S.C. Code Regs. § § 61-64.VI.RHB 6.3

Current through Register Vol. 48, No. 9, September 27, 2024

Section 61-64.VI.RHB 6.3 - General Provisions for all Therapeutic Equipment

6.3.1 Radiation Safety Officer.

6.3.1.1 The registrant shall designate an individual who will be responsible for radiation protection for the therapeutic equipment. Such individual may be a radiological physicist, and shall:

6.3.1.1.1 Be qualified by training and experience concerning all hazards and precautions involved in operating the therapeutic equipment for which he or she is responsible;

6.3.1.1.2 Recommend a detailed program of radiation safety for effective compliance with the applicable requirements of this regulation;

6.3.1.1.3 Give instructions concerning hazards and safety practices to individuals who may be exposed to radiation from the therapeutic equipment; and

6.3.1.1.4 Ensure surveys are performed and carry out other procedures as required by this regulation.

6.3.1.2 Each therapeutic machine shall be under the administrative control of the Radiation Safety Officer, who will be responsible for the safe operation of the equipment.

6.3.2 Procedures.

6.3.2.1 Written operating procedures as well as specified safety rules shall be established for each therapeutic unit facility and approved by the Radiation Safety Officer.

6.3.2.1.1 Operating procedures. The written operating procedures to be implemented shall include the following:

6.3.2.1.1.1 Policies and procedures for pregnant workers;

6.3.2.1.1.2 Policies and procedures for personnel monitoring;

6.3.2.1.1.3 Policies and procedures for training new employees;

6.3.2.1.1.4 Policies and procedures for identifying and reporting misadministrations; and

6.3.2.1.1.5 Policies and procedures for quality assurance addressing annual equipment performance testing on radiation therapy simulators and CT scanners used for treatment planning.

6.3.2.1.2 Emergency Procedures. The emergency procedures shall include instructions for contacting the therapeutic radiological physicist when operational problems or emergencies occur and the actions that are to be taken until the physicist can be contacted.

6.3.2.2 Operators and maintenance personnel shall be familiar with and have available a copy of the written operating and emergency procedures. Documentation must be maintained indicating that the operator or maintenance person has read and agrees to adhere to the operating procedures.

6.3.3 Operator Requirements and Training.

6.3.3.1 The registrant shall assure that all therapeutic equipment under his or her control is operated only by a radiation therapist possessing a current, valid certificate from the South Carolina Radiation Quality Standards Association. For the purpose of this Part, a radiation therapist is defined as a person who applies radiation to humans for therapeutic purposes; performs treatment setups, including, but not limited to, patient positioning, setting of treatment parameters on the control panel, and verification of treatment accessories; or documents daily treatments for a patient's chart.

6.3.3.2 In-house modification, repairs, or preventative maintenance on therapeutic equipment components or safety interlocks may be performed only by or under the direct supervision of persons who have received at least the minimum training specified in RHB 6.3.3.12 and demonstrated competence specified in RHB 6.3.3.13.

6.3.3.3 No person other than a licensed practitioner or a radiation therapist possessing a current, valid certificate from the South Carolina Radiation Quality Standards Association shall use equipment emitting ionizing radiation on humans for therapeutic purposes.

6.3.3.4 No person shall employ or designate as a radiation therapist a person who does not hold a certificate issued by the South Carolina Radiation Quality Standards Association.

6.3.3.5 No person holding a certificate issued by the South Carolina Radiation Quality Standards Association shall use equipment emitting ionizing radiation on humans for therapeutic purposes unless under the direction and supervision of a licensed practitioner and unless so directed by prescription of a licensed practitioner.

6.3.3.6 No person who is not certified by the South Carolina Radiation Quality Standards Association shall take, use, or exhibit the title of "limited practice radiographer," "radiographer," "radiation therapist," or any other title, sign, display, or declaration that tends to lead the public to believe that the person is authorized to apply ionizing radiation on humans for therapeutic purposes.

6.3.3.7 A student enrolled in and attending a school or college of medicine, radiologic technology, radiation therapy, or a curriculum approved by the South Carolina Radiation Quality Standards Association, or a resident in an approved graduate education program of medicine may apply ionizing radiation to humans without a certificate from the South Carolina Radiation Quality Standards Association, as long as the student or resident is under the direct supervision of a licensed practitioner or direct supervision of a certified radiation therapist appropriately trained to supervise the specific procedure.

6.3.3.8 The registrant shall display each operator's current certificate in public view, not obstructed by any barrier, equipment, or other object. The registrant may also post a notice to the public that South Carolina Radiation Quality Standards Association certificates are available for review upon request.

6.3.3.9 The registrant shall ensure that each operator has received training specific to the equipment and procedures in use at his or her facility, including machine specific training, use of personnel monitoring devices, quality assurance procedures, and the operating procedures required by RHB 6.3.2. Documentation of this training for each operator shall be made available for Departmental review.

6.3.3.10 The registrant shall ensure all operators receive at least one (1) month of on-the-job training before assuming operational responsibility. Documentation of training shall include, at a minimum, the date the operator was assigned therapeutic responsibility; the training completion date; and topics covered in training.

