Sol_-_OAA-14-000041_SCMS_QA.pdf

1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES

UNDER DPAS (15 CFR 700)

2. CONTRACT NUMBER 3. SOLICITATION NUMBER 4. TYPE OF SOLICITATION 5. DATE ISSUED 6. REQUISITION/PURCHASE NUMBER

SEALED BID (IFB) June 29, 2007

NEGOTIATED (RFP)

7. ISSUED BY

U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT

OFFICE OF ACQUISITION AND ASSISTANCE

M/OAA/GH SA-44 Building 301 4th Street, SW.

WASHINGTON, DC 20547

CODE 8. ADDRESS OFFER TO (If other than Item 7)

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

9. Sealed offers in original and See section L___________________ copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if hand carried, in the depository located in

Until local time ______________________ (Hour)

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L. All Offers are subject to all terms and conditions contained in this solicitation.

A. NAME B. TELEPHONE (NO COLLECT CALLS) C. E-MAIL ADDRESS

AREA CODE NUMBER EXT.

qaq@usaid.gov

(X) SEC. DESCRIPTION PAGE(S) (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

A X SOLICITATION/CONTRACT FORM x I CONTRACT CLAUSES

X B SUPPLIES OR SERVICES AND PRICES/COSTS PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT x J LIST OF ATTACHMENTS

X D PACKAGING AND MARKING PART IV - REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE x

X F DELIVERIES OR PERFORMANCE

X G CONTRACT ADMINISTRATION DATA x L INSTR., CONDS., AND NOTICES TO OFFERORS

X H SPECIAL CONTRACT REQUIREMENTS x M EVALUATION FACTORS FOR AWARD

K

REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within ________ calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT 10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS (%)

(See Section I, Clause No. 52-232-8)

14. ACKNOWLEDGEMENT OF AMENDMENTS AMENDMENT NO. DATE AMENDMENT NO. DATE

(The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated:

CODE FACILITY

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER15A. NAME AND

ADDRESS

OF OFFEROR

(Type or print)

15B. TELEPHONE NUMBER 17. SIGNATURE 18. OFFER DATE

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS IS DIFFERENT FROM

ABOVE - ENTER SUCH ADDRESS IN SCHEDULE

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: 23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM (4 copies unless otherwise specified)

10 U.S.C. 2304(a) ( ) 41 U.S.C. 253(c) ( )

24. ADMINISTERED BY (If other than Item 7) 25. PAYMENT WILL BE MADE BYCODE CODE

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

(Signature of Contracting Officer)

(REV. 9-97)

10. FOR INFORMATION CALL:

Artaveya J. Carter 202 567-5325

11. TABLE OF CONTENTS

STANDARD FORM 33

SOLICITATION, OFFER AND AWARD

SOLICITATION

OFFER (Must be fully completed by offeror)

AWARD (To be completed by Government)

N/A 1 105

SOL-OAA-14-000041

X

See Attached Table of Contents

RFP No. SOL-OAA-14-000041

Table of Contents

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICE/COSTS

B.1 PURPOSE

B.2 CONTRACT TYPE

B.3 ESTIMATED COST, FIXED FEE, AND OBLIGATED AMOUNT

B.4 PRICE SCHEDULE

B.5 COST REIMBURSABLE

B.6 INDIRECT COSTS :

B.7 CEILING ON INDIRECT COST RATES AND FINAL REIMBURSEMENT FOR

INDIRECT COSTS

B.8 SUBCONTRACTORS

[END OF SECTION B]

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C.1 Statement of Work C.2 – Objective and Guiding Principles C.3 – Scope of Work (SOW) C.4 Detailed Technical Specifications C.4.1: Objective 1: Quality Assurance C.4.2 Objective 2: Quality Control C.4.3. Objective 3: Technical Leadership/Technical Assistance C.4.4 Objective 4: Collaboration

[END OF SECTION C]

SECTION D - PACKAGING AND MARKING

D.1 AIDAR 752.7009 MARKING (JAN 1993)

D.2 MARKING AND BRANDING POLICY

[END OF SECTION D]

SECTION E - INSPECTION AND ACCEPTANCE

E.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

E.2 INSPECTION AND ACCEPTANCE

[END OF SECTION E]

SECTION F - DELIVERIES OR PERFORMANCE

F.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

F.2 PERIOD OF PERFORMANCE

F.3 PERFORMANCE STANDARDS

F.4 REPORTS AND DELIVERABLES OR OUTPUTS

F.5 KEY PERSONNEL

F.6 AIDAR 752.7005 SUBMISSION REQUIREMENTS FOR DEVELOPMENT

EXPERIENCE DOCUMENTS (September 2013)

F.7 AIDAR 752.242-70 PERIODIC PROGRESS REPORTS (OCT 2007)

F.8 PLACE OF PERFORMANCE

F.9 AUTHORIZED WORK WEEK

F.10 LEVEL OF EFFORT (COST PLUS FIXED FEE)

[END OF SECTION F]

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 AIDAR 752.7003 DOCUMENTATION FOR PAYMENT (NOV 1998)

G.2 ADMINISTRATIVE CONTRACTING OFFICE

G.3 CONTRACTING OFFICER’S REPRESENTATIVE (COR)

G.4 TECHNICAL DIRECTIONS / RELATIONSHIP WITH USAID

G.5 ACCEPTANCE AND APPROVAL

G.6 PAYING OFFICE

G.7 ACCOUNTING AND APPROPRIATION DATA

G.8 CONTRACTOR'S PAYMENT ADDRESS

G.9 CONTRACTOR’S PRIMARY POINT OF CONTACT

[END OF SECTION G]

