Anticipated STATEMENT OF WORK FARGO.docx

STATEMENT OF WORK

Board Certified or Board Eligible Medical Physicist for Testing Equipment and Radiation Safety Officer Fargo VA Healthcare System

1. BACKGROUND. The contractor shall provide a board Certified or board eligible Medical or Health Physicist to provide on-site annual, and as needed, performance evaluation/testing of imaging, medical equipment producing radiation, radiofrequencies and routine, emergency Radiation Safety Officer (RSO) services for the Fargo VA Health Care System (FVHCS). The duties for the Fargo VA Health Care System (FVAHCS) are at Fargo, North Dakota. Radiation Materials Licensing experience is a requirement. The Contractor shall furnish personnel to provide Radiation Safety Officer Duties to fulfill the Radiation Materials Licensing requirement as specified by the National Health Physics Program (NHPP). The contractor’s personnel serve as the RSO for the organization and for the comprehensive Radiation Safety Program for the Fargo VA Health Care System in Fargo ND. The FVAHCS makes extensive use of ionizing radiation and radioisotope material in the diagnosis and treatment of disease in the veteran population.

2. OBJECTIVES. The FVHCS is seeking a solution to provide Radiation Safety services (equipment testing, lead shield planning), including Radiation Safety Officer to fulfill the Radiation Materials Licensing requirement as specified by the National Health Physics Program (NHPP). The contractor’s personnel serve as the RSO for the organization and is a major component for the comprehensive Radiation Safety Program for the Fargo VA Health Care System in Fargo ND. The RSO helps manage U.S. Nuclear Regulatory (NRC)/VHA Materials Permit as amended for receipt, location, possession, use, storage, and transfer of radioactive material. Preparing Permit applications, amendments, correspondence, and timely responses for signature to NRC and VHA-NHPP as needed, in accordance with all regulations.

The RSO helps facilitate dosimetry program for a National Voluntary Laboratory Accreditation Program (NVLAP) certified vendor for occupational exposure to ionizing radiation including monthly additions, collection, evaluation, reporting, distribution, and deletion of personal monitoring devices. The RSO is involved with the oversight of the personnel monitoring program and eliminating/reducing or controlling exposure to radiation hazards.

3. QUALIFIED PERSONNEL: All Radiation Physicists performing services under this contract shall work under a board certified Medical/Health Physicist from one of the following boards: American Board of Radiology, American Board of Health Physicists or American Board of Medical Physicists or Canadian College of Physicist in Medicine. Candidate can either be master’s Level or PhD. The Contractor must meet state licensure to practice as medical health physicist, and or Radiation Safety Officer and have membership (or eligibility for membership) to the American Association of Physicists in Medicine (AAPM). The Proposed Physicist must have minimum qualification requirements in Title 10, Part 35.50, of the Code of Federal Regulations (10 CFR 35). The RSO must also be approved by a permit amendment from the VHA National Health Physics Program (NHPP). Board-eligibility must be maintained throughout the contract period of performance. All continuing education courses required for maintaining certification/eligibility must be current. Documentation verifying current licensure and certifications must be provided quarterly, or as requested, to ensure adequate licensure and certification status.

Personnel must also have experience in Hospital Medical Physics and be familiar, experience with state regulations (North Dakota, Minnesota), and VA regulations. The personnel will be identified in the proposal and shall be considered key personnel as essential for the successful completion of the work performed. Any changes to the assignment of personnel must be communicated to the Contracting Officer Representative (COR) and Imaging Supervisor at least 5 days before new personnel will visit the FVHCS. Proposed Physicist must be approved by the National Health Physics Program (NHPP) program to function as a Radiation Safety Officer (RSO) on the FVHCS Radiation Materials License.

The Contractor shall provide personnel qualified and licensed as a Radiation Safety Officer and Associate Radiation Safety Officer if warranted and approved by the NHPP. Qualifications for all responsible personnel shall meet the requirements of under 10 CFR 30.33(a)(3), 10 CFR 35.2, 10 CFR 35.13, 10 CFR 35.14, 10 CFR 35.24, 10 CFR 35.50, 10 CFR 35.57, and 10 CFR 35.59.

The Contractor shall provide personnel who is fully recognized and approved by the United States Nuclear Regulatory Commission (U.S. NRC).

Following contract award, the contractor shall be required to initiate measures for assigned personnel to be added to Fargo VA Materials Permit as Radiation Safety Officer within thirty calendar days. Contractor assigned RSO(s) shall conduct training of VA staff assigned with assisting Radiation Safety measures as required.

LAWS, PERMITS AND LICENSES: Services performed as part of this PWS, and contract must be in accordance with all applicable laws, ordinances, regulations, and service requirements as enforced by Federal, state, local and industry. The Contractor shall be following US NRC, to include obtaining and maintaining all required licenses and permits required by Federal, state, local and industry laws. Contractor is required to coordinate and support Fargo VAMC Director in maintaining a current RSO Permit, as approved by NHPP, for the Fargo VA Medical Center.

4. POLICY/HANDBOOKS. The Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide Radiation Safety Officer services for FVAHCS, under the terms and conditions stated herein and must adhere to following directives/regulations/requirements by regulatory and accreditation bodies:

· VHA Directive 1105 - Management of Radioactive Materials https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3080

· VHA Directive 1105.02 Nuclear Medicine and Radiation Safety Administrative Service https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7519

· VHA Handbook Directive 1105.04 - Fluoroscopy Safety https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7454

· VHA Directive 1105.05 - Magnetic Resonance (MR) Safety https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6430

· VHA Directive 1129 – Radiation Protection for Machine Sources of Ionizing Radiation https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8273

· VHA Directive 1663: Health Care Resources Contracting - Buying https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

· VHA Handbook 1907.01: Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

· Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

· VHA Directive 1004.08 Disclosure of Adverse Events to Patients and local Emergency, Radiation Disaster policies. https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8120

· 10 CFR 35. 3045 Report and Notification of a medical of a medical event https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-3045.html

· 10 CFR 35.24 NRC Authority and responsibilities for the radiation protection program https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-0024.html

· VHA Directive 0320 VHA Comprehensive Medical Emergency Radiological Response Team Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8906

· VHA Directive 0320.05, Medical Emergency Radiological Response Team https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8425

· 10 CFR 30.6 Communications NRC: https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0006.html

· American College of Radiology Disaster preparedness for Radiology Professionals https://www.acr.org/-/media/ACR/Files/Legal-and-Business-Practices/Disaster-Preparedness/Disaster-Preparedness-for-Radiology-Professionals.pdf

· U. S. Department of Health and Human Services: https://www.remm.nlm.gov/

· 10 CFR 30.50 Reporting Requirements NRC. https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0050.html

· 10 CFR 30.50 Reporting Requirements NRC. https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0050.html

5. DEFINITIONS/ACRONYMS. Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

· Contracting Officer (CO) – The person executing this contract on behalf of the Government with the authority to enter and administer contracts and make related determinations and findings.

· Contracting Officer’s Representative (COR) – A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

· Veterans’ Health Administration (VHA): The central office for administration of the VA medical centers through throughout the United States. The VHA is in Washington, D.C.

· Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers.

· COS: Chief of Staff

· CPARS: Contractor Performance Assessment Reporting System

· EHR: Electronic Health Record - electronic health record system used by the VA

· HIPAA: Health Insurance Portability and Accountability Act

· ISO: Information Security Officer

· POP: Period of Performance

· PWS: Performance Work Statement

· QA/QI: Quality Assurance/Quality Improvement

· QM/PI: Quality Management/Performance Improvement

· QASP: Quality Assurance Surveillance Plan

· ABHP: American Board of Health Physics

· ABRB: American Board of Radiology

· ACR: American College of Radiology

· ALARA: As Low as Reasonable Achievement

· ADP: Automated Data Processing

· AMA: American Medical Association

· CQI: Continuous Quality Improvement

· ISO: Information Security Officer

· JCAHO: Joint Commission on Accreditation of Healthcare Organizations

· NCQA: National Committee for Quality Assurance

· NRC: Nuclear Regulatory Commission

· OSHA: Occupational Safety and Health Administration

· PO: Privacy Officer

· PO: Purchase Order

· QA: Quality Assurance

· QI: Quality Improvement

· RSO: Radiation Safety Officer

· SDB: Small Disadvantaged Business

· USC: United States Code

· VA: Department of Veterans Affairs

· VA NHPP: VA National Health Physics Program

· VISN: Veterans Integrated Service Network

· VISTA: Veterans Health Information Systems & Technology Architecture

6. SCOPE OF WORK:

a. The contractor shall furnish all labor, material, supplies, carry equipment onsite, and qualified personnel to provide on-site Radiation Physicist services and Radiation Safety Officer services Fargo VA Health Care System in accordance with the terms and conditions stated herein. VA may increase the number of equipment items or test covered under this contract at no change to the applicable contract price schedule.

b. The onsite diagnostic physics services include the testing and inspection of equipment and programs including nuclear medicine cameras/SPECT CT, ultrasound units, MRI equipment, CT equipment, radiation producing equipment within the Fargo Health Care System assuring compliance with the American College of Radiology (ACR) and National Health Physics Program.

c. The contractor provides service of testing of radiology equipment to ensure the equipment is operating safely and the lowest possible dose to patients. Inspection dates and times for equipment testing will be mutually agreed upon and established. Policy reviews may be provided via electronic means and submitted for recommendation.

d. RSO must perform routine work : radiation safety surveys within FVAHCS facilities for the safe and effective use of these modalities are established by the National Health Physics Program (NHPP), Nuclear Regulatory Commission (NRC) 10 CFR 19, 20, 30, and 35, among others, Occupational Health and Safety Administration (OSHA), Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Department of Transportation (DOT), Veterans Health Administration (VHA), Joint Commission, and Officer Inspector General, American College of Radiology (ACR).

e. The RSO must help provide oversite to the Radiation Physics program and Nuclear Medicine Department. The RSO provides emergency consultation in response to a facility Emergency Disaster or Radiologic Emergency event. Policy reviews may be provided via electronic means and submitted for recommendation. Radioisotope materials licensing experience is a requirement.

f. The RSO shall help maintain oversight of radioactive material within the Radiation Safety Program, where responsibilities include, but are not limited to the following:

1. Ensuring safe use of radioactive materials and regulatory compliance along with the VA medical facility Director as well as the VA medical facility Radiation Safety Committee.

