Statement of Work - Personnel Dosimetry Services.pdf

Attachment 1 Statement of Work

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STATEMENT OF WORK

PERSONNEL DOSIMETRY SERVICES

VA NORTH TEXAS HEALTH CARE SYSTEM

1. All dosimetry services are highly regulated by the United States Nuclear Regulatory Commission

(USNRC) Title 10, Code of Federal Regulations, Part 20-Standards for Protection Against Radiation

(reporting and recording requirements). United States Department of Labor, Code of Federal Regulations

(CFR) Title 29, Part 1910 – Occupational Safety and Health Standards. Failure to maintain an appropriate dosimetry program and provide individual monitoring devices or equipment could result in regulatory non‐compliance with the possibility of fines, lawsuits, and / or the revocation of our permit to use byproduct material under the Master Material License issued to the Department of Veterans Affairs by the

NRC. Loss of our permit would result in the termination of all Radiology operations, all other clinical & therapeutic uses of radioactive materials, and the research use of radioactive materials.

2. The contractor/dosimetry processor must hold a current personnel dosimetry accreditation from the

National Voluntary Laboratory Accreditation Program (NVLAP) of the US National Institute of

Standards and Technology (NIST) for all radiation testing categories required by the VA North Texas

Health Care System (VANTHCS). This laboratory is accredited in accordance with recognized

International Standard ISO/IEC 17025:2005. Contractor MUST provide a copy of their NVLAP accreditation certificate to the Contracting Officer.

3. The contractor/dosimetry processor must be approved in this accreditation process for the type of radiation included in the NVLAP program that most closely approximates the type of radiation for which the individual using the dosimeter is monitored. The dosimetry processor must be directly accessible for consult to review non-routine, complex dosimetry exposure data anomalies that can occur during processing and require dose reconstruction.

4. The contractor/dosimeter processor must be able to calculate, provide and store the following information:

a. Deep Dose Equivalent (DDE) to the whole body

b. Eye Dose Equivalent (LDE)

c. Shallow Dose Equivalent (SDE)

d. Committed Effective Dose Equivalent (CEDE)

e. Committed Dose Equivalent (CDE)

f. Total Organ Dose Equivalent (TODE)

g. Total Effective Dose Equivalent (TEDE)

h. Intake Quantity and Radionuclide

5. Dosimeters used to detect X-ray and Gamma radiation must have a dose measurement range of 1 mrem to 1000 mrem. Dosimeters used to detect Beta radiation must be capable of dose measurements as low as 10 mrem to 1000 rem. Dosimeters used to detect Neutron must be capable of dose measurement;

fast 20 mrem to 25 rem and thermal 10 mrem to 5 rem.

6. Reports of radiation exposures MUST be made on Nuclear Regulatory Commission (NRC) Form 4

(Cumulative Occupational Dose History) and NRC Form 5 (Occupational Dose Record for a Monitoring

Period) or equivalents.

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7. The government MUST be able to directly interact with the contractor’s qualified technical representatives to evaluate, analyze, and interpret complex dosimetry data. The contractor MUST have web access capability to a database that contains dosimetry records for the VANTHCS. The government

MUST be able to:

• Add, transfer, or delete personnel

• Add additional dosimeters to existing personnel

• Review records (wearer, badge type, frequency, dose history, etc.)

• Summarize results (exposure levels, ALARA, etc.)

• Review exposure histories per entire account

• Review exposure histories for an individual

• Add current year dose for an individual

• Reactivate wearers and dosimeters

• Assign spare dosimeters

• List unreturned dosimeters

• Download data files for unreturned dosimeters

• Download monthly data file reports for badge readings (exposures for specified periods)

The on-line system shall be sufficiently easy to use such that it is more efficient to use than manually requesting changes by telephone.

8. The contractor MUST be able to automatically compute an estimated dose for a missing dosimeter for a wear period. The vendor MUST be able to replace the computed dose if the dosimeter is found and returned for processing.

9. The contractor MUST provide emergency consultation when requested. This process shall be completed within 24 hours of notification.

