Solicitation - W81K0025QA117 - Final - Combined.pdf

WOMEN-OWNED SMALL

BUSINESS (WOSB)

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

1. REQUISITION NUMBER PAGE 1 OF

2. CONTRACT NUMBER 3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE

DATE

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME b. TELEPHONE NUMBER (No collect 8. OFFER DUE DATE/

LOCAL TIME

9. ISSUED BY

13b. RATING

14. METHOD OF SOLICITATION

CODE

15. DELIVER TO 16. ADMINISTERED BY CODE

18a. PAYMENT WILL BE MADE BY CODE17a. CONTRACTOR/

OFFEROR

CODE

FACILITY

CODE

CODE

TELEPHONE NUMBER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN

OFFER

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

BELOW IS CHECKED

REQUEST

FOR QUOTE

(RFQ)

INVITATION

FOR BID

(IFB)

REQUEST

FOR

PROPOSAL

(RFP)

SEE ADDENDUM

19.

ITEM NUMBER

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Government Use Only)

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH

AND DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND

ON ANY ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS

SPECIFIED

29. AWARD OF CONTRACT: REFERENCE OFFER

DATED . . YOUR OFFER ON SOLICITATION

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

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR

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

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

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

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

10. THIS ACQUISITION IS UNRESTRICTED OR

NORTH AMERICAN

INDUSTRY CLASSIFICATION

STANDARD (NAICS):

SIZE STANDARD:

13a. THIS CONTRACT IS A

RATED ORDER UNDER

THE DEFENSE PRIORITIES

AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

SET ASIDE: % FOR:

11. DELIVERY FOR FREE ON

BOARD (FOB) DESTINATION

UNLESS BLOCK IS MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

ARE ARE NOT ATTACHED

ARE ARE NOT ATTACHED

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

8(A)

ECONOMICALLY

DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

SMALL BUSINESS

NOTE: OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30.

calls)

Solicitation/Contract Form Continuation

OsmoPro Max Osmometers

Product Service Code: 6515

SCOPE OF WORK

No delivery of supplies shall be made by the Contractor until all RMF tasks have been completed by the Contractor/Government and approval granted by the Government.

The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to perform the following:

Delivery of a fully functional: OsmoPro MAX, Automated Osmometer with 3 Level Prolinol Controls and 2 Level Renol Controls.

Instrument Installation Employee on-site training Instrument validation

The equipment shall be provided and delivered by the Contractor in the space determined by the Government. All equipment delivered by the Contractor shall be FDA approved for use, in new condition, and fully operational in accordance with manufacturer literature specifications.

SALIENT CHARACTERISTICS

1. Required Technical Specification Characteristics: This is a BRAND name requirement for 2 Each OsmoProMAX, Automated Osmometers.

2. Features:

a. Increased accuracy and precision

b. High volume throughput

c. Positive patient Identification

d. Internal cleaning system to prevent carryover and cross-contamination

3. Training:

a. Training for WBAMC Laboratory/technical staff not to exceed 20 personnel and for two WBAMC clinical engineers.

b. Vendor shall offer two (2) training classes to accommodate shift workers

c. Due to differing work schedules, the vendor shall provide training classes to ensure one is in the morning and one training class in the afternoon.

d. Both Morning and Afternoon classes shall be conducted on the same day.

e. Upon completion of training, the vendor shall provide a sign-in roster of all staff that attended training.

4. Installation:

a. Vendor Install shall include uncrating, inside delivery to clinic, set up, validation and certifying equipment to ensure equipment is properly working, removal/disposal of all excess trash and packaging material.

b. Vendor shall provide a manufacturer trained installer, all tools/equipment, material, and parts for installation.

5. Additional Notes:

a. NO Grayed or refurbished items shall be offered.

b. NO partial orders shall be allowed.

c. Vendor shall be responsible for shipping the complete order to listed contract delivery address.

d. Loading dock is available at location.

**END**

W81K0025QA117

Continuation of Supplies or Services and Prices/Costs

Additional Information/Notes

Item Supplies/Service Quantity Unit Unit Price Amount

Risk Management Framework (RMF) approval IAW Attachment #1 DHA MDE Cybersecurity/Risk Management Framework (RMF) updated 17 Jan 2024 (RMF). RMF approval must be received before any products/equipment are shipped and any invoicing is submitted.

