Fla. Admin. Code Ann. R. 64E-5.625 - Safety Instructions and Precautions for Liquid Iodine, Radiopharmaceutical Therapy, Manual Brachytherapy, Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery
(1) A licensee shall provide oral and written
radiation safety instructions to all personnel caring for patients or human
research subjects, who cannot be released under Rule
64E-5.622, F.A.C., undergoing
radiopharmaceutical therapy or manual brachytherapy. This training shall be
provided initially prior to caring for patients and refresher training shall be
provided at least every 12 months. The instruction shall describe the
licensee's procedures for notification of the RSO and an authorized user in
case of the patient's death or medical emergency.
(2) The instruction for radiopharmaceutical
therapy shall be commensurate with the duties of the personnel and describe the
procedures for:
(a) Patient or human research
subject control;
(b) Visitor
control, including;
1. Routine visitation to
hospitalized individuals in accordance with paragraph
64E-5.312(1)(a),
F.A.C.; and,
2. Visitation
authorized in accordance with subsection
64E-5.312(5),
F.A.C.
(c) Contamination
control; and,
(d) Waste
control.
(3) The
instruction for manual brachytherapy shall be commensurate with the duties of
the personnel and describe:
(a) Size and
appearance of the brachytherapy sources;
(b) Safe handling and shielding
instructions;
(c) Procedures for
patient or human research subject control; and,
(d) Procedures for visitor control,
including;
1. Routine visitation to
hospitalized individuals in accordance with paragraph
64E-5.312(1)(a),
F.A.C.; and,
2. Visitation
authorized in accordance with paragraph
64E-5.312(5),
F.A.C.
(4) A
licensee shall provide instruction for remote afterloader units, teletherapy
units, and gamma stereotactic radiosurgery units as described in Rule
64E-5.636, F.A.C.
(5) A licensee shall keep a record of
individuals receiving instruction required by subsections (1), (2), (3) and
(4), above, which includes a list of topics covered, the date of instruction,
and the name of the individual who gave the instruction. Such record shall be
maintained for inspection by the department for 3 years.
(6) A licensee shall take the following
safety precautions for each patient or human research subject receiving manual
brachytherapy or radiopharmaceutical therapy who cannot be released under Rule
64E-5.622, F.A.C.
(a) Post the patient's or human research
subject's door with a "Caution: Radioactive Material" sign and note on the door
or on the patient's chart where and how long visitors may stay in the patient's
room.
(b) Measure promptly, after
administration of the dosage, the dose rates in contiguous restricted and
unrestricted areas with a radiation measurement survey instrument to
demonstrate compliance with the requirements of Rule
64E-5.312, F.A.C. Retain for 3
years a record of each survey that includes the time and date of the survey, a
plan of the area or list of points surveyed, the measured dose rate at several
points expressed in millirems per hour, the instrument used to make the survey,
and the initials of the individual who made the survey.
(c) Provide the patient with radiation safety
guidance before authorizing release of the patient that will help to keep
radiation dose to household members and the public as low as reasonably
achievable.
(d) Notify the RSO and
an authorized user immediately if the patient dies or has a medical
emergency.
(7)
Individuals receiving radiopharmaceutical therapy shall be provided a private
room with a private sanitary facility or a room with another individual who is
receiving unsealed radioactive materials who cannot be released under Rule
64E-5.622, F.A.C. Individuals
receiving manual brachytherapy shall be provided a private room or a room with
another individual who is receiving manual brachytherapy and cannot be released
under Rule 64E-5.622, F.A.C. The licensee
shall not place an individual receiving manual brachytherapy in the same room
with a patient who is not receiving manual brachytherapy.
(8) A licensee shall take these additional
safety precautions for radiopharmaceutical therapy patients or human research
subjects who cannot be released by Rule
64E-5.622, F.A.C.:
(a) Monitor material and items removed from
the patient's or human research subject's room to determine that any
contamination cannot be distinguished from the natural background radiation
level with a radiation detection survey instrument set on its most sensitive
scale and with no interposed shielding, or handle these materials and items as
radioactive waste.
(b) Survey the
patient's room and private sanitary facility for removable contamination before
assigning another patient to the room. The room shall not be reassigned until
removable contamination is less than 200 disintegrations per minute (3.33 Bq)
per 100 square centimeters or the wipe samples are equal to background when
surveyed with an instrument using a probe with a maximum window thickness of
2.0 mg/cm and a minimum probe diameter of 1.5 inches.
(9) For manual brachytherapy patients or
human research subjects who cannot be released by Rule
64E-5.622, F.A.C., the licensee
shall have the applicable emergency response equipment available near each
treatment room to respond to the following:
(a) A source that is dislodged from the
patient or human research subject; and,
(b) A sealed source lodged within the patient
following removal of the source applicators.
