Section 157.64. Unsealed radioactive material — written directive required.

 

(1)   Use of unsealed radioactive material for which a written directive is required. A licensee may use any unsealed radioactive material prepared for medical use and for which a written directive is required that is any of the following:

(a) Obtained from 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.

(b) Excluding production of PET radionuclides, is prepared by any of the following:

1. An authorized nuclear pharmacist.

2. A physician who is an authorized user and who meets the requirements specified in sub. (4) or s. DHS 157.63 (5) .

3. An individual under the supervision of either an authorized nuclear pharmacist or physician who is an authorized user as specified in s. DHS 157.61 (3) .

(c) Obtained from an NRC or agreement state licensee for use in research under an investigational new drug application accepted by FDA.

(d) Prepared by the licensee for use under an investigational new drug protocol accepted by FDA.

(2)   Safety instruction. In addition to the requirements of subch. X , a licensee shall do all the following:

(a) Provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who have received therapy with a drug containing radioactive material and cannot be released under s. DHS 157.62 (8) . The instruction shall be commensurate with the duties of the personnel and include all the following:

1. Patient or human research subject control.

2. Visitor control, including both the following:

a. Routine visitation to hospitalized individuals under s. DHS 157.23 (1) (a) 1.

b. Visitation authorized under s. DHS 157.23 (1) (b) .

3. Contamination control.

4. Waste control.

5. Notification of the radiation safety officer or his or her designee and the authorized user if the patient or the human research subject dies or has a medical emergency.

(b) Retain a record of individuals receiving instruction under s. DHS 157.71 (15) .

(3)   Safety precautions.

(a) For each patient or human research subject who cannot be released under s. DHS 157.62 (8) , a licensee shall do all the following:

1. Quarter the patient or the human research subject in one of the following:

a. A private room with a bathroom.

b. A room, with a bathroom, with another person who also has received therapy with a radioactive drug containing radioactive material and who cannot be released under s. DHS 157.62 (8) .

2. Visibly post a "Radioactive Materials" sign on the door of a patient's or the human research subject's room and note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room.

3. Either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity 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 such material and items as radioactive waste.

(b) A licensee shall notify the radiation safety officer or his or her designee and the authorized user as soon as possible if the patient or human research subject has a medical emergency and immediately if the patient dies.

(4)   Training for use of unsealed radioactive material for which a written directive is required. Except as provided in s. DHS 157.61 (10) , a licensee shall require an authorized user of unsealed radioactive material for the uses authorized under sub. (1) to have obtained written attestation under sub. (8) (a) and to be a physician who meets either of the following requirements:

(a) Is certified by a medical specialty board whose certification process is recognized by the department, the NRC or an agreement state and who meets the requirements of par. (b) 2. g. To be recognized, a specialty board shall require all candidates for certification to do all of the following:

1. Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs shall include 700 hours of training and experience as described in par. (b) 1. and (b) 2. a. , b. , c. , d. , and e. Eligible training programs shall be approved by the residency review committee of the accreditation council for graduate medical education, the royal college of physicians and surgeons of Canada, or the committee on post-graduate training of the American osteopathic association.

2. Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed radioactive material for which a written directive is required.

(b) Has completed 700 hours of certified training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive that includes all the following:

1. 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. Chemistry of radioactive material for medical use.

e. Radiation biology.

2. Work experience under the supervision of an authorized user who meets the requirements in this subsection, s. DHS 157.61 (10) , or equivalent agreement state requirements. A supervising authorized user who meets the requirements of this paragraph shall also have experience under subd. 2. g. in administering dosages in the same dosage category or categories as the individual requesting authorized user status. The work experience shall involve all of the following:

a. Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys.

b. Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters.

c. Calculating, measuring, and safely preparing patient or human research subject dosages.

d. Using administrative controls to prevent a medical event involving the use of unsealed radioactive material.

e. Using procedures to contain spilled radioactive material safely.

f. Using proper decontamination procedures.

g. Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of 3 cases in each of the following categories for which the individual is requesting authorized user status: oral administration of less than or equal to 1.22 GBq (33 millicurie) of sodium iodide I-131 for which a written directive is required; oral administration of greater than 1.22 GBq (33 millicuries) of sodium iodide I-131; parenteral administration of any beta emitter or a photon-emitting radionuclide with a photon energy less than 150 keV, for which a written directive is required; and/or parenteral administration of any other radionuclide for which a written directive is required. Experience with at least 3 cases of oral administration of greater than 1.22 GBq (33 millicuries) of I-131 also satisfies the requirement for experience with 3 cases of oral administration of less than or equal to 1.22 GBq (33 millicuries) of I-131.

