the results to applicants 14

6.2 Annual reporting 14

7. Legal and Ethical Information 14

Appendix A – Assessment Notes Template 15

Links 17

1. Guidelines Governing Membership of Selection Committees and Panels 17

2. Conflict of Interest and Confidentiality Agreement for Review Committee Members,

External Reviewers, and Observers 17

3. Conflict of Interest and Confidentiality for Review Committee Members, External

Reviewers, and Observers 17

4. Policy and Guidelines on the Assessment of Contributions to Research and Training 17

5. Guidelines for the Preparation and Review of Applications in Engineering and the

Applied Sciences 17

6. Guidelines for the Preparation and Review of Applications in Interdisciplinary Research 17

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1. Research Tools and Instruments program

1.1 Program objectives

Research Tools and Instruments (RTI) grants foster and enhance the discovery, innovation and training capability of university researchers in the natural sciences and engineering by supporting the purchase of research equipment.

1.2 Program description

RTI grants are one-year awards of up to $150,000 that assist in the purchase or fabrication of research equipment with a net cost between $7,001 and $250,000 (before taxes, customs and importation fees, transportation and shipping charges, assembly and installation costs).

NSERC will only accept requests:

* for tools and instruments that form a comprehensive system intended to support NSERC-funded research in the natural sciences and engineering (bundling of unrelated tools and instruments will not be accepted);

* for the purchase or rental of new, used or refurbished equipment; or for the repair or upgrade of equipment; or for the fabrication of equipment that is not readily available off the shelf; and

* for equipment that is purchased after the application deadline.

Note that equipment and items that are part of laboratory infrastructure or intended to render other equipment compliant with health and safety standards are not eligible for RTI support.

1.3 Nature of research supported

Research in the natural sciences and engineering (NSE) encompasses a broad spectrum of activities. These activities range from curiosity-driven investigations with no immediate or even midterm application, as their importance stems from the intellectual structure of the discipline, right up to applied research or solutions to problems suggested by social and industrial needs. The Research Tools and Instruments program is open to activities across the entire spectrum. The program aims to foster activities that position Canada as a participant and leader in global science and engineering. In this sense, it can be both a flexible resource for Canada and create a favourable environment for the development of research personnel.

Increasingly, research on the most significant problems in the NSE requires the combined knowledge, expertise and contributions of many researchers, often from various disciplines. Creativity and innovation are at the heart of all research advancements. NSERC strives to fully value the role of collaborative endeavours and interdisciplinary work as a means to greater achievement in research through the peer-review system.

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1.4 Eligible and ineligible expenses

Eligible and ineligible expenses pertaining specifically to the RTI program are listed below. Consult the Tri-Agency Financial Administration Guide for information about the eligibility of expenditures for the direct costs of research and the rules governing the use of grant funds.

Type of Expenditure

Eligible Costs

Non-Eligible Costs

(Costs not eligible for funding

must not be included in the

application.)

Equipment

Purchase or rental of equipment including taxes, shipping and handling

-

Other

?

?

?

?

?

?

?

Transportation/shipping costs for purchased equipment; Fabrication, assembly, and installation of the equipment; Extended warranty or service contract;

Brokerage and customs charges for the importation of equipment and supplies; Testing/calibrations costs; On-site costs of training staff to use equipment;

Software licensing or upgrades.

?

?

?

?

?

?

Salaries and benefits;

Travel;

Insurance costs for equipment and research vehicles; Laboratory infrastructure; Costs of the construction, renovation or rental of laboratories or supporting facilities

Equipment or items intended to render other equipment compliant with health and safety standards

1.5 Eligibility to apply

In addition to NSERC’s Eligibility Criteria for Faculty, applicants and co-applicants must each currently hold or be applying for one of the following NSERC research grants at the time of application: Discovery Grant, Discovery Development Grant, Strategic Partnerships Grants, Collaborative Research and Development Grants, Canada Research Chairs, or Canada Excellence Research Chairs.

Eligibility decisions are the responsibility of NSERC staff. Selection Committee members who have doubts about a researcher’s eligibility should review the application on the same basis as all others, but should alert NSERC staff to the potential problem(s) as soon as possible.

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2. Membership

2.1 Membership selection process

RTI Selection Committee members are appointed every year, for a one-year term. Potential members can include established researchers, early-stage scientists and engineers from universities, government or industry. Potential members are approached by Program Officers regarding their willingness to serve on the Committees; they need not be NSERC grantees.

Past members may be approached by Program Officers to provide recommendations and references for potential new members. These recommendations can include comments on the background, stature, and experience of nominees. Factors such as the nominee’s involvement in collaborative and interdisciplinary research may also be considered. To learn more about the selection of members consult the Guidelines Governing Membership of Selection Committees. 

The following documents must be read and agreed to by all members of NSERC’s Evaluation Groups, Selection Committees, or Panels upon appointment and on an annual basis thereafter:

* Conflict of Interest and Confidentiality Agreement for Review Committee Members,  External Reviewers, and Observers 

* Conflict of Interest and Confidentiality Policy of the Federal Research Funding  Organizations 

Acceptance of a term as a member brings with it a commitment to participate in the evaluation of applications assigned to a committee within guidelines established by NSERC. Members and chairs must adhere to NSERC policies and guidelines including those on conflict of interest, diversity and gender equality, communication with applicants, and confidentiality.

The size of the RTI Committee depends on the number of applications received. Prior to receiving the applications, a pool of reviewers will be assembled, covering a wide range of expertise. The selection of members will be finalized once all applications are received, and will be based on the expertise required and the number of applications submitted to the Committee.

2.2 Roles and responsibilities

2.2.1 Members

Members participate in the evaluation of applications and make recommendations to NSERC based on their assessment. Specific responsibilities of members include:

* participating in preparatory meetings/discussions and information sessions prior to submitting their scores;

* submitting expertise “comfort ratings” for the applications;

* providing input on assignments (e.g., possible transfer of the RTI application to another

7

Selection Committee);

* flagging applications where there are concerns related to Subject Matter Eligibility (SME), eligibility of equipment requested and/or budget items;

* reviewing all assigned applications;

* identifying applications that would benefit from partial funding, if applicable;

* submitting scores in a forced distribution for all assigned applications;

* participating in further discussion of some applications if required; and

* preparing messages to applicants on partial funding recommendations.

2.2.2 Chairs

Chairs provide leadership to ensure a high-quality, peer-review process. Over the course of the review process, Chairs may provide their input and recommendation to NSERC on:

* the final membership slate;

* the final assignment of applications;

* possible transfers of applications to other Selection Committees;

* subject matter eligibility concerns raised by NSERC or members;

* possible rejection of applications (e.g., incomplete applications, ineligibility of equipment, requests not intended to support NSERC-funded research in the NSE);

* final ranking of applications with similar scores; and

* policy issues.

2.2.3 NSERC staff

NSERC staff are not committee members and do not evaluate applications. Staff oversee the membership and the review process and provide advice on NSERC policies, guidelines, and procedures.

2.3 Orientation session

In December (or earlier in the fall, if possible), a virtual orientation session is usually held for Selection Committee members with the Chair(s) and NSERC Program Officers. The purpose of the session is to provide information on important NSERC policies and

committee practices, and to provide an opportunity for questions. The Program Officer and Chair will present information on the following topics:

* Competition cycle – An overview of the timetable of the RTI Grants competition, with information on the responsibilities of Committee members, and the role of the Program Officers and Chair.

* Conflict of interest – NSERC’s guidelines on conflict of interest, with tips on how to avoid potential conflict of interest situations.

* Confidentiality – Members’ evaluations should be made in isolation and not discussed with other Committee members or with individuals outside of the Committee.

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* RTI grant review process – An overview of the criteria and review procedures, including what to look for in various sections of the RTI application and the Canadian Common CV (CCV).

2.4 Time commitment

A Selection Committee member’s preparation for the RTI competition involves:

* attending the orientation session;

* in-depth reviewing of the applications to which they are assigned as a reviewer;

* identifying applications where there are concerns related to Subject Matter Eligibility (SME), eligibility of equipment and/or budget items, and those that would benefit from partial funding awards, if applicable. These applications may need further discussion with the NSERC Program Officer, Chair and other reviewers; and

* arriving at a score in a forced distribution for all assigned applications.

Each Selection Committee member normally reviews on average between 20 and 40

applications. The time required for this review will vary according to the Committee workload and the workload of the individual member.

3. Review Procedures

3.1 Assignment of applications

3.1.1 Selection Committee assignment

Applications are initially assigned to a Selection Committee according to the information submitted by the applicant. Applicants select the evaluation group that best fits their research discipline. Their suggestion is used for the preliminary assignment of the application to the appropriate RTI Selection Committee. Committee members can flag applications where a transfer to another committee may be more suitable. These cases may be discussed with the Selection Committee Chairs before final decisions are made; however, NSERC makes the final decision on assignments.

3.1.2 Assignment of committee reviewers

Each application is assessed by up to five (5) Selection Committee members. In order to assist in the assignment of applications, members are asked to provide their expertise comfort or knowledge levels for the applications received for a given year (e.g., H = high, M = medium, L = low, VL = very low, X = cannot review due to language proficiency, or C = conflict of interest).

NSERC staff, in collaboration with the Chair(s), assign reviewers to each application using the identified comfort levels, information about possible conflicts of interest, and in consideration of linguistic abilities, along with the need to balance workload.

9

Usually by the end of November or early December, each member is provided with the final list of applications for which they are responsible to review. Members may be asked to review applications that are not in their primary research field. Any problem with the assignment of applications should be flagged and brought to the NSERC Program Officer’s attention as soon as possible/ early in the process.

3.1.3 External reviewers

There are no external reviewers for the RTI program.

3.2 Applications and review material

3.2.1 Incomplete or non-adherent application

The onus is on the applicant to provide complete and sufficient information that adheres to NSERC General Presentation Guidelines and Instructions for Completing an Application. Problems related to the application content should be brought to the attention of the Program Officer. In order to maintain the principle of fairness in the competition, applicants must adhere to the guidelines in the preparation of application materials. Should NSERC staff determine that the information provided is incomplete or non-adherent to NSERC guidelines or instructions, the application may be rejected.

An application will be rejected if the following information is not provided at the time of submission (where applicable):

* The letter confirming a cash contribution from an organization other than the applicant’s or co-applicants’ institution[s] towards the purchase of the equipment.

* The authorization from NSERC confirming the use of funds from NSERC grants (with the exception of DG funds) towards the purchase of the equipment.

* The justification for not submitting two (2) recent quotations for any items or any systems costing more than $25,000 (before taxes).

3.2.2 Review materials

Selection Committee members will have access to the following application material in a secure electronic environment in early December:

* RTI applications;

* assignment and scoring spreadsheet; and

* assessment notes template.

Members are required to review their assignments and determine whether they have a conflict of interest and have the linguistic capacity to review the proposals. Members should notify the NSERC Program Officer of any issues related to the applications.

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4. Evaluation of Applications

4.1 Selection criteria

Applications are assessed on the basis of the selection criteria listed below. Selection Committee members provide an overall score based on all five criteria. There is no specified weighting of the criteria.

