[47 Pa.B. 2722]
[Saturday, May 13, 2017]
[Continued from previous Web Page]
CHAPTER 221. X-RAYS IN THE HEALING ARTS
GENERAL PROVISIONS § 221.1. Purpose and scope.
This chapter establishes requirements for the use of X-ray equipment by or under the supervision of a licensed practitioner of the healing arts. A registrant or licensee who uses X-rays in the healing arts shall comply with this chapter. This chapter is in addition to, and not in substitution for, other applicable provisions of this article.
§ 221.2. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
AAPM—American Association of Physicists in Medicine.
Air kerma—Kerma in air.
Air kerma rate—Air kerma per unit time.
Aluminum equivalent—The thickness of type 1100 aluminum alloy—the nominal chemical composition of type 1100 aluminum alloy is 99% minimum aluminum, .12% copper—affording the same attenuation, under specified conditions, as the material in question.
Automatic exposure control—A device which automatically controls one or more technique factors [in order] to obtain at preselected locations a desired quantity of radiation.
Beam axis—A line from the source through the centers of the X-ray fields.
Beam-limiting device—A device providing a means to restrict the dimensions of the X-ray field.
[Certified components—Components of X-ray systems which are subject to regulations promulgated under the Radiation Control for Health and Safety Act of 1968 (42 U.S.C.A. §§ 263b—263n).]
CBCT—Cone beam computed tomography—A digital volume tomography method used in some imaging applications using two-dimensional digital detector arrays and a cone-shaped X-ray beam, instead of fan-shaped, that rotates around to generate a high-resolution 3D image with high geometric accuracy. Reconstruction algorithms can be used to generate images of any desired plane.
CINE—Cineradiography—A motion picture record of successive images appearing on a fluoroscopic screen.
CR—Computed radiography—A digital X-ray imaging method in which a photo-stimulable phosphor is used to capture and store a latent image. The latent image is read out by stimulating the phosphor with a laser. CR systems may use cassettes to house the phosphor or it may be integrated into a DR system.
CT—Computed tomography—The production of a tomogram by the acquisition and computer processing of X-ray transmission data.
Cephalometric device—A device intended for the radiographic visualization and measurement of the dimensions of the human head.
* * * * * Control panel—The part of the X-ray control upon which are mounted the switches, knobs, pushbuttons and other hardware necessary for manually setting the technique factors.
DDR—Direct digital radiography—An X-ray imaging method in which a digital sensor, usually incorporating a thin-film transistor, is used to capture an X-ray image. Some DDR systems use a scintillator to convert X-rays to light and a photodiode array to convert light to charge, while others use a photoconductor to convert X-rays directly to charge, which is stored on the thin-film transistor.
DR—Digital radiography—
(i) An X-ray imaging method (or radiography) which produces a digital rather than film projection image.
(ii) The term includes CR and DDR.
DRL—Diagnostic reference level—An investigational level, set as a standard by a recognized body (for example, the American College of Radiology, the American Association of Physicists in Medicine, the National Council on Radiation Protection and Measurements or similar), used to identify unusually high radiation doses for common diagnostic medical X-ray imaging procedures. DRLs are suggested action levels above which a facility should review its methods and determine if acceptable image quality can be achieved at lower doses. DRLs should not be applied to an individual patient.
Dead-man switch—A switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.
Dental panoramic system—A device intended to produce a radiographic image of both dental arches on one film.
Diagnostic source assembly—The tube housing assembly with a beam-limiting device attached.
Diagnostic X-ray system—An X-ray system designed for irradiation of a part of the human body for the purpose of diagnosis or visualization.
Direct supervision—A licensed practitioner of the healing arts who exercises general supervision and is present in the facility and immediately available to furnish assistance and direction throughout the performance of the procedure. The licensed practitioner does not have to be present in the room when the procedure is being performed.
Dose length product—The indicator of the integrated radiation dose from a complete CT examination. It addresses the total scan length by the following formula:
DLP (mGy − cm) = CTDIvol (mGy) × scan length (cm)
Electronic brachytherapy—A modality of radiation therapy where an electrically generated source of ionizing radiation is placed in or near the tumor or target tissue to deliver therapeutic radiation dosage. X-ray devices specifically designed and solely used to treat skin cancer lesions are not considered electronic brachytherapy devices under this definition and must meet the applicable parts of this title pertaining to registration and use.
Emerging technology—An innovative medical technology that uses an ionizing radiation source.
Entrance exposure rate—The exposure in air per unit time at the point where the center of the useful beam enters the patient.
FGI—Fluoroscopic-guided interventional procedures—An interventional diagnostic or therapeutic procedure performed by means of percutaneous or other access routes, usually with local anesthesia or intravenous sedation, which uses external ionizing radiation in the form of fluoroscopy to do all of the following:
(i) Localize or characterize a lesion, diagnostic site or treatment site.
(ii) Monitor the procedure.
(iii) Control and document therapy.
Field emission equipment—Equipment using an X-ray tube in which electrons are emitted from the cathode solely by the force between an electric field and the electrons.
Filter—Material placed in the useful beam to modify the spectral energy distribution and flux of the transmitted radiation and preferentially absorb selected radiation.
Filtration—The amount of material placed in the useful beam to modify the radiation's characteristics, typically expressed in terms of millimeters of aluminum or copper equivalent.
Fluoroscopic imaging assembly—A subsystem in which X-ray photons produce a fluoroscopic image. The term includes the image receptors such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.
Fluoroscopic system—See fluoroscopic imaging assembly.
Focal spot—The area projected on the anode of the X-ray tube by the electrons accelerated from the cathode and from which the useful beam originates.
General supervision—The overall direction and control of a licensed practitioner of the healing arts. The licensed practitioner is not required to be present during the performance of the procedure.
HVL—Half-value layer [(HVL)]—
(i) The thickness of specified material which attenuates the exposure rate by 1/2 when introduced into the path of a given beam of radiation. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.
