Attachment 1 FAR 13.5 Sole Source Justification - P1_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: 11/15/24 Page 1 of 7

REVISION: 01

Acquisition ID#: 36C244-25-AP-3046

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C244-25-AP-3046

1. Contracting Activity:

Department of Veterans Affairs (VA), Network Contracting Office (NCO) 4, Veterans Integrated Services Network (VISN) 4, Station 646, VA Pittsburgh Healthcare System, University Drive C, Pittsburgh, PA 15240, 646-25-3-066-0413

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

This procurement is for the acquisition of 100 ISOFLEX LAL replacement mattresses specifically designed for the Stryker Model S3 EX 3005 beds in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and FAR 13.501 Special Documentation Requirements. The contract will be a firm-fixed-price award, as a new contract action. The total estimated value of this procurement is This procurement will utilize a limited competition among authorized distributors as part of the brand name requirement process.

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

The VA Pittsburgh Healthcare System requires the replacement of 100 ISOFLEX LAL mattresses (Product#: 2860000019). These mattresses are crucial for maintaining patient care standards, as they are compatible exclusively with the Stryker Model S3 EX 3005 beds currently used at the facility. The mattresses include advanced air-flow technology, gel column design, and breathable fabric to mitigate patient bedsores, enhance comfort, and promote healing. The unique features include:

Pressure Redistribution: Helps to minimize patient bedsores by redistributing pressure evenly.

Airflow Technology: Maintains a stable microclimate by providing consistent airflow, which is key in preventing skin maceration.

Gel Column Design: The open gel structure enables free air movement, promoting skin health and enhancing comfort.

The total estimated value of the procurement is , and the required delivery is immediate to avoid disruptions in patient care due to inoperable beds.

Unique Characteristics that Limit Availability to Only One Source:

The ISOFLEX LAL mattresses are uniquely compatible with the Stryker Model S3 EX 3005 beds currently in use at the VA Pittsburgh Healthcare System. These mattresses feature proprietary airflow technology and gel support systems that are integral to their function. Replacement with any other brand would render the beds unusable, leading to substantial delays and duplication of costs

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Acquisition ID#: 36C244-25-AP-3046 due to the need for reconfiguration or replacement of the entire bed systems.

In addition:

Compatibility: Specifically designed to integrate with the Stryker air pumps already deployed throughout the facility, ensuring system-wide consistency.

Upkeep and Warranty: The procurement of these Stryker mattresses provides a warranty of ten

(10) years for the IsoFlex LAL foam/gel; three (3) years for the Mattress Cover assemblies and Fire Barrier; and three (3) years for the Stryker Air Pump unit for low air loss . The warranty specifies that the Stryker Mattresses must be used with the current Stryker bed frames already in service.

Compatibility with Existing Systems: The Stryker mattresses are fully compatible with the Stryker bed frames already in use, ensuring seamless integration without requiring new equipment or facility modifications.

Compliance with Standards: The Stryker ISOFLEX LAL mattresses comply with patient care standards set by the VA to mitigate pressure ulcers. The combination of gel column design and airflow ensures the highest levels of patient care.

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

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 ISOFLEX LAL mattresses are uniquely compatible with the Stryker Model S3 EX 3005 beds currently in use at the VA Pittsburgh Healthcare System. These mattresses are critical for patient care, providing advanced features such as airflow technology and pressure redistribution that prevents bedsores and promotes healing. Any attempt to procure mattresses from a different manufacturer would require replacing the entire bed infrastructure, leading to significant additional costs, operational downtime, and training requirements for clinical staff. Accordingly, Stryker Corporation is the only firm capable of providing these mattresses without causing substantial duplication of cost that could not be expected to be recovered through competition.

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Acquisition ID#: 36C244-25-AP-3046

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

Market research was conducted in accordance with FAR Part 10 and VAAR 810. The following efforts were made:

Veteran Small Business Certification (VetCert): A search was conducted in the VetCert system using NAICS code 339113, which yielded 934 possible SDVOSB/VOSB vendors.

SBA DSBS Portal: A search using NAICS 339113 and the keyword "hospital mattress" yielded no suitable vendors.

