Jefo -redacted - IOR Maintenance.pdf

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY (JEFO)

STRYKER CORPORATION

CONTRACT SPE2D1-20-D-0011

(1) Defense Logistics Agency (DLA) Troop Support, Medical Supply Chain, Capital Equipment Division, is the contracting activity.

(2) This sole source justification is for purchase of extended warranty maintenance coverage for integrated operating room equipment on a sole source basis.

(3) The action submitted for approval is a JEFO for an acquisition of full-service maintenance services for Stryker Operating Room (OR) Integration Systems and Endoscopy Systems at Naval Medical Center (NMC) San Diego from Stryker Corporation (Stryker) under Patient Monitoring and Capital Equipment (PMCE) Contract SPE2D1-20-D-0011 which expires on July 16, 2030.

The total dollar value of this requirement is $ 941,659.27.

(4) The authority waiving the competition requirements is FAR16.505(b)(2)(i)(b): only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

The use of this authority is necessary since the United States Navy (US Navy) at NMC San Diego requires extended warranty maintenance coverage for their Stryker OR Integration Systems and Endoscopy Systems. This requirement is essential and critical to the continuing functionality of Stryker OR Integration Systems and Endoscopy Systems at NMC San Diego.

Stryker is the only authorized source for the maintenance services on Stryker OR Integration Systems and Endoscopy Systems because it is the original equipment manufacturer (OEM) for Stryker products and it does not provide replacement parts for its products to any third-party service organizations. Any replacement equipment must be from the OEM (Stryker) of the system to maintain current Risk Management Framework (RMF) Authorization to Operate (ATO) for the system since using a non-OEM replacement equipment could void the OEM’s responsibility of maintaining the RMF ATO for the system. Devices serviced by third-party vendors may have non-factory-authorized parts or parts scavenged from other Stryker equipment, and they carry a substantial risk of impaired function or performance of the device.

Stryker has the sole proprietary license for the operating software on Stryker OR Integration Systems and Endoscopy Systems. The annual extended warranty maintenance coverage provided by Stryker consists of software updates along with equipment repair. Repairs of the Stryker OR Integration Systems and Endoscopy Systems often require interaction with the Stryker’s proprietary operating software. No other entity is authorized to perform service on the Stryker OR Integration Systems and Endoscopy Systems other than Stryker.

(5) The required extended warranty maintenance coverage is available on Stryker’s PMCE Contract

SPE2D1-20-D-0011. The contract pricing has previously been determined fair and reasonable via comparison with commercial pricing, invoices, and other than certified cost or pricing data.

(6) Market research performed by DLA Troop Support Biomedical Engineer in September 2020 confirmed that Stryker possesses the sole ability to provide the required maintenance services for Stryker OR Integration Systems and Endoscopy Systems and no other sources are able to supply maintenance or repair coverage under the extended warranty maintenance.

(7) There are no other facts supporting the use of this JEFO.

(8) PMCE vendors have the opportunity to add products that fall within the scope of the PMCE solicitation at any time; however, currently there are no other known PMCE vendors that would be able to offer the extended warranty maintenance coverage for existing Stryker OR Integration Systems and Endoscopy Systems.

(9) As the Contracting Officer, I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.

Date

I hereby certify that the requirements that form the basis of this justification are accurate, that these supplies meet the Government's minimum needs and that this justification is accurate and complete to the best of my knowledge and belief.

I have reviewed this justification and recommend approval.

I have reviewed this justification and recommend approval.

I have reviewed this justification and recommend approval.

DLA Counsel-Troop Support

I have reviewed and hereby approve this justification.

DLA Troop Support Competition Advocate