(ii) The term is used to describe the penetrating ability of the radiation.
Healing arts screening—The testing of human beings using X-ray machines for the detection or evaluation of health indications when the tests are not specifically and individually ordered for the purpose of diagnosis or treatment by a licensed practitioner of the healing arts legally authorized to prescribe the X-ray tests.
Health physics—An application of physics concerned with protection of people and the environment from the biological effects of radiation.
High-risk procedure—Any radiologic procedure that utilizes energies of less than 1 million electron volts that could exceed skin doses of 200 rads.
IORT—Intraoperative radiation therapy—A modality of therapy in which therapeutic levels of ionizing radiation are applied to a target area, such as a cancer tumor, while the area is exposed during surgery.
Image intensifier—[A device] An image receptor with electronic amplification, installed in its housing, which instantaneously converts an X-ray pattern into a corresponding light image of higher energy density.
Image receptor—A device, such as a fluorescent screen or radiographic film, which transforms incident X-ray photons either into a visible image or into another form which can be made into a visible image by further transformations.
Intensifying screen—A fluorescent screen which transforms incident X-ray photons into a visible image.
Intraoral dental radiography—A modality of dental radiography in which the image receptor is placed inside a patient's oral cavity.
kV—Kilovolts
kVp—Peak tube potential (see kilovolts peak).
Kerma—A measure of energy transferred from radiation to matter and means kinetic energy released per unit mass. It is related to, but not the same as, absorbed dose. Unit of measure is gray.
Kilovolts peak (kVp)—The maximum value of the potential difference across the X-ray tube during an exposure.
* * * * * Line-voltage regulation—The difference between the no-load and the load line potentials expressed as a percent of the load line potential calculated using the following equation:
Percent line-voltage regulation = 100 (Vn − V1)/V1
where
Vn = No-load line potential and
V1 = Load line potential.
Low-risk procedure—Any radiologic procedure that is not a high-risk procedure.
mA—Milliampere.
mAs—Milliampere second.
mR—Milliroentgen.
Maximum line current—The root-mean-square current in the supply line of an X-ray machine operating at its maximum rating.
Medical physics—An application of physics that addresses the needs of medicine or health care. Subfields of medical physics include the following:
(i) Therapeutic medical physics.
(ii) Diagnostic medical physics or imaging.
(iii) Nuclear medical diagnostic or molecular imaging and therapy.
(iv) Medical health physics or radiation protection.
Mobile X-ray system—[see] See X-ray equipment.
Patient—An individual subjected to healing arts examination, diagnosis or treatment.
Peak tube potential—The maximum value of the potential difference across the X-ray tube during an exposure.
Performance phantom—A device specifically approved by the QMP or QE for evaluation of operational conformance with tolerances established by the QMP, QE or manufacturer.
Personal supervision—A licensed practitioner of the healing arts who exercises general supervision and is present in the room or adjacent control area during the performance of the procedure.
Phototimer—A method for controlling the radiation exposures to an image receptor by measuring the radiation which reaches a radiation monitoring device. The radiation monitoring device is part of an electronic circuit which controls the duration of time the tube is activated.
* * * * * Protective barrier—A barrier of radiation absorbing material used to reduce radiation exposure. The term includes the following types:
(i) Primary protective barrier—Material used to reduce radiation exposure from the useful beam.
(ii) Secondary protective barrier—Material used to reduce exposure from stray, leakage or scattered radiation.
QE—Qualified expert—The term as defined in § 215.2 (relating to definitions).
QMP—Qualified medical physicist—An individual who is competent to independently provide clinical professional services and practices only in health or radiological physics, or in the subfields of medical physics.
(i) A QMP meets all of the following credentials:
(A) Certified in the field of medical physics, radiological physics, medical health physics or health physics by an appropriate National certifying body recognized by the Department.
(B) Complies with the certifying body's requirements for continuing education and recertification.
(C) Provides clinical professional services and practices only in health/radiological physics or in one or more of the subfields of medical physics, consistent with the individual's training and experience, and in accordance with his respective certifying body's code of ethics.
(ii) An individual who does not meet the requirements of subparagraph (i) shall meet each of the following credentials to qualify as a QMP:
(A) Has earned a master's or doctoral degree, or both, in physics, medical physics, biophysics, radiological physics, health physics or equivalent disciplines from an accredited college or university.
(B) Has 3 years of documented relevant clinical training and experience in each of the subfields in the definition of ''medical physics,'' under the supervision of a QMP who is qualified to practice in the same subfield, for each of the areas in which the individual intends to practice.
(C) Completes the continuing education requirements of an applicable certifying body of health/radiological physics or in one or more of the subfields of medical physics in which the individual practices.
(iii) An individual who has been practicing as a QMP in health/radiological physics or in one or more of subfields of medical physics for at least 5 years prior to ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) is exempt from the requirements of subparagraphs (i) and (ii). Documentation of at least 5 years of practicing as a QMP in health/radiological physics or in one or more of the subfields of medical physics must be maintained for each of the fields or subfields, or both, in which the individual practices. As of ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) an individual who qualifies as a QMP under this subparagraph shall meet the continuing education requirements in subparagraph (ii)(C).
Radiation therapy simulation system—A radiographic or fluoroscopic X-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field.
Radiograph—An image receptor on which an image is created directly or indirectly by an X-ray pattern and results in a permanent record.
Radiographic imaging system—A system whereby an image is produced on an image receptor by the action of ionizing radiation.
Radiological physics—See health physics.
Rating—The operating limits specified by the component manufacturer.
Registrant—A person who is legally obligated to register with the Department under this article and the act.
Research—One of the following:
(i) Theoretical analysis, exploration or experimentation.
(ii) The extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental testing of models, devices, equipment, materials and processes. The term includes the external administration of X-ray radiation to human beings for diagnostic or therapeutic purposes or in an equivalent manner as a diagnostic or therapeutic procedure.
