72065621R00001 RFP.pdf

Date Issued: October 19, 2020

Closing Date for Submission of Questions: 3:00PM Maputo Time, October 26, 2020

Closing date for Submission of Past Performance: November 13, 2020

Closing date for Receipt of Proposals: 3:00PM Maputo Time, November 20, 2020

Subject: Request for Proposals (RFP) No. 72065621R00001

Adapting and Modifying Optimized Sample Transport Routes for Achieving Impact (AMOSTRA) in Mozambique

Dear Sir/Madam:

The United States Government, represented by the United States Agency for International Development (USAID) Mission in Mozambique is seeking proposals from qualified organizations interested in providing the services under the Adapting and Modifying Optimized Sample Transport Routes for Achieving Impact (AMOSTRA) Activity as described in the attached solicitation.

This procurement will be conducted under a full and open competition under which US and other organizations within Geographic Code 935 are eligible to compete and the North American Industry Classification (NAICS) code is 541990. The procedures set forth in Federal Acquisition Regulation (FAR) Part 15 will apply.

USAID/Mozambique anticipates awarding one Cost-Plus Incentive Fee-Performance Incentive (CPIF-PI) type contract as a result of the solicitation. The estimated cost range for this procurement is $15 million for the implementation of this activity for a total estimated period of 3 years plus 2 option years, subject to availability of funds. Offerors must propose costs that are realistic and reasonable corresponding with their technical approach.

USAID encourages participation to the maximum extent possible of small business concerns, small disadvantaged business concerns, and women-owned small business concerns in this activity as the prime contractor or as subcontractors in accordance with Part 19 of the FAR.

The RFP and any amendments to this solicitation will be issued and posted on the Contract Opportunities website at https://beta.sam.gov. It is the Offeror’s responsibility to check the https://www.fbo.gov/ website periodically for official updates and amendments to the solicitation. It is the responsibility of the recipient of this solicitation document to ensure that it has been received from the internet in its entirety and USAID bears no responsibility for data errors resulting from transmission or conversion processes.

Offerors are encouraged to read the entire solicitation, which includes the closing date and time, all pertinent contract requirements, and the conditions and instructions required for submitting a proposal. Pursuant to Block 12 of Standard Form 33 of this RFP, USAID requires that offers stay valid for 270 days from the closing date of this RFP.

The primary point of contact for this RFP is Ms. Petrina Williams. Any questions related to this RFP must be submitted by email to mteixeira@usaid.gov with a copy to Petrina Williams at pwilliams@usaid.gov by 3:00 p.m. Maputo Time on October 26, 2020. No questions will be accepted after this date. Each email must contain a subject line, which clearly indicates the name of the offeror and the solicitation number. Any amendments to this solicitation will be furnished via https://beta.sam.gov.

Proposals in response to this RFP are due by electronic mail to Petrina Williams at pwilliams@usaid.gov with a copy to Marianne Pinto-Teixeira at mteixeira@usaid.gov no later than 3:00 p.m. Maputo Time, on November 20, 2020.

The issuance of this solicitation in no way obligates USAID to award a contract, nor does it commit USAID to pay for any costs incurred in the preparation and submission of the proposal.

Furthermore, the Government reserves the right to reject any and all offers, if such action is considered to be in the best interest of the Government.

Thank you for your interest in USAID programs.

Sincerely, Petrina Williams Contracting Officer mailto:mteixeira@usaid.gov mailto:pwilliams@usaid.gov https://www.fbo.gov/ mailto:pwilliams@usaid.gov

U.S. Agency for International Development/Mozambique Office of Acquisition and Assistance Rua 1231, No., 41 Bairro Central “C”, Maputo, Mozambique

REPRESENTATIONS, CERTIFICATIONS AND OTHER

EVALUATION FACTORS FOR AWARD

INSTR., CONDS., AND NOTICES TO OFFERORS

LIST OF ATTACHMENTS

CONTRACT CLAUSES

SPECIAL CONTRACT REQUIREMENTS

CONTRACT ADMINISTRATION DATA

DELIVERIES OR PERFORMANCE

INSPECTION AND ACCEPTANCE

PACKAGING AND MARKING

DESCRIPTION/SPECS./WORK STATEMENT

SUPPLIES OR SERVICES AND PRICES/COSTS

SOLICITATION/COCONTRACT FORM

258 21 352189 Marianne Pinto-Teixeira

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

UNDER DPAS (15 CFR 700)

2. CONTRACT NUMBER 3. SOLICITATION NUMBER

72065618R00008

4. TYPE OF SOLICITATION 5. DATE ISSUED

REQ-656-18-000012

SEALED BID (IFB)

NEGOTIATED (RFP)

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7) SAME AS NUMBER 7

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

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

(Hour) (Date) CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. 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 I

B PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

C J

D PART IV - REPRESENTATIONS AND INSTRUCTIONS

E F G L H M

K STATEMENTS OF OFFERORS

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

12. In compliance with the above, the undersigned agrees, if this offer is accepted within 270 calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT 10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS (%) (See Section I, Clause No. 52-232-8)

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

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

CODE FACILITY 16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN 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 G.6 (4 copies unless otherwise specified)

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

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

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

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

(Signature of Contracting Officer)

(REV. 9-97)

10. FOR INFORMATION CALL:

11. TABLE OF CONTENTS

STANDARD FORM 33

SOLICITATION

OFFER (Must be fully completed by offeror)

AWARD (To be completed by Government)

N/A 3 126

X

X

X

X

X

X

X

X

X

X

X

X

X

X mteixeira@usaid.gov

TABLE OF CONTENTS

PART I – THE SCHEDULE 8

SECTION B - SUPPLIES OR SERVICES AND PRICE/COSTS 8

B.1 8 B.2 8 B.3 Error! Bookmark not defined.

