[Federal Register Volume 60, Number 36 (Thursday, February 23, 1995)]
[Notices]
[Pages 10118-10122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4382]
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NUCLEAR REGULATORY COMMISSION
Abnormal Occurrence Report; Section 208 Report Submitted to the
Congress
Notice is hereby given that pursuant to the requirements of Section
208 of the Energy Reorganization Act of 1974, as amended, the Nuclear
Regulatory Commission (NRC) has published and issued another periodic
report to Congress on abnormal occurrences (AOs), ``Report to Congress
on Abnormal Occurrences: July-September 1994'' (NUREG-0090, Vol. 17,
No. 3).
Under the Energy Reorganization Act of 1974, which created NRC, an
AO is defined as ``an unscheduled incident or event that the Commission
(NRC) determines is significant from the standpoint of public health or
safety.'' NRC has made a determination that an incident or event
involving an actual loss or significant reduction in the degree of
protection against radioactive properties of source, special nuclear,
and by-product material is an AO.
This report addresses five AOs at NRC-licensed facilities. One
involved a medical brachytherapy misadministration, two involved
medical teletherapy misadministrations, one involved a medical sodium
iodide misadministration, and one involved a medical sodium iodide
event. One AO report submitted by an Agreement State is included. It
involved the loss of management and procedural control of a radioactive
source.
The report also contains updates of six AOs previously reported by
NRC licensees and three AOs previously reported by Agreement State
licensees. Two ``Other Events of Interest'' [[Page 10119]] concerning
nuclear power reactors are also reported. One involved the fracture of
a frozen pipe at Dresden Unit 1 with a consequent release of water, and
the other involved the possible deliberate exposure of a contract
laborer to radiation at Quad Cities Nuclear Power Station.
Section 208 of the Energy Reorganization Act of 1974, as amended,
also requires NRC to provide a wide dissemination of information
relating to these reported occurrences. Descriptions of the NRC
licensee AOs for the third quarter of calendar year 1994, are provided
below and have been reported to Congress in NUREG-0090, Vol. 17, No. 3.
NRC Material and Medical Licensees
(Industrial Radiographers, Medical Institutions, Industrial Users,
etc.)
94-15 Sodium Iodide Event at Welborn Memorial Baptist Hospital in
Evansville, Indiana
The following information pertaining to this event is also being
reported concurrently in the Federal Register. Appendix A (see General
Criterion 1) of this report notes that a moderate exposure to, or
release of, radioactive material licensed by or otherwise regulated by
the Commission can be an abnormal occurrence.
Date and Place--March 9, 1994; Welborn Memorial Baptist Hospital,
Inc.; Evansville, Indiana.
Nature and Probable Consequences--On May 16, 1994, the licensee
reported to NRC that a pregnant patient was administered 185
megabecquerel (MBq) (5 millicurie [mCi]) of sodium iodide-131 (I-131)
on March 9, 1994, as prescribed in the written directive for the
treatment of Graves' disease (hyperthyroidism). The licensee did not
know that the patient was pregnant at the time of the administration.
On May 10, 1994, the licensee was informed by a private practice
physician that the patient was 22-weeks pregnant at the time of
treatment. As a result, the patient's fetus received an unintended
radiation dose.
The patient was referred to the licensee with possible
hyperthyroidism. To confirm the suspect condition, the licensee
administered a 440.3 kilobecquerel (11.9 microcurie) I-131 capsule of
the patient on March 7, 1994, and measured an 82-percent thyroid uptake
over the ensuing 25 hours. The licensee stated that prior to
administering the I-131 diagnostic capsule on March 7, 1994, the
patient was questioned and informed both the treating physician and the
nuclear medicine technologist administering the capsule that she was
not pregnant. The licensee diagnosed the patient's condition as Graves'
disease and the treating physician perscribed a 185 MBq (5 mCi) I-131
therapy treatment. On March 9, 1994, a 185 MBq (5 mCi) I-131 capsule
was orally administered by one of the licensee's nuclear medicine
technologists, as prescribed. Prior to the treatment on March 9, 1994,
the technologist questioned the patient once more and was again
informed by the patient that she was not pregnant.
