[33 Pa.B. 4393]
[Continued from previous Web Page]
ADMINISTRATIVE CONTROLS § 221.11. Registrant responsibilities.
(a) The registrant is responsible for directing the operation of X-ray systems under his administrative control and shall [do the following:
(1) Assure] assure that the requirements of this article are met in the operation of the X-ray systems.
[(2) Permit only auxiliary personnel who have met the applicable radiologic requirements of 49 Pa. Code, Part I, Subpart A (relating to professional and occupational affairs) to operate X-ray systems for diagnostic or therapeutic purposes when employed by a licensed practitioner of the healing arts at the location at which the licensed practitioner practices.
(3) Permit only auxiliary personnel employed by a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government to operate X-ray systems for diagnostic or therapeutic purposes in accordance with written job descriptions and employe qualifications.]
(b) An individual who operates an X-ray system shall be instructed adequately in the safe operating procedures and be competent in the safe use of the equipment. The instructions shall include, but not be limited to, items included in Appendix A (relating to determination of competence) and there shall be continuing education in radiation safety, biological effects of radiation, quality assurance and quality control.
* * * * * (e) Except for patients who cannot be moved out of the room, only the staff and ancillary personnel or other persons required for the medical procedure or training shall be in the room during the radiographic exposure. The following apply for individuals other than the patient being examined:
* * * * * (2) All persons required for the medical procedure shall be protected from the [scatter] stray radiation by protective aprons or whole protective barriers of at least 0.25 millimeter lead equivalent or shall be so positioned that the persons are not in the direct line of the useful beam and the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.
(3) A patient who cannot be removed from the room shall be protected from the [scatter] stray radiation by protective barriers of at least 0.25 millimeter lead equivalent material unless the shield would compromise the health of the individual or shall be so positioned that the patient is not in the direct line of the useful beam and the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.
* * * * * (l) The registrant shall have a quality assurance program. This quality assurance program shall be documented and be in accordance with guidelines established by the Department or by another appropriate organization recognized by the Department. At a minimum, the quality assurance program shall address repeat rate; image recording, processing and viewing; and maintenance and modifications to the quality assurance program. Records shall be maintained by the registrant for inspection by the Department for 3 years. The Department's guidelines and a list of recognized organizations will be maintained and made available on the Department's website and on request.
* * * * * § 221.13. Information to be submitted by persons [proposing] requesting approval to conduct healing arts screening.
(a) The Department will consider efficacy as a factor in evaluating healing arts screening procedures. In its review, the Department will consider national medical organization consensus statements as well as peer reviewed scientific and medical literature that addresses the efficacy of the proposed screening procedures. The review may also consider relevant information from appropriate Federal agencies. For procedures that result in an individual organ dose or deep dose equivalent greater than 1 mSv (100 mrem) to a screened individual the Department will consult with the Department of Health (DOH) for assistance in reviewing the efficacy of the proposed procedures but the final decision will remain that of the Department. DOH will have access to all relevant materials when rendering their review.
(b) A person requesting that the Department approve a healing arts screening program shall submit in writing the following information [and evaluation] for evaluation by the Department. If information submitted to the Department becomes invalid or outdated, the registrant shall immediately notify the Department.
* * * * * (5) An evaluation of all known alternate methods [not involving ionizing radiation which] that could achieve the goals of the screening program and why these methods are not used in preference to the proposed X-ray examinations.
(6) An evaluation by a qualified expert of the X-ray systems to be used in the screening program. The evaluation shall show that the systems satisfy the requirements of this article. The evaluation shall include a measurement of patient entrance exposures and calculation of the maximum shallow dose, deep dose equivalent and organ dose from the X-ray examinations to be performed.
(7) A description of the diagnostic [film] X-ray quality control program.
(8) A copy of the technique chart for the X-ray examination procedures to be used if exposure parameters are set manually or a description of how exposure parameters are determined.
(9) The qualifications of [an individual] all individuals who will be operating the X-ray systems.
* * * * * (11) The name [and], address and qualifications of the individual who will interpret the [radiographs] screening procedure results.
(12) A description of the [procedures to be used in] information and procedure for advising the individuals screened of the potential for false positive or negative results and the implications for the patient; the procedure for recording informed consent for the procedure following disclosure of this information; and the procedure for advising the individuals screened and their private practitioners of the healing arts of the results of the screening procedure and further medical needs indicated.