B.4 COST SCHEDULE10

B.5 Error! Bookmark not defined.10

B.6 COST REIMBURSABLE 111

B.7 SHARE RATIOSError! Bookmark not defined.1 B.8 111

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK 12

C.1 Error! Bookmark not defined.

C.2 Error! Bookmark not defined.2 C.3 Error! Bookmark not defined.9 C.4 TECHNCIAL APPROACHError! Bookmark not defined.2 C.5 295 C.6 295

SECTION D - PACKAGING AND MARKING 27

D.1 27 D.2 27 D.3 27 D.4 29

SECTION E - INSPECTION AND ACCEPTANCE 30

E.1 30 E.2 30

E.3 PERFORMANCE STANDARS30

SECTION F – DELIVERIES OR PERFORMANCE 32

F.1 32 F.2 32 F.3 32 F.4 Error! Bookmark not defined.

F.5 REPORTS AND DELIVERABLES 33

F.6 Error! Bookmark not defined.6 F.7 Error! Bookmark not defined.46 F.8 Error! Bookmark not defined.46 F.9 Error! Bookmark not defined.46 F.10 Error! Bookmark not defined.7

SECTION G - CONTRACT ADMINISTRATION DATA 49

G.1 4949 G.2 500 G.3 501 G.4 511 G.5 Error! Bookmark not defined.1 G.6 522 G.7 533 G.8 533

SOL-72065621R00001 Adapting and Modifying Optimized Sample Transport Routes for Achieving Impact (AMOSTRA)

G.9 533

SECTION H - SPECIAL CONTRACT REQUIREMENTS 54

H.1 NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE544

H.2 FOREIGN GOVERNMENT DELEGATIONS TO INTERNATIONAL CONFERENCES (JAN 2002)544

H.3 544 H.4 545 H.5 5555 H.6 555 H.7 556 H.8 5654

H.9 AIDAR 752.211-70 LANGUAGE AND MEASUREMENT 566

H.10 SUBCONTRACTING PLAN REPORT FOR INDIVIDUAL CONTRACTS AND SUMMARY

CONTRACTING REPORT 56

H.11 566 H.12 567 H.13 Error! Bookmark not defined.1 H.14 Error! Bookmark not defined.2 H.15 622 H.16 Error! Bookmark not defined.65 H.17 655

H.18 MEDICAL EVACUATION (MEDEVAC) SERVICES (JUL 2007)656

H.19 666 H.20 666 H.21 667 H.22 677 H.23 688 H.24 688 H.25 68 68 H.26 6869 H.27 680 H.28 680 H.29 680 H.30 682 H.31 683 H.32 684 H.33 6874 H.34 6875 H.35 6876 H.36 6876

PART II - CONTRACT CLAUSES 83

SECTION I - CONTRACT CLAUSES 78

I.1 7878

I.2 FAR 52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN

INTERNAL CONFIDENTIALITY AGREEMENTS JAN 2017 (DEVIATION 2015-02)Error! Bookmark not defined.1 I.3 832

I.4 FAR 52.216-10 INCENTIVE FEE (JUN 2011) 6582

I.5 FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)6583

I.6 Error! Bookmark not defined.3 I.7 FAR 52.227-23 RIGHTS TO PROPOSAL DATA (TECHNICAL) (JUNE 1987)Error! Bookmark not defined.

I.8 FAR 52.247-67 SUBMISSION OF TRANSPORTATION DOCUMENTS FOR AUDIT (FEB 2006)

Error! Bookmark not defined.

I.9 AIDAR 752.7037 CHILD SAFEGUARDING STANDARDS (AUG 2016)Error! Bookmark not defined.90 I.10 FAR 52.243-7 NOTIFICATION OF CHANGES (JAN 2017)Error! Bookmark not defined.91 I.11 FAR 52.222-2 PAYMENT FOR OVERTIME PREMIUMS (JUL 1990)Error! Bookmark not defined.92

I.12 FAR 52.222-56 CERTIFICATION REGADING TRAFFICKING IN PERSONS COMPLIANCE PLAN

(OCT 2020)Error! Bookmark not defined.93 I.13 AIDAR 752.211-70 LANGUAGE AND MEASUREMENT (JU 1992)Error! Bookmark not defined.93 I.14 Error! Bookmark not defined.94 I.15 Error! Bookmark not defined.94

PART III – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS 95

SECTION J - LIST OF ATTACHMENTS 95

PART IV – REPRESENTATIONS AND INSTRUCTIONS 96

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS 96

K.1 976

K.2 FAR 52.203-18 FAR 52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT

REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS REPRESENTATION (JAN

2017)Error! Bookmark not defined.96 K.3 987

K.4 FAR 52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS AND

CERTIFICATIONS (DEC 2014) 100

K5 INSURANCE - IMMUNITY FROM TORT LIABILITY98100

K.6 AGREEMENT ON, OR EXCEPTIONS TO, TERMS AND CONDITIONS98100

K.7 Error! Bookmark not defined.1

SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS 102

L.1 Error! Bookmark not defined.2

L.2 NOTICE LISTING SOLICITATION PROVISIONS INCORPORTATED BY REFERENCE98102

L.3 FAR 52.215-1 INSTRUCTIONS TO OFFERORS - COMPETITIVE ACQUISISTION (JAN 2017 102 L.4 Error! Bookmark not defined.

