Or. Admin. R. 333-116-0380 - Imaging and Localization: Safety Precautions

(1) For each patient or human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with OAR 333-116-0260 or 333-116-0190, a licensee must:

(a) Provide a private room with a private sanitary facility;

(b) Post the door with a "Caution: Radioactive Material" sign and note on the door or on the patient's chart where and how long visitors may stay in the patient's room;

(c) Authorize visits by individuals under age 18 only on a case-by-case basis with the approval of the authorized user after consultation with the Radiation Safety Officer;

(d) Promptly after administration of the dosage, measure the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of OAR 333-120-0180 of these rules and retain until inspection by the Authority a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in mrem per hour, the instrument used to make the survey and the initials of the individual who made the survey;

(e) Either monitor material and items removed from the room to determine that any contamination cannot be distinguished from the natural background radiation level with an appropriate radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle materials and items as radioactive waste;

(f) Instruct the patient or human research subject and, where appropriate, the individual's family, orally and in writing concerning radiation safety precautions that will help to keep radiation dose to household members and the public as low as reasonably achievable before authorizing release of the individual;

(g) Survey the room and private sanitary facility for removable contamination with an appropriate radiation detection survey instrument before assigning another patient to the room. The room must not be reassigned until removable contamination is less than 33.3 Bq (2000 dpm) per 100 square centimeters; and

(h) Measure the thyroid burden of each individual who helped prepare or administer a liquid dosage of iodine-131 within three days after administering the dosage. A record of each thyroid burden measurement must be retained in accordance with OAR 333-120-0650 of these rules. Each record must contain the date of measurement, the name of the individual whose thyroid burden was measured, the calculated thyroid burden, the effective dose equivalent, the name of the individual who made the measurements and the signature of the Radiation Safety Officer. Other procedures acceptable to the Authority may be used for individuals who only prepare, but do not administer, doses of stabilized I-131.

(2) A licensee must notify the Radiation Safety Officer or the authorized user immediately if the patient or human research subject dies or has a medical emergency.

Notes

Or. Admin. R. 333-116-0380

HD 1-1991, f. & cert. ef. 1-8-91; HD 1-1995, f. & cert. ef. 4-26-95; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 26-2018, minor correction filed 02/01/2018, effective 2/1/2018

Statutory/Other Authority: ORS 453.635

Statutes/Other Implemented: ORS 453.605 - 453.807