42 CFR § 482.53 - Condition of participation: Nuclear medicine services.
(a) Standard: Organization and staffing. The organization of the nuclear medicine service must be appropriate to the scope and complexity of the services offered.
(1) There must be a director who is a doctor of medicine or osteopathy qualified in nuclear medicine.
(2) The qualifications, training, functions, and responsibilities of nuclear medicine personnel must be specified by the service director and approved by the medical staff.
(b) Standard: Delivery of service. Radioactive materials must be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice.
(1) In-house preparation of radiopharmaceuticals is by, or under the supervision of, an appropriately trained registered pharmacist or a doctor of medicine or osteopathy.
(2) There is proper storage and disposal of radioactive material.
(3) If laboratory tests are performed in the nuclear medicine service, the service must meet the applicable requirement for laboratory services specified in § 482.27.
(c) Standard: Facilities. Equipment and supplies must be appropriate for the types of nuclear medicine services offered and must be maintained for safe and efficient performance. The equipment must be -
(1) Maintained in safe operating condition; and
(2) Inspected, tested, and calibrated at least annually by qualified personnel.
(d) Standard: Records. The hospital must maintain signed and dated reports of nuclear medicine interpretations, consultations, and procedures.
(1) The hospital must maintain copies of nuclear medicine reports for at least 5 years.
(2) The practitioner approved by the medical staff to interpret diagnostic procedures must sign and date the interpretation of these tests.
(3) The hospital must maintain records of the receipt and disposition of radiopharmaceuticals.
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