Specimen_Storage_Solicitation.doc

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

3. SOLICITATION NO.

2014-N-15808

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE NO.

000HCPCG-2014-67994

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 3 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 2920 Brandywine Road, Atlanta, Georgia 30341 until 2:00p local time June 30,2014 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

Juanita A. Waters

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2933

C. E-MAIL ADDRESS

11. TABLE OF CONTENTS

(x)

DESCRIPTION

(x)

DESCRIPTION

X

REPRESENTATIONS, CERTIFICATIONS, AND

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 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

CODE

FACILITY

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

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

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

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 404-718-8100

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©

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

The purpose of this requirement is for Laboratory Services to measure a Lipids profile (LP) from biologic specimens collected at the National Center for Health Statistics’ (NCHS) National Health and Nutrition Examination Survey Centers and develop a laboratory manual comprised of the Tasks outlined in the Performance Work Statement (PWS) in Section C.

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Year 1 - Total Cholesterol

Year 1 - HDL-Cholesterol

Year 1 – Triglycerides

Year 1 - Apo (B)

Draft Laboratory Manual

Year 2 - Total cholesterol

Year 2 - HDL-cholesterol

Year 2 - Triglycerides

Year 2 - Apo (B)

Year 3 - Total cholesterol

Year 3 - HDL-cholesterol

Year 3 - Triglycerides

Year 3 - Apo (B)

Year 4 - Total cholesterol

Year 4 - HDL-cholesterol

Year 4 - Triglycerides

Year 4 - Apo (B)

Year 5 - Total cholesterol

Year 5 - HDL-cholesterol

Year 5 - Triglycerides

Year 5 - Apo (B)

Year 6 – Total cholesterol

Year 6 – HDL-cholesterol

Year 6 - Triglycerides

Year 6 – Apo (B)

Year 6 – Final Laboratory Manual 250/Each 250/Each 250/ Each

250/Each

1/JOB

4600/Each

4600/Each

2400/Each

2400/Each

4600/Each

4600/Each

2400/Each

2400/Each

4600/Each

4600/Each

2400/Each

2400/Each

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46/Each

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24 Each

1/Job

Lipids Profile (LP) Test from Biologic Specimens collected at the NHANES Examination Centers.

(No Funds are obligated on the basic IDIQ contract. Funds will be obligated on each individual Task Order. Lines of Accounting to be Determined when Task Orders are placed.)

· The Government guarantees a minimum order of 24 Units each Fiscal Year under this contract unless the contract should be terminated for cause.

SECTION C – DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

Performance-Based Performance Work Statement

Laboratory Lipids Analyses for NHANES 2014-2019

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 performance work statement (PBPWS) seeks to obtain laboratory measurements on biologic specimens for total cholesterol, triglycerides, Apo (B), and HDL-cholesterol among participants 6 years and older. 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 triglycerides and Apo (B) must be measured on fasting specimens these tests can only be measured from participants examined in the morning session. Since fasting is not a requirement for total cholesterol and HDL-cholesterol measurements these tests will be measured on all participants in all sessions. Total cholesterol and HDL-cholesterol tests will be performed among participants 6 years and older. Triglycerides and Apo (B) tests will be performed among participants 12 years and older.

The goals of this component are to: 1) Monitor the prevalence and trends in major cardiovascular conditions and risk factors in the U.S.; 2) Evaluate prevention and treatment programs targeting cardiovascular disease in the U.S.

The main element of the cardiovascular disease laboratory component in NHANES is blood lipid levels. Cardiovascular disease is the leading cause of death in the United States. An estimated 4.8 million Americans have congestive heart failure. Increasing prevalence, hospitalizations, and deaths have made congestive heart failure a major chronic condition in the United States.

One serum lipoprotein sub-fraction may emerge as independent risk factors for coronary heart disease-Apolipoprotein B. The test was last measured in NHANES III in 1988-91 and 1991-94, 2005 to present, respectively.

The data will be used to: 1) Monitor the status of hypertension prevalence, awareness, treatment and control and the success of the National HBP Education Program; 2) monitor the status of hyperlipidemia and the success of the National Cholesterol Education Program; 3) Estimate the prevalence of congestive heart failure and compare to the baseline data from the NHANES I.

