[Federal Register Volume 59, Number 55 (Tuesday, March 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6629]
[[Page Unknown]]
[Federal Register: March 22, 1994]
=======================================================================
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
Abnormal Occurrences for Third Quarter CY 1993; Dissemination of
Information
Section 208 of the Energy Reorganization Act of 1974, as amended,
requires NRC to disseminate information on abnormal occurrences (i.e.,
unscheduled incidents or events that the Commission determines are
significant from the standpoint of public health and safety). During
the third quarter of CY 1993, the following incidents at NRC licensees
were determined to be abnormal occurrences (AOs) and are described
below, together with the remedial actions taken. The events are also
being included in NUREG-0090, Vol, 16, No. 3, (``Report to Congress on
Abnormal Occurrences: July-September 1993''). This report will be
available at NRC's Public Document Room, 2120 L Street NW. (Lower
Level), Washington, DC 20555 about three weeks after the publication
date of this Federal Register Notice.
Other NRC Licensees (Industrial, Radiographers, Medical Institutions,
Industrial Users, etc.)
93-9 Medical Sodium Iodide Misadministration at Osteophatic Hospital
Founders Association DBA (doing business as) Tulsa Regional Medical
Center in Tulsa, Oklahoma
One of the AO reporting guidelines notes that a diagnostic dose of
a radiopharmaceutical to a part of the body receiving radiation
improperly, if greater than five times the intended dose to that body
part, should be considered an abnormal occurrence. (The definition of a
misadministration was revised on 10 CFR 35.2 and became effective on
January 27, 1992. The revision defines a new type of misadministration
involving sodium iodide. The existing abnormal occurrence guidelines
for misadministrations do not include specific examples for these types
of misadministrations but are presently under revision.)
Date and Place--July 27, 1993; Osteopathic Hospital Founders
Association DBA (doing business as) Tulsa Regional Medical Center;
Tulsa, Oklahoma.
Nature and Probable Consequences--The licensee reported that on
July 27, 1993, a wrong patient was administered 0.21 gigabecquerel
(GBq) (5.7 millicuries [mCil]) of iodine-131 (I-131). On July 27, 1993,
diagnostic procedures were prescribed for two outpatients, patients A
and B, using technetium-99m) (Tc-99m) for patient A and I-131 for
patient B. Prior to the administration, the technologist involved in
the procedure believed that patient A was the one prescribed to receive
I-131 and addressed patient A by name and requested a second form of
identification. Patient A responded positively and presented a social
security card as the second means of identification. The technologist
copied the social security number and attached it to patient A's chart.
However, the written directive was not checked for verification of the
patient's name. As a result patient A was administered a 0.21 GBq (5.7
mCi) dosage of I-131 intended for patient B.
The technologist recognized the misadministration within minutes of
its occurrence and immediately notified the nuclear medicine physician.
The physician prescribed Ipecac to induce vomiting, which was
administered within 15 minutes of the administration of I-131, and
Lugol's solution (potassium iodide) as a blocking agent which was
administered after emesis, approximately 45 minutes after the I-131
administration. The referring physician and patient were notified of
the misadministration.
The licensee reported that the patient received a thyroid dose of
about 1600 centigray (cGy) (1600 rad) as a result of the
misadministration. The patient will be examined during subsequent
follow-up visits to the medical center.
The NRC staff retained a medical consultant to evaluate the
potential medical effects on the patient as a result of the
misadministration. The medical consultant estimated that, due to the
administration of Lugol's solution, the dose to the patient's thyroid
is in the range of 400-700 cGy (400-700 rad). The medical consultant
believes the medical consequences of the misadministration would be
negligible.
Cause or Causes--10 CFR part 35 states that individuals under the
supervision of authorized users must follow the instructions of
supervising authorized users and follow the written radiation safety
and quality management procedures established by the licensee. The
licensee's Quality Management (QM) Program states that ``prior to each
administration the patient's identity as the individual named in the
written directive will be verified by more than one method.'' The
licensee's program also states that ``The person administering the
radiopharmaceutical must verify that the type of radiopharmaceutical,
the dosage, and route of administration are in accordance with the
written directive and check the dosage in a dose calibrator.'' However,
the licensee staff failed to check the written directive.
Actions Taken to Prevent Recurrence
Licensee--The licensee revised the QM procedures to prevent
recurrence of similar misadministrations. The revisions include the
following requirements: (1) the prescribing physician must be present
at each administration of I-131 dosage for whole body scans; (2) the
technologists must double check the radiopharmaceutical and patient
identification against the written directive; and (3) the technologists
must cross check the department's requisition with the name, the dose,
and the patient's identifying documents.
NRC--NRC Region IV conducted an inspection at Tulsa Regional
Medical Center on August 10-11, 1993, to review the circumstances
associated with the misadministration and its possible cause(s). The
NRC staff is currently reviewing the inspection results for possible
violations, and enforcement action is pending (Reports from Osteopathic
Hospital Founders Association DBA (doing business as) Tulsa Regional
Medical Center in Tulsa, Oklahoma [Docket No. 030-02893], submitted to
NRC on July 30, 1993, and August 10, 1993, in accordance with 10 CFR
35.33.)
93-10 1981 Fatal Radiation Exposure of a Radiographer in Northeast
Oklahoma
In response to a 1993 General Accounting Office report entitled
``Nuclear Regulation,'' NRC conducted a file review of this previously
reported event.
One of the AO reporting guidelines notes that an exposure of the
whole body of an individual to 250 millisievert (25 rem) or more of
radiation can be considered an abnormal occurrence.
Note--This event occurred in January 1981 in Oklahoma, and was
previously reported to Congress in NUREG-0090, Vol. 4, No. 1 as an
``Other Event of Interest.'' At that time, NRC did not identify the
event as an AO because it had not been conclusively determined that
the radiation exposure resulted from material subjected to licensing
by NRC or by the Agreement States. NRC reevaluated the incident
against the AO reporting criteria in 1993 and concluded that the
event should be classified as an AO.
Date and Place--January 1981; location determined to be
northeastern Oklahoma based on best available information.
Nature and Probable Consequences--On January 22, 1981, the State of
Oklahoma notified NRC Region IV that an individual has been admitted to
the Okmulgee Memorial Hospital, Okmulgee, Oklahoma, with serious
radiation injuries to his chest and left forearm. The individual was
later determined to be an unemployed radiographer living in Henryetta,
Okalahoma.
On January 5, 1981, an NRC licensee (Bill Miller, Inc.) in
Henryetta, Oklahoma, reported that a radiographic exposure device
containing a 1221 gigabecquerel (33 curie) iridium-192 source was
discovered missing following a quarterly inventory on January 2, 1981.
The licensee stated that the device had been stored in a locked
enclosure in a company truck while the truck was parked in the back
yard of a licensee employee's residence in Henryetta. NRC investigators
later noted signs of forced entry on the truck's camper shell door and
determined that the theft occurred about December 30, 1980. A search
for the missing source by representatives of the licensee and the State
of Oklahoma Department of Public Health was unsuccessful. The licensee
subsequently reported on January 5, 1981, that the missing source had
been anonymously returned intact to a licensee representative's
residence.
NRC investigators interviewed the exposed individual, and he stated
that he could not recall how or when he received the exposure. Medical
authorities estimated his exposure occurred between December 15, 1980
and January 5, 1981. Cytogenetic studies of a sample of the patient's
blood indicated that he received an equivalent whole body dose of 365
centigray (cGy) (365 rad) from iridium-192 or 405 cGy (405 rad) from
cobalt-60. The individual maintained that he had last worked with a
radioactive source during the first week of October 1980 and that he
first noticed an irritation on his chest and arm in November 1980.
The exposed individual refused to be interviewed by NRC a second
time. He directed that any further contact with him be made through his
lawyer. On July 27, 1981, NRC Region IV was notified that the
individual had died of his injuries. NRC conducted a second
investigation, but no substantial additional facts were identified.
Cause or Causes--Based on circumstantial evidence, it appears that
the death was caused by a self-inflicted exposure to the stolen source.
The licensee's security measures were found to meet NRC requirements in
10 CFR 20.207 and 34.23.
Actions Taken to Prevent Recurrence
Licensee--NRC documents indicate that no licensee action was
warranted or taken.
NRC--The investigation identified no violations of NRC
requirements. (NRC Investigation Report No. 030-15283/81-01 dated April
21, 1981; Memorandum from C. L. Cain, Radiation Specialist, to Glen D.
Brown, Chief, Fuel Facility and Material Safety Branch, Region IV,
dated February 18, 1981; and Memorandum from Karl V. Seyfrit, Director,
Office of Inspection and Enforcement, NRC Region IV, to Victor Stello,
Jr., Director, Office of Inspection and Enforcement, NRC Headquarters,
dated August 14, 1981.
Dated at Rockville, MD this 16th day of March 1994.
For the Nuclear Regulatory Commission.
Samuel J. Chilk,
Secretary of the Commission.
[FR Doc. 94-6629 Filed 3-21-94; 8:45 am]
BILLING CODE 7590-01-M