1. The excellence of the applicant(s):

* knowledge, expertise, and experience of the applicant(s) in the NSE; and

* extent to which the applicant(s) have relevant experience and demonstrated ability to fully use the equipment.

2. The merit of the proposed research program(s):

* overall quality of the research program(s);

* feasibility of the research program(s); and

* potential for major advances in the discipline.

3. The need and urgency for the equipment; including availability of, and access to, similar equipment:

* the impact of a delay in the acquisition of the equipment;

* potential for the new equipment to move the research forward or help to launch new research directions;

* impact of the new equipment on the pace of progress for existing or proposed research;

* availability of other equipment/facilities/services in the vicinity;

* impact of limited or lack of access to existing equipment; and

* the need to upgrade or replace obsolete or failed equipment.

4. The suitability of the proposed equipment for the proposed research program(s):

* for multi-user applications, demonstration that the proposed equipment is suitable for a multi-user facility and for the desired applications;

* demonstration that the equipment is essential to do the work and that there are no other more cost effective ways of obtaining the results;

* probable degree of utilization by, or accessibility for, the applicant(s) and other users;

* capability of applicant(s) to fully utilize the equipment; and

* accessibility of the equipment, both in terms of location and the availability of technical support to assist in operations.

When the justification for the equipment is based to some extent on the anticipated use by, or benefit to, other NSE sectors, the applicant should describe the support secured from these sources or the demonstrated efforts that have been made to secure it. The RTI Selection Committee should consider this information for this criterion.

11

5. The importance of the equipment for the training of highly qualified personnel:

* the quality and extent of training;

* the opportunity for hands-on training; and

* the potential to provide marketable skills for students trained on the equipment.

Note: The necessity of the requested item(s) for the completion of student projects and theses should be addressed under the third criterion — need and urgency for the equipment, including availability of, and access to, similar equipment).

4.2 Review process

Up to five members will be assigned to assess each RTI application. Members should not expect to receive external reviewer reports since there are no external reviews requested for

RTI applications. Committee members’ evaluations should be made in isolation and should not be discussed with other members of the Committee, except during any teleconference scheduled for flagged applications. Members should not discuss applications with individuals outside of the Committee at any time. Members should contact their NSERC Program Officer for assistance in any regard and at any time.

Applications are assessed on the basis of the five evaluation criteria. Members will score each application from 1 to 10 (10 being the highest score), ensuring a forced distribution. Members provide an overall score for each application based on all five criteria; there is no specified weighting of the criteria.

Once NSERC receives the scores from all members, they will be entered into a spreadsheet and the applications will be ranked based on the average score.

At any point during the review, applications may be flagged by NSERC staff, the Chair, or members of the committee for additional discussion.

4.2.1 Eligibility of subject matter and of the equipment

While reviewing applications, Selection Committee members are asked to consider subject matter eligibility and eligibility of equipment, to note any anomalies in the budget, and to bring both to the attention of the NSERC Program Officer. These cases may require further input from the Chair and members, and will be resolved before the results are finalized.

With respect to subject matter eligibility, members should specifically note how equipment purchased with RTI grants is going to be used, as the intent is for equipment grants to foster and enhance the discovery, innovation and training capability of university researchers in the natural sciences and engineering (NSE). Equipment funded by the RTI grant can be used for research that falls outside the NSE, but applicants must clearly document that the primary and majority of the use will be directed toward NSERC-funded research in NSE. Applications are assessed based on the NSERC-funded research that will be supported.

12

4.2.2 Partial funding recommendations

Awarded RTI grants should normally be for the full cost of the recommended items (including tax, transportation and eligible installation costs). RTI Selection Committees may recommend partial funding, but the amount recommended must be sufficient to allow for the purchase of a functional unit. Ineligible items will be deducted by NSERC. The Committees must provide NSERC staff with details of the partial award, including a listing of all components recommended for funding. Program Officers will prepare written comments to specify which components of the equipment are being funded.

In the Budget Justification section, applicants are ask to outline any ‘Relationship to Other Sources of Support’ and explain any relationship and/or overlap (conceptual or financial) between work supported by other funding sources and work supported by NSERC, including the application under review. In its review, the Selection Committee will focus specifically on other equipment support and its relationship to the current proposal.

4.2.3 Implicit or unconscious biases

NSERC asks committee members to consistently guard against the possibility of unconscious bias influencing the decision-making process, whether this bias is based on a school of thought, fundamental versus applied research, certain sub-disciplines, areas of research or approaches (including emerging ones), size or reputation of an institution, age, personal factors, sex or gender of the applicant. NSERC cautions members against any judgment of an application based on such factors.

NSERC is actively engaged in increasing diversity and gender equity in its peer review process to increase the inclusion of women and other under-represented groups in the NSE. For

reference, see NSERC’s Policy Statement on Gender Equality in Science and Engineering and available resources such as Strengthening Canada’s Research Capacity: The Gender Dimension and NSERC 2020: A Strategic Plan. 

4.2.4 Deliverables

Selection Committee members will submit scores (for all applications assigned to them) to the NSERC Program Officer.

4.2.5 Use of the assessment notes template

Using the Assessment Notes Template provided by NSERC will help Selection Committee members ensure that all criteria are taken into account when formulating recommendations for RTI applications; however, its use is not mandatory. NSERC does not collect these notes, but requires that all material used by members during the competition be destroyed at the end of their work on the Committee. See Appendix for Template.

13

5. Confidentiality

Details of the scoring, deliberations, and recommendation on a specific application are confidential and must never be divulged. Release of information must be done by NSERC. Under no circumstances should members divulge to anyone the recommendations emanating from the peer review process.

In accordance with the Conflict of Interest and Confidentiality Agreement for Review Committee  Members, External Reviewers, and Observers (Federal Research Funding Organizations) and the Conflict of Interest and Confidentiality Agreement for Review Committee Members, External  Reviewers, and Observers (NSERC), members are not permitted to discuss specific results or the deliberations. Requests from applicants or enquiries on competition results, individual cases, or discussions must be redirected to NSERC staff.

6. Competition Results

6.1 Communication of the results to applicants

NSERC Program Officers prepare a document for each applicant indicating how the application ranked in the competition and, in the case of partial funding, which items are being funded, as recommended by the Selection Committee.

6.2 Annual reporting

NSERC releases a statistical package of results at the end of the competition cycle on the

NSERC website. A brief annual report is also prepared by NSERC Program Officers, as needed, which could be distributed to groups such as department chairs in a given discipline, professional associations, etc.

7. Legal and Ethical Information

Legal and ethical information can be found in Section 9 of the Discovery Grants peer review  manual.

14

Appendix A – Assessment Notes Template

Research Tools and Instruments Grant Application

Applicant

Department/University

Title of Proposal

$EVALUATION

Amount Requested

CRITERIA

Excellence of the applicant(s)

Calibre of the applicant(s)

Relevant experience to use the equipment

Demonstrated ability to fully use the equipment

Merit of the proposed research program(s)

Quality of research program(s)

Feasibility of the research program(s)

Potential for major advances in the discipline

Need for and urgency of the equipment; including availability of, and access to, similar equipment

Impact of delay in the acquisition of the equipment

Potential for the new equipment to move the research forward or help to launch new research directions

Impact of the new equipment on the pace of progress for existing or proposed research

Availability of other equipment/facilities/services in the vicinity

Impact of limited or lack of access to existing equipment

Need to upgrade or replace obsolete or failed equipment

Suitability of the proposed requested equipment

15

for the proposed research program(s)

Probability of utilization or accessibility of outside users Suitability for a multi-user facility and for the desired applications

Capability of applicant(s) to utilize equipment Demonstration that the equipment is essential to do the work and there are no other more cost-effective ways of obtaining results

Probable degree of utilization by, or accessibility for, the applicant(s) and other users

Capability of applicant(s) to utilize equipment

Accessibility of equipment (location and availability of technical support)

Importance of the equipment for the training of highly qualified personnel, HQP

Importance of the equipment for training

Quality and extent of training

Training received could be a marketable skill for HQP

Opportunities for hands-on training

OTHER CONSIDERATIONS

Eligibility of the Subject Matter

Eligibility of the equipment and expenses (Reviewed by Selection Committee Member)

Other comments (e.g., special circumstances):

Overall Impression/Priority:

Recommendation (explain and describe item(s) if a partial award is recommended): $

Score:

16

Links

1. Guidelines Governing Membership of Selection Committees and Panels 

2. Conflict of Interest and Confidentiality Agreement for Review Committee Members,  External Reviewers, and Observers 

3. Conflict of Interest and Confidentiality for Review Committee Members, External  Reviewers, and Observers 

4. Policy and Guidelines on the Assessment of Contributions to Research and Training 

5. Guidelines for the Preparation and Review of Applications in Engineering and the Applied  Sciences 

6. Guidelines for the Preparation and Review of Applications in Interdisciplinary Research

17

Manage EP Online/WP Online access

BUSINESS EMPLOYER

Updated on 10 Apr 2018

Use this form to change your administrator or close

the EP Online/WP Online account

(For business employers only)

Ministry of Manpower Work Pass Division

Web http://www.mom.gov.sg Contact us http://www.mom.gov.sg/contact Page 1 of 3

Manage EP Online/WP Online access

BUSINESS EMPLOYER

PART A

I want to (Please only tick ? 1 option):

* Change administrator for EP Online / WP Online / Both accounts (Please circle accordingly)

* Close my EP Online / WP Online / Both accounts (Please circle accordingly)

Details of my organisation

Unique Entity Number:

CPF Submission Number:

- -Organisation’s Name:

Address:

Postal Code:

Contact number:

(Office)

(Mobile)

Ministry of Manpower Work Pass Division

Web http://www.mom.gov.sg Contact us http://www.mom.gov.sg/contact Page 2 of 3

Manage EP Online/WP Online access

BUSINESS EMPLOYER

PART B

Only complete Part B if you wish to change your administrator.

Details of my new administrator

Name (as appears on NRIC/Passport):

NRIC number/FIN:

Contact number:

(Office) (Mobile)

Designation:

Relationship with my organisation (Please only tick ? 1 option):

* Sole proprietor/Partner/Director registered with ACRA

* Employee

* Outsourced HR consultant

* Outsourced secretariat consultant

* Outsourced relocation consultant

Ministry of Manpower Work Pass Division

Web http://www.mom.gov.sg Contact us http://www.mom.gov.sg/contact Page 3 of 3

EP Online/WP Online terms and conditions

acknowledgement form

How to complete this form

* The declaration section below can only be acknowledged and signed by the following personnel:

If your organisation is registered as a/an

To be signed by your

Employment agency

Key appointment holder

Sole proprietorship

Sole proprietor

Partnership

Partner

Private limited (Pte Ltd), Limited (Ltd) or Limited liability partnership

Employee of managerial level and above

* Submit the completed acknowledgement form using iSubmit (www.mom.gov.sg/iSubmit). Select option 3 as the request type. Incomplete forms will not be processed.

Declaration by your organisation

1. I have read and understood the terms and conditions for EP Online/WP Online and agree to be bound by them.

2. I will ensure that all my EP Online/WP Online users read and understand the terms and conditions and agree to bind them to the terms and conditions. I agree to be responsible for their transactions done using EP Online/WP Online.

