Sole Source Justification -MDS.pdf

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID:__36C249-25-AP-2684___

Effective Date: 11/15/24 Page 1 of 5

REVISION: 01

1. Contracting Activity: Department of Veterans Affairs, Veterans Healthcare Administration (VHA), Veteran Integrated Service Network (VISN) 09, Network Contracting Office (NCO) 09.

2237: TBD.

2. Nature and/or Description of the Action Being Processed: This procurement is for commercially available services in accordance with Federal Acquisition Regulation (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 justification using the format of FAR 6.303-2.

Per FAR subpart 16.503 Requirements contracts (b) Application. (1) A requirements contract may be appropriate for acquiring any supplies or services when the Government anticipates recurring requirements but cannot predetermine the precise quantities of supplies or services that designated Government activities will need during a definite period.

Veteran Integrated Network Service (VISN) 9 medical centers in Tennessee and Kentucky in the next five years plan on activating several new as-built leases that require procuring additional Midmark Corporation (Midmark) designated medical products and reorganizing/reallocating Government-owned Midmark medical products – e.g. procedure/examination chairs/tables, casework, workstations, etc., amongst its existing facilities and outpatient clinics.

Action is an as-needed recurrent requirement subject to equipment lifecycle supported service/maintenance timeline and agency reorganization/realignment/growth plans. Midmark products have varying service life dependent on the equipment that range from 5 – 10 years, whereby Midmark will no longer provide any support/service. VISN9 medical centers have procured multiple quantities of Midmark products in the past several years that are in various ranges of their service life.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: white glove delivery and installation service of Midmark products throughout VISN 9 service locations on an as-needed basis.

White glove delivery and installation considers:

Assigning a project manager from order placement to final acceptance by customer, de-installation of existing brand equipment, providing continuous protection from damage, taking the product directly to its intended use location, unpacking it, installing it, testing it, wiping it down, removing all packing material and contractor-generated waste, and on-site basic user instructions.

The estimate for this service covers a five-year ordering period 2025 through 2030 with a not to exceed (NTE) value of $750,000.00.

Ordering Period 1: 9/1/2025 – 12/31/2025

Effective Date: 11/15/24 Page 2 of 5

Ordering Period 2: 1/01/2026 – 12/31/2026 Ordering Period 3: 1/01/2027 – 12/31/2027 Ordering Period 4: 1/01/2028 – 12/31/2028 Ordering Period 5: 1/01/2029 – 12/31/2029 Ordering Period 6: 1/31/2030 – 8/31/2030

Note: Ordering periods are aligned with Midmark’s business practice of setting new prices at the beginning of every calendar year.

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

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Midmark sells its examination/procedure chairs/tables via VHA mandatory use Strategic Acquisition Center (SAC) non-expendable (NX) equipment contract 36C10G24D0070 and the National Acquisition Center (NAC) Federal Supply Service (FSS) contract 36F79721D0152. The services offered by both contracts are limited to dock-to-delivery only. VISN 9 medical centers operate with manpower shortages in logistics and other services requiring timely installation and configuration of needed equipment with minimum adverse impact to medical center/clinic operations for safe, effective, and efficient delivery of patient care to the veterans they serve.

Proper servicing of complex, lifesaving and life-sustaining medical devices is vital to their safe and effective functioning and the safety of patients and device users. Original equipment manufacturers (OEMs) dedicate extensive resources to establishing comprehensive servicing programs to ensure that their devices are properly maintained and continue to meet safety and effectiveness standards as determined by FDA.

OEM servicing programs must follow strict requirements set out in FDA’s Quality System Regulation, 21 Code of Federal Regulation (CFR) 820, which include specific instructions for training, part and component replacement, documentation of servicing activities, and more. In addition, OEMs and their authorized servicers are subject to numerous other FDA regulations covering reporting of adverse events, recalls, registration with the agency, and many others. This comprehensive set of post-market requirements helps ensure that all servicing done to a medical device is done by properly equipped technicians; that all work is thoroughly documented; and adverse events are reported to the agency.

