Medical Physicist Services SOW DRAFT.pdf

DRAFT

Statement of Work

Medical Physicist Services

San Francisco Veterans Affairs Health Care System

SFVAHCS

San Francisco

Medical Physicist Services

Description of Services

1. Scope of Work. The Contractor shall furnish all equipment, supplies, personnel, supervision, transportation, and software to provide medical physicist testing/reporting services in support of medical and dental X-Ray equipment, including CT scanners for Radiology and/or Nuclear

Medicine (mobile and/or fixed), PET scanners, SPECT/CT scanners, D-SPECT scanner, ultrasound, DEXA, and MRI scanners. The services are to be provided at the San Francisco

Veterans Affairs Health Care System (SFVAHSC) located at 4150 Clement Street, San Francisco, California, 94121, the Santa Rosa VA Outpatient Clinic CBOC, the Eureka VA Outpatient Clinic

CBOC, and the Oakland VA Outpatient Clinic CBOC. Key elements of the medical physics X-Ray testing/reporting for medical and dental X-Ray units include:

1.1. Overall testing of the medical X-Ray equipment, dental X-Ray equipment, and MRI equipment.

1.2. Evaluation of all medical X-Ray and MRI equipment.

1.3. Ensuring SFVAHCS facility complies with X-Ray testing standards, regulations as indicated by VHA National Health Physics Program (NHPP), and federal and professional organizations.

1.4. Coordination with the SFVAHCS Radiation Safety Officer (RSO) for scheduling, reporting, addressing immediate safety issues, re-testing, and addressing any questions regarding testing results.

1.5 Annual quality assurance review of all X-Ray procedures including required quality assurance program specific for each type of modality (CT, fluoroscopic, nuclear medicine).

1.6 Annual certification of CT units for diagnostic procedures including the PET/CT and

SPECT/CT.

1.7 Available consultation with the Radiation Safety Committee as required for clarification and/or recommendations. This may include telephone conference and/or attendance at the Radiation

Safety Committee.

1.8 Annual inspection of lead garment inventory and personal protection equipment (PPE), including thyroid shields, gloves, goggles, table and scatter drapes, portable lead shield devices, patient shields, and of their proper storage and use. This inspection includes PPE inventory located at the Santa Rosa VA Outpatient Clinic, the Eureka VA Outpatient Clinic, the Oakland VA

Outpatient Clinic, as well as the San Francisco VA Health Care System at 4150 Clement Street.

1.9 Available consultation for additional safety training as needed.

2. Personnel. This contract requires that certain tasks be performed by a licensed Medical

Physicist; therefore, the Contractor will be required to designate specific individuals to perform as

Medical Physicists or Medical Physicist technicians. The same individual may perform duties of a contract medical physicist.

2.1. Qualifications. Prior to commencing work, all contractor employees shall meet certain criteria to perform work under this contract as a Medical Physicist. Qualification documents must be submitted to the RSO or his/her designee and be approved. All qualifications are subject to review by the SFVAHCS Chief of Staff and/or approval by the SFVAHCS Facility Director.

2.1.1. Medical Physicist:

2.1.1.1. The Contractor Medical Physicist shall meet the following education, certification, and qualification standards:

• Hold a Master’s degree in medical physics, health physics, a physical science or engineering discipline from a college or university accredited by an organization recognized by the U.S. Department of Education

• Hold current Board Certification in Diagnostic Radiological Physics by the American

Board of Radiology (ABR) or American Board of Medical Physics

• Meet American College of Radiology (ACR)/ Food and Drug Administration (FDA) qualifications for mammography medical physicist

• Accreditation of PET equipment in Nuclear Medicine

• Accreditation of CT equipment (16 & 64 slice) in Nuclear Medicine and Radiology

• Accreditation of CT equipment for diagnostic procedures for SPECT/CT, PET/CT, and

D-SPECT in Nuclear Medicine

• Accreditation of new and/or modified lead construction for diagnostic procedures

2.1.1.2. The Contractor Medical Physicist shall have current knowledge, understanding, and recent experience in the following:

• As an RSO or consultant to a medical facility licensed by the NRC and/or facility and issued a VA permit to perform nuclear medicine and biomedical research

• With a facility licensed by the State of California Radiological Health

• Changes in standards by regulations, recommendations, or updates from professional organizations such as the AAPM, ACR, TJC, and similar professional organizations

• Meeting the VISN 21 medical physics regulatory mandates from the VHA National Health Physics Program and JCAHO accreditation

• Calibration and testing of diagnostic X-Ray equipment

• Experience in and qualifications for certifying PET/CT, SPECT/CT, and D-SPECT equipment

• Extensive review of existing, modified, and/or newly installed lead shielding in locations to be used for diagnostic procedures using X-Rays and/or nuclear medicine procedures

• Experience in certifying MRI scanners

• Knowledge of current professional Medical Physicist practices and radiation safety program requirements, guidelines, and policies to ensure compliance with national standards

• A long history with SFVAHCS with a proven track record of litigious-free history of providing medical physics testing is highly recommended

2.2 Contractor’s employee(s) will be under the ultimate supervisory responsibility of the

Contractor.

