Section 157.65. Manual brachytherapy.

 

(1)   Use of sources for manual brachytherapy. A licensee shall use only brachytherapy sources for therapeutic medical uses under either of the following criteria:

(a) As approved in the sealed source and device registry.

(b) In research under an effective investigational device exemption application accepted by the FDA, provided the requirements of s. DHS 157.61 (6) (a) are met.

(2)   Source implant and removal requirements.

(a) Immediately after implanting sources in a patient or a human research subject, a licensee shall make a survey to locate and account for all sources that have not been implanted.

(b) Immediately after removing the last temporary implant source from a patient or a human research subject, a licensee shall conduct a survey of the patient or the human research subject with a radiation detection survey instrument, with the sources shielded and outside the room, to confirm that all sources have been removed from the patient.

(c) A licensee shall retain a record of the surveys under s. DHS 157.71 (16) .

(3)   Brachytherapy sources inventory.

(a) A licensee shall maintain accountability at all times for all brachytherapy sources in storage or use.

(b) Promptly after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area.

(c) A licensee shall maintain a record of the brachytherapy source accountability under s. DHS 157.71 (17) .

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

(a) Provide radiation safety instruction, initially and at least once in each year, at intervals no greater than 13 months, to personnel caring for patients or human research subjects undergoing implant therapy and cannot be released under s. DHS 157.62 (8) . To satisfy this requirement, the instruction shall be commensurate with the duties of the personnel and include all of the following:

1. Size and appearance of the brachytherapy sources.

2. Safe handling and shielding instructions.

3. Patient or human research subject control.

4. Visitor control, including both of the following:

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

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

5. Notification of the radiation safety officer or his or her designee and an authorized user if the patient or the human research subject dies or has a medical emergency that causes the patient's condition to suddenly deteriorate.

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

(5)   Safety precautions.

(a) For each patient or human research subject receiving brachytherapy who may not be released under s. DHS 157.62 (8) , a licensee shall do both the following:

1. Not quarter the patient or the human research subject in the same room as a person who is not receiving brachytherapy.

2. Visibly post a "Radioactive Materials" sign on the door of the patient's or 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 human research subject's room.

(b) A licensee shall have available, near each treatment room, emergency response equipment to respond to a source that is any of the following:

1. Inadvertently dislodged from the patient.

2. Inadvertently lodged within the patient following removal of the source applicators.

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

(6)   Calibration measurements of brachytherapy sources.

(a) Prior to the first medical use of brachytherapy sources, a licensee shall do all the following:

1. Determine the source output or activity using a dosimetry system that meets the requirements of s. DHS 157.67 (6) .

2. Determine source positioning accuracy within applicators.

3. Use published protocols accepted by nationally recognized bodies to meet the requirements of subds. 1. and 2.

(b) A licensee shall mathematically correct the outputs or activities determined in par. (a) for physical decay at intervals consistent with one percent physical decay.

1. For strontium-90 sources for ophthalmic treatments, only an authorized medical physicist may calculate the activity of each source used to determine the treatment times for ophthalmic treatments. The decay shall be based on the activity determined under par. (a) .

2. A licensee shall retain a record of the activity of each strontium-90 source under s. DHS 157.71 (28) .

(c) A licensee shall retain a record of each calibration under s. DHS 157.71 (18) .

(7)   Therapy-related computer systems. A licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems under published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing shall include, as applicable, verification of all of the following:

(a) Source-specific input parameters required by the dose calculation algorithm.

(b) Accuracy of dose, dwell time and treatment time calculations at representative points.

(c) Accuracy of isodose plots and graphic displays.

(d) Accuracy of the software used to determine radioactive source positions from radiographic images.

(8)   Training for use of manual brachytherapy sources. Except as provided in s. DHS 157.61 (10) , a licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under sub. (1) to have obtained written attestation under sub. (10) (a) and to be a physician who meets either of the following requirements:

(a) Is certified by a medical 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 do all of the following:

1. Successfully complete a minimum of 3 years of residency training in a radiation oncology program approved by the residency review committee of the accreditation council for graduate medical education or 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, that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy.

(b) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes all of the following:

1. Two hundred 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. Radiation biology.

2. Five hundred hours of 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 at a medical institution, involving all of the following:

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

b. Checking survey meters for proper operation.

c. Preparing, implanting and removing brachytherapy sources.

d. Maintaining running inventories of material on hand.

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

f. Using emergency procedures to control radioactive material.

3. Three years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in this subsection, s. DHS 157.61 (10) , or equivalent agreement state requirements, as part of a formal training program approved by the residency review committee for radiation oncology of the accreditation council for graduate medical education or the royal college of physicians and surgeons of Canada or the committee on postdoctoral training of the American osteopathic association. The experience may be obtained concurrently with the supervised work experience required by subd. 2.

(9)   Training for ophthalmic use of strontium-90. Except as provided in s. DHS 157.61 (10) , a licensee shall require an authorized user of strontium-90 for ophthalmic radiotherapy to have obtained written attestation under sub. (10) (b) and be a physician who has had classroom and laboratory training applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy that meets all of the following criteria:

(a) Twenty-four hours of classroom and laboratory training that includes all of the following:

1. Radiation physics and instrumentation.

2. Radiation protection.

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

4. Radiation biology.

(b) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of 5 individuals. The supervised clinical training shall include all of the following:

1. Examination of each person to be treated.

2. Calculation of the dose to be administered.

3. Administration of the dose.

4. Follow up and review of each individual's case history.

(10)   Written attestation.

(a) Manual brachytherapy sources. A licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under sub. (1) to have obtained written attestation, signed by a preceptor authorized user who meets the requirements in sub. (8) , s. DHS 157.61 (10) , or equivalent agreement state requirements, that the individual has satisfactorily completed the requirements in sub. (8) (a) 1. or (b) and has achieved a level of competency sufficient to function independently as an authorized user of manual brachytherapy sources for the medical uses authorized under sub. (8) .

(b) Ophthalmic use of strontium-90. A licensee shall require an authorized user for ophthalmic use of strontium-90 to have obtained written attestation, signed by a preceptor authorized user who meets the requirements in sub. (8) or (9) , s. DHS 157.61 (10) , or equivalent agreement state requirements, that the individual has satisfactorily completed the requirements in sub. (9) (a) and (b) and has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic use.

CR 01-108 : cr. Register July 2002 No. 559 , eff. — see Note at the start of the chapter; CR 06-021 : am. (1) (intro.) and (6) (a) (intro.), r. and recr. (8) and (9), cr. (10) Register October 2006 No. 610 , eff. 11-1-06; CR 09-062 : am. (8) (b) 2. (intro.), 3., and (10) Register April 2010 No. 652 , eff. 5-1-10.

Note

A licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with par. (a). Microsoft Windows NT 6.1.7601 Service Pack 1 An example of a nationally recognized body is the American Association of Physicists in Medicine. 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