P03 JA AP 0253_S_redacted.pdf

36C261-25-AP-0253

Effective Date: 02/01/2022

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C261-25-AP-0253 JOFOC Tracker ID: 671

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Network Contracting Office 21

2. Nature and/or Description of the Action Being Processed: VA San Francisco Health Care System (VASFHCS), is requesting for brand name non-biological implant 5-year consignment with Stryker Neurological. The proposed action is for a sole source Indefinite Delivery, Indefinite Quantity (IDIQ) contract with consignment language in accordance with VAAR 816.770, Consignment Agreements, and as implemented via VHA Directive 1081.02, VHA Surgical Implants. The IDIQ contract will have a 5-year period of performance consisting of 5 ordering periods.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: VASFHCS, Radiology Service has an estimated Stryker Retriever Coil Stent non-biological implant usage of $500,000.00 over a 5-year period. The maximum aggregate value of orders that can be placed under this contract is $500,000.00.

The consignment shelf stocking level value will be approximately $438,015.00. Over 30 different Stryker Coil, stent, and stent-retriever non-biological implants will be immediately available for scheduled and unscheduled procedures maximizing quality of care. VASFHCS has a need for these implants based upon the physician’s determination of medical necessity during procedures.

4. Statutory Authority Permitting Other than Full and Open Competition: 38 U.S. Code 8123 - “Procurement of prosthetic appliances. The Secretary may procure prosthetic appliances and necessary services required in the fitting, supplying, and training and use of prosthetic appliances by purchase, manufacture, contract, or in such other manner as the Secretary may determine to be proper, without regard to any other provision of law.”

VA exercised limited use of Title 38 U.S. Code 8123 to execute alternative procedures for the purchase of surgical implants as signed by SECVA on October 5, 2017. Source: (VHA Directive 1081.02 Appendix A dated November 23, 2018).

FAR 13.5 Simplified Procedures for Certain Commercial Items:

In accordance with VHA Directive 1081.02, the authority for this J&A is cited in 41 U.S.C. 253(c)(5), FAR 6.302-5 and VAAR 806.302-5(b)(1), Authorized or required by statute under (38 U.S.C. Section 8123).

These prosthetic items/sensory aids are not available for purchase on an existing contract and will be purchased on an open-market basis because the patient's medical need cannot be met using a required source of supply or service where there is medical justification to support the need.

Medical justification is supported in the consult placed by the VA clinician.

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): VHA 1081.02, November 23, 2018 section 5 (i)(1) “Prescribing Specialty Clinicians have the authority to select which surgical implant is medically necessary, and often as an immediate need during surgery.” Stryker 360 Coil implants were the brand name implants selected as the preferred implants by the VA San Francisco Health Care System Radiology Service prescribing specialty clinicians.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: These items are specifically selected by the physicians based on currently available medical technology and available industry implants. Because the physicians select these items based on their professional judgment and medical necessity during the procedure, the sole sourcing of these items is deemed the most practicable approach. Sole sourcing is authorized in this situation under 38 U.S.C. 8123.

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

Non-biological implants will be determined fair and reasonable in accordance with (IAW) FAR 13.106- 3(a)(2)(iii) Current price lists. They will also be compared with similar items in a related industry IAW FAR 13.106-3(a)(2)(iv). Stryker 360 Coil Stents are offered to industry via catalogue price listing. Though non-biological coils vary in pricing, Stryker Retriever Coil Stents will be compared to similar coils/stents offered in the industry. Each Veteran procedure is a standalone micro purchase prosthetics requirement and will be paid via General Purchase Card (GPC) by purchasing agents.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The CO confirmed the contractor’s assertions that they are the only provider of their proprietary Retriever Coil Stents. Market research consisted of vendor statements, a search of the NAC catalog, Supply Chain Master Catalog, as well as GSA. Stryker only distributes through company representatives and consigning inventory to the facility is a standard for this product.

No other market research is needed. A synopses of proposed contract action is not required in accordance with VAAR 805.202. This justification will be posted in accordance with FAR 6.305(a).

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Physicians are currently trained on the use of Stryker Retriever Coil Stents. The use of a particular manufacturer’s implants requires highly specialized training on the part of the physician. In the prosthetic implant industry, product selection is based on “physician preference/experience” as authorized via 38 U.S.

Code 8123 and VHA directive 1081.02).

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

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: As VA Clinicians are trained on new implants, they continue to request these implants through implant supply chain management. The Medical Centers rely on the expertise and judgment of their clinicians to prescribe the devices they need for patient care and contracting cannot direct or influence their decisions. Therefore, the devices outlined in this J&A would be considered physician’s preference items.

KONSTANTI

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MATHEW

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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.

Konstantin Nodaros Date:

Acquisition Utilization Specialist VA San Francisco 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.

Mathew B. Czeshinski Date:

Contracting Officer Network Contracting Office 21

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.

Digitally signed by AMANDA HILDRETH Date: 2025.02.20 10:35:59 -06'00'

Amanda J Hildreth Date:

Branch Chief, Supply II Network Contracting Office 21

AMANDA HILDRETH