Minnesota Administrative Rules

4732.0520 QUALITY ASSURANCE PROGRAM.

Subpart 1.

General requirements.

A registrant conducting radiographic or therapeutic procedures using radiation-producing equipment must implement a site-specific quality assurance program. The program must include:

A.

a description of the quality control procedures for radiation protection;

B.

initial training and documentation for employees as specified in part 4732.0510;

C.

the equipment performance tests which are to be completed at intervals not to exceed 24 months and related evaluation documentation, including films, as appropriate, as specified in nationally recognized standards, according to:

(1)

Code of Federal Regulations, title 21, section 1020.30, for diagnostic equipment and Code of Federal Regulations, title 21, section 892, for therapeutic equipment;

(2)

the manufacturer's specifications; or

(3)

this chapter;

D.

the documentation of any correction of any deficiencies found during the equipment performance tests and verification of the actions taken;

E.

when an operating parameter has been exceeded, the radiation-producing equipment must not be used or must be limited to those uses permitted by the registrant, radiation safety officer, or physicist by established written procedures for no longer than 14 days until corrective actions have been taken and verified to have corrected the out-of-limits parameters;

F.

calibrations and documentation as required in part 4732.0700. This includes the calibration record of any electronic equipment used in quality control tests;

G.

radiation program audits as specified in part 4732.0540; and

H.

a retake or reject analysis program as specified in part 4732.0535.

Subp. 2.

Additions.

In addition to subpart 1, each registrant with therapeutic x-ray equipment must also make spot checks as specified in parts 4732.0900 to 4732.0940.

Subp. 3.

Records.

The registrant must maintain the quality assurance program records according to part 4732.0330.

Statutory Authority:

MS s 144.12

History:

32 SR 777

Published Electronically:

December 10, 2007