Minn. R. agency 144, ch. 4732, EQUIPMENT REQUIREMENTS, pt. 4732.0870

Current through Register Vol. 49, No. 20, November 12, 2024

Part 4732.0870 - REQUIREMENTS FOR STEREOTACTIC MAMMOGRAPHIC EQUIPMENT

Subpart 1.Equipment requirements.

Radiation-producing equipment specifically designed to perform stereotactically guided breast biopsies must meet the requirements of this chapter and:

A. nationally recognized standards such as Code of Federal Regulations, title 21, section 1020;

B. the equipment manufacturer's specifications; or

C. part 4732.1100.

Subp. 2.Registrant requirements.

The registrant must ensure that:

A. individuals operating the equipment meet the requirements of Minnesota Statutes, section 144.121, subdivision 5, or the Food and Drug Administration's Mammographic Quality Standards Act requirements;

B. individuals have completed equipment manufacturer's training or equivalent and initial site-specific training in the registrant's operating and emergency procedures;

C. the training in item B is documented and records kept; and

D. the entire system for stereotactic breast biopsies including the equipment performance, procedures, and records are evaluated annually by a diagnostic radiographic physicist.

Subp. 3.Quality assurance and quality control procedures.

The registrant must ensure that:

A. all manufacturer's quality assurance or quality control procedures follow the test procedures established by the registrant, recommendations of a nationally recognized standard, or the manufacturer's specifications;

B. the frequency of the quality assurance or quality control procedures, and corrective actions as a result of quality control testing are followed and documented; and

C. the facility's operating and emergency procedures include quality assurance or quality control procedures.

Subp. 4.Records.

Records must be maintained according to part 4732.0330.

Minn. R. agency 144, ch. 4732, EQUIPMENT REQUIREMENTS, pt. 4732.0870

32 SR 777

Statutory Authority: MS s 144.12