ATTACHMENT 1 - PWS.docx

Performance Work Statement (PWS)

RayStation Commissioning Services

1. GENERAL:

SERVICES REQUIRED: The Contractor shall furnish all personnel to provide services necessary to perform onsite Therapeutic Medical Physicist Support Services, to commission the RayStation Treatment Planning System (TPS) by RaySearch Labs for service on the following 3 Radiation Treatment Delivery systems for the Department of Veterans Affairs Medical Center, James A. Haley Veterans Hospital: 1) Varian TrueBeam STx linac; 2) Varian Edge linac; and 3) Accuray Cyberknife M6 linac (with fixed cones, Iris, and MLC heads.) The Radiation Oncology Service holds accreditation from APEx, so commissioning services must adhere to standards & guidelines set forth by this governing body. In addition, the on-site radiation oncology services must meet or exceed practices set forth in the American College of Radiology Guidelines for Radiation Oncology:

http://www.acr.org/Quality-Safety/Standards-Guidelines/Practice-Guidelines-by-Modality/Radiation-Oncology http://www.acr.org/Quality-Safety/Standards-Guidelines/Technical-Standards-by-Modality/Medical-Physics.

2. PLACE OF PERFORMANCE:

Services shall be provided on site in Radiation Oncology Service, VAMC 13000 Bruce B. Downs. Blvd., Tampa, FL 33612.

3. DEFINITIONS/ACRONYMS:

AAPM: American Association of Physics in Medicine ACGME: Accreditation Council for Graduate Medical Education ABR: American Board of Radiology ACR: American College of Radiology (www.acr.org/) ACO: Administrative Contracting Officer AOA: American Osteopathic Association BAA: Business Associate Agreement CAMPEP: Commission on Accreditation of Medical Physics Educational Programs (http://www.campep.org/default.asp) CDC: Centers for Disease Control and Prevention CEU: Certified Education Unit CME: Continuing Medical Education CMS: Centers for Medicare and Medicaid Services CO: Contracting Officer COR: Contracting Officer’s Representative COS: Chief of Staff CPARS: Contractor Performance Assessment Reporting System CPRS: Computerized Patient Recordkeeping System- electronic health record system used by the VA.

FSMB: Federation of State Medical Boards HHS: Department of Health and Human Services HIPAA: Health Insurance Portability and Accountability Act IGRT: Image Guided Radiation Therapy is the process of frequent two and three-dimensional imaging, during a course of radiation treatment, used to direct radiation therapy utilizing the imaging coordinates of the actual radiation treatment plan.

IMRT: Intensity Modulated Radiation Therapy is the process of delivering highly conformal radiotherapy to the tumor while sparing the surrounding normal tissues by varying radiation intensity across treatment portals.

MU: Monitor Unit is a measure of machine output of a linear accelerator in radiation therapy.

NHPP: National Health Physics Program- NHPP provides regulatory oversight for the Nuclear Regulatory Commission master materials license issued to VHA to include permitting for use of materials, on-site inspections, and investigations of allegations, medical events, and incidents. In addition, we provide oversight for machine sources of ionizing radiation used for radiation therapy. Finally, we aid and technical information for uses of ionizing radiation for healthcare diagnosis and treatment and non-human biomedical research. (http://www.patientcare.va.gov/NHPP.asp) NROP: National Radiation Oncology Program NRC: National Radiation Safety Committee POP: Period of Performance PPD: Purified Protein Derivative PWS: Performance Work Statement QASP: Quality Assurance Surveillance Plan QMP: Quality Management Program RPC: Radiological Physics Center SPE: Senior Procurement Executive SRS: Stereotactic Radio Surgery: a minimally invasive form of surgical intervention which makes use of a three-dimensional coordinated system to locate small targets inside the body and to perform on them some action such as ablation, biopsy, lesion, injection, stimulation, implantation, radiosurgery (SRS) etc.

SRT: Stereotactic Radio Therapy TJC: The Joint Commission TLD: Thermoluminescent Dosimeter- a device that measures radiation dose VA: Department of Veterans Affairs VAMC: Veterans Affairs Medical Center VHA: Veterans Health Administration

4. QUALIFICATIONS:

4.1 The commissioning personnel shall be Therapeutic Medical Physicists who are Board Certified in Medical Physics or Therapeutic Medical Physics by the ABR and maintain licensure with the Board of Licensure for Professional Medical Physicists, if applicable. Certification must be maintained throughout the contract period of performance.

