2012 - N - 14276 - Solicitation - DIABETES.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 60

2. CONTRACT NO.

3. SOLICITATION NO.

2012-N-14276

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE

NO.

000HCPCG-2012-41266

7. ISSUED BY CODE 8219 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

2920 Brandywine Road

Atlanta, GA 30341-5539

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until 2:00p local time 04/24/2012

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Marie Francoise. Bartkevicius

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-8493

C. E-MAIL ADDRESS

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 33

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 6 X J LIST OF ATTACHMENTS 41

X D PACKAGING AND MARKING 19 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 20 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 21 X K OTHER STATEMENTS OF OFFERORS 42

X G CONTRACT ADMINISTRATION DATA 26 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 43

X H SPECIAL CONTRACT REQUIREMENTS 30 X M EVALUATION FACTORS FOR AWARD 50

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 8219 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

2920 Brandywine Road

Atlanta, GA 30341-5539

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-498-4050

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

Section B - Supplies or Services and Prices/Costs

SCENARIO 1

August 15, 2012 – January 24, 2013 (Six months)

CLIN 0001 – Glycohemoglobin, Fasting Glucose, OGTT, and Insulin – Scenario 1 with OGTT Lab Measurements

Lab Measurements QTY Unit Price Extended Price

CLIN 0001-01 Glycohemoglobin Min: 0

Max: 250

CLIN 0001-02 Fasting Glucose

CLIN 0001-03 OGTT

CLIN 0001-04 Insulin

TOTAL

January 25, 2013 – January 24, 2014 (12 months)

CLIN 0002 – Glycohemoglobin, Fasting Glucose, OGTT, and Insulin – Scenario 1 with OGTT Lab Measurements

Lab Measurements QTY Unit Price Extended Price

CLIN 0002-01 Glycohemoglobin

Max: 4373

CLIN 0002-02 Fasting Glucose

Max: 2004

CLIN 0002-03 OGTT

CLIN 0002-04 Insulin

January 25, 2014 – January 24, 2015 (12 months)

CLIN 0003 – Glycohemoglobin, Fasting Glucose, OGTT, and Insulin – Scenario 1 with OGTT Lab Measurements

Lab Measurements QTY Unit Price Extended Price

CLIN 0003-01 Glycohemoglobin

CLIN 0003-02 Fasting Glucose

CLIN 0003-03 OGTT

CLIN 0003-04 Insulin

January 25, 2015 - January 24, 2016 (12 months)

CLIN 0004 - Glycohemoglobin, Fasting Glucose, OGTT, and Insulin - Scenario 1 with OGTT Lab Measurements

Lab Measurements QTY Unit Price Extended Price

CLIN 0004-01 Glycohemoglobin

CLIN 0004-02 Fasting Glucose

CLIN 0004-03 OGTT

CLIN 0004-04 Insulin

January 25, 2016 - January 24, 2017 (12 months)

CLIN 0005 - Glycohemoglobin, Fasting Glucose, OGTT, and Insulin - Scenario 1 with OGTT Lab Measurements

Lab Measurements QTY Unit Price Extended Price

CLIN 0005-01 Glycohemoglobin

CLIN 0005-02 Fasting Glucose

CLIN 0005-03 OGTT

CLIN 0005-04 Insulin

January 25, 2017 - June 14, 2017 (6 months)

CLIN 0006 - Glycohemoglobin, Fasting Glucose, OGTT, and Insulin - Scenario 1 with OGTT Lab Measurements

Lab Measurements QTY Unit Price Extended Price

CLIN 0006-01 Glycohemoglobin

Max: 38

CLIN 0006-02 Fasting Glucose

Max: 20

CLIN 0006-03 OGTT

CLIN 0006-04 Insulin

SCENARIO 2

August 15, 2012 - January 24, 2013 (Six months)

CLIN 0001 - Glycohemoglobin, Fasting Glucose, and Insulin - Scenario 2 without OGTT Lab Measurements

Lab Measurements QTY Unit Price Extended Price

CLIN 0001-01 Glycohemoglobin

CLIN 0001-02 Fasting Glucose

CLIN 0001-03 Insulin

January 25, 2013 - January 24, 2014 (12 months)

CLIN 0002 - Glycohemoglobin, Fasting Glucose, and Insulin - Scenario 2 without OGTT Lab Measurements

Lab Measurements QTY Unit Price Extended Price

CLIN 0002-01 Glycohemoglobin

CLIN 0002-02 Fasting Glucose

CLIN 0002-03 Insulin

January 25, 2014 - January 24, 2015 (12 months)