(13) A description of the procedures for the retention or disposition of the [radiographs] diagnostic images, data and other records pertaining to the X-ray examination.
* * * * * (15) An approximation of the frequency of screening activities and duration of the entire screening program.
§ 221.15. Use of X-rays in research on humans.
* * * * * (b) If not exempted under subsection (a), a person shall submit, in writing, the following information and evaluation to the Department and receive approval by the Department before conducting the research. If the information submitted to the Department becomes invalid or outdated, the person shall immediately, in writing, notify the Department.
* * * * * (3) An evaluation of all known alternate methods [not involving ionizing radiation which] that could achieve the goals of the research program and why these methods are not used in preference to the X-ray examinations.
* * * * * (6) A copy of the technique chart which specifies the information for the X-ray examination procedures to be used if exposure parameters are set manually or a description of how exposure parameters are determined.
* * * * * (9) The name, [and] address and qualifications of the individual who will interpret the [radiographs] data.
(10) A copy of the research protocol authorized by a committee consisting of at least three qualified persons. [One] At least one of the committee members shall be knowledgeable in radiation effects on humans.
(11) The provisions for independent institutional review.
* * * * *
DIAGNOSTIC INSTALLATIONS GENERAL REQUIREMENTS § 221.25. Beam quality.
(a) Diagnostic X-ray systems shall have filtration that satisfies the requirements of Table I. The requirements of this section shall be considered to have been met if it can be demonstrated that the half value layer of the primary beam is not less than that shown in Table II.
* * * * * (Editor's Note: The existing Table II which appears at 25 Pa. Code page 221-18, serial page (249290) is deleted and replaced by the following Table II displayed in normal font for clarity.)
Table II
Design operating range (Kilovolts peak) Measured potential
(Kilovolts peak)Minimum half-value layer (millimeters of aluminum) Specified dental systems* All other X-ray systems Below 51 30 1.5 0.3 40 1.5 0.4 50 1.5 0.5 51 to 70 51 1.5 1.2 60 1.5 1.3 70 1.5 1.5 Above 70 71 2.1 2.1 80 2.3 2.3 90 2.5 2.5 100 2.7 2.7 110 3.0 3.0 120 3.2 3.2 130 3.5 3.5 140 3.8 3.8 150 4.1 4.1 Note: Half value layers for kilovoltages not listed in Table II may be determined by interpolation or extrapolation. * Dental systems manufactured after December 1, 1980 designed for use with intra-oral image receptors.
(b) Beryllium window tubes shall have a minimum of [.5] 0.5 millimeter aluminum equivalent filtration permanently installed in the useful beam.
* * * * * § 221.29. Kilovoltage (kV) accuracy.
(a) [The] For variable kV units, the kV output may not vary from the set-indicated value by more than 10% over the range of technique factors normally used. Discrepancies of more than 10% between set-indicated and measured kV values shall be investigated by a qualified expert or service [engineer] agent and appropriate action taken.
(b) For fixed kV units, the kV output may not vary from the set-indicated value by more than 20% over the range of technique factors normally used. Discrepancies of more than 20% between set-indicated and measured kV values shall be investigated by a qualified expert or service agent and appropriate action taken.
§ 221.36a. Limitation of useful beam of fluoroscopic equipment.
* * * * * (d) The minimum field size at the greatest source to image receptor distance shall be containable in a square of 5 centimeters by 5 centimeters unless otherwise provided in 21 CFR 1020.32(b) (relating to [fluorascopic] fluoroscopic equipment).
* * * * * § 221.38a. Entrance exposure rate.
* * * * * (c) Frequency of output measurements. Output measurements [required by] to show compliance with this section shall be made at least annually and after maintenance that could affect the output of the machine.
* * * * *
OTHER SYSTEMS § 221.61. Radiation therapy simulation systems.
[Radiation therapy simulation systems shall comply with §§ 221.35a--221.43a. Radiation therapy simulation systems are exempt from §§ 221.36a, 221.38a, 221.39a and 221.41a if the systems that do not meet the requirements in § 221.41a (relating to fluoroscopic timer) are provided with a means of indicating the cumulative time that an individual patient has been exposed to X-rays. In this case, procedures shall require that the timer be reset between examinations.]
