Attachment 1 - Statement of Work.pdf

Statement of Work

Title: NHANES General Chemistry Laboratory Testing 2025-2030

Period of performance of this contract is: 2/14/2025 to 2/13/2030

Base Period: 2/14/2025 to 2/13/2026 Option Period One: 2/14/2026 to 2/13/2027 Option Period Two: 2/14/2027 to 2/13/2028 Option Period Three: 2/14/2028 to 2/13/2029 Option Period Four: 2/14/2029 to 2/13/2030

SECTION 1 – BACKGROUND

The National Health and Nutrition Examination Survey (NHANES) is a program of studies conducted by the National Center for Health Statistics (NCHS) designed to provide national statistics on the health and nutritional status of the civilian, non-institutionalized U.S.

population through household interviews, standardized physical examinations, and the collection of biologic samples in special mobile examination centers. The survey oversamples minority groups and other subgroups of the population. It is estimated that approximately 20,000 individuals ages one year and older will be examined during the period of performance of this contract. The purpose of the testing is to generate national estimates and monitor trends in chronic diseases, such as kidney, liver and heart disease.

This Statement of Work (SOW) seeks to obtain Clinical Laboratory Improvement Amendments (CLIA) certified laboratory measurements on biological specimens.

NHANES is requiring an Indefinite Delivery/Indefinite Quantity (IDIQ) in order to be able to place orders for the below listed chemistry tests:

• 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

The contractor shall provide all labor, equipment, supplies, services, permits, and licenses necessary to perform these measurements. The specimens will bear only anonymized sample IDs. The contractor will not be privy to any otherwise original identifiers such as participants’ social security numbers, etc. As well, the contractor will not be given access to any derived means, with which personally identifiable information could be arrived.

Definitions

• Analyte- component represented in the name of a measurable quantity (ISO 17511), NOTE: The terms biomarker and analyte are used interchangeably throughout this document.

• Assay-detailed description of a measurement according to one or more measurement principles and to a given measurement method, based on a measurement result (JGM 200:2012) NOTE: The terms assay and method are used interchangeably throughout this document.

SECTION 2 – PURPOSE/OBJECTIVE

The assessment of specific nutritional, metabolic, nephrological, and urologic conditions in the population plays a critical role in determining their potential associations with other health conditions such as iron-deficiency anemia, obesity, diabetes, and hypertension. It also aids in monitoring the prevalence of these diseases and related risk factors over time.

These data are invaluable for program planning, initiatives, and other public health activities, documenting the burden of specific diseases and syndromes, and serving as epidemiological data for the development of ongoing surveillance reporting systems relevant to nutritional, metabolic, nephrological, and urologic diseases. These efforts will allow NCHS, Centers for Disease Control and Prevention (CDC) to provide NHANES study participants results and release data on the NHANES website for public use.

An IDIQ with firm fixed price task orders, with options, 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.

SECTION 3 – SCOPE OF WORK

At the Task Order level, submit current CLIA certificate, review the NHANES Contract Laboratory Manual, develop and test systems for testing and reporting 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:

1. Comprehensive Metabolic Panel (CMP) consisting of the following 14 tests {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};

2. Seven additional chemistry tests {cystatin-C, gamma glutamyl transferase (GGT), iron, lactate dehydrogenase (LDH), magnesium, uric acid, and hs-CRP};

3. Lipid panel {triglycerides, total cholesterol and HDL} and;

4. Urinary albumin and urinary creatinine testing;

5. Submit test results and QC results in a base year, and four potential option years;

6. Submit quarterly reports including proficiency testing results,

7. Provide updated CLIA certificate as needed,

8. Store NHANES samples for at least one year; and

9. Development and delivery of laboratory procedure manual(s).

At the task order level, on average, five shipments of samples (approximately 40-75 samples per shipment) will arrive at the laboratory each week. The samples are not collected during a two-week summer vacation and the last two weeks of December.

