Redacted Limiting-Competition-under-SAT Newborn Testing.pdf

CUI//SP-SSEL

Newborn Testing

Control No: 25-MRCO-WEST-269

CUI Version – February 2017

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: Medical Readiness Contracting Office – West (MRCO-W), Fort Hood Healthcare Contracting Branch, (HdHCB), Fort Hood, Texas.

2. Description of Action: The Martin Army Community Hospital (MACH), Fort Benning, GA, has a need for Newborn PKU Metabolic Reference testing. The performance period will be from 1 October 2025 through 30 September 2028, with a base plus two (2) option years. This acquisition is restricted to Georgia Department of Public Health and is a mandatory blood test for newborns.

Nature: ☐ New Requirement ☒ Follow-on Requirement

Contract Vehicle: ☒ Purchase Request Number PR 0012284050

Pricing/Contract Type: ☒ Fixed

Funds: ☒ Other Funds: __DHP_X____ FY: ____FY26___

Name of Proposed Contractor(s) and Address:

Georgia Department of Public Health.

2 Peachtree Street, FL 33 Atlanta, Georgia, 30303-3142 Cage Code: 6DZR5 ATTN: Jeannine Galloway, MPH, Maternal and Child Health Director, 404-327-7950, Jeannine.Galloway@dph.ga.gov

3. Description of Services or Supplies:

Newborn metabolic screening is a test done on all babies shortly after birth to check for certain genetic and metabolic disorders that can affect a baby's health. These conditions, if left undetected and untreated, can cause developmental delays, intellectual disabilities, or even death.

The screening typically involves a heel prick to collect a small blood sample, which is then sent to a lab for analysis. The newborn screening includes phenylketonuria (PKU) methylmalonic acidemia.

Controlled by: Army Controlled By: ODASA(P) CUI Category(ies): General Procurement and Acquisition Distribution/Dissemination Control: FED ONLY POC: Clarence C Cude, Jr., 254-553-8440 mailto:Jeannine.Galloway@dph.ga.gov

The price from the Georgia Department of Public Health is set at $88.33 for the duration of the contract.

Estimated Value: The estimated value of this effort is $127,195.20 for all years.

Period of Performance:

Period of Performance:

Base Period: 1 October 2025 to 30 September 2026 (240 Tests) Value: $21,199.20 Option Period 1: 1 October 2026 to 30 September 2027 (480 Tests) Value: $42,398.40 Option Period 2: 1 October 2027 to 30 September 2028 (480 Tests)Value: $42,398.40 FAR § 52.217-8 option: 1 October 2028 to 31 March 2029 (240 Tests) Value: $21,199.20 Total Value: $127,195.20

The MTF has verified they want 240 tests the base year and 480 tests for the first and second option year. The FAR § 52.217-8 extension is half of the second option year for 240 tests.

There is no increase in cost of the test between FY26, FY27 and FY28. The increase in the number of tests is the reason for the annual cost increase. The cost of the tests will remain at $88.33 throughout the duration of the contract.

Vendor Name

CAGE

Code

Business Size

Location Point of Contact Capability Assessment

Georgia Department of Public Health

6DZR5 Other Than Small

2 Peachtree St NW FL

33. Atlanta, Georgia 30303-3142

Name: Jeannine Galloway, MPH, Maternal and Child Health Director, 404-327-7950, Jeannine.Galloway@dph.ga.gov

4. Authority:

☒ FAR § 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited:

The screening is state mandated by the state of Georgia. Some states require mandatory testing of newborns shortly after birth to check for certain genetic and metabolic disorders that can affect a baby's health. These conditions, if left undetected and untreated, can cause developmental delays, intellectual disabilities, or even death. The screening typically involves a heel prick to collect a small blood sample, which is then sent to a lab for analysis. The newborn screening includes phenylketonuria (PKU) methylmalonic acidemia. Georgia is one of those states requiring newborn PKU testing.

Defense Health Agency (DHA) discontinued centralized contracts for newborn PKU testing as most state laboratories now offer testing that is compliant with the Recommended Universal Screening Panel (RUSP) with confirmatory testing. Affected Medical Treatment Facilities (MTFs) were advised to develop arrangements with an appropriate state newborn screening program for newborn PKU testing. MTFs were advised to utilize the state labs that they reside in, in order to maximize the benefits of the case management, consultation, and referral capabilities offered by those labs.

If not approved, the MTF will be unable to provide the required newborn PKU testing as outlined by the State of Georgia.

The previous contract, W91YTZ-21-P-0184, was a sole source to the Georgia Department of Public Health with a period of performance of 1 October 2021 to 30 September 2025.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR § 5.101 and FAR § 5.203 ☐ do not apply due to the $ threshold, ☒ apply and will be followed, or ☐ do not apply due to an exception at 5.202 ______________________.

Requirement to post justification in accordance with FAR § 8.405-6(b)(3), FAR § 13.105(c), or FAR § 16.505(a)(4)(iii)(A)

☒ Action is NOT a brand name restriction and is under $250K, no posting required.

7. Market Research:

Market research revealed the recommended newborn tests are not available on the Government Services Administration (GSA) under the Federal Supply Schedule (FSS). The contract specialist conducted a small business search on the new SBA website at https://search.certifications.sba.gov/ with the NAICS code 621511 and the keyword “PKU” which showed no results and again with the keyword “PKU” which showed eighteen (18) small business (SB) results including low protein diets, firefighting chemicals, produce, cybersecurity, crane services, welding supplies, battery packs and auditing services. The market research results reveal there is not two or more small businesses that can fill this requirement. Results from this search did not identify two or more small businesses that could provide the newborn testing.

This is not a new requirement. Market research showed it is not available on GSA and not available on SBA. After conducting the market research, the contracting officer determined the recommended source will be used in accordance with FAR § 13.106-1(b)(1), for purchases not https://search.certifications.sba.gov/ exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

A sources sought was not posted as the Georgia Department of Public Health is the only state run laboratory in Georgia compliant with RUSP. This has been a re-occurring requirement and there will continue to be a future need for these services.

8. Other Facts: N/A

9. Technical/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: Barbara Nobles Title: Supply Contracting Officer’s Representative (COR) Signature: XXXXXXXXXXXXXXXXXXXXXXXXXXXX

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10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon price analysis and historical prices paid for same or similar services.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government.

Additionally, I approve this justification to limit competition subject to the availability of FY26 funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name: FREDICINDA D. JONES Title: Contracting Officer Signature:

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Contracting Officer Fredicinda D. Jones reviewed and approved on 26 July 2025.

Second Review: Contracting Officer Fredicinda D. Jones reviewed and approved on 7 August 2025.