2. Completing day to day actions required by NRC regulations, for the VA medical facility’s radioactive materials permit, which include, but are not limited to, the tasks and actions described in Appendix A of VHA Directive 1105 as well as NRC NUREG-1556, Vol. 9, Rev.3 and NUREG 1556 Vol. 11, Rev. 1.

3. Performing periodic audits and surveys of services and sections using radioactive materials and reporting results to the Radiation Safety Committee (RSC).

4. Investigate overexposures, accidents, isotope spills, losses, thefts, unauthorized receipts, uses, transfers, disposals, medical events, and other deviations from approved radiation safety practice and implement corrective actions as necessary.

g. The RSO provides oversite of Radiation Program by Medical Physicist/Radiation safety officer: Manage U.S. Nuclear Regulatory (NRC)/VHA Materials Permit as amended for receipt, location, possession, use, storage, and transfer of radioactive material. Preparing Permit applications, amendments, correspondence, and timely responses for signature to NRC and VHA-NHPP as needed, in accordance with all regulations.

h. Facilitates dosimetry program for a National Voluntary Laboratory Accreditation Program (NVLAP) certified vendor for occupational exposure to ionizing radiation including monthly additions, collection, evaluation, reporting, distribution, and deletion of personal monitoring devices. Provides oversight of the personnel monitoring program and eliminating/reducing or controlling exposure to radiation hazards.

i. RSO must perform radiation safety surveys within FVHCS facilities to ensure compliance with the current American College of Radiology (ACR) and National Health Physics Program (NHPP) as required.

7. RADIATION SAFETY OFFICER and Diagnostic Physicists

a. QUALITY CONTROL: Work performed under this contract shall be subject to evaluation by the Contract Officers Representative (COR) in accordance with the contract terms and conditions.

b. PLACE OF PERFORMANCE: Fargo Veteran Affairs Health Care System, 2101N Elm Street, Fargo, ND 58103

c. EQUIPMENT. Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide on-site Radiation safety program services and Radiation Safety Officer services at the Fargo VA in accordance with the terms and conditions stated herein. The Fargo VA HCS will provide a person to operate the equipment and be present during the inspection.

TRAVEL: Travel expenses will be covered under the contract.

1. HOURS:

VA Business Hours regular administrative working hours: 8:00 am – 5:00 pm Monday through Friday, excluding Federal Holidays. There may be times when the Contractor could be needed to work after regular working hours.

Provision of 24 hours a day, 7 days week service.

The certified Health Physicist or Medical Physicist (Radiation safety officer) shall respond to emergency situations within one (1) hour by phone and on-site and within 8 hours based on severity of the event or disaster to accomplish the radiation safety services, testing of medical equipment including non-emergent work. The RSO shall be available onsite at VA, and four hours for non-emergency situations when notified by the VA COR, Imaging Supervisor, Chief or VA designee(s).

10 CFR 30.50 Reporting Requirements NRC.

https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0050.html

FEDERAL HOLIDAYS: The holidays observed by the Federal Government are:

· New Year’s Day

· President’s Day

· Martin Luther King’s Birthday

· Memorial Day

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

· Juneteenth

· Any other day specifically declared by the President of the United States to be a Federal Holiday

GENERAL PROVISIONS.

Services will be provided at the Fargo VA Health Care System (VAHCS), 2101 N Elm Street Fargo, ND 58103. Services will be provided at FVHCS during the hours of 8:00am – 5:00pm, Monday through Friday, excluding Federal Holidays. Inspection dates and times will be mutually agreed upon and established. Policy reviews may be provided via electronic means and submitted for recommendation. Change of times or dates of survey visits must be coordinated with the department at least two (2) weeks in advance.

Contractor staff performing inspection will be subject to a background investigation and receive a favorable adjudication from the VA Security Center (VSC). If security clearance is not completed prior to the start of the contract, the Contractor will be responsible for the actions of those individuals they provide to perform services for the VAHCS.

The position sensitivity has been designated as low sensitivity. The level of background investigation is a National Agency Check with Written Inquiries. The level of risk associated with the contracted employee position is equivalent to the level required of a VA Employee working in such a position.

Contractor staff performing inspections will complete and sign VA’s National Rules of Behavior and Privacy Policy training prior to performing inspections.

Contractor will provide equipment calibration records for all equipment used to test equipment.

VA may increase the number of equipment items or test covered under this contract at no change to the applicable contract price schedule.

