C01 Sole Source Justification Stryker OR Lights_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

Sole Source Justification Under Simplified Procedures for Certain Commercial Items in Accordance with FAR 13.5

Operating Room Surgical Light Upgrade to Stryker SLX LED Surgical Lights

Acquisition Plan Action ID: 36C244-23-AP-4919

1. Contracting Activity:

Department of Veterans Affairs, VISN 4, Network Contracting Office 4, Commodities 1 in support of the VA Pittsburgh Healthcare System (VAPHS) at University Drive C, Pittsburgh, PA 15240-1003.

Purchases Request #: 646-24-1-233-0002.

2. Nature and/or Description of the Action Being Processed:

VAPHS has an Unusual and Compelling Urgency requirement for Stryker SLX Lights and associated S- Series Booms in two identified Operating Rooms (ORs) 1 and 5 and a Sole Source procurement with TrillaMed, LLC is appropriate.

This action is for a Sole Source procurement of Stryker SLX Lights and associated S-Series Booms in ORs 1 and 5 in accordance with Federal Acquisition Regulation (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 Competition Requirements, but still require a justification using the format of FAR 6.303-2.

This procurement will be awarded as a new, firm-fixed-price (FFP) contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

VAPHS seeks to replace existing surgical lights in ORs 1 and 5 with Stryker SLX Lights and associated S-Series booms. This upgrade will provide the surgeons and operating room staff with an ergonomic workspace that will allow unrestricted access to their patient. The booms will house all lighting, audio-visual equipment, and other necessary surgical equipment, keeping the equipment clean and off the floor. The SLX Lights have features including touch wall control, HD in-light cameras, and the EndoLite feature that can customize the surgical lighting in the OR to meet the needs of the procedure. The SLX Surgical Lights and Boom are built on a suspension system that will provide the surgical team freedom of mobility, as well as the ability to pinpoint direct light on the required source spot during a procedure.

Product & Service:

Product Qty Item / Part #

1 SFP / LIGHT / LIGHT 2 FT 3203

Effective Date: 02/01/2022 Page 2 of 5

2 STRYKECAM FOR F-GEN 2 P36000

3 BUNDLE, STRYKECAM READY 2 P43779

4 LIGHT OR FLAT PANEL HANDLE 4 CY 9000150

5 UDM INTERSTITIAL AND SUSPENSION

CABLES 4 CY 9000103

6 Preparation Camera StrykerCam HD 2 CY 9600105 7 Multi Color Touch wall control display 2 CY 1008104

8 STERILE CONTROL PREP 6 CY 9000122

9 STERILE CONTROL+ LIGHT HANDLE 6 CY 9000123

10 LIGHT / SFP 1 FD 2203

11 LIGHT / SFP 1 FD 2207

Service Qty Item / Part #

12 OR Renovation Services - OR 1 1 8888888720 13 OR Renovation Services - OR 5 1 8888888720 14 Chromophare Installation 4 RS 0006008

15 Installation-Implementation Staging Charge 1 8888888401

16 ICTS Engineering Services 1 8888888900 17 Pre-Install Hardware 1 Pre-Install

Total Estimated Cost of this Contract:

Estimated Delivery Date / Period of Performance: Vendor and VAPHS staff shall develop a site schedule, to avoid any disruptions in patient care. Factors to consider: Product manufacturing, Shipping, Room preparations to include Infection Control Risk Assessment (ICRA), the tear down of old hardware, Install of new hardware as well as any finishing touches for a complete a turnkey project. We will require the vendor that is awarded the contract to be onsite within 15 calendar days of the awarded contract to discuss the project in full as well as to inspect the sight and provide any feedback that might impede this project being completed. Installation should occur as soon as possible but no later than 45 days after equipment and supplies arrive onsite. Once installation has started within an operating room, this installation must be completed within 3 calendar days.

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:

( ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

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

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

Effective Date: 02/01/2022 Page 3 of 5

( ) 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):

On September 12, 2023, failure of the surgical lights in OR 1 resulted in the need for the attending surgeon to resort to the use of a surgical headlamp. This is classified as a device failure during an operative case which could have resulted in increased operative time, increased anesthesia time, and difficulty visualizing to operative site (due to the small incision size for this procedure). The resulting Joint Patient Safety Report (JPSR) was classified as a near miss and the recommendation has been made that the operating room not be used for anything more than the most superficial cases until the surgical lights have been replaced. The loss of a single operating room causes the surgical team to extend their workday to facilitate more procedures in the other operating rooms, increasing the likelihood of staff fatigue heightening the risk to Veteran care.

The Stryker SLX Lights and S-Series Booms are required at VAPHS to preclude impairment of healthcare delivery capabilities and mission performance. There is serious risk of injury to Veteran patients if the current equipment were to remain in use in ORs 1 & 5. There is indication they are likely to fail at any time, evidenced by instances of flickering in the lights during surgical procedures.

