4731 RADIATION SAFETY

4731.4475 MOBILE REMOTE AFTERLOADER UNITS; ADDITIONAL REQUIREMENTS. Subpart 1. General requirements. A licensee providing mobile remote afterloader service must: A. check survey instruments before medical use at each address of use or on each day of use, whichever is more frequen…

4731.4476 RADIATION SURVEYS. Subpart 1. Surveys required. In addition to the survey requirement under part 4731.2200, a licensee must make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source in …

4731.4477 TELETHERAPY AND GAMMA STEREOTACTIC RADIOSURGERY UNITS; FULL-INSPECTION SERVICING. Subpart 1. Inspection and servicing required. A licensee must have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement to …

4731.4478 TELETHERAPY AND GAMMA STEREOTACTIC COMPUTER SYSTEMS. A licensee must perform acceptance testing on the treatment planning system of teletherapy and gamma stereotactic computer systems according to published protocols accepted by nationally recognized bodies. At a minimu…

4731.4479 REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS; TRAINING. Subpart 1. Training and education requirements. Except as provided under part 4731.4414, a licensee must require an authorized user of a sealed source for a use authorized …

4731.4500 RADIATION PROTECTION PROGRAM RECORDS. Subpart 1. Records of authority and responsibilities; radiation protection programs. A licensee must retain: A. a record of actions taken by the licensee's management according to part 4731.4405, subpart 1, item A, for five years. T…

4731.4501 WRITTEN DIRECTIVE RECORDS. Subpart 1. Written directive. A licensee must retain a copy of each written directive required under part 4731.4408 for three years. Subp. 2. Administration procedures. A licensee must retain a copy of the procedures required under part 4731.4…

4731.4502 INSTRUMENT CALIBRATION RECORDS. Subpart 1. Activity measurement instruments. A licensee must maintain a record of instrument calibrations required under part 4731.4420 for three years. The record must include: A. the model and serial numbers of the instrument; B. the da…

4731.4503 DOSAGE RECORDS. A licensee must maintain a record of dosage determinations required under part 4731.4422 for three years. The record must contain: A. the identity of the radiopharmaceutical; B. the patient's or human research subject's name or identification number, if …

4731.4504 LEAK TEST AND INVENTORY RECORDS. Subpart 1. Leak tests. A licensee must retain records of leak tests required under part 4731.4424, item B, for three years. The records must contain: A. the model number and serial number, if one has been assigned, of each source tested;…

4731.4505 SURVEY RECORDS; AMBIENT RADIATION EXPOSURE. A licensee must retain a record of each survey required under part 4731.4426 for three years. The record must include: A. the date of the survey; B. the results of the survey; C. the instrument used to make the survey; and D. …

4731.4506 RELEASE RECORDS; INDIVIDUALS CONTAINING RADIOACTIVE MATERIAL OR IMPLANTS. Subpart 1. Release basis. A licensee must retain a record of the basis for authorizing the release of an individual according to part 4731.4427, if the total effective dose equivalent is calculate…

4731.4507 MOBILE MEDICAL SERVICE RECORDS. A. A licensee must retain a copy of each letter that permits the use of radioactive material at a client's address of use, according to part 4731.4428, item A, subitem (1). Each letter must clearly delineate the authority and responsibili…

4731.4509 MOLYBDENUM-99, STRONTIUM-82, AND STRONTIUM-85 CONCENTRATION RECORDS. A licensee must maintain a record of the molybdenum-99 concentration or strontium-82 and strontium-85 concentration tests required under part 4731.4435, item B, for three years. The record must include…

4731.4510 SAFETY INSTRUCTION RECORDS. A licensee must maintain a record of safety instructions required under parts 4731.4441 and 4731.4453 and the operational and safety instructions required by part 4731.4466 for three years. The record must include: A. a list of the topics cov…

4731.4511 SURVEY RECORDS; SOURCE IMPLANT AND REMOVAL. A licensee must maintain a record of the surveys required under parts 4731.4451 and 4731.4464 for three years. The record must include: A. the date and results of the survey; B. the survey instrument used; and C. the name of t…

