US · guidance
CMS SOM App. A, Tag A-1044
§482.53(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.
Interpretive Guidelines §482.53(c)
The nuclear medicine service must use equipment and supplies that are designed and,
when applicable, approved to be used in conjunction with radioactive materials.
Equipment must be maintained so that it operates safely to minimize hazards to patients
and hospital personnel as much as possible. Accordingly, it must be inspected, tested,
and calibrated by personnel with the necessary qualifications. Personnel may be either
hospital employees or contracted. Personnel must follow the manufacturer’s quality
assurance instructions for acceptance testing (upon installation and after major upgrades)
and maintenance testing. Inspections, testing and calibration must occur at least annually
unless required to be more frequent according to the manufacturer’s instructions.
The hospital must have a policy and procedure for staff who operate the equipment to
follow if they suspect a malfunction.
Survey Procedures §482.53(c)
• Does the hospital have documentation that indicates that the equipment and supplies
it uses in nuclear medicine services are appropriate for use with radioactive materials?
• Is the hospital able to demonstrate how personnel, whether employees or contractors,
who inspect, test, calibrate, and maintain nuclear medicine services equipment are
qualified to do so?
• Review equipment maintenance records. Verify that equipment is tested, calibrated
and otherwise maintained at least annually, following the manufacturer’s
recommended procedures. Verify that if the manufacturer requires more frequent
than annual testing and maintenance that the hospital adheres to the manufacturer’s
prescribed schedule.
• Ask nuclear medicine services staff who operate equipment what they would do if
they suspected a malfunction. Does the hospital have a policy to address this and are
staff familiar with it?
History
Rev. 141, Issued: 07-10-15, Effective: 07-10-15, Implementation: 07-10-15
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
739086a1f51c5d1c95e5eab1d12b370997b87503c75f6e055e92ce16b7530c83
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