Manufacturer's Part Number: RMF Product Service Code: 6515 Pricing Arrangement: Firm Fixed Price

1 Each

OSMOPRO MAX Automated Osmometer

Manufacturer's Part Number: OSMOPRO MAX Product Service Code: 6515 Pricing Arrangement: Firm Fixed Price

2 Each

Instrument unpacking, installation, training & validation services

Manufacturer's Part Number: ITV-SKC-PROMAX Product Service Code: 6515 Pricing Arrangement: Firm Fixed Price

1 Each

CONTROL PROTINOL 3 Levels 3 mL Vials

- Pkg 9

Manufacturer's Part Number: 3MA028 Product Service Code: 6515 Pricing Arrangement: Firm Fixed Price

27 Each

CONTROL, RENOL 2 Levels Urine Osmolality - 3 mL Vial - Pkg 8

Manufacturer's Part Number: 3LA085 Product Service Code: 6515 Pricing Arrangement: Firm Fixed Price

20 Each

Continuation of Inspection and Acceptance

Overall Contract Inspection/Acceptance Locations

Inspection and Acceptance Location

Both Destination Instructions: Delivery during business hours of 0800 top 1500 hrs MST Monday - Friday, except Federal holidays.

DoDAAC: HT0848 CountryCode: USA

AMC BEAUMONT BLISS - PB

18511 HIGHLANDER MEDICS STREET, FORT BLISS TX 79918

FORT BLISS, TX 79918

UNITED STATES

Jerry Mata Email: jerry.a.mata.civ@health.mil Telephone: 915-742-1749

Inspection and Acceptance Location

Both Destination Instructions: Delivery during business hours of 0800 top 1500 hrs MST Monday - Friday, except Federal holidays.

DoDAAC: HT0848 CountryCode: USA

AMC BEAUMONT BLISS - PB

18511 HIGHLANDER MEDICS STREET, FORT BLISS TX 79918

FORT BLISS, TX 79918

UNITED STATES

Jerry Mata Email: jerry.a.mata.civ@health.mil Telephone: 915-742-1749

Inspection and Acceptance Location

Both Destination Instructions: Delivery during business hours of 0800 top 1500 hrs MST Monday - Friday, except Federal holidays.

DoDAAC: HT0848 CountryCode: USA

AMC BEAUMONT BLISS - PB

18511 HIGHLANDER MEDICS STREET, FORT BLISS TX 79918

FORT BLISS, TX 79918

UNITED STATES

Jerry Mata Email: jerry.a.mata.civ@health.mil Telephone: 915-742-1749

Inspection and Acceptance Location

Both Destination Instructions: Delivery during business hours of 0800 top 1500 hrs MST Monday - Friday, except Federal holidays.

DoDAAC: HT0848 CountryCode: USA

AMC BEAUMONT BLISS - PB

18511 HIGHLANDER MEDICS STREET, FORT BLISS TX 79918

FORT BLISS, TX 79918

UNITED STATES

Jerry Mata Email: jerry.a.mata.civ@health.mil Telephone: 915-742-1749

Inspection and Acceptance Location

Both Destination Instructions: Delivery during business hours of 0800 top 1500 hrs MST Monday - Friday, except Federal holidays.

DoDAAC: HT0848 CountryCode: USA

AMC BEAUMONT BLISS - PB

18511 HIGHLANDER MEDICS STREET, FORT BLISS TX 79918

FORT BLISS, TX 79918

UNITED STATES

Jerry Mata Email: jerry.a.mata.civ@health.mil Telephone: 915-742-1749

Continuation of Deliveries or Performance

Party to Pay Transportation Cost: Government

Point Type: Destination

Line Item Delivery Schedule Quantity Address and POC Special Handling/Notes

Delivery Schedule From date of lead time event to delivery 270 Calendar Days Date of Award

1 Each Ship To DoDAAC: HT0848 CountryCode: USA

AMC BEAUMONT BLISS - PB

18511 HIGHLANDER MEDICS

STREET, FORT BLISS TX

79918

FORT BLISS, TX 79918

UNITED STATES

Jerry Mata Email: jerry.a.mata.civ@health.

mil Telephone: 915-742-1749

FoB Details

Party to Pay Transportation Cost:

Contractor

Point Type: Destination

Delivery Schedule From date of lead time event to delivery 30 Calendar Days 30 days after RMF approval

