_SOL-OAA-13-000995_-_USAID_GHSC_RFP_for_Rapid_Test_Kits.pdf

Date Issued January 17, 2014 Questions Due: January 30, 2014 @ 5 pm EST Past Performance Due: February 17, 2014 @ 5 pm

EST

Closing Date: March 3, 2014 3 pm EST

Subject: Request for Proposal (RFP) # SOL-OAA-13-000995:

USAID Global Health Supply Chain Program – Rapid Test Kits (GHSC-RTKs)

The United States Agency for International Development (USAID) is seeking proposals from qualified small business entities to procure and supply HIV Rapid Test Kits (RTK) for the USAID’s Global Health Supply Chain Program, as further described in the attached Request for Proposal

(RFP).

This procurement is being conducted through full and open competition among small business entities for which the procedures described in FAR PART 15 of the Federal Acquisition Regulation (FAR), will apply. Proposals will be accepted only from bona-fide small business entities in the U.S. USAID encourages proposals from potential new partners. The successful offeror must have or establish its management office for this indefinite delivery, indefinite quantity (IDIQ) contract in the Washington, DC Metropolitan Area.

USAID anticipates the award of one Single Award Indefinite Delivery, Indefinite Quantity contract (IDIQ) to a qualified small business for a five (5) year ordering period. The maximum ordering limitation of the contract resulting from this RFP will be $300,000,000; the maximum aggregate dollar value of task orders awarded to the successful contractor cannot exceed this contract ceiling. USAID also anticipates the award of one initial Task Order as a result of this solicitation as further described in Section L.

There is no guarantee on the number of task orders that the successful contractor will receive or the amount of money beyond the minimum order guarantee set forth in the RFP. The primary North American Industry Classification System (NAICS) code for this acquisition is 541611; the secondary NAICS code is 423450. The authorized geographic code for the prime contractor of this procurement is 937. However, the prime contractor will have an authorized geographic code of 935 for the sub-procurement of commodities and services in support of this award.

Please refer to Section L of this RFP for information regarding proposal submission instructions.

Offerors should take into account the expected delivery time required so that proposals are received in USAID by the deadline listed above. Failure to comply with these instructions will deem any submission unacceptable and it will not be reviewed or evaluated.

Only hard copies associated with electronic copies (CDs) will be accepted; faxed copies or emails containing attachments are not acceptable, nor will they be reviewed or evaluated.

Section M states the criteria by which proposals will be evaluated. Oral explanations or instructions given before award of the contract will not be binding.

Questions or comments from potential offerors concerning this RFP must be submitted no later the date and time listed above. All questions related to the RFP must be submitted to:

Malcolm Saldanha (LabQ@usaid.gov) . Unless otherwise notified by an amendment to the RFP, no questions will be accepted after this date.

This RFP and any future amendments can be viewed and downloaded from the Internet at the Federal Business Opportunities website at www.fedbizopps.gov. USAID bears no responsibility for data errors resulting from transmission or conversion processes. Further, be aware that amendments to solicitations are occasionally issued and will be posted on the same Internet site from which you downloaded the solicitation. You are therefore advised to regularly check the above website for any amendments.

Finally, this RFP in no way obligates USAID to award a contract nor does it commit USAID to pay any cost incurred in the preparation and submission of a proposal. Award of a Contract under this RFP is subject to availability of funds and other internal USAID approvals.

Sincerely, Michael Clark Contracting Officer mailto:Malcolm mailto:LabQ@usaid.gov http://www.fedbizopps.gov/

Table of Contents

ACRONYMS

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICE/COSTS

B.1 PURPOSE

B.2 CONTRACT TYPE AND SERVICES

B.3 MAXIMUM CONTRACT CEILING

B.4 MINIMUM ORDER GUARANTEE

B.5 CEILING ON FIXED FEE

B.6 APPROVED SUBCONTRACTORS

B.7 LABOR

B.8 LABOR (UNBURDENED CDR) RATE CHANGES

B.9 INDIRECT COSTS

B.10 ADVANCE UNDERSTANDING ON CEILING ON INDIRECT COST RATES

B.11 COST REIMBURSABLE

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C.1.1 INTRODUCTION

C.1.2 BACKGROUND

C.1.3 GOING FORWARD

C.2 PROCUREMENT AND DELIVERY OF HIV RAPID TEST KITS

C.2.1 PROCUREMENT OF APPROVED RTKs

C.2.2 LOGISTICS

C.2.3 QUALITY ASSURANCE AND QUALITY CONTROL

C.2.4 METRICS

C.2.5 DATA VISIBILITY

C.3 COLLABORATION

C.4 MANAGEMENT

C.5 TRANSITION

SECTION D – PACKAGING AND MARKING

D.1 AIDAR 752.7009 MARKING (JAN 1993)