(5)   Training for the oral administration of sodium iodide i-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries). Except as provided in s. DHS 157.61 (10) , a licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries), to have obtained written attestation under sub. (8) (b) and to be a physician who meets any of the following requirements:

(a) Is certified by a medical specialty board whose certification process includes all of the requirements in par. (c) and whose certification process has been recognized by the department, the NRC or an agreement state.

(b) Is an authorized user under sub. (4) (a) or (b) for specified uses of I-131 listed in subs. (4) (b) 2. g. and (6) , or equivalent agreement state requirements.

(c) Has successfully completed training and work experience, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive that includes both of the following:

1. Eighty hours of classroom and laboratory training in 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. Work experience, under the supervision of an authorized user who meets the requirements in sub. (4) (a) or (b) , (5) or (6) , s. DHS 157.61 (10) , or equivalent agreement state requirements. A supervising authorized user who meets the requirements in sub. (4) (b) or s. DHS 157.61 (10) , shall also have experience in administering the same category of sodium iodide I-131 use as specified in sub. (4) (b) 2. g. The work experience shall involve all of the following:

a. Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys.

b. Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters.

c. Calculating, measuring, and safely preparing patient or human research subject dosages.

d. Using administrative controls to prevent a medical event involving the use of radioactive material.

e. Using procedures to contain spilled radioactive material safely and using proper decontamination procedures.

f. Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of less than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131.

(6)   Training for the oral administration of sodium iodide i-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries). Except as provided in s. DHS 157.61 (10) , a licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries) to have obtained written attestation under sub. (8) (c) and to be a physician who meets any of the following requirements:

(a) Is certified by a medical specialty board whose certification process includes all of the requirements in par. (c) and whose certification has been recognized by the department, the NRC or agreement state.

(b) Is an authorized user under sub. (4) (a) or (b) for use of I-131 greater than 1.22 Gigabecquerel (33 millicuries) under sub. (4) (b) 2. g. , or equivalent agreement state requirements.

(c) Has successfully completed training and experience, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive, that includes both of the following:

1. Eighty hours of classroom and laboratory training in 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. Work experience, under the supervision of an authorized user who meets the requirements in sub. (4) (a) or (b) , this subsection, s. DHS 157.61 (10) , or equivalent agreement state requirements. A supervising authorized user, who meets the requirements in sub. (4) (b) , or s. DHS 157.61 (10) , shall also have experience in administering dosages of I-131 greater than 1.22 Gigabecquerels (33 millicuries) as specified in sub. (4) (b) 2. g. The work experience shall involve all the following:

a. Ordering, receiving and unpacking radioactive materials safely and performing the related radiation surveys.

b. Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters.

c. Calculating, measuring and safely preparing patient or human research subject dosages.

d. Using administrative controls to prevent a medical event involving the use of radioactive material.

e. Using procedures to contain spilled radioactive material safely and using proper decontamination procedures.

f. Administering dosages to patients or human research subjects, that includes at least 3 cases involving the oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131.

(7)   Training for the parenteral administration of unsealed radioactive material requiring a written directive. Except as provided in s. DHS 157.61 (10) , a licensee shall require an authorized user for the parenteral administration requiring a written directive to have obtained written attestation under sub. (8) (d) and to be a physician who meets any of the following requirements:

(a) Is an authorized user under sub. (4) for the specific parenteral uses listed in sub. (4) (b) 2. g. , or equivalent agreement state requirements.

(b) Is an authorized user under s. DHS 157.65 (8) or 157.67 (17) , or equivalent agreement state requirements and who meets the requirements in par. (c) 1. and 2.