L.5 FAR 52.232-38 SUBMISSION OF ELECTRONIC FUNDS TRANSFER INFORMATION WITH OFFER

(JUL 2013) Error! Bookmark not defined.

L.6 SUBMISSION OF PAST PERFORMANCE INFORMATION

L.7 Error! Bookmark not defined.

L.8 Error! Bookmark not defined.8 L.9 Error! Bookmark not defined.

L.10 WAIVERS UNDER FAR Part 4.2101 PROHIBITION ON COVERED TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE AND EQUIPMENT 118

SECTION M - EVALUATION FACTORS FOR AWARD 121

M.1 Error! Bookmark not defined.1

M.2 Error! Bookmark not defined.1 M.3 12524 M.4 Error! Bookmark not defined.25 M.5 Error! Bookmark not defined.25 M.6 12525

PART I – THE SCHEDULE

SECTION B - Supplies or Services and Price/Costs

B.1 PURPOSE

The purpose of this Contract is to provide services under the Adapting and Modifying Optimized Sample Transport Routes for Achieving Impact (AMOSTRA) activity specified within the Scope of Work (SOW) to provide an effective and efficient transportation system for laboratory specimens including viral load (VL) for HIV patients on antiretroviral therapy (ART), HIV Early Infant Diagnosis (EID) and Tuberculosis (TB) specimens.

B.2 CONTRACT TYPE AND SERVICES

The anticipated contract is a Cost-Plus Incentive Fee-Performance Incentive (CPIF-PI) type contract. The general structure and management of the incentive fee arrangements are described in Sections B.3 and B.4. For consideration set forth in the contract, the Offeror shall provide the deliverables or outputs described in Section C (Statement of Work) and comply with all solicitation requirements.

B.3 ESTIMATED COST AND INCENTIVE FEE AND OBLIGATED AMOUNT

(a) The period of performance for this contract is three (3) base years with two (2) option years from award issuance. The estimated cost of the work required hereunder, exclusive of fee (s), if any, is TBD (until contract award). The possible incentive fee will be negotiated with the apparent successful offeror before contract signing and will be based upon a formula that accounts for the relationship of total allowable costs to total target costs as set out in FAR 16.405-1. The minimum and maximum target incentive fees, if any, are $TBD and $TBD respectively. The estimated cost plus all possible fees, if any, is $TBD.

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

(c) Funds obligated hereunder are anticipated to be sufficient through ___TBD____.

B.4 COST SCHEDULE

The following budget table will capture the final negotiated budget for the performance of the work required to achieve the objectives of this activity.

Cost Categories Total Cost

Salaries and Wages

Fringe Benefits

Consultants

Travel, Transportation and Per Diem

Equipment and Supplies

Subcontracts

Allowances

Overhead

G&A

Material Overhead

Total Estimated Cost

Total Target Fee

Total Est. Cost Plus Minimum Fee

Incentive Metrics

Contractors should propose a reasonable base fee in accordance with the quantity and risks, given the challenges of this procurement. The performance incentive and monitoring plan is attached (Attachment J.8).

B.5 INDIRECT COSTS

For the Prime Contractor:

Pending the establishment of a 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:

Description Rate

Base 1/ 2/

Type 1/ 2/

Period 1/ 2/

1/Base of Application Type of Rate: Provisional Period:

2/Base of Application:

Type of Rate: Provisional Period:

3/Base of Application:

Type of Rate: Provisional

For Each of the Major Subcontractor (s)*

Description Rate

Base 1/ 2/

Type 1/ 2/

Period 1/ 2/

1/Base of Application:

Type of Rate:

Period:

2/Base of Application:

Type of Rate:

Period:

3/Base of Application:

Type of Rate:

Period:

Note 1: Contractors may recover applicable indirect costs (i.e., overhead, G&A, etc.) if it is part of the contractor's usual accounting procedures, consistent with FAR Part 31, and Negotiated Indirect Cost Rate Agreement (NICRA).

B.6 COST REIMBURSABLE

The U.S. dollar costs allowable will be limited to reasonable, allocable and necessary costs determined in accordance with FAR 52.216-7, “Allowable Cost and Payment,” FAR52.216-7 and AIDAR 752.7003, “Documentation for Payment.”

B.7 SHARE RATIOS

Should the contractor exceed the target cost during performance of the contract, the overrun cost ratio will be 75%/25%. This means that for every dollar that the contractor exceeds the target cost, the government will pay 75% and the remaining 25% will be deducted from the contractor’s incentive fee payout. The share ratio for underruns will be 25%/75%, which means for every dollar the contractor saves (below the target cost), the contractor will keep 75%. The share ratio will be calculated every three months.

B. 8 MINIMUM AND MAXIMUM FEES

The minimum and maximum fees the contractor can expect to earn during the performance period will be 2% and 8% respectively.

