[Federal Register Volume 68, Number 75 (Friday, April 18, 2003)]
[Notices]
[Pages 19233-19239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9605]


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NUCLEAR REGULATORY COMMISSION


Report to Congress on Abnormal Occurrences, Fiscal Year 2002; 
Dissemination of Information

    Section 208 of the Energy Reorganization Act of 1974 (Public Law 
93-438) identifies an abnormal occurrence (AO) as an unscheduled 
incident or event that the U.S. Nuclear Regulatory Commission (NRC) 
determines is significant from the standpoint of public health or 
safety. The Federal Reports Elimination and Sunset Act of 1995 (Public 
Law 104-66) requires that AOs be reported to Congress annually. During 
fiscal year 2002, 10 events that occurred at facilities licensed or 
otherwise regulated by the NRC and/or Agreements States were determined 
to be AOs. The report describes three AOs at facilities licensed by the 
NRC. One event involved the degradation of the reactor head at a 
nuclear power plant, the second event involved a gamma stereotactic 
radiosurgery misadministration and the third event involved an 
overexposure of a radiopharmacist at a materials facility. The report 
also discusses seven events at facilities licensed by Agreement States. 
As required by section 208, the discussion for each event includes the 
date and place, the nature and probable consequences, the cause or 
causes, and the action taken to prevent recurrence. Each event is also 
being described in NUREG-0090, Vol. 25, ``Report to Congress on 
Abnormal Occurrences, Fiscal Year 2002.'' This report will be available 
electronically at the NRC Web site http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/.

Nuclear Power Plants

02-1 Performance Deficiency Resulting in Reactor Vessel Head 
Degradation at Davis-Besse Nuclear Power Station in Oak Harbor, Ohio

    Date and Place--March 6, 2002; Davis-Besse Nuclear Power Station, a 
pressurized-water reactor plant designed by Babcock and Wilcox Company, 
operated by First Energy Nuclear Operating Company and located near Oak 
Harbor, Ohio.
    Nature and Probable Consequences--On February 16, 2002, the Davis-
Besse facility began its 13th refueling outage, which included 
inspections of the control rod drive mechanism (CRDM) nozzles in 
accordance with NRC Bulletin 2001-01, ``Circumferential Cracking of 
Reactor Pressure Vessel Head Penetration Nozzles,'' issued on August 3, 
2001. These nozzles penetrate through the reactor pressure vessel (RPV) 
head and are attached by welds. Nozzle cracking was first discovered in 
the industry in the late 1980s. The concern with cracking is the 
potential loss of control rod drive function (rod ejection) and the 
resultant loss of coolant accident (LOCA) should the cracks reach a 
critical size and orientation. Also of concern is the potential for the 
reactor coolant to leak through small cracks in CRDM nozzles and cause 
boric acid corrosion of the RPV head. The RPV head is an integral part 
of the reactor coolant pressure boundary (Figure 1) and loss of its 
integrity can likewise result in a LOCA.
    On February 27, 2002, the licensee notified the NRC that non-
destructive examination of CRDM Nozzles 1, 2 and 3 identified that 
those nozzles contained small through-wall cracks. The licensee decided 
to repair these three nozzles plus two other nozzles with identified 
cracks that did not appear to be through-wall. The repair process 
included machining away the lower portion of the CRDM nozzle to a point 
above the cracks in the nozzle material. During this activity, CRDM 
nozzle 3 loosened in the head and on March 6, 2002, the licensee began 
an investigation to identify the cause. At the same time, activities 
were underway to remove boric acid deposits from the top of the RPV 
head caused by leakage of reactor coolant from the cracks and past 
leaking CRDM flanges. After removing the boric acid deposits, the 
licensee identified a large corrosion cavity in the head material 
adjacent to CRDM Nozzle 3 (Figure 2). The cavity was approximately 6 
inches in length and 4 to 5 inches in width. Within this area the 6.63 
inch thick low alloy steel head was corroded away leaving only the 
stainless steel cladding layer on the inside. The remaining cladding 
layer ranged in thickness from 0.20 to 0.31 inches. Subsequent 
metallurgical examination of this section of cladding identified a 
shallow crack approximately \3/8\ inch in length. This cladding layer 
is designed as a corrosion resistant layer and is not specifically 
designed to retain reactor operating pressure. In addition to the 
cavity adjacent to Nozzle 3, a comparatively

