W81K0223Q0132 Reagent Brand Name Solicitation.pdf

SEE ADDENDUM

(No Collect Calls)

W81K0223Q0132 21-Aug-2023

b. TELEPHONE NUMBER

(360)-486-0729

8. OFFER DUE DATE/LOCAL TIME

02:00 PM 05 Sep 2023

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA X ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W81K029. ISSUED BY

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

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

DYLAN J. FORD

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

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

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

0011881959-0002

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED OR X

SMALL BUSINESSX

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

W40M RHCO PACIFIC

MEDICAL READINESS CONTR OFC PACIFIC

BLDG 339 CLARK ROAD

FORT SHAFTER HI 96858-5098

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE HT0864 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

AMC MADIGAN LEWIS - MM

AMC MADIGAN LEWIS - MM

FITZSIMMONS

BLDG 940A

JOINT BASE LEWIS MCCH WA 98431-1100

TEL: (253) 968-1110 FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,250

NAICS:

325413

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF54

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

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

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

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

W81K0223Q0132

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 9 Pack

(PAK)

Virotrol II

FFP

Contractor shall provide Virotrol II IAW the SOW. Part Number: 00115B POP:

01 October 2023-30 September 2024. Each pack includes 10 vials / 4 mL’s per pack, refrigerated.

FOB: Destination

MFR PART NR: 00115B

PURCHASE REQUEST NUMBER: 0011881959-0002

PSC CD: 6550

NET AMT

0002 49 Pack

CARD MKR LT LOWPLU

Contractor shall provide CARD MKR LT LOWPLU IAW the SOW. Part Number: 149 POP: 01 October 2023-30 September 2024. Each pack contains 6 vials / 3 mL’s per pack, frozen.

FOB: Destination

MFR PART NR: 149

0003 11 Pack

ViroClear SARS COV-2

Contractor shall provide ViroClear SARS COV-2 5x4ml IAW the SOW. Part Number: 200505 POP: 01 October 2023-30 September 2024. Each pack contains 5 vials / 4mL’s per pack, refrigerated.

FOB: Destination

MFR PART NR: 200505

0004 1 Each Unity Real Time 1 Year Ann Sub

FFP

Contractor shall provide Unity Real Time 1 Year Annual Subscription IAW the SOW. Part Number: 8004-1 POP: 01 October 2023-30 September 2024.

FOB: Destination

MFR PART NR: 8004-1

1001 9 Pack

OPTION Option Period 1 Virotrol II

Option Period 1, Contractor shall provide Virotrol II IAW the SOW. Part Number:

00115B POP: 01 October 2024-30 September 2025. Each Pack contains 10 vials / 4 mL’s per pack, refrigerated.

FOB: Destination

MFR PART NR: 00115B

1002 49 Pack

OPTION Option Period 1 CARD MKR LT LOWPLU

Option Period 1, Contractor shall provide CARD MKR LT LOWPLU IAW the SOW. Part Number: 149 POP: 01 October 2024-30 September 2025. Each pack contains 6 vials / 3 mL’s per pack, frozen.

FOB: Destination

MFR PART NR: 149

1003 11 Pack

OPTION Option Period 1 ViroClear SARS COV-2

Option Period 1 Contractor shall provide ViroClear SARS COV-2 5x4ml IAW the SOW. Part Number: 200505 POP: 01 October 2024-30 September 2025. Each pack contains 5 vials / 4mL’s per pack, refrigerated.

FOB: Destination

MFR PART NR: 200505

1004 1 Each OPTION OPY1 Unity Real Time 1 Year Ann Sub

FFP

Option Period 1, Contractor shall provide Unity Real Time 1 Year Annual Subscription IAW the SOW.Part Number: 8004-1 POP: 01 October 2024-30 September 2025.

FOB: Destination

MFR PART NR: 8004-1

2001 9 Pack

OPTION Option Period 2 Virotrol II

Option Period 2, Contractor shall provide Virotrol II IAW the SOW. Part Number:

00115B POP: 01 October 2025-30 September 2026. Each Pack contains 10 vials / 4 mL’s per pack, refrigerated.

FOB: Destination

MFR PART NR: 00115B

2002 49 Pack

OPTION Option Period 2 CARD MKR LT LOWPLU

Option Period 2, Contractor shall provide CARD MKR LT LOWPLU IAW the SOW. Part Number: 149 POP: 01 October 2025-30 September 2026. Each pack contains 6 vials / 3 mL’s per pack, frozen.

FOB: Destination

MFR PART NR: 149

2003 11 Pack

OPTION Option Period 2 ViroClear SARS COV-2

Option Period 2, Contractor shall provide ViroClear SARS COV-2 5x4ml IAW the SOW. Part Number: 200505 POP: 01 October 2025-30 September 2026. Each pack contains 5 vials / 4mL’s per pack, refrigerated.

FOB: Destination

MFR PART NR: 200505

2004 1 Each OPTION OPY2 Unity Real Time 1 Year Ann Sub

FFP

Option Period 2, Contractor shall provide Unity Real Time 1 Year Annual Subscription IAW the SOW. Part Number: 8004-1 POP: 01 October 2025-30 September 2026.

FOB: Destination

MFR PART NR: 8004-1

3001 9 Pack

OPTION Option Period 3 Virotrol II

Option Period 3, Contractor shall provide Virotrol II IAW the SOW. Part Number:

00115B POP: 01 October 2026-30 September 2027. Each Pack contains 10 vials / 4 mL’s per pack, refrigerated.

FOB: Destination

MFR PART NR: 00115B

3002 49 Pack

OPTION Option Period 3 CARD MKR LT LOWPLU

Option Period 3, Contractor shall provide CARD MKR LT LOWPLU IAW the SOW. Part Number: 149 POP: 01 October 2026-30 September 2027. Each pack contains 6 vials / 3 mL’s per pack, frozen.

FOB: Destination

MFR PART NR: 149

3003 11 Pack

OPTION Option Period 3 ViroClear SARS COV-2

Option Period 3, Contractor shall provide ViroClear SARS COV-2 5x4ml IAW the SOW. Part Number: 200505 POP: 01 October 2026-30 September 2027. Each pack contains 5 vials / 4mL’s per pack, refrigerated.

FOB: Destination

MFR PART NR: 200505

3004 1 Each OPTION OPY3 Unity Real Time 1 Year Ann Sub

FFP

Option Period 3, Contractor shall provide Unity Real Time 1 Year Annual Subscription IAW the SOW. Part Number: 8004-1 POP: 01 October 2026-30 September 2027.

FOB: Destination

MFR PART NR: 8004-1

4001 9 Pack

OPTION Option Period 4 Virotrol II

Option Period 4, Contractor shall provide Virotrol II IAW the SOW. Part Number:

00115B POP: 01 October 2027-30 September 2028. Each Pack contains 10 vials / 4 mL’s per pack, refrigerated.

FOB: Destination

MFR PART NR: 00115B

4002 49 Pack

OPTION Option Period 4 CARD MKR LT LOWPLU

Option Period 4, Contractor shall provide CARD MKR LT LOWPLU IAW the SOW. Part Number: 149 POP: 01 October 2027-30 September 2028. Each pack contains 6 vials / 3 mL’s per pack, frozen.

FOB: Destination

MFR PART NR: 149

4003 11 Pack

OPTION Option Period 4 ViroClear SARS COV-2

Option Period 4, Contractor shall provide ViroClear SARS COV-2 5x4ml IAW the SOW. Part Number: 200505 POP: 01 October 2027-30 September 2028. Each pack contains 5 vials / 4mL’s per pack, refrigerated.

FOB: Destination

MFR PART NR: 200505

4004 1 Each OPTION OPY4 Unity Real Time 1 Year Ann Sub

FFP

Option Period 4, Contractor shall provide Unity Real Time 1 Year Annual Subscription IAW the SOW. Part Number: 8004-1 POP: 01 October 2027-30 September 2028.