[END OF SECTION B]

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

Adapting and Modifying Optimized Sample Transport Routes for Achieving Impact

(AMOSTRA)

C.1 INTRODUCTION

To achieve the United States Government (USG) and Government of the Republic of Mozambique (GRM) health goals, patients must have access to timely and accurate diagnostic technologies to aid in the diagnosis and monitoring of life-threatening diseases. The primary purpose of Adapting and Modifying Optimized Sample Transport Routes for Achieving Impact (AMOSTRA) is to provide an effective and efficient transportation system for laboratory specimens including viral load (VL) for HIV patients on antiretroviral therapy (ART), HIV Early Infant Diagnosis (EID) and Tuberculosis (TB) specimens. This system will operate under the supervision of the GRM and will gradually be transitioned to the government to manage. This directly supports the GRM’s strategic objectives in the Mozambique National Development Strategy (2015 - 2035) that calls for the eradication of large epidemics and the diseases that are the major causes of mortality, including HIV/AIDS, and Tuberculosis. Achieving the reduction of HIV prevalence from 14% in 2015 to 5% in 2035 as called for in the strategy requires an effective laboratory specimen transportation system. Additionally, the Health Sector Strategic Plan (PESS, 2015-2024) calls for strengthening transport systems for laboratory samples.

This activity will be focused on five key objectives: 1) Increased access to diagnostic testing with a focus on HIV VL, EID and TB testing; 2) Improved timeliness of diagnostic test results / shortened turnaround times between specimen collection and return of results; 3) Reducing the cost of specimen referrals by ensuring cost-effective means for packaging, transporting and returning test results; 4) Assured quality of diagnostics testing through proper handling of specimens and test results; 5) Support for a national platform for reporting, monitoring, coordinating, and continuous quality improvement of specimen transport. AMOSTRA will expand access to viral load monitoring, EID and TB testing by competitively engaging transporters, including both private sector and community-level transporters, to operate a cost-effective specimen referral system.

C.2 BACKGROUND

C.2.1 Background

The Ministry of Health in Mozambique and USG have partnered to improve laboratory services to support diagnosing and monitoring HIV, TB and other diseases. Mozambique has made significant investments in expanding testing capacity for VL for HIV patients on antiretroviral therapy (ART), EID for HIV exposed infants and diagnosis and drug sensitivity testing among TB suspects.

The USG currently invests $400 million in health in Mozambique annually with a particular focus on HIV/AIDS, tuberculosis, malaria, and maternal and child health. The goal of the President's Emergency Plan for AIDS Relief (PEPFAR) in Mozambique is to support the country’s efforts to achieve HIV epidemic control by 2020 through evidence-based policies and interventions to drive progress and save lives. TB interventions aim to reach at least 90% of people with TB and treat at least 90% of them.

In support of these goals, USAID, via PEPFAR and the TB program, provides nearly $50 million to monitor ART success using VL testing, conduct EID and provide TB suspects with TB diagnosis and treatment annually. With such investments, it is imperative to look for additional efficiencies and further the GRM along their journey to self-reliance when it comes to managing a sample transportation system. In addition, PEPFAR minimum program requirements include the optimization of VL and EID lab networks to provide 100% coverage of VL monitoring and reporting annually1.

Mozambique is a rural country of 11 provinces and 29.6 million people1 and ranks low on the Human Development Index at 180 out of 189 countries.2 Sixty percent of Mozambicans live on less than $1.25/day with a gross national income of $600 per capita.3 Seventy percent of Mozambicans are estimated to be poor and 37% destitute. National HIV prevalence is estimated at 13%, with substantial variation in provincial prevalence rates and an estimated 1.9 million people living with HIV. Of the estimated number of people living with HIV (PLHIV), 45% are currently on Anti-Retroviral Therapy (ART). Mozambique has one of the highest rates of multi-drug resistant TB at 3.5 percent.4 Generally, urban health indicators are much better than rural where access to basic treatment monitoring services and diagnostics is still limited. The country has a slow economic growth trajectory following the 2016 hidden debt crisis and the economic performance has yet to revert to the pre-crisis levels of 7% annual growth.

The health system faces several major challenges, including limited funding, insufficient infrastructure, and a critical shortage of human resources. Over 90% of Mozambicans live in an underserved primary health care area defined as over a one hour walk from a primary health care center.5 Overall, the ratio of population per hospital bed is 1 bed per 1,038 persons, with substantial variation across the country.6 Human resources for health (HRH) are severely constrained with 7.8 doctors, 26.8 nurses, and a total of 100.2 health care workers (HCW) per 100,000 people.7 Together with uneven geographic distribution and limited supervision, there are an inadequate number of trained and competent health care workers in all cadres. Diagnosis of disease remains a challenge in Mozambique; with VL, EID and TB testing being notable challenges. Inefficient specimen transport, inefficient laboratory testing process, long turn-around times, and inadequate effort expended to ensure all VL tests results are returned to the patient and used to improve patient management are the major challenges to the diagnostic system in Mozambique.

The Public Health network of the Country is classified into four levels: Quaternary (Central and Specialized Hospitals), Tertiary (Provincial Hospitals), Secondary (District, General and Rural Hospitals) and Primary (Health Clinics). At the moment clinical laboratory services follow the same organizational levels. The National Directorate of Medical Assistance oversees the Department of Clinical Laboratories (DCL). This department in turn coordinates the activities of clinical laboratories in general. The head of DCL coordinates and determines policy guidelines for clinical laboratories. Central laboratories providing for public health are under the National Institute of Health. The military laboratory, which is under the jurisdiction of the Ministries of

1 COP20 Minimum Program Requirements 2 Human Development Report, 2018, UNDP 3 World Bank, 2014 4 National Tuberculosis Drug Resistance Survey (2010). Mozambique has the highest rate of MDR-TB in Southern Africa.