4.1.1 The contractor shall have significant experience commissioning linear accelerators specifically with the RayStation treatment planning system (TPS), i.e., having commissioned a minimum of 40 RayStation TPS’s.

4.1.2 The commissioning personnel shall not be employees of, or subcontracted by, any of the vendors whose equipment is included in the systems being commissioned (i.e., Accuray, RayStation, or Varian.)

4.2 Technical Proficiency - Contract Therapeutic Medical Physicist shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read, and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history and shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations that govern medical staff behavior.

5. CONTRACTOR RESPONSIBILITIES

5.1 Full RayStation Data Collection for Varian TrueBeam STx – Photons: Perform beam data measurements and validation measurements based on the guidelines for RayStation Treatment Planning System for three (3) standard photon energies (6, 10 and 18 MV with open and EDWs), two (2) FFF photon energies (6 and 10 FFF with open fields.) PDD and Profile comparisons shall be performed with software capable of analyzing this data for commissioning quality standards listed in this document.

This includes:

5.1.1 PDD and profile measurements per RayStation requirements

5.1.2 Report of PDD and profile comparisons to representative data using AAPM MPPG5b region-based analysis. Report will minimally include:

- Summary of difference between D10 for photons between representative and collected data.

- Summary table broken down by energy, field size, depth, passing rate and passing criteria

- Detailed analysis of every scan with graphs of representative and collected data, graph of region-based analysis with descriptions of energy, field size, depth, passing rate and passing criteria

5.1.3 Open field output factors per RayStation requirements

5.1.4 TPS point dose measurements

5.1.5 IMRT / VMAT commissioning per RayStation's recommendations based on:

Saez, et. al. "A Novel procedure for determining the optimal MLC configuration parameters in treatment planning systems based on measurements with a Farmer Chamber"

5.1.6 Enhanced Dynamic Wedge (EDW) verification

5.1.7 Absolute dose calibration checks following AAPM TG-51 protocol

5.1.8 Annual beam QA baseline measurements

5.1.9 Small field Photon Dosimetry for four energies

5.1.10 All open field output factors for 1 cm and 2 cm field sizes

5.1.11 Small field MLC TPS Validation

5.1.12 Beam steering until symmetry is less than 1% for all beams

5.2 Full RayStation Data Collection for Varian TrueBeam STx – Electrons: Perform beam data measurements and validation measurements based on the guidelines for RayStation Treatment Planning System for five (5) electron energies (6, 9, 12, 16, and 20 MeV with six electron cones). PDD and Profile comparisons shall be performed with software capable of analyzing this data for commissioning quality standards listed in this document.

5.2.1 PDD and profile measurements per RayStation requirements

5.2.2 Report of PDD and profile comparisons to representative data using AAPM MPPG5b region-based analysis. Report will minimally include:

- Summary of difference between R50 for electrons between representative and collected data.

- Summary table broken down by energy, field size, depth, passing rate and passing criteria

- Detailed analysis of every scan with graphs of representative and collected data, graph of region-based analysis with descriptions of energy, field size, depth, passing rate and passing criteria

5.2.3 Electron cone output factors

- Measurement of all cone output factors at 100 SSD

- Spot check verification of cone output factors at 105 SSD & 110 SSD

5.2.4 TPS Point Dose Verification

5.2.5 Absolute dose calibration checks following AAPM TG-51 protocol

5.2.6 Beam steering until symmetry is less than 1% for all beams -

5.2.7 Annual beam QA baseline measurements

5.3 ACR / APEX Accreditation Support for TrueBeam STx

5.3.1 TPS Validation for ACR / APEX Accreditation

5.3.2 Per AAPM MPPG5b guidelines, the following TPS validations shall be performed:

- Photons: Tests 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 7.1, 7.2, 7.3, 7.4

- Electrons: Tests 8.0, 8.1, 8.2

5.3.3 Deliverables:

MPPG5b validation report

5.4 RayStation Validation Data Collection for Varian Edge (2nd TrueBeam) – Photons: Perform beam data collection and validation measurements for RayStation Treatment Planning System for three (3) standard photon energies (6, 10 and 18 MV with open and EDWs), two (2) FFF photon energies (6 and 10 FFF with open fields.) for comparison against the other TrueBeam. PDD and Profile comparisons shall be performed with software capable of analyzing this data for commissioning quality standards listed in this document.

5.4.1 PDD and profile measurements per RayStation requirements

5.4.2 Report of PDD and profile comparisons to representative data using AAPM MPPG5b region-based analysis. Report shall minimally include:

- Summary of difference between D10 for photons between representative and collected data.

