Florida Regulations 64E-5.636: Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
Current as of: 2024 | Check for updates
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(1) Listed below are the safety and instruction requirements for a licensee:
(a) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;
(b) Permit only individuals approved by the authorized user, RSO, or authorized medical physicist to be present in the treatment room during treatment with the source(s);
(c) Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and,
(d) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include the following:
1. Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;
2. The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and,
3. The names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally.
(2) A copy of the procedures required by Fl. Admin. Code R. 64E-5.636(1)(d), of this section must be physically located at the unit console.
(3) A licensee shall post instructions at the unit console to inform the operator of the following:
(a) The location of the procedures required by paragraph (4)(a), of this rule; and,
(b) The names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally.
(4) A licensee shall provide instruction, initially and at least annually, to all individuals who operate the unit, as appropriate to the individual’s assigned duties, in the following:
(a) The procedures identified in Fl. Admin. Code R. 64E-5.636(1)(d), of this rule; and,
(b) The operating procedures for the unit.
(5) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.
(6) A licensee shall retain a record of individuals receiving instruction required by Fl. Admin. Code R. 64E-5.636(4), of this section. These records shall be maintained for 3 years and must include the list of topics covered, the date of the instruction, the name(s) of the attendee(s) and the name(s) of the individual(s) who provided the instruction.
(7) A licensee shall retain a copy of the procedures required by paragraphs 64E-5.636(1)(d) and 64E-5.636(4)(b), F.A.C., until the licensee no longer possesses the remote afterloader, teletherapy unit or gamma stereotactic radiosurgery unit.
Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 8-25-91, Formerly 10D-91.753, Amended 2-11-10.
(b) Permit only individuals approved by the authorized user, RSO, or authorized medical physicist to be present in the treatment room during treatment with the source(s);
(c) Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and,
(d) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include the following:
1. Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;
2. The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and,
3. The names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally.
(2) A copy of the procedures required by Fl. Admin. Code R. 64E-5.636(1)(d), of this section must be physically located at the unit console.
(3) A licensee shall post instructions at the unit console to inform the operator of the following:
(a) The location of the procedures required by paragraph (4)(a), of this rule; and,
(b) The names and telephone numbers of the authorized users, the authorized medical physicist, and the RSO to be contacted if the unit or console operates abnormally.
(4) A licensee shall provide instruction, initially and at least annually, to all individuals who operate the unit, as appropriate to the individual’s assigned duties, in the following:
(a) The procedures identified in Fl. Admin. Code R. 64E-5.636(1)(d), of this rule; and,
(b) The operating procedures for the unit.
(5) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.
(6) A licensee shall retain a record of individuals receiving instruction required by Fl. Admin. Code R. 64E-5.636(4), of this section. These records shall be maintained for 3 years and must include the list of topics covered, the date of the instruction, the name(s) of the attendee(s) and the name(s) of the individual(s) who provided the instruction.
(7) A licensee shall retain a copy of the procedures required by paragraphs 64E-5.636(1)(d) and 64E-5.636(4)(b), F.A.C., until the licensee no longer possesses the remote afterloader, teletherapy unit or gamma stereotactic radiosurgery unit.
Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History-New 8-25-91, Formerly 10D-91.753, Amended 2-11-10.