P03 Att 1 FAR 13.5 Sole Source Justification - Over SAT_signed.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:__ 36C242-23-AP-1479 ___________________

1. Contracting Activity: Department of Veterans Affairs, VISN 2, Network Contracting Office (NCO) 2, 2875 Union Road, Suite 3500, Cheektowaga, NY 14227 procuring the requirement for Department of Veterans Affairs, VISN 02, Northport VA Medical Center, 79 Middleville Road, Northport, NY 11768.

2237: 632-24-1-6050-0002

2. Nature and/or Description of the Action Being Processed: This procurement is for the Northport Medical Center (632) for a firm-fixed price preventative maintenance purchase order for a San-I-Pak autoclave sterilizer/compactor. The purpose of the maintenance contract is to reduce service costs and improve equipment turn-around time and reliability. This will be a new contract to follow current purchase order 36C24219P0024 which ends 10/8/2023. The anticipated period of performance is from October 9, 2023 - October 8, 2024 with a provision of four (4) option years. The estimated base year cost is $79,512.24, and the total estimated cost is $422,141.16.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Northport VAMC requires a service maintenance plan for the San-I-Pak autoclave sterilizer/compactor currently in use. The services to be provided by the contractor under this agreement shall consist of furnishing all parts, labor and transportation to provide preventive maintenance and repair of a SAN-I-PAK MARK VI-N autoclave sterilizer/compactor. This autoclave sterilizer/compactor machine has an insulated pressure chamber in which saturated steam is used to elevate the temperature to decontaminate infectious waste. This machine allows for Northport VAMC to treat our red bag waste on-site rather than having it removed by a licensed medical waste contractor. VAMC Northport is seeking one monthly service call visit and 24-hour response by a certified technician for any mechanical problems that arise between monthly service visits. Equipment includes:

Manufacturer Model# Item Description Serial Number

San-I-Pak Mark VI-N Autoclave Sterilizer/Compactor R6-5041112-716-4978-4

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

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

( ) 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): San-I-Pak Pacific, Inc. is the only company that can provide all the necessary OEM parts and perform all the necessary repairs for the Mark VI-N autoclave equipment as the software is proprietary. These maintenance services are considered “highly specialized” and thus there is only one responsible source. The software running the equipment is proprietary.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Due to the proprietary nature, San-I-Pak is the only authorized company able to perform maintenance on its autoclave equipment. They have the technical expertise to provide maintenance and service, as well as being the only company with access to manuals and design specifications of its autoclave equipment. San-I-Pak is the only company that can access its systems remotely and offer certified parts that meet the original manufacturer’s specifications. San-I-Pak technicians are the only OEM trained and certified personnel authorized to perform service on this autoclave equipment as software is proprietary. However, VetBiz, SBA, GSA, and the NAC websites were used to determine if there were any other vendors capable of providing service and/or maintenance on the San-I-Pak equipment. Additionally, a Notice of Intent to Sole Source was posted to Contract Opportunities from March 24, 2023 through April 7, 2023 seeking information from contractors who may be capable of providing the required maintenance service. No vendors responded that are capable of performing services. Therefore, it has been determined that San-I-Pak Pacific, Inc. is the only company capable of providing these services on this highly specialized equipment to the agency.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Current purchase order 36C24219P0024 had less than 3% increases between option years and the estimated IGCE reflects the same anticipated slight increase between current contract option year 4 and the anticipated base year of the new contract and each option year. The anticipated costs to the government are considered fair and reasonable based on comparison to the IGCE and previous purchases.

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

Market Research Was Not Conducted: This requirement is currently procured under purchase order 36C24219P0024 for Northport VA Medical Center with small business, original equipment manufacturer (OEM) San-I-Pak Pacific, Inc. A search of the VIP database was conducted utilizing NAICS 811210 with keywords “Mark VI-N, San-I-Pak, and autoclave” which resulted in zero SDVOSB/VOSB. This does not satisfy the rule of two for SDVOSB/VOSB set-aside in accordance with 38 U.S.C. 8127(d). A search under SBA website under NAICS code 811210 with keywords “San-I-Pak” produced no results and “autoclave” produced one SDVOSB, but the site will not advance to view the specific vendor. Conducted a GSA search for Services with keywords “autoclave” which produced 95 results, “Mark VI-N” produced 289 results, and “sanipak” produced no results. The results for autoclave produced vendors for small scale autoclaves, parts, and different brand units than required to be serviced in this request. The results for Mark VI-N did not produce a vendor for this specific equipment, it produced anything with the name Mark in the description. A search of the NAC database was conducted utilizing key words “autoclave maintenance, autoclave service, mark vi-n, and san-i-pak” which produced no results.

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

Notice of Intent to Sole Source, 36C24224Q0001 was posted to Contract Opportunities from March 24, 2023 through April 7, 2023 seeking information from contractors who could potentially provide the required maintenance service received no response. No response was received from San-I-Pak Pacific, Inc. due to their submittal of a quote showing their interest. Capability statements were not required as they are the OEM and already performing services at the Northport VAMC under contract.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: San-I-Pak Pacific, Inc. is the sole manufacturer, distributor of parts, and sole service provider for its autoclave equipment. The software is proprietary and any changes or modification can only be done by San-I- Pak as they do not have any authorized third party service providers.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: OEM small business, San-I-Pak Pacific, Inc.

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:

In situations involving complex medical equipment, it is difficult to remove barriers to competition because the OEM is the only qualified company capable to provide the repair and maintenance of its own specialized medical equipment. This is especially true where proprietary software, specific diagnostics tools, and specialized electronics are used to maintain the equipment in accordance with

OEM specifications. Unless the manufacturer chooses to license its software and authorize local service providers to maintain the San-I-Pak equipment, the only alternative would be to replace the existing San-I-Pak equipment with a more generic brand. At this time, the Northport VAMC is satisfied with the quality and operation of the installed equipment, its maintenance and repair.

VAMC Northport’s autoclave sterilizer/compactor is critical to patient care as this machine sterilizes red bag waste onsite and eliminates the need for a separate Regulated Medical Waste (RMW) contract. If this machine is down for more than a few days, red bag waste quickly builds up and the facility must seek an emergency RMW removal contract at considerable expense. Maintaining the daily operation of this machine is critical to the facility and must be performed by a trusted contractor who can guarantee the parts and trained labor at a moment’s notice if there is a mechanical issue. Northport VAMC currently does not have the sufficient budget to replace the San-

I-Pak equipment thus the reason to have equipment properly maintained through the life of the contract. Considerations for new equipment will be made when the existing equipment reaches the end of its life cycle span.

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.

Alan Jamros Date Administrative Officer Northport VA Medical Center

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

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.

Safa Shleiwet Date

Contracting Officer NCO 2, James J. Peters VA Medical Center

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.

Janine Childs Date

NCO 2 Branch Chief - Services Team II

Buffalo VA Medical Center https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx