Florida Regulations 64E-5.625: Safety Instructions and Precautions for Liquid Iodine, Radiopharmaceutical Therapy, Manual Brachytherapy, Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery
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(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 Fl. Admin. Code R. 64E-5.622, 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 Fl. Admin. Code R. 64E-5.312(1)(a); 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 Fl. Admin. Code R. 64E-5.312(1)(a); and,
2. Visitation authorized in accordance with Fl. Admin. Code R. 64E-5.312(5)
(4) A licensee shall provide instruction for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as described in Fl. Admin. Code R. 64E-5.636
(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 Fl. Admin. Code R. 64E-5.622
(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 Fl. Admin. Code R. 64E-5.312 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 Fl. Admin. Code R. 64E-5.622 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 Fl. Admin. Code R. 64E-5.622 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 Fl. Admin. Code R. 64E-5.622:
(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 Fl. Admin. Code R. 64E-5.622, 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 Fl. Admin. Code R. 64E-5.1320
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 5-15-96, Formerly 10D-91.7321, Amended 2-11-10.
(a) Patient or human research subject control;
(b) Visitor control, including;
1. Routine visitation to hospitalized individuals in accordance with Fl. Admin. Code R. 64E-5.312(1)(a); 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 Fl. Admin. Code R. 64E-5.312(1)(a); and,
2. Visitation authorized in accordance with Fl. Admin. Code R. 64E-5.312(5)
(4) A licensee shall provide instruction for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as described in Fl. Admin. Code R. 64E-5.636
(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 Fl. Admin. Code R. 64E-5.622
(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 Fl. Admin. Code R. 64E-5.312 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 Fl. Admin. Code R. 64E-5.622 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 Fl. Admin. Code R. 64E-5.622 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 Fl. Admin. Code R. 64E-5.622:
(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 Fl. Admin. Code R. 64E-5.622, 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 Fl. Admin. Code R. 64E-5.1320
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 5-15-96, Formerly 10D-91.7321, Amended 2-11-10.