[Code of Federal Regulations]

[Title 42, Volume 3]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR482.53]



[Page 500-501]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 482_CONDITIONS OF PARTICIPATION FOR HOSPITALS--Table of Contents

 

                  Subpart D_Optional Hospital Services

 

Sec. 482.53  Condition of participation: Nuclear medicine services.



    If the hospital provides nuclear medicine services, those services 

must meet the needs of the patients in accordance with acceptable 

standards of practice.

    (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 direct 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 Sec. 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.



[[Page 501]]



    (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.

    (4) Nuclear medicine services must be ordered only by practitioner 

whose scope of Federal or State licensure and whose defined staff 

privileges allow such referrals.



[51 FR 22042, June 17, 1986, as amended at 57 FR 7136, Feb. 28, 1992]