Florida Regulations 64E-5.622: Release of Patients or Human Research Subjects Treated with Radiopharmaceuticals, Implants or Remote Afterloader Units
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(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.
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. History-New 8-25-91, Amended 5-15-96, Formerly 10D-91.730, Amended 10-8-00, 2-11-10.
Terms Used In Florida Regulations 64E-5.622
- Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
(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.
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. History-New 8-25-91, Amended 5-15-96, Formerly 10D-91.730, Amended 10-8-00, 2-11-10.