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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER FLICENSE REGULATIONS
RULE §289.256Medical and Veterinary Use of Radioactive Material

(a) Purpose.

  (1) This section establishes requirements for the medical and veterinary use of radioactive material and for the issuance of specific licenses authorizing the medical and veterinary use of radioactive material. Unless otherwise exempted, no person shall manufacture, produce, receive, possess, use, transfer, own, or acquire radioactive material for medical or veterinary use except as authorized in a license issued in accordance with this section.

  (2) A person who manufactures, produces, receives, possesses, uses, transfers, owns, or acquires radioactive material prior to receiving a license is subject to the requirements of this chapter.

  (3) A specific license is not needed for a person who:

    (A) receives, possesses, uses, or transfers radioactive material in accordance with the regulations in this chapter under the supervision of an authorized user as provided in subsection (s) of this section, unless prohibited by license condition; or

    (B) prepares unsealed radioactive material for medical use in accordance with the regulations in this chapter under the supervision of an authorized nuclear pharmacist or authorized user as provided in subsection (s) of this section, unless prohibited by license condition.

(b) Scope.

  (1) In addition to the requirements of this section, all licensees, unless otherwise specified, are subject to the requirements of §289.201 of this title (relating to General Provisions for Radioactive Material), §289.202 of this title (relating to Standards for Protection Against Radiation from Radioactive Materials), §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), §289.252 of this title (relating to Licensing of Radioactive Material), and §289.257 of this title (relating to Packaging and Transportation of Radioactive Material).

  (2) Veterinarians who receive, possess, use, transfer, own, or acquire radioactive material in the practice of veterinary medicine shall comply with the requirements of this section except for subsections (d), (dd) and (uuu) of this section.

  (3) An entity that is a "covered entity" as that term is defined in HIPAA (the Health Insurance Portability and Accountability Act of 1996, Title 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 United States Department of Health and Human Services.

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

  (1) Address of use--The building or buildings that are identified on the license and where radioactive material may be prepared, received, used, or stored.

  (2) Area of use--A portion of an address of use that has been set aside for the purpose of preparing, receiving, using, or storing radioactive material.

  (3) Authorized medical physicist--An individual who meets the following:

    (A) the requirements in subsections (j) and (m) of this section; or

    (B) is identified as an authorized medical physicist or teletherapy physicist on one of the following:

      (i) a specific medical use license issued by the agency, the United States Nuclear Regulatory Commission (NRC), or an agreement state;

      (ii) a medical use permit issued by an NRC master material licensee;

      (iii) a permit issued by an NRC, or agreement state broad scope medical use licensee; or

      (iv) a permit issued by an NRC master material license broad scope medical use permittee; and

    (C) holds a current Texas license under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602, in therapeutic radiological physics for uses in subsections (rr) and (ddd) of this section

  (4) Authorized nuclear pharmacist--A pharmacist who meets the following:

    (A) the requirements in subsections (k) and (m) of this section; or

    (B) is identified as an authorized nuclear pharmacist on one of the following:

      (i) a specific license issued by the agency, the NRC, or an agreement state that authorizes medical use or the practice of nuclear pharmacy;

      (ii) a permit issued by an NRC master material licensee that authorizes medical use or the practice of nuclear pharmacy;

      (iii) a permit issued by the agency, the NRC, or an agreement state licensee with broad scope authorization that authorizes medical use or the practice of nuclear pharmacy; or

      (iv) a permit issued by an NRC master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

    (C) is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

    (D) is designated as an authorized nuclear pharmacist in accordance with §289.252(r) of this title; and

    (E) holds a current Texas license under the Texas Pharmacy Act, Occupations Code, Chapters 551 - 566, 568, and 569, as amended, and who is certified as an authorized nuclear pharmacist by the Texas State Board of Pharmacy.

  (5) Authorized user--An authorized user is defined as follows:

    (A) for human use, a physician licensed by the Texas Medical Board; or a dentist licensed by the Texas State Board of Dental Examiners; or a podiatrist licensed by the Texas State Board of Podiatric Medicine who:

      (i) meets the requirements in subsections (m), (gg), (jj), (nn), (oo), (pp), (qq), (zz), (aaa), (ccc) or (ttt) of this section; or

      (ii) is identified as an authorized user on any of the following:

        (I) an agency, NRC, or agreement state license that authorizes the medical use of radioactive material;

        (II) a permit issued by an NRC master material licensee that is authorized to permit the medical use of radioactive material;

        (III) a permit issued by a specific licensee with broad scope authorization issued by the agency, the NRC, or an agreement state authorizing the medical use of radioactive material; or

        (IV) a permit issued by an NRC master material licensee with broad scope authorization that is authorized to permit the medical use of radioactive material.