[[Page 19234]]

small cavity was identified adjacent to Nozzle 2. This cavity was 
approximately 1.75 inches wide, 4 inches long, and 0.25 inches deep. 
Region III sent an Augmented Inspection Team (AIT) to the site to 
determine the facts and circumstances of the head degradation, 
beginning on March 12, 2002, and held a public exit meeting on April 5, 
2002. A follow-up inspection identified several apparent violations of 
Agency regulations. The apparent violations will be processed in 
accordance with Agency procedure.
    On April 8, 2002, prior to discovery of the crack in the cladding, 
the licensee submitted a safety significance assessment for the 
degraded RPV head to the NRC. This assessment determined that the as-
found stainless steel cladding layer would have remained intact during 
anticipated operational occurrences and postulated accidents. Further, 
this assessment determined that had the RPV head failed due to the 
corrosion: (a) Adequate core cooling could have been established and 
maintained for the long term, (b) the reactor could have been placed 
and maintained in a safe shutdown condition, and (c) the integrity of 
containment would not have been compromised. The NRC staff is 
performing an independent assessment and reviewing the adequacy of the 
licensee's assessment. The NRC has not reached a final conclusion on 
the significance of this condition.
    Cause or Causes--On April 18, 2002, the licensee submitted its Root 
Cause Analysis Report to the NRC. In this report, the licensee 
concluded that the most probable technical cause of the RPV head 
degradation was boric acid corrosion resulting from leakage through a 
crack in the CRDM penetration nozzle attributable to primary water 
stress corrosion cracking. Further, this corrosion had occurred over a 
period of several years. Absent more definitive information, the 
licensee's technical root cause analysis represents a plausible 
scenario for the degradation.
    The licensee has completed a number of activities designed to 
identify management and human performance issues which contributed to 
this event. Several management and human performance issues were 
subsequently identified by both the licensee and NRC. NRC continues to 
monitor these activities and independently assess the effectiveness of 
the licensee's efforts in this area.
Actions Taken To Prevent Recurrence
    Licensee--The licensee elected to replace the damaged head with one 
procured from the owners of the canceled Midland nuclear power plant 
located in Michigan. The licensee has also completed a number of 
activities designed to identify the management and human performance 
deficiencies which contributed to the degradation of the reactor vessel 
head and implemented a series of inspections and evaluations to 
identify and correct any other potentially problematic plant issues.
    NRC--Region III issued Confirmatory Action Letter (CAL) 3-02-001 on 
March 13, 2002, and Revised CAL 3-02-001A on May 15, 2002, which 
detailed specific licensee actions to be taken before NRC would 
consider restart of Davis-Besse. The NRC issued two Information Notices 
(IN) and two Bulletins to promptly inform the industry of the event: IN 
2002-11, ``Recent Experience with Degradation of Reactor Pressure 
Vessel Head''; IN 2002-13, ``Possible Indicators of Ongoing Reactor 
Pressure Vessel Head Degradation''; Bulletin 2002-01, ``Reactor 
Pressure Vessel Head Degradation and Reactor Coolant Pressure Boundary 
Integrity''; and Bulletin 2002-02, ``Reactor Pressure Vessel Head and 
Vessel Head Penetration Nozzle Inspection Programs.''
    The NRC placed Davis-Besse under the Inspection Manual Chapter 0350 
``Oversight of Operating Reactor Facilities in a Shutdown Condition 
With Performance Problems'' on April 29, 2002. Further inspections and 
assessment of Davis-Besse performance will be performed before plant 
restart is considered. The NRC also chartered a Lessons Learned Task 
Force (LLTF). The objective of this task force was to independently 
evaluate the NRC's regulatory processes related to assuring RPV head 
integrity in order to identify and recommend areas for improvement that 
may be applicable to either the NRC or the nuclear industry. The LLTF 
completed its evaluation and its conclusions were reviewed by a Senior 
Management Review Team to determine appropriate Agency actions. The 
recommendations of the Senior Management Review Team were issued 
November 26, 2002. A Commission meeting was held on January 14, 2003, 
to brief the Commission on the Senior Management Review Team 
recommendations and the Commission approved proceeding with the 
recommendations.
    This event is considered open for the purpose of this report.