Physicist must be approved on Radiation Materials License by National Health Physics Program.

d. STANDARDS: The services to be performed by the contractor will be performed in accordance with VA policies and procedures and the regulations of the medical staff bylaws of the VA facility.

i. Key Personnel: The VA Full Time Equivalency (FTE): FTE is defined by VA as a minimum of 80 hours every two weeks and does not include holidays.

ii. The minimum number of Board-Certified physicists required to provide coverage daily for Radiation Safety Officer is one key personnel as defined in paragraph Hours of Operation in this section.

iii. The Contractor shall be responsible for providing coverage to the VA during periods of vacancies of the Contractor’s personnel due to sick leave, personal leave, vacations, and additional coverage as required. In the event a scheduled physicist is unable to complete an assigned shift, the contractor shall provide replacement physicist coverage within two (2) hours and notify the Contracting Office Representative (COR) at the Fargo VA Health Care System immediately of the schedule change.

iv. Personnel Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the CO, in writing, within 15 calendar day (s) after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitution.

v. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

vi. For temporary substitution where the key person shall not be reporting to work for three 3 consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

vii. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA Imaging COS, supervisor or designee show documented clinical problems or continual unprofessional behavior/actions with any Contractor’s physicist (s), s/he may request, without cause, immediate replacement of said Contractor’s physicist (s). The CO and COR shall deal with issues raised concerning Contractor’s physicist (s) conduct. The final arbiter on questions of acceptability is the CO.

viii. Contingency Plan: Because continuity of care and requirements of radioisotope licensure requirements as described in VHA Directive 1105 and 1129 https://www.va.gov/vhapublications/publications.cfm?pub=1&order=asc&orderby=pub_Number.

ix. It is an essential part of FVAHCS medical services, the Contractor shall have a contingency plan in place to be utilized if the Contractor’s physicist (s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

x. Provide written report of completed audits/surveys to Imaging Supervisor or designee within thirty (30) working days of performance of the survey.

I. HEALTH PHYSICS INSTRUMENTATION REQUIREMENTS

The RSO(s) shall provide the following services, and report as necessary to BIOMED for tracking of instrument calibration:

A. Calibration of instruments used for performing ambient dose rate surveys which includes calibration in dose rate (e.g., R/hr) and/or count rate (e.g., cpm) as needed, required by regulation, or deemed appropriate by a qualified expert.

B. Calibration of instruments used for direct measurement of radiopharmaceuticals as needed, required by regulation, or deemed appropriate by a qualified expert. Radioactive calibration sources shall be provided by Fargo, however, all written procedures for completing such calibrations as well as knowledge and expertise shall be provided by the RSO(s).

C. Calibration of instruments used for the detection and quantification of removable radioactive contamination. Required calculations include but are not limited to; lower level of detectability (LLD), minimum detectable activity (MDA), detector efficiencies for all photon energies applicable to Fargo VA. Sealed radioactive sources shall be provided by Fargo VA, however, all written procedures for completing such calibrations as well as knowledge and expertise shall be provided by the RSO(s).

D. Perform an annual review and summary of the Radiation Safety Program involving by-product material and will present the summary to the Radiation Safety Committee.

e. DUTIES AND RESPONSIBILITIES

i. Help provide radiation protection program (RPP) oversight, including machine sources of ionizing radiation during routine committee meetings and as part of an annual radiation safety program review. Including committee membership for appropriate functional areas using machine sources (e.g., radiation oncology, radiology, and cardiology, etc.).

ii. Assist with operationalizing radiation safety procedures to include periodic review standards that conform with regulations, VA requirements, and good radiation safety and medical physics practices.

iii. Ensure (for the licensee) that the radiation safety activities are being performed with federal and state regulations.

iv. Completing ALARA reviews and evaluation occupational and public doses related to the use of machine sources, if required.

v. Reviewing and recommend proposed changes to training, equipment, facilities and radiation safety procedures or practices.

vi. Providing structural shielding design reports for linear accelerators to NHPP for approval before installation of the equipment and shielding survey reports before first clinical use of the equipment. Ensuring structural shielding design reports and shielding surveys conform to NCRP Report No. 151 or current document.

vii. Ensures the equipment inspection frequency is 12 months and deficiencies identified in the inspection process are corrected in a timely fashion.

viii. Ensures rooms where x-ray equipment is used are shielded per NCRP Report No. 147 or current document and documentation demonstrating compliance is maintained.

ix. Ensures compliance with the VHA Fluoroscopy Safety Handbook 1105.04. Providing ongoing reviews for computed tomography (CT) scanning protocols to help reduce possible radiation dose for those procedures.

x. Providing oversight for safe use of radioactive materials with a focus to ensure occupational and public doses are as low as reasonably achievable (ALARA) and a safety conscious work environment is achieved.

xi. Establishes Radiation Safety committee membership to include the Chair, RSO, a management representative, a nursing service representative, and other key staff such as a clinical representative for each type of medical authorized use, a representative for research use, and work center representatives (based on potential health and safety or patient safety risks) from among nursing staff, nuclear medicine technologists, or other ancillary workers and subject matter experts such as a biomedical engineer.

