Dosimetry Services SOW.pdf

RADIATION DOSIMETRY SERVICES

STATEMENT OF WORK

San Francisco Veterans Affairs Health Care System

The San Francisco Veterans Affairs Health Care System (SFVAHCS) uses radioactive material and X-Rays for medical and research purposes. Personnel who utilize radioactive material and/or X-Rays are required to have monitoring devices or dosimeters or badges

(whole body/ extremity badges) for measuring whole body deep dose, lens of the eye, extremity, and/or finger exposure. A reliable dosimetry provider is needed to furnish monitoring devices and to maintain records of exposure from radioactive material use or ionizing radiation producing machines at the SFVAHCS.

BACKGROUND INFORMATION:

There are two sources of radiation under discussion herein, Radioactive Materials and Ionizing

Radiation Producing Machines.

1) Radioactive Materials (RAM)

The U.S. Nuclear Regulatory Commission (NRC) oversees the use of radioactive materials

(RAM) at VA facilities by way of an overall license entitled, the VA Master Materials License

(MML), which was issued to the Department of Veterans Affairs (DVA) as a whole, many years ago. The NRC then approved the VA National Health Physics Program (NHPP) to be the VA-overseer of the DVA MML. Thus, Veterans Affairs Health Care System at San Francisco

(SFVAHCS) utilizes RAM under a permit granted by the NHPP.

2) Ionizing Radiation Producing Machines (IRPM)

For IRPM (X-Ray) use, SFVAHCS has committed to follow guidance promulgated from the

DVA, the Food and Drug Administration, the National Health Physics Program (NHPP), the

Nuclear Regulatory Commission (NRC), the Joint Commission on Accreditation of Healthcare

Organizations, and California Title 17 regulations, regarding the use of IRPM.

Importantly, each VA must monitor worker exposures to RAM and IRPM at radiation detection level of sensitivity sufficiently to demonstrate compliance with the occupational and environmental dose limits set by the above regulatory bodies. At a minimum, each permittee shall monitor occupational exposure to radiation from radiation sources under the control of the permittee and shall supply, and require the use of, individual (personnel) monitoring devices. Maintaining an acceptable dosimetry program requires using a reliable dosimetry provider. Failure to maintain an adequate dosimetry program and to provide individual monitoring devices could result in severe penalties, lawsuits, fines, and/or the revocation of our permit to use RAM under the MML issued to the DVA by the NRC. Loss of our NHPP-granted permit would result in the termination of all Nuclear Medicine clinical operations and all other clinical, therapeutic, and research uses of RAM and IRPM. In addition to the penalties and fines, SFVAHCS would face the enormous costs from the mandated decommissioning of those physical areas where RAM and IRPM were formerly used.

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DEFINITIONS:

“Dosimetry provider” refers to an individual or an organization that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the device and hence the wearer.

“Individual monitoring device” refers to a device designed to be worn by a single individual for the assessment or measurement of radiation levels or its concentrations on surface areas, of the concentrations or quantities of RAM or IRPM, and/or the use of the results of these measurements to evaluate exposures and doses.

“Occupational dose” is the dose received by an individual in the course of employment in which the individual’s assigned duties involve exposure to RAM or IRPM from licensed sources of radiation in the possession of the licensee (here permittee).

OBJECTIVES:

The purpose for this contract is to have a dosimetry provider to supply, process, evaluate, package, and ship dosimeters, as well as maintain records for dosimeter exposures and supply necessary reports of exposures (at a sufficient level of sensitivity) in an efficient manner and which meet all applicable regulatory requirements. The dosimetry provider must be able to demonstrate and provide the licensing and specific requirements listed below, prior to the award of the contract.

LICENSING REQUIREMENTS:

1. The dosimetry provider must hold a current personnel dosimetry accreditation from the

National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology (NIST) in all categories.

2. The dosimetry provider must be approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored.

3. The dosimetry provider must be able to calculate, provide, and store the deep-dose equivalent to the whole body, lens of the eye dose equivalent, shallow-dose equivalent to the skin, and the shallow-dose equivalent to the extremities.