CLIN 0003 - Glycohemoglobin, Fasting Glucose, and Insulin - Scenario 2 without OGTT Lab Measurements

Lab Measurements QTY Unit Price Extended Price

CLIN 0003-01 Glycohemoglobin

CLIN 0003-02 Fasting Glucose

CLIN 0003-03 Insulin

January 25, 2015 - January 24, 2016 (12 months)

CLIN 0004 - Glycohemoglobin, Fasting Glucose, and Insulin - Scenario 2 without OGTT Lab Measurements

Lab Measurements QTY Unit Price Extended Price

CLIN 0004-01 Glycohemoglobin

CLIN 0004-02 Fasting Glucose

CLIN 0004-03 Insulin

January 25, 2016 - January 24, 2017 (12 months)

CLIN 0005 - Glycohemoglobin, Fasting Glucose, and Insulin - Scenario 2 without OGTT Lab Measurements

Lab Measurements QTY Unit Price Extended Price

CLIN 0005-01 Glycohemoglobin

CLIN 0005-02 Fasting Glucose

CLIN 0005-03 Insulin

January 25, 2017 - June 14, 2017 (6 months)

CLIN 0006 - Glycohemoglobin, Fasting Glucose, and Insulin - Scenario 2 without OGTT Lab Measurements

Lab Measurements QTY Unit Price Extended Price

CLIN 0006-01 Glycohemoglobin

Max: 38

CLIN 0006-02 Fasting Glucose

CLIN 0006-03 Insulin

Section C - Description/Specification/Performance Based Work Statement

Laboratory Diabetes Analyses for NHANES 2012-2017

C.1 GENERAL

C.1.1 Background

The National Health and Nutrition Examination Surveys (NHANES) are a series of cross-sectional surveys 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 surveys oversample the two largest race/ethnic minority groups, non-Hispanic blacks and Mexican-Americans, along with other subgroups of the population.

This performance-based work statement (PBWS) seeks to obtain laboratories for laboratory measurements on biologic specimens for a diabetes profile (DP) which includes a plasma glucose, two-hour Oral Glucose Tolerance

Test (OGTT), serum insulin, and glycohemoglobin. The contractor shall provide any and all labor, equipment, supplies, services, permits, and licenses necessary to perform these measurements. The period of performance is from 8/15/2012 to 6/14/2017. A six (6) month startup period, two (2) two- year cycles are necessary for the data collection and six (6) months is needed at the end of the survey for data clean up and possible repeat analysis of test results. Tasks awarded under this contract will be incrementally funded. A single award may result from this solicitation, with fixed-price contract(s) anticipated. These tests must be batched as a single award.

Blood specimens are collected in morning, afternoon and evening sessions. For the morning session the participants are required to fast at least 9 hours. Since glucose, OGTT, and insulin must be measured on fasting specimens these tests can only be measured from participants examined in the morning session plus participants who are borderline diabetic or taking insulin or diabetic pills. Since fasting is not a requirement for glycohemoglobin measurements this test will be measured on all participants in all sessions. These tests will be performed on participants aged 12 years and older.

Please provide price estimates for two scenarios indicated in Section B - Supplies or Services and

Prices/Costs. 1 st scenario with OGTT and 2 nd scenario without OGTT:

st Scenario: Glycohemoglobin, glucose, OGTT, and insulin nd

Scenario: Glycohemoglobin, glucose, and insulin

C.2 Objective and Scope

C.2.1 Objective:

The Contractor shall furnish the necessary personnel, materials, services and facilities, and otherwise do all things necessary or incident to the performance of the tasks described below

The objective of this PBWS firm-fixed price competitive negotiated contract is to seek laboratories to measure plasma glucose, two-hour Oral Glucose Tolerance Test (OGTT), serum insulin, and glycohemoglobin assays from biologic specimens collected at the NHANES exam center and develop a laboratory manual comprised of the following three (3) tasks.

Task 1: Diabetes profile testing of 100-250 samples from August 15, 2012 to January 24, 2013. Task 1 will be completed within six months after the delivery of specimens.

Task 1 will only be performed if a new contract is awarded other than the incumbent contractor.

Task 2: Diabetes profile testing of 2004 – 4400 samples from NHANES January 25, 2013 to June 14, 2017. Task 2 will be completed within six month after final delivery of specimens.

Task 3: Laboratory Manual- – The manual is to be developed in accordance with the instructions found at page 19 under Deliverables or Performance. Any subsequent changes to the manual from NHANES 2012-2017 must be submitted as they occur.