The specimens arrival and the type of shipment (dry ice, freezer packs, or ambient temperature) will be agreed upon by NHANES COR and the contractor. Have contingency plans in place in case shipments are delayed. This work shall provide laboratory measurements for the above stated chemistry tests and will allow the NCHS to provide data for public use.

The contractor shall be capable of high throughput testing of 3200-5000 samples each year (2025-2030) from NHANES. For appropriate analytes, NHANES is requesting a method that must be stable and directly proportional to the amount of analyte present in the sample. General chemistry panel assays must be FDA-approved or FDA-cleared, current, stable, and available. If the test method and/or instrument must be changed, then the contractor shall perform general chemistry testing and reporting of 150-200 samples provided by NHANES for a method validation study. The contractor shall provide an assessment of specified analytes (Section 2) using NHANES specimens. All NHANES general chemistry data must be comparable throughout the survey. This will be assessed on a random basis using blinded samples. Test and quality control results must be transmitted to NHANES via electronic data files in a format/manner stipulated by NHANES security stewards no later than three weeks after receipt of samples (See Section 8- Deliverables). The contractor shall have well-established quality assurance and competency assessment programs in operation that are regularly evaluated.

Have the ability to store all NHANES samples for a minimum of one year at -80oC.

Send updated CLIA certificate as needed throughout the length of the contract.

SECTION 4 – TASKS TO BE PERFORMED

Tasks

The contractor shall:

Task 1: Submit current CLIA certificate.

Task 2: Complete the ‘Initial Requirement Laboratory Checklist’ provided by NCHS, which collects laboratory contact information.

a. The completed checklist must be submitted to the COR, and all systems and processes must be developed, validated and operational;

b. Review the NHANES Contract Laboratory Manual, which explains how to set up a new laboratory in the Sample Result System (SRS) and submitting data through a secure site managed by the NHANES data collection contractor;

Task 3: The contractor shall work with the COR and the NHANES data collection contractor via virtual meeting to set up the shipping address, sample requirements and system demonstration for uploading testing and QC data submission.

Task 4: Receive Shipments, Analyze and report NHANES participant data and quality control data for CMP samples sent on a weekly basis.

• Creatinine (serum) shall be measured using a enzymatic method and calibrated using National Institute of Standards and Technology (NIST) Identity and Access Management (ISDM) standards to the lowest level of 0.1mg/dL.

Task 5: Receive Shipments, Analyze and report NHANES participant data and quality control data for cystatin C samples sent on a weekly basis. Cystatin C shall be calibrated using IFCC certified reference material down to 0.5 mg/L.

Task 6: Receive Shipments, Analyze and report NHANES participant data and quality control data for GGT samples sent on a weekly basis.

Task 7: Receive Shipments, Analyze and report NHANES participant data and quality control data for iron samples sent on a weekly basis.

Task 8: Receive Shipments, Analyze and report NHANES participant data and quality control data for LDH samples sent on a weekly basis.

Task 9: Receive Shipments, Analyze and report NHANES participant data and quality control data for Magnesium samples sent on a weekly basis.

Task 10: Receive Shipments, Analyze and report NHANES participant data and quality control data for Uric Acid samples sent on a weekly basis.

Task 11: Receive Shipments, Analyze and report NHANES participant data and quality control data for hs-CRP samples sent on a weekly basis.

Task 12: Receive Shipments, Analyze and report NHANES participant data and quality control data for Total Cholesterol samples sent on a weekly basis.

• Cholesterol must be measured enzymatically in serum in a series of coupled reactions that hydrolyze cholesteryl esters and oxidize the 3-OH group of cholesterol.

Task 13: Receive Shipments, Analyze and report NHANES participant data and quality control data for HDL samples sent on a weekly basis.

• A direct (measured) HDL method in serum is required.

Task 14: Receive Shipments, Analyze and report NHANES participant data and quality control data for Triglyceride samples sent on a weekly basis.

• Triglycerides must be measured enzymatically in serum using a series of coupled reactions in which triglycerides are hydrolyzed to produce glycerol.

