P03 - Exception to Fair Opportunity - 36C259-25-AP-2277 - Pyxis System_Redacted.pdf

Request for Exception to Fair Opportunity Memo

Effective Date: 03/15/2023 Page 1 of 3 Revision: 02 Acquisition ID#: 36C259-25-AP-2277

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval

For

Exception to Fair Opportunity Memo

Acquisition Plan Action ID: 36C259-25-AP-2277

PR IFCAP: 660-25-2-984-0026

JOFOC Tracking: FY25 – NCO 19 - 2134

1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 19, located at 6162 South Willow Drive, Greenwood Village, CO, 80111

Organizational Activity: Department of Veterans Affairs, George E. Wahlen VA Medical Center (VAMC), 500 Foothill Blvd, Salt Lake City, UT 84148

2) Description of Action: The proposed brand name requirement is for a Pyxis Automated Medication Dispenser System as follows:

a) 1 Medical Enterprise Server-based System, Model 1B Medstation Tower (MESRS-1B

MEDSTATION ES TOWER,1HH,1FH P/N 352-1)

b) 1 Pyxis Enterprise Server Refrigerator, 13 cubic foot model (Pyxis ES Refrigerator 13 CF, RHG-

15 P/N RHG-15)

3) Description of Supplies or Services: The proposed action is to purchase an additional Pyxis machine system which stores medications for patient use. These machines are intended to increase medication security by restricting access of medications to only authorized users. In addition, these machines also automatically record both anyone who accesses a medication as well as for whom that medication was dispensed. This reduces the risk of drug loss due to diversion (defined as medication that is illegally taken or redirected from its intended and legal purpose).

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.

( ) 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.

Effective Date: 03/15/2023 Page 2 of 3 Revision: 02 Acquisition ID#: 36C259-25-AP-2277

( ) 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: This is a brand name justification in support of FAR 11.105, Items Peculiar to One Manufacturer. The brand name Pyxis Automated Medication Dispenser System is required so that this additional system will work in conjunction with the other Pyxis systems already in use and will not require any changes to existing systems or procedures that could otherwise cause confusion in processes and procedures leading to unacceptable risk to patients.

No other brand name dispenser systems will be interoperable or compatible with the currently fielded Pyxis systems.

6) Efforts to Obtain Competition: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government’s requirements. Competition will be limited to authorized distributors of Pyxis products.

In accordance with FAR 16.505(a)(4)(iii), this justification will be posted on the NASA SEWP website with the solicitation.

7) Actions to Increase 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.

8) Market Research: The Government’s technical experts conducted market research by reviewing other similar products. 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 that are required for their existing Pyxis systems. Additionally, the Pyxis manufacturer (Carefusion) provided documentation showing that although they have authorized distributors, they are the sole manufacturer of Pyxis products. Based on all of these market research efforts, the Government’s technical experts have determined that only Pyxis systems can meet all of VA’s needs.

9) Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Date

Pharmacy ADPAC Program Manager George E. Wahlen VAMC

Effective Date: 03/15/2023 Page 3 of 3 Revision: 02 Acquisition ID#: 36C259-25-AP-2277

11. Determination that Anticipated Cost is Fair and Reasonable: A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable shall be determined through competition, comparison of proposed prices to prices found reasonable on previous similar purchases, and/or current price listings in the NASA SEWP catalogs.

12. Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Joseph B. Wurmstein Date Contracting Officer

NCO 19