S02-Attachment D Brand Name Justification MPT to SAT BC Signed - Copy.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Brand Name Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification for Brand Name IAW FAR 13.106-1 For

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

Acquisition Plan Action ID: 36C257-24-AP-2261 JFOC NUMBER: FY24-NCO 17-1456

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 17 (NCO 17), located at 5441 Babcock Rd. Ste 302, San Antonio, TX 78240, in support of the El Paso Veterans Administration Healthcare System (ELPVHCS), Pathology and Laboratory Medicine Service (P&LMS), located at 5001 North Piedras Street., El Paso, TX 79930-4210. Purchase Request Number:

756-24-3-960-0352

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: El Paso VA Health Care System (EPVAHCS), requires nine (9) Abbott / ID NOW Brand Instruments, Barcode scanners, and printer w/ accessories for the laboratory services. El Paso VA Laboratory currently has Abbott RALS for all Point of Care testing, so our technicians are very familiar with the system and have given excellent testing results - as per FDA standards. The Abbot ID Now equipment is needed to perform molecular POCT of Strep A, Influenza A and B, and COVID-19 tests.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

A unique characteristic of the Abbott ID NOW is that it uses isothermal nucleic acid amplification technology that provides molecular results as soon as 7 minutes for individual testing of Strep A, Influenza A, and B, and COVID-19 with one instrument. The Abbott ID NOW is CLIA Waived which is crucial for our current Provider licensing availability because non-CLIA Waived instruments require licensing from a Provider per testing site and the number of licensures available from our Medical Director are not enough for all CBOC sites. The Abbott ID NOW was granted marketing authorization by the FDA on 8/10/2023. There is a limited market availability of CLIA Waved Point of Care Testing systems that are FDA-approved. The Abbott ID NOW is a perfect fit for our Outpatient Clinic setting and the CBOCs because all test results do not need reflex molecular confirmatory testing. Those other available Point of Care systems have significant disadvantages to our local VA Laboratory testing such as big size equipment, longer testing times such as 20 minutes or more with panel testing, no connectivity available to a secure LIS for the transmittal of patient test results, no single test available (most come in panels), the missing of one of the tests required (Strep A, Influenza A and B, and COVID-19), and not cleared of Emergency Use Authorization from the FDA. The following is the brand name/ Model/ and exact part # of required equipment:

https://www.acquisition.gov/?q=/browse/far/13

Last Updated: 02/01/22 Page 2 of 3

In addition, the Abbott ID NOW is the only responsible source as other available CLIA Waived Point of Care systems in the open market does not meet our VA’s Laboratory standard for testing:

• Cobas Liat System offers combo testing for testing we are not required such as Influenza A/B & RSV which causes unnecessary testing and health care cost and a longer testing time of 20 minutes.

• Cue’s COVID-19 Diagnostic Test is limited in our required testing by not offering Strep A testing, it has been granted Emergency Use Authorization (EUA) from the FDA but not cleared from EUA (meaning that there is no reasonable assurance of safety and effectiveness when the device is used as intended), and the Cue Reader needs to be connected to the Cue Health App on a mobile device.

No secure connection can be established between the Cue Reader and the LIS-CPRS patient chart.

Testing turnaround time is 20 minutes which is longer than Abbott ID NOW.

• The Biofire Spotfire System has a Biofire Spotfire Respiratory (R) Panel that provides testing for the 5 most probable viruses that cause respiratory tract infections, including influenza, rhinovirus, respiratory syncytial virus, and SARS-CoV-2. This panel does not include Strep A. Strep A is available in the BioFire FilArray Pneumonia Panel which tests for a total of 33 clinically relevant targets. To have all three needed VA Laboratory Point of Care tests, we would need to buy the two previously mentioned panel kits individually causing unnecessary testing and expenditure. The instrument consists of a Biofire Spotfire CPU module that has a tablet-sized touch screen and an extra 1 to 4 modules that can be stacked and where the testing occurs. The Biofire Spotfire System is a great tool in the Hospital setting where Clinical decisions involving in-patient stay and/or pre-surgical procedures rely on vast laboratory testing.

• The Sofia 2 Platform is a rapid diagnostic testing that involves lateral-flow fluorescent immunoassay technology which is not molecular testing. Molecular confirmatory testing would be needed for negative results of Strep A and positive results of COVID-19. The Sofia 2 Platform does offer individual testing of Strep A, Influenza A and B, and COVID-19, but the fact that the testing is not molecular, definite clinical decisions cannot be made at the finishing of testing with Sofia 2 Platform until the result of molecular confirmatory testing is available. 6. 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.

Estimated Purchase: $27,630.00

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

In accordance with FAR part 10 and VAAR part 810, market research has been conducted for this acquisition. Veterans Small Business (VetCert) database was searched for NAICS code 334516 which

Last Updated: 02/01/22 Page 3 of 3 resulted in 212 vendors however when reached out to several of them they were not able to provide this requirement due to the fact they were not authorized distributors. Further market research was done on other business applications and found vendors Fisher Scientific and McKesson were able to provide the Abbott ID Now Instrument: Diagnostic Test and Controls a large business was able to meet this requirement. A search was conducted on FPDS and found Abbot Rapid DX North America, LLC, a large business could provide this requirement. DBBS search was conducted and found no small business with keyword ID NOW. Searched GSA Advantage keyword NAT024 which also resulted in 0 vendors able to provide this requirement. Based on market research, 3 large businesses were found to recommend posting on this requirement on FBO brand name open market unrestricted.

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.

Michael J. Tusinger Contracting Officer https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466