RFP Diabetes 2021- 05.21 final.doc

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Lab Testing for NHANES Diabetes Profile Federal contract opportunity
Solicitation number
75D30121R71894
Issued by
Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services

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PAGE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

1. REQUISITION NUMBER

PAGE 1 OF

2. CONTRACT NO.

3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER

5. SOLICITATION NUMBER

75D30121R71894

6. SOLICITATION

ISSUE DATE

05/21/2021

7. FOR SOLICITATION INFORMATION CALL:
a. NAME

Florence P. Black

b. TELEPHONE NUMBER (No collect calls)

(412) 386-6455

8. OFFER DUE DATE/

LOCAL TIME

06/15/2021

9. ISSUED BY
CODE

10. THIS ACQUISITION IS

12. DISCOUNT TERMS

FORMTEXT

Centers for Disease Control and Prevention

Office of Acquisition Services 626 Cochrans Mill Rd, Building 140 Pittsburgh, PA 15236-0070

X UNRESTRICTED

SET ASIDE:

SIC: 621511

SIZE STANDARD:

X SEE SCHEDULE

UNDER DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

X

IFB

FORMTEXT

RFQ

RFP

15. DELIVER TO
CODE
16. ADMINISTERED BY
CODE
436

SAME AS BLOCK 9

CODE

18a. PAYMENT WILL BE MADE BY
CODE
434

Centers for Disease Control and Prevention (FMO)

PO Box 15580

Atlanta, GA 30333-0080

TELEPHONE NO.

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

“See Continuation Pages”

(Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

X 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

X ARE

28.

CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

29.

AWARD OF CONTRACT: REFERENCE

DATED

30a. SIGNATURE OF OFFEROR/CONTRACTOR
31a. UNITED STATES OF AMERICA (Signature of Contracting Officer)

30b. NAME AND TITLE OF SIGNER (Type or print)

30c. DATE SIGNED

31b. NAME OF CONTRACTING OFFICER (Type or print)

Dawn Redman 31c. DATE SIGNED

32a. QUANTITY IN COLUMN 21 HAS BEEN
33. SHIP NUMBER
34. VOUCHER NUMBER

FORMTEXT

RECEIVED

36. PAYMENT
37. CHECK NUMBER

32b. SIGNATURE OF AUTHORIZED GOV’T REPRESENTATIVE 32c. DATE

41a. I CERTIFY THIS AMOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

38. S/R ACCOUNT NUMBER

39. S/R VOUCHER NUMBER

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC’D 42d. TOTAL CONTAINERS

40. PAID BY

AUTHORIZED FOR LOCAL REPRODUCTION

SEE REVERSE FOR OMB CONTROL NUMBER AND PAPERWORK BURDEN STATEMENT STANDARD FORM 1449 (10-95)

TABLE OF CONTENTS

Section
Document/Clause/Provision
Page No.
A
Standard Form 1449
Table of Contents
i
B
Continuation of SF1449 (Block 19 – 24)
2
C
Contract Clauses
4
D
Contract Documents, Exhibits or Attachments
16
E
Solicitation Provisions
31

SECTION B – CONTINUATION OF SF 1449

Base Period Items

ITEM
SUPPLIES / SERVICES
QTY / UNIT
UNIT PRICE
EXTENDED PRICE
0001
Base Period - Glycohemoglobin

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200

MAX: 5000 Each

0002
Base Period - Fasting Glucose

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

MAX: 2500 Each

0003
Base Period - Insulin

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

0004
Quarterly Reports in accordance with Statement of Work
MIN: 0 each

MAX: 4 each

0005
Laboratory Procedure Manual in accordance with Statement of Work
MIN: 0 each

MAX: 3 each

0006
Initial Requirement Laboratory Checklist
MIN: 0 each

MAX: 1 each

Option Period 1 Items

ITEM
SUPPLIES / SERVICES
QTY / UNIT
UNIT PRICE
EXTENDED PRICE
1001
Option Year 1 - Glycohemoglobin

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

1002
Option Year 1 - Fasting Glucose

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

1003
Option Year 1 - Insulin

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

1004
Quarterly Reports in accordance with Statement of Work
MIN: 0 each

Option Period 2 Items

ITEM
SUPPLIES / SERVICES
QTY / UNIT
UNIT PRICE
EXTENDED PRICE
2001
Option Year 2 - Glycohemoglobin

