Final APPROVED JOFOC Package for Microbiology Test Kits_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C249-21-AP-1972

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Network Contracting Office (NCO) 9, 1639 Medical Center Parkway, Suite 400, Murfreesboro, TN 37129. Purchase Order Number: 626-22-1-066-0002.

2. Nature and/or Description of the Action Being Processed:

This acquisition is in support of Tennessee Valley Healthcare Service (TVHS) for purchasing the supplies outlined below in Paragraph 3, under the authority listed in Paragraph 4. The supplies will be utilized in direct response to the worldwide pandemic, SARS CoV-19, also known as COVID-19 and colloquially as the Coronavirus. The supplies will also support other Microbiology testing compatible with the Panther Fusion equipment owned by TVHS and located at the Nashville VA Medical Center, 1310 24th Ave South, Nashville, TN 37212.

This acquisition will be 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. The acquisition will result in a new five-year Firm Fixed-Price Indefinite Delivery, Indefinite Quantity contract, consisting of a five consecutive ordering periods of 12 months each, valued as follows:

Ordering Periods Dates Effective Estimated Price Ordering Period One 10/01/2021 09/30/2022 $ 838,590.00 Ordering Period Two 10/01/2022 09/30/2023 $ 838,590.00 Ordering Period Three 10/01/2023 09/30/2024 $ 838,590.00 Ordering Period Four 10/01/2024 09/30/2025 $ 838,590.00 Ordering Period Five 10/01/2025 09/30/2026 $ 838,590.00

TOTAL $ 4,192,950.00

3. Description of Supplies/Services :

The required supplies consist of the Hologic Incorporated (Hologic) Panther Reagent and Panther Fusion Testing Supplies for Microbiology Testing of the COVID-19 virus and other valued testing.

Hologic is currently considered sole source for the instrument system, assay kits and associated reagents of this machinery. The test kits are required supplies for the testing of Veteran patients and are only compatible with the purchased and previously awarded Hologic Panther Fusion System.

Annual orders are estimated to consist of the following volumes or are ordered as needed:

Product # Description Annual Quantity 303570 Aptima HPV Assay, 100 Test 10 303010 Aptima HPV Calibrators Kit As Needed 303011 Aptima HPV Controls Kit As Needed PRD-03565 Aptima HIV-1 Quant, US IVD, 100 Test 9

PRD-03566 Aptima HIV-1 Quant Calibrator Kit As Needed PRD-03567 Aptima HIV-1 Quant Control Kit As Needed PRD-03705 Aptima HCV Quant Dx Assay Kit, 100 Test 16 PRD-03706 Aptima HCV Quant Dx Control Kit As Needed PRD-03707 Aptima HCV Quant Dx Calibrator Kit As Needed 303236 Aptima HPV 16 18/45 Genotype Assay 10 303235 Aptima HPV 16 18/45 Calibrators kit As Needed PRD-03868-CPR APTIMA HBV Quant Assay, Cost Per Reportable 290

PRD-03869 HBV Viral Load Assay Controls, Aptima As Needed PRD-03872 HBV Viral Load Assay Calibrators, Aptima As Needed PRD-06419 Aptima SARS-CoV-2 Assay EUA, 250 Test 96 PRD-06420 Aptima SARS-CoV-2 Assay Controls 48

PRD-06660 HOLOGIC SPECIMEN LYSIS TUBE, SOLID CAP (1200

TUBES PER BAG)

303096 Panther Run Kit As Needed 503762 Specimen Aliquot Tubes (SAT) As Needed 504415 Transport Tube Cap As Needed PRD-03503 Aptima Specimen diluent As Needed PRD-03654 Aptima Specimen Diluent Kit As Needed CL0041 Caps, AMP/P.R.S.(CL0045) DIAG. As Needed CL0040 Caps, TCR/SEL.(CL0038) DIAG. As Needed 501604 Spare Caps, PP, 60mL, TCR APTIMA 2x50 As Needed 501616 Spare Caps, 30mL Tube As Needed 103036A Non-penetrable caps As Needed 105668 Aptima Penetrable Caps 10 104772-02 MTUs (multi-tube units) As Needed 902731 Solid Waste Bag As Needed 902714 Waste Bag Cover As Needed 303014 Assay Fluids Kit As Needed 303000 Aptima Auto Detect As Needed

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 C Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The Panther Fusion System is proprietary to Hologic - all required testing kits that are compatible with this system and are only available through Hologic, a Large business and sole manufacturer.

The testing kits are required to conduct COVID-19 testing as well as other pertinent testing at the Nashville facility. The Panther system cannot operate without testing supplies that are capable of being used with that system. Currently the facility has an on-going need for the kits in order to continue fulfilling the testing requirements for patients as well as employees at the Nashville VA Medical Center.

If the procurement of Hologic test kits is not made, the Panther System will become inoperable, bringing to a halt all COVID/HIV type testing at the facility, thus creating a tremendous backlog of patient testing, including vital results required to diagnose patients needing critical life-saving care.

A resurgence of the COVID virus, if not immediately diagnosed within the Veteran population, may cause another wide-spread outbreak of the virus, leading to patient complications and possibly death.

Additionally, changing systems would require re-training of personnel and re-development of test algorithms resulting in months-long delays and countless manhours exceeding $660K in added costs.

The disruption to patient care would be an unacceptable consequence of changing vendors, particularly amid a resurging pandemic.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A Sources Sought Notice under solicitation number 36C24921Q0437 was posted to Beta SAM on 07/19/2021 and closed on 07/26/2021. The notice, utilizing North American Industry Classification System (NAICS) 325413 In-Vitro Diagnostic Substance Manufacturing and Product Service Code (PSC) 6550 In-Vitro Diagnostic Substances, Reagents, Test Kits and sets, detailed the need for Hologic, Inc., manufactured microbiologic testing kits and supplies compatible with the Hologic Panther System, purchased and in the possession of the Tennessee Valley Healthcare Service.

No other source submission was received other than that of the manufacturer. Market research confirmed the availability of no other vendors with the capability to manufacturer or distribute the required kits and supplies.

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

A search of BetaSam and Federal Procurement Data System (FPDS) reports many examples of historical negotiated pricing between Hologic and the government, which have proven consistent over time. Based on the findings, the government can anticipate receiving pricing reflective of true market value, which is likely to be determine fair and reasonable.

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

Market Research Was Not Conducted:

A search was made by NCO 9 for Service-Disabled Veteran Owned Small Businesses (SDVOSB)