Single Source Justification - Stryker Procare_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 3

REVISION: 01

Acquisition ID#:

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:

PR IFCAP 2237:

JOFOC Tracking Number:

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office

(NCO19), VISN 19, 6162 S Willow Drive, Suite 300, Greenwood Village, CO 80111.

Organizational Activity: Department of Veterans Affairs, Eastern Colorado Health Care System (ECHCS), Rocky Mountain Regional VA Medical Center (RMRVAMC), 1700 N.

Wheeling Street, Aurora, CO 80045; VISN 19.

2. Nature and/or Description of the Action Being Processed: This procurement is for Stryker ProCare in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

The clinical engineering department proposes to enter into a new Firm Fixed Price (FFP) contract for the service and maintenance for Stryker surgical instruments used in the operating room (OR).

3. Description of Supplies/Services Required to Meet the Agency’s Needs: ECHCS requires both planned and unplanned maintenance for the surgical tools used in the operating room. This requirement provides services for preventive maintenance to ensure that the equipment is safe for patient care. Additionally, corrective maintenance will be included for any broken, defective, or inadequate parts. The service package also includes equipment and software upgrades.

The total value of the contract, including a base year and four option years, The resulting contract will include FAR clause at 52.217-8 – Option to Extend Services. If exercised for up to 6 months, the 52.217-8 option will be exercised at the same rates as those in effect under the contract at the time the contract is extended.

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

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or

Expert Services ( ) International Agreement ( ) Authorized or Required by Statute

Effective Date: 11/15/24 Page 2 of 3

Acquisition ID#:

( ) 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):

Stryker surgical tools are highly specialized, and Stryker is the sole provider of services for its equipment. In order to ensure equipment accuracy and patient safety, preventative maintenance and repairs services for Stryker equipment can only be performed by Stryker trained and authorized/certified personnel. All equipment must be serviced in accordance with manufacturer specifications, since any deviation from these service procedures could put patients at risk of injury or death. In addition to having an authorized Stryker service technician, suitable replacement equipment parts can only be provided by the manufacturer.

The use of an unauthorized Stryker technician or non-manufactured Stryker part could lead to equipment failure or malfunction resulting in possible patient injury or death. In addition, use of unauthorized repair services would invalidate product warranties. The utilization of untrained and uncertified sources would present a significant liability and risk to the Government. To use a different vendor would necessitate the replacement of all existing Stryker surgical equipment, accessories, and attachments, at an estimated cost of

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted as described in paragraph 8 below and Stryker Sales, LLC is the only vendor able to provide the required services. A sole source award will be completed to meet the needs of the Eastern Colorado VA Health Care System and maintain performance of their surgical instruments. This strategy is determined to be in the best interest of the Government as Stryker is the only responsible source capable of providing the required services.

A notice of the proposed action will be synopsized via the Government Point of Entry (GPE) in accordance with FAR 5.201, and the agency will make publicly available the justification required by FAR 6.305(a) within 14 days after contract award.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The price will be analyzed in accordance with FAR 13.106-3(a)(2). The price will be compared to the Independent Government Cost Estimate (IGCE) as well as previous prices paid by the Government by searching the Federal Procurement Data System (FPDS) for similar requirements.

8. Description of the Market Research Conducted and the Results, or a Statement of the

Reasons Market Research Was Not Conducted: In accordance with FAR Part 10 and VA Acquisition Regulation (VAAR) Part 810, the VA has conducted market research to arrive at the most suitable acquisition approach. Market research was conducted by searching the Small Business Administration’s (SBA) Veteran Small Business Certification Database, SBA’s Dynamic Small Business Database, Federal Procurement Data System (FPDS), System for Award Management (SAM) and contacting the large business manufacturer to determine vendors that can provide the required services. On June 13, 2025, , confirmed that Stryker is the sole manufacturer and sole provider of services for its equipment. It was also confirmed that all equipment replacement

Effective Date: 11/15/24 Page 3 of 3

Acquisition ID#:

parts are manufactured in the United States. Market research has determined that this requirement is only available from Stryker, the large business manufacturer.

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

Utilizing Stryker will also serve to maintain warranties, mitigate patient risk, avoid unexpected maintenance and repair costs, and minimize equipment downtime.

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

Stryker Sales, LLC. (Large Business)

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: Due to the nature of the equipment, there is currently only one option that is considered a qualified service source (Stryker). Other sources for maintenance contracts will continue to be evaluated in the future to determine if they have the required certifications and capabilities.

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.

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.

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.

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