Wis. Admin. Code Department of Health Services DHS 157.62 - Technical requirements

(1) POSSESSION, USE AND CALIBRATION OF INSTRUMENTS TO MEASURE THE ACTIVITY OF UNSEALED RADIOACTIVE MATERIALS.

(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.

(b) A licensee shall calibrate the instrumentation required in par. (a) according to nationally recognized standards or the manufacturer's instructions.

(c) A licensee shall retain a record of each instrument calibration required by this subsection under s. DHS 157.71 (6).

(2) CALIBRATION OF SURVEY INSTRUMENTS.

(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.

(b) A licensee shall do all the following:

1. Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source.

2. Calibrate each scale used to show compliance at a sufficient number of readings to determine the response characteristics of the instrument.

3. Conspicuously note on the instrument the date of calibration.

Note: Two separated readings on each scale or decade are typically used for linear scale instruments.

(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%.

(d) A licensee shall retain a record of each survey instrument calibration under s. DHS 157.71 (7).

(3) DETERMINATION OF DOSAGES OF UNSEALED RADIOACTIVE MATERIAL FOR MEDICAL USE.

(a) A licensee shall determine and record the activity of each dosage prior to medical use.

(b) For a unit dosage, this determination shall be made by using one of the following methods:

1. Direct measurement of radioactivity.

2. A decay correction, based on the measurement made by either of the following:

a. A manufacturer or preparer licensed under s. DHS 157.13 (4) (i) or by NRC or another agreement state.

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.

c. A PET radioactive drug producer licensed under s. DHS 157.13 (1) (j) or by NRC or another agreement state.

(c) For other than unit dosages, the determination of dosages of unsealed radioactive material shall be made through one of the following methods:

1. Direct measurement of radioactivity.

2. A combination of direct measurements of radioactivity and mathematical calculations.

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.

(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.

(e) A licensee shall retain a record of the dosage determination required by this subsection under s. DHS 157.71 (8).

(4) AUTHORIZATION FOR CALIBRATION, TRANSMISSION AND REFERENCE SOURCES.

(a) Any person authorized by s. DHS 157.13 (5) for medical use of radioactive material may receive, possess and use any of the following radioactive material for check, calibration, transmission and reference use:

1. 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 manufacturer's approved instructions.

2. Any radioactive material with a half-life not longer than 120 days in individual amounts not to exceed 0.555 GBq (15 mCi).

3. Any radioactive material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 microcuries) or 1000 times the quantities in ch. DHS 157 Appendix F.

4. Technetium-99m in amounts as needed.

5. Flourine-18 in amounts as needed.

(b) Radioactive material in sealed sources authorized by this subsection shall not be used in either of the following:

1. For medical use as defined in s. DHS 157.03 (211), except in accordance with the requirements in s. DHS 157.66 (1).

2. Bundled or aggregated to create activity greater than the maximum activity of any single sealed source authorization under this section.

(c) A licensee using calibration, transmission, and reference sources in accordance with the requirements in this subsection need not list these sources on a specific medical use license.

(5) REQUIREMENTS FOR POSSESSION OF SEALED SOURCES AND BRACHYTHERAPY SOURCES.

(a) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.

(b) A licensee in possession of a sealed source shall do both the following:

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.

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.

3. Test the source for leakage at any time there is reason to suspect that the sealed source might have been damaged or might be leaking.

(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 µCi) of radioactive material on the sample.

(d) A licensee shall retain leakage test records under s. DHS 157.71 (9).

(e) If the leakage test reveals the presence of 185 Bq (0.005 µCi) or more of removable contamination, a licensee shall do both the following:

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.

2. File a report to the department within 5 working days of the leakage test as specified under s. DHS 157.72 (3).

(f) A licensee need not perform a leakage test on any of the following sources:

1. A source containing only radioactive material with a half-life of less than 30 days.

2. A source containing only radioactive material as a gas.

3. A source containing 3.7 MBq (100 µCi) or less of beta or gamma-emitting material or 0.37 MBq (10 µCi) or less of alpha-emitting material.

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.

5. Seeds of iridium-192 encased in intact nylon ribbon.

(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).

(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.

(7) SURVEYS FOR AMBIENT RADIATION EXPOSURE RATE.

(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.

(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).

(c) A licensee shall retain a record of each survey under s. DHS 157.71 (10).

(8) RELEASE OF INDIVIDUALS CONTAINING RADIOACTIVE DRUGS OR IMPLANTS CONTAINING RADIOACTIVE MATERIAL.

(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).

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.

(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:

1. Guidance on the interruption or discontinuation of breast-feeding.

2. Any information on the potential consequences of failure to follow the guidance.

(c) A licensee shall maintain a record, as required by s. DHS 157.71 (11), of the basis for authorizing the release of an individual, under par. (a).

(d) A licensee shall maintain a record of instructions provided to breast-feeding women under par. (b) according to record retention requirements of s. DHS 157.71 (11) (b).

(9) PROVISION OF MOBILE MEDICAL SERVICE.

(a) A licensee providing mobile medical service shall do all of the following:

1. Obtain a letter signed by the management of each client for which services are rendered by the licensee that permits the use of radioactive material at the client's address and clearly delineates the authority and responsibility of the licensee and the client.

2. Check instruments used to measure the activity of unsealed radioactive materials for proper function before medical use at each client's address or on each day of use, whichever is more frequent. The check for proper function shall include a test to verify accurate calibration using a known radioactive source.

3. Check survey instruments for proper operation with a dedicated check source before use at each client's address.

4. Before leaving a client's address, survey all areas of use to ensure compliance with the requirements in subch. III.

(b) A mobile medical service may not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client shall be received and handled in conformance with the client's license.

(c) A licensee providing mobile medical services shall retain the letter required in par. (a) 1. and the record of each survey required in s. DHS 157.71 (12) (b).

(10) DECAY-IN-STORAGE.

(a) A licensee may hold radioactive material with a physical half-life of less than 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee does both the following:

1. Monitors radioactive material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding.

2. Removes or obliterates all radiation labels except for material that will be handled as biomedical waste after it has been released.

(b) A licensee shall retain a record of each disposal permitted under s. DHS 157.71 (13).

Notes

Wis. Admin. Code Department of Health Services DHS 157.62

CR 01-108: cr. Register July 2002 No. 559, eff. - see Note at the start of the chapter; corrections in (9) (c) and (10) (b) made under s. 13.93(2m) (b) 7, Stats., Register July 2002 No. 559; CR 06-021: am. (2) (a), (3) (b) 2. a., (4) (intro.) and (8) (d) Register October 2006 No. 610, eff. 11-1-06; CR 09-062: am. (1) (b) and (3) (c) 3., cr. (3) (b) 2. c. Register April 2010 No. 652, eff. 5-1-10. Amended by, correction in (4) (b) made under s. 35.17, Stats., Register January 2018 No. 745, eff. 2/1/2018 Amended by, CR 22-015: r. and recr. (4), cr. (5) (b) 3. Register June 2023 No. 810, eff. 7/1/2023