C.2.2 Scope:

This technical approach involves three (3) primary tasks for a startup study in 2012; a six (6) month start-up, four (4) twelve (12) month periods and a six (6) month cleanup in 2017. This work will provide laboratory measurements for diabetes profile testing. Specifically, this effort will allow the CDC to post the data available via a web site for public use. The technical approach for this phase involves the following:

C.2.3 Work Breakdown Structure:

Provide Diabetes Profile

(DP) testing

Task 1: NHANES testing of samples

Task 2: NHANES testing of samples

Task 3 Lab Manual

-Determine quantities

--Submit DP/QC results

-Re-run/resubmit any specimens that don’t pass

QA/QC review

-Submit quarterly reports

-Provide CLIA and CAP documents

-Notify PO any unforeseen problems immediately

-Deliver any changes to laboratory manual

-Determine DP quantities

--Submit DP/QC results

-Re-run/resubmit any specimens that don’t pass QA/QC review

-Submit quarterly reports

-Provide CLIA and CAP documents

-Notify PO any unforeseen problems immediately

-Deliver laboratory manual

-Deliver any changes to laboratory manual

The technical approach for this phase involves the following three (3) tasks:

Task 1 will provide high-throughput diabetes profile testing for 100-250 samples from August 15, 2012 to January

24, 2013. Task 1 will be completed within six (6) months after the delivery of specimens. Task 1 will only be performed if a new contract is awarded other than the incumbent contractor.

Glycohemoglobin

The Contractor shall provide an assessment of glycohemoglobin from single whole blood specimens. 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 must be a participant in the national glycohemoglobin standardization program. The same assay must be available for the entire period of the contract.

The test system must be capable of high throughput to accommodate the projected workload on a weekly basis.

Data should be transmitted to NHANES in electronic data files in a format stipulated by NHANES.

Glucose and OGTT

The Contractor shall provide an assessment of plasma glucose and OGTT, fasting and 2-hour glucose specimens, 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 entire period of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data should be transmitted to NHANES in electronic data files in a format stipulated by NHANES.

Insulin

The Contractor shall provide an assessment of serum insulin in fasting specimens. 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 entire period of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data should be transmitted to NHANES in electronic data files in a format stipulated by NHANES.

The assays must be stable and available as was used for Task 1 to Task 2.

Test results and quality control results must be supplied in machine-readable format no later than three weeks (3) after receipt of specimens. Offerors must have a well-established quality assurance program. Data should be transmitted to NHANES in electronic data files in a format stipulated by NHANES.

Task 2 will provide high-throughput 2004-4400 measurements of any specimens from January 25, 2013 to June 14, 2017.

Glycohemoglobin

The Contractor shall provide an assessment of glycohemoglobin from single whole blood specimens. 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 must be a participant in the national glycohemoglobin standardization program. The same assay must be available for the entire period of the contract.

The test system must be capable of high throughput to accommodate the projected workload on a weekly basis.

Glucose and OGTT

The Contractor shall provide an assessment of plasma glucose and OGTT, fasting and 2-hour glucose specimens, 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 entire period of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data should be transmitted to NHANES in electronic data files in a

The Contractor shall provide an assessment of serum insulin in fasting specimens. 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 entire period of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data should

Test results and quality control results must be supplied in machine-readable format no later than three weeks (3) after receipt of whole blood specimens. Offerors must have a well-established quality assurance program. Data should be transmitted to NHANES in electronic data files in a format stipulated by NHANES.

The assays must be stable and available as was used for Task 1 to Task 2.

Task 3: Laboratory Manual- – The manual is to be developed in accordance with the instructions found at page 19 under Deliverables or Performance. Any subsequent changes to the manual from NHANES 2012-2017 must be submitted as they occur.

C.3 CONTRACTOR FURNISHED

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

C.4 Project Identification & Purpose

C.4.1 Background and Need

C.4.1.1 BACKGROUND

It is estimated that approximately 20,000 individuals ages one and older will be examined during the period of performance of this contract. This sample size for each analyte may be altered by changes in fund availability. The number of specimens for each laboratory analyses will vary due to different age targets for each assay.

C.4.1.2 PROJECT FUNDING

This is a fixed-price, requirements-type contract. Under this contract, services may be ordered on an as needed basis. Payment for these services shall be in accordance with the prices set forth herein not to exceed the current funding. Funds may be increased or decreased unilaterally by the

Contracting Officer by modification to the contract. The Contractor shall not accept orders in excess of funds allotted to this contract. Funds allotted to this contract do not constitute an obligation of the Government to place orders in value up to such amounts. The obligation of the

Government is only to the extent of the orders issued under this contract.

C.4.1.3 NHANES BACKGROUND

Data collection for the 2012-2017 survey will begin in August 2012 and conclude in June 2017.

