26 Tex. Admin. Code § 511.46 - Radiologic 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.
Notes
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