LSJ - Screening Cups_Redacted.pdf

Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 2 of 3 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: ____________

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

(FAR 8.405-6(a)(1)(i)(B));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405- 6(a)(1)(i)(C)); or

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rationale/explanation to support cited authority:

The VA Pathology and Laboratory Medicine Service (P&LMS) National Enforcement Office mandates that the Hampton VA Medical Center P&LMS follow the guidance set forth in the VHA Laboratory Waived Testing Regulations when conducting drug screening testing.

The Hampton VA Medical Center P&LMS uses the UNIPAC Middleware Software Program in correlation with the main LAB’s Siemens VISTA Chemical Analyzer to conduct its drug screening. The software itself had been specifically designed to work with the ONESCREEN 12 PANEL Screening Cups flat front design. It’s cut off testing levels ensure that the P&LMS methodology of a lateral flow chromatographic immunoassay could be used to maintain the Waived Testing regulations set forth by the VA P&LMS National Enforcement Office.

To switch to another cup would require implementing a new methodology. Once validated and approved, would require a new Standard of Performance and TMS course # 3826436 (HAM-Drug Screen, Urine) to be rewritten. It would also result in the need to purchase new UNICAP Middleware Software for data entry and for Operators (approx. 170) to have to be retrained and pass competency testing for the new methodology.

Switching methodology to use a different cup would be extremely costly in terms of time, cost, and patient care.

Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 3 of 3 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: ____________

Based on the market research above and not being able to meet the VA Rule of Two for this requirement the CO believes that the most advantageous acquisition strategy for the government is to directly solicit American Screening, LLC under the authority of FAR 8.405-6 and award a subsequent purchase order under American Screening LLC’s, FSS contract GS07F-0008W.

6. BRAND NAME ONLY (Delete this section if it does not apply): This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e).

7. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

James Risbon Date:

Contracting Officer Supply/Service Team1

NCO 6

JAMES

RISBON

Digitally signed by

JAMES RISBON

Date: 2026.09.25 10:00:43 -04'00'