Chemonics International- Request For Information From Private Laboratories For Capacity Assessment To Perform Comprehensive HIV Viral Load And EID/IVT Molecular Laboratory Diagnostic Services

CHEMONICS INTERNATIONAL REQUEST FOR INFORMATION (RFI) FROM PRIVATE LABORATORIES RFI NUMBER: PSM-NIGERIA-LAB-2021-001 ISSUED BY: CHEMONICS INTERNATIONAL INC ( www.chemonics.com ) DEADLINE FOR QUESTIONS: 12:00PM WEST AFRICA TIME, WEDNESDAY APRIL 7, 2021 TO labrfi@chemonics.com DEADLINE FOR RESPONSES: 5:00PM WEST AFRICA TIME, THURSDAY APRIL 22, 2021 TO labrfi@chemonics.com

SECTION 1: INTRODUCTION The Global Health Supply Chain Program – Procurement and Supply Management (GHSC-PSM) project (alternately referred to herein as ‘Chemonics” or “GHSC-PSM” or “Buyer”) is an official project of the United States Agency for International Development (USAID) implemented by Chemonics International. GHSC-PSM seeks to understand the private sector market for comprehensive HIV-viral load and Early Infants’ diagnosis/lnfants virologic testing (HIV-VL and EID/IVT) molecular laboratory diagnostic services in Nigeria.

The purpose of this Request for Information (RFI) is to identify and collect information from interested private Nigerian laboratories regarding their capacity to perform comprehensive HIV Viral Load and EID/IVT molecular laboratory diagnostic services that could be offered on a price per result basis.

Interested organizations are invited to submit information in response to this RFI as per the specifications detailed in Section 3: Information Requested. Please note that issuance of this RFI does not in any way obligate Chemonics or USAID to award a contract nor does it commit Chemonics or USAID to pay for costs incurred in the preparation and submission of responses. By issuing this RFI, Chemonics does not express an intent, commitment, or promise to purchase any supplies or services. Responses to this RFI will not be considered by Chemonics as offers to enter into a contract; this RFI is for information collection purposes only to assist USAID and Chemonics in understanding the laboratory services market.

Background The GHSC-PSM project provides procurement and supply chain management services and support to the President’s Emergency Plan for AIDS Relief (PEPFAR), the President’s Malaria Initiative (PMI), and the USAID Office of Population and Reproductive Health (PRH). This includes the supply of a wide range of health commodities, including commodities for HIV/AIDS, malaria, maternal and child health, and infectious diseases. In Nigeria, a significant focus of PEPFAR supported programs, including USAID’s GHSC-PSM project, is procurement and management of HIV-VL and EID/IVT molecular laboratory diagnostic tests and services for more than 1,000,000 PEPFAR supported patients nation-wide.

The Objective of the RFI The main objective of this RFI is to directly identify private laboratories that would be interested in providing comprehensive HIV Viral Load and EID/IVT molecular laboratory diagnostic services for PEPFAR supported patients that could be offered on a price per result basis in Nigeria. GHSC-PSM may proceed to issue a formal solicitation for offers following the RFI.

SECTION 2: INSTRUCTIONS TO INTERESTED PARTIES Response submission : All responses to this RFI must be received via email to LabRFI@chemonics.com no later than 5:00PM West Africa Time, Thursday April 22, 2021.

Questions : Questions must be submitted via email to LabRFI@chemonics.com no later than 12:00PM West Africa Time, Wednesday April 7, 2021. Responses to all questions submitted will be shared in a summarized document on Tuesday April 13, 2021.

Required information : Section 3 below provides details on the information to be included in submitted responses. Please note that organizations are not required to submit responses to all questions; however, interested parties are encouraged to submit as much information as possible Information and all correspondence and documents relating to the offer shall be in English.

SECTION 3: INFORMATION REQUESTED A MAXIMUM OF 5 PAGES SHOULD BE PREPARED AS A RESPONSE TO THE QUESTIONS BELOW

(1) The following information should be included at the beginning of the RFI response:

Organization’s Name Organization’s Address Organization’s Website (if available) Organization’s Date Universal Numbering System (DUNS) (if available) Name of Organisation’s Point of Contact (POC) POC’s Title POC’s Email Address POC’s Phone Number

(2) Please briefly summarize your experience, using attached Annex A, on providing HIV Viral Load and EID/IVT testing Supplies and Services, to include the following:

(a) Is your laboratory accredited nationally and/or internationally, including implementation of Laboratory Quality Management Systems (QMS) and IQA/ EQA processes?

(b) Is your laboratory registered with the Medical Laboratory Science Council of Nigeria (MLSCN) as required by national laws?

(c) Do you currently provide diagnostic testing for HIV/AIDS patients?