4. The dosimetry provider must be able to calculate, provide, and store the following information:

a. Total Organ Dose Equivalent (TODE)

b. Total Effective Dose Equivalent (TEDE)

5. The dosimetry provider must be able to store the following information:

a. Committed Dose Equivalent (CDE) organ

b. Committed Effective Dose Equivalent (CEDE) organ

c. Intake quantity and Radionuclide

d. Solubility Class

e. Description of Internal Deposition

6. The dosimetry provider must be able to provide evidence of the following:

a. Maintain an in-house quality assurance program.

b. Minimum five years of experience as a dosimetry processor.

c. Satisfactory performance record with NVLAP in all germane categories.

SPECIFIC REQUIREMENTS:

The following listed items must be used as criteria/specifications for evaluating a dosimetry provider) for individual monitoring devices and services.

The dosimetry provider must provide individual radiation monitoring devices that meet these criteria:

1. Aluminum oxide whole-body dosimeters that can assess X-Ray, gamma, and beta exposure.

2. Lithium fluoride thermo-luminescent dosimeters (TLD) for assessing extremity exposure.

3. Neutron detection dosimeters that can assess fast, intermediate and thermal neutron exposure. Neutron dosimeter shall have the capacity to be integrated into aluminum oxide whole-body dosimeters which will allow this dosimetry to be used as a whole body

(personnel) dosimeter.

4. Aluminum oxide whole-body dosimeters with emergency response re-read capabilities and the demonstrated ability to record radiation exposures as low as at 1 mrem increments.

5. Master controls (dosimeters used for assessing background radiation during transit and storage) at no charge for all types of dosimeters.

6. Aluminum oxide TLD environmental (for a physical area such as a room) dosimeters.

7. Dosimeters will have permanent waterproof ID labels that cannot be smeared and/or removed and must provide barcode capability.

8. Dosimeters shall be identified by clearly visible icons that show where the dosimeter is to be worn.

9. Extremity badges shall be provided in three sizes (S, M, L).

10. Color coding shall be used on all dosimeters to identify the specific wear period for that dosimeter.

The dosimetry provider must provide radiation monitoring services that meet the following criteria:

1. All radiation dosimetry services must meet current 10 CFR Part 20 reporting and recording requirements, including appropriate controls to ensure the protection of personally identifiable information (PII). There must be a method to securely transmit PII between the vendor and the customer (e.g., via a secure internet site). PII transmitted includes full names, dates of birth, and exposure rates.

2. Reports of radiation exposures must be made on NRC Form 4 and NRC Form 5 or their equivalent. Reports must also be supplied electronically upon request in a format which meets the NRC "REMIT" format.

3. On-line support for on-line exposure reports, shipment tracking and account maintenance transactions (i.e., dosimeter add/delete/reactivate administrative capabilities, spare badge assignments, addition of previous exposure history to current records).

4. On-line support shall provide unlimited access to “helpline.”

5. Absent badge reports for each wear period can be supplied within 24 hours within receipt of dosimeters.

6. Twenty-four-hour emergency dosimeter processing service upon request.

7. Exposure reports shall be supplied within 8 working days from receipt of dosimeters.

8. A separate fetal dosimetry monitoring program which includes cumulative totals during the gestation period (9 months).

9. “As Low As Reasonably Achievable” (ALARA) notification and immediate phone notification and e-mail or fax memo for high exposures for any processed dosimeter exceeding specified ALARA trigger limits.

10. Termination report summaries of personnel radiation exposures shall be supplied within 30 days of notice of terminating an employee badge service.

11. ALARA report summaries will be provided on a quarterly basis with an additional annual

ALARA review summary for all monitored employees for all accounts.

12. The RSO or designee shall be notified by telephone or email of all readings above the notification levels set by the RSO.

13. Dosimeters shall be supplied seven workdays before the beginning of any designated wear period to allow time for distribution of dosimeters, once received.

14. A representative of the company will provide site visits and software training upon request.

15. Monthly report listing same-company dosimetry results at other institutions in Reports shall sum up each individua’s exposures across all facilities for comparison with regulatory limits.

