Okla. Admin. Code § 252:410-11-1

Current through Vol. 41, No. 19, June 17, 2024

Section 252:410-11-1 - General provisions and description

(a)Scope. This Subchapter establishes requirements for the use of radiation machines (x-ray systems and particle accelerators) for therapeutic purposes in the healing arts and in the practice of veterinary medicine.

(b)Applicability. The requirements of this Subchapter apply to any person who possesses a therapeutic system described in subsection (a) of this section and causes radiation to be produced through the operation or testing of the machine in the state.

(c)Authorization required. No persons subject to this Subchapter may perform any radiation management activity with such a therapeutic system unless:

(1) they hold a DEQ-issued radiation machine operating permit and have registered their system with DEQ;

(2) their therapeutic systems and management of radiation safety meet the applicable requirements of this Chapter; and

(3) they are supervised by a practitioner as defined in this section.

(d)Related requirements. Persons subject to this Subchapter are also subject to the general requirements of Subchapter 1, the permitting and registration requirements of Subchapters 3 and 7, the radiation protection standards in Subchapter 20, and all requirements of Subchapter 23.

(e)Definitions. As used in this Subchapter:

(1)"<1 MeV system" means a therapeutic system with energies of less than 1 MeV.

(2)"Pre-1989 system" means a therapeutic system manufactured prior to March 1, 1989.

(3)"Post-1989 system" means a therapeutic system manufactured on or after March 1, 1989.

(4)"Medical event" means any event, except for events resulting from a direct intervention by a patient or human research subject that could not have been reasonably prevented by the permittee, in which the administration of radiation therefrom results in either:

(A) a dose that differs from the prescribed dose by more than 0.05 Sv (5 rem) to an organ or tissue, or 0.5 Sv(50 rem) shallow dose equivalent to the skin; and

(i) the total dose or dosage delivered differs from the prescribed dosage by 20 percent or more or falls outside the prescribed dosage range; or

(ii) the fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 percent or more;

(B) a dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, o.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from an administration of a dose or dosage to the wrong individual or human research subject; or

(C) a dose to the skin or an organ or tissue other than the treatment site that exceeds by 0.5 Sv (50 rem) to an organ or tissue and 20 percent the dose expected from the administration defined in the prescribed dose.

(5)"Practitioner" means an individual who is licensed by either the State Board of Medical Licensure and Supervision or the State Board of Osteopathic Examiners to practice medicine and surgery or by the State Board of Veterinary Medicine Examiners to practice veterinary medicine. This licensed individual may delegate the task of applying radiation for purposes of therapy to others who are not so licensed but shall maintain control over and retain full responsibility for all radiation applications.

(6)"Prescribed dose" means the localized therapeutic dose to be delivered as described in the treatment plan.

(7)"System of 1 MeV or more" means a therapeutic system with energies of one MeV or more.

(8)"Therapeutic system" means an x-ray system or particle accelerator that produces x-rays and/or particles used for therapeutic purposes in the healing arts and in the practice of veterinary medicine.

(9)"Treatment Plan" means an authorized practitioner's order for the administration of therapeutic radiation as specified in OAC 252:410-11-2(b).

Okla. Admin. Code § 252:410-11-1

Added at 17 Ok Reg 1136, eff 6-1-00; Amended at 29 Ok Reg 672, eff 7-1-12