2.3. Contractor’s employee(s) shall act in a thoroughly professional manner at all times. They shall work in harmony with other members of SFVAHCS Staff where they are working. Tact and courtesy are mandatory when interacting with patients and staff.

3. Medical Physicist shall provide the following services for the equipment listed in

Appendix 1:

3.1. Conduct annual surveys of all fixed and/or mobile X-Ray equipment and MRI scanners on-site. Surveys will also be performed after repair of equipment or for installation (acceptance testing) of any new equipment. Typically, SFVAHCS receives an average of three new pieces of imaging equipment each year. Ensure any portable X-Ray units, regular diagnostic C-arms and O-arms, and dental equipment used at the SFVAHCS are used in compliance with ALARA (As Low

As Reasonably Achievable) requirements. Generate a report to the RSO for concurrence with findings. Re-testing may be required if there is an equipment issue that must be repaired.

3.2. Certification of Radiology CT and/or MRI and/or Nuclear Medicine PET/CT, SPECT/CT for diagnostic purposes. Generate a report to the RSO for concurrence with findings. Retesting may be required if there is an equipment issue that must be repaired.

3.3. Annual review of CT protocols for Radiology and Nuclear Medicine to determine if patient doses and techniques are within acceptable community standards, State of California standards, National Standards, and do meet inspection criteria by The Joint Commission, NHPP, or other regulatory agencies. Assessing patient radiation doses when requested by the SFVAHCS.

3.4 Ensuring SFVAHCS facility complies with X-Ray testing standards and regulations as indicated by the VHA National Health Physics Program and federal and professional organizations.

3.5 Coordination with the SFVAHCS Radiation Safety Officer (RSO) for addressing immediate radiation protection issues (occupational or medical), reporting any safety issues, and scheduling re-testing issues or addressing any questions regarding testing results.

3.6 Consultation with the SFVAHCS Radiation Safety Officer (RSO) for addressing personal protection equipment (PPE) issues, as it relates to the maintenance and operation of protective devices, such as apparel, table and scatter drapes, portable shielding devices, patient shields, and their proper storage and use.

3.7 Immediate consultation with the SFVAHCS Radiation Safety Officer (RSO) when addressing deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers or patients.

3.8 Annual quality assurance review of all X-Ray procedures, including required quality assurance program specific for each type of modality (CT, fluoroscopic, nuclear medicine).

3.9 Annual certification of CT unit for diagnostic procedures using the PET/CT, SPECT/CT, and

Optima CT in Nuclear Medicine.

3.10 Available consultation with the Radiation Safety Committee (RSC) as required for clarification and/or recommendations. This may include telephone conference and/or attendance at the Radiation Safety Committee.

3.11 Professional recommendations that will minimize significant whole-body exposure to unique high patient procedures in different modalities.

3.12 A written report of the results of performance testing of all new or relocated imaging equipment shall be provided to the RSO or service supervisor within 5 working days after completion of the inspection. All imaging equipment shall be inspected at least annually, not to exceed 14 months.

4. Emergency Services

4.1. In an emergency, Contractor and/or contractor’s employees shall perform an X-Ray test of medical and/or dental equipment within twenty-four hours (24) hours at the SFVAHCS and/or

Santa Rosa CBOC and/or Eureka CBOC and/or Oakland CBOC.

4.2 For emergencies services, it is highly preferable for the Contractor to be located in close proximity to the San Francisco Bay area counties, thus permitting reliable and efficient emergency services without delay of patient care. Highest consideration will be given for contractors who are local compared to remote vendors.

5. Scheduling of Emergency Services:

5.1. In case of emergency, Contractor’s employee shall be required to report (in person) within twenty-four (24) hours after receipt of verbal or written notice by the SFVAHCS to the VA

Facilities listed in Appendix 2.

5.2. Emergency services shall be paid for at the same hourly rates specified in the contract Price

Schedule.

6. Scheduling of Regular Services:

6.1 The Medical Physicist shall provide the SFVAHCS Radiation Safety Officer with a tentative schedule for planned X-Ray equipment testing, training, quality assurance evaluation, and review of CT protocols. Due to patient care issues, the schedule will be flexible based on equipment availability. The contractor can tentatively work around equipment availability during working hours as follows: M-F (7:00 am to 4:30 pm) and/or after normal hours and/or weekends and/or holidays. The contractor and/or the RSO will coordinate with the specific service and/or services.

