Solicitation - HT940626QE1070001.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 calls)

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.

Solicitation/Contract Form Orthoscan Mini C-Arm Fluoroscopy Maintenance and Service Agreement

Product Service Code: J065

HT940626QE1070001

Supplies or Services & Prices or Costs Additional Information/Notes

Item Supplies / Services Quantity Unit Unit Price Amount

Maintenance and Service agreement for (2) Orthoscan TAU 1512 Mini C-Arm Fluoroscopy Systems for Navy Medicine Readiness Training Command (NMRTC) Sigonella's Orthopedic and OR Department:

ECN 098596 SN 5N0279

ECN 098597 SN 5N0274

Period of Performance 30September2026 - 29September2027.

See Performance Work Statement for more detailed information.

Product Service Code: J065 Pricing Arrangement: Firm Fixed Price

4 Quarter (Time)

Option Line Item

Option Period 1 Maintenance and Service agreement for (2) Orthoscan TAU 1512 Mini C-Arm Fluoroscopy Systems for Navy Medicine Readiness Training Command (NMRTC) Sigonella's Orthopedic and OR Department:

ECN 098596 SN 5N0279

ECN 098597 SN 5N0274

Period of Performance 30September2027 - 29September2028.

See Performance Work Statement for more detailed information.

Product Service Code: J065 Pricing Arrangement: Firm Fixed Price

4 Quarter (Time)

Option Line Item

Option Period 2 Maintenance and Service agreement for (2) Orthoscan TAU 1512 Mini C-Arm Fluoroscopy Systems for Navy Medicine Readiness Training Command (NMRTC) Sigonella's Orthopedic and OR Department:

ECN 098596 SN 5N0279

ECN 098597 SN 5N0274

Period of Performance 30September2028 - 29September2029.

See Performance Work Statement for more detailed information.

Product Service Code: J065 Pricing Arrangement: Firm Fixed Price

4 Quarter (Time)

Option Line Item

Option Period 3 Maintenance and Service agreement for (2) Orthoscan TAU 1512 Mini C-Arm Fluoroscopy Systems for Navy Medicine Readiness Training Command (NMRTC) Sigonella's Orthopedic and OR Department:

ECN 098596 SN 5N0279

ECN 098597 SN 5N0274

Period of Performance

4 Quarter (Time)

30September2029 - 29September2030.

See Performance Work Statement for more detailed information.

Product Service Code: J065 Pricing Arrangement: Firm Fixed Price

Option Line Item

Option Period 4 Maintenance and Service agreement for (2) Orthoscan TAU 1512 Mini C-Arm Fluoroscopy Systems for Navy Medicine Readiness Training Command (NMRTC) Sigonella's Orthopedic and OR Department:

ECN 098596 SN 5N0279

ECN 098597 SN 5N0274

Period of Performance 30September2030 - 29September2031.

See Performance Work Statement for more detailed information.

Product Service Code: J065 Pricing Arrangement: Firm Fixed Price

4 Quarter (Time)

Option Line Item

Option Period 5 Optional 6 Month Extension:

Maintenance and Service agreement for (2) Orthoscan TAU 1512 Mini C-Arm Fluoroscopy Systems for Navy Medicine Readiness Training Command (NMRTC) Sigonella's Orthopedic and OR Department:

ECN 098596 SN 5N0279

ECN 098597 SN 5N0274

Period of Performance 30September2031 - 29March2032.

See Performance Work Statement for more detailed information.

Product Service Code: J065 Pricing Arrangement: Firm Fixed Price

6 Months

Description/Specifications/Statement of Work

Requirements This is a maintenance and service requirement for two Orthoscan TAU 1512 Mini C-Arms for NMRTC Sigonella.

Packaging and Marking

Inspection and Acceptance

DFARS Clauses Incorporated by Full Text

252.229-7003 Tax Exemptions (Italy). (Mar 2012)

TAX EXEMPTIONS ( ITALY ) (MAR 2012)

(a) As the Contractor represented in its offer, the contract price, including the prices in subcontracts awarded under this contract, does not include taxes from which the United States Government is exempt.

(b) The United States Government is exempt from payment of ( ) tax in accordance with Article 72 of the implementing Imposta Valore Aggiunto IVA IVA decree on all supplies and services sold to United States Military Commands in Italy .

(1) The Contractor shall include the following information on invoices submitted to the United States Government:

( ) The contract number.i

(ii) The tax exemption claimed pursuant to Article 72 of Decree Law 633, dated October 26, 1972 . IVA

(iii) The following fiscal code(s): [Contracting Officer must insert the applicable fiscal code(s) for military activities within 80156020630 Italy :

80028250241 for Army, 80156020630 for Navy, or 91000190933 for Air Force].

(2)( ) Upon receipt of the invoice, the paying office will include the following certification on one copy of the invoice:i

"I certify that this invoice is true and correct and reflects expenditures made in Italy for the Common Defense by the United States Government pursuant to international agreements. The amount to be paid does not include the tax, because this transaction is not IVA subject to the tax in accordance with Article 72 of Decree Law 633, dated October 26, 1972 ."

An authorized United States Government official will sign the copy of the invoice containing this certification.

(ii) The paying office will return the certified copy together with payment to the Contractor. The payment will not include the amount of the tax. IVA

(iii) The Contractor shall retain the certified copy to substantiate non-payment of the tax. IVA

(3) The Contractor may address questions regarding the tax to the Ministry of Finance, Office, Rome (06) 520741. IVA IVA

(c) In addition to the tax, purchases by the United States Forces in Italy are exempt from the following taxes: IVA

(1) (Production Tax for Petroleum Products). Imposta di Fabbricazione

(2) (Consumption Tax for Electrical Power). Imposta di Consumo

(3) (Customs Duties). Dazi Doganali

(4) e Merci per Via e per Via (Port Fees). Tassa di Sbarco d'Imbarco sulle Transportate Aerea Maritima

(5) de (Vehicle Circulation Tax). Tassa Circolazione sui Veicoli

(6) (Registration Tax). Imposta di Registro

(7) (Stamp Tax). Imposta di Bollo

(End of clause)

Overall Contract Inspection/Acceptance Locations

Acceptance Location

Acceptance Destination Instructions: See Statement of Work (SOW) or Performance Work Statement (PWS) for Acceptance/inspection criteria.

DoDAAC: HT0488 CountryCode: ITA

NAV HSPTL SIGONELLA ITALY - MM

USNH SIGONELLA ITALY, SS 192 KM 76 NAS1

SICILY 95100

ITALY

Agostina Randazzo

Email: Agostina.randazzo.LN@health.mil Telephone: 01139095563791

Option Line Item

Acceptance Location

Acceptance Destination Instructions: See Statement of Work (SOW) or Performance Work Statement (PWS) for Acceptance/inspection criteria.

DoDAAC: HT0488 CountryCode: ITA

NAV HSPTL SIGONELLA ITALY - MM

USNH SIGONELLA ITALY, SS 192 KM 76 NAS1

SICILY 95100

ITALY

Agostina Randazzo Email: Agostina.randazzo.LN@health.mil Telephone: 01139095563791

Option Line Item

Acceptance Location

Acceptance Destination Instructions: See Statement of Work (SOW) or Performance Work Statement (PWS) for Acceptance/inspection criteria.

DoDAAC: HT0488 CountryCode: ITA

NAV HSPTL SIGONELLA ITALY - MM

USNH SIGONELLA ITALY, SS 192 KM 76 NAS1

SICILY 95100

ITALY

Agostina Randazzo Email: Agostina.randazzo.LN@health.mil Telephone: 01139095563791

Option Line Item

Acceptance Location

Acceptance Destination Instructions: See Statement of Work (SOW) or Performance Work Statement (PWS) for Acceptance/inspection criteria.

DoDAAC: HT0488 CountryCode: ITA

NAV HSPTL SIGONELLA ITALY - MM

USNH SIGONELLA ITALY, SS 192 KM 76 NAS1

SICILY 95100

ITALY

Agostina Randazzo Email: Agostina.randazzo.LN@health.mil Telephone: 01139095563791

Option Line Item

Acceptance Location

Acceptance Destination Instructions: See Statement of Work (SOW) or Performance Work Statement (PWS) for Acceptance/inspection criteria.