D.2 BRANDING POLICY

D.3 PACKAGING AND PACKING PROVISIONS

SECTION E – INSPECTION AND ACCEPTANCE

E.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

SOL-OAA-13-000995

E.2 INSPECTION AND ACCEPTANCE

E.3 RESPONSIBLE OFFICIAL

SECTION F - DELIVERIES OR PERFORMANCE

F.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

F.2 PERIOD OF PERFORMANCE

F.3 PLACE OF PERFORMANCE

F.4 PERFORMANCE STANDARDS

F.5 REPORTS AND DELIVERABLES OR OUTPUTS

F.6 ORDERING PROCEDURES

F.7 KEY PERSONNEL

F.8 TASK ORDER LIMITATIONS

F.9 TASK ORDER ADMINISTRATION

F.10 AIDAR 752.7005 SUBMISSION REQUIREMENTS FOR DEVELOPMENT EXPERIENCE DOCUMENTS

(SEPTEMBER 2013) (Class Deviation OAA-DEV-13-01c)

F.11 AIDAR 752.242-70 PERIODIC PROGRESS REPORTS (OCT 2007)

SECTION G – CONTRACT ADMINISTRATION DATA

G.1 752.7003 DOCUMENTATION FOR PAYMENT (NOV 1998)

G.2 PAYMENT AND VOUCHERS

G.3 CONTRACTING OFFICER

G.4 CONTRACTING OFFICER'S REPRESENTATIVE (COR)

G.5 CONTRACTOR’S PRIMARY POINT OF CONTACT

G.6 PAYING OFFICE

G.7 ACCOUNTING AND APPROPRIATION DATA

G.8 CONTRACTOR'S PAYMENT ADDRESS

G.9 TECHNICAL DIRECTIONS / RELATIONSHIP WITH USAID

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

H.2 CONSCIENCE CLAUSE IMPLEMENTATION (ACQUISITION) – SOLICITATION PROVISION

(FEBRUARY 2012)

H.3 CONDOMS (ACQUISITION) (JUNE 2005)

H.4 PROHIBITION ON THE PROMOTION OR ADVOCACY OF THE LEGALIZATION OR PRACTICE OF

PROSTITUTION OR SEX TRAFFICKING (ACQUISITION) (APRIL 2010)

H.5 AIDAR 752.225-70 SOURCE AND NATIONALITY REQUIREMENTS (FEB 2012) (Class Deviation No.

OAA-DEV-12-01c)

H.6 AIDAR 752.7004 EMERGENCY LOCATOR INFORMATION (JUL 1997)

H.7 AIDAR 752.7007 PERSONNEL COMPENSATION (JUL 2007)

H.8 ADDITIONAL REQUIREMENTS FOR PERSONNEL COMPENSATION

H.9 INFORMATION SYSTEM SECURITY

H.10 AIDAR 752.228-3 DEFENSE BASE ACT (DBA) INSURANCE

H.11 AUTHORIZED GEOGRAPHIC CODE

H.12 LOGISTIC SUPPORT

H.13 LANGUAGE REQUIREMENTS

H.14 NONEXPENDABLE PROPERTY PURCHASES AND INFORMATION TECHNOLOGY RESOURCES

H.15 EXECUTIVE ORDERS ON TERRORISM FINANCING

H.16 FOREIGN GOVERNMENT DELEGATIONS TO INTERNATIONAL CONFERENCES (JAN 2002)

H.17 AIDAR 752.7032 INTERNATIONAL TRAVEL APPROVAL and notification requirements (Jan 1990)

H.18 USAID DISABILITY POLICY (DEC 2004)

H.19 COMPLIANCE WITH SECTION 508 OF THE REHABILITATION ACT OF 1973, AS AMENDED

H.20 LOGISTIC SUPPORT GOVERNMENT FURNISHED FACILITIES OR PROPERTY

H.21 RIGHT TO PROCURE FROM OTHER SOURCES

H.22 REPORTING OF FOREIGN TAXES (JULY 2007)

H.23 NONDISCRIMINATION (June 2012)

H.24 SUBCONTRACTING CONSENT

H.25 ORGANIZATIONAL CONFLICTS OF INTEREST: PRECLUSION FROM FURNISHING CERTAIN

SERVICES AND RESTRICTION ON USE OF INFORMATION (Indefinite Delivery, Indefinite Quantity) (Evaluation Services)

H.26 ORGANIZATIONAL CONFLICT OF INTEREST

H.27 SUBCONTRACTING PLAN AND THE SF 294 – SUBCONTRACTING REPORT FOR INDIVIDUAL

CONTRACTS AND SF 295 - SUMMARY CONTRACTING REPORT

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 (APR 2010)