(a) Fluoroscopic systems used solely for radiation therapy simulations shall comply with §§ 221.35a, 221.37a, 221.40a and 221.41a. The requirements in § 221.41a (relating to fluoroscopic timer) may also be satisfied if a means is provided to indicate the cumulative time that an individual patient has been exposed to X-rays. In this case, procedures shall require that the timer be reset between examinations.
(b) CT units used solely for therapy simulations shall comply with §§ 221.202(f)(1), (7) and (8) and 221.203.
THERAPEUTIC X-RAY SYSTEMS WITH ENERGIES LESS THAN 1 MEV § 221.73. Surveys.
(a) A facility shall have a survey made by, or under the direction of, a qualified expert [or a radiological physicist]. The survey shall also be done after a change in the facility or equipment which might cause a change in radiation levels.
* * * * * § 221.74. Calibration.
* * * * * (b) The calibration of the radiation output of the X-ray system shall be performed by or under the direction of a [radiological physicist] qualified expert for radiation therapy calibration who is physically present at the facility during the calibration.
* * * * * § 221.75. Spot checks.
Spot checks shall be performed on X-ray systems capable of operation at greater than 150 kVp. The spot checks shall meet the following requirements:
(1) The procedures shall be in writing and shall have been developed by a [radiological physicist] qualified expert for radiation therapy calibration.
* * * * *
COMPUTED TOMOGRAPHY X-RAY SYSTEMS § 221.202. Equipment requirements.
* * * * * (f) [Beam quality. The HVL shall be at least 3.2 millimeters aluminum at 120 kVp.
(g)] Additional requirements applicable to CT X-ray systems containing a gantry manufactured after September 3, 1985.
* * * * * [(h) Exemption of CT units used solely for therapy simulations. CT units used solely for therapy simulations are exempt from this section and §§ 221.203--221.205.]
§ 221.204. Radiation measurements and performance evaluations.
(a) Radiation measurements.
(1) The CTDI or [MSDAD] MSAD along the two axes specified in paragraph (2)(ii) shall be measured. The CT dosimetry phantom shall be oriented so that the measurement point 1.0 centimeter from the outer surface and within the phantom is in the same angular position within the gantry at the point of maximum surface exposure identified. The CT conditions of operation shall be reproducible and correspond to typical values used by the registrant. If the point of maximum surface exposure constantly changes due to system design, then measurements shall be taken at four different locations--top left, top right, bottom left, bottom right--1 centimeter from the outer surface of the phantom.
* * * * * § 221.205. Operating procedures.
(a) Information shall be available at the control panel regarding the operation and performance evaluations of the system. The information shall include the following:
* * * * * (3) [The distance in millimeters between the tomographic plane and the reference plane if the reference plane is utilized.
(4)] A current technique chart available at the control panel which specifies for each routine examination the CT conditions of operation and the number of scans per examination.
* * * * *
APPENDIX A
DETERMINATION OF COMPETENCE [The following are areas in which an individual shall have expertise for the competent operation of diagnostic X-ray equipment:
(1) Familiarization with equipment.
(i) Identification of controls.
(ii) Function of each control.
(iii) How to use a technique chart.
(2) Radiation Protection.
(i) Collimation.
(ii) Filtration.
(iii) Gonad shielding and other patient protection devices if used.
(iv) Restriction of X-ray tube radiation to image receptor.
(v) Personnel protection.
(vi) Grids.
(vii) Proper use of personnel dosimetry, if required.
(viii) Understanding units of radiation.
(3) Film Processing.
(i) Film speed as related to patient exposure.
(ii) Film processing parameters.
(iii) Quality assurance program.
(iv) Identification of film artifacts and corrective actions, if necessary.
(v) Identification of adequate film exposure on the resultant radiograph, and corrective actions, if necessary.
(4) Procedures.
(i) Knowledge of anatomy and physiology.
(ii) Knowledge of positioning and radiographic demonstration of the requested anatomy with corrective actions, if necessary.
(5) Emergency Procedures. Termination of exposure in event of automatic timing device failure.
(6) Continuing education. Continuing education annually to include radiation protection.]
