P03 JOFOC.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

36C250-26-AP-1122

VHAPG Part 806.3 OFOC Page 1 of 5 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C250-26-AP-1122

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C250-26-AP-1122

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Louis Stokes Cleveland

Veterans Affairs Medical Center (CLE VAMC) and Network Contracting Office (NCO) 10. This is a Justification for Other Than Full and Open Competition.

Transaction: 541-26-4-775-0244

2. Nature and/or Description of the Action Being Processed: Network Contracting Office (NCO) 10 intends to award a new, firm fixed price, single source, base plus two option year purchase order to Hologic, a large business.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This task order is required to purchase reagents and consumables for women’s health testing on methodology currently in use at the Cleveland VA Medical Center. These reagents and consumables are proprietary in nature as they are uniquely made for only the Hologic Panther system. These reagents will allow for chlamydia, gonorrhea, trichomonas, bacterial vaginosis, and yeast STD testing to be done for our women veteran population. Consumables will be used to maintain the instrumentation and perform quality control measures to ensure accurate patient testing.

Delivery of supplies will be as requested by the service.

Description/Part Number* 302923 - Kit, Aptima Combo 2 100-TEST Kit (PANTHER) PRD-05186 - BV ASSAY, APTIMA, 100-Test Kit, IVD PRD-05189 - CV/TV ASSAY, APTIMA, 100-Test Kit, IVD 301040 - Kit, APTIMA COMBO 2 Urine Spec Coll, 50/box 301041 - Kit, APTIMA COMBO 2 Swab Spec Coll, 50/box PRD-03546 - Aptima Multitest Swab Collection, 50/box 303536-CPR - APTIMA TRICH PANTHER Cost per Reportable

For

Other Than Full and Open Competition (>SAT)

36C250-26-AP-1122

VHAPG Part 806.3 OFOC Page 2 of 5 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C250-26-AP-1122

303096 - Run Kit, PANTHER 303014 - Aptima Assay Fluids Kit (1000 tests) 303013 - Aptima Auto Detect Kit (1000 tests) 104772-02 - Multi-tube units (MTUs) 902731 - Panther Waste Bag Kit 504405 - Panther Waste Bin Cover CL0040 - Caps, TCR/SEL.(CL0038) DIAG.

CL0041 - Caps, AMP/P.R.S.(CL0045)DIAG.

105668 - Kit, Penetrable Caps (AS NEEDED) 303085 - Lbld, Advanced Cleaning Solution, 255 mL 501604 - Spare Caps, PP, 60mL, TCR APTIMA 2x50 501616 - Spare Caps,30mL tube (501213)Diagnostics 301110 - APTIMA CT/GC Cntrls Kit (1 tray) IVD

PRD-05187 - BV CONTROLS, APTIMA, 100T, IVD

PRD-05188 - BV CALIBRATOR, APTIMA, 100T, IVD

PRD-05190 - CV/TV CONTROLS, APTIMA, 100T, IVD

PRD-05191 - CV/TV CALIBRATOR, APTIMA, 100T, IVD

302807 - Aptima Trichomonas Controls Kit

ESTIMATED DOLLAR VALUE: $701, 100.00

REQUIRED DELIVERY DATE: Base plus two option years

Base January 2, 2026 through, Januar 1, 2027 OY 1 January 2, 2027 through, January 1, 2028

OY2 January 2, 2028 through, January 1, 2029

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 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority): Based on market research described in section 6 of this document, it was determined that no other source is reasonably available to facilitate this request. It is unreasonable to consider another vendor as these are the only products that are compatible with the Hologic Panther system. This instrument consolidates the testing done for women’s health patients and brings some send-

For

Other Than Full and Open Competition (>SAT)

36C250-26-AP-1122

VHAPG Part 806.3 OFOC Page 3 of 5 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C250-26-AP-1122 out testing in-house. The instrumentation meets the Medical Center’s needs as a high throughput analyzer capable of handling the volume of testing for Wade Park and all outpatient facilities. It will also be the main source of COVID testing for the main hospital and surrounding outpatient clinics. It would not be in the best interest of the government to consider another vendor as time because resources would need to be spent training end-users, developing testing platforms in our computer system, and establishing a bi-directional interface for results to transmit from the vendor to our electronic health records.

Accordingly, Hologic is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research efforts could not provide any additional sources to meet the government’s requirements because this instrumentation is proprietary to the Hologic Panther system by which all testing will be standardized on for future testing at the medical center and surrounding Community-Based Outpatient Clinics (CBOC).

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The CO will use a comparison of the proposed prices to historical prices paid for the same/similar items and a comparison of the proposed price to the IGCE, as well as any of the other price analysis techniques identified in FAR 13.106-3(a)(2)(ii), as necessary, to determine the price to be fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted by the Contracting Officer and Pathology and Laboratory Medicine Service (P&LMS) to determine if there were other vendors capable of providing the reagents that meet CLE VAMC's specific requirements. The following sources were reviewed:

GSA eLibrary, National Contracts, ECAT, SAM.gov, Interagency Contract Directories, NAC, SEWP, FPDS, SCMC, OMB, BIC and FDA:

Keywords Used: "cytology reagents" Results: no products or vendors

DSBS:

NAICS Code Searched: 325413 (In Vitro Diagnostic Substance

Manufacturing)

For

Other Than Full and Open Competition (>SAT)

36C250-26-AP-1122

VHAPG Part 806.3 OFOC Page 4 of 5 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C250-26-AP-1122

Keywords Used: "cytology reagents" Results: A search under this NAICS code identified no results

The NMR does apply to this procurement under NAICS 325413, and the SBA has not issued an NMR waiver. The VA and SBA Rule of Two cannot be met; no SDVOSBs or VOSBs are capable of supplying Hologic reagents. This requirement is a single source and will be awarded to the OEM, Hologic, a large business.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: FITARA is not required as this is not an IT buy.

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

Hologic-Large Business Kyle Neighbors 445 Simarano Drive Marlborough, MA 01752

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: On-going research of the industry market place will be conducted to determine if there are new entrants into this product arena.

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.

Robert J.McPeak Acting Adminitrative Officer (P&LMS) VISN 10, VA Northeast Ohio Healthcare System

ROBERT

MCPEAK

Digitally signed by

ROBERT MCPEAK

Date: 2025.11.20 11:52:17 -05'00'

For

Other Than Full and Open Competition (>SAT)

36C250-26-AP-1122

VHAPG Part 806.3 OFOC Page 5 of 5 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C250-26-AP-1122

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.

Rachelle J. Hamer Contracting Officer Network Contracting Office (NCO) 10

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Adam P. Weber Branch Chief – Supply Team #1 Network Contracting Office (NCO) 10

RACHELLE HAMER

Digitally signed by

RACHELLE HAMER

Date: 2025.11.20 12:03:12 -05'00'

ADAM

WEBER

Digitally signed by ADAM

WEBER

Date: 2025.11.20 13:44:37 -05'00'