JA _Redacted.pdf

Control # 21-RHCO-C-299

(25 February 2016)

Sole Source Justification and Approval Review Document Under FAR 13.501*

(*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: SUPPLY

Authority: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Amount: $3,259,200.00

Prepared by:

Contracting Officer:

Technical Representative:

Requirements Representative:

Reviews

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

Legal Counsel Typed Name:

Signature: _ Date: ______________________

Command Advocate for Competition Typed Name: Phone#: ______________________

Signature: __ _______ Date: ______________________

(See FAR 2.101 and 3.104-4)

Automated Core Laboratory

(See FAR 2.101 and 3.104-4)

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Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity:

Darnall Army Medical Center (CRDAMC), Fort Hood, TX 76544

2. Description of Action: Carl R. Darnall Army Community Medical Center (CRDAMC) requests a base plus one (1) option year firm-fixed-price, bridge contract with Abbott Laboratories, to allow sufficient time to process the follow-on contract. This action will be accomplished through the use of a firm-fixed-priced bridge contract with Defense Health Program (DHP) funds.

3. Description of Supplies/Services: This requirement is for an Automated Core Laboratory for Carl R. Darnall Army Medical Center (CRDAMC), Fort Hood, Texas 76544. The contract includes a fully automated laboratory (Automated Processing System), the necessary equipment/analyzers, providing the required reagents, and maintenance for contractor owned and one (1) twelve-month option through 30 September 2023.

Base Period: 01 October 2021 to 30 September 2022 Value: $1,629,600.00 Option Period 1: 01 October 2022 to 30 September 2023 Value: $1,629,600.00

Total: $3,259,200.00

The base year and the option are Subject to Availability of Funds.

4. Authority Cited: 41 United States Code 1901 as implemented in 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:

(a). Due to COVID-19 vendors were not allowed to be in the facility to conduct a site visit prior to the solicitation process. Due to COVID-19, construction was not allowed to occur in the Lab because of the high demand of tests that needed to be run. CRDAMC's Facility Department was not able to allow any construction in the Lab to change the layout of the Lab to match the awardee's automation track. A sole source bridge is necessary for the interim until the new laboratory configuration is complete and ready to be competed full and open.

The current Core Laboratory utilizes a computerized track system, which comprises nine (9) components; this includes analyzers, centrifuges, decapper, storage unit, and an instrument

(See FAR 2.101 and 3.104-4)

Page 3 of 7 (25 February 2016) management system. This system performs all the testing for CRDAMC, which includes over 36,000 tests per month or over one million tests a year. CRDAMC supports more than 42,000 active duty personnel and more than 145,000 family members and retirees. A break in service would result in completely shutting down the Core Laboratory, effective 01 October 2021;

conducting no tests mission failure will occur. Without a Core Laboratory there would be a negative impact on the Military Treatment Facility (MTF); because all testing would need to be sent out on the network.

Twenty-four (24) months will allow sufficient time for a competitive solicitation, award, and installation.

(b). The alternative to approving the base plus one (1) option year bridge contract would be outsourcing 36,000 tests per month. This alternative would not be an efficient alternative due to the delay in receiving test results and would be very expensive.

(c). This base plus one (1) option year bridge contract with the incumbent is the only feasible method to avoid an interruption is services because COVID-19 restrictions prevent another contractor from entering the MTF to design a Core Laboratory layout and perform the construction necessary to establish a Core Laboratory layout for its equipment to perform the needed services by the 1 October 2021 due date. There would be an unacceptable lapse of service between 01 October 2021 and the time that it would take a new contactor to be selected and the completion of the Core Laboratory. It would not be cost effective or realistic to expect another contractor to perform during the interim period.

6. Efforts to Obtain Competition: The follow-on award will be competed for maximum competition.

7. Actions to Increase Competition: It is not possible to compete this proposed acquisition in time for the Core Laboratory to be operational and to commence on 01 October 2021. However, the follow-on requirement will be a competitive award.

