Sources sought diabetes.pdf

Sources Sought entitled “2021-44634_NHANES Diabetes Profile”

This notice shall not be construed as a RFP or as any commitment or obligation on the part of the Government to issue a solicitation. The Government does not intend to award a contract on the basis of this request, so proposals will not be considered. No reimbursement will be made for any costs associated with providing information in response to this synopsis or any follow-up information requests.

As permitted by FAR Part 10, this is a market research tool being utilized for informational and planning purposes. Your responses will assist the Government in the development of its acquisition strategy for a possible Request for Proposal (RFP), to be issued at a later date, and in determining whether any type of small business set-aside is possible for this procurement or whether full and open competitive procedures should be utilized.

This is strictly market research and the Government will not entertain any questions.

The CDC is conducting this Sources Sought to identify contractors who possess the capabilities to provide services as specified in the attached draft Statement of Work and to determine their availability and capability. If your firm is interested in this requirement and has performed similar projects, please submit your response in accordance with the submission instructions below.

Based on the responses to this Sources Sought Notice, this requirement may be set-aside for small business or procured through full and open competition.

Submission Instructions:

Responses via electronic mail (email) are due on or before April 9, 2021, at 1:00 pm Eastern Time to Ms. Florence P. Black, email address: fpblack@cdc.gov and must include the information requested below. Only emailed responses will be accepted. Responses greater than 15 pages double-sided pages (including all attachments) will not be considered. Late responses will not be accepted. The full title must be included in the subject line of the email: “2021- 44634_NHANES Diabetes Profile”

The North American Industry Classification System (NAICS) Code for this Sources Sought Notice is 621511 – Size Standards in millions of dollars: $35.0 million.

Qualified laboratories shall submit a statement of interest demonstrating the organization’s qualifications to perform the defined work. Responses must be complete and sufficiently detailed to address the specific information. The documentation shall address, at a minimum, the following:

A. Company Profile to include:

1. Company name and address;

2. Two points of contact (names, titles, phone numbers and email addresses);

mailto:fpblack@cdc.gov mailto:fpblack@cdc.gov

3. DUNS number and CAGE Code, as registered in the System for Award Management (SAM) at http://www.betaSam.gov/:

4. Business designation/status (must correlate with SAM registration):

_____ Small business _____ HUBZone _____ WOSB

_____ 8(a) _____ VOSB _____ SDVOSB

_____ Small Disadvantaged Business ______Large business

B. Documentation, in detail, of the company’s capability:

a. Staff expertise, including availability, experience, and formal and other training;

b. Completed projects in the last 5 years of similar size and scope;

c. Corporate experience and management capability;

d. Examples of prior completed Government contracts, reference, and other related information;

C. Staff expertise, including availability, experience, and training;

D. Comments or opinions pertaining to the difficulty and/or feasibility of the potential requirement or proposed acquisition, possible solutions and/or approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts;

E. Proposed NAICS code if you believe a different NAICS is more appropriate. If so, you must provide specific rationale for the NAICS you recommend.

This notice shall not be construed as a RFP or as any commitment or obligation on the part of the Government to issue a solicitation. The Government does not intend to award a contract on the basis of this request, so proposals will not be considered. No reimbursement will be made for any costs associated with providing information in response to this synopsis or any follow-up information requests. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications and capabilities to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

http://www.betasam.gov/ http://www.betasam.gov/

Confidentiality – No proprietary, classified, confidential, or sensitive information should be included in the response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Response is strictly voluntary - it is not mandatory to submit a response to this notice to participate in any formal RFP process that may take place in the future. However, it should be noted that information gathered through this notice may significantly influence the acquisition strategy. All interested parties will be required to respond separately to any solicitations posted as a result of this sources sought notice.

Draft Statement of Work entitled “2021-44634_NHANES Diabetes Profile”

GENERAL

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 (MEC). The survey oversamples the largest race/ethnic minority groups, including Hispanics, non-Hispanic blacks, and non-Hispanic Asians, along with 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.

