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# Technical Assistance Request, National Institutes of Health, Bethesda, Maryland, Regarding Exemption from 10 CFR 35.315 (a) (7)

## HPPOS-316 PDR-9306280230

See the memorandum from J. E. Glenn to R. R. Bellamy dated July 7, 1992. 

This NMSS memo responds to technical assistance request from Region I, dated May 26, 1992, regarding an amendment request from the National Institutes of Health (NIH), Bethesda, Maryland. NIH had requested an exception to 10 CFR 35.315 (a) (7) to allow dedication of certain patient rooms for sequential radiopharmaceutical therapies prior to decontamination to levels required for unrestricted occupancy and assignment to a non-therapy patient. The licensee does not survey and decontaminate the patient room after release of each therapy patient, but rather after every two therapy patients. As noted in the inspection report, this practice requires an exemption from the requirements of 10 CFR 35.315 (a) (7) because the regulation does not anticipate subsequent use of the room by therapy patients and the required decontamination level of 200 disintegration per minute (dpm) per 100 square centimeters (100 cm2) is for release of the room as an unrestricted area. HPPOS-259 contains a related topic.

In a letter dated May 15, 1992, the licensee submitted procedures to ensure the safety of facility personnel who frequent the vicinity of a dedicated therapy patient room. These were:
        -  The licensee stated that the door to a contaminated therapy room would remain closed when the room is unoccupied.  The therapy room door should remain locked whenever possible to prevent unauthorized entry to an unoccupied restricted area. 
        -  The licensee stated that patient care staff are fully aware that contaminated rooms may not be used by non-therapy patients until the room has been decontaminated to levels required for unrestricted occupancy and the caution signs have been removed by the NIH Radiation Safety Branch staff. The licensee does not describe a positive mechanism to ensure that the patient care staff does not release a contaminated room for unrestricted use. Relying only on the absence of radioactive material caution signs may not be adequate. The licensee should provide additional procedures to ensure that patient care staff are formally notified by NIH Radiation Safety Branch staff when a therapy room can be released for unrestricted use. 
        -  It is NRC's understanding that the licensee does not attempt to decontaminate the therapy room to a specific contamination level between subsequent therapies.  The licensee should be required to decontaminate the dedicated therapy room, prior to use by any other therapy patient, to the restricted area action level for removable surface contamination of 2200 dpm/100 cm2 as described in Regulatory Guide 8.23, "Radiation Safety Surveys at Medical Institutions." 

In summary, the licensee's request for an exemption (to be provided by license amendment) from the requirements of 10 CFR 35.315 (a) (7) may be granted at such time the licensee provides additional commitments that include the decontamination level limits described in Item 3 above.

**Regulatory references:** 10 CFR 35.315, Regulatory Guide 8.23

**Subject codes:** 4.3, 4.4, 5.0, 11.1

**Applicability:** Byproduct Material

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