DoDAAC: HT0488 CountryCode: ITA

NAV HSPTL SIGONELLA ITALY - MM

USNH SIGONELLA ITALY, SS 192 KM 76 NAS1

SICILY 95100

ITALY

Agostina Randazzo Email: Agostina.randazzo.LN@health.mil Telephone: 01139095563791

Option Line Item

Acceptance Location

Acceptance Destination

Instructions: See Statement of Work (SOW) or Performance Work Statement (PWS) for Acceptance/inspection criteria.

DoDAAC: HT0488 CountryCode: ITA

NAV HSPTL SIGONELLA ITALY - MM

USNH SIGONELLA ITALY, SS 192 KM 76 NAS1

SICILY 95100

ITALY

Agostina Randazzo Email: Agostina.randazzo.LN@health.mil Telephone: 01139095563791

Deliveries or Performance

Line Item Delivery Schedule Quantity Address and POC

Delivery Period From 30 Sep 2026 to 29 Sep 2027

4 Quarter (Time) Service Performance Site DoDAAC: HT0488 CountryCode: ITA

NAV HSPTL SIGONELLA ITALY - MM

USNH SIGONELLA ITALY, SS 192 KM 76 NAS1

SICILY 95100

ITALY

Agostina Randazzo Email: Agostina.randazzo.LN@health.mil Telephone: 01139095563791

Period of Performance From 30 Sep 2026 To 29 Sep 2027

Option Line Item

Delivery Period From 30 Sep 2027 to 29 Sep 2028

4 Quarter (Time) Service Performance Site DoDAAC: HT0488 CountryCode: ITA

NAV HSPTL SIGONELLA ITALY - MM

USNH SIGONELLA ITALY, SS 192 KM 76 NAS1

SICILY 95100

ITALY

Agostina Randazzo Email: Agostina.randazzo.LN@health.mil Telephone: 01139095563791

Period of Performance From 30 Sep 2027 To 29 Sep 2028

Option Line Item

Delivery Period From 30 Sep 2028 to 29 Sep 2029

4 Quarter (Time) Service Performance Site DoDAAC: HT0488 CountryCode: ITA

NAV HSPTL SIGONELLA ITALY - MM

USNH SIGONELLA ITALY, SS 192 KM 76 NAS1

SICILY 95100

ITALY

Agostina Randazzo Email: Agostina.randazzo.LN@health.mil Telephone: 01139095563791

Period of Performance From 30 Sep 2028 To 29 Sep 2029

Option Line Item

Delivery Period From 30 Sep 2029 to 29 Sep 2030

4 Quarter (Time) Service Performance Site DoDAAC: HT0488 CountryCode: ITA

NAV HSPTL SIGONELLA ITALY - MM

USNH SIGONELLA ITALY, SS 192 KM 76 NAS1

SICILY 95100

ITALY

Agostina Randazzo Email: Agostina.randazzo.LN@health.mil Telephone: 01139095563791

Period of Performance From 30 Sep 2029

To 29 Sep 2030

Option Line Item

Delivery Period From 30 Sep 2030 to 29 Sep 2031

4 Quarter (Time) Service Performance Site DoDAAC: HT0488 CountryCode: ITA

NAV HSPTL SIGONELLA ITALY - MM

USNH SIGONELLA ITALY, SS 192 KM 76 NAS1

SICILY 95100

ITALY

Agostina Randazzo Email: Agostina.randazzo.LN@health.mil Telephone: 01139095563791

Period of Performance From 30 Sep 2030 To 29 Sep 2031

Option Line Item

Delivery Period From 30 Sep 2031 to 29 Mar 2032

6 Months Service Performance Site DoDAAC: HT0488 CountryCode: ITA

NAV HSPTL SIGONELLA ITALY - MM

USNH SIGONELLA ITALY, SS 192 KM 76 NAS1

SICILY 95100

ITALY

Agostina Randazzo Email: Agostina.randazzo.LN@health.mil Telephone: 01139095563791