(c) Is certified by a medical specialty board whose certification process has been recognized by the department under s. DHS 157.65 (8) or 157.67 (17) or equivalent agreement state requirements; and who meets the following requirements:

1. Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations, for which a written directive is required, of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. The training shall include all of the following:

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. Has work experience with any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. This work experience shall be under the supervision of an authorized user with experience in parenteral administration under sub. (4) (b) 2. g. , for which a written directive is required, and who meets the requirements in sub. (4) , s. DHS 157.61 (10) , this subsection, or equivalent agreement state requirements. The work experience shall involve all the following:

a. Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys.

b. Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters.

c. Calculating, measuring, and safely preparing patient or human research subject dosages.

d. Using administrative controls to prevent a medical event involving the use of unsealed radioactive material.

e. Using procedures to contain spilled radioactive material safely, and using proper decontamination procedures.

f. Administering dosages to patients or human research subjects, that include at least 3 cases involving the parenteral administration, for which a written directive is required, of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV and/or at least 3 cases involving the parenteral administration of any other radionuclide, for which a written directive is required.

(8)   Written attestation.

(a) Unsealed radioactive material for which a written directive is required. A licensee shall require an authorized user of unsealed radioactive material for the uses authorized under sub. (1) to have obtained written attestation that the individual has satisfactorily completed the requirements in sub. (4) (a) 1. and (b) 2. g. , or sub. (4) (b) and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under sub. (1) . The written attestation shall be signed by a preceptor authorized user who meets the requirements in this subsection, s. DHS 157.61 (10) , or equivalent agreement state requirements. The preceptor authorized user, who meets the requirements in sub. (4) (b) or s. DHS 157.61 (10) shall have experience under sub. (4) (b) 2. g. in administering dosages in the same dosage category or categories as the individual requesting authorized user status.

(b) Oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 Gigabecquerels (33 millicuries). A licensee shall require an authorized user of sodium iodide I-131 for oral administration to have obtained written attestation that the individual has satisfactorily completed the requirements in sub. (5) (c) and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under sub. (1) . The written attestation shall be signed by a preceptor authorized user who meets the requirements in sub. (4) , (5) or (6) , s. DHS 157.61 (10) , or equivalent agreement state requirements. A preceptor authorized user, who meets the requirements of sub. (4) (b) or s. DHS 157.61 (10) , shall have experience in administering I -131 dosage less than 1.22 Gigabecquerels (33 millicuries) under sub. (4) (b) 2. g.

(c) Oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries). A licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than Gigabecquerels (33 millicuries) to have obtained written attestation that the individual has satisfactorily completed the requirements in sub. (6) (c) and has achieved a level of competency sufficient to function independently as an authorized user under sub. (1) . The written attestation shall be signed by a preceptor authorized user who meets the requirements in sub. (4) or (6) , s. DHS 157.61 (10) , or equivalent agreement state requirements. A preceptor authorized user, who meets the requirements of sub. (4) (b) or s. DHS 157.61 (10) , shall have experience in administering dosages of I-131 greater than 1.22 Gigabecquerels (33 millicuries) as specified in sub. (4) (b) 2. g.

(d) Parenteral administration of unsealed radioactive material requiring a written directive. A licensee shall require an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive to have obtained written attestation that the individual has satisfactorily completed the requirements in sub. (7) (b) or (c) and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive. The written attestation shall be signed by a preceptor authorized user who meets the requirements in sub. (4) , s. DHS 157.61 (10) , or equivalent agreement state requirements. A preceptor authorized user, who meets the requirements in sub. (4) or s. DHS 157.61 (10) shall have experience in administering parenteral dosages as specified in sub. (4) (b) 2. g.

CR 01-108 : cr. Register July 2002 No. 559 , eff. — see Note at the start of the chapter; CR 06-021 : r. and recr. (4) to (6), cr. (7) and (8) Register October 2006 No. 610 , eff. 11-1-06; CR 09-062 : am. (1) (a), (b) (intro.), (4) (b) 2. (intro.), (5) (b), (c) 2. (intro.), (6) (c) 2. (intro.), (7) (c) 2. (intro.), (8) (a) to (d) 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