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

2002
Option Year 2 - Fasting Glucose

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

2003
Option Year 2 - Insulin

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

2004
Quarterly Reports in accordance with Statement of Work
MIN: 0 each

Option Period 3 Items:

ITEM
SUPPLIES / SERVICES
QTY / UNIT
UNIT PRICE
EXTENDED PRICE
3001
Option Year 3 - Glycohemoglobin

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

3002
Option Year 3 - Fasting Glucose

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

3003
Option Year 3 - Insulin

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

3004
Quarterly Reports in accordance with Statement of Work
MIN: 0 each

Option Period 4 Items:

ITEM
SUPPLIES / SERVICES
QTY / UNIT
UNIT PRICE
EXTENDED PRICE
4001
Option Year 4 - Glycohemoglobin

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

4002
Option Year 4 - Fasting Glucose

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

4003
Option Year 4 - Insulin

Testing of NHANES specimens in accordance with the Statement of Work.

MIN: 200 Each

4004
Quarterly Reports in accordance with Statement of Work
MIN: 0 each
4005
Laboratory Procedure Manuals in accordance with Statement of Work
MIN: 0 each

MAX: 3 each

B.1

TYPE OF CONTRACT

This is an IDIQ contract for commercial items. Individual task orders will be fixed priced. The Contracting Officer is the only individual authorized to issue task orders under this contract.

B.2

MINIMUM AND MAXIMUM QUANTITIES

The Government, through the issuance of task order(s) or otherwise (if Contractor does not receive a task order), shall pay a one-time minimum of $2,500.00 to the contractor during the contract’s five-year period of performance (base period plus four option periods).

The maximum for the contract’s five-year period of performance (base period plus four option periods) shall be any quantity or combination of supplies and services not exceeding $535,000.000 dollars.

SECTION C - CONTRACT CLAUSES

Contract Terms and Conditions

FAR/HHSAR

TITLE AND DATE

52.202-1

Definitions (June 2020) 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (June 2020) 52.203-12 Limitation on Payments to Influence Certain Federal Transactions (June 2020)

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (May 2011)

52.204-13

System for Award Management Maintenance (Oct 2018) 52.204-18

Commercial and Government Entity Code Maintenance (AUG 2020)

52.204-19

Incorporation by Reference of Representations and Certifications (Dec 2014)

52.212-4

Contract Terms and Conditions – Commercial Items (OCT 2018) 52.229-3

Federal, State, and Local Taxes (Feb 2013)

52.232-23

Assignment of Claims (May 2014) 52.232-39

Unenforceability of Unauthorized Obligations (June 2013)

52.232-40

Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 52.242-13 Bankruptcy (July 1995)

52.242-15

Stop Work Order (Aug 1989)

52.246-4 Inspection of Services – Fixed Price (Aug 1996) 352.203-70

Anti-Lobbying (Dec 2015)

352.222-70

Contractor Cooperation in EEO Investigations (Dec 2015)

352.224-70

Privacy Act (Dec 2015)

352.224-71

Confidentiality of Information (Dec 2015)

352.239-74

Electronic Information and Technology Accessibility (Dec 2015)

C.1 52.252-2 --CLAUSES INCORPORATED BY REFERENCE (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

https://www.acquisition.gov/ http://www.hhs.gov/policies/hhsar/subpart301-1.html

C.2 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2021)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (June 2020), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X_ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Jun 2020) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11)

(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Mar 2020) (15 U.S.C. 657a).

__ (ii) Alternate I (Mar 2020) of 52.219-3.

__ (12)

(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (Mar 2020) of 52.219-4.

__ (13) [Reserved]

__ (14)

(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-6.

__ (15)

(i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-7.

_X_ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

__ (17)

(i) 52.219-9, Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Jun 2020) of 52.219-9.

__ (v) Alternate IV (Jun 2020) of 52.219-9 __ (18)

(i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

__ (ii) Alternate I (Mar 2020) of 52.219-13.

__ (19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar 2020) (15 U.S.C. 657f).

_X_ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Nov 2020) (15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (MAR 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Mar2020) (15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15U.S.C. 637(a)(17)).