xii. The RSO(s) shall review and assist with administration of unsealed radioactive material requiring a written directive as well as the release of patient determination to ensure compliance with all regulatory requirements.

xiii. Participates quarterly meetings at intervals not to exceed 6 calendar months and establishing a committee quorum of at least one-half of committee membership for meetings, which must include the RSO and management representative and makes recommendations as necessary.

xiv. Prepares records and reporting committee results as required by executive management and/or Title 10 Code of Federal Regulations (CFR) Part 35 and ensuring the records document executive management approvals for actions under 10 CFR Part 35 to include these administrative requirements.

xv. Collaborates with other facility committees as needed and administrative oversight of the Radiation Safety Committee minutes by ensuring the submitted copy of Radiation Safety Committee minutes to a higher-level committee within 45 days after the date of the Radiation Safety Committee meeting.

xvi. Reviews annually the radiation safety program review as specified in 10 CFR 20.1101, to include locations of use with emphasis on decommissioning records as specified in 10 CFR Part 30.

xvii. Reviews or audits as needed based on the radioactive materials, by-product material scope of use.

xviii. Evaluates results from audits, reviews, and inspections to determine possible generic issues or trends. Identify root causes, specify corrective actions and actions to prevent recurrence, and determine if any results are applicable to other uses of radioactive materials.

xix. Follow-up to resolve health and safety issues and radiation safety program deviations as needed.

xx. Reviews, at least every 6 months, occupational and public doses.

xxi. Reviews, at least every 6 months, any identified health and safety issues or possible radiation safety program deviations from regulatory compliance or required practices.

xxii. Reviews and suggest, recommends changes to training, equipment, facilities and radiation safety procedures or practices to imaging management.

xxiii. Ensures sealed source inventories are completed:

(1) Quarterly, for sealed sources with either current activity greater than 1 millicurie or current activity greater than 1000 times the quantities in 10 CFR Part 20, Appendix C.

(2) Semiannually, for all other sealed sources except sources specifically exempted by 10 CFR 30.

(3) Ensuring sealed source records are maintained for transfer or disposition to document leak test results if the sealed source was required by regulation or permit condition to have a leak test.

(4) Providing results if requested, for sealed source inventories and leak tests to NHPP.

(5) Providing oversight for security of radioactive materials by:

(a) Compliance with regulations in 10 CFR 20.1802, and 10 CFR Part 37.

(b) Prevention of adversary or unauthorized removal of radioactive materials.

(c) Compliance with the security guidelines in VHA Handbook 1200.06, Control of Hazardous Agents in VA Research Laboratories.

(d) Focusing on adequate security commensurate with possible risks of radioactive materials unauthorized use.

(e) Classifying sealed sources, not in active use for their intended clinical or research purpose for a period of 24 months, as disused sources, and evaluation the disused sources for disposal as expeditiously as possible.

(f) Reviewing and evaluation human subject research (if the research only requires use of the results of tests using ionizing radiation that has been conducted for medical care purposes only) by:

i. Compliance with regulations in 10 CFR 35.6 for radioactive materials use in human subject research.

ii. Compliance with guidelines for obtaining and documenting research informed consent as required by VHA Handbook 1200.05, Requirements for the Protection of Human Subjects in Research.

iii. Using NRC documents (NUREG-1556 series) as guidance to prepare and submit requests for new, renewed, or amended permits.

xxiv. Ensures radiation safety program implementation to be consistent with the program codes (i.e., whether broad-scope or limited-scope medical or research uses) and permitting conditions approved for the permittee.

xxv. Ensures approvals for authorized users and locations of use (except as authorized per 10 CFR 35.14) are limited to broad-scope permittees.

xxvi. Recommend and help provide corrective actions for identified safety problems.

xxvii. Verify the corrective actions have been implemented by imaging management.

xxviii. If necessary, stop operations which are identified as unsafe.

xxix. Be available for contact by facility staff per regulations and license conditions.

xxx. Ensures compliance with posting requirements specified in 10 CFR Part 19 and 21.6, as in the following:

(1) VHA Radioactive Material Permit No. 33-15145-03 issued under VHA NRC License No. 030-18950 VA authorizes the use of radioactive materials at this location.

(2) Ensures VHA license, amendments, and supporting application are available for examination by contacting NHPP at 501-257-1571, or mailing address NHPP (115HP/NLR), Bldg. 101, Room 208, 2200 Fort Roots Drive, North Little Rock, AR 72114.

(3) Establishes and helps imaging management implement radiation safety procedures and reviews them periodically to ensure their conformity with regulations, the requirements of VHA Handbooks regarding radiation safety, and good radiation safety and medical physics practices.

(4) Communicates personnel in regulatory requirements, the requirements of VHA Handbook, and proper radiation protection practices before first working with radiation or make available a course of instruction for same.

(5) Conducts or supervise radiation surveys and to keep records of such surveys and tests, including summaries or corrective measures recommended or instituted.

