D14. USE OF RADIATION GENERATING EQUIPMENT.pdf

D.14 USE OF RADIATION GENERATING EQUIPMENT

36C25922R0102

DEPARTMENT OF VETERANS AFFAIRS

Oklahoma City VA Health Care System

Center Memorandum 114-2 March 1, 2017

USE OF RADIATION GENERATING EQUIPMENT

1. Summary: Center Memorandum 114-2, dated January 30, 2013 is rescinded and reissued with no changes.

2. Purpose: To establish regulations for all personnel to operate radiation-generating equipment or to work within an area where radiation-generating equipment is operated.

3. Policy & Procedure:

a. Radiation Protection Guide: Exposure limitations will follow the recommendations of the Federal Radiation Council and the National Council on Radiation Protection and Measurements. In general, personnel exposures will be limited to an amount that is As Low As Reasonably Achievable (ALARA).

b. Qualification of Operators:

(1) The Radiology Service Chief is certified by the American Board of Radiology (ABR) or the American Board of Nuclear Medicine (ABNM), as required by VHA Handbook 1100.19, Credentialing and Privileging.

(a) Privileging requirements for the performance of radiologic procedures are recommended based on training and/or experience, current competence and health status, as well as consideration of any information related to medical malpractice allegations or judgments, loss of medical staff membership, loss and/or reduction of clinical privileges, or challenges to licensure.

(b) All requests for initial and renewal credentials and clinical privileges and recommendations regarding appointment and privileging action are reviewed by the Radiology Service Chief. He must maintain performance data on all physicians and use this data in recommending renewal of privileges. Physician performance data includes competency review of interpretations, personal workload, maintenance of certification, and participation/attendance in quality improvement activities. In addition, it may contain other factors as deemed necessary.

(2) Radiologists are physicians who have completed an Accreditation

Council for Graduate Medical Education (ACGME) accredited radiology residency program, or an equivalent foreign program, and who perform and interpret diagnostic imaging or interventional studies. Radiologists follow the guidelines of the American College of Radiology (ACR) and American Institute of Ultrasound in Medicine (AIUM) in regard to the Standard of Practice, and they are guided by the Appropriateness http://vaww1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1806

Center Memorandum 114-2, March 1, 2017

Criteria developed by the ACR.

(3) Diagnostic Radiologic Technologists (GS-0647 series) and Medical Instrument Technicians (GS-0649 series) are Hybrid Title 38 employees who are trained in the operation of equipment employing radiant energy for the purpose of diagnosis and treatment of the human body. Modalities of equipment operated by DRTs include radiography, mammography, fluoroscopy, DXA, ultrasound, CT, and MRI. Technologists act under the supervision of a radiologist. Using protocols determined by the radiologist, the technologist is responsible for patient identification and safety screening, explanation of the procedure to the patient, proper shielding and positioning, selection of technical acquisition factors, and initial quality control of images. Technologists may administer contrast agents under the direct supervision of a physician. Technologists may start peripheral intravenous lines for the purpose of contrast administration if they have undertaken training to do so, or have graduated from an American Registry of Radiologic Technologists (ARRT) recognized program that includes intravenous access in its curriculum, and have demonstrated competency by a period of proctoring.

(4) All radiology staff is required to complete the annual Radiation safety training assigned by the Talent Management Coordinator.

c. Qualification of Generator:

(1) A new generator shall not be used until a radiation analysis of the generator has been made by the Medical Physicist. The Medical Physicist will also evaluate the adequacy of the room which will house this machine. The Administrative Officer of the using service shall schedule, with the Medical Physicist, a time for the radiation analysis prior to routine use. Such radiation analysis will normally include:

(a) Quantity and quality of the primary radiation produced for the usual operating modes.

(b) The quantity of scattered radiation produced during proposed typical operating modes with quality measurements in some instances.

(c) The quantity of leakage radiation outside the primary beam.

(d) The adequacy of protective measures, such as lead shielding, primary beam backstops, angulation restrictions, and interlocks.

