JA for FAR 13.5_Abbott Follow-On_Bridge_Redacted.pdf

Control No: 21-RHCO-C-098 Chemistry/Immunoassay Testing Abbott Laboratories

Version September 2018 FOR OFFICIAL USE ONLY

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS-SOLE SOURCE JUSTIFICATION AND

APPROVAL

Program/Equipment: Bridge contract with Abbott Laboratories for Chemistry and Immunoassay testing and analysis for the Department of Pathology and Area Laboratory Services (DPALS) at William Beaumont Army Medical Center, Soldier Family Medical Clinic and Mendoza Medical Clinic, El Paso, Texas

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Amount:

Prepared by:

Contracting Officer:

Technical:

Requirements:

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FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items Sole Source Justification and Approval

1. Contracting Activity: Regional Health Contracting Office-Central

2. Description of Action: The Regional Health Contracting Office Central requests approval for a new firm-fixed-price contract with Abbott Laboratories for Chemistry and Immunoassay testing, analysis to allow for the decommissioning of the hospital for the Department of Pathology and Area Laboratory Services (DPALS), William Beaumont Army Medical Center, El Paso, Texas. The period of performance is 1 October 2020 to 31 March 2021, utilizing fiscal year 2021, DHP Operations and Maintenance funds.

X An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B

3. Description of Supplies/Services: William Beaumont Army Medical Center (WBAMC) requires chemistry and immunoassay laboratory testing services, which includes four leased analyzers, maintenance services, and reagents under a Cost per Test (CPT) arrangement.

a. The Contractor shall provide Chemistry/Immunoassay reagents on a cost-per-test arrangement. These supplies are necessary to provide patient testing for the Department of Pathology and Area Laboratory Services (DPALS), William Beaumont Army Medical Center, El Paso, TX.

b. WBAMC Main Hospital requires (1) one modular, continuous, customizable laboratory track line to include (2) two chemistry analyzers, (2) immunoassay analyzers along with (2) two centrifuges, (1) one capper, (1) one decapper, (1) one resealer, (1) one recapper, (1) one refrigerated storage/retrieval unit, (1) input/output module with STAT priority capabilities, (1) one deionized water unit, and middleware.

SFCC and SFMC require a (1) one integrated chemistry/immunoassay analyzer at each site.

Delivery Period: 1 October 2020 to 31 March 2021. Total Value:

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5:

X Other: Federal Acquisition Regulation 13.501(a) (1) (ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: During the relocation/decommissioning of current William Beaumont Army Medical Center facility, the Department of Pathology and Area Laboratory Services (DPALS) requires the ability to continue chemistry and

Version September 2018 FOR OFFICIAL USE ONLY immunoassay laboratory testing services. The required testing services cannot be turned off until the current hospital is decommissioned, which has been postponed from 1 September 2020 until 1 April 2021. RHCO-C has awarded a competitive long term contract (W81K00-20-C-0006) to Roche Diagnostics Corporation to provide these services in support of the opening of the new facility. The solicitation was competed to afford interested vendors the opportunity to compete for the requirement at the new hospital. However, due the delay in transitioning to the new location until April 2021, a bridge contract will need to be executed in order to continue the vital patient services at the current location. Abbott Laboratories is the current contractor providing services at the active facility and has the capability to provide a continuation of these critical services with the existing analyzers without a break in service. There is a short time frame between the decommissioning of the current hospital and the commissioning of the new hospital (approx. six months). Also, there is a 30 to 60 day validation correlation process, which is necessary to deliver, install, validate and correlate the system prior to it becoming fully operational. Additionally, with the DHA RMF requirement, if the vendor does not have a current ATO, the timeframe needed to establish services is substantially longer. Due to the immediate need for these services, it is not feasible to solicit a contract with any other source other than Abbott without there being a lapse in services.

.Award to another vendor would result in a significant delay in providing the critical patient testing/diagnosis because of the amount of time that would be required for the delivery, installation, validation/ correlation studies and training for staff on new instrumentation on at least six instruments (depending on the platform). In order to provide Chemistry and Immunoassay testing, comprised of 110 laboratory tests, it is critical to the Department of Defense mission to provide access to care. Abbott Laboratories is the only company that possesses the unique ability to instantly meet this requirement because they own the in-house required chemistry and immunoassay analyzers currently in use.

6. Efforts to Obtain Competition: The Contracting Officer published the Notice of Intent to award a Sole Source contract on beta.SAM.gov on 1 September 2020 to 6 September 2020, as required by FAR 5.201. No responses were received

Subcontracting competition. In accordance with FAR Subpart 19.705-2, the Contracting Officer has taken actions to determine whether the proposed contractual obligation requires a sub-contracting plan. According to FAR Part 19.702(a)(1)-Statutory Requirement, the incumbent contractor is required to have a subcontracting plan in place. Reagents/Consumables-Various Viral Assays are customarily available in the commercial market place. Historically, and to date, these companies do not provide subcontracting opportunities for these types of items. Therefore, a D&F for Lack of Subcontracting Opportunities will be executed prior to proceeding with the solicitation.

7. Actions to Increase Competition: RHCO-C has awarded a competitive long term contract (W81K00-20-C-0006) to Roche Diagnostics Corporation to provide these services in support of the opening of the new facility. The solicitation was competed to afford interested vendors the opportunity to compete for the requirement at the new hospital. However, due the delay in transitioning to the new location until April 2021, a bridge contract will need to be executed in order to continue the vital patient services at the current location.

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8. Market Research: Based on market research, there are other vendors capable of providing chemistry and immunoassay testing. However, due to the immediate need for the required services and the short period of performance, the contracting officer has determined that limiting competition is in the best interest of the Government.

9. Interested Sources: Three vendors (Abbott Laboratories, Beckman Coulter and Roche Diagnostics responded to solicitation, W81K00-20-R-0002, for similar support that was issued 24 March 2020, and was ultimately awarded to Roche Diagnostics Corporation on 15 July 2020.

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. W81K00-20-P-0097.

(2) The competitive status of these actions. Sole Source.

(3) Authority previously cited if less than full and open competition was used. 41 U.S.C. 1901 (or 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5

(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. RHCO-C executed a competitive long term requirement support of the new facility. The solicitation afforded interested vendors the opportunity to compete for the requirement at the new hospital.

(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. During the relocation/ decommissioning of current William Beaumont Army Medical Center facility, the Department of Pathology and Area Laboratory Services (DPALS) required the ability to continue chemistry and immunoassay laboratory testing services. The required testing services could not be terminated until the current hospital is decommissioned.

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b. Class J&A: This Class J&A will cover all future actions for these items/services (as appropriate). Each action will be supported by a memorandum for record stating the action is within the scope of the class J&A in each contract file. 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.

Typed Name: Date: 15 SEP 20 Title: Signature:

9/15/2020

X

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.

Typed Name: Date: 15 SEP 20 Title: Signature:

9/15/2020

X

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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.

Signature:

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

Date:

Title: Contracting Officer Signature:

Version September 2018 FOR OFFICIAL USE ONLY

Approval

Based on the foregoing justification, I hereby approve the procurement of a new contract with Abbott Laboratories for Chemistry and Immunoassay testing and analysis for the Department of Pathology and Area Laboratory Services (DPALS), William Beaumont Army Medical Center, El Paso, Texas for the estimated amount of on a sole source basis pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.501, subject to availability of FY21 funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Signature: