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