Redacted Justification FAR Part 13.pdf

CUI//SP-PROCURE//FEDCON

Control Number: 26-HRCO-34

JUNE 2025

JUSTIFICATION REVIEW DOCUMENT

FAR Part.102 Justification and Approval for Restricting Competition

Program/Equipment: This requirement is for Newborn Screening Services at Fort Bragg, NC, Womack Army Medical Center (WAMC) for the Department of Pediatrics.

Authority: 10 U.S.C. § 3204(a)(1) as implemented by Federal Acquisition Regulation (FAR) 6.103-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

Amount: $1.66M (This includes the base year and four option years)

Prepared by: Frank A. Fogg Phone: 910-907-7290

Contract Specialist Date: 7 January 2026 E-mail: frank.a.fogg.civ@health.mil

Contracting Officer: Anush Collins Phone: 210-221-3235

Contracting Officer Date: 7January 2026 E-mail: anush.m.collins.civ@army.mil

Technical: Kimberly Coleman Phone: 910-907-8858

Contracting Office Representative Date: 7 January 2026 E-mail: kimberly.d.coleman.civ@health.mil

Requirements: Kimberly Coleman Phone: 910-907-8858

Contracting Office Representative Date: 7 January 2026 E-mail: kimberly.d.coleman.civ@health.mil

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

Legal Counsel:

Jesse T. Greene Phone: (785) 240-7653 Attorney-Advisor (Contract and Fiscal Law) Email:jesse.t.greene.civ@health.mil

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Digitally signed by

GREENE.JESSE.TRAVIS.10369

06940 Date: 2026.03.13 08:42:00 -05'00'

JUNE 2025

FAR Part 12.102 Justification and Approval for Restricting Competition

1. Requiring Activity: Womack Army Medical Center, Fort Bragg, NC.

2. Contracting Activity: Bragg Services Branch (BSB), Health Regional Contracting Office (HRCO), United States Army Health Contracting Activity (USAHCA)

3. Description of Action: WAMC, Department of Pediatrics requests approval for a new Firm-Fixed Price (FFP) contract for non-personal services for Newborn Screening Testing. Operation and Maintenance (O&M) Appropriations funds will be used to fund the resultant contract.

4. Description of Supplies/Services: This requirement is for the procurement of services mandated by North Carolina State Statute. The proposed contract will have a base period of performance from 1 April 2026, through 31 March 2031, with four 12-month option periods. The estimated total contract value is $1,655,280.00, including all option periods. This is a service requirement, and as such, FAR 52.217-8, "Option to Extend Services," will be included in the contract.

Item Quantity Delivery Date

Estimated Unit Price

Estimated Value

NC State Newborn Screening

2,280 1 April 2026 $132.00 $300,960.00

Period Period of Performance (POP) Estimated Value Base 1 April 2026 through 31 March 2027 $300,960.00

Option 1 1 April 2027 through 31 March 2028 $300,960.00 Option 2 1 April 2028 through 31 March 2029 $300,960.00 Option 3 1 April 2029 through 31 March 2030 $300,960.00 Option 4 1 April 2030 through 31 March 2031 $300,960.00

Estimated Total Price $1,504,800.00 FAR 52.217-8 1 April 2031 through 30 September 2031 $150,480.00

Estimated Overall Total Price $1.66M

5. Authority Cited: 10 U.S.C. § 3204(a)(1) as implemented by Federal Acquisition Regulation (FAR) 6.103-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

6. Reason for Authority Cited: The Newborn Screening Program in North Carolina is established in accordance with General Statute, G.S. 130A-125. Per 10A NCAC 42B.0102, all attending physicians shall collect specimens for each newborn in North Carolina and submit those specimens to the North Carolina Department of Health and

JUNE 2025

Human Services (NCDHHS). As a result of this state statute, NCDHHS is the only source capable of providing the services required by WAMC. An email from the NCDHHS Laboratory Director, received on 3 December 2025, confirmed they are the sole authorized newborn screening laboratory in the state.

7. Efforts to Obtain Competition: A sources sought synopsis was posted to SAM.gov on 29 January 2026, and no responses were received. In accordance with North Carolina State Statute, only NCDHHS is authorized to perform these services.

Therefore, no effective competition is available for this requirement.

8. Actions to Increase Competition: At this time, it is not possible to compete this acquisition due to state law mandating a single provider.