This Statement of Work (SOW) seeks to obtain laboratory measurements on biologic samples for a diabetes profile (DP), which includes plasma glucose, serum insulin and glycohemoglobin. These tests will be performed on participants aged 12 years and older. Blood samples are collected in morning, afternoon and evening sessions. Plasma glucose and serum insulin will be measured on participants from the morning session, since these participants are asked to fast at least 9 hours. Since fasting is not a requirement for glycohemoglobin measurements, this test will be measured on all participants in all sessions. Specimens will be collected on a regular basis throughout the year and shipped to the testing laboratory on a weekly basis, 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 any and all labor, equipment, supplies, services, permits, and licenses necessary to perform these measurements. These tests must be batched as a single award. However, the government retains the right to only fund a portion of the tests each year.

Data collection for the NHANES 2021-2026 survey cycles will commence in 2021 and conclude in 2026.

Prior to the commencement of data collection, all data management, programming, quality control and reporting system changes must be developed.

1.2 Objective and Scope

1.2.1 Objective

The purpose of the diabetes profile testing in NHANES is to determine a national estimate of diabetes prevalence (diagnosed and undiagnosed); identify the risk factors; permit a national cohort to be established for follow-up studies of this condition; and provide critical information to clinicians and public health officials for the development of preventive care and community-based interventions. In 2015, diabetes was the seventh leading cause of death in the United States. More than 30 million Americans are living with diabetes, and 86 million are living with prediabetes, which is a serious health condition that increases a person’s risk of type-2 diabetes and other chronic diseases. The prevalence of diabetes and overweight (one of the major risk factors for diabetes) continues to increase. Substantial new efforts to prevent or control diabetes have begun, including the Diabetes Prevention Trial and the National Diabetes Education Program.

Under this contract, the contractor laboratory will measure plasma glucose, serum insulin and glycohemoglobin levels from biologic samples collected at the NHANES Mobile Examination Center (MEC) and develop a laboratory procedure manual.

1.2.2 Scope

Statement of Work

This technical approach involves five primary tasks: 1) submit current Clinical Laboratory Improvement Amendments (CLIA) certificate, review the NHANES Contract Laboratory Manual, develop and test systems for testing and reporting NHANES diabetes profile samples for length of the contract, submit NHANES Initial Requirements Laboratory Checklist, and perform diabetes profile testing on 150-200 samples provided by NHANES; 2) perform diabetes profile testing and submit results in a base year, and four potential option years, submit quarterly reports, provide updated CLIA certificate as needed and store NHANES samples for at least one year; 3) Development and delivery of laboratory procedure manual(s).

This work shall provide laboratory measurements for the diabetes profile. Specifically, this effort will allow the National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC) to provide diabetes profile data for public use.

These objectives include the following five tasks:

Task 1 (Base Period):

• Attend initial conference call to discuss requirements of contract (“Kick-Off Meeting”);

• Submit current CLIA certificate;

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

• Submit NHANES Initial Requirements Laboratory Checklist, which collects laboratory contact information;

• Perform diabetes profile (glucose, glycohemoglobin and insulin) testing and reporting of 150-200 samples provided by NHANES, prior to analyzing and reporting NHANES participant data and quality control data for dieabetes profile sent on a weekly basis. Must be capable of high throughput diabetes profile testing of 500 – 4700 samples each year from NHANES 2021-2026. Data (test and quality control results) must be transmitted to NHANES in electronic data files in a format stipulated by the contract officer representative (COR), no later than three weeks (see Section 3.2.1) after receipt of blood samples.

o All NHANES diabetes profile laboratory data must be comparable throughout the survey. This will be assessed on a random basis using blinded samples. The contractor shall perform laboratory analysis using the following methods:

o The Contractor shall provide an assessment of glycohemoglobin from single whole blood samples. The Contractor must document that the method used is a calibrated system with at least 2 years of quality control data and a between-run, among-run CV less than 5%.

o The Contractor shall provide an assessment of fasting plasma glucose samples using the hexokinase method. The Contractor must document that the method used is a calibrated system with at least 2 years of quality control data and a between-run, among-run CV less than 5%.

