A11 - Synopsis of Proposed Contract Action - 2025-89636.pdf

The Centers for Disease Control and Prevention (CDC) has a services requirement to develop and test systems for testing and reporting National Health and Nutrition Examination Survey (NHANES) chemistry data, submit NHANES Initial Requirements Laboratory Checklist (if applicable) and perform laboratory testing and upload data within 21-days (3 weeks) of receipt of the samples:

• Comprehensive Metabolic Panel (CMP): albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, blood urea nitrogen (BUN), creatinine, glucose, potassium, sodium, chloride, total bilirubin, total calcium, and total protein;

• Other Chemistry tests requested: cystatin-C, gamma glutamyl transferase (GGT), iron, lactate dehydrogenase (LDH), magnesium, and uric acid;

• High-sensitivity C-reactive protein (hs-CRP);

• Lipid Panel: Total cholesterol, high-density lipoprotein (HDL), and triglycerides;

• Urinary albumin and urinary creatinine

Furthermore, the CDC is to seek CLIA-certified laboratories to measure biochemical testing from biologic samples collected at the NHANES mobile examination center (MEC), and develop a laboratory procedure manual for each method grouped by instrument. These objectives are comprised of include the following:

IDIQ Objective 1: Testing Performed in CLIA-certified Laboratory

Results for analytes specified below are to be reported back to study participants. Therefore, all testing must be complaint with regulations outlined by the CLIA. Submit data and quality control (QC) data with 21 days (3 weeks) after receipt of samples.

• The contractor shall perform all work necessary to receive, inventory, test, report results and store NHANES samples. Contractor must have capability to receive samples from examination centers for shipments of varied sizes.

• The contractor shall perform testing an estimated average of 3000-5000 samples each year for a Comprehensive Metabolic Panel (CMP) {albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, blood urea nitrogen (BUN), creatinine, glucose, potassium, sodium, chloride, total bilirubin, total calcium, and total protein}, additional chemistry tests for cystatin-C, gamma glutamyl transferase (GGT), iron, lactate dehydrogenase (LDH), magnesium, and uric acid and triglycerides.

• The contractor shall perform testing an estimated average of 3200-5000 samples each year for total cholesterol and HDL.

• The contractor shall perform testingan estimated average of 3600-5000 samples each year for hs-CRP.

• The contractor shall perform testing an estimated average of 3500-5000 samples each year for urinary albumin and urinary creatinine.

IDIQ Objective 2: Develop and deliver laboratory procedure manuals to the project officer and Contract Officer Representative (COR).

• The laboratory procedure manuals are to be developed in accordance with the instructions found in and delivered by the date stated in Section 8 – Deliverables and Reporting Schedules. Any subsequent updates or modifications to the laboratory manuals from NHANES 2025-2030 must be submitted as they occur.

A competitive acquisition will be accomplished on the basis of a Full & Open competition utilizing FAR part 15 for the acquisition of commercial items in conjunction with FAR 15 procedures for the utilization of a trade-off source selection. Services for the above shall be in accordance with the requirements set forth in the Statement of Work referenced in the soliciation.

Place of performance will occur at the contractor’s facility. The Government intends to award a single, Firm Fixed Price Indefinite Delivery/Indefinite Quantity (IDIQ) type contract with a one

(1) year basic and four (4), one (1) year option periods. To be eligible to receive an award resulting from this solicitation, a contractor must have an active registration in the System For Award Management. All responsible sources may submit a proposal which shall be considered by the agency. The solicitation is anticipated to be posted on SAM.gov on or around December 16, 2024.