_X_ (27) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

__ (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan2020) (E.O.13126).

_X_ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

_X_ (31) (i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

_X_ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

X__ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

X (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

X (35) (i) 52.222-50, Combating Trafficking in Persons (Oct 2020) (22 U.S.C. chapter 78 and E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

X_ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989).

__ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)).

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

__ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun2014) of 52.223-14.

__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) (42 U.S.C. 8259b).

__ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

X (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

__ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun2016) (E.O. 13693).

__ (47) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

__ (ii) Alternate I (Jan 2017) of 52.224-3.

__ (48) 52.225-1, Buy American-Supplies (Jan2021) (41 U.S.C. chapter 83).

__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (Jan 2021)(41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I (Jan 2021) of 52.225-3.

__ (iii) Alternate II (Jan 2021) of 52.225-3.

__ (iv) Alternate III (Jan 2021) of 52.225-3.

_X_ (50) 52.225-5, Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007) (42 U.S.C. 5150).

__ (55) 52.229-12, Tax on Certain Foreign Procurements (Jun 2020).

__ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

__ (57) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

X (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (31 U.S.C. 3332).

__ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

__ (60) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (61) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

__ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

__ (iii) Alternate II (Feb 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

__ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

__ (7) 52.222-55, Minimum Wages Under Executive Order 13658 (Nov 2020).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.O.11246).

(viii) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(x) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(xiii)

(A) 52.222-50, Combating Trafficking in Persons (Oct 2020) (22 U.S.C. chapter 78 and E.O 13627).

(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May2014) (41 U.S.C. chapter 67).

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Nov 2020).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

(xix)

(A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

C.3

52.216-18 – Ordering (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from the date of contract award through 10 days prior to contract expiration.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor's fax number; or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor's email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of clause)

C.4 52.216-19 -- Order Limitations (Oct 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than 10 analyses, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor --

(1) Any order for a single item in excess of the maximum for each line item;

(2) Any order for a combination of items in excess of the contract maximums; or

(3) A series of orders from the same ordering office within 10 days that together call for quantities exceeding the limitation in subparagraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within five (5) days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.5

52.216-22 -- Indefinite Quantity. (Oct 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule (see B.2) as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after 60 days after the end of the period of performance.

(End of Clause) C.6 52.217-8 -- Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 20 days prior to the end of the period of performance.

(End of Clause)

C.7 52.217-9 -- Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 20 days prior to the end of the period of performance; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months.

(End of Clause) C.8 Issuance of Task/Delivery Orders

Although the Contractor may not be required to conduct all of the tasks set forth in this Statement of Work, 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 each task/delivery order successfully.

Performance hereunder shall be accomplished by task/delivery 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. If the Contractor does not accept the task/delivery order and cannot reach agreement on an individual order basis, it shall be considered a dispute and be handled in accordance with contract clause 52.212-4 Contract Terms and Conditions – Commercial Items, section (d) Disputes.

(End of Clause)

C. 9 Invoicing Information

CDC0_G018 Payment by Electronic Funds Transfer (Feb 2018)

(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 –System for Award Management, in Section C, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In the case that EFT information is not within the System of Award Management, FAR 52.232-34 requires mandatory submission of Contractor’s EFT information directly to the office designated in this contract to receive that information (hereafter: “designated office”); see below. The contractor shall submit the EFT information within the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is either attached to this contract or may be obtained by contacting the Contracting Officer or the CDC Office of Financial Resources at 678-475-4510.

(c) In cases where the contractor has previously provided such information, 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 Office of Financial Resources (OFR)

PO Box 15580

Altanta, GA 30333

OR – Fax copy to : 404-638-5342

CDCA_G001 – Invoice Submission (Mar 2021)

(a) The Contractor shall submit the original contract invoice/voucher in one of the following ways: 1) mail, 2) facsimile, 3) email:

Mailing Address:

The Centers for Disease Control and Prevention

Office of Financial Resources (OFR)

P.O. Box 15580 Atlanta, GA 30333

Fax: 404-638-5324 Email: cpbapinv@cdc.gov

NOTE: Submit only one Invoice in PDF format per attachment.

