Justification and Approval Modified for FAR Part 12.201-1_Fully Signed_Redacted.pdf

CUI

Control Number: FY26-0514

Controlled by: Defense Health Agency (DHA) Controlled by: Healthcare Contracting Division - West CUI Category: Source Selection Information Limited Dissemination Control: FED Only POC: Merlinda M. Labaco at merlinda.m.labaco.civ@health.mil

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

1 NOV 2024

CUI//PROCURE

Justification and Approval (J&A) for Federal Acquisition Regulation (FAR) 12.201-1 Simplified Procedures

1. Identification of the Agency and Contracting Activity:

Defense Health Agency (DHA), DHA Contracting Activity (DHACA), Healthcare Contracting Division (HCD) - West.

2. Nature and/or Description of Action being Approved:

This is an individual justification for a new, sole-source, single-award Blanket Purchase Agreement (BPA) to the Oregon Health Authority (OHA). The contract type will be Firm-Fixed- Price (FFP) per newborn screening test ordered.

3. Description of Supplies/Services: The proposed contractor is the Oregon Health Authority.

The contractor shall provide comprehensive newborn metabolic screening services for five Military Treatment Facilities (MTFs): Naval Hospital (NH) Guam, NH Yokosuka, NH Okinawa, Misawa Air Force Base (AFB), and Yokota AFB.

The contractor is fully responsible for the testing required for newborn screening. Testing should be comprehensive and include organic acidemias, fatty acid oxidation disorders, amino acid disorders, endocrine disorders, lysosomal storage diseases, Cystic fibrosis, Biotinidase deficiency, Classic galactosemia, hemoglobinopathies, Severe Combined Immunodeficiency disease (SCID), Spinal Muscular Atrophy, and X-linked Adrenal Leukodystrophy (XALD).

Additionally, the contractor will supply all required testing materials to include newborn screen-testing cards and envelopes. The contractor shall provide access to their website to retrieve patient test results for manual entry into our electronic health record. The contractor shall notify the five (5) designated Military Treatment Facilities (MTFs) of any abnormal/critical patient test results immediately.

Newborn screening is standard of care and mandated for all neonates born at the five MTFs.

Screening has typically included organic acidemias, fatty acid oxidation disorders, amino acid disorders, endocrine disorders, lysosomal storage diseases, Cystic fibrosis, Biotinidase deficiency, Classic galactosemia, hemoglobinopathies, Severe Combined Immunodeficiency disease (SCID), Spinal Muscular Atrophy, and X-linked Adrenal Leukodystrophy (XALD).

Historical workload has been up to 550 patient tests per year.

3 NOV 2024

Proven Success and Established OCONUS Logistics: OHA is the incumbent provider and has a proven track record of successfully managing the complex logistics of receiving time-sensitive biological samples from the Indo-Pacific AOR. They have established protocols for handling international shipments, accounting for customs and time zone delays, and ensuring sample integrity upon arrival. This is not a theoretical capability; it is a demonstrated performance that mitigates significant risk to the program.

Geographic Proximity and Time Zone Advantage: OHA’s location on the U.S. West Coast provides a distinct logistical advantage for shipments originating from Japan and Guam. This shorter transit time compared to Midwest or East Coast laboratories is critical for ensuring the viability of the blood spot samples. Furthermore, the reduced time zone difference facilitates urgent communication regarding critical/abnormal results, directly impacting patient safety and immediate follow-up care.

Unique Combination of Integrated Services: While other state health authorities exist, none have demonstrated the willingness or established capability to service these OCONUS MTFs.

OHA offers a unique and essential combination: the full suite of RUSP testing, integrated public health case management, a network of pediatric subspecialists for consultation, and the proven logistical capability to support the Indo-Pacific region. No commercial lab or other state authority has presented a comparable, complete service package for this specific requirement.

6. Efforts to Obtain Competition: A Notice of Intent to Sole Source (which also served as a Sources Sought) was publicized on SAM.gov under notice ID HT941026N0017 from January 15, 2026, to January 30, 2026. The notice described the Government's requirement for newborn screening services for the five OCONUS MTFs and invited any interested parties to submit a capability statement. At the conclusion of the posting period, zero (0) responses were received.

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

The primary barrier to competition is the unique status and integrated public health infrastructure of a state-designated health authority. This is not a barrier that the Government can remove.

However, the Government will take the following actions to encourage competition in the future:

Prior to the expiration of this BPA, the Government will conduct market research to determine if any commercial laboratories have developed programs that offer a comparable level of integrated public health case management and specialty consultation.

The Government will also assess whether other state health authorities are willing and able to provide these services to overseas military dependents, which would allow for competition among state-level entities in the future.

8. Market Research:

Market research was conducted to identify sources capable of meeting this requirement.

4 NOV 2024

Mandatory Sources: A review confirmed this service is not available from AbilityOne or

UNICOR.

Market Survey: A Notice of Intent/Sources Sought (HT941026N0017) was posted to SAM.gov for 15 days. The notice clearly described the requirement to provide newborn screening services for five MTFs in the Indo-Pacific. The posting resulted in zero (0) capability statements or expressions of interest, strongly indicating a lack of available or willing sources other than the incumbent.

Follow-up with Incumbent: Following the lack of market response, the Government confirmed that the Oregon Health Authority has a continued interest in, and capability to, perform the requirement.

This research conclusively demonstrates that while the services are commercial, only one source has the proven capability and willingness to perform the work for these specific OCONUS locations.

9. Other Facts:

This is a new consolidated requirement, combining the needs of five MTFs previously satisfied through other means. The consolidation will standardize care, improve quality control, and generate significant administrative efficiencies.

a. Procurement History:

(1) Is this a new requirement? Yes. This is a new consolidated requirement that combines the needs of five separate MTFs into a single BPA to standardize care and streamline contract administration.

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

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? Not Applicable.

b. Additional Information:

The consolidation of this requirement under a single BPA is expected to generate significant administrative efficiencies. Utilizing the GCPC as the method of payment for orders against the BPA will further streamline the procurement process, reduce administrative burden on both the Government and the contractor, and ensure prompt payment for services rendered.

10. Interested Sources:

To date, no sources other than the Oregon Health Authority have expressed interest in this requirement.