3. I am aware that the Ministry of Manpower (MOM) may vary the terms and conditions and create new ones at any time. I am aware that the changes will take effect on the date specified in the notice. My EP Online/WP Online users and I will check the terms and conditions in the system periodically for any updates. I understand that if we continue to use EP Online/WP Online after the new terms and conditions have taken effect, we are deemed to have accepted the changes.

4. If I breach any of the terms and conditions, I am aware that my organisation’s EP Online/WP Online account may be suspended or terminated. The account suspension or termination will not affect MOM’s right to take other actions against me or my organisation.

Declaration by company’s authorised representative

I hereby declare that the information provided in this form is true and correct.

Name (as appears on NRIC/Passport): Organisation’s name:

NRIC number/FIN:

Signature:

Designation:

Date

(DD-MM-YYYY)

WPCA 001

EP Online/WP Online user agreement

This agreement contains the terms and conditions which will bind customers of the EP Online and WP Online systems provided by the Ministry of Manpower.

1 Definition of terms

1.1 In this agreement, the following words and phrases will have the meanings assigned to them except where the context otherwise requires:

“MOM”, “We”, means Ministry of Manpower.

“Our” or “Us”

“EP Online” means the electronic system designed for the provision of services in relation to all passes issued by MOM, including Employment Pass, S Pass, Training Employment Pass, Long Term Visit Pass, Dependant's Pass and Letter of Consent.

“WP Online” means the electronic system designed for the provision of services in relation to Work Permits.

“Services” means the facilities provided through the EP Online or WP Online system.

“Customer”, means the administrator or user of the EP Online or WP Online system,

“You” or “Your” including a person or organisation, holding a CorpPass or SingPass ID. This comprises employees, agents and authorised users.

“SingPass ID” means Singapore Personal Access ID assigned to the customer.

“CorpPass ID” means Singapore Corporate Access ID assigned to the customer.

“CPFB” means Central Provident Fund Board.

“Employer” means any person or organisation employing or intending to employ a foreigner.

“Information” means data, whether true or not, of an individual or organisation which allows the party to be identified from it, or together with other data that the customer is likely to have access to.

1.2 Any reference to the legislation is deemed as reference to it as amended and revised from time to time and also includes its subsidiary legislation, unless otherwise specified.

2 Services to be provided

2.1 You will have access to the services in EP Online or WP Online to carry out any of the transactions provided by the system.

2.2 We may vary the services provided through EP Online and WP Online and will notify you of the variations by posting an announcement on EP Online or WP Online. We reserve the right to reject any transactions submitted by you through EP Online and WP Online.

WPCA 001

EP Online / WP Online User Agreement

2.3 We may verify and share the information retrieved, stored or transmitted through the services with any Government agencies as and when necessary to serve you in the most effective way, unless such sharing is prohibited by legislation. Your information will not be shared with non-Government entities, except where such entities are authorised to carry out specific duties relating to the services provided by the Government.

2.4 To speed up transactions, we may display information you have provided to us or other Government agencies. We will only retain information if it is necessary for us to serve you effectively.

2.5 To safeguard your information from unauthorised persons, we will secure all electronic transmission with appropriate security technology.

3 Closure of services for maintenance

3.1 We reserve the right to make EP Online and WP Online unavailable for system maintenance as and when necessary. We will take reasonable steps to notify you of the system unavailability by posting an announcement on our website, EP Online or WP Online. We will not be responsible for any damage or loss resulting from the system unavailability.

4 Purchase of compatible hardware and software

4.1 You need to buy, install and maintain your own hardware and software products for access to EP Online and WP Online.

4.2 Your hardware and software must meet the specifications prescribed in the 'Recommended PC Specification' and 'Technical Guidelines'. We reserve the right to change the prescribed specifications, and will notify you of these changes through an announcement on EP Online or WP Online.

5 Fees and charges

5.1 You must pay all fees and charges promptly. If there is any disagreement on the amount paid, you must

inform us within 7 days from the statement date. If we decide in your favour, the excess amount will be refunded to you.

5.2 Payments must be made through GIRO (applicable to business employers and employment agencies) or other forms of electronic methods approved by us. For GIRO payments, you can view or print the bill from EP Online and WP Online from the 5th of every month. GIRO deductions will be made on the 17th of the month or the next working day if the 17th is a Saturday, Sunday or Public Holiday. You must ensure that you have sufficient funds in your GIRO bank account. If the GIRO deduction is unsuccessful, your access to EP Online and WP Online will be limited or suspended.

5.3 If you intend to terminate the GIRO bank account, you must notify us in writing at least 14 days before the termination date.

5.4 We may review and vary the charges and payment schedule under this agreement by posting an announcement on EP Online or WP Online.

6 Intellectual property

6.1 The contents of the EP Online and WP Online systems such as specifications, materials, programs, text, graphics, logos or trademarks developed by us and our authorised agents are protected by copyright, trademark and other forms of proprietary rights. These rights are owned by, licensed and controlled by us. No parts of EP Online and WP Online may be reproduced, distributed, adapted, modified, republished, displayed, broadcast or transmitted in any manner or by any means without our prior written consent. You must use the services in a manner that will not infringe these rights.

WPCA 001

EP Online / WP Online User Agreement

7 Change of address and contact details (For business employers and employment agencies)

Change of address

Change of contact details

EP Online

You must notify MOM.

You must notify MOM.

WP Online

You must notify CPFB.

You must notify CPFB.

You must notify the respective Government agencies within 14 days of the change.

8 Cessation of business (For business employers and employment agencies)

8.1 If you intend to cease business or are facing insolvency or bankruptcy proceedings, you must notify us in writing at least 14 days before such intent or proceedings are instituted.

9 EP Online and WP Online accounts

9.1 We have the right to decide whether you can log in to EP Online and WP Online using your CorpPass or SingPass. To change or reset the passwords for CorpPass and SingPass, you can refer to the CorpPass and SingPass websites for more information.

9.2 You must protect the secrecy of your CorpPass and SingPass IDs at all times and must not disclose to any person(s). You are responsible for all transactions done using your CorpPass or SingPass ID, regardless of whether you have authorised such use, and must bear all charges, losses or damages resulting from these transactions.

9.3 You must inform us immediately if an unauthorised transaction may be or has been done using your CorpPass or SingPass ID.

9.4 You must ensure that persons accessing EP Online and WP Online are authorised. You are responsible for terminating the person's access to EP Online or WP Online if the person is no longer authorised. We reserve the right to limit the number of administrators and users for all EP Online and WP Online accounts (applicable to business employers and employment agencies).

9.5 You are responsible for updating us of any changes to the administrators or users of the EP Online and WP Online accounts (applicable to business employers and employment agencies).

9.6 For business employers and employment agencies, we reserve the right to terminate the EP Online and WP Online accounts under any of these conditions:

a) No regular logins to the accounts.

b) Account does not have any administrators or users.

c) The business entity is no longer operating or in existence.

9.7 We reserve the right not to grant access to EP Online and WP Online if you are assessed to be unsuitable to assume the responsibilities of an administrator or user.

9.8 We reserve the right to withdraw access to EP Online and WP Online immediately whenever you have contravened any of the following:

a) The Employment Act (Chapter 91).

b) The Employment of Foreign Manpower Act (Chapter 91A).

c) The Employment Agencies Act (Chapter 92) or licensing conditions.

d) The Foreign Employee Dormitories Act 2015.

e) The Immigration Act (Chapter 133).

f) The Work Injury Compensation Act (Chapter 354).

g) The Workplace Safety and Health Act (Chapter 354A).

h) The provisions of the terms and conditions for use of the EP Online and WP Online accounts. This includes being involved in transactions and activities which are inconsistent with the intent and purpose of the legislations and online account conditions.

WPCA 001

EP Online / WP Online User Agreement

10 Your responsibilities

10.1 Before you can retrieve, store or transmit the employer’s or foreigner’s information using the services, you must get their written consent for you to perform the transaction and to allow MOM to display their information. You must produce the written consent if MOM requests for it.

10.2 You must use the information retrieved, stored or transmitted through the services for its prescribed purpose.

10.3 You must take the necessary measures to prevent unauthorised access to the system. You must ensure that only your employees, agents and authorised users are allowed to transact, retrieve, store or transmit information through the EP Online and WP Online accounts for your business operations.

10.4 You must not retrieve, store or transmit information through EP Online and WP Online if you are not registered as an administrator or user of that account.

10.5 You must not use the services in EP Online and WP Online for any illegal purpose or in any other manner inconsistent with the terms and conditions of use.

10.6 If you are an employment agency licence holder, you must use the employment agency's EP Online and WP Online accounts to transact for your clients.

10.7 You must ensure that all information submitted through the services is complete, true, correct and consistent with the supporting documents. If you fail to do so, it will cause delay in the processing or rejection of your electronic submission. You are liable for all costs incurred due to the submission of false or incorrect information.

10.8 You must retain the complete set of documents used to support the application, issuance or cancellation of all passes for 3 years from the date of application. If you are unable to produce these documents to us when required, the passes may be cancelled and you will have to bear the cost of sending the foreigner home.

10.9 You and your employees, agents and authorised users must always comply with our instructions or directions, online guide and other documents on the use of EP Online and WP Online.

10.10 You must download and save or print all GIRO bills or payment receipts issued from the use of EP Online or WP Online. The bills and receipts will only be available in EP Online and WP Online for 3 months from the payment date. We will not provide you with the monthly GIRO bills or payment receipts.

10.11 You are prohibited from violating or attempting to violate the security of EP Online and WP Online including:

a) Accessing information or logging into a server or account which you are not authorised to access.

b) Attempting to probe, scan or test the vulnerability of EP Online and WP Online.

c) Breaching or attempting to breach the security or authentication measures of the system.

11 Disclaimer

11.1 While we take every care to provide the services, the Government disclaims all liabilities whatsoever for:

a) Any loss of or any inability to retrieve data or information however caused including non-delivery, misuse, misdelivery as a result of any interruption, suspension or termination of services.

b) Any inaccuracy in the information or resources available, received or transmitted through EP Online and WP Online.

c) Any malfunction, defect or error in the EP Online and WP Online systems.

d) Any delay or inability on our part in the provision of the services under this agreement because of any electronic, mechanical, system, data processing or telecommunication defect or failure, act of God, civil disturbance or any events outside our control.

Further, no guarantee is given that:

WPCA 001

EP Online / WP Online User Agreement

a) EP Online and WP Online will always be accessible.

b) EP Online and WP Online will be free from errors or defects.

c) Any identified error will be corrected.

d) EP Online and WP Online will be free from virus or other malicious, destructive or corrupting code, agent, program or macro.

We will not be responsible or liable for any direct, incidental or consequential damage or loss that may result from such errors, defects or harmful components.

12 Suspension of access to services

12.1 We will suspend access to the services if you have provided incomplete, false, incorrect or inconsistent information or breached any of the responsibilities under Clause 10. Wilful misrepresentation or submission of false information may result in prosecution. You will be held responsible and liable for any levies or charges incurred due to false or incorrect information.

12.2 We may suspend all or part of the services if you fail to make full payment of the fees and charges for the services. Non-payment of fees for either EP Online or WP Online may result in suspension of both accounts (if applicable). You will be required to pay the amount owed up till the day of suspension. Once this is done, we may choose to restore the services, in which case this agreement will resume.

