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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER EREGISTRATION REGULATIONS
RULE §289.226Registration of Radiation Machine Use and Services

(a) Purpose.

  (1) This section provides for the registration of persons using radiation machines and persons who are in the business of providing radiation machine services.

  (2) Requirements for the registration of persons using radiation machines.

    (A) No person shall use radiation machines except as authorized in a certificate of registration issued by the Department of State Health Services (department) per the requirements of this section.

    (B) A person who receives, possesses, uses, owns, or acquires radiation machines before receiving a certificate of registration is subject to the requirements of this chapter.

(b) Scope.

  (1) In addition to the requirements of this section, all registrants are subject to the requirements of:

    (A) §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections);

    (B) §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services);

    (C) §289.205 of this title (relating to Hearing and Enforcement Procedures); and

    (D) §289.231 of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation).

  (2) Registrants using radiation machines in the healing arts are also subject to the requirements of §289.227 of this title (relating to Use of Radiation Machines in the Healing Arts). Morgues, educational facilities, and forensic medicine or investigations utilizing radiation machines for non-human use are subject to the specific requirements of §289.227 of this title.

  (3) Registrants using analytical and other industrial radiation machines, such as x-ray equipment used for cathodoluminescence, ion implantation, gauging, or electron beam welding, are subject to the requirements of §289.228 of this title (relating to Radiation Safety Requirements for Industrial Radiation Machines).

  (4) Registrants using accelerators, therapeutic radiation machines, simulators, and electronic brachytherapy devices are also subject to the requirements of §289.229 of this title (relating to Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices).

  (5) Registrants using mammography radiation machines are also subject to the requirements of §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).

  (6) Registrants using radiation machines in industrial radiographic operations are also subject to the requirements of §289.255 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography).

  (7) Registrants using radiation machines in dental medicine are subject to the requirements of §289.232 of this title (relating to Radiation Control Regulations for Dental Radiation Machines).

  (8) Registrants using radiation machines in veterinary medicine are subject to the requirements of §289.233 of this title (relating to Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine).

  (9) Registrants using laser radiation machines are subject to the requirements of §289.301 of this title (relating to Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices).

  (10) To determine compliance with the requirements in this chapter for radiation machines, all radiation air kerma rate or dose measurements for fluoroscopy or computed tomography radiation machines shall be performed by a licensed medical physicist with a specialty in diagnostic medical physics.

  (11) For purposes of this section, radiation services include:

    (A) measurement of air kerma rate or dose measurements on radiation machines that are not for human use;

    (B) measurement of air kerma for human-use, general radiographic and special purpose radiation machines, as defined in §289.227 and §289.229 of this title, by or under the supervision of a licensed medical physicist;

    (C) performance of services specified in paragraph (10) of this subsection or services requiring a licensed medical physicist as specified in §289.227(e) and §289.229 of this title on radiation machines for human use;

    (D) demonstration and sale of radiation machines or imaging acquisition systems that require the individual to operate a radiation machine or cause a radiation machine to be energized;

    (E) assembly, installation or repair of a radiation machine to ensure it is operating according to manufacturer's specifications;

    (F) completion of equipment performance evaluations (EPE) on dental radiation machines and machines used in veterinary medicine; and

    (G) provision of radiation machines to a facility for limited periods.

  (12) For purposes of this section, a person providing the services described in paragraph (11)(G) of this subsection is a provider of equipment.

  (13) For purposes of this section, a practitioner of the healing arts is a person licensed to practice healing arts by either the Texas Medical Board as a physician, the Texas Board of Chiropractic Examiners, or the Texas State Board of Podiatric Medical Examiners.

  (14) For purposes of this section, a physician is an individual licensed by the Texas Medical Board.

  (15) For purposes of this section, a certified physician is a physician licensed by the Texas Medical Board and certified in radiation oncology or therapeutic radiology.

  (16) For purposes of this section, veterinary-use is the use of a radiation machine for the practice of veterinary medicine as defined by Texas Occupations Code Chapter 801. Animal research is not considered veterinary-use.

  (17) This section does not apply to an entity under the jurisdiction of the federal government.

(c) Prohibitions.

  (1) No person shall cause the operation of a radiation machine that results in exposure of an individual to the useful beam for training, demonstration, or other non-healing arts purposes.

  (2) No person shall use radiation machines or perform radiation machine services except as authorized in a certificate of registration issued by the department per the requirements of this section.

  (3) Radiation machines shall be designated for human-use or veterinary-use but shall not be designated for both unless one of the following conditions are met:

    (A) the machine use is for human research conducted per subsection (u) of this section; or

    (B) the facility has applied for and received written authorization from the department.

(d) Exemptions.

  (1) Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this section, provided that the dose equivalent rate averaged over an area of 10 square centimeters (cm2 ) does not exceed 0.5 millirem per hour (mrem/hr)(0.005 mSv per hour (mSv/hr)) at 5 centimeters (cm) from any accessible surface of such equipment. The production, testing, or factory servicing of such equipment shall not be exempt.

  (2) Radiation machines in transit or storage incident to transit are exempt from the requirements of this section. This exemption does not apply to the providers of radiation machines for mobile services.

  (3) Facilities that have placed all radiation machines in storage, including on-site storage secured from unauthorized use or removal, and have notified the department in writing, are exempt from the requirements of this section. This exemption is void if any radiation machine is energized resulting in the production of radiation. Before resuming use of the machine(s) for human use, the machine shall meet all requirements of this section.

  (4) Inoperable radiation machines are exempt from the requirements of this section. For this section, an inoperable radiation machine means a radiation machine that cannot be energized when connected to a power supply without repair or modification.

  (5) Domestic television receivers, video display terminals, transmission microscopes, and electron microscopes, including the servicing of such devices, are exempt from the requirements of this section.

Cont'd...

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