64E-5.633. Manual Brachytherapy Sources Inventory and Surveys

(1) The licensee shall maintain accountability at all times for all manual brachytherapy sources in storage or use.

(a) As soon as possible each time brachytherapy sources are returned to an area of storage from an area of use, the licensee shall immediately count or otherwise verify the number returned to ensure that all sources taken from the storage area have been returned; and

(b) As soon as possible after removing the sources from a patient or a human research subject, the licensee shall immediately count or otherwise verify the number of sources and return them to a secure storage area.

(2) A licensee shall make a record of the use of manual brachytherapy sources which includes:

(a) For temporary implants;

1. The number and activity of sources removed from storage, the room number of use and patient’s name, the time and date the sources were removed from storage, the number and activity of sources in storage after the removal, and the name of the individual who removed the sources from storage; and

2. The number and activity of sources returned to storage, the room number of use and patient’s name, the time and date the sources were returned to storage, the number and activity of sources in storage after the return, and the name of the individual who returned the sources to storage.

(b) For permanent implants;

1. The number and activity of sources removed from storage, the room number of use and patient’s name, the time and date the sources were removed from storage, the number and activity of sources in storage after the removal, and the name of the individual who removed the sources from storage;

2. The number and activity of sources returned to storage, the room number of use and patient’s name, the time and date the sources were returned to storage, the number and activity of sources in storage after the return, and the name of the individual who returned the sources to storage; and

3. The number and activity of sources permanently implanted in the patient or human research subject.

(3) Immediately after implanting sources in a patient or human research subject and immediately after removal of sources from a patient or human research subject, the licensee shall make a radiation survey of the patient or human research subject and the area of use to confirm that no sources have been misplaced. The licensee shall make a record of each survey. This record shall contain the date and results of the survey, the survey instrument used and the name of the individual who performed the survey.

(4) A licensee shall maintain the records required in subsections 64E-5.633(2) and (3), F.A.C., for 3 years.

Rulemaking Authority 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History–New 8-25-91, Formerly 10D-91.748, Amended 2-11-10, 12-26-13.