Information Notice 1999-11, Incidents Involving the Use of Radioactive Iodine-131
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D. C. 20555
April 16,1999 NRC INFORMATION NOTICE 99-11: INCIDENTS INVOLVING THE USE OF
RADIOACTIVE IODINE-131
Addressees
All medical use licensees.
Purpose
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to alert
addressees to recent incidents involving the use of radioactive iodine-131. It is expected that
recipients will review this information for applicability to their facilities and consider actions, as
appropriate, to avoid similar problems. However, suggestions contained in this information
notice are not new NRC requirements; therefore, no specific actions nor written response
is required.
Description of Circumstances
The following cases are recent events, reported to NRC, that have resulted in unintended
radiation doses to humans, as the result of the administration of radioactive iodine:
Case 1: A patient was scheduled for a thyroid ablation after removal of a cancerous thyroid.
Before the ablation dose was given to the patient, she was interviewed by both a nuclear
medicine technologist and an authorized-user physician. The interview included discussion of
pregnancy and breast-feeding status; the patient emphatically denied either circumstance. As a
result, the patient was administered 5.75 gigabecquerels (155.2 millicuries) of iodine-131.
Unbeknownst to the licensee, the patient's referring physician had ordered a pregnancy test, in
the belief that such a test was standard practice. Four hours after the administration of the
radioiodine dosage, the results of the pregnancy test were forwarded to the nursing station. The
test was positive and a subsequent ultrasound determined that the patient was approximately
13.5 weeks pregnant, with twins, at the time of the administration. The total effective dose
equivalent to each fetus was estimated to be 0.38 gray (38 rads) and the committed dose
equivalent to each of the fetal thyroids was estimated at 2000 gray (200,000 rads). Before the
ablation, the patient also underwent a metastatic scan, using 100 megabecquerels (2.7 millicuries) of iodine-131, and two thyroidectomy surgeries, each within the period of time that
she was pregnant. As in the ablation procedure, licensee staff collected the patient's history, including most recent menses. And in each case, the patient emphatically denied the possibility
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IN 99-11 April 16,1999 of pregnancy. NRC determined that this case did not constitute a misadministration, since the
patient received the intended dosage, and the licensee had taken reasonable steps to ascertain
the medical status of the patient, prior to the administration of radioiodine.
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Case 2: A patient was scheduled to receive a dosage of iodine-1 31 for the treatment of
thyroiditis, in accordance with an authorized user's written directive. Before the treatment, licensee staff interviewed the patient regarding pregnancy status and the patient certified that
she was not pregnant and signed an informed consent form. The patient was administered 341 megabecquerels (9.2 millicuries) of iodine-131. A month after the treatment, the patient
discovered that she had been approximately 4 months pregnant at the time of the treatment, and notified the licensee. The licensee estimated that the dose to the fetal thyroid was 88 gray
(8800 rads) committed dose equivalent. As in the case above, NRC determined that this
incident did not constitute a misadministration, since the patient received the intended dosage, and the licensee had taken reasonable steps to ascertain the medical status of the patient, before the administration of radioiodine.
Case 3: A patient was scheduled to receive a dosage of 370 megabecquerels (10 millicuries) of
iodine-1 31 for the treatment of hyperthyroidism, in accordance with an authorized user's written
directive. A second physician, not familiar with the patient, administered this dosage. The
physician went to the patient's room, verified his name and administered the dosage. However, at that time, the hospital had two patients with the exact same name, and the physician failed to
verify the patient's identity through a second means. The event was discovered in time to allow
the administration of a thyroid-blocking agent, KI, to limit the uptake of iodine by the patient's
thyroid. This incident, which constituted a misadministration because it involved the wrong
patient, resulted in a committed dose equivalent of approximately 1.4 gray (140 rads) to
the thyroid.
Case 4: A referring physician orally requested a nuclear medicine department to give his patient
370 megabecquerels (10 millicuries) iodine-131 for a whole body scan. The nuclear medicine
technologist questioned the procedure, during a telephone conversation with the referring
physician. However, the technologist subsequently gave the dosage ordered by the referring
physician to the patient, without a written directive. Later consultation between the authorized
user and the referring physician determined that the patient should have received a thyroid
uptake and scan, involving 740 kilobecquerels (20 microcuries) of iodine-131. This incident, which constituted a misadministration because the administered dosage exceeded the intended
dosage by more than 20 percent, resulted in a committed dose equivalent of approximately 270
gray (27,000 rads) to the patient's thyroid.
Case 5: Two patients were scheduled to receive therapeutic dosages of iodine-131, in
accordance with written directives prepared by an authorized user. One patient was to receive
296 megabecquerels (8 millicuries) and the other 1.11 gigabecquerels (29.9 millicuries). After
assaying the vials containing the dosages, the technologist reversed the lids on the vial shields.
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IN 99-11 April 16, 1999 The lids contained the dosage information. Because of the reversal of the lids, the technologist
inadvertently administered the larger dosage to the first patient, which exceeded the prescribed
dosage by 370 percent.
Discussion:
Cases one and two, although not misadministrations, are included in this information notice to
illustrate the significant unintended consequences that can result from the administration of
radioiodine to a female patient whose pregnancy status has not been conclusively determined.
Although there is no NRC requirement that licensees perform pregnancy tests on female
patients of child-bearing age, NRC believes that cases one and two offer information that could
be significant to its licensees, and thereby warrant inclusion in this information notice. In
particular, case one points out the need for communication and coordination between the
authorized-user and the referring physician. Cases three, four, and five illustrate the importance
of verifying correct dosages and patient identity before administration; - ensuring that all
referring physician requests for administrations involving greater than 1.11 megabecquerels (30
microcuries) of iodine-131 are followed by a written directive, prepared by an authorized-user
physician, before administration.
Although errors involving the use of radioiodine seldom occur, when they do, the consequences
can be significant because of the high radiation doses involved. Licensee procedures for the
safe handling and use of radioiodine must address the objectives of the quality management
rule contained in 10 CFR 35.32. The objectives, for the administration of iodine-I 31 in excess of
1.11 megabecquerels (30 microcuries), include: (1) preparing a written directive before
administration; (2) verifying the patient's, or human research subject's identity, by more than one
method, as the individual named in the written directive; (3) ensuring that each administration is
in accordance with the written directive; and (4) ensuring that unintended deviations from the
written directive are identified and evaluated. Cases three, four, and five illustrate why licensee
employees who administer licensed materials, including radioiodine, under the supervision of an
authorized user physician, must receive instruction in the licensee's written quality management
procedures, and must follow those instructions. Licensees are reminded that they are
responsible for ensuring that the instructions are given to the appropriate employees, and for
ensuring that the employees can and will follow those instructions. By paying attention to detail, and adhering to established departmental policy and procedures, many incidents involving
radioiodine may be avoided.
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Attachment 1
April 16, 1999
Page 1 of i
LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
Information
Date of
Notice No.
Subject
Issuance
Issued to
99-09 Problems Encountered when
3/24/99
All medical licensees authorized
manually EditingTreatment Data
on the Nucletron misroselectron-HDR
(New) Model 105-999 to conduct high-dose-rate (HDR)
remote after loading
brachytherapy treatments
99-06
99-05
99-04
99-03
1998 Enforcement Sanctions as
a Result of Deliberate Violations of
Inadvertent Discharge of Carbon
Dioxide Fire Protection System
and Gas Migration
Unplanned Radiation Exposures
to Radiographers, Resulting from
failures to follow Proper Radiation
Safety Procedures
Exothermic Reactions Involving
Dried Uranium Oxide Powder
(Yellowcake)
Guidance to Users on the
Implementation of a New
Single-Source Dose-
Calculation Formalism and Revised
Air-Kerma Strength Standard
for lodine-125 Sealed Sources
Deterioration of High-Efficiency
Particulate Air Filters in a
Pressurized Water Reactor
Containment Fan Cooler Unit
3/19/99
3/8/99
3/8/99
1/29/99
1/21/99
1/20/99
All U. S. Nuclear Regulatory
Commission licensees.
All holders of licenses for nuclear
power, research, and test reactor, and fuel cycle facilities
All radiography licensees.
All operating uranium recovery
facilities that produce oxide
powder (U308) (yellowcake)
All medical licensees authorized to
conduct brachytherapy
treatments.