(6) Ensures that personal monitoring devices are used as required, that records are kept of the results of such monitoring, and to review the monitoring reports promptly to ensure that investigatory and regulatory limits are not exceeded. These records must be kept in suitable organized file for the life of the facility. Note: For information regarding records management, see VHA Directive 6300 for records control. Ensure that required signs and notices are properly posted. Monitor compliance with the requirements of VHA Handbook 1105.04.

(7) Notifies facility Director, or designee, of significant safety hazards, unsafe operations, significant violations of VHA Handbook 1105.04, exposures of staff or members of the public that exceed regulatory requirements, and medical misadministration’s or any corrective actions.

(8) Reviews prior to construction, plans for rooms in which ionizing radiation producing equipment is to be installed, including room layout, shielding, viewing, and communications systems. Perform, or have a qualified expert perform, radiation surveys, equipment testing, calibrations as indicated after installation, but before clinical use of the equipment, including summaries of corrective measures recommended or instituted.

(9) Ensure that required signs and notices are properly posted.

(10) Assist with known or suspected cases of excessive or abnormal radiation exposure to determine the cause(s), steps to prevent its recurrence, and assist with completion of required remedial reports.

(11) Provides continuous (24 hours/365-day) coverage for Radiation Safety emergencies, and RSO duties.

(12) Provides Emergency Disaster coverage to the local facility during Radiologic events, sentinel events.

(13) Reviews and approves changes to RPP (with licensee management) before implementation.

(14) Ensures quality control programs are working effectively and follow the local, state, national regulations.

(15) Ensures local guidelines and policies for the safe, effective use of diagnostic x-ray equipment are established by the Health Care System’s Radiation Safety Committee.

(16) Verifies implementation of corrective actions by imaging supervisor.

(17) Ensures availability for contact by facility staff per regulations and license conditions

(18) Manages U.S. Nuclear Regulatory (NRC)/VHA Materials Permit as amended for receipt, location, possession, use, storage, and transfer of radioactive material.

(19) Prepares Permit applications, amendments, correspondence, and timely responses for signature to NRC and VHA-NHPP as needed, in accordance with all regulations.

(20) Provides expert knowledge and experience for advising and recommending action/trigger levels for investigation levels for personnel exposures and survey areas.

(21) Provide Recommendations:

(a) Coordinates with the FVHCS Imaging and BioMed department to assure annual hazard testing, and newly installed equipment and shielding acceptance testing is performed. This includes review of testing results and implementation of any corrections and/or recommendations.

(b) Communicate with the facility Chief of Staff (COS), Chief of Imaging, Imaging Supervisor, and Administrative Officer to COS (Contracting Officer Representative - COR), Fargo Radiation Safety Committee.

(c) Facility dosimetry program from a National Voluntary Laboratory Accreditation Program (NVLAP) certified vendor for occupational exposure to ionizing radiation including monthly additions, collection, evaluation, reporting, distribution, and deletion of personal monitoring devices. Provides oversight of the personnel monitoring program and eliminating/reducing or controlling exposure to radiation hazards.

(d) Instruct and consult personnel in Imaging, nuclear medicine, and support services that work nearby restricted areas where ionizing radiation is authorized.

(e) Conduct onsite Annual Imaging Audits of the Imaging department: General X-Ray, Dexascan, CT, MRI, and Fluoroscopy to include quality control, and quality assurance.

(f) Conduct onsite Annual Imaging Audits of the Dental department, quality control and quality assurance.

(22) Action or Trigger Levels

(a) Provides expert knowledge and experience for advising and recommending investigation levels:

(b) Personnel exposures

(c) Area surveys: dose rate and contamination

(d) Types and amounts of radioactivity are secured, inventoried, and accounted for to prevent unauthorized uses or misappropriations

(23) As Low as Reasonably Achievable (ALARA)

(a) Informs/instruct management, committees, and staff of ALARA regulatory/license requirements

(b) Informs/instruct workers of licensee/management commitment to ALARA

(c) Investigates deviations from ALARA practices for cause, and recommend action plans

(d) Enforces the ALARA regulatory/license requirements

(24) Audits/Reports/Reviews

(a) Reviews (at least annually) the RPP content, make suggestions, recommendations and helps Imaging supervisor with implementation with radiology management to improve the program.

(b) Onsite Annual Imaging Audits of the Imaging department: general x-ray, dexa, CT, Fluoroscopy, and dental department to include recommendations for quality control, including review of VHA program checklist.

(c) Audits (at least semiannually) the RPP and the ALARA program, documents and report results to radiation safety committee.

(d) Audits (at least annually) the adequacy of procedures for preventing medical events, including written directive compliance, patient identification for patients exposed to radiation.

(e) Reviews (quarterly) occupational, public doses of individual trigger levels are excessive and prepares a summary report of regulatory limits which is reported to the Radiation safety officer.

(f) Reviews (quarterly) doses of patients who received procedures and prepare summary report.

