J065--FY24: PM-Repair Service SPS Reprocessing System Base Period

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

AP 36C248-23-AP-6496

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: 36C248-23-AP-6496, Preventive Maintenance and Repair Services for Sterilization Processing System (SPS) at the VA Caribbean Healthcare System

Contracting Activity: Department of Veterans Affairs, Regional Procurement Office (RPO) East, Network Contracting Office (NCO) 8, VA Caribbean Healthcare System, San Juan, Puerto Rico. The applicable Purchase Request for this acquisition is 672-24-1-2563-0006.

Nature and/or Description of the Action Being Processed: This procurement is for Preventive Maintenance and Repair Services for five (5) low temperature Sterrads 100NX , Sterilization Processing System (SPS). The VACHS have a sterilization requirement under the program Sterile Processing Service (SPS) for Nursing Service to sterilize all equipment for critical and semi-critical processes Reusable Medical Equipment (RME). The sterile equipment is to be used in the VA Caribbean Healthcare System (VACHS) and its satellite clinics throughout Puerto Rico and the U.S. Virgin Islands. The Biomedical Service is responsible for the maintenance and repairs of this equipment. The VACHS, Sterrad Sterilizers is primarily used for heat- and moisture-sensitive medical devices that cannot be steam sterilized.

This acquisition is to be process under the authority of 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, but still require a justification using the format of FAR 6.303-2.

FITARA approval is not required since Product/Service Code J065, Maintenance, Repairs, and Rebuilding of Equipment Medical Dental and Veterinarian Equipment is not listed as IT Product Service Codes (PSC) Requiring FITARA Approval (see VA OIT PSC Codes).

The proposed vendor for this procurement is:

Advanced Sterilization Products Services Inc.

33 Technology Dr.

Irvine, CA 92618-2346

Congressional District: 47

Description of Supplies/Services Required to Meet the Agency s Needs: To perform Preventive Maintenance and Repair Services for Sterilization Processing System (SPS) in accordance with manufacture standards. Service must be performed by qualified personnel certified to work with the schedule equipment listed in this acquisition. Only certified manufacturing field service technician has up-to-date information, manuals, specialized tools, parts, and supplies. Only Advanced Sterilization Products Services (ASPS), Inc. has the certification authority for this equipment, training to maintained certification valid, and access to service codes to restore and certified the system to proper operation.

Period of performance: The period of performance for this effort will be a Base Period of 12 months and four (4) one-year option periods. Each option will be exercised at the government s discretion. In addition, the resulting contract will have an additional option to extend the services for up to six (6) months at the government s discretion. The expected period of performance for base period is April 5, 2024 through April 4, 2025, plus four option period each year thereafter.

The Independent Government Cost Estimate (IGCE) is as follows:

Period

Expected Period of Performance

Amount

Base year

04/05/2024-04/04/2025

$79,900.00

First Option

04/05/2025-04/04/2026

$79,900.00

Second Option

04/05/2026-04/04/2027

$79,900.00

Third Option

04/05/2028-04/04/2029

$79,900.00

Fourth Option

04/05/2030-04/04/2031

$79,900.00

Total contract value

$371,535.00

-8 Six Month Extension

04/05/2030-09/04/2030

$39,950.00

Total Value w-Extension

$411,485.00

The requested service is for the following schedule equipment:

Manufacturer

Model

Serial number

VA property number

Location

ASPS

STERRAD 100NX (#8)

1041110219

65212010

SPS DECON

ASPS

STERRAD NX (#9)

0033111265

65212550

SPS DECON

ASPS

STERRAD NX (#10)

0033111263

65212549

SPS DECON

ASPS

STERRAD 100NX (#12)

1047201483

65249916

SPS DECON

ASPS

STERRAD 100NX (#13)

1047201486

65249917

SPS DECON

*Additional equipment: The VACHS have two Sterrad 100NX to be incorporated into solicitation or resulting contract once the renovation Outpatient Clinics in Mayaguez and Ponce are completed and equipment is installed by ASPS Inc. and accepted by Government. The equipment has been received and warehoused by Government.

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

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): As described in the Market Research Report, Advanced Sterilization Products Services (ASPS) Inc. is the only capable source with available personnel in the region to fulfill the service to the schedule equipment in this acquisition. ASPS Inc. is a Large Business. Only certified personnel shall perform services on this equipment; otherwise, warranties may be voided. Moreover, this is the only authorized company that have access to provide replacement parts from manufacturers and the only company supported by FAR 11.105, Items Peculiar to One Manufacturer. Service under ASPS will also avoid the malfunction of the equipment and at the same time will avoid putting the life and safety of patients at risk.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Competition for this requirement is not possible since ASPS Inc. is the only certified/authorized local vendor to provide maintenance services for Sterrads 100NX , Sterilization Processing System. ASPS Inc. provided an Exclusivity Letter to evidence that they are the only source capable of fulfilling these services in Puerto Rico. A copy of this document can be found in the acquisition plan briefcase. A search on the SBA VetCert website revealed that there are no SDVOSB nor VOSB that can fulfill this requirement. A sources sought notice is not needed at this time since there is enough evidence that this is the only company that can fulfill this requirement.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This acquisition will be conducted under FAR 13.501(a). Since there will be no competition, the vendor may be required to provide evidence of catalog prices and or other sales receipts to other customers in order to validate that the final prices are fair and reasonable.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The market research demonstrated that only Advanced Sterilization Products Services (ASPS) Inc. is the sole service provider for Sterrads 100NX , Sterilization Processing System (SPS) equipment in Puerto Rico. ASPS Inc. is a large business located in Irvine, CA, with office located in San Juan PR to support the requirement of procurement.

During FY18, the government establish contract number 36C24818C0244 - PM and Repair Sterrad Sterilizer System establishing a multiple-year contract with ASPS Inc. as the exclusive service provider for SPS products in Puerto Rico. The company is demonstrating interest to a new requirement for up to five years (Base Period plus four one-year Options).

Any Other Facts Supporting the Use of Other than Full and Open Competition: Full and Open Competition is not feasible since only ASPS, Inc. can fulfill this requirement. To maximize the competition, the government may need to buy/replace existing equipment, but again will end up in a sole-source position when acquiring preventive maintenance services.

The preventive maintenance and repairs services to be provided to these type of sterilizers systems shall be provided by an authorized dealer with service personnel which have been trained and certified to perform maintenance and repairs for this type of equipment. Therefore, Full and Open Competition for any type of sterilizer most likely will not be possible. In addition, it is in the best interest to the Government to initiate a single source procurement with the only company capable to maintain schedule equipment listed in procurement to manufacturer's specification

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: ASPS Inc. has demonstrated interest and capability to fulfill this requirement.

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: As previously indicated, to foster competition, the Government will need to buy/replace existing sterilization system, which is not currently budgeted nor the equipment has reached it s useful life. The equipment is in good condition and functions to standards to meet the medical need. At this time there is no need to burden the budget with equipment that could end up in the same position with a single supplier when purchasing maintenance and repair services. Therefore, the best course of action is to solicit this requirement to ASPS Inc.

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.

Juan A Estrella

Program POC/COR

Bio Medical Technician

VACHS Biomedical

Israel Rodriguez

Procurement POC

Contracting Officer

NCO-8, San Juan Services Team

Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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.

Baryan Sierra

Contracting Officer

NCO-8, San Juan Services Team

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.

Maribel Santa

Branch Chief

NCO-8 San Juan Services Team