10. Dosimeters MUST have permanent waterproof ID labels that cannot be smeared and/or removed and be color coded for alternate months.

11. Finger dosimeters MUST be provided in no less than four (4) sizes (small, medium, large, and extra-large), have permanent waterproof ID labels that cannot be smeared and/or removed, and be color coded for alternate months.

12. Master controls MUST be provided for all types of dosimeters. At least two (2) master controls must be provided with each major shipment.

13. Contractor MUST provide absent badge reports for each wear period within twenty-four (24) hours of receipt of dosimeters.

14. Twenty-four (24) hour emergency dosimeter processing service MUST be provided upon request.

15. Exposure reports will be supplied within ten (10) days of receipt of dosimeters.

16. Contractor MUST have a separate fetal dosimetry monitoring program which includes cumulative total on exposures from year to year. The occupational exposure of a declared pregnant woman does not exceed 500 mrem.

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17. Contractor MUST have capability of immediate (within 24 hours of discovery) ALARA notification and memos for high exposures for any dosimeter exceeding specified ALARA Trigger limits.

18. Termination report summaries of personnel radiation exposures are to be supplied within forty-five

(45) days of receipt of last badge after termination of employee.

19. ALARA report summaries will be provided on a monthly/quarterly basis with an additional annual

ALARA review summary (Form 5) for all monitored employees.

20. Fees assessed for lost/late dosimeters will be credited upon return of the badge in accordance with the contractor’s policy.

21. Dosimeters MUST be supplied ten (10) days prior to beginning of wear period to allow time for distribution.

22. Shipments shall include individual printed packing lists for each group of users. The individual packing lists shall include the numerical order of the dosimeters. Other information provided in the list should include, but is not limited to, the following:

• Participant name

• Badge control identification

• Badge type

• Prescribed wear period, by date

23. Contractor MUST SUPPLY dosimeters for additions to the program within five (5) days from date of notification, if indicated by Radiation Safety Office. If dosimeters are not required within five (5) days, they are to be sent with the next regular shipment. Contractor’s program MUST have capability of indicating date a badge is required.

24. Contractor MUST have capability to provide summing of exposures across all in-house facilities for limits which an individual is badged by the vendor. A monthly report MUST be provided listing individuals who are seen to have activity in other accounts during the reporting year.

25. Contractor MUST be able to provide exposure reports or other electronic means.

26. All subcontracting plans shall be provided to the Contracting Officer. The contractor shall ensure that subcontractor meets all the requirements specified in this Statement of Work (SOW) and all other applicable federal/state regulations and requirements. The manufacture supplier of the personal dosimeters shall be in direct control of the design, modifications, and quality of the personal dosimeters.

In addition, the selected vendor shall be NVLAP accredited in ANSI N13.11 categories IA, IIA, IIIA, IV, and V. The personnel dosimeters shall be NVLAP certified type or combination of types, having neutron exposure detection capabilities. Currently, VANTHCS has 28 subaccounts with a total of approximately

615 personnel dosimeters (~7380 annual) to be processed. There are approximately: (active dosimeters fluctuate).

The contractor software used must be integrated with radiation exposures from our university partner, the University of Texas Southwestern Medical Center. They would need to transfer all existing records and provide meter reports for each individual to maintain accurate tracking and compliance. The records for these persons are permanent and must be maintained in perpetuity. The databases for these persons are

36C25726Q0184 Page 4 of 10 complex and are based on date of birth and social security number (SSN). SSN and other identifiers are required by the USNRC, for specific identification of the individual, per 10 CFR 19.13 and 10 CFR

20.2203.

placement Row Labels Count of Service control 82-Control-XC 24 chest 82-Standard-CH 59 collar 82-Standard-CL 424 environmental 82-Standard-EV 19 fetal monitor 82-Standard-FM 9 waist 82-Standard-WS 4 control 83-Control-XC 4 TLD+ chest 83-Standard-CH 45 TLD+ environmental 83-Standard-EV 3 control ORA-Control-XC 6

Ring - left ORA-Standard-

LU 17

Ring - right ORA-Standard-

RU 37

Grand Total 651

27. This service will begin upon receipt of notice of award of contract, with one (1) Year Base and four (4)

Option Years. Based on current active participant counts and current unreturned dosimeter counts calculated at the time of renewal.