The registrant shall ensure that individuals who operate diagnostic X-ray equipment have received training on the subjects listed in this appendix. The individual shall be trained and competent in the general operation of the X-ray equipment, and in the following subject areas, as applicable to the procedures performed and the specific equipment utilized:
(1) Basic properties of radiation.
(2) Units of measurement.
(3) Sources of radiation exposure.
(4) Methods of radiation protection.
(5) Biological effects of radiation exposure.
(6) X-ray equipment.
(7) Image recording and processing.
(8) Patient exposure and positioning.
(9) Procedures.
(10) Quality assurance.
(11) Regulations.
CHAPTER 223. VETERINARY MEDICINE
RADIOACTIVE MATERIAL § 223.21. In vitro testing.
A veterinarian who uses radioactive material for in vitro testing shall comply with [§ 217.46 (Reserved)] 10 CFR 31.11 (relating to general license for use of by-product material for certain in vitro clinical or laboratory testing) but is exempt from [§§ 219.181--219.186 (Reserved)] 10 CFR Part 20 Subpart K (relating to waste disposal).
§ 223.22. Sealed sources.
A veterinarian who uses sealed sources for therapeutic treatment of animals shall comply with [Chapter 224, Subchapters G--I (Reserved)] 10 CFR Part 35 Subparts F, G, H, and K but is exempt from [§§ 224.408 and 224.409 (Reserved)] 10 CFR 35.632--35.645 and 35.2632--35.2645.
CHAPTER 224. MEDICAL USE OF RADIOACTIVE MATERIAL
Subchapter A. GENERAL § 224.10. Incorporation by reference.
* * * * * (b) Notwithstanding the requirements incorporated by reference, 10 CFR 35.8, [35.990] 35.4001 and [35.991] 35.4002 (relating to information collection requirements: OMB approval; violations; and criminal penalties) are not incorporated by reference.
Subchapter B. OTHER REQUIREMENTS § 224.21. [Supervision] (Reserved).
[ In addition to the incorporation by reference of 10 CFR Part 35 (relating to medical use of byproduct material), the licensee shall also:
(1) Permit only auxiliary personnel who have met the applicable radiologic requirements of 49 Pa. Code, Part I, Subpart A (relating to professional and occupational affairs) to use radioactive materials for diagnostic or therapeutic purposes.
(2) Permit only auxiliary personnel employed by a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government to use radioactive materials for diagnostic or therapeutic purposes in accordance with written job descriptions and employee qualifications.]
§ 224.22. Authorization for calibration, transmission and reference sources.
Notwithstanding the incorporation by reference of 10 CFR [Part 35] 35.65 (relating to authorization for calibration, transmission, and reference sources), a licensee authorized for medical use radioactive materials may not receive, possess [and] or use [sealed sources of radioactive material up to 1,110 MBq (30 mCi) apiece] radium in total quantity of 3.7 MBq (100 µci) or more for check, calibration, transmission and reference use except as specifically authorized by the Department.
§ 224.23. Decay-in-storage.
Notwithstanding the incorporation by reference of 10 CFR Part 35 (relating to medical use of byproduct material), a licensee may hold sealed sources of radioactive material with a physical half-life [-] of up to 300 days for decay-in-storage before disposal in ordinary trash.
CHAPTER 225. RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS
Subchapter A. GENERAL PROVISIONS § 225.1. Purpose and scope.
* * * * * (b) Persons using only radiation-producing machines for industrial radiographic operations need not comply with § 225.2a [(Reserved)] (relating to incorporation by reference) unless otherwise specified in Subchapter B (relating to radiation-producing machines).
* * * * * § 225.4a. Radiation safety program.
(a) A person who intends to use radiation-producing machines for industrial radiography shall have a program for training personnel, written operating procedures and emergency procedures, an internal review system and an organizational structure for radiographic operations which includes specified delegations of authority and responsibility for operation of the program. This program shall be approved by the Department before commencing industrial radiographic operations.
(b) The registrant shall notify the Department of intended changes to the registrant's radiation safety program and obtain Departmental approval.
Subchapter B. RADIATION-PRODUCING MACHINES
GENERAL ADMINISTRATIVE REQUIREMENTS § 225.71. Definitions.
The following words and terms, when used this subchapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * Field radiography--A location where radiographic operations are conducted (onsite or offsite) other than those designated as a permanent radiographic facility.