The same assay must be available for the base and option year periods of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data shall be transmitted to NHANES in electronic data files in a format stipulated by NHANES. Comparison study results and quality control results must be submitted to the COR within three weeks of completion of the comparison study for statistical analysis.

o The Contractor shall provide an assessment of serum insulin in fasting samples. There must be a single source of antibody for the entire study and the assay must be standardized to the WHO insulin standard. The Contractor must document that the method used is a calibrated system with at least 2 years of quality control data and a between-run, among-run CV less than 5%. The same assay must be available for the base and option year periods of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data shall be transmitted to NHANES in electronic data files in a format stipulated by NHANES. Comparison study results and quality control results must be submitted to the COR within three weeks of completion of the comparison study for statistical analysis.

• The Contractor must be a participant in the National Glycohemoglobin Standardization Program. The same assay must be available for the base and option year periods of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data shall be transmitted to NHANES in electronic data files in a format stipulated by NHANES. Comparison study results and quality control results must be submitted to the COR within three weeks of completion of the comparison study for statistical analysis.

• Test results and quality control results must be supplied in a machine-readable format no later than three weeks (3) after receipt of blood samples. The Contractor must have well-established quality assurance and competency assessment programs in operation that are regularly evaluated. Data should be transmitted to NHANES in electronic data files in a format stipulated by NCHS.

• Submit quarterly reports are a comprehensive document which includes a general overview of overall operation of NHANES testing, including any corrective action; log of samples received/tested and if there were any issues with sample receipt; sample analysis issues; sample storage issues; quality control issues, including internal and external quality control; any instrument calibration, linearity, maintenance or troubleshooting performed; and comparison study tracking. Specific instruction can be found on Line (2) of Section 3.1.3 – General Requirements and delivered by a date to be determined at award.

• Develop and deliver of laboratory procedure manuals.

o Laboratory procedure manuals are to be developed in accordance with the instructions found on Line (7) of Section 3.1.3 – General Requirements and delivered by the date to be determined at award. Any subsequent updates or modifications to the laboratory procedure manuals from shall be submitted as they occur. Laboratory procedure manual for all three tests must be developed in a format stipulated by the NCHS PO/COR.

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

Task 2 – 4 (Option Period 2-4)

• Analyze and report NHANES participant data and quality control data for diabetes profile samples sent on a weekly basis. Must be capable of high throughput diabetes profile testing of 500 – 4700 samples each year from NHANES 2021-2026. Data (test and quality control results) must be transmitted to NHANES in electronic data files in a format stipulated by the contract officer representative (COR), no later than three weeks (see Section 3.2.1) after receipt of blood samples. Diabetes profile assays must be FDA-approved or FDA-cleared, current, stable, and available.

• Test results and quality control results must be supplied in a machine-readable format no later than three weeks (3) after receipt of blood samples. The Contractor must have well-established quality assurance and competency assessment programs in operation that are regularly evaluated. Data should be transmitted to NHANES in electronic data files in a format stipulated by NCHS.

o All NHANES diabetes profile laboratory data must be comparable throughout the survey. This will be assessed on a random basis using blinded samples. The contractor shall perform laboratory analysis using the following methods:

The Contractor shall provide an assessment of glycohemoglobin from single whole blood samples. The Contractor must document that the method used is a calibrated system with at least 2 years of quality control data and a between-run, among-run CV less than 5%.

The Contractor shall provide an assessment of fasting plasma glucose samples using the hexokinase method. The Contractor must document that the method used is a calibrated system with at least 2 years of quality control data and a between-run, among-run CV less than 5%. The same assay must be available for the base and option year periods of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data shall be transmitted to NHANES in electronic data files in a format stipulated by NHANES. Comparison study results and quality control results must be submitted to the COR within three weeks of completion of the comparison study for statistical analysis.