12.3 We may suspend the services for up to a maximum period of 1 year or until the conclusion of any investigation, if we decide that you have infringed any of the following:

a) The Employment Act (Chapter 91).

b) The Employment of Foreign Manpower Act (Chapter 91A).

c) The Employment Agencies Act (Chapter 92) or licensing conditions.

d) The Foreign Employee Dormitories Act 2015.

e) The Immigration Act (Chapter 133).

f) The Work Injury Compensation Act (Chapter 354).

g) The Workplace Safety and Health Act (Chapter 354A).

Alternatively, we can terminate this agreement as described under Clause 13.4.

13 Termination of agreement

13.1 MOM or the customer may terminate this agreement by giving 1 month's notice in writing.

13.2 Upon termination of the agreement for whatever reason, you cannot continue to use the services.

13.3 Termination of this agreement will not affect the accrued rights or liabilities of either party nor will any remedy which any party has against the other be affected.

13.4 We can also terminate this agreement immediately without any notice if you have done any of the following:

a) Ceased the business operations, or had the business declared as bankrupt or insolvent.

b) Breached the terms and conditions of this agreement.

c) Infringed the Employment Act (Chapter 91).

d) Infringed the Employment of Foreign Manpower Act (Chapter 91A).

e) Infringed the Employment Agencies Act (Chapter 92) or licensing conditions.

f) Infringed the Foreign Employee Dormitories Act 2015.

g) Infringed the Immigration Act (Chapter 133).

h) Infringed the Work Injury Compensation Act (Chapter 354).

i) Infringed the Workplace Safety and Health Act (Chapter 354A).

14 Assignment of agreement

14.1 You must not, without our prior written consent, sub-contract, transfer or assign this agreement or benefits or obligations or any part thereof, to any other party.

WPCA 001

EP Online / WP Online User Agreement

15 Applicable law

15.1 This agreement will be governed by the laws of the Republic of Singapore.

15.2 A person who is not a party to this agreement will not have rights under the Contracts (Rights of Third Parties) Act to enforce any term.

15.3 By accessing or using EP Online or WP Online, you agree that Singapore law (including without limitation the Electronic Transactions Act, Chapter 88) will govern such access and the services.

16 Mediation

16.1 In the event of any dispute, claim, question or disagreement arising from and relating to this agreement or the breach thereof, no party can proceed to litigation or any other forms of dispute resolution unless the parties have made reasonable efforts to resolve the same through mediation in accordance with the mediation rules of the Singapore Mediation Centre. A party who receives a notice for mediation from the other party must consent and participate in the mediation. Any failure to comply with this clause will be deemed as a breach of the agreement.

17 Variation

17.1 We may vary the terms and conditions of this agreement and create new terms and conditions at any time by notifying you of the changes. The changes will take effect on the date specified on the notice. If you continue to use the services after the specified time, you will be deemed to have accepted the changes. We will notify you of any changes via an announcement on EP Online or WP Online or in such manner as we deem appropriate.

18 Exclusion of liability

18.1 We will in no event be liable for any damage, loss or expense including without limitation, direct, special or consequential damage or economic loss arising from or in connection or referable to:

a) Any access, the use or inability to access EP Online and WP Online or the services, or reliance on the information in EP Online and WP Online.

b) Any system, server or connection failure, error, omission, interruption or delay in transmission.

c) Any computer virus or other malicious, destructive or corrupting code, program or macro that may affect your computer equipment, program or other properties.

19 Indemnity

19.1 You agree not to hold us liable for any claim or legal action, resulting from the use of the services or breach of the terms and conditions of use.

uMobility Introduction, Installation, and

Configuration Course

Title: uMobility Introduction, Installation, and Configuration

Confidential 2003-2010 Varaha Systems, Inc. Page 1 of 11

THIS DOCUMENT AND THE DATA DISCLOSED HEREIN OR HEREWITH IS PROPRIETARY AND IS NOT TO BE REPRODUCED, USED OR DISCLOSED IN WHOLE OR IN PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF VARAHA SYSTEMS. COPYRIGHT, © Varaha Systems 2010

2003-2010 Varaha Systems, Inc. All Rights Reserved.

This document is the confidential property of Varaha Systems, Inc. No part of this document may be reproduced or transmitted in any form or by any means, electronic or otherwise, including photocopying, reprinting, scanning, or recording, for any purpose, without the express written permission of Varaha Systems, Inc.

TRADEMARKS

uMobility is a trademark of Varaha Systems, Inc.

All other company, brand, product or service names mentioned herein are the trademarks or registered trademarks of their respective owners.

DISCLAIMER

Information in this document is subject to change without notice and should not be construed as a commitment on the part of Varaha Systems, Inc. Varaha Systems, Inc. does not assume any responsibility or make any warranty against errors that may appear in this document.

Varaha Systems, Incorporated

2650 Valley View Lane

Building 1, Suite 200

Dallas, Texas 75234

Tel: +1-972-241-2151

Fax: +1-972-243-1505

E-mail: info@varaha.com

Visit us at: http://www.varaha.com

Title: uMobility Introduction, Installation, and Configuration

Confidential 2003-2010 Varaha Systems, Inc. Page 2 of 11

THIS DOCUMENT AND THE DATA DISCLOSED HEREIN OR HEREWITH IS PROPRIETARY AND IS NOT TO BE REPRODUCED, USED OR DISCLOSED IN WHOLE OR IN PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF VARAHA SYSTEMS. COPYRIGHT, © Varaha Systems 2010

Table of Contents

Day I uMobility and FMC Overview 4

Day II TECHNICAL SALES – PRE 7

Day III TECHNICAL SALES – POST 9

Day IV Hands On 11

Title: uMobility Introduction, Installation, and Configuration

Confidential 2003-2010 Varaha Systems, Inc. Page 3 of 11

THIS DOCUMENT AND THE DATA DISCLOSED HEREIN OR HEREWITH IS PROPRIETARY AND IS NOT TO BE REPRODUCED, USED OR DISCLOSED IN WHOLE OR IN PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF VARAHA SYSTEMS. COPYRIGHT, © Varaha Systems 2010

Day I uMobility and FMC Overview

1. FMC – Introduction - 1 Hours

a. What is FMC?

i. Traditional View of FMC

ii. Varaha View of FMC

b. Components of FMC

i. PBX, Wi-Fi, Cellular

ii. Single mode vs Dual Mode

c. PBX Features (Mobile Desk) Features

i. Basic calls

ii. VoIP Calling

iii. Call waiting, 2 lines support

iv. Call hold/unhold

v. Call transfer

vi. Voicemail, MWI

d. Mobility features

i. Modes of Operation

1. Single Mode

2. Dual Mode

ii. Single Mode Operation

1. Single number reach

2. Enterprise dialing

iii. Dual Mode Operation

1. VoIP calling

2. Call move and hand offs

iv. Comparison with other approaches

1. When is it “VoIP” ?

2. SNR vs Forwarding?

e. Break – 10 Min

2. Overview of Technologies 1 Hour

a. Devices - Smartphones

i. Market direction

ii. iPhone, iPod Touch, iPad

1. Platforms

2. Prospects/Limitations

Title: uMobility Introduction, Installation, and Configuration

Confidential 2003-2010 Varaha Systems, Inc. Page 4 of 11

THIS DOCUMENT AND THE DATA DISCLOSED HEREIN OR HEREWITH IS PROPRIETARY AND IS NOT TO BE REPRODUCED, USED OR DISCLOSED IN WHOLE OR IN PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF VARAHA SYSTEMS. COPYRIGHT, © Varaha Systems 2010

iii. Blackberry

1. Platforms

2. Prospects/Limitations

iv. Android phones

1. Platforms

2. Prospects/Limitations

v. Symbian and WM

1. Platforms

             2. Prospects/Limitations

b. Networks

i. Cellular networks

1. Overview

2. CDMA

3. GSM

4. 3G Data networks

ii. Wi-Fi networks

1. Overview

Break - 10 Minutes

3. uMobility – 1 Hour

a. Universal mobility – Vision to product

b. uMobility components

c. Deployment configurations

d. Single mode/dual mode

e. Upsell opportunities with uMobility

i. PBX components

ii. Service Opportunities

Exam! - 15 Minutes

Lunch and emails – 1 Hour

4. Customer use cases - 1 Hour

a. Healthcare – Pyam

b. Retail - Large Home Improvement store

Title: uMobility Introduction, Installation, and Configuration

Confidential 2003-2010 Varaha Systems, Inc. Page 5 of 11

THIS DOCUMENT AND THE DATA DISCLOSED HEREIN OR HEREWITH IS PROPRIETARY AND IS NOT TO BE REPRODUCED, USED OR DISCLOSED IN WHOLE OR IN PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF VARAHA SYSTEMS. COPYRIGHT, © Varaha Systems 2010

c. Warehouse – Steel warehousing operation

d. Manufacturing – Cable manufacturing plant

e. Road Warrior – Telecommunication Company

f. International traveler – Mobile Professional

5. Customer Engagement – 0.5 hours

a. Prospects and Activities

b. Qualified customer activities

c. Trial tricks

d. Barriers elimination

e. Closing

Need for site survey

I need coffe!e

6. uMobility tools at your fingertip 2 Hours

a. uMobility portal overview

i. Marketing and Sales portal

ii. Operations portal

iii. Boilerplate

b. ROI xls tool

c. Device support and staying current

d. Project plan

e. Pricing services

Beer Hour

Title: uMobility Introduction, Installation, and Configuration

Confidential 2003-2010 Varaha Systems, Inc. Page 6 of 11

THIS DOCUMENT AND THE DATA DISCLOSED HEREIN OR HEREWITH IS PROPRIETARY AND IS NOT TO BE REPRODUCED, USED OR DISCLOSED IN WHOLE OR IN PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF VARAHA SYSTEMS. COPYRIGHT, © Varaha Systems 2010

Day II TECHNICAL SALES – PRE

1. Operating System Linux – 1.5 Hours

a. Brief overview

b. Xterm windows, commands : ls, rpm, cd

c. RedHat Linix versus CentOS

d. Standard components

a. Database

b. Web server

c. Media Handler

e. Services

a. Status and monitoring

2. Protocols 2 Hours

a. Session Initiation Protocol (SIP)

b. Realtime Protocol (RTP)

c. Transport selection (UDP/TCP)

d. SIP Overview

i. Why SIP?

ii. Text-based, background

iii. Line/Trunk Side

e. Call Flows

i. Message details

ii. Impact of wireless

1. Retransmissions and delay

2. Packet loss

iii. SIP tracing

3. 802.11/Wi-Fi/Cellular Networks 1.5 Hours

a. Nature of wireless

i. Weather, obstructions, frequency issues

b. Cellular standards (GSM/CDMA) and impact on devices i. Cell size/power/etc.