Prior to the commencement of data collection, all data management, programming, quality control and reporting system changes must be developed. This will occur during the five months from contract award until data collection commencement. Approximately 5,000 individuals are expected to be examined per year. This contract will cover laboratory testing of samples collected during the 2012 to 2017 data collection.

For approximately eleven months of the year (with breaks of about two weeks during the holiday season at the end of the calendar year and about two weeks in the summer), specimens will be collected and shipped to the contracting laboratory.

The contractor shall use an automated system for data handling and transmittal as specified by

NCHS. This will be developed prior to the commencement of specimen collection and shipping.

C.5 PERFORMANCE SCHEDULE

On average two shipments of specimens (approximately 200 specimens per shipment) will arrive at the laboratory each week. The specimens are not collected during a 2 week summer vacation and the last 2 weeks of December.

The shipping schedule and the type of shipment (dry ice, freezer packs, or ambient temperature) will be agreed upon by the Contracting Officer’s Representative and the Contractor.

August, 2012 Conference call to discuss requirements of contract

November, 2012 Test data and test quality control (QC) data transmitted to NHANES data collection contractor.

December, 2012 Test scenarios for early and routine report of findings conducted.

December, 2012 Draft laboratory manual delivered.

February, 2013 First results transmitted to NHANES data collection contractor.

February, 2017 Last results transmitted to NHANES data collection contractor.

June, 2017 All outstanding results, Quality Control (QC), required reports, and final laboratory manual delivered to NCHS.

C.6 SPECIFIC REQUIREMENTS FOR ALL LABORATORY ANALYSES

C.6.1 Performance-based Outputs and Standards. Performance-based Matrix for specific outputs and standards

C.15.

C.6.2 In preparation for the performance of samples obtained from participants examined in the National

Health and Nutrition Examination Surveys NHANES 2012-2017:

C.7 GENERAL REQUIREMENTS FOR ALL LABORATORY ANALYSES

In preparation for the performance of the laboratory analyses on individuals examined in the National Health and

Nutrition Examination 2012-2017, the Contractor specifically shall:

1. Maintain an adequate storage facility (-70 degrees C ) for specimens upon receipt and for any excess specimen remaining in vials after analyzing the samples. Excess samples will be packed on dry ice and shipped by an overnight shipper to SriSai (NHANES Surplus Sera Repository) in Germantown, MD. The timetable for sending these samples to the Germantown repository will be determined by the Contracting Officer’s

Representative and the Contractor. The Contractor should be able to store specimens for at least one year. The government will pay for shipment of samples to SriSai’s Repository.

2. Accept delivery of specimens on a predetermined schedule supplied by the National Center for Health

Statistics (NCHS).

3. Prepare a laboratory manual with the Contracting Officer’s Representative’s 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 for laboratory values will also be included along with published documentation to support the choice of the ranges. The manual must be delivered as a Microsoft Word file. The Contracting

Officer’s Representative will provide the format of the manual.

4. Maintain records for reporting results and document quality control information, which at a minimum will include the following (all results must be linked to the sample person’s identification number):

a. Quality control information relevant to this project. The specifications for data output of these data will be provided by the Government (see Information Technology Section, Section B).

b. A laboratory log containing a record of the status of all vials upon arrival, date of receipt, deviations from protocol or good laboratory practice, i.e. proper labeling and packaging, and an account of all vials.

c. A laboratory log containing a record of all handling, storage, and manipulation of specimens, which might affect the quantitative results reported (e.g., freezing, thawing of sera, spilled, contaminated).

d. A quality assurance system by which random or systematic errors may be detected and monitored.

5. All sample person values must be linked to:

a. Analytic batch and date of analysis.

b. Quality control values measured as part of the batch, 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.

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

d. Reagents by batch, reagent's expiration dates, and date of change of reagents. Reagents should be identified by lot number and manufacturer.

e. All repeated values and reasons for test repeats should be recorded. Repeat tests for abnormal ranges, 2% random repeats, or for specimens 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.

6. Proficiency testing through independent laboratories such as the College of American Pathologists or a comparable program shall be done and results reported to the Contracting Officer’s Representative for biological specimens.

7. The laboratory must be CLIA-certified or equivalent certification. Provide copy of CLIA certification. If

CLIA-exempt, provide supporting documentation.

8. Critical call or life-threatening results will be electronically transmitted to the NCHS data collection contractor.

9. For quality control assessment, the laboratory should apply the Westgard rules if applicable to the test method. The Offeror should provide quality control rules for fasting glucose, OGTT glucose(if included), glycohemoglobin, and insulin.