(e) Evidence of proper operation of timer, rectifiers, and contactor.

(2) The Medical Physicist shall be called by the Administrative Officer of the using service to evaluate the radiation circumstances following the change of an x-ray tube or any alteration that may affect the radiation output of the machine.

(3) The Medical Physicist shall normally perform a routine radiation analysis for each generator annually.

(4) Special restrictions. Depending on the particular utilization of the RGE, there normally will be some special protective requirements. Examples:

(a) Non-portable equipment will be installed in a designated radiation area.

(b) The walls and doors to the area will receive adequate radiation protection as determined by specific designs.

(c) Fluoroscopes will be equipped with exposure limitation timers which may be set for a time not exceeding five minutes.

(d) Portable lead screens may be required.

(e) Personal shielding, in addition to lead aprons, may be required.

(5) The responsibilities of the DRTs will include maintaining compliance with these regulations. All DRT staff must remain current with their ARRT certification.

d. General Conditions:

(1) Personnel Dosimeters:

(a) All radiation workers will wear radiation dosimeters when required by the RSO. The determination will be based on the potential for radiation doses in excess of 10% of radiation-dose limits.

(b) These dosimeters will be changed at a frequency determined by the RSO and the OKC VA HCS Radiation Safety Committee. It is the responsibility of individuals who are assigned dosimeters to wear, store, and return them properly.

(2) Equipment configuration:

(a) The available collimating devices on the RGE will be used to minimize the field size to that which is appropriate for the required exposure.

(b) The RGE will not be operated in any normal situation without an added filter equivalent to at least 2 mm of aluminum.

(3) Portable equipment: When portable equipment is used in patient areas, the adjacent patients shall be protected from the direct beam and from scatter by the use of portable screens, or the patient to be radiographed shall be moved away from other patients.

(4) General radiographic equipment operation:

(a) The radiographic generator operator shall close the doors of the radiographic room before an exposure is made.

(b) Personnel in the radiation room shall be limited to a minimum number consistent with the performance of the required exposures. Under ordinary circumstances, the workers occupationally exposed to radiation shall not restrain the patient within the direct x-ray beam during x-ray exposure. Any person assisting the patient during x-ray exposure shall wear a lead apron.

e. Operation of Fluoroscopic Apparatus: Only qualified physicians with documented training in the use of fluoroscopy equipment shall operate fluoroscopy equipment in the examination of patients.

(1) Personnel in the radiation room shall be limited to the minimum number consistent with the performance of the required exposures.

(2) All persons in the radiation room during the time of such exposures shall wear leaded aprons unless a portable lead screen is provided for protection during exposures.

(3) When the hands of a fluoroscopist must be near the useful beam, leaded gloves are recommended.

f. Special Situations Coordinated through the Administrative Officer of the using service:

(1) On request, the Medical Physicist will evaluate the exposure situation for any individual procedure, new or otherwise.

(2) On request, the Medical Physicist will evaluate proposed changes from the normal situation, such as reducing the amount of added filtration for unusual requirements.

g. Emergencies:

(1) In the event of external emergencies such as fire or earthquake, operation should be terminated at least during the interval of the emergent situation. If there is any reason to believe the equipment has been affected, the Medical Physicist should be consulted before returning the equipment to normal use.

(2) In the event of any unusual circumstances, notify the Medical

Physicist for radiation evaluation or Engineering Service for equipment repair.

4. Qualifications for Operating Fluoroscopy Equipment: Personnel who operate fluoroscopes for imaging of patients are divided into two groups: physicians who may both operate the equipment and supervise non-physicians in the operation of fluoroscopes, and non-physicians who may operate fluoroscopes only under the direct supervision of a physician. The physician and non-physician requirements are outlined in paragraph 6 of VHA Handbook 1105.04.

a. Qualifications for Staff Physicians. A staff physician must have completed the training requirements detailed in paragraph 5 in order to perform fluoroscopy, or to directly supervise qualified non-physician personnel in the operation of a fluoroscope.

b. Qualifications for Resident Physicians. A resident physician may operate a fluoroscope, or may directly supervise qualified non-physician personnel in the operation of a fluoroscope, provided that the resident physician has completed fluoroscopy safety training as defined by the residency program, and is supervised, directly or indirectly, by an attending physician who is privileged in fluoroscopy and who checks each study as specified by the facility resident supervision policy.

