FAR 13.5 Sole Source Justification - 36C242-24-AP-2340 - R1_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

36C242-24-AP-2340

Effective Date: 02/01/2022 Page 1 of 6

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C242-24-AP-2340

1. Contracting Activity:

Department of Veterans Affairs, VISN 2, VA Network Contracting Office 2, 130 W. Kingsbridge Rd., Bronx, NY 10468, in support of VA New York Harbor Healthcare System (NYHHCS), Margaret Cochran Corbin VA Medical Center, 423 East 23rd Street, New York, NY 10010.

Purchase request number: 630-24-3-4520-0155

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

This procurement is for the Endodry Drying & Storage System that consists of scope storage cabinets, accessories (e.g., scope hookups and transport cassettes and lids), and transport carts, that are needed for use with the Medivators Advantage Plus Automatic Endoscope Reprocessors (AERs) that are being installed in the Sterile Processing Service (SPS) at the Manhattan Campus of VA NYHHS in April 2024.

This action will be awarded as a new firm-fixed-price contract.

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

Three Medivators Advantage Plus AERs are being installed in Sterile Processing Service at the Manhattan Campus of VA New York Harbor Healthcare System in April 2024. This request is to obtain several items for use with the Medivators Advantage Plus AERs: seven Endodry Advantage scope drying cabinets, scope hookups, Advantage transport cassettes and lids, and Cleanascope Advantage transport carts. All of these items are necessary for use with the Medivators Advantage Plus AERs and must be compatible with these reprocessors.

Item No. Description Qty

1. DRY1002 Endodry Adv Cabinet Ss Or

75” H x 24” W x 22” D Single-sided Cabinet with Door Opening Right

2. CAS1000 Model Cas-1000 Assy, Cassette, Transport 56

3. CGS10192 2yr Gold Contract Endodry Cabinet 7

4. 28611 Model 2-8-611 Assy, Hook-up, Oly 12

5. 28511 Model 2-8-511 Assy, Hook-up, Oly 2

6. 28210 Model 2-8-210 Assy, Hook-Up Olympus 2K 2

7. 103467 Cleanascope Adv 10 Tray 1

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64.6"H x 25.1”W x 22.4"D (in)

8. 103466 Cleanascope Adv 6 Tray

41.7"H x 25.1”W x 22.4"D (in)

9. 103457 Model 103457 Cas Advantage Clear Lid 28

10. INS1011 Installation, Assessment, and Training 1

The estimated value of the proposed action is

Delivery date: 10 weeks ARO

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):

This is a brand name justification in support of FAR 11.105, Items Peculiar to One Manufacturer.

This is a brand name only request. The purpose of this procurement is to obtain equipment and items for use with the Medivators Advantage Plus AERs being installed in SPS Manhattan. The Advantage Plus Transport Cassettes, Cleanascope Advantage Transport Carts, scope hookups, Medivators AERs, and the Endodry Advantage cabinets are compatible and designed to be used as a hands-free system to maximize reprocessing efficiency and efficacy, increase patient safety by reducing the likelihood of cross-contamination, and reduce potential for damaging endoscopes due unnecessary handling. After use, the scope is put into the transport cassette and covered with the lid, which is placed in the transport cart and taken to SPS. Once in SPS, the cassette is withdrawn, the hookup is affixed to the scope and then the hook up is placed in the designated space in the cassette. This ensures that the scope is secured and that the tubes and channels that send the enzymatic detergent, alcohol, etc. through the scope to disinfect it are connected properly. The scope hook ups connect the scope to the AER and to the Endodry cabinet. Per the manufacturer, these hook ups are not compatible with any other AER or drying cabinet. The cassette is put into the AER for high-level disinfection of both the scope and the hook up; the latter must also be disinfected to prevent cross-contamination. The only way to disinfect the hook up is while it is connected to the scope in the AER. From the AER, the cassette with the disinfected scope and hook up goes to the

Effective Date: 02/01/2022 Page 3 of 6

Endodry cabinet. The hook up is connected to the cabinet where the scope and hook up block are dried using instrument air that flows from the cabinet through the scope and the block. Once the scope is dried it can be stored and/or taken into the clean transport cart to be taken to the point of use when needed again. All of this occurs without excessive handling of the scope (a hands-free workflow system), which will reduce the repair costs of scopes as well as downtime when the scopes are unavailable for patient care. The scope hookups are specific to the scopes in use in GI, OR, and other clinical areas at the Manhattan Campus. The hookups are the only connectors that can be used to connect the scopes to the Medivators Advantage Plus AERs for proper high-level disinfection and to the Endodry cabinet for drying. The Transport Cassette Advantage Clear Lids fit the cassettes, and protect the endoscopes from damage during transport, keep high-level disinfected scopes ready for patient use, and prevent cross-contamination from debris on used scopes during transport. The lids are clear, so when used with a color liner (e.g., green for clean and red for dirty), staff can easily identify clean and dirty scopes. All of these items are compatible with the Medivators Advantage Plus AERs being installed in Manhattan SPS and are necessary to create the desired hands-free workflow that maximizes patient safety and protects the scopes.

