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DHS 157.61(3)(b)1. 1. Instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material.
DHS 157.61(3)(b)2. 2. Require the supervised person to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, the written radiation protection procedures established by the licensee and the regulations of this chapter, and license conditions.
DHS 157.61(3)(c) (c) A licensee who permits supervised activities under pars. (a) and (b) is responsible for the acts and omissions of the supervised individual.
DHS 157.61(4) (4)Written directives.
DHS 157.61(4)(a)1.1. A written directive must be dated and signed by an authorized user prior to administration of I-131 sodium iodide greater than 1.11 Megabequerels (30 microcuries), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material.
DHS 157.61(4)(a)2. 2. If, because of the emergent nature of the patient's condition, a delay in providing a written directive would jeopardize the patient's health, an oral directive from an authorized user is acceptable provided the information contained in the oral directive is documented immediately in writing in the patient's record and a written directive is prepared within 48 hours of the oral directive.
DHS 157.61(4)(a)3. 3. A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to the administration of the dosage of radioactive drug containing radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose or the next fractional dose.
DHS 157.61(4)(a)4. 4. If, because of the patient's condition, a delay to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and a revised written directive is signed by the authorized user within 48 hours of the oral revision.
DHS 157.61(4)(b) (b) The written directive shall contain the patient or human research subject's name and all of the following information:
DHS 157.61(4)(b)1. 1. For the administration of a dosage of a radioactive drug, the name, dosage and administration route of the radioactive drug.
DHS 157.61(4)(b)2. 2. For each anatomically distinct treatment site exposed to gamma stereotactic radiosurgery, total dose, treatment site and number of target settings per treatment.
DHS 157.61(4)(b)3. 3. For teletherapy, the total dose, dose per fraction, number of fractions, treatment site and overall treatment period.
DHS 157.61(4)(b)4. 4. For high dose rate remote afterloading brachytherapy, the radionuclide, treatment site, dose per fraction, number of fractions and total dose.
DHS 157.61(4)(b)5. 5. For all other brachytherapy including low dose rate, medium dose rate and pulsed dose rate afterloading, both of the following:
DHS 157.61(4)(b)5.a. a. Prior to implantation, treatment site, the radionuclide and dose.
DHS 157.61(4)(b)5.b. b. After temporary implantation, but prior to completion of the procedure, the radioisotope, treatment site, number of sources, and total source strength and exposure time or, instead of total source strength and exposure time, the total dose.
DHS 157.61(4)(b)5.c. c. For permanent implantation, the radioisotope, treatment site, number of sources, total source strength, total dose and method of implantation.
DHS 157.61(4)(c) (c) A licensee shall retain the written directive under s. DHS 157.71 (3).
DHS 157.61(5) (5)Procedures for administrations requiring a written directive.
DHS 157.61(5)(a)(a) For any administration requiring a written directive, a licensee shall develop, implement and maintain written procedures to help ensure both of the following:
DHS 157.61(5)(a)1. 1. The patient's or human research subject's identity is verified by more than one method before each administration.
DHS 157.61(5)(a)2. 2. Each administration is performed according to the provisions of a written directive.
DHS 157.61(5)(b) (b) The procedures required by par. (a) shall address all of the following items that are applicable for the licensee's use of radioactive material:
DHS 157.61(5)(b)1. 1. Verifying the identity by more than one method of the patient or human research subject.
DHS 157.61(5)(b)2. 2. Verifying that the specific details of the administration are under the treatment plan, if applicable, and the written directive.
DHS 157.61(5)(b)3. 3. Checking both manual and computer-generated dose calculations, if performed.
DHS 157.61(5)(b)4. 4. Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic remote afterloader, teletherapy or gamma stereotactic radiosurgery units.
DHS 157.61(6) (6)Suppliers for sealed sources or devices for medical use. For medical use, a licensee may only use the following:
DHS 157.61(6)(a) (a) Sealed sources or devices manufactured, labeled, packaged and distributed under a license issued under subch. II or the equivalent requirements of the NRC or another agreement state.
DHS 157.61(6)(b) (b) Teletherapy sources manufactured and distributed under a license issued under subch. II or the equivalent requirements of the NRC or another agreement state.
DHS 157.61(6)(c) (c) Sealed sources or devices non-commercially transferred from a medical licensee.
DHS 157.61(7) (7)Training for radiation safety officer. Except as provided in sub. (10), a licensee shall ensure that an individual fulfilling the responsibilities of the radiation safety officer has training in radiation safety, regulatory issues and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by a radiation safety officer, authorized medical physicist, authorized nuclear pharmacist or authorized user, as appropriate, who is authorized for the type of use for which the licensee is seeking approval. A licensee shall also require the radiation safety officer to be a person who has obtained written attestation under sub. (12) (a) and meets any of the following requirements:
DHS 157.61(7)(a) (a) Is certified by a specialty board whose certification process has been recognized by the department, the NRC or another agreement state. To be recognized, a specialty board shall require all candidates for certification to have either of the following:
DHS 157.61(7)(a)1.a.a. A bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of 20 college credits in physical science.
DHS 157.61(7)(a)1.b. b. Five or more years of professional experience in health physics (graduate training may be substituted for no more than 2 years of the required experience) including at least 3 years in applied health physics.
DHS 157.61(7)(a)1.c. c. Passed an examination administered by diplomates of the specialty board, which evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry.
DHS 157.61(7)(a)2.a.a. Master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university.
DHS 157.61(7)(a)2.b. b. Two years of full-time practical training and/or supervised experience in medical physics either under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the department, the NRC, or another agreement state or in clinical nuclear medicine facilities providing diagnostic and/or therapeutic services under the direction of physicians who meet the requirements for authorized users in s. DHS 157.61 (10), 157.63 (5) or 157.64 (4).
DHS 157.61(7)(a)2.c. c. Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety.
DHS 157.61 Note Note: Specialty boards whose certification processes have been recognized by the department, the NRC or an agreement state will be posted on the NRC's web site at www.nrc.gov.
DHS 157.61(7)(b) (b) Has completed a structured educational program consisting of all the following:
DHS 157.61(7)(b)1. 1. 200 hours of classroom and laboratory training in all the following areas:
DHS 157.61(7)(b)1.a. a. Radiation physics and instrumentation.
DHS 157.61(7)(b)1.b. b. Radiation protection.
DHS 157.61(7)(b)1.c. c. Mathematics pertaining to the use and measurement of radioactivity.
DHS 157.61(7)(b)1.d. d. Radiation biology.
DHS 157.61(7)(b)1.e. e. Radiation dosimetry.
DHS 157.61(7)(b)2. 2. One year of full-time radiation safety experience under the supervision of the individual identified as the radiation safety officer on a department, NRC or another agreement state license or a permit issued by a NRC master material licensee that authorizes similar types of uses of radioactive material involving all the following:
DHS 157.61(7)(b)2.a. a. Shipping, receiving, and performing related radiation surveys.
DHS 157.61(7)(b)2.b. b. Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters and instruments used to measure radionuclides.
DHS 157.61(7)(b)2.c. c. Securing and controlling radioactive material.
DHS 157.61(7)(b)2.d. d. Using administrative controls to avoid mistakes in the administration of radioactive material.
DHS 157.61(7)(b)2.e. e. Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures.
DHS 157.61(7)(b)2.f. f. Using emergency procedures to control radioactive material.
DHS 157.61(7)(b)2.g. g. Disposing of radioactive material.
DHS 157.61(7)(c) (c) Is any one of the following:
DHS 157.61(7)(c)1. 1. A medical physicist who has been certified by a specialty board whose certification process has been recognized by the department, NRC or another agreement state under sub. (8) (a) and has experience in radiation safety for similar types of use of radioactive material for which the licensee is seeking the approval of the individual as radiation safety officer.
