1_2248410_Univ. of Washington Testing Service_PSM.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

ROCKVILLE OFFICE National Institutes of Health National Institute of Allergy And Infectious Diseases Bethesda, MD 20892

PRE-SOLICITATION MEMORANDUM

TO: PRE-SOLICITATION FILE

THRU: CONTRACTING OFFICER

FROM: LEAH HINSON, CONTRACT SPECIALIST

SUBJECT: PRE-SOLICITATION MEMO FOR AMBIS 2248410

FOR: QRT-PCR TESTING ANALYSIS; BATCHED MALI SAMPLE TESTING

NAICS CODE: 541380 / $19M – TESTING LABORATORIES

SERVICE ORDER / CODE Q301

DATE: NOVEMBER 26, 2024

I. Background

The research in the Laboratory of Immunogenetics (LIG) focuses on the cellular and molecular mechanisms that underlie the signaling functions of immune cell receptors. This work encompasses a wide spectrum of experimental approaches from the structural determination of immune receptors to live-cell image analysis of the behavior of chemotactic receptors. The Malaria Infection Biology and Immunity Unit (MIBIS) section of the Laboratory of Immunogenetics (LIG) focuses on the cellular and molecular mechanisms that leads to acquired immunity to malaria. Approximately 500 million cases of P. falciparum malaria occur annually among the world’s poorest populations, claiming the lives of nearly a million children each year in Africa alone. The development of a malaria vaccine is widely viewed as a key step toward malaria control and possibly eradication, yet current malaria vaccine candidates confer only partial, short-lived protection at best. Optimism that a highly effective malaria vaccine can be developed stems in part from the observation that humans can acquire immunity to malaria through repeated P. falciparum infections. However, the nature of the immune response that confers protection against malaria is poorly understood. In the MIBIU, the aim is to fill this critical knowledge gap by applying recent advances in immunology and genomics-based technology to carefully conducted longitudinal cohort studies in malaria-endemic areas. For this requirement, the University of Washington (UW) will perform qRT-PCR on approximately 2800 blood samples collected during the course of the L9LS monoclonal antibody clinical trial conducted in Mali. The University of Washington laboratory performs the only qRT-PCR assay for the detection and quantification of Plasmodium parasites that has received Drug Development Tool Biomarker Qualification through the U.S. FDA. Their qRT-PCR assay is recognized as among the most sensitive and robust molecular diagnostic assays for malaria in the world, allowing for the detection of malaria parasites in human blood up to 3-4 days earlier than by conventional blood smears.

Description of the supplies/services to be purchased: The UW will perfom qRT-PCR on approximately 3600 dried blood spots collected during the course of the monoclonal antibody clinical trial in Mali.

Description of need:

• qRT-PCR Testing analysis; batched sample from Mali testing submission (approx. 3600 at a price range of $52.53- CY 2024-$54.63- CY 2025 per sample.)

• Billing to be monthly or quarterly in arrears

II. Period of Performance: 1/01/2025-12/31/2025

III. Considerations

• Mandatory and Preferred sources such as Ability One, HHS Internal contracts and FSS contract mechanisms will be searched for this acquisition.

• Small business set-aside will be considered if marketplace finds evidence of a reasonable expectation of 2 or more small businesses can make reasonable offers.

• NIH Policy Manual 6307-3 (Clearance, justifications and/or approvals) - not required for this acquisition

• FAR 39.2, 508 Compliance – not applicable

• Other special considerations, including green purchasing (FAR 23), licensing agreements, data rights, information security, and Individual Privacy Protection – No additional considerations

• The Buy American Act (BAA) not applicable for a commercial service.

• Made in America Rule (Executive Order 14005) - not applicable to a commercial service

• Labor Standards Act – not applicable (commercial, catalog service).

• NAICS CODE: 541830 – TESTING LABORATORIES BUSINESS SIZE STANDARD

OF $19M

• Sole Source Justification: This requirement was submitted with a sole source justification and will be taken into consideration during market research.

IV. Market Price Estimate

• The Government Market Price estimate is not expected to exceed $196,668.00 based on an open- market research quote attached to the AMBIS request.

V. Market Analysis This memorandum is in accordance with Federal Acquisition Regulation (FAR) Part 10.000, which describes the policies and procedures for conducting market research to arrive at the most suitable approach to acquiring, distributing, and supporting supplies and services. This part Implements requirements of 41 U.S.C. 1901(a)(1).