Period of Performance From 30 Sep 2031 To 29 Mar 2032

FAR Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

52.242-15 Stop-Work Order. Aug 1989

Contract Administration Data

CAGE: _____________________

UEI: _____________________

Vendor POC: _____________________

Vendor Phone: ____________________

Vendor E-mail: ____________________

Notes to Vendor:

- At a minimum, the SF1449 and Attachment- Cost Breakdown Per Year and Equipment must be completed and documentation provided from OEM stating that you are an authorized service provider for the Orthoscan Mini C-Arm equipment to be considered for this opportunity. Please respond to blocks 17a and 30a-c on page 1 and the vendor information on page 11, as well as provide your prices in EUROs on the Contract Line Item Numbers (CLINs). Cursive font signatures without digital certification will not be accepted (if you cannot digitally sign with certification, print/sign/scan your page one).

- Offeror will provide all license agreements, End User License Agreements (EULA), Terms of Service (TOS), Federal Payment Plans, Extended Payment Plans, and other similar instruments or agreements, required to be signed, or agreed to, by the Government that the offeror or any of its suppliers or subcontractors (at any level) require. The Government may review to ensure terms and conditions are consistent with Federal law and otherwise satisfy the Government's needs.

Among terms and conditions that are not acceptable, which makes an offer ineligible for award, include: those such as Government indemnification of any party;

choice of law or forum for disputes; mandatory arbitration; any language that would or might require the Government to renew or extend performance or usage of any item, product, or service; or any other feature that unduly puts a burden or restriction on the Government.

- Vendor to reference request for quotes number (RFQ#) HT940626QE107 on all inquiries.

- All proposals should be inclusive of all costs (e.g. Shipping and Handling). Shipping should be included in the quote total, but NOT separately priced; shipping costs are always considered in the evaluation process.

- Award will be made on the basis of the lowest evaluated price and the capability to meet the requirement detailed in the Performance Work Statement.

PROMPT PAYMENT

For Prompt Payment Act purposes, this contract is subject to the 7 calendar day constructive acceptance period.

Billing / Payment in arrears

For all questions, POC:

Ms. Lisa Wilk Contract Specialist, Branch 5 Healthcare Contracting Division (HCD - Southeast) Defense Health Agency Contracting Activity (DHACA) Email: lisa.c.wilk.civ@health.mil

DFARS Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports. Dec 2018 252.232-7008 Assignment of Claims (Overseas). Jun 1997

DFARS Clauses Incorporated by Full Text

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

WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (JAN 2023)

(a) As used in this clause- Definitions.

"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) The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Electronic invoicing.

Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

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

(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) The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site WAWF training.

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

(f) The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for WAWF payment instructions.

this contract or task or delivery order:

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

(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.

INVOICE TYPE: Receiving Report (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.

Invoice_2 in 1 Service

(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) The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating Document routing.

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 HT9406

Admin DoDAAC HT9406

Inspect By DoDAAC N/A

Ship To Code HT0488

Ship From Code N/A

Mark For Code N/A

Service Approver (DoDAAC) HT0488

Service Acceptor (DoDAAC) HT0488

Accept at Other DoDAAC N/A

LPO DoDAAC N/A

DCAA Auditor DoDAAC N/A

Other DoDAAC(s) N/A

(*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) The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in Payment request.

accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

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

(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.

