Minn. R. agency 144, ch. 4732, REGISTRATION REQUIREMENTS, pt. 4732.0280

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

Part 4732.0280 - SERVICE PROVIDER'S RESPONSIBILITY

Subpart 1.General requirements.

A person shall not make, sell, lease, transfer, lend, repair, or install radiation-producing equipment or the parts used in connection with this equipment unless the parts and equipment, when properly placed in operation, meet the federal requirements for the equipment manufacturer's specifications and the requirements of this chapter.

Subp. 2.Notification requirements.

A registered service provider must meet the notification requirements in this subpart.

A. A person selling, leasing, or transferring radiation-producing equipment must notify the commissioner in writing within 15 days of the sale, lease, or transfer, and must supply the name and address of the purchaser and other pertinent information required by the commissioner.

B. Installation calibrations and equipment performance test reports must be sent to the facility within 30 days of the tests. The service provider must keep copies of these test reports for four years after completion.

C. The test reports must include written recommendations for necessary corrections or improvements.

Subp. 3.Calibration reports at time of installation.

At the time of installation, calibrations must be performed on diagnostic or industrial radiation-producing equipment prior to first use on patients according to nationally recognized standards, such as:

A. Code of Federal Regulations, title 21, section 1020;

B. the manufacturer's specifications;

C. parts 4732.1100 to 4732.1130; and

D. the service provider's written report, which must include:

(1) the facility name, address, and contact person;

(2) the date of equipment performance tests;

(3) the serial number of the equipment, room number, or name if applicable;

(4) the numerical results of the tests including any appropriate films. If the result of the test is not a numerical answer, a pass or fail or "yes" or "no" answer is acceptable;

(5) any written recommendations necessary for corrective actions to maintain compliance with this chapter; and

(6) the name and registration information of the service provider performing the testing.

Subp. 4.Equipment performance tests.

At the time of the equipment performance tests, the tests must be completed at intervals not to exceed 24 months. The tests must be performed over the clinical range on the equipment according to parts 4732.1100 to 4732.1130; Code of Federal Regulations, title 21, section 1020; or the manufacturer's specifications. The registered service provider must keep copies of these test reports for four years after completion. The service provider's written report to the facility must include:

A. the facility name, address, and contact person;

B. the date of equipment performance tests;

C. the serial number of the equipment, room number, or name if applicable;

D. the numerical results of the tests including any appropriate films. If the result of the test is not a numerical answer, a pass or fail or "yes" or "no" answer is acceptable;

E. any written recommendations necessary for corrective actions to maintain compliance with this chapter; and

F. the name and registration information of the service provider performing the testing.

Subp. 5.Individual monitoring.

The vendor employing registered service providers must provide individual monitoring devices and reports for their occupational exposure according to part 4732.0440, where applicable.

Subp. 6.Phantom use.

The use of humans is prohibited for maintenance, demonstration, and training. A phantom must be used for these purposes.

Minn. R. agency 144, ch. 4732, REGISTRATION REQUIREMENTS, pt. 4732.0280

32 SR 777

Statutory Authority: MS s 144.12