The contractor must notify the RSO immediately of any issues involving availability and/or issues resulting from testing and/or findings.

6.2 All work, regardless of when performed, shall be paid for at the same hourly rates specified in Schedule. Contract Employees must be physically present at a VA facility listed in Appendix

2 and perform the required services for payment. Payment does not include standing by or being on-call.

7. On-Call/ Stand-By: This contract does not include on-call services.

8. Government Furnished Equipment & Software: The government will provide this:

8.1 No equipment will be provided by the Government on a routine basis. The contractor may, on a case-by-case basis, coordinate with the Radiation Safety Office for any special requests, such as providing government computer and software equipment.

8.2 For any clinical radioisotope sources needed for purposes of calibration testing, such as those needed for PET/CT scanners, SPECT/CT, and D-SPECT in Nuclear Medicine, the contractor shall coordinate with the SFVAHCS Radiation Safety Office and provide sufficient notice for the placement of any source orders. (See Statement of Work, Detailed Description).

9. Contractor Furnished Equipment and Software: The Contractor shall provide all testing equipment and/or necessary equipment to complete testing of X-Ray equipment and/or MRI scanners. At a minimum:

9.1 For testing all diagnostic X-Ray equipment (fixed and/or mobile), CT scanners (Radiology and/or Nuclear Medicine), PET/CT scanners and SPECT/CT (Nuclear Medicine), mobile radiographic units, mobile C-arm units and O-arm units, and MRI scanners (Radiology).

9.2 All phantoms for testing of X-Ray equipment at the SFVAHCS.

10. Travel/Transportation: The Contractor shall provide all Travel/Transportation necessary to perform the requirements of this contract.

10.1 The majority of the work will be accomplished at the SFVAHCS. The other CBOCs included in this statement of work is the Santa Rosa medical clinic, the Eureka medical clinic, and the

Oakland medical unit. Due to the nature of the services required, the Contractor shall be required to travel to all sites identified in Appendix 2.

10.2 All travel related costs, including lodging or any other miscellaneous costs, shall be the sole responsibility of the contractor and shall be excluded in the firm fixed unit price on the Price

Schedule.

10.3 The Contractor shall not charge the hourly rate for services while in transit to any of the sites listed in Appendix 2.

11. Regulations:

11.1 The Contractor shall perform services in accordance with local, state, and/or federal regulations at all locations listed in Appendix 2. The Contractor shall apply the appropriate procedures depending upon the location where the services are being provided.

11.2 The contractor will begin testing of X-Ray equipment during the first quarter of the fiscal year (Q1: Oct 1 to Dec 31) and establish a schedule that will ensure completion of X-Ray testing no later than the end of the fourth quarter of the fiscal year (Q4: July 1 to Sept 30).

12. Contractor Personnel Security Requirements - Information Systems Access

Upon contract award, all key personnel shall be subject to the appropriate type of background investigation or screening per SFVAHCS/VHA policy as delineated below and must receive a favorable adjudication from the local VA facility or VA Security and Investigations Center (SIC) depending on the type of investigation/screening required. This requirement is also applicable to all subcontract personnel. If the investigation or screening is not completed prior to the start date of the contract, the Contractor will be responsible for the actions of those individuals they provide to perform work for VA.

Contract personnel who previously received a favorable adjudication as a result of Government background investigation or screening may be exempt from this contract requirement provided that they can provide documentation to support the previous adjudication. Proof of previous adjudication must be submitted by the Contractor to VA Contracting Officer. Proof of previous adjudication is subject to verification. Some positions may be subject to periodic re-investigation/screening.

12.1 Position Risk/Sensitivity. For all positions required under this contract, the position risk/sensitivity has been designated as: Low Risk/Non-Sensitive.

12.2 Background Investigation/Screening. Since it is anticipated that the Contractor or contract personnel will be providing direct or ancillary health care services at a VA facility(s) for more than

180 days under a single contract or series of contracts, the background investigation/screening commensurate with the requirements of this contract is: Background Investigation is National

Agency Check with Written Inquiries (NACI).

12.2.1 Non-citizen contract personnel will be subject to a National Agency Check with Law

Enforcement and Credit (NACLC). NACLC investigations require the same forms and processes as the NACI investigations, however with the addition of a credit check.

12.2.2 The C&A requirements do not apply, and that a security accreditation package is not required.

12.3 Contractor Responsibilities

12.3.1 The Contractor shall prescreen all personnel to ensure they are able to read, write, speak, and understand the English language.

