Attachment 1 FAR 13.5 Brand Name Justification - Over SAT.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: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

(Brand Name)

Acquisition Plan Action ID: 36C257-23-AP-3348

1. Contracting Activity: Department of Veterans Affairs, Veterans Healthcare Administration, Regional Procurement Office West, Network Contracting Office VISN 17, on behalf of the Audie L. Murphy VA Medical Center (VAMC), 2237 # 671-23-3- 213-0172.

2. Nature and/or Description of the Action Being Processed: The proposed action is for a firm-fixed-priced delivery order for Brand name Steris AMSCO 7053hp. The Steris AMSCO 7053hp offers a complete and thorough cleaning and sterilization of medical instruments for surgery and other outpatient procedures. This acquisition will meet the demands of the busiest Sterile Processing Departments within Audie L.

Murphy VA Medical Center.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This is contract action is to replace two (2) of AMSCO 7053HP Washer/Disinfectors which has reached end of service life. The Washer/Disinfectors will be utilize to wash and disinfect all surgical Instruments before and after surgery. These instruments can withstand the High Temperatures cleaning process that the Steris Brand name can offer. This process renders Surgical Instruments safe for Sterile Processing Service (SPS) staff to handle and assemble Instrument sets in preparation for Sterilization.

SPS falls under VHA Directive1116 (2) dated 23 March 2016, which includes specific requirements for the standardization of equipment types and for ensuring that reprocessing requirements are met. This Directive applies anywhere sterile processing or High-Level Disinfection (HFD) occurs in VA facilities. AUTHORITY: 38 U.S.C. 7301. The estimated cost of this acquisition is $447,344.75.

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

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( ) 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 contractor is uniquely qualified based on their explicit experience with Audie L. Murphy VA Hospitals Sterile processing service to meet the form, fit, and functionality of the existing equipment and space. Currently this contractor performs all maintenance on the equipment within Sterile Processing based on a current maintenance contract. Maintenance contract is in base year and old equipment Serial numbers will be swapped out with upgraded equipment serial numbers and included in maintenance contract. Furthermore, Steris is equipped to perform the removal and installation of the equipment more efficiently based on specific equipment specifications and the layout of Sterile processing with minimal downtime. Staff is also already trained and competent with how to use equipment and extra training will not be required.

Based on extensive market research, as described in paragraph eight of this document, it was determined that limited competition is viable among authorized resellers for this brand name item. This is a brand name justification in support of FAR 11.105, Items Peculiar to One Manufacturer. Steris AMSCO 7053hp brand name is the only washer/disinfectors that delivers a validated process for cleaning reusable da Vinci system instruments. These instruments are highly used at the VAMC as a method to provide skilled surgeons with greater visualization, precision and expertise in performing more complex, minimally invasive surgeries, including dissection and reconstruction. Any other brand name washer/disinfectors could decrease patient safety as they are not certified to clean and disinfect the Da Vinci instruments. Failure to adequately reprocess contaminated instruments that is, not cleaning and disinfecting or sterilizing them before using them on subsequent patients can lead to the spread of deadly pathogens. The Steris washer is a proprietary, clinically proven washer/disinfector that VA currently utilizes and utilizing a different brand of washer will introduce different systems which adds complexity to the surgical process due to requiring proper and efficient use of different systems to include interpretation of results from each system rather than one which can inadvertently place patients at risk. The washer also comes with documentation features that enable accurate recordings and storage of data in compliance with VHA regulatory standards and auditing. Procuring an alternate brand would also result in duplication of costs to the government in the form of additional equipment, surgical staff training. The replacement of current government owned equipment is not expected to be recovered through competrtion.

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. However, the

Effective Date: 02/01/2022 Page 3 of 4 undersigned VA technical representative determined that limited competition is available among authorized resellers. Furthermore, in accordance with FAR 5.301, 16.505(b)(2)(ii)(D), and 16.505(a)(4)(iii), the award notice for this action will be synopsized on the Contract Opportunities website (www.Sam.gov) and this justification will be made publicly available within 14 days of award.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The CO anticipates cost to the Government will be fair and reasonable based on competition, IAW FAR 13.106-2(b)(3), Comparative evaluation will be utilized. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The government will look at two factors 1.

Techical capability and 2. Price. The Government will evaluate each offer in accordance with the requirements of the solicitation / Statement of Work to include technical capability, delivery schedule, warranty, experience, and installation requirements. Price: the prices of all quotes received will be compared to each other. If the price of the higher rated quotes is higher, the Government will determine if the additional value of the higher rated quotes is worth the level of premium imposed by the higher price.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The Government’s technical experts conducted market research during January 2023, and then again in

June of 2023 by reviewing other similar washer/disinfector. The other similar washers reviewed included Xenex Disinfection Services and Sotera Health. Based on reviews of these products, the Government’s technical experts determined that none of these products can meet the Government’s interoperability and compatibility requirements previously discussed. Additionally, none of these other products can offer the cleaning and sterilization of the da Vinci system instruments. Additionally, VA networking Subject Matter Experts regularly review industry trade publications and conduct internet research to ascertain if any other brand name software is available.

Based on all of these market research efforts, the Government’s technical experts have determined that only Steris brand name washer/disinfector can meet all of VA’s needs.

In addition to the above market research, the CS contacted Steris Corporation in July

2023 via e-mail to inquired about any authorized resellers they may have. The representative informs the CS that they have authorized resellers that can meet VA’s requirement to include 2 SDVOSBs and 1 small business.

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

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.

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

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

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

Julia Adams Sterile Processing Service, Chief

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.

Latasha Messer Contracting Officer, Log Per

NCO 17

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.

Jeff Morris Division Chief

NCO 17

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