2 Each Ship To DoDAAC: HT0848 CountryCode: USA

AMC BEAUMONT BLISS - PB

18511 HIGHLANDER MEDICS

STREET, FORT BLISS TX

79918

FORT BLISS, TX 79918

UNITED STATES

Jerry Mata Email: jerry.a.mata.civ@health.

mil Telephone: 915-742-1749

FoB Details

Party to Pay Transportation Cost:

Government

Point Type: Destination

Delivery Schedule From date of lead time event to delivery 90 Calendar Days Instrument unpacking, installation, training and validation after receipt of equipment

1 Each Ship To DoDAAC: HT0848 CountryCode: USA

AMC BEAUMONT BLISS - PB

18511 HIGHLANDER MEDICS

STREET, FORT BLISS TX

79918

FORT BLISS, TX 79918

UNITED STATES

Jerry Mata Email: Jerry.a.mata.civ@health.

mil Telephone: 915-742-1749

FoB Details

Party to Pay Transportation Cost:

Government

Point Type: Destination

Delivery Schedule From date of lead time event to delivery 30 Calendar Days Controls may be shipped after receipt of equipment

27 Each Ship To DoDAAC: HT0848 CountryCode: USA

AMC BEAUMONT BLISS - PB

18511 HIGHLANDER MEDICS

STREET, FORT BLISS TX

79918

FoB Details

Party to Pay Transportation Cost:

Government

0004 FORT BLISS, TX 79918

UNITED STATES

Jerry Mata Email: jerry.a.mata.civ@health.

mil Telephone: 915-742-1749

Point Type: Destination

Delivery Schedule From date of lead time event to delivery 30 Calendar Days Controls may be shipped 30 days after receipt of equipment

20 Each Ship To DoDAAC: HT0848 CountryCode: USA

AMC BEAUMONT BLISS - PB

18511 HIGHLANDER MEDICS

STREET, FORT BLISS TX

79918

FORT BLISS, TX 79918

UNITED STATES

Jerry Mata Email: jerry.a.mata.civ@health.

mil Telephone: 915-742-1749

FoB Details

Party to Pay Transportation Cost:

Government

Point Type: Destination

Contract Clauses

FAR Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities.

Dec 2023

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

Nov 2021

52.204-27 Prohibition on a ByteDance Covered Application. Jun 2023 52.222-50 Combating Trafficking in Persons. Nov 2021 52.225-13 Restrictions on Certain Foreign Purchases. Feb 2021 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving. May 2024 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

DFARS Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

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. Nov 2023 252.232-7003 Electronic Submission of Payment Requests and Receiving Reports. Dec 2018 252.232-7010 Levies on Contract Payments. Dec 2006 252.244-7000 Subcontracts for Commercial Products or Commercial Services. Nov 2023 252.246-7008 Sources of Electronic Parts. Jan 2023 252.247-7023 Transportation of Supplies by Sea. Oct 2024

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting.

(DEVIATION 2024-O0013 REVISION 1)

May 2024 Deviation 2024-O0013 May 2024

252.203-7000 Requirements Relating to Compensation of Former DoD Officials. Sep 2011

FAR Clauses Incorporated by Full Text

52.219-14 Limitations on Subcontracting (DEVIATION 2021-O0008) (Oct 2022) Deviation 2021-O0008 (Feb 2023)

LIMITATIONS ON SUBCONTRACTING (FEB 2023) (DEVIATION 2021-O0008)

(a) This clause does not apply to the unrestricted portion of a partial set-aside.

(b) Definition. Similarly situated entity, as used in this clause, means a first-tier subcontractor, including an independent contractor, that--

(1) Has the same small business program status as that which qualified the prime contractor for the award (e.g., for a small business set-aside contract, any small business concern, without regard to its socioeconomic status); and

(2) Is considered small for the size standard under the North American Industry Classification System (NAICS) code the prime contractor assigned to the subcontract.