12.3.2 The Contractor shall submit the following required forms to the VA Contracting Officer, through the COR, within five (5) business days of contract award:

12.3.2.1 Standard Form 85, Questionnaire for Non-Sensitive Positions

12.3.2.2 Standard Form 86A, Continuation Sheet for Questionnaires

12.3.2.3 Optional Form 306, Declaration for Federal Employment

12.3.2.4 Electronic Fingerprint Verification or FD 258, U.S. Department of Justice Fingerprint

Applicant Chart

12.3.3 Prior to completing the required forms, contract personnel should review the attachments entitled Common Errors on NACI Security Questionnaires, Example_SF85, Example_OF306, and

General Questions and Answers about OPM background Investigations (see item 3.2 of this contract for these attachments) in order to ensure the forms are properly completed. Please note that incomplete forms will be rejected and could result in a delay of work under the contract.

12.3.4 Once the items requested in paragraph 3b above are received, VA will pre-screen these items for completeness and forward them to the appropriate party(s) in order to initiate the required background investigation(s) or screening(s) within fourteen (14) calendar days of appointment.

Only after the VA Contracting Officer notifies the Contractor that the background investigation(s) or screening(s) was initiated, shall the Contractor be authorized to provide services under the contract. As previously stated, if the investigation or screening is not completed prior to the start date of the contract, the Contractor will be responsible for the actions of those individuals they provide to perform work for SFVAHCS.

12.3.5 The Contractor, when notified of an unfavorable determination by the Government, shall withdraw the contract person from consideration of working under the contract.

12.3.6 Failure to comply with these Contractor personnel security requirements may result in termination of the contract for default.

13. APPENDICES

13.1 Appendix 1 List of Medical Equipment (see Appendix 1)

13.2 Appendix 2 VA Facilities (see Appendix 2)

13.3 Appendix 3 Technical Description of Services Performed (see Appendix 3)

13.4 Appendix 4 Information System Security Regulations (see below)

Appendix 4. Information System Security Regulations

APPENDIX C — VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY

LANGUAGE FOR INCLUSION IN CONTRACTS, AS APPROPRIATE

NOTE: Any sections (1-14) which DO NOT apply should not be included in the Statement of Work (SOW), Performance Work Statement (PWS), Product Description (PD) or contract.

1. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR

52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial

Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and

Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with

Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector

General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA

Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS)

140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology

(NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security

(TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38

U.S.C. § 5705, Confidentiality of medical quality- assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access

Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National

Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA

Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA. The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s

Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in.

Exceptions to this paragraph will only be granted with the written approval of the VA CO.

3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and

VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The

ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance 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 shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and

Security Program. The Office of Human Resources and Administration/Operations, Security and

Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial

Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d);

Contractor operations required to be in United States. All contractors and subcontractors working with

VA information must be permanently located within a jurisdiction subject to the law of the United

States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

(1) Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.

(2) Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a

VA project discontinued for any reason.

(3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company- owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(5) Contractor/subcontractor personnel have their authorization to work in the United States revoked.

(6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA accesses will return VA- issued property to VA.

This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office.

Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.

4. TRAINING. This entire section applies to all acquisitions which include section 3.

a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems:

(1) VA Privacy and Information Security Awareness and Rules of Behavior course (Talent

Management System (TMS) #10176) initially and annually thereafter.

(2) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to

VA information and information systems initially and annually thereafter; and

(3) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role- based information security training].

b. The contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training 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 required training is complete.

5. SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any

Information Security and Privacy language.

a. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following:

(1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA believed to have been compromised.

(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.

c. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

d. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA

Information Systems VA Information Security Program, and VA Information Security Knowledge

Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

e. 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 the VA Office of 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.

f. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive

Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

g. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity

(VHA) shall be made in accordance with the executed BAA.

h. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages— Reimbursement for Data

Breach Costs.

Privacy: Based upon review of the PWS/SOW as presented, the contractor will have access to VA sensitive information to fulfill the terms of the contract. That sensitive information will include PII/PHI. However, this situation falls under an exception to the BAA rule, specifically for treatment purpose. A BAA will not be required. Please contact the team with any questions.

https://www.va.gov/oal/library/vaar/vaar852.asp#85221176 https://www.va.gov/oal/library/vaar/vaar852.asp#85221176 https://www.va.gov/oal/library/vaar/vaar852.asp#85221176

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 VHA records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VHA 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, the Contractor shall maintain all records created for Government use or created in the course of 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. VHA 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 VHA or destroyed except 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, the Contractor must report to VHA. 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 VHA 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 VHA 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 VHA policy.

8. The Contractor shall not create or maintain any records containing any non-public VHA information that is 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. The VHA 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 VHA 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 VHA-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. Flow down 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.

End of Statement of Work