DHS 157.61(7)(c)2. 2. An authorized user, authorized medical physicist or authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual has radiation safety officer responsibilities.
DHS 157.61(8) (8)Training for an authorized medical physicist. Except as provided in sub. (10), a licensee shall require the authorized medical physicist to have training for the type of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the type of use for which the individual is seeking authorization. A licensee shall also require the authorized medical physicist to be an individual who has obtained written attestation under sub. (12) (b) and meets either of the following requirements:
DHS 157.61(8)(a) (a) Certified by a specialty board whose certification process has been recognized by the department, the NRC or an agreement state. To be recognized, a specialty board shall require all candidates for certification to have all of the following:
DHS 157.61(8)(a)1.a.a. A master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university.
DHS 157.61(8)(a)1.b. b. Attained two years full-time practical training and/or supervised experience in medical physics under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the department, the NRC or an agreement state or in clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements for authorized users in s. DHS 157.61 (10), 157.65 (8) or 157.67 (17).
DHS 157.61(8)(a)1.c. c. Passed an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery.
DHS 157.61 Note Note: Specialty boards whose certification processes have been recognized by the department, the NRC or an agreement state will be posted on the NRC's web site at www.nrc.gov.
DHS 157.61(8)(b) (b) Holds a master's or doctorate degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and completion of one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the type of use for which the individual is seeking authorization. This training and work experience shall be conducted in clinical radiation facilities that provide high energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services and shall include all of the following:
DHS 157.61(8)(b)1. 1. Performing sealed source leak tests and inventories.
DHS 157.61(8)(b)2. 2. Performing decay corrections.
DHS 157.61(8)(b)3. 3. Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable.
DHS 157.61(8)(b)4. 4. Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable.
DHS 157.61(9) (9)Training for an authorized nuclear pharmacist. Except as provided in sub. (10), the licensee shall require the authorized nuclear pharmacist to be a pharmacist who has obtained written attestation under sub. (12) (c) and meets either of the following requirements:
DHS 157.61(9)(a) (a) Is certified by a specialty board whose certification process has been recognized by the department, the NRC or an agreement state and who has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in sub. (12) (c) and has achieved a level of competency sufficient to independently operate a nuclear pharmacy. To be recognized, a specialty board shall require all candidates for certification to have all of the following:
DHS 157.61(9)(a)1. 1. Graduated from a pharmacy program accredited by the American council on pharmaceutical education or have passed the foreign pharmacy graduate examination committee examination.
DHS 157.61(9)(a)2. 2. A current, active license to practice pharmacy.
DHS 157.61(9)(a)3. 3. Evidence of having acquired at least 4000 hours of training and experience in nuclear pharmacy practice. Academic training may be substituted for no more than 2000 hours of the required training and experience.
DHS 157.61(9)(a)4. 4. Evidence of having passed an examination in nuclear pharmacy administered by diplomates of the specialty board, that assesses knowledge and competency in the procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development.
DHS 157.61 Note Note: Specialty boards whose certification processes have been recognized by the department, the NRC or an agreement state will be posted on the NRC's web site at www.nrc.gov.
DHS 157.61(9)(b) (b) Has completed 700 hours in a structured educational program including all of the following requirements:
DHS 157.61(9)(b)1. 1. Two hundred hours of classroom and laboratory training covering all of the following areas:
DHS 157.61(9)(b)1.a. a. Radiation physics and instrumentation.
DHS 157.61(9)(b)1.b. b. Radiation protection.
DHS 157.61(9)(b)1.c. c. Mathematics pertaining to the use and measurement of radioactivity.
DHS 157.61(9)(b)1.d. d. Chemistry of radioactive material for medical use.
DHS 157.61(9)(b)1.e. e. Radiation biology.
DHS 157.61(9)(b)2. 2. Supervised practical experience in a nuclear pharmacy involving all the following:
DHS 157.61(9)(b)2.a. a. Shipping, receiving and performing related radiation surveys.
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Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.