HT940624Q0067.docx

HT940624Q0067

Section SF 1449 - CONTINUATION SHEET

VENDOR/CUSTOMER/PAYMENT

CAGE: _____________________

UEI: _____________________

Vendor POC: _____________________

Vendor Phone: ____________________

Vendor E-mail: ____________________

Notes to Vendor:

-At a minimum, the SF1449 must be completed to be considered for this opportunity. Please respond to blocks 17a and 30a-c on page 1 and the vendor information on page 3, as well as provide your price(s) on the Contract Line Item Number(s) (CLINs). Cursive font signatures will not be accepted.

-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#) HT940624Q0067on 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. Only NEW product offers will be accepted.

-For competitive service buys, type: 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:

Cynthia.e.scharnowske.civ@health.mil

OPHTHALMOLOGY EQUIPMENT MAINTENANCE

FFP

OPHTHALMOLOGY EQUIPMENT MAINTENANCE

Equipment located at Naval Medical Center Portsmouth and Branch Health Clinics.

“Vendor to provide annual services for Naval Medical Center Portsmouth and its outlying Branch Health Clinics. Services are to be provided in accordance with the Performance Work Statement for equipment listed within the chart.”

FOB: Destination

PURCHASE REQUEST NUMBER: 0012114855

J065

NET AMT

FFP

OPHTHALMOLOGY EQUIPMENT MAINTENANCE

Equipment located at Naval Medical Center Portsmouth and Branch Health Clinics.

“Vendor to provide annual services for Naval Medical Center Portsmouth and its outlying Branch Health Clinics. Services are to be provided in accordance with the Performance Work Statement for equipment listed within the chart.”

FOB: Destination

NET AMT

FFP

OPHTHALMOLOGY EQUIPMENT MAINTENANCE

Equipment located at Naval Medical Center Portsmouth and Branch Health Clinics.

“Vendor to provide annual services for Naval Medical Center Portsmouth and its outlying Branch Health Clinics. Services are to be provided in accordance with the Performance Work Statement for equipment listed within the chart.”

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERY INFORMATION

30-SEP-2025

CHASITY FAVOR

ATTN SUPPLY OFFICER BLDG 250

54 LEWIS MINOR STREET

PORTSMOUTH VA 23708-2297

HT0242

30-SEP-2026

HT0242

30-SEP-2027

HT0242

CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 3 months.

(End of clause)

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 7 months provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 5 days before the contract expires. The preliminary notice does not commit the Government to an extension.

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

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 36 months.

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

FAR Clauses http://acquisition.gov/far DFARS Clauses http://www.acq.osd.mil/dpap/dars/dfars/index.htm

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

(a) Definitions. As used in this clause—

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

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

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

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

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

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

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

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

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

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

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

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

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

(ii) For fixed price line items—

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

________INVOICE TYPE: Receiving Report (Combo) _______________________________

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

____________Invoice_2 in 1 Service _____________________________________

(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*

(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.

amanda.m.aitchison.civ@health.mil; Kimberly.t.outlaw.civ@health.mil

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

PERFORMANCE WORK STATEMENT

Department of Defense Defense Health Agency Performance Work Statement

Ophthalmology Equipment Maintenance and Service Agreement

20240412

Naval Medical Readiness and Training Command, Portsmouth

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide maintenance and repair services to all Carl Zeiss Ophthalmology equipment listed in this PWS and its subcomponents.

1.1.1 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to provide full maintenance support for the items listed in Section 1.1.3 and all support items / components as defined in this PWS except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.1.2 Background: : The Ophthalmology department of the below Commands have a reoccuring requirement for a service and maintenance plan for Carl Zeiss Ophthalmology Equipment and its components. See below table for details of purchase dates and Commands.

NMRTC Portmouth is located at 620 John Paul Jones Cir, Portsmouth VA 23708.

NAS Oceana is located at 1750 Tomcat Blvd., Virginia Beach, VA 23460.

BHC Boone is located at 1035 Nider Blvd., Virginia Beach, VA 23459.

BHC NNSY is located at 277 Berren St., Portsmouth, VA 23704.

NSN Sewells Point is located at 1721 Admiral Taussig Blvd., Norfolk VA 23511.

