United States Nuclear Regulatory Commission - Protecting People and the Environment

U.S. Nuclear Regulatory Commission

Technical Assistance Request, National Institutes of Health, Bethesda, Maryland, Regarding Exemption from 10

CFR 35.315 (a) (7)

HPPOS-316 PDR-9306280230

Title: Technical Assistance Request, National Institutes

of Health, Bethesda, Maryland, Regarding Exemption from 10

CFR 35.315 (a) (7)

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:

1. The licensee stated that the door to a contaminated

therapy room would remain closed when the room is


The therapy room door should remain locked whenever

possible to prevent unauthorized entry to an unoccupied

restricted area.

2. 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.

3. 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


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

Page Last Reviewed/Updated Thursday, March 29, 2012