C.1.2 Objective and Scope

C.1.2.1 Objective:

The objective of this firm-fixed price competitive negotiated contract with options is to seek laboratories to measure a Lipids profile (LP) from biologic specimens collected at the NHANES exam center and develop a laboratory manual comprised of the following three (3) tasks.

Task 1: A cross comparison of 250 NHANES 2014 serum specimens. There will be a five month overlap between this contract and the existing contractor performing the same work. During this overlap period the same specimens will be measured at both laboratories. The test results from each contract will undergo statistical methods that will determine if the results are comparable. This exercise ensures the continuity of data trends over time. Task 1 will be performed within a five-month time frame upon delivery of serum specimens.

Task 2: Lipids profile (LP) testing of 2400 -4600 samples each year from NHANES 2015-2019. Task 2 will be completed within eighteen months after the delivery of specimens.

Task 3: Laboratory Manual- – The manual is to be developed in accordance with the instructions found at Paragraph f. of Section 3.2.1.3 and delivered by the date outlined under DELIVERABLES. Any subsequent changes to the manual from NHANES 2014-2019 must be submitted as they occur.

C.1.2.2 Scope:

This technical approach involves three (3) primary tasks. This technical approach involves three (3) primary tasks for a comparison study in 2014, and a base year with option years. This work will provide laboratory measurements for which the Lipids profile (LP) will include measurements for total cholesterol, triglycerides, Apo (B), and HDL-cholesterol. Specifically this effort will allow the National Centers for Disease Control & Prevention to post the data available via a web site for public use. The lipids profile includes total cholesterol, triglycerides, Apo (B), and HDL-cholesterol. The technical approach for this phase involves the following:

C.1.2.3 Work Breakdown Structure SHAPE \* MERGEFORMAT

SHAPE \* MERGEFORMAT

C.1.2.4 The technical approach for this phase involves the following three (3) tasks:

Task 1 will be a comparison study to provide high-throughput Lipids profile (LP) measurements for 200-250 NHANES 2014 serum samples. The laboratory must be a participant in the CDC LSP and be standardized. The laboratory preferably should use quality control materials for each run that are linked to the CDC Lipid Standardization program.

All laboratory data must be comparable throughout the survey with the same laboratory and methods used. The contractor shall perform laboratory analysis for one or more of the following:

Cholesterol must be measured enzymatically in serum in a series of coupled reactions that hydrolyze cholesteryl esters and oxidize the 3-OH group of cholesterol. The laboratory must have at least two years of continuous experience in testing these analytes. The volume of samples, required to be processed with results available to NCHS within 3 weeks of receipt of specimens, require a high throughput.

The direct HDL method in serum is required. The laboratory must have at least two years of continuous experience in testing these analytes. The number of samples sent each week with the transmission of results to NCHS within 3 weeks of receipt of the specimens, requires a high throughput.

Triglycerides must be measured enzymatically in serum using a series of coupled reactions in which triglycerides are hydrolyzed to produce glycerol. The laboratory must have at least two years of continuous experience in testing these analytes. The number of samples sent each week with the transmission of results to NCHS within 3 weeks of receipt of the specimens, requires a high throughput.

Apolipoprotein (B) must be measured by using a nephelometer method. The laboratory must have at least two years of continuous experience in testing these analytes. The number of samples sent each week with the transmission of results to NCHS within 3 weeks of receipt of the specimens, requires a high throughput.

Test results and quality control results must be supplied in machine-readable format no later than three weeks (3) after receipt of serum 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 Lipids profile (LP) for 2400-4600 samples each year from NHANES 2015-2019. The laboratory must be a participant in the CDC LSP and be standardized. The laboratory preferably should use quality control materials for each run that are linked to the CDC Lipid Standardization program.

All laboratory data must be comparable throughout the survey with the same laboratory and methods used. The contractor shall perform laboratory analysis for one or more of the following:

Cholesterol must be measured enzymatically in serum in a series of coupled reactions that hydrolyze cholesteryl esters and oxidize the 3-OH group of cholesterol. The laboratory must have at least two years of continuous experience in testing these analytes. The volume of samples, required to be processed with results available to NCHS within 3 weeks of receipt of specimens, require a high throughput.

The direct HDL method in serum is required. The laboratory must have at least two years of continuous experience in testing these analytes. The number of samples sent each week with the transmission of results to NCHS within 3 weeks of receipt of the specimens, requires a high throughput.

