Section R12-1-611.01. Electronic Brachytherapy to Deliver Interstitial and Intracavity Therapeutic Radiation Dosage

A.      Electronic brachytherapy devices used to deliver interstitial

and intracavity therapeutic radiation dosage shall be subject to the requirements of this Section, and unless otherwise speci- fied in this Section shall be exempt from the requirements of R12-1-611.

1.        An electronic brachytherapy device that does not meet the requirements of this Section shall not be used for irra- diation of patients; and

2.        An electronic brachytherapy device shall only be utilized for human use applications specifically approved by the

U.S. Food and Drug Administration (FDA), unless partic- ipating in a research study approved by the registrant’s Institutional Review Board (IRB).

B.       Each facility location authorized to use an electronic brachytherapy device in accordance with this Section shall possess appropriately calibrated portable monitoring equip- ment. At a minimum, such equipment shall include a portable survey instrument capable of measuring dose rates over the range 10 μSv (1 mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instrument shall be capable of measuring as low as 10 μSv (1 mrem) per hour in the energy range of the electronic brachytherapy unit for which the survey instrument is to be used. Published correction factors utilized in conjunc- tion with the instrument’s readings may be used to achieve sensitivity. The survey instrument or instruments shall be operable and calibrated before first use, at intervals not to exceed 12 months, and after survey instrument repairs.

C.      Facility Design Requirements for Electronic Brachytherapy Devices. In addition to shielding adequate to meet require- ments of R12-1-603(C), the treatment room shall meet the fol- lowing design requirements:

1.        If applicable, provision shall be made to prevent simulta- neous operation of more than one therapeutic radiation machine in a treatment room.

2.        Access to the treatment room shall be controlled by a door at each entrance.

3.        Each treatment room shall have provisions to permit con- tinuous oral communication and visual observation of the

patient from the treatment control panel during irradia- tion. The electronic brachytherapy device shall not be used for patient irradiation unless the patient can be observed.

4.        For electronic brachytherapy devices capable of operat- ing below 150 kVp, radiation shielding for the staff in the treatment room may be available, either as a portable shield or as localized shielded material around the treat- ment site or both, in lieu of the requirements for room shielding. The shielding shall meet the requirements of R12-1-603(C).

5.        For electronic brachytherapy devices capable of operat- ing at or greater than 150 kVp, the facility must meet the requirements of R12-1-611(B)(4).

D.      Control Panel Functions. The control panel, in addition to the displays required by other provisions in this Section, shall:

1.        Provide an indication of whether electrical power is avail- able at the control panel and if activation of the electronic brachytherapy source is possible;

2.        Provide an indication of whether x-rays are being pro- duced;

3.        Provide a means for indicating electronic brachytherapy source potential and current;

4.        Provide the means for terminating an exposure at any time; and

5.        Include an access control (locking) device that will pre- vent unauthorized use of the electronic brachytherapy device.

E.       Timer. A suitable irradiation control device (timer) shall be provided to terminate the irradiation after a pre-set time inter- val or integrated charge on a dosimeter-based monitor.

1.        A timer shall be provided at the treatment control panel. The timer shall indicate the planned setting and the time elapsed or remaining;

2.        The timer shall not permit an exposure if set at zero;

3.        The timer shall be a cumulative device that activates with an indication of “BEAM-ON” that retains its reading after irradiation is interrupted or terminated. After irradi- ation is terminated and before irradiation can be reiniti- ated, it shall be necessary to reset the elapsed time indicator;

4.        The timer shall terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system has not previously terminated irradiation.

5.        The timer shall permit setting of exposure times as short as 0.1 second; and

6.        The timer shall be accurate to within one percent of the selected value or 0.1 second, whichever is greater.

F.       Qualified Medical Physicist Support.

1.        The services of a Qualified Medical Physicist shall be required in facilities having electronic brachytherapy devices. The Qualified Medical Physicist shall be respon- sible for:

a.         Evaluation of the output from the electronic brachytherapy source;

b.        Generation of the necessary dosimetric information;

c.         Supervision and review of treatment calculations prior to initial treatment of any treatment site;

d.        Establishing the periodic and day-of-use quality assurance checks and reviewing the data from those checks as required in subsection (J);

e.         Consultation with the authorized user in treatment planning, as needed; and

f.         Performing calculations/assessments regarding patient treatments that may constitute a medical event.