Oak Ridge Institute for Science and Education calculated the fetal
whole body and thyroid doses at NRC request. The fetal dose to the
thyroid was calculated as 7,000-12,000 centigray (cGy) (7,000-12,000
rad), and the fetal whole body dose was calculated as 0.55 cGy (0.55
rad). Based on the calculated fetal dose there are a range of possible
consequences, the most likely being no significant harm to the fetus.
At NRC request, the Radiation Emergency Assistance Center/Training Site
in Oak Ridge, Tennessee, contacted the licensee to discuss the dose
assessment and potential fetal effects.
On May 10, 1994, a physician specializing in maternal fetal
medicine, not affiliated with the licensee, discussed the incident with
the licensee. The patient was informed of the exposure and possible
consequences to the fetus by the material fetal specialist.
NRC Region III learned the patient was aware that she was being
administered radioactive materials, and subsequent to the
administration she realized she was pregnant. It should be noted that
since this was not a misadministration, there was no requirement to
notify the patient.
Cause or Causes--The principal cause for the event was licensee
reliance on the patient's assurance of non-pregnancy. Licensee
procedures do not require determination of pregnancy status through
serum testing, or other appropriately documented means, for all female
patients of child bearing age. The patient was apparently unaware of
her pregnancy status at the time of I-131 administration on March 9,
1994.
Action Taken To Prevent Recurrence
Licensee--The licensee is in the process of developing internal
policies which will address options for pregnancy status determination
including serum pregnancy testing or suitable written proof, such as
evidence of a hysterectomy. The legal implications and options for
written proof of non-pregnancy are being evaluated by the licensee.
Until policies have been finalized, the licensee plans to administer
pregnancy tests to all female patients of child bearing age, unless
appropriate proof of non-pregnancy is available as determined by the
authorized user. For patients unwilling to undergo pregnancy testing,
radiopharmaceuticals will not be administered and the authorized user
will be consulted for the appropriate course of action.
NRC--NRC Region III conducted a safety inspection from May 18
through June 8, 1994, to review the circumstances surrounding the event
and to evaluate aspects of the licensee's radiopharmaceutical Quality
Management Program (Reg. 1). No regulatory violations associated with
the event were identified. The licensee's procedure appears to have
been followed in this specific case. NRC regulations do not include
requirements for patient pregnancy verification prior to administration
of radiopharmaceuticals. However, NRC is in the process of developing
regulations which will address the administration of
radiopharmaceuticals to breast feeding and pregnant patients.
94-16 Teletherapy Misadministration at Medical Center Hospital in
Chillicothe, Ohio
The following information pertaining to this event is also being
reported concurrently in the Federal Register. Appendix A of this
report notes that a therapeutic dose that results in any part of the
body receiving unscheduled radiation can be considered an abnormal
occurrence.
Date and Place--July 21 and 22, 1994; Medical Center Hospital;
Chillicothe, Ohio.
Nature and Probable Consequences--On July 27, 1994, the licensee
reported that a patient received a radiation dose of approximately 300
centigray (cGy) (300 rad) to an unintended treatment site using a
cobalt-60 teletherapy unit.
A patient was scheduled to receive 1400 cGy (1400 rad) in a series
of seven treatments for cancer of the esophagus. Each of the treatments
was to consist of two radiation exposures of 100 cGy (100 rad) each
delivered from different angles. The first treatment was performed on
July 21. Following the first of the to exposures during the second
treatment on July 22, the technologist found inconsistencies in the
angles of treatment documented in the written directive and in the
patient simulation sheet. Upon further review, the licensee determined
that the wrong treatment angles had been used during the first
treatment and part of the second treatment. [[Page 10120]]
As a result of the incorrect angles of exposure, the treatment site
received only part of the prescribed dose and adjacent tissue received
a higher does than intended. The licensee estimates a dose of 300 cGy
(300 rad) to the unintended site. Under normal conditions, the
unintended site would have received approximately 20-50 cGy (20-50
rad).
The treatment angles were corrected on the patient's chart, and the
radiation dose was modified to compensate for the reduced dosage
delivered in the initial treatments. The patient was informed and no
adverse medical effects are expected.
The patient was notified verbally on July 26, 1994 and in writing
as required by 10 CFR 35.33. According to the medical consultant, there
will be no medical consequences as a result of the misadministration.