The Medivators AERs, Endodry Cabinets, and all other accessories are in use in SPS at the Brooklyn Campus of VA NYHHS. Replicating the system in Manhattan offers redundancy in the event of an outage at either site.

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

Market research was conducted, details of which are in section 8 of this justification. This effort did not yield any additional sources that can meet the Government's requirements.

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

The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

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

Market Research Was Not Conducted:

This market research is for the Endodry Drying & Storage System.

Conducted a search on SBA DSBS for SDVOSBs using NAICS Code 339113 (Surgical Appliance and Supplies Manufacturing) and keywords Endodry, Medivator, and Steris. One SDVOSB was found using keyword Steris. however, provides medical equipment maintenance, parts, and supplies. They do not sell the Steris Endodry system.Conducted a search on SBA DSBS for VOSBs using NAICS Code 339113 (Surgical Appliance and Supplies Manufacturing) and keywords Endodry, Medivator, and Steris. There were no VOSBs found.

Conducted a search on SBA DSBS for small businesses using NAICS Code 339113 (Surgical Appliance and Supplies Manufacturing) and keywords Endodry, Medivator, and Steris. Two small businesses

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Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

36C242-24-AP-2340

were found using keyword Steris. (1) however, Sustainment Technologies, LLC provides medical equipment maintenance, parts, and supplies. They do not sell the Steris Endodry system. (2) however, You First Services, Inc. is involved with SteriSpace air sterilization and has no relation to this requirement.

A quote from was submitted with the FORCE procurement documents noting that (large business) is an interested source for this requirement. Upon inquiry to of as to if there are any authorized SDVOSBs for the Endodry system, I received a reply that is an authorized SDVOSB for the Endodry system.

Published Special Notice INTENT TO SOLE SOURCE - ENDODRY DRYING & STORAGE SYSTEM to VETERANS HEALTHCARE SUPPLY SOLUTIONS (36C24224Q0627) to Contract Opportunities from May 3, 2024 through May 17, 2024. The Notice included complete descriptions of all items with part numbers and quantities.

Received an email dated May 14, 2024 from , Administrative Assistant/Lead Customer Service, Medivators Products of stating that they represent Steris for capital equipment and would like to be considered for a quote on this requirement. a letter of supply from , Director, Strategic Accounts, Steris Corporation Also attached was capability statement showing that they are a small business. Verified via SBA DSBS that is registered as a small business.

Verified via SAM.gov that , is currently registered with an expiration of May 29, 2024 and has no exclusions.

Received an email dated May 17, 2024 from , Account Manager, stating that is a SDVOSB authorized distributor for Steris/

Medivators products, and can provide exact matches per request. , National Director, Government Accounts, dated October 9, 2023. Also was capability statement showing that they are a SDVOSB. Verified via VetCert that is certified as a SDVOSB. Verified via SAM.gov that , is currently registered with an expiration of May 3, 2025 and has no exclusions.

Verified via SAM.gov that , is currently registered with an expiration of December 27, 2024 and has no exclusions.

Verified via FedDataCheck that is rated “green” with no issues found that would prevent them from receiving an award.

Verified via FedDataCheck that is rated “yellow” with one issue found. The one issue is a Termination for Cause or Default was from March 24, 2021 his CO does not consider it prevent from receiving an award.

Verified via FedDataCheck that is rated “green” with no issues found that would prevent them from receiving an award.

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In conclusion there are three interested contractors for this requirement. One small business, one SDVOSB, and one large business.

This requirement does not meet the VA Rule of Two.

Any Other Facts Supporting the Use of Other than Full and Open Competition:

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

Firm 1:

Firm 2:

Firm 3:

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:

No actions are planned. There is adequate competition for this requirement.

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 Title Facility

5/22/2024________________________ Date

NYHHCS - Manhattan Campus

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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.

Date

Contract Specialist

NCO 2 | PCOE

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.

Date

NCO 2