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[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
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