16. Reports of dosimeters that are unreturned during a wear period.

17. Web access capability: at a minimum the provider must demonstrate the following capabilities:

a) Add, delete, and transfer personnel dosimeters.

b) Records access: downloadable exposure (dose) history, badge types, ALARA results, add lifetime cumulative exposure history from other institutions (if same dosimetry provider), and list unworn badge for No Charge credit.

c) Provide initial and upon-request on-site training for providers’ web-based applications.

LOGISTICAL REQUIREMENTS:

1. The contractor will provide supplies during the normal work week, not including federal holidays and weekends. All badges shipped to the SFVAHCS will have a control badge(s) to deduce potential exposure to ionizing radiation during shipment.

3. The contractor will provide a telephone number for a customer service representative that is available during normal working hours. The contractor will also provide an email address for customer service available during normal working hours or after-working hours.

4. The Radiation Safety Office will collect the badges and return to the contractor for evaluation. The contractor will evaluate the badges and determine the exposure for each badge and generate a written report for each person identified in the series. The contractor will ensure the background reading is subtracted from all badges based on the controls shipped (returned) with the badges.

5. Whole body and/or extremity badges are provided by the contractor on a monthly and/or a quarterly basis. Emergency badges will be provided by the contractor when needed. The contractor will provide emergency readings of specified radiation badge(s) at the request of the medical center for purposes of an unexpected exposure or suspected exposure and/or by direction of the RSO for concern of health and safety reasons.

6. The contractor will send the badges to the SFVAHCS via U.S. mail or vendor carrier on a monthly and/or quarterly basis. The box containing the badges will be clearly marked, “Do

Not X-Ray” or other appropriate warning labels. The contractor ensures the badges arrive at a minimum of one week before the end of the month (for monthly basis) and at a minimum one week before the end of each quarter (for quarterly basis).

7. The SFVAHCS will collect the badges quarterly and mail back the badges to the contractor via U.S. mail. The box containing the badges will be clearly marked, “Do Not X-Ray” or other appropriate warning labels.

8. The contractor will advise if there are any potential disruptions of mailing out badges. The contractor will provide emergency readings of specified radiation badge(s) at the request of the medical center for purposes of an unexpected exposure or suspected exposure and/or by direction of the RSO for concern of health and safety reasons.

9. The Supervisory Health Physicist/ Radiation Safety Officer (RSO) or members of the

RSO staff will be the point of contact (POC) for the contractor. The RSO staff will provide the mailing address and phone numbers of the Radiation Safety Office personnel.

TYPES OF DOSIMETRY

There are four type of dosimetry (radiation badges) that are required:

1. Badges for measuring ionizing radiation to the whole body deep, eye, shallow

2. Badges for measuring ionizing radiation to the extremity (hands/fingers)

3. Badges for emergency response in the form of whole body deep, eye, shallow

4. Special badges for measuring ionizing radiation to the embryo (fetal badges)

Whole body and/or extremity or ring badges are issues monthly and/or quarterly

1. Emergency badges are issued yearly or when needed

2. Fetal badges are issued monthly for nine months, when needed

Control dosimeters (master control and/or series control) are required to be included with shipments for monitoring radiation exposure received during transit of badges.

Minimal Dose equivalents. The minimal reporting levels vary according to the dosimeter type and radiation quality:

1. Photon (X-Ray or gamma ray) is 1 mrem

2. Beta is 10 mrem

3. Fetal is 1 mrem

4. Ring for extremity is 30 mrem

5. Badges can be selected to have a lower end threshold

6. Environmental badge threshold of 1 mrem

7. Whole body and finger ring badge threshold of 10 mrem

8. Emergency badge threshold of 10 mrem

Radiation Quality: Types of energies of radiation contributing to whole body dose equivalent:

1. Beta

2. Beta high energy (strontium, phosphorous)

3. Beta low energy (thallium, krypton)

4. Photon (X-Ray or gamma ray)

5. Photon, beta mixture

6. Photon high energy greater than 200 keV

7. Photon low energy less than 40 keV

8. Photon medium energy 40 keV to 200 keV

QUARTERLY BADGES:

