Or. Admin. Code § 333-116-0120

Current through Register Vol. 63, No. 11, November 1, 2024

Section 333-116-0120 - Mobile Nuclear Medicine Service Administrative Requirements

(1) The Authority will only license mobile nuclear medicine services in accordance with OAR 333-116-0300, 333-116-0320, and 333-116-0400 of this division and OAR 333-102-0130.

(2) Mobile nuclear medicine service licensees must:

(a) Obtain a letter signed by the management of each client for which services are rendered that authorizes use of licensed radioactive material at the client's address of use. This letter must clearly delineate the authority and responsibility of both the client and the mobile medical service. If the client is licensed, the letter must document procedures for notification, receipt, storage and documentation of transfer of radioactive material delivered to the client's address for use by the mobile medical service. The mobile nuclear medicine service licensee must retain the letter for three years after the last provision of service.

(b) Check instruments used to measure the activity of unsealed byproduct material for proper function before use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function must include a constancy check;

(c) Check survey instruments for proper operation with a dedicated check source before use at each client's address; and

(d) Survey all areas of use to ensure compliance with the requirements in division 333-120 before leaving a client's address.

(3) If a mobile nuclear medicine service provides services that the client also is authorized to provide, the client is responsible for assuring that services are conducted in accordance with the rules in this division while the mobile nuclear medicine service is under the client's direction.

(4) A mobile nuclear medicine service may not order radioactive material to be delivered directly from the manufacturer or the distributor to the client's address of use unless the client has a radioactive materials license. Radioactive material delivered to the client's address of use must be received and handled in conformance with the client's license.

(5) A mobile medical service licensee must, at a minimum, maintain the following documents onboard each mobile unit:

(a) Current operating and emergency procedures;

(b) Copy of the current license;

(c) Copies of the letter required by section (2) of this rule;

(d) Current calibration records for each survey instrument and diagnostic equipment or dose delivery device in use; and

(e) Survey records covering uses associated with the mobile unit during, at a minimum, the preceding 90 calendar days.

(6) A licensee must retain copies of the records specified in this rule in accordance with OAR 333-100-0057. The records required for subsections (2)(b), (2)(c) and (2)(d) of this rule must include the date of the survey or test, the results of the survey or test, the instrument used to make the survey or source used to perform the test, and the name of the individual who performed the survey or test.

Or. Admin. Code § 333-116-0120

HD 1-1991, f. & cert. ef. 1-8-91; HD 1-1995, f. & cert. ef. 4-26-95; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807