FOB: Destination

MFR PART NR: 8004-1

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 0002 Destination Government Destination Government 0003 Destination Government Destination Government 0004 Destination Government Destination Government 1001 Destination Government Destination Government 1002 Destination Government Destination Government 1003 Destination Government Destination Government 1004 Destination Government Destination Government 2001 Destination Government Destination Government 2002 Destination Government Destination Government 2003 Destination Government Destination Government 2004 Destination Government Destination Government 3001 Destination Government Destination Government 3002 Destination Government Destination Government 3003 Destination Government Destination Government 3004 Destination Government Destination Government 4001 Destination Government Destination Government 4002 Destination Government Destination Government 4003 Destination Government Destination Government 4004 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 30-SEP-2024 9 AMC MADIGAN LEWIS - MM

AMC MADIGAN LEWIS - MM

FITZSIMMONS

BLDG 940A

JOINT BASE LEWIS MCCH WA 98431-1100

(253) 968-1110 FOB: Destination

HT0864

0002 30-SEP-2024 49 (SAME AS PREVIOUS LOCATION)

0003 30-SEP-2024 11 (SAME AS PREVIOUS LOCATION)

0004 30-SEP-2024 1 (SAME AS PREVIOUS LOCATION)

1001 30-SEP-2025 9 (SAME AS PREVIOUS LOCATION)

1002 30-SEP-2025 49 (SAME AS PREVIOUS LOCATION)

1003 30-SEP-2025 11 (SAME AS PREVIOUS LOCATION)

1004 30-SEP-2025 1 (SAME AS PREVIOUS LOCATION)

2001 30-SEP-2026 9 (SAME AS PREVIOUS LOCATION)

2002 30-SEP-2026 49 (SAME AS PREVIOUS LOCATION)

2003 30-SEP-2026 11 (SAME AS PREVIOUS LOCATION)

2004 30-SEP-2026 1 (SAME AS PREVIOUS LOCATION)

3001 30-SEP-2027 9 (SAME AS PREVIOUS LOCATION)

3002 30-SEP-2027 49 (SAME AS PREVIOUS LOCATION)

3003 30-SEP-2027 11 (SAME AS PREVIOUS LOCATION)

3004 30-SEP-2027 1 (SAME AS PREVIOUS LOCATION)

4001 30-SEP-2028 9 (SAME AS PREVIOUS LOCATION)

4002 30-SEP-2028 49 (SAME AS PREVIOUS LOCATION)

4003 30-SEP-2028 11 (SAME AS PREVIOUS LOCATION)

4004 30-SEP-2028 1 (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions--Commercial Products and

Commercial Services

DEC 2022

ADDENDUM TO 52.212-4

(w) UNILATERAL MODIFICATIONS

In addition to 52.212-4(c), the Government may make unilateral modifications considered administrative in nature.

These include, but are not limited to, changes in the accounting and appropriation data, payment and issuing office addresses, and other corrections that have no effect on the terms and conditions of the contract.

(x) The non-FAR Part 12 discretionary FAR and DFARS clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 herein for locations where full text can be found.

(y) Reference Department of Defense Directive (DoDD) 6459.01, Sexual Assault and Response (SAPR) Program

(z) TAS Reporting For reporting purposes, FAR Clause 52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards, the Treasury Account Symbol (TAS) is 97 0130.

(End Addendum 52.212-4)

52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

JUN 2020

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

JAN 2017

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards

JUN 2020

52.204-13 System for Award Management Maintenance OCT 2018 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.204-23 Prohibition on Contracting for Hardware, Software, and

Services Developed or Provided by Kaspersky Lab and Other Covered Entities

NOV 2021

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment

NOV 2021

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

NOV 2021

52.219-6 Notice Of Total Small Business Set-Aside NOV 2020 52.222-19 Child Labor -- Cooperation with Authorities and Remedies DEC 2022 52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-26 Equal Opportunity SEP 2016 52.222-27 Affirmative Action Compliance Requirements for

Construction

APR 2015

52.222-35 Equal Opportunity for Veterans JUN 2020 52.222-36 Equal Opportunity for Workers with Disabilities JUN 2020 52.222-37 Employment Reports on Veterans JUN 2020 52.222-50 Combating Trafficking in Persons NOV 2021 52.223-18 Encouraging Contractor Policies To Ban Text Messaging

While Driving

JUN 2020

52.225-13 Restrictions on Certain Foreign Purchases FEB 2021 52.232-18 Availability Of Funds APR 1984 52.232-33 Payment by Electronic Funds Transfer--System for Award

Management

OCT 2018

52.232-40 Providing Accelerated Payments to Small Business Subcontractors

MAR 2023

52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

52.239-1 Privacy or Security Safeguards AUG 1996 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights DEC 2022 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7012 Safeguarding Covered Defense Information and Cyber

Incident Reporting

JAN 2023

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

JAN 2023

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services

JAN 2023

252.204-7020 NIST SP 800-171 DoD Assessment Requirements JAN 2023 252.204-7021 Contractor Compliance with the Cybersecurity Maturity

Model Certification Level Requirement

JAN 2023

252.211-7003 Item Unique Identification and Valuation JAN 2023 252.211-7008 Use of Government-Assigned Serial Numbers SEP 2010 252.223-7008 Prohibition of Hexavalent Chromium JAN 2023 252.225-7002 Qualifying Country Sources As Subcontractors MAR 2022 252.225-7012 Preference For Certain Domestic Commodities APR 2022 252.225-7036 Buy American--Free Trade Agreements--Balance of

Payments Program--Basic

JAN 2023

252.225-7048 Export-Controlled Items JUN 2013 252.225-7056 Prohibition Regarding Business Operations with the Maduro

Regime

JAN 2023

252.225-7060 Prohibition on Certain Procurements from the Xinjiang Uyghur Autonomous Region

JUN 2023

252.225-7972 (Dev) Prohibition on the Procurement of Foreign-Made Unmanned Aircraft Systems (DEVIATION 2020-O0015)

MAY 2020

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006

CLAUSES INCORPORATED BY FULL TEXT

52.204-27 PROHIBITION ON A BYTEDANCE COVERED APPLICATION (JUN 2023)

(a) Definitions. As used in this clause--

Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Information technology, as defined in 40 U.S.C. 11101(6)--

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use-

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a Federal contract.

(b) Prohibition. Section 102 of Division R of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328), the No TikTok on Government Devices Act, and its implementing guidance under Office of Management and Budget (OMB) Memorandum M-23-13, dated February 27, 2023, "No TikTok on Government Devices" Implementation Guidance, collectively prohibit the presence or use of a covered application on executive agency information technology, including certain equipment used by Federal contractors. The Contractor is prohibited from having or using a covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor's employees; however, this prohibition does not apply if the Contracting Officer provides written notification to the Contractor that an exception has been granted in accordance with OMB Memorandum M-23-13.

(c) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (c), in all subcontracts, including subcontracts for the acquisition of commercial products or commercial services.

(End of clause)

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations. (NOV 2015)

(a) Definitions. As used in this clause--

Inverted domestic corporation means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Subsidiary means an entity in which more than 50 percent of the entity is owned--

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

(b) If the contractor reorganizes as an inverted domestic corporation or becomes a subsidiary of an inverted domestic corporation at any time during the period of performance of this contract, the Government may be prohibited from paying for Contractor activities performed after the date when it becomes an inverted domestic corporation or subsidiary. The Government may seek any available remedies in the event the Contractor fails to perform in accordance with the terms and conditions of the contract as a result of Government action under this clause.

(c) Exceptions to this prohibition are located at 9.108-2.

(d) In the event the Contractor becomes either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation during contract performance, the Contractor shall give written notice to the Contracting Officer within five business days from the date of the inversion event.

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 30 Days;

provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 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.

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 this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.acq.osd.mil/DPAP/dars/dfarspgi/current/index.html

52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (NOV 2020)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any Defense Acquisition Regulation (48 CFR Chapter 2) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (JAN 2023)

(a) Definitions. As used in this clause—

“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit, activity, or organization.

“Document type” means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

“Local processing office (LPO)” is the office responsible for payment certification when payment certification is done external to the entitlement system.

“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232- 7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall—

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items—

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

(D/D) Combo

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

N/A

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial financing, submit a commercial financing request.

(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice and receiving report in one step.]

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

Field Name in WAWF Data to be entered in WAWF

Pay Official DoDAAC HQ0490

Issue By DoDAAC W81K02

Admin DoDAAC** W81K02

Inspect By DoDAAC HT0864

Ship To Code HT0864

Ship From Code ____

Mark For Code ____

Service Approver (DoDAAC) ____

Service Acceptor (DoDAAC) ____

Accept at Other DoDAAC ____

LPO DoDAAC ____

DCAA Auditor DoDAAC ____

Other DoDAAC(s) ____

**INSPECTOR: TBD

**ACCEPTOR: TBD

RECEIVING OFFICE POC: TBD

CONTRACT SPECIALIST: Dylan Ford, dylan.j.ford.civ@health.mil

CONTRACTING OFFICER: Scott A. Barr, scott.a.barr.civ@health.mil

ADDITIONAL CONTACT: TBD

** Inspector / Acceptor: Assigned individual and / or individual with approved WAC certification or

** Inspector / Acceptor: Assigned individual and / or individual with approved COR appointment.

(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s WAWF point of contact.

See Above.

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEVIATION 2018-

O0021) (JUN 2023)

(a) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph

(a) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, 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.

(b)(1) Notwithstanding the requirements of any other clauses of this contract, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (b) (1) in a subcontract for commercial products or commercial services. 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 (NOV 2021) (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 (NOV 2021) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L.

117-328).

(vi) 52.219-8, Utilization of Small Business Concerns (OCT 2022) (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 $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vii) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(viii) 52.222-26, Equal Opportunity (SEP 2016) (E.O. 11246).

(ix) 52.222-35, Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212).

(x) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).

(xi) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

(xii) 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.

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

(xiv)(A) 52.222-50, Combating Trafficking in Persons (NOV 2021) (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).

(xv) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services- Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xvii) 52.222-54, Employment Eligibility Verification (MAY 2022) (E.O. 12989).

(xviii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022).

(xix) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706).

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

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

(xxi) 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. Subtitle A, Part V, Subpart G Note).

(xxii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxiii) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph (c) of 52.232-40.

(xxiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) (46 U.S.C. 55305 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 products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

STATEMENT OF WORK

STATEMENT OF WORK FOR CORE LABORATORY QUALITY CONTROL MATERIALS

GENERAL REQUIREMENTS:

1. SCOPE OF WORK:

1.1 The contractor shall provide quality control materials listed in Table 1 in support of Madigan Army Medical Center, Joint Base Lewis McChord, WA.

1.2 The contractor shall provide the customer with a comprehensive quality control program that complies with the requirements in section 4. The contractor shall provide the customer with local administrative rights to the software. Provides customer software to meet regulations from Clinical Laboratory Improvement Amendments (CLIA) ’88 and College of American Pathologist (CAP) requirements.

1.3 The contractor shall provide software that is compatible with Data Innovations Instrument Manager

1.4 The contractor shall provide Software listed on the Defense Health Agency (DHA) Approved Products List.

1.5 The contractor shall provide lot reserves for 12 months or longer for high volume controls.

The Contractor shall perform to the standards of this Statement of Work (SOW).

2. GOVERNMENT-FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND SERVICES

2.1. GENERAL. None.

3. SPECIFIC TASKS:

3.1. DESCRIPTION: The Contractor shall provide quality control materials in Table 1 (including all quality control materials, software, support, licenses).

3.1.1 The software shall be capable of interfacing with the Data Innovations Instrument Manager (DIIM). The Contractor shall have an established driver compatible for interfacing the analyzer with DIIM.

3.1.2 The Contractor shall provide the quality control materials and shall coordinate exact quantities and shipment schedule with the Designated Government Point of Contact prior to shipment IAW Paragraph 3.2.3 Deliveries (below).

3.1.3. The Contractor shall provide peer data review software and include any cost to maintain access to the software through the lifecycle of the contract.

3.2 QUALITY CONTROL MATERIALS.

All assays shall be FDA approved.

TABLE 1 Required Quality control materials

QUALITY CONTROL MATERIAL

CARD MKR LT LOWPLU

VIROCLEAR SARS COV-2 5X4ML

VIROTROL II

3.2.1 The manufacturer will sequester the required quality control materials to ensure that no more than one lot change occurs per contract year.

3.2.2 All quality control material provided will be identical to those used in the FDA 510K approval application.

All quality control materials will be provided as follows:

3.2.2.1 Be provided by a single manufacturer.

3.2.2.2 Be marked with the required storage temperature.

3.2.2.3 Be maintained at the proper storage temperature during transportation from the Contractor's storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

3.2.2.4 Quality control material will be ready to use and not require reconstitution unless prior approval is given by the customer.

3.2.2.5 All deliverable shall be liquid ready and not require reconstitution. If liquid ready quality control is not available, lyophilized quality control shall be approved by the Designated Government Point of Contact.

3.2.3 Deliveries of required items will be per monthly periodic orders called or emailed in to the Contractor by the designated Government Point of Contract or others as identified in the contract. Orders shall be delivered to the delivery location identified within 7 calendar days from order placement. The quantities identified by order shall not exceed the amount identified by the corresponding CLIN of the contract.

4. INFORMATION MANAGEMENT.

4.1 The quality control software shall be capable of interfacing with the Data Innovations Instrument Manager (DIIM). The Contractor shall have an established driver compatible for interfacing the analyzer with DIIM.

4.2 The QC software shall have a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user.

4.3 The QC software shall provide the capability to write user defined Westgard QC Rules. In addition, it shall integrate with the result manager for autoverification of results, allow viewing and maintaining of QC data across multiple levels and lots for connected analyzers, provide a mechanism to maintain an action log of comments from QC review, provide real-time access to QC charts, graphs (Levy-Jennings) and provide the ability to add comments, and eliminate data point(s) from statistics. The QC software shall include the ability to apply Westgard quality control result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

4.4 The software shall be the most up to date version of software (i.e. Windows 10) that has the most current security upgrades and security patches.

4.5 The Contractor shall provide local administrative rights to the government in order to manage the software.

4.6 The software shall be compatible with all Core Laboratory Instrumentation to include, but not limited to Cobas 8000, Osmo1 Osmometer, Medtox ScanReader, Quidel Sofia, Diagnostica Stago, Alifax Roller 20.

4.7 The software shall be able to allow the government user to add 3rd party quality control files to software.

ADDITIONAL INSTRUCTIONS

A. EXCLUSION FROM PARTICIPATION IN FEDERAL HEALTH CARE PROGRAMS (OCTOBER 2015)

1. The Contractor shall not employ or contract with any individual or entity (hereinafter collectively referred to as “person”) to provide items or services that will be included in invoices submitted to the Government under this contract if such person is listed on the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) List of Excluded Individuals and Entities (LEIE) or the TRICARE Sanctioned Provider List. The Government is legally prohibited from paying for provision of items or services by such persons. The prohibition extends to services beyond direct patient care, such as services of persons in executive or leadership roles and administrative and management services, whether or not such services are billed separately. The LEIE may be found at http://oig.hhs.gov/fraud/exclusions.asp, and the TRICARE Sanctioned Provider list at http://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-Safety-of- Healthcare/Program-Integrity/Sanctioned-Providers. The LEIE and TRICARE Sanctioned Provider List are hereinafter collectively referred to as “the Lists.”

2. Prior to start of contract performance, the Contractor shall (a) query the Lists to determine whether the name of any person the Contractor employs or contracts with to provide services or items for which payment may be made under this contract appears on the Lists, and (b) certify to the Contracting Officer that the Contractor has queried the Lists and no such names appear on either of the Lists.

3. During performance of the contract, and prior to persons other than those whose names were queried in accordance with paragraph 2, above, (hereinafter “new persons”) providing services or items under the contract, the Contractor shall (a) query the Lists as in paragraph 2, and (b) certify to the Contracting Officer that the names of such new persons do not appear on either of the Lists.

4. The Contractor is advised that during performance of the contract, MTF personnel will periodically recheck of the names of contractor personnel working in the MTF against the Lists. The Government will notify the Contractor in the event any contractor personnel working in the MTF appear on either of the Lists.

5. Should any person providing items or services under the contract appear on either of the Lists at any time during contract performance, the Contractor shall promptly remove that person from the contract.

6. Violation of any aspect of the above paragraphs shall be considered a material breach of the contract and may result in termination of the contract.

7. The Contractor is further advised that, in accordance with Civil Monetary Penalties Law [CMP] (codified at 42 USC § 1320a-7a):

a. There are steep civil monetary penalties associated with billing the Government for providing items or services by a person on either of the Lists, and with failing to return to the Government any overpayments received for provision of such items or services.

b. Billing under the contract for provision of items or services by a person on either List may also result in exclusion of the person that employs or contracts with such person.

8. HHS OIG has issued a Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs with additional information on the CMP. The Special Advisory Bulletin may be found at http://oig.hhs.gov/exclusions/files/sab-05092013.pdf.

B. PERSONALLY IDENTIFIABLE INFORMATION, PROTECTED HEALTH INFORMATION, AND

FEDERAL INFORMATION REQUIREMENTS (REVISED 10/27/2020)

1. General Requirements Overview - Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Laws

This Section addresses the Contractor’s requirements under The Privacy Act of 1974 (Privacy Act), The Freedom of Information Act (FOIA), and The Health Insurance Portability and Accountability Act (HIPAA) as set forth in applicable statutes, implementing regulations and Department of Defense (DoD) issuances. In general, the Contractor shall comply with the specific requirements set forth in this Section and elsewhere in this Contract. The Contractor shall also comply with requirements relating to records management as described herein.

This Contract incorporates by reference the federal regulations and DoD issuances referred to in this Section. If any authority is amended or replaced, the changed requirement is effective when it is incorporated under contract change procedures. Where a federal regulation and any DoD issuance govern the same subject matter, the Contractor shall first follow the more specific DoD implementation unless the DoD issuance does not address or is unclear on that matter. DoD issuances are available at http://www.dtic.mil/whs/directives.

For purposes of this Section, the following definitions apply.

DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDI 5400.11, DoD Privacy and Civil Liberties Programs, January 29, 2019 and DoDI 5400.11-R, Department of Defense Privacy Program, May 14, 2007.

HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S.

Department of Health and Human Services (HHS) and codified at 45 Code of Federal Regulations (CFR) Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-E (Enforcement), as amended. Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this Section and are not included in the term HIPAA Rules.

DoD HIPAA Issuances means the DoD issuances implementing the HIPAA Rules in the DoD Military Health System (MHS). These issuances are DoDM 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in DoD Health Care Programs,” March 13, 2019, DoDI 6025.18, Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs, March 13, 2019, and DoDI 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs, August. 12, 2015.

Defense Health Agency (DHA) Privacy Office is the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Chief is the HIPAA Privacy and Security Officer for DHA.

2. Records Management

When creating and maintaining official government records, the Contractor shall comply with all federal requirements established by 44 United States Code (U.S.C.) Chapters 21, 29, 31, 33 and 35, and by 36 CFR, Chapter XII, Subchapter B – Records Management. The Contractor shall also comply with DoD Administrative Instruction No. 15 (DoD AI-15), “OSD Records and Information Management Program” (May 3, 2013) and Records Management requirements outlined in the current TRICARE Operations Manual (TOM).

3. Freedom of Information Act (FOIA)

The Contractor shall comply with the following procedures if it receives a FOIA request and immediately contact the DHA FOIA Officer for evaluation/action:

The Contractor shall inform beneficiaries that DHA FOIA procedures require a written request preferably sent via the National FOIA Portal at: www.FOIA.gov. However, requesters may also submit requests via email at DHA.FOIA@mail.mil; or via postal delivery addressed to the DHA Freedom of Information Service Center, 7700 Arlington Boulevard, Suite 5101, Falls Church, Virginia 22042-5101. All FOIA requests shall describe the desired record as completely as possible to facilitate its retrieval from files and to reduce search fees which may be borne by the requestor. Contract and/or Modification numbers must be included in all FOIA requests seeking DHA procurement records. Although the administrative time limit to grant or deny a request (ten working days after receipt) does not begin until the request is received by DHA, the Contractor shall act as quickly as possible and respond to DHA within ten working days.