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

The laboratory must have at least two years of continuous experience in testing these analytes. The number of samples sent each week with the transmission of results to NCHS within 3 weeks of receipt of the specimens, requires a high throughput.

Apolipoprotein (B) must be measured by using a nephelometer method. The laboratory must have at least two years of continuous experience in testing these analytes. The number of samples sent each week with the transmission of results to NCHS within 3 weeks of receipt of the specimens, requires a high throughput.

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 serum 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 3: Laboratory Manual- – The manual is to be developed in accordance with the instructions found at Paragraph f. of Section 3.2.1.3 and delivered by the date outlined under DELIVERABLES. Any subsequent changes to the manual from NHANES 2014-2019 must be submitted as they occur.

C.1.2.5 The Contractor will furnish all required staffing, equipment, supplies, services, permits, and licenses necessary to perform the contract.

C.2.1 SPECIFIC REQUIREMENTS FOR ALL LABORATORY ANALYSES

C.2.2 Performance-based Outputs and Standards. See Paragraph 5 - Performance-based Matrix for specific outputs and standards.

C.2.3 Technical Services.

C.2.3.1 In preparation for the performance of serum samples obtained from individuals examined in the National Health and Nutrition Examination Surveys NHANES 2014-2019:

C.2.3.1.1 Information Technology Requirements. Contractor shall:

a. Have in place an automated system for data handling and transmittal for importing sample transmittal information into the system; tracking samples in process; entering analysis results; flagging abnormal or out of range results; and entering quality control data.

b. Repeat 2% of the specimens in a random manner.

c. Provide detailed auditing information including date, time, and technician identification.

d. Generate quarterly reports to NCHS in an electronic version using Microsoft Word.

e. Generate an electronic file of the results and quality control data in a government specified format using column delimitated data files generated by software such as Excel. The final format will be negotiated by the contractor and the Project Officer.

f. 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 by the date of receipt, the date and run number of testing, and the technician who completed these tasks.

C.2.3.1.2 Record Storage. Contractor shall:

Keep historical records/archives of transmissions and results to support resolution of questions or issues regarding particular samples for Task 1 through Task 3. All results must be linked to the sample person’s identification number to include:

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 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.

C.2.3.1.3 General Requirements. Contractor shall:

a. Keep quality control information relevant to this project.

b. Keeps a laboratory log containing a record of the status of all vials upon arrival, date of receipt, deviations from protocol or good laboratory practice, and an account of all vial. Also, 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).

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

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

e. Accept delivery of specimens on a predetermined schedule supplied by the National Center for Health Statistics (NCHS).

f. Prepare a laboratory manual with the Project Officer'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 Project Officer will provide the format of the manual.

g. Enrolled in a proficiency testing through independent laboratories such as the College of American Pathologists or a comparable program. Report results to the Project Officer for serum specimens.

h. CLIA (Clinical Laboratory Improvement Amendment) -certified or equivalent certification. If CLIA-exempt, provide supporting documentation.

i. Transmit critical call or life-threatening results electronically transmitted to the NCHS Data Collection Contractor.

j. Apply the Westgard quality control rules for total Lipids Profile.

k. 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.

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

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

n. Notify the Project Officer 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 Project Officer. All modifications shall be documented in the laboratory manual as to how and why they were imposed.

o. Performance of a method must be judged on both the practicality and reliability of the methods. In evaluating the practicality of a method, speed, cost, technical skill required, dependability and safety must be considered.

To judge these factors, provide the following:

a. Time needed for analysis of one specimen alone;

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

c. Time in hours’ use for preventive maintenance, reagent preparation, calibration, trouble shooting, and total operating time.

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

C.3.1 The table in Section B summarizes the number of specimens to be tested from the survey for the Base Period and all Optional Periods of Performance.

C.4.1 OTHER REQUIREMENTS

C.4.1.1 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, Project Officer, and other program management personnel.

C.4.1.2 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, skills, and abilities to perform the tasks in this contract.

