Sole Source Justification_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS (VA)

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:

1. Contracting Activity:

Network Contracting Office 16 (NCO 16), located at the Galleria Financial Center, 5075 Westheimer Road, Suite 750, Houston, TX 77056 in support of the Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Boulevard Houston, TX 77030.

Requisition Number:

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

The MEDVAMC, Biomedical Engineering Department and Sterile Processing Services (SPS) Department is requesting the procurement for a service contract to maintain and service the Sterrad sterilizers. The units are prone to failure and require regular Preventative Maintenance (PM) and on-site support to function at maximum efficiency.

This is a new requirement with options. The anticipated contract performance period will include one twelve-month base with four twelve-month options. Each option will be exercised at the Government’s discretion. The tentative base period of performance is September 30, 2024 through September 29, 2025. The Government is contemplating a Firm-Fixed Price type contract. The estimated value of the proposed action is

This procurement is in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Products and Commercial Services 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, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C.1901 or the authority of 41 U.S.C.1903.

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

The Biomedical Engineering Department at the MEDVAMC currently owns Sterrad equipment and is proprietary only to Advanced Sterilization Products Inc. (ASP). The Sterrad sterilization systems utilize a patented, proprietary, low-temperature hydrogen peroxide pas plasm technology that sterilizes medical instruments and devices. This technology is an alternative to Ethylene oxide (EtO) which had been used widely prior to the development of the STERRAD technology. The contractor is responsible to provide PM and calibrations, unlimited on-site corrective maintenance, unlimited technical telephone support, provision of all parts, labor, travel to perform service and repairs, online continuing education, and product system improvements.

Effective Date: 02/01/2022 Page 2 of 4

The PM service must be performed by qualified personnel certified to work with the schedule equipment listed in this acquisition. Only certified manufacturing field service technicians has up-to-date information, manuals, specialized tools, parts, and supplies. Only ASP has the certification authority for this equipment and access to service codes to restore the system to proper operation.

The PM shall be two (2) semi-annual inspections per Original Equipment Manufacturer (OEM) standards for each device listed below, including replacement of worn and defective parts, per manufacturer’s specifications.

Equipment Listing:

Sterrad ST100NX ALLClear 1-DR DUO (SN 1047180335) Full 100NX1-3 Coverage Sterrad ST100NX ALLClear 1-DR DUO (SN 1047180337) Full 100NX1-3 Coverage Sterrad ST100NX ALLClear 1-DR DUO (SN 1047211171) Full 100NX1-3 Coverage Sterrad ST100NX ALLClear 1-DR DUO (SN 1047211134) Full 100NX1-3 Coverage

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)

ASP is the only source to provide services for Sterrad Sterilizers located at the MEDVAMC. ASP has demonstrated unique capabilities across the MEDVAMC and have established a systematic approach in providing support and maintenance. ASP currently does not have formal business relationship with any Small Businesses (SB), including Service-Disabled Veteran-Owned Small Business (SDVOSB) and Veteran-Owned Small Business (VOSB), to provide servicing of ASP systems or to supply OME parts. ASP has not trained personnel of any SDVOSB, VOSB, or other SB on how to service ASP systems. Service attempted or performed by unauthorized persons will void ASP warranties and/or service agreements for the specific system. This is in accordance with the provisions of ASP’s product warranty policy and service agreements. In addition, proprietary parts are necessary to service all ASP systems.

This acquisition is necessary to ensure that PM and emergency repairs can be conducted so that the unit can remain operating within manufacturer’s specifications and minimize any downtime.

Effective Date: 02/01/2022 Page 3 of 4

The Sterrad sterilizer systems currently in place at MEDVAMC have an approximate value of , and have an estimated useful remaining life of 8-14 years. To avoid duplication and/or unreasonable increase of cost, the Government’s best approach will be a continuation of service contract with a base plus four (4) option years to maximize the lifespan of the already purchased equipment.

Due to these facts, ASP is the only responsible source and no other services will satisfy agency requirements. If a sole source award is not made to ASP, surgeries would be delayed and canceled which would be detrimental to the treatment of our Veterans.

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

Sources sought notice number 36C25624Q0957 was posted on the Governmentwide Point of Entry (GPE) known as Contract Opportunities on May 29, 2024 and closed on June 05, 2024. The intent of the notice was to determine the availability of sources regarding who would be authorized, interested, and capable in providing the required support and PM to MEDVAMC.

The sources sought notice stated, “If no responses to this notice are received, from either authorized distributors of the cited brand name nor from manufacturers marketing a potentially equivalent brand, then this action will be sole sourced to the manufacturer.”

7. Determination by the Contracting Officer (CO) that the Anticipated Cost to the Government will be Fair and Reasonable:

The CO hereby determines that the anticipated cost to the Government for this contract action is expected to be fair and reasonable. The CO will compare the proposed prices to the Independent Government Cost Estimate and to prices paid on similar procurements.

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

Market Research Was Not Conducted:

In addition to the sources sought notice; market research was also conducted by database queries to the Electronic Contract Management System (eCMS), General Services Administration (GSA) eLibrary, Dynamic Small Business Search (DSBS), Veteran Small Business Certification (VetCert), AbilityOne, and Federal Procurement Data System (FPDS).

Based on the market research conducted, there is no reasonable expectation that quotations will be received from two or more certified VetCert listed SDVOSB/VOSBs and award can be made at a fair and reasonable price that offers the best value to the Government. In addition, no small business in any of the other targeted socio-economic groups appeared to be qualified or capable for a set-aside or sole source procurement. ASP is a large business and sole proprietary for Sterrad sterilizers support and maintenance.

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

Full and Open Competition is not feasible since ASP is the only entity authorized to provide all scheduled PM, corrective maintenance, repairs, OEM parts, calibrations, telephone support, and full access to ASP’s software for calibration and repairs for the Government. Reference the attached letter from ASP declaring they are the sole servicing provider of ASP systems and supplier of OEM parts. Therefore, ASP is the only available source for this unique service.