SOW IgE.pdf

NHANES IgE Laboratory Testing 2024-2029

Period of performance of this contract is: 01/01/2025 to 12/31/2029 Base Period: 01/01/2025 to 12/31/2025 Option Period One: 01/01/2026 to 12/31/2026 Option Period Two: 01/01/2027 to 12/31/2027 Option Period Three: 01/01/2028 to 12/31/2028 Option Period Four: 01/01/2029 to 12/31/2029

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), within the Centers for Disease Control and Prevention (CDC), designed to provide national statistics on the health and nutritional status of the non-institutionalized U.S. civilian population through household interviews, standardized physical examinations, and the collection of biologic samples in special mobile examination centers (MECs). The survey oversamples minority groups and other subgroups of the population. It is estimated that approximately 20,000 individuals ages one-year and older shall be examined during the period of performance of this contract. The purpose of the testing is to generate national estimates on the prevalence and degree of allergic sensitization to common aeroallergens (indoor and outdoor) and food allergens.

NCHS requires Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory services for measuring 21 allergen-specific levels of immunoglobulin E (IgE), total IgE using Fluorescent Enzyme Immunoassay (FEIA), and seven optional food-specific IgEs.

21 Allergen-specific IgEs:

1. Alternaria alternata

2. Aspergillus fumigatus

3. Cladosporium herbarum

4. Penicillium

5. German cockroach (Blatella germanica)

6. Dog dander

7. Cat dander

8. Dust mite (Dermatophagoides 1arina)

9. Dust mite (Dermatophagoides pteronyssinus)

10. Mouse urine proteins

11. Rye grass

12. Bermuda grass

13. Oak

14. Birch

15. Russian thistle

16. Ragweed short/common (Ambrosia artemisilfolia)

17. Cow’s milk

18. Egg

19. Peanut

20. Shrimp

21. alpha-gal

Seven (7) Optional Allergen-specific food IgEs:

1. Wheat

2. Soy

3. Sesame

4. Almond

5. Cashew

6. Walnut

7. Fish (cod)

Specimens shall be collected on a regular basis throughout the year and shipped to the testing laboratory weekly, with the exception of two weeks for a summer break and two weeks over the holiday season at the end of the year. The Contractor shall provide all labor, equipment, supplies, services, permits, and licenses necessary to perform the services. The specimens will bear only anonymized sample IDs. The Contractor shall not be privy to any original identifiers such as participants’ social security numbers, etc.; and shall not be given access to any means with which personally identifiable information could be derived.

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 allergic diseases (including food allergies) constitutes significant public health concerns that afflict millions of people in the U.S and can cause significant morbidity in the population. Additionally, the economic burden of these health outcomes is substantial and has continued to increase, not only in terms of health care costs but also in terms of lost productivity and reduced quality of life. In the context of the COVID-19 pandemic, trend analyses are especially critical for understanding how changes in environmental exposures (including within the home) and COVID-19 infections have affected allergic and respiratory diseases in a nationally representative sample. Because climate change is expected to have profound effects on lung health and allergic diseases, continued research in this area is crucial. The proposed content will enable more robust investigations of the role of indoor allergen and microbial (host and environmental) exposures in chronic allergic diseases and lung health than previously possible. These data are invaluable for program planning, initiatives, and other public health activities documenting the burden of specific diseases and syndromes; and for serving as epidemiological data for the development of ongoing surveillance reporting systems relevant to allergic diseases. These efforts will allow NCHS to provide study participants results and release data on the NHANES website for public use.

The objective of this firm-fixed price contract is to seek a CLIA-certified laboratory to measure total and IgE-specific allergens from biologic samples collected at the NHANES mobile examination centers (MECs) using FEIA, and to develop a laboratory procedure manual for each method grouped by instrument. Specifically –

Objective 1: Testing Performed in CLIA-certified Laboratory Results for analytes specified below are to be reported back to study participants. Therefore, all testing shall be complaint with regulations outlined by the CLIA. Submit data and quality control

(QC) data with 21 days after receipt of samples.

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

Testing shall be performed on an average of 3600-5000 samples each year for total serum IgE and 21 allergen-specific IgEs: [Alternaria alternata, Aspergillus fumigatus, Cladosporium herbarum, Penicillium, German cockroach (Blatella germanica), dog dander, cat dander, dust mite (Dermatophagoides farinae; Dermatophagoides pteronyssinus), mouse urine proteins, rye grass, Bermuda grass, oak, birch, Russian thistle, ragweed short/common (Ambrosia artemisilfolia), cow’s milk, egg, peanut, shrimp, and alpha-gal] using FEIA.

The contractor shall perform testing on an average of 3600-5000 samples each year for seven optional allergen-specific food IgE’s – wheat, soy, sesame, almond, cashew, walnut, and fish (cod).

Objective 2: Develop and deliver laboratory procedure manuals The laboratory procedure manuals are to be developed in accordance with the instructions found in and delivered to the Contracting Officer’s Representative (COR) by the date stated in Section 8, Deliverables and Reporting Schedules. Any subsequent updates or modifications to the laboratory manuals from NHANES 2024-2029 shall be submitted as they occur.

Objective 3: Complete and deliver data for any crossover study needed in the event of a method and/or instrument change.

SECTION 3 – SCOPE OF WORK

In the base year, submit a current CLIA certificate, review the NHANES Contract Laboratory Manual, develop and test systems for testing and reporting NHANES IgE data, submit NHANES Initial Requirements Laboratory Checklist (if applicable), and perform laboratory testing and upload of data within 21-days of receipt of the samples:

1. Use FEIA to measure total IgE and 21 allergen-specific IgEs consisting of the following:

Alternaria alternata, Aspergillus fumigatus, Cladosporium herbarum, Penicillium, German cockroach (Blatella germanica), dog dander, cat dander, dust mite (Dermatophagoides farinae; Dermatophagoides pteronyssinus), mouse urine proteins, rye grass, Bermuda grass, oak, birch, Russian thistle, ragweed short/common (Ambrosia artemisilfolia), cow’s milk, egg, peanut, shrimp, and alpha-gal.

2. Use FEIA to measure 7 optional allergen-specific food IgEs consisting of the following:

Wheat, soy, sesame, almond, cashew, walnut, and fish (cod).

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

4. Submit quarterly reports,

5. Provide updated CLIA certificate as needed,

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

7. Develop and deliver laboratory procedure manual(s).

This work shall provide laboratory measurements for the above stated IgE tests and will allow the government to provide data for public use.

SECTION 4 – TASKS TO BE PERFORMED

Task 1: Base Period The contractor shall:

a. Submit current CLIA certificate.

b. Complete the ‘Initial Requirement Laboratory Checklist’ provided by NCHS, which collects laboratory contact information (if applicable).

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

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

c. Receive Shipments

1. On average, five shipments of samples from different locations (approximately 75-

105 samples total) 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 shipping schedule and the type of shipment (dry ice, freezer packs, or ambient temperature) will be agreed upon by NHANES COR and the Contractor.

2. Have contingency plans in place in the event shipments are delayed.

d. Analyze and report NHANES participant data and quality control data for IgE samples sent on a weekly basis.

1. Total and specific IgE’s shall be measured using FEIA.

2. IgE assays shall be FDA-approved or FDA-cleared, current, stable, and available.

3. The method shall have at least an 84% sensitivity and 85% specificity, have an analytical measurement range of 0.1-100 kUA/I and a CV <15%.

4. To the best of the contractor’s ability, the same assay shall be available for the entire five-year period of the contract. If the test method and/or instrument must be changed, then the contractor shall perform IgE testing and reporting of 150-200 samples provided by NHANES for a method validation study.

5. The Contractor shall have well-established quality assurance and competency assessment programs in operation that are regularly evaluated.

6. The Contractor shall provide an assessment of specified analytes (Section 2) using NHANES specimens.

7. All NHANES IgE data shall be comparable throughout the survey. This shall be assessed on a random basis using blinded samples.

8. Test and quality control results shall be submitted to NHANES via electronic data files in a format stipulated by NCHS no later than three weeks after receipt of samples (See Section 8, Deliverables).

9. Submit quarterly reports as a comprehensive document which includes:

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

ii. A log of samples received/tested, and whether there were any issues with sample receipt.

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

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

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

vi. Comparison study tracking.

vii. Notify the COR of any unforeseen problems, or potential changes in method or instrumentation in a timely manner.

10. Store all NHANES samples for a minimum of 1 year at -70oC or colder.

Task 1: Option Period 1-4

1. Receive Shipments – Same as, “Base Period”

2. Analyze and report NHANES participant data and quality control data for IgE samples sent on a weekly basis. Same as “Base Period.”

3. Test and quality control results shall be submitted to NHANES via electronic data files in a format stipulated by NCHS no later than three weeks after receipt of samples (See Section 8, Deliverables).

