United States Nuclear Regulatory Commission - Protecting People and the Environment

U.S. Nuclear Regulatory Commission

Request for Interpretation of 10 CFR 35.33 (c) Regarding Diagnostic Misadmin istration Reporting Threshold Levels

HPPOS-270 PDR-9306100037

Title: Request for Interpretation of 10 CFR 35.33 (c)

Regarding Diagnostic Misadministration Reporting Threshold

Levels

See the memorandum from S. A. Treby to J. E. Glenn dated

May 31, 1991. This OGC memo responds to an Region I

request for guidance on which threshold level in 10 CFR

35.33 (c) applies for notifying the NRC and the referring

physician of a diagnostic misadministration in instances in

which "a patient, not scheduled for a nuclear medicine

study at all, inadvertently receives a diagnostic dosage of

a radiopharmaceutical." It is OGC opinion that any

diagnostic misadministration to a patient not intended to

receive any radiopharmaceutical is a dosage "five-fold

different" from the intended dosage; thus making applicable

the reporting requirements of 10 CFR 35.33 (c).

According to the request for guidance from Region I, the

facts in this incident are as follows: A recent NRC

inspection revealed that a diagnostic misadministration of

a radiopharmaceutical occurred at Ephrata Community

Hospital ("Ephrata") on November 17, 1987. The

misadministration occurred because the nursing staff

submitted an incorrect request for a "biliary study"

instead of a "biliary sono study". The Nuclear Medicine

staff performed a "hepatobiliary" study using 4 millicuries

of Hepatolite Visofenin when the patient should not have

received any radiopharmaceutical at all. The dose to the

target organ and the whole body of the patient from this

misadministration as estimated by the licensee's consultant

were supposedly less the 2 rem and 500 millirem,

respectively. The licensee's consultant considered that

the above criteria in 10 CFR 35.33 (c) applies in the

instance when a patient who is not scheduled to receive any

radiopharmaceuticals receives them.

At the outset, we note that as stated in the request for

guidance from Region I, this incident was a diagnostic

misadministration. The term misadministration is defined

(in relevant part) in 10 CFR 35.2 as an administration of:

(2) a radiopharmaceutical to the wrong patient; or

(4) a diagnostic dosage of a radiopharmaceutical differing

from the prescribed dosage by morethan 50 percent.

The administration of a radiopharmaceutical to a patient

who is not supposed to receive any certainly falls within

the definition in (2) above. In addition, such an incident

is also within the scope of definition (4) above, on the

basis that when no dosage of a radiopharmaceutical is

prescribed, any dosage is a dosage differing from the

prescribed dosage by more than 50 percent.

10 CFR 35.33 (c) requires notification of the NRC and the

referring physician of a diagnostic misadministration

within 15 days:

"if the misadministration involved the use of byproduct

material not intended for medical use, administration of a

dosage five-fold different from the intended dosage, or

administration of byproduct material such that the patient

is likely to receive an organ dose greater that 2 rem or a

whole body dose greater than 500 millirem."

Region I has asked which of the latter two thresholds

applies in this case (i.e., the threshold of a dosage

five-fold different from the intended dosage or the

threshold of an organ dose of greater than 2 rem or a whole

body dose greater than 500 millirem). The licensee applied

the organ or whole body dose criterion and therefore did

not report the misadministration to the NRC. OGC believes

that if either the "five-fold different" dose level

threshold or the organ dose / whole body dose threshold in

35.33 (c) is exceeded, then a licensee is required to

notify the NRC and the referring physician. It is true, as

the memorandum requesting guidance states, that application

of the "five-fold different" dose threshold in 35.33 (c)

would mean that any diagnostic administration to a patient

not intended to receive a dosage would have to be reported

to the NRC because the intended dosage would be zero. OGC

does not agree with the conclusion in the memorandum that

such a result could be considered as inconsistent with the

current requirement in 35.33 (c), which makes it clear that

not all diagnostic misadministration have to be reported to

NRC.

OGC believes that the "five-fold different" threshold does

apply, on the basis that when no dosage is intended, any

dosage is "five-fold different from the intended dosage."

In other words, notification is required for any diagnostic

misadministration involving a dosage to a patient not

intended to receive any radiopharmaceutical, because any

dosage is five-fold different from the intended dosage.

There is no legal basis, either in the plain language of

35.33 (c) or in the statement of consideration, for

concluding that the five-fold different dose threshold

should not be applied to an incident such as occurred at

Ephrata.

Based on OGC's interpretation of 35.33 (c), both dose

thresholds in 35.33 (c) apply to any diagnostic

misadministration and if either threshold is exceeded,

notification is required. Therefore, Ephrata was required

to notify both the NRC and the referring physician of the

November 12, 1987 diagnostic misadministration on the basis

that the dosage administered was five fold different from

the intended dosage.

Regulatory references: 10 CFR 35.2, 10 CFR 35.33

Subject codes: 2.2, 12.11

Applicability: Byproduct Material

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