1.1.3 Scope: Uninterrupted operation of the Carl Zeiss Ophthalmology Equipment are vital to support of the Navy mission. An annual service contract is required to support the installed equipment located within the various Departments across multiple Commands. The service contract would include access to technicians via phone, text, or email, technical phone support during procedures, on-site preventative maintenance every 12 months, and on-site emergency service for malfunctioning equipment. Service will include full coverage on parts/travel/labor charges, full coverage on replacement consoles/parts, hardware or software upgrade, all software updates, shipping to ensure parts are available to on-site technicians during service and maintenance, and a 24 hr response time for preventative maintenance. Response time and requirements for Corrective maintenance is listed in Specific Tasks section 2.2.

1.1.4 Period of Performance (PoP):

BASE YEAR (01 OCT 2024 – 30 SEP 2025)

OPTION YEAR 1 (01 OCT 2025 – 30 SEP 2026)

OPTION YEAR 2 (01 OCT 2026 – 30 SEP 2027)

1.2 Administrative specifications

1.2.1 Place of performance: The work shall be performed at the below locations.

1.2.2 Recognized Federal holidays: Vendor is not required to work on the below federal holidays.

Independence Day

1.2.3 Hours of operation: The contractor is responsible for conducting business Monday thru Friday, between 8:00 A.M. to 4:30 P.M. except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.3 Contractor Identification

1.3.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the Government understands that the person is contractor support personnel.

2.0 SPECIFIC TASKS

2.1 Service Agreement for Annual Preventative Maintenance and Corrective Maintenance

2.1.1 Preventive maintenance. Shall be performed once a year in accordance with the Original Equipment Manufacturers (OEM) recommendations. The contractor shall be qualified / authorized by the OEM (IE: Certified Agent of the OEM) in the repair of all equipment listed within this contract. Certification of the OEM must be current (within 2 years) at all times prior to contract award and throughout contract period. Contractor and its employees shall maintain qualifications throughout entire contract period. In the event that a sub-contractor is used for this requirement, the sub-contractor must be a Certified Agent of the OEM. Qualification includes but not limited to the certification of all repair persons and repair facilities by the OEM( original equipment Manufactuers) as being trained / qualified to perform required repairs. The Government shall maintain the right to seek proof of qualification prior to award and anytime during contract period of performance. Additionally, contractor must have ready access to parts inventory of OEM replacement parts.

2.1.2 This contract shall provide annual preventative maintenance services which include on-site corrective repairs and calibration in accordance with the Original Manufacturer’s Equipment requirements, normal working hour coverage (8:00 A.M. to 4:00 P.M. Monday through Friday excluding Federal holidays); emergency service and routine preventive maintenance services to Department of Defense owned equipment. It shall include all systems, subsystem components, and assemblies, (i.e.: contractor responsible for total maintenance of entire system). All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated. Preventative maintenance and corrective repairs, if needed shall be done prior to the 15th of May each fiscal year to the main component and all subcomponents listed below.

2.1.3 The contractor shall make a best effort to schedule and complete annual preventive maintenance services prior to the 15th of May, but no later than the last day of the month.

Vendor shall report to Biomedical Engineering Bldg. 250 1st floor located at 54 Lewis Minor St. Portsmouth, VA 23708. The contact number is 757-953-5336. The FSE shall personally notify Biomedical Engineering (BME) of problems that result in the equipment being left disabled upon their departure. After normal duty hours, contractor FSE’s shall notify the Officer of the Day Desk (Bldg 2, 2nd Floor).

2.1.4 The contractor shall provide to BME a Field Service Report (FSR) within two (2) days after completion of all service performed. The service report shall include, but not be limited to: contract number, equipment description (model, serial number, equipment control number) contractor’s log number, detailed description of the service(s) performed, replacement part(s) information (part number, part value, nomenclature, unit price, manufacturer, if not OEM, and whether the part is new/used/reconditioned), the completion date and time, man-hours expended, model and serial numbers, and the name of the FSE performing the service. In the event that agents/sub-contractor’s are used in the performance of repairs, said agent shall be identified on the service report by company name and contact information (i.e., telephone number). Additionally contractor will be required to affix a tag on equipment upon the completion of a preventative maintenance inspection. Tag may either be a “sticker” or “hanging tag”. As a minimum the tag shall contain: the name of the contractor, technician performing inspection and date of inspection legibly printed. FSR will be emailed to BME distribution email at usn.hampton-roads.nmrtc-portsmouth-va.list.nmcp-dfabiomed@health.mil.

2.1.5 All test equipment used in the performance of this contract must be calibrated (if required / as required by manufacture of test equipment) and shall be in compliance with Joint Commission (JC) Original Equipment Manufacturer (OEM) and Federal Drug Administration (FDA) standards as required.