c. 802.11 (Howard 802.11 data)

i. a, b, g, n and impact on devices

ii. 802.11 QoS/best practices for VoIP over WLAN

4. Systems Engineering 2 Hours

Title: uMobility Introduction, Installation, and Configuration

Confidential 2003-2010 Varaha Systems, Inc. Page 7 of 11

THIS DOCUMENT AND THE DATA DISCLOSED HEREIN OR HEREWITH IS PROPRIETARY AND IS NOT TO BE REPRODUCED, USED OR DISCLOSED IN WHOLE OR IN PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF VARAHA SYSTEMS. COPYRIGHT, © Varaha Systems 2010

a. Connectivity

b. Deployment engineering

i. Proxy versus SIP server

ii. Domains

iii. SBC/FW/ALG

iv. Address and port mapping

1. Port usage (Guide)

v. VPN Access

c. Cellular standards (GSM/CDMA) and impact on devices

i. Cell size/power/etc.

ii. Optimal Routing

d. Site Survey

i. Overview of the site survey document

ii. Check list

Title: uMobility Introduction, Installation, and Configuration

Confidential 2003-2010 Varaha Systems, Inc. Page 8 of 11

THIS DOCUMENT AND THE DATA DISCLOSED HEREIN OR HEREWITH IS PROPRIETARY AND IS NOT TO BE REPRODUCED, USED OR DISCLOSED IN WHOLE OR IN PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF VARAHA SYSTEMS. COPYRIGHT, © Varaha Systems 2010

Day III TECHNICAL SALES – POST

1. PBX Readiness

a. User Provisioning in PBX

b. Connectivity, basic calling, features

2. uMC server Verification

a. Logging in

b. Basic connectivity

c. Service status

3. uMC Installation

a. Overview

b. Hardware

c. Site survey to network diagram

4. uMobility Configuration

a. Configuration

b. Configuration verification –

i. What did I miss?

ii. What can go wrong?

iii. Verification scripts

c. Making/receiving calls

Title: uMobility Introduction, Installation, and Configuration

Confidential 2003-2010 Varaha Systems, Inc. Page 9 of 11

THIS DOCUMENT AND THE DATA DISCLOSED HEREIN OR HEREWITH IS PROPRIETARY AND IS NOT TO BE REPRODUCED, USED OR DISCLOSED IN WHOLE OR IN PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF VARAHA SYSTEMS. COPYRIGHT, © Varaha Systems 2010

5. uMobility Server Operations and Administration

a. User provisioning

i. Starting check list

ii. Bulk provisioning

b. Client Installation and Configuration

c. Over-the-air installation (OTA) i. OTA debugging

d. uMobility System Administration

i. Events

ii. Alarms

iii. Logs

iv. Debug logs

e. uMC System Data Back-up and Restore

f. uMC Client/Server Troubleshooting

g. Proxy and use of proxy

h. Diagnostics

i. Reserve Pool

Title: uMobility Introduction, Installation, and Configuration

Confidential 2003-2010 Varaha Systems, Inc. Page 10 of 11

THIS DOCUMENT AND THE DATA DISCLOSED HEREIN OR HEREWITH IS PROPRIETARY AND IS NOT TO BE REPRODUCED, USED OR DISCLOSED IN WHOLE OR IN PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF VARAHA SYSTEMS. COPYRIGHT, © Varaha Systems 2010

Day IV Hands On

1. PBX Configuration

a. SIP hardware

b. SIP ports (licenses)

c. Reserve pool

d. Pilot number

i. Hunt group

ii. Maximum lines

e. Verification

2. Lab

i. uMC installation

ii. License installation

iii. uMC provisioning

iv. Client Software upload

v. User(s) provisioning

vi. OTA

vii. User testing

Title: uMobility Introduction, Installation, and Configuration

Confidential 2003-2010 Varaha Systems, Inc. Page 11 of 11

THIS DOCUMENT AND THE DATA DISCLOSED HEREIN OR HEREWITH IS PROPRIETARY AND IS NOT TO BE REPRODUCED, USED OR DISCLOSED IN WHOLE OR IN PART TO ANYONE WITHOUT THE WRITTEN PERMISSION OF VARAHA SYSTEMS. COPYRIGHT, © Varaha Systems 2010

Fannie Mae Multifamily Energy and Water Market Research Survey:

Survey Database User Manual

February 17, 2015

© Fannie Mae 2015

Contents

Fannie Mae Multifamily Energy and Water Market Research Survey: 1

Survey Database User Manual 1

Contents 2

I. Introduction 3

II. About Fannie Mae’s Green Initiative 3

III. About the Survey 4

IV. About the Survey Database 4

V. Survey Database Layout 5

VI. Additional Resources 5

VII. Survey Database Description Table 6

VIII. Appendix A: Definitions 18

Property Types 18

Resident Populations 18

Floor Areas 18

Parking Areas 19

Building Types 19

Water Use Types 20

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 2

I. Introduction

In 2012, Fannie Mae conducted the Multifamily Energy and Water Market Research Survey (the “Survey”). The goal of the Survey was to provide analytical information that could be used by the owners of multifamily properties to assist in the reduction of energy and water consumption and costs, and to minimize impact of multifamily properties on the environment. Additionally, the Survey was launched to assist the U.S. Environmental Protection Agency (EPA) in the development of the ENERGY STAR® Score for Multifamily Housing. More than 1,000 multifamily property owners and managers submitted responses describing the characteristics of their properties and providing energy and water consumption and costs from January 2011 through December 2011.

Fannie Mae shared the Survey data with EPA to explore the development of the 1-100 ENERGY STAR® Score  for Multifamily Housing1. In 2014, the EPA successfully launched the ENERGY STAR® Score based on the data in the Survey. Fannie Mae also analyzed the Survey data and published findings on energy and water consumption costs and trends in multifamily properties in the white paper, Transforming Multifamily Housing:  Fannie Mae’s Green Initiative and ENERGY STAR® for Multifamily2. The survey data and supporting documents were made publicly available in 2015 to enable further research on energy and water consumption and associated costs at multifamily properties.

This user manual provides a summary of key information about the Survey database. All identifying property information has been removed to maintain the confidentiality of those who submitted data. The database includes only the data reported at the time of the Survey; it has not been updated over time.

Fannie Mae would like to extend special thanks to the multifamily owners and property management firms who submitted data to the Survey. We are also grateful for the support for the Survey from the Urban Land Institute, the National Multifamily Housing Council, and the Commercial Real Estate Finance Council.

II. About Fannie Mae’s Green Initiative

Fannie Mae Multifamily Mortgage Business launched the Green Initiative in 2010. The mission of the Fannie Mae Multifamily Green Initiative is to enhance the quality, affordability, and environmental sustainability of multifamily housing in the United States. The Green Initiative provides leadership in the multifamily industry by offering loans for smart property improvements, and delivering innovative tools to measure and capture the value of energy and water efficiency.

Our partnership with the EPA resulted in the ENERGY STAR® Score for Multifamily Housing, a national rating system that is publicly accessible, nationally recognized, and built on statistically-based quantifiable data. Fannie Mae is proud to be an ENERGY STAR® Partner, and will continue to support the EPA and other industry partners to help increase financing options and other tools that will enhance the energy-efficiency and affordability of rental housing in the United States.

1 Information about the ENERGY STAR Score for Multifamily Housing in the United States is available at http://www.energystar.gov/buildings/tools-and-resources/energystarscoremultifamilyhousingunitedstates 

2 “Transforming Multifamily Housing: Fannie Mae’s Green Initiative and ENERGY STAR® for Multifamily” is available at www.fanniemaegreeninitiative.com 

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 3

III. About the Survey

Fannie Mae included an instructional booklet, instructions on how to request 12 months of energy and water data, and a return envelope with the original Market Research Energy and Water Survey Questionnaire. The following Survey materials are available on the Fannie Mae Green Initiative website:

* 2012 Multifamily Market Research Energy and Water Survey Questionnaire: This document includes the full text of the questions included in the Survey, as well as the multiple choice options provided for some questions.

* Instructional Booklet: This document includes detailed instructions on providing energy and water data, as well as more detailed definitions for the terms used in some of the Survey questions. This material is intended to be used in conjunction with the database and this manual.

Fannie Mae received survey response submissions from 1,163 multifamily properties. It is important to note that some properties did not provide answers to all questions on the survey, and submitted partial information on energy or water consumption, associated costs, and property characteristics. Of the total responses received, 672 properties provided energy and water data, 278 properties provided energy data only, 64 properties provided water data only, and 149 properties completed only property characteristic information and provided no energy or water data. All submissions were reviewed to identify appropriate data that was suitable for analysis and publication.

Properties that did not provide at least one of the most critical property characteristics, either square footage or the number of units, were excluded. Additionally, a number of properties provided incomplete or incorrect data for energy and water use and cost. If a property did not provide a full twelve months of energy and/or water data, the incomplete data was removed from the database. If a property provided data that represented extreme outliers for energy use, water use, or cost values, the extreme data was removed from the database.3 A total of 955 properties are included the published database, all of which were provided to the EPA for the development of the ENERGY STAR® score.

IV. About the Survey Database

To simplify the database for ease of use, Fannie Mae reviewed and, in some cases, edited data prior to publication. These changes did not impact the data used for development of the ENERGY STAR® score and the Fannie Mae white paper; only data excluded from those analyses was affected. Examples of changes include:

* Removed columns: No respondents reported energy use for survey questions about District Hot Water, District Chilled Water, Wood, Kerosene, or On-Site Electricity, so these fields were removed. Similarly, respondents were asked to report water consumption using one of twelve options for Type of Water Use (listed in Appendix A), but no respondents reported use for Alternative Water Generated On-Site or Municipally Reclaimed Water. The twelve types were consolidated into three categories based on the area served (Indoor, Outdoor, or All Uses).

* Free response options: Certain multiple choice questions in the survey allowed a free response answer in addition to the choices provided. Fannie Mae reviewed the free response answers provided and, in some cases, modified the values to enhance clarity. For example, Question 4 of the survey is a multiple choice question with the following allowable values: (i) Rental, (ii) Cooperative, (iii) Condo, (iv) None of the above (free response), and (v) More than

3 The outliers removed as part of Fannie Mae’s analysis differed from outliers applied by EPA during the development of the ENERGY STAR score for multifamily properties. Due to this and other adjustments to the data, there are slight differences between the summary statistics from the database and the survey results published in Fannie Mae’s 2014 white paper.

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 4

one of the above (free response). Based on answers to the free response options, some properties were classified as “Rental/Condo” in the database.

* Missing or incomplete data: Data for certain fields was not provided by respondents, or incomplete data was provided. Fields with missing or incomplete data were populated with “Not Provided” for text fields, and “-9999” for number fields.

V. Survey Database Layout

The survey data is available in MEWMR-Survey-Database.xlsx, a Microsoft Excel file database. The Survey Database Description Table on the following pages contains the following information about each database field:

* Column in Database: The letter of the column in the database where the field can be found.

* Field: The title of the column in the database. Fields in the table are color coded to match the Field Types in the database. Gray columns contain property characteristics data, green columns contain energy information, and light blue columns contain water information. Dark blue columns contain data that was included in development of the ENERGY STAR® Score.

* Field Type: Indicates whether the field is a property characteristic, energy characteristic, water characteristic, or included in the development of the ENERGY STAR® Score.

* Data Type: Indicates the type of information collected, including whether the data is a number or text. For text fields, a description of the type of question that was asked is provided (e.g., yes/no question, multiple choice, free response).