Cause or Causes--The error occurred because the simulated gantry
angles had not been converted to the treatment unit gantry angles, and
gantry angle conversion factors were not included in the licensee's
treatment chart checks conducted by the technologists.
The root causes of the problem were discussed with the licensee on
September 1, 1994, during an Enforcement Conference. The causes
appeared to be the following: (1) Written procedures were not developed
to address gantry angle conversions; (2) the technologists did not have
an adequate understanding of the informal gantry angle conversion
procedures; (3) the informal gantry angle conversion procedure was not
part of the licensee's annual refresher training program; (4)
technologists did not fully understand their responsibilities to
resolve discrepancies in a treatment plan; and (5) gantry angle
conversion factors were not included in the licensee's treatment chart
checks conducted by the technologists.
Action Take To Prevent Recurrence
Licensee--The licensee's corrective actions included: (1) Revising
the simulation data form to include a specific location to document the
converted gantry angles; (2) initialing all angle conversions by the
person performing the conversion, and having a second individual
independently verify the conversions prior to treatment; (3)
instructing the technologists to review all treatment information and
to resolve any discrepancy prior to continuing treatment; (4)
performing all future gantry angle conversions by the licensee rather
than by the licensee's simulation contractor; and (5) conducting a
review of past treatment plans back to 1988, with emphasis on those
which did not identify any additional errors.
NRC--NRC Region III conducted an inspection on August 1, 1994, to
review the circumstances surrounding the misadministration (Ref. 2).
NRC also retained a medical consultant to review the case. An
Enforcement Conference was held on September 1, 1994, to discuss the
inspection findings and actions taken by the licensee. On September 20,
1994, NRC Region III issued a Notice of Violation with a Severity Level
III (Severity Levels I through V range from the most significant to the
least significant) violation with no civil penalty assessed. The
licensee's corrective and preventive actions will be reviewed during
the next NRC inspection of the licensed program.
94-17 Sodium Iodide Misadministration at St. Joseph Mercy Hospital
in Pontiac, Michigan
The following information pertaining to this event is also being
reported concurrently in the Federal Register. Appendix A of this
report notes that administering a diagnostic dose of a
radiopharmaceutical differing from the prescribed dose by more than 50
percent in which the event results in adverse health effects worse than
expected for the normal range of exposures prescribed for the
diagnostic procedure can be considered an abnormal occurrence.
Date and Place--July 26, 1994; St. Joseph Mercy Hospital; Pontiac,
Michigan.
Nature and Probable Consequences--On July 27, 1994, the licensee
reported to NRC that a misadministration occurred involving a patient
receiving the wrong radiopharmaceutical for a diagnostic procedure.
The patient's referring physician requested a thyroid scan which
involves administration of a standard prescription at St. Joseph Mercy
Hospital of a 9.25 megabecquerel (MBq) (0.25 millicurie [mCi]) sodium
iodide-123 (I-123) capsule. However, the licensee administered a 92.5
MBq (2.5 mCi) I-131 capsule. The amount of activity that was
administered is normally used following removal of the thyroid to
examine a patient for the spread of cancer from the thyroid through the
body.
NRC retained a medical consultant to review the case. The medical
consultant concluded that the resultant unnecessary dose to the
patient's thyroid would result in a low, but finite, probability of
hypothyroidism developing in the future. Also, there is a lifetime
probability of developing radiation-induced thyroid cancer of 10
percent, including a risk of fatal thyroid carcinoma of approximately 1
percent. The licensee has arranged for the patient to be seen by a
endocrinologist, and for repeat thyroid imaging with I-123 to be
performed several months after the misadministration.
The patient was notified in person by the Radiation Safety Officer
on July 27, 1994. Subsequently, the patient was also given a written
report that was dated August 5, 1994.
Cause or Causes--Part of the cause of the misadministration was the
lack of the treating physician's involvement in the patient's
examination prior to the I-131 administration. The administrative staff
and technologists failed to have the examination clarified by a
treating physician with the referring physician prior to administration
of the I-131. Causal factors for this event also included the failure
of licensee management to ensure implementation of the licensee's
written Quality Management Program. Contributing factors also appear to
include deficiencies in training, and a failure to follow through on
matters.
Action Taken To Prevent Recurrence
Licensee--The licensee took the following corrective actions: (1)
Held a training session which included the Radiation Safety Officer,
treating physicians and technologists; (2) instituted a limit on the
number of individuals who will be involved in the use of I-131; and (3)
required a written directive to be filled out and signed by a treating
physician.
NRC--NRC Region III conducted an inspection on August 1, 1994, to
review the misadministration (Ref. 3). A Conformatory Action Letter
(CAL) was issued to the licensee on August 2, 1994, which described the
commitments made by the licensee as to which actions will be taken
prior to the administration of I-131. An Enforcement Conference was
held on August 24, 1994, to discuss the inspection findings and actions
taken by the licensee in response to the CAL.
In October 1994, NRC proposed an $8,000 fine against the licensee
for violations of NRC requirements involved in a diagnostic procedure
using radioactive iodine at the hospital. The violations involve: (1)
Failure to have signed written directives by an authorized user prior
to administration of I-131 in quantities greater than 1.11 MBq (0.03
mCi) on July 26, and in two previous instances where the I-131 was the
intended radiopharmaceutical; (2) failure to have a clinical procedure
for the proper administration of I-131 for [[Page 10121]] whole body
scans; and (3) failure to provide proper instruction to the nuclear
medicine staff. The licensee paid the civil penalty.
94-18 Multiple Teletherapy Misadministrations at Sinai Hospital in
Detroit, Michigan
The following information pertaining to this event is also being
reported concurrently in the Federal Register. Appendix A of this
report notes that a therapeutic dose that results in any part of the
body receiving unscheduled radiation can be considered an abnormal
occurrence.
Date and Place--July 28 and August 3, 1994; Sinai Hospital;
Detroit, Michigan.
Nature and Probable Consequences--On July 28, 1994, and August 3,
1994, misadministrations occurred on two separate patients when the
licensee's therapists failed to verify correct teletherapy machine
parameters prior to treatment.
Beginning on July 19, 1994, a patient was to received 4500
centigray (cGy) (4500 rad) in a series of 25 treatments to the left
neck area. The first seven treatments were completed without incident.
However, on the eighth treatment on July 28, one faction was set up
using the wrong treatment angle. This resulted in a radiation dose of
90 cGy (90 rad) being received by the right shoulder and neck area
instead of the left neck area.
Beginning July 5, 1994, another patient was to receive 5000 cGy
(5000 rad) in a series of 25 treatments to the right shoulder area. The
first 20 treatments were completed without incident. However, on the
21st treatment on August 3, the teletherapy unit was positioned using
the wrong treatment angle. This resulted in a radiation dose of 100 cGy
(100 rad) being received by the right lung area instead of the right
shoulder area.
An NRC medical consultant reviewed both cases and concluded that no
significant adverse side effects or tissue injury are expected.
Cause or Causes--The cause of both misadministrations was human
errors by several of the licensee's therapists. The therapists failed
to verify the collimator angle, the wedge setting, and the treatment
site before administering the teletherapy dose to the patients.
Action Taken To Prevent Recurrence
Licensee--The corrective actions taken included: (1) Suspending all
teletherapy treatments pending an internal investigation, and
identification of appropriate corrective actions prior to re-start of
the teletherapy treatments; (2) developing procedures which require
independent verification of proper treatment parameters during patient
set-up; and (3) installing a record-and-verify system on the
teletherapy unit to ensure that all major treatment parameters are
checked prior to a treatment.
NRC--NRC Region III conducted an inspection July 29 through August
12, 1994, to review the circumstances surrounding the two
misadministrations (Ref. 4). NRC also retained a medical consultant to
review the case. An Enforcement Conference was held on September 8,
1994, to discuss the inspection findings and actions taken by the
licensee. On September 21, 1994, NRC Region III issued a Notice of
Violation with a Severity Level III (Severity Levels I through V range
from the most significant to the least significant) violation with no
civil penalty assessed. The licensee's corrective and preventive
actions will be reviewed during the next NRC inspection of the licensed
program.
As required by 10 CFR 35.33(a), the licensee, for each
misadministration, notified the referring physician and patient after
the discovery of the incident and submitted a written report to the
patient, including a statement that the report submitted to NRC Region
III will be made available upon request.