(g) Reviews (quarterly) dose rate and contamination survey results and prepare summary report.

(h) Review incidents involving ionizing radiation issues and subsequent actions.

(i) Reports and notification of a medical, sentinel event per regulation which include doses, radiation levels, leaking source or concentrations of radioactive materials exceeding a constraint or limit individuals exceeding the regulatory dose limits.

(j) Reports and notifies of an unintended dose to an embryo/fetus or a nursing child which exceeds the regulatory limits.

(k) Monitors and report any theft or loss of licensed materials.

(l) Annually reviews and updates of the EPA’s National Emission Standards for Hazardous Air Pollutants (NESHAPs), if required.

(m) Annually review and update of the Fluoroscopy Safety Program including ALARA, shielding surveys, inventories, and equipment, calibration, and performance testing, quality management program, policies, procedure, and written directives.

(n) Annually review and update of OIG checklist on quality control, quality assurance, Fluoroscopy.

(o) Annual review and update of radiation physics program policies, procedures, or written directives.

(p) Annual onsite safety audit of surgery and dental department radiation practices.

(q) Reviews quarterly MRI quality control documents and signature of concurrence.

(25) Contamination/Spill/Response

(a) Establish a procedure, training for spill response in the Radiation physics program including:

i. Liquid spills

ii. Gas and aerosol releases

iii. Establish a procedure for skin and another surface decontamination

iv. Train workers in spill response and decontamination techniques

v. Estimate skin/organ dose

vi. Emergency Disaster Response

(26) Facility Designation, Design, and Shielding

(a) Identify addresses and areas of use

(b) Identify restricted, unrestricted, and controlled areas

(c) Consult on facility design and shielding

(27) Provide notification, communication of Workers

(a) Notify workers likely to receive >100 mRem/year

(b) Provide radiation safety instruction to personnel caring for radiopharmaceutical patients per regulations.

(c) Provide an annual review and summary of the radiation safety program to the Radiation Safety Committee.

(d) Provide Annual Radiation safety training, which includes a radiation safety PowerPoint, and test for staff and personnel commensurate with risk of exposure to ionizing radiation from use of fluoroscopy, or x-rays covering the local, state, and federal regulations

(e) Provide education staff in radiation protection and radiation protection including, individuals of exceeding the regulatory dose limits

(f) Leak source

(g) Report and notification of a medical event per regulation

(h) Report and notification of an unintended dose to an embryo/fetus or a nursing child that exceeds the regulatory limits

(i) Theft or loss of licensed radioisotope materials

(j) Operating procedures

(k) Declared Pregnant Woman (DPW) regulations

(l) Department of Transportation (DOT) training on transporting radioactive materials

(m) Notification of RSO

(n) Regulations and license conditions

(o) Where do I wear my radiation badge training?

(p) Develop, distribute, and assist in operationalizing of up-to-date RPP procedures

(q) How to maintain current license, submit amendment, renewal of license

(r) Assure the possession, use and storage of byproduct material is consistent with the regulations, license conditions, sealed source, and Device Registry (SSDR) certificates, and any manufactures recommendations or instructions

(28) Machine Registration/Calibration. Assure that calibration and testing are performed per regulations and/or license conditions and according to professional standards of good practice.

(29) Medical Events

(a) Review and advise on written procedures to prevent medical and other addressable events

(b) Investigate medical events as to cause(s); consult and advise with management on appropriate corrective action(s)

(c) Report medical events, including sentinel events to management and to regulatory authorities per regulations

(d) Maintain written procedures to prevent medical and other addressable events

(e) Investigate medical events as to cause(s); identify and take timely, appropriate corrective action(s)

(f) Report medical events to management and to regulatory authorities per regulations overexposures, accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, disposals, medical events and other deviations from approved radiation safety practice, report event to the appropriate authorities, and implement corrective actions.

(g) Respond and provide support during an Emergency Disaster regarding Radiologic Events.

(h) Perform onsite evaluation, calculations of radioactive material as necessary during medical event or disaster

(30) Ordering/Receiving/Transporting Packages Containing Radioactive Material

(a) All orders authorized by the RSO, RSO designee, or authorized user

(b) Receipt address and area of use approved by the RSO packages properly secured when not attended

(c) Packages received, surveyed, swiped, and processed per federal, state, regulations, and license conditions

(d) Licensed material is transported, or offered for transport, in accordance with all applicable DOT requirements

(e) Ensure proper documentation of transportation of Radioactive Materials are maintained, stored

(31) Patient Protection

(a) Advise on policies for identifying pregnant patients

(b) Perform fetal dose measurements/estimations

(c) Assist in development of appropriate guidelines and policies per approved criteria/regulations

(d) Provide patient radiation safety instructions

(e) Establish dose calibration and quality control procedures per regulations

(f) Perform dose calibrator calibration and quality control procedure

(g) Establish prescribed dosage list (AU approved)