* * * * * Safety device--As applied to radiation-producing machines in this subchapter, a device or component that causes the unit to de-energize or interrupt the beam.
* * * * * [Temporary job site--A location where industrial radiography is performed for 180 days or less during any consecutive 12 months other than the location listed in a registration.]
§ 225.73. Training of personnel.
* * * * * (b) Persons performing [temporary job site] field radiography shall comply with the training requirements in [10 CFR 34, Subpart D (relating to radiation safety requirements)] Appendix A.
GENERAL TECHNICAL REQUIREMENTS § 225.82. Operating requirements.
(a) When radiographic operations are performed at a location other than a permanent radiographic installation, a minimum of two radiographic personnel shall be present to operate the X-ray device. At least one of the radiographic personnel shall be qualified as a radiographer. The other individual may be either a radiographer [or], a radiographer's assistant or a radiographer trainee.
* * * * * § 225.83. Records required at [temporary job] field radiography sites.
Each registrant or licensee conducting radiographic operations at a [temporary job] field radiography site shall maintain and have available for inspection by the Department at that job site, the following records or documents:
* * * * *
RADIATION-PRODUCING MACHINE REQUIREMENTS § 225.101. Cabinet X-ray systems and baggage/package X-ray systems.
* * * * * (d) The registrant shall [evaluate the cabinet X-ray system to assure compliance with 10 CFR 20.1301 and 21 CFR 1020.40 if the system is a certified cabinet X-ray system. Records of these evaluations shall be maintained for inspection by the Department while the system is in the possession of the registrant or until the evaluation is replaced by an update following modifications.] perform radiation surveys to demonstrate compliance with 10 CFR 20.1301 (relating to dose limits for individual members of the public) and maintain records of these surveys for inspection by the Department for 3 years:
(1) Upon installation of the equipment.
(2) Following a change in the initial arrangement, relocation of the unit, or following any maintenance requiring the disassembly or removal of any shielding component.
(3) When a visual inspection reveals an abnormal condition.
* * * * * § 225.102. Shielded room X-ray radiography.
* * * * * (b) [The registrant shall provide personnel monitoring equipment to every individual who operates, positions material for irradiation, or performs maintenance on a radiation-producing machine for shielded room X-ray radiography.
(c)] * * *
(c) As an alternative to subsection (b), the registrant may use an independent radiation monitoring system that displays the radiation intensity or displays when radiation levels have returned to their pre-irradiation levels.
(d) With the exception of the provisions of §§ 225.4a and 225.84 (relating to radiation safety program; and operating and emergency procedures), shielded room radiography is exempt from all other provisions of this chapter.
§ 225.103. [Temporary job] Field site radiography.
* * * * *
CHAPTER 226. LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING
GENERAL § 226.3a. Abandonment of a sealed source.
In addition to incorporation by reference of 10 CFR [Part 39 (relating to licenses and radiation safety requirements for well logging)] 39.15 and 39.77 (relating to agreement with well owner or operator; and notification of incidents and lost sources; abandonment procedures for irretrievable sources), the requirements of § 78.111 (relating to abandonment) shall also be met.
CHAPTER 227. RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT, X-RAY GAUGING EQUIPMENT, ELECTRON MICROSCOPES AND X-RAY CALIBRATION SYSTEMS
ANALYTICAL X-RAY EQUIPMENT § 227.11a. Equipment requirements.
(a) Open-beam configurations shall have a safety device which either prevents the entry of any portion of an individual's body into the primary X-ray beam path, or causes the beam to be terminated or interrupted upon entry into the path. A registrant may apply to the Department for an exemption from the requirement of a safety device. The application for an exemption shall include the following:
* * * * * (2) The reason each of these safety devices cannot be used.
* * * * * § 227.12a. Area requirements.
* * * * * (c) The local components of an analytical X-ray system shall be located and arranged and shall include sufficient shielding or access control so that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the limits given in [§ 219.51 (Reserved)] 10 CFR 20.1301 (relating to dose limits for individual members of the public). For systems utilizing X-ray tubes, these requirements shall be met at any specified tube rating.
* * * * * § 227.13a. Operating requirements.
