P03 JA 36C248-20-AP-0067 Stryker Equpment Services- Redacted.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 08 Page 1 of 4 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C248-20-AP-0067

1. Contracting Activity: Department of Veterans Affairs, VISN 8, Malcom Randall VA Medical Center, Biomedical Engineering Department, Network Contracting Office 8- NF/SG Services Team. Purchase request #573-20-1-624-0007.

2. Nature and/or Description of the Action Being Processed: This procurement is for a new firm fixed price services contract. Services include preventative maintenance (PM) and emergency repair services for Stryker surgical equipment owned and maintained by the Sterile Processing Department within the Malcom Randall VAMC.

FAR 13.5 Simplified Procedures for Certain Commercial Items: This procurement is for equipment services 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.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Malcom Randall VAMC has a requirement for PM and emergency repair services for Stryker-brand name surgical tools. This contract will cover various pieces of surgical tools that were purchased separately. Prior to the need for this contract, the original purchases of surgical tools were purchased using numerous and varied purchase order numbers. Many of these purchases included maintenance for 3 years through Stryker corporation and the anticipated need for these PM’s and emergency repairs are for those pieces of equipment/tools that are out of warranty. The estimated dollar value during the base year is $161,505.74 with an aggregate value (base plus options) of $807,528.70. If not awarded sooner the anticipated period of performance for one base year, February 1, 2020 – January 31, 2021, plus four optional periods.

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 6.302-4 ( ) 4 International agreement per FAR 6.302-5 ( ) 5 Authorized or required by statute FAR 6.302-6

OFOC SOP Revision 08 Page 2 of 4 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

( ) 6 National security per FAR 6.302-6 ( ) 7 Public Interest per FAR 302-7

FAR 13.5 Simplified Procedures for certain commercial items: The authority for applying the simplified procedures for commercial items of FAR 13.5 is 41 USC 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority: Stryker Corporation is the original equipment manufacturer (OEM) of the surgical tools to be maintained under this requirement. It is critical that the surgical tools be maintained in accordance with OEM specification by trained Stryker Field Service Engineers (FSEs) that are authorized to repair and maintain orthopedic surgical tools. The technology and designs are proprietary to Stryker Corporation. As such, Stryker will not divulge this information to entities outside of its organization. Using third party companies carries a large risk in place of O.E.M. technicians:

Additional information includes:

Repairs not meeting strict standards required by Stryker –Third parties that are not certified or trained by Strykers ProCare services are not tested to Stryker strict standards and it is unlikely that products serviced by third party vendors will adhere to these same strict standards. Stryker does not sell repair components to any third party repair center and is the only repair center in the U.S. using O.E.M. components and Stryker trained ProC e technicians.

Sterility – Stryker has evaluated the biological safety of all lubricants used in each device and has found them to be non-harmfulk for accidental exposure to the patient wound site. Stryker has not evaluated the lubricants used by third party companies and cannot guarantee the biological safety of any chemical or lubricant used outside of our knowledge.

Safety Standard Concer s – Stryker designs, manufactures, and services it’s devices to meet required international safety standards. Certification to these standards is confirmed through independent testing and audit by certified outside organizations. On our devices, you will see the “marks” demonstrating compliance to these standards such as : CE, CSA and UL. When devices are serviced by a third party, conformance to these standards of safety becomes null and void.

Liability – Potential unanticipated liability is also of great concern. The use of sub-s andard or poorly repaired products in the event of a reportable incident may lead to adverse consequences bringing risk to the Government legal or otherwise.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research indicates Stryker is the only party authorized to certify, repair, and service Stryker manufactured equipment, specifically surgical instruments, and does not train parties outside of its own entities to service and repair this equipment.

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7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The price for maintenance and repairs will be considered fair and reasonable in accordance with FAR13.106-3(a) (2)(ii) based on comparisons with prices found reasonable on previous purchases. VA259-16-C-0290 in the amount of $174,894.00 and VA248-17-P-0767 in the amount of $172,662.00 per year to provide identical maintenance services can be used. The scope and complexity of the services provided are comparable to the size and scope of services at Malcom Randall VA.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Stryker is the only party authorized to repair and service Stryker manufacturer equipment, specifically surgical instruments, and does not train parties outside of its own entities to service and repair this equipment. Should the market research show a saturation of third party servicers then the Government can move to competitively procure this requirement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None.

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: Stryker would need to allow third parties to service their equipment. Until Strykker does so this requirement will remain a sole source.

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.