Effective Date: 11/15/24 Page 3 of 5

This requirement is essential to maintain OEM and Food & Drug Administration (FDA) standards and thereby precludes consideration of services by another company. This white glove service adds value to the basic dock-to-dock delivery service covered under existing Midmark contracts by providing an integrated solution to get the equipment to the actual location where it will be used without introducing another layer of coordination between Midmark and the government and increasing the risk of VISN 9 medical centers having unacceptable delays in fulfilling its requirements along with increased risk to patient and staff safety to proper functioning of Midmark equipment installed by non-OEM approved vendors.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought notice, 36C24925Q0392 was posted from 7/29/2025 to 8/11/2025 on sam.gov Contract Opportunity website IAW FAR subpart 5.2 Synopses of Proposed Contract Actions. The notice sought Midmark trained and certified preferred partners that could meet this requirement other than Midmark themselves. The notice did state that if no viable responses were received, then the government would sole source to Midmark. No viable responses were received.

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

The government anticipates the cost will be fair and reasonable based on the various elements considered under FAR 13.106-3 (a)(2), and, in particular, Midmark services offered by ECAT vendors’ pricelist. The government will also consider the Bureau of Labor and Statistics (BLS) consumer price index data (CPI) for the ordering periods extending beyond the current fiscal year.

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

Market Research Was Not Conducted: Market research conducted pursuant to FAR Part 10, VAAR Part 810 and PPM 2016-05(REVISED AUG 2019) considered the following:

• Used https://search.certifications.sba.gov/ database to identify certified capable service-disabled veteran-owned small businesses (SDVOSBs) and veteran-owned small businesses (VOSBs) under NAICS 811210 with none listed capable of meeting this requirement along with any other small business.

• Queried the Government-wide database of contracts and other procurement instruments intended for use by multiple agencies available at www.contractdirectory.gov and other Government and commercial databases that provide information relevant to agency acquisitions.

• Participated in interactive, on-line communication among industry, acquisition personnel, and customers.

• Contacted knowledgeable individuals in Government and industry regarding market capabilities to meet requirements.

• Reviewed catalogs and other generally available product literature published by manufacturers, distributors, and dealers or available on-line.

• Synopsized the proposed acquisition [see section 6 above], advising industry of the pending acquisition and soliciting inquiries from interested parties https://www.acquisition.gov/?q=/browse/far/10 https://www.va.gov/oal/library/vaar/vaar810.asp https://www.va.gov/oal/library/vaar/vaar810.asp https://www.va.gov/oal/docs/business/pps/ppm201605.pdf https://search.certifications.sba.gov/ https://www.contractdirectory.gov/

Effective Date: 11/15/24 Page 4 of 5

Market research found that Midmark Corporation SAC NX and FSS contracts do not offer white glove services and must be procured via open market from the original equipment manufacturer (OEM), Midmark. Midmark services under ECAT are not available unless the service is tied to an ECAT equipment/product order. Because the equipment/product is available on a SAC NX contract, ECAT cannot be used.

Lastly, responses from the Midmark-recommended SDVOSBs and Midmark representatives found that none of the SD/VOSBs were Midmark-certified trained installers. Midmark did not identify any certified trained installers other than from a large business, namely, EMSAR, with International Organization for Standardization (ISO) certification 13485 for medical devices.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

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

Midmark Corporation, 60 Vista Drive, Versailes, OH 45380 [Large Business]

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:

The Department of Veterans Affairs will continue to seek vendors capable of providing the needed services in future procurements. However, at the present time, based on available market research, and Midmark’s need to be FDA compliant relative to their medical devices/products, there are no other vendors capable of providing the required services other than Midmark.

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.

VISN 9 Healthcare Technology Manager

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.

Contracting Officer NCO9, Logististics & Prosthetics https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

Effective Date: 11/15/24 Page 5 of 5

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.

Branch Chief NC09, Logistics & Prosthetics