WHOLE BODY BADGES AND EXTREMITY (RING) BADGES

Issue period Series code #whole body #rings #holders

Quarterly O2 15 0 15

Quarterly B12 5 0 5

Quarterly EN 5 0 5

Quarterly CC 55 0 55

Quarterly GD 20 0 20

Quarterly IR 10 0 10

Quarterly NM 10 10 10

Quarterly RN 10 0 10

Quarterly OR 35 0 35

Quarterly PMT 5 0 5

Quarterly RSO 5 0 5

Quarterly RSQ 45 0 45

Quarterly SQ 20 0 20

Quarterly SPR 30 0 30

Total: 270 10 270

MONTHLY BADGES:

WHOLE BODY BADGES EXTREMITY (RING) BADGES

Issue period Series code #whole body #rings #holders

Monthly SPR 10 0 10

EMERGENCY BADGES (WHEN NEEDED)

EMERGENCY BADGES

Issue period Series code #badges #metal clips Control

When needed Emergency when needed

Reports:

• Monthly and quarterly (no social security and no date of birth) Annual Form

• Annual statistical summary report for series Termination Reports

• Dose estimate reports (lost and/or damaged) Special reports

• Annual ALARA comparison report

• Annual CD/DVD summary

• Report of personnel utilizing same company service at other locations

Electronic capabilities:

• Direct access to company database to make changes, delete, add, gather historical data and/or request special dosimetry and/or add dosimetry (whole body/finger ring)

• Ability to scan in badges locally on desktop computer with handheld device provided by contractor

• Ability to make changes in dose assessment status from standard to ED1 or ED2 calculations or vice-versa

Special requests:

• Fetal badges

• Overnight emergency services EDE2 calculations

Accreditation:

National Institute of Standards and Technology (NVLAP) Compliance with ANSI/HPS

N13.11 for whole body badges

Compliance with ANSI/HPS N13.32 for extremity (finger ring) badges

Invoicing: All invoices from the contractor shall be submitted electronically in accordance with

VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

More information on the VA Financial Services Center is available at http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

• Tungsten e-Invoice Setup Information: 1-877-489-6135

• Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

• FSC e-Invoice Contact Information: 1-877-353-9791

• FSC e-invoice email: vafsccshd@va.gov

1. GENERAL. . 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.

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

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http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.fsc.va.gov/einvoice.asp mailto:VA.Registration@Tungsten-Network.com mailto:vafsccshd@va.gov

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.

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.

6. INFORMATION SYSTEM DESIGN AND DEVELOPMENT. This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (to include the subcomponents of each) designed or developed for or on behalf of VA by any non-VA entity.

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

a. Information systems designed or developed on behalf of VA at non-VA facilities shall comply with all applicable Federal law, regulations, and VA policies. This includes standards for the protection of electronic Protected Health Information (PHI), outlined in 45 C.F.R. Part 164, Subpart C and information and system security categorization level designations in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems and FIPS 200, Minimum Security Requirements for Federal Information Systems. Baseline security controls shall be implemented commensurate with the FIPS 199 system security categorization (reference VA Handbook 6500 and VA Trusted Internet Connections (TIC) Architecture).

b. Contracted new developments require creation, testing, evaluation, and authorization in compliance with VA Assessment and Authorization (A&A) processes in VA Handbook 6500 and VA Information Security Knowledge Service to obtain an Authority to Operate (ATO). VA Directive 6517, Risk Management Framework for Cloud Computing Services, provides the security and privacy requirements for cloud environments.

c. VA IT contractors, subcontractors and third-party service providers shall address and/or integrate applicable VA Handbook 6500, VA Handbook 6517, Risk Management Framework for Cloud Computing Services and Information Security Knowledge Service specifications in delivered IT systems/solutions, products and/or services. If systems/solutions, products and/or services do not directly match VA security requirements, the contractor shall work though the COR/CO to identify the VA organization responsible for governance or resolution. Contractors shall comply with FAR 39.1, specifically the prohibitions referenced.

d. The contractor (including producers and resellers) shall comply with Office of Management and Budget (OMB) M-22-18 and M-23-16 when using third-party software on VA information systems or otherwise affecting the VA information. This includes new software purchases and software renewals for software developed or modified by major version change after the issuance date of M- 22-18 (September 14, 2022). The term “software” includes firmware, operating systems, applications and application services (e.g., cloud-based software), as well as products containing software. The contractor shall provide a self- attestation that secure software development practices are utilized as outlined by Executive Order (EO)14028 and NIST Guidance. A third-party assessment provided by either a certified Federal Risk and Authorization Management Program (FedRAMP) Third Party Assessor Organization (3PAO) or one approved by the agency will be acceptable in lieu of a software producer's self- attestation.

