P03 - 36C257-24-AP-5210-FY25-912 JOFOC NCO17 COVID Testing Reagents - HCA Approved.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification >SAT‐$7.5M under FAR13.5

Effective Date: 11/15/24

REVISION: 01

Acquisition ID#: 36C257‐25‐AP‐5210

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN

ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257‐25‐AP‐5210 JFOC Number: FY25‐NCO 17‐841

1. Contracting Activity: The Department of Veterans Affairs, Network Contracting Office (NCO) 17, 5441 Babcock Road, San Antonio, TX 78240 for the North Texas Veterans Health Care System (NTVHCS), Pathology & Laboratory Medicine Service. Purchase Request Number: 549‐25‐2‐190‐ 0015.

2. Nature and/or Description of the Action Being Processed: This procurement is for an Indefinite Delivery Indefinite Quantity (IDIQ) contract, for supplies of Molecular Instrument Covid Testing Kits, Cepheid 510K/Food and Drug Administration (FDA) approved XPRESS COV‐2/FLU/RSV PLUS and XPRESS COVID PLUS. COVID testing reagents and supplies for use on the Cepheid equipment.

in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303‐2. Cepheid reagents must be compatible with the Cepheid equipment. The NTVHCS request for the IDIQ with 3‐year ordering periods. This will be a new Firm Fixed Price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The vendor shall provide KIT, IVD XPRESS, COV‐2/FLU/RSV PLUS, 10 TEST and KIT,10 TEST, XPRESS COVID PLUS, US‐IVD supplies listed below that are compatible with the government‐rental Cepheid equipment in option year 2 two. Currently, NTVHCS has five (5) Cepheid instruments that already run six (6) other assays.

All training is currently in place with Cepheid instruments. This requirement will allow the NTVHCS Pathology and Laboratory Medicine Service to maintain the standard of care of current patient care services without incurring high fee basis testing costs. The estimated cost for procurement is as follows:

Ordering Period 1: 03/14/2025‐03/13/2026 $474,840.00 (FY25) Ordering Period 2: 03/14/2026‐03/13/2027 $546,066.00 (FY26) Ordering Period 3: 03/14/2027‐03/13/2028 $627,975.90 (FY27)

Total: $1,648,881.90

Item Description Item Number Quantity

KIT,IVD XPRESS,COV‐2/FLU/RSV

PLUS, 10 TEST

CAT# XPRS4PLEX‐10 576

KIT,10 TEST, XPRESS COVID

PLUS,US‐IVD

CAT# XPRS‐COV2‐10 216

Effective Date: 11/15/24

REVISION: 01

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106‐1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Cepheid provides testing cartridges for various assays that are required to be tested in healthcare organizations. One of the assays is the COVID testing cartridges that were instrumental in combating COVID‐19 in VANTHCS. The EUA version of COVID cartridges was one of the first available tests during the beginning of the pandemic. This will be discontinued and will be replaced by 510K/FDA‐approved versions. The Cepheid instrument has the capability of random access and is capable of reporting results in less than one (1) hour. Other assays currently in use at the VANTHCS are MRSA, CARBA‐R, CDIFF, MTB, BCR‐ABL, and MVP.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Conducted market research to identify if other potential vendors could provide all the COVID tests needed but did not identify another vendor capable of providing what is needed. Posted NOI 36C25725Q0103 11/07/2024 closed on 11/15/2024 resulted in resulting in (1) one response from Abbott Rapid Diagnostics however they have their equipment therefore; would not be considered since the government already has Cepheid equipment. Cepheid instruments have high throughput, one (1) instrument can run 16 tests simultaneously. The ID now is one at a time and ideal for Point of care settings, not high‐volume testing. Cepheid is the manufacturer and distributor for the COVID test needed. No other responses were received therefore, it is advantageous to procure all of the items listed above from a sole vendor to ensure there are no delays in the shipment of regents and supplies needed to perform patient testing.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The Contracting Officer shall determine pricing to be fair and reasonable based on a comparison of the proposed prices with prices found reasonable in previously awarded contracts and or procurements.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market

Research Was Not Conducted: Market Research conducted pursuant to FAR Part 10, VAAR Part 810, and PPM 2016‐05 (revised Aug 2019. Search engines such as VetCert, FPDS, Dynamic Small Business (DSBS) VetCert: A search of NAICS Code 325413 resulted in 90 vendors – 87 SDVOSBs and 3 VOSBs. Of the

