216 R.I. Code R. 216-RICR-40-20-5.3

Current through December 26, 2024

Section 216-RICR-40-20-5.3 - General Administrative Requirements for Facilities Using Therapeutic Radiation Machines

5.3.1Administrative Controls

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

5.3.2Prohibition on Use

A therapeutic radiation machine which does not meet the provisions of this Part or has not received U.S. Food and Drug Administration (FDA) clearance or premarket approval, must not be used for irradiation of patients/human research subjects.

5.3.3Qualification Requirements for Therapeutic Radiation Machine Authorized Physicians

A. The registrant for any therapeutic radiation machine subject to §§ 5.6, 5.7, 5.8, 5.12 or 5.13 of this Part must require the Authorized Physician to be:

1. Currently certified in:

a. Radiation Oncology by the American Board of Radiology (ABR); or

b. Radiation Oncology by the American Osteopathic Board of Radiology(AOBR); or

c. Radiation Oncology by the Royal College of Physicians and Surgeons of Canada.

5.3.4Qualification Requirements for Medical Physicist

A. The registrant for any therapeutic radiation machine subject to §§ 5.6, 5.7, 5.8, 5.12 or 5.13 of this Part must require the Qualified Medical Physicist to:

1. Be registered with the Agency, under the provisions of Part 3 of this Subchapter, as a provider of clinical radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and

2. Be currently certified by the American Board of Radiology in:

a. Therapeutic Radiological Physics; or

b. Radiological Physics; or

c. Therapeutic Medical Physics; or

3. Be currently certified by the American Board of Medical Physics in Radiation Oncology Physics; or

4. Be currently certified by the Canadian College of Physicists in Medicine (CCPM) in Radiation Oncology Physics.

5.3.5Qualifications of Operators

A. Individuals who will be operating a therapeutic radiation machine for medical use must possess a current license as a Radiation Therapist in accordance with Subchapter 05 Part 34 of this Chapter, Licensure of Radiographers, Nuclear Medicine Technologists, and Radiation Therapists, unless the individual is specifically exempted from licensure by said Regulations.

B. The names and training of all personnel currently operating a therapeutic radiation machine must be kept on file at the facility. Information on former operators must 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.

5.3.6Written Safety Procedures

Written safety procedures, Rules, and posted emergency procedure must be developed by a radiation oncology safety team and must 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 must be able to demonstrate familiarity with these safety procedures, rules, and emergency procedures.

5.3.7Exposure Prohibited

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

5.3.8Visiting Authorized Physician

A. A registrant may permit any physician to act as a Visiting Authorized Physician under the term of the registrant's Certificate of Registration for up to sixty (60) days per calendar year under the following conditions:

1. The Visiting Authorized Physician 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

2. The Visiting Authorized Physician meets the requirements established for Authorized Physician(s) in §5.3.3 of this Part; and

3. The registrant must maintain copies of the written permission required in §5.3.8(A)(1) of this Part and documentation that the Visiting Authorized Physician met the requirements of §5.3.8(A)(2) of this Part for five (5) years from the date of the last visit.

5.3.9Quality Management Program Training

All individuals associated with the operation of a therapeutic radiation machine must be instructed in and must comply with the provisions of the registrant's safety assessment program, radiation protection program, and quality management program. In addition to the requirements of this Part, these individuals are also subject to the requirements of §§1.7.1, 1.7.5 and 1.10.3 of this Subchapter.

5.3.10Information and Maintenance Record and Associated Information

A. The registrant must maintain the following information in an auditable form in a separate file or package for each therapeutic radiation machine, for inspection by the Agency:

1. Report of acceptance testing and commissioning.

2. Records of all shielding designs and surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by this Part, as well as the date(s) and name(s) of person(s) who performed such activities.

3. Records of maintenance and/or modifications performed on the therapeutic radiation machine as well as the date(s) and name(s) of person(s) who performed such services.

4. Record of the approval process for authorizing the return of the therapeutic radiation machine to clinical use after service, repair, or upgrade, as determined by the radiation oncology safety team.

5.3.11Records Retention

All records required by this Part must be retained until disposal is authorized by the Agency unless another retention period is specifically authorized in this Part. All required records must be retained in an auditable form 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 archived as long as a complete copy of said record can be retrieved until such time as the Agency authorizes final disposal.

5.3.12Report and Notification of a Dose to an Embryo/Fetus

A. A registrant must report any dose to an embryo/fetus that is greater than fifty (50) mSv (five (5) rem) dose equivalent that is a result of an administration of radiation to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the prescribing physician.

B. The registrant must notify the Agency by telephone no later than the next calendar day after discovery of a dose to the embryo/fetus that requires a report in §5.3.12(A) of this Part.

C. The registrant must submit a written report to the Agency within fifteen (15) days after discovery of a dose to the embryo/fetus that requires a report in §5.3.12(A) of this Part.

1. The written report must include:

a. The registrant's name and registration number;

b. The name of the prescribing physician;

c. A brief description of the event;

d. Why the event occurred;

e. The effect, if any, on the embryo/fetus;

f. What actions, if any, have been taken or are planned to prevent recurrence; and

g. Certification that the registrant notified the pregnant individual or mother (or the mother's responsible relative or guardian), and if not, why not.

2. The report must not contain the individual's or child's name or any other information that could lead to identification of the individual.

D. The registrant must provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than twenty-four (24) hours after discovery of an event that would require reporting under §§5.3.12(A) of this Part, unless the referring physician personally informs the registrant either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. The registrant is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within twenty-four (24) hours, the registrant must make the appropriate notifications as soon as possible thereafter. The registrant may not delay any appropriate medical care for the embryo/fetus, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother. If an oral notification is made, the registrant must inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the registrant upon request. The registrant must provide such a written description if requested.

E. A registrant must:

1. Annotate a copy of the report provided to the Agency with the:

a. Name of the pregnant individual who is the subject of the event; and

b. Identification number or if no other identification number is available, the social security number of the pregnant individual who is the subject of the event; and

2. Provide a copy of the annotated report to the referring physician, if other than the registrant, no later than fifteen (15) days after the discovery of the event.

216 R.I. Code R. 216-RICR-40-20-5.3

Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/27/2023