STATEMENT OF WORK OMAHA VA HOSPITAL.pdf

STATEMENT OF WORK

RADIATION SAFETY SERVICES

NEBRASKA WESTERN IOWA HEALTH CARE SYSTEM

I. RADIATION SAFETY REQUIREMENTS

A. The contractor provided Radiation Safety Officer(s) (RSO) shall provide Radiation Safety

Services for the VA Nebraska-Western Iowa Health Care System (VA NWIHCS) pertaining to the following uses of ionizing radiation with respect to location:

i. Omaha VA Medical Center, 4101 Woolworth Avenue, Omaha, NE 68105

1. Broadscope Radioactive Material License to include:

a. Diagnostic Nuclear Medicine

b. Therapeutic Nuclear Medicine

c. Research

2. Machine produced ionizing radiation

a. Diagnostic Radiology

b. Medical Fluoroscopy

c. Research use of Fluoroscopy

d. Clinical Lab X-Ray Blood Irradiator

ii. Lincoln Community Based Outpatient Clinic (CBOC), 420 Victory Park Drive;

Lincoln, NE 68510

1. Machine produced ionizing radiation

a. Diagnostic Radiology

b. Medical Fluoroscopy

iii. Grand Island (CBOC), 2201 North Broadwell Avenue; Grand Island, NE 68803

1. Machine produced ionizing radiation

a. Diagnostic Radiology

b. Medical Fluoroscopy

B. The primary duty location will be the Omaha VA Medical Center. The RSO(s) will be required to conduct site visits at least quarterly at the Lincoln and Grand Island CBOCs.

i. RSO(s) shall coordinate transportation with the Chief of Imaging Services, Imaging Services Manager, or other designated authority within the NWIHCS Imaging Services Department.

C. The Radiation Safety Program shall be run in accordance with applicable directives/regulations/requirements from various entities:

i. Pertinent regulatory and/or accreditation authorities include, but are not limited to the following:

1. Nuclear Regulatory Commission (NRC)

2. National Health Physics Program (NHHP)

a. VHA Directive 1105, Management of Radioactive Materials, dated February 24, 2021.

b. VHA Directive 1129, Radiation Protection for Machine Sources of Ionizing Radiation, dated February 5, 2015 with respect to the DRAFT revision proposed November 2021.

c. VHA Directive 1105.04, Fluoroscopy Safety, dated June 18, 2018.

d. VHA Directive 1105.03, Mammography Program Procedures & Standards, updated May 21, 2018.

3. Department of Transportation (DOT)

4. Environmental Protection Agency (EPA)

5. Food and Drug Administration (FDA)

6. The Joint Commission (TJC)

7. The American College of Radiology (ACR)

ii. The RSO shall 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, 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. Providing applicable personnel radiation safety training in accordance with regulatory requirements and commensurate with respective duties.

5. 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.

iii. The RSO shall maintain oversight of machine sources of ionizing radiation pertaining to the use of Diagnostic Imaging and/or Medical Fluoroscopy, as specified in VHA Directives 1105.03, 1129, and 1105.04. Duties include, but are not limited to the following:

1. Establishing and implementing radiation safety procedures commensurate with the use of fluoroscopy and reviewing them periodically to ensure their conformity with Federal radiation safety regulations.

2. Ensuring regulatory standards for radiation safety and medical physics practices are followed throughout the facility.

3. Instructing personnel of requirements in Federal radiation safety regulations applicable to fluoroscopy.

4. Conducting or supervising radiation surveys where indicated and to keep records of such surveys and tests.

5. Assist each service or section performing fluoroscopy and/or computed tomography and periodically review records of doses to patients as part of a clinical quality assurance program.

