Section_J.2_PMI_Task_Order.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)

NEGOTIATED (RFP)

7. ISSUED BY 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 _____________________________ copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until local time _______________________ (Hour) (Date)

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.

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

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

A SOLICITATION/CONTRACT FORM I CONTRACT CLAUSES

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

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

D PACKAGING AND MARKING PART IV - REPRESENTATIONS AND INSTRUCTIONS

E INSPECTION AND ACCEPTANCE

F DELIVERIES OR PERFORMANCE

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

H SPECIAL CONTRACT REQUIREMENTS 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, the offeror will 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 following the terms of this solicitation.

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 OFFER 15A. 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 BY CODE 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: Email

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)

1 N/A 57

SOL-OAA-12-000128

X

U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT

OFFICE OF ACQUISITION AND ASSISTANCE

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

WASHINGTON, DC 20547

See Section L

See Section L

Paul Burford GHcommodityIDIQ@usaid.gov

X 1

X 6-8

X 9-29

X 30-31

X 32

X 33-34

X 35-38

X 39-50

X 51-57

$.00

Christopher J. Egaas

Contracting Officer

President’s Malaria Initiative (PMI) Task Order

TABLE OF CONTENTS

ACRONYMS

SECTION B – SUPPLIES OR SERVICES AND PRICE/COSTS

B.1. PURPOSE

B.2. ORDER TYPE

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

B.4. PRICE SCHEDULE

B.5. LABOR

B.6. ALLOWABLE COSTS

B.7. PAYMENT

SECTION C – STATEMENT OF WORK

C.1 Statement Of Work C.2 Objective 1: Global Commodity Procurement and Logistics C.3 Objective 2: Systems Strengthening – Supply Chain Technical Assistance C.4 Objective 3: Global Collaboration

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

E.2 INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

F.2. PLACE OF PERFORMANCE

F.3. REPORTING REQUIREMENTS

F.4. PERSONNEL

F.5. WORK WEEK

SECTION G – CONTRACT ADMINISTRATION DATA

G.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

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……………………………………………….…………………………….36

G.7 ACCOUNTING AND APPROPRIATION DATA

G.8 CONTRACTOR'S PAYMENT ADDRESS

G.9 TECHNICAL DIRECTIONS/RELATIONSHIP WITH USAID…...……..……………….36

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

H.2 AIDAR 752.225-70 SOURCE AND NATIONALITY REQUIREMENTS (FEB 2012)

H.3 AIDAR 752.7004 EMERGENCY LOCATOR INFORMATION (JUL 1997)

H.4 AIDAR 752.7007 PERSONNEL COMPENSATION (JUL 2007)

H.5 ADDITIONAL REQUIREMENTS FOR PERSONNEL COMPENSATION

H.6 INFORMATION SYSTEM SECURITY

H.7 DEFENSE BASE ACT (DBA) INSURANCE

H.8 AUTHORIZED GEOGRAPHIC CODE

H.9 LOGISTIC SUPPORT

H.10 LANGUAGE REQUIREMENTS

H.11 NONEXPENDABLE PROPERTY PURCHASES AND INFORMATION

TECHNOLOGY RESOURCES

H.12 EXECUTIVE ORDERS ON TERRORISM FINANCING

H.13 FOREIGN GOVERNMENT DELEGATIONS TO INTERNATIONAL CONFERENCES

(JAN 2002)

H.14 752.7032 INTERNATIONAL TRAVEL APPROVAL AND NOTIFICATION

REQUIREMENTS (JAN 1990)

H.15 USAID DISABILITY POLICY (DEC 2004)

H.16 COMPLIANCE WITH SECTION 508 OF THE REHABILITATION ACT OF 1973, AS

AMENDED

H.17 LOGISTIC SUPPORT GOVERNMENT FURNISHED FACILITIES OR PROPERTY 45

H.18 RIGHT TO PROCURE FROM OTHER SOURCES

H.19 REPORTING OF FOREIGN TAXES (JULY 2007)

H.20 NONDISCRIMINATION (June 2012)

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

INDIVIDUAL CONTRACTS AND SF 295 - SUMMARY CONTRACTING REPORT

H.22 SMALL DISADVANTAGED BUSINESS (SDB) PARTICIPATION PROGRAM

TARGET

H.23 SUBCONTRACTING CONSENT

H.24 CONSCIENCE CLAUSE IMPLEMENTATION (FEBRUARY 2012)……………………48

H.25 CONDOMS (JUNE 2005)…………………………………………………..…………………49

H.26 PROHIBITION ON THE PROMOTION OR ADVOCACY OF THE LEGALIZATION

OR PRACTICE OF PROSTITUTION OR SEX TRAFFICKING (APRIL 2010)…...…………48

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) ……………………….…………………………………………………………………………53

ACRONYMS

ACT Artemisinin-based combination therapy APS Annual program statement CDC Centers for Disease Control CHAI Clinton Health Access Initiative DIFD Department for International Development (United Kingdom) GH Global health ITN Insecticide treated net LLIN Long-lasting insecticide treated net NGO Non-governmental organization IPTp Intermittent preventive treatment for pregnant women IDIQ Indefinite Delivery, Indefinite Quantity contract PMI President’s Malaria Initiative QA Quality assurance RFTOP Request for task order proposal RDT Rapid diagnostic test TOCOR Task order contracting officer’s representative USAID United States Agency for International Development USG United States Government WHO World Health Organization

SECTION B – SUPPLIES OR SERVICES AND PRICE/COSTS

B.1. PURPOSE

The purpose of this Task Order is to provide USAID Missions, Bureaus, and operating units with a worldwide mechanism to support the President’s Malaria Initiative’s (PMI) and USAID’s goal of reducing the burden of malaria and supporting related activities pursuant to USAID’s maternal and child health and other infectious disease goals. The Task Order will primarily support USAID’s implementation of malaria programs through the procurement, management and delivery of high quality, safe, and effective malaria commodities; the provision of on the‐ground logistics, supply chain, and related systems strengthening technical assistance and implementation capacity; and provide technical leadership to strengthen the global supply, demand, financing, and introduction of existing and future malaria commodities.

Upon request from USAID, this Task Order may be called upon to serve the needs of related maternal child health other infectious disease programs when consistent with malaria programmatic activities. This task order 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.

The IDIQ requirements and terms are not repeated within this TO but are additive to the terms of this TO; therefore, this document is a streamline representation of PMI’s unique needs. The combination of the IDIQ and TO terms and conditions represent the full set of contractual requirements from the PMI program.

B.2. ORDER TYPE

This is a cost plus fixed fee, term type contract. For the consideration set forth in the contract, the Contractor shall provide the deliverables or outputs described in Section C and comply with all contract requirements.

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

(a) The estimated amount for the performance of the work required hereunder, exclusive of any fixed fee is $__________. The fixed fee is $__________. The estimated cost plus fixed fee is $_________.

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

(C) Funds obligated hereunder are anticipated to be sufficient through TBD.

B.4. PRICE SCHEDULE

The total Summary budget is:

Line Item Year 1 Year 2 Year 3 Year 4 Year 5 TOTAL

1. TOTAL LABOR

Headquarters Labor Direct Salaries $ HQ Consultants $ Total HQ Labor Costs $ Field Labor Direct Salaries $ Field Consultants $ Total Field Labor Costs $

TOTAL LABOR $

2. FRINGE BENEFITS

HQ Fringe $ Field Fringe

TOTAL FRINGE

BENEFITS

3. SUBCONTRACTS

HQ Subcontracts $ Field Subcontracts $

TOTAL SUBCONTRACTS $

4. TRAVEL, TRANSPORTATION & PER DIEM

HQ Travel & Per Diem Field Travel & Per Diem Total Travel, Transportation & Per Diem

5. ALLOWANCES $

6. OTHER DIRECT

COSTS

Sub-Total Direct Costs $ $ $ $ $ $

7. INDIRECT COSTS

Overhead G&A (If Any)

TOTAL INDIRECT COSTS $

Sub-Total (Direct + Indirect) $ $ $ $ $ $

8. FIXED FEE % % % % % $

9. COMMODITY PROCUREMENT

Malaria products 241M 248M 256M 263M 271M $1,279M Cost Recovery on Commodities

Sub-Total Commodity Procurement

TOTAL CPFF $ $ $ $ $ $

B.5. LABOR

The following is the price schedule per year, please note that CLINs contain multiple positions/individuals per Labor Category (chart filled upon award):

CLIN Labor Category Daily Rate Level of Effort Total 0001 A $ $ 0001 B $ $ 0001 C $ $ 0001 D $ $ 0001 E $ $ 0001 F $ $

B.6. ALLOWABLE COSTS

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.

B.7. PAYMENT

The paying office is (See Section G)

[END OF SECTION B]

SECTION C – STATEMENT OF WORK

C.1 STATEMENT OF WORK

C.1.1. Background

The President’s Malaria Initiative (PMI)

Malaria prevention and control is a major focus of US Government foreign assistance objectives.

