JA_Sole Source Purchase Order_W81K0424P0018_26 Sep 20241.pdf

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Notice of Intent to Sole Source - Reference Laboratory Testing Services
Solicitation number
24-HRCO-379
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This document is a Justification Review Document for a Sole Source, Purchase Order for Clinical Reference Laboratory Testing Services. The authority for this sole source is 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.106-1(b)(2). The total amount is unknown. Laboratory Corporation of America is the only contractor capable of meeting the requirement within the allotted timeframe and possesses the necessary Risk Management Framework Authorization to Operate. A Notice of Intent was posted on SAM with a response deadline of September 27, 2024, but no interested sources have responded. This is a new requirement in support of the patient care mission for U.S. Air Force Medical Treatment Facilities. The reference laboratory must provide comprehensive support across multiple clinical and anatomic pathology disciplines. The incumbent contractor is Laboratory Corporation of America under Contract W81K0412D0017, which was awarded on a competitive basis and expires on September 30, 2018. The agency involved is the Department of the Army Medical Command.

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CUI//SP-SSEL

1 AUG 2022

CUI//SP-SSEL

Control Number:

Justification Review Document for Sole Source, Purchase Order

Program/Equipment: Clinical Reference Laboratory Testing Services

Authority: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.106-1(b)(2)

Amount: $

Prepared by:

Typed Name: Phone: 210-274-8614

Title:

Contracting Officer:

Typed Name: Kirk Heyen Phone: 210-295-4600

E-Mail: kirk.e.heyen.civ@health.mil Date: 26 SEP 2024

Technical Representative:

Typed Name:

Requirements Representative:

Typed Name:

Controlled by: HRCO/ASB Controlled by: HRCO CUI Category: SSEL Limited Dissemination Control: FEDCON POC: Kirk Heyen kirk.e.heyen.civ@health.mil

CUI/SP-SSEL

Current DoD approved mechanisms for approval and/or ATO are via DoD Instruction (DoDI) 8582 and 8510 (e.g., Risk Management Framework (RMF)). Currently there is only one contractor capable of meeting this requirement within the timeframe allotted and possesses an RMF ATO. Laboratory Corporation of America, is the only logical and responsible contractor in place and currently doing this work with the same customers requiring these services. It is essential that clinical reference laboratory testing services continue without disruption and any source other than Laboratory Corporation of America, would cause unacceptable delay that would negatively impact the mission of the MHS and patient care.

6. Efforts to Obtain Competition: A sole source contract with Laboratory Corporation of America, is necessary to ensure that there is no break in service for the Reference Laboratory Testing Services. A Notice of Intent was posted on SAM on 26 September 2024 and will close on 27 September 2024. Currently, no interested sources.

a. Effective competition. Due to the timelines involved to find a replacement, only Laboratory Corporation of America, was deemed capable of fulfilling the specific needs of the government – especially since they have been performing this work since 01 Apr 2021 and already have employees already familiar with this requirement.

b. Subcontracting competition. Laboratory Corporation of America is a large business concern and has a commercial subcontracting in place.

7. Actions to Increase Competition: There are no practical alternatives available to increase competition for this requirement.

8. Market Research: Market research was conducted IAW FAR Part 10 on 26 September 2024 for this effort.

9. Interested Sources: To date, no other sources have expressed an interest in the purchase order in writing or otherwise. Any proposals received shall be considered.

10. Other Facts: None

a. Procurement history.

i. Contract numbers and dates of all awarded contracts for these same requirements.

DADA109800001, Smith-Kline Beecham, 30 September 2002 - 31 March 2003.

DADA1003D0030, Quest Diagnostics, 1 April 2003-31 March 2005. This was an interim contract awarded to Quest Diagnostics, Inc. in order to complete the competitive acquisition that would follow.

CUI/SP-SSEL

W81K0405DM001, Quest Diagnostics, 1 April 2005 – 31 March 2006. This was a letter contract awarded to the incumbent in order to complete the competitive acquisition that would follow.

W81K0406D0001, Quest Diagnostics, 1 April 2006 – 30 September 2010. This was a competitive follow-on contract.

W81K040D0011, Quest Diagnostics, 1 October 2010 – 30 March 2012. This was an interim contract awarded to the incumbent in order to complete the completive acquisition that would follow.

W81K0411D0007, Quest Diagnostics, this was a competitive follow-on contract, awarded on 22 April 2011, that was protested on 5 May 2011 by LabCorp and subsequently terminated as describe below.

W81K0412D0013, Quest Diagnostics, 1 April 2012 - 31 March 2013. This was an interim contract awarded to Quest to prevent a break in service. The Center for Health Care Contracting (CHCC) (now HRCO) conducted corrective action following the LabCorp protest, terminated contract W81K04-11-D-0007 on 1 June 2012, and awarded the follow-on contract, W81K04-12-D- 0017, to LabCorp. On 12 June 2012, Quest protested to the Government Accountability Office (GAO), the award to LabCorp arguing that the evaluation of their Technical Capability was unreasonable, reevaluation was unreasonable, unequal discussions, and requested a stay. HRCO agreed to conduct corrective action, thus rendering the Quest protest academic. HRCO conducted corrective action and again notified Quest on 12 September 2012 that LabCorp was the successful offeror and confirmed the award of contract number W81K04-12-D-0017. Quest again protested to the GAO on 25 September 2012 and requested a stay. GAO denied the Quest protest on 19 December 2012. Quest promptly appealed to the United States Court of Federal Claims (COFC) on 26 December 2012.

W81K0413D0029, Quest Diagnostics, 1 April 2013- 30 September 2013. This was an interim contract awarded to Quest Diagnostics to prevent a break in service while awaiting a decision from COFC. Following resolution of the final protest, the stay was lifted and contractW81K04- 12-D-0017 remained in place.

W81K0412D0017, Laboratory Corporation of America, 1 October 2013 - 30 September 2018 (Included a 6-month transition period from 1 April 2013 to 30 September 2013).

ii. The competitive status of these actions.

Contract DADA109800001 was solicited on a full and open competition basis and awarded to Smith-Kline Beecham, Inc. (now Quest Diagnostics, Inc.). Interim contract DADA10-03-0-0030 was awarded on a sole-source basis to Quest Diagnostics, Inc. Contract W81K04-05-D- M001 was awarded as a letter contract to Quest Diagnostics, Inc. in order to complete the competitive acquisition that would follow. Contract W81K04-06-D-0001 was solicited on a full and open competition basis and awarded to Quest Diagnostics, Inc. Contract W81K04-10-D-0011 was awarded as an interim contract on a sole source basis in order to complete the competitive follow-on action. Contract W81K04-11-D-0007, which was solicited on a full and open

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