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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.
DHS 157.61(9)(b)2.b. b. Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and if appropriate, instruments used to measure alpha-emitting or beta-emitting radionuclides.
DHS 157.61(9)(b)2.c. c. Calculating, assaying and safely preparing dosages for patients or human research subjects.
DHS 157.61(9)(b)2.d. d. Using administrative controls to avoid medical events in the administration of radioactive material.
DHS 157.61(9)(b)2.e. e. Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures.
DHS 157.61(10) (10)Training for experienced radiation safety officer, teletherapy or medical physicist, authorized user and nuclear pharmacist.
DHS 157.61(10)(a)(a) An individual identified as a radiation safety officer, a teletherapy or medical physicist, or a nuclear pharmacist on a department, NRC or another agreement state license, the permit issued by a licensee of broad scope or the permit issued by an NRC master material licensee before October 24, 2002 need not comply with the training requirements of subs. (7) to (9), respectively.
DHS 157.61(10)(b) (b) An individual identified as a radiation safety officer, an authorized medical physicist, or an authorized nuclear pharmacist on a department, NRC or another agreement state license, the permit issued by a licensee of broad scope or the permit issued by NRC master material licensee between October 24, 2002 and April 29, 2005 need not comply with the training requirements of s. DHS 157.61 (7), (8) or (9).
DHS 157.61(10)(c) (c) A physician, dentist or podiatrist identified as an authorized user for the medical, dental or podiatric use of radioactive material on a department, NRC or another agreement state license, the permit issued by a licensee of broad scope or the permit issued by an NRC master material licensee before October 24, 2002 who performs only those medical uses for which they are authorized need not comply with the training requirements of ss. DHS 157.63 to 157.67.
DHS 157.61(10)(d) (d) Individuals who are not required to comply with the training requirements as described in this section may serve as preceptors for, and supervisors of, applicants seeking authorization on department licenses for the same uses for which these individuals are authorized.
DHS 157.61(11) (11)Recentness of training. The training and experience specified in this section and ss. DHS 157.63 to 157.67 shall have been completed within 7 years preceding the date of license application. If the training and experience specified in this section and ss. DHS 157.63 to 157.67 have not been completed within 7 years preceding the date of license application, additional related continuing education and experience shall be required.
DHS 157.61(12) (12)Written attestation.
DHS 157.61(12)(a)(a) Radiation safety officer. The licensee shall ensure that an individual fulfilling the responsibilities of the radiation safety officer has obtained written attestation, signed by a preceptor radiation safety officer, that the individual has satisfactorily completed the requirements in sub. (7) (a) 1. a. and b., 2. a. and b., (b), or (c), has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval and has achieved a level of radiation safety knowledge sufficient to independently function as a radiation safety officer for a medical use of radioactive material.
DHS 157.61(12)(b) (b) Authorized medical physicist. A licensee shall ensure that the individual has obtained written attestation that the individual has satisfactorily completed the requirements in sub. (8) (a) 1. a. and b. or (b), has 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 and has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation shall be signed by a preceptor authorized medical physicist who meets the requirements in sub. (8) or (10), or equivalent agreement state requirements, for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status.
DHS 157.61(12)(c) (c) Authorized nuclear pharmacist. A licensee shall ensure that the individual has obtained written attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in sub. (9) (a) or (b) and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.
DHS 157.61 History History: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; CR 06-021: am. (1) (g), r. and recr. (7) to (10), cr. (12) Register October 2006 No. 610, eff. 11-1-06; CR 09-062: am. (10) (a) and (12) (b), renum. (10) (b) to be (10) (c), cr. (10) (b) Register April 2010 No. 652, eff. 5-1-10; CR 16-078: am. (7) (a) 2. b., (8) (a) 1. b., (10) (a), (c), cr. (10) (d) Register January 2018 No. 745, eff. 2-1-18.
DHS 157.62 DHS 157.62 Technical requirements.
DHS 157.62(1) (1) Possession, use and calibration of instruments to measure the activity of unsealed radioactive materials.
DHS 157.62(1)(a)(a) For direct measurements performed under sub. (3), a licensee shall possess and use instrumentation to measure the activity of unsealed radioactive materials prior to administration of unsealed radioactive materials to each patient or human research subject.
DHS 157.62(1)(b) (b) A licensee shall calibrate the instrumentation required in par. (a) according to nationally recognized standards or the manufacturer's instructions.
DHS 157.62(1)(c) (c) A licensee shall retain a record of each instrument calibration required by this subsection under s. DHS 157.71 (6).
DHS 157.62(2) (2)Calibration of survey instruments.
DHS 157.62(2)(a)(a) A licensee shall calibrate the survey instruments used to show compliance with this subchapter and subch. III before first use, at a frequency not to exceed 13 months and following any repair that will affect the calibration.
DHS 157.62(2)(b) (b) A licensee shall do all the following:
DHS 157.62(2)(b)1. 1. Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source.
DHS 157.62(2)(b)2. 2. Calibrate each scale used to show compliance at a sufficient number of readings to determine the response characteristics of the instrument.
DHS 157.62(2)(b)3. 3. Conspicuously note on the instrument the date of calibration.
DHS 157.62 Note Note: Two separated readings on each scale or decade are typically used used for linear scale instruments.
DHS 157.62(2)(c) (c) A licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than 20%.
DHS 157.62(2)(d) (d) A licensee shall retain a record of each survey instrument calibration under s. DHS 157.71 (7).
DHS 157.62(3) (3)Determination of dosages of unsealed radioactive material for medical use.
DHS 157.62(3)(a)(a) A licensee shall determine and record the activity of each dosage prior to medical use.
DHS 157.62(3)(b) (b) For a unit dosage, this determination shall be made by using one of the following methods:
DHS 157.62(3)(b)1. 1. Direct measurement of radioactivity.
DHS 157.62(3)(b)2. 2. A decay correction, based on the measurement made by either of the following:
DHS 157.62(3)(b)2.a. a. A manufacturer or preparer licensed under s. DHS 157.13 (4) (i) or by NRC or another agreement state.
DHS 157.62(3)(b)2.b. b. An NRC or other agreement state licensee only for use in research in accordance with an RDRC protocol or and IND protocol accepted by FDA.
DHS 157.62(3)(b)2.c. c. A PET radioactive drug producer licensed under s. DHS 157.13 (1) (j) or by NRC or another agreement state.
DHS 157.62(3)(c) (c) For other than unit dosages, the determination of dosages of unsealed radioactive material shall be made through one of the following methods:
DHS 157.62(3)(c)1. 1. Direct measurement of radioactivity.
DHS 157.62(3)(c)2. 2. A combination of direct measurements of radioactivity and mathematical calculations.
DHS 157.62(3)(c)3. 3. A combination of volumetric measurements and mathematical calculations, based on the measurement made by a manufacturer or preparer licensed under s. DHS 157.13 (4) (i), a PET radioactive drug producer licensed under s. DHS 157.13 (1) (j), or equivalent NRC or other agreement state requirements.
DHS 157.62(3)(d) (d) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage differs from the prescribed dosage by more than 20% or if the dosage does not fall within the prescribed dosage range.
DHS 157.62(3)(e) (e) A licensee shall retain a record of the dosage determination required by this subsection under s. DHS 157.71 (8).
DHS 157.62(4) (4)Authorization for calibration, transmission and reference sources. Any person authorized by s. DHS 157.13 (5) for medical use of radioactive material may receive, possess and use the following radioactive material for check, calibration, transmission and reference use:
DHS 157.62(4)(a) (a) A sealed source that does not exceed 1.11 GBq (30 mCi) that is manufactured and distributed by a person licensed under s. DHS 157.13 (4) (j) or equivalent NRC or agreement state regulations or redistributed by a person authorized to redistribute sealed sources, provided that the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturers approved instructions.
DHS 157.62(4)(b) (b) Any radioactive material with a half-life not longer than 120 days in individual amounts not to exceed 0.555 GBq (15 mCi).
DHS 157.62(4)(c) (c) Any radioactive material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 mCi) or 1000 times the quantities in ch. DHS 157 Appendix F.
DHS 157.62(4)(d) (d) Technetium-99m in amounts as needed.
DHS 157.62(5) (5)Requirements for possession of sealed sources and brachytherapy sources.
DHS 157.62(5)(a)(a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.
DHS 157.62(5)(b) (b) A licensee in possession of a sealed source shall do both the following:
DHS 157.62(5)(b)1. 1. Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee.
DHS 157.62(5)(b)2. 2. Test the source for leakage at intervals not to exceed 6 months or at other intervals approved by the department, NRC or another agreement state in the sealed source and device registry.
DHS 157.62(5)(c) (c) To satisfy the leak test requirements of this section, a licensee shall measure the sample so that the leakage test may detect the presence of 185 Bq (0.005 mCi) of radioactive material on the sample.
DHS 157.62(5)(d) (d) A licensee shall retain leakage test records under s. DHS 157.71 (9).
DHS 157.62(5)(e) (e) If the leakage test reveals the presence of 185 Bq (0.005 mCi) or more of removable contamination, a licensee shall do both the following:
DHS 157.62(5)(e)1. 1. Immediately withdraw the sealed source from use and store, dispose or cause it to be repaired under the requirements in subchs. II and III.
DHS 157.62(5)(e)2. 2. File a report to the department within 5 working days of the leakage test as specified under s. DHS 157.72 (3).
DHS 157.62(5)(f) (f) A licensee need not perform a leakage test on any of the following sources:
DHS 157.62(5)(f)1. 1. A source containing only radioactive material with a half-life of less than 30 days.
DHS 157.62(5)(f)2. 2. A source containing only radioactive material as a gas.
DHS 157.62(5)(f)3. 3. A source containing 3.7 MBq (100 mCi) or less of beta or gamma-emitting material or 0.37 MBq (10 mCi) or less of alpha-emitting material.
DHS 157.62(5)(f)4. 4. A source stored and not being used. A licensee shall, however, test each source for leakage before any use or transfer unless it has been leakage-tested within 6 months before the date of use or transfer.
DHS 157.62(5)(f)5. 5. Seeds of iridium-192 encased in intact nylon ribbon.
DHS 157.62(5)(g) (g) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession. A licensee shall retain each inventory record under s. DHS 157.71 (9).
DHS 157.62(6) (6)Labelling of vials and syringes. Each syringe and vial that contains a radioactive drug containing radioactive material shall be labeled to identify the radioactive drug. Each syringe shield and vial shield shall also be labeled unless the label on the syringe or vial is visible when shielded.
DHS 157.62(7) (7)Surveys for ambient radiation exposure rate.
DHS 157.62(7)(a)(a) Except as provided in par. (b), a licensee shall survey with a radiation detection survey instrument at the end of each day of use all areas where radioactive drugs containing radioactive material requiring a written directive were prepared for use or administered.
DHS 157.62(7)(b) (b) A licensee need not perform the surveys required under par. (a) in an area where patients or human research subjects are confined when the patients or human research subjects cannot be released under sub. (8).
DHS 157.62(7)(c) (c) A licensee shall retain a record of each survey under s. DHS 157.71 (10).
DHS 157.62(8) (8)Release of individuals containing radioactive drugs or implants containing radioactive material.
DHS 157.62(8)(a)(a) A licensee may authorize the release from its control of any person who has been administered radioactive drugs or implants containing radioactive material if the total effective dose equivalent to any other person from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem).
DHS 157.62 Note Note: WISREG 1556, Vol. 9, Guidance for Medical Use of Radioactive Material describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 mSv (0.5 Rem). It is available from the following website: http://dhs.wisconsin.gov/radiation/radioactivematerials/index.htm.
DHS 157.62(8)(b) (b) A licensee shall provide the released person or the person's parent or guardian with instructions, including written instructions, on actions recommended to maintain doses to other persons as low as is reasonably achievable if the total effective dose equivalent to any other person is likely to exceed one mSv (0.1 rem). If the total effective dose equivalent to a breast-feeding infant or child could exceed one mSv (0.1 rem) assuming there were no interruption of breast-feeding, the instructions shall also include all the following:
DHS 157.62(8)(b)1. 1. Guidance on the interruption or discontinuation of breast-feeding.
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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.