36C25022D0059_2.docx

Part 806.3 Other Than Full and Open Competition (OFOC) Attachment 7: Request for Sole Source Justification Format >SAT

GENERAL INFORMATION

BASE NOTICE TYPE

Network Contracting Office 10 Battle Creek VA Medical Center 5500 Armstrong Rd.

Battle Creek MI 49037

POINT OF CONTACT*

Contract Specialist Jeffrey Rozema jeffrey.rozema@va.gov

AWARD INFORMATION

MODIFICATION NUMBER

LINE ITEM NUMBER

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

Justification and Approval Notice

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C250-22-AP-2343

1. Contracting Activity: Department of Veterans Affairs, VISN 10, LTC Charles S. Kettles VA Medical Center, 2215 Fuller Road, Ann Arbor, MI 48105/Network Contracting Office 10 2237: 506-22-2-1565-0099

2. Nature and/or Description of the Action Being Processed:

The Pathology & Laboratory Medicine Services (PALMS), Molecular Department, performs COVID testing for screening and monitoring patients and employees of the VA Ann Arbor, Saginaw, Battle Creek and the CBOCs (Toledo, Flint, Jackson, and Adrian). Other sites in VISN 10 will also be sending their specimens for testing at VA Ann Arbor. The Cobas SARS-CoV-2, for use on the Roche Cobas 6800/8800 Systems, is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in clinician-instructed self-collected nasal swab specimens, and clinician-collected nasal, nasopharyngeal and oropharyngeal swab specimens from individuals who meet COVID-19 clinical and/or epidemiological criteria. Cobas SARS-CoV-2 is for use only under Emergency Use Authorization (EUA) in laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meets requirements to perform high or moderate complexity tests.

This action will be awarded as a new open market, firm-fixed price, 2-year IDC. Roche Diagnostics Corporation requires a minimum 2-year contract in order to receive the discounted pricing for the SARS-CoV-2 480T kit, with a minimum order quantity of 10 kits per year (or 20 kits in the first year).

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The following Roche Diagnostics Corporation SARS-CoV-2 kits and estimated quantities are required:

Total

4. Statutory Authority Permitting Other than Full and Open Competition:

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The Molecular Laboratory of PALMS currently utilized the Roche Diagnostics Corporation Cobas 6800 which they use for HPV testing. On that same platform they also run COVID testing for employees and patients. Roche Diagnostics Corporation is the sole manufacturer and distributor of Cobas SARS-CoV-2 test kits and control kits, under Emergency-Use-Authorization (EUA) only and no other company can provide these reagent and control kits to be used on the Cobas 6800/8800 Systems.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Roche Diagnostics Corporation has provided supporting documentation stating they are the sole manufacturer and distributor of Cobas SARS-CoV-2 test kits and control kits, under Emergency-Use-Authorization (EUA) only and no other company can provide the reagent kits and controls to be used on the existing Cobas 6800 System.

A notice of intent to sole source with Roche Diagnostics Corporation was published on Contract Opportunities (ref: 36C25022Q0420) on March 16, 2022 and closed on March 20, 2022. No vendor responses were received in response to this intent to sole source.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The anticipated cost will be considered fair and reasonable in comparison to pricing on previously awarded contracts where pricing has been evaluated as fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

VIP search using NAICS 325413 resulted in 45 potential SDVOSB/VOSB sources. Narrowing the VIP search using keyword “Roche” resulted in zero SDVOSB/VOSB sources. VA “Rule of Two” is not attainable. Search of SBA DSBS using the same NAICS/keyword search criteria resulted in one potential small business – International Diagnostic Equipment, LLC, 42075 Remington Ave, Temecula, CA 92590 – although the capability narrative for the vendor did not mention Roche Diagnostics equipment or supplies. The searches of GSA Advantage and VA NAC/SAC/MedSurg/Prime Vendor did not result in any potential sources for the required reagents and controls. Search of Contract Opportunities, specifically 36C25622Q0221 and 36C25719N0755, indicate sole source procurements to Roche Diagnostics Corporation for the SARS-CoV-2 reagent and control kits. Letter from Roche Diagnostics Corporation dated January 20, 2022 verifies Roche as the sole manufacturer and distributor for the Cobas SAR-CoV-2 test. A notice of intent to sole source with Roche Diagnostics Corporation was published on Contract Opportunities (ref: 36C25022Q0420) on March 16, 2022 and closed on March 20, 2022. No vendor responses were received in response to this intent to sole source.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

The required SARS-CoV-2 reagent and control testing kits from Roche Diagnostics Corporation are specific to use on the Roche Cobas 6800/8800 testing platform which was purchased for the Ann Arbor PALMS in October 2020. No other SARS-CoV-2 test kits are compatible or acceptable.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46256

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:

The proposed contract action is for reagent and control test kits for a period of two years. After the two years, if a follow-on contract is required for additional SARS-CoV-2 kits, the market will be surveyed to determine if Roche Diagnostics Corporation distributes these products through any SDVOSB/VOSB’s, small businesses, or any other large businesses that could lead to a competitive procurement.

Rev: 12 Effective Date: 02/01/22 Page 5 of 5