P03 J_A Xenex Disinfecting Units Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257-22-AP-3636 JOFOC Tracker 2022-07-13T11:42:19

1. Contracting Activity: Department of Veterans Affairs (VA), VISN 17, Central Texas Veterans Affairs

Healthcare System (CTVAHCS) and Network Contracting Office 17 VHA Regional Procurement Office- West (RPOW) 124 E HWY 67 Suite 100 Duncanville, TX 75137 2237:674-22-4-5122-0027

2. Nature and/or Description of the Action Being Processed: This requirement is for Xenex Disinfection Tracking System (DTS) that will be used to disinfect hospital medical equipment. The DTS allows users to tell the last time equipment was cleaned and in turn drop potential risk for exposure to dirty equipment for patients. The resulting contract will be Firm Fixed Type for approximately 180 days delivery requirement and a three-year support package.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The DTS is a disinfection tracking system that comprises of a small sensor device that transmits the disinfection data to an online portal that is accessible by the end user to assess the disinfection status of equipment, space, or surface. The DTS system captures the disinfection events from either a disinfectant wipe or Ultraviolet (UV) light, sends all of the disinfection data using cellular network to an online portal for access to disinfection activity log. It is estimated that the XDTS will be manufactured, delivered, and deployed within 180 days with an additional period that includes trouble shooting, additional training, and deployment within three years from the delivery and Government accepted date.

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 ( ) 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 system is required to automatically monitor the disinfection status of the equipment, space, or surface, disinfection by any method manual using disinfectant wipes or UV, and an online portal for supervisor or end user to be able to view the cleaning log which is automatically collected and stored by the DTS and its companion online portal. Such cleaning logs are important for

Effective Date: 02/01/2022 Page 2 of 3 accreditation visits by the Joint Commission, Inspector General, or other relevant regulatory agency.

The contractor holds the exclusive license from the Department of Veterans Affairs to manufacture and sell these DTS technology systems to the VA. Certifying and validating another company to manufacture the disinfecting units will result in over $2M in costs and over 24 months in delays since it will require the integration of a project team including Medical, Logistics, and Contracting personnel affecting the ability of the VA to provide timely care to Veterans. Furthermore, the alternate to this technology is manual log keeping using pen and paper which is time consuming, inadequate, expensive and can lead to improper tracking of sanitation of cleanliness. Due to these facts, sole source acquisition to Xenex Disinfection Services Incorporated is required.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought synopsis with intent to sole source to Xenex Disinfection Services Incorporated was issued on 06/08/2022 to 06/13/2022 to seek other sources that could provide the Xenex Disinfecting Systems. It was confirmed that only Zenex Disinfection Services Incorporated is the only source that can fulfill this requirement. There are no other vendors that are currently certified to manufacture the required disinfecting systems.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Price is expected to be fair and reasonable and will be evaluated against prices in the current market for similar disinfection systems. Price will also be compared to prices found reasonable on previous purchases, current price catalogs Xenex Disinfecting Systems Incorporated charge for these systems to other VA departments, and to the Independent Government Estimate.

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

Market Research Was Not Conducted: As described in Section 6 above, market research in accordance with FAR Part 10 was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition, and soliciting inquiries from interested parties. No SB concerns other in any socio-economic category other than the OEM (Xenex) SB responded to the notice, nor appears capable of fulfilling this requirement. This requirement can be fulfilled by Xenex Disinfection Services Incorporated SB under NAICS 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing as the current VA certified and validated vendor to manufacture the disinfecting systems. This requirement is for supplies manufactured in the US, the buy American Act does apply.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This particular technology was studied in CTVHCS as part of a research study sponsored by the National Institute of Health and found to improve cleaning rates among front line workers after deployment of the DTS eliminating the risk of pathogens infection prior to surgical procedures.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Xenex Disinfection Services Incorporated. 1074 Arion Cir Ste 116 San Antonio, TX 78216-3085.

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 assess the cost of certifying and validating another vendor. In addition, the Government will continue to monitor the availability of similar technology in the medical industry to see if future acquisition for disinfecting systems can be procured with compatible disinfecting systems.

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

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.