HAR §11-45-235. Quality management program

(a) Each applicant or licensee subject to section 11-45-236 or section 11-45-238 shall establish and maintain a written quality management program to provide high confidence that radiation shall be administered as directed by the authorized user. The quality management program shall include written policies and procedures to meet the following specific objectives: (1) Before administration, a written directive is prepared for any external beam radiation therapy dose; (A) Notwithstanding this paragraph, a written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user before the administration of the external beam radiation therapy dose or the next external beam radiation therapy fractional dose; (B) Notwithstanding this paragraph, if, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive shall be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by an authorized user within forty- eight hours of the oral revision; (C) Notwithstanding this paragraph, if, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive shall be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared and signed by an authorized user within twenty-four hours of the oral directive. (2) Before the administration of each course of radiation treatments, the patient's identity is verified, by more than one method, as the individual named in the written directive; (3) External beam radiation therapy final plans of treatment and related calculations are in accordance with the respective written directives; (4) Each administration is in accordance with the written directive; and (5) Any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken. (c) Development of quality management program. §11-45-235 45-171 (1) Each application for a license subject to section 11- 45-236 or section 11-45-238 shall develop a quality management program as part of the application required by subchapter 2. The licensee shall implement the program upon issuance of a license by the department; (2) Each existing licensee subject to sections 11-45-236 and 11-45-238 shall, within thirty days of the effective date of this chapter, submit to the department a written certification that a quality management program has been implemented. (d) As a part of the quality management program, the licensee shall: (1) Develop procedures for, and conduct a review of, the quality management program including, since the last review, an evaluation of a representative sample of patient administrations, all recordable events, and all misadministrations to verify compliance with all aspects of the quality management program; (2) Conducted these reviews at intervals not to exceed twelve months; (3) Evaluate each of these reviews to determine the effectiveness of the quality management program and, if required, make modifications to meet the requirements of subsection (b); and (4) Maintain records of each review, including the evaluations and findings of the review. (e) The licensee shall evaluate and respond, within thirty days after discovery of the recordable event, to each recordable event by: (1) Assembling the relevant facts including the cause; (2) Identifying what, if any, corrective action is required to prevent recurrence; and (3) Retaining a record, in an auditable form, of the relevant facts and what corrective action, if any, was taken. (f) The licensee shall retain: (1) Each written directive; and (2) A record of each administered radiation dose, in an auditable form. (g) The licensee may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased. (h) The licensee shall evaluate each misadministration and shall take the following actions in response to a misadministration: (1) Notify the department by telephone no later than the next calendar day after discovery of the misadministration; (2) Submit a written report to the department within fifteen days after discovery of the misadministration. The written report shall include: the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to §11-45-235 45-172 prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the patient or the patient's responsible relative or guardian (this person shall subsequently be referred to as "the patient"), and if not, why not, and if the patient was notified, what information was provided to the patient. The report shall not include the patient's name or other information that could lead to identification of the patient; (3) Notify the referring physician and also notify the patient of the misadministration no later than twenty- four hours after its discovery, unless the referring physician personally informs the licensee either that he/she shall inform the patient or that, based on medical judgment, telling the patient would be harmful. The licensee is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within twenty-four hours, the licensee shall notify the patient as soon as possible thereafter. The licensee shall not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the misadministration, because of any delay in notification; (4) Retain a record of each misadministration. The record shall contain the names of all individuals involved (including the prescribing physician, allied health personnel, the patient, and the patient's referring physician), the patient's social security number or identification number if one has been assigned, a brief description of the event, why it occurred, the effect on the patient, what improvements are needed to prevent recurrence, and the actions taken to prevent recurrence; and (5) If the patient was notified, furnish, within fifteen days after discovery of the misadministration, a written report to the patient by sending either a copy of the report that was submitted to the department, or a brief description of both the event and the consequences as they may effect the patient, provided a statement is included that the report submitted to the department can be obtained from the licensee; (i) Aside from the notification requirement, nothing in subsection (h) affects any rights or duties of licensees and physicians in relation to each other, patients, or the patient's responsible relatives or guardians. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71) §11-45-236 Therapeutic radiation machines of less than five hundred kilovolts. (a) When the x-ray tube is operated at its maximum rated §11-45-236 45-173 tube current for the maximum kilovolts, the leakage air kerma rate shall not exceed the value specified at the distance specified for that classification of therapeutic radiation machine: (1) Five to fifty kilovolt systems: The leakage air kerma rate measured at any position five centimeters from the tube housing assembly shall not exceed one hundred miilirad (one milligray) in any one hour. (2) Greater than fifty and less than five hundred kilovolt systems: The leakage air kerma rate measured at a distance of one meter from the source in any direction shall not exceed one rad (one centigray) in any one hour. This air kerma rate measurement may be averaged over areas no larger than one hundred square centimeters. In addition, the air kerma rate at a distance of five centimeters from the surface of the tube housing assembly shall not exceed thirty rad (thirty centigray) per hour. (b) Permanent beam limiting devices: Permanent diaphragms or cones used for limiting the useful beam shall provide at least the same degree of attenuation as required for the tube housing assembly. (c) Adjustable or removable beam limiting devices: (1) All adjustable or removable beam limiting devices, diaphragms, cones or blocks shall not transmit more than five percent of the useful beam for the most penetrating beam used; (2) When adjustable beam limiting devices are used, the position and shape of the radiation field shall be indicated by a light beam. (d) The filter system shall be so designed that: (1) Filters can not be accidentally displaced at any possible tube orientation; (2) For equipment installed after the effective date of this chapter, an interlock system prevents irradiation if the proper filter is not in place; (3) The air kerma rate escaping from the filter slot shall not exceed one rad (one centigray) per hour at one meter under any operating conditions; and (4) Each filter shall be marked as to its material of construction and its thickness. (e) Tube immobilization: (1) The x-ray tube shall be so mounted that it can not accidentally turn or slide with respect to the housing aperture; and (2) The tube housing assembly shall be capable of being immobilized for stationary portal treatments. (f) The tube housing assembly shall be so marked that it is possible to determine the location of the source to within five millimeters, and such marking shall be readily accessible for use during calibration procedures. (g) Contact therapy tube housing assemblies shall have a removable shield of material, equivalent in attenuation to 0.5 millimeters of lead at one hundred kilovolts, which can be positioned over the entire useful beam exit port during periods §11-45-236 45-174 when the beam is not in use. (h) A suitable irradiation control device shall be provided to terminate the irradiation after a pre-set time interval. (1) A timer which has a display shall be provided at the treatment control panel. The timer shall have a pre-set time selector and an elapsed time indicator; (2) The timer shall be a cumulative timer which activates with an indication of "BEAM-ON" and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator; (3) The timer shall terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation; (4) The timer shall permit accurate pre-setting and determination of exposure times as short as one second; (5) The timer shall not permit an exposure if set at zero; (6) The timer shall not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and (7) Timer shall be accurate to within one percent of the selected value or one second, whichever is greater. (i) The control panel, in addition to the displays required by other provisions in this section, shall have: (1) An indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible; (2) An indication of whether x-rays are being produced; (3) Means for indicating x-ray tube potential and current; (4) The means for terminating an exposure at any time; (5) A locking device which shall prevent unauthorized use of the therapeutic radiation machine; and (6) For therapeutic radiation machines manufactured after the effective date of this chapter, a positive display of specific filter(s) in the beam. (j) When a control panel may energize more than one x-ray tube: (1) It shall be possible to activate only one x-ray tube at any time; (2) There shall be an indication at the control panel identifying which x-ray tube is activated; and (3) There shall be an indication at the tube housing assembly when that tube is energized. (k) Target-to-skin distance (TSD): There shall be a means of determining the central axis TSD to within one centimeter and of reproducing this measurement to within two millimeters thereafter. (l) Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five seconds after the x-ray §11-45-236 45-175 "ON" switch is energized, the beam shall be attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly. In addition, after the unit is at operating parameters, the shutter shall be controlled electrically by the operator from the control panel. An indication of shutter position shall appear at the control panel. (m) Each therapeutic radiation machine equipped with a beryllium or other low-filtration window shall be clearly labeled as such upon the tube housing assembly and shall be provided with a permanent warning device on the control panel that is activated when no additional filtration is present, to indicate that the dose rate is very high. (n) Facility design requirements for therapeutic radiation machines capable of operating in the range fifty kilovolts to five hundred kilovolts: In addition to shielding adequate to meet requirements of section 11-45-241, the treatment room shall meet the following design requirements: (1) Provision shall be made for continuous two-way aural communication between the patient and the operator at the control panel; (2) Provision shall be made to permit continuous observation of the patient during irradiation and the viewing system shall be so located that the operator can observe the patient from the control panel. The therapeutic radiation machine shall not be used for patient irradiation unless at least one viewing system is operational. (o) Treatment rooms which contain a therapeutic radiation machine capable of operating above one hundred fifty kilovolts shall meet the following additional requirements: (1) All protective barriers shall be fixed except for entrance doors or beam interceptors; (2) The control panel shall be located outside the treatment room or in a totally enclosed booth, which has a ceiling, inside the room; (3) Interlocks shall be provided such that all entrance doors, including doors to any interior booths, shall be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel; and (4) When any door referred to in paragraph (3) is opened while the x-ray tube is activated, the air kerma rate at a distance of one meter from the source shall be reduced to less than one hundred millirad (one milligray) per hour. (p) Full calibration measurements: (1) Full