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

H.2 AIDAR 752.7004 EMERGENCY LOCATOR INFORMATION (JUL 1997)

H.3 AIDAR 752.225-70 SOURCE AND NATIONALITY REQUIREMENTS (FEB 2012) ... 47

H.4 INSURANCE AND SERVICES

H.5 AUTHORIZED GEOGRAPHIC CODE

H.6 NONEXPENDABLE PROPERTY PURCHASES AND INFORMATION TECHNOLOGY

RESOURCES

H.7 AIDAR 752.7007 PERSONNEL COMPENSATION (JUL 2007)

H.8 ADDITIONAL REQUIREMENTS FOR PERSONNEL COMPENSATION

H.9 EMPLOYMENT COSTS OF THIRD COUNTRY NATIONALS AND COOPERATING

COUNTRY NATIONALS

H.10 LOGISTIC SUPPORT

H.11 LANGUAGE REQUIREMENTS

H.12 EXECUTIVE ORDER ON TERRORISM FINANCING (MARCH 2002)

H.13 REPORTING OF FOREIGN TAXES (JULY 2007)

H.14 USAID DISABILITY POLICY - ACQUISITION (DECEMBER 2004)

H.15 HOMELAND SECURITY PRESIDENTIAL DIRECTIVE-12 (HSPD-12) (September

2006)

H.16 FOREIGN GOVERNMENT DELEGATIONS TO INTERNATIONAL CONFERENCES

(JAN 2002)

H.17 ORGANIZATIONS ELIGIBLE FOR ASSISTANCE (ACQUISITION) (JUNE 2005)

H.18 CONSCIENCE CLAUSE IMPLEMENTATION (ACQUISITION) – SOLICITATION .. 53

H.19 CONDOMS (ACQUISITION) (JUNE 2005)

H.20 PROHIBITION ON THE PROMOTION OR ADVOCACY OF THE

H.21 SUBCONTRACTING PLAN AND THE SF 294 - SUBCONTRACTING REPORT FOR

INDIVIDUAL CONTRACTS AND SF 295 - SUMMARY CONTRACTING REPORT

AND THE ELECTRONIC SUBCONTRACTING REPORTING SYSTEM (eSRS)

H.22 SUBCONTRACTING CONSENT

H.23 SMALL DISADVANTAGED BUSINESS (SDB) PARTICIPATION PROGRAM

TARGET

H.24 NONDISCRIMINATION (June 2012)

H.25 COMPLIANCE WITH SECTION 508 OF THE REHABILITATION ACT OF 1973,

H.26 ORGANIZATIONAL CONFLICTS OF INTEREST: PRECLUSION FROM

[END OF SECTION H]

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

I.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

I.2 52.203-13 CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT

I.3 52.209-9 UPDATES OF PUBLICLY AVAILABLE INFORMATION REGARDING

RESPONSIBILITY MATTERS (JUL 2013)

I.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

I.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

I.6 52.222-50 Combating Trafficking in Persons (Feb 2009) I.7 52.232-22 Limitation of Funds (Apr 1984)

I.8 52.232.99 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS (DEVIATION) (AUG 2012)

I.9 52.247-67 SUBMISSION OF TRANSPORTATION DOCUMENTS FOR AUDIT (FEB

2006)

I.10 AIDAR 752.242-70 PERIODIC PROGRESS REPORTS (JULY 1998)

I.11 AIDAR 752.7032 INTERNATIONAL TRAVEL APPROVAL AND NOTIFICATION69

[END OF SECTION I]

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

[END OF SECTION J]

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF

OFFERORS

K.1 NOTICE LISTING SOLICITATION PROVISIONS INCORPORATED BY REFERENCE72

K.2 52.204-8 annual representations and certifications (Jul 2013) K.3 52.209-7 Information Regarding Responsibility Matters (Jul 2013)

K.4 52.230-1 COST ACCOUNTING STANDARDS NOTICES AND CERTIFICATION (MAY

2012)

K.5 52.230-7 PROPOSAL DISCLOSURE--COST ACCOUNTING PRACTICE CHANGES

(APR 2005)

K.6 INSURANCE - IMMUNITY FROM TORT LIABILITY

K.7 MENTOR-PROTÉGÉ PROGRAM – AIDAR 719.273, THE UNITED STATES AGENCY

FOR INTERNATIONAL DEVELOPMENT (USAID) MENTOR-PROTÉGÉ PROGRAM80

K.8 AGREEMENT ON, OR EXCEPTIONS TO, TERMS AND CONDITIONS

K.9 AUTHORIZED NEGOTIATORS

K.10 DATA UNIVERSAL NUMBERING SYSTEM (DUNS) NUMBER

K.11 CONTRACTOR PURCHASING SYSTEM REVIEW

K.12 PROPERTY ADMINISTRATION SYSTEM REVIEW

K.13 SIGNATURE

[END OF SECTION K]

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

L.1 NOTICE LISTING SOLICITATION PROVISIONS INCORPORATED BY REFERENCE82

L.2 52.215-1 INSTRUCTIONS TO OFFERORS—COMPETITIVE ACQUISITION (JAN

2004)

L.3 52.216-1 TYPE OF CONTRACT (APR 1984)

L.4 52.233-2 SERVICE OF PROTEST (SEP 2006)

L.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

L.6 GENERAL INSTRUCTIONS TO OFFERORS

L.7 INSTRUCTIONS FOR THE PREPARATION OF THE TECHNICAL PROPOSAL

L.8 INSTRUCTIONS FOR THE PREPARATION OF THE COST PROPOSAL (CPFF)