C.4.2 Performance-based Matrix For Laboratory Lipids Analyses for NHANES

Incentives/Payment-Quality Link

The Contractor shall provide QC and test results to Westat

Contractor shall submit quarterly status report

Contractor shall test data transmission electronically

Contractor shall test the report of findings

Contractor shall develop and submit laboratory manual Accuracy & timeliness

Timeliness

Accuracy timeliness

Accuracy

Accuracy & timeliness Not later than 21 days of testing

Not Later Than the 15th day of each quarter

Successful imported of file into the NHANES Data Collection data base

Successful imported of file into the NHANES Data Collection and generation of a report of findings letter

Final manual approved by Program Office Surveillance system will be primarily site inspections and review of lab status reports, and QA/QC

Review of the report by the PO

All data is QCed for accuracy by the PO.

Spot checking of the letters by the PO.

Review of manual by PO.

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.

As prescribed in 46.304, insert the following clause:

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.

(End of clause)

SECTION D – PACKAGING AND MARKING

There are no clauses/provisions included in this section.

SECTION E – INSPECTION AND ACCEPTANCE

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 COR/Project Officer) 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 deliverable.

(End of Clause)

SECTION F – DELIVERIES OR PERFORMANCE

F.1 The period of performance will commence on the date of award and continue for a base period of five (5) months, four (4) 12-month Option Periods and an additional Option Period of five ( 5) months.

F.2 Deliverables

F.2.1 Performance Schedule

On average, two shipments of specimens (approximately 50-75 specimens per shipment) will arrive at the laboratory each week. The specimens are not collected during a two (2) week summer vacation (Usually the last week in June and the first week in July. If this should be changed, the vendor will be notified well in advance for rescheduling purposes.) and the last two (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 Project Officer and the Contractor.

August, 2014

Conference call or site visit to discuss requirements of contract.

November, 2014

Test data and test QC data transmitted to NHANES data collection contractor.

November, 2014

Draft laboratory manual delivered.

December, 2014

Test scenarios for early and routine report of findings conducted.

February, 2015

First results transmitted to NHANES data collection contractor.

The test results for specimens will be transmitted weekly to the NHANES Contractor, Westat, throughout the life of the contract except for two weeks in the summer when specimens are not collected and the last two weeks in December when specimens are not collected.

February, 2019

Last results transmitted to NHANES data collection contractor.

July 1, 2019 All outstanding results, QC, required reports, and final laboratory manual delivered to NCHS.

F.2.2 Delivery Schedule Number of Copies and Delivery Date

F.2.2.1 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. This manual must be reviewed and updated on a periodic basis throughout the study.

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 Hardcopy

Delivery Date:

Draft Manual/Three months after the start of the contract.

Final Manual:

July 1, 2019

F.2.2.2 Progress Reports

Progress Reports shall include:

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). Description of any major problems such as missing data, out of range values or inconsistent data and what was done to overcome them;

c). Internal and external quality control for runs containing NHANES specimens; and d). Instrument calibration and repairs; reagent lots and dates of use.

Delivery Date: Quarterly after the start of the data collection.

Delivery Method: Electronically by E-mail to the Project Officer

F.2.2.3 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.

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

The Contractor shall perform all work under this contract at the contractor’s facility.

(End of Clause)

SECTION G – CONTRACT ADMINISTRATION DATA

G.1 Contracting Officers Representative (COR) Technical Guidance (Sep 2009)

Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof. In the event that the Contractor feels that full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer in a letter separate of any required report(s) within two (2) weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction. If the Contractor fails to provide the required notification within the said two (2) week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposes of this contract that the technical direction was within the scope. No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government COR is not authorized to change any of the terms and conditions of this contract. Changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the delegation memorandum for the COR. Any changes in COR delegation will be made by the Contracting Officer in writing with a copy being furnished to the Contractor.

(End of Clause)

G.2.

Contracting Officer’s Representative (COR)

NCHS COR

Brenda Lewis, MT (ASCP), MPH

Clinical Laboratory Scientist

Planning Branch

Division of Health and Nutrition Examination Surveys

National Center for Health Statistics

Centers for Disease Control and Prevention

3311 Toledo Road, Room 4219

Hyattsville, MD 20782

Telephone: 301-458-4343

G.3.

Government Furnished Property – Biologic specimens collected at the NHANES examination centers will be provided to the vendor to measure a lipids profile (LP) in accordance with Section C of the contract. .

G.4 CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (April 2013)

In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS). The CDC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to prepare and report these contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor.

The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not-concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations.

The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website.

The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of their designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor’s responsibility to notify the CDC contracting office, in writing (letter or email), when their CPARS representative information needs to be changed or updated. Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations.