* Description: A detailed description of the data collected.

* Source: The source of the data. This column links to the question number in the original survey questionnaire, or indicates whether the information was derived from other responses or referenced from alternative sources.

VI. Additional Resources

To find out more:

* Green Initiative Website: www.fanniemaegreeninitiative.com 

* Green Initiative e-mail: greeninitiative@fanniemae.com 

* ENERGY STAR® Multifamily Score: http://www.energystar.gov/buildings/tools-and-resources/energystarscoremultifamilyhousingunitedstates 

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 5

VII. Survey Database Description Table

Database Column

Field

Field Type

Data Type

Description

Source

A

Property ID

Property characteristic

Number

Unique identifier assigned to each property.

Derived

B

12 months of energy data provided

Property characteristic

Text: Y/N

Indicator of whether energy data covers a full 12 months. Determined based on response to Q11 and review of energy data provided.

Derived

C

Energy Space Served

Property characteristic

Text

Space served by energy data provided. Properties were classified as providing Whole Property data, Common Space Only, or Not Providing Energy based on response to Q12.

Derived

D

12 Months of Water Data Provided

Property characteristic

Text: Y/N

Indicator of whether water data covers a full 12 months. Determined based on response to Q16 and review of water data provided.

Derived

E

Water Space Served

Property characteristic

Text

Space served by water data provided. Properties were classified as providing Indoor data, Outdoor data, Indoor/Outdoor, or Not Providing Water based on response to Q17.

Derived

F

State

Property characteristic

Text: Free Response

State where property is located.

Q1

G

Region

Property characteristic

Text

U.S. Census region associated with the state where the property is located.

Referenced

H

CDD

Property characteristic

Number

Cooling degree days (CDD). Determined by U.S. EPA based on property ZIP Code.

Referenced

I

HDD

Property characteristic

Number

Heating degree days (HDD). Determined by U.S. EPA based on property ZIP Code.

Referenced

J

Year Built (Range)

Property characteristic

Text

Year when property was built. Responses are presented as a decade range (e.g., 1961-1970, 1971-1980).

Q3

K

Primary Property

Type Present at

Your Property

Property characteristic

Text: Multiple Choice, Single Response

Property type. Allowable values: Rental, Cooperative, Condo, None of the above, and More than one of the above. Based on additional

details that were provided, some properties were classified as

“Rental/Condo.” Definitions are included in Appendix A.

Q4

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 6

Database Column

Field

Field Type

Data Type

Description

Source

L

Primary Resident population

Property characteristic

Text: Multiple Choice, Single Response

Resident population. Allowable values: No majority population/general purpose housing, Military, Student, Senior/Independent Living, Special Accessibility Needs, and Other dedicated housing that represents the

majority of the population. Based on additional details that were

provided, some properties were classified as “No majority/general purpose housing.” Definitions are included in Appendix A.

Q5

M

Government Subsidies

Property characteristic

Text: Y/N

Indicator of whether the property received one or more types of public, local state, or federal affordable housing subsidies for some or all units.

Q6

N

Utility Subsidies

Property characteristic

Text: Y/N

Indicator of whether the property or residential tenants receive a government-provided subsidy payment for utility costs.

Q7

O

Rent-controlled/rent stabilized?

Property characteristic

Text: Y/N

Indicator of whether the property is rent controlled or rent stabilized.

Q8

P

Affordable?

Property characteristic

Text

Indicator of whether a property is identified as affordable through question Q6, or based on a cross-check with Fannie Mae records. Properties are classified as Affordable or Market Rate.

Derived

Q

Green Building Certification?

Property characteristic

Text: Multiple Choice, Multiple Response

Indicator of whether green building certification was received.

Allowable values: EarthCraft, Enterprise Green Communities Criteria, Green Globes, GreenPoint, Home Energy Rating System, LEED, National Green Building Program, ENERGY STAR, and Other.

Q9

R

Fitness Center

Property characteristic

Text: Y/N

Indicator of whether there is a Fitness Center on the property.

Q13

S

Fitness Center Energy Included?

Property characteristic

Text: Y/N

Indicator of whether the energy use associated with the fitness center is included in the energy consumption data provided.

Q13a

T

Outdoor recreation area with lights?

Property characteristic

Text: Y/N

Indicator of whether there is an outdoor recreation area with lights on the property.

Q14

U

Outdoor rec lights energy included?

Property characteristic

Text: Y/N

Indicator of whether the energy use associated with the outdoor recreation areas is included in the energy consumption data provided.

Q14a

V

Unmetered water sources

Property characteristic

Text: Multiple Choice, Multiple Response

Unmetered water sources used at the property. Allowable values:

Rainwater harvesting (e.g. rain barrels, cisterns), Wells, Retention

ponds, Other, and None.

Q18

W

Total amount of

irrigated areas

Property characteristic

Number

Total amount of irrigated area. Areas that are not irrigated or are not on the property grounds have a value of 0.

Q19

X

Units for irrigated

areas

Property characteristic

Text: Multiple Choice, Single Response

Units for irrigated area reported in Q19. Allowable values: Acres and Square Footage.

Q19a

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 7

Database Column

Field

Field Type

Data Type

Description

Source

Y

Types of irrigated

areas

Property characteristic

Text: Multiple Choice, Multiple Response

Type of irrigated area. Allowable values: Garden/Shrub/Flower Beds, Trees, Open Space/Grass Lawns, and Other.

Q19b

Z

Other irrigated areas

Property characteristic

Text: Free Response

Type of irrigated area. Free response option for respondents that answered “Other” for Q19b. See above for allowable values.

Q19b

AA

Total Gross Internal Floor Area

Property characteristic

Number

Total gross internal floor area. Definitions are included in Appendix A.

Q20

AB

Common Area Floor Area

Property characteristic

Number

Common area floor area. Definitions are included in Appendix A.

Derived

Based on answer to Q22. Some respondents provided percentage values rather than square feet; these were converted to square feet.

AC

Total Gross Rentable Retail and Commercial floor area

Property

characteristic

Number

Total gross rentable retail and commercial floor area. Definitions are included in Appendix A.

Q23

AD

Total open parking floor area

Property characteristic

Number

Floor area of open parking lots. Definitions are included in Appendix A.

Q24a

AE

Total non-enclosed parking floor area

Property characteristic

Number

Floor area of non-enclosed parking. Definitions are included in

Appendix A.

Q24b

AF

Total enclosed parking floor area

Property characteristic

Number

Floor area of enclosed parking. Definitions are included in Appendix A.

Q24c

AG

Parking hours per week

Property characteristic

Number

Number of hours parking can be accessed by residents.

Q24d

AH

Presence of parking

Property characteristic

Text: Y/N

Indicator of whether parking is present. Some respondents did not

provide detailed parking area information, but confirmed the

presence/absence of parking in a follow-up question. For respondents that did not specifically answer this follow-up question, a value was determined based on Q24.

Derived

AI

Building Type

Property characteristic

Text: Multiple Choice, Single Response

Type of building. Allowable values: High-rise building, Mid-rise building, Low-rise building, Garden, Towngarden, Townhouse, Single Family, and Other. Data was collected for up to 13 building types in each property. See Appendix A for definitions.

Q25a

AJ

If other, please specify

Property

characteristic

Text: Free Response

Type of building. Free response option for respondents that answered “Other” for Q25a. See above for allowable values.

Q25a

AK

Number of buildings this applies to

Property characteristic

Number

Number of buildings associated with the building type in Q25a.

Q25b

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 8

Database Column

Field

Field Type

Data Type

Description

Source

AL

Number of floors above existing grade plan

Property

characteristic

Number

Number of floors above ground, associated with the building type in Q25a.

Q25c

AM

Number of floors below existing grade plan

Property characteristic

Number

Number of floors below ground, associated with the building type in Q25a.

Q25d

AN

Number of units

per building

Property characteristic

Number

Number of units per building, associated with the building type in Q25a. Includes every type of space livable by a resident including the super’s or manager’s apartment, model units, vacant, occupied and down units.

Q25e

AO – DH

Multiple

Property characteristic

Multiple

Repeat of fields described in Column AK-AP. Building type data was collected for up to 13 building types.

Multiple

DI

Total number of

studio units

Property characteristic

Number

Number of studio/efficiency/junior bedroom units for all the buildings on the property. Defined as having a kitchen/living area with a separate

bathroom. A junior 1 bedroom is defined as the same as a

studio/efficiency with a separate space for sleeping and is usually separated by a half wall or temporary wall.

Q26a

DJ

Total number of

1 bedroom units

Property characteristic

Number

Number of 1 bedroom units for all the buildings on the property.

Q26b

DK

Total number of

2 bedroom units

Property characteristic

Number

Number of 2 bedroom units for all the buildings on the property.

Q26c

DL

Total number of

3 bedroom units

Property characteristic

Number

Number of 3 bedroom units for all the buildings on the property.

Q26d

DM

Total number of

4 bedroom units

Property characteristic

Number

Number of 4 or more bedroom units for all the buildings on the property.

Q26e

DN

Total average physical occupancy

Property characteristic

Text

Average physical occupancy percentage for the entire property. Some respondents provided a percentage value, while others provided a range (e.g., 90-100%).

Q27

DO

Building Type

(Property Level)

Property characteristic

Text

Type of building identified for the entire property, as indicated by one of the following: High-rise, Mid-rise, Low-rise, Mixed. Determined based on the Building Type and Number of Floors provided in Q25. Low-rise properties include those that responded Garden, Townhouse, and Low-rise. Mixed was used to describe properties with no single building type.

Derived

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 9

Database Column

Field

Field Type

Data Type

Description

Source

DP

Total Number of Units

Property characteristic

Number

Number of units. Calculated based on the number of units of each configuration (e.g., studio, 1BR, 2BR, etc.) in Q26. Number of units was also provided by building type in Q25, but fewer respondents answered this question and the results were not as reliable. In some cases, respondents provided a total number of units instead of or in addition to a breakdown by bedroom configuration, in which case the total number of units was used.

Derived

DQ

Unit Range

Property characteristic

Text

Category based on the Total Number of Units. Results were classified as one of the following: 5-49, 50-99, 100-149, 150-299, or 300+ units.

Derived

DR

Unit Density

Property characteristic

Number

Number of units per thousand square feet

Derived

DS

Number of BRs

Property characteristic

Number

Total number of bedrooms. Sum of number of bedrooms in 1-bedroom units, 2-bedroom units, etc.

Derived

DT

Bedrooms/Unit

Property characteristic

Number

Total number of bedrooms divided by total number of units

Derived

DU

Average Floor

Area/Unit

Property characteristic

Number

Total gross internal floor area divided by total number of units.

Derived

DV

Pool type

Property characteristic

Text: Multiple Choice, Single Response

Type of pool. Allowable values: Recreational, Short Course, Olympic, and Other. Data was provided for up to 3 pool types in each property.

Q28a

DW

If other, please specify:

Property characteristic

Text: Free Response

Type of pool. Free response option for respondents that answered “Other” for Q28a. See above for allowable values.

Q28a

DX

Pool location

Property characteristic

Text: Multiple Choice, Single Response

Pool location. Allowable values: indoor and outdoor.

Q28b

DY

Is the pool heated?