(h) Assay and record patient dosages

(i) Enforce policy for identifying pregnant patients

(j) Perform fetal dose measurements/estimations

(k) Release per approved criteria/regulations

(l) Radiation safety instructions provided

(m) Advise on policies for identifying pregnant patients and perform fetal dose measurements/estimations

(32) Personnel Monitoring

(a) Establish a system to ensure that monitors are worn and returned in a timely manner, including:

(b) Advise on who and when individuals should be monitored

(c) Advise on where and how personnel monitoring devices shall be worn

(d) Advise on the use of personnel monitoring devices

(e) Establish a bioassay program consistent with regulatory requirements and use, if required

(f) Perform and record bioassay measurements, if required

(g) Interpret the results of personnel monitoring and bioassay measurements, if required

(h) Advise the staff of their personnel monitoring and bioassay results, if required

(i) Assist in study of doses exceeding trigger levels as to cause

(j) Investigate cause of doses which exceed the trigger levels

(k) Provide written dose reports to staff who are separated from the facility

(l) Review the use of personnel monitoring devices and provide annual dose reports to employees

(33) Post or Reference Documents and Notices

(a) Applicable rules or regulations

i. License, license conditions, documents incorporated into the license by reference and amendments

ii. Notice of radiation effects in Imaging Department

iii. Operating procedures applicable to license activities

iv. Post Notices of radiation effects in Imaging department

v. Any notice of violation, proposed imposition of civil penalty or order and license response

vi. Notice to Employees

vii. Applicable rules or regulations

(b) Posting and Labeling

i. Doors and/or rooms and areas

ii. Containers, syringes, or syringe shields

iii. Emergency liquid spill procedures

iv. Emergency Tc-99 aerosol spill procedures

(c) Pregnant Workers

i. Review previous occupational doses

ii. Advise worker on dose reduction

iii. Discuss Declared Pregnant Woman (DPW) status

iv. Monitor monthly doses

v. Modify DPW job functions as necessary to keep conceptus dose below regulatory limit

(34) Radiation Accidents

(a) Attend institution’s radiation accident committee and advise as necessary.

(b) Advise on the design of the radiation accident response plan.

(c) Assist in the response to radiological accidents or emergencies.

(d) RSO responds to emergent radiological accidents or facility Emergency Disaster regarding Radiation Disaster initially within 1 hour via phone call and on-site within 8 hours based on severity of the event or disaster.

(35) Records. Provide a record system to help assure that the appropriate records are maintained in with applicable Regulations.

(36) Surveys and Survey Instruments

(a) Surveys for ambient radiation exposure rate

(b) Surveys for fixed and removable contamination

(c) Surveys after source implant and removal

(d) Surveys of therapeutic treatment units

(e) Radiation survey instrument calibrations

(37) Sealed-Source Leak Test and Inventory

(a) Perform semiannual sealed-source leak test

(b) Perform semiannual sealed-source inventories

xxxi. Waste Disposal

(1) Return to supplier

(2) Transfer to authorized recipient

(3) Disposal-by-decay the sealed source inventory greater than 1 millicurie for usage, storage, or recycling; status is reported to the VHA-NHPP under password protected code; incumbent updates annually the “Approved Radiopharmaceutical Doses for Diagnostic Imaging and Therapeutic Procedures.”

xxxii. Management Skills

(1) Interact effectively with medical facility staff

(2) Present radiation safety information in a clear manner to radiation safety committee

(3) Organize and maintain a record keeping system

(4) Interact with regulatory agencies.

xxxiii. RSO Authority. The RSO will be provided sufficient authority to:

(1) Provide implementation guidance based on written RPP

(2) Identify radiation safety problems

(3) Recommend, or provide corrective actions verbally and/or in writing

(4) Provide immediate feedback regarding any unsafe operations

(5) Terminate unsafe operations

(6) Verify implementation of corrective actions according to applicable state, Federal regulations. Report necessary data, compliance issues to state, federal agencies, including the Nuclear Regulatory Commission (NRC).

8. DIAGNOSTIC MEDICAL PHYSICS TESTING

a. The Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide on-site diagnostic medical physics support or services for the Veterans Health Administration (VHA), under the terms and conditions stated herein and must adhere to VHA Handbook 1105.04, Fluoroscopy Safety, dated July 6, 2012, http://vaww./va.gov/vhapublications/ViewPublications.asp?pub_ID=2764.

b. The Contractor shall comply with radiation protection standards in 29 CFR 1910.1096 and immediately report any unsafe conditions with the potential to adversely impact the facility radiation workers or patients to the Radiation Safety Officer (RSO).

9. GENERAL REQUIREMENTS

a. Performance. All work shall be performed by a qualified diagnostic medical physicist. A qualified diagnostic medical physicist is a person who is certified by the American Board of Radiology, American Board of Medical Physics, or the Canadian College of Physicists in Medicine. For diagnostic computed tomography (CT), nuclear medicine, or MRI, a qualified medical physicist can meet the following requirements in lieu of board certification:

· A graduate degree in physics, medical physics, biophysics, radiologic physics, medical health physics, or a closely related science…