STATEMENT OF WORK REVISED.pdf

STATEMENT OF WORK

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, 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 Clinic CBOC, the Eureka Clinic CBOC, and the Oakland 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 (and throughout the entire duration of the contract), 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 at any time as requested 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

• Contractor shall provide verification of continuing medical physics education by an accredited Medical Physics program, such as the Commission on Accreditation of Medical

Physics Education Program (CAMPEP), or an equivalent accredited educational program, and subject to review by the Radiation Safety Office. Certification/ educational credits must be provided to the Radiation Safety Office on an annual basis.

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

• As a 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

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, even after major services.

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

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

Optima CT in Nuclear Medicine.

3.9 Available consultation with the Radiation Safety Committee (RSC) as required for clarification and/or recommendations. This may include telephone conference during normal working hours and/or attendance at the Radiation Safety Committee, as determined by the RSO.

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

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.

4.3 For radiological emergencies, the Contractor may be expected to conduct risk assessments, access accurate patient doses, identify potential radiation emergencies, create incident action plans, and conduct training drills, with the primary objective to minimize radiological risk for all.

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.

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 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 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 within 60 days of contract award date and ensure completion of all testing by the final day of the 12 month period for each year.

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 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

14.1 GENERAL

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.

14.2 ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. 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.

b. 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.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of

Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security

Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-

U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

14.3 VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR

52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements.

VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are compliant with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records

Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information

Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records

Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA

Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose, and dispose of VA information only in compliance with the terms of the contract and applicable

Federal and VA information confidentiality and security laws, regulations, and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations, and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. 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.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate

Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with

VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor 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 health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

14.4 INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-

VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally, Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the

PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and

Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor’s systems in accordance with VA Handbook

6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office.

Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the

ISO for entry into VA’s POA&M management process. The contractor/subcontractor must use

VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities.

Security deficiencies must be corrected within the timeframes approved by the government.

Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new

C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally owned or contractor/subcontractor owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW, or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook

6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

(1) Vendor must accept the system without the drive.

(2) VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then,

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

14.5 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 COTR 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.

14.6 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.

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.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access)

(2) Description of the event, including:

(a) date of occurrence

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code

(3) Number of individuals affected or potentially affected

(4) Names of individuals or groups affected or potentially affected

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text

(6) Amount of time the data has been out of VA control

(7) The likelihood that the sensitive personal information will or has been compromised

(Made accessible to and usable by unauthorized persons)

(8) Known misuses of data containing sensitive personal information if any

(9) Assessment of the potential harm to the affected individuals

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy

Incidents, as appropriate and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis; the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports

(3) Data breach analysis

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

14.7 TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and

VA information systems shall complete the following 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 Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems.

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training.

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor 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 C&A requirements do not apply, and a Security Accreditation Package is not required

End of Statement of Work