Procedures that always require direct supervision of the resident for radiation safety purposes include any that have potential to exceed a skin dose of 3 Gy. Examples of potentially high-dose procedures are:

(1) Cardiac catheterization;

(2) Radiofrequency cardiac catheter ablation;

(3) Vascular embolization;

(4) Stent and filter placement;

(5) Thrombolytic and fibrinolytic procedures;

(6) Percutaneous transhepatic cholangiography;

(7) Endoscopic retrograde cholangiopancreatography;

(8) Transjugular intrahepatic portosystemic shunt;

(9) Percutaneous nephrostomy;

(10) Biliary drainage; or

(11) Urinary or biliary stone removal.

c. Qualifications for Diagnostic Radiologic Technicians (DRTs). A

Diagnostic Radiologic Technologist (DRT), General Schedule (GS) 647, may operate a fluoroscope under the direct supervision of a fluoroscopy-trained physician, but may not independently operate fluoroscopic equipment.

d. Qualifications for Catheterization Medical Instrument Technician

(CCMIT). A Cardiac Catheterization Medical Instrument Technician (CCMIT), GS-649, may operate a fluoroscope during a cardiology procedure under the direct supervision of a fluoroscopy-trained cardiologist, but may not independently operate fluoroscopic equipment.

e. Qualifications for Therapeutic Radiologic Technologists (TRT). A

Therapeutic Radiologic Technologist (TRT), GS-648, may operate a fluoroscope during a radiotherapy simulation procedure under the direct supervision of a fluoroscopy-trained radiation oncologist, but may not independently operate fluoroscopic equipment.

f. Qualifications for Registered Nurses (RNs), Nurse Practitioners (NPs), and Physician Assistants (PAs). Registered nurses, nurse practitioners, and physician assistants may operate fluoroscopes provided they have completed the training requirements detailed in paragraph 7, if the procedure is within their area of competency, and under the direct supervision of a physician trained in fluoroscopy.

Examples include, but are not limited to:

(1) A nurse in the operating room who positions and collimates a portable fluoroscope during a surgical procedure under the direction of a fluoroscopy-trained surgeon; or

(2) A nurse assigned to the gastrointestinal medicine service who centers a fluoroscopy tower and turns on the beam under the direction of a fluoroscopy trained gastroenterologist.

g. Qualifications for Diagnostic Medical Physicists and Health Physicists. A diagnostic medical physicist or medical health physicist is qualified to perform quality assurance testing of all fluoroscopes. A therapeutic medical physicist is qualified to perform quality assurance testing of fluoroscopes used in radiation oncology. NOTE:

Board certification is strongly recommended for physicists who perform quality assurance testing.

5. Safety Training:

a. Training of Physicians

(1) Each physician who operates or directs the operation of fluoroscopic equipment for a medical procedure must be trained in fluoroscopy operation and safety to include: didactic lessons, hands-on-operation, and clinical operation under a preceptor physician.

(2) Didactic training need not be performed at or by the VA medical facility, provided that the trainee demonstrates: evidence of the date(s) of training; the name(s) of the person(s) providing the training; the topics included in the training; the duration of the training; the test questions, if available; and evidence of successful completion. Didactic training must include the following topics, with successful completion of a written examination:

operation;

image quality;

(a) Physics of x-ray production and interaction;

(b) The technology of fluoroscopy machines, including modes of

(c) Characteristics of image quality and technical factors affecting

(d) Dosimetric quantities and units;

(e) Biological effects of radiation;

(f) Principles of radiation protection in fluoroscopy;

(g) Applicable Federal regulations and VHA requirements; and

(h) Techniques for minimizing dose to the patient and staff.

