DHS 157.68DHS 157.68 Radioactive drugs for medical use. DHS 157.68(1)(1) Preparation. A licensee authorized to manufacture, prepare or transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium radioactive drugs shall ensure that any individual preparing the drugs is one of the following: DHS 157.68(1)(b)(b) An individual under the supervision of an authorized nuclear pharmacist. DHS 157.68(1)(c)2.2. Is identified as an authorized nuclear pharmacist on a license issued by the department, an agreement state or the NRC. DHS 157.68(1)(c)3.3. Is identified as an authorized nuclear pharmacist by a licensee who is authorized by the department, an agreement state or the NRC to designate authorized nuclear pharmacists operating under their license. DHS 157.68(1)(c)4.4. Functioned as a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and practiced at a pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009. DHS 157.68(2)(2) Documentation. A licensee shall provide to the department a copy of all the following, as appropriate: DHS 157.68(2)(a)(a) A copy of each individual’s certification by a specialty board whose certification process has been recognized by the department, the NRC, or an agreement state as specified in s. DHS 157.61 (9). DHS 157.68(2)(e)(e) The state pharmacist licensure, no later than 30 days after the date that the licensee allows, under sub. (1) (c) 1. and 2., the individual to work as an authorized nuclear pharmacist. DHS 157.68(2)(f)(f) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009. DHS 157.68 HistoryHistory: CR 06-021: cr. Register October 2006 No. 610, eff. 11-1-06; CR 09-062: am. (1) (intro.) and (2) (e), cr. (1) (c) 4. and (2) (f) Register April 2010 No. 652, eff. 5-1-10; CR 22-015: am. (2) (a) Register June 2023 No. 810, eff. 7-1-23. DHS 157.70DHS 157.70 Other medical uses of radioactive material or radiation from radioactive material. A licensee may use radioactive material or a radiation source approved for medical use that is not specifically addressed in ss. DHS 157.63 to 157.67 if all of the following criteria are met: DHS 157.70(2)(2) Approval. The applicant or licensee has received written approval from the department in a license and uses the material under this chapter and specific conditions the department considers necessary for the medical use of the material. DHS 157.70 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter. DHS 157.71(1)(1) Records of authority and responsibilities for radiation protection programs. DHS 157.71(1)(a)(a) A licensee shall retain a record of actions taken by the licensee’s management under s. DHS 157.61 (1) (a) for 5 years. The record shall include a summary of the actions taken and a signature of licensee management. DHS 157.71(1)(b)(b) A licensee shall retain a current copy of the authorities, duties and responsibilities of the radiation safety officer as required by s. DHS 157.61 (1) (d). The record shall include the signature of the radiation safety officer and licensee management. DHS 157.71(1)(c)(c) For each Associate Radiation Safety Officer appointed under s. DHS 157.61 (1) (b), the licensee shall retain, for 5 years after the Associate Radiation Safety Officer is removed from the license, a copy of the written document appointing the Associate Radiation Safety Officer signed by the licensee’s management. DHS 157.71(2)(2) Records of radiation protection program safety changes. A licensee shall retain a record of each radiation protection program change made under s. DHS 157.61 (2) (a) for 5 years. The record shall include a copy of the old and new procedures, the effective date of the change and the signature of the licensee management that reviewed and approved the change. DHS 157.71(3)(3) Records of written directives. A licensee shall retain a copy of each written directive as required by s. DHS 157.61 (4) for 3 years. DHS 157.71(4)(b)3.3. An identification number assigned by the licensee or, if no other identification number is available, the social security number of any person who is the subject of a medical event. DHS 157.71(4)(b)7.7. Whether the licensee notified the affected individual or the affected individual’s responsible relative or guardian and, if not, whether the failure to notify was based on guidance from the referring physician. DHS 157.71(5)(5) Record of a dose to an embryo or fetus or a nursing child. A licensee shall retain a record of a dose to an embryo or fetus or a nursing child reported under s. DHS 157.72 (2) for 3 years. The record shall contain all of the following: DHS 157.71(5)(c)(c) An identification number assigned by the licensee or, if no other identification number is available, the social security number of the pregnant individual or nursing child who is the subject of the event. DHS 157.71(5)(d)(d) A brief description of the event, why it occurred, any effect on the embryo or fetus or nursing child and any actions taken or planned to prevent recurrence. DHS 157.71(5)(e)(e) Whether the licensee notified the pregnant individual or mother, or the mother’s or child’s responsible relative or guardian, and if the licensee did not, whether such failure to notify was based on guidance from the referring physician. DHS 157.71(6)(6) Records of instrument calibrations. A licensee shall maintain a record of instrument calibrations required by s. DHS 157.62 (1) for 3 years. The record shall include the model and serial number of the instrument, the date of the calibration, the results of the calibration and the name of the individual who performed the calibration. DHS 157.71(7)(7) Records of radiation survey instrument calibrations. A licensee shall maintain a record of radiation survey instrument calibrations required by s. DHS 157.62 (2) for 3 years. The record shall include the date of the calibration, the results of the calibration, the name of the person who performed the calibration, and the model and serial number of the instrument. DHS 157.71(8)(8) Records of dosages of unsealed radioactive material for medical use. A licensee shall maintain a record of dosage determinations required by s. DHS 157.62 (3) for 3 years. The record shall contain the radiopharmaceutical, patient’s or human research subject’s name or identification number if one has been assigned, the prescribed dosage, the determined dosage or a notation that the total activity is less than 1.1 MBq (30 microcuries), the date and time of the dosage determination and the name of the individual who determined the dosage. DHS 157.71(9)(9) Records of possession of sealed sources and brachytherapy sources. DHS 157.71(9)(a)(a) A licensee shall retain a record of leak tests required by s. DHS 157.62 (5) (b) for 3 years. The record shall contain the model number and serial number if one has been assigned of each source tested, the identity of each source radionuclide and its estimated activity, the results of the test, the date of the test and the name of the person who performed the test. DHS 157.71(9)(b)(b) A licensee shall retain a record of the semi-annual physical inventory of sealed sources and brachytherapy sources required by s. DHS 157.62 (5) (g) for 3 years. The inventory record shall contain the model number of each source and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source and the name of the person who performed the inventory. DHS 157.71(10)(10) Records of surveys for ambient radiation exposure rate. A licensee shall retain a record of each survey required by s. DHS 157.62 (7) for 3 years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey and the name of the person who performed the survey. DHS 157.71(11)(11) Records of the release of persons containing radioactive drugs or implants containing radioactive material. DHS 157.71(11)(a)(a) A licensee shall retain a record of the basis for authorizing the release of a person for 3 years after the date of release if the total effective dose equivalent is calculated by any of the following methods: DHS 157.71(11)(a)1.1. Using the retained radioactivity in the body rather than the radioactivity administered. DHS 157.71(11)(a)2.2. Using an occupancy factor less than 0.25 at one meter to determine radiation exposure to persons physically near the patient. DHS 157.71(11)(a)3.3. Using the biological or effective half-life of the radioactive material retained in the body. DHS 157.71(11)(a)4.4. Considering the shielding by tissue to calculate the exposure to persons physically near the patient. DHS 157.71(11)(b)(b) A licensee shall retain a record for 3 years after the date of release that the instructions required by s. DHS 157.62 (8) (b) were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 mSv (0.5 rem). DHS 157.71(12)(12) Records of administrative and technical requirements that apply to the provision of mobile services. DHS 157.71(12)(a)(a) A licensee shall retain a copy of the letter that permits the use of radioactive material at a client’s address of use, as required by s. DHS 157.62 (9) (a) 1., for 3 years after the last provision of service. DHS 157.71(12)(b)(b) A licensee shall retain the record of each survey required by s. DHS 157.62 (9) (a) 4. for 3 years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey and the name of the person who performed the survey. DHS 157.71(13)(13) Records of decay-in-storage. A licensee shall maintain a record of the disposal of licensed materials as required by s. DHS 157.62 (10) for 3 years. The record shall include the date of the disposal, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container and the name of the person who performed the disposal. DHS 157.71(14)(14) Records of contaminant concentration. A licensee shall maintain a record of the contaminant concentration tests required by s. DHS 157.63 (3) (b) for 3 years. The record shall include, for each measured elution or extract, all of the following: DHS 157.71(14)(a)(a) The ratio of the measures expressed as kilobecquerel (microcurie) of molybdenum-99, strontium -82 or strontium-85 per megabecquerel of technetium-99m or rubidium-82 chloride injection. DHS 157.71(15)(15) Records of instruction and training. A licensee shall maintain a record of instructions and training required by ss. DHS 157.64 (2), 157.65 (4) and 157.67 (4) for 3 years. The record shall include a list of the topics covered, the date of the instruction or training, the names of the attendees and the names of the persons who provided the instruction. DHS 157.71(16)(16) Records of radiation surveys of patients and human research subjects. A licensee shall maintain a record of the surveys required by ss. DHS 157.65 (2) and 157.67 (2) for 3 years. Each record shall include the date and results of the survey, the survey instrument used and the name of the person who made the survey. DHS 157.71(17)(b)(b) For temporary implants, the record shall include all of the following: DHS 157.71(17)(b)1.1. The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the person who removed them from storage and the location of use. DHS 157.71(17)(b)2.2. The number and activity of sources returned to storage, the time and date they were returned to storage and the name of the person who returned them from storage. DHS 157.71(17)(c)(c) For permanent implants, the record shall include all of the following: DHS 157.71(17)(c)1.1. The number and activity of sources removed from storage, the date they were removed from storage and the name of the person who removed them from storage. DHS 157.71(17)(c)2.2. The number and activity of sources returned to storage, the date they were returned to storage and the name of the person who returned them to storage. DHS 157.71(17)(c)3.3. The number and activity of sources permanently implanted in the patient or human research subject. DHS 157.71(18)(18) Records of calibrations on brachytherapy sources. A licensee shall maintain a record of the calibrations on brachytherapy sources required by s. DHS 157.65 (6) for 3 years after the last use of the source. The record shall include the date of the calibration, the manufacturer’s name, model number and serial number for the source and instruments used to calibrate the source, the source output or activity, source positioning accuracy within applicators and the signature of the authorized medical physicist. DHS 157.71(19)(19) Records of installation, maintenance, adjustment and repair. A licensee shall retain a record of the installation, maintenance, adjustment and repair of remote afterloader units, teletherapy units and gamma stereotactic units as required by s. DHS 157.67 (3) for 3 years. For each installation, maintenance, adjustment and repair, the record shall include the date, description of the service and names of the persons who performed the work. DHS 157.71(20)(a)(a) A licensee shall retain a record of the calibration, intercomparison and comparisons of its dosimetry equipment done under s. DHS 157.67 (6) for the duration of the license. DHS 157.71(20)(b)(b) For each calibration, intercomparison or comparison, the record shall include all of the following: DHS 157.71(20)(b)2.2. The model numbers and serial numbers of the instruments that were calibrated, intercompared or compared. DHS 157.71(20)(b)3.3. The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison. DHS 157.71(20)(b)4.4. The names of the persons who performed the calibration, intercomparison or comparison. DHS 157.71(21)(21) Records of teletherapy, remote afterloader and gamma stereotactic radiosurgery full calibrations. DHS 157.71(21)(a)(a) A licensee shall maintain a record of the teletherapy, remote afterloader and gamma stereotactic radiosurgery full calibrations required by s. DHS 157.67 (7) to (9) for 3 years.
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Department of Health Services (DHS)
Chs. DHS 110-199; Health
administrativecode/DHS 157.71(4)(a)
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