Antonio Valenti, 011+39-095564930, antonino.valenti2.LN@health.mil

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

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

(End of clause)

Special Contract Requirements 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.

means the DoD issuances implementing the Privacy Act, which are DoDI 5400.11, DoD Privacy and Civil Liberties Programs, January DoD Privacy Act Issuances 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.

means the DoD issuances implementing the HIPAA Rules in the DoD Military Health System (MHS). These issuances are DoDM 6025.18, DoD HIPAA Issuances "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.

is the DHA Privacy and Civil Liberties Office. The DHA Privacy Office Chief is the HIPAA Privacy and Security Defense Health Agency (DHA) Privacy Office 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 2 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 Research clause in the Defense Federal Acquisition Regulation Supplement (DFARS) at 48 CFR 252.235-7004. A separate DFARS provision, 48 CFR 235.072(e), requires that the clause be incorporated in contracts that include or may include research involving human subjects in accordance with 32 CFR 219, DoDI 3216.02, and 10 U.S.C. 980, including research that meets exemption criteria under 32 CFR 219.101(b), the clause applies to solicitations and contracts awarded by any DoD component, regardless of mission or funding Program Element Code. Thus, in the event a contractor participates in a study or demonstration project or other activity that involves human subject research, then the contractor shall comply with Protection of Human Subject Research clause. COs may not determine whether an activity is exempt from human subject research requirements. If contractor activity appears to involve human subject research, then the contractor shall consult the DHA Privacy Office, which may contact the Research Regulatory Oversight Office in the Office of the Under Secretary of Defense for Personnel and Readiness (OUSD(P&R)).

7. Privacy Act and HIPAA Training

The Contractor shall ensure that its entire staff, including subcontractors and consultants that perform work on this Contract receive training on the Privacy Act, HIPAA, and the federal regulations on confidentiality of substance use disorder patient records, 42 CFR Part 2. Refer to FAR 52.224-3 regarding specific requirements for Privacy Training appropriate to the Contractor's scope of involvement with DHA's PHI and its regulatory responsibilities as either a Covered Entity, or Business Associate.

The Contractor shall ensure all employees and subcontractors supply a certificate of all training completion to the Contracting Officer's Representative (COR) within 30 days of being assigned and on an annual basis based on the trainee's birth month thereafter.

8. HIPAA Business Associate Provisions

8.1 Business Associate - General Provisions

The Contractor meets the definition of Business Associate, and DHA meets the definition of a covered entity under the HIPAA Rules and the DoD HIPAA Issuances. Therefore, a Business Associate Agreement (BAA) between the Contractor and DHA is required to comply with the HIPAA Rules and the DoD HIPAA Issuances. The contractor shall use the DoD BAA, which shall be used by all organizational entities within the DoD, referred to collectively as the "DoD Components", located at, https://www.health.mil/Military-Health-Topics/Privacy-and-CivilLiberties/Privacy-Contract-Language/HIPAA-Compliant-Business- Associate-Agreement-for- the-MHS. b.i. and (3)b.ii

9. Breach Response

[This paragraph 9 is inoperative, and all references herein to "paragraph 9" shall be deemed to refer to the TOM breach responses provisions, if the contract incorporates the TOM by reference

9.1 Definitions Related to Breach response

means a loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where: (1) a person other than an 9.1.2 Breach authorized user accesses or potentially accesses PII; or (2) an authorized user accesses or potentially accesses PII for an other than authorized purpose. The foregoing definition is based on the definition of breach in DoDM 6025.18. Breaches are classified as either possible or confirmed (see the following two definitions) and as either cyber or non-cyber (i.e., involving either electronic PII/PHI or paper/oral PII/PHI).

is an incident where the possibility of unauthorized access is suspected (or should be suspected) and has not been ruled out. For 9.1.3 A possible breach example, if a laptop containing PII/PHI is lost, and the contractor does not initially know whether or not the PII/PHI was encrypted, then the incident must initially be classified as a possible breach, because it is impossible to rule out the possibility of unauthorized access to the PII/PHI. In contrast, that possibility can be ruled out immediately, and a possible breach has not occurred, when misdirected postal mail is returned unopened in its original packaging. However, if the intended recipient informs the contractor that an expected package has not been received, then a possible breach exists until and unless the unopened package is returned to the contractor. In determining whether unauthorized access should be suspected, the contractor shall consider at least the following factors:

-How the event was discovered;

-Did the information stay within the covered entity's control;

-Was the information actually accessed/viewed; and -Ability to ensure containment (e.g., recovered, destroyed, or deleted).

is an incident in which it is known that unauthorized access could occur. For example, if a laptop containing PII/PHI is lost and the 9.1.4 A confirmed breach contractor knows that the PII/PHI is unencrypted, then the contractor should classify and report the incident as a confirmed breach, because unauthorized access could occur due to the lack of encryption (the contractor knows this even without knowing whether or not unauthorized access to the PII/PHI has actually occurred).