PMI was launched by President Bush in 2005 and continued as a key objective of the Global Health Initiative by President Obama, is the US Government’s program to reduce the burden of malaria and mortality by accelerating delivery and scale up of proven prevention and treatment malaria interventions. PMI is an interagency initiative led by USAID and implemented together with the Centers for Disease Control (CDC). It is overseen by the US Global Malaria Coordinator, who is advised by an Interagency Advisory Group, comprised of representatives of USAID, Centers for Disease Control and Prevention, Department of Health and Human Services, Department of State, Department of Defense, National Security Council and the Office of Management and Budget. Implementation of the Initiative is closely coordinated with the efforts of partner governments and national and international partners, including the non-governmental and private sectors.

The PMI strategy is based on the goals and objectives mandated in the Lantos-Hyde United States Leadership against HIV/AIDS, Tuberculosis, and Malaria Act. It aims to halve the burden of malaria (morbidity and mortality) in 70 percent of the at-risk populations in Africa (approximately 450 million residents) over the six-year funding period (2009-2014) of the USG Global Health Initiative. A key priority of the PMI in focus and non-focus countries and regional programs will be the provision and management of lifesaving commodities including insecticide-treated nets (ITNs), especially long-lasting insecticide treated nets (LLINs), effective treatment with artemisinin-based combination therapies (ACTs), and drugs for the treatment of uncomplicated and severe malaria, insecticides, equipment and supplies for indoor residual spraying (IRS), antimalarial drugs for the intermittent preventive treatment for pregnant women (IPTp), rapid diagnostic tests (RDTs) and laboratory supplies and equipment for malaria diagnosis. In addition to this established set of interventions, PMI will also focus on implementing new evidence-based policies, interventions and strategies as they emerge that could have a significant impact on the prevention and treatment of malaria.

There are several new commodity based interventions and innovations that are expected to emerge and added to the intervention mix to achieve malaria control. These may include, but are not limited to: vaccines, new first-line malaria treatments (both artemisinin and non-artemisinin based), new medicines for use in IPTp, seasonal malaria chemoprevention, new vector control tools such as durable wall linings and new LLIN technology that combats insecticide resistance.

This task order must support the implementation of new interventions and related technologies by providing procurement, logistics, and delivery support through any means required to achieve PMI and USAID’s malaria health outcomes.

Related procurement and logistics contracts

Several USAID Global Health mechanisms exist or will be developed in the future that either directly or indirectly support the implementation of PMI’s and USAID’s malaria program.

1. The DELIVER Task Order 3 and Task Order 7 have supported PMI’s malaria commodity procurement and supply chain work to date http://deliver.jsi.com/dhome/health/malaria.

2. The Indoor Residual Spray IDIQ http://www.pmi.gov/technical/irs/index.html provides implementation and technical leadership in the areas of indoor residual spraying and vector control.

3. The NetWorks Project http://www.networksmalaria.org/ implements a comprehensive approach to improving LLIN distribution systems, by developing stronger, more efficient distribution programs to ensure broader coverage and correct use of this life-saving intervention.

4. The System for Improving Access to Pharmaceuticals and Services (SIAPS) project http://siapsprogram.org/ continues to provide technical assistance in the areas of logistics, pharmaceutical management and ACT implementation.

5. The United States Pharmacopeia Promoting the Quality of Medicines http://www.usp.org/global-health-impact-programs/promoting-quality-medicines-pqmusaid project continues to provide technical assistance to country programs to help ensure the quality of antimalarial drugs, and develop and reinforce existing national drug laboratory systems to better enable drug quality monitoring.

Other PMI cooperative agreements and contracts can be found on www.pmi.gov. In addition, the Contractor will be required to coordinate with the above USAID mechanisms plus others, Global Fund and other donors, National Malaria Control Programs, and Essential Drugs and National Food and Drug Administrations as necessary, Central/National Medical Stores, and others that are described further in section C.3 of this document to support worldwide commodities procurement and implementation goals of the PMI.

C.1.2. TASK ORDER OVERVIEW

• Objective 1: Improve the provision of health commodities through global commodity procurement and logistics.

• Objective 2: Strengthen in-country supply chain systems through supply chain technical assistance.

• Objective 3: Global collaboration to engage strategically to improve long term global supply of health commodities.

The Contractor must develop malaria commodity procurement and supply chain technical assistance program that is responsive to USAID’s current and future malaria objectives and programmatic approaches. However, there is the possibility that other governments, NGOs, private sector, or public organizations may order, finance, obtain and report on commodities through this contract mechanism. If that need arises, and upon request from USAID, the

Contractor will provide procurement services and/or related technical assistance for these other organizations.

The Contractor must develop an implementation plan that includes evidence-based strategies that identify and implement best practices for systems strengthening and integration, deploy innovative solutions to problems in supply chain management and long-term commodity availability, leverage global and local partnership efforts, build local capacities and increase country ownership, and produce measurable results. The Contractor must develop roles and responsibilities with and leverage the capacities of local (in-country) partners in the commercial, NGOs, and public sectors (as appropriate) for the execution of the Task Order’s work.

