P03 SSJ - AccuProbe Reagents Fully Exe.pdf

VHAPM Part 813.106 Page 1 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C241-20-AP-2608

1. Contracting Activity: Department of Veterans Affairs, VISN 1, VA Connecticut Healthcare System, 950 Campbell Street, West Haven CT 06516

PR-IFCAP: 689-21-1-7455-0007

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The service is requesting a 5-Year Blanket Purchase Agreement for TB Reagents/Kits for the VA Connecticut Healthcare System. The estimated cost is $89,330.00. The VA Connecticut Healthcare System has the equipment currently in place for reagent testing. Products will be ordered as needed. Please see below chart for listing of products.

Part Number Description

Est.

Qty.

Annual 102845 Kit, AccuProbe AVIUM COMPLEX 30 102850 Kit, AccuProbe M. GORDONAE 10 102855 Kit, AccuProbe M.KANASAII 1 102860 Kit, AccuProbe m.TUBERCULOSIS 20 102800 Kit, AccuProbe RGTS 200-TESTS 1 301078 Kit, SYSCHECK IVD CDRH 20 201791 Kit, Detection Reagent 3

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Gen-Probe Incorporated was acquired by Hologic Incorporated in 2012. The AccuProbe supplies provided by Hologic are used to identify Mycobacterium species; the product is reliable and provides a quick and essential identification for our patient population. The supplies will include the above associated products for testing; accuprobe identification kits (MAC, TB and M.

gordonae), leader 50 paper, culture ID reagent, detection reagent, and syscheck. Hologic is the only vendor that offers this mycobacterial identification kit and technology. The following equipment is in place for testing the reagents; Leader 50 instrument, sonicator.

4. Description of market research conducted and results or statement why it was not conducted:

Market Research information was gathered from the following sites; VISTA, Federal Procurement Data System (FPDS), Systems Award Management System (SAMs), Small Business Administration (SBA), General Service Administration (GSA), Internet, National Acquisition Strategies (NAC), North

VHAPM Part 813.106 Page 2 of 2 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

American Industry Classification System (NAICS), and Vendor Information Page (VIP). The suggested vendor in VISTA is Gen-Probe Incorporated (Small Business). However, as indicated above Gen- Probe was acquired by Hologic Incorporated (Large Business). In speaking to Vincent Piscitelli, reagents and kits were purchased previously through logistics via purchase card (R10137, 0R5597, 0R2073, R08123, R09266, 0R1027). Mr. Piscitelli was informed by Hologic that a contract would be needed to purchase reagents and kits in moving forward.

A search of FPDS for AccuProbe Test Kits found both companies listed. In speaking to Jennifer Shea, Contract Analyst for Hologic Incorporated. She confirmed that Hologic had purchased Gen-Probe, and that Hologic would be submitting invoices for the reagents and kits purchased. The company is not listed on any Federal Schedules, nor is the products. A search of SAMs, found that Hologic is listed as a Large Business. Although Gen-Probe is listed on the Small Business Administration website. They will not be used in purchasing the items because of Hologic proprietorship over all products manufactured under Gen-Probe. In searching GSA eLibrary, Hologic is not listed. In searching the internet, the AccuProbe products were found to be offered through Hologic. The company and products are not listed on any Federal Acquisition site (NAC/SAC). NAICS 325413 is listed as In-Vitro Diagnostic Substance Manufacturing. In searching VIP, (4) contractors were found under the NAICS/keyword search.

In searching FPDS for some of the products:

1. Gordonae Kits; Only (1) contractor provided the product (Gen-Probe)

2. Tuberculosis Kits: (4) contractors provided the product; Chembio Diagnostics Inc., Idexx Laboratories Inc., Hologic Inc., Qiagen N.V.

3. Avium Complex Kits; Only (1) contractor provided the product (Hologic)

4. Culture ID Reagent; Only (1) contractor provided the product (Gen-Probe)

VIP RFI #AP2608 was sent to all contractors listed under NAICS. There were no responses received.

GSA RFI RFQ1454710 was posted on GSA under 65 VII: 555-4, there were (6) contractors. There were no responses.

Sources Sought Notice 36C24120Q0566 was posted. Received 1 response from Hologic Incorporated. They can provide the products and the equipment. They also provided a sole source letter that they are the only manufacturer/distributor for the products.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name: Julie Lemire Date Name: David McElwee Date Title: Contracting Officer Title: Program Support NCL VISN 1