Brand_Name_or_Equal_JA_Medicine_Cabinet_Redacted.pdf

Control No: 19-RHCO-C-552

Program/Equipment: Automated Medication Dispensers

Version – September 2018 FOR OFFICIAL USE ONLY

FAR PART 13.501 BRAND NAME OR EQUAL JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Program/Equipment: San Antonio Military Medical Center (SAMMC), Department of Pharmacy, Joint Base San Antonio-Ft Sam Houston, Texas/Automated Medication Dispensing cabinets

Authority: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 13.501(a) -- Sole source (including brand name) acquisitions.

Amount: $ .

Prepared by:

Contracting Officer:

Technical:

Requirements:

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

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FAR Part 13.501 Brand Name or Equal Justification and Approval for Other than

Full and Open Competition

1. Contracting Activity: Regional Health Contracting Office-Central

2. Description of Action: San Antonio Military Medical Center (SAMMC), Department of Pharmacy, Joint Base San Antonio-Ft Sam Houston, Texas requests a new firm-fixed-price contract for the Pyxis Anesthesia 3500 and Medstation 3500 medication cabinets or an equivalent product. The Government projects award for 30 August 2019 and utilizing fiscal year 2019, procurement funds.

3. Description of Supplies/Services: The requirement is for the procurement of the Pyxis Anesthesia 3500 and Medstation 3500 medication cabinets or an equal product, which are used to securely store, dispense and safely administer patient-specific “on demand” (i.e. crash cart) medications at the point of use within the clinics and wards.

Estimated Delivery date: 15 September 2019 Total Value: $

4. Authority Cited: 10 U.S.C. 2304(c)(1), as implemented by FAR Part 13.501(a) -- Sole source (including brand name) acquisitions.

5. Reason for Authority Cited: The Pyxis Anesthesia system has already been risk management framework (RMF)/Authority to Operate (ATO) accredited and approved by the Defense Health Agency. The RMF approval process typically takes approximately a year to accomplish. The current medication dispensing system reached its life expectancy 31 December 2018. The system now requires constant maintenance, which ultimately delays and disrupts patient care. Additionally, DHA is standardizing the maintenance and support contracts to utilize the BD CareFusion Pyxis ES platform or an equivalent across the military treatment facilities and DoD hospitals in efforts to minimize implementation costs and time.

(a) In accordance with section 888(a) of the National Defense Authorization Act for Fiscal Year 2017 (Pub. L. 114-328), the justification and approval addressed in FAR 13.501(a) is required in order to use brand name or equal descriptions or proprietary specifications and standards (DFARS 213.501(a)(ii).

Connection to the Military Health System (MHS) Application Access Gateway (MAAG) allows site access without a server. The Business-to-Business (B2B) connectivity is managed by the Defense Health Agency (DHA) Pharmacy Operation Division (POD). BD has already established connectivity with the MAAG, which is a component of the existing ATO that supports the MAAG servers. Because the DHA POD manages these functions of the point of use cabinets in their portfolio for the Navy and Air Force (ALL cabinets for these services are Pyxis ES), there are huge cost/configuration/implementation savings if the Army aligns with Pyxis. All Army sites will need to consolidate servers along with the maintenance and support contracts into the DHA POD efforts.

Version – September 2018 FOR OFFICIAL USE ONLY

There are other vendors who provide automated medication dispensing cabinets.

Each vendor has unique specifications that are attributed to their brand name product, therefore, it is necessary to solicit as brand name or equal. The Pharmacy Inpatient Automation Solution (PIAS) effort required a lead time of approximately 18 months to design, build, and implement regional servers, which included the completion of cybersecurity certification and accreditation (C&A) activities. The PIAS is provided through the Pyxis ES platform from BD.

The existing system reached EOL 31 December 2018. The new requirement is for delivery of the system. Due the age of the system, it requires constant maintenance, which creates delays and disruption to patient care, putting the hospital at great risk due to the out-of-date cabinet infrastructure.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered.

a. Effective Competition: If there are vendors who can meet the brand name or equal requirements, their proposals will be considered.

b. Subcontracting Competition: Subcontracting competition will be achieved by requiring the vendor to submit a subcontracting plan in accordance with 52.219-9 and that has been previously approved by a government contracting officer

7. Actions to Increase Competition: The Government will continue to monitor the marketplace for any new entrants who can comply with the requisite configurations that are compliant with the DHA infrastructure and keep abreast of DHA guidelines for any changes so that the maximum amount of vendors may be considered.

8. Market Research: Market research was conducted. The SBA’s Dynamic Small Business Search (DSBS) was reviewed to identify small business vendors and determine potential set-asides or subcontracting possibilities to provide automated medication dispensing cabinets. The results revealed zero vendors identified.

(Reference PCF files Market Research DSBS, Ability One, GSA eLibrary).

In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a request for information or sources notification was posted to Federal Business Opportunities (FBO) on 11 July 2019 for five days. BD was the only company who submitted a response to the Sources Sought notification. However, Omnicell submitted questions in response to the Solicitation, W81K0019Q0209. Based on these questions about the salient characteristics of the equipment, the contracting officer has determined that it is best to change the strategy from a “full and open” requirement to a “brand name or equal”.

9. Interested Sources: Solicitation W81K00-19-Q-0209 was posted on FBO on 17 July 2019 with a closing date of 31 July 2019. The due date for questions was 24 July 2019.

Questions were received from BD and Omnicell. The solicitation was amended to extend the due date for responses until 21 August 2019. A further extension is projected to revise the solicitation to incorporate the applicable brand name or equal language and to

Version – September 2018 FOR OFFICIAL USE ONLY allow adequate time for vendors to respond. Based on Omnicell’s questions, discussions with the customer and contracting officer, the contracting officer made the decision to change the strategy to a Brand Name or Equal requirement.

10. Other Facts: Discuss any other facts supporting the use of other than full and open competition, such as the following:

a. Procurement History:

(1) Contract numbers and dates of the last several contracts for these same requirements. This is a new requirement for RHCO-C. Some of the existing equipment was purchased by DLA under contract SPM2D1-12-D-8302 as a full and open requirement in the amount of $295,219.00. There is no information available regarding the remainder of the equipment.

(2) The competitive status of these actions. Not applicable.

(3) Authority previously cited if less than full and open competition was used. Not applicable.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. Not applicable.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. Not applicable.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. Not applicable.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. Not applicable

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11. Technical Certification: I certify 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.

12. Requirements Certification: I certify 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.

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13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: ☐ cost analysis ☐ price analysis

☐ should cost ☒ IGCE ☐ audit: ☐ other

As a part of this basis, certified cost or pricing data:

☐ will be required.

☒ will not be required and the following exception applies (FAR 15.403):

☐ Prices that will be agreed upon are based on adequate price competition.

☐ Prices that will be agreed upon are based on prices set by law or regulation.

☒ A commercial item is being acquired.

☐ A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

☐ The contract action is a modification to a contract or subcontract for commercial item(s).

☐ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

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Approval

Based on the foregoing justification, I hereby approve the procurement of Pyxis Anesthesia 3500 and Medstation 3500 medication cabinets or an equivalent product for the estimated amount of $2,638,044.00 on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 1901(a)(1)(ii), Competition Requirements and provided that the services or property herein described have otherwise been authorized for acquisition.