- Summary table broken down by energy, field size, depth, passing rate and passing criteria

- Detailed analysis of every scan with graphs of representative and collected data, graph of region-based analysis with descriptions of energy, field size, depth, passing rate and passing criteria

5.4.3 Open field output factors per RayStation requirements for comparison to other TrueBeam

5.4.4 TPS point dose measurements

5.4.5 IMRT / VMAT commissioning per RayStation's recommendations based on:

Saez, et. al. "A Novel procedure for determining the optimal MLC configuration parameters in treatment planning systems based on measurements with a Farmer Chamber"

5.4.6 Enhanced Dynamic Wedge (EDW) verification

5.4.7 Absolute dose calibration checks following AAPM TG-51 protocol

5.4.8 Beam steering until symmetry is less than 1% for all beams

5.4.9 Beam model validation (VMAT passes at 95% for 3%/2mm)

5.4.10 Annual beam QA baseline measurements

5.4.11 Small field Photon Dosimetry for four energies

5.4.12 All open field output factors for 1 cm and 2 cm field sizes

5.4.13 Small field MLC TPS Validation

5.5 RayStation Validation Data Collection for Varian Edge (2nd TrueBeam) – Electrons: Perform beam data collection and validation measurements for five (5) electron energies (6, 9, 12, 16, and 20 MeV with six electron cones). PDD and Profile comparisons shall be performed with software capable of analyzing this data for commissioning quality standards listed in this document.

5.5.1 PDD and profile measurements per RayStation requirements

5.5.2 Report of PDD and profile comparisons to other TrueBeam using AAPM MPPG5b region-based analysis. Report will minimally include:

- Summary of difference between R50 for electrons between representative and collected data.

- Summary table broken down by energy, field size, depth, passing rate and passing criteria

- Detailed analysis of every scan with graphs of representative and collected data, graph of region-based analysis with descriptions of energy, field size, depth, passing rate and passing criteria

5.5.3 Measurement of all cone output factors at 100 SSD

5.5.4 TPS Point Dose Verification

5.5.5 Absolute dose calibration checks following AAPM TG-51 protocol

5.5.6 Beam steering until symmetry is less than 1% for all beams

5.5.7 Annual beam QA baseline measurements

5.6 ACR / APEX Accreditation Support for Edge

5.6.1 TPS Validation for ACR / APEX Accreditation

5.6.2 Per AAPM MPPG5b guidelines, the following TPS validations shall be performed:

- Photons: Tests 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 7.1, 7.2, 7.3, 7.4

- Electrons: Tests 8.0, 8.1, 8.2

5.6.3 Deliverables:

MPPG5b validation report

5.7 Full RayStation Data Collection for Accuray M6 Cyberknife

5.7.1 Perform beam data measurements and validation measurements based on the guidelines for RayStation Treatment Planning System for all three accelerator head configurations: Cones, Iris and MLC

5.7.2 In-air and water percentage depth dose, TPR and profile measurements for RayStation for all three accelerator head configurations: Cones, Iris and MLC

5.7.3 Output factors for RayStation for all three accelerator head configurations: Cones, Iris and MLC

5.7.4 TPS point dose verification measurements for all three accelerator head configurations: Cones, Iris and MLC

5.7.5 Absolute Dose Calibration check following AAPM TG-51 and the TG-135 protocol for all three accelerator head configurations: Cones, Iris and MLC

5.8 Deliverables (for all RayStation work)

5.8.1 Commissioning Review with the physicist

5.8.2 Review of TPS configuration and settings

5.8.3 Bound Hardback Databook

5.8.4 Commissioning report

5.8.5 Report with all values required for annual QA

5.8.6 All scanning data shall be provided digitally in a format accessibly by the facility With No Sensitive Data but Requires Training

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

VA INFORMATION CUSTODIAL LANGUAGE:

a. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

b. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

c. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

d. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

SECURITY INCIDENT INVESTIGATION:

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH:

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

SECURITY CONTROLS COMPLIANCE TESTING:

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

TRAINING:

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training before being granted access to VA information and its systems.

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Rules of Behavior before being granted access to VA information and its systems.

b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

The Certification and Accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required for this SOW.