A. The results of market research have determined that the Government's needs can be met by product/service of a type customarily available in the commercial marketplace.

B. The following methods were utilized to conduct Market Research:

• Open-market search

• Mandatory government sources of supply/services (AbilityOne)

• GSA Advantage search

• Reviewed product info, manufacturer website, distributor info (Partner’s, VARs) etc.… contracts

• Searched FPDS records

• Previous Orders & Solicitations

• Reviewed Sole Source justification

C. Results of Market Research were as follows:

• In accordance with FAR Subpart 8.002(a) (1) Priorities for Use of Government Supply Sources, research conducted revealed that none of the mandatory Government sources could satisfy this requirement.

o This service is not available through Ability One

• A GSA Advantage search revealed that this service, as required, is not available on existing FSS contracts

• A search of the open market does not reveal this service is available from multiple Vendors

• SAM.gov revealed the sole source vendor required to complete this project, the University of Washington, has an active SAM registration under UEI # K41JMJCBC443 and is presumed to be a large business under NAICS code 541380

• Procurement History: FY 24 AMBIS 2227812, 75N93024P01010, NOI-NIAID-24 2227812 awarded 8/19/2024, FY 23 AMBIS 2181609, 75N93023P01055, NOI-NIAID- 23-2181609 awarded 8/10/2023; Procurement History: FY22 AMBIS 2136048, 75N93022P00913, NOI-NIAID-2136048; Procurement History: FY 23 AMBIS 215673, 75N93023P00107, NOI-NIAID-2152673 all awarded to Univ. of Washington as a sole source open market award.

• A search of FPDS records using NAICS code 541380 revealed that NIH has previously procured services for similar laboratory testing using sole source open market mechanisms and for similar cost. These records will be used in the file in support of Price Reasonableness

• Sole Source justification supports the need to purchase this requirement solely from the University of Washington

VI. Justification for other than Full and Open Competition ☒ 41 USC 1901(e)(2) and FAR Part 13.106-1(b): Only one responsible source ☐ 41 USC 501 and FAR Part 8.405-6: Federal Supply Schedule (FSS), limited competition demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

A. Name and address of the proposed contactor:

University of Washington 750 Republican St, Room F870 Seattle, WA 98104

B. Describe why only the proposed contractor can provide the requested supply/service:

The University of Washington laboratory performs the only qRT-PCR assay for the detection and quantification of Plasmodium parasites that has received Drug Development

Tool Biomarker Qualification through the U.S. FDA. Their qRT-PCR assay is recognized as among the most sensitive and robust molecular diagnostic assays for malaria in the world, allowing for the detection of malaria parasites in human blood up to 3-4 days earlier than by conventional blood smears.

C. UW’s qRT-PCR assay uses a contact free laser cutting system that effectively eliminates cross-contamination during dried blood spot processing. Their assay validation data demonstrated that the TaqMan probe-based assay on the Abbott m2000 automated extraction/amplification platform is highly sensitive and specific across a wide range of parasite densities for dried blood spot samples. The University of Washington laboratory is actively working with FDA to further expand the qualified context of use for this assay including for use in endemic field studies. The assay has been validated with respect to accuracy, correlation, precision, analytical sensitivity, analytical specificity, and carryover.

Therefore, UW provides the expertise and comprehensive services to cover every aspect of the project and continue providing these follow-on services.

D. Market Research Interpretation:

• These testing services, as required and outlined, are not available on existing government contract mechanisms such as HHS NITAAC or GSA contracts. The commercial deliverable, as required, is only available from one open market source.

• The small business set aside will be dissolved, based on the procurement history, and lack Of evidence that we’d potentially receive competitive and responsive quotes from two or more small businesses – the “rule of two”.

VII. Procurement Recommendation:

• Based on the market research interpretation, the Contracting Officer (CO) recommends:

An open market purchase order, with a sole source restriction to University of Washington o Without a small-business set-aside, due to the rule of two. per FAR Part 19.502-2(a)

VIII. Competition FAR Part 5.201 Based on the estimate market price, which is over $25,000 publicizing/dissemination is required, this will be posted for 10 days on SAM.gov.

Contracting Officer