10. All laboratory staff must follow the guidelines outlined by the Centers for Disease Control (MMWR 36;

2S, 1987) for the prevention of HIV transmission in health-care settings if they are performing biological testing.

11. Provide list of possible comment codes associated with the laboratory results that might be required.

C.8 SPECIFIC REQUIREMENTS

Throughout the course of NHANES 2012-2017, the Contractor shall:

1. Repeat a 2% random sample of the specimens tested to monitor the reproducibility of results.

2. Notify the Contracting Officer’s Representative immediately of any current or foreseeable problems with the data collection and/or preparation. The need for modification in procedures shall be determined by the mutual agreement of the Contractor and the Contracting Officer’s Representative. All modifications shall be documented in the laboratory manual as to how and why they were imposed.

3. Submit a progress report quarterly, beginning three months after the start of data collection, to the Contracting

Officer’s Representative including; 1) a summary of the status of all specimens including date of arrival, deviations from protocol, handling, storage, and manipulation of vials and all laboratory procedures used; 2) a description of any major problems such as missing data, out of range values or inconsistent data and what was done to overcome them, and plotted graphs of each level of control. The format of the report will be decided between the Contractor and NCHS Contracting Officer’s Representative.

4. Submit results electronically to The NHANES Survey Contractor on a flow basis. All results shall be submitted within three (3) weeks after specimen receipt.

5. Three months after the start of the Contract, the Contractor shall deliver a laboratory manual that includes detailed information on techniques and materials to be used in the assay and the quality control procedures (see section A3).

This manual must be reviewed and updated on a periodic basis throughout the study. All updates must be delivered to the Contracting Officer’s Representative. This manual must be delivered in an electronic format using Microsoft

Word.

C.9 REQUIREMENTS FOR EACH LABORATORY ANALYSIS

Glycohemoglobin

The Contractor shall provide an assessment of glycohemoglobin from single whole blood specimens. 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 must be a participant in the national glycohemoglobin standardization program. The same assay must be available for the entire period of the contract.

The test system must be capable of high throughput to accommodate the projected workload on a weekly basis.

Glucose

The Contractor shall provide an assessment of plasma glucose and OGTT fasting and 2-hour glucose specimens 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 entire period of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data should be transmitted to NHANES in electronic data files in a

The Contractor shall provide an assessment of serum insulin in fasting specimens. 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 entire period of the contract. The test system must be capable of high throughput to accommodate the projected workload on a weekly basis. Data should

C.10 INFORMATION TECHNOLOGY REQUIREMENTS

1. Contract Laboratory Functions

The contractor shall use an automated system for data handling and transmittal

The biologic samples will be appropriately packaged in the field, labeled with a bar coded sample identification number, and shipped via Federal Express to the laboratory for analysis. Tracking data will be forwarded to the

NHANES Survey Contractor’s Home Office for follow-up with the contract laboratories. The contract laboratory will be responsible for utilizing an automated system for performing the following functions:

a. Importing sample transmittal information into the system;

b. Tracking samples in process;

c. Entering analysis results: The final or best result will be entered in the results field. If abnormal or out-of-range results are re-tested the final data will be flagged with an appropriate comment code for the re-test;

d. Flagging abnormal or out of range results;

e. Entering quality control data: Entering quality control data including running bench quality control tests, and

2% random repeats;

f. Provide detailed auditing information: Provide detailed auditing information including date, time, and technician identification for each major activity;

g. Generate quarterly reports to NCHS: An electronic version of this report in Word is preferred.

h. Generate an electronic file of the results and quality control data: Generate an electronic file of the results and quality control data in a government specified format. Column delimitated data files generated by software such as Excel is one possible method of the data transmission format. The final format will be negotiated by the contractor and the Contracting Officer’s Representative.

C.11 OVERVIEW OF PROCESSING REQUIREMENTS

The Federal Express Air bill number will be used as the Shipment identifier for acknowledgment of receipt and tracking of shipment information. A transmittal file listing the contents of the shipment and any relevant sample information (e.g. age, gender) that is required will also be provided. Transmittal information will be transmitted electronically to the contract laboratory.

Strict control of the sample at the lab is critical. The contractor should have in place an automated process for tracking receipt and processing of the samples from time of receipt in the lab to output of the analysis data. The contractor should have the ability to track the date of receipt, the date and run number of testing, and the technologist who completed these tasks.

C.12 ELECTRONIC PROCESSING CAPABILITIES

Electronic transmission of files will be transmitted by e-mail as the method of communication with the contract laboratories. The government will establish a toll-free 800 number for receipt and transmission of electronic files.

