P03 - SSJ - COVID Reagents - NCO-12 VHA.pdf

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 3 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C25222AP1290

1. Contracting Activity: Department of Veterans Affairs, Milwaukee VAMC, Pathology and

Laboratory Medicine Service (PLMS), along with Network Contracting Office (NCO) 12, Great Lakes Acquisitions Center (GLAC). 695-22-2-944-0355

2. Nature and/or Description of the Action Being Processed: This procurement is for a firm fixed price contract for COVID testing due to the Covid Mandate 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.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: VISN 12 Pathology and Laboratory Medicine Service (PLMS) is requesting additional supplies to begin tesing employees due to the COVID Mandate that all employees be vaccinated or they will be tested for COVID on a daily or weekly schedule.

2 month estimate of $382,401.92

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):

In 2020, due to the COVID-19 Pandemic, Milwaukee laboratory purchased the ThermoFisher King Fisher Flex and the Applied Biosystems 7500 Dx instrumentation. The ThermoFisher TaqPath SARS-CoV-2 assay is a test for SARS-CoV-2 FDA EUA approved for use on the ThermoFisher and Applied Biosystems instrumentation. Since significant

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 3

Revision 03 Date: 02/11/2021 validation processes, training, and staffing has been implemented utilizing this assay, only the ThermoFisher FDA EUA TaqPath Assay will meet the needs of this procurement.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The ThermoFisher FDA EUA TaqPath Assay is the only FDA EUA approved assay for use with the current instrumentation. Other assays would require a Laboratory Developed Test Assay, which is not supported by the P&LMS Pathology Director, which again is a lengthy and costly validation.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Pricing is fair and reasonable, the new quote is less than what we previously paid ordering these testing supplies in 2021.

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

Reasons Market Research Was Not Conducted: A search of VETBIZ concluded that there was no SDVOSB or VOSB that could provide the facility this testing. It was also was concluded through market research that no small business could provide this testing.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: VISN 12 testing needs remain high and a fast turnaround time is critical. This contract will be an emergency contract due to the ongoing COVID-19 Pandemic.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None.

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: None.

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.

Jeanne Donkle Date Supervisor Milwaukee VAMC

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.

https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 3

Revision 03 Date: 02/11/2021

Teresa Beers-Wesolowski Date Contracting Officer

GLAC/NCO 12

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.

David Picchi Date NCO 12/Branch Chief - Supplies

GLAC