2.        If the Qualified Medical Physicist is not a full-time employee of the registrant, then the operating procedures required by subsection (G) shall also specifically address how the Qualified Medical Physicist is to be contacted for problems or emergencies, as well as the specific actions, if any, to be taken until the Qualified Medical Physicist can be contacted.

G.      Operating Procedures.

1.        Only individuals approved by the authorized user, Radia- tion Safety Officer, or Qualified Medical Physicist shall be present in the treatment room during treatment;

2.        Electronic brachytherapy devices shall not be made avail- able for medical use unless the requirements of subsec- tions (A), (H), and (I) have been met;

3.        The electronic brachytherapy device shall be inoperable, either by hardware or password, when unattended  by qualified staff or service personnel;

4.        During operation, the electronic brachytherapy device operator shall monitor the position of all persons in the treatment room, and all persons entering the treatment room, to prevent entering persons from unshielded expo- sure from the treatment beam;

5.        If a patient must be held in position during treatment, mechanical supporting or restraining devices shall be used;

6.        Written procedures shall be developed, implemented, and maintained for responding to an abnormal situation. These procedures shall include:

a.         Instructions for responding to equipment   failures and the names of the individuals responsible for implementing corrective actions; and

b.        The names and telephone numbers of the authorized users, the Qualified Medical Physicist, and the Radi- ation Safety Officer to be contacted if the device or console operates abnormally.

7.        A copy of the current operating and emergency proce- dures shall be physically located at the electronic brachytherapy device control console;

8.        Instructions shall be maintained with the electronic brachytherapy device control console to inform the oper- ator of the names and telephone numbers of the autho- rized users, the Qualified Medical Physicist, and the Radiation Safety Officer to be contacted if the device or console operates abnormally; and

9.        The Radiation Safety Officer, or the Radiation Safety Officer’s designee, and an authorized user shall be noti- fied immediately if the patient has a medical emergency, suffers injury or dies. The Radiation Safety Officer or the Qualified Medical Physicist shall inform the manufac- turer of the event.

H.      Safety Precautions for Electronic Brachytherapy Devices.

1.        Any person in the treatment room, other than the person being treated, shall wear personnel monitoring devices;

2.        An authorized user and a Qualified Medical Physicist shall be physically present during the initiation of all new patient treatments involving the electronic brachytherapy device;

3.        After the first treatment one of the following individuals shall be physically present during continuation of all patient treatments involving the electronic brachytherapy device:

a.         A Qualified Medical Physicist, or

b.        An authorized user, or

c.         A certified therapy technologist (CTT) certified by the Arizona Medical Radiologic Technology Board of Examiners, under the direct supervision of an

authorized user, who has been trained in the opera- tion and emergency response for the electronic brachytherapy device;

4.        When shielding is required by subsection (C)(4), surveys shall be conducted to ensure that the requirements of R12-1-408, R12-1-414, and R12-1-416 are met. Alterna- tively, a Qualified Medical Physicist shall designate shield locations sufficient to meet the requirements of R12-1-603(C) and R12-1-607(C) for any individual, other than the patient, in the treatment room; and

5.        All personnel in the treatment room are required to remain behind shielding during treatment. A Qualified Medical Physicist shall approve any deviation from this requirement and shall designate alternative radiation safety protocols, compatible with patient safety, to pro- vide an equivalent degree of protection.

I.        Electronic Brachytherapy Source Calibration Measurements.

1.        Calibration of the electronic brachytherapy source output shall be performed by, or under the direct supervision of, a Qualified Medical Physicist. If the control console is integral to the electronic brachytherapy device, the required procedures shall be kept where the operator is located during electronic brachytherapy device operation;

2.        Calibration of the electronic brachytherapy source output shall be made for each electronic brachytherapy source, or after any repair affecting the x-ray beam generation, or when indicated by the electronic brachytherapy source quality assurance checks;

3.        Calibration of the electronic brachytherapy source output shall utilize a dosimetry system appropriate for the energy output of the unit and calibrated by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL). The calibration shall have been performed within the pre- vious 24 months and after any servicing that may have affected system calibration;

4.        Calibration of the electronic brachytherapy source output shall include, as applicable, determination of:

a.         The output within two percent of the expected value, if applicable, or determination of the output if there is no expected value;

b.        Timer accuracy and linearity over the typical range of use;

c.         Proper operation of back-up exposure control devices;

d.        Evaluation that the relative dose distribution about the source is within five percent of that expected; and

e.         Source positioning accuracy to within one millime- ter within the applicator;

5.        Calibration of the x-ray source output required shall be in accordance with current published recommendations from a recognized national professional association with expertise in electronic brachytherapy (when available). In the absence of a calibration protocol published by a national professional association, the manufacturer’s cali- bration protocol shall be followed.