[END OF SECTION L]

SECTION M - EVALUATION FACTORS FOR AWARD

M.1 NOTICE LISTING SOLICITATION PROVISIONS INCORPORATED BY REFERENCE100

M.2 GENERAL INFORMATION

M.3 EVALUATION CRITERIA

M.4 COST EVALUATION

M.5 DETERMINATION OF COMPETITIVE RANGE

M.6 SOURCE SELECTION

M.7 CONTRACTING WITH SMALL BUSINESS CONCERNS AND DISADVANTAGED

ENTERPRISES

[END OF SECTION M]

Acronym List

API Active Pharmaceutical Ingredient ARV Antiretroviral drug BI Business Intelligence BP British Pharmacopoeia CDC Centers for Disease Control and Prevention CHAI Clinton Health Access Initiative COA Certificates of Analysis COC Certificates of Conformance COR Contracting Officer Representative CSL Commodities, Security and Logistics GDP Good Distribution Practices GF Global Fund GH Global Health GLP Good Laboratory Practices GMP Good Manufacturing Practices HIDN Office of Health, Infectious Diseases and Nutrition HIV/AIDS Human Immunodeficiency Virus /Acquired Immunodeficiency Syndrome IP International Pharmacopoeia IDIQ Indefinite Quality, Indefinite Delivery Contract ISO International Organization of Standardization ITN Insecticide Treated Bednets IUD Intrauterine Device NDRA National Drug Regulatory Authority NGO Non-governmental Organization OHA Office of HIV/AIDS OHS Office of Health of Health Systems Strengthening OOS Out of Specification PEPFAR President’s Emergency Plan for AIDS Relief PMI President’s Malaria Initiative PQM Promoting the Quality of Medicines PRH Office of Population and Reproductive Health PTA Preventive Technologies Agreement PV Pharmacovigilance QA Quality Assurance QAP Quality Assurance Program QC Quality Control RDT Rapid Diagnostic Test RTK Rapid Test Kit (USAID specific terminology for HIV RDT) RUTF Ready to Use Therapeutic Food SCH Supply Chain for Health SCMS Supply Chain Management Systems SIAPS System for Improved Access to Pharmaceuticals and Services SOPs Standard Operating Procedures SOW Scope of Work SRA Stringent Regulatory Agency TB Tuberculosis UNFPA United Nations Population Fund UNAIDS Joint United Nations Programme on HIV/AIDS UNICEF United Nations Children's Fund

USAID United States Agency for International Development USFDA United States Food and Drug Administration USG United States Government USP United States Pharmacopoeia VMMC Volunteer Male Medical Circumcision WHO World Health Organization WHO MQAS World Health Organization Model Quality Assurance System WHO PQP World Health Organization Prequalification Program

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICE/COSTS

B.1 PURPOSE

The purpose of this contract is to provide the services in the Scope of Work (SOW) specified in Section C for USAID’s Global Health Supply Chain-Quality Assurance Program.

B.2 CONTRACT TYPE

This is a Cost-Plus-Fixed-Fee (CPFF) term contract. For the consideration set forth below, the Contractor shall provide the results, deliverables or outputs described in Section C and F in accordance with the performance standards specified in Section C.

B.3 ESTIMATED COST, FIXED FEE, AND OBLIGATED AMOUNT

(a) The estimated cost for the performance of the work required hereunder, exclusive of fixed fee, if any, is TBD at time of award. The fixed fee, if any, is TBD at time of award. The estimated cost plus fixed fee, if any, is TBD.

(b) Within the estimated cost plus fixed fee (if any) specified in paragraph (a) above, the amount currently obligated and available for reimbursement of allowable costs incurred by the Contractor (and payment of fee, if any) for performance hereunder is TBD at time of award. The Contractor shall not exceed the aforesaid obligated amount.

(c) Funds obligated hereunder are anticipated to be sufficient through TBD at time of award.

B.4 PRICE SCHEDULE

As the period of performance for this contract is five years with one (1), three (3) year option period, the Contract Line Item Number (CLIN) budget structure must be broken out into the base and option periods.

Contract Line Item Numbers (CLINs)

CLIN 0001 (Contract Years 1through5)

0001a Total Estimated Cost $TBD 0001b Fixed Fee $TBD 0001c Total Estimated Cost plus Fixed Fee $TBD

CLIN 0002 (Contract Years 6 through 8- OPTION) 0002a Total Estimated Cost $TBD 0002b Fixed Fee $TBD 0002c Total Estimated Cost plus Fixed Fee $TBD

B.5 COST REIMBURSABLE

The U.S. dollar costs allowable shall be limited to reasonable, allocable and necessary costs determined in accordance with FAR 52.216-7, Allowable Cost and Payment, FAR 52.216-8, Fixed Fee, if applicable, and AIDAR 752.7003, Documentation for Payment.

B.6 INDIRECT COSTS :

The contract clause entitled “FAR 52.216‐7, Allowable Cost and Payment (JUN 2011)”, specifies that the indirect cost rates shall be established for each of the contractor’s accounting periods that apply to this contract. Pending establishment of revised provisional or final indirect cost rates, allowable indirect costs shall be reimbursed on the basis of the following negotiated provisional or predetermined rates and the appropriate bases:

Offeror Fringe Rate

Overhead Rate %

Overhead Ceiling Rate%

G&A Rate %

G&A Ceiling Rate %

PRIME (Insert Name) Base of Application Source: (insert) Period: (insert)

SUBCONTRACTOR(S)

Name (s))

Base of Application Source: (insert) Period: (insert)

B.7 CEILING ON INDIRECT COST RATES AND FINAL REIMBURSEMENT FOR

INDIRECT COSTS

(a) Reimbursement for allowable indirect costs shall be at final negotiated rates but not in excess of the ceiling rates.

