Fla. Admin. Code Ann. R. 64E-5.622 - Release of Patients or Human Research Subjects Treated with Radiopharmaceuticals, Implants or Remote Afterloader Units
(1) Except as authorized by subsection
64E-5.622(4),
F.A.C., a licensee shall not authorize release from confinement for medical
care any patient administered a radiopharmaceutical until:
(a) The dose rate from the patient is less
than 5 millirems (50 µSv) per hour at a distance of 1 meter, or
(b) The activity in the patient is less than
30 millicuries (1.11 GBq).
(2) Except as authorized by subsection
64E-5.622(4),
F.A.C., a licensee shall not authorize release from confinement for medical
care any patient administered a permanent implant until the dose rate from the
patient is less than 5 millirems (50 µSv) per hour at a distance of 1
meter.
(3) Immediately after
removing the last temporary implant source from a patient, the licensee shall
make a radiation survey of the patient with a radiation survey instrument to
confirm that all sources have been removed. The licensee shall not release a
patient treated by temporary implant from confinement for medical care until
all sources have been removed.
(4)
Licensees and license applicants whose proposed procedures to release
individuals who have been administered radiopharmaceuticals or permanent
implants containing radioactive material from the control of licensees differ
from those specified in subsections (1) and (2), above, must submit their
proposed procedures to the department for approval. The procedures must:
(a) Demonstrate that the total effective dose
equivalent to any other individual from exposure to the released individual is
not likely to exceed 500 millirem (5 µSv);
(b) Contain a copy of the instructions
including written instructions to be given to the released individual, or the
individual's parent or guardian, on actions recommended to maintain doses to
other individuals as low as is reasonably achievable if the total effective
dose equivalent to another individual is likely to exceed 100 millirem (1
µSv). If the dose to a breast-feeding infant or child could exceed 100
millirem (1 µSv) if there were no interruption of breast-feeding, the
instructions also shall include:
1. Guidance
on the interruption or discontinuance of breast-feeding; and,
2. Information on the consequences of failing
to follow the guidance.
(c) Specify that the licensee shall maintain
a record of the basis for authorizing the release of an individual from their
control who has been administered radiopharmaceuticals or permanent implants
containing radioactive material for 3 years after the date of
release.
(5) A licensee
shall maintain a record of patient surveys which demonstrates compliance with
subsections 64E-5.622(3) and
(6), F.A.C., for 3 years. Each record shall
include the date of the survey, the name of the patient, the dose rate from the
patient expressed as millirems (microsieverts) per hour and measured within 1
meter from the patient, and the initials of the individual who performed the
survey.
(6) Before releasing a
patient or human research subject from licensee control, a licensee shall
survey the patient or the human research subject and the remote afterloader
unit with a portable radiation detection survey instrument to confirm that the
source(s) has been removed from the patient or human research subject and
returned to the safe shielded position.
Notes
Rulemaking Authority 404.051, 404.061, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (6), (10), (11), 404.061(2), (3), 404.081, 404.141 FS.
New 8-25-91, Amended 5-15-96, Formerly 10D-91.730, Amended 10-8-00, 2-11-10.
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
(1) Except as authorized by subsection 64E-5.622(4), F.A.C., a licensee shall not authorize release from confinement for medical care any patient administered a radiopharmaceutical until:
(a) The dose rate from the patient is less than 5 millirems (50 µSv) per hour at a distance of 1 meter, or
(b) The activity in the patient is less than 30 millicuries (1.11 GBq).
(2) Except as authorized by subsection 64E-5.622(4), F.A.C., a licensee shall not authorize release from confinement for medical care any patient administered a permanent implant until the dose rate from the patient is less than 5 millirems (50 µSv) per hour at a distance of 1 meter.
(3) Immediately after removing the last temporary implant source from a patient, the licensee shall make a radiation survey of the patient with a radiation survey instrument to confirm that all sources have been removed. The licensee shall not release a patient treated by temporary implant from confinement for medical care until all sources have been removed.
(4) Licensees and license applicants whose proposed procedures to release individuals who have been administered radiopharmaceuticals or permanent implants containing radioactive material from the control of licensees differ from those specified in subsections (1) and (2), above, must submit their proposed procedures to the department for approval. The procedures must:
(a) Demonstrate that the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 500 millirem (5 µSv);
(b) Contain a copy of the instructions including written instructions to be given to the released individual, or the individual's parent or guardian, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to another individual is likely to exceed 100 millirem (1 µSv). If the dose to a breast-feeding infant or child could exceed 100 millirem (1 µSv) if there were no interruption of breast-feeding, the instructions also shall include:
1. Guidance on the interruption or discontinuance of breast-feeding; and,
2. Information on the consequences of failing to follow the guidance.
(c) Specify that the licensee shall maintain a record of the basis for authorizing the release of an individual from their control who has been administered radiopharmaceuticals or permanent implants containing radioactive material for 3 years after the date of release.
(5) A licensee shall maintain a record of patient surveys which demonstrates compliance with subsections 64E-5.622(3) and (6), F.A.C., for 3 years. Each record shall include the date of the survey, the name of the patient, the dose rate from the patient expressed as millirems (microsieverts) per hour and measured within 1 meter from the patient, and the initials of the individual who performed the survey.
(6) Before releasing a patient or human research subject from licensee control, a licensee shall survey the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe shielded position.
Notes
Rulemaking Authority 404.051, 404.061, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (6), (10), (11), 404.061(2), (3), 404.081, 404.141 FS.
New 8-25-91, Amended 5-15-96, Formerly 10D-91.730, Amended 10-8-00, 2-11-10.