6.        The registrant shall maintain a record of each calibration in an auditable form for the duration of the registration. The record shall include: the date of the calibration; the manufacturer's name, model number and serial number for the electronic brachytherapy device and a unique identifier for its electronic instrument or instruments brachytherapy source; the model numbers and serial numbers of the instrument or instruments used to cali-

brate the electronic brachytherapy device; and the name and signature of the Qualified Medical Physicist respon- sible for performing the calibration.

J.        Periodic and Day-of-Use Quality Assurance Checks for Elec- tronic Brachytherapy Devices.

1.        Quality assurance checks shall be performed on each electronic brachytherapy device:

a.         At the beginning of each day of use;

b.        Each time the device is moved to a new room or site; and

c.         After each x-ray tube installation.

2.        The registrant shall perform periodic quality assurance checks required in accordance with  procedures estab- lished by the Qualified Medical Physicist;

3.        To satisfy the requirements of this subsection, radiation output quality assurance checks shall include at a mini- mum:

a.         Verification that output of the electronic brachyther- apy source falls within three percent of expected val- ues, as appropriate for the device, as determined by:

i.         Output as a function of time, or

ii.        Output as a function of setting on a monitor chamber.

b.        Verification of the consistency of the dose distribu- tion to within three percent (or the manufacturer’s or Qualified Medical Physicist’s documented recom- mendation not to exceed five percent), observed at the source calibration required by subsection (I); and

c.         Validation of the operation of positioning methods to ensure that the treatment dose exposes the intended location within one millimeter; and

4.        The registrant shall use a dosimetry system that has been intercompared within the previous 12 months with the dosimetry system described in this Section to make the quality assurance checks required in subsection (J)(3);

5.        The registrant shall review the results of each radiation output quality assurance check to ensure that:

a.         An authorized user and Qualified Medical Physicist is immediately notified if any parameter is not within its acceptable tolerance, and the electronic brachytherapy device is not used until the Qualified Medical Physicist has determined that all parameters are within their acceptable tolerances;

b.        If all radiation output quality assurance check parameters appear to be within their acceptable range, the acceptable quality assurance checklist shall be reviewed and signed by either the autho- rized user or Qualified Medical Physicist prior to the next patient use of the unit. In addition, the Qualified Medical Physicist shall review and sign the results of each radiation output quality assurance check at intervals not to exceed 30 days.

6.        To satisfy the requirements of subsection (J)(1), safety device quality assurance checks shall, at a minimum, assure:

a.         Proper operation of radiation exposure indicator lights on the electronic brachytherapy device and on the control console;

b.        Proper operation of viewing and intercom systems in each electronic brachytherapy facility, if applicable;

c.         Proper operation of radiation monitors, if applicable;

d.        The integrity of all cables, catheters or parts of the device that carry high voltages; and

e.         Connecting guide tubes, transfer tubes, transfer- tube-applicator interfaces, and treatment spacers are

free from any defects that interfere with proper oper- ation.

7.        If the results of the safety device quality assurance checks required in subsection (J)(6) indicate the malfunction of any system, a registrant shall secure the control console in the OFF position and not use the electronic brachyther- apy device except as may be necessary to repair, replace, or check the malfunctioning system.

8.        The registrant shall maintain a record of each quality assurance check required by this Section in a legible form for three years.

a.         The record shall include the date of the quality assurance check; the manufacturer's name, model number and serial number for the electronic brachytherapy device; the name and signature of the individual who performed the periodic quality assur- ance check and the name and signature of the Quali- fied Medical Physicist who reviewed the quality assurance check;

b.        For radiation output quality assurance checks required by subsection (J)(3), the record shall also include the unique identifier for the electronic brachytherapy source and the manufacturer's name; model number and serial number for the instrument or instruments used to measure the radiation output of the electronic brachytherapy device.

K.      Therapy-related Computer Systems. The registrant shall per- form acceptance testing on the treatment planning system of electronic brachytherapy-related computer systems in accor- dance with current published recommendations from a recog- nized national professional association with expertise in electronic brachytherapy (when available). In the absence of an acceptance testing protocol published by a national profes- sional association, the manufacturer’s acceptance testing pro- tocol shall be followed.