The choice of the method of transmission of data will be negotiated between the Contractor and the Contracting

Officer’s Representative.

C.13 RECORD STORAGE

Labs should maintain historical records/archives of transmissions and results to support resolution of questions or issues regarding particular samples throughout the course of the study.

C.14 Additional Information to be addressed as Applicable:

Systems Security and Safeguards

Federal Information Systems Management Act (FISMA) of 2002 (P.L. 107-347) requires each agency to develop, document, and implement an agency-wide information security program to safeguard information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor (including subcontractor), or other source. FISMA requires agencies to provide information security protections commensurate with the security risks to federal information collected or maintained for the agency and information systems used or operated on behalf of an agency by a contractor.

The National Institute of Standards and Technology (NIST) has issued publications that provide guidance in the establishment of minimum security controls for management, operational and technical safeguards needed to protect the confidentiality, integrity and availability of a Federal Information system and its information.

Pursuant to Federal and Department of Health and Human Services (HHS) Information

Security Program policies, the contractor and any subcontractor performing under this contract shall comply with the following requirements:

The contractor shall ensure the confidentiality, integrity, and availability of sensitive federal information and/or federal information systems, including development of an

IT Security Plan….. (see FAR 7.103(u), 7.105(b)(17), and 39.101).

The contractor shall develop and maintain the software product in compliance with information system security regulatory requirements, while ensuring the application functions and performs in accordance with the business needs, objectives, and operational specifications agreed upon in this contract.

The contractor will take appropriate action to mitigate security risks and vulnerabilities and ensure compliance with HHS and CDC policies as defined in

FISMA and NIST security guidance.

The contractor shall ensure information and system security requirements are considered and implemented, and complied with in all phases or stages of product during the period of performance of the contract.

If new or unanticipated threats or vulnerabilities are discovered by either the

Government or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party for appropriate resolution and action.

The contractor shall not publish or disclose in any manner, without the Contracting

Officer’s written consent, the details of any safeguards either designed or developed by the Contractor under this contract or otherwise provided by the Government.

The contractor shall afford the Government access to the Contractor’s facilities, installations, technical capabilities, operations, documentation, records, and databases to the extent required to carry out a program of inspection to safeguard against threats and hazards to the security, integrity, and confidentiality of

Government data.

The certification and accreditation (C&A) process remains the primary standard by which system security is evaluated. Consistent with Departmental requirements, security documentation to include the constituent parts of the C&A package must be maintained and reviewed for each system reported under FISMA, including contractor systems. A contractor system is defined as any general support system, major application, or minor application hosted or maintained by contractor staff including information system used or operated by a contractor of an agency or other organization on behalf of CDC. This includes all systems physically or logically located within the boundaries of the contractor facilities and systems which reside within CDC boundaries but the primary support for which is delivered by contractor staff. NIST and Departmental guidance provide minimum documentation standards for C&A packages. C&A packages typically consist of the following:

- Risk Assessment

- System Security Plan

- Baseline Security Requirements

- Contingency Plan and Contingency Plan Test Plan and Results

- ST&E Plan and Security Assessment Report

- Plan of Action and Milestones

- Self Assessment

While CDC personnel are responsible for the review, approval, implementation, and annual evaluation of the C&A package and the SSP, the initial responsibility for the development of the required documentation may be assigned to the contractor.

References for adherence:

(1) Federal Information Security Management Act of 2002 (FISMA), Title III, E-

Government Act of 2002, Pub. Law 107-347 http://csrc.nist.gov/policies/FISMA-final.pdf

(2) NIST SP 800-18, Guide for Developing Security Plans for Federal Information

Systems http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf

(3) NIST SP 800-53 Rev2, Recommended Security Controls for Federal Information

Systems http://csrc.nist.gov/publications/nistpubs/800-53-Rev2/sp800-53-rev2-final.pdf

Annex 1, Low Impact Baseline http://csrc.nist.gov/publications/nistpubs/800-53-Rev2/sp800-53-rev2-annex1.pdf

Annex 2, Moderate Impact Baseline http://csrc.nist.gov/publications/nistpubs/800-53-Rev2/sp800-53-rev2-annex2.pdf

Annex 3, High-Impact Baseline http://csrc.nist.gov/publications/nistpubs/800-53-Rev2/sp800-53-rev2-annex3.pdf

(4) NIST SP 800-64 Rev2, Security Considerations in System Development Life Cycle http://csrc.nist.gov/publications/nistpubs/800-64-Rev2/SP800-64-Revision2.pdf

(5) NIST SP 800-37 Rev 1, DRAFT Guide for Security Authorization of Federal

Information Systems: a Security Lifecycle Approach http://csrc.nist.gov/publications/PubsDrafts.html#SP-800-37-Rev.%201

