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RULE §511.46Radiologic Services

(a) A limited services rural hospital (LSRH) shall maintain, or have available, diagnostic radiologic services according to needs of the patients. All radiology equipment, including X-ray equipment, mammography equipment and laser equipment, shall be licensed and registered as required under Texas Administrative Code Title 25 (25 TAC) Chapter 289 (relating to Radiation Control). When therapeutic services are also provided, the services, as well as the diagnostic services, shall meet professionally approved standards for safety and personnel qualifications as required in 25 TAC §§289.227, 289.229, 289.230, and 289.231 (relating to Use of Radiation Machines in the Healing Arts; Radiation Safety Requirements for Accelerators, Therapeutic Radiation Machines, Simulators, and Electronic Brachytherapy Devices; Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography; and General Provisions and Standards for Protection Against Machine-Produced Radiation, respectively). Portable X-ray equipment may be acceptable as a minimum requirement.

(b) An LSRH shall adopt, implement, and enforce policies and procedures describing the radiologic services provided in the LSRH and how the LSRH maintains employee and patient safety.

(c) LSRH policies shall address the quality aspects of radiologic services by:

  (1) performing radiologic services only upon the written order of a physician, podiatrist, dentist, or other practitioner, who is practicing within the scope of their license and education, and a concise statement of the reason for the examination; and

  (2) limiting the use of any radioactive sources in the facility to physicians who have been granted privileges for such use based on their training, experience, and current competence.

(d) An LSRH shall minimize hazards to patients and personnel when providing radiologic services, particularly ionizing radiology procedures.

(e) An LSRH shall adopt, implement, and enforce policies and procedures to address safety including:

  (1) regulation of the use, removal, handling, and storage of any radioactive material that is required to be licensed by the Texas Department of State Health Services (DSHS);

  (2) precautions against electrical, mechanical, and radiation hazards;

  (3) proper shielding where radiation sources are used;

  (4) acceptable monitoring devices for all personnel who might be exposed to radiation, including requiring monitoring devices be worn by all personnel in any area with a radiation hazard;

  (5) personnel monitoring dosimeters for nuclear medicine workers to measure their radiation exposure;

  (6) maintenance of radiation exposure records on personnel;

  (7) authenticated dated reports of all examinations performed shall be made a part of the patient's medical record;

  (8) inspection of equipment shall be made by or under the supervision of a licensed medical physicist in accordance with 25 TAC §289.227(o) (relating to Use of Radiation Machines in the Healing Arts). Defective equipment shall be promptly repaired or replaced; and

  (9) exposure reports and documentation shall be available for review.

(f) Only personnel designated as qualified by the medical staff shall use the radiology equipment and administer procedures.

(g) LSRH personnel shall provide radiologic services only on the order of individuals granted privileges by the medical staff.

(h) A qualified full-time, part-time, or consulting radiologist shall supervise the ionizing radiologic services and shall interpret radiology tests that are determined by the medical staff to require a radiologist's specialized knowledge. For purposes of this section a radiologist is a physician who is qualified by education and experience in radiology in accordance with medical staff bylaws.

(i) An LSRH shall maintain records of radiologic services. The radiologist or other individuals in accordance with subsections (f) and (h) of this section shall sign reports of their interpretations.

(j) A physician or other practitioner within the scope of their license and education shall read, date, sign, and authenticate all examination reports.

(k) The radiology department shall meet all applicable federal, state, and local laws, codes, rules, regulations, and ordinances.

(l) Procedure manuals shall include procedures for all examinations performed, infection control in the facility, treatment or examination rooms, dress code of personnel, and cleaning of equipment.

(m) When the LSRH provides nuclear medicine services, these services shall meet the needs of the patients in accordance with acceptable standards of practice and be licensed in accordance with 25 TAC §289.256 (relating to Medical and Veterinary Use of Radioactive Material).

  (1) The LSRH shall adopt, implement, and enforce policies and procedures describing the LSRH's nuclear medicine services and how the LSRH maintains employee and patient safety with regard to these services.

  (2) The organization of the nuclear medicine services shall be appropriate to the scope and complexity of the services offered.

  (3) The LSRH shall have a medical director or clinical director who is a physician qualified in nuclear medicine.

  (4) The medical director or clinical director shall specify the qualifications, training, functions, and responsibilities of nuclear medicine personnel and the medical staff shall approve them.

  (5) Radioactive materials shall be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice and in accordance with 25 TAC §289.256.

  (6) In-house preparation of radiopharmaceuticals shall be by, or under, the direct supervision of an appropriately trained licensed pharmacist or physician.

  (7) There shall be proper storage and disposal of radioactive materials.

  (8) When nuclear medicine services staff perform clinical laboratory tests, the nuclear medicine staff shall comply with CLIA 1988 in accordance with the requirements specified in 42 CFR Part 493.

  (9) Equipment and supplies shall be appropriate for the types of nuclear medicine services offered and shall be maintained for safe and efficient performance. Qualified personnel shall inspect, test, and calibrate the equipment at least annually.

  (10) The LSRH shall maintain signed and dated reports of nuclear medicine interpretations, consultations, and procedures.

  (11) The physician approved by the medical staff to interpret diagnostic procedures shall sign and date the interpretations of these tests.

  (12) The LSRH shall maintain records of the receipt and disposition of radiopharmaceuticals until disposal is authorized by DSHS in accordance with 25 TAC §289.256.

  (13) Only an individual whose scope of state licensure and whose defined staff privileges allow referrals to nuclear medicine services shall order such services.

Source Note: The provisions of this §511.46 adopted to be effective October 5, 2023, 48 TexReg 5668

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