6.3.3.11 The registrant shall maintain a record of all training for each operator. Such records shall be made available for Departmental inspection. Training records of former operators shall be retained for a period of at least two (2) years, or until the next Department inspection, whichever is later.

6.3.3.12 Training of in-house and test maintenance personnel shall include:

6.3.3.12.1 Fundamentals of Radiation Safety.

6.3.3.12.1.1 Characteristics of radiation.

6.3.3.12.1.2 Units of radiation dose.

6.3.3.12.1.3 Hazards of excessive exposure to radiation.

6.3.3.12.1.4 Levels of radiation from therapeutic equipment.

6.3.3.12.1.5 Methods used to prevent radiation exposure including shielding, interlocks, safety rules, and radiation monitoring equipment.

6.3.3.12.2 Use and care of personnel monitoring equipment employed at the facility.

6.3.3.12.3 Location and use of all operating controls.

6.3.3.12.4 Requirements of pertinent state regulations.

6.3.3.12.5 Registrant's written operating and emergency procedures.

6.3.3.13 In-house personnel who are to perform or directly supervise modifications, tests, or maintenance work shall demonstrate the following capabilities to the Radiation Safety Officer:

6.3.3.13.1 Ability to read and understand electrical diagrams.

6.3.3.13.2 A thorough knowledge of the principles and operation of the therapeutic equipment.

6.3.3.13.3 A thorough knowledge of the safety interlock system.

6.3.3.13.4 Ability to understand, use, and check the operation of radiation survey instruments.

6.3.3.14 The registrant shall maintain a record of all training for in-house testing and maintenance personnel. Such records shall be made available for Departmental inspection.

6.3.4 Training for Therapeutic Radiation Machine Authorized Users.

6.3.4.1 For any therapeutic radiation machine covered in Part VI the registrant shall require the authorized user to be a licensed practitioner who:

6.3.4.1.1 Is certified in:

6.3.4.1.1.1 Radiation oncology or therapeutic radiology by the American Board of Radiology, or Radiology (combined diagnostic and therapeutic radiology program) by the American Board of Radiology prior to 1976;

6.3.4.1.1.2 Radiation oncology by the American Osteopathic Board of Radiology;

6.3.4.1.1.3 Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology";

6.3.4.1.1.4 Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

6.3.4.1.2 Is in the active practice of therapeutic radiology and has completed two hundred (200) hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit, five hundred (500) hours of supervised work experience, and a minimum of three (3) years of supervised clinical experience.

6.3.4.1.2.1 To satisfy the requirement for instruction, the classroom and laboratory training shall include radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of ionization radiation, and radiation biology.

6.3.4.1.2.2 To satisfy the requirement for supervised work experience, training shall be under the supervision of an authorized user and shall include review of the full calibration measurements and periodic quality assurance checks, evaluation of prepared treatment plans and calculation of treatment times/patient treatment settings, using administrative controls to prevent misadministrations, implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console, and checking and using radiation survey meters.

6.3.4.1.2.3 To satisfy the requirement for a period of supervised clinical experience, training shall include one (1) year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two (2) years of clinical experience in therapeutic radiology under the supervision of an authorized user. The supervised clinical experience shall include:

6.3.4.1.2.3.1 Examining individuals and reviewing their case histories to determine their suitability for external beam radiation therapy treatment, and any limitations/contraindications;

6.3.4.1.2.3.2 Selecting proper dose and how it is to be administered;

6.3.4.1.2.3.3 Calculating the therapeutic radiation machine doses and collaborating with the authorized user in the review of patients' progress and consideration of the need to modify originally prescribed doses and/or treatment plans as warranted by patients' reaction to radiation; and

6.3.4.1.2.3.4 Post-administration follow-up and review of case histories.

6.3.4.2 The registrant shall maintain a record of all training for each authorized user. Such records shall be made available for Departmental inspection.

6.3.5 Control.

6.3.5.1 The Radiation Safety Officer shall maintain a current list of all personnel who are qualified to service the therapeutic equipment.

6.3.5.2 No registrant shall permit a therapeutic unit to operate at any time with a safety interlock bypassed, except for necessary testing.

6.3.5.3 The accelerator shall not be used for treatment of patients unless the operator can maintain visual observation of the patient and audible communication with the patient.

6.3.5.4 No individual other than the patient shall be in the therapy room during irradiation.

6.3.5.5 Individuals shall not be exposed to the useful beam except for therapy purposes and unless such exposure has been ordered in writing by a therapeutic radiation machine authorized user. This provision specifically prohibits deliberate exposure of an individual for training, demonstration, or other non-healing-arts purposes.

6.3.6 Technique indicators. Instrumentation readouts and controls on the therapy control console must be clearly identified and easily discernable.

6.3.7 The accelerator is used in such a manner that patients, workers, and the general public are protected from radiation hazards and the provisions of Part III of this regulation are met.

6.3.8 No therapeutic machine shall be left unattended unless it is secured against unauthorized use.

S.C. Code Regs. § 61-64.VI.RHB 6.3

Replaced and amended by State Register Volume 40, Issue No. 06, eff. 6/24/2016; State Register Volume 47, Issue No. 05, eff. 5/26/2023.