[End of Clause] G.5 Contracting Officer (Jul 1999)

(a) The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

(b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

(End of Clause)

G.6 Contract Communications/Correspondence (Jul 1999)

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

(End of Clause)

G.7 Payment by Electronic Funds Transfer (Dec 2005)

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In addition to Central Contractor Registration, the contractor shall make the designation by submitting the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Financial Management Office at (404) 498-4050.

(c) In cases where the contractor has previously provided such designation, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

(d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA 30333

Or – Fax copy to: 404-638-5342

(End of Clause)

G.8 Invoice Submission - Part 1 (Mar 2006)

(a) The Contractor shall submit the original contract invoice/voucher to the shown below:

The Centers for Disease Control and Prevention Financial Management Office (FMO) P.O. Box 15580 Atlanta, GA 3033

(b) Please do not forget to submit a copy of each invoice directly to the Project Officer and Contracting Officer or Contract Administrator concurrently with submission to the Financial Management Office (FMO). It saves time, postage, and speeds up the payment processing by emailing the invoices to the 3 listed email addresses below:

Financial Management Office (FMO): Email: FMOAPINV@CDC.GOV, Fax: 404-638-5324

Contracts Specialist: Nina Waters, 770-488-2933

Contracting Officer’s Representative (COR): David Lacher, M.D. (301)458-4343

(c) The Contractor is required to submit a copy of each invoice directly to the Project Officer concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(e) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Contract Number, if Appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (c) (1).

(13) DUNS + 4 Numbers

(End of Clause)

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 Type of Contract

The Government anticipates awarding a Firm-Fixed Price/Indefinite Delivery-Indefinite Quantity (IDIQ) Task Order contract to be awarded for this requirement.

H.2 Government Rights in Data

All data, software and supporting materials acquired under this contract become the property of the U.S. Government. Under no circumstances shall an offeror place a copyright that will in any way limit the Government’s use of any of the materials for which the vendor develops, provides and/or receives payment under this contract.

The Contractor shall not provide any government documents, information, or licensed material in any form to sources not authorized by NCHS without written approval during the period of performance of this requirement and any time afterwards. Execution of non-disclosure statements will be required.

H.3 Review of Data

The following persons may review the data: NCHS Project Officer and Contracting Officer Representative; NCDC&P Project Representative, NIH Project Representative, the NHANES Data collection contractor, and outside consultants as requested by the Project Officer or Alternate Project Officer.

H.4 Identification and Disposition of Data

The Contractor guarantees that it will not tabulate, analyze, release or use the data without prior written approval of the Contracting Office and the Project Officer. The Contractor will release all tabulations and reports solely to the Project Officers or their designee. Copies of quality control data may be maintained in the contracting laboratory. If method development is done as part of this project, the Contractor may keep that data. All biologic specimens must be returned to the Project Officer and may not be used for other purposes unless approved by the Project Officer.

H.5 Smoke Free Working Environment (May 2009)

In compliance with Department of Health and Human Services (DHHS) regulations, all contractor personnel performing work within CDC/ATSDR facilities shall observe the CDC/ATSDR smoke-free working environment policy at all times. This policy prohibits smoking in all CDC/ATSDR buildings and in front of buildings which are open to the public. This policy is also applicable to contractor personnel who do not work full-time within CDC/ATSDR facilities, but are attending meetings within CDC/ATSDR facilities.

H.6 Privacy Act (Sep 2009)

(a) Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the Government. The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl.

(b) The COTR is hereby designated as the official who is responsible for monitoring contractor compliance with the Privacy Act.

(c) The Contractor shall follow the Privacy Act guidance as outlined in the Privacy Act of 1974 (5 USC 552a) and Section 308(d) of the Public Health Service Act.

(End of Clause) H.7 Dissemination of Information (May 2010)

No information related to data obtained under this contract shall be released or publicized without the prior written consent of the COR.

(End of Clause)

H.8 Data Subject to Confidentiality Requirements (May 1998)

The type(s) of data subject to the Clause at 352.224-70, Confidentiality of Information, which has been incorporated by reference in Section I, are as follows:

All Data generated by this procurement, including personally identifying information.

Following are the requirements for handling these data:

The Contractor is prohibited from publicizing or disseminating information without the prior review and comment of the Project Officer. All data and products developed under this contract shall become and remain the property of the Government.