* * * * * (d) Emergency procedures shall be written and posted near the equipment and shall list the names and telephone numbers of personnel to contact. The emergency procedures shall also provide information necessary to de-energize the equipment, such as location and operation of the power supply or circuit breakers.
§ 227.14. Personnel requirements.
(a) An individual may not operate or maintain analytical X-ray equipment unless the individual has received instruction in and demonstrated competence as to:
* * * * * (7) The applicable regulations of this article and those incorporated by reference.
* * * * * (c) Reported dose values may not be used for the purpose of determining compliance with [§ 219.31 (relating to occupational dose limits for adults)] 10 CFR 20.1201 (relating to occupational dose limits for adults) unless they are evaluated by a qualified expert.
* * * * *
CHAPTER 228. RADIATION SAFETY REQUIREMENTS FOR PARTICLE ACCELERATORS
GENERAL PROVISIONS § 228.2. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
Accelerator or particle accelerator--A radiation-producing machine that imports kinetic energies of one of the following:
* * * * * Filter--Material placed in the useful beam to [absorb the less penetrating radiation.] modify the spectral energy distribution and flux of the transmitted radiation and remove radiation that does not contribute to the efficacy of the useful beam.
* * * * * Particle accelerator--See the definition of ''accelerator.''
* * * * * [Qualified expert--An individual having the knowledge and training to measure ionizing radiation, to evaluate safety techniques and to advise regarding radiation protection needs. For example, individuals certified in the appropriate field by the American Board of Radiology, or the American Board of Health Physics or the American Board of Medical Physics or those having equivalent qualifications. With reference to the calibration of radiation therapy equipment, an individual having, in addition to the preceding qualifications, training and experience in the clinical applications of radiation physics to radiation therapy. For example, individuals certified in therapeutic radiological physics or X-ray and radium physics by the American Board of Radiology, or radiation oncology physics by the American Board of Medical Physics; or those having equivalent qualifications.]
* * * * *
ADMINISTRATIVE CONTROLS § 228.11a. Licensee responsibilities.
(a) A person may not possess, operate or permit the operation of an accelerator unless the accelerator and installation meet the applicable requirements of this article.
* * * * * [(d) Exposure of a personnel monitoring device to deceptively indicate a dose delivered to an individual is prohibited.]
§ 228.12. Information and maintenance record and associated information.
The licensee shall maintain records of surveys, calibrations, maintenance, machine malfunctions and modifications performed on the accelerators, including the names of persons who performed the services. The [registrant or] licensee shall keep these records for inspection by the Department for [4] 5 years.
NOTIFICATION AND LICENSING PROCEDURES § 228.21a. Notification and license requirements.
(a) A person who intends to purchase, construct or acquire an accelerator shall notify the Department of this intent by filing an application for a specific license within 30 days after the initial order is issued to obtain any or all parts of the accelerator.
(1) The application shall be filed in duplicate on a form prescribed by the Department and shall be accompanied by the required fee as described in § 218.11(d) (relating to registration, renewal of registration and license fees).
* * * * * (g) A license issued under this chapter may not be transferred, assigned or in any manner disposed of, either voluntarily or involuntarily, to any person except through submission of a written request by the licensee to the Department for approval.
§ 228.23a. Expiration and termination of a license.
* * * * * (d) If the licensee does not submit an application for license renewal under § 228.24a on or before the expiration date specified in the license, the licensee shall:
(1) Terminate the use of, and transfer or dispose of the accelerator.
* * * * * (3) Submit a completed Department Form [ER-BRP-314] 2900-PM-RP0314, ''Certificate of Disposition of Materials,'' describing the disposition of materials in paragraph (2).
* * * * *
GENERAL RADIATION SAFETY REQUIREMENTS § 228.31a. Limitations.
* * * * * (b) A licensee may not permit an individual to act as an operator of an accelerator until the individual:
* * * * * (2) Has received copies of and instruction in this chapter and Chapters 219 and 220 (relating to standards for protection against radiation; and notices, instructions and reports to workers; inspections and investigations), pertinent [registration and] license conditions and the licensee's operating and emergency procedures and demonstrated understanding thereof.
* * * * * § 228.32a. Shielding and safety design requirements.
(a) The licensee shall consult a qualified expert for radiation protection concerning the shielding design of an accelerator installation [and shall have the expert perform a radiation safety survey prior to the first use of the accelerator and when changes are made in shielding operations, equipment or occupancy of adjacent areas].