(d) Does your laboratory utilize nationally approved VL/EID instruments, reagents, supplies and consumables (for instance, Roche, Abbott, Cepheid or Hologic)?

(e) Does your laboratory provide an all-inclusive testing service on a price-per-result basis for HIV/AIDS patients that includes the cost of all reagents/supplies, instrument usage, instrument maintenance, storage, infrastructure and staff?

(f) Do the distributors of equipment you work with for diagnostics products and services provide inventory management support to you, through a vendor management inventory service or other arrangements?

(g) Please describe your participation in safe, reliable, pickup and transport of plasma and/or DSB specimens from ART sites around Nigeria ,

( h) Does your Lab data management system have the ability to interoperate with the National laboratory information System (LIMS) (for remote sample login and return of results) and National Data Repositories (NDR)?

(i) Please describe your protocols for solid and liquid waste management (onsite or through centralized waste disposal) following national guidelines and/or manufacturers recommendations.

( j) Is back-up testing capacity available to your laboratory through collaboration with another laboratory that is nationally and/or internationally recognized for implementing laboratory Quality Management System (QMS) for testing in case of testing disruptions?

(k) Describe the space available in your infrastructure for the installation of any high throughput HIV/EID-IVT equipment.

Please include your laboratory name and the date on Annex A where indicated.

( 3) An Important element of PEPFAR programs is Data Management and Reporting. Please briefly summarize your experience and capacity, using attached Annex B, to include the following:

(a) Regular reporting of testing numbers, error rates, and or instrument failures and other key performance indicators (KPIs)

(b) Regular reporting of reagent and consumable inventory levels for all testing laboratories

(c) Regular reporting of all pending reagent and consumable orders to include lot number, manufacturer date, expiry date, agreed delivery dates, actual delivery dates

( d) Tracking and reporting of samples collected at requesting facilities and/or sample collection hubs

( e) Evidence of patient data protection and data security

Please include your laboratory name and the date on Annex B where indicated.

(4) Please include additional information such as technical qualifications, certifications, brochures or other relevant documentation with respect to your laboratory’s capabilities.

SECTION 4: CONFIDENTIALITY Information provided through the RFI will be shared with USAID and other PEPFAR stakeholders in Nigeria.

RFI PSM-Nigeria-Lab-2021-001 Lab Name: Date:

Annex A. Experience providing HIV Viral Load and EID/IVT testing Supplies and Services

(a) Is your laboratory accredited nationally and/or internationally, including implementation of Laboratory Quality Management Systems (QMS) and IQA/EQA processes?

(b) Is your laboratory registered with the Medical Laboratory Science Council of Nigeria (MLSCN) as required by national laws?

(c) Do you currently provide diagnostic testing for HIV/AIDS patients?

(d) Does your laboratory utilize nationally approved VL/EID instruments, reagents, supplies and consumables (for instance, Roche Abbott, Cepheid or Hologic)?

(e) Does your laboratory provide an all-inclusive testing service on a price-per-result basis for HIV/AIDS patients that includes the cost of all reagents/supplies, instrument usage, instrument maintenance, storage, infrastructure and staff?

(f) Do the distributors of equipment you work with for diagnostics products and services provide inventory management support to you, through a vendor management inventory service or other arrangements?

(g) Please describe your participation in safe, reliable, pickup and transport of plasma and/or DBS specimens from ART sites around Nigeria

(h) Does your Lab data management system have the ability to be interoperate with the National laboratory information system (LIMS) (for remote sample login and return of results) and National Data Repositories (NDR)?

(I) Please describe your protocols for solid and liquid waste management (onsite or through centralized waste disposal) following national guidelines and/or manufacturers recommendations

(j) Is back-up testing capacity available to your laboratory through collaboration with another laboratory that is nationally and/or internationally recognized tor implementing laboratory Quality Management System (QMS) tor testing In case of testing disruptions?

(k) Describe the space available in your infrastructure for the installation of any high throughout HIV/EID-IVT equipment

RFI PSM-Nigeria-Lab-2021-001 Lab Name: Date:

Annex B, Data Management and Reporting (a) Regular reporting of testing numbers, error rates, and or Instrument failures and other KPIs

(b) Regular reporting of reagent and consumable inventory levels for all testing laboratories

(c ) Regular reporting of all pending reagent and consumable orders to include lot number, manufacturer date, expiry date, agreed delivery dates, actual delivery dates

(d) Tracking and reporting of samples collected at requesting facilities and/or sample collection hubs

( e) Evidence of patient data protection and data security

Chemonics International- Request For Information From Private Laboratories For Capacity Assessment To Perform Comprehensive HIV Viral Load And EID/IVT Molecular Laboratory Diagnostic Services

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