Brand Name Justification.pdf

Acquisition Plan: 36C247-23-AP-2883

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C247-23-AP-2883

1. Contracting Activity: Department of Veterans Affairs, VISN 7, Ralph H. Johnson VA Medical

Center located at 109 Bee Street, Charleston, South Carolina.

The purchase request number is 534-23-3-783-0255.

2. Nature and/or Description of the Action Being Processed: This procurement is for four (4) new

Endoscope Reprocessor Systems in accordance with FAR 13.5 Simplified Procedures for Certain

Commercial Items 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 a justification using the format of FAR 6.303-2.

This requirement is intended to be solicited as a Brand-Name requirement and awarded as a new Firm

Fixed Price (FFP) contract for four (4) Medivators Advantage Plus Automated Endoscope

Reprocessors

The total estimated value for the one-time procurement is $261,422.76.

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

The Medivators Advantage Plus Automated Endoscope Reprocessor is a fully automated, computer-based asynchronous endoscope reprocessor that monitors each endoscope channel separately for blockage and proper flow ensuring complete high-level disinfection.

Technicians can load devices into one of two independent basins, using a hands-free foot pedal, for loading using the convenient transport cassette which provides protection and recontamination prevention. Use of the wash cycle with INTERCEPT™ Detergent eliminates the need for manual brushing and flushing of the endoscope. Continuous automated leak testing and a programmable alcohol flush are standard attributes. The fully automated cycle uses RAPICIDE PA High-Level

Disinfectant, with proven endoscope material compatibility, to effectively kill TB, hepatitis viruses, C-diff, VRE, MRSA and CRE in 5 minutes at 86°F (30°C).

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.

(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 3

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above: The Steris Technicians can load devices into one of two independent basins, using a hands-free foot pedal, for loading using the convenient transport cassette which provides protection and recontamination prevention. Use of the wash cycle with

INTERCEPT™ Detergent eliminates the need for manual brushing and flushing of the endoscope.

Continuous automated leak testing and a programmable alcohol flush are standard attributes. The fully automated cycle uses RAPICIDE PA High-Level Disinfectant, with proven endoscope material compatibility, to effectively kill TB, hepatitis viruses, C-diff, VRE, MRSA and CRE in 5 minutes at

86°F (30°C).

These systems monitor endoscope channels for blockage and ensure that high level disinfectant is delivered to all channels. The automated cycle eliminates variability of manual cleaning. The validated cleaning claim enhances endoscope reprocessing and the leak test enables disinfection of leaky endoscopes prior to repair. An automated alcohol flush facilitates drying of endoscope channels

An incorporated barcode reader facilitates fast and accurate data entry. The remote diagnostics allow for efficient servicing and for computerized cycle documentation and reporting. The ADVANTAGE

PLUS integrates with the SPM® Surgical Asset Tracking Software and other tracking software solutions for active monitoring and process verification.

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

Thorough market research as well as communication with the vendor was returned with all authorized distributors. The vendor returned list of authorized distributors is used to maximize competition as well as eliminate any potential grey market sources.

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

Reasonable: Competition is available for this requirement and is expected to result in competitive as well as fair and reasonable pricing.

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

Market Research Was Not Conducted: Queries were conducted through VIP, GSA, and communication with the Original Equipment Manufacturer(OEM). The VIP query was returned with

4 results and the GSA query was returned with 11 SDVOSB vendors. The OEM responded with a sole source letter and four (4) SDVOSB vendors (ASE Direct, Inc., VHSS Veterans Healthcare

Supply Solutions, Janz Corp.,1st American Medical Distributors, Inc.) and 1 small business vendor

(Surgical Tools) as the authorized distributors for these systems.

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: Small Business-

Surgical Tools, Inc., SDVOSB- ASE Direct, Inc., VHSS Veterans Healthcare Supply Solutions, Janz

Corp.,1st American Medical Distributors, 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:

Continuous communication with the Original Equipment Manufacturer (OEM) will be conducted periodically for additional authorized sources. Continuous market research will be conducted regularly to identify additional products available that can meet this requirement for future 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.

https://www.steris.com/healthcare/products/spm-surgical-asset-tracking-software

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

Matt Couture, PhD, RN

Acting Chief for SPS

Ralph H. Johnson VAMC

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.

Thomas Nicholls

Contracting Officer

VISN 7-Ancillary Patient Care Team

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.

Jason S. Compton

Branch Chief

VISN 7-Ancillary Patient Care Team https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx