J A Ref Lab Testing Services - Final (Redacted).pdf

CUI//SP-SSEL

(See FAR 2.101 and 3.104-4)

(AUG 2022)

CUI//SP-SSEL

Control Number: 25-HRCO-34

Justification Review Document For Other Than Full and Open Competition

Program/Equipment: Clinical Reference Laboratory Testing services for the U.S.

Army, U.S. Air Force, U.S. Navy, U.S. Coast Guard, and Defense Health Agency (DHA) Medical Treatment Facilities (MTF) worldwide. The Contractor shall provide all required facilities, labor, equipment, materials, software interfaces, transportation, and services necessary for clinical reference laboratory testing.

Authority: 10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii)(B), Only one responsible source and no other supplies or services will satisfy agency requirements.

Amount: $90 Million

Prepared by:

Typed Name: Deyanira C. Narvaez DSN: 471-6057

Title: Contract Specialist Date: _07 Jan 2025

E-mail: deyanira.c.narvaez.civ@health.mil

Typed Name: David D. Robledo DSN: 471-4410

Title: Contracting Officer Review Date: _07 Jan 2025

E-Mail: david.robledo17.civ@health.mil

Controlled by: USAHCA Controlled by: HRCO CUI Category: SSEL Limited Dissemination Control: FEDCON POC: David D. Robledo david.robledo17.civ@health.mil mailto:deyanira.c.narvaez.civ@health.mil mailto:david.robledo17.civ@health.mil mailto:david.robledo17.civ@health.mil

CUI/SP-SSEL

(See FAR 2.101 and 3.104-4)

Clinical Reference Laboratory Testing Services

U.S. Army, U.S. Air Force, U.S. Navy, U.S. Coast Guard, and Defense Health Agency (DHA) Medical Treatment Facilities (MTF) Worldwide.

Technical Representative

Typed Name: Danny R. Deuter DSN: 471-7060

Title: Program Analyst, DHA Health Care Operations, Secondary COR

Date Reviewed: _07 Jan 2025

Requirements Representative

Typed Name: CDR Colleen Cordrick DSN: 471-6040

Title: Director, Center for Laboratory Medicine Services, Defense Health Agency, COR

Date Reviewed: _07 Jan 2025

Reviews

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

Chief of the Contracting Office:

Typed Name: Cornelia Vance DSN: 471-5609

Signature:

Legal Counsel

Typed Name: Jesse T. Greene Phone: 785-240-7654

GREENE.JESSE.TR

Signature: AVIS.1036906940

Digitally signed by

GREENE.JESSE.TRAVIS.1036906940

Date: 2025.01.08 10:04:18 -06'00'

VANCE.CORNELIA.V Digitally signed by VANCE.CORNELIA.VIRGINIA.10160826

IRGINIA.1016082631 31

Date: 2025.01.08 07:28:53 -06'00'

(See FAR 2.101 and 3.104-4)

Command Advocate for Competition

Typed Name: Kerry Alvarenga DSN: 471-5267

Signature:

Senior Contracting Official

Typed Name: COL Michelle Lewis DSN: 471-3298

LEWIS.MICHELLE.A

Signature: NNE.1024441055

LEWIS.MICHELLE.ANNE.1024441055

Date: 2025.01.13 11:55:30 -06'00'

ALVARENGA.KERRY.A Digitally signed by

ALVARENGA.KERRY.ANN-

NN-MARIE.1185865882 MARIE.1185865882 Date: 2025.01.10 06:08:42 -06'00'

(See FAR 2.101 and 3.104-4)

Justification and Approval

For Other Than Full and Open Competition

1. Contracting Activity: U.S. Army Health Contracting Activity (USAHCA), Health Readiness Contracting Office (HRCO), 2199 Storage Street, Building 4197, Suite 68, Joint Base San Antonio (JBSA) Fort Sam Houston, TX 78234-5074.

2. Description of Action: Requests approval of modification to increase the ceiling for W81K04-21-D-0001 for service through 31 December 2025. The firm-fixed-price (FFP), indefinite delivery indefinite quantity (IDIQ) contract was awarded to Laboratory Corporation of America (LabCorp). The increase amount will be funded with Defense Health Program (DHP) funds. Estimated share and ceiling arrangements and fee or profit are not applicable to this acquisition. The current contract period of performance ends 31 December 2025.

3. Description of Supplies/Services:

a. The Government requires clinical reference laboratory testing services to support the patient care mission for U.S. Army, U.S. Air Force, U.S. Navy, U.S. Coast Guard, and Defense Health Agency (DHA) Medical Treatment Facilities (MTFs) in accordance with Army Regulation 40-3 Medical, Dental, and Veterinary Care, Chapter 14 Medical Laboratory Management.

b. Clinical reference laboratory testing includes comprehensive support generally encompassing the American Medical Association's Current Procedural Terminology (CPT). This includes support across multiple clinical and anatomic pathology disciplines to include chemistry, hematology and coagulation, urinalysis, transfusion medicine, microbiology, molecular, histology, cytology, and genetic testing. The current contract provides comprehensive reference laboratory supporting 5,583 unique, individually orderable tests and panels. Request the total contract ceiling value change from $204,639,688.42 to $294,639,688.42, a net increase of $90,000,000.

4. Authority Cited: The statutory authority permitting other than full and open competition is Title 10 United States Code 2304(c)(1) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii)(A) and (B), Only one responsible source and no other supplies or services will satisfy agency requirements.