2.1.6 The contractor shall provide trained, experienced, English speaking personnel, labor, tools, diagnostic equipment, software, test phantoms, material, supplies, transportation, parts and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety testing (ST) and corrective maintenance

2.1.7 The contractor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator will be made available to answer technical questions regarding system operations and applications. The contractor points of contact (POC). Service calls shall be placed 24 hours a day, 7 days a week by calling a vendor supplied toll free response center. Qualified service reps are required to make a “best effort” to call back within 4-hours during normal business hours (8am – 5pm EST Monday – Friday excluding Federal Holidays) to schedule service visit.

2.2 Corrective Maintenance. Normal working hour maintenance coverage will be Monday through Friday, between 8:00 A.M. to 4:30 P.M. A contractor Service Tech shall respond via telephone within 4 hours after receipt of trouble call, and make a best effort to provide on-site service no later than the close of business (4:30 pm) on the next business day. Vendor is to make a best effort to have all equipment operational within 72 hours of initial on-site response.

2.2.1 In the event that emergency service outside the normal working hours are required by the Government, additional work shall be billable to the Government at published commercial rates, and negotiated and approved by a Contracting Officer prior to services rendered. Government request for corrective maintenance will be placed by BME, to the contractor’s POC. Corrective Maintenance shall be completed during the hours specified in the contract.

2.3 Base Access. Vendors and contractors will apply for, and maintain, base access. This can be done at https://dbids-global.dmdc.mil/home/. Vendors and contractors will also complete form SECNAV 5512/1 and submit to BME points of contacts Mr. Benjamin Lee benjamin.c.lee8.civ@health.mil and HMC Malcolm Roberts malcolm.j.roberts4.mil@health.mil for processing.

2.3.1 The contractor representative(s) at each site is encouraged to request a pre-maintenance inspection prior to the onset of the contract. As all apparent discrepancies must be identified upon submittal of quote, any and all claims must be received within 30 days of contract award or prior to contract start whichever occurs first. All non-apparent / hidden discrepancies must be identified no later than the first scheduled preventative maintenance. Any claims resulting from hidden defects must be received within 30 days of first scheduled preventative maintenance. Any equipment found to be inoperable during this pre-maintenance inspection would be repaired using a separate purchase order. The cost of repairs shall not exceed contractor’s normal retail rate for required repairs. The government certifies that the equipment to be maintained under this contract will be in good operating condition on the effective date of this contract. For the purpose of this contract, the clause, “good operating condition” means the conditions necessary for the equipment to function as intended without corrective maintenance. The contractor agrees to leave the equipment in good operating condition at the expiration of this contract. During the final week of this contract, the Government will make final inspection of the equipment. Any correction of deficiencies noted during this inspection shall be resolved prior to contract end. The Government reserves the right to request the repair (at no additional cost to the Government) of items identified with latten defects after contract termination, when it has been determined that defects either are a result of contractor’s performance or should have been discovered during normal performance of work under this contract.

2.3.2 The Government will not be responsible for the damage or loss due to fire, theft, accident, or other disaster of contractor supplies, materials, or for the personal belongings brought onto Government property by contractor’s personnel.

2.4 Replacement Parts: The contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacements parts are required to be shipped. Shipping shall be performed in the fastest reasonable means possible (i.e., next day air) at no additional cost to the Government. All replacement parts shall be new and certified as OEM replacement parts. In the event that new parts are not available, rebuilt parts and sub-assemblies are allowed provided that they are warranted to be free of defects for a period of time that meets or exceeds warranties of similar replacement parts. The contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. Vendor is not responsible for consumable items. The contractor shall specifically annotate on the final Field Service report the use and identification of rebuilt parts and the period of warranty. When discrepancies occur, the Government will make the final determination on whether a replacement part is of equal or better quality. Replacement parts must maintain the integrity of system / equipment certification to include compliance with any UL, AMA, Joint Comission (JC), manufacturer’s certifications or any other certifications as they apply.

2.4.1 The contractor shall at their expense, replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM. Vendor is not responsible for consumable items.

2.4.2 Contractor installed replacement parts shall become the property of the Government and the replaced malfunctioning part shall become the property of the contractor. Replaced items shall be properly disposed of at no additional cost to the Government (contractor to pay all “environmental fees” where required).

2.4.3 Contractor’s pricing shall be inclusive of all cost including parts, labor, travel and shipping, unless otherwise indicated.

2.4.4 Freight, postage, and storage charges associated with shipment and receipt of replacement parts, and the return of parts shall be the responsibility of the contractor.

2.5 Software: The contractor must include software revisions and updates (field service changes), which are required due to FDA, or manufacturer announced safety-hazard recall, to include FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Updates shall be performed as soon as possible after release, but no later than the first scheduled Preventative Maintenance Inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment by the OEM, contractor shall provide installation within 30 days of release regardless of preventative maintenance schedules.

2.6 Removal of Government Property. Whenever the repair of equipment cannot be performed at the Government site as determined by the contractor, the contractor shall notify BME who will make arrangements for the contractor to remove the item to the contractor’s designated site. The contractor may be required to sign a Government form accepting responsibility for the Government equipment. The contractor shall provide a detailed description of removed items. For associated items / accessories, contractor to provide a detailed description and quantities of items to be removed. Description to include as a minimum manufacturers serial numbers and equipment control number (ECN) of all equipment / items removed. In the event that items / sub-assemblies / accessories are repaired via “Repair by Replacement” a detailed description of replaced items is to be included upon return of repaired components.

2.6.1 All charges resulting from a contractor determined requirement to transport Government owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the contractor.

2.7 Equipment Modification Upgrades. The contractor shall only incorporate OEM specified modifications, alterations and upgrades. Approval shall be obtained from BME prior to the contractor installation of any modification, alteration, or upgrades.

2.7.1 The contractor shall maintain contact with the OEM to determine the requirement for field modifications and to ensure accomplishment of these modifications in accordance with the time schedule set forth by the OEM.

2.7.2 The Government shall not alter the system without prior notification to the contractor.

2.7.3 The contractor at no additional cost shall provide software updates to the Government. Installation of updates will be left to the discretion of the Government. All supplied software is to be warranted current and free of defects such as viruses.

2.8 Service beyond the Scope of the Contract. The contractor shall immediately, but not later than 24 consecutive hours after discovery, notify BME, in writing, of the existence or the development of any defects in, or repair required to the scheduled equipment, which the contractor considers they are not responsible for under the terms of this contract.

2.8.1 At the same time of the notification, the contractor shall furnish BME with written estimate of the cost to make the necessary repairs. Repairs considered by the contracting Officer to be outside the scope of this contract shall not be covered under this contract, but shall be ordered under a separate purchase order.

3.0 Points of Contact

3 .1 Points of Contact: The points of contact for BME are:

Mr. Benjamin Lee benjamin.c.lee8.civ@health.mil 757-953-5336 HMC Malcolm Roberts malcolm.j.roberts4.mil@health.mil 757-953-5336 RS2 Chasity Favor chasity.l.favor.mil@health.mil 757-953-5336

PRIVACY & SECURITY PHI

Personally Identifiable Information, Protected Health Information, and Federal Information Requirements (Revised 10/27/2020)

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

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

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

For purposes of this Section, the following definitions apply.

DoD Privacy Act Issuances means the DoD issuances implementing the Privacy Act, which are DoDI 5400.11, DoD Privacy and Civil Liberties Programs, January 29, 2019 and DoDI 5400.11- R, Department of Defense Privacy Program, May 14, 2007 HIPAA Rules means, collectively, the HIPAA Privacy, Security, Breach and Enforcement Rules, issued by the U.S. Department of Health and Human Services (HHS) and codified at 45 Code of Federal Regulations (CFR) Part 160 and Part 164, Subpart E (Privacy), Subpart C (Security), Subpart D (Breach) and Part 160, Subparts C-E (Enforcement), as amended. Additional HIPAA rules regarding electronic transactions and code sets (45 CFR Part 162) are not addressed in this Section and are not included in the term HIPAA Rules.

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

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

2. Records Management

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

3. Freedom of Information Act (FOIA)

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

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

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

4. Systems of Records

In order to meet the requirements of the Privacy Act and the DoD Privacy Act Issuances, the Contractor shall identify to the DHA Contracting Officer (CO) systems of records that are or will be maintained or operated for DHA where records of PII collected from individuals are maintained and specifically retrieved using a personal identifier. Upon identification of such systems to the CO, and prior to the lawful operation of such systems, the Contractor shall coordinate with the DHA Privacy Office to complete systems of records notices (SORNs) for submission and publication in the Federal Register as coordinated by the Defense Privacy, Civil Liberties, and Transparency Division, and as required by the DoD Privacy Act Issuances.

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

5. Privacy Impact Assessment (PIA)

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

6. Data Sharing Agreement (DSA)

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

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

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

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

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

• DSA for De-Identified Data

• DSA for PHI

• DSA for PII Without PHI

• DUA for Limited Data Set

DSAs executed for contract support will expire after 1 year or at the end of the contract option 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.