(b) An accelerator facility shall have primary and secondary protective barriers that are necessary to assure compliance with [§ 219.51 (Reserved)] 10 CFR Part 20 Subpart D (relating to dose limits for individual members of the public).
§ 228.34a. Accelerator controls and interlock systems.
* * * * * (b) Entrances into a target room or high radiation areas shall have interlocks that meet the requirements of [§§ 219.91 and 219.154 (Reserved)] 10 CFR Part 20 Subpart G (relating to control of exposure from external sources in restricted areas) and 10 CFR 20.1902 (relating to posting requirements). If the radiation beam is interrupted by a door opening, it shall be possible to reinitiate the radiation exposure only by closing the door first and then by manual action at the control panel.
* * * * * § 228.35. Operating procedures.
* * * * * (g) For accelerators used in the healing arts, operating procedures shall meet the following requirements:
* * * * * (4) [Misadministrations] A medical reportable event for radiation-producing machine therapy, as defined in § [215.2] 219.3 (relating to definitions), shall be reported as required under § 219.228 (relating to reports of medical reportable events for radiation-[prodicing] producing machine therapy [misadministrations]).
(5) [Only auxiliary personnel who have met the applicable radiologic requirements of 49 Pa. Code Part I, Subpart A (relating to occupational affairs) when employed by a licensed practitioner of the healing arts at the location at which the licensed practitioner practices shall be permitted to operate accelerators for therapeutic purposes.
(6) Only auxiliary personnel employed by a health care facility regulated by the Department of Health, the Department of Public Welfare or the Federal government shall be permitted to operate accelerator systems for therapeutic purposes in accordance with written job descriptions and employe qualifications.
(7)] An individual who operates an accelerator system shall be instructed adequately in the safe operating procedures and be competent in the safe use of the equipment. The instructions shall include, but not be limited to, items included in Appendix A (relating to determination of competence). There shall be continuing education in radiation safety, biological effects of radiation, quality assurance and quality control.
§ 228.37. Production of radioactive material.
(a) A licensee who produces radioactive material incidental to the operation of an accelerator shall comply with the general license requirements of § [217.48 (Reserved)] 217.144 (relating to incidental radioactive material produced by a particle accelerator).
(b) A licensee possessing radioactive material intentionally produced by bombarding nonradioactive material with the accelerator beam shall comply with the specific license requirements of [§§ 217.51--217.57 (Reserved)] Chapter 217 (relating to licensing of radioactive material).
§ 228.38. Radiation safety surveys.
(a) [A] Prior to first use, a facility shall have [an initial] a survey made by, or under the direction of, a qualified expert for radiation protection. A survey shall also be done after a change in the facility or equipment, including a relocation of the equipment within the irradiation or treatment room.
* * * * * (d) If the survey required by subsection (a) indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by [§ 219.31 or § 219.51 (Reserved)], 10 CFR 20.1201 (relating to occupational dose limits for adults) or 10 CFR 20.1301 (relating to dose limits for individual members of the public), the licensee shall do the following:
* * * * * § 228.39. Records.
In addition to the requirements of [§§ 219.201--219.211 (Reserved)] 10 CFR Part 20, Subpart L (relating to records), the licensee shall maintain:
* * * * *
RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL AND RESEARCH ACCELERATORS § 228.41a. Warning devices.
* * * * * (b) A high radiation area shall meet the requirements of [§ 219.91 (Reserved)] 10 CFR 20.1601 (relating to control of access to high radiation areas).
§ 228.43. Radiation surveys.
* * * * * (c) Area surveys shall be made in accordance with the written procedures established by a qualified expert for radiation protection or the radiation safety officer of the accelerator facility.
(d) Records of surveys shall be kept current and on file at an accelerator facility. Records of surveys shall be maintained as described in [Chapter 219, Subchapter L (Reserved)] 10 CFR Part 20, Subpart L (relating to records).
§ 228.44. Ventilation systems.
(a) A licensee shall control the concentration of radioactive material in air to meet the requirements of [§ 219.34 (Reserved)] 10 CFR 20.1204 (relating to determination of internal exposure).