H.9 Issuance of Task/Delivery Orders

The Contractor shall be capable of providing the staff necessary to conduct the required work. The timing, magnitude, and scope of each requirement cannot be predicted until the Government determines the specific work to be performed. The Contractor should expect a fluctuating workload throughout the performance period of this contract and will provide the technical, professional, managerial, and clerical support required to complete the task order successfully. The technical monitor, project officer, or designee may accompany the Contractor to each site for the purpose of monitoring the Contractors startup activities and may elect to remain at the site to monitor Contractor activities.

Performance hereunder shall be accomplished by task orders issued under this contract in accordance with the following procedure:

As the Government identifies specific requirements for work to be performed under this contract, a Task Delivery Order will be issued unilaterally. The Order will detail the requirements and associated funding. The NCHS program official will subsequently provide a predetermined delivery schedule for those requirements. If the Contractor does not accept the Task/Delivery Order and cannot reach agreement on an individual task order basis, it shall be considered a dispute and handled according to the provision of the contract in Section I, FAR 52.233-01 Disputes – Alternate I” (Oct 1995).

H.10 Prohibition on the Use of Appropriated Funds for Lobbying Activities (Jul 1999)

The contractor is hereby notified of the restrictions on the use of Department of Health and Human Service's funding for lobbying of Federal, State and Local legislative bodies.

Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient (and their subcontractors) of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions; the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement. For additional information of prohibitions against lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.

In addition, the current Department of Health and Human Services Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support, or defeat legislation pending before the Congress, or any State or Local legislature except in presentation to the Congress, or any State or Local legislative body itself.

The current Department of Health and Human Services Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature.

(End of Clause)

H.11 Non-Disclosure Agreement for Contractor and Contractor Employees (Mar 2006)

(a) The contractor shall prepare and submit a Non-Disclosure Agreement (NDA) to the Contracting Officer prior to access of government information or the commencement of work at CDC.

(b) The NDA made part of this clause, exhibit I and II , is required in service contracts where positions and/or functions proposed to be filled by contractor’s employees will have access to non-public and procurement-sensitive information. The NDA also requires contractor’s employees properly identify themselves as employees of a contractor when communicating or interacting with CDC employees, employees of other governmental entities (when communication or interaction relates to the contractor’s work with the CDC), and members of the public. The Federal Acquisition Regulation (FAR) 37.114 (c), states “All contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public or Congress that they are Government officials, unless, in the judgment of the agency, no harm can come from failing to identify themselves. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.”

(c) The Contractor shall inform employees of the identification requirements by which they must abide and monitor employee compliance with the identification requirements.

(d) During the contract performance period, the Contractor is responsible to ensure that all additional or replacement contractors’ employees sign a NDA and it is submitted to the Contracting Officer prior to commencement of their work with the CDC.

(e) Contractor employees in designated positions or functions that have not signed the appropriate NDA shall not have access to any non-public, procurement sensitive information or participate in government meeting where sensitive information may be discussed.

(f) The Contractor shall prepare and maintain a current list of employees working under NDAs and submit to the Contracting Officer upon request during the contract period of performance. The list should at a minimum include: contract number, employee’s name, position, date of hire and NDA requirement.

EXHIBIT I

Centers for Disease Control and Prevention (CDC)

Contractor Non-Disclosure Agreement

I. Non-public Information

[Name of contractor] understands that in order to fulfill the responsibilities pursuant to [Contract name and number] between the Centers for Disease Control and Prevention and [Name of CDC contractor] dated [date], employees of [contractor] will have access to non-public information, including confidential and privileged information contained in government-owned information technology systems. For purposes of this agreement, confidential information means government information that is not or will not be generally available to the public. Privileged information means information which can

HYPERLINK "http://www.hyperdictionary.com/dictionary/not" not be disclosed without the prior written consent of the CDC.

In order to properly safeguard non-public information, [contractor] agrees to ensure that prior to being granted access to government information or the commencement of work for the CDC, whichever is applicable, all employees will sign a Non-Disclosure Agreement (NDA) provided by the CDC prior to beginning work for the CDC. Contractor agrees to submit to the contracting official the original signed copies of NDAs signed by the contractor’s employees in accordance with the instructions provided by the contracting official.