(10) The licensee shall establish a bioassay
program to measure the thyroid burden of each individual who helps prepare,
prepares or administers a dosage of unsealed iodine 131 or iodine 125 in
accordance with Rule 64E-5.1320,
F.A.C.
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 5-15-96, Formerly 10D-91.7321, Amended 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) A licensee shall provide oral and written radiation safety instructions to all personnel caring for patients or human research subjects, who cannot be released under Rule 64E-5.622, F.A.C., undergoing radiopharmaceutical therapy or manual brachytherapy. This training shall be provided initially prior to caring for patients and refresher training shall be provided at least every 12 months. The instruction shall describe the licensee's procedures for notification of the RSO and an authorized user in case of the patient's death or medical emergency.
(2) The instruction for radiopharmaceutical therapy shall be commensurate with the duties of the personnel and describe the procedures for:
(a) Patient or human research subject control;
(b) Visitor control, including;
1. Routine visitation to hospitalized individuals in accordance with paragraph 64E-5.312(1)(a), F.A.C.; and,
2. Visitation authorized in accordance with subsection 64E-5.312(5), F.A.C.
(c) Contamination control; and,
(d) Waste control.
(3) The instruction for manual brachytherapy shall be commensurate with the duties of the personnel and describe:
(a) Size and appearance of the brachytherapy sources;
(b) Safe handling and shielding instructions;
(c) Procedures for patient or human research subject control; and,
(d) Procedures for visitor control, including;
1. Routine visitation to hospitalized individuals in accordance with paragraph 64E-5.312(1)(a), F.A.C.; and,
2. Visitation authorized in accordance with paragraph 64E-5.312(5), F.A.C.
(4) A licensee shall provide instruction for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as described in Rule 64E-5.636, F.A.C.
(5) A licensee shall keep a record of individuals receiving instruction required by subsections (1), (2), (3) and (4), above, which includes a list of topics covered, the date of instruction, and the name of the individual who gave the instruction. Such record shall be maintained for inspection by the department for 3 years.
(6) A licensee shall take the following safety precautions for each patient or human research subject receiving manual brachytherapy or radiopharmaceutical therapy who cannot be released under Rule 64E-5.622, F.A.C.
(a) Post the patient's or human research subject's door with a "Caution: Radioactive Material" sign and note on the door or on the patient's chart where and how long visitors may stay in the patient's room.
(b) Measure promptly, after administration of the dosage, the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of Rule 64E-5.312, F.A.C. Retain for 3 years a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in millirems per hour, the instrument used to make the survey, and the initials of the individual who made the survey.
(c) Provide the patient with radiation safety guidance before authorizing release of the patient that will help to keep radiation dose to household members and the public as low as reasonably achievable.
(d) Notify the RSO and an authorized user immediately if the patient dies or has a medical emergency.
(7) Individuals receiving radiopharmaceutical therapy shall be provided a private room with a private sanitary facility or a room with another individual who is receiving unsealed radioactive materials who cannot be released under Rule 64E-5.622, F.A.C. Individuals receiving manual brachytherapy shall be provided a private room or a room with another individual who is receiving manual brachytherapy and cannot be released under Rule 64E-5.622, F.A.C. The licensee shall not place an individual receiving manual brachytherapy in the same room with a patient who is not receiving manual brachytherapy.
(8) A licensee shall take these additional safety precautions for radiopharmaceutical therapy patients or human research subjects who cannot be released by Rule 64E-5.622, F.A.C.:
(a) Monitor material and items removed from the patient's or human research subject's room to determine that any contamination cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle these materials and items as radioactive waste.
(b) Survey the patient's room and private sanitary facility for removable contamination before assigning another patient to the room. The room shall not be reassigned until removable contamination is less than 200 disintegrations per minute (3.33 Bq) per 100 square centimeters or the wipe samples are equal to background when surveyed with an instrument using a probe with a maximum window thickness of 2.0 mg/cm and a minimum probe diameter of 1.5 inches.
(9) For manual brachytherapy patients or human research subjects who cannot be released by Rule 64E-5.622, F.A.C., the licensee shall have the applicable emergency response equipment available near each treatment room to respond to the following:
(a) A source that is dislodged from the patient or human research subject; and,
(b) A sealed source lodged within the patient following removal of the source applicators.
(10) The licensee shall establish a bioassay program to measure the thyroid burden of each individual who helps prepare, prepares or administers a dosage of unsealed iodine 131 or iodine 125 in accordance with Rule 64E-5.1320, F.A.C.
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 5-15-96, Formerly 10D-91.7321, Amended 2-11-10.