Permanent Final Adoptions
TITLE 252. Department of Environmental Quality
CHAPTER 410. Radiation Management
[OAR Docket #12-447]
RULEMAKING ACTION:
PERMANENT final adoption.
RULES:
Subchapter 3. Radiation Machines - Common Requirements
Part 3. Radiation Safety Management
252:410-3-33 [AMENDED]
Subchapter 11. Use of X-rays and/or Particles for Therapeutic Purposes in the Healing Arts and Veterinary Medicine
Part 1. General Provisions
252:410-11-1 [AMENDED]
252:410-11-2 [AMENDED]
252:410-11-4 [AMENDED]
Part 7. Radiation Safety Management
252:410-11-71 [AMENDED]
252:410-11-74 [AMENDED]
252:410-11-75 [AMENDED]
252:410-11-81 [AMENDED]
AUTHORITY:
Environmental Quality Board and Radiation Management Advisory Council powers and duties, 27A O.S. ยงยง 2-2-101, 2-2-104, 2-2-201, and 2-9-104
DATES:
Comment period:
September 1, 2011 through November 8, 2011.
Public hearing:
October 6, 2011 Radiation Management Advisory Council and November 15, 2011 Environmental Quality Board.
Adoption:November 15, 2011
Submitted to Governor:
November 21, 2011
Submitted to House:
November 21, 2011
Submitted to Senate:
November 21, 2011
Gubernatorial Approval:
December 21, 2011
Legislative Approval:
March 29, 2012Final Adoption:
March 29, 2012SUPERSEDED EMERGENCY ACTIONS:
N/AINCORPORATION BY REFERENCE:
N/AANALYSIS:
The proposed rulemaking amends Subchapter 11 rules regulating the used of radiation producing machines for therapeutic purposes in the healing arts. The term "medical event" is defined. Permittees are required to develop procedures to guard against medical events and similar incidents. Requirements for treatment planning simulators and other imaging equipment are updated to address newer technologies used in Oklahoma. The duration of certain record keeping requirements is increased to the life of the radiation machine permit. Changes have been proposed to the record keeping requirements in Subchapter 3 to complement those in Subchapter 11.
The Radiation Management Advisory Council voted to amend portions of the rules proposed by staff. These amendments allowed for electronic approval of treatment plans and clarified a separate document was not required to document the treatment plan. These amendments were in OAC 252:410-11-1(e)(9) and OAC 252:410-11-2(b).
CONTACT PERSON:
The contact person is Mike Broderick. He can be reached at mike.broderick@deq.ok.gov (e-mail), (405) 702-5100 (phone) or (405) 702-5101 (fax). The DEQ is located at 707 N. Robinson, Oklahoma City, Oklahoma 73102. The mailing address is P.O. Box 1677, Oklahoma City, Oklahoma 73101-1677.
PURSUANT TO THE ACTIONS DESCRIBED HEREIN, THE FOLLOWING RULES ARE CONSIDERED FINALLY ADOPTED AS SET FORTH IN 75 O.S., SECTION 308.1(A), WITH AN EFFECTIVE DATE OF JULY 1, 2012:
SUBCHAPTER 3. Radiation Machines - Common Requirements
PART 3. RADIATION SAFETY MANAGEMENT
252:410-3-33. Recordkeeping
(a) Subchapters 11 through 17. Unless exempted, persons subject to Subchapters 11, 13, 15 and/or 17 must maintain the following records:
(1) DEQ permit and registration documentation;
(2) a written radiation management program;
(3) written operating and emergency procedures which include restrictions required for the safe operation of each machine;
(4) *required records of surveys and survey reports;
(5) *survey instrument calibration records;
(6) computer verifications, repair, maintenance, corrective actions and modifications;
(7) machine manufacturer specifications and instructions,
(8) personnel monitoring records;
(9) a copy of all correspondence to and from DEQ regarding each machine; and
(10) training records giving dates, locations, topics and hours of both initial and refresher training, instructor names, sign-in sheets, a copy of each examination given, and examination scores.
(b) Additional requirements for Subchapter 11. Persons subject to Subchapter 11 must maintain the following additional records:
(1) a record of each medical event which identifies the date, operator, practitioner, radiological physicist and describes the incident and any corrective actions,
(2) records of leakage radiation measurements in accordance with 252:410-11-51;
(3) recorded maximum value of the absorbed dose rate as specified by the manufacturer for machine parameters in accordance with 252:410-11-64;
(43) *calibrations of machines and dosimetry systems in accordance with 252:410-11-73 and ,74 and 75;
(54) *spot-check measurements, qualified expert reviews and corrective actions taken to remedy identified deficiencies in accordance with 252:410-11-76;
(6) records of acceptance testing and initial surveys in accordance with 252:410-11-72;
(75) *records of maintenance and modifications; and
(86) A current copy of the following documents must be maintained at or in the area of the control panel:
(A) operating and emergency procedures;
(B) quality assurance and quality control plan;
(C) manufacturer specifications and instructions;
(D) record of the maximum value of the absorbed dose rate specified by the manufacturer for machine parameters;
(E) latest machine/system calibration; and
(F) records of the most recent spot-check measurements and qualified expert reviews.
