P03 DF_SingleSourceJustification-signed.pdf

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6640--IDIQ Roche Histology Reagent for VISN 23
Solicitation number
36C26324Q0012
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This document is a single source justification for a procurement of Roche histology reagents for Veterans Integrated Service Network 23. The Department of Veterans Affairs Network Contracting Office 23 requires procurement of Roche testing supplies that are compatible with and FDA approved for use on Roche stainers owned by the agency. The estimated cost for the base period is $180,459.15 with a total estimated value of $721,836.60. Market research found that testing supplies must be obtained from the equipment manufacturer or authorized providers, as third party supplies could impact quality and regulatory compliance. A sources sought notice did not receive any responses, justifying restricting competition to the original equipment manufacturer Roche Diagnostics Corporation. The contracting officer and branch chief approved the single source award in accordance with FAR 13.106-1.

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

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

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding $750,000

Acquisition Plan Action ID: 36C263-23-AP-4961

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 23 (NCO23), 2501 W 22nd Street, Sioux Falls, SD 57105

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Procurement of Roche Histology Reagents Procurement for VISN 23. The estimated cost for the base period of performance is $180,459.15 with a total estimated cost of the IDIQ is $721,836.60.

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

Procurement of laboratory testing supplies is done through the manufacturer or authorized service providers of the equipment that is performing the tests. Testing supplies must be compatible with and FDA approved to operate on the Roche Stainers. Orders received must be the same lot number per shipment per site for reasonable QC purposes. Testing supplies must be used according to manufacturer’s specifications to meet the performance characteristics and quality assessments as defined by the 1988 Clinical Laboratory Improvement Act.

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

A search on OSDBU’s VIP database using using NAICS Code: 339112 with Keyword of Roche. Found 1 SDVOSB Company (Branch Medical LLC) which listed Roche supplies in the VetBiz profile. An examination of the product list on their website (http://www.branchmed.com) did not find Roche testing supplies. Company listed are Bio-Rad, Bruker, Beckman Coulter, Sarstedt, Sight OLO, Global Focus, Global Industrial, Path Supply, Globe Scientific, Inc, and Heathrow Scientific Testing supplies are not on the AbilityOne Procurement List.

A search for the GSA’s eLibrary Database for Roche Diagnostic Corporation found GSA/FSS and VA Contracts. All of these list equipment and diabetic supplies. None list any of the reagent supplies requested on this procurement.

A search of the SBA’s DSBS using NAICS Code: 334516 with Keyword of Roche found three company (Everite Machine Products Company, AMP Scientific LLC, The Lloyd Company). These companies do not sell testing supplies for Roche Laboratory equipment.

A sole source sources sought notice 36C26323Q1177 was published on SAM.Gov on Sept 13, 2023. At the close of the notice period on Thursday September 21, 2023, the Department of Veteran Affairs received zero response.

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.

John Milroy Date Contracting Officer

6. One Level Above the Contracting Officer: I certify the justification meets requirements for other than full and open competition.

Travis Johnson Date Branch Chief – Supply/Services Team 3 Supervisory Contracting Officer Network Contracting Office 23 (NCO 23)

JOHN MILROY

Digitally signed by JOHN

MILROY

Date: 2023.09.22 12:45:01 -05'00'

9/22/23

TRAVIS

JOHNSON

Digitally signed by TRAVIS

JOHNSON

Date: 2023.09.22 12:55:50 -05'00'

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