(b) Subject Line must contain the word “Invoice” Example: Subject: Invoice SAM12345 for Contract 75D30121***********

(c) The content/details of the email must include the below information provided in the body of the email:

· Contract or PO Number:

· Invoice Number:

· Amount:

· Vendor Name:

Only one invoice can be sent to the mailbox with the above relevant details in the body (multiple invoices need to be sent in multiple emails)

(d) The contractor shall submit a copy of the invoice to the cognizant contracting office previously identified in this contract. These invoice copies shall be addressed to the attention of the Contracting Officer.

(e) Do not send Links, Zip Files, or .DAT files containing PDF Invoices

(f) The Contractor is X, is not required to submit a copy of each invoice directly to the Contracting Officer’s Representative (COR) concurrently with submission to the Contracting Officer.

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

(h) 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 Task Order 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 Number

(14) Electronic funds transfer (EFT) banking info For the status of invoices, please contact the OFR Service desk at ofrservicedesk@cdc.gov

NOTE: If your invoice has supporting documents, please combine the invoice and supporting documents as one PDF file. Do not submit the invoice and its supporting documents separately.

C.10 Evaluation of Contractor Performance Utilizing CPARS (Apr 2015)

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]

C.11 Special Contract Requirements

11.1 Data Subject to Confidentiality Requirements

The contractor will release no information, including biological samples, from the data obtained or used under this contract to any persons except authorized staff of NCHS and authorized staff of the NCHS data collection contractor.

To preclude observation of confidential information by persons not employed on the project, the contractor shall maintain all laboratory samples and other confidential records related to this contract under lock and key.

Specifically:

a) NHANES samples must be stored in freezers that are continuously monitored for temperature and access in compliance with all applicable CLIA regulations in a secured facility. The facility must have continuous fire monitoring with lockable freezers.

b) Confidential records, such as NHANES biological samples, data and reports, must be kept locked up at all times when they are not actually being used. That is, they must be kept in locked cabinets or in locked rooms after business hours and whenever the persons using them are not present.

c) If records are maintained in electronic form, the medium on which the files are stored (CD ROMS, removable hard drives) must also be kept in locked containers or, if maintained on a computer, access secured by all available means (including keyboard locks, passwords, encryption, etc. and office locks).

d) Computers containing confidential data should never be maintained in an open, unsecured space. Only a limited number of authorized staff may have keys or other means of access to such cabinets or rooms.

e) When confidential records are in use, whether by themselves or viewed on computer monitors, they must be kept out of the sight of persons not authorized to work with the records.

f) Except as needed for operational purposes, copies of confidential records (paper documents, electronic files, laboratory samples, or records of other kinds) are not to be made. Any duplicate copies made of confidential records are to be destroyed as soon as operational requirements permit. Approved means of destruction include shredding, burning, and macerating.

g) Should re-use of electronic media (hard drives, rewriteable compact disks) containing confidential records be contemplated, extreme care should be taken not to dispose of information in such a way that it can be recovered by unauthorized users of the electronic medium involved. Guidance for the disposition of paper and other types of records shall be provided by the NCHS Confidentiality Officer.

h) No records containing information on NCHS survey respondents may be electronically sent to or accessed from a contractor employee’s home or telecommuting work site or removed from the contractor’s offices.

By a specified date, which may be no later than the date of completion of the contract, the contractor will return all laboratory samples and any other data collected or coded under the contract to NCHS or destroy all such data, as specified by the contract.

11.2 Comply with Information Security and Confidentiality Requirements

The Contractor is not permitted to extract DNA from NHANES serum samples.

11.3 Review and Comment

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

11.4 Identification of Data

The contractor shall identify the technical data delivered to the Government as required by this contract with the number of the contract and the name and address of the contractor or subcontractor that generated the data.

11.5 Government Data Rights

The Government shall have unlimited rights in all data, software and supporting materials acquired under this contract. Under no circumstances shall the contractor place a copyright that will in any way limit the Government’s use of any of the materials for which the contractor 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.