1.        Acceptance testing shall be performed by, or under the direct supervision of a Qualified Medical Physicist. At a minimum, the acceptance testing shall include, as appli- cable, verification of:

a.         The source-specific input parameters required by the dose calculation algorithm;

b.        The accuracy of dose, dwell time, and treatment time calculations at representative points;

c.         The accuracy of isodose plots and graphic displays;

d.        The accuracy of the software used to determine radi- ation source positions from radiographic images; and

e.         If the treatment planning system is different from the treatment delivery system, the accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

2.        The position indicators in the applicator shall be com- pared to the actual position of the source or planned dwell positions, as appropriate, at the time of commissioning.

3.        Prior to each patient treatment regimen, the parameters for the treatment shall be evaluated for correctness and approved by the authorized user and the Qualified Medi- cal Physicist through means independent of that used for the determination of the parameters.

L.       Training for e-brachytherapy Authorized Users.

1.        The registrant for any therapeutic radiation machine sub- ject to this Section shall require the authorized user to be a physician who is certified in:

a.         Radiation oncology or therapeutic radiology by the American Board of Radiology or radiology (com-

bined diagnostic and therapeutic radiology program) by the American Board of Radiology prior to 1976; or

b.        Radiation oncology by the American Osteopathic Board of Radiology; or

c.         Radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”; or

d.        Therapeutic radiology by the Canadian Royal Col- lege of Physicians and Surgeons; or

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 radi- ation therapy unit, 500 hours of supervised work experi- ence, and a minimum of three years of supervised clinical experience.

a.         To satisfy the requirement for instruction, the class- room and laboratory training shall include:

i.         Radiation physics and instrumentation;

ii.        Radiation protection;

iii.      Mathematics pertaining to the use and measure- ment of ionization radiation; and

iv.       Radiation biology.

b.        To satisfy the requirement for supervised work expe- rience, training shall be under the supervision of an authorized user and shall include:

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

ii.        Evaluation of prepared treatment plans and cal- culation of treatment times or patient treatment settings or both;

iii.      Using administrative controls to prevent medi- cal events as described in R12-1-444;

iv.       Implementing emergency procedures to be fol- lowed in the event of the abnormal operation of an external beam radiation therapy unit or con- sole; and

v.        Checking and using radiation survey meters.

c.         To satisfy the requirement for a period of supervised clinical experience, training shall include one year in a formal training program approved by the Resi- dency Review Committee for Radiology of the Accreditation Council for Graduate Medical Educa- tion or the Committee on Postdoctoral Training of the American Osteopathic Association and an addi- tional two years of clinical experience in therapeutic radiology under the supervision of an authorized user. The supervised clinical experience shall include:

i.         Examining individuals and reviewing their case histories to determine their suitability for exter- nal beam radiation therapy treatment, and any limitations or contraindications or both;

ii.        Selecting proper dose and how it is to be administered;

iii.      Calculating the therapeutic radiation machine doses and collaborating with the authorized user in the review of patients' progress and con- sideration of the need to modify originally pre- scribed doses or treatment plans as warranted by patients' reaction to radiation or both; and

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

3.        Notwithstanding the requirements of this subsection, the registrant for any therapeutic radiation machine subject to this Section may also submit the training of the prospec-

tive authorized user physician for Agency review on a case-by-case basis if the training includes substantially equivalent training as that listed in subsection (L)(2) and the training includes dosimetry calculation training and experience.

4.        A physician shall not act as an authorized user until such time as the physician's training has been reviewed and approved by the Agency.

M.     Training for Qualified Medical Physicist. The registrant for any therapeutic radiation machine subject to this Section shall require the Qualified Medical Physicist to:

1.        Be certified with the Agency, as a provider of radiation services in the area of calibration and compliance surveys of external beam radiation therapy units; and

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

a.         Therapeutic radiological physics; or

b.        Roentgen-ray and gamma-ray physics; or

c.         X-ray and radium physics; or

d.        Radiological physics; or

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

4.        Be certified by the Canadian College of Physicists in Medicine; or

5.        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 year of full-time training in medical physics and an additional year of full-time work experi- ence under the supervision of a Qualified Medical Physi- cist at a medical institution. This training and work experience shall be conducted in clinical radiation facili- ties 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 this subsection under the supervision of a Qualified Medical Physicist during the year of work experience.