(6) NIST SP 800-37, Guide for the Security Certification & Accreditation of Federal

Information Systems http://csrc.nist.gov/publications/nistpubs/800-37/SP800-37-final.pdf

(7) NIST SP 800-60 (Volume I), Guide for Mapping Types of Information and

Information

Systems to Security Categories.

http://csrc.nist.gov/policies/FISMA-final.pdf http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf http://csrc.nist.gov/publications/nistpubs/800-53-Rev2/sp800-53-rev2-final.pdf http://csrc.nist.gov/publications/nistpubs/800-53-Rev2/sp800-53-rev2-annex1.pdf http://csrc.nist.gov/publications/nistpubs/800-53-Rev2/sp800-53-rev2-annex2.pdf http://csrc.nist.gov/publications/nistpubs/800-53-Rev2/sp800-53-rev2-annex3.pdf http://csrc.nist.gov/publications/nistpubs/800-64-Rev2/SP800-64-Revision2.pdf http://csrc.nist.gov/publications/PubsDrafts.html#SP-800-37-Rev.%201 http://csrc.nist.gov/publications/nistpubs/800-37/SP800-37-final.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol1-Rev1.pdf

Volume II, Appendices to Guide for Mapping Types of Information and Information

Systems to Security Categories http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

(8) FIPS PUB 199, Standards for Security Categorization of Federal Information and http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199-final.pdf

(9) FIPS PUB 200, Minimum Security Requirements for Federal Information and http://csrc.nist.gov/pubications/fips/fips200/FIPS-200-final-march.pdf

(10) FAR 52.239-1, Privacy or Security Safeguards http://www.acquisition.gov/far/current/html/FARTOCP52.html#wp340130 http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol1-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199-final.pdf http://csrc.nist.gov/pubications/fips/fips200/FIPS-200-final-march.pdf http://www.acquisition.gov/far/current/html/FARTOCP52.html#wp340130

C.15 Glycohemoglobin, Glucose, OGTT, and Insulin

Laboratory Measurements

PERFORMANCE-BASED MATRX TO QASP

Desired End

Result

Feature(s) of end result to be surveilled

(Indicator).

The required performance level for each feature

(Standard).

Quality

Assurance

Incentives/Payment-Quality Link

Contractor shall produce “Project

Progress Reports”

The Contractor shall provide QC and Results to

Westat electronically within 3 weeks of each run.

Re-run/resubmit any specimens that don’t pass QA/QC review

Contractor shall notify the PO of any unforeseen or foreseen problems with the testing or delivery of data.

Contractor must maintain QC statistics

The vendor will follow Westgaard

QC rules

Timeliness;

completeness

Accuracy & timeliness

Due quarterly; satisfactory completeness and accuracy.

Monitored by Contracting

Officer’s Representative

Due 3 weeks after receipt of samples; satisfactory completeness and accuracy.

Officer’s Representative.

Due 3 weeks after receipt of samples; satisfactory completeness and accuracy.

Due within 3 days after identification of technical problems. Monitored by

Contracting Officer’s

Representative

Maintain throughout the contract performance period.

Maintain throughout the contract performance period.

Monitored by Contracting

Officer’s Representative

Surveillance system will be primarily by

POs review.

Surveillance system will be primarily by

POs and review of lab and

QA/QC of data.

If fault of

Contractor, they will retest at their expense.

The contractor will keep the

PO appraised of the status and rectification of the problems primarily site inspections by

POs and review of lab and

QA/QC of data primarily site inspections by

POs and review of lab and

QA/QC of data

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 selections are made.

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

1996)a) Definition. “Services,” as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services. (b) The

Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the

Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires. (c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work. (d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties. (e) If any of the services do not conform with contract requirements, the

Government may require the

Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by reperformance, the Government may—

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce the contract price to reflect the reduced value of the services performed.

(f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may—

(1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service; or

(2) Terminate the contract for default.

Section D - Packaging and Marking

There are no clauses/provisions included in this section.

Section E - Inspection and Acceptance

FAR SOURCE TITLE AND DATE

52.246-4 Inspection of Services – Fixed Price (Aug 1996)

E.1 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the

Contracting Officer, or his duly authorized representative (who for the purposes of this contract shall be the

Contracting Officer’s Representative - COR) at the destination of the articles, services or documentation.

(End of Clause)

E.2 Acceptance

Final acceptance will be based on the completion of each delivery/task order.

