Newborn Screening Services   2

Notice of Intent to Sole Source

HT941026N0017

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE FIRM-FIXED-PRICE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division West (HCD-W), intends to award a contract for Newborn Screening Services in support of five Military Treatment Facilities (MTFs):

Naval Hospital (NH) Guam

NH Yokosuka, Japan

NH Okinawa, Japan

Misawa Air Force Base (AFB), Japan

Yokota AFB, Japan

The authority for this action is Federal Acquisition Regulation (FAR) 13.501, Sole Source Acquisitions. The Government has determined that only one source is reasonably available to meet the Government's needs.

Intended Sole Source Vendor

OREGON HEALTH AUTHORITY

Unique Entity ID: HFJRBHKCBPR5
CAGE: 1GVR0

500 Summer St NE # E-82

Salem, Oregon 97301-1064

Product Service Code (PSC): Q301 Medical Laboratory Testing Services

NAICS Code: 621511 Medical Laboratories

Required Newborn Bloodspot Screening Panel

The comprehensive panel includes, but is not limited to, the following disorders:

Organic Acidemias : Propionic acidemia (PA), Methylmalonic acidemia (MMA), Isovaleric acidemia (IVA), 3-methylcrotonyl CoA carboxylase deficiency (3MCC), 3-hydroxy-3-methylglutaryl CoA lyase deficiency (HMG), Multiple carboxylase deficiency (MCD), Beta-ketothiolase deficiency (BKT), Glutaric acidemia (Types I and II), Malonic acidemia (MAL), and others.

Fatty Acid Oxidation Disorders: Carnitine uptake defect (CUD), MCAD, VLCAD, LCHAD, Trifunctional protein deficiency (TFP), SCAD, Carnitine palmitoyl transferase deficiency (Types I and II), and others.

Amino Acid Disorders: Arginosuccinic aciduria (ASA), Citrullinemia (CIT), Maple syrup urine disease (MSUD), Homocystinuria (HCY), Phenylketonuria (PKU), Tyrosinemia (Types I, II, III), and Arginase deficiency (ARG).

Endocrine Disorders: Primary congenital hypothyroidism (CH) and Congenital adrenal hyperplasia (CAH).

Lysosomal Storage Diseases: Pompe, Mucopolysaccharidosis Type I (MPS I), Fabry, Gaucher, and Infantile Krabbe Disease.

Other Core Disorders: Cystic Fibrosis, Biotinidase deficiency, Classic Galactosemia, Hemoglobinopathies (e.g., Sickle Cell Disease), Severe Combined Immunodeficiency (SCID), Spinal Muscular Atrophy (SMA), and X-linked Adrenal Leukodystrophy (XALD).

Anticipated Additions: Guanidinoacetate methyltransferase deficiency (Summer 2026) and Mucopolysaccharidosis Type II (MPSII) (early 2027).

The Oregon Health Authority (OHA) is uniquely capable of meeting the Government's full requirement. The determination to award this action on a sole-source basis is based on the following:

OHA provides a service that fundamentally transcends the capabilities of a commercial laboratory. As a state-designated public health entity, OHA operates an integrated public health infrastructure that is a unique and essential qualification for this requirement. This system provides three critical functions that a commercial entity cannot replicate:

Integrated Public Health Case Management: OHA's service is not merely transactional testing. It includes a robust, state-managed case management system. Upon detection of an abnormal result, OHA's public health nurses and coordinators actively manage the case, leveraging an established network of pediatric sub-specialists in endocrinology, genetics, and immunology for immediate clinical consultation. This ensures that a definitive diagnosis and treatment plan are established, a capability not offered as a unified service by commercial labs.

Guaranteed Continuity of Care for a Transient Military Population: Military families are highly mobile. When a screening is performed by OHA, the results become part of an official state health record. This record is portable and can be seamlessly shared with other state health departments and civilian healthcare providers when a military family relocates. This government-to-government data pathway is critical for ensuring long-term follow-up and continuity of care for a child's entire life, preventing critical health data from being lost or fragmented, a risk inherent with commercial providers.

Comprehensive, State-Validated Program: OHA is responsible for the health of its entire population and provides a single, accredited, and validated program that screens for all disorders on the national Recommended Uniform Screening Panel (RUSP). Their program is a public trust, not just a service line, providing an unparalleled level of quality assurance, long-term data integrity, and alignment with national public health standards that the Government requires to safeguard the health of military dependents born overseas.

In summary, only a state-level public health authority can provide the integrated system of testing, specialist consultation, and life-long continuity of care required. Therefore, the Oregon Health Authority is the only source reasonably available to fulfill the Government's complete requirement.

This notice of intent is not a request for competitive proposals, and no solicitation document exists for this requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required services for United States NH Guam, NH Yokosuka, NH Okinawa, Misawa AFB, and Yokota AFB. Capability statements shall not exceed six (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order.

If a vendor challenges the basis of this requirement, please email capability statements as a Microsoft Word or Adobe PDF attachment to Merlinda M. Labaco at Merlinda.m.labaco.civ@health.mil. The closing date for challenges is no later than 1:00 pm Pacific Standard Time, 30 January 2026.

NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED