Justification_and_Approval_Redacted.pdf

CUI

Control Number: FY27-1005

Controlled by: Defense Health Agency (DHA) Controlled by: HCD-NE CUI Category(ies ): Source Selection Limited Dissemination Control: FEDCON POC: Justin Balster

Justification and Approval (J&A) for Other than Full and Open Competition Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) Parts 6 and

Implemented by Class Deviation 2026-00017, Revision 1

1. Identification of the Agency and Contracting Activity: Defense Health Agency, Defense Health Network - East

2. Approval is requested to award a new firm-fixed-price contract to the Tennessee Department of Health, Division of Laboratory Services, for commercial newborn dried blood spot screening laboratory services and associated reporting. The estimated value of the contract is for a 12-month base period and four 12-month option periods. The total potential value, including a potential six-month extension under FAR 52.217-8, Options to Extend Services, is . The base period will be funded with available FY 2027 funds. Exercise of option periods and any extension under FAR 52.217-8 is contingent upon the availability of funds and compliance with applicable fiscal law, appropriation, and option-exercise requirements. The contractor legal entity address, remittance address, and laboratory/specimen-shipping address will be verified and reflected in the award document.

3. This requirement is for commercial newborn dried blood spot screening laboratory services and associated reporting for newborns delivered at Blanchfield Army Community Hospital. Blanchfield Army Community Hospital is physically located in Tennessee. The requiring activity will retain supporting documentation establishing that newborns delivered at the facility are subject to applicable Tennessee newborn screening requirements. Tennessee Code Annotated§ 68-5-401 requires newborn testing for specified metabolic, genetic, and other heritable conditions as designated by the Tennessee Department of Health. Tennessee Comp. R. & Regs. 1200-15-01-.02 requires hospital officials and attending physicians to submit satisfactory newborn blood specimens to the State Public Health Laboratory, Department of Health, in the manner directed by TOH. The contractor shall receive, test, analyze, and report results for newborn dried blood spot specimens in accordance with applicable Tennessee newborn screening requirements. This requirement does not include newborn hearing screening, critical congenital heart disease screening, or other clinical screening functions performed by the hospital or attending provider.

A summary of the estimated requirements and cost is as follows:

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

1 OCT 2024

CUI

Control Number:

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2024

of Entry in accordance with RFO FAR Part 5 and FAR 12.202. The notice will identify the Tennessee Department of Health, Division of Laboratory Services, as the intended source and explain the basis for restricting competition.

Any timely responses, capability statements, quotations, or proposals received will be evaluated to determine whether the respondent can meet the Tennessee-required specimen-submission process and all other stated Government requirements.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition:

The principal barrier to competition is Tennessee's requirement that satisfactory newborn blood specimens be submitted to the State Public Health Laboratory, Department of Health.

Before exercising each option, the requiring activity and contracting officer will conduct updated market research and review applicable Tennessee statutes, regulations, TOH newborn screening procedures, and responses to public notices to determine whether any change would permit another source to meet the Tennessee-required submission process. The results of this review will be documented in the contract file.

8. Market Research: Market research was conducted through review of Tennessee Code Annotated§ 68-5-401; Tennessee Comp. R. & Regs. 1200-15-01-.02; Tennessee Department of Health newborn screening program information; Tennessee Department of Health Division of Laboratory Services information; current, historical fees and TOH-established fees

This research confirmed that hospital officials and attending physicians must submit satisfactory newborn blood specimens to the State Public Health Laboratory, Department of Health, in accordance with TOH requirements. TOH Division of Laboratory Services operates the Tennessee Newborn Screening Laboratory. No alternate commercial source was identified that could receive and process newborn blood specimens in a manner that satisfies the Tennessee-required submission process. Market research supports the contracting officer's determination that the proposed price is fair and reasonable through analysis of current and historical TOH-established fees, historical prices paid, the independent Government cost estimate, and other relevant pricing information.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? Yes

(2) If 9.a.(1) is No, was the action just prior to this one competed? Not Applicable