e. The contractor shall ensure all delivered applications, systems and information systems are compliant with Homeland Security Presidential Directive (HSPD) 12 and VA Identity and Access management (IAM) enterprise identity management requirements as set forth in OMB M-19-

17, M-05-24, FIPS 201-3, Personal Identity Verification (PIV) of Federal Employees and Contractors (or its successor), M-21-31 and supporting NIST guidance. This applies to Commercial Off-The-Shelf (COTS) product(s) that the contractor did not develop, all software configurations and all customizations.

f. The contractor shall ensure all contractor delivered applications and systems provide user authentication services compliant with VA Handbook 6500, VA Information Security Knowledge Service, IAM enterprise requirements and NIST 800-63, Digital Identity Guidelines, for direct, assertion-based authentication and/or trust-based authentication, as determined by the design and integration patterns. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV and/or Common Access Card (CAC), as determined by the business need and compliance with VA Information Security Knowledge Service specifications.

g. The contractor shall use VA authorized technical security baseline configurations and certify to the COR that applications are fully functional and operate correctly as intended on systems in compliance with VA baselines prior to acceptance or connection into an authorized VA computing environment. If the Defense Information Systems Agency (DISA) has created a Security Technical Implementation Guide (STIG) for the technology, the contractor may configure to comply with that STIG. If VA determines a new or updated VA configuration baseline needs to be created, the contractor shall provide required technical support to develop the configuration settings. FAR 39.1 requires the population of operating systems and applications includes all listed on the NIST National Checklist Program Checklist Repository.

h. The standard installation, operation, maintenance, updating and patching of software shall not alter the configuration settings from VA approved baseline configuration. Software developed for VA must be compatible with VA enterprise installer services and install to the default “program files” directory with silently install and uninstall. The contractor shall perform testing of all updates and patching prior to implementation on VA systems.

i. Applications designed for normal end users will run in the standard user context without elevated system administration privileges.

j. The contractor-delivered solutions shall reside on VA approved operating systems. Exceptions to this will only be granted with the written approval of the COR/CO.

k. The contractor shall design, develop, and implement security and privacy controls in accordance with the provisions of VA security system development life cycle outlined in NIST 800-37, Risk Management Framework for Information Systems and Organizations: A System Life Cycle Approach for Security and Privacy, VA Directive and Handbook 6500, and VA Handbook 6517.

l. The Contractor shall comply with the Privacy Act of1974 (the Act), FAR 52.224- 2 Privacy Act, and VA rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish a VA function.

m. The contractor shall ensure the security of all procured or developed information systems, systems, major applications, minor applications, enclaves and platform information technologies, including their subcomponents (hereinafter referred to as “Information Systems”) throughout the life of this contract and any extension, warranty, or maintenance periods. This includes security configurations, workarounds, patches, hotfixes, upgrades, replacements and any physical components which may be necessary to remediate all security vulnerabilities published or known to the contractor anywhere in the information systems (including systems, operating systems, products, hardware, software, applications and firmware). The contractor shall ensure security fixes do not negatively impact the Information Systems.

n. When the contractor is responsible for operations or maintenance of the systems, the contractor shall apply the security fixes within the timeframe specified by the associated controls on the VA Information Security Knowledge Service. When security fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the contractor shall provide written notice to the VA COR/CO that the patch has been validated as to not affecting the Systems within 10 business days.

7. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE OR USE.

This entire section applies to information systems, systems, major applications, minor applications, enclaves, and platform information technologies (cloud and non- cloud) hosted, operated, maintained, or used on behalf of VA at non-VA facilities.

a. The contractor shall comply with all Federal laws, regulations, and VA policies for Information systems (cloud and non-cloud) that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities.