For Tasks 12-14, the laboratory must be a participant in the CDC Lipid Standardization Program (LSP), and LSP testing samples must be included in the analytic runs with NHANES samples. LSP results must be sent to the NCHS COR quarterly.

Task 15: Receive Shipments, Analyze and report NHANES participant data and quality control data for urinary albumin samples sent on a weekly basis.

• A measurement of human urinary albumin is requested using a method that is calibrated to NIST standards and provides a linear calibration curve that spans the entire Analytical Measurement Range (AMR).

Task 16: Receive Shipments, Analyze and report NHANES participant data and quality control data for urinary creatinine samples sent on a weekly basis.

Task 17: Submit quarterly reports as a comprehensive document which includes:

1. Provide a general overview of NHANES testing, including any corrective action.

2. A log of samples received/tested and if there were any issues with sample receipt.

3. A log of sample analysis and/or storage issues.

4. Quality control issues, including internal and external quality control.

5. Any instrument calibration, linearity, maintenance or troubleshooting performed.

6. Proficiency testing results.

7. Comparison study tracking.

8. Notify NHANES COR if any unforeseen problems, potential changes in method or instrumentation in a timely manner.

Task 18: Prepare procedure manuals for testing requested in the SOW. Only one manual needed for testing performed on a single platform

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

No Government furnished property will be provided to the contractor to support the statement of work.

SECTION 6 – PERIOD OF PERFORMANCE, PLACE OF PERFORMANCE, and

CONTRACT SUPPORT HOURS

The period of performance will commence on the date of award and consist of one, 12-month base period, with four 12-month option periods.

SUBSECTION A – PLACE OF PERFORMANCE

All required staffing, equipment, supplies, services, permits, and licenses necessary to perform the contract will be furnished by the contractor and will take place entirely off site at the contractor’s facility.

SUBSECTION B – CONTRACT SUPPORT HOURS

The contractor must be available to receive samples per a predetermined schedule and conduct other task during regular business hours. The contractor shall have procedures in place to receive delayed shipments that occur outside of regular business hours. The contractor shall also have procedures in place to monitor for fire, smoke, intrusion, mechanical freezer failure, and freezer alarm systems, SECTION 7 – TRAVEL

There will be no required travel.

SECTION 8 - DELIVERABLES/REPORTING SCHEDULE

Deliverables Quantity

Task Order Base Period (2025):

Task 1

CLIA Certificate 1

Task Order Base Period (2025):

Task 2

Completed Checklist 1

Task Order Base Period (2025):

Task 3

Confirmation of ability to upload test data in a format/manner approved by NHANES security stewards

Task Order Base Period & all Option Years 2025 – 2030

Task 4

Task 5

Task 6

Task 7

Task 8

Task 9

Task 10

Task 11

Task 12

Task 13

Task 14

Continuous NHANES Cycle Data Test Results

Comprehensive Metabolic Panel (14 tests)

Cystatin-C

Gamma glutamyl transferase

(GGT)

Iron

Lactate dehydrogenase (LDH)

Magnesium

Uric acid hs-CRP

Cholesterol, total

HDL

Triglycerides

Urinary albumin

Up to 5000 per test per year/Data upload

The following tables summarize the expected number of samples to be tested from the survey:

BASE Period: February 14, 2025 – February 13, 2026

TEST

Estimated Average

MIN QTY

(# of samples or items/year)

Estimated Average

MAX QTY

(# of samples or items/year)

Initial Requirements Laboratory Checklist 1 each 1 each Comprehensive Metabolic Panel (CMP)