All Contractor, Pharmaceutical Company Representative (PCR), and Healthcare Industry Representatives (HIR) will coordinate with Contracting Officer Representative for instructions, so they follow James A. Haley Veterans’ Hospital policies:

HPM NO. 90-25; JANUARY 2014; HEALTHCARE VENDOR ACCESS AND COMPETENCY

HPM NO. 132-04; DECEMBER 2012; SECURITY MANAGEMENT PROGRAM

HPM NO. 132 05; DECEMBER 2012; HOSPITAL IDENTIFICATION PROGRAM

HPM NO. 11-91; MAY 2013; PHARMACEUTICAL COMPANY REPRESENTATIVE

HIR are required to report to MSDU (Room GC-003), immediately after entering the facility. HIR will be required to sign into the monitoring system and print a badge for proper identification. The Healthcare Industry Representatives for Nutrition and Food Services, Office of Information and Technology, and Social Work Services are in included in this policy; vendors (HIR) for Pharmacy Services are to follow (HPM 11-91) policy. HIR must be sponsored by a physician, a Service Chief, or their designee, for a specified date and a specified case. HIR are not permitted in patient care areas or clinics unless a prior appointment has been made.

Pharmaceutical Company Representative (PCR) refers to anyone acting on behalf of a pharmaceutical company or its business partners for the purpose of promoting the use of items managed under the VA formulary process. These items primarily include drugs, but to a lesser extent also include any medical supplies, nutritional supplements, and similar commodities managed under the VA formulary process.

a. Sign-In: PCRs may visit VA Medical care facilities no earlier than 8:00 a.m. and stay no later than 3:30 p.m., Monday through Friday, unless they receive prior approval from both the Chief of the Service that they will be visiting and the Chief of Pharmacy. Representatives visiting the JAHVH must sign in at the Pharmacy Administrative Office (Located in Trailer 78) and wear a visitor’s badge as well as their company’s personal name badge while in the hospital.

Vendors: Reference Hospital Memorandum Policy Number 90-25 Healthcare Vendor Access and Competency.

Contractors and/or project managers: Will be issued a PIV/ID badge in accordance with the facility PIV Policy. Contactors will contact their assigned VA Contracting Officer Representative (COR) for coordination.

Contract Personnel/Sub-Contractors: Contractors are responsible for the daily accountability and identification of all personnel assigned to their respective contract including sub-contractors. Contractors will identify personnel using the following procedures as appropriate.

Construction Project contract personnel will report to the contractor for issuance of a temporary self-adhesive identification badge. This badge will be issued daily and must include the following information: Company name, project number, date, and name of individual. Contractor will maintain a daily log of all personnel.

Contract personnel not involved in an actual construction project will report to police dispatch for issuance of a numbered badge. A driver’s license or photo ID will be required each day upon entering the facility, in exchange for the badge, and will be given back once the badge is returned to police dispatch. The contractor will provide Police Service with a list of names for all sub-contract personnel requiring access to the facility. It is the responsibility of the contractor to update the list as necessary.

NPR OPC; CBOCs and Off-site Lease facilities with VA Police staffing: As above with check-in with VA Police.

Off-site Lease facilities w/o VA Police staffing: Coordinate with COR, Administrative Officer, or Service Point of Contact.

Records Management Language for Contracts When Federal agencies acquire goods or services, they need to determine what Federal records management requirements should be included in the contract. Federal contractors often create, send, or receive Federal records. Federal contracts should provide clear legal obligations describing how the contract employees must handle Federal records.

Agency records officers, procurement counsel, and acquisitions officers must discuss how to integrate records management obligations into their existing procurement processes. The National Archives and Records Administration (NARA) has developed the following language to be included as an agency-specific term and condition in Federal contracts for a variety of services and products. Most contracts should include language on records management obligations, but each contract should be evaluated individually. For example, the data-rights paragraph (Paragraph 10 below) may not be appropriate for all contracts. Instead, agencies may be better served by one of the established data-rights clauses in the Federal Acquisition Regulations.

This language should not replace specific records management requirements included within Federal information system contracts.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created while performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. James A. Haley Veterans’ Hospital and Clinics and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of James A. Haley Veterans’ Hospital and Clinics or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to James A. Haley Veterans’ Hospital and Clinics. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to James A. Haley Veterans’ Hospital and Clinics control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and James A. Haley Veterans’ Hospital and Clinics guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with James A. Haley Veterans’ Hospital and Clinics policy.

8. The Contractor shall not create or maintain any records containing any non-public James A. Haley Veterans’ Hospital and Clinics information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. James A. Haley Veterans’ Hospital and Clinics owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which James A. Haley Veterans’ Hospital and Clinics shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take James A. Haley Veterans’ Hospital and Clinics-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] D. Flowdown of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.