calibration of a therapeutic radiation machine subject to section 11-45-236 shall be performed by, or under the direct supervision of, a qualified medical physicist: (A) Before the first medical use following §11-45-236 45-176 installation or reinstallation of the therapeutic radiation machine; (B) At intervals not exceeding one year; and (C) Before medical use under the following conditions: (i) Whenever quality assurance check measurements indicate that the radiation output differs by more than five percent from the value obtained at the last full calibration and the difference cannot be easily discerned; and (ii) Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. (D) Notwithstanding the requirements of subparagraph (C): (i) Full calibration of therapeutic radiation machines with multi-energy capabilities is required only for those modes and/or energies that are not within their acceptable range; and (ii) If the repair, replacement or modification does not affect all energies, full calibration shall be performed on the affected energy that is in most frequent clinical use at the facility. The remaining energies may be validated with quality assurance check procedures against the criteria in clause (i). (2) To satisfy the requirement of paragraph (1), full calibration shall include all measurements recommended for annual calibration by NCRP Report 69, "Dosimetry of X-Ray and Gamma Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50 MeV" (1981). (3) The licensee shall maintain a record of each calibration for the duration of the license. The record shall include the date of the calibration, the manufacturer's name, model number, and serial number for both the therapeutic radiation machine and the x-ray tube, the model numbers and serial numbers of the instruments used to calibrate the therapeutic radiation machine, and the signature of the qualified medical physicist responsible for performing the calibration. (q) Periodic quality assurance checks: (1) Periodic quality assurance checks shall be performed on therapeutic radiation machines subject to this section, which are capable of operation at greater than fifty kilovolts. (2) To satisfy the requirement of paragraph (1), quality assurance checks shall meet the following requirements: (A) The licensee shall perform quality assurance §11-45-236 45-177 checks in accordance with written procedures established by the qualified medical physicist; and (B) The quality assurance check procedures shall specify the frequency at which tests or measurements are to be performed. The quality assurance check procedures shall specify that the quality assurance check shall be performed during the calibration specified in subsection (p). The acceptable tolerance for each parameter measured in the quality assurance check, when compared to the value for that parameter determined in the calibration specified in subsection (p), shall be stated. (3) The cause for a parameter exceeding a tolerance set by the qualified medical physicist shall be investigated and corrected before the system is used for patient irradiation; (4) Whenever a quality assurance check indicates a significant change in the operating characteristics of a system, as specified in the qualified medical physicist's quality assurance check procedures, the system shall be recalibrated as required in subsection (p); (5) The licensee shall use the dosimetry system described in section 11-45-234(c)(2) to make the quality assurance check required in paragraph (2); (6) The licensee shall have the qualified medical physicist review and sign the results of each radiation output quality assurance check at intervals not to exceed one month; (7) Therapeutic radiation machines subject to this section shall have safety quality assurance checks of each external beam radiation therapy facility performed at intervals not to exceed one month; (8) To satisfy the requirement of paragraph (7), safety quality assurance checks shall ensure proper operation of: (A) Electrical interlocks at each external beam radiation therapy room entrance; (B) Proper operation of the "BEAM-ON" and termination switches; (C) Beam condition indicator lights on the access door(s), control console, and in the radiation therapy room; (D) Viewing systems; (E) Electrically operated treatment room doors from inside and outside the treatment room; (9) The licensee shall promptly repair any system identified in paragraph (8) that is not operating properly. (10) The licensee shall maintain a record of each quality assurance check required by paragraphs (1) and (7) for three years. The record shall include the date of the §11-45-236 45-178 quality assurance check, the manufacturer's name, model number, and serial number for the therapeutic radiation machine, the manufacturer's name, model number and serial number of the instrument(s) used to measure the radiation output of the therapeutic radiation machine, and the signature of the individual who performed the periodic quality assurance check. (r) Operating procedures: (1) The therapeutic radiation machine shall not be used for irradiation of patients unless the requirements of subsections (p) and (q) have been met; (2) Therapeutic radiation machines shall not be left unattended unless it is secured pursuant to subsection (i); (3) When a patient shall be held in position for radiation therapy, mechanical supporting or restraining devices shall be used; (4) The tube housing assembly shall not be held by an individual during operation unless the assembly is designed to require such holding and the peak tube potential of the system does not exceed fifty kilovolts. In such cases, the holder shall wear protective gloves and apron of not less than 0.5 millimeters lead equivalency at one hundred kilovolts; (5) A copy of the current operating and emergency procedures shall be maintained at the therapeutic radiation machine control console; and (6) No individual other than the patient shall be in the treatment room during exposures from therapeutic radiation machines operating above one hundred fifty kilovolts. At energies less than or equal to one hundred fifty kilovolts, any individual, other than the patient, in the treatment room shall be protected by a barrier sufficient to meet the requirements of subchapter 4. (s) Each facility location authorized to use a therapeutic radiation machine in accordance with this section shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range one millirem (ten microsieverts) per hour to one thousand millirems (ten millisieverts) per hour. The survey instrument(s) shall be operable and calibrated in accordance with section 11-45-240. [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71)