4. Submit quarterly reports as a comprehensive document as specified in “Base Period.”

5. Store all NHANES samples for a minimum of 1 year at -70oC or colder.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

No government furnished property will be provided under the contract.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

All performance shall take place off-site at the contractor’s facility. The Contractor shall be available to receive samples per a predetermined schedule and conduct other tasks 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 - No travel shall be required.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Task Deliverable Quantity/Format Due Date Deliver To

CLIA

Certification

CLIA

Certificate

1/PDF Within 30 calendar days of award

NHANES

COR

Initial Requirements Laboratory Checklist (if applicable)

Completed Checklist

1/PDF Within 30 calendar days of award

NHANES

COR

Data Test Confirmation of ability to upload test data in a format/manner approved by

NHANES

security stewards

Email Within 30 calendar days of award

NHANES

COR

2024-2029 continuous NHANES Cycle Data Test Results

Analyze participant samples sent on a weekly basis. Study Participant and QC data submitted within 3 weeks

Up to 5000 per test per year/Data upload

Within 3 weeks (21-days) of sample receipt during the Continuous

NHANES

biospecimen collection

NHANES

Designated Secure Site

Blaney, Robert (CDC/IOD/OPHDST/NCHS) need to check with Brian

Task Deliverable Quantity/Format Due Date Deliver To Quarterly Reports

Quarterly Reports

4 per year/Electronic Report

Quarterly (every 3 months) at the start of data collection

NHANES

COR

Laboratory Procedure Manuals

Complete procedure manuals

1 per year/Electronic Report

Within 180 days of award

NHANES

COR

Updated Procedure Manuals

Updated procedure manuals

4 per year/Electronic Report

As necessary with procedural changes

NHANES

COR

SECTION 9 – MINIMUM VENDOR QUALIFICATIONS

The Contractor shall:

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

2. 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.

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

SECTION 10 – ADDITIONAL REQUIREMENTS

1. 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 (44 U.S.C. 3561-3583). 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.

2. Review and Comment All materials developed or information of whatever nature resulting from work performed under this contract shall be submitted to the COR for review and comment.

3. Identification of Data The contractor shall identify required technical data delivered to the Government as the contract number and the name and address of the contractor or subcontractor that generated the data.

Miller, Donna M. (CDC/IOD/OPHDST/NCHS) Contractor does not need to sign NCHS' NDA or complete NCHS confidentiality training if this contractor is not going to extract DNA from the samples. Please confirm DNA will not be extracted under this contract.

9/9/2024: Renee confirmed DNA will not be extracted. This section can be deleted.

4. Human Subjects Protections in Research Procurement Involving Human Subjects. The NCHS ERB provides human subjects approval and review for biospecimen collection during the survey and storage of biospecimens. This includes the collection, receiving, testing, and storage of biospecimens.

5. 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 shall 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 shall 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 shall be done at the cost of the Contractor.

6. 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 Contracting Officer (CO), Contracting Officer Representative (COR), and other program management personnel.

7. 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.

8. Site Visits and Laboratory Inspections Contract Officer Representative(s) will conduct annual site visits and laboratory inspections of Contractor to assess the analytic and post-analytic processes of NHANES samples.

9. Material Transfer Agreement (MTA) The Contractor is required to sign a Material Transfer Agreement (MTA) prior to the receipt of NHANES blood samples. This agreement describes the terms of appropriate handling and uses of NHANES samples, which is approved by the National Center for Health Statistics (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 III of the Foundations for Evidence Based Policy Making Act of 2018 ( 44 U.S.C. 3561-3583, 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.

10. Contractor Data Requirements (Rights in Data) The Contractor is prohibited from publicizing or disseminating information without the prior written approval of the contract officer representative (COR). All data and products developed under this contract shall become and remain the property of the Government.

The Contractor guarantees that it shall not tabulate, analyze, release or use the data without prior written approval of the COR. The Contractor shall 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 shall be returned to the COR, and may not be used for other purposes unless approved by the COR.

11. General Requirements

1. Keep quality control information relevant to this project.

a. All internal (bench) quality control for runs containing NHANES samples. QC shall 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 or colder for blood) for samples upon receipt and to store for at least one year any excess blood 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 National Center for Health Statistics (NCHS).

7. Prepare a laboratory procedure manual with the NHANES PO/COR approval, which shall 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 shall be included along with published documentation to support the choice of the ranges. The manual shall 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 Clinical Laboratory Improvement Amendment (CLIA) certified.

10. The Contractor shall 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 testing1.

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 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 shall 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.

Should the name of the NCHS Medical Officer and NCHS COR be provided in the SOW? If so, please include.

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 the COR.

22. Store all NHANES samples for a minimum of 1 year at -70oC or colder.

23. Notify the COR of any unforeseen problems, potential changes in method or instrumentation in a timely manner.