Property characteristic

Text: Y/N

Indicator of whether the pool is heated.

Q28c

DZ

Energy consumption and cost included?

Property characteristic

Text: Y/N

Indicator of whether energy consumption and cost for the pool were included in the data provided.

Q28d

EA

Water consumption and cost included?

Property characteristic

Text: Y/N

Indicator of whether water consumption and cost for the pool were included in the data provided.

Q28e

EB

Number of months in use in 2011

Property characteristic

Number

Number of months the pool was in use in 2011.

Q28f

EC

How many pools does this apply to?

Property characteristic

Number

Number of pools associated with the building type in Q85a.

Derived

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 10

Database Column

Field

Field Type

Data Type

Description

Source

ED-ES

Multiple

Property characteristic

Multiple

Repeat of fields described in Column DX-EE. Pool data was provided for up to 3 pool types.

Multiple

ET

Presence of a pool

Property characteristic

Text: Y/N

Indicator of whether a pool is present. Some respondents did not provide detailed pool information, but confirmed the presence/absence

of a pool in a follow-up question. For respondents that did not

specifically answer this follow-up question, a value was determined based on Q28.

Derived

EU

Number of Dishwasher Hookups

Property characteristic

Number

Number of dishwasher hookups for all of buildings on the property

(rental units, common buildings commercial/retail space). Includes

inoperable and operable units.

Q29a

EV

Presence of a Dishwasher

Property characteristic

Text: Y/N

Indicator of whether dishwashers are present. Some respondents did

not provide detailed dishwasher information, but did confirm the

presence/absence of dishwashers in a follow-up question. For

respondents that did not specifically answer this follow-up question, a value was determined based on Q29a.

Derived

EW

Location of Dishwashers

Property characteristic

Text: Multiple choice, Single Response

Location of dishwashers. Some respondents did not provide detailed dishwasher information, but did provide location information in a follow

up multiple choice question. Allowable values: Residential, Common

Area, Residential and Common Area. For respondents that did not specifically answer this follow-up question, a value was determined based on Q29b.

Derived

EX

Number of Laundry Hookups

Property characteristic

Number

Number of laundry hookups for all of the buildings on the property. Includes both pay-per-use and free washer, dryer or combination units with a unique plug.

Q29b

EY

Presence of Laundry Hookups

Property characteristic

Text: Y/N

Indicator of whether laundry hookups are present. Some respondents did not provide detailed laundry hookup information but did confirm the presence/absence of laundry hookups in a follow-up question. For respondents that did not specifically answer this follow-up question, a value was determined based on Q29b.

Derived

EZ

Location of Laundry Hookups

Property characteristic

Text: Multiple Choice, Single Response

Location of laundry hookups. Some respondents did not provide

detailed laundry hook up information but did provide location

information in a follow-up multiple choice question. Allowable values: Residential, Common Area, Residential and Common Area, and Not Determined. For respondents that did not specifically answer this follow-up question, a value was determined based on Q29b.

Derived

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 11

Database Column

Field

Field Type

Data Type

Description

Source

FA

Number of Elevators

Property characteristic

Number

Number of elevators at the property. Includes penthouse and freight elevators.

Q29c

FB

Number of resident bathrooms

Property characteristic

Number

Number of resident bathrooms at the property. Includes both half and full in residential units.

Q29d

FC

Common area restrooms

Property characteristic

Number

Number of common area restrooms at the property. Half bathrooms counted as 1 full bathroom.

Q29e

FD

Total number of

computers in

common area

Property characteristic

Number

Number of computers at the property. Includes leasing and business centers and retail/commercial space and all computers in staff and common area spaces.

Q29f

FE

Presences of on-site commercial cooking

Property characteristic

Text: Y/N

Indicator of whether on-site commercial cooking is present, such as a restaurant or dining facility.

Q30

FF

Number of walk-in refrigeration/freezer units

Property

characteristic

Number

Number of walk-in refrigeration/freezer units at the property. Defined as large units used to store refrigerated goods which a person can walk into.

Q30a

FG

Percentage of all

residential units

have kitchens

Property characteristic

Number

The percentage of all residential units that have kitchens. Includes kitchen that have a stove top/cook top, at least one cupboard, small counter space, any size refrigerator and a sink (separate from the bathroom sink).

Q31

FH

Percent of gross floor area that is heated

Property characteristic

Text

Percent of gross indoor floor area that is heated by mechanical heating equipment. Some respondents provided a percentage value, while others provided a range (e.g., 90-100%).

Q32a

FI

Percent of gross floor area that is cooled

Property characteristic

Text

Percent of gross indoor floor area that is cooled by mechanical cooling equipment. Some respondents provided a percentage value, while others provided a range (e.g., 90-100%).

Q32b

FJ

Who pays hot water?

Property characteristic

Text: Multiple Choice, Single Response

Who pays for hot water costs? Allowable values include: Tenant-

directly or individually metered, Owner--master metered or invoiced, Tenant through Ratio Utility Billing System (RUBS), and Other.

Q33a

FK

Who pays plug load?

Property characteristic

Text: Multiple Choice, Single Response

Who pays for plug load? Allowable values include: Tenant--directly or

individually metered, Owner--master metered or invoiced, Tenant

through Ratio Utility Billing System (RUBS), and Other.

Q33b

FL

Who pays cooling?

Property characteristic

Text: Multiple Choice, Single Response

Who pays for cooling costs? Allowable values include: Tenant--directly or individually metered, Owner--master metered or invoiced, Tenant through Ratio Utility Billing System (RUBS), and Other.

Q33c

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 12

Database Column

Field

Field Type

Data Type

Description

Source

FM

Who pays heating system?

Property characteristic

Text: Multiple Choice, Single Response

Who pays for heating costs? Allowable values include: Tenant-

directly or individually metered, Owner--master metered or invoiced, Tenant through Ratio Utility Billing System (RUBS), and Other.

Q33d

FN

Residential hot water system

Property characteristic

Text: Multiple Choice, Single Response

Type of hot water system that supplies the residential units. Allowable values: Combined with Heating Boiler, Domestic Hot Water heater tank (standard), Domestic Hot Water heater tank (condensing), Domestic Hot Water heater heat pump, Domestic Hot Water heater central tankless, Hot Water heater point of use tankless, Central steam heat exchanger, Solar thermal (if more than 50% of the DHW load), Co-generation/Combined Heat and Power, and Other.

Q34

FO

Other hot water system

Property characteristic

Text: Free Response

Type of hot water system. Free response option for respondents that answered “Other” for Q34. See above for allowable values.

Q34

FP

Primary hot water fuel type

Property characteristic

Text: Multiple choice, Single Response

The primary hot water fuel type used to heat domestic water for the

resident units. Allowable values: Electricity, Natural Gas,

Propane/Liquid Propane, District Hot Water, District Steam, Fuel Oil No. 1 and No. 2, Fuel Oil No. 4, Fuel Oil No. 5 and No. 6, Coal (anthracite, bituminous), Kerosene, Wood/Wood Pellets, Solar, Other (ex: coke).

Q34a

FQ

Other hot water

fuel type

Property characteristic

Text: Free Response

The primary hot water type used to heat domestic water for the residents. Free response for respondents that answered “Other” for Q34a. See above for allowable values.

Q34a

FR

Residential cooling system

Property characteristic

Text: Multiple Choice, Single Response

The type of cooling system used by residential units. Allowable values: Window A/C, Thru the Wall A/C, Individual Split System (air source heat pump), Individual Split System (ground source/geothermal heat pump), Ductless Split System, Central System—Electric Chiller—Air

Cooled, Central System—Electric Chiller—Water Cooled, Central

System—Absorption Chiller, Conventional Water Source Heat Pumps with Cooling Tower, Other, and No cooling system.

Q35

FS

Other cooling system

Property characteristic

Text: Free Response

The type of cooling system used by residential units. Free response for respondents that answered “Other” for Q35. See above for allowable values.

Q35

FT

Presence of commercial cooling tower

Property characteristic

Text: Y/N

If a property has a commercial cooling tower.

Q36

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 13

Database Column

Field

Field Type

Data Type

Description

Source

FU

Residential heating system

Property characteristic

Text (Multiple Choice)

The type of heating system used in residential units. Allowable values: Forced Air Furnace, Hot Water Boiler—Radiator/Baseboard, Hot Water

Boiler—Fan Coil/PTAC, Steam Boiler to Hot Water—

Baseboard/Radiator, Steam Boiler to Hot Water—Fan Coil/PTAC,

Steam—1-pipe, Steam—2-pipe, Heat Pump—Air Source, Heat

Pump—Ground Source, Electric Resistance, Individual Split System

(air source heat pump), Individual Split System (ground

source/geothermal heat pump), Heating stove burning wood, coal or coke, Portable electric heaters, Portable kerosene heaters, Fireplace, and Other.

Q37

FV

Other residential

heating system

Property characteristic

Text: Multiple Choice, Single Response

The type of heating system used in residential units. Free response for respondents that answered “Other” for Q37. See above for allowable values.

Q37

FW

Renovation 1 (year):

Property characteristic

Number

Year the last major renovation was completed.

Q38

FX

Type of renovation

Property characteristic

Text: Multiple Choice, Multiple Response

Type of renovation that took place. Allowable values: Cosmetic

(Kitchen cabinets, flooring, countertops, wall coverings, etc.), Envelope

(Doors, windows, roof, siding, insulation), Mechanical, Electrical,

Plumbing—Central Plant (HVAC), Mechanical, Electrical, Plumbing— Tenant Units (Lighting, appliances, plumbing fixtures), and Other.

Q38a

FY

Other type of

renovation

Property characteristic

Text: Free Response

The type of renovation that took place. Free response for respondents that answered “Other” for Q38a. See above for allowable values.

Q38a

FZ

Renovation of Energy Systems

Property characteristic

Text: Y/N

Indicator of whether renovations occurred that affected energy use. Properties with either no renovations or only cosmetic renovations were designated as having no renovations that affected energy use.

Derived

GA

Electricity: Site kBtu

Energy

characteristic

Number

Annual reported electricity use in Site kBtu. Calculated from the total annual use reported across all electricity meters, in the billing units provided, converted to kBtu.

Derived

GB

Electricity: Source kBtu

Energy

characteristic

Number

Annual reported electricity use in Source kBtu. Calculated by

multiplying the Electricity Site kBtu by 3.14, the source-site conversion factor for electricity.

Derived

GC

Electricity: Cost

Energy

characteristic

Number

Annual reported electricity cost. Calculated from the total annual cost reported across all electricity meters.

Derived

GD

Natural Gas: Site kBtu

Energy

characteristic

Number

Annual reported natural gas use in Site kBtu. Calculated from the total annual use reported across all natural gas meters, in the billing units provided, converted to kBtu.

Derived

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 14

Database Column

Field

Field Type

Data Type

Description

Source

GE

Natural Gas: Source kBtu

Energy

characteristic

Number

Annual reported natural gas use in Source kBtu. Calculated by

multiplying the Natural Gas Site kBtu by 1.05, the source-site

conversion factor for natural gas.

Derived

GF

Natural Gas: Cost

Energy

characteristic

Number

Annual reported natural gas cost. Calculated from the total annual cost reported across all natural gas meters.