11.6 HSPD-12 Compliance

As part of the Federal HSPD-12 directive, all information systems deployed within/outside of any federal infrastructure must be able to support HSPD-12 compliant Personal Identity Verification (PIV) of federal employees and contractors. The government has complied with HSPD-12 by issuing PIV cards with embedded digital certificates to all users of federal information systems. In accordance with this directive, all vendors providing hardware and software to the federal government are required to ensure that these PIV cards will integrate with their software and hardware at the application level. Contractor must be able to implement and support PIV card integration.

11.7 Standard for Security Configurations

The Contractor shall apply approved security configurations to information technology (IT) that is used to process information on behalf of CDC. The following security configuration requirements apply.

· The Contractor shall configure its computers that contain CDC data with the applicable United States Government Configuration Baseline (USGCB) (see http://usgcb.nist.gov/) and ensure that its computers have and maintain the latest operating system patch level and anti-virus software level. Note: USGCB is applicable to all computing systems, including desktops and laptops—regardless of function—but not including servers.

· The Contractor shall ensure IT applications operated on behalf of CDC are fully functional and operate correctly on systems configured in accordance with the above configuration requirements. The Contractor shall use Security Content Automation Protocol (SCAP)-validated tools with USGCB Scanner capability to ensure its products operate correctly with USGCB configurations and do not alter USGCB settings—see http://scap.nist.gov/validation/. The Contractor shall test applicable product versions with all relevant and current updates and patches installed. The Contractor shall ensure currently supported versions of information technology products meet the latest USGCB major version and subsequent major versions.

· The Contractor shall ensure IT applications designed for end users run in the standard user context without requiring elevated administrative privileges.

· The Contractor shall ensure hardware and software installation, operation, maintenance, update, and patching will not alter the configuration settings or requirements specified above.

· The Contractor shall (1) include Federal Information Processing Standard (FIPS) 201-compliant (see http://nvlpubs.nist.gov/nistpubs/FIPS/NIST.FIPS.201-2.pdf), Homeland Security Presidential Directive 12 (HSPD-12) card readers with the purchase of servers, desktops, and laptops; and (2) comply with FAR Subpart 4.13, Personal Identity Verification.

· The Contractor shall ensure that its subcontractors (at all tiers) which perform work under this contract comply with these requirements.

11.8 508 Compliance

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. All final deliverables must comply with applicable Section 508 accessibility standards, and CDC reserves the right to reject deliverables that fail to meet the standards. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or SOW, shall be the responsibility of the contractor or consultant retained to produce the Web- suitable content or communications material. Regardless of format, all electronic documents - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities.

The following Section 508 provisions apply to the content or communications material identified in this SOW:

36 CFR 1194.22, .31, and .41

Documents must be in unlocked form. Acceptance checklists for various file formats are available at http://www.hhs.gov/web/508/index.html.

SECTION D: CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

1.2 Objective and Scope

1.2.1 Objective

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

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

1.2.2 Scope

Statement of Work This technical approach involves five primary tasks: 1) submit current Clinical Laboratory Improvement Amendments (CLIA) certificate, review the NHANES Contract Laboratory Manual, develop and test systems for testing and reporting NHANES diabetes profile samples for length of the contract, submit NHANES Initial Requirements Laboratory Checklist, and perform diabetes profile testing on 150-200 samples provided by NHANES; 2) perform diabetes profile testing and submit results in a base year, and four potential option years, submit quarterly reports, provide updated CLIA certificate as needed and store NHANES samples for at least one year; 3) Development and delivery of laboratory procedure manual(s). This work shall provide laboratory measurements for the diabetes profile. Specifically, this effort will allow the National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC) to provide diabetes profile data for public use.

These objectives include the following five tasks:

Task 1 (Base Period):

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

· Submit current CLIA certificate;

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

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

· Perform diabetes profile (glucose, glycohemoglobin and insulin) testing and reporting of 150-200 samples provided by NHANES, prior to analyzing and reporting NHANES participant data and quality control data for diabetes profile sent on a weekly basis. Must be capable of high throughput diabetes profile testing of 200 – 5000 samples each year from NHANES 2021-2026. Data (test and quality control results) must be transmitted to NHANES in electronic data files in a format stipulated by the contract officer representative (COR), no later than three weeks (see Section 3.2.1) after receipt of blood samples.

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

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

· The Contractor shall provide an…

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