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

MATTERS (JUL 2013)

I.4 52.216-18 ORDERING (OCT 1995)

I.5 52.216-19 ORDER LIMITATIONS (OCT 1995)

I.6 52.216-22 INDEFINITE QUANTITY (OCT 1995)

I.7 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

I.8 52.232.99 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS

(DEVIATION) (AUG 2012)

I.9 FAR 52.222-50 COMBATING TRAFFICKING IN PERSONS (FEB 2009)

I.10 FAR 52.244-2 SUBCONTRACTS (OCT 2010)

I.11 FAR 52.232-12 ADVANCE PAYMENTS (MAY 2001)

I.12 52.232-12 ADVANCE PAYMENT - ALTERNATE II MAY 2001

PART III – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

PART IV – REPRESENTATIONS AND INSTRUCTIONS

SECTION K – REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

K.1 NOTICE LISTING SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

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 PROGRAM

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

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

L.1 NOTICE LISTING SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

L.2 GENERAL INSTRUCTIONS

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

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

L.5 DELIVERY INSTRUCTIONS

L.6 INSTRUCTIONS FOR THE PREPARATION OF THE TECHNICAL PROPOSAL

L.7(a) ORGANIZATION OF THE TECHNICAL PROPOSAL

L.7(b) CONTENT OF THE TECHNICAL PROPOSAL

L.8 TECHNICAL PROPOSAL INSTRUCTIONS

L.9 INSTRUCTIONS FOR THE PREPARATION OF THE COST/BUSINESS PROPOSAL

L.10 INSTRUCTIONS FOR THE PREPARATION OF THE BRANDING IMPLEMENTATION PLAN (BIP) AND

MARKING PLAN

SECTION M - EVALUATION FACTORS FOR AWARD

M.1 GENERAL INFORMATION

M.2 TECHNICAL EVALUATION FACTORS

M.3 EVALUATION OF THE COST/BUSINESS PROPOSAL (See Section L.9)

M.4 DETERMINATION OF COMPETITIVE RANGE

M.5 SOURCE SELECTION

ACRONYMS

ADS Automated Directives System APS Annual Program Statement CCN Cooperating Country Nationals CDR Ceiling Daily Rate COR Contracting Officer’s Representative CPFF Cost-Plus-Fixed-Fee CQI Continuous Quality Improvement CST Contractor Salary Threshold FAR Federal Acquisition Regulation FFP Firm-Fixed-Price GH Global Health HIDN Office of Health, Infectious Diseases and Nutrition IDIQ Indefinite Delivery, Indefinite Quantity Contract KPI Key Performance Indicator NGO Non-Governmental Organization OHA Office of HIV/AIDS OHS Office of Health Systems PMI President’s Malaria Initiative PMP Performance Monitoring Plan PRH Office of Population and Reproductive Health QA Quality Assurance RFTOP Request for Task Order Proposal RTK Rapid Test Kit SKU Stock Keeping Unit SOW Scope of Work TCN Third Country Nationals TO Task Order TOCOR Task Order Contracting Officer’s Representative USAID United States Agency for International Development USG United States Government WHO World Health Organization

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. USAID Task Order Contracting Officers (TOCOs) will request work through the issuance of task orders during the ordering period as specified in Section F of the contract.

B.2 CONTRACT TYPE AND SERVICES

This is a Single Award Indefinite Delivery Indefinite Quantity contract (IDIQ) utilizing individual task orders to provide services related to the procurement and supply of Rapid Test Kits (RTKs) to the designated locations worldwide. The Government will issue task orders that are either Cost-Plus-Fixed-Fee (CPFF) or Firm Fixed Price (FFP) term/completion. USAID intends to issue multiple task orders under this IDIQ.

B.3 MAXIMUM CONTRACT CEILING

This is a Single Award IDIQ with an overall ceiling price of $300,000,000. The maximum aggregate dollar value of the task orders awarded cannot exceed this Contract ceiling.

B.4 MINIMUM ORDER GUARANTEE

The minimum order guarantee for this Contract is $25,000. USAID is required to order and the contractor is required to furnish the minimum order amount of funding. The initial obligation is expected to be applied towards the first task order issued along with the award of the basic contract.

Following this initial obligation, individual task orders will obligate funds to cover the work required under each task order.

B.5 CEILING ON FIXED FEE

a) For each CPFF task order issued under this IDIQ, the TOCO and Contractor agree to negotiate a set dollar amount for fixed fee. In negotiating the fixed dollar amount for fee, the TOCO must consider the policies and factors for establishing fee in FAR 15.404-4 as well as any applicable USAID policy on establishing a fixed fee amount and any additional considerations received to include a Letter of Credit. In no event, however, may the amount of fixed fee in any individual task order exceed ___ percent (offeror must propose ceiling percentage) of the task order’s estimated cost, excluding fee. The fee ceiling applies to the prime contractor and any subcontractor.

b) The Total Estimated Cost-Plus-Fixed-Fee for each task order must be negotiated in accordance with the terms of the IDIQ contract.

c) Fee will not be applied to the cost of commodities.