(c) Additional requirements for Subchapter 15. Persons subject to Subchapter 15 must maintain the following additional *records:
(1) *records of daily system inspections and maintenance;
(2) utilization records;
(3) records of alarm system and entrance control checks;
(4) records of personnel monitoring;
(5) at each temporary job site, a copy of the operating and emergency procedures, applicable rules, latest survey records, records of equipment problems identified in daily checks at the temporary job site, and, when operating under reciprocity, a copy of the primary authorization or permit authorizing the use of the licensed machines, and for each survey instrument at each temporary job site, verification of current calibration.
(d) Additional requirements for Subchapter 17. Persons subject to Subchapter 17 must maintain the current electrical circuit diagrams of the particle accelerator and its safety interlock systems.
(e) Date and signature. Records marked with asterisks (*) must also contain the date and signature of the individual performing the service.
(f) Location. All records must be kept in the principal office of the permittee and made available for DEQ review.
(g) Duration. Records shall be kept for the duration specified in Subchapter 1.
SUBCHAPTER 11. Use of X-Rays and /Or Particles for Therapeutic Purposes in the Healing Arts and Veterinary Medicine
PART 1. GENERAL PROVISIONS
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, and the radiation protection standards in Subchapter 20the 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 licenseepermittee, 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 written directiveprescribed dose.
(5) "Practitioner" means an individual who is licensed by either the Oklahoma Board of Medical ExaminersState 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 in the healing arts of to practice veterinary sciencemedicine. 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.
(67) "System of 1 MeV or more" means a therapeutic system with energies of one MeV or more.
(78) "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).
252:410-11-2. Accountability for therapeutic systems used to treat humans
Permit applicants, whose therapeutic systems will be used to treat humans, must designate in the application the practitioners who will be in charge of the treatments and certify that the designees have had substantial training and experience in deep therapy techniques or in the use of therapeutic systems. Applicants shall also comply with 252:410-3-3, 3-31 and 3-32.
(a) Designation of authorized practitioners. Permit applicants, whose therapeutic systems will be used to treat humans, must designate in their application the practitioners who will supervise treatments and certify that those designees have had substantial training and experience in the therapy techniques for which they will be authorized.
(b) Treatment plan. A treatment plan in written or electronic form must be approved by an authorized practitioner before the initial administration of therapeutic radiation.
(1) The treatment plan must contain the patient's name, dose per fraction, number of doses, total dose, and sufficient information to accurately describe proper localization of the therapeutic dose.
(2) If, because of the emergent nature of the patient's condition, a delay in order to provide a treatment plan or revision to a treatment plan would jeopardize the patient's health, an oral directive is acceptable. The information in the oral directive must be documented in writing as soon as possible. A treatment plan must be prepared within 48 hours of the oral directive.
(3) Permittees shall retain records of each treatment plan for 3 years.
(c) Procedures for treatment planning and administration of therapeutic radiation. Permittees shall develop, implement and maintain written procedures to provide high confidence that:
(1) The patient's identity is verified before each administration; and
(2) Each administration of therapeutic radiation is in accordance with the treatment plan.
252:410-11-4. Operational requirements for practitioners; Medical event
Therapeutic system permittees shall notify DEQ by telephone of any treatment of a human which results in a medical event. Notice must be given no later than the next business day after the event and followed up with a written noticereport within 15 days after discovery of the medical event. The written report shall include the names of the permittee, the prescribing practitioner, the radiological physicist and the radiological technician, a brief description of the event, why the event occurred, the effect on the individual who received the treatment, what improvements are needed to prevent recurrence, actions taken to prevent recurrence, whether the permittee notified the individual or individual's responsible relative or guardian and if not, why, and if there was notification, what information was provided. Neither the notice or report shall identify the individual receiving the treatment by name.
PART 7. RADIATION SAFETY MANAGEMENT
252:410-11-71. Radiation protection plan
All radiation machine permitteestherapeutic system permittees and applicants shall comply with applicable requirements in Subchapter 3.
252:410-11-74. Calibrations of systems of 1 MeV or more
(a) Frequency. A system of 1 MeV or more must be calibrated before it is first used for irradiation of a patient and thereafter at least every 12 months and when any change occurs in the system which might significantly alter the calibration, spatial distribution, or other characteristics of the therapy beam.
(b) Protocol and procedures. The calibration of systems of 1 MeV or more shall be performed using an established calibration protocol acceptable to DEQ. One acceptable calibration protocol is entitled, "A Protocol for the Determination of Absorbed Dose from High-Energy Photon and Electron Beams," Task Group 21, Radiation Therapy Committee, American Association of Physicists in Medicine, Medical Physics 10(6): 741-771, Nov/Dec 1983."AAPM's TG-51 Protocol for Clinical Reference Dosimetry of high-energy photon and electron beams.", Medical Physics 26 (9): 1847-1890, Sept. 1999. If another protocol is used, the person performing the calibration needs to record the name and methods used in the calibration report. Upon review of the report, DEQ may require a copy of the protocol for review and/or may require that calibration be performed under another protocol.