(b) The contractor shall make no changes in its established method of classifying or allocating indirect costs without the prior written approval of the Contracting Officer.

(c) USAID is not obligated to pay any additional amount on account of indirect costs above the ceiling rates established in the contract.

(d) This understanding will not change any monetary ceiling, obligation or cost limitation established in the contract.

B.8 SUBCONTRACTORS

Pursuant to FAR Clause 52.244-4, the following subcontractors were identified and agreed to during negotiations to provide the services covered by this contract.

[To be completed at Award]

[END OF SECTION B]

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C.1 Statement of Work

C.1.1 Introduction

This contract will serve as the primary vehicle through which USAID will help assure the quality of health commodities procured in support of global health programs. This contract must provide for the design, development, and implementation of a comprehensive product QAP.

C.1.2 Background

USAID is headquartered in Washington, D.C. and maintains USAID Missions in more than 75 countries across the globe. USAID/Washington is comprised of five geographic bureaus and four functional bureaus. The five geographic bureaus are as follows:

Africa Asia Europe Eurasia, Latin America and the Caribbean Middle East

The four functional bureaus are as follows:

Bureau for Global Health (GH) Bureau for Economic Growth, Education and Environment Bureau for Democracy, Conflict, and Humanitarian Assistance Bureau for Food Security

The work described in this Statement of Work (SOW) falls under the cognizance of the Bureau for Global Health (GH). GH has the overarching goal of improving human health and their portfolio includes programs that represent the commitment of the USG to prevent suffering, save lives, and create a brighter future for families across the globe. Successful implementation of USG health programs in partner countries is dependent in part on an uninterrupted supply of health commodities.

Procurement of Health Commodities. Procurement of health commodities has been a focus of USAID GH for over 30 years. Since 2005, USAID partners have procured and delivered more than 4,300 different products valued at $2.4 billion and has provided more than $700 million in systems strengthening technical assistance in more than 50 countries. These activities support USAID GH’s vision, “a world where people lead healthy, productive lives and where mothers and children survive and thrive”.

Currently, three Offices in GH procure health commodities for USAID programs and Presidential initiatives globally. They are the:

Office of Health, Infectious Diseases and Nutrition (HIDN). HIDN manages a diverse portfolio. It is responsible for managing the Bureau for Global Health’s activities in child health, maternal health, neonatal health, and infectious diseases such as tuberculosis, malaria, avian influenza, and neglected tropical diseases, and for providing technical leadership in each of these areas. The activities also include programs in nutrition/micronutrients, food security, health policy and health systems strengthening, and child survival and health grants with non-governmental organizations (NGOs) as well as in monitoring, reporting, and performance management. USAID’s major malaria program, the President’s Malaria Initiative (PMI) is implemented out of the HIDN office.

HIDN and PMI currently apply a comprehensive Quality Assurance Program (QAP) to all health commodities. Under HIDN and PMI, implementing partners procure health commodities approved by the United States Food and Drug Administration (USFDA), other stringent regulatory authorities (SRA) or health commodities pre-qualified by the World Health Organization Prequalification Program (WHO PQP). Health commodities with these certifications are deemed safe, efficacious, and of good quality. As needed, health commodities are also purchased from pre-approved USAID international wholesalers.

As part of the QAP, every batch of every drug procured with malaria funds is subject to some level of quality testing at an ISO (International Organization for Standardization) certified or World Health Organization (WHO) pre-qualified laboratory, using pharmacopeial standards.

These laboratories are located on several continents including Asia, Africa, Europe, and North America. Insecticide treated nets (ITN) and rapid diagnostic tests (RDT) for malaria are also subjected to quality testing to assure acceptable performance. With the exception of ITN, all testing is conducted prior to the release of product from quarantine; test results are reviewed and approved by both the current contractor providing QA services and USAID. On a smaller scale, HIDN also oversees the procurement and related quality control testing of other health commodities. These include essential medicines, drugs for neglected tropical diseases, and drugs for TB, among other health commodities.

Office of HIV/AIDS (OHA). OHA provides HIV/AIDS technical leadership for USAID and has primary responsibility for leading USAID’s efforts within the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). This responsibility entails the following: ensuring the technical integrity of Agency and Mission strategies; providing global technical leadership on the full range of issues related to HIV/AIDS prevention, care, and treatment; managing numerous research and field support programs; and monitoring and reporting on the impact of the Agency’s HIV/AIDS program. As part of PEPFAR, the Supply Chain Management Systems (SCMS) project was established to provide a secure, reliable supply chain for health commodities. Since 2005, SCMS, managed by OHA/Supply Chain for Health (SCH), has procured approximately $1.5 billion of health commodities to support global HIV/AIDS programs. A robust QAP for health commodities has been implemented. Extensive efforts have addressed all aspects of quality assurance including quality control, vendor pre-qualification, technical assistance, global collaboration, and technical leadership. Current QA activities include a risk-based sampling, testing, and release system for medicines. QA systems to evaluate the quality of other products such as rapid diagnostic tests, other laboratory tests, and food products have also been implemented. In most cases, quality control testing is conducted in WHO prequalified or ISO certified laboratories located in Africa, Asia, or North America. In addition to product quality control, a vendor pre-qualification program has been implemented to provide additional confidence that products purchased meet USAID quality standards.