(b) A licensee may not vent, release or otherwise discharge airborne radioactive material to an unrestricted area which does not meet the requirements of [§ 219.51 (Reserved)] 10 CFR 20.1301 (relating to dose limits for individual members of the public). Every reasonable effort shall be made to maintain releases of radioactive material to uncontrolled areas as far below these limits as practicable. Compliance with this section shall be demonstrated as described in [§ 219.52 (Reserved)] 10 CFR 20.1302 (relating to compliance with dose limits for individual members of the public).
RADIATION SAFETY REQUIREMENTS FOR ACCELERATORS USED IN THE HEALING ARTS § 228.61. Leakage radiation to the patient area.
(a) New equipment shall meet the following requirements:
* * * * * (2) For each system, the licensee shall determine or obtain from the manufacturer the leakage radiation existing at the positions specified in paragraph (1) for the specified operating conditions. The [registrant or] licensee shall maintain records for 5 years on leakage radiation measurements for inspection by the Department.
* * * * * § 228.75. Calibrations.
* * * * * (b) The calibration shall be performed by, or under the direct supervision of, a qualified expert for radiation therapy calibrations.
(c) Calibration radiation measurements required by subsection (a) shall be performed using a dosimetry system meeting the following specifications:
* * * * * (4) The system has had constancy checks performed on the system as specified by a qualified expert for radiation therapy calibrations.
* * * * * § 228.76. Spot checks.
Spot checks shall be performed on systems subject to this subchapter during full calibrations and thereafter once in each calendar month. The spot checks shall meet the following requirements:
(1) The procedures shall be in writing and [shall have been] developed by a qualified expert for radiation therapy calibrations.
* * * * *
APPENDIX A
DETERMINATION OF COMPETENCE [The following are areas in which an individual shall have expertise for the competent operation of radiation therapy equipment, the administration of radiation therapy treatment and determination of treatment portals:
(1) Familiarization with equipment.
(i) Identification of controls.
(ii) Function of each control.
(2) Radiation protection.
(i) Personnel protection.
(ii) Use of shielding blocks.
(iii) Understanding of dose units.
(iv) Grids.
(3) Film processing.
(i) Ability to produce quality films for use by a physician.
(ii) Knowledge of portal film exposure factors.
(iii) Film processing parameters.
(4) Procedures.
(i) Knowledge of anatomy and physiology.
(ii) Knowledge of patient immobilization devices to allow treatment with minimal patient movement.
(iii) Ability to position patient to allow for treatment of desired area.
(5) Emergency procedures.
(i) Termination of treatment in event of machine primary and secondary and dose monitoring system failure.
(ii) Termination of treatment in the event of patient movement during treatment.
(6) Continuing education. Continuing education annually to include radiation protection.]
The licensee shall ensure training on the subjects listed in Appendix A has been conducted. The individual shall be trained and competent in the general operation of the radiation therapy equipment and its functions, and in the following subject areas, as applicable to the procedures performed and the specific equipment utilized:
(1) Basic properties of radiation.
(2) Units of measurement.
(3) Sources of radiation exposure.
(4) Methods of radiation protection.
(5) Biological effects of radiation exposure.
(6) Medical accelerator operation.
(7) Treatment planning and execution.
(8) Patient positioning and protection.
(9) Operating and emergency procedures.
(10) Quality assurance.
(11) Regulations.
CHAPTER 230. PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL
Subchapter A. SCOPE AND DEFINITIONS § 230.3. Incorporation by reference.
* * * * * (b) Notwithstanding the requirements incorporated by reference, 10 CFR 71.2, 71.6, 71.13(c) and (d), 71.24, 71.31, 71.33, 71.35, 71.37, 71.38, 71.39, 71.41, 71.43, 71.45, [71.47,] 71.51, 71.52, 71.53, 71.55, 71.59, 71.61, 71.63, 71.64, 71.65, 71.71, 71.73, 71.74, 71.75, 71.77, [71.83,] 71.99 and 71.100 are not incorporated by reference.
CHAPTER 240. RADON CERTIFICATION
Subchapter A. GENERAL PROVISIONS
GENERAL § 240.2. Scope.
* * * * * (b) This chapter is in addition to, and not in substitution for, other applicable provisions of this article.
[Pa.B. Doc. No. 03-1731. Filed for public inspection August 29, 2003, 9:00 a.m.]
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