(3) Hands-on training ideally needs to be conducted on the model of fluoroscope that is to be used. Training needs to encompass the use of controls, activation of various modes of operation, and displays. This phase of training may include: demonstrations of the effect of different modes of operation on the dose rate to a simulated patient, and may include demonstration of the dose-rates at various locations in the vicinity of the fluoroscope. NOTE: Practitioners who regularly operate a fluoroscope at the time this policy is issued are considered to have met the requirements for hands-on and preceptor training.

(4) Preceptor training consists of operation of the fluoroscope for clinical purposes under the supervision of a physician experienced in the operation of the device. Completion of this phase of training must include written confirmation, signed by the preceptor physician, that the individual has achieved a level of competency sufficient to function independently as a fluoroscopy operator. NOTE:

Practitioners who regularly operate a fluoroscope at the time this policy is issued are considered to have met the requirements for hands-on and preceptor training.

(5) When considering the recommendation of privileges for a medical procedure that requires fluoroscopy, the Executive Committee of the Medical Staff (ECMS) must determine whether the physician’s training meets these requirements.

The ECMS may seek the opinion of an expert, such as the RSO, a medical physicist, or the Chief of Radiology in performing this task. NOTE: In many medical facilities, the Professional Standards Board, the Medical Executive Committee, or the Clinical Executive Board is designated to act as the ECMS.

(6) Training need only be undertaken once for purposes of meeting the requirements of this Handbook. However, this Handbook does not limit the ability of facility officers to prescribe additional training as is deemed necessary.

(7) Reasons for additional training could include, but are not limited to: If adoption of new fluoroscopic technology, high personal dosimetry approaching regulatory limits (see subpar. 8b of VHA Handbook 1105.04), observation of poor practices, resumption of fluoroscopic procedures after a long period of inactivity, or need for periodic courses to refresh skills.

b. Training of Non-physicians

(1) Non-physician personnel who operate fluoroscopic equipment must undertake didactic, hands-on, and preceptor training. Training requirements for non-physicians differ from physicians only in that the preceptor may be either a physician privileged in fluoroscopy, or a DRT or a CCMIT who is trained to operate a fluoroscope.

(2) The medical facility Director must designate a qualified person(s) to evaluate whether training, received at the facility or elsewhere, meets these requirements.

(a) This individual will ordinarily be the RSO, a medical physicist, or the Chief of Radiology Service. This individual must issue a signed and

163038 dated form or memorandum stating the employee is qualified to operate fluoroscopes.

Technologists who are American Registry of Radiologic Technologists (ARRT) certified in radiography or radiation therapy, or who are registered cardiovascular invasive specialists with Cardiovascular Credentialing International are considered to have met the didactic portion of the training requirement.

(b) Training need only be undertaken once for purposes of meeting the requirements of VHA Handbook 1105.04. However, the Handbook does not limit the ability of facility officers to prescribe additional training as is deemed necessary.

6. Definition: As used herein, radiation-generating equipment (RGE) refers to ionizing radiation. If the generation is by electronic means, tube potentials of 5 KVP and higher are included. Mode of utilization includes: calibration, research, fluoroscopy, therapy, and roentgenography.

7. References:

VHA Handbook 1100.19, Credentialing and Privileging DRT Qualification Standards can be found in VA Handbook 5005/15, Part II, Appendix G25 VHA Handbook 1105.04: Fluoroscopy Safety

8. Follow-up Responsibility: Radiation Physicist; RSO (114)

9. Renewal Date: March 1, 2021

Kristopher W.

Digitally signed by Kristopher W. Vlosich

163038

DN: dc=gov, dc=va, o=internal, ou=people, 0.9.2342.19200300.100.1.1=kristopher.vlosi

Vlosich 163038 ch@va.gov, cn=Kristopher W. Vlosich

Date: 2017.03.01 12:46:44 -06'00'

Kristopher Wade Vlosich Health Care System Director http://vaww1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1806 http://vaww1.va.gov/ohrm/Directives-Handbooks/Documents/5005-15.pdf