Office of Population and Reproductive Health (PRH). PRH provides strategic direction, technical leadership and support to USAID Mission programs in population, voluntary family planning, and reproductive health. It manages programs that advance and apply state-of-the-art technologies, expand access to quality services, promote healthy behaviors, broaden contraceptive availability and choices, strengthen policies and systems to address family planning and reproductive health needs, and improve data collection and use. Within PRH, the Commodities Security and Logistics (CSL) Division manages the current QAP for contraceptives, condoms, and other health commodities. The current contractor providing QA services implements a risk–based QAP. This QAP includes the following activities: supplier surveillance activities, good manufacturing practice (GMP) inspections, plant visits, and independent sampling and testing. Currently, the current contractor operates an independently certified quality control laboratory to test physical and chemical properties of health commodities, utilizing additional laboratories if needed. These facilities are located in Asia and North America. The current contractor also maintains a database of all test data, quality technical documentation, and relevant QAP documents. Key data analyzed by the current contractor include supplier performance on identified quality indicators, summary test information, process capability values, statistical control charts, reports on surveillance audits, and product complaints. In addition to the above outlined activities, the current contractor provides global technical leadership in the quality arena and capacity building on regulating and assessing the quality of medicines. The current contractor providing QA services also provides CSL with technical advice regarding product specifications and technical requirements for purchase agreements. Finally, as part of the current QAP program, the current contractors providing QA services conduct post acceptance/shipment sampling and testing of products throughout the supply chain (i.e. during transport, warehouses, service delivery points). The current contractors providing QA services also collaborate with manufacturers and relevant global stakeholders regarding issues which arise such as responding to product complaints, conducting investigations, and supporting product recalls.

Systems Strengthening Technical Assistance. In addition to the procurement of health commodities, these three offices provide systems strengthening technical assistance to strengthen partner country supply chains and increase commodity security. There is a fourth office that does not procure health commodities but also provides technical assistance in supply chain management and commodity security. This office is called the Office of Health Systems (OHS).

OHS works across the Agency’s entire portfolio of global health and is responsible for technical leadership and direction in health systems strengthening. The Office focuses on health policy, quality assurance, workforce policy, pharmaceutical management and standards, and information monitoring, and evaluation.

Capacity Building. USAID is committed to strengthening quality assurance systems in developing countries and supporting sustainable approaches to capacity building that are aligned with country priorities. Many developing countries lack the structures and systems required to regulate health commodities. Limited technical expertise, insufficient infrastructure, and a paucity of policies outlining the regulation of medicines contribute to countries’ inability to ensure and safeguard the quality and safety of medicines in circulation.

To address such lack of infrastructure, capacity building efforts have been undertaken by current contractors performing QA services on behalf of HIDN, OHA, and PRH. For example, contractors performing QA functions have provided technical assistance to host countries (primarily the national drug regulatory authority), in order to: 1. strengthen drug registration processes; 2. support compliance with international standards; 3. provide technical staffing; and 4. assist with complaint resolution.

Technical Leadership. As a result of their expertise on a breadth of technical issues, QA professionals working with the current contractors performing QA activities have established a reputation as global technical leaders in health commodities quality assurance. The current contractors performing QA services has played an active role in revising the World Health Organization Model Quality Assurance System audit checklist, validating shelf-life and stability data of health commodities, completing method transfers, conducting and participating in inter–laboratory studies, and collaborating on clinical studies.

Through these activities, the current contractors performing QA services have been able to transfer knowledge to drug regulatory authorities in partner countries and serve as a resource to national laboratories.

Under the PMI, the Task Order 7 Malaria group has implemented a stringent quality assurance/quality control program, recognized by international donors and malaria partners as a program that takes the necessary inward-looking and self-policing steps to ensure products of good quality are procured. The procurement and appropriate management of malaria commodities necessitates expertise across several technical fields; the PMI is an integral part of global level policy setting, coordinating malaria control efforts with the WHO, the Global Fund and the World Bank.

In collaboration with the Tanzanian government, OHA has implemented an innovative solution related to testing the quality of pharmaceuticals in the field. Near infrared spectroscopy technology was implemented by the current contractor performing QA services contractor that streamlined the drug quality testing process, increased efficiency of testing, and reduced overall costs of the QAP.

Global Collaboration. Due to their technical expertise, OHA and PRH and the current contractors performing QA functions have collaborated successfully with global partners regarding health commodities quality assurance issues. These global partners include the Global Fund (GF), the WHO, UNITAID, the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Clinton Health Access Initiative (CHAI), the United Nations Population Fund (UNFPA), standards bodies such as ASTM International and the ISO, and others. USAID and current contractors performing QA services have worked with global partners to identify product quality issues, share information, and develop strategies to address product quality issues. Currently, global collaborative efforts are underway to harmonize donor quality requirements for pharmaceuticals and other health commodities. Through these collaborations, the current contractors performing QA services have developed a global leadership role in health commodities quality issues and a reputation for expertise in the international QA arena.

Existing GH Health Commodity Procurement and Systems Strengthening Technical Assistance Mechanisms. The GH Bureau currently uses two contract mechanisms and various implementing partners to procure and deliver health commodities (numbers 1 and 2 below), and GH uses five contract mechanisms to provide systems strengthening technical assistance to strengthen supply chain management and commodity security (numbers 1 through 5 below). These mechanisms are described below.

1. USAID | DELIVER PROJECT. The USAID | DELIVER PROJECT (DELIVER) is a single-award IDIQ. The prime contractor is John Snow, Inc. (JSI). The DELIVER team also has the following primary members: 3i Infotech; Abt Associates; The Center for International Health and Development at Boston University School of Public Health; Crown Agents Consultancy, Inc.; FHI 360; Fuel Logistics Group (Pty) Ltd.; The Manoff Group, Inc.; MAP International;

PATH; UPS Supply Chain Solutions; and U.S. Pharmacopeia. DELIVER provides global procurement and delivery of health commodities for non-PEPFAR programs as well as providing supply chain technical assistance.

2. Supply Chain Management System (SCMS). SCMS is a single-award IDIQ. The prime contractor is the Partnership for Supply Chain Management, a non-profit consortium of 13 organizations led by John Snow Inc. Research & Training Institute and Management Sciences for Health (MSH). Other partners in the non-profit consortium include: Booz Allen Hamilton, Crown Agents USA, Inc., The Manoff Group, MAP International, North-West University, Northrop Grumman, RTT, UPS Supply Chain Solutions, Voxiva, and 3i Infotech. As part of U.S.

PEPFAR, SCMS provides global procurement and delivery of health commodities to HIV/AIDS programs around the world, as well as providing systems strengthening technical assistance.

3. System for Improved Access to Pharmaceuticals and Services (SIAPS). The SIAPS project is a cooperative agreement implemented by MSH with four core partners, Accreditation Council for Pharmacy Education (ACPE), Harvard University, Logistics Management Institute (LMI) and University of Washington. Specialized resource partners include Africa Medical and Research Foundation (AMREF), Ecumenical Pharmaceutical Network, Results for Development (R4D), RTT Group, Village Reach, and William Davidson Institute. The SIAPS project aims to ensure the availability of quality-assured pharmaceutical products and effective pharmaceutical services needed to achieve desired health outcomes by applying systems-strengthening approaches and principles of country ownership, integration of health programming, sustainability, and improved performance metrics.

4. Promoting the Quality of Medicines (PQM). The PQM program is a cooperative agreement that is implemented by the United States Pharmacopoeia (USP). This cooperative agreement works to strengthen quality assurance mechanisms at the country level. This is accomplished by improving medicines quality control laboratories and systems for monitoring the quality of medicines in the marketplace and by collaborating with worldwide efforts to combat counterfeit and substandard medicines. The latter includes support for regional initiatives to develop regulatory capacity, sharing of information on product quality, and developing improved tools and approaches to detect counterfeit and substandard medicines. PQM is working as well to expand the pool of World Health Organization (WHO) prequalified manufacturers of second line TB medicines.

5. Preventive Technologies Agreement (PTA). PTA, among other things, implements USAID’s comprehensive quality assurance program for all contraceptives and condoms procured and provided by USAID worldwide. This includes a wide range of product quality assurance and technical assistance activities. Product quality assurance activities include development and review of technical specifications, pre-shipment product sampling and testing for condoms and IUDs, confirmatory testing for hormonal contraceptives that are approved by the USFDA, a Stringent Regulatory Authority (SRA) or WHO PQP, review of manufacturer quality documentation for all contraceptives and condoms, performing stability studies, and conducting manufacturing audits. Technical assistance activities include conduct of investigations regarding product quality issues or issues of diversion, theft, counterfeit, and substandard products, assessments of testing laboratories, development of standard operating procedures (SOPs), and development of risk-based quality assurance strategies.

For additional information regarding the scope and scale of commodity procurement, refer to Section J of Single Award IDIQ for Procurement and Supply Chain Assistance for detailed historical transaction procurement and logistics data for SCMS and DELIVER for FY2011-2012. For additional information regarding the scope and scale of technical assistance, refer to the project websites listed above or refer to USAID’s Development Experience Clearinghouse (DEC), which has been updated with periodic reports from projects listed above.

C.1.3 Going Forward

USAID is restructuring its existing portfolio of projects related to health commodity procurement and systems strengthening technical assistance related to supply chain management and commodity security.

A diagram of the new portfolio of projects is illustrated in Figure 1 below. Contractors under the Global Health Supply Chain Program include the Procurement and Supply Chain Assistance Contractor (referred to as Procurement Contractor for the remainder of this document), Laboratory Contractor, the Business Intelligence and Analytics Contractor, and the Technical Assistance Awardees.

Figure 1: USAID Global Health Supply Chain Program

The Global Health Supply Chain Program includes the following awards:

Single Award IDIQ for Commodity Procurement and Systems Strengthening technical assistance:

The DELIVER and SCMS IDIQs are being consolidated into a single award IDIQ. This IDIQ must provide a comprehensive array of services for USAID health commodity procurement and related systems strengthening technical assistance encompassing the different elements of a comprehensive supply chain (e.g. quantification/forecasting, procurement, transportation, warehousing, and information systems). The single award IDIQ contractor must coordinate with contractors under the multiple award IDIQ and contractors/awardees/grantees under the multiple supply chain assistance mechanisms (IDIQ, cooperative agreements, and grants) to ensure technical assistance efforts are complementary and not duplicative. Quality assurance services for the multiple IDIQ must be provided by the Quality Assurance award, except in instances that are defined in Section C.2.3.

Multiple award IDIQ for Systems Strengthening technical assistance with a target of four awards:

These awards must provide technical assistance to improve the availability of health commodities. At least one award will be a small business set aside with a target of two small business awards. Contractors under this multiple award IDIQ must coordinate with the single award IDIQ and awardees/grantees under the multiple systems strengthening assistance mechanism(s) to ensure technical assistance efforts are complementary and not duplicative.

Single award IDIQ for Procurement Service Agent for Laboratory Supplies: The IDIQ must have the responsibility for the procurement and shipment of laboratory supplies to designated destinations/stakeholders for use in host country programs. This IDIQ will be a small business set aside. Quality assurance services for this award will be provided by the Quality Assurance Contract.

