Fla. Admin. Code Ann. R. 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.
Notes
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.
New 8-25-91, Formerly 10D-91.748, Amended 2-11-10, 12-26-13.
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(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.
Notes
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.
New 8-25-91, Formerly 10D-91.748, Amended 2-11-10, 12-26-13.