(14 test) 25 5000

Cystatin-C 25 5000 Gamma Glutamyl Transferase (GGT) 25 5000

Iron 25 5000 Lactate Dehydrogenase (LDH) 25 5000

Magnesium 25 5000 Uric Acid 25 5000

High-Sensitivity C-reactive protein (hs-

CRP) 25 5000

Total Cholesterol 25 5000 High-Density lipoprotein (HDL) 25 5000

Triglycerides 25 5000 Urinary Albumin 25 5000

Urinary Creatinine 25 5000 Quarterly Reports 1 4

Laboratory Procedure Manuals 1 5

Task 15

Task 16

Urinary creatinine

Task Order Base Period & all Option Years 2025 – 2030 Task

Quarterly Reports Four (4) per year/Electronic Report

Task Order Base Period & all Option Years 2025 – 2030 Task

Complete/ updated procedure manuals

Four (4) per year/Electronic Report

Option Period 1: February 14, 2026 – February 13, 2027

Estimated Average

MIN QTY

(# of samples or items/year)

Estimated Average

MAX QTY

(# of samples or items/year) Comprehensive Metabolic Panel (CMP)

(14 test) 0 5000

Cystatin-C 0 5000 Gamma Glutamyl Transferase (GGT) 0 5000

Iron 0 5000 Lactate Dehydrogenase (LDH) 0 5000

Magnesium 0 5000 Uric Acid 0 5000

High-Sensitivity C-reactive protein (hs-

CRP) 0 5000

Total Cholesterol 0 5000 High-Density lipoprotein (HDL) 0 5000

Triglycerides 0 5000 Urinary Albumin 0 5000

Urinary Creatinine 0 5000 Quarterly Reports 0 4

Laboratory Procedure Manuals 0 5

Option Period 2: February 14, 2027 – February 13, 2028

Estimated Average

MIN QTY

(# of samples or items/year)

Estimated Average

MAX QTY

(# of samples or items/year)

Comprehensive Metabolic Panel (CMP) (14 test) 0 5000

Cystatin-C 0 5000 Gamma Glutamyl Transferase

(GGT) 0 5000

Iron 0 5000 Lactate Dehydrogenase (LDH) 0 5000

Magnesium 0 5000 Uric Acid 0 5000

High-Sensitivity C-reactive protein (hs-CRP) 0 5000

Total Cholesterol 0 5000 High-Density lipoprotein 0 5000

(HDL)

Triglycerides 0 5000

Urinary Albumin 0 5000 Urinary Creatinine 0 5000

Option Period 3: February 14, 2028 – February 13, 2029

Estimated Average

MIN QTY

(# of samples or items/year)

Estimated Average

MAX QTY

(# of samples or items/year)

Comprehensive Metabolic Panel (CMP) (14 test) 0 5000

Cystatin-C 0 5000 Gamma Glutamyl Transferase

(GGT) 0 5000

Iron 0 5000 Lactate Dehydrogenase (LDH) 0 5000

Magnesium 0 5000 Uric Acid 0 5000

High-Sensitivity C-reactive protein (hs-CRP) 0 5000

Total Cholesterol 0 5000 High-Density lipoprotein (HDL) 0 5000

Triglycerides 0 5000 Urinary Albumin 0 5000

Urinary Creatinine 0 5000

Option Period 4: February 14, 2029 – February 13, 2030

Estimated Average

MIN QTY

(# of samples or items/year)

Estimated Average

MAX QTY

(# of samples or items/year)

Comprehensive Metabolic Panel (CMP) (14 test) 0 5000

Cystatin-C 0 5000 Gamma Glutamyl Transferase (GGT) 0 5000

Iron 0 5000

Lactate Dehydrogenase (LDH) 0 5000 Magnesium 0 5000 Uric Acid 0 5000

High-Sensitivity C-reactive protein (hs-

CRP) 0 5000

Total Cholesterol 0 5000 High-Density lipoprotein (HDL) 0 5000

Triglycerides 0 5000 Urinary Albumin 0 5000

Urinary Creatinine 0 5000 Quarterly Reports 0 4

Laboratory Procedure Manuals 0 5

Performance Matrix for General Chemistry Testing

Desired End Result

Feature(s) of end result to be surveilled (Indicator).

The required performance level for each feature (Standard).

Quality Assurance

Incentives/Pay ment-Quality Link

The contractor shall submit data and quality control (QC) data.

The contractor shall develop and deliver laboratory procedure manuals to the project officer and Contract Officer Representati ve (COR).

