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RULE §289.227Use of Radiation Machines in the Healing Arts

(a) Purpose. This section establishes requirements for the use of radiation machines in the healing arts.

(b) Scope.

  (1) The registrant shall be responsible for directing the operation of the radiation machines under the administrative control of the registrant. The registrant shall assure that the requirements of this section are met in the operation of such radiation machines. All usage of such machines under this section shall be made by or under the supervision of a practitioner of the healing arts.

  (2) In addition to the requirements of this section, all registrants, unless otherwise specified, are subject to the requirements of §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections), §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services), §289.205 of this title (relating to Hearing and Enforcement Procedures), §289.226 of this title (relating to Registration of Radiation Machine Use and Services), and §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation).

  (3) The use of mammography radiation machines is subject to the requirements in §289.230 of this title (relating to Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography), and §289.234 of this title (relating to Mammography Accreditation). The use of dental radiation machines is subject to the requirements in §289.232 of this title (relating to Radiation Control Regulations for Dental Radiation Machines). However, dental radiation machines located in a facility that also has other healing arts radiation machines will be inspected at the intervals specified in §289.231(ll)(2) of this title, and equipment performance evaluations performed at the interval specified for a medical facility in subsection (o)(1) of this section. The use of radiation machines for veterinary medicine is subject to the requirements in §289.233 of this title (relating to Radiation Control Regulations for Radiation Machines in Veterinary Medicine).

  (4) An entity that is a "covered entity" as that term is defined in HIPAA (the Health Insurance Portability and Accountability Act of 1996, 45 Code of Federal Regulations, Parts 160 and 164) may be subject to privacy standards governing how information that identifies a patient can be used and disclosed. Failure to follow HIPAA requirements may result in the department making a referral of a potential violation to the U.S. Department of Health and Human Services.

(c) Prohibitions.

  (1) The agency may prohibit use of radiation machines that pose significant threat or endanger occupational and public health and safety, in accordance with §289.205 of this title and §289.231 of this title.

  (2) Individuals shall not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. This provision specifically prohibits intentional exposure for the following purposes:

    (A) exposure of an individual for training, demonstration, or other non-healing arts purposes;

    (B) exposure of an individual for the purpose of healing arts screening, except as authorized by §289.226(h) of this title; and

    (C) exposure of an individual for the purpose of research, except as authorized by §289.226(t)(1) of this title.

  (3) Non-image-intensified fluoroscopic systems shall not be used.

(d) Exemptions.

  (1) Portable x-ray systems designed to be hand-held are exempt from the requirements of subsection (i)(11) of this section. The portable radiation machine shall be held by the tube housing support or handle.

  (2) Individuals who are sole practitioners and sole operators and the only occupationally exposed individual are exempt from the following requirements:

    (A) §289.203(b) of this title, "Posting of notices to workers;"

    (B) §289.203(c) of this title, "Instructions to workers;" and

    (C) operating and safety procedures in accordance with subsection (i)(2) of this section.

  (3) Registrants are exempt from the posting of the radiation area requirements in §289.231(x)(1) of this title provided that the operator has continuous surveillance and access control of the radiation area.

(e) Definitions. The following words and terms, when used in this section, shall have the following meanings unless the context clearly indicates otherwise.

  (1) Accessible surface--The external surface of the enclosure or housing provided by the manufacturer.

  (2) Air kerma--The kinetic energy released in air by ionizing radiation. Kerma is the quotient of dE by dM, where dE is the sum of the initial kinetic energies of all the charged ionizing particles liberated by uncharged ionizing particles in air of mass dM. The SI unit of air kerma is joule per kilogram and the special name for the unit of kerma is the gray (Gy). For purposes of this section, when exposure in air measured in roentgen (R) is to be converted to dose in air measured in gray (Gy), a nationally recognized standard air conversion factor shall be used.

  (3) Aluminum equivalent--The thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question. The nominal chemical composition of type 1100 aluminum alloy is 99% minimum aluminum, 0.12% copper.

  (4) Attenuate--To reduce the exposure rate upon passage of radiation through matter.

  (5) Attenuation block--A block or stack, having dimensions 20 centimeters (cm) by 20 cm by 3.8 cm, of type 1100 aluminum alloy or other materials having equivalent attenuation. The nominal chemical composition of type 1100 aluminum alloy is 99% minimum aluminum, 0.12% copper.

  (6) Automatic exposure control (AEC)--A device that automatically controls one or more technique factors in order to obtain a required quantity of radiation at preselected locations (See definition for phototimer).

  (7) Automatic exposure rate control (AERC)--A device that automatically controls one or more technique factors in order to obtain a required quantity of radiation per unit time at preselected locations.

  (8) Barrier (See definition for protective barrier).

  (9) Beam axis--A line from the source through the centers of the x-ray fields.

  (10) Beam-limiting device--A device that provides a means to restrict the dimensions of the x-ray field.

  (11) Beam quality (diagnostic x-ray)--A term that describes the penetrating power of the x-ray beam. This is identified numerically by half-value layer and is influenced by kilovolt peak (kVp) and filtration.

  (12) Bone densitometer--A device intended for medical purposes to measure bone density and mineral content by x-ray transmission measurements through the bone and adjacent tissues.

  (13) Calibration of instruments--The comparative response or reading of an instrument relative to a series of known radiation values over the range of the instrument.

  (14) Category 1 continuing medical education units (CMEU)--Educational activities designated as Category I and approved by the Accreditation Council for Continuing Medical Education, the American Osteopathic Association, a state medical society, or an equivalent organization.

  (15) Central axis of the beam--A line passing through the virtual source and the center of the plane figure formed by the edge of the first beam-limiting device.

  (16) Certified x-ray systems--X-ray systems that have been certified in accordance with Title 21, Code of Federal Regulations (CFR).

  (17) Certified radiologist--A physician certified by the American Board of Radiology, the American Osteopathic Board of Radiology, the Royal College of Physicians and Surgeons of Canada, or Le College des Medecins du Quebec.

  (18) Coefficient of variation or C--The ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:

Attached Graphic

  (19) Collimator--A device or mechanism by which the x-ray beam is restricted in size.

  (20) Computed tomography (CT)--The production of a tomogram by the acquisition and computer processing of x-ray transmission data.

  (21) Computed tomography dose index (CTDI)--CTDI represents the average absorbed dose along the z-axis from a series of contiguous irradiations. CTDI approximates the average central dose values associated with a spatially complex dose distribution in a reference acrylic phantom for one particular set of exam techniques. CTDI is defined exclusively for axial scanning.

  (22) Control panel--The part of the radiation machine control upon which are mounted the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors.

  (23) CT conditions of operation--All selectable parameters governing the operation of a CT system including, but not limited to, nominal tomographic section thickness, filtration, and the technique factors as defined in this subsection.

  (24) CT gantry--The tube housing assemblies, beam-limiting devices, detectors, and the supporting structures and frames that hold these components.

  (25) Cumulative air kerma (CAK)--The air kerma accumulated at a specific point in space relative to the fluoroscopic gantry during a procedure. CAK does not include tissue backscatter and is measured in Gy. Some manufacturers identify CAK as cumulative dose (CD).

  (26) Diagnostic source assembly--The tube housing assembly with a beam-limiting device attached.

  (27) Diagnostic x-ray system--An x-ray system designed for irradiation of any part of the human body for the purpose of diagnosis or visualization.

  (28) Dose-area product (DAP)--Dose-area product is the integral of air kerma (absorbed dose to air) across the entire x-ray beam emitted from the x-ray tube. DAP is a surrogate measurement for the entire amount of energy delivered to the patient by the beam. DAP is measured in R x cm2 (cGy x cm2 ).

  (29) Dose-length product (DLP)--DLP is the CTDIvol multiplied by the scan length (slice thickness x number of slices) in centimeters. It reflects the total energy absorbed attributable to the complete scan acquisition but is independent of what is actually scanned.

  (30) Entrance exposure (Entrance air kerma)--The entrance exposure in air expressed in roentgens (R) or the entrance dose in air (air kerma) expressed in gray (Gy), measured at the point where the center of the useful beam enters the patient.

  (31) Entrance exposure rate (air kerma rate)--The exposure (air kerma) per unit time at the point where the center of the useful beam enters the patient.

  (32) Field emission equipment--Equipment that uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.

  (33) Field size--The dimensions along the major axes of an area in a plane perpendicular to the central axis of the beam at the normal treatment or examination source-to-image distance and defined by the intersection of the major axes and the 50% isodose line.

  (34) Filter--Material placed in the useful beam to preferentially absorb selected radiations.

  (35) Fluoroscopic system--A system in which x-ray photons produce a fluoroscopic image. It 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.

  (36) Fluoroscopically-Guided Interventional (FGI) Procedures--An interventional diagnostic or therapeutic procedure performed via percutaneous or other access routes, usually with local anesthesia or intravenous sedation, which uses external ionizing radiation in the form of fluoroscopy to localize or characterize a lesion, diagnostic site, or treatment site, to monitor the procedure, and to control and document therapy. FGI procedures may include but not be limited to:

    (A) TIPS creation (transjugular intrahepatic portosystemic shunt);

    (B) Embolization (any location, any lesion);

    (C) Stroke therapy;

    (D) Biliary drainage;

    (E) Angioplasty with or without stent placement;

    (F) Stent-graft placement;

    (G) Chemoembolization;

    (H) Angiography and intervention for gastrointestinal hemorrhage;

    (I) Carotid stent placement;

    (J) RF (radiofrequency) cardiac ablation;

    (K) Complex placement of cardiac EP (electrophysiology) devices; and


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