SSJ- PM_ OVER_SAT Diasorin 4-22--_Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:________VA-21-00051818 Diasorin Molecular_Herpes/CMV

1. Contracting Activity: 689-21-3-7455-0755. Department of Veterans Affairs, VISN 01, VA

Connecticut Medical Center.

2. Nature and/or Description of the Action Being Processed: This request is for a long-term BPA agreement (base plus 4 option years) for a firm-fixed price with base year period of May 1, 2021 through April 30, 2022 with Diasorin Molecular. The testing kits and consumables are required for HSV (Herpes Simplex Virus), VZV (Varicella Zoster Virus), Flu A/B & RSV, CMV (Cytomegalovirus) and Babesia qualitative and quantitative PCR testing at the Virology Department at the West Haven VA Lab. These kits are sold by Diasorin Molecular and have been used in the Virology Lab for years to provide this testing to the VISN 1 Labs as a Reference Lab. The estimated yearly cost is $172,600 and the 5-year cost is $863,000.00.

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

Item # Description/Part Number*

Qty

1 HSV 1 Primer Pair (PN# MOL9003) (23 per year) 115 2 HSV 2 Primer Pair (PN# MOL9004) (23 per year) 115 3 VZV Primer Pair (PN# MOL9024) (18 per year) 90 4 CMV Primer Pair (PN# MOL9002) (2 per year) 10 5 Simplexa Extraction & Amplification Ctrl (PN# MOL9000) (12 per yr.) 60 6 Simplexa HSV 1&2 Positive Control Pack (PN#MOL2160) (2 per yr.) 10 7 Simplexa CMV Molecular Control (PN# MOL8002) (2 per year) 10 8 2.5x Universal Master Mix (MOL9010) (24 per year) 96 9 Universal Disc case of 100 (PN# MOL1400) (4 per year) 20

10 Universal Disc Sealers 250 (PN# MOL1500) (2 per year) 10 11 Simplexa HSV 1&2 Direct Kit w/MOL1455 (PN#MOL2150) (24 tests) (4 per year) 20

12 Simplexa Extraction (PN# MOL9300) (10 per year) 50

13 Babesia Primer Pair (MOL9063)(6/year) 30

14 TA Master Mix (MOL9070)(10/year) 50 15 Simplexa Extraction and Amp control set (MOL9000)(12/year) 60

16 Estimated shipping and handling/year 5

The Virology Lab service at the West Haven Campus of the VA Connecticut Healthcare System may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and referencing the PO# and any special instructions. Volumes are estimated quantity derived from the previous FY19/FY20 usage, but the government does not guarantee volumes as listed; they are estimates ONLY.

Base Period of Performance: May 1, 2021 to April 30, 2022. The IGCE will provide the estimated costs for both the base year and the 5-year BPA.

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

(X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1.

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2.

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3.

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5.

( ) (6) National Security per FAR 6.302-6.

( ) (7) Public Interest per FAR 6.302-7.

5.Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Diasorin Molecular LLC is the only manufacturer and authorized distributor that can attain the level of technical sophistication required.

These test kits and supplies for qualitative and quantitative Viral PCR testing are specific to the Viruses being tested. These kits are specific for the genes that will identify the virus and help to confirm (qualitate) its presence as well as quantitate using PCR technology. These manufactured tests are built in response to diagnostic testing trends identified and evaluated by Diasorin.

This testing has already been approved by the FDA and validated by the VA Connecticut laboratory. No other time nor materials need to be invested by VA Connecticut to continue using these kits for testing.

New equipment costs and the use of new reagents as well as the Validation of a new system are not warranted. This request is to ensure that the kits are available, provide ease of ordering, and fair pricing for the Virology Lab so that this service continues without interruption. This testing is already in use in the Virology Lab (Reference Lab for VISN 1 Labs) at VACT and these kits are required in order to provide a continuum of service for VISN 1 Veterans. This testing has already been validated, FDA approved and implemented so no further cost would be incurred. This request is to ensure that the kits are available, provide ease of ordering, and fair pricing for the Virology Lab so that this service continues without interruption. This testing will only work on the DIASORIN analyzers that are owned by the VA and there are no authorized distributors.

6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A search on GSA Advantage was done and these products are not available under Federal Supply Schedule contract. Diasorin Molecular is the manufacturer and has no authorized distributors for these kits and supplies and has provided a letter attesting to that. Diasorin reagents are the only reagents that will work on the Diasorin analyzers that are in place in the lab. Testing has already been validated and utilized at the VACT Virology Lab providing prompt results to the VISN 1 clinicians.

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

The cost of performing these tests “In House” is significantly less expensive than can be performed by the VISN 1 reference lab. One example is Babesia testing. VA CT cost . The reference lab is $ . The other tests show similar savings. The current pricing is in line with the historical pricing and an additional discount is included in new quote.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Technical Market Research was used before the VACT Virology department adopted these test procedures for Herpes Virus, Cytomegalovirus and Varicella Zoster Virus.

VA CT anticipates expanding their test menu. Several validation studies were required before this testing could be employed and duplication of this process would incur a large expense by the government as well as tech time, etc. to adopt any other method. The clinicians throughout VISN 1 have been relying on this method for their antiviral therapy and prognosis and it has proven to be reliable and provide quick results. The instrumentation used for this testing is already on site and has been validated to perform this testing. Lengthy validation studies would need to be performed and take time away from implementing any new tests for patients or cause a delay in the reporting of results.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This testing is already taking place in the VACT Virology department for the VISN 1 Labs and extensive amount of time was spent validating these assays. The VA owns this equipment and no other equipment would be required to continue with this same methodology. The results are reliable and accurate, and the clinicians are satisfied with this method.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: See section 6 above.

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: This equipment is state of the art and the lab has confirmed they will be staying with this system for the next 5 years. Unless new technologies should become available, VISN 1 is already using the current state of the art technology.

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.

_____________________________ 4/15/2021 Name: David McElwee Date Title: NCL Program Support Facility: NCL office, VISN 1

David G.

McElwee 142454

Digitally signed by David G. McElwee 142454 Date: 2021.04.15 12:57:22 -04'00'

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.

Name : Linda Ward Date Title: Branch Chief Facility: Manchester VAMC

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.

Name : Tammy Fox Date NCO/PCO 01 Division Chief Facility:

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 ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Name : Joseph Maletta Date Executive Director, RPO East VHA Head of Contracting Activity (HCA)

Linda J. Ward 155235 Digitally signed by Linda J. Ward 155235 Date: 2021.04.16 09:08:11 -04'00'

Tammy A Fox 706200

Digitally signed by Tammy A Fox 706200 Date: 2021.04.22 12:45:07 -04'00'

JOSEPH MALETTA

1347841

Digitally signed by JOSEPH

MALETTA 1347841

Date: 2021.04.22 15:29:17 -04'00'