Attachment 1 FAR 13.5 Sole Source Justification - Over SAT-W Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

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

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C242-24-AP-1374

1. Contracting Activity:

Department of Veterans Affairs, VISN 02, Albany Stratton VA Medical Center located at 113 Holland Ave, Albany, NY 12208.

Funding is supported with 2237 526-24-4-041-0160.

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

This is a request for other-than full and open competition for the preventative maintenance of ASP Sterrad 100NX, serial number 1047211306, 1047211305, 1047180282 to ensure proper operation.

Period of performance (POP) for this requirement is one year, effective 09/15/2024 through 09/14/2025, to include four (4) option years. The total dollar value for this requirement is

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

The proposed firm fixed price purchase order is to provide a service agreement for preventative maintenance and repairs on the following ASP equipment:

Item QTY Model Serial Model Description Coverage Period A 1 ST100NX ALLClear 1-DR DUO 1047211306 ASP Sterrad 100NX 9/15/2024 - 9/14/2025 B 1 ST100NX ALLClear 1-DR DUO 1047211305 ASP Sterrad 100NX 9/15/2024 - 9/14/2025 C 1 ST100NX ALLClear 1-DR DUO 1047180282 ASP Sterrad 100NX 10/1/2024 - 9/14/2025

Contractor shall be an authorized service provider for ASP Sterrad 100NX & Velocity product line, the equipment used at the JPP VA Bronx location.

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

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( ) 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):

Only one source is capable of providing the supplies or services required. A sole source proprietary letter was received stating that Advanced Sterilization Products (ASP) is the sole-source service provider or ASP Sterrad 100NX & Velocity Systems. ASP has not trained, certified or acknowledged any third party to service this Class III medical device. ASP is the only entity authorized to provide all scheduled preventive maintenance, corrective maintenance, repairs, OEM parts, calibrations, telephone support, and full access to ASP’s software for calibration and repairs for the Government.

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

A search of the Veteran Small Business Certification (VetCert) database utilizing NAICS code 811210 was conducted which yielded 241 results.

A search of the SBA DSBS search engine using NAICS code 811210 and keywords “ASP” identified sixteen (16) vendors that matched the search criteria. None of these vendors are authorized service providers for the ASP Sterrad 100NX & Velocity Systems. A search was conducted using NAICS code 811210 and the keyword “Sterrad” and “100NX” which identified zero (0) vendors.

A search of GSA eLibrary using the keywords “ASP Sterrad 100NX”, identified zero (0) contracts that matched the search criteria.

A Google search of, “ASP Sterrad 100NX maintenance service”, identified zero (0) vendors other than the Original Equipment Manufacturer (OEM) that can meet the needs of this requirement.

A notice of intent to sole source, 36C24224Q0588, was posted to SAM.gov from 5/08/2024 – 5/15/2024. Zero (0) responses were received.

A sole source proprietary letter received from the Original Equipment Manufacturer (OEM) Advanced Sterilization Products (ASP) stated that ASP is the sole authorized service provider for the ASP Sterrad 100NX. ASP has not trained, certified, or acknowledged any third party to service this medical device.

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

Price reasonableness was determined by comparing the vendors quoted annual price to the similar procurment (36C24221P1148: POP 8/1/2021 to 7/31/2026, East Orange, NJ). 36C24221P1148 had an annual price of $ for a total $ for 5 years for ASPs full service option.

The vendor's quoted yearly price of is 49% more than the comparable contract 36C24221P1148 price of $ for the same POP and piece of equipment. Approximately 7% of this can be accounted for with inflation as the comparable contract was awarded prior to the COVID-

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

19 Pandemic. The remaining 42% can be accounted for as the customer is asking for a preferred service (24/7 coverage) rather than a full service (weekday coverage).

There is a 3% volume discount offered by the vendor we are taking advantage of. The four (4) provisional option years increase once upon Option Year 3 of 3%. Pricing is determined to be fair and reasonable upon comparison with proposed prices.

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

Market Research Was Not Conducted: See section 6.

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

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: N/A

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:

None, as the reason for this sole-source are patents and copyrights associated with ASP Sterrad 100NX & Velocity equipment.

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.

Name:Laura Fernandez-Lago Date Title: Bio Engineer-COR Facility: Bronx VAMC

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.

Name: Nathan Northrup Date Title: Contracting Officer Facility: Bath VAMC

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

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.

Name: Janine Childs Date NCO 2 Supervisory Contract Specialist

Facility: WNYHCS, Buffalo