The Contractor shall provide an assessment of serum insulin in fasting samples. There must be a single source of antibody for the entire study and the assay must be standardized to the WHO insulin standard. The Contractor must document that the method used is a calibrated system with at least 2 years of quality control data and a between-run, among-run CV less than 5%. The same assay must be available for the base and option year periods of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data shall be transmitted to NHANES in electronic data files in a format stipulated by NHANES. Comparison study results and quality control results must be submitted to the COR within three weeks of completion of the comparison study for statistical analysis.

o Submit quarterly reports are a comprehensive document which includes a general overview of overall operation of NHANES testing, including any corrective action; log of samples received/tested and if there were any issues with sample receipt; sample analysis issues; sample storage issues; quality control issues, including internal and external quality control; any instrument calibration, linearity, maintenance or troubleshooting performed; and comparison study tracking. Specific instruction can be found on Line (2) of Section 3.1.3 – General Requirements and delivered by the date to be determined at award.

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

If a method or instrument change must occur, provide the comparison study/method validation results and quality control results the NHANES PO/COR within three weeks of completion of the comparison study for statistical analysis.

The Contractor shall inform the contract officer representative (COR) of any changes in laboratory methods or instrumentation between the base year and any of the option years within three business days of knowledge of any potential change(s). A comparison study shall be performed between the old and new method or instrument, using a minimum of 150 NHANES samples. Comparison study results, manufacturer correlation data, and quality control results must be submitted to the NCHS COR within three weeks of completion of the comparison study for statistical analysis.

Specific requirements for comparison study/method validations can found on Lines (19 and 20) of Section 3.1.3 – General Requirements and delivered by the date requested by NHANES PO/COR.

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

Task 5 (Option Period 5)

• Analyze and report NHANES participant data and quality control data for diabetes profile samples sent on a weekly basis. Must be capable of high throughput diabetes profile testing of 500 – 4700 samples each year from NHANES 2021-2026. Data (test and quality control results) must be transmitted to NHANES in electronic data files in a format stipulated by the contract officer representative (COR), no later than three weeks (see Section 3.2.1) after receipt of blood samples. Diabetes profile assays must be FDA-approved or FDA-cleared, current, stable, and available.

• Test results and quality control results must be supplied in a machine-readable format no later than three weeks (3) after receipt of blood samples. The Contractor must have well-established quality assurance and competency assessment programs in operation that are regularly evaluated. Data should be transmitted to NHANES in electronic data files in a format stipulated by NCHS.

o All NHANES diabetes profile laboratory data must be comparable throughout the survey. This will be assessed on a random basis using blinded samples. The contractor shall perform laboratory analysis using the following methods:

The Contractor shall provide an assessment of glycohemoglobin from single whole blood samples. The Contractor must document that the method used is a calibrated system with at least 2 years of quality control data and a between-run, among-run CV less than 5%.

The Contractor shall provide an assessment of fasting plasma glucose samples using the hexokinase method. The Contractor must document that the method used is a calibrated system with at least 2 years of quality control data and a between-run, among-run CV less than 5%. The same assay must be available for the base and option year periods of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data shall be transmitted to NHANES in electronic data files in a format stipulated by NHANES. Comparison study results and quality control results must be submitted to the COR within three weeks of completion of the comparison study for statistical analysis.

The Contractor shall provide an assessment of serum insulin in fasting samples. There must be a single source of antibody for the entire study and the assay must be standardized to the WHO insulin standard. The Contractor must document that the method used is a calibrated system with at least 2 years of quality control data and a between-run, among-run CV less than 5%. The same assay must be available for the base and option year periods of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data shall be transmitted to NHANES in electronic data files in a format stipulated by NHANES. Comparison study results and quality control results must be submitted to the COR within three weeks of completion of the comparison study for statistical analysis.

o Submit quarterly reports are a comprehensive document which includes a general overview of overall operation of NHANES testing, including any corrective action; log of samples received/tested and if there were any issues with sample receipt; sample analysis issues; sample storage issues; quality control issues, including internal and external quality control; any instrument calibration, linearity, maintenance or troubleshooting performed; and comparison study tracking. Specific instruction can be found on Line (2) of Section 3.1.3 – General Requirements and delivered by the date to be determined at award.