B.6 APPROVED SUBCONTRACTORS

[FAR clause 52.244-2, SUBCONTRACTS is incorporated in Section I, below is the fill in for paragraph (j) for this clause.]

Name Cage Code

B.6(a) RESOURCE ORGANIZATIONS

Task order contracting officers (TOCOs) may grant separate subcontract approvals for subcontractors not listed above for task orders in accordance with FAR part 52.244-2 and 44.202-2.

B.7 LABOR

(Only applicable to cost type task orders)

Central management costs will be handled through the following method:

The contractor can bill USAID directly for key personnel performing IDIQ management costs under task orders.

B.7(a) Unburdened Ceiling Daily Rates (CDR)

(1) The Unburdened Ceiling Daily Rates apply to all labor (the prime contractor, subcontractor, TCNs, CCN’s, and consultant salaries) on cost-type task orders. CDRs do not apply to fixed-priced task orders. Additional requirements and approvals under the contract still apply to labor costs, including, but not limited to:

a. AIDAR 752.7007 Personnel Compensation (July 2007) (See Section H.),

b. Approval of subcontractors under FAR Part 42,

c. Approval of any final salary rates above the Contractor Salary Threshold (CST) (see

ADS 302), and

d. Rules requiring that CCN and TCN labor comply with the local compensation plan limitations, as further provided below.

(2) Approved labor rates for all labor will be negotiated under task orders at equal to, or lower than, the CDRs. Final approval of labor rates is provided by the TOCO. The Government shall not be obligated to pay any daily rate that exceeds the ceiling daily rates set forth in the table below.

(3) Each CDR for personnel listed below is “unburdened” and must only include salary costs or consulting rates of the individual providing the services. The CDR for employees must not include the following:

• Payroll costs (fringe benefits, FICA, allowances, differentials, etc.);

• Indirect Costs applicable to labor; and

• Profit or fee, if any.

The CDRs set forth below are valid for the IDIQ Period of Performance, and are for a productive eight (8) hour day. The CDRs apply to all subcontractors under the contract, including those set forth in Section B.6 and new subcontractors proposed for specific cost-type task orders.

(4) The unburdened ceiling daily rates for each labor category/group below represent the mid-level and senior-level rate in each category/grouping. Up to three levels of unburdened ceiling daily rates for each labor category/grouping are included in the contract to provide more flexibility under task orders.

No. Illustrative Labor Category Daily Rate

Senior Level Daily Rate Mid Level

Daily Rate Junior Level

1 IDIQ Director $ N/A N/A

2 Task Order Director (if different from 1 above)

$ N/A N/A

3 Procurement and Logistics Manager $ $

4 Finance Manager $ $

Note 1: The Unburdened Ceiling Daily Rates apply to any task order(s) that are awarded under this Contract.

Note 2: The Unburdened Ceiling Daily Rates apply to all labor (the prime contractor, subcontractor, TCNs, CCN’s, and consultant salaries). CCN and TCN labor are also governed by the local compensation plan limitations as further provided in note 3 below.

Note 3: Locally Hired National Personnel or Other Non-U.S. Expatriate Rates:

All locally hired national personnel and other non-U.S. expatriates must be paid in accordance with AIDAR 722.170.

Salaries for individual locally-hired personnel and other non-U.S. expatriates under this contract and any resulting subcontract must be in accordance with AIDAR 752.7007, Personnel Compensation (July 2007), and should be based upon a combination of factors including the prevailing compensation paid to personnel performing comparable work in the cooperating country as determined by USAID and consideration of the individual's education, work experience and recent relevant salary history.

Unless otherwise authorized by USAID, the compensation for CCN and TCN labor shall not exceed the prevailing compensation paid to personnel performing comparable work in the cooperating country as determined by USAID and shall be paid in the currency of the cooperating country.]

[Note 4: The Unburdened Ceiling Daily Rates above do not apply to Fixed-priced task Orders.]

(5) Definition of labor categories:

a. IDIQ Director – Primary point of contact for the USG government on overall IDIQ procedural and substantive matters. The IDIQ Director bears primary responsibility for the success of the Contracts (TO and IDIQ).

b. Task Order Director(s) – Task Order Director(s) serve as the main point of contact for each TO and share responsibility for the success of the program with the IDIQ Director.

c. Finance Manager – Finance Manager (s) serve as the main point of contact for financial management issues related to each TO.

d. Procurement and Logistics Manager – Procurement and Logistics Manager (s) serve as the main point of contact for procurement issues related to each TO.