(c) Applicability. This clause applies only to--

(1) Contracts that have been set aside for any of the small business concerns identified in 19.000(a)(3);

(2) Part or parts of a multiple-award contract that have been set aside for any of the small business concerns identified in 19.000(a)(3);

(3) Contracts that have been awarded on a sole-source basis in accordance with subparts 19.8, 19.13, 19.14, and 19.15;

(4) Orders expected to exceed the simplified acquisition threshold and that are--

(i) Set aside for small business concerns under multiple-award contracts, as described in 8.405-5 and 16.505(b)(2)(i)(F); or

(ii) Issued directly to small business concerns under multiple-award contracts as described in 19.504(c)(1)(ii);

(5) Orders, regardless of dollar value, that are--

(i) Set aside in accordance with subparts 19.8, 19.13, 19.14, or 19.15 under multiple-award contracts, as described in 8.405-5 and 16.505(b)(2)(i)(F);

or

(ii) Issued directly to concerns that qualify for the programs described in subparts 19.8, 19.13, 19.14, or 19.15 under multiple-award contracts, as described in 19.504(c)(1)(ii); and

(6) Contracts using the HUBZone price evaluation preference to award to a HUBZone small business concern unless the concern waived the evaluation preference.

(d) Independent contractors. An independent contractor shall be considered a subcontractor.

(e) Limitations on subcontracting. By submission of an offer and execution of a contract, the Contractor agrees that in performance of a contract assigned a North American Industry Classification System (NAICS) code for--

(1) Services (except construction), it will not pay more than 50 percent of the amount paid by the Government for contract performance, excluding certain other direct costs and certain work performed outside the United States (see paragraph (e)(1)(i)), to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the prime contractor’s 50 percent subcontract amount that cannot be exceeded. When a contract includes both services and supplies, the 50 percent limitation shall apply only to the service portion of the contract. The following services may be excluded from the 50 percent limitation:

(i) Other direct costs, to the extent they are not the principal purpose of the acquisition and small business concerns do not provide the service.

Examples include airline travel, work performed by a transportation or disposal entity under a contract assigned the environmental remediation NAICS code 562910), cloud computing services, or mass media purchases.

(ii) Work performed outside the United States on awards made pursuant to the Foreign Assistance Act of 1961, or work performed outside the United States required to be performed by a local contractor.

(2) Supplies (other than procurement from a nonmanufacturer of such supplies), it will not pay more than 50 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the prime contractor’s 50 percent subcontract amount that cannot be exceeded. When a contract includes both supplies and services, the 50 percent limitation shall apply only to the supply portion of the contract;

(3) General construction, it will not pay more than 85 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the prime contractor’s 85 percent subcontract amount that cannot be exceeded; or

(4) Construction by special trade contractors, it will not pay more than 75 percent of the amount paid by the Government for contract performance, excluding the cost of materials, to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count towards the prime contractor’s 75 percent subcontract amount that cannot be exceeded.

(f) The Contractor shall comply with the limitations on subcontracting as follows:

(1) For contracts, in accordance with paragraphs (c)(1), (2), (3) and (6) of this clause--

[Contracting Officer check as appropriate.]

[ ] By the end of the base term of the contract and then by the end of each subsequent option period; or

[ ] By the end of the performance period for each order issued under the contract.

(2) For orders, in accordance with paragraphs (c)(4) and (5) of this clause, by the end of the performance period for the order.

(g) A joint venture agrees that, in the performance of the contract, the applicable percentage specified in paragraph (e) of this clause will be performed by the aggregate of the joint venture participants.

(1) In a joint venture comprised of a small business protégé and its mentor approved by the Small Business Administration, the small business protégé shall perform at least 40 percent of the work performed by the joint venture. Work performed by the small business protégé in the joint venture must be more than administrative functions.

(2) In an 8(a) joint venture, the 8(a) participant(s) shall perform at least 40 percent of the work performed by the joint venture. Work performed by the 8(a) participants in the joint venture must be more than administrative functions.

(End of clause)

DFARS Clauses Incorporated by Full Text

252.232-7006 Wide Area WorkFlow Payment Instructions. (Jan 2023)

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.

2-n-1 Combo

(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that require shipment of a deliverable.)

(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.

(Contracting Officer: Insert either "Invoice 2in1" or the applicable invoice and receiving report document type(s) for fixed price line items for services.)

(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 W81K00

Admin DoDAAC W81K00 Inspect By DoDAAC HT0848 Ship To Code HT0848 Ship From Code ____ Mark For Code ____ Service Approver (DoDAAC) HT0848 Service Acceptor (DoDAAC) HT0848 Accept at Other DoDAAC ____ LPO DoDAAC ____ DCAA Auditor DoDAAC ____ Other DoDAAC(s) ____ (*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance locations apply, insert "See Schedule" or "Not applicable.")