Multiple Awards for Specialized Supply Chain Assistance: These awards are anticipated to be made through annual program statements (APS) to invite and encourage organizations with specialized capabilities. One APS will seek capabilities for research, innovation and evaluation, and access to the state-of-the-art in supply chain management from academia as well as the private, commercial, and other sectors. Another possible APS will be for organizations in the "global south" with demonstrated capabilities in supply chain management, assistance, and/or training, to support local capacity building, and provide for South-to-South assistance and access to regional specializations. Other awards may be made in areas of specialization (e.g., management information system, information technologies) if there is sufficient demand from field. Grantees and awardees under this mechanism must coordinate with the single award IDIQ and multiple award IDIQ to ensure technical assistance efforts are complementary and not duplicative.

Quality Assurance Award: The Quality Assurance (QA) award must promote the effectiveness and efficiency of USAID QA services by combining and coordinating QA activities across health elements. This activity must provide independent, essential, comprehensive quality assurance/control services covering the different health elements in the Bureau. The QA award must provide QA services for commodities purchased under the single award IDIQ (except as defined in the single award IDIQ) as well as the single award IDIQ for laboratory supplies and other programs within GH. The HIV/AIDS and CSL Task Orders must be required to obtain all quality assurance services from the USAID Quality Assurance contractor, unless otherwise directed by USAID.

Business Intelligence and Analytics Award: The Business Intelligence and Analytics (BI&A) award is expected to collect and integrate data from multiple partner systems and generate reports and alerts based on established thresholds. By embedding BI&A into existing process applications, USAID's control, management, and ownership of information must be enhanced to facilitate information sharing and coordination across health elements within the Bureau's supply chain Program. The BI&A award must collect data from all partners under the Global Health Supply Chain Program.

C.2 – Objective and Guiding Principles

The overall goal of this contract is to establish and implement a comprehensive Quality Assurance Program (QAP).

The contractor must implement a QAP that is compliant with Federal regulations and USAID policies and procedures that is cost-effective, high-performing, transparent, and flexible and provides the best value for the USG

C.3 – Scope of Work (SOW)

To accomplish the overall contract goal objective as stated in C.1 Introduction, the QA Contractor must address the following components:

I. Objective 1: Establish a comprehensive QAP for the Bureau for Global Health: The QA Contractor must establish a QAP with appropriate standard operating procedures (SOP) that are compliant with applicable USG and USAID regulations ADS 312 (Eligibility of Restricted Products) and 22 CFR 228 (Rules on Source and Nationality for Products and Services), policies and other requirements regarding quality standards for health commodities.

II. Objective 2: Design and implement a Quality Control (QC) strategy to be approved by

USAID that provides for appropriate monitoring of the quality of health commodities procured on behalf of USAID. The QA Contractor must establish and maintain comprehensive QC activities as part of the overall QAP. QC activities must include sampling of products, transporting of samples, identifying appropriate laboratory testing facilities, monitoring results of testing, and implementing actions based upon the results of QC testing.

III. Objective 3: Provide technical leadership and technical assistance in quality assurance. As requested and funded by USAID, the QA Contractor must utilize technical knowledge to engage with and provide technical support and training to partner country governments, USAID implementing partners, and other donors or partners.

IV. Objective 4: Collaborate with global partners; and contractors under the Global Health Supply Chain Program.* The QA contractor must forge partnerships with international organizations, nongovernmental organizations, academic institutions, and work with other key stakeholders to address global quality assurance issues of mutual concern. The QA Contractor must interface with contractors under the Global Health Supply Chain Program and current contractors providing QA services.

*Contractors under the Global Health Supply Chain Program as described in Section C.1.3 include the Procurement and Supply Chain Assistance Contractor (referred to as Procurement Contractor for the remainder of this document), Laboratory Contractor, the Business Intelligence and Analytics Contractor, and the Technical Assistance Awardees.

Figure 2: Objectives of Quality Assurance Contract of USAID Global Health Supply Chain Program

C.4 Detailed Technical Specifications

C.4.1: Objective 1: Quality Assurance

Establish a comprehensive Quality Assurance Program for the Global Health Bureau The QA Contractor must implement and sustain a comprehensive QAP that is capable of addressing the requirements of USAID GH, particularly of the Office of HIDN, OHA, and Office of PRH. For the purposes of this contract, the term ‘QA’ is defined as the sum of all the activities and processes required to ensure that health commodities medicines and products are safe, effective, and of acceptable quality for clients and patients.

Collectively, these activities serve to mitigate risks to both the patient/recipient and USAID.

For the purpose of this contract health commodities include but are not limited to, the following:

1. Pharmaceuticals

a. Antiretroviral medicines

b. Antimalarial medicines

c. Medicines to treat tuberculosis)

d. Medicines to treat opportunistic infections

e. Other anti-infective medicines

f. Hormonal Contraceptives

g. Essential medicines

2. Ready to Use Therapeutic/Supplementary Foods (RUTF)

3. Laboratory equipment, reagents, and consumables

4. Insecticide Treated Bednets

5. Condoms and Intrauterine Devices

6. Rapid Diagnostic Tests (RDTs) for Malaria, HIV, etc.

7. Kits for Voluntary Male Medical Circumcision

8. Medical supplies (gloves, gowns, etc.)

9. Medical Equipment (hospital beds, etc.)

10. Other health commodities as requested

The QA Contactor must design and implement a comprehensive QAP which balances the probability of the occurrence of product defects and patient harm, the severity of the harm, and the resources required and available to assure quality. As such, the QA Contractor must develop a risk-based strategy and approach to quality assurance that must serve to minimize cost, ensure compliance to specifications and other contract requirements, and mitigate risks for patients and for USAID. The overall QAP must, at a minimum, address key activities aimed at assuring the quality of health commodities. The QA Contractor must create detailed and explicit SOPs, and such SOPs must address all aspects of the QAP. Additionally, the QA Contractors must be capable of responding immediately to urgent issues throughout the life of the contract.