Completeness and timeliness of review;

feasibility of recommendations

Completeness and timeliness of procedures manual

21 days (3 weeks) after receipt of samples

Within 180 days of award

Reviewed by the COR and

PM

Reviewed by the COR and

PM.

1. Positive incentives:

a. Payment of contract labor rate for satisfactory service.

b. Contractor performance evaluated using the automated Contractor Performance Assessment Reporting System

(CPARS).

The evaluation will be considered when future

AGENCY

contract

SECTION 9 – REFERENCE MATERIALS

Not applicable.

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

Contractor shall:

1. Be a CLIA-compliant laboratory currently performing the requested testing.

2. Be a participant in the CDC Lipid Standardization Program (LSP) and LSP testing samples must be included in the analytic runs with NHANES samples. LSP results must be sent to the NCHS COR quarterly.

3. Perform NIST calibration for cystatin C, serum creatinine and urinary albumin measurements.

4. Be enrolled in a proficiency-testing program through independent laboratories such as the College of American Pathologists (CAP) or a comparable program and report the results of the proficiency testing to the COR in the quarterly reports.

5. Have all required staffing, equipment, supplies, services, permits, and licenses necessary to perform the contract.

SECTION 11 – ADDITIONAL REQUIREMENTS

1. Section 508 Compliance selections are made.

2. Payment is linked to quality through FAR 52.246-4 Inspection of Services— Fixed-Price.

Complete and deliver data for any crossover study needed in the event of a method and/or instrument change.

Accuracy, completeness, and timeliness of results

As necessary with changes.

Review of scan analysis results and scan auditing log by COR and data

Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are:

The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria

302 Functional Performance Criteria

502 Inoperability with Assistive Technology

503 Applications

504 Authoring Tools

602 Support Documentation

603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a http://www.hhs.gov/web/508 http://www.access-board.gov/sec508/standards.htm http://hhs.gov/web/508 contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the contractor at its expense.

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats is available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer (CO) or Representative.

2. Confidentiality

NCHS Confidentiality Laws: NCHS data, including specimens, are collected under confidentiality statutes including the Privacy Act of 1974 (5 U.S.C. 552a) and Section 308(d) of the Public Health Service Act [42 U.S.C. 242m(d)] which prohibits NCHS from using any personal information for any purpose other than what was described during the informed consent process and from sharing that information with anyone not clearly identified during the informed consent process. Additionally, NCHS data are protected by Title III, the Confidential Information Protection and Statistical Efficiency Act (CIPSEA), of the Foundations for Evidence-Based Policymaking Act of 2018 which was codified in 2019 (Pub. L. No. 115-435, 132 Stat. 5529). CIPSEA provides for stiff fines and imprisonment for violations of confidentiality. Persons who willfully disclose the NCHS confidential information accessed under this contract in any manner to a person or agency not entitled to receive it, shall be guilty of a class E felony and imprisoned for not more than 5 years, or fined not more than $250,000, or both. CIPSEA reinforces laws such as the Privacy Act and Section 308(d) of the Public Health Service Act, which guarantees that data provided to CDC\NCHS shall not be disclosed without the respondent’s consent.

3. Review and Comment

All materials developed or information of whatever nature resulting from work performed under this contract shall be submitted to the contract officer representative (COR) for review and comment.

4. Incorporation of Technical Proposal

The contractor’s technical proposal, including all revisions thereto, submitted in response to this Solicitation is hereby incorporated into the contract by reference. The contractor shall perform the work substantially as set forth in the technical proposal. Any revisions to the technical proposal that would significantly alter the technical approach must be approved in writing by the CO. In the event of a conflict between the Statement of Work, and the contractor’s technical proposal, the Statement of Work will take precedence.

5. Identification of Data

The contractor shall identify the technical data delivered to the Government as required by this contract with the number of the contract and the name and address of the http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html contractor or subcontractor that generated the data.

