BNJ - SIMULATOR TASK TRAINERS.doc

Attachment 1: Request for Exception to Fair Opportunity Memo

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval

For

Exception to Fair Opportunity Memo

Acquisition Plan Action ID: 36C250-24-AP-4698

1. Contracting Activity: Department of Veterans Affairs, Network contracting Office 10 located at 260 E University Avenue, Cincinnati, OH 45219-2356, in support of VISN 10, Cincinnati VA Medical Center (CVAMC), 3200 Vine Street, Cincinnati, OH 45220-2213. 2237 #: 539-24-4-854-0025.

2. Description of Action: This new request from the Cincinnati VA Medical Center (CVAMC) Simulation Program is for a firm fixed price award to purchase (2) different brand name task trainer devices at end of life and replacement disposable insert supplies.

3. Description of Supplies or Services: The CVAMC Simulation Program uses an extensive collection of training devices to develop clinical skills needed for staff to maximize patient comfort while minimizing risks of complications during lumbar punctures and enhance patient comfort and confidence of staff performing blood pressure checks at bedsides. The required supplies/services include:

· BPLP2101 – Lumbar Puncture and Spinal Epidural Training Model – Quantity of 1 Each

· BPLP2201 – Replacement Tissue for Epidural and Lumbar Puncture - Lumbar Insert – Quantity of 1 Each

· BPLP2204 – Replacement Tissue for Epidural and Lumbar Puncture - Obese Lumbar Insert – Quantity of 1 Each

· BPTT2-1006 – Midscapular Thoracentesis Ultrasound Replacement Tissue – Quantity of 1 Each

· BPPARA1302 - Paracentesis Replacement Insert – Quantity of 1 Each

· BPH663 – Central Line Insert for Item BPH660-HP – Quantity of 2 Each

· Deluxe Blood Pressure Simulator with Speaker System – Quantity of 1 Each

· Freight Charges – Shipping to: CVAMC, 3200 Vine Street, Cincinnati, OH 45220-2213 – Quantity of 1 Each The total estimated value of the proposed action is $19,313.00.

4. Statutory Authority: The statutory authority permitting an exception to fair opportunity is Section 41 U.S.C. 4106(c) as implemented by the Federal Acquisition Regulation (FAR) 16.505(b)(2)(i):

( ) FAR 16.505(b)(2)(i)(A): The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

(X) FAR 16.505(b)(2)(i)(B): Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. BRAND NAME ONLY ( ) FAR 16.505(b)(2)(i)(C): The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

( ) FAR 16.505(b)(2)(i)(D): It is necessary to place an order to satisfy a minimum guarantee.

( ) FAR 16.505(b)(2)(i)(E): For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source”. The statutory authority permitting an exception to fair opportunity for this action is 38 U.S.C. 8127(c), known as the Veterans First Contracting Program which provides the authority to directly contract with a Service-Disabled Veteran-Owned Small Business (SDVOSB) or a Veteran-Owned Small Business (VOSB).

5. Rationale Supporting Use of Authority Cited Above: 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. Simulation training teaches participants how to treat patients, handle critical situations and reduces medical errors which results in improved patient outcomes, increased confidence levels and competencies. The requestor is vendor agnostic but require brand name Elevate Healthcare Blue Phantom model task trainers and replacement inserts. No alternative product is acceptable because their extensive collection of Elevate Health task trainers is calibrated to work optimally with these specific models. Furthermore, no other inserts (disposable items) are compatible with the task training models (durable items) currently in use.

6. Efforts to Obtain Competition: A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable. Market research was conducted, details of which are in the market research section of this document.

7. Actions to Increase Competition: Describe actions taken, or that will be taken, to remove or overcome any barriers to competition before initiating any subsequent acquisitions for the supplies, or services required, including challenges to restrictive data markings, data rights, preparation of a performance-based work statement, and etc. 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. Market Research: Provide a description of the market research conducted among the contract holders and the results. If market research was not conducted, the reasons it was not conducted should be stated. When citing FAR 16.505(b)(2(i)(b) or FAR 16.505(b)(2)(i)(e), the only possible way to state in paragraph 5 of the J&A that there is only one contractor who can fulfill the agency’s needs is to conduct market research, and it should be summarized here. The requester has utilized task training simulation devices similar to those specified for the past 13 years. He has attended numerous simulation conferences and has evaluated all alternative products available in the market. Additionally, he has consulted with multiple experts from both governmental and commercial simulation sectors to obtain a comprehensive understanding of the current state of the task training market.

Market research queries were conducted using VetCert, SBA DSBS, NASA SEWP, GSA Advantage and eLibrary, FPDS-NG, AbilityOne catalog and other sources. A single GSA contract was found; however, the Vendor reported on 08/22/2024 that it is “in the process of submitting a new price list deletion that includes these items.” No other contracts were found. The product NAICS code was not listed in the NMR Class Waiver.

The OEM, Elevate Healthcare, LLC is a small business. The proprietary technology used to manufacture these training models is patented. The OEM provided a list of 10 small businesses and 4 large businesses that are authorized distributors. There is no expectation of obtaining offers from two or more responsible SD/VOSB concerns. The VA Rule of Two has not been met for this requirement. The SBA Rule of Two is met. Based upon the market research findings, it is determined that this requirement can be competed as an open market small business set aside to obtain a fair and reasonable price.

9. Other Facts: The instruments will not be interfaced with the VA IT system. The C&A requirements do not apply, and a security accreditation package is not required.

For the blood pressure cuff, the requestor is vendor and product agnostic; however, the blood pressure cuff must meet the following specifications (as outlined in the Statement of Work): it should have a palpable radial pulse, the ability to add an auscultatory gap, adjustable systolic and diastolic parameters, and the capability to be accurately calibrated.

Effective Date: 03/15/2023 Revision: 02