B.7(b) Minimum Qualifications

In order to perform the statement of work set forth in Section C, the contractor must provide personnel that meet the minimum education and experience requirements set forth below.

These minimum qualifications for mid-level and senior personnel correspond to the Unburdened Ceiling Daily Rates above.

Education + Experience Requirements

Level Academic Degree*

AND Years of Relevant Work Experience**

Junior BS/BA 3 years or lower

Mid Ph.D.

JD/ABD

MS/MA/MB

BS/BA

Senior

Ph.D.

JD/ABD

MS/MA/MB

BS/BA

*Highest degree obtained should be related to work being performed.

**Experience should be related to the work being performed.

***English language proficiency is required for all positions.

B.7(c) Subcontractor Rates

(1) The Unburdened Ceiling Daily Rates apply to all subcontractor labor on cost-type task orders.

(2) For subcontractors with a cost accounting system that only processes fully burdened rates, the contractor may include in its TO proposal, (i) the fully burdened rate proposed to the contractor by the subcontractor, (ii) allocation of the Contractor’s indirect costs in accordance with established accounting practices, and (iii) a reasonable profit. If the rates proposed to USAID, inclusive of the Prime’s allocable indirect costs and a reasonable profit, exceed the contract’s unburdened CDRs , the contractor must disclose the amount of the indirect costs and the amount of the proposed profit that were added to the subcontractor’s proposed rates. The TOCO will negotiate reasonable labor rates using that information.

B.8 LABOR (UNBURDENED CDR) RATE CHANGES

The labor rates are fixed for all contract years; however, the contractor may submit a proposal reducing the labor rates and/or indirect rates at any time during the life of this contract. The Government will review these proposals and determine if the revised rates are realistic and in the best interests of the Government. If the rates are accepted, the Government will modify the contract by incorporating the new rates into the contract.

B.9 INDIRECT COSTS

(Only applicable to CPFF task orders)

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:

For Prime Contractor:

Description Rate Base Type Period 1/ 2/ 3/ 1/ 2/ 3/ 1/ 2/ 3/

1/Base of Application:

Type of Rate:

Period:

2/Base of Application:

Type of Rate:

Period:

3/Base of Application:

Type of Rate:

Period:

Source:

For Subcontractors

Description Rate Base Type Period 1/ 2/ 3/ 1/ 2/ 3/ 1/ 2/ 3/

1/Base of Application:

Type of Rate:

Period:

2/Base of Application:

Type of Rate:

Period:

3/Base of Application:

Type of Rate:

Period:

Source:

B.10 ADVANCE UNDERSTANDING ON CEILING ON INDIRECT COST RATES

(Only applicable to CPFF Task Orders)

(a) Reimbursement for indirect costs shall be at the lower of the negotiated final or predetermined rates, or the following ceiling rates:

For Prime Contractor:

Description Rate Base Type Period 1/ 2/ 3/ 1/ 2/ 3/ 1/ 2/ 3/

1/Base of Application:

Type of Rate:

Period:

2/Base of Application:

Type of Rate:

Period:

3/Base of Application:

Type of Rate:

Period:

For Subcontractors:

Description Rate Base Type Period 1/ 2/ 3/ 1/ 2/ 3/ 1/ 2/ 3/

1/Base of Application:

Type of Rate:

Period:

2/Base of Application:

Type of Rate:

Period:

3/Base of Application:

Type of Rate:

Period:

(b) The Government will not be obligated to pay any additional amount should the final indirect cost rates exceed the negotiated ceiling rates. If the final indirect cost rates are less than the negotiated ceiling rates, the negotiated rates will be reduced to conform to the lower rates.

(c) This understanding shall not change any monetary ceiling, obligation, or specific cost allowance or disallowance. Any changes in classifying or allocating indirect costs require the prior written approval of the Contracting Officer.

(d) The contractor shall make no change in its established method of classifying or allocating indirect costs without prior written approval of the Contracting Officer and the Office of Acquisition and Assistance, Contract Audit Support Division.

B.11 COST REIMBURSABLE

(Only applicable to CPFF Task Orders)

The U.S. dollar costs allowable must be limited to reasonable, allocable, and allowable costs determined in accordance with FAR 52.216-7, Allowable Cost and Payment, and FAR 52.216-8, Fixed Fee, if applicable: AIDAR 752.7003, Documentation for Payment; OMB Circular 1-21, Cost Principles for Educational Institutions and OMB Circular A-122, Cost Principles for Non-profit organizations.

