Section 157.61. Administrative requirements.

 

(1)   Authority and responsibilities for the radiation protection program.

(a) In addition to the radiation protection program requirements of s. DHS 157.21 , a licensee's management shall approve in writing any of the following:

1. A request for license application, renewal or amendment before submittal to the department.

2. Authorization prior to using licensed materials for any individual to work as an authorized user, authorized nuclear pharmacist or authorized medical physicist.

3. A radiation protection program change that does not require a license amendment and is permitted under sub. (2) .

(b) A licensee's management shall appoint a radiation safety officer who agrees in writing to be responsible for implementing the radiation protection program. A licensee, through the radiation safety officer, shall ensure that radiation safety activities are being performed under licensee-approved procedures and regulatory requirements.

(c) For up to 60 days each year, a licensee may permit an authorized user or an individual qualified to be a radiation safety officer to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer, as provided in par. (f) , provided the licensee takes the actions required in pars. (b) , (d) , (f) and (g) . A licensee may simultaneously appoint more than one temporary radiation safety officer if needed to ensure that the licensee has a temporary radiation safety officer that satisfies the requirements to be an radiation safety officer for each of the different uses of radioactive material permitted by the license.

(d) A licensee shall establish in writing the authority, duties and responsibilities of the radiation safety officer.

(e) A licensee that is authorized for 2 or more different types of uses of radioactive material under ss. DHS 157.64 , 157.65 and 157.67 or 2 or more types of units under s. DHS 157.67 shall establish a radiation safety committee to oversee all uses of radioactive material permitted by the license. The committee shall include an authorized user of each type of use permitted by the license, the radiation safety officer, a representative of the nursing service and a representative of management who is neither an authorized user nor a radiation safety officer, and may include other members as the licensee deems appropriate.

(f) A licensee shall provide the radiation safety officer sufficient authority, organizational freedom, time, resources and management prerogative to perform all the following functions:

1. Identify radiation safety problems.

2. Initiate, recommend or provide corrective actions.

3. Stop unsafe operations.

4. Verify implementation of corrective actions.

(g) A licensee shall retain a record of actions taken under pars. (a) , (b) and (d) according to the record retention requirements of s. DHS 157.71 (1) .

(2)   Radiation protection program changes.

(a) A licensee may revise its radiation protection program without department approval if the revision meets all the following criteria:

1. The revision does not require a license amendment.

2. The revision complies with the requirements of this chapter and the license.

3. The revision has been reviewed and approved by the radiation safety officer and licensee management.

4. The affected individuals are instructed on the revised program before the changes are implemented.

(b) A licensee shall retain a record of each change under s. DHS 157.71 (2) .

(3)   Supervision.

(a) A licensee who permits the receipt, possession, use or transfer of radioactive material by an individual under the supervision of an authorized user shall do all the following:

1. Instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, requirements of this chapter and license conditions regarding the use of radioactive material.

2. Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, requirements of this chapter and license conditions regarding the medical use of radioactive material.

(b) A licensee who permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user shall do all of the following:

1. Instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material.

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.

(c) A licensee who permits supervised activities under pars. (a) and (b) is responsible for the acts and omissions of the supervised individual.

(4)   Written directives.

(a)

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.

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.

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.

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.

(b) The written directive shall contain the patient or human research subject's name and all of the following information:

1. For the administration of a dosage of a radioactive drug, the name, dosage and administration route of the radioactive drug.

2. For each anatomically distinct treatment site exposed to gamma stereotactic radiosurgery, total dose, treatment site and number of target settings per treatment.

3. For teletherapy, the total dose, dose per fraction, number of fractions, treatment site and overall treatment period.

4. For high dose rate remote afterloading brachytherapy, the radionuclide, treatment site, dose per fraction, number of fractions and total dose.

5. For all other brachytherapy including low dose rate, medium dose rate and pulsed dose rate afterloading, both of the following:

a. Prior to implantation, treatment site, the radionuclide and dose.

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.

c. For permanent implantation, the radioisotope, treatment site, number of sources, total source strength, total dose and method of implantation.

(c) A licensee shall retain the written directive under s. DHS 157.71 (3) .

(5)   Procedures for administrations requiring a written directive.

(a) For any administration requiring a written directive, a licensee shall develop, implement and maintain written procedures to help ensure both of the following:

1. The patient's or human research subject's identity is verified by more than one method before each administration.

2. Each administration is performed according to the provisions of a written directive.

(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:

1. Verifying the identity by more than one method of the patient or human research subject.

2. Verifying that the specific details of the administration are under the treatment plan, if applicable, and the written directive.

3. Checking both manual and computer-generated dose calculations, if performed.

4. Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic remote afterloader, teletherapy or gamma stereotactic radiosurgery units.

(6)   Suppliers for sealed sources or devices for medical use. For medical use, a licensee may only use the following:

(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.

(b) Teletherapy sources manufactured and distributed under a license issued under subch. II or the equivalent requirements of the NRC or another agreement state.

(c) Sealed sources or devices non-commercially transferred from a medical licensee.

(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:

(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:

1.

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.

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.

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.

2.

a. Master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university.

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 157.63 (5) or 157.64 (4) .

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.

(b) Has completed a structured educational program consisting of all the following:

1. 200 hours of classroom and laboratory training in all the following areas:

a. Radiation physics and instrumentation.

b. Radiation protection.

c. Mathematics pertaining to the use and measurement of radioactivity.

d. Radiation biology.

e. Radiation dosimetry.

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:

a. Shipping, receiving, and performing related radiation surveys.

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.

c. Securing and controlling radioactive material.

d. Using administrative controls to avoid mistakes in the administration of radioactive material.

e. Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures.

f. Using emergency procedures to control radioactive material.

g. Disposing of radioactive material.

(c) Is any one of the following:

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.

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.

(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:

(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:

1.

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.

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 157.65 (8) or s. DHS 157.67 (17) .

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.

(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:

1. Performing sealed source leak tests and inventories.

2. Performing decay corrections.

3. Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable.

4. Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable.

(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:

(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:

1. Graduated from a pharmacy program accredited by the American council on pharmaceutical education or have passed the foreign pharmacy graduate examination committee examination.

2. A current, active license to practice pharmacy.

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.

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.

(b) Has completed 700 hours in a structured educational program including all of the following requirements:

1. Two hundred hours of classroom and laboratory training covering all of the following areas:

a. Radiation physics and instrumentation.

b. Radiation protection.

c. Mathematics pertaining to the use and measurement of radioactivity.

d. Chemistry of radioactive material for medical use.

e. Radiation biology.

2. Supervised practical experience in a nuclear pharmacy involving all the following:

a. Shipping, receiving and performing related radiation surveys.

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.

c. Calculating, assaying and safely preparing dosages for patients or human research subjects.

d. Using administrative controls to avoid medical events in the administration of radioactive material.

e. Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures.

(10)   Training for experienced radiation safety officer, teletherapy or medical physicist, authorized user and nuclear pharmacist.

(a) An individual identified as a radiation safety officer, a teletherapy or authorized 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.

(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) .

(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 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 .

(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.

(12)   Written attestation.

(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.

(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.

(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.

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.

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 . Microsoft Windows NT 6.1.7601 Service Pack 1 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 . Microsoft Windows NT 6.1.7601 Service Pack 1 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 . Microsoft Windows NT 6.1.7601 Service Pack 1