If the laptop is subsequently recovered and forensic investigation reveals that files containing PII/PHI were never accessed, then the possibility of unauthorized access can be ruled out, and the contractor should re-classify the incident as a non-breach incident.

is an incident that satisfies the definition of breach in Section 164.402 of the HIPAA Breach Rule. The text of the HHS definition states: 9.1.5 A HHS breach

Breach means the acquisition, access, use, or disclosure of PHI in a manner not permitted under subpart E of this part [i.e. the HIPAA Privacy Rule] which compromises the security or privacy of the PHI.

HHS breach excludes:

Any unintentional acquisition, access, or use of PHI by a workforce member or person acting under the authority of a DoD covered entity or a business associate, if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted under the HIPAA Privacy Rule.

Any inadvertent disclosure by a person who is authorized to access PHI at a DoD covered entity or business associate to another person authorized to access PHI at the same DoD covered entity or business associate, or organized health care arrangement in which the DoD covered entity participates, and the information received as a result of such disclosure is not further used or disclosed in a manner not permitted the HIPAA Privacy Rule.

A disclosure of PHI where a DoD covered entity or business associate has a good faith belief that an unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information.

Except as provided in this definition, an acquisition, access, use, or disclosure of PHI in a manner not permitted under this issuance is presumed to be a breach unless the DoD covered entity or business associate, as applicable, demonstrates that there is a low probability that the PHI has been compromised based on a risk assessment of at least the following factors:

The nature and extent of the PHI involved, including the types of identifiers and the likelihood of re-identification;

The unauthorized person who used the PHI or to whom the disclosure was made;

Whether the PHI was actually acquired or viewed; and

The extent to which the risk to the PHI has been mitigated.

is a violation or imminent threat of violation of computer security policies, acceptable use policies, or standard security practices, 9.1.6 A cybersecurity incident with respect to electronic PII/PHI. A cybersecurity incident may or may not involve a breach of PII/PHI. For example, a malware infection would be a possible breach if it could cause unauthorized access to PII/PHI. However, if the malware only affects data integrity or availability (not confidentiality), then a non-breach cybersecurity incident has occurred.

9.2 General

The breach response requirements shall be followed for all unauthorized use or disclosure of information regardless of whether the information is PHI or 9.2.1 solely PII.

Because DoD defines "breach" to include possible (suspected), as well as actual (confirmed) breaches, the Contractor shall implement these breach 9.2.2 response requirements immediately upon the Contractor's discovery of a possible breach. These procedures focus on the first two steps (breach identification and reporting) of a comprehensive breach response program, but also require addressing the remaining steps: containment, mitigation (which includes individual notification), eradication, recovery, and follow-up.

The contractor shall establish internal processes for carrying out the procedures set forth below. These processes shall assign responsibility for investigating, 9.2.3 classifying, reporting and otherwise responding to breaches and cybersecurity incidents. The contractor should consult with the DHA Privacy Office where guidance is needed, such as when the contractor is uncertain whether a discovered breach is the contractor's responsibility (e.g., if the contractor discovers a breach not caused by the contractor), or how the contractor is to classify an incident (breach vs. non-breach, confirmed vs. possible, cyber vs. non-cyber). Under no circumstances will a contractor delay reporting a confirmed or possible breach to the DHA Privacy Office beyond the 24-hour deadline.. In conjunction with its initial investigation, the contractor shall immediately take steps to minimize any impact from the occurrence, proceed with further investigation of any relevant details (such as root causes, vulnerabilities exploited), and initiate further breach response steps.