[END OF SECTION B]

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C.1.1 INTRODUCTION

The United States Agency for International Development (USAID) is the U.S. Government’s (USG’s) principal implementing organization for international development assistance. The purpose of this Indefinite Delivery Indefinite Quantity Contract (IDIQ) is to serve as the primary vehicle through which USAID will procure and provide HIV Rapid Test Kits (RTK). This IDIQ is set aside for small businesses.

This IDIQ will serve the needs of USAID as well as other entities, including but not limited to other USG agencies, partner country governments, Non-Governmental Organizations (NGOs), and other donors.

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)

• Economic Growth, Education and Environment

• 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 has procured and delivered more than 4,300 different products valued at $2.4 billion and has provided more than $500 million in supply chain 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, 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.

• 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.

• 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.

Supply Chain Technical Assistance. In addition to the procurement of health commodities, these three offices provide supply chain 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.

Existing GH Health Commodity Procurement and Supply Chain 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), http://www.pmi.gov/ http://www.pmi.gov/ http://www.pepfar.gov/ http://www.pepfar.gov/ and GH uses four contract mechanisms to provide supply chain technical assistance to strengthen supply chain management and commodity security (numbers 1 through 4 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. The USAID | DELIVER PROJECT provides global procurement and delivery of health commodities for non-PEPFAR programs as well as providing supply chain technical.

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 supply chain technical assistance.

3. System for Improved Access to Pharmaceuticals (SIAPS). The SIAPS project is a cooperative agreement implemented by Management Sciences for Health (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 http://deliver.jsi.com/dhome http://scms.pfscm.org/scms http://www.msh.org/global-presence/siaps.cfm http://www.usp.org/global-health-impact-programs/promoting-quality-medicines-pqmusaid expand the pool of World Health Organization (WHO) prequalified manufacturers of second line TB medicines.

For additional information regarding the scope and scale of commodity procurement, refer to Section J for detailed transaction 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 supply chain technical assistance related to supply chain management and commodity security. A diagram of the new portfolio of projects is illustrated in Figure 1 below.

Figure 1: USAID Global Health Supply Chain Architecture

The architecture for the supply chain follow-on includes the following awards:

• Single Award IDIQ for Commodity Procurement and Supply Chain Technical Assistance. The DELIVER and SCMS IDIQs are being be consolidated into a single award IDIQ. This IDIQ will provide a comprehensive array of services for USG health commodity procurement and related supply chain 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 will be provided by the Quality Assurance award, except in instances that are defined in Section C.2.3.

• Multiple Award IDIQ for Supply Chain Technical Assistance. These awards will provide technical assistance to improve the availability of health commodities. At least one award will be a small business set aside. Contractors under this multiple award IDIQ must coordinate with the single award IDIQ for Commodity Procurement and Supply Chain Technical Assistance and awardees/grantees under the multiple supply chain assistance mechanism(s) to ensure technical assistance efforts are complementary and not duplicative.

• Single Award IDIQ for HIV Rapid Test Kit: The Rapid Test Kit IDIQ will have the responsibility for the procurement and shipment of HIV rapid test kits (RTKs) 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 award.

• 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 multiple supply chain technical assistance mechanism(s) to ensure technical assistance efforts are complementary and not duplicative.

• Quality Assurance Award. The Quality Assurance (QA) award will promote the effectiveness and efficiency of USAID QA services by combining and coordinating QA activities across health elements. This activity will 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 for procurement and technical assistance (except as defined in the IDIQ) as well as the single award IDIQ for Procurement of HIV RTKs.

• 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 into existing process applications, USAID's control, management, and ownership of information will be enhanced to facilitate information sharing and coordination across health elements within the Bureau's supply chain architecture. The BI award must collect data from all partners under the Global Health Bureau’s Supply Chain architecture.

C.2 PROCUREMENT AND DELIVERY OF HIV RAPID TEST KITS

As the primary diagnostic tool for determining HIV/AIDs status and the gateway for care and treatment of HIV positive people, RTKs play a vital role in combatting the global HIV/AIDS epidemic.

Without an adequate and timely supply of quality RTKs, HIV/AIDS programs cannot function.

Thus the contractor will play a vital role in supporting the USG’s goal of achieving an AIDS-free generation in our lifetime.

The primary objective of this Contract is to ensure the availability of approved HIV Rapid Test Kits (RTKs) using a global procurement strategy. A RTK defined is an assay for diagnosis of infection with HIV-1/2 or type specific diagnosis of HIV-1 and HIV-2, from which test results can be read directly, within 30 minutes of the time the specimen is applied to the device, without calibration or calculations.