(See FAR 2.101 and 3.104-4)

5. Reason for Authority Cited:

Clinical reference laboratory services are complex and heavily regulated medical services that directly impact effective medical operations and positive patient outcomes.

The contractor has approximately 5,100 different laboratory tests identified for all DOD medical facilities. All tests are done at the contractor’s premises. The requiring medical activities rely upon the contractor’s test results for quality, accuracy, and comparability across the DOD medical community. This specialized service ensures continuity of care across the DOD. Additional testing required for the COVID 19 pandemic, unforeseen special operations (e.g., Operation Allies Refugees (OAR), Operation Allies Welcome (OAW)), and perfluoroalkyl and polyfluoroalkyl substances (commonly known as PFAS) testing, and the proliferation genetic testing were unanticipated expenses on the current IDIQ contract resulting in the need to increase the IDIQ ceiling. Only one vendor, LabCorp, has the approved software to connect with the government’s MHS Genesis medical system. Any other vendor would not only be required to go through the approval process which can take 6 months to a year for approval, but the use of multiple reference laboratories could inadvertently contribute to misdiagnosis, inappropriate treatment, and a myriad of other negative consequences affecting patient care.

Awarding to any other source other than LabCorp would cause unacceptable delays and increased costs that would negatively impact the mission of the Military Health System and patient care.

6. Efforts to Obtain Competition:

a. Effective competition. Competition for this action is not feasible for the reasons explained above. No other efforts will be made to obtain competition for the current effort. A follow-on competitive IDIQ is currently being worked and is estimated to be awarded in December 2025. LabCorp is the incumbent and the only company that can meet the clinical reference laboratory testing services requirement of providing uninterrupted patient care without causing unacceptable delays in fulfilling the agency’s requirements.

b. Subcontracting competition. An approved commercial subcontracting plan is in place pursuant to FAR Subpart 19.704. The approved commercial plan, submitted by the incumbent contractor, provides maximum practicable opportunities for small business participation.

7. Actions to Increase Competition: It is not possible to compete an interim contract and ensure continued performance prior to the expiration of the current task orders.

(See FAR 2.101 and 3.104-4)

The competitive follow-on contract is currently being worked and will be posted on System for Award Management (SAM.gov) in anticipation of award in December 2025.

8. Market Research: Market research reveals that there are only two contractors capable of doing a requirement of this magnitude. For the reasons listed in paragraph 5 above, Lab Corp, is the only responsible contractor with the management, structure, experience, resources and approved software already in place to continue performing the needed essential clinical reference laboratory testing services through the expiration of the current IDIQ.

9. Interested Sources: N/A

10. Other Facts:

a. Procurement History:

(1) Contract numbers and dates of the last several awards:

• W81K04-21-D-0001, Laboratory Corporation of America, 01

April 2021 – 31 December 2025 (included a 6-month transition period from 01 January 2021 – 31 March 2021).

• W81K04-18-D-0029, Laboratory Corporation of America, 01 October 2018 - 31 March 2021.

(2) Competitive status of these actions:

• Contract W81K04-21-D-0001, which was solicited on a full and open competition basis was awarded to Laboratory Corporation of America.

• Contract W81K04-18-D-0029, was awarded on a sole-source basis to Laboratory Corporation of America to allow time to meet all new Government interface requirements (MHS Genesis), to meet requisite approvals to connect (Authority to Operate) to the Government’s network and information systems and allow time for follow-on award.

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

(See FAR 2.101 and 3.104-4)

DEUTER.DANNY.RI Digitally signed by

DEUTER.DANNY.RICHARD.1085973777

CHARD.1085973777 Date: 2025.01.07 12:45:34 -06'00'

CORDRICK.COLLE Digitally signed by

EN.IRENE.1260838 CORDRICK.COLLEEN.IRENE.12

(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.

b. Other facts: Not Applicable

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.

Signature: Date: _07 Jan 2025

Typed Name: Danny R, Deuter Title: Program Analyst, DHA Health Care Operations, Secondary COR

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: CDR Colleen Cordrick Title: Director, Center for Laboratory Medicine Services, COR

(See FAR 2.101 and 3.104-4)

ROBLEDO.DAV Digitally signed by

ID.1187545990 Date: 2025.01.07 13:19:25 -06'00'

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair reasonable based on the following: (1) There will be no change in unit prices by the incumbent contractor due to increasing the ceiling of the contract and (2) any additional tests added to the price list in the contract will be determined fair and reasonable based on a completed price analysis in accordance with FAR Subpart 15.404-1. Furthermore, it will be supported by an independent government cost estimate and historical data. These services are considered commercial and therefore, certified cost and pricing data will not be required in accordance with the exception at FAR subpart 15.403-1(b)(3).

Typed Name: David D. Robledo Title: Contracting Officer

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

ROBLEDO.DAVID.1187545990

Signature: ID.1187545990 Date: 2025.01.07 13:19:40 -06'00' Date: _07 Jan 2025

Typed Name: David D. Robledo Title: Contracting Officer

ROBLEDO.DAV

(See FAR 2.101 and 3.104-4)

GALLAGHER.DANIEL. Digitally signed by

GALLAGHER.DANIEL.JOSEPH.1034

JOSEPH.1034297360 297360 Date: 2025.01.15 17:02:41 -06'00'

Approval

Based on the foregoing justification, I hereby approve the modification to increase the ceiling for Clinical Reference Laboratory Testing services on an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c) as implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii)(B), Only one responsible source and no other supplies or services will satisfy agency requirements subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: Date: 15 January 2025

Typed Name: Daniel J. Gallagher

Title: Deputy to the Commanding General