In the event of a cybersecurity incident not involving a PII/PHI breach, the contractor shall follow applicable DoD cybersecurity and NIST requirements, which 9.2.4 include United StatesComputer Emergency Readiness Team (US-CERT) reporting (see paragraph 9.3). If at any point a contractor finds that a cybersecurity incident involves a PII/PHI breach (possible or confirmed), the contractor shall immediately initiate the reporting procedures set forth below. The contractor shall also continue to follow any required cybersecurity incident response procedures and other applicable DoD cybersecurity requirements.

Contractors shall require subcontractors who discover a possible breach or cybersecurity incident to initiate the incident response requirements herein by 9.2.5 reporting the incident to the contractor immediately after discovery. The time of that report to the contractor shall trigger the contractor's DHA Privacy Office reporting deadline (24 hours) under paragraph 9.3.2. If a cybersecurity incident is involved, the contractor's deadline for US-CERT reporting (1 hour) runs from the time the incident is confirmed. The contractor shall require the subcontractor to cooperate as necessary to meet these deadlines, maintain records, and otherwise enable the contractor to complete the breach response requirements herein. Alternatively, the contractor and subcontractor may agree that the subcontractor shall report directly to US-CERT and the DHA Privacy Office, and that the subcontractor shall be responsible for completing the response process, provided that such agreement requires the subcontractor to inform the contractor of the incident and the subsequent response actions.

Contractors shall maintain records of all breach and cybersecurity incident investigations, regardless of the outcome. Investigations identifying unauthorized 9.2.6 disclosures must be logged for HIPAA and Privacy Act disclosure accounting purposes, whether or not individual notification is required under the HIPAA Breach Rule.

Contractors, when acting as HIPAA-covered entities, and not as business associates, are not subject to the breach response requirements herein. However, 9.2.7 such contractors are subject to both the HIPAA Breach Rule (applicable to them in their capacity as covered entities) and DoD cybersecurity requirements (applicable to them in their capacity as DoD contractors).

9.3 Reporting Provisions

Immediately upon discovery of a possible or confirmed breach or cybersecurity incident, the contractor shall initiate an investigation. If the incident involves 9.3.1 electronic PII/PHI, and if the investigation finds a confirmed breach or cybersecurity incident, the contractor shall report it, within 1 hour of confirmation, to the US- CERT Incident Reporting System at https://forms.uscert.gov/report/, as required by the Department of Homeland Security (DHS).

Note: DHS no longer requires US-CERT reporting of non-cyber breaches or unconfirmed electronic breaches. However, DHS permits US-CERT reporting of unconfirmed cyber-related incidents on a voluntary basis. Thus, if a contractor is uncertain whether a possible cyber-related incident should be treated as confirmed and thus reportable, the contractor may voluntarily report the incident.

Before submission to US-CERT, the contractor shall save a copy of the on-line report. After submitting the report, the contractor shall record the US-CERT incident reporting number, which shall be included in the initial report to the DHA Privacy Office as described in paragraph 9.3.2.

Note: Regardless of whether or not an incident is confirmed as a breach, the contractor must also investigate whether or not the incident impacts data integrity or availability of PII/PHI. If such impact is confirmed, then the incident is reportable to US-CERT as a cybersecurity incident. For guidance on investigating the impact on data integrity and availability, refer to DoD cybersecurity and NIST guidance.

The contractor shall provide any updates to the initial US-CERT report by email to soc@uscert.gov, with the Reporting Number in the subject line. The contractor shall provide a copy of the initial or updated US-CERT report to the DHA Privacy Office if requested. Contractor questions about US-CERT reporting shall be directed to the DHA Privacy Office, not the US- CERT office.

In addition to US-CERT reporting, the contractor shall report to the DHA Privacy Office by submitting the form specified below within 24 hours of discovery of 9.3.2 a breach (possible or confirmed), unless the breach falls within a category that the Privacy Office has determined to be not reportable. This 24-hour period runs from the time of discovery, unlike the 1 hour USCERT reporting period, which runs from the time a cybersecurity incident is confirmed. Thus, depending on the time period needed to confirm, the report to the DHA Privacy Office may be due either before or after the US-CERT report.