5 Luis & Cabral, Geographic accessibility to primary healthcare centers in Mozambique, 2016 6 MISAU/MOH – DRH. Relatório Anual dos Recursos Humanos. Maputo, Abril 2014 7 MOH/MISAU, 2016. WHO (2006) estimates 230 medical professionals per 100,000 people as a minimum threshold necessary to provide essential health interventions.

Defense, operates independently. The University teaching laboratories are under the Ministry of Education. Private laboratories generally have no formal agreement with the government. In the provinces, there is a provincial point of contact that is responsible for networking, and reporting to the central level. At the level of the district, there are supposed to be points of contact that supervise activities in the health centers and report to the provincial POCs; however, this structure does not consistently function as it should.

The laboratory specimen referral and diagnostic network is a multi-tiered system where samples are collected, packaged, transported, and analyzed. Specimens must be adequately maintained through sample collection, labelling, picking, packaging, transportation, and storage in a temperature-controlled environment. The first tier of the laboratory network includes health facilities that serve as collection sites where health care providers work with a patient to collect and prepare dried blood spots (DBS), a blood sample or a sputum specimen. For HIV, collection sites may not have the equipment (centrifuges) necessary to separate plasma from whole blood and are limited to taking dried blood spots. The second tier facilities or “collection hubs” serve as a point of collection for other sites as well as samples from their own patients and may be capable of centrifuging whole blood or taking DBS samples (see Figure 1 for a diagram of the full VL testing process). As many second-tier facilities have GeneXpert instruments, TB specimens are often analyzed at this level. HIV specimens are currently sent for analysis to the 3rd tier laboratories that have specialized technology, equipment, and human resources to complete polymerase chain reaction (PCR) analysis. When specimens are transported in a manner that maintains integrity of the specimen, diagnostic machines analyze the specimen and produce a result, which is then transmitted back to the original referring facility clinician to inform diagnosis and treatment options.

Figure 2.1.1: Process for HIV Viral Load Testing

In order to reach the US Government’s goal of detecting 90% of all TB cases by 2022, Mozambique has to detect 145,800 cases each year – nearly 60% more than the detections over the past year. In addition, of the 92,381 notified cases in 2018, only 39% were bacteriologically confirmed. Not only does Mozambique have to find more than 145,000 additional cases each year, they need to confirm that the cases they have notified truly have TB by way of a bacteriological test using GeneXpert analysis.

In 2018, an estimated 92,700 people were treated for TB; however, TB deaths rose by 22% and TB cases rose by 16% (over the period of 2012 to 2017). Overall, TB diagnosis stands at 57% of estimated incidence. Of those diagnosed, only 41% percent were diagnosed with rapid diagnostics (WHO 2018 TB Profile for Mozambique). While drug-sensitive and MDR-TB notifications have increased markedly over the last 5 years, an estimated 66% of previously treated/relapsed patients were bacteriologically confirmed to have rifampicin resistant TB.

Utilization of Mozambique’s 288 GeneXpert machines stood at 35%8. Of Mozambique’s 162,000 estimated TB cases, 58,000 are also HIV infected (36%). While TB/HIV co-infection is a significant problem in Mozambique, HIV is not fully driving the TB epidemic. A large number of TB patients require focused TB diagnostic services as close as possible to where they access health services, to allow for timely diagnosis.

There has been remarkable progress in the number of people on life-saving ART, which reached 1,212,562 in 2019, up from 16,155 in 2005. Growth has been particularly strong in recent years, more than doubling between 2014 and 2019. The number of health facilities offering ART increased from 255 in 2011 to over 1,368 in FY 2019. The number of patients receiving a viral load (VL) test to monitor the effectiveness of their treatment regimen increased from 390,574 in the first quarter of FY2019 to 618,064 in the first quarter of FY2020. Viral load suppression has risen from 78% in the second quarter of FY19 to 81% in the first quarter of FY20. The analysis of VL has been one of the most critical tools for switching patients to regimens that will improve their health. The current capacity of the HIV PCR network is composed of 28 instruments in 14 labs that allows for 936,660 VL & EID tests per year and the network continues to grow. The 14 labs that serve the referral system for VL and EID are continually being optimized to match testing demand, power, productivity and HR capacity and other factors. New machines will be placed within the diagnostic network, as dictated by optimization studies, to continue to grow testing capacity. The most common sample collection is with DBS but the country is gradually transitioning to plasma samples as the primary sample type due to available instrument technology.

There has also been progress in testing infants for HIV through EID sample referrals. The number of infants tested for HIV in 2019 was 111,566, up from 108,467 infants tested in 2018.

In FY 2019, EID enabled PEPFAR Mozambique to increase the number of pediatric patients enrolled on ART to 55,000. While access to EID services has improved over time through the use of 133 point of care (POC) machines and sample referral using dried blood spot collection;

the number of EID tests hasn’t risen as dramatically as expected. Without further expansion of sample collection, referral and results retrieval, many infants will go undiagnosed and will not receive life-saving treatment.