8. Market Research: Sources Sought was posted on 2 March 2021 for seven (7) days onto Beta.Sam.gov. Received a three (3) response to the sources sought. Several vendors are available and capable of providing the required Core Laboratory. No vendor, other than the current contractor, would be able to be fully operational on 01 October 2021, due to the length of set-up time after the award which includes; designing and installing the Core Laboratory, Facilities Department to prepare the Laboratory with properly place electrical outlets, source of water, a water drains, and other modifications, calibrate and validate the equipment, and the time required for IT. A break in Service is will have a negative impact on the Military Treatment Facility

(MTF).

9. Interested Sources: Due to the negative impact on the MTF, meeting the requirement of a fully operational Automated Core Laboratory on 01 October 2021, and in the best interest of the

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Government; the only acceptable vendor is the current vendor Abbott Laboratories, they are currently successfully providing services at CRDAMC, use of any other vendor would incur a lengthy break in service.

10. Other Facts:

a. Procurement history

W81K00-19-D-0006:

(2). Competitive Status of these actions: Sole Source (Bridge Contract)

(3). Authority previously cite if less than full and open competition was used:

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

(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. It is not possible to compete this proposed acquisition in time for the Core Laboratory to be operational and to commence on 01 October 2019. There would not be sufficient time for the vendor to complete the required steps in order for the Automated Core Laboratory to be operational on 01 October 2019. Once the award is made, the Awardee will need to specially design an Automated Core Laboratory that meets the specific contractual required equipment and dimensions of the CRDAMC laboratory. After the awardee designs the Core Laboratory, the design will be provided to the Facility Department. A separate construction contract will need to be procured to modify, countertops, water supply, water drains, and s plan / Core Laboratory layout. In addition to the construction, there is Information Management; Risk Management Framework (RMF), and other Information Technology (IT) compatibility issues.

While planning for the follow-on contract, the Government's requirement changed due to additional analyzers and new equipment being incorporated into the Automated Core Laboratory configuration. The new laboratory configuration will enhance the capabilities of the laboratory.

However, by revising the Government's requirement for a new laboratory configuration, the milestones on the acquisition strategy required re-adjustment and movement to the right. Due to these significant requirement changes, the follow-on contract has been delayed to incorporate a new lab configuration. Additionally, new market research was necessary to obtain additional data such as number of tests that will conducted annually for the new analyzer and the associated pricing. The changes to the follow-on requirement necessitate the continuation of current laboratory services in the current configuration. Because laboratory services need uninterrupted

Page 5 of 7 (25 February 2016) services and the current contractor can meet the Government's current contract without needing to obtain an IT certifications, a sole source bridge is necessary for the interim until the new laboratory configuration is complete and ready to competed full and open.

(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. Due to time required by a new awardee to set-up and be fully operational a bridge contract to Abbott Laboratories, is necessary.

(6). An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. N/A.

(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. N/A.

b. Other facts. N/A.

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.

S 30 March 2021

T

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.

Signatu 30 March 2021

Typed

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. Fair and reasonable pricing will be determined by using price analysis and the Independent Government Estimate. As part of the basis certified cost or pricing date is not required per FAR 15.403-1(b)(3).

Signature: ___ _Date: ________________________________

(See FAR 2.101 and 3.104-4)

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Typed Name: Title: Contracting Officer

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature: __ __Date: ________________________________

Typed Name: Title: Contracting Officer

(See FAR 2.101 and 3.104-4)

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Approval Based on the foregoing justification, I hereby approve a bridge contract for the procurement of an Automated Core Laboratory for CRDAMC, with a total dollar value of $3,259,200.00 on an other than full and open competition basis, pursuant to the authority of 41 U.S.C. 1901 as implemented by 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: ______Date: ________________________________

Typed Name: Title: Command Advocate for Competition.