Minnesota Administrative Rules

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.

Statutory Authority:

MS s 144.12

History:

32 SR 777

Published Electronically:

December 10, 2007