(**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)

(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.

N/A

(Contracting Officer: Insert applicable information or "Not applicable.")

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

(End of clause)

Addendum to 52.212-4, Contract Terms and Conditions - Commercial Products and Commercial Services

ADDENDUM TO 52.212-4

Paragraph52.212-4(w) is hereby added:

(w) The non-FAR Part12 discretionary FAR and DFARS clauses included herein are incorporated intothis contract either by reference or in full text.

If incorporated byreference, see clause 52.252-2 herein for locations where full text can be found.

(End of Addendum)

Contract Terms and Conditions Required To Implement Statutes or Executive Orders — Commercial Products and Commercial Services

FAR Clauses Incorporated by Full Text

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Products and Commercial Services.

(DEVIATION 2025-O0003 and 2025-O0004)

(Jan 2025) Deviation 2025-O0004 (Mar 2025)

Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Products and Commercial Services (MAR 2025) (DEVIATION 2025-O0003 and 2025-O0004)

(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 products and commercial services:

(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 Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(3) 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).

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

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(7) 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 products and commercial services:

[Contracting Officer check as appropriate.]

[ ] (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C.

4655).

[ ] (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (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.)

[ ] (4) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) (41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community-see FAR 3.900(a).

[X] (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

[ ] (6) [Reserved].

[ ] (7) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

[ ] (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

[X] (9) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

[ ] (10) 52.204-28, Federal Acquisition Supply Chain Security Act Orders-Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec 2023) (Pub. L. 115-390, title II).

[ ] (11)

(i) 52.204-30, Federal Acquisition Supply Chain Security Act Orders-Prohibition. (Dec 2023) (Pub. L. 115-390, title II).

[ ] (ii) Alternate I (Dec 2023) of 52.204-30.

[ ] (12) 52.209-6, Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded. (Jan 2025) (31 U.S.C. 6101 note).

[ ] (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

[ ] (14) [Reserved].

[ ] (15) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (15 U.S.C. 657a).

[ ] (16) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[ ] (17) [Reserved]

[X] (18)

(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.

[ ] (19)

(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.

[ ] (20) 52.219-8, Utilization of Small Business Concerns (Jan 2025)(15 U.S.C. 637(d)(2) and (3)).

[ ] (21)

(i) 52.219-9, Small Business Subcontracting Plan (Jan 2025) (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 (Jan 2025) of 52.219-9.

[ ] (22)

(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.

[X] (23) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 657s).

[ ] (24) 52.219-16, Liquidated Damages-Subcontracting Plan (Sep 2021) (15 U.S.C. 637(d)(4)(F)(i)).

[ ] (25) 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (Feb 2024) (15 U.S.C. 657f).

[ ] (26)

(i) 52.219-28, Postaward Small Business Program Rerepresentation (Jan 2025) (15 U.S.C. 632(a)(2)).

[ ] (ii) Alternate I (Mar 2020) of 52.219-28.

[ ] (27) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

[ ] (28) 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 (Oct 2022) (15 U.S.C. 637(m)).

[ ] (29) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

[ ] (30) 52.219-33, Nonmanufacturer Rule (Sep 2021) (15 U.S.C. 637(a)(17)).

[ ] (31) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

[ ] (32) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2025)(E.O. 13126).

[ ] (33) [Reserved]

[ ] (34) [Reserved]

[ ] (35)

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

[ ] (ii) Alternate I (Jul 2014) of 52.222-35.

[X] (36)

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

[ ] (ii) Alternate I (Jul 2014) of 52.222-36.

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

[ ] (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

[X] (39)

(i) 52.222-50, Combating Trafficking in Persons (Nov 2021) (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).

[ ] (40) 52.222-54, Employment Eligibility Verification (Jan 2025) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

[ ] (41)

(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)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[ ] (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.)

[ ] (42) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (May 2024) (42 U.S.C. 7671, et seq.).

[ ] (43) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (May 2024) (42 U.S.C. 7671, et seq.).

[ ] (44) 52.223-20, Aerosols (May 2024) (42 U.S.C. 7671, et seq.).

[ ] (45) 52.223-21, Foams (May 2024) (42 U.S.C. 7671, et seq.).