GSA Advantage and VA Supply Chain Master Catalog (SCMC): Searches were conducted that yielded three SDVOSBs authorized to sell Stryker mattresses were identified. These are Beacon Point Associates LLC, TrillaMed, LLC, and Academy Medical Inc.

Review of Product Literature: Several manufacturers were reviewed, including Stryker, Joerns Healthcare Inc., Hillrom, and others. No alternatives were found that could meet the requirements for compatibility.

Contact with OEM: Biomedical engineering and clinical staff contacted Stryker, and it was confirmed that only Stryker or their authorized SDVOSBs as Beacon Point Associates LLC, TrillaMed, LLC, and Academy Medical Inc. could provide the required mattresses based on proprietary technology that meets the Government’s needs. A total of three SDVOSB resellers (Beacon Point Associates LLC, TrillaMed, LLC, and Academy Medical Inc.) were identified as capable of providing the required Stryker mattresses. These resellers will be approached for quotes.

A synopsis of the proposed contract action, advising industry of the pending acquisition and soliciting inquiries from interested parties, will be posted to SAM.gov. Additionally, the solicitation will be posted publicly to ensure that adequate price competition exists among authorized distributors.

There is no SBA class waiver for NAICS code 339113. This procurement exceeds the Simplified Acquisition Threshold, and the NMR clause 52.219-33 will be included in the solicitation. Despite identifying three SDVOSB suppliers, the procurement will be unrestricted due to the manufacturer being a large business.

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

The Contracting Officer has determined that the anticipated cost of is fair and reasonable based on previous procurement history and pricing benchmarks for similar specialized medical equipment. The firm-fixed-price nature of the contract ensures cost stability. In addition, a price comparison with similar products available through authorized distributors was conducted to validate the reasonableness of the pricing.

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

Market Research Was Not Conducted:

In accordance with FAR Part 10, VAAR Part 810, and PPM 2016-05 (REVISED AUG 2019), comprehensive market research was conducted to determine whether the procurement of ISOFLEX LAL Stryker Mattresses could be accomplished in a manner that supports competition and considers

Effective Date: 11/15/24 Page 4 of 7

Acquisition ID#: 36C244-25-AP-3046 service-disabled veteran-owned small businesses (SDVOSBs) and veteran-owned small businesses (VOSBs), as required by the Veterans First Contracting Program.

Market Research Techniques Used:

Veteran Small Business Certification (VetCert): A search was conducted using the VetCert system with NAICS code 339113. This search yielded 934 possible SDVOSB/VOSB vendors.

SBA DSBS Portal Search: The SBA DSBS portal was used to search for vendors using NAICS code 339113 and the keyword "hospital mattress," but no potential vendors were identified.

VA Vendor Information Pages (VIP) Database: The Vendor Information Pages database was reviewed in accordance with VAAR Class Deviation 810.001-70 to determine if two or more SDVOSBs or VOSBs were available to meet the requirements. This review confirmed that three SDVOSB vendors were capable of supplying Stryker ISOFLEX mattresses: Beacon Point Associates LLC, TrillaMed, LLC, and Academy Medical Inc.

Contacting Industry Experts and OEM: Biomedical engineering and clinical staff contacted the OEM, Stryker Corporation, to confirm that only Stryker could provide the necessary mattresses due to proprietary hardware compatability requirements. An informal quote was provided by Stryker on October 8, 2024.

Reviewing Historical Acquisition Data: A contract for 100 Stryker IsoFlex Mattresses for the Pittsburgh VA Medical Center was awarded on 2/21/2025. These mattresses are now in use. The lead time from when this procurement package was submitted to when the mattress where put into service took approximatly 6 months. During this time an additional 100 mattresses have been to found to have the fluid infiltration.

Review of Product Literature: The market research also included a review of available product literature from various manufacturers including Joerns Healthcare Inc., Hillrom, Rotec, and Umano Medical. None of these alternatives were found to meet the technical compatability requirements of the Stryker bed frames and associated air pumps.