[SSD—The distance between the source and the skin of the patient.]
SID—Source-image receptor distance—The distance from the source to the center of the input surface of the image receptor.
SRDL—Substantial radiation dose level—An appropriately selected dose used to trigger additional dose-management actions during a procedure and medical follow-up for a radiation level that might produce a clinically relevant injury in an average patient.
SSD—The distance between the source and the skin of the patient.
Scattered radiation—Radiation that, during passage through matter, has been deviated in direction.
* * * * * Tube housing assembly—The tube housing with the X-ray tube installed. The term includes high-voltage or filament transformers, or both, and other appropriate elements when contained within the tube housing.
Unintended dose—A radiation dose in diagnostic or interventional X-ray resulting from an error in procedure or equipment malfunction.
Useful beam—The radiation which passes through the tube housing port and the aperture of the beam-limiting device when the exposure switch or timer is activated.
* * * * *
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 assure that the requirements of this article are met in the operation of the X-ray systems.
(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 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.
(1) The operator or the individual who supervises the operation of a high-risk procedure shall have additional instruction, including certification or registration in the applicable specialty by a professional organization recognized by the Department. Continuing education for high-risk procedures shall occur, at a minimum, every 2 years.
(2) Continuing education for all other (low-risk) procedures shall occur, at a minimum, every 4 years.
(c) [A chart] Protocol information, which specifies the techniques for examinations performed with the system, shall be provided in the vicinity of each diagnostic X-ray system's control panel. [This chart] The protocol shall include information pertinent to the particular examination, such as:
* * * * * (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[;], DRLs, image recording, processing and viewing[;], image quality and artifacts, and maintenance and modifications to the quality assurance program. For CT, each study shall be checked. If an artifact is present, the registrant shall take corrective action as appropriate. Records shall be maintained by the registrant for inspection by the Department for [3] 5 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.
(m) Neither the X-ray tube housing nor the collimating device may be [hand-held] handheld during the exposure unless specifically designed to be handheld.
(n) Functional damage to a patient organ or a physiological system that results from a prescribed causative procedure shall be reported to the Department as outlined in § 219.229 (relating to other medical reports).
(o) The registrant shall maintain records documenting the QMP's qualifications and compliance with continuing education requirements.
(Editor's Note: The following section is proposed to be added and printed in regular type to enhance readability.)
§ 221.16. Training, competency and continuing education.
(a) Training and competency. The registrant shall ensure that:
(1) An individual who operates X-ray equipment during diagnostic or interventional procedures or supervises the operation of X-ray equipment during a procedure is trained and competent in all of the following subject areas, as applicable to the procedures performed and the specific equipment utilized:
(i) Basic properties of radiation.
(ii) Units of measurement.
(iii) Sources of radiation exposure.
(iv) Methods of radiation protection for patients and others.
(v) Biological effects of radiation exposure.
(vi) Facility-specific and modality-specific X-ray equipment.
(vii) Facility-specific and modality-specific image recording and processing.
(viii) Patient exposure and positioning.
(ix) Facility-specific and modality-specific procedures.
(x) Facility-specific and modality-specific quality assurance.
(xi) Facility-specific and modality-specific dose reduction, monitoring and recording procedures.
(xii) Units of measurement and dose, such as dose-area product values, CT dose index and air kerma.
(xiii) Factors affecting fluoroscopic outputs.
(xiv) High-level control options.
(xv) Dose management including dose reduction techniques, monitoring and recording.
(xvi) Principles and operation of the specific fluoroscopic X-ray system to be used.
(xvii) Fluoroscopic and fluorographic outputs of each mode of operation on the system to be used clinically.
(xviii) Applicable State and Federal regulations.
(2) An individual who operates X-ray equipment during potentially high-risk diagnostic or interventional procedures or supervises the operation of X-ray equipment during these procedures is registered or credentialed and privileged in the applicable specialty by a professional organization recognized by the Department.
(3) Documentation demonstrating compliance with this section is maintained for inspection by the Department.
(b) Continuing education.
(1) The registrant shall ensure that individuals who operate X-ray equipment during diagnostic or interventional procedures or supervise the operation of X-ray equipment during a procedure complete continuing education in biological effects of radiation, quality assurance and quality control, and radiation safety, including concepts for minimizing patient and occupational dose and emerging technologies.
(i) An individual who performs low-risk procedures shall complete continuing education every 4 years.
(ii) An individual who performs high-risk procedures shall complete continuing education every 2 years. In addition to the topics in this paragraph, the continuing education must include facility and X-ray unit-specific methods to manage patient dose.
(2) Documentation of continuing education must be maintained for inspection by the Department for 5 years.
DIAGNOSTIC INSTALLATIONS GENERAL REQUIREMENTS § 221.21. Diagnostic equipment requirements.
(a) Diagnostic systems incorporating one or more certified components shall comply with 21 CFR 1020.30—1020.33.
(b) Equipment registered after ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) must comply with 21 CFR 1010.2 (relating to certification).
§ 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.
TABLE I
Filtration Required vs. Operating Voltage
Operating Voltage (kVp) Total Filtration (inherent plus added) (millimeters aluminum equivalent) Below 50 .5 millimeters 50—70 1.5 millimeters Above 70 2.5 millimeters
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]
X-Ray Tube Voltage (kilovolt peak)
Design Operating Range Measured Operating Potential Minimum HVL
(mm of Aluminum)Specified Dental Systems1 Other X-Ray Systems2 Other X-Ray Systems3 Below 51 30 1.5 0.3 0.3 40 1.5 0.4 0.4 50 1.5 0.5 0.5 51 to 70 51 1.5 1.2 1.3 60 1.5 1.3 1.5 70 1.5 1.5 1.8 Above 70 71 2.1 2.1 2.5 80 2.3 2.3 2.9 90 2.5 2.5 3.2 100 2.7 2.7 3.6 110 3.0 3.0 3.9 120 3.2 3.2 4.3 130 3.5 3.5 4.7 140 3.8 3.8 5.0 150 4.1 4.1 5.4 1 Dental X-ray systems designed for use with intraoral image receptors and manufactured after December 1, 1980. 2 Dental X-ray systems designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other X-ray systems subject to this section and manufactured before June 10, 2006. 3 All X-ray systems, except dental X-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006.