[ ] (46) 52.223-23, Sustainable Products and Services (MAR 2025) (DEVIATION 2025-O0004)) (7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671l).

[ ] (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)

(i) 52.225-1, Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83).

[ ] (ii) Alternate I (Oct 2022) of 52.225-1.

[ ] (49)

(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) (19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 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 [Reserved].

[ ] (iii) Alternate II (Jan 2025) of 52.225-3.

[ ] (iv) Alternate III (Feb 2024) of 52.225-3.

[ ] (v) Alternate IV (Oct 2022) of 52.225-3.

[ ] (50) 52.225-5, Trade Agreements (NOV 2023) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[X] (51) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (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. Subtitle A, Part V, Subpart G Note).

[ ] (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

[ ] (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

[ ] (55) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) (E.O. 13513).

[ ] (56) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

[ ] (57) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C.

3805).

[ ] (58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

[X] (59) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) (31 U.S.C. 3332).

[ ] (60) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

[ ] (61) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

[ ] (62) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

[ ] (63) 52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act-Covered Foreign Entities (Nov 2024) (Sections 1821-1826, Pub. L. 118-31, 41 U.S.C. 3901 note prec.).

[ ] (64) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

[ ] (65)

(i) 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).

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

[ ] (iii) Alternate II (Nov 2021) 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 products and commercial services:

[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 for Contractor Workers Under Executive Order 14026 (Jan 2022).

[ ] (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

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

[ ] (10) 52.247-69, Reporting Requirement for U.S.-Flag Air Carriers Regarding Training to Prevent Human Trafficking (Jan 2025) (49 U.S.C. 40118 (g)).

(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 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) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) (41 U.S.C. 4712).

(iii) 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)).

(iv) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(v) 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).

(vi) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

(vii)

(A) 52.204-30, Federal Acquisition Supply Chain Security Act Orders-Prohibition. (Dec 2023) (Pub. L. 115-390, title II).

(B) Alternate I (Dec 2023) of 52.204-30.

(viii) 52.219-8, Utilization of Small Business Concerns (Jan 2025) (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.

(ix) [Reserved]

(x) [Reserved]

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

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

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

(xiv) 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.

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

(xvi)

(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).

(xvii) 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).

(xviii) 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).

(xix) 52.222-54, Employment Eligibility Verification (Jan 2025) (E.O. 12989).

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

(xxi) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(xxii)

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

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

(xxiii) 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).

(xxiv) 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.

(xxv) 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.

(xxvi) 52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act-Covered Foreign Entities (Nov 2024) (Sections 1821-1826, Pub. L. 118-31, 41 U.S.C. 3901 note prec.).

(xxvii) 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.

(End of clause)

Addendum to Contract Clauses

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations. Nov 2015 52.223-5 Pollution Prevention and Right-to-Know Information. May 2024 52.223-10 Waste Reduction Program. (DEVIATION 2025-O0004) May 2024 Deviation 2025-O0004 Mar 2025

DFARS Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

252.225-7993 Prohibition on Providing Funds to the Enemy. (DEVIATION 2024-O0003) Dec 2023 Deviation 2024-O0003 Dec 2023 252.204-7003 Control of Government Personnel Work Product. Apr 1992 252.225-7048 Export-Controlled Items. Jun 2013

FAR Clauses Incorporated by Full Text

52.252-6 Authorized Deviations in Clauses. (Nov 2020)

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 DOD FAR Supplement [insert regulation name] (48 CFR Chapter 2) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of clause)

List of Contract Documents, Exhibits, or Attachments

Identifier Document Name Document Description Reference Identifier

Date Line Item Page Numbers

Document Type

Provided Under Separate Cover

0001 Attachment #1 Supporting Technical Documentation

DHA

MDE Cyb ersecurity

- RMF Re quirements

17 Jan

16 Attachment No

Defense Health Agency (DHA) Contracting Requirements for Medical Device and Equipment (MDE) Cybersecurity/Risk Management Framework (RMF)

Updated: January 17, 2024

DHA MDE Cybersecurity/RMF Contract/ordering Requirements Version 01-17-2024 ii | P a g e

Version Matrix

Version Date Author Description

1.0 16 November2018 Completed initial draft of Cybersecurity Language.

1.1 31 January2019 Updated document to reflect vendor comments/suggestions.