6. Human Subjects Protections in Research

Procurement Involving Human Subjects. The NCHS Ethics Review Board provides human subjects approval because NHANES is classified as surveillance per 45 CFR 46.102(l)(2), and is excluded under the Common Rule, 2018 requirements. The applicable multiyear NHANES protocol (#2024-01) was reviewed using the “NCHS Practices and Procedures for the Protection of Human Subjects in Primary Data Collection Excluded from or Exempt under the Common Rule”. Protocol #2024-01 was approved on July 11, 2024, and expires on December 31, 2027. It included a general review of biospecimen collection and shipment during the survey and the receipt, testing, and storage of biospecimens by laboratories.

7. Record Storage

The contractor shall keep historical records/archives of transmissions and results to support resolution of questions or issues regarding particular samples for continuous NHANES for a minimum of 3 years after the final payment. All results must be linked to the sample person’s identification number to include:

1. Analytic batch/run number, date of receipt, and date of analysis.

2. Quality control values measured as part of the batch/run, expected control values, lot number of the controls and the manufacturer, and date of expiration of control materials. If control materials are prepared in house, a description of the procedure, data, and the date must be included.

3. Standard reference materials used to provide long-term comparability of values.

4. Reagents by batch/run, reagent's expiration dates, and date of change of reagents.

Reagents should be identified by lot number and manufacturer.

5. All repeated values and reasons for test repeats should be recorded. Repeat tests for abnormal ranges or for samples that have been compromised in the shipping process will be done at the cost of the Government. All other repeats will be done at the cost of the contractor.

8. Contractor Coordination

To ensure effective and efficient production of laboratory measurements, the contractor shall establish and maintain work procedures that facilitate close and continuous coordination with the CO, COR, and other program management personnel.

9. Contractor Personnel

To function effectively and efficiently as a team member in this environment, the contractor shall ensure personnel possess a high degree of subject matter knowledge, skill, and ability to perform the tasks in this contract.

10. Site Visits and Laboratory Inspections

CORs will conduct annual site visits and laboratory inspections of contractor to assess the analytic and post-analytic processes of NHANES samples.

11. Material Transfer Agreement (MTA)

The contractor is required to sign a MTA prior to the receipt of NHANES urine samples.

This agreement describes the terms of appropriate handling and uses of NHANES samples, which is approved by the NCHS Ethics Review Board. NCHS is subject to the Privacy Act and operates under the authority and restrictions of Section 308(d) of the Public Health Service Act and Title V of the E-Government Act of 2002 (PL 107-347), which provides in summary that information obtained under a pledge of confidentiality may be used only for the purpose for which it was supplied, and may not be disclosed, published or released in identifiable form to anyone not authorized to receive it unless the establishment or person supplying the information has consented.

12. Contractor Data Requirements (Rights in Data)

The contractor is prohibited from publicizing or disseminating information without the prior written approval of the COR. All data and products developed under this contract shall become and remain the property of the Government.

The contractor guarantees that it will not tabulate, analyze, release or use the data without prior written approval of the COR. The contractor will release all tabulations and reports solely to the COR or his/her designee. Copies of quality control data of the laboratory instrumentation may be maintained in the contracting laboratory for auditing purposes only.

If the instrument, method or laboratory location changes, the laboratory is required to perform a method validation study. The laboratory may keep the method validation data, for auditing purposes only (i.e. CLIA inspections, etc.), but may never release the data, even after the contract has ended, without prior written approval of the COR. All biologic samples must be returned to the COR, and may not be used for other purposes unless approved by the COR.

13. General Requirements

1. Keep quality control information relevant to this project.

a. All internal (bench) quality control for runs containing NHANES samples.

QC must be run on the same date, as the date of analysis of NHANES samples.

2. Keep a laboratory log containing a record of the status of all NHANES samples/vials upon arrival, including NHANES shipper number, container number, vessel number, date of receipt, condition of samples, and number of samples received; deviations from protocol or good laboratory practice; and an account of all vials, number of samples analyzed; number of QC repeats; due date of results; date of analysis; number of analytes unable to be tested due to any reason, such as quantity not sufficient, contaminated sample or incorrect sample; any deviation in testing protocol; and dates results were submitted. In addition, a record of all handling, storage, and manipulation of samples, which might affect the quantitative results reported (e.g., specimen thaw date, specimen return to freezer date, number of days at refrigerated temperatures, date samples were sent to biorepository for all analytes.