D. The RSO(s) shall ensure all required notifications and reports involving overexposures to hospital personnel and/or members of the general public as well as sentinel events are submitted to the Medical Facility Director.

i. Establish points of contact within the VA Facility to keep open lines of communication and authority involving radiation safety either for radioactive material, sealed sources, or machine sources of ionizing radiation.

ii. Communicate required information to the appropriate authorities for any of the above listed events. The NHPP is the point of contact between VHA facilities and the NRC along with other regulatory authorities.

E. The contractor provided RSOS(s) shall develop and maintain written policies and procedures in accordance with NUREG 1556 Vol. 9, Rev 3, applicable VHA Directives, and/or TJC, pertaining to the safe use of ionizing radiation.

F. The contractor provided RSO(s) shall manage the personnel radiation monitoring program for VA NWIHCS. This includes the following:

i. Distribute, collect, and maintain radiation dosimeters meeting NVLAP certification designed to monitor the external radiation dose received by individuals as required per applicable regulations and VHA Directives.

ii. Provide an internal monitoring program to determine the radiation internal dose in individuals in accordance with applicable regulations and VHA Directives.

iii. Reviewing, at least quarterly, occupational, and public doses and reporting the analysis to the RSC.

iv. Manage and maintain the ALARA (As Low as Is Reasonably Achievable) program for all VA NWIHCS locations where ionizing radiation is used. The program will establish personnel exposure investigational levels that, when exceeded, will initiate investigation by the RSO(s) of the cause of the exposure and a consideration of actions that might be taken to reduce the probability of recurrence. All such findings shall be reported by the RSO(s) to the Radiation Safety Committee (RSC) at each scheduled RSC meeting or as needed.

G. For medical use at the VA Nebraska-Western Iowa Health Care System, the RSO shall be actively involved with the Radiation Safety Committee in the performance of its duties.

Examples include, but not limited to, reporting on pertinent findings and inspections related to the use of radioactive material, radiation producing equipment, radiation exposure, and other matters related to regulatory requirements of the NHHP and/or other governing bodies.

H. The RSO(s) shall be available on-site at VA, and be available after regular hours as needed, to accomplish the functions of the Radiation Safety Services within thirty minutes for emergencies and three hours for non-emergency situations when notified by the VA Contracting Officer’s Representative (COR), Chairman of the Radiation Safety Committee, or other VA designee(s).

I. The RSO(s) shall provide technical direction to the Radiation Safety Committee in the development and update of the VA Nebraska-Western Iowa Health Care System (VA NWIHCS-O) Radiation Safety Manual to ensure compliance with applicable regulations.

J. 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.

K. The RSO(s) shall be responsible for arranging the transportation of byproduct materials and ensuring compliance with Department of Transportation (DOT) regulations and other requirements as applicable.

L. The RSO(s) shall be responsible for the proper regulation of machine produced ionizing radiation and work with Biomedical Engineering (BIOMED) and the COR to ensure compliance with NRC and NHPP requests.

II. 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 VA NWIHCS, 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 VA NWIHCS. Sealed radioactive sources shall be provided by VA NWIHCS, 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.

III. VA REQUIREMENTS

A. All files produced and maintained under the requirements of this contract shall remain on the VA Nebraska-Western Iowa Health Care System campus in the designated location.

IV. QUALIFICATIONS

A. 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.

B. The Contractor shall provide personnel who is fully recognized and approved by the

United States Nuclear Regulatory Commission (U.S. NRC).

C. The Contractor shall provide personnel who are knowledgeable of VA’s National Health Physics Program (NHPP) and Joint Commission for Accreditation for Hospital guidelines and standards and eligible for approval by NHPP for the Radioactive Material Broadscope Permit as well as machine produced radiation.

D. Personnel shall be experienced with the types and quantities of licensed material that is authorized on the license for a medical broad scope program.

E. Following contract award, the contractor shall be required to initiate measures for assigned personnel to be added to VA NWIHCS 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.

V. 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 in compliance with 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 Omaha VAMC Director in maintaining a current RSO Permit, as approved by NHPP, for the Omaha VA Medical Center.