1.2 06 February2019 CyberLOG Final Document.

1.3 25 March 2019 CyberLOG Addition of Section B 1.11.

1.4 11 January 2022 CyberLOG Review of and clarification of requirements.

1.5 03 October 2023 CyberLOG/ICS Review of and clarification of requirements.

2.0 17 January 2024 CyberLOG/ICS/J6 Changes to support requirements, SMA, and NSP statement.

DHA MDE Cybersecurity/RMF Contracting Requirements Version 1-17-2024 iii | P a g e

Table of Contents A. General Defense Health Agency (DHA) Medical Device and Equipment (MDE) Cybersecurity/Risk

Management Framework (RMF) Contracting Requirements

1. New MDE and Software Purchases RMF Requirements:

B. DHA Cybersecurity/RMF Acceptance/MDE Delivery Requirements

1. System Security Requirements

2. RMF Assessment Timeframes

3. Business to Business (B2B) Connectivity Requirements

4. Warranty and Post-Warranty Service Maintenance Agreement RMF/Cybersecurity

Requirements/Continuous Monitoring/Risk Management

5. Cybersecurity Regulations and Guidance

1) Cybersecurity Regulations and Guidance

1 | P a g e

All requirements in this document will be referenced by a single Not Separately Priced (NSP) Contract Line Item (CLIN) in the contract/order and shall be included in vendor’s pricing with no additional or separate charges.

The government will not enter into a Non-Disclosure Agreement (NDA) with the vendor.

Federal law provides criminal prosecution of any Government employee disclosing confidential information, with or without an NDA (see 18 USC §1905).

All requirements in this document apply to stand-alone contracts as well as delivery or task orders under an ordering contract and call orders under a blanket purchase agreement. If the vendor receives a delivery or task order under an ordering contract or a call order under a blanket purchase agreement, the vendor shall ensure that all devices provided under the scope of said contract maintain the required/authorized security posture; the vendor shall not change versions without proper notification to both the program office responsible for device management, the contract agency, and the cyber security analysts. The vendor shall not make any delivery, nor receive payment prior to RMF approval on the updated version.

A. General Defense Health Agency (DHA) Medical Device and Equipment (MDE)

Cybersecurity/Risk Management Framework (RMF) Contracting Requirements

1. New MDE and Software Purchases RMF Requirements:

For the purposes of this contract/order, MDE is defined as any system, device, or software intended for use in, or in direct support of, the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or equipment used in the direct support of the medical mission.

The vendor agrees to comply with References listed in Section: 5 Cybersecurity Regulations and Guidance.

1.1. The vendor shall establish and maintain a test/laboratory environment that includes all contract/ordered equipment, to include 3rd party components that fall under the authorization boundary, and/or included in this contract/order, to support the RMF/Cybersecurity requirements. The vendor test lab shall be used for all self-assessment activities, Independent Verification and Validation (IV&V) compliance testing, and post Authority to Operate (ATO), or RMF Approval (herein referred to as Approval) actions.

1.2. Any commercial cloud offerings hosted outside the DHA Med-COI network must be Federal Risk and Authorization Management Program (FedRAMP) approved prior to implementing DHA RMF/Cybersecurity activities for the MDE. FedRAMP certification falls outside the DHA Cyber Logistics’ (CyberLOG) or Program Management Office’s (PMO) purview and is the responsibility of the vendor.

Information on FedRAMP certification can be found at www.fedramp.gov.

1.3. Software patches and updates: Many enterprises within the DoD automate patch installations and software updates for operating systems and DoD

2 | P a g e standard software applications. For applications such as databases and developed applications, updates must be scheduled in coordination with DHA.

Vendors shall notify the assigned DHA Cybersecurity Analyst and make available for DHA Contracting Officer’s Representative (COR) review if required, any updates/changes to the system prior to installation, to include but not limited to software updates, operating system, application upgrades, patches, and/or addition/removal of components. For purchases made through the DHA Integrated Clinical Systems Program Management Office (ICS PMO), the vendor shall submit all requests to dha.detrick.PEO-Med-Sys-J-6.mbx.dha-ics-cyber-rmf@health.mil. For all other purchases, or if the analyst is unknown, the vendor shall submit all requests to dha.detrick.med-log.mbx.cyberlog@health.mil.

Software updates will…