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

If a method or instrument change must occur, provide the comparison study/method validation results and quality control results the NHANES PO/COR within three weeks of completion of the comparison study for statistical analysis.

The Contractor shall inform the contract officer representative (COR) of any changes in laboratory methods or instrumentation between the base year and any of the option years within three business days of knowledge of any potential change(s). A comparison study shall be performed between the old and new method or instrument, using a minimum of 150 NHANES samples. Comparison study results, manufacturer correlation data, and quality control results must be submitted to the NCHS COR within three weeks of completion of the comparison study for statistical analysis.

Specific requirements for comparison study/method validations can found on Lines (19 and 20) of Section 3.1.3 – General Requirements and delivered by the date requested by NHANES PO/COR.

• Develop and deliver of laboratory procedure manuals.

o Laboratory procedure manuals are to be developed in accordance with the instructions found on Line (7) of Section 3.1.3 – General Requirements and delivered by the date stated in Section 9.1 – Performance Schedule. Any subsequent updates or modifications to the laboratory procedure manuals from shall be submitted as they occur. Laboratory procedure manual for both urinary creatinine and urinary albumin must be developed in a format stipulated by the

NCHS PO/COR.

• Perform any clean-up of the data or quality control as requested by the NHANES

PO/COR.

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

2. CONTRACTOR FURNISHED

All required staffing, equipment, supplies, services, permits, and licenses necessary to perform the contract.

3. SPECIFIC REQUIREMENTS FOR ALL LABORATORY ANALYSES

Technical Services

Technical services, in preparation of the performance of serum samples obtained from individuals examined in the National Health and Nutrition Examination Survey (NHANES) 2021-2026, include:

Technical Requirements

Contractor shall:

1) Have in place industry standard processes for providing the laboratory services described herein related to the de-identified/anonymized samples (e.g. only vessels with numbers) for the following: transmittal information to NHANES contractor; receipt by the NHANES contractor; tracking samples that are in process; entering analysis results;

flagging abnormal or out of range results; and entering quality control data.

2) Repeat 2% NHANES samples in a random manner.

3) Provide detailed information on date, time, batch/run number, and technician identification.

4) Generate quarterly reports using Microsoft Word and submit to NCHS via a CDC approved transmission solution (e.g. secure FTP, etcetera) in coordination with the NCHS contract officer representative (COR) of the contract.

5) Generate Microsoft Excel-based spreadsheet(s) of results and quality control information in a government-specified format (i.e. column delimited), via a secure transmission method (e.g. secure FTP) approved by the COR. The final format will be agreed upon between the contractor and the COR.

6) Have in place CLIA-compliant processes for tracking receipt and processing of NHANES samples from receipt in the lab, to output of the analysis product. This analysis product will include the date of receipt, date of analysis, run/batch number, and the technician who completed these tasks. Reports shall be auditable and customizable by date of receipt, date of analysis, run/batch number of testing, or the technician’s identification.

Record Storage

Contractor shall:

Keep historical records/archives of transmissions and results to support resolution of questions or issues regarding particular samples for Task 2 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.

General Requirements

1) Contractor shall keep all government contract electronic records for 3 years after final payment [FAR4.703(b)]. 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., biological sample thaw date, biological sample 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 (-80 degrees C for whole blood, plasma and serum) for samples upon receipt and to store for at least one year any excess whole blood, plasma and serum samples 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 contract officer representative’s (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 Clinical Laboratory Improvement Amendment (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 the three analytes requested in this diabetes profile requirement.

12) Transmit all critical or life-threatening results, electronically to the NCHS Data Collection Contractor through secure FTP site, and contact the NCHS Medical Officer via phone.