N.      Qualifications of Operators. Individuals who will be operating a therapeutic radiation machine for medical use shall be certi- fied by the Agency as a CTT by the Arizona Medical Radio- logic Technology Board of Examiners.

O.      Additional training requirements.

1.        A registrant shall provide instruction, initially and at least annually, to all individuals who operate the electronic brachytherapy device, as appropriate to the individual's assigned duties, in the operating procedures identified in subsection (G). If the interval between patients exceeds one year, retraining of the individuals shall be provided.

2.        In addition to the requirements of subsection (L) for ther- apeutic radiation machine authorized users and subsec- tion (M) for Qualified Medical Physicists, these individuals shall also receive device-specific instruction initially from the manufacturer, and annually from either the manufacturer or other qualified trainer. The training shall be of a duration recommended by a recognized national professional association with expertise in elec- tronic brachytherapy (when available). In the absence of any training protocol recommended by a national profes- sional association, the manufacturer’s training protocol shall be followed. The training shall include, but not be limited to:

a.         Device-specific radiation safety requirements;

b.        Device operation;

c.         Clinical use for the types of use approved by the FDA;

d.        Emergency  procedures,  including  an  emergency drill; and

e.         The registrant’s quality assurance program.

3.        A registrant shall retain a record of individuals receiving manufacturers instruction for three years. The record shall include a list of the topics covered, the date of the instruction, the name or names of the attendee or attend- ees, and the name or names of the individual or individu- als who provided the instruction.

P.       Mobile Electronic Brachytherapy Service. A registrant provid- ing mobile electronic brachytherapy service shall, at a mini- mum:

1.        Check all survey instruments before medical use at each address of use or on each day of use, whichever is more restrictive;

2.        Account for the electronic brachytherapy x-ray tube in the electronic brachytherapy device before departure from the client’s address; and

3.        Perform, at each location on each day of use, all of the required quality assurance checks specified in this Sec- tion to assure proper operation of the device.

Q.      Medical events shall be reported to the Agency. For purposes of this Section “medical event” means a therapeutic radiation dose from a machine:

1.        Delivered to the wrong patient;

2.        Delivered using the wrong mode of treatment;

3.        Delivered to the wrong treatment site; or

4.        Delivered in one week to the correct patient, using the correct mode, to the correct therapy site, but greater than 130 percent of the prescribed weekly dose; or

R.      A therapeutic radiation dose from a machine with errors in the calibration, time of exposure, or treatment geometry that result in a calculated total treatment dose differing from the final, prescribed total treatment dose by more than 20 percent, except for treatments given in 1 to 3 fractions, in which case a difference of more than 10 percent constitutes a medical event.

S.       Reports of therapy medical events:

1.        Within 24 hours after discovery of a medical event, a reg- istrant shall notify the Agency by telephone by speaking to an Agency  staff member. The registrant shall  also notify the referring physician of the affected patient and the patient or a responsible relative or guardian, unless the referring physician personally informs the registrant either that he or she will inform the patient, or that in his or her medical judgment, telling the patient or the patient’s responsible relative or guardian would be harm- ful to one or the other, respectively. If the Agency staff member, referring physician, or the patient’s responsible relative or guardian cannot be reached within 24 hours, the registrant shall notify them as soon as practicable. The registrant shall not delay medical care for the patient because of notification problems.

2.        Within 15 days following the verbal notification to the Agency, the registrant shall report, in writing, to the Agency and individuals notified under subsection (S)(1). The written report shall include the registrant’s name, the referring physician’s name, a brief description of the event, the effect on the patient, the action taken to prevent recurrence, whether the registrant informed the patient or the patient’s responsible relative or guardian, and if not, why not. The report shall not include the patient’s name or other information that could lead to identification of the patient.

3.        Each registrant shall maintain records of all medical events for Agency inspection. The records shall:

a.         Contain the names of all individuals involved in the event, including:

i.         The physician,

ii.        The allied health personnel,

iii.      The patient,

iv.       The patient’s referring physician,

v.        The patient’s identification number if one has been assigned,

vi.       A brief description of the event,

vii.     The effect on the patient, and

viii.    The action taken to prevent recurrence.

b.        Be maintained for three years beyond the termina- tion date of the affected registration.

Historical Note

New Section R12-1-611.01 made by final rulemaking at 20 A.A.R. 811, effective May 3, 2014 (Supp. 14-1).