Effective Date: 11/15/24

REVISION: 01

vendors listed on VetCert, zero (0) vendors provided Kit IVD XPRESS COV‐2/FLU/RSV PLUS, 10 TEST CAT Kit IVD XPRESS COV‐2/FLU/RSV PLUS, 10 TEST CAT laboratory testing. Other vendors found did not appear to provide Kit IVD XPRESS COV‐2/FLU/RSV PLUS, 10 TEST CAT. Ability One: Searched for “Kit IVD XPRESS COV‐ 2/FLU/RSV PLUS, 10 TEST CAT” which no matches found on NAICS and PSC codes for supplies and services.

UNICOR: A review of the list of the types of items that UNICOR provides does not include laboratory Kit IVD XPRESS COV‐2/FLU/RSV PLUS, 10 TEST CAT. GSA eLibrary: A search for “Kit IVD XPRESS COV‐ 2/FLU/RSV PLUS, 10 TEST CAT” yielded 0 schedules. Cepheid does have a GSA schedule, but these tests are not available on schedule Cepheid ( GS‐07F‐0597T) they only do the service on equipment no reagents or testing. SBA DSBS: A search of NAICS Code 325413 and the keyword “Kit IVD XPRESS COV‐2/FLU/RSV PLUS, 10 TEST CAT”, resulted in 4 SDVOSB/VOSBs, 0 WOSBs, 2 8(a), and 1 HUB Zone Certified. Of the vendors found, none provide COVID reagents. FPDS: A search keyword “IVD XPRESS COV‐2/FLU/RSV PLUS, 10 TEST CAT”, resulted in an award to Cepheid for $1,023,090.00 for base plus four years period of performance 09/3/2022‐09/30/2027 to Indian Health Service contract number 75H70722P00243.

Posted NOI 36C25725Q0103 11/07/2024 closed on 11/15/2024 resulted in resulting in (1) one response from Abbott Rapid Diagnostics however they have their equipment therefore; would not be considered s Cepheid provided a letter dated January 9, 2025, the all requests for sole‐source representations. Cepheid is currently the sole manufacturer of Xpert reagents, and GeneXpert® systems are manufactured exclusively for Cepheid. Xpert reagent test cartridges are designed and manufactured to only be used with Cepheid’s instruments. Cepheid is currently the only authorized provider of service for GeneXpert systems to customers within the United States, excluding territories. Currently, North Texas Veteran Healthcare System is utilizing Cepheid equipment and the required test Kit IVD XPRESS COV‐2/FLU/RSV PLUS, 10 TEST CAT is only compatible with Cepheid equipment. The Buy American statute applies; use clause 52.225‐1 Buy American‐Supplies and provision 52.225‐2 Buy American Certificate. This is a domestic end product made in the United States; therefore, according to Subpart FAR 25.4 Trade Agreement Act does not apply.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This is a critical requirement in nature of the brand name supply orders for the FDA‐approved COVID test needed for the Cepheid equipment. There are currently 5 Cepheid instruments in use at Dallas Pathology and Laboratory Medicine, Fort Worth Outpatient Clinic, and Bonham performing 8 different testing cartridges. Any delays in obtaining these COVID tests could significantly disrupt testing processes, ultimately affecting patient care.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Cepheid, 904 East Caribbean Drive, Sunnyvale, CA 94089 was considered due to the nature of the supplies authorized to be used on Cepheid instrumentation.

Abbott Rapid Diagnostics, 200 Abbott Park Road, Abbott Park, IL 60064‐3503 responded but was not considered because the government requires reagents compatible with existing Cepheid equipment.

Cepheid instruments have high throughput, one (1) instrument can run 16 tests simultaneously.

The ID now is one at a time and ideal for Point of care settings, not high‐volume testing, laboratories.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The VA will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed and to potentially include other manufacturer instruments within the marketplace that would meet the standard of care currently in place.

Effective Date: 11/15/24

REVISION: 01

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona

Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Mary Joy Ramirez Microbiology Supervisor Pathology & Laboratory Microbiology

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jose D. Campa Contracting Officer NCO 17

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Michael J. Tusinger Director of Contracting Network Contracting Office 17

c. Director of Contracting: I certify the justification meets requirements for other than full and open competition.

Mark A. Layman Director of Contracting Network Contracting Office 17

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Curtis M. Jordan Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)