Search of Government and Commercial Databases: Searches were conducted on GSA Advantage, VA Supply Chain Master Catalog (SCMC), and VetCert. These searches yielded three SDVOSB suppliers with GSA contracts were idenfied as capable of fulfilling the requirement (Beacon Point Associates LLC, TrillaMed, LLC, and Academy Medical Inc..)

Nonmanufacturer Rule (NMR) Findings: There is no SBA class waiver for NAICS code 339113. Due to the manufacturer being a large business, the procurement exceeds the Simplified Acquisition Threshold, necessitating an unrestricted, brand name solicitation. Clause 52.219-33 will be included in the solicitation and resulting award.

Effective Date: 11/15/24 Page 5 of 7

Consideration to Buy American Act (BAA) and Trade Agreements Act (TAA): According to the Federal Acquisition Institute (FAI) Buy American and Trade Agreements Decision Tool for Supplies, the Buy American statute applies to this procurement. Clause FAR 52.225-1 Buy American – Supplies and provision FAR 52.225-2 Buy American Certificate will be included in the solicitation and resulting award. No exceptions to the Buy American Act apply to this acquisition. This item is manufactured in the USA. The market research concluded that while there were three SDVOSB resellers of Stryker mattresses (Beacon Point Associates LLC, TrillaMed, LLC, and Academy Medical Inc.), the manufacturer itself is a large business and holds proprietary rights to the product.

Conclusion: As described in above, market research, in accordance with FAR Part 10, was conducted. Based on the findings, the procurement will proceed as a brand name requirement for Stryker mattresses, utilizing authorized SDVOSB distributors to fulfill the Department’s requirements where possible. Given the proprietary nature of the equipment and the inability of alternative brands to meet the technical requirements, Stryker remains the only responsible source capable of satisfying the agency's needs without incurring additional costs or causing delays that could negatively impact patient care.

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:

These sources were idenfied through the market research process, and written confirmation of their ability to fulfill the requirement as authorized Stryker distributors has been documented and stored in the acquisition file. This letter of interest was received directly from Stryker. The businesses listed below were idenfied as authorized resellers for Stryker’s MedSurg roup (CMF, Communications, Endoscopy, Instruments, and Medical) products in federal healthcare to include Department of Defense (DOD), Department of Veteran Affairs (VA), Indian Health Services (IHS), Federal Bureau of Prisons (FBOP), Department of State, and all other federally funded entities. Stryker products may not be sold by other resellers without WRITTEN AUTHORIZATION directly from Stryker. Any Stryker product(s) sold to the Government through a Stryker authorized reseller is verified to be new products (not grey market) and will come with the full OEM warranty.

Beacon Point Associates LLC - SDVOSB

TrillaMed, LLC - SDVOSB

Academy Medical Inc. - SDVOSB

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:

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The VA Pittsburgh Healthcare System will evaluate alternative solutions and conduct market research for future acquisitions to foster competition where possible. Actions that could be undertaken include:

Conducting further market research to identify new potential suppliers.

Exploring opportunities to standardize equipment that is compatible with multiple vendors, reducing reliance on a single source.

Soliciting industry input through Requests for Information (RFIs) to assess market capability for providing similar equipment.

If a follow-on competitive acquisition is planned, the Government will explore opportunities to enhance compatibility between systems and consider alternative manufacturers to meet its needs.

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 Date Title Facility

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.

Benjamin Villasenor Date Contracting Officer NCO 4, Commodities 1

05/13/2025

KIERSTEN

ELLIOTT

Digitally signed by

KIERSTEN ELLIOTT

Date: 2025.05.13 15:54:04 -04'00'

BENJAMIN VILLASENOR

Digitally signed by BENJAMIN

VILLASENOR

Date: 2025.05.14 10:51:03 -04'00'

Effective Date: 11/15/24 Page 7 of 7

Acquisition ID#: 36C244-25-AP-3046

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.

Holly Bricker Date Branch Chief

NCO 4, Commodities 1

HOLLY BRICKER

Digitally signed by HOLLY

BRICKER

Date: 2025.05.14 11:02:20 -04'00'