In response to requests received by the Contractor for the release of information, unclassified information, documents and forms which were previously provided to the public as part of routine services shall continue to be made available in accordance with previously established criteria. All other requests from the public for release of DHA records and, specifically, all requests that reference FOIA shall be immediately forwarded to DHA, ATTENTION: Freedom of Information Officer, for appropriate action. Direct contact, including interim replies, between TRICARE contractors and such requestors is not authorized. The Contractor shall process requests by individuals for access to records about themselves in accordance with directions from the DHA Freedom of Information Service Center. If such a requestor specifically makes the request under the Privacy Act or does not make clear whether the request is made under FOIA or the Privacy Act, the Contractor shall process the request in accordance with directions from the DHA Privacy Office. If requestor specifically seeks PHI under HIPAA, the Contractor shall follow paragraph 8.1.6, relating to individual rights of access to PHI.

4. Systems of Records

In order to meet the requirements of the Privacy Act and the DoD Privacy Act Issuances, the Contractor shall identify to the DHA Contracting Officer (CO) systems of records that are or will be maintained or operated for DHA where records of PII collected from individuals are maintained and specifically retrieved using a personal identifier.

Upon identification of such systems to the CO, and prior to the lawful operation of such systems, the Contractor shall coordinate with the DHA Privacy Office to complete systems of records notices (SORNs) for submission and publication in the Federal Register as coordinated by the Defense Privacy, Civil Liberties, and Transparency Division, and as required by the DoD Privacy Act Issuances.

Following proper SORN publication and Government confirmation of Contractor authority to operate the applicable system(s), the Contractor shall also comply with the additional systems of records and SORN guidance, in coordination with the DHA Privacy Office, regarding periodic system review, amendments, alterations, or deletions set forth by the DoD Privacy Act Issuances, Office of Management and Budget (OMB) Memorandum 99-05, Attachment B, OMB Circular A-130, and Privacy Act of 1974 requirements applicable to contractors operating systems of records on behalf of federal agencies. The Contractor shall promptly advise the DHA Privacy Office of changes in systems of records or their use that may require a change in the SORN.

5. Privacy Impact Assessment (PIA)

If DHA data is stored on a Contractor owned system, a PIA is required from the Contractor.

6. Data Sharing Agreement (DSA)

6.1. (Applies if contract requirements involve the use of DHA data (including PII/PHI, a limited data set, or de-identified data))

The Contractor shall consult with the DHA Privacy Office to determine if the Contractor must obtain a DSA or Data Use Agreement (DUA), when DHA data will be accessed, used, disclosed or stored, to perform the requirements of this Contract.

The Contractor shall comply with the permitted uses established in a DSA/DUA to prevent the unauthorized use and/or disclosure of any PII/PHI, in accordance with the HIPAA Rules and DoD HIPAA Issuances. Likewise, the Contractor shall comply with the DoD Privacy Act Issuances.

Prior to using any data involving PHI for research purposes, as defined by HIPAA, the Contractor must gain approval from the DHA Privacy Board. Thus, the Contractor shall comply with DHA Privacy Board requests for additional documentation.

To begin the DSA request process, the Contractor shall submit a DSA Application (DSAA) to the DHA Privacy Office. Upon approval, the requestor shall enter into one of the following agreements, depending on the data involved:

DSA for De-Identified Data DSA for PHI DSA for PII Without PHI DUA for Limited Data Set

DSAs executed for contract support will expire after 1 year or at the end of the contract option year, whichever comes first. If the contractual use of DHA data will continue after the DSA expiration date, the Contractor shall submit a DSA Renewal Request template to the Privacy Office; however, if the DSA will not be renewed, the Contractor shall close the DSA by providing a Certificate of Data Disposition (CDD) to the DHA Privacy Office.

6.2. (Applies if contract requirements may include human subject research)

This Contract incorporates by reference the Protection of Human Subject…