Section F - Deliveries or Performance

F.1 Deliverable(s) Schedule (Jul 1999)

Delivery Schedule, Number of Copies, and Delivery Date

a. Laboratory Test Results:

Submit results and QC files electronically to The NHANES Survey Contractor on a flow basis. Delivery Date: On a flow, basis three (3) weeks after the specimens are received.

b. Progress Reports

Include a) a summary of the status of all specimens including date of arrival, deviations from protocol, handling, storage, and manipulation of vials, and all laboratory procedures used; b) a description of any major problems such as missing data, out of range values or inconsistent data and what was done to overcome them; internal and external quality control for runs containing NHANES specimens; instrument calibration and repairs;

reagent lots and dates of use. The laboratory should provide an overview of their existing capabilities to meet this requirement. Delivery Date: Quarterly, delivered electronically by E-mail to the Contracting Officer’s Representative three months after the start of data collection.

c. Laboratory Manual

The manual will include instructions on the location for the storage of samples, and detailed information on the techniques and materials used in the assay and quality control procedures. The document must be submitted in electronic form in Word using the template provided by NCHS in addition to one hard copy of the electronic version.

Number of Copies: 1. Delivery Date: Three months after the start of the contract. This manual must be reviewed and updated on a periodic basis throughout the study.

Deliverables Due Date

Laboratory Test Results

On a flow, basis three (3) weeks after the specimens are received.

Progress Reports Quarterly, delivered electronically by E-mail to the Contracting Officer’s Representative three months after the start of data collection.

Laboratory Manual Three months after the start of the contract. This manual must be reviewed and updated on a periodic basis throughout the study.

F.2 Period of Performance (Jul 1999)

(a) Contract: The period of performance of this contract shall not exceed 66 months. The effective date of the contract is shown on the face page of the contract.

(b) Task Orders: The time for completion for each task or delivery order shall be determined under each individual task or delivery order through the mutual agreement of the parties involved. Task/delivery orders under this contract may be awarded by the Contracting Officer at any time within the contract period. The actual performance of the work may extend beyond the contract period.

(c) The period of performance is from 8/15/2012 to 6/14/2017. A six (6) month startup period, two (2) two- year cycles are necessary for the data collection and six (6) months is needed at the end of the survey for data clean up and possible repeat analysis of test results. All laboratory data must be comparable throughout the survey with the same laboratory and methods used. (End of Clause)

F.3 Place(s) of Performance (Jul 1999)

The Contractor shall perform all work under this contract at the contractor’s location. (End of Clause)

F.4 PERFORMANCE SCHEDULE

On average, two shipments of specimens (approximately 50 specimens for each analyte per shipment) will arrive at the laboratory each week. The specimens are not collected during a 2 week summer vacation and the last 2 weeks of

December. The shipping schedule and the type of shipment (dry ice, freezer packs, or ambient temperature) will be agreed upon by the Contracting Officer’s Representative and the Contractor.

August, 2012 Conference call to discuss requirements of contract

November, 2012 Test data and test QC data transmitted to NHANES data collection contractor.

December, 2012 Test scenarios for early and routine report of findings conducted.

December, 2012 Draft laboratory manual delivered.

February, 2013 First results transmitted to NHANES data collection contractor.

February, 2017 Last results transmitted to NHANES data collection contractor.

June, 2017 All outstanding results, QC, required reports, and final laboratory manual delivered to

NCHS.

F.5 DELIVERABLES FOR THE REQUEST FOR CONTRACT

1. Copies of Proficiency testing through independent laboratories such as the College of American Pathologists or a comparable program for 2011 and 2012.

2. Provide copy of CLIA certification. If CLIA-exempt, provide supporting documentation.

The standard laboratory method procedure (LPM) used in the laboratory for each analyte in the diabetes profile will satisfy most of the deliverables for steps 3-14. Those not explicitly in the LPM should be addressed separately.

3. A summary of the analytical procedure.

4. Hazards for the procedure and special safety precautions for handling and disposal of hazardous materials are to be clearly stated. Specify any protective clothing and safety equipment required (e.g., barriers, safety glasses, gloves, clip-on monitors, etc.) and type of spill kit to use if necessary.

5. Specimen collection, storage, and handling procedures; criteria for specimen rejection

a. Specify specimen type and requirements.

b. Indicate amount of specimen required, include both optimum and minimum. Assays that require a smaller amount of blood are encouraged.

c. List acceptable containers, anticoagulants, preservatives, and sterility requirements as well as prohibited containers, anticoagulants, etc., which may create significant analytical interference and compromise test results. If appropriate, the Contractor may screen any blood drawing equipment, collection and storage containers that may cause analytical interference and compromise test results.

d. Clearly state specimen stability and storage requirements.

f. List…