The QA Contractor must undertake new QAP activities as the requirements for health programs and healthcare product needs evolve. The QA Contractor must stay current with new technologies and approaches, determine applicability, and propose innovative enhancements to these activities or propose new QAP activities that would improve the effectiveness or efficiency of the QAP.

C.4.1.1 Compliance with USAID Policies and Regulations

Under this contract the QA Contractor will not undertake procurement of health commodities for distribution purposes, however, the QA Contractor must maintain close communication with the Procurement Contractors in order to help USAID ensure compliance with applicable requirements, including ADS 312 ( regarding quality Eligibility of Restricted Products), and 22 CFR 228 (Rules on Source and Nationality for Products and Services) which contain the USAID policy directives that regulate procurement of restricted products, including pharmaceuticals and other medical devices (i.e. condoms). Monthly conference calls or meetings will be required in order to ensure this communication. Some health commodities have been pre-approved by USAID (i.e.

ARVs). For health commodities that have NOT been pre-approved by USAID, the Procurement contractor must seek approval from the QA Contractor and USAID prior to purchase. For health commodities that have not been pre-approved, the QA contractor will recommend approval (or not) to USAID where a final determination will be made. Only USAID can provide ADS 312 clearance to procure commodities that have not been pre-approved.

In order to avoid stock-outs or delays, the QA Contractor must conduct reviews of products that are not preapproved by USAID and make recommendations regarding sourcing of these products to USAID and the Procurement Contractors (See C.3.IV). Details pertaining to the types of pharmaceuticals that can be procured are illustrated in the ADS 312 Help Document attached in Section J.

C.4.1.2 Vendor Pre-Qualification

The QA Contractor must identify potential quality sources in collaboration with the Procurement Contractors. The QA Contractor must evaluate identified vendors, to be defined as a manufacturer or wholesale distributor, for compliance with quality standards and recommend approval or disapproval to USAID. Approved vendors are eligible to provide health commodities to USAID implementing partners.

For currently approved and prospective wholesale distributors, the QA Contractor must:

1. Develop or adopt a quality assurance audit checklist based on GDP. Audits must include but are not limited to a review of SOPs, a physical inspection of warehouse, a review of prequalification procedures and files, and inspection of quality control facility to enable the QA Contractor and USAID to objectively evaluate vendors.

2. Propose an audit schedule to conduct quality audits of currently approved and potential wholesale distributors as directed by USAID. Refer ADS312 Help Document for a list of currently approved wholesale distributors.

3. Prepare audit reports with observations and present to the wholesale distributor and to USAID. The QA Contractor must monitor the implementation of recommended corrective actions as needed, based on an agreed upon timeline. The QA Contractor must recommend to USAID that the manufacturer be approved or disapproved as a wholesale distributor for health commodities for USAID health programs.

As part of the vendor pre–qualification process, the QA Contractor must maintain documentation and files for each wholesale distributor as a paper trail for pre–qualification activities. In the event an approved wholesale distributor is failing to perform to expectations, the QA Contractor must recommend corrective actions to the wholesale distributor and notify USAID of such corrective actions.

Similarly, for prospective manufacturers, the QA Contractor must:

1. Develop or adopt a quality assurance checklist based on GMP to enable the QA Contractor and USAID to objectively evaluate vendors

2. Propose an audit schedule to conduct quality audits of currently approved and potential pharmaceutical manufacturers, and manufacturers of other types of health commodities located mostly in Asia and Europe

3. Prepare audit reports with observations and present to the manufacturer and to USAID. The QA Contractor must monitor the implementation of corrective actions as needed and establish an appropriate timeline for completion. The QA Contractor must recommend to USAID that the manufacturer be approved or disapproved as a manufacturer for health commodities for USAID health programs.

The QA Contractor must monitor and evaluate the in-process quality controls of health commodities and generate new or utilize an existing report card. These report cards must track the manufacturing performance of manufacturers and business performance (i.e. on time delivery).

C.4.1.3 Documentation

The QA Contractor must remain updated of information on US and international regulatory requirements pertinent to health commodities procured for USAID funded programs and managed through the QAP. Specifically, the QA Contractor must interpret GMP, GDP and associated regulations and guidance as applicable to the QAP and review scientific documents, publications, product dossiers and other applicable documents, from a regulatory standpoint.

The QA Contractor must review documents and report the findings relevant to the commodities procured on behalf of USAID to USAID. This effort requires that the QA Contractor maintain relevant documentation in a retrievable and searchable format to be shared with the BI&A Contractor. Documentation Includes but is not limited to the following:

1. Certificates of analysis

2. Test results

3. Product labeling and labeling changes

4. Relevant safety alerts of other organizations

5. Regulatory status of relevant manufacturers with supporting documentation

6. Credentials for testing laboratories

7. Product recall information

C.4.1.4 Product Recalls

Product recalls are an inevitable reality in a global health program involving the delivery of health commodities.

Types of recalls are expected but not limited to the following:

1. Recalls initiated by the manufacturer or

2. Recalls initiated by USAID at the recommendation of the QA Contractor, upon review of quality control testing…