The breach report form required within the 24-hour deadline shall be sent by e-mail to: DHA.PrivacyOfficer@mail.mil. The contractor shall also e-mail the report to the CO, the COR and its usual point of contact at the applicable Program Office. Encryption is not required, because reports and notices shall not contain PII/PHI. If electronic mail is not available, telephone notification is also acceptable (at 703-275-6363), but all notifications and reports delivered telephonically must be confirmed in writing as soon as technically feasible.

Contractors shall prepare the breach reports required within the 24-hour deadline by completing the Breach Reporting Department of Defense Form DD 2959 (Breach of PII Report), available at https://www.esd.whs.mil/Portals/54/Documents/DD/forms/dd/dd2959.pdf. For non-cyber incidents without a US-CERT number, the contractor shall assign an internal tracking number and include that number in Box 1.e of the DD Form 2959. The contractor shall coordinate with the DHA Privacy Office for subsequent action, such as beneficiary notification, and mitigation. The contractor must promptly update the DD Form 2959 as new information becomes available.

When a Breach Report Form initially submitted is incomplete or incorrect due to unavailable information, or when significant developments require an update, the Contractor shall submit a revised form or forms promptly after the new information becomes available, stating the updated status and previous report date(s) and showing any revisions or additions in red text. The Contractor shall provide updates to the same parties as required for the initial Breach Report Form.

9.4 Individual Notification Provisions

If the DHA Privacy Office determines that individual notification is required, the Contractor shall provide written notification to beneficiaries affected by the 9.4.1 breach as soon as possible, but no later than 10 working days after the breach is discovered and the identities and addresses of the beneficiaries are ascertained.

The 10 day period begins when the Contractor is able to determine the identities (including addresses) of the beneficiaries whose records were impacted. If notification cannot be accomplished within 10 working days, the contractor shall notify the DHA Privacy Office.

The Contractor's proposed notification to be issued to the affected beneficiaries shall be 2 submitted to the DHA Privacy Office for approval. The notification 9.4.2 to beneficiaries shall include, at a minimum, the following:

-Specific data elements, -Basic facts and circumstances, -Recommended precautions the beneficiary can take, -Federal Trade Commission (FTC) identity theft hotline information, and -Any mitigation support services offered, such as credit monitoring.

Contractors shall ensure any envelope containing written notifications to affected individuals are clearly labeled to alert the recipient to the importance of its contents, e.g., "Data Breach Information Enclosed," and that the envelope is marked with the identity of the Contractor and/or subcontractor organization that suffered the breach.

If media notice is required, the contractor will submit a proposed notice and suggested media outlets for the DHA Privacy Office review and approval (which will include coordination with the DHA Communications Division).

In the event the Contractor is uncertain on how to apply the above requirements, the Contractor shall consult with the CO, who will consult with the Privacy 9.5 Office as appropriate when determinations on applying the above requirements are needed.

The Contractor shall, at no cost to the government, bear any costs associated with a breach of PII/PHI that the Contractor has caused or is otherwise responsible for addressing.

Contract Clauses

FAR Clauses Incorporated by Reference

Number Title Effective Date

Alternate/ Deviation

Variation Effective Date

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements. Jan 2017 52.204-9 Personal Identity Verification of Contractor Personnel. Jan 2011 52.204-13 System for Award Management-Maintenance. (Deviation 2026-O0038) Feb 2026

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded. (Deviation 2026-O0038)

Feb 2026

52.209-10 Prohibition on Contracting With Inverted Domestic Corporations. (Deviation 2026-O0038) Feb 2026 52.212-4 Terms and Conditions-Commercial Products and Commercial Services. (Deviation 2026-O0038) Feb 2026 52.222-3 Convict Labor. (Deviation 2026-O0038) Feb 2026 52.222-50 Combating Trafficking in Persons. (Deviation 2026-O0038) Feb 2026 52.222-90 Addressing DEI Discrimination by Federal Contractors. (Deviation 2026-O0040, Revision 1) Apr 2026 52.225-14 Inconsistency between English Version and Translation of Contract. Feb 2000 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving. May 2024 52.229-6 Taxes-Foreign Fixed-Price Contracts. Feb 2026 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.