    (B) for veterinary use, an individual who is, a veterinarian licensed by the Texas State Board of Veterinary Medical Examiners; and

      (i) is certified by the American College of Veterinary Radiology for the use of radioactive materials in veterinary medicine; or

      (ii) has received training in accordance with subsections (gg), (jj), (nn) - (qq), (zz), (aaa), (ccc), and (ttt) of this section as applicable; or

      (iii) is identified as an authorized user on any of the following:

        (I) an agency, NRC, or agreement state license that authorizes the veterinary use of radioactive material;

        (II) a permit issued by an NRC master material licensee that is authorized to permit the medical use of radioactive material;

        (III) a permit issued by a specific licensee with broad scope authorization issued by the agency, the NRC, or an agreement state authorizing the medical or veterinary use of radioactive material; or

        (IV) a permit issued by an NRC master material licensee with broad scope authorization that authorizes the medical use of radioactive material.

  (6) Brachytherapy--A method of radiation therapy in which plated, embedded, activated, or sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, intraluminal, or interstitial application.

  (7) Brachytherapy sealed source--A sealed source or a manufacturer-assembled source train, or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

  (8) High dose-rate remote afterloader--A device that remotely delivers a dose rate in excess of 1200 rads (12 gray (Gy)) per hour at the point or surface where the dose is prescribed.

  (9) Institutional Review Board (IRB)--Any board, committee, or other group formally designated by an institution and approved by the United States Food and Drug Administration (FDA) to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects.

  (10) Low dose-rate remote afterloader--A device that remotely delivers a dose rate of less than or equal to 200 rads (2 Gy) per hour at the point or surface where the dose is prescribed.

  (11) Management--The chief executive officer or other individual delegated the authority to manage, direct, or administer the licensee's activities.

  (12) Manual brachytherapy--A type of brachytherapy in which the sealed sources, for example, seeds and ribbons, are manually inserted either into the body cavities that are in close proximity to a treatment site or directly in the tissue volume.

  (13) Medical event--An event that meets the criteria in subsection (uuu)(1) of this section.

  (14) Medical institution--An organization in which several medical disciplines are practiced.

  (15) Medical use--The intentional internal or external administration of radioactive material, or the radiation from radioactive material, to patients or human research subjects under the supervision of an authorized user.

  (16) Medium dose-rate afterloader--A device that remotely delivers a dose rate greater than 200 rads (2 Gy) and less than or equal to 1200 rads (12 Gy) per hour at the point or surface where the dose is prescribed.

  (17) Mobile nuclear medicine service--A licensed service authorized to transport radioactive material to, and medical use of the material at, the client's address. Services transporting calibration sources only are not considered mobile nuclear medicine licensees.

  (18) Output--The exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit, a brachytherapy source, a remote afterloader unit, or a gamma stereotactic radiosurgery unit, for a specified set of exposure conditions.

  (19) Patient--A human or animal under medical care and treatment.

  (20) Permanent facility--A building or buildings that are identified on the license within the State of Texas and where radioactive material may be prepared, received, used, or stored. This may also include an area or areas where administrative activities related to the license are performed.

  (21) Preceptor--An individual who provides, directs, or verifies the training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a radiation safety officer.

  (22) Prescribed dosage--The specified activity or range of activity of unsealed radioactive material as documented in a written directive or in accordance with the directions of the authorized user for procedures in subsections (ff) and (hh) of this section.

  (23) Prescribed dose--Prescribed dose means one of the following:

    (A) for gamma stereotactic radiosurgery, the total dose as documented in the written directive;

    (B) for teletherapy, the total dose and dose per fraction as documented in the written directive;

    (C) for brachytherapy, either the total sealed source strength and exposure time, or the total dose, as documented in the written directive; or

    (D) for remote afterloaders, the total dose and dose per fraction as documented in the written directive.

  (24) Pulsed dose-rate remote afterloader--A special type of remote afterloading device that uses a single sealed source capable of delivering dose rates greater than 1200 rads (12 Gy) per hour, but is approximately one-tenth of the activity of typical high dose-rate remote afterloader sealed sources and is used to simulate the radiobiology of a low dose rate remote afterloader treatment by inserting the sealed source for a given fraction of each hour.

  (25) Radiation safety officer (RSO)--For purposes of this section, an individual who:

    (A) meets the requirements in subsections (h) and (m) of this section; or

    (B) is identified as an RSO on one of the following:

      (i) a specific license issued by the agency, the NRC, or an agreement state that authorizes the medical or veterinary use of radioactive material; or

Cont'd...

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