Derived

GG

Fuel Oil: Site kBtu

Energy

characteristic

Number

Annual reported fuel oil use in Site kBtu. Calculated from the total annual use reported across all fuel oil meters, in the billing units provided, converted to kBtu.

Derived

GH

Fuel Oil: Type

Energy

characteristic

Number

Type of fuel oil. Indicated when selecting the fuel type for each energy meter. Allowable values: No.1, No.2, No. 4, No. 5 and No.6.

Derived

GI

Fuel Oil: Source kBtu

Energy

characteristic

Number

Annual reported fuel oil use in Source kBtu. Calculated by multiplying the Fuel Oil Site kBtu by 1.01, the source-site conversion factor for fuel oil.

Derived

GJ

Fuel Oil: Cost

Energy

characteristic

Number

Annual reported fuel oil cost. Calculated from the total annual cost reported across all fuel oil meters.

Derived

GK

District Steam:

Site kBtu

Energy

characteristic

Number

Annual reported district steam use in Site kBtu. Calculated from the total annual use reported across all district steam meters, in the billing units provided, converted to kBtu.

Derived

GL

District Steam:

Source kBtu

Energy

characteristic

Number

Annual reported district steam use in Source kBtu. Calculated by

multiplying the District Steam Site kBtu by 1.20, the source-site

conversion factor for district steam.

Derived

GM

District Steam: Cost

Energy

characteristic

Number

Annual reported district steam cost. Calculated from the total annual cost reported across all district steam meters.

Derived

GN

Other: Site kBtu

Energy

characteristic

Number

Annual reported other energy use in Site kBtu. Calculated from the total annual use reported across all other meters, in the billing units provided, converted to kBtu.

Derived

GO

Other: Source kBtu

Energy

characteristic

Number

Annual reported other energy use in Source kBtu. Calculated by multiplying the Other Site kBtu by the source-site conversion factor for the applicable fuel.

Derived

GP

Other: Cost

Energy

characteristic

Number

Annual reported other energy cost. Calculated from the total annual cost reported across all Other meters.

Derived

GQ

Total: Site kBtu

Energy

characteristic

Number

Total Site kBtu summed across all fuel types.

Derived

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 15

Database Column

Field

Field Type

Data Type

Description

Source

GR

Total: Source kBtu

Energy

characteristic

Number

Total Source kBtu summed across all fuel types.

Derived

GS

Total: Cost

Energy

characteristic

Number

Total Cost summed across all fuel types.

Derived

GT

Site EUI

Energy

characteristic

Number

Total Site kBtu divided by Total gross floor area.

Derived

GU

Source EUI

Energy

characteristic

Number

Total Source kBtu divided by Total gross floor area.

Derived

GV

Site Energy/Unit (kBtu/Unit)

Energy

characteristic

Number

Total Site kBtu divided by Number of Units. Calculated if unit

information was provided.

Derived

GW

Source Energy/Unit (kBtu/Unit)

Energy

characteristic

Number

Total Source kBtu divided by Number of Units. Calculated if unit information was provided.

Derived

GX

Energy Cost ($)/sq. ft.

Energy

characteristic

Number

Total Cost divided by Total gross floor area.

Derived

GY

Energy Cost ($)/Unit

Energy

characteristic

Number

Total Cost divided by Total Number of Units. Calculated if unit

information was provided.

Derived

GZ

Indoor Use Meters: Gallons

Water

characteristic

Number

Annual reported water use for Indoor Use meters in gallons. Calculated from the total annual use reported across all Indoor Use water meters (Types 01, 02, 03, and 04 in Appendix A), in the billing units provided, converted to gallons.

Derived

HA

Indoor Use Meters: Cost

Water

characteristic

Number

Annual reported water cost for Indoor Use meters. Calculated from the total annual cost reported across all Indoor Use water meters (Types 01, 02, 03, and 04 in Appendix A).

Derived

HB

Outdoor Use Meters: Gallons

Water

characteristic

Number

Annual reported water use for Outdoor Use meters in gallons. Calculated from the total annual use reported across all Outdoor Use water meters (Types 05, 06, 07, and 08 in Appendix A), in the billing units provided, converted to gallons.

Derived

HC

Outdoor Use Meters: Cost

Water

characteristic

Number

Annual reported water cost for Outdoor Use meters. Calculated from the total annual cost reported across all Outdoor Use water meters (Types 05, 06, 07, and 08 in Appendix A).

Derived

HD

All Uses Meters: Gallons

Water

characteristic

Number

Annual reported water use for All Uses meters in gallons. Calculated from the total annual use reported across all All Uses water meters (Types 09, 10, 11, and 12 in Appendix A), in the billing units provided, converted to gallons.

Derived

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 16

Database Column

Field

Field Type

Data Type

Description

Source

HE

All Uses Meters:

Cost

Water

characteristic

Number

Annual reported water cost for All Uses meters. Calculated from the total annual cost reported across all All Uses water meters (Types 09, 10, 11, and 12 in Appendix A).

Derived

HF

Total Water Use (Gal)

Water

characteristic

Number

Total Water Use summed across all water meters.

Derived

HG

Total Water Use Intensity (gal/sq. ft.)

Water

characteristic

Number

Total Water Use divided by Total gross floor area.

Derived

HH

Total Water (gal/unit/day)

Water

characteristic

Number

Total Water Use divided by Number of Units divided by 365 days per year.

Derived

HI

Total Water Cost

Water

characteristic

Number

Total Water Cost summed across all water meters.

Derived

HJ

Water Cost ($/sq. ft.)

Water

characteristic

Number

Total Water Cost divided by Total gross floor area.

Derived

HK

Water Cost ($/Unit)

Water

characteristic

Number

Total Water Cost divided by Number of Units.

Derived

HL

Analyzed in ENERGY STAR Score for Multifamily

ENERGY STAR Score

Text: Y/N

Properties marked as ‘Y’ were analyzed and included in the model to create the ENERGY STAR Score for Multifamily Properties.

Referenced

HM

Survey Weights for ENERGY STAR Score Analysis

ENERGY STAR Score

Number

Weighted values for properties that were analyzed and included in the model to create the ENERGY STAR Score for multifamily properties. Survey weights were constructed by EPA to account for stratification in the survey sample, and were based on the region and number of units. More information is available in the Technical Reference: ENERGY

Referenced

STAR Score for Multifamily Housing.

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 17

VIII. Appendix A: Definitions

This section provides definitions for terms used in the Survey documents. These definitions can also be found in the Survey Instructional Booklet that accompanied the original 2012 Survey.

Property Types

* Rental: A building with more than four units in which tenants make a monthly payment and have no title to the unit where they reside.

* Cooperative or Co-op: A residential or mixed-use building wherein a corporation or trust holds title to a group of housing units and the common areas for the use of all the residents. The individual participants own a share in the cooperative which entitles them to occupy an apartment as if they were owners, to have equal access to the common areas, and to vote for members of the Board of Directors which manages the cooperative.

* Condo: A building with a form of property ownership where the purchaser receives title to a unit in a multi-unit building and a proportionate share in common areas.

Resident Populations

* No majority population/general purpose housing: The property is not inhabited by any dedicated population. This includes properties that are primarily occupied by single individuals and families.

* Military Housing: A multifamily rental property in which the units are occupied by persons serving in or employed by the military or that is located in an area where military and military related employment accounts for 20 percent or greater of the local employment base.

* Student Housing: A multifamily rental property in which the units are leased to undergraduate and/or graduate students.

* Senior/Independent Living Housing: Rental properties restricted to the elderly that also provide limited programs of assistance with domestic activities (meals, housekeeping, activities, transportation, etc.). Typically, a unit in an Independent Living Community resembles a standard market unit. Independent Living Communities generally are not licensed and generally do not provide assistance with Activities of Daily Living (ADLs) or healthcare. Activities of Daily Living (ADLs) are services provided in connection with the management of medications and assistance with bathing, dressing, toileting, ambulating, eating, and other similar activities.

* Special Accessibility Needs: Residents living in the property are covered by the American Disabilities Act.

Floor Areas

* Gross internal floor area: Measured between the principal exterior surfaces of the enclosing fixed walls of all buildings. Include all common area spaces, residential tenant units, and basements (livable and non- livable by tenants), and also rentable square footage of retail and commercial spaces. If numbers were not readily available, respondents were guided to consult building drawings and blue prints, use a measuring wheel to measure units, and add the rentable square footage and common area square footage.

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 18

* Common area spaces: Includes engineering rooms, utility closets, hallways, stairways, connecting corridors between buildings, community rooms, staff offices, lobbies, atria, entryways, cafeterias, kitchens in shared recreation/community rooms, storage areas, elevator shafts, indoor pools, fitness rooms, lounges, and enclosed tennis courts. Does not include any floor space that is located within any occupied or unoccupied apartment, or retail/commercial spaces.

* Retail and commercial space: Sum of the retail and commercial tenant space in the building(s) on a property.

Parking Areas

For all parking area questions, respondents were instructed to not include floor area estimates. Respondents were guided to verify parking floor area by obtaining information from building blue prints, resurfacing project reports, using a measuring wheel, or by counting parking spaces and accounting for driving lanes. Estimating based on aerial photographs, such as from Google Earth, was not recommended.

* Open parking: An area without a solid roof, walls and ventilation. Open parking does include partially enclosed spaces such as a surface lot with sun shades or tin roofing with a light.

* Non-enclosed parking: An area with an overhead covering but no walls and no ventilation requirements. It includes a multilevel parking structure that requires light during daytime hours.

* Enclosed parking: An area with an overhead covering, walls and ventilation requirements. This is typically an underground garage. “Tuck under” parking is considered fully enclosed.

Building Types

* High-rise building: A single structure of ten or more stories containing five or more separate dwelling units.

* Mid-rise building: A single structure of five to nine stories containing five or more separate dwelling units.

* Low-rise building: A single structure of one to four stories containing five or more separate dwelling units.

* Garden: One structure of one to four stories containing five or more separate dwelling units that is part of a group of buildings that surround at least one lawn or courtyard.

* Towngarden: One structure in a series of attached structures, each of which contain one to four stories and one to four separate dwelling units, that is part of a group of buildings that surround at least one lawn or courtyard.

* Townhouse: One structure in a series of attached structures, each of which contain one to four stories and one to four separate dwelling units.

* Single family home: An individual, detached structure of one to four stories containing one to four separate dwelling units.

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 19

Water Use Types

?

01

Municipally Supplied Potable Water – Indoor Use

?

02

Municipally Supplied Reclaimed Water – Indoor Use

?

03

Alternative Water Generated On-Site – Indoor Use

?

04

Other – Indoor Use

?

05

Municipally Supplied Potable Water – Outdoor Use

?

06

Municipally Supplied Reclaimed Water – Outdoor Use

?

07

Alternative Water Generated On-Site – Outdoor Use

?

08

Other – Outdoor Use

?

09

Municipally Supplied Potable Water – All Uses

?

10

Municipally Supplied Reclaimed Water – All Uses

?

11

Alternative Water Generated On-Site – All Uses

?

12

Other – All Uses

© 2015 Fannie Mae. Trademarks of Fannie Mae. 2/17/2015 20