VL samples that are sent from referring sites are logged using the DISA Link system that allows program managers to track sample Turn Around Times (TATs), including the time it takes to go from taking the sample from a patient to transporting the sample to the lab or health facility with POC instruments (henceforth referred to as a “testing site”). As of 2019, this portion of the TAT was approximately 6 days. To keep pace with the growing demand while ensuring competition

8 Cazabon D, Pande T, Kik S, et al. Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: A trend analysis from 2014 - 2016. Gates Open Res. 2018;2:35.

among vendors, the USG is balancing the number of tests performed on different types of HIV PCR machines (made by Roche, Abbott, Hologic and Biomerieux.) This mix is likely to evolve over time and the sample transport system must also stand ready to adapt as machines and sampling approaches evolve.

Progress in providing TB diagnosis had improved, but with some decline over recent years due to shortages of GeneXpert cartridges and a lack of regular maintenance. The number of TB suspects tested for TB using GeneXpert analysis in 2019 was 65,939, up from 31,975 tests in 2018. The number of health facilities offering GeneXpert testing is 181. These health facilities have a total of 185 GeneXpert machines. TB testing continues to play a critical role in ensuring TB suspects receive an accurate TB diagnosis; 95,919 of presumptive TB suspects were confirmed and enrolled on TB treatment in 2019. Transport distances and turnaround times for TB Sputum samples are typically much shorter as those diagnostic machines are more widely available at health facilities. TB samples taken at facilities that provide HIV services are generally transported along with HIV-related samples but are not currently tracked from their point of origin in the way HIV samples are.

C.2.2 Summary of Relevant USG and Donor Activities

The Ministry of Health, National Directorate of Medical Assistance, Central Department of Laboratory (DNAM/DCL) in Mozambique is currently focusing its efforts to improve strategic planning for laboratory services to support HIV and TB. The GRM and partners have made significant investments in expanding testing sites for VL, EID and TB over the last several years and have successfully increased testing volumes. Key considerations facing the diagnostic network include: conventional and POC optimal machine capacity and placement, sample transportation network design, plasma vs DBS (Introduction of plasma as the network is 100% DBS based), adult and pediatric POC integration, TB/HIV testing integration, and transition from an obsolescing platform (CAP/CTM phase out by 2022).

Other donors that have supported the laboratory system in Mozambique include: the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), the Clinton Health Access Initiative (CHAI), UNITAID, and WHO. With UNITAID support, CHAI worked with UNICEF and MISAU to launch a pilot to demonstrate how POC EID successfully reduces result turnaround time and increases the number of HIV-positive infants identified and initiated on antiretroviral therapy (ART). In a cluster randomized control trial, they helped the GRM demonstrate that

89.7 percent of infants diagnosed using POC EID were initiated on treatment within 60 days, compared to the 12.75 percent through conventional EID. Furthermore, 99.2 percent of POC EID results were returned within 60 days, compared to just 7.2 percent in conventional testing.

Both studies showed that the cost to administer POC EID may also be lower than conventional tests. With new multiplexing capabilities for the GeneXpert machine for EID, this finding will guide the expansion of EID in Mozambique.

HIV and TB specimen transport is largely supported by the donor community, but it is currently fragmented among many implementing partners. PEPFAR clinical partners managed by both the Centers for Disease Control and Prevention (CDC) and USAID, operate specimen transport networks within the provinces they support for HIV testing, care and treatment. For many years, lab specimens were transported on demand without regular pick-up schedules, owing to long TATs. This changed in FY17, when a PEPFAR clinical partner introduced regular specimen pick-ups that improved TATs. In FY18, all partners employed a regular pick-up schedule, but these efforts remain loosely coordinated. Each clinical partner negotiates separately with transporters giving rise to variable TATs and costs.

All efforts to improve laboratory systems are accompanied by implementation of laboratory information systems at 12 reference laboratories (DISA) and major hospitals (BLISS open LIS), and by specimen repository and tracking systems at 152 district-level specimen hubs (DISA link). Electronic records systems were introduced to reduce data entry and increase accountability. These records also provide meaningful data for patient and program monitoring, including MER indicator reporting for PLHIV.

CDC and WHO have supported Mozambique by guiding laboratories towards accreditation through a framework of audits and evaluations.

Support was provided to teach laboratory managers how to implement practical quality management systems in resource-limited settings. This allowed the National TB Reference Laboratory (NTRL) to gain accreditation for three tuberculosis assays.

The GF provided $19.3 million for TB and $13 million for HIV support between 2017-2019.

Support to labs from the GF includes laboratory commodities, TB specimen transportation, and specimen transport standards setting and training.

Health Alliance International supported the NTP and provincial health departments to pilot studies of LED SS microscopy, Gene Xpert testing for TB, using a new mHealth platform called GxAlert at several sites in Manica and Sofala provinces. GxAlert software was installed on five Xpert computers, and test results are now uploaded daily via a USB internet modem to a secure online database. A web-based interface allows real-time analysis of test results and generates SMS result notifications to key individuals. In addition, the Stop TB Partnership (through TB Reach) placed ten Xpert machines and ten LED microscopes at public sector facilities across four provinces. However, GxAlert has not gone to scale for all 288 sites due to insufficient resources.

A TB Diagnostic Network Assessment coordinated by the TB team in USAID Washington is planned in the coming year. The assessment will comprehensively evaluate the country’s TB diagnostic network to assess the functionality and performance of the national TB diagnostic network from the perspective of its ability to meet the needs of the country’s national TB strategic plan. From this exercise, several evidence-based short- and medium-term interventions that improve access will be proposed.