94-19 Brachytherapy Misadministration Involving the Use of a
Strontium-90 Eye Applicator at the University of Massachusetts Medical
Center in Worcester, Massachusetts
The following information pertaining to this event is also being
reported concurrently in the Federal Register. Appendix A (see Event
Type 5 in Table A-1) of this report notes that a therapeutic dose that
results in an actual dose less than 0.5 times the prescribed dose can
be considered an abnormal occurrence. In addition, Criterion No. 11
under ``For All Licensees'' in Appendix A notes that a serious
deficiency in management or procedural controls in major areas can be
considered an abnormal occurrence.
Date and Place--July 29, 1994; University of Massachusetts Medical
Center; Worcester, Massachusetts.
Nature and Probable Consequences--NRC Region I was notified on
August 1, 1994, by the licensee of a brachytherapy misadministration
involving the use of a strontium-90 (Sr-90) eye applicator. On July 29,
1994, a physician performed an ophthalmic treatment on a patient using
a Sr-90 eye applicator without first removing the stainless steel mask
from the source. Because of this oversight, the licensee estimated that
the treatment site received 107 centigray (cGy) (107 rad) of radiation,
rather than the 1250 to 2000 cGy (1250 to 2000 rad) that was intended.
In addition, whereas the beta radiation from the eye applicator source
only affects the surface of the eye, the bremsstrahlung radiation
resulting from the interaction of the beta particles on the stainless
steel mask is more penetrating. The patient returned on August 2, 1994,
for the completion of the therapy to bring the total dose delivered
within the originally prescribed range. The licensee expects that the
clinical outcome of the misadministration will be inconsequential for
the patient.
Cause or Causes--According to the licensee a combination of factors
led to the misadministration: (1) Infrequent use of the ophthalmic
applicator and the fact that its appearance with the mask is similar to
its appearance with the mask removed; (2) the event occurred on a
Friday afternoon and the stress of the week's work affected the
alertness of the individuals involved; and (3) the most experienced
physicists were not available, and a relatively inexperienced physicist
prepared the source and was unaware that the source was equipped with a
stainless steel mask.
Actions Taken to Prevent Recurrence
Licensee--The licensee is reviewing the feasibility of modifying
the mask in some manner to make it more easily distinguished from the
unmasked source. In addition, the licensee has employed two new
radiation oncology physicians and a new chief physicist.
NRC--NRC conducted a special inspection on August 3, 1994. The
inspector determined that the physician was assisted by a dosimetrist
who had not previously been directly involved with the procedure. When
the physician requested that the dosimetrist provide him with the eye
applicator source in order to perform the treatment, the dosimetrist
handed him the source with the stainless steel mask in place. The
dosimetrist stated that she was unaware that the source was equipped
with a mask and that the mask needed to be removed. The physician and
other licensee staff stated that it is the assistant's responsibility,
in this case the dosimetrist's responsibility, to remove the stainless
steel mask from the source before handing the eye applicator to the
physician. The treatment was administered by the physician with the
mask in place. While cleaning the eye applicator later that same day,
the licensee determined that the treatment had been performed with the
mask in place. The licensee stated that the patient and the patient's
physician were notified that there had been an [[Page 10122]] underdose
and the patient returned on August 2, 1994, for the completion of the
therapy. The patient was given a written report of the
misadministration on August 9, 1994. The licensee submitted a report
for the misadministration on August 10, 1994. NRC Region I has enlisted
the services of a medical consultant to evaluate the clinical
consequences of this misadministration and awaits his report.
A copy of NUREG-0090, Vol. 17, No. 3 is available for inspection or
copying for a fee at the NRC Public Document Room, 2120 L Street NW.
(Lower Level), Washington, D.C. 20037, or at any of the nuclear power
plant Local Public Document Rooms throughout the country.
Copies of this report (or any of the previous reports in this
series), may be purchased from the Superintendent of Documents, U.S.
Government Printing Office, Post Office Box 37082, Washington, DC
20013-7082. A year's subscription to the NUREG-0090 series publication,
which consists of four issues, is also available.
Copies of the report may also be purchased from the National
Technical Information Service, U.S. Department of Commerce, 5285 Port
Royal Road, Springfield, VA 22161.
Dated at Rockville, MD this 16th day of February, 1995.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Acting Secretary of the Commission.
[FR Doc. 95-4382 Filed 2-22-95; 8:45 am]
BILLING CODE 7590-01-M