All holders of licences for nuclear
power, research and test reactors;
and fuel cycle facilities.
99-02
99-01
98-33 Regulatory
NRC Regulations Prohibit
Agreements that Restrict or
Discourage an Employee from
Participating in Protected Activities
8/28/98
All holders of a Nuclear
Commission license
98-30
Effect of the Year 2000
Computer Problem on NRC
Licensees and Certificate Holders
8/12/98
All material and fuel cycle
licensees and certificate holders
Attachment 2
April 16, 1999 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
Information
Date of
Notice No.
Subject
Issuance
Issued to
97-15, Sup 1 Reporting of Errors and
4116/99
All holders of operating licensees
Changes inLarge-Break/Small- Break Loss-of-Coolant Evaluation
models of Fuel Vendors and
Compliance with 10 CFR 50.46(a)(3)
for nuclear power reactors, except
those who have permanently
cease operations and have
certified that fuel has been
permanently removed from the
reactor
99-10
99-09
99-08 Degradation of Prestressing
4/13/99
Tendon Systems in Prestressed
Concrete Containments
Problems Encountered When
3/24199
Manually Editing Treatment Data
on The Nucletron Microselectron-HDR
(New) Model 105.999 Urine Specimen Adulteration
4/1199 Fire Protection Preaction
3/22/99
Sprinkler System Deluge Valve
Failures and Potentials Testing
Deficiencies
All holders of Ols for nuclear
power reactors
All medical licensees authorized
to conduct high-dose-rate (HDR)
remote after loading
brachytherapy treatments
All holders of operating licensees
For nuclear power reactors and
licensees authorized to possess
or use formula quantities of
strategic special nuclear material
(SSNM)
All NRC licensees
All U.S. Nuclear Regulatory
Commission licensees
99-07
99-06
1998 Enforcement Sanctions as a
3/19/99
Result of Deliberate Violation on
NRC Employee Protection
Requirements
OL = Operating License
CP = Construction Permit
IN 99-11 April 16,1999 This information notice requires no specific action nor written response. If you have any
questions about the information contained in this notice, please address your questions to the
technical contact listed below, or to the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical Contact:
Jamnes Cameron, Rill
(630) 829-9833 E-mail: jlc@nrc.gov
Attachments:
1. List of Recently Issued NMSS Information Notices
2. List of Recently Issued NRC Information Notices
-I
IN 99-11 April 13,1999 This information notice requires no specific action nor written response. If you have any
questions about the information contained in this notice, please address your questions to the
technical contact listed below, or to the appropriate regional office.
(Orig. signed by F. Combs, for)
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical Contact:
Jamnes Cameron, Rill
(630) 829-9833 E-mail: jlc@nrc.gov
Attachments:
1.
List of Recently Issued NMSS Information Notices
2.
List of Recently Issued NRC Information Notices
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questions about the information contained in this notice, please address your questions to the
technical contact listed below, or to the appropriate regional office.
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical Contact:
Jamnes Cameron, Rill
(630) 829-9833 E-mail: jlc@nrc.gov
Attachments:
3.
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4.
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4.
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questions about the information contained in this notice, please address your questions todthe
technical contact listed below, or to the appropriate regional office.
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Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
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Office of Nuclear MaterialI4afety
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Technical Contact:
Jamnes Cameron, Rill
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(630) 829-9833 E-mail: jlcenrc.gov
Attachments:
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List of Recently Issued NMSS Information Notices
4.
List of Recently Issued NRC Information.Notices
DISTRIBUTION: Closes IMNS 7282
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questions about the information contained in this notice, p1 se address your questions to the
technical contact listed below, or to the appropriate reglo
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Do Id A. Cool, Director
D ision of Industrial and
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Office of Nuclear Material Safety
and Safeguards
Technical Contact:
Jamnes Came on, DNMS
(630) 829-98 3 E-mail JL
NRC.GOV
Attachments:
3.
List of Recently Issu d NMSS Information Notices
4.
List of Recently Is
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technical contact listed below, or to the appropriate reglonI office.
D
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Office of Nuclear Material Safety
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Technical Contact:
Jamnes Ca eron, DNMS
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Attachments:
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List of Recently Iss d NMSS Information Notices
4.
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