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 intraoral image receptors.]
(b) Beryllium window tubes shall have a minimum of 0.5 millimeter aluminum equivalent filtration permanently installed in the useful beam.
* * * * * § 221.35a. Fluoroscopic X-ray systems.
(a) General requirements. Fluoroscopic X-ray systems shall use an image intensifier and, in addition to the requirements of §§ 221.1—221.34a, shall meet the requirements of §§ 221.36a—221.38a (relating to limitation of useful beam of fluoroscopic equipment; activation of fluoroscopic tube; and entrance exposure rate).
(b) Operator qualifications. In addition to the applicable sections of these regulations, the operation of a fluoroscopic X-ray system for clinical purposes is limited to:
(1) A licensed practitioner working within his scope of practice.
(2) A Department-recognized radiologist assistant working within his scope of practice and under the direct supervision of a licensed practitioner working within his scope of practice.
(3) An individual who passed the American Registry of Radiologic Technologists exam or equivalent, holds a valid certification and is under the personal supervision of a licensed practitioner working within his scope of practice.
(4) A medical resident, radiologist assistant or radiologic technology student in training who is under the personal supervision of a licensed practitioner working within his scope of practice.
(c) QMP evaluations. Fluoroscopic equipment shall be evaluated by or under the direction of a QMP within 30 days after installation and after any maintenance of the system that may affect the exposure rate. Thereafter, evaluations shall be made at intervals not to exceed 14 months from the date of the prior evaluation by or under the direction of a QMP. At a minimum, evaluations shall include all of the following:
(1) A measurement of entrance exposure rates over a representative range of attenuating materials, including those that are expected to drive the system to maximum output in all modes clinically used, including fluoroscopy, high-level control, acquisition, digital subtraction and CINE, when available. Measurements shall be performed with a calibrated dosimetry system per manufacturer recommendations not to exceed 2 years and records maintained for 5 years for inspection by the Department. Measurements shall be made as follows:
(i) For systems without automatic exposure control, by utilizing an mA and kVp typical of the clinical use of the fluoroscopic system.
(ii) For systems with automatic exposure control, by utilizing sufficient attenuating material in the useful beam to produce an mA and kVp typical of the clinical use of the fluoroscopic system.
(2) A measurement and verification of compliance of maximum air kerma rate for fluoroscopy and high-level control, if available.
(3) An evaluation of high-contrast resolution and low-contrast resolution in both fluoroscopic and spot-film modes.
(4) An evaluation of the operation of the 5-minute timer, warning lights, interlocks and collision sensors.
(5) An evaluation of the beam quality and collimation in the fluoroscopy and spot-film modes.
(6) An evaluation of the availability and accuracy of technique indicators and integrated radiation dose displays.
(7) An evaluation of changes that may impact patient and personnel protection devices.
(d) Additional requirements for facilities performing FGI.
(1) The registrant utilizing FGI studies shall establish and implement written procedures, or procedures documented in an electronic reporting system, that include all of the following:
(i) Identification of individuals who are authorized to use fluoroscopic systems for interventional purposes.
(ii) A method to be used to monitor patient radiation dose during FGI.
(iii) Dose notification levels, as appropriate, at which the physician is notified for actions that may be taken for patient safety.
(iv) SRDL values referencing or consistent with Nationally-recognized standards.
(v) Actions to be taken for cases when an SRDL is exceeded, which may include patient follow-up.
(vi) A review of the established procedures at an interval not to exceed 12 months.
(2) Records of policies and procedures shall be maintained for inspection by the Department. If the registrant revises a policy or procedure, documentation shall be maintained that includes the justification for the revision.
(3) A record of radiation output information shall be maintained so the radiation dose to the skin may be estimated in accordance with established protocols. The record must include all of the following:
(i) Patient identification.
(ii) Type and date of examination.
(iii) Identification of the fluoroscopic system used.
(iv) Peak skin dose, cumulative air kerma or dose area product used if the information is available on the fluoroscopic system.
(4) If the peak skin dose, cumulative air kerma or dose area product is not displayed on the fluoroscopic system, records must include all of the following information necessary to estimate the radiation dose to the skin in accordance with established protocol or the following, as necessary:
(i) Fluoroscopic mode, such as high-level or pulsed mode of operation.
(ii) Cumulative fluoroscopic exposure time.
(iii) Number of films or recorded exposures.
(5) The registrant shall maintain records for 5 years for inspection by the Department.
INTRAORAL DENTAL RADIOGRAPHIC SYSTEMS (Editor's Note: The following section is proposed to be added and printed in regular type to enhance readability.)
§ 221.57. Facilities using CR or DR.
(a) When exposure indicators are available, the facility shall establish, document and post an acceptable range for the exposure values for examinations routinely performed at the facility. The indicated exposure values for each image shall be compared to the established range. Consistent deviations from established ranges shall be investigated, corrective actions taken as necessary and results documented.
(b) Facilities shall establish and follow an image QC program in accordance with the recommendations of a QMP, the system manufacturer or a Nationally-recognized organization.
(c) Facilities other than dental, podiatric and veterinary shall complete phantom image evaluation using a phantom approved by a QMP, system manufacturer or the Department. The evaluation shall be completed on a quarterly basis and include, at a minimum, all of the following:
(1) Artifacts.
(2) Spatial resolution.
(3) Contrast/noise.
(4) Workstation monitors.
(5) Exposure indicator constancy.
(d) In addition to subsections (a)—(c), CR facilities shall erase all CR cassettes, at a minimum, on a weekly basis.
(e) Dental and podiatric facilities shall maintain and operate photostimulable storage phosphor and DDR systems in accordance with manufacturer specifications.
(f) The facility shall maintain records for 5 years for inspection by the Department.
OTHER SYSTEMS § 221.61. Radiation therapy simulation systems.
(a) Fluoroscopic systems used solely for radiation therapy simulations shall only comply with §§ [221.35a] 221.35a(a) and (b), 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)] 221.202(h)(1), (7) and (8) and 221.203 (relating to equipment requirements; and facility design requirements).
(Editor's Note: Sections 221.63—221.65 are proposed to be added and printed in regular type to enhance readability.)
§ 221.63. Therapy imaging guidance systems.
(a) The QMP shall develop QC procedures and tolerances for therapy imaging guidance systems following Nationally-recognized standards or those recommended by the manufacturer.
(b) If a system is a CBCT, it must conform to the requirements of § 221.64 (relating to CBCT).
§ 221.64. CBCT.
(a) The following radiation measurements shall be evaluated annually and as soon as practical after a component repair or change which, in the opinion of the QMP, may affect the performance of the CBCT unit:
(1) Beam alignment. The X-ray field in the plane of the image receptor may not exceed beyond the edge of the image receptor by more than 2% of the SID, when the axis of the X-ray beam is perpendicular to the plane of the image receptor. In addition, the center of the X-ray field must be aligned with the center of the image receptor to within 2% of the SID.
(2) A performance evaluation shall be performed by or under the direct supervision of a QMP. The evaluation shall follow Nationally-recognized standards and tolerances or those recommended by the manufacturer. The evaluation shall be performed within 30 days of initial installation, at intervals not to exceed 12 months, and within 30 days after any change or replacement of components which, in the opinion of the QMP, could cause a change in the radiation output or image quality.
(3) The registrant shall document and implement QC guidelines in accordance with Nationally-recognized guidelines.
(4) The registrant shall document and implement a policy addressing deviations from established protocols.
(5) In addition to the requirements of § 221.16 (relating to training, competency and continuing education), the CBCT X-ray system shall only be operated by an individual who has been specifically trained in its operation.
(6) The facility shall maintain documentation of the established standards and tolerances and testing results for 5 years for inspection by the Department.
(b) The CBCT operator shall have instructions on all of the following:
(1) Performing routine QC, including the use of the CBCT phantom.
(2) A schedule of routine QC appropriate for the system.
(3) Allowable variations set by the QMP, if required, for the indicated parameters.
(4) The results of at least the most recent routine QC completed on the system.
(c) CBCT systems capable of operating at no greater than 100 kV or 20 mA are exempt from an annual QMP performance evaluation.
§ 221.65. X-ray attenuation systems.
CT systems solely used to calculate attenuation coefficients or for image registration in nuclear medicine studies must meet the requirements in §§ 221.202—221.205 unless otherwise exempted as follows:
(1) Section 221.202(a) (relating to equipment requirements) is exempted.
(2) Instead of § 221.204(a) (relating to performance evaluations, routine QC and surveys), the registrant shall complete a performance evaluation on the CT system following the recommendations of a QMP, the system manufacturer or a Nationally-recognized organization at intervals not to exceed 14 months.
(3) Section 221.204(a)(4)(xi) is exempted.
(4) Instead of § 221.204(b), checks shall be established and documented by the registrant following Nationally-recognized guidelines or those recommended by the manufacturer.
THERAPEUTIC X-RAY SYSTEMS WITH ENERGIES LESS THAN 1 MEV § 221.71. Equipment requirements.
* * * * * (m) Unless it is possible to bring the X-ray output to the prescribed exposure parameters within 5 seconds, the entire useful beam shall be automatically attenuated by a shutter having a lead equivalency not less than that of the tube housing assembly.
(1) After the unit is at operating parameters, the shutter shall be controlled electrically by the operator from the control panel.
(2) An indication of shutter position must appear at the control panel.
(n) Electronic brachytherapy devices are exempt from the requirements in subsections (k)—(m).
COMPUTED TOMOGRAPHY X-RAY SYSTEMS § 221.201. Definitions.
In addition to the definitions in §§ 215.2 and 221.2 (relating to definitions), the following words and terms, when used in this section and §§ 221.202—221.205, have the following meanings, unless the context clearly indicates otherwise:
Alert value—A dose index value (for example, CTDIvol (mGy) or of DLP (mGy-cm)) that is set by the registrant or licensee, or both, to trigger an alert to the operator prior to scanning within an ongoing examination. The alert value represents a value well above the registrant's or licensee's established range for the examination that warrants more stringent review and consideration before proceeding.
CS—Contrast scale—The change in the linear attenuation coefficient per CT number relative to water; that is:
CS = (Ux - Uw)/((CT)x - (CT)w)
Where:
Ux = Linear attenuation coefficient of the material of interest
Uw = Linear attenuation coefficient of water
(CT)x = CT number of the material of interest
(CT)w = CT number of water
[CT number—The number used to represent the X-ray attenuation associated with each elemental area of the CT image.]
CT—Computed tomography—The production of a tomogram by the acquisition and computer processing of X-ray transmission data.
CT conditions of operation—The selectable parameters governing the operation of a CT X-ray system including, but not limited to, nominal tomographic section thickness, filtration and the technique factors as defined in this chapter.
CT dosimetry phantom—The phantom used for determination of the dose delivered by a CT X-ray system.
CT number—The number used to represent the X-ray attenuation associated with each elemental area of the CT image:
where:
k = A constant, a normal value of 1,000 when the Hounsfield scale of CTN is used.
µx = Linear attenuation coefficient of the material of interest.
µw = Linear attenuation coefficient of water.
CTDI—Computed tomography dose index—
(i) The integral of the dose profile along a line perpendicular to the tomographic plane divided by the product of the nominal tomographic section thickness and the number of tomograms produced in a single scan.
where:
z = Position along a line perpendicular to the tomographic plane.
D(z) = Dose at position z.
T = Nominal tomographic section thickness (cm).
N = Number of tomograms produced in a single scan.
(ii) This definition assumes that the dose profile is centered around z = 0 and that, for a multiple tomogram system, the scan increment between adjacent scans is NT.
[CT conditions of operation—The selectable parameters governing the operation of a CT X-ray system including, but not limited to, nominal tomographic section thickness, filtration and the technique factors as defined in this chapter.]
CTDI100—An accumulated multiple scan dose at the center of a 100-mm scan that requires integration of the radiation dose profile from a single axial scan over specific integration limits. In the case of CTDI100, the integration limits are +50 mm, which corresponds to the 100-mm length of the commercially available ''pencil'' ionization chamber. CTDI100 is acquired using a 100-mm long, 3-cc active volume CT ''pencil'' ionization chamber, one of the two standard CTDI acrylic phantoms (16 and 32 cm diameter) and a stationary patient table.
CTDIvol—Volume Computed Tomography Dose Index—A radiation dose parameter derived from the CTDIw (weighted or average CTDI given across the field of view), that is:
CTDIvol = (N)(T)(CTDIw)/I,
where:
N = number of simultaneous axial scans per X-ray source rotation,
T = thickness of one axial scan (mm), and
I = table increment per axial scan (mm).
Thus,
CTDIvol = (1 / pitch) × CTDIw
CTDIw—Weighted Computed Tomography Dose Index—The estimated average CTDI100 across the field of view. The equation is:
CTDIw = 1/3 CTDI100.center + 2/3 CTDI100.edge
Where 1/3 and 2/3 approximate the relative areas represented by the center and edge values derived using the 16 cm or 32 cm acrylic phantom. CTDIw uses CTDI100 and an f-factor for air (0.87 rad/R or 1.0 mGy/mGy).
Detector—A device that provides a signal or other indication suitable for measuring one or more quantities of incident radiation.
Dose profile—The dose as a function of position along a line.
Elemental area—The smallest area within a tomogram for which the X-ray attenuation properties of a body are depicted.
Gantry—The tube housing assemblies, beam-limiting devices, detectors, transformers, if applicable, and the supporting structures and frames which hold these components.
Lux—A unit illumination equivalent to 1 lumen per square centimeter or .0929 foot-candles.
[MSAD—Multiple scan average dose—The calculated average dose to the tissue within each slice in a series utilizing an ion chamber. The MSAD is calculated using the following equation:
MSAD = (F × K × L × E)/(T × N)
Where
F = Factor to convert exposure in air to absorbed dose in lucite in RADS/mR
K = Calibration factor to account for the ion chamber's response and volume.
L = Effective length of ion chamber in millimeters (mm)
E = Exposure reading in milliroentgen (mR)
T = Nominal slice thickness in millimeters (mm) and
N = Number of slices per scan]
Modulation transfer function—The modulus of the Fourier transform of the impulse response of the system.
Multiple tomogram system—A [computed tomography] CT X-ray system which obtains X-ray transmission data simultaneously during a single scan to produce more than one tomogram.
Noise—The standard deviation of the fluctuations in the CT number expressed as a percentage of the attenuation coefficient of water. Its estimate (Sn) is calculated using the following expression:
Sn = 100 × CS × S/Uw
Where:
CS = Contrast scale
Uw = Linear attenuation coefficient of water.
S = Estimated standard deviation of the CT number of picture elements in a specified area of the CT image.
Nominal tomographic section thickness—The full-width at half-maximum of the sensitivity profile taken at the center of the cross-sectional volume over which X-ray transmission data are collected.
Notification value—A dose index value (for example, CTDIvol (mGy) or DLP (mGy-cm)) that is set by the registrant to trigger a notification to the operator prior to scanning when the dose index exceeds the established range for the examination.
Performance phantom—A phantom which has a capability of providing an indication of [contrast scale] CS, noise, nominal tomographic section thickness, the resolution capability of the CT system for low and high contrast objects, and measuring the mean CT number for water or other reference materials.
* * * * * § 221.202. Equipment requirements.
(a) Accreditation. All diagnostic CT X-ray systems must be accredited by an accrediting organization recognized by the Department within 1 year from first patient use.
(b) Technical and safety information. The technical and safety information relating to the conditions of operation, dose information and imaging performance provided by the CT manufacturer shall be maintained by the facility and readily accessible to the operators.
[(a)] (c) Termination of exposure. The operator shall be able to terminate the X-ray exposure at any time during a scan, or series of scans under X-ray system control, of greater than 0.5 second duration. Termination of the X-ray exposure shall necessitate resetting of the conditions of operation prior to initiation of another scan.
[(b)] (d) Tomographic plane indication and alignment.
(1) For any single tomogram system, a means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.
(2) For any multiple tomogram system, a means shall be provided to permit visual determination of the location of a reference plane. This reference plane may be offset from the location of the tomographic plane.
[(c)] (e) Status indicators and control switches.
(1) The CT X-ray control and gantry shall provide visual indication whenever X-rays are produced and, if applicable, whether the shutter is open or closed.
(2) The emergency buttons or switches shall be clearly labeled as to their function.
(3) Each individual scan or series of scans shall require initiation by the operator.
[(d)] (f) Indication of CT conditions of operation. The CT X-ray system shall be designed so that the CT conditions of operation to be used during a scan or a scan sequence are indicated prior to the initiation of a scan or a scan sequence. On equipment having all or some of these conditions of operation at fixed values, this requirement may be met by permanent markings. Indication of CT conditions of operation shall be visible from any position from which scan initiation is possible.
[(e)] (g) Leakage radiation. The leakage radiation from the diagnostic source assembly measured at a distance of 1 meter in any direction from the source may not exceed 100 milliroentgens (25.8 µC/kg) in 1 hour when the X-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.
[(f)] (h) Additional requirements applicable to CT X-ray systems containing a gantry manufactured after September 3, 1985.
(1) The total error in the indicated location of the tomographic plane or reference plane by the light field or laser indicator may not exceed 5 millimeters.
(2) If the X-ray production period is less than 0.5 second, the indication of X-ray production shall be actuated for at least 0.5 second. Beam-on and shutter status indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.
(3) The CT X-ray system shall be normalized to water.
(4) The CT number for water for a region of interest, not exceeding 100 square millimeters, shall be 0 ± [10.0] 7.0 CT number units. The facility's performance phantom shall be utilized, with the technique factors specified by the [qualified expert] QMP, to confirm compliance. In instances when a CTN of 0 for water is inappropriate, as in 3D treatment planning, the [qualified expert] QMP may establish and maintain an equivalent value.
(5) With the performance phantom, the mean CT number of water of one group of pixels may not differ from the mean CT number of water of a second group of pixels equal size within the same image by more than the manufacturer's published specifications, or those established by the QMP.
(6) The noise, utilizing the facility's performance phantom, may not exceed the manufacturer's published specifications.
(7) The total error between the indicated and actual slice thickness may not exceed 2.0 millimeters.
(8) A distance of at least 100 millimeters measured in a CT image shall agree with the actual distance to within ± 5%.
(9) Premature termination of the X-ray exposure by the operator shall necessitate resetting the CT conditions of operation prior to the initiation of another scan.
§ 221.204. [Radiation measurements and performance evaluations] Performance evaluations, routine QC and surveys.
[(a) Radiation measurements.
(1) The CTDI or 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.
(2) CT dosimetry phantoms shall be used in determining the radiation output of a CT X-ray system. The phantoms shall meet the definition for a CT dosimetry phantom under 21 CFR 1020.33(b)(6) (relating to computed tomography (CT) equipment).
(i) The phantoms shall be specifically designed for CT dosimetry and deemed appropriate by the facility's qualified expert and the Department.
(ii) CT dosimetry phantoms shall provide a means for the placement of dosimeters along the axis of rotation and along a line parallel to the axis of rotation 1.0 centimeter from the outer surface and within the phantom. The means for the placement of dosimeters or alignment devices at other locations may be provided.
(iii) Any effects on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom.
(iv) Dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present.
(3) In addition to the items in subsection (b), the following items shall be evaluated annually or after any component repair or change which in the opinion of the qualified expert may effect the performance of the CT unit:
(i) HVL (half value layer) determination at the most commonly used kVp or 120 kVp.
(ii) CTDI or MSAD as specified in § 221.201 (relating to definitions) for commonly used techniques.
(iii) Tomographic plane indication (light/laser alignment).
(iv) Slice thickness as specified in § 221.202(g)(7) (relating to equipment requirements).
(v) Distance readout calibration.
(4) The measurement of the radiation output of a CT X-ray system shall be performed with a dosimetry system that has calibration traceable to National Institute of Standards and Technology. The calibration of the system shall be in accordance with an established calibration protocol. The calibration protocol published by the AAPM is accepted as an established protocol. Other protocols which are equivalent will be accepted, but the user shall submit that protocol to the Department for concurrence that the protocol is equivalent.
(5) An mR/mAs value shall be determined at least annually for the head and body.
(6) Procedures and results shall be maintained for 5 years and be available for review by the Department.]
(a) Performance evaluations.
(1) The performance evaluation of the CT X-ray system shall be performed by or under the direction of a QMP.
(2) Evaluation standards and tolerances shall be established by a QMP and maintained by the facility. These standards and tolerances must meet Nationally-recognized standards and tolerances for the CT X-ray system.
(3) The performance evaluation of a CT X-ray system shall be performed after initial installation and before use on human patients. Thereafter, the evaluation shall be made at intervals not to exceed 14 months.
(4) The performance evaluation must include all of the following:
(i) Geometric factors and alignment, including alignment light accuracy and table incrementation accuracy.
(ii) Slice localization from scanned projection radiograph (localization image).
(iii) Slice thickness.
(iv) Image quality including high-contrast (spatial) resolution, low-contrast resolution, image uniformity, noise and artifact evaluation.
(v) CT number accuracy.
(vi) Image quality for acquisition workstation display devices (video and hard copy when applicable).
(vii) A review of the results of the routine QC required under subsection (b).
(viii) A safety evaluation of audible and visual signals and posting requirements.
(ix) A review of commonly used CT protocols along with the evaluation for appropriateness of dose and image quality, in comparison with the older protocols. The review should be by the QMP along with the radiologist and lead CT technologist.
(x) For dosimetry, a review of the protocols deemed appropriate by the QMP which could result in significant doses. This review must include acquisition and reconstruction parameters, and radiation dose. At a minimum, the QMP shall review the following clinical protocols, if performed, at intervals not to exceed 14 months:
(A) Pediatric head (1 year of age).
(B) Pediatric abdomen (5 years of age; 40—50 lbs. (about 20 kg)).
(C) Adult head.
(D) Adult abdomen (70 kg).
(E) Brain perfusion.
(xi) Review DRL, notification values and alert values for the procedures reviewed under subparagraph (x).
(xii) Review actions to be taken when a dose alert value is exceeded including patient follow-up.
(xiii) Review the process determining who has access and authority to make changes to the protocol management systems, including a policy or procedure to prevent inadvertent or unauthorized modifications to a CT protocol.
(5) A performance evaluation shall be made within 30 days after any change or replacement of components which, in the opinion of the QMP, could cause a change in the radiation output or image quality.
(6) Dose measurements of a CT unit shall be performed with a calibrated dosimetry system. The calibration of the system shall be traceable to a National standard. The dosimetry system must have been calibrated within the preceding 2 years.
(b) [Performance evaluations] Routine QC.
(1) Written [performance evaluation] routine QC procedures shall be developed by a [qualified expert] QMP. These procedures shall be available for review by the Department.
(2) The [performance evaluation procedures shall include at least] routine QC procedures must include, at a minimum, all of the following using the facility's performance phantom:
(i) Noise.
[(ii) Contrast scale.
(iii) Spatial resolution (low and high contrast).
(iv)] (ii) Mean CT number for water.
[(v) Acceptable tolerances.]
(iii) Artifact evaluation.
(3) [The performance evaluation shall be performed at intervals not to exceed 3 months by the qualified expert or an individual designated by the qualified expert.] The routine QC shall be performed at intervals not to exceed 1 week.
(4) [The qualified expert need not be present during the performance evaluation, but shall be informed within 48 hours of any problems or unacceptable deviations.] The QMP need not be present during the routine QC.
(5) [Performance evaluations] Routine QC shall include acquisition of images obtained with the performance phantom using the same processing mode and CT conditions of operation as are used to perform the measurements required by subsection (a).
[(6) Records of the performance evaluations shall be maintained for inspection by the Department for at least 4 years.]
(c) Radiation protection surveys.
(1) All CT X-ray systems installed after ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) and those systems not previously surveyed shall have a survey performed by or under the direction of a QMP. In addition, a survey shall be performed after a change in the facility or equipment which might cause a significant increase in radiation hazard.
(2) The registrant shall obtain a written report of the survey from the QMP, and a copy of the report shall be made available to the Department upon request.
(d) Records. Records of the performance evaluations and surveys shall be maintained for inspection by the Department for at least 5 years. Routine QC records shall be maintained for at least 1 year.
§ 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:
(1) The dates of the latest radiation measurements and performance evaluation and the location within the facility where the results of those tests may be obtained.
(2) Instructions on the use of the CT phantoms including a schedule of performance evaluations appropriate for the system, allowable variations for the indicated parameters and the results of at least the most recent performance evaluation conducted on the system.
(3) 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.]
(a) In addition to the training requirements in § 221.16 (relating to training, competency and continuing education), a CT X-ray system shall be operated only by an individual who has been specifically trained in its operation.
(b) All of the following information must be readily available to the CT operator:
(1) Instructions on the use of the CT phantoms and a process for reporting deviations in protocols including a schedule of routine QC appropriate for the system, allowable variations for the indicated parameters and the results of at least the most recent performance evaluation conducted on the system.
(2) Current protocol information available at the control panel which specifies for each routine examination the CT conditions of operation.
[(b)] (c) If the radiation measurements and performance evaluation of the CT X-ray system indicates that a system operating parameter has exceeded a tolerance established by the [qualified expert] QMP, the use of the CT X-ray system on patients shall be limited to those uses permitted by established written instructions of the [qualified expert] QMP.
CHAPTER 223. VETERINARY MEDICINE
GENERAL PROVISIONS § 223.1. Purpose and scope.
This chapter establishes radiation safety requirements for persons utilizing radiation sources in veterinary medicine. Persons who use radiation sources for veterinary medicine or research on animals shall comply with this chapter. The requirements of this chapter are in addition to and not in substitution for other applicable requirements of this article.
RADIOACTIVE MATERIAL § 223.22. Sealed and unsealed sources.
A veterinarian who uses sealed or unsealed sources for therapeutic treatment of animals shall comply with [10 CFR Part 35, Subparts F, G, H and K but is exempt from 10 CFR 35.632—35.645 and 35.2632—35.2645] 10 CFR Part 30 and 31.11 (relating to rules of general applicability to domestic licensing of byproduct material; and general license for use of byproduct material for certain in vitro clinical or laboratory testing).
ADMINISTRATIVE CONTROLS (Editor's Note: The following section is proposed to be added and printed in regular type to enhance readability.)
§ 223.31. Registrant responsibilities.
(a) The registrant is responsible for directing the operation of X-ray systems under the registrant's administrative control and shall assure that the requirements of this article are met for the operation of the X-ray systems.
(b) A person who operates an X-ray system shall be instructed adequately about safe X-ray operating procedures and be competent in the safe use of X-ray equipment. The instructions must include the subjects listed in Chapter 221, Appendix A (relating to determination of competence). The person shall receive continuing education at least every 4 years in radiation safety, biological effects of radiation, species-specific positioning techniques, QA and QC.
(c) Written safety procedures and rules shall be available at the facility and include restrictions of the operating technique required for the safe operation of the particular X-ray system. The operator shall be able to demonstrate familiarity with these procedures and rules.
(d) Only the staff, ancillary facility personnel or other persons required for the medical procedure or training may be in the room during the radiographic exposure. All of the following requirements apply to persons involved with the examination:
(1) An individual or extremity may not be positioned in the useful beam unless required to conduct the procedure.
(2) Individuals shall be positioned so that no part of the body will be struck by the useful beam unless protected by at least 0.5 millimeter lead equivalent material. The lead equivalent of the material is to be determined at 60 kV.
(3) Each person shall be protected from stray radiation by protective aprons or whole protective barriers of at least 0.25 millimeter lead equivalent or shall be positioned so that no person is 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.
(e) If an animal or image receptor requires auxiliary support during a radiation exposure, all of the following requirements apply:
(1) Mechanical holding devices or chemical restraint shall be used when the technique permits.
(2) An individual may not be used routinely to hold image receptors or subjects. Procedures and auxiliary equipment designed to minimize personnel exposure commensurate with the needed diagnostic information shall be used.
(3) An individual who holds the animal or image receptor shall be protected as required under subsection (d).
(f) The registrant shall have a QA program. The QA program must 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 QA program must address radiation safety to personnel and modifications to the QA program.
(g) Neither the X-ray tube housing nor the collimating device may be handheld during the exposure unless specifically designed and shielded to be handheld.
(h) CT systems used solely for nonhuman imaging are exempt from §§ 221.202—221.205.
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