C.2.1 PROCUREMENT OF APPROVED RTKs

The contractor is responsible for the procurement and delivery of approved HIV RTKs. The approved list of HIV RTKs and their manufacturers can be found at:

http://www.usaid.gov/sites/default/files/documents/1864/usaid_approved_test_kit_list.pdf

The approved list of HIV RTKs and their manufacturers is provided in Section J. Section J also contains a listing of the Top Five RTK purchased over the past five years. The contractor will receive all RTK order requests from the holder of the single award IDIQ for procurement and technical assistance, or from other entities approved by USAID. While the Contractor must provide customer service and order fulfillment services for all these orders, including orders received simultaneously, it is not expected that the Contractor will initiate RTK orders on their own initiative.

a) Commodity Procurement and Subcontract Management. The contractor will be responsible for tendering and administering commodity subcontracts through the solicitation, evaluation, negotiation, award, management, and administration of supply http://www.usaid.gov/sites/default/files/documents/1864/usaid_approved_test_kit_list.pdf subcontracts, under USAID technical guidance and in compliance with USG contracting rules. The contractor will be responsible for securing competitive bids through open source tenders or, where sole-source or limited source procurement is required, the Contractor must assist the USG in securing the appropriate waivers by preparing necessary documentation for the waiver requests, and shall be responsible for developing sole source justification documentation when the situation warrants a sole-source subcontract. The contractor is responsible for the proper procurement of commodities in accordance with the FAR, AIDAR, USAID internal policies and procedures and other appropriate government regulations. The contractor must provide and operate a procurement management system that is capable of efficient and transparent processing of all procurement transactions.

b) Commodity Supplier Performance Management. The contractor must track supplier performance through use of supplier performance scorecards. The criteria used in the scorecard must be consistent and comparable across multiple years of the contract and across the variety of RTKs and suppliers. Possible metrics for the score card include, but are not limited to, the following:

• percentage of on-time supplier deliveries

• supplier defect rate

• supplier order cycle time

• percentage of delivered orders as expected and documented

On-time is defined as delivery within 14 calendar days from the promised date.

c) Commodity Procurement Risk Mitigation. The contractor must maintain, communicate, and take action according to its contingency plans and product risk profiles to mitigate the most likely risks affecting supply. Likely risks that affect purchasing may include, but are not limited to:

• production delays

• disruption of raw material and component supplies

• problems with manufacturing capacity

• extreme changes in supply or demand of products

• Shelf life

• long lead times (currently 6-12 weeks)

• theft

• delays receiving order requisitions

• delays receiving pre-order confirmation

• shipment scheduling delays

• reduced accuracy of forecasting and planning

• registration and customs delays

The contractor must have a supply-side risk strategy that helps mitigate upstream risks to the continuous flow of commodities to customers. The contractor must continuously monitor potential problems affecting the supply of RTKs, proactively communicate to the TOCOR and the Mission’s Activity Manager the risks posed by the problems, and co-implement solutions that address the problems.

C.2.2 LOGISTICS

Ensure efficient and high-performing logistics services for HIV RTK delivery and related services.

Under USAID guidance and over the entire period of performance of this Contract, the Contractor may be responsible for managing logistics processes to deliver any commodity to designated points in partner countries, including but not limited to customer order fulfillment, and freight forwarding. The contractor will develop and maintain logistics processes and procedures that are fully compliant with all applicable USG contracting laws and regulations, including the Federal Acquisition Regulation (FAR) and USAID’s ADS policies and procedures.

This activity may include, but is not limited to, the following elements:

a) Customer Order Fulfillment Procedures. The contractor must provide customer service and order fulfillment services for all orders received from the Single-Award IDIQ for Procurement & Technical Assistance mechanism or any requestor approved by USAID.

The approval for procurement will be obtained from USAID and transmitted to the Contractor as a Requisition Order through the Single-Award IDIQ for Procurement & Technical Assistance mechanism. Based upon the contents of the applicable Price Quote and the Requisition Order, the Contractor will place a purchase order with appropriate international or local vendors and coordinate freight forwarding for the order. The contractor must undertake all steps necessary to take and fulfill orders. These steps may include procuring the services of in-country customs clearance agents and freight forwarders. Once the order is placed, the Contractor will communicate all relevant order information (including delivery and consignee information) to the Business Intelligence and Analytics and the Single-Award IDIQ for Procurement & Technical Assistance mechanism to inform in-country coordination and consignee staff. The contractor must have and maintain the electronic interface capability to provide data on current and historical orders to the Single-Award IDIQ for Procurement & Technical Assistance mechanism and Business Intelligence and Analytics mechanisms to inform the customer.