4731.4512 BRACHYTHERAPY SOURCE ACCOUNTABILITY RECORDS. A licensee must maintain a record of brachytherapy source accountability required under part 4731.4452 for three years as follows: A. for temporary implants, the record must include: (1) the number and activity of sources rem…

4731.4513 BRACHYTHERAPY SOURCE CALIBRATION RECORDS. A licensee must maintain a record of the calibrations of brachytherapy sources required under part 4731.4455 for three years after the last use of the source. The records must include: A. the date of the calibration; B. the manu…

4731.4514 STRONTIUM-90 DECAY RECORDS. A licensee must maintain a record of the activity of a strontium-90 source required under part 4731.4456 for the life of the source. The record must include: A. the date and initial activity of the source as determined under part 4731.4455; a…

4731.4515 INSTALLATION, MAINTENANCE, ADJUSTMENT, AND REPAIR RECORDS. A licensee must retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as required under part 4731.4465…

4731.4516 SAFETY PROCEDURES RECORDS. A licensee must retain a copy of the procedures required under part 4731.4466, items B, subitem (4), and E, subitem (2), until the licensee no longer possesses the remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery u…

4731.4517 DOSIMETRY EQUIPMENT RECORDS. A licensee must retain a record of the calibrations, intercomparisons, and comparisons of dosimetry equipment required under part 4731.4468 for the duration of the license. For each calibration, intercomparison, or comparison, the record mus…

4731.4518 CALIBRATION RECORDS; TELETHERAPY, REMOTE AFTERLOADER, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS. A licensee must maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required under parts 4731.4469…

4731.4519 SPOT CHECK RECORDS; TELETHERAPY UNITS. A. A licensee must retain a record of each periodic spot check for teletherapy units required under part 4731.4472 for three years. The record must include: (1) the date of the spot check; (2) the unit manufacturer's name; (3) the …

4731.4520 SPOT CHECK RECORDS; REMOTE AFTERLOADER UNITS. A. A licensee must retain a record of each spot check for remote afterloader units required under part 4731.4473 for three years. The record must include, as applicable: (1) the date of the spot check; (2) the unit manufactu…

4731.4521 SPOT CHECK RECORDS; GAMMA STEREOTACTIC RADIOSURGERY UNITS. A. A licensee must retain a record of each spot check for gamma stereotactic radiosurgery units required under part 4731.4474 for three years. The record must include: (1) the date of the spot check; (2) the man…

4731.4522 OPERABILITY RECORDS; MOBILE REMOTE AFTERLOADER UNITS. A licensee must retain a record of each check for mobile remote afterloader units required under part 4731.4475 for three years. The record must include: A. the date of the check; B. the manufacturer's name, model nu…

4731.4523 SURVEY RECORDS; THERAPEUTIC TREATMENT UNITS. A licensee must maintain a record of radiation surveys of treatment units made according to part 4731.4476 for the duration of use of the unit. The record must include: A. the date of the measurements; B. the manufacturer's n…

4731.4524 FULL-INSPECTION SERVICING RECORDS; TELETHERAPY AND GAMMA STEREOTACTIC RADIOSURGERY UNITS. A licensee must maintain a record of the full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units required under part 4731.4477 for the duration of use o…

4731.4525 MEDICAL EVENT; REPORT AND NOTIFICATION. Subpart 1. Report required. A licensee must report any event as a medical event, except for an event that results from patient intervention, in which: A. the administration of radioactive material or radiation from radioactive mat…

4731.4526 DOSE TO AN EMBRYO/FETUS OR CHILD; REPORT AND NOTIFICATION. Subpart 1. Report required; embryo/fetus. A licensee must report any dose to an embryo/fetus that is greater than five rems (50 mSv) dose equivalent that is a result of an administration of radioactive material …

4731.4527 REPORT OF LEAKING SOURCE. A licensee must file a report within five days if a leak test required under part 4731.4424 reveals the presence of 0.005 microcurie (185 Bq) or more of removable contamination. The report must be filed with the commissioner. The written report…

4731.4528 REPORT AND NOTIFICATION FOR AN ELUATE EXCEEDING PERMISSIBLE MOLYBDENUM-99, STRONTIUM-82, AND STRONTIUM-85 CONCENTRATIONS. Subpart 1. Telephone notification. The licensee must notify, by telephone, the commissioner and the distributor of the generator, within seven days …

4731.4600 DEFINITIONS. Subpart 1. Scope. The following definitions apply to parts 4731.4605 to 4731.4620. Subp. 2. Accredited. "Accredited" means an individual who has satisfactorily completed a nationally recognized examination in nuclear medicine and who maintains the registrat…

4731.4605 MINIMUM STANDARDS FOR NUCLEAR MEDICINE TECHNOLOGISTS. Subpart 1. General requirements. Except as specified in part 4731.4610, any individual working as a nuclear medicine technologist in Minnesota must meet the following minimum eligibility requirements: A. graduation f…

4731.4610 EXCEPTIONS. The individuals in items A to D are exempt from the examination requirement in part 4731.4600, subpart 2: A. a licensed practitioner of the healing arts who is listed as an authorized user on an agreement state or United States Nuclear Regulatory Commission …

4731.4612 TRAINING FOR INDIVIDUALS FUNCTIONING AS A NUCLEAR MEDICINE TECHNOLOGIST BEFORE JANUARY 1, 2011, WHO ARE NOT ACCREDITED. Subpart 1. Training program. Individuals working as a nuclear medicine technologist before January 1 , 2011, who are not accredited must complete a tr…

4731.4615 DOCUMENTATION OF COMPETENCY. Subpart 1. Nuclear medicine technologist; January 1, 2011. An individual functioning as a nuclear medicine technologist prior to January 1, 2011, and who is not accredited must obtain documentation that the individual is competent to apply i…

4731.4620 REQUIREMENTS FOR OPERATORS OF FUSION IMAGING DEVICES. Subpart 1. Accreditation required. When a unit is operated as a fusion imaging device or in a dual mode such as a SPECT/CT or PET/CT device, the operator must be accredited or must meet the requirements in chapter 47…

4731.6000 PURPOSE AND SCOPE. Subpart 1. Applicability. Parts 4731.6000 to 4731.6270 apply to the issuance of a license authorizing the use of and the radiation safety requirements for sealed sources containing radioactive materials used to irradiate objects or materials using gam…

4731.6010 SPECIFIC LICENSE; APPLICATION. A person must file an application for a specific license authorizing the use of sealed sources in an irradiator on the application for material license form prescribed by the commissioner. An application for a license, other than a license…

4731.6020 SPECIFIC LICENSE; APPROVAL. The commissioner shall approve an application for a specific license for the use of licensed material in an irradiator if the applicant meets the general requirements under parts 4731.3070, subpart 1, items A to D, and 4731.3070, subpart 2, a…

4731.6030 START OF CONSTRUCTION. An applicant may not begin construction of a new irradiator before submitting to the commissioner an application for a license for the irradiator and the fee required under Minnesota Statutes, section 144.1205. Activities undertaken before the iss…

4731.6040 APPLICATIONS FOR EXEMPTIONS. An application for a license or for amendment of a license authorizing use of a teletherapy-type unit for industrial irradiation of materials or objects may include proposed alternatives to the requirements under parts 4731.6000 to 4731.6270…

4731.6050 PERFORMANCE CRITERIA; SEALED SOURCES. Subpart 1. Applicability. Sealed sources installed after July 1, 1993, must meet the performance criteria of subparts 2 to 4. Subp. 2. General requirements. Sealed sources must: A. have a certificate of registration issued by the NR…

4731.6060 ACCESS CONTROL. Subpart 1. Panoramic irradiators. A. Each entrance to a radiation room at a panoramic irradiator must have a door or other physical barrier to prevent entry of personnel if the sources are not in the shielded position. Product conveyor systems may serve …

4731.6070 SHIELDING. Subpart 1. Panoramic irradiators. For panoramic irradiators, the radiation dose rate in areas that are normally occupied during operation may not exceed two millirems (0.02 mSv) per hour at any location 30 centimeters or more from the wall of the room when th…