USAID also encourages the Contractor to collaborate with private businesses, utilizing an approach both with local or regional nonprofit/private business when feasible and appropriate, as well as with US small or disadvantaged businesses.

C.2 OBJECTIVE 1: GLOBAL COMMODITY PROCUREMENT AND LOGISTICS

The Contractor must be prepared to perform the following tasks under Objective 1.

C.2.1 Health Commodity Procurement

The Contractor will be responsible for the timely procurement, delivery, and management of commodities, per agreed cost and shipment date as provided under the task order, including, without limitation, by purchase order, and/or OAA approval package, and/or COR agreement.

The contractor will not receive a fee on the cost of commodities that it procures and DISTRIBUTES. THE Contractor may recover cost of headquarters procurements teams (the level of effort) as a DIRECT COST.

The Contractor must use firm fixed price subcontracts for procurement of commodities, unless is the Contractor can demonstrate and document for the file a clear cost benefit and risk mitigation to using an alternative contracting arrangement for commodity procurement.

The Contractor must further be responsible for redressing any failures to meet terms and conditions of commodity delivery through, without limitation, adequate supervision and management of vendors and/or subcontractors, insurance claims, ensuring adequate contractual remedies, and enforcing contractual remedies on vendor subcontracts.

The Contractor should anticipate managing malaria and related commodity procurement volume in the range of $225-$300 million on an annual basis. The exact type and value of the commodities cannot be predicted at this time. Each year, exact procurement needs will be outlined in the malaria operational plans (MOP) which can be found on www.pmi.gov. In addition, the PMI annual reports available http://www.pmi.gov/resources/reports/index.html as well as the data provided in IDIQ Section J.9 provide historic information on the number and types of commodities procured over time.

Commodities to be procured under this task order will include, but are not limited to the following:

• Insecticide-treated nets (ITNs) including long-lasting insecticide-treated nets (LLINs);

• Drugs including but not limited to artemisinin-based combination therapies (ACTs), sulfadoxine-pyrimethamine, chloroquine, primaquine and artesunate drugs for use in the treatment of severe malaria including equipment for parenteral administration;

• New malaria medicines, vector control technologies, vaccines, and commodities as needed;

• Maternal child health and other infectious disease medicines and supplies when requested by USAID and consistent with the goals and objectives of this Task Order;

• Rapid diagnostic tests (RDTs) and equipment for safe storage, disposal and transport;

• Laboratory equipment and supplies including microscopes, stain and slides; and

• Other commodities as approved by USAID.

The Contractor should have the capacity to provide procurement services as detailed below on a worldwide basis to any country designated by USAID.

C.2.1.1. Health Commodity Strategic Sourcing

The Contractor must develop and implement strategic sourcing strategies and procurement operations with demonstrated ability to obtain best value. The Contractor must continuously review the marketplace for commodities and continuously review its supply contracts to ensure strategic alignment with USAID goals and to ensure that the USG is receiving the best value.

The contractor must ensure, via a continuous, structured strategic sourcing process, that commodity procurement operations are acquiring health commodities. This strategic sourcing process must, at a minimum, take into account:

• the current and projected state of the supplier base, customer locations and volumes, changes to QA protocol and changes in supplier QA status, risks to continuous supply, storage and transport cost considerations and coordination or procurement with other donors.

• the emergence of new health commodities and/or new suppliers.

• the emergence of other health priorities and/or unforeseen events.

The contract must maintain the flexibility to manage commodity transitions in the phase-out of existing commodities and the introduction of new commodities as per applicable guidelines.

C.2.1.2. Health Commodity Selection

As stated in the IDIQ requirements and in addition:

The contractor must meet USAID’s ADS 312 requirements for the purchase of commodities.

The contractor must define and execute prequalification processes and criteria for malaria commodities. This is accomplished by working with domestic and international standards and partners as appropriate. The contractor must identify and partner with international organizations, technical bodies, and other partners to develop prequalification criteria for USAID-procured health commodities. Examples include:

• other UN Agency prequalification;

• prequalification through internationally recognized wholesalers;

• technical bodies such as the U.S. Food and Drug Administration;

• the European Medicines Agency;

• the WHO Prequalification Project;

• the WHO Pesticide Evaluation Scheme; and

• other agencies

Criteria will be based on technical input from USAID, other USG agencies, and other experts as designated with respect to dimensions such as quality and efficacy. This list of products, with characteristics such as pack size, cost, etc. and vendors will be assessed and modified as new products become available or newer, more stringent quality criteria are developed.

This list of malaria products are referred to as “Illustrative List of Commodities” as described in IDIQ Section J.8.