(c) Performance. The calibration shall be performed under the direct supervision of a radiological physicist.
(d) Dosimetry system. Full calibration radiation measurements of systems of 1 MeV or more shall be performed with a dosimetry system that has:
(1) a calibration factor for cobalt-60 gamma rays traceable to a national standard;
(2) been calibrated within the previous two years and after any servicing that may have affected its calibration;
(3) been calibrated in such a fashion that an uncertainty can be stated for the radiation quantities monitored by the system; and
(4) had constancy checks performed on the system as specified by a radiological physicist.
(e) Precision. Calibrations shall be in sufficient detail that the dose at a reference point in soft tissue may be calculated to within an uncertainty of 5 percent.
(f) Outcome. The calibration of the therapy beam shall include but not be limited to:
(1) verification that the therapeutic system is operating in compliance with the design specifications concerning the:
(A) light localizer and back-pointer alignment with the isocenter when applicable,
(B) variation in the axis of rotation for the table, gantry and jaw system, and
(C) beam flatness and symmetry at the specified depth;
(2) the absorbed dose rate at various depths of water for the range of field sizes used, for each effective energy, that will verify the accuracy of the dosimetry of all therapy procedures utilized with that therapy beam;
(3) the uniformity of the radiation field to include symmetry and flatness;
(4) dependency of beam output on gantry angle;
(5) verification that existing isodose charts applying to the machine continue to be valid or are updated to existing machine conditions; and
(6) verification of transmission and electron buildup factors for all accessories such as wedges, shadow trays attached to the radiation head to support auxiliary beam blocking material, and compensators.
252:410-11-75. Treatment planning Simulators simulators and other imaging equipment used in the therapeutic process.
Simulators used for therapy treatment planning must be calibrated annually by a qualified expert. This calibration must include checks for the:
(1) accuracy of the TSD (target source distance) indicator;
(2) variation in the axis of rotation for the table gantry and jaw system;
(3) integrity of the isocenter; and
(4) degree of congruence of the radiation field with the field indicated by the localizing device, which must be within five millimeters of any field edge.
(a) Policies and procedures for imaging equipment. Therapeutic system permittees shall develop policies and procedures to ensure the proper operation of all imaging equipment used in the treatment planning or treatment process.
(b) Calibration of imaging equipment. Imaging equipment used for treatment planning and delivery must be calibrated annually by a qualified expert. This calibration must include:
(1) For conventional simulators:
(A) Collimator, gantry, and couch isocenter determination, and coincidence;
(B) verification of table positioning under typical patient load;
(C) high and low contrast resolution;
(D) imaging dose and
(E) all monthly and daily spot checks required by OAC 252:410-11-75(c).
(2) For CT simulators:
(A) Indexing and positioning accuracy under scanner control;
(B) gantry tilt indication accuracy and reproducibility;
(C) spatial and contrast resolution;
(D) imaging dose and
(E) all monthly and daily spot checks required by OAC 252:410-11-75(c).
(3) For other x-ray imaging equipment used in treatment planning or delivery:
(A) Beam quality and energy if applicable;
(B) imaging dose and
(C) all monthly and daily spot checks required by OAC 252:410-11-75(c).
(c) Periodic Spot Checks. Periodic spot checks are required to ensure that the previous calibration is still valid. Daily and Monthly Spot checks of imaging equipment may be performed by radiation therapy technologists, x-ray technologist or other similarly qualified personnel. Spot checks shall be reviewed by a qualified expert at least annually. These spot checks must include:
(1) Monthly checks for conventional simulators:
(A) Accuracy verification for field size, gantry and collimator angle, cross hair centering, and focal spot indicator;
(B) light field, radiation field coincidence and
(C) image quality.
(2) Daily checks for conventional simulators:
(A) Localizing laser alignment and
(B) distance indicator.
(3) Monthly checks for CT simulators:
(A) Orientation of gantry, wall and ceiling lasers with respect to imaging plane;
(B) orientation of CT table top with respect to imaging plane;
(C) table position indicator accuracy, reproducibility;
(D) x-ray field uniformity and
(E) CT number verification for 4 or more materials.
(4) Daily checks for CT simulators:
(A) Alignment of gantry lasers with imaging plane;
(B) CT number verification for water;
(C) image noise and
(D) in plane spatial integrity.
(5) Monthly checks for other x-ray imaging equipment used in treatment planning or delivery:
(A) Imaging and treatment coordinate system coincidence (four cardinal angles for planar imaging);
(B) scaling or geometric distortion and
(C) image quality.
(6) Daily checks for other x-ray imaging equipment used in treatment planning or delivery: Imaging and treatment coordinate system coincidence.
252:410-11-81. Records
Records required by this Subchapter shall be maintained as required by 252:410-1-4(b) and 252:410-3-33, except that records of calibration determinations required by 252:410-11-73 and 252:410-11-74 shall be maintained for five (5) years after completion of the full calibration. Records of manufacturer specified maximum dose rate, acceptance testing and initial surveys required in 252:410-11-64 and 252:410-11-72 must be maintained until the permit holder is no longer subject to radiation management requirements.
[OAR Docket #12-447; filed 4-25-12]