3. All reagent lots and dates of use for each analyte used in testing NHANES samples.

4. Maintain a quality assurance system by which random or systematic errors may be detected and monitored.

5. Have in place a storage facility (-70 degrees C for urine) for samples upon receipt and to store for at least one year any excess urine specimens remaining in vials after analyzing the samples. The government will pay for the shipment of returned samples.

6. Accept delivery of samples on a predetermined schedule supplied by the NCHS.

7. Prepare a laboratory procedure manual with the NHANES COR approval, which will include detailed information on techniques and materials to be used in the assay and the quality control procedures to be used. Normal ranges and upper and lower limits of detection (LOD), for laboratory values will be included along with published documentation to support the choice of the ranges. The manual must be delivered as a Microsoft Word file. The COR will provide the government mandated 508-compliance guidelines and format for the manuals.

8. Be enrolled in a proficiency-testing program through independent laboratories such as the College of American Pathologists (CAP) or a comparable program and report the results of the proficiency testing to the COR in the quarterly reports.

9. Be CLIA certified.

10. The contractor must have well-established quality assurance and competency assessment programs in operation that are regularly evaluated and CLIA-compliant.

11. Provide documentation that verifies performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1) accuracy; (2) precision; (3) the reportable range of test results; and (4) the manufacturer's reference intervals (normal values) for each of urinary albumin and creatinine requirement.

12. Transmit all critical or life-threatening results, electronically to the NCHS data collection contractor, and contact the NCHS Medical Officer.

13. Apply Westgard quality control rules for urinary albumin/creatinine measurements.

14. Follow the guidelines outlined for the prevention of HIV transmission in health-care settings if they are performing biological testing.

15. Coordinate with NCHS data collection contractor to develop a list of possible comment codes associated with the laboratory results that might be required.

16. Repeat testing of 2% NHANES samples in a random manner to monitor the reproducibility of results.

17. Notify the NHANES PO/COR immediately of any current or foreseeable problems with the data collection and/or preparation. The need for modification in procedures, because of these problems or potential problems shall be determined by the mutual agreement of the contractor and the COR. All modifications to the procedures shall be documented in the laboratory manual as to how and why they were decided.

18. Perform a method that is practical and reliable. Practicality of a method will be based on speed, cost, technical skill required, dependability and safety. To judge practicality and reliability, provide the following in the proposal:

a. Time needed for analysis of one specimen;

b. Number of samples which can be analyzed per unit of time under routine conditions; and

c. Time in hours for preventive maintenance, reagent preparation, calibration, troubleshooting, and total operating time (which includes analyses of samples)

19. Indicate acceptable alternative methods or analytical test systems (backup instrumentation) and recommended storage conditions including optimal and maximum storage time for sample retention.

20. Perform a method validation study in the advent of a change in method or instrumentation, and provide the following:

a. NHANES participant and quality control data for a minimum of 150 NHANES samples analyzed simultaneously on the old and new instrumentation/method on the same date.

b. Manufacturer correlation data and graphical results between the old and new instrumentation/method.

c. Results of any in-house method validation studies done comparing the old and new methods, that incorporates the entire analytical measurement range (AMR) of analyte(s). *Other samples may be used, in lieu of NHANES samples, as NHANES participants typically fall within normal ranges.

d. Any quality control data run on both the old and new instruments that used the same manufacturer and lot number(s) and any repeatability/precision data ran on the new and old instruments.

21. Participate in inter-laboratory method validation under direction of NHANES

PO/COR.

22. Store all NHANES samples for a minimum of 1 year at -80oC

23. Notify NHANES COR/PO if any unforeseen problems, potential changes in method or instrumentation in a timely manner.