C.2.1.3. Health Commodity Procurement and Subcontractor Management

As stated in the IDIQ requirements.

C.2.1.4. Commodity Procurement Risk Management.

The Contractor must develop, continuously update, and maintain contingency plans and product risk profiles to mitigate the most likely risks affecting supply that could in turn result in a resurgence of malaria or loss of life. Likely risks that affect this constant and reliable flow of health commodities 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;

• long lead times;

• theft;

• reduced accuracy of forecasting and planning;

• registration and customs delays.

The contractor must maintain a risk management strategy that will maximize the continuous flow of key, critical malaria commodities, particularly medicines. The contractor must continuously monitor potential problems affecting supply, communicate such risks to USAID, and propose solutions to USAID that best address such issues.

As part of PMI’s risk mitigation strategy, the contractor must order monthly deliveries of, on average, 500,000 to 750,000 treatments of branded artemether lumefantrine and branded artesunate amodiaquine for the stockpile inventory, which is subsequently allocated to different countries based on need. The weight-band distribution of each presentation of ACTs must be determined in collaboration with the USAID/PMI team at the beginning of the task order and at the beginning of each ordering period (annually or semi-annually). The contractor should be prepared to expand stockpile holdings to include additional ACT products if/when necessary and at the discretion of USAID/PMI. At present, the inventory is maintained in a UPS leased warehouse located in Roermond, Netherlands due to flight locations to Africa and proximity to key suppliers. The contractor must maintain inventory/stockpile in a location with similar proximity to Africa and key suppliers.

C.2.1.5. Health Commodity Supplier Forecasting

The contractor must maintain and communicate current and accurate order forecasts to its suppliers for all malaria commodities. Annual forecasts will be determined in collaboration with appropriate in-country partners based on in-country need and in line with Malaria Operations Plans (MOP) which are available at www.pmi.gov. At a minimum, these forecasts should take into account and link to the following:

• Current stock-on-hand

• Demand forecasts developed at both the global and country level

All historical commodity supplier forecasts must be maintained in an analyzable form such as a single spreadsheet, and the forecasts must be comparable to actual orders placed with suppliers for each review period. The contractor must make the commodity supplier forecasts available to the BI contract.

C.2.1.6. Health Commodity Customer Demand Forecasting

The contractor must work with appropriate in-country partners to forecast the customer demand for malaria commodities, identifying the type, quantity, and timing of those commodities to be procured under this mechanism. On an annual basis, the contractor must forecast the demand for ACTs, LLINs and RDTs in each PMI country. Forecasting for other malaria products vary between countries and are outlined in country MOPs. Where appropriate, the contractor must coordinate with other entities procuring the same commodities to improve the customer demand forecast accuracy and coordinate the commodity procurement and supply planning.

The health commodity customer demand forecasting accuracy must be tracked across the life of the contract, over time and across commodities and countries. All historical commodity http://www.pmi.gov/ supplier forecasts must be maintained in an analyzable form such as a single spreadsheet, and the forecasts must be comparable to actual orders placed by customers for each review period.

C.2.1.7. Product Registration

The contractor must identify suppliers that meet global and/or country registration requirements for the health commodities procured under this contract. While compliance with country registration requirements and other registration requirements remains the responsibility of the suppliers, the contractor may be called on to facilitate the product registration process by articulating to both the supplier and the country drug regulatory authority, the particular need for a product by USAID programs in-country. The contractor must maintain a current and accurate database of the products registered in each country.

C.2.1.8. Health Commodity Supplier Performance Management

C.2.1.9. Performance Management and KPIs

The Contractor must coordinate commodity procurements and deliveries with other international donors, particularly the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM), and partner country counterparts. The contractor must liaise with existing international donors and initiatives such as the Global Fund, UNICEF, UNITAID, the Roll Back Malaria Global Partnership, the World Health Organization, to ensure a coordinated approach for the forecasting, purchasing, tracking and delivering of malaria commodities. In some cases, USAID may call upon the contractor to complete procurements on behalf of other international donors, in collaboration with USAID.

C.2.1.10. Coordinated Health Commodity Procurement

C.2.1.11. Continuous Improvement.

C.2.2 Logistics. Logistics services for commodity delivery

The Contractor must manage any and all logistics processes to deliver malaria commodities to any point in a partner country. Logistics functions may include, but not be limited to:

• customer order fulfillment;

• freight forwarding;

• obtaining tariff exemptions;

• customs clearance;

• warehousing;

• transportation; and

• inventory management.

All functions and processes must be fully compliant with all applicable USG laws and regulations. This activity includes, but is not limited to, the following elements:

C.2.2.1. Customer Order Fulfillment

C.2.2.2. Warehousing and Inventory Management

As stated in the IDIQ requirements.

