Minnesota Administrative Rules

4732.0610 REPORTS OF MEDICAL EVENTS OR INCIDENTS INVOLVING RADIATION-PRODUCING EQUIPMENT.

Subpart 1.

Notification within 24 hours.

A registrant possessing any radiation-producing equipment must notify the commissioner within 24 hours of discovering any medical event.

Subp. 2.

Additional reports.

In addition to any notification required by subpart 1, the registrant must submit a written report within 30 days to the commissioner to include:

A.

a description of any event or incident for which notification is required;

B.

what corrective actions were taken or planned to ensure against a recurrence; and

C.

the extent of the dose of radiation to any individual, including:

(1)

the name and birth date of each individual;

(2)

the estimates of each individual's dose;

(3)

the date of the event;

(4)

the cause of the dose; and

(5)

the corrective actions taken or planned to ensure against a recurrence.

Subp. 3.

Notification of occupational levels exceeded.

A registrant must notify the commissioner of any individual worker who was exposed beyond the worker's occupational dose under part 4732.0410 within 30 days of discovery. The registrant must notify the individual and provide a copy of the report. The information reported must include the dose data and results obtained under this chapter, as shown in records maintained by the registrant according to part 4732.0440, subpart 10. Each notification and report must:

A.

be in writing; and

B.

include appropriate identifying data, including the name of the registrant, the name of the exposed individual worker, and the date of the dose.

Subp. 4.

Notification of a fluoroscopic event.

Each facility using fluoroscopic equipment for interventional or special procedures must have available a record of patient exposure received per procedure for the commissioner's review. A patient's skin entrance exposure dose that exceeds 600 rads (6,000 milliGray) must be reviewed by the facility's radiation safety committee (RSC). If a facility does not have a radiation safety committee, the registrant must provide the commissioner within 30 days of the event, documentation stating why the patient's dose exceeded 600 rads (6,000 milliGray). In addition, if the patient's entrance exposure dose exceeds 600 rads (6,000 milliGray), the RSC or registrant must have an established policy and procedure to ensure appropriate potential skin injury and follow-up information is given to the patient.

Statutory Authority:

MS s 144.12

History:

32 SR 777

Published Electronically:

December 10, 2007