Every day without the addition of these new lights our Clinicians run the risk of serious injury or death due to the importance of the overhead lighting system. Even when the lights flicker can cause an unwanted flinch or movement that could cause the nick of a major artery or the cutting of the wrong muscle fiber. If the lights were to fail completely during a procedure, Veteran lives would be put at risk of serious injury and/or potentially death. VAPHS Biomedical Engineering staff, which has been trained as well as educated to make such repairs on VAPHS medical equipment if repairs are possible, has made numerous attempts to repair this equipment but the current lighting systems are outdated and have reached their end of life. The equipment continues to fail and has been deemed as uneconomical to repair by VA Pittsburgh Biomedical Engineering professionals overseeing the work and we must replace any faulty equipment as directed by our Biomedical Engineering Staff.

The Government intended to procure the OR lighting equipment and installation for ORs 1 & 5 in the summer of 2022 for FY22. An in-depth exploration with building engineers for structural integrity was conducted. It was decided that the completion of OR surgical lights would take a phased approach to limit disruptions to patient care and safety. For this reason, ORs 1 & 5 were removed from the scope of work for the previously awarded Contract (36C24422P0379). A contract was awarded in June 2023 (36C24423P0565) for this requirement; however, the contractor was not able to meet the specified delivery schedule because of an unrealistic delivery schedule established by the Government. The Government issued a Stop Work Order terminating for convenience.

The Stryker SLX Lights and S-Series Booms are a major system of highly specialized equipment. The system is innovative, with unique features that integrate the most up-to-date technology. They are seen as the industry standard and are far superior to the operative lights currently in place at VAPHS. The SLX Lights have many options for customization, control, and lighting upgrades. This will allow for seamless improvement in the future within the surgical workspaces allowing for our surgeons to customize and control the operating room environment specifically for the needs of the patient. Any alternate solution would result in additional short-term costs related to switching

Effective Date: 02/01/2022 Page 4 of 5 between the use of systems and additional long-term costs associated with the upkeep and maintenance of multiple systems in the operating rooms.

The procurement of Stryker brand equipment within ORs 1 and 5 will also ensure standardization within the facility. OR 4 has already been upgraded with same equipment under Contract 36C24422P0379 awarded 03/22/2022 to TrillaMed LLC for the procurement of Stryker SLX Lights. A uniform surgical lighting system will maintain and glean efficiencies for future maintenance, testing, and training when compared to a hybrid mix of surgical light brand names and the nuances inherent within the multiple systems. TrillaMed LLC has experience installing the same equipment in the same medical facility and has demonstrated superior performance.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Due to the failure of the current lights in OR 1 and the imminent failure of the current lights in OR 5, it is critical that the VA pursue a Sole Source contract with TrillaMed LLC for the Stryker SLX Lights and associated booms. Soliciting as many potential sources as possible is not practicable given the critical situation of the OR lights and the severe consequences of lighting failures, including the potential for disruption to patient care and the excessive risk to staff and patient safety.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

NCO 4 will leverage the following sources for determining price reasonableness: recent acquisition history, Analytics, Data and Decision Support Unified Platform (ADDS UP), and Federal Procurement Data System (FPDS).

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

Market Research Was Not Conducted:

The Contracting Officer has determined that it is in the Government’s best interest to rely on the Market Research Report, dated 3/8/2023 documented for Purchase Order 36C24423P0565 because of its recency and relevancy to the current requirement. That report documented that the Original Equipment Manufacturer (OEM) sells these equipment/services directly to the Government and has 3-5 Services Disabled Veteran Owned Small Business (SDVOSB) Authorized Distributors that could supply the equipment/services to the Government. However, due to the Unusual and Compelling Urgency of the Government’s requirement, this procurement would best be served with a Sole Source award to TrillaMed, LLC because of their demonstrated ability to provide and install this equipment in this facility.

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

Gray Market regulations currently preclude using any vendor that does not have OEM authorization for warranty, maintenance, and servicing of this suite of equipment. The duty station requires the Stryker suite of equipment and inherent protections provided by authorized distributors and solicitation and contract will include VAAR 852.212-71.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Not applicable.

Effective Date: 02/01/2022 Page 5 of 5

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:

Changes in the Open Market and technological advances in the surgical light marketplace may remove barriers to competition in future acquisitions. In addition, a project is planned for FY24 to complete the upgrade to the lighting systems in the remaining Operating Rooms at VAPHS. This will remove barriers to competition, as it may preclude the need for a Sole Source procurement.

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.

Inventory Management Specialist, SSL, FAC-II VA Pittsburgh Healthcare 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.

Contracting Officer NCO 4 Commodities 1

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.

Branch Chief

NCO 4 Commodities 1

SCOTT

DELUISIO

Digitally signed by

SCOTT DELUISIO

Date: 2023.09.12 18:15:33 -04'00'

ANDREA

BUCKLEY

Digitally signed by

ANDREA BUCKLEY

Date: 2023.09.13 09:10:23 -04'00'

HOLLY

WATSON

Digitally signed by HOLLY

WATSON

Date: 2023.09.13 10:21:05 -04'00'