C.2.2.3. Freight Forwarding and Transportation

As stated in the IDIQ requirements.

C.2.2.4. In- Country Commodity Distribution.

As stated in the IDIQ requirements and in addition:

To the greatest extent possible, the point at which commodities are consigned in-country should be appropriate to ensure the physical security and integrity of the commodities to their point of consumption. As necessary, USAID requires that the Contractor must be capable of distributing products to the “last mile,” including directly to beneficiaries, as requested by USAID using multiple channels – public, private and community. For example, the Contractor must support LLINs campaign logistics including distribution and temporary warehousing to the household level. In cases where the Contractor is managing in-country supply chain operations, the contractor must also have the capacity to collect related and appropriate data at all levels of engagement (e.g., commodity stock data, case management data, etc.) The Contractor must also implement and augment direct supply chain logistics and capability to the facility or community level for malaria and related commodities. In addition to the capability for delivery to the “last mile” (e.g. health facility, community and/or individual households), the contractor must also have the capacity to provide related technical assistance on use (e.g., distribution of IEC/BCC materials on proper use of nets or how to hang nets) as well as have the capacity to collect logistics and related data at the “last mile.” Refer to the Malaria Operations Plans at www.pmi.gov for indicative LLIN distribution plans.

C.2.2.5. Financial Management.

C.2.2.6. Continuous Improvement.

C.2.3 Health Commodity Quality Assurance. Provide Health Commodities That Meet Required Quality Requirements

The Contractor must ensure that appropriate quality assurance and quality control (QA/QC) processes are in place and maintained for as long as the contractor retains chain of custody of the commodities. The contractor must acquire and maintain appropriate documentation supporting the quality certifications for all malaria commodities and related essential health commodities that are procured under this mechanism. These QA/QC processes ensure the quality of the commodities, and that commodities have met certain safety requirements. This activity includes but is not limited to the following elements:

C.2.3.1 Collaboration with QA Contractor and other USAID Designee.

It is the responsibility of the contractor, in collaboration with USAID, to ensure compliance with applicable USG and country requirements regarding quality. The contractor must fully cooperate with USAID in assuring the quality of malaria and related health commodities.

C.2.3.2 Adherence to USAID’s Quality Assurance Requirements.

Only quality assured commodities that have been approved by USAID may be procured by the contractor. The Contractor must ensure compliance with applicable USG and country requirements regarding all aspects of quality and related specifications. The Contractor must be responsible for acquiring and maintaining appropriate documentation supporting the quality certifications of pharmaceuticals, RDTs and vector control commodities. The Contractor must ensure that QA/QC processes are in place, maintained throughout the supply chain and reviewed/revisited periodically to ensure all standard operating procedures reflect the most up-to-date, internationally accepted practices. The Contractor must have the ability to independently sample and perform testing of procured products and to support pre-acceptance quality testing in-country when necessary, and to continually update QA/QC processes to ensure compliance with evolving innovations and industry best practices. The Contractor must possess the ability to subcontract with different laboratories that are certified and have demonstrated capabilities testing malaria pharmaceuticals, ITNs/LLINs and RDTs and future malaria-related products (e.g., new chemical entities under development intended to treat malaria but not yet approved).

The Contractor must demonstrate an understanding of and ability to apply domestic and international guidelines, policies, and regulations regarding the quality, safety, efficacy and use of malaria pharmaceutical products, LLINs and diagnostic supplies and equipment. The Contractor must demonstrate their understanding of the challenges of providing these products, and addressing issues common to the procurement and management of antiinfectives for use in developing countries, such as sub-standard antimalarial medicines.

The Contractor must also address the technical challenges in testing these commodities for quality. Additionally, the Contractor must recognize a dynamic and shifting procurement environment and respond accordingly, adapting QA/QC policies as necessary to be responsive to new products as they become available.

The Contractor must collaborate, communicate and share information, as mandated by USAID, on a timely basis with any designated USAID personnel or external partner.

C.2.3.3 Managing Product Recalls.

C.2.3.4 In-House QA Capability.

As stated in the IDIQ requirements and in addition:

For this task order the contractor must propose and demonstrate the ability to independently establish a QA operation for health commodities procured under this task order. QA operations for this task order include, but are not limited to, the following

Quality Assurance (QA)

a) Establish a QA strategy addressing the requirements of the task order. The quality assurance strategy must include appropriate standard operating procedures 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. As part of the QA strategy, 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.

