| (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.
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