Section 124.19. Nuclear medicine services.

 

(1)   Nuclear medicine service.

(a) Requirement. If a hospital provides nuclear medicine services, the services shall meet the needs of the hospital's patients in accordance with acceptable standards of professional practice.

(b) Organization and staffing.

1. The organization of the nuclear medicine service shall be appropriate for the scope and complexity of the services offered.

2. There shall be a physician director who is qualified in nuclear medicine to be responsible for the nuclear medicine service.

3.

a. The qualifications, education, training, functions and legal responsibilities of nuclear medicine personnel shall be specified by the director of the service and approved by the medical staff and chief executive officer.

b. Only persons approved by the hospital may participate in the preparation of radiopharmaceuticals.

c. All persons who administer radioisotopes shall be approved by the medical staff and by the hospital's administrative staff.

4. The number and types of personnel assigned to nuclear medicine shall be adequate to provide the needed services.

(c) Location. Nuclear medicine services shall be provided in an area of the hospital that is adequately shielded.

(d) Radioactive materials. Radioactive materials shall be prepared, labeled, used, transported, stored and disposed of in accordance with applicable regulations of the U.S. nuclear regulatory commission and ch. DHS 157 .

(e) Equipment and supplies.

1. Equipment and supplies shall be appropriate for the types of nuclear medicine services offered and shall be maintained for safe and efficient performance.

2. All equipment shall be maintained in safe operating condition and shall be inspected, tested and calibrated at least annually by a radiation or health physicist.

(f) Records.

1. Authenticated and dated reports of nuclear medicine interpretations, consultations and therapy shall be made part of the patient's medical record and copies shall be retained by the service.

2. Records shall note the amount of radiopharmaceuticals administered, the identity of the recipient, the supplier and lot number and the date of therapy.

3. The hospital shall provide for monitoring the staff's exposure to radiation. The cumulative radiation exposure for each staff member shall be recorded in the service's records at least monthly.

4. Records of the receipt and disposition of radiopharmaceuticals shall be maintained. Documentation of instrument performance and records of inspection shall be retained in the service.

(2)   Mobile nuclear medicine services. The use of mobile nuclear medicine services by a facility to meet the diagnostic needs of its patients shall be subject to approval of the medical staff and the chief executive officer. The services offered by the mobile nuclear medicine unit shall comply with all applicable rules of this section.

Cr. Register, January, 1988, No. 385 , eff. 2-1-88; correction in (1) (d) made under s. 13.93 (2m) (b) 7., Stats., Register September 2003 No. 573 ; correction in (1) (d) made under s. 13.92 (4) (b) 7., Stats., Register January 2009 No. 637 .