13) Apply Westgard quality control rules for glycohemoglobin, plasma glucose and serum insulin 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 contract officer representative (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 biological sample;

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:

1 Centers for Disease Control and Prevention (CDC). (1989). Recommendations for Prevention of HIV Transmission in Health-Care Settings. MMWR. Morbidity and Mortality Weekly Reports., Vol 38, Supplement 6. Retrieved February 2018, from https://www.cdc.gov/mmwr/preview/mmwrhtml/00001450.htm

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).

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

4. OTHER REQUIREMENTS

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.

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.

Site Visits and Laboratory Inspections

Contract Officer Representative(s) may conduct annual site visits and laboratory inspections of Contractor to assess the analytic and post-analytic processes of NHANES samples.

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 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.

5. CONFIDENTIALITY LAWS

All contractor employees, subcontractors, or other consultants will strictly adhere to confidentiality policies and procedures set forth by CDC/NCHS. The contractor will not try to reidentify any NHANES respondents or use the NHANES samples or data accessed under this contract for any administrative or judicial purposes.

NHANES data, including laboratory samples accessed under this contract, are collected under the Privacy Act (5 U.S.C. 552a) and Section 308(d) of the Public Health Service Act (42 U.S.C. 242m(d)) which guarantees that data provided to CDC\NCHS shall not be disclosed without the respondent’s consent.

Additionally, NHANES data and biological samples are collected under the Confidential Information Protection and Statistical Efficiency Act (CIPSEA) [Title III of the Foundations for Evidence-Based Policymaking Act of 2018 (Pub. L. No. 115-435, 132 Stat. 5529)]. CIPSEA protects information that is acquired for exclusively statistical purposes under a pledge of confidentiality. This law applies to Federal statistical agencies, including CDC/NCHS, that acquire information under these carefully prescribed conditions. The protection of information collected under this law is supported by a penalty of a Class E Felony for a knowing and willful disclosure of confidential information. This includes imprisonment for up to five years and fines up to $250,000.

6. 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 will not tabulate, analyze, release or use the biological samples or coded 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 during the life of the contract.

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 contract officer representative (COR), and may not be used for other purposes unless approved by the COR.

7. DELIVERABLES

Performance Schedule

DATE NHANES DIABETES PROFILE (DP)

PERFORMANCE SCHEDULE 2020-2025

Task 1:

June 15, 2021 – June 14, 2022

• Conference call or site visit to discuss requirements of contract (“Kick-

Off Meeting”);

• Submit current CLIA certificate due within 30 days of award;

• Review the NHANES Contract and CDC Laboratory Manual, test data and QC reporting into a secure site with NHANES Data Collection contractor due within 30 days of award;

• Submit Initial Requirements Laboratory Checklist to NHANES PO/COR due within 30 days of award;

• Conduct testing of 150-200 NHANES diabetes profile (glucose, glycohemglobine and insule) samples and submit data and QC data to NHANES PO/COR due within 60 days of award and 500-4700 diabetes profile samples receive on a weekly basis)

• Deliver Laboratory Procedure manual to NHANES PO/COR due within 60 days of award;

• Analyze NHANES participant samples for diabetes profile sent on a weekly basis. Participant and QC data submitted within 3 weeks;

• Submit quarterly reports every 3 months.

Task 2-4 June 15, 2022 – June 14, 2025

• Three option years;

• Analyze NHANES participant data and quality control data for dieabetes profile (glucose, glycohemoglobin and insulin) samples sent on a weekly basis. Participant data submitted within 3 weeks;

• Submit quarterly reports every 3 months.

Task 5 June 15, 2026 – June 14, 2026

• Final option year;

• Analyze NHANES participant data and quality control data for diabetes profile samples sent on a weekly basis. Participant data submitted within 3 weeks;

• Submit quarterly reports every 3 months;

• All outstanding results, QC, required reports, and final laboratory procedure manual (if updated since initial delivery) delivered to NHANES

PO/COR;

• Deliver updated Laboratory Procedure manuals to NHANES PO/COR.