• All dosimeters (whole body, collar, fetal, waist, chest) and extremity (ring) dosimeters

• All Occupational Radiation Exposure reports must be formatted to meet the requirements specified in 10 CFR Part 19 & 20

• Set up, transfer, deletion, or reactivation of a monitored individual

• Series or group separation (i.e., new series or account)

• Complete computer system web access capabilities as stated including access time (Medical

Center owned, or vendor provided equipment)

• Training of personnel to adopt vendor’s service, if necessary

• Adjustment of dose record by Radiation Safety Officer

• Up to 150 extra holders per year, if requested

• Individual termination summary reports (Form 5)

• Exposure reports

• Estimate report

• Fetal Report

• METER report

• Unreturned dosimeters

• ALARA monthly reports

• Annual statistical summary for entire account

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• Vendor developed web-based reporting tools designed to help radiation safety staff track, trend, evaluate, and assess radiation safety

• Individual annual NRC Form 5 exposure reports or an accepted equivalent [Note: Annual

Form 5 reports are to be delivered to the VANTHCS by April 30th (or approximately 120 days calendar days) after the end of the previous calendar year.]

28. Dosimeters for each account (broken down by service) are to be addressed as follows:

FOR RADIATION SAFETY:

Radiation Safety, VANTHCS

Radiation Safety Officer (007)

4500 S. Lancaster Rd.

Dallas, TX 75216

29. The dose recording, tracking, and reporting system cannot be dependent on IT infrastructure (Wi-Fi).

VANTHCS does not support IT infrastructure (Wi-Fi).

VA SENSITIVE INFORMATION

30. 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.

31. 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 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

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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.

f. The certification and accreditation (authorization) requirements do not apply, and that a

Security Accreditation Package is not required

32. 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 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 onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures follow 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 while 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.

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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 to 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 to such court orders or other requests to the VA contracting officer for response.

l. For service that involves 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.

33. 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 considering the degree of protection for the data, e.g., unencrypted, plain text.

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

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(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 may be incurred to repair falsified or damaged credit records, histories, or financial affairs.

34. 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.

b. The contractor shall provide the contracting officer and/or the COR 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.

35. Information System Officer, Information Protection: The contractor will not have access to VA

Desktop computers they will not have access to online resources belonging to the government.

36. Privacy Officer: The contractor will not have access to protected Patient Health Information (PHI) nor will they have capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for contractor analysis is de-identified.

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37. NARA Records Management Language for Contracts (May 2017)

1. Contractor shall comply with all applicable records management laws and regulations, as well as

National Archives and Records Administration (NARA) records policies, including but not limited to the

Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII

Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the government are Federal records subject to the provisions of 44 U.S.C.

chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the

Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

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

4. Dallas VA Medical Center and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Dallas VA Medical Center or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity.

Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Dallas VA Medical Center. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment are properly protected. The contractor shall not remove material from government facilities or systems, or facilities or systems operated or maintained on the government’s behalf, without the express written permission of the

Head of the Contracting Activity. When information, data, documentary material, records and/or equipment are no longer required, it shall be returned to Dallas VA Medical Center control, or the contractor must hold it until otherwise directed. Items returned to the government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with

Paragraph (4).

6. The contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The

36C25726Q0184 Page 10 of 10 contractor (and any sub-contractor) is required to abide by Government and Dallas VA Medical Center guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Dallas VA Medical Center policy.

8. The contractor shall not create or maintain any records containing any non-public Dallas VA Medical

Center information that is not specifically tied to or authorized by the contract.

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

10. The Dallas VA Medical Center owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Dallas

VA Medical Center shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management

System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The contractor is responsible for confirming that training has been completed according to agency policies, including initial training and any annual or refresher training.