P03. PM_Part806.3_Atch5_FAR6_JA_OVER_SAT Endodry Cabinets.pdf

OFOC SOP Revision 11 Page 1 of 4 Original Date: 03/22/11 Revision 11 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:_______ 36C244-21-AP-3021____________________________________

1. Contracting Activity: Department of Veterans Affairs, VISN 4, Philadelphia VA Medical Center, 3900

Woodland Ave, Philadelphia, 19104. PR#: 642-21-2-330-0022

2. Nature and/or Description of the Action Being Processed: The Department of Veterans Affairs, Philadelphia VA Medical Center, has a new Brand Name Only requirement for (8) eight Medivators ENDODRY Endoscope Cabinets. The Medivators ENDODRY Endoscope Cabinets are cabinets that ensure endoscopes remain safe and dry during storage. The cabinets currently in use by the facility no longer meet the needs of the medical center. The Endodry Cabinets will replace the existing cabinets in the GI Clinic. The estimated value of this procurement is $363,380.12

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Department of Veterans Affairs, Philadelphia VA Medical Center, has a Brand Name only requirement for (8) eight Medivators ENDODRY Endoscope Cabinets. The Medivator Endodry & Storage System are cabinets that ensure endoscopes to remain safe and dry during storage. The ENDODRY Storage and Drying system is an air supply system that compresses air from equipment provided via cable connectors.

The system forces HEPA filtered air through all endoscope channels. The goal is to make sure the endoscope remains dry and fluid-free in order to eliminate residue and moisture. The intended use for the cabinets is required to replace the medical center’s Inner-space endoscope cabinets. The Inner-space cabinets do not have continuous air feed through the endoscope that will ensure a dry high-level disinfected scope. The replacement of the current cabinets with the Medivator Endodry Cabinets will improve cleaning effectiveness and increase efficiencies.

4. Statutory Authority Permitting Other than Full and Open Competition:

(X ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

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 Medivators Endodry Endoscope Cabinets are specifically compatible with the Olympus flexible endoscopes, currently in

OFOC SOP Revision 11 Page 2 of 4

Revision 11 Date: 02/11/2021 use with the Philadelphia VAMC’s GI Endoscopy unit. The Endodry cabinets are the only endoscope cabinet that is compatible with the Medivators Advantage plus AERS currently in use at the Philadelphia VAMC. Medivator equipment is standard equipment in the VA / VISN 4 minimizing the need for additional consumables. No other equipment on the market is compatible with both the flexible scopes and the Medivator Advantage Plus AERS currently in use at the medical center.

Purchasing any other brand of cabinet will result in the medical center needing to replace all of their flexible GI scopes and the Advantage Plus AERs which will be costly both monetarily and in the potential delays in patient care resulting from the replacement of and education on the use and proper cleaning and sterilization of new scopes.

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

An internet and catalog search was performed and since August 2019 25 VA hospitals across the country have installed Medivator Endodry cabinets. The SPS chiefs at those medical centers were contacted to determine their satisfaction with the Medivator Endodry Cabinets. All of the chiefs expressed having high levels of satisfaction with the cabinets. Research was conducted to find comparable devices that are standardized to the VA SPS Departments but Endodry is the only cabinet on the market that has a validated 100% “bone dry” drying claim. The “bone dry” capability of the cabinets mitigates the risk of scopes becoming contaminated after High Level -Disinfection.

7. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable by the Contract Specialist:

This is a brand name only requirement, however there are multiple authorized distributors of Medivator brand equipment. To ensure that the procurement is competed so that the Government receives as many quotes as possible and is able to ensure a fair and reasonable price through competition, Medivators was contacted for a list of authorized distributors. Medivators provided a list of 5 authorized distributors of their equipment, which includes four SDVSOBs and one Small Business.

8. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: Within VISN 4 there have been at least three prior procurements for Medivators Endodry cabinets in the last two years, specifically for the VA Pittsburgh Healthcare System, Wilmington VAMC, and Wilkes-Barre VAMC. The prices were determined to be fair and reasoble based on the IGCE and a comparison of competitive quotes received in response to posted RFQs. It is expected that the quotes received for this procurement from the authorized distributors will also be fair and reasonable.

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

Customer Market Research: Market research was conducted using GSA’s e-Library System, VETBIZ database, FPDS, ECAT, Beta.sam.gov. Based on market research there are three (3) SDVOSB distributors for this brand name equipment.

Contracting Market Research: Reviewed prior procurements and contacted Medivators to determine who the authorized distributors are and their socioeconomic status. There are four (4) SDVOSB authorized distributors.

OFOC SOP Revision 11 Page 3 of 4

Revision 11 Date: 02/11/2021

10. Any Other Facts Supporting the Use of Other than Full and Open Competition Researched comparable devices used across the VA nationally, most VAs have standardized to these devices and are highly satisfied with its performance and reliability. The majority of the VAMCs in VISN 4 have standardized to the Medivator Endodry Cabinets for endoscope HLD promoting supporting consumable product standardization and standardized processing procedures for semi-critical RME devices used in Endoscopy.

Medivators is the only manufacturer of the ENDODRY Cabinets and provides validation for 100% “bone dry” internal channels within on hour. Stores scope up to 31 days with no increase in microbial levels. This system delivers continuous scope air flow with double HEPA filtration. The cabinets include a visual indicator to show when the scope is completely done.

EndoDry has data that supports a 31 day storage time. Previous data from the market shows 7 days. EndoDry has data for 30 days.

Compatible with flexible scopes and minimizes endoscope handling and potential recontamination

EndoDry works hand in hand specifically with the (6 Advantage Plus Medivator machines) that we have on site. The cassettes and hookup blocks allow staff to handle scopes “hands free”. This mitigates risk of damage and cross contamination.

This purchase will increase department efficiency and provide additional patient safety for safe reprocessing. The Endodry cabinets meet all requirements for endoscope storage in the VA Directive 1116(2) and the ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities.

Medivator is the only manufacturer of the designed cabinets.

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

Customer received quote directly from Medivators.

12. 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:

13. 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.

Keith Smith Date SPS Assistant Chief Philadelphia

KEITH L. SMITH

394939

Digitally signed by KEITH L.

SMITH 394939

Date: 2021.08.05 13:22:15 -04'00'

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Revision 11 Date: 02/11/2021

14. 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.

Andrea Aultman-Smith Date NCO4, Contracting Officer

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.

Caroline L. Robinette Date NCO4, Branch Chief

Andrea Aultman- Smith 155562

Digitally signed by Andrea Aultman-Smith 155562 Date: 2021.08.05 13:52:13 -04'00'

Caroline L.

Robinette 135596

Digitally signed by Caroline L. Robinette 135596 Date: 2021.08.10 07:25:55 -04'00'