Figure C.2.2.1: VL Lab Network (COP18)

C.2.3 Lessons Learned A number of lessons have been learned regarding the operation of sample transport within diagnostic networks.

1. Efficient route optimization requires routine route optimization analysis to ensure that the routes minimize pickup costs while maximizing patient access to testing services at collection sites. This analysis requires professional logistics expertise.

2. Specimen transportation requires flexibility to adapt to referral network changes to accommodate fluctuating laboratory testing capacity.

3. Throughout the health network, less than half of the health facilities account for over 80% of the volume. The most efficient way the USG has found to address these differences is to segment the network with different transportation strategies for high and low volume sites.

4. A sustainable specimen transportation network must take into consideration ease of management by the GRM.

5. Fragmentation of sample transport under multiple clinical partners makes it difficult to coordinate and establish consistent pricing for transporting samples while optimizing across provincial borders. The major opportunities determined in a recent analysis include:

a. A National tender with a bulk collector would reduce the number of separate contracts held with clinical IPs and increase the ability to hand over to MISAU and DCL in the near-term.

b. The referring sites have been much more of a challenge due to the low volumes and high cost of routine pick-ups. The model of collection for lower volumes could be further optimized through community collection, GAAC groups or local outsourcing with standardized and streamlined payment methods (reducing the burden of coordination on clinical IPs), or through other innovative technologies.

6. Transport and tracking of samples are better monitored, and costs can be reduced if the following technologies were introduced into the specimen referral network:

a. Continually updating GIS mapping or site geo-locations with standard codes that speak to GRM and PEPFAR system site identifiers; and allow routine route optimization to pick up samples within agreed upon TATs and cost.

b. Bar-coding to link to DISA and track specific types of specimens transported.

c. Mobile payment solutions for community transporters.

d. An information system that signals specimens are ready for pick-up. Some systems come with an automated route-optimization calculation for on-demand pick-up.

e. GPS tracking systems that monitor kilometers traveled driver performance and help regulate fuel management.

f. Digital temperature monitoring devices with capability of downloading or providing readable temperature logs via USB ports.

7. TB sample referrals have been limited, however, a few distinct requirements for TB are clear:

a. A TB specimen referral system that was piloted in Mozambique by Challenge TB in 2016-20179 found several activities to be crucial: motorbikes provided an option for low cost sample referrals but required the installation of boxes to hold samples safely. In addition, log books and tools for data collection were not readily available and needed to be provided.

9 GLI GUIDE, to TB Specimen Referral Systems and Integrated Networks

b. There is little current data on sample referrals for TB testing or analysis of true instrument capacity; making it difficult to predict demand for TB testing (location, volumes and true capacity).

c. While sample referral networks in other countries using a hub and spoke specimen referral model designed primarily for HIV samples did result in increased testing volumes, they did not consider strict guidelines for TB turnaround times, and resulted in TATs as long as 14 days. TB TATs must be shorter and TB sample transport may need to be provided on-demand to meet patient needs.

C.3 PURPOSE AND ACTIVITIES

C.3.1 Purpose

The primary purpose of AMOSTRA is to provide an effective and efficient transportation system for VL (supporting HIV patients on ART), EID and tuberculosis specimens. This system will be operated under the supervision of the GRM and should be aimed at reducing the cost of specimen referrals to prepare for a more affordable transition to the government to manage and finance. AMOSTRA will increase access to diagnostic testing while improving the timeliness of diagnostic test results by ensuring shortened turnaround times between specimen collection and return of results. AMOSTRA will also assure the quality of diagnostic testing through proper handling of specimens and through support of a national platform for specimen transport reporting, monitoring and coordination that leads to continuous quality improvement of specimen transport.

C.3.2 Geographic Focus

AMOSTRA has a base performance period of three years, with two option years. This activity is envisioned to roll out on a province by province basis until achieving national coverage. For the first year of implementation, USAID and the successful bidder will jointly determine the focus provinces during the work plan development phase.

C.3.3 Performance Objectives

The activity will be focused on five key objectives:

1. Increased access to diagnostic testing with a focus on HIV VL, EID and TB testing;

2. Improved timeliness of diagnostic test results / shortened turnaround times between specimen collection and return of results;

3. Reducing the cost of specimen referrals by ensuring cost-effective means for packaging, transporting and returning test results;

4. Assured quality of diagnostic testing through proper handling of specimen and test results;

and

5. Support for a national platform for reporting, monitoring, coordinating, and continuous quality improvement of specimen transport.

The five objectives described above support the activity to meet the key performance indicators described below:

Figure 3.3.1: Key Performance Indicators and Targets

Key Performa nce Indicator

Description of Indicator

Data Source

Reporti ng

Frequen cy

Targ ets

Pick-ups

Numerator

Denomi-nator

The total number of missed pick-ups The total number of expected pick-ups

Facility Speci-men Register and visit log

Monthly <1%

On-time speci-men delivery

Numerator

Denomi-nator

Total Number of specimens that were delivered within the standard lead time

Total Number of specimens delivered

Specimen Manifest Form

Monthly 100%

Speci-men Delivery Rate

Total number of specimens delivered at the testing site.