Security controls for collecting, processing, transmitting, and storing of VA sensitive information, must be in place. The controls will be tested by VA or a VA sanctioned 3PAO and approved by VA prior to hosting, operation, maintenance or use of the information system or systems by or on behalf of VA. This includes conducting compliance risk assessments, security architecture analysis, routine vulnerability scanning, system patching, change management procedures and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures shall be the same as procedures used to secure VA-operated information systems.

b. Outsourcing (contractor facility, equipment, or staff) of systems or network operations, telecommunications services or other managed services require Assessment and Authorization (A&A) of the contractor’s systems in accordance with VA Handbook 6500 as specified in VA Information Security Knowledge Service. Major changes to the A&A package may require reviewing and updating all the documentation associated with the change. The contractor’s cloud computing systems shall comply with FedRAMP and VA Directive 6517 requirements.

c. The contractor shall return all electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) on non-VA leased or non-VA owned IT equipment used to store, process or access VA information to VA in accordance with A&A package requirements. This applies when the contract is terminated or completed and prior to disposal of media. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Information Security Knowledge Service requirements and NIST 800-88. The contractor shall send a self-certification that the data destruction requirements above have been met to the COR/CO within 30 business days of termination of the contract.

d. All external internet connections to VA network involving VA information must be in accordance with VA Trusted Internet Connection (TIC) Reference Architecture and VA Directive and Handbook 6513, Secure External Connections and reviewed and approved by VA prior to implementation. Government-owned contractor-operated systems, third party or business partner networks require a Memorandum of Understanding (MOU) and Interconnection Security Agreements (ISA).

e. Contractor procedures shall be subject to periodic, announced, or unannounced assessments by VA officials, the OIG or a 3PAO. The physical security aspects associated with contractor activities are also subject to such assessments. The contractor shall report, in writing, any deficiencies noted during the above assessment to the VA COR/CO. The contractor shall use VA’s defined processes to document planned remedial actions that address identified deficiencies in information security policies, procedures, and practices. The contractor shall correct security deficiencies within the timeframes specified in the VA Information Security Knowledge Service.

f. All major information system changes which occur in the production environment shall be reviewed by the VA to determine the impact on privacy and security of the system. Based on the review results, updates to the Authority to Operate (ATO) documentation and parameters may be required to remain in compliance with VA Handbook 6500 and VA Information Security Knowledge Service requirements.

g. The contractor shall conduct an annual privacy and security self-assessment on all information systems and outsourced services as required. Copies of the assessment shall be provided to the COR/CO. The VA/Government reserves the right to conduct assessment using government personnel or a third-party if deemed necessary. The contractor shall correct or mitigate any weaknesses discovered during the assessment.

h. VA prohibits the installation and use of personally owned or contractor-owned equipment or software on VA information systems. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW, PWS, PD or contract. All security controls required for government furnished equipment must be utilized in VA approved Other Equipment (OE). Configuration changes to the contractor OE, must be funded by the owner of the equipment. All remote systems must use a VA-approved antivirus software and a personal (host-based or enclave based) firewall with a VA-approved configuration. The contractor shall ensure software on OE is kept current with all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-virus software and the firewall on the non-VA owned OE. Approved contractor OE will be subject to technical inspection at any time.

i. The contractor shall notify the COR/CO within one hour of disclosure or successful exploits of any vulnerability which can compromise the confidentiality, integrity, or availability of the information systems. The system or effected component(s) need(s) to be isolated from the network.

A forensic analysis needs to be conducted jointly with VA. Such issues will be remediated as quickly as practicable, but in no event longer than the timeframe specified by VA Information Security Knowledge Service. If sensitive personal information is compromised reference VA Handbook

6500.2 and Section 5, Security Incident Investigation.

j. For cases wherein the contractor discovers material defects or vulnerabilities impacting products and services they provide to VA, the contractor shall develop and implement policies and procedures for disclosure to VA, as well as remediation. The contractor shall, within 30 business days of discovery, document a summary of these vulnerabilities or defects. The documentation will include a description of the potential impact of each vulnerability and material defect, compensating security controls, mitigations, recommended corrective actions, root cause analysis and/or workarounds (i.e., monitoring). Should there exist any backdoors in the products or services they provide to VA (referring to methods for bypassing computer authentication), the contractor shall provide the VA CO/CO written assurance they have permanently remediated these backdoors.

k. All other vulnerabilities, including those discovered through routine…