P03 FAR 13.5 Sole Source Justification - Over SAT CO 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: 36C262-23-AP-1973

1. Contracting Activity: The Long Beach VA Medical Center located at 5901 East Seventh Street, Long Beach, California 90822, has a need for on-going services to have a contractor provide preventative maintenance and intervening services including all necessary parts, labor, and transportation required to repair the (11) Government-Owned Getinge Sterilizers.

2. Nature and/or Description of the Action Being Processed: The services to be provided by the contractor under this agreement shall consist of furnishing all necessary parts, labor, and transportation required to repair the (11) Government-Owned Getinge Sterilizers. Contractor will perform all Preventative Maintenance Inspections (PMIs) will be done at the manufacturer’s recommended frequency in accordance with the VA Long Beach’s maintenance schedule.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Service includes two (2) PMIs per year for the Unloaders (WAA081542 and WAA078051), 8668 Washers (WAA081315 and WAA081303), and 9128 Washer (USR0746001) and four (4) PMIs per year for the MP129 Water Savers (10K0997, 10L1075 and 10L1076) and 733 HC Sterilizers (10J10103, 10H10119, and URA012672). A check-up of the covered products including wear and tear parts check according to manufacturer’s guidelines during system inspection and calibration. Preventive maintenance inspections will be performed on a weekday at a time set once the contract is awarded. No other parts and/or test equipment shall be provided by the VA for the performance of this contract. It is the responsibility of the Vendor to bring the appropriate equipment and/or supplies necessary to complete the work as required within.

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

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

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 requesting service is Biomed Engineering Service (138B) at the VA Long Beach HCS. Corrective Maintenance consists of repair and labor time to correct an equipment in case of malfunction. The contractor will supply, at its own expense, necessary OEM manufactured parts (hardware & software), provided that replacement of the parts is required because of normal wear and tear, or outright failure or as otherwise deemed necessary by the contractor. The contractor will provide all labor associated with the repair of the equipment covered under the contract agreement.

Inadequate or improper repairs performed by the contractor will be correctly repaired at a time convenient to the VA at no additional expense to the VA. As the equipment manufacturer, Getinge USA Inc. (Getinge) is the sole-source supplier of factory authorized OEM (original equipment manufacturer) replacement parts and accessories for your equipment. Getinge OEM parts are tested for performance, longevity, and cost effectiveness. They are service parts which meet OEM operational requirements and provide the best performance life in application of use. Getinge Care Service is the sole-source for OEM technicians who are trained and certified to perform scheduled and unscheduled maintenance on Getinge equipment.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Getinge has provided an official letter dated December 2022 Getinge Care Service is the sole-source for OEM technicians who are trained and certified to perform scheduled and unscheduled maintenance on Getinge equipment. As the equipment manufacturer, Getinge USA Inc. (Getinge) is the sole-source supplier of factory authorized OEM (original equipment manufacturer) replacement parts and accessories for your equipment. Getinge OEM parts are tested for performance, longevity, and cost effectiveness. Getinge has maintained an uninterrupted certification to the ISO standards for quality management systems 9001 and 13485 since 2006. ISO 13485 specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Getinge has submitted a quote for the services and the quote was evaluated for fair and reasonable pricing. Due to the requirement having proprietary right with one contractor the price evaluation and determination was compared to the price paid for previous contracts for the same service. The contracting officer determined the price of $261,522.67 from Getinge USA Sales fair and reasonable based on comparison of proposed prices. Contract No. 36C26218C0020 was awarded with a Base Year and Four Option Years from 12/01/2017 to 11/30/2022 and was used to determine the price fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

The Contract Specialist performed a Vendor Information Pages (VIP) search under the NAICS Code:

811210 – Electronic and Precision Equipment Repair and Maintenance. PSC Code: J065 – Maintenance and Repair of Medical, Dental and Veterinary Equipment and Supplies. In referencing the Keyword: Getinge for possible SDVOSB/VOSB concerns who could meet the need of this request.

The search returned Zero (0) SDVOSB/VOSB concerns. Getinge USA Inc. (Getinge) is the sole-source

Effective Date: 02/01/2022 Page 3 of 4 supplier of factory authorized OEM (original equipment manufacturer) replacement parts and accessories for your equipment.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: As previously stated, there are no contractors who are authorized to perform service to the existing equipment at the Long Beach VA. As the equipment manufacturer, Getinge USA Inc. (Getinge) is the sole-source supplier of factory authorized OEM (original equipment manufacturer) replacement parts and accessories for your equipment. Getinge Care Service is the sole-source for OEM technicians who are trained and certified to perform scheduled and unscheduled maintenance on Getinge equipment

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: This procurement is for the services consisting of furnishing all necessary parts, labor, and transportation required to repair the (11) Government-Owned Getinge Sterilizers. Contractor will perform all Preventative Maintenance Inspections (PMIs) and as stated above there are no other contractors who are licensed to provide these services to this specific equipment. Based on Market Research findings there are zero (0) SDVOSB/VOSB concerns that can meet the needs of this request. Market Research returned 1 qualified source Getinge USA 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: This procurement is for government owned Getinge steriizers, this system can only be maintained by Getinge USA Inc. based on this Software being considered having proprietary technology and not provided to 3rd parties for the purpose of providing software maintenance.

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: Arcelia Medina Title: Contract Specialist Facility: NCO 22 SAVAHCS

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: Won Chae Title: Branch Chief Services Team 5 Facility: NCO 22