16 Del. Admin. Code § 4465-X-3.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4465-X-3.0 - General Administrative Requirements for Facilities Using Therapeutic Radiation Machines

3.1 Administrative Controls. The registrant shall be responsible for directing the operation of the therapeutic radiation machines that have been registered with the Agency. The registrant or the registrant's agent shall ensure that the requirements of Part X are met in the operation of the therapeutic radiation machine(s).

3.2 A therapeutic radiation machine that does not meet the provisions of these regulations shall not be used for irradiation of patients.

3.3 Training for Therapeutic Radiation Machine Authorized Users. The registrant for any therapeutic radiation machine subject to 6.0 or 7.0 shall require the authorized user to be a physician who:

3.3.1 Is certified in:

3.3.1.1 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; or

3.3.1.2 Radiation oncology by the American Osteopathic Board of Radiology; or

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

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

3.3.2 Is in the active practice of therapeutic radiology, and has completed 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.

3.3.2.1 To satisfy the requirement for instruction, the classroom and laboratory training shall include:

3.3.2.1.1 Radiation physics and instrumentation;

3.3.2.1.2 Radiation protection;

3.3.2.1.3 Mathematics pertaining to the use and measurement of ionization radiation; and

3.3.2.1.4 Radiation biology.

3.3.2.2 To satisfy the requirement for supervised work experience, training shall be under the supervision of an authorized user and shall include:

3.3.2.2.1 Review of the full calibration measurements and periodic quality assurance checks;

3.3.2.2.2 Evaluation of prepared treatment plans and calculation of treatment times/patient treatment settings;

3.3.2.2.3 Using administrative controls to prevent misadministrations;

3.3.2.2.4 Implementing emergency procedures to be followed in the event of the abnormal operation of an external beam radiation therapy unit or console; and

3.3.2.2.5 Checking and using radiation survey meters.

3.3.2.3 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:

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

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

3.3.2.3.3 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

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

3.3.3 Notwithstanding the requirements of subsections 3.3.1 and 3.3.2 the registrant for any therapeutic radiation machine subject to 6.0 may also submit the training of the prospective authorized user physician for Agency review on a case-by-case basis.

3.3.4 A physician shall not act as an authorized user for any therapeutic radiation machine until such time as said physician's training has been reviewed and approved by the Agency.] ^{2 */}

3.4 Training for Qualified Medical Physicist. The registrant for any therapeutic radiation machine subject to 6.0 or 7.0 shall require the Qualified Medical Physicist to:

3.4.1 Be registered with the Agency, under the provisions of Part B of these regulations, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and

3.4.2 Be certified by the American Board of Radiology in:

3.4.2.1 Therapeutic medical physics; or

3.4.2.2 Diagnostic medical physics; or

3.4.2.3 Nuclear medical physics; or

3.4.2.4 Radiological physics; or

3.4.2.5 Be certified by the American Board of Medical Physics in Radiation Oncology Physics; or

3.4.2.6 Be certified by the Canadian College of Medical Physics; or

3.4.2.7 Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university, and have completed one (1) year of full time training in medical physics and an additional year of full time work experience under the supervision of a Qualified Medical Physicist at a medical institution. This training and work experience shall be conducted in clinical radiation facilities that provide high-energy external beam radiation therapy (photons and electrons with energies greater than or equal to one MV/one MeV). To meet this requirement, the individual shall have performed the tasks listed in 4.1, 6.16, 7.20 and 6.16, 7.21 under the supervision of a Qualified Medical Physicist during the year of work experience. 3.4.3 Notwithstanding the provisions of 3.4.2.7 certification pursuant 3.4.2, 3.4.2.5 and/or 3.4.2.4 shall be required on or before, for all persons currently qualifying as a Qualified Medical Physicist pursuant to 3.4.2.7 ^{3 */}

3.5 Qualifications of Operators.

3.5.1 Individuals who will be operating a therapeutic radiation machine for medical use shall be state certified, American Registry of Radiologic Technologists (ARRT) registered Radiation Therapists.^{4 /}

3.5.2 The names and training of all personnel currently operating a therapeutic radiation machine shall be kept on file at the facility. Information on former operators shall be retained for a period of at least two (2) years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.]

3.6 Written safety procedures and rules shall be developed by a Qualified Medical Physicist and shall be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator shall be able to demonstrate familiarity with these rules.

3.7 Individuals shall not be exposed to the useful beam except for medical 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.

3.8 Visiting Authorized User. Notwithstanding the provisions of 3.7 a registrant may permit any physician to act as a visiting authorized user under the term of the registrant's Certificate of Registration for up to sixty (60) days per calendar year under the following conditions:

3.8.1 The visiting authorized user has the prior written permission of the registrant's management and, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee (where applicable); and

3.8.2 The visiting authorized user meets the requirements established for authorized user(s) in 3.3.1 and 3.3.2 and

3.8.3 The registrant shall maintain copies of the written permission required in 3.8.1 and documentation that the visiting authorized user met the requirements of 3.8.2 for five (5) years from the date of the last visit.

3.9 All individuals associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with the provisions of the registrant's quality management program. In addition to the requirements of Part X, these individuals are also subject to the requirements of Part D, Sections 45.0, 17.0, and 37.0 of these regulations.

3.10 Information and Maintenance Record and Associated Information. The registrant shall maintain the following information in a separate file or package for each therapeutic radiation machine, for inspection by the Agency:

3.10.1 Report of acceptance testing;

3.10.2 Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by Part X, as well as the name(s) of person(s) who performed such activities;

3.10.3 Records of maintenance and/or modifications performed on the therapeutic radiation machine, as well as the name(s) of person(s) who performed such services;

3.10.4 Signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.

3.11 Records Retention. All records required by Part X shall be retained until disposal is authorized by the Agency unless another retention period is specifically authorized in Part X. All required records shall be retained in an active file from at least the time of generation until the next Agency inspection. Any required record generated prior to the last Agency inspection may be microfilmed or otherwise archived as long as a complete copy of said record can be retrieved until such time as the Agency authorizes final disposal.

² */ Statutory language may be required to implement these sections of the regulation.

³ */ Statutory language may be required to implement these sections of the regulation.

⁴ /"Standards for an Accredited Educational Program in Radiologic Sciences", Joint Review Committee on Education in Radiologic Technology, 2001.

16 Del. Admin. Code § 4465-X-3.0

16 DE Reg. 1274 (6/1/2013)
22 DE Reg. 401( 11/1/2018) (Final)