Information to be shared should include, but is not limited to: all elements of the List of Approved HIV Rapid Tests contained in Section J, updated SKUs in the event of a change, estimated total landed cost by mode by SKU broken out by unit cost, freight, insurance, customs, other; and estimated delivery lead time. The contractor should be aware that the list of quality approved RTKs and vendors will be continually assessed and/or modified as new products become available, or if newer, more stringent quality criteria are developed.

b) Insurance. The contractor must possess sufficient insurance to cover the value of the products in transit and/or storage and must ensure secure chain of custody until the commodities are consigned and handed over the intended recipient.

c) Freight Forwarding. The contractor must provide freight forwarding, insurance and consignment that promote efficient and secure delivery of procured commodities. The contractor must ensure timely, accurate, safe, and cost-effective freight-forwarding services for all commodities procured through this Contract. The contractor must be responsible for the secure storage and logistics of these commodities from the point commodities are released by the suppliers, until the point at which the Contractor delivers them to the in-country consignee(s). The contractor, or its own subcontractor, if applicable, must maintain direct control of and responsibility for the consignment and chain of custody control up to the point of consignment in country. The contractor must maintain documentation regarding chain of custody on file for any needed reviews by

USAID.

d) Continuous Quality Improvement. For the life of the project, the Contractor must establish a continuous quality improvement (CQI) process to evaluate and improve its internal processes. The contractor must conduct periodic reviews of logistics practices and results, and participate in the assessment of proposed alternatives. The CQI process may include, but is not limited to, external audits of policies, procedures, and processes, and analysis of data and performance history, as well as other activities. The continuous improvement process also includes identifying special and reoccurring delivery problems and devising timely and cost-effective solutions for them.

C.2.3 QUALITY ASSURANCE AND QUALITY CONTROL

The contractor is responsible for incorporating the appropriate health commodity quality assurance (QA) and quality control (QC) processes. In collaboration with USAID’s QA contractor or USAID designee, the Contractor is responsible for maintaining the appropriate documentation supporting the quality of RTKs procured under this mechanism.

This activity includes, but is not limited to, the following elements:

a) Collaboration with QA Contractor or other USAID Designee. It is the responsibility of the Contractor, in collaboration with USAID and USAID’s QA contractor (or other USAID designee), to ensure compliance with applicable USG and country requirements regarding quality. The contractor must fully cooperate with the QA contractor or other USAID designee in assuring the quality of health commodities. This cooperation may include but is not limited to the following:

i. Collaboration in the design and implementation of efficient and effective quality assurance systems across both organizations.

ii. Cooperative evaluations of the quality of prospective commodity suppliers.

iii. Evaluation of contractor storage and transport conditions.

iv. Continuous communication.

v. Data transparency across contractors

b) Managing Product Recalls. The contractor must immediately identify a recalled product that is in its custody (prior to being consigned) and prevent its delivery to customers.

Should a QA issue necessitating a recall of a product procured by the Contractor be identified after consignment, the Contractor must collaborate with all mechanisms on all USAID-requested activities related to the recall of that product.

C.2.4 METRICS

The contractor shall propose and submit a Performance Monitoring Plan (PMP), which shall include the Continuous Quality Improvement (CQI) process mentioned in section C.2.2d. The PMP shall also define measurable Key Performance Indicators (KPIs) to be used to assess Contractor’s performance on a regular basis. KPIs will highlight the performance focus and level required by USAID to meet the contract requirements and shall be structured to allow for a periodic assessment of the Contractor’s performance. KPIs will be agreed upon by the Contractor and USAID within 90 days of contract award.

The following chart is illustrative of the minimum KPIs the Contractor is expected to include as part of the Performance section of the PMP and of how these KPIs will be used for Contractor evaluation.

Weight Performance indicators Actual performance Comments

25% All shipped commodities are authorized for distribution in their countries of destination

25% Availability for On-Time-Shipment 25% On-Time Delivery at Consignee’s warehouse

25% Responsiveness to USAID (Subjective)

100% Possible Total Earned X%

The actual performance will determine one evaluation status among the following:

Status 90%+ Preferred 70-89% Acceptable <70% Probationary

Evaluation of the Contractor performance shall be conducted on an annual basis by the TOCOR and the Contracting Officer (if available), and shall form the basis of the Contractor’s permanent performance record with regard to this Contract.

C.2.5 DATA VISIBILITY

The contractor must deliver a wide range of data to allow USAID to effectively manage global supply chain activities. The contractor must have the capability of exchanging and reporting data as described in Section F. The following requirements pertain to IT systems are intended to achieve cost efficiencies, clarify data management rights and ensure data is continuously available.

a) Information Systems Capabilities. The contractor must have information system(s) that enable the Contractor to perform the functions described in Section C.2.1 and C.2.2.

b) Data. In addition to management and execution of the contractor’s internal processes, the contractor must make data available for the Business Intelligence and Analytics contractor and other entities as directed by USAID. The contractor is fully responsible for ensuring the integrity, accuracy, completeness and availability of data. The contractor must rectify and complete gaps or issues in the quality of the data as directed by USAID.