ITNs and rapid diagnostic tests RDTs for malaria are also subjected to quality testing to assure acceptable performance. With the exception of ITNs, all testing must be conducted prior to the release of product from quarantine; test results must be reviewed and approved by both the contractor and USAID.

b) Prequalifying wholesale distributors and manufacturers of malaria-related and other health commodities to support the task order. The contractor must evaluate identified vendors (i.e., either manufacturers and or wholesale distributors) for compliance with quality standards and recommend approval or disapproval to USAID. The approved vendors are eligible to provide health commodities to USAID under this task order.

Regarding currently approved and prospective wholesale distributors, the contractor must:

i. Develop or adopt a quality assurance audit checklist. Audits must include but are not limited to: a review of SOPs, a physical inspection of warehouse(s), and a review of prequalification procedures and files, thereby enabling the Contractor and USAID to objectively evaluate vendors.

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

iii. Prepare audit reports with observations and, if necessary, the corrective action plan, and present to the wholesale distributor and to USAID. The Contractor must monitor the implementation of recommended corrective actions as needed, based on an agreed upon timeline. The 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 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 Contractor must recommend corrective actions to the wholesale distributor and notify USAID of such corrective actions. In addition, the 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) Collaborating with other international organizations to harmonize quality assurance practices. The Contractor must collaborate with other international organizations such as UNICEF and WHO on quality assurance activities and standards. The Contractor must review and evaluate approval processes employed to review potential vendors, applied by other international organizations and, if acceptable, USAID will approve potential vendors based on these reports. Such collaboration with international partners will result in a reduction of duplicative effort and avoidance of significant costs. Ultimate approval and acceptance of vendors and distributors approved through QA/QC processes of other international organizations remains, however, at the discretion of USAID.

d) Maintaining a robust strategy of QC activities that fit within the overall QA strategy as appropriate for malaria-related and other health commodities procured under the task order.

e) Maintaining appropriate documentation and dossiers supporting the quality certifications of pharmaceuticals and other health-related commodities provided by the task order. Documentation Includes but is not limited to the following:

• Certificates of analysis

• Test results

• Product labeling and labeling changes

• Relevant safety alerts of other organizations

• Regulatory status of relevant manufacturers with supporting documentation

• Credentials for testing laboratories

• Product recall information

f) Developing a recall management plan with communication protocol to initiate and manage recalls under the task order.

Quality Control

a) Oversee product-specific sampling protocols across all malaria-related and other health commodities, including appropriate handling, transport and storage to ensure strict chain-of-custody as appropriate under the task order. Specifically, the Contractor must develop and propose a risk-based sampling strategy for each type of malaria and health commodity.including the appropriate sampling methodology of contract awarded. The sampling strategy must identify risk levels for each health commodity and propose corresponding sampling frequencies based on this determination. This comprehensive sampling strategy must include sampling at various points in a supply chain, including manufacturing site, in transit, or after delivery. The Contractor must process collected samples including secure, appropriate transport to the appropriate laboratory testing facility. The Contractor must provide documentation and services needed to assure transit and port clearance of samples. The Contractor must maintain complete and accurate records and documentation at each step of the sampling process and must work closely with the procurement team in order to collect and process samples appropriately.

b) Harmonize sampling with rigorous, product-appropriate testing regimen using qualified laboratories for products provided under the task order. The Contractor must identify and establish contractual relationships with a number of appropriately qualified laboratory testing facilities capable of producing reliable, accurate, and precise testing results. The contractor must demonstrate that it is using the most cost-effective testing facilities to test health commodities. The Contractor must select specific laboratories that have the requisite testing capabilities to test health commodities with health commodity specific requirements. The Contractor must obtain USAID approval for use of such laboratories. Facilities that provide quality control testing of health commodities must be ISO-17025 certified, WHO pre-qualified, or otherwise approved by USAID. The Contractor must respond to multiple, diverse and simultaneous demands for quality services. The Contractor must have an understanding of product-specific technical requirements in order to develop quality control processes. Required testing capabilities include but are not limited to the following:

• Pharmaceuticals – i.e. full monograph, or separate analyses, and sterility according to monographs in the United States Pharmacopoeia (USP), the British pharmacopoeia (BP), or the International Pharmacopoeia (IP). In some cases an in-house method may be used if appropriate but only when authorized to another qualified laboratory via a technology transfer.

• Rapid Diagnostic Tests – e.g., sensitivity, stability and compliance with any other requirements of the approved manufacturing package insert.

• Insecticide Treated Bednets – i.e., physical inspections (visual, bursting strength), and analytic assays to determine chemical content (e.g., HPLC, GC).

The Contractor must provide a report to USAID on the results of quality testing for health commodities. This report should include all elements of testing, for example identity, assay, and other pharmacopoeial requirements for pharmaceuticals that are tested. The Contractor must also report all out of specification (OOS) results to USAID. Health commodities failing quality testing may present a risk to patients.

The Contractor must take action to mitigate any risks to the patient/recipients or the US Government, as directed by USAID. This action may include consultation with a pharmacist at USAID (a list will be provided by USAID) and a product recall if directed by USAID.

c) Maintain sample retention program for some malaria-related products, as determined by USAID as part of QC program as needed under the task order. The purpose of the retention store is to preserve sample batches of health commodities procured by the Procurement Contractors. These sample batches may be required at a future date to confirm (or not) the quality of the product. The QA Contractor must store retained samples in a health commodity retention store, the location(s) of which must be decided and agreed to by both the QA Contractor and USAID.

d) Conduct analyses on quality trends based on accumulated data to inform QA/QC practices as needed under the task order.

e) Manage data generated from testing and recommend recalls when appropriate for malaria-related and other health commodities needed under the task order.

C.2.4 Data Visibility. Provide Appropriate Visibility of Data

C.2.4.1. Information Systems Capabilities.

C.2.4.2. Data.

C.2.4.3. Data Standards.

C.2.4.4. Data Loss Prevention.

C.2.4.5. Updates to Information Systems.

C.2.4.6. Data Ownership.

C.2.4.7. Existing Support Tools.

C.2.4.8. Product Ordering & Tracking.

C.3 OBJECTIVE 2: SYSTEMS STRENGTHENING – SUPPLY CHAIN TECHNICAL ASSISTANCE.

This Task Order defines in-country supply chain systems broadly and includes public, private, and non-profit sectors. The contractor must have the capacity to work in countries with supply chains of varying degrees of complexity and capacity. The contractor must address USAID’s commitment to building high performance and responsive supply chains through the provision of technical assistance as described in the terms and conditions of the

IDIQ.

Details for PMI focus countries can be found at http://www.pmi.gov/countries/mops/fy13/index.html. This list of countries and type of technical assistance is not intended to be exhaustive and is expected to change and potentially expand over the life of the Task Order. The Contractor must have the capacity to respond to increasing or changing demand for technical assistance or direct implementation support, including “last mile” delivery. The Contractor should have the capacity to mobilize short term technical assistance and implementation support to any country that is receiving USAID/PMI financed commodities currently and in the future.

Tasks under this component objective will primarily be driven by Mission and partner country needs. The Contractor is required to devise flexible and creative solutions to meet the unique needs of each country and ensure that quality commodities reach the end user.

C.3.1. Strategic Planning: Provide Strategic Planning and Design Assistance

The contractor, in collaboration with country partners, must provide systems strengthening technical assistance to support the strategic planning activities related to supply chain management and commodity security.

The Strategic Planning technical assistance tasks include, but are not limited to, the following:

C.3.1.1. Supply Chain Strategic Plan Development.

C.3.1.2. Strategic Implementation.

As stated in the IDIQ requirements

C.3.2. In- Country Logistics

The contractor must provide both short- and long- term technical assistance to partner countries in supply chain management and commodity security. The In-Country Logistics technical assistance tasks include, but are not limited to, the following:

C.3.2.1. Commodity Quantification and Forecasting.

In collaboration with partner country counterparts, the contractor must provide technical assistance to partner country counterparts to reliably quantify, forecast and support supply planning for all classes of malaria and related commodities. To the greatest extent possible, the methodologies to quantify these commodities must include and incorporate aspects such as the epidemiology of malaria, consumption, seasonality, and behavior. The contractor must provide technical assistance to health care and service-delivery programs in the timely submission of accurate forecasting data, procurement requests, and as necessary, detailed supply plans. The contractor must assist programs to ensure compliance that procurement requests reflect national treatment guidelines, local drug product registration requirements, and other related regulations. When requested by USAID, the contractor must provide assistance to country stakeholders in new product quantification, forecasting, and procurement planning for future transitions to newer and more efficacious products or new interventions such as seasonal malaria chemoprophylaxis. The contractor must provide technical assistance to countries, routinely collaborate and convene with stakeholders, and support the development of clearly understood, dependable systems, used by all service delivery programs dependent on USG-funded supplies, for the estimation of re-supply needs.

C.3.2.2. Health Commodity Supply Planning.

C.3.2.3. Procurement.

As stated in the IDIQ requirements.

C.3.2.4. Health Commodity Warehousing and Inventory Management.

As stated in the IDIQ requirements and in addition:

In collaboration with partner country counterparts, the contractor must provide technical assistance related to equipment and storage requirements for the proper management of supplies when requested by USAID. If requested to do so by USAID, the contractor must evaluate critical equipment and storage needs to ensure the storage conditions support the desired quality assurance standards and procedures and the secure storage of supplies on a short and longer term basis. The contractor may, from time to time, be requested by USAID to advise and/or oversee warehouse/facility design and construction, racking, refurbishment, etc.