9. Market Research: Market research was conducted in accordance with FAR Part 10.

Internet searches and a review of North Carolina state law confirm that NCDHHS is the only laboratory authorized to provide the required services to the Department of Pediatrics at WAMC. A search on the Small Business Administration's Dynamic Small Business Search was performed using NAICS code 621511 (Medical Laboratories) and the keyword “Newborn Screening” with no results. A search on GSA eLibrary performed on 17 February 2026 also found no businesses capable of meeting the requirement.

10. Interested Sources: To date, no sources have expressed interest in writing or otherwise, in response to the synopsis published on SAM.gov.

11. Other Facts: During market research NCDHHS provided a sole source email stating they are the sole source provider of the laboratory program and testing, as authorized by NC State Statute.

a. Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements.

Contract Action Number

Contractor Procurement Method

Amount (est.) Period of Performance

W91YTZ22P0024 HEALTH &

HUMAN

SERVICES

, NORTH

CAROLINA

Sole Source $902,880.00 1 April 2022-31 March 2026

(2) This prior action was a sole-source award to NCDHHS, as the same state statute was in effect, making them the only authorized provider.

JUNE 2025

b. Other facts: A Performance Work Statement (PWS) will be posted with the solicitation. It is anticipated that NCDHHS will be the only entity that can perform the required service in accordance with North Carolina State Statute.

(3) Authority previously cited if less than full and open competition was used. The previous authority used in the current contract’s J&A is FAR 13.50113.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items

(4) The contracting officer initially intended to use full and open competition to select a source for the prior contract however, while conducting market research for this requirement it was discovered that the only authorized newborn screening laboratory in the State per Statute and rule is NCDHHS. An email from the Laboratory Billing Supervisor at NCDHHS received on 3 December 2025 stated they are the only authorized newborn screening laboratory in the state per statute and rules. The Newborn Screening Program in North Carolina was established in accordance with the General Statute, G.S. 130A-125. Per 10A NCAC 42B.0102, all attending physicians shall collect or ensure the collection of specimens for each newborn in North Carolina and submit those specimens to NCDHHS.

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

(6) 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. The previous acquisition had a J&A prepared under the authority of 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. The state of North Carolina’s statue requiring this sole source vendor remains the same.

JUNE 2025

12. 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.

Kimberly D. Coleman Chief, Direct Healthcare Provider Program

13. 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.

Kimberly D. Coleman Chief, Direct Healthcare Provider Program

Fair and Reasonable Cost Determination: I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable. Price reasonableness will be established based on the price analysis conducted prior to the actual award. Pricing submitted will be based on statutory and regulatory rates set by the State of North Carolina for these mandated services, which are applicable to all customers. This price will be compared to the Independent Government Estimate (IGE), and historical pricing of the previous contract for reasonableness. Certified cost or pricing data is not required per FAR 15.403-1(c) because this is a commercial acquisition.

Anush Collins Contracting Officer

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

Anush Collins Contracting Officer

COLLINS.ANUSH.M.

1186173461

Digitally signed by

COLLINS.ANUSH.M.1186173461

Date: 2026.03.12 16:18:31 -05'00'

COLLINS.ANUSH.

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Date: 2026.03.12 16:18:53 -05'00'

COLEMAN.KIMBER

LY.DENISE.111388

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COLEMAN.KIMBERLY.DENISE.

1113888691 Date: 2026.03.13 11:06:47 -04'00'

COLEMAN.KIMBER

LY.DENISE.111388

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COLEMAN.KIMBERLY.DENISE.

1113888691 Date: 2026.03.13 11:06:14 -04'00'

JUNE 2025

Approval

Based on the foregoing justification, I hereby approve the procurement of a Newborn Screening Contract on an other than full and open competition basis pursuant to the authority of 10 U.S.C. § 3204(a)(1) as implemented by FAR 6.103-1. This acquisition will be conducted using the commercial product and commercial service procedures of FAR Part 12. The estimated value of the new contract is $1.66 million for a five-year period of performance (base and four one-year options, including the potential for a six-month extension under FAR 52.217-8) from 1 April 2026 to 30 September 2031. This approval is subject to the availability of funds and provided that the services herein described have otherwise been authorized for this acquisition.

Carolyn D. Tyson Alternate Advocate for Competition (CAFC)