36C25223P1182_1.docx

OR Integration Madison, WI VAMC

36C25223AP2495

GENERAL INFORMATION

BASE NOTICE TYPE

GLAC (69D)

115 South 84th Street, Suite 101 Milwaukee WI 53214-1476

POINT OF CONTACT*

Jim Hedman james.hedman2@va.gov

AWARD INFORMATION

LINE ITEM NUMBER

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C252-23-AP-2495

1. Contracting Activity: Department of Veterans Affairs, VISN 12, William S. Middleton Memorial Veterans Hospital, 607-23-3-969-0116.

2. Nature and/or Description of the Action Being Processed: This is a justification for a firm fixed price procurement for new Stryker Sales, LLC (“Stryker”) Operating Room (OR) Integration equipment 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: The William S. Middleton Memorial Veterans Hospital located in Madison, WI has the requirement for new OR Integration equipment. Delivery is required as soon as possible. The estimated value is [REDACTED].

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

(X) Unusual and Compelling Urgency

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

(X) International Agreement

(X) Authorized or Required by Statute

(X) National Security

(X) 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 equipment is in use at the William S. Middleton Memorial Veterans Hospital located in Madison, WI. New Stryker equipment would require minimal additional training to clinicians, biomedical engineering, sterile processing, anesthesia, and engineering. A change to a new vendor with unfamiliar equipment would involve extensive training to all multidisciplinary staff (all areas mentioned above) on equipment functionality, proper use, and troubleshooting practices for proper resolution. Introducing a new vendor would require perioperative services to secure multiple weeks to fully train staff, as well as additional time, resources, and coordination to secure on-site vendor guidance. Currently, all Madison-area hospitals and surgery centers utilize Stryker technology. At the Madison VA, all surgeons are contracted from the University of Wisconsin (UW) Hospital. Every surgeon that has operating privileges and performs any kind of laparoscopic surgery at the Madison VA is from the UW Hospital, American Family Childrens Hospital, or Meriter Hospital in Madison, WI. At these hospitals, they utilize Stryker Integration and Laparascopic equipment. With this knowledge, surgeons already have the required skillset for this equipment and will not have added stressors that accompany learning a new system. If the Madison VA does not continue with the accustomed Stryker equipment for integration, the physicians that operate regularly may struggle to recall the new VA integration system procedures which presents unacceptable risks for operations.

Additionally, employing the same vendor throughout the area would allow the Madison VA to borrow any needed or necessary equipment among the other hospitals when something is broken, not sterile, or out for repair. Utilizing Stryker would allow all Madison-area hospitals to keep patient care local, reduce surgical cancellations, and maintain surgical transfers for emergent purposes only, while reducing the focus on equipment loans and repairs in the event a different system was purchased. A major change to the system could have a negative impact to provider outcomes, ultimately resulting in longer surgical procedure time and time in which a patient remains under anesthesia.

Continuing with Stryker equipment would decrease the implementation, operational, and fiscal effects on the facility. Switching to another system would require an increase in the budget immensely to over five million with additional multi-department training, new servers for implantation, as well as purchasing new scopes, cameras, and light cords. There are also added costs of insufflation tubing changes, smoke evacuation tubing, and standalone pieces of equipment. Additionally, the Madison VA Sterile Processing Department (SPD) would require a complete overhaul of equipment identification, reprocessing parameters, and education to the department. In an event that the Madison VA would require the UW to reprocess equipment from a system of other than Stryker for emergent needs, the parameters and sterilization techniques utilized at UW may not coincide with the required instructions for use (IFU). The multi-departmental change would have drastic effects at many angles, where Stryker has Pneumoclear built into their insufflation system to evacuate the smoke, not requiring additional tubing or another piece of equipment in the room. In addition, the 1688 4K video tower platform solution will provide a seamless transition for the hospital. The 1688 camera components are the same size and follow the same sterilization protocols as the existing 1488 system. The 1688 camera system is backward compatible with existing sterilization trays. Changing to a completely new system would require different sterilization parameters and new sterilization trays to be purchased for sterile processing. As Stryker is already implemented and the server is already built, switching to another vendor would require a brand-new server to be placed, costing the VA two million additional dollars to be created and configured. Moreover, there is no guarantee a new server or cloud configurations would be approved for use by VA/IT if another vendor was utilized as Stryker remains in use.

Stryker has ergonomic endoscopy tools that make surgery more predictable and efficient, with products for cross-specialty visualization in arthroscopy, urology, gynecology, and laparoscopy. As Stryker provides advanced technologies in endoscopy, it is important to note that the endoscope design that Stryker offers is the central hub to the provider’s practice and surgical activity in the OR. As Stryker offers equipment that prioritizes ergonomic design, optimal workflow and efficiency in the OR suite is maintained, with patient and physician safety and the forefront. While comparable vendors demonstrate similar functionality, the design and capabilities from an ergonomics perspective are lacking. Stryker offers equipment with ergonomics-related considerations that include equipment accessories (handles, button positioning), rotational functionalities (to reduce musculoskeletal injuries in clinicians with use), as well as control measures to allow additional safety and performance measures within the OR suite (light cord on/off switch).

Finally, failing to replace end-of-life equipment with updated Stryker equipment and technologies will continue to lead to OR shutdowns for piecemealed replacement parts and repairs which will require additional Veterans to seek Community Care. It is more cost-effective to complete a one-time purchase and upgrade for uniformity among all OR suites. As a six-bed OR, the Madison VA cannot afford to lose Veterans to Community Care as it strives to provide surgical services in all areas excluding Pediatrics, Gynecology, and Transplant. Navigating an OR suite that is suboptimal from a functionality standpoint jeopardizes patient safety and can lead to system failure intraoperatively. These failures could be multifaceted and could include the monitors themselves, the Stryker system (camera, light box, or insufflation components), or the overhead lighting system. If failure occurs (relating to end-of-life equipment) during a surgical procedure, a Veteran patient’s outcome is at risk or may require further intervention (1) at a later date, or (2) requiring immediate emergent transfer to the University Hospital. Additionally, if there are no replacement options as the system has met its end-of-life technological progression, the Madison VA may have no other choice than to (1) shut the affected OR down indefinitely or (2) borrow from the University Hospital, requiring additional funds to meet the borrowing needs. A one-time purchase is favorable to ensure all OR suites are upgraded to same level technological advancements and capabilities to meet our Veteran patient needs.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: This acquisition will be competed among eligible SDVOSB vendors.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Anticipated cost will be considered fair and reasonable IAW FAR 13.106-3(a)(1): whenever possible, base price reasonableness on competitive quotations or offers.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: A VIP search for NAICS 334510 and keyword, “Stryker” showed zero results. A VetCert search with NAICS 334510 showed 296 VOSB or SDVOSB results.

The CO reviewed market research leading to purchase order number 36C25222P1149 which showed several SDVOSB distributors and one Other Than Small Business (manufacturer). The CO contacted the manufacturer directly to confirm if it has any authorized small business distributors, including VOSBs or SDVOSBs. It responded with at least two authorized SDVOSBs, and it is working to update its list of other authorized SDVOSB distributors.

Appropriate clause 52.225-1 Buy American-Supplies and provision 52.225-2 Buy American Certificate will be included in the solicitation to ensure Buy American Act compliance. Trade Agreement Act would be excepted by FAR 25.401(a)(1), set-asides for small businesses.

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:

[REDACTED]

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: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

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.

[REDACTED]

William S. Middleton Memorial Veterans Hospital

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.

Contracting Officer

NCO 12

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.

[REDACTED]

c. Director of Contracting: I certify the justification meets requirements for other than full and open competition.

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

[REDACTED]