Total number of specimens dispatched from the collection site

Specimen Manifest Form, Specimen Register

Biweekly 100%

Results Delivery Rate

Total number of results delivered within set time

Total number of results dispatched from the testing site

Result Dispatch Form

Monthly 100%

Number of Speci-mens

Numerator Total number of Specimens collected from the collection site for transportation by type within a defined period

Specimen Manifest

Weekly, Monthly

TBD

on an annu-al basis

Additionally, USAID anticipates the addition of an indicator to measure user satisfaction and another for the transition to GRM management. This compilation of measures will be the basis for measuring the contractor’s performance in this performance-based contract.

While specific activities are not defined in this statement of objectives, activities must accomplish the objectives above and meet the key performance indicators outlined above. In addition to the objectives and key performance indicators, the operating constraints in the following section must also be considered.

C.3.4 Operating Constraints

Objective 1 - Considerations for increasing access to diagnostic testing with a focus on HIV VL, EID and TB testing include:

a. Through the implementation of this activity, the offeror should support the development of the local transportation sector as well as community mechanisms for referring specimens.

It is expected that transporters not selected to serve as subcontractors will be provided constructive feedback on why they were not selected.

b. Pick up samples for approximately 1,500 sites (this serves as the basis for AMOSTRA, but the exact number may change over time as new sites are activated) and deliver to testing sites (up to 200 sites).

Objective 2 - Considerations for improving timeliness of diagnostic test results / shortened turnaround times between specimen collection and return of results include:

a. Prior to arrival at each health facility, notify the designated contacts of the health facilities/sample processing and storage hub and implementing partners of impending sample pickup and delivery operations no less than 30 minutes before arrival at the respective health facility/sample processing and storage hub and implementing partners.

b. All contacts need to be documented and shared between referring facilities and receiving testing sites such that any delays in return of results, as well as any priority results, can be communicated via phone by the testing site to the testing facility that referred the sample.

Objective 3 - Considerations for reducing the cost of specimen referrals by ensuring cost-effective means for packaging, transporting and returning test results include:

a. Monitor the sample pickup and delivery operations carefully and rapidly address any issues that arise including issues of accessibility, vehicle breakdown, lagging delivery times, or security. These issues must be reported as soon as they occur along with proposed mitigation/management measures.

b. Vehicles shall be properly registered, insured, maintained, and include the appropriate packaging for the collection and transportation of stipulated specimen types.

c. Maintain a complete security plan which will include sufficient precautions to ensure that no unauthorized personnel have access to the items being transported. The security plan will be presented to USAID.

Objective 4 - Considerations for assuring quality of diagnostic testing through proper handling of specimens and test results include:

a. Deliver products on time, without loss or damage, and ensure security of products throughout the entire transport.

b. Implement and follow the guidance found in the World Health Organization (WHO) Technical Report Series, NO. 957 2010, WHO Technical Report Series, No. 961, 2011 (Model Guidance for the Storage and transport of Time and Temperature Sensitive Pharmaceutical Products), WHO Guidance on Regulations for the Transport of Infectious Substances 2015-2016 (WHO/HSE/GCR/2015.2), and national regulations. The regulations pertaining to sample handling are subject to updates/changes and implementation must adapt accordingly.

c. The Service Provider(s) shall conduct a reverse run on a daily or weekly basis (depending on the nature of the test) from the date that samples are delivered to each testing site to pick up hard copy sample result reports that will be delivered to each originating health facility and associated clinical implementing partners in cases where the results have not been transmitted electronically.

d. Submit downloaded temperature logs for every consignment of samples conveyed using digital temperature readers. Provide adequate temperature regulated boxes, with at least 48 hours of cold life, to convey clinical samples that are cold chain dependent. This consists of utilizing passive containers which can be loaded on to an ambient vehicle and maintaining temperature within the required range for the duration of the delivery to the point of destination. Provide conditioned ice packs to guarantee optimal storage conditions throughout the sample transportation period. The samples must be protected from condensation from the ice packs or water packs.

e. Maintain and observe strict adherence to patient confidentiality guidelines and infection control measures during all aspects of specimen transport and result retrieval.

f. Ensure proper documentation and chain of custody of samples and results throughout the turnaround time by recording all clinical samples and patients’ results picked up and delivered. All the sample pickup and delivery notes shall have unique reference numbers to be able to track samples and corresponding results, must be in quadruplicate, and must be signed indicating: receipt of the specimen, its condition, temperature of the delivery package, and time of collection/delivery.

Objective 5 - Considerations for supporting a national platform for reporting, monitoring, coordinating and continuous quality improvement of specimen transport include:

a. Regularly engage with the USG and GRM in the route planning process and continually seek to optimize routes and operations to provide service coverage to the health facilities and testing sites.

b. Present to a national steering committee on a monthly basis to update the committee on overall system performance, bottlenecks and coordination issues.

c. Work will build and maintain close working relationships with USAID, CDC, clinical partners, the DCL, INS, MISAU, and other relevant partners. Collaboration is expected to achieve increased VL, EID and TB testing. This includes working closely with the relevant entities (including sites) to establish schedules, expected TAT and vehicle pick-up modalities, requesting feedback and sharing feedback to sites/partners as part of continuous quality improvement processes.

d. Maintain close coordination and harmonization of activities with other health implementation partners in the provinces in the event of a disease outbreak (such as COVID-19, for example) that requires diagnostic specimen referral using the VL, EID and TB specimen referral network.

C.4 Technical Approach

C.4.1…