PM_Part813.5_Atch1_FAR13.5_JA_OVER_SAT - Stryker_Redacted.pdf

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 4 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-21-AP-2055

1. Contracting Activity: Department of Veterans Affairs, VISN 21, Department of Veterans Affairs, Northern California Healthcare System, 10535 Hospital Way, Mather, CA 95655. 612-21-2-445-0001

2. Nature and/or Description of the Action Being Processed: Network Contracting Office (NCO) 21 anticipates the award of a firm fixed price contract to deliver three (3) each mobile Opterating Room (OR) Trailers 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 contract will be full and open competition for OR trailers with the installation of a brand name requirement for Stryker Surgical Lights/Booms in the trailers.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The procurement is for the delivery of 3 each OR Trailers which will include the installation of brand name Stryker Surgical Lights/Booms in the trailers for the VANCHCS.

The Stryker SLX Surgical Lights/Booms are required to meet the government’s minimum needs for proper integration and quality of services required in the OR trailers.

The Stryker SLX Surgical Lights/Booms provide lighting of the surgical field where the actual surgery is being performed in a high intensity light and reduced shadow effect capability. The booms also provide additional electrical/medical gas and allow for equipment to be placed near the surgical field without taking up floor space. The VANCHCS currently has two (2) Stryker In-light surgical cameras that can be attached to a Stryker Surgical Light.

Three Stryker SLX Surgical Lights/Booms, including a dual light camera-ready system, 3 monitor mounts, anesthesia boom, and equipment boom will be installed in each OR trailer operating suite.

The estimated value of the Stryker Brand Name is

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

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( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

( ) International Agreement ( ) Authorized or Required by Statute ( ) 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): The current surgical lights at the VA Northern California Healthcare System at the Mather campus are Stryker surgical lights. The lights were purchased as the Berchtold F628 lights, which were recently re-branded by Stryker as the SLX lights. These lights were purchased in conjunction with the Stryker S Series Booms (Anesthesia and Equipment) in Fiscal Year (FY) 19, at a total cost of $482,312.61 for 4 rooms. Stryker Booms were also ordered as part of the Cath Lab project in FY19 at a total cost of $141,573.67 for two rooms. In addition, Stryker surgical in-light cameras were purchased in FY20, at a total cost of $24,007.60 for two cameras.

During discussions with other manufacturers (Olympus, Steris, and Skytron) for the surgical lights, it was determined that they are unable to use the existing Stryker In-light surgical cameras which would require the procurement of extra in-light cameras, which would require an additional cost of around $25k to utilize two cameras for the OR trailers.

In addition, the Stryker surgical lights have 4 color temperature settings, medical grade surgical lens glass material (to prevent degradation and fading over time), and allows for built in, light controls within the surgical light handle. Some, but not all, of the options are available with the other vendors, but only Stryker provides all the options required by the Surgical team.

For the Surgical Lights and Booms, the main feature of the Stryker lights that no other vendor is currently able to support is the medical grade surgical glass lenses used in the surgical lights. Most manufacturers utilize a medical grade plastic that over time degrades and dulls the lights, rendering them to shine at a non-optimal brightness for procedures. Use of the surgical grade glass allows them to maintain their brightness through the 10+ years of their lifecycle. Considering the cost of the trailers, the surgical lights and booms should also be functional through the lifetime of the OR trailer.

In summary, if another manufactur other than Stryker were to be purchased, the VA would have a loss of capital in the amount of $165,580. In addition having to procure two more cameras in the amount of $25,000.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought was issued under 36C26121Q0460 which resulted in two potential contractors – Large Business and Small Business). A sources sought was also issued on GSA which resulted in one potential contractor (

– Small Business), same small business from 36C26121Q0460. When both sources were questioned on whether the brand name would affect their ability to offer the trailers, stated they could offer the brand names and stated they would have to offer an equal to the brand names.

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This procurement will be full and open competition with a brand name justification. As many potential sources who offer OR trailers and also offer the Stryker brand name lights/booms are able to be solicited and can compete on this requirement.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: It is anticipated that there will be competition for this procurement, therefore, the cost will be determined fair and reasonable in accordance with FAR 13.106-3(a)(1) competitive offers.

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

Market Research Was Not Conducted: Market research was first conducted prior to the procurement of the Stryker Surgical Lights and Booms for the Operating Rooms back in FY19. Market research was then conducted again in late FY20 and early FY21. Olympus, Stryker, Skytron, Steris, brought their lights in for evaluation with the surgeons. It was determined that Olympus, Skytron and Steris are unable to use the existing Stryker In-light surgical cameras purchased in FY19 as they are not able to support the medical greade surgical glass lenses.

A sources sought was posted to Contract Opportunities on March 16, 2021 that resulted in two responses – Large Business and – Small Business). The sources sought was not clear if the Olympus and Stryker brand was required or not so a separate email was submitted to inquire whether a brand name would affect their ability to bid on the requirement.

stated they’d offer the brand name. stated they’d offer an equal.

A sources sought was posted to GSA on April 2, 2021 that resulted in one response from

– Small Business (same small business from the Contract Opportunities posting).

A sources sought was also submitted via email to the three SDVOSB contractors (

) listed in the requisitioner’s market research document. didn’t respond, responded with a no bid and response was incomplete therefore it is impossible to determine if offers what is required.

VIP was queried utilizing NAICS 321991 which resulted in one VOSB and 19 SDVOSBs. The capability narratives were reviewed and found only two potential contractors and ) out of the list of 20 VOSB/SDVOSBs.

specializes in Medical Diagnostic Imaging implementation and USP 797

& 800 Chemo Compounding Pharmacy projects, however, it is not clear if they specialize in mobile operating room projects. fabricates modular buildings, but their website is under construction and it cannot be determined if they fabricate the kind of trailer in this procurement.

The SBA DSBS was queried utilizing NAICS 321991 and keyword “operating room” which resulted in no prospective contractors.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: No other facts are applicable at this time.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: – Large Business offering Brand Name, – Small Business offering Equal to Brand Name

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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: No actions are anticipated to remove or overcome barriers to competition as there is no anticipation of future procurments for OR Trailers for the VA Northern California Health Care System.

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.

Victor Wei Date Supervisory Biomedical Engineer VA Northern California 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.

Megan Barr Date Contracting Officer VA Sierra Nevada Health Care System

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.

Brooke C. Robison Date Director of Contracting

Network Contracting Office (NCO) 21