N23-21-08 FAR 13.5 JandA REDACTED (1).pdf

VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT‐$7M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Original Date: 08/30/17 Revision 02 Date: 08/04/2020

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C263‐21‐AP‐1319

1. Contracting Activity: Contracting Activity: Department of Veterans Affairs, Network 23 Contracting Office (NCO 23), 4801 Veterans Drive, Saint Cloud, MN 56303

Organizational Activity: Department of Vetrans Affairs, Minneapolis VA Health Care System, One Veterans Drive, Minneapolis MN 55417

2237: 618‐21‐2‐8424‐0138

2. Nature and/or Description of the Action Being Processed: A firm‐fixed price purchase order for the procurement of reagents for the Roche COBAS 6800 System used to perform testing for COVID‐19 at the Minneapolis VA Health Care System.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Roche COBAS 6800 reagents used to perform testing for COVID‐19 to include following:

120 Each‐ COBAS SARS‐COV2 480T Kit (Item Number: 9343733190)

60 Each‐ KIT COBAS 6800/8800 BUFF NEG RMC IVD (Item Number: 7002238190)

60 Each‐ COBAS SARS‐COV‐2 Control Kit (Item Number: 9175440190)

360 Each‐ KIT COBAS 6800/8800 WASH IVD (Item Number: 6997503190)

120 Each‐ KIT COBAS 6800/8800 SPEC DIL REAGENT IVD (Item Number: 6997511190)

120 Each‐ KIT COBAS 6800/8800 LYS REAGENT IVD (Item Number: 6997538190)

180 Each‐ KIT COBAS 6800/8800 MGP IVD (Item Number: 6997546190)

60 Each‐ COBAS OMNI PROCESSING PLATE (Item Number: 5534917001)

60 Each‐ COBAS OMNI AMPLIFICATION PLATE (Item Number: 5534941001)

120 Each‐ COBAS OMNI PIPETTE TIPS (96 tips per rack) (Item Number: 5534925001)

60 Each‐ Solid Waste Bag With Insert Set of 20 (Item Number: 8030073001)

Estimated Cost: $1,007,064.60

Period of Performance: Date of Award until 9/30/2021

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

PM Part 813.5 SAP for Certain Commercial Items Original Date: 08/30/17 Revision 02 Date: 08/04/2020

( ) 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): These reagents are needed as soon as possible to aid VISN 23 in the combat of the COVID‐19 virus, as the COBAS analyzer will be installed the week of January 11, 2021. This analyzer will allow the VA to run COVID‐19 tests in house at a high volume for the entire VISN to avoid any delay in patient care to the veterans served by VISN 23. In addition, this system is highly specialized equipment used for utilizing real‐time reverse transcriptase polymerase chain reaction (RT‐PCR) testing for the qualitative detection of nucleic acids in the Ribonucleic Acid (RNA) of the COVID‐19 virus. These reagents will be used on this equipment that will have a high throughput, which will also allow Minneapolis to act as a referral laboratory for the rest of the VISN for COVID‐19 testing. This will insure there is no delay in patient care for all of VISN 23. Currently the VISN 23 is relying on and paying referral laboratories to run these tests at cost between $75.00 and $99.00 per test, and have a turn around time of 48‐72 hours.

Calculations project the in‐house cost per test to be around $18 and testing has a 3 hour turn around time. Bringing this test in house will result in a significant cost savings and decrease our turn around time significantly.

Only these Roche reagents are compatible with this new analyzer that is being installed to perform

FDA emergency approved COVID‐19 testing.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Roche has no authorized distributors or resellers. In addition, a notice of intent was issued on January 13, 2021 on the Contract Opportunities Portion of beta.SAM.gov IAW FAR 5.201, and at this time, no responses have been received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The government believes the anticipated cost will be considered fair and reasonable IAW FAR 13.106‐3(a)(2)(ii), based upon comparison of proposed prices with prices found reasonable on previous purchases.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: In accordance with VA Procurement Policy Memorandum 2016‐05 ‐ Implementation of the Veterans First Contracting Program, U.S.C. §§ 8127, Market Research was conducted on Vetbiz.gov using 325413, with 40 results returned. However, Roche is the exclusive manufacturer and distributor of the COBAS 6800 System and the corresponding reagents. There are no other sources of these supplies.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

PM Part 813.5 SAP for Certain Commercial Items Original Date: 08/30/17 Revision 02 Date: 08/04/2020

Rachel Pike

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: These are the only reagents that are compatible with the Roche COBAS 6800 that is currently being installed to perform FDA emergency approved COVID‐19 testing.

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.

01/13/2021

Date Laboratory Contract Liason Minneapolis VA Health Care System

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.

1/13/2020

Andrea Harter Date Contracting Officer Network 23 Contracting Office (NCO 23)

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

1/13/2020

Jameson Schwartz Date Branch Chief Network 23 Contracting Office (NCO 23)

[SIGNATURE REDACTED]

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PM Part 813.5 SAP for Certain Commercial Items Original Date: 08/30/17 Revision 02 Date: 08/04/2020

01/15/2021

Daryl A. Berg Date Director of Contracting Network 23 Contracting Office (NCO 23)

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

01/19/2021

Terry L. Spitzmiller Date Executive Director Regional Procurement Office Central (VHA)