Fuel Cycle Facilities (Other Than Nuclear Power Plants)

    None of the events that occurred at fuel cycle facilities during 
this period was significant enough to be reported as an AO.

Other NRC Licensees (Industrial Radiographers, Medical Institutions, 
etc.)

    The NRC determined that the following events which occurred at 
facilities, licensed or otherwise regulated by the NRC, during this 
reporting period were significant enough to be reported as AOs:

02-2 Gamma Stereotactic Radiosurgery (Gamma Knife) Misadministration at 
St. Luke's Medical Center in Milwaukee, Wisconsin

    Date and Place--July 10, 2001; St. Luke's Medical Center; 
Milwaukee, Wisconsin.
    Nature and Probable Consequences--A patient undergoing Gamma 
Stereotactic Radiosurgery (Gamma Knife) was prescribed treatment of 20 
Gy (2,000 rad) to a portion of the brain. During the treatment, the 
licensee completed three of eight treatment fractions and approximately 
one-half of the fourth fraction when the medical physicist and 
radiation therapist realized that the administered treatment utilized 
the treatment parameters for another patient, resulting in a dose of 
12.8 Gy (1,280 rad) to an unintended portion of the brain (i.e., wrong 
treatment site).
    For treatment, the licensee's medical physics staff prepared 
treatment plans for two patients, to be treated on the same day. The 
treatment plan for Patient A consisted of a prescribed dose of 18 Gy 
(1,800 rad). Prior to initiating treatment of Patient A, someone on the 
licensee's staff handed the plan of treatment for Patient B to the 
licensee's radiation therapist; later, the therapist could not recall 
who had handed her the plan. Using Patient B's treatment plan, the 
treatment team set up and delivered the first three fractions to 
Patient A and began delivery of the fourth fraction. The error was 
discovered by the medical physicist during delivery of the fourth 
fraction. Once notified of the error, the radiation oncologist 
terminated the treatment.
    The medical physicist determined that the treatment delivered a 
dose of 12.8 Gy (1,280 rad) to an unintended region of the patient's 
brain. The radiation oncologist determined that the location of the 
unintended site was far enough away from the intended site to proceed 
with the intended treatment.

[[Page 19235]]

The licensee subsequently administered the intended treatment without 
incident. The radiation oncologist did not anticipate any immediate 
adverse effects to the patient because of the treatment to the wrong 
site. He was not certain of the potential for any long-term effects as 
a result of the misadministration.
    The NRC contracted with a medical consultant to evaluate the 
medical data associated with the July 10, 2001, misadministration and 
assess any probable deterministic effects to the exposed patient. The 
consultant agreed with the licensee's assessment. With regard to long-
term affects, the NRC's consultant concluded that the misadministration 
may be at the threshold of late central nervous system injury and may 
produce symptoms. The consultant further opined that long-term follow 
up was indicated for the patient and that the patient was eligible for 
inclusion in the Department of Energy's Office of Epidemiology and 
Health Surveillance voluntary life-time morbidity study. The licensee 
conducted medical follow up of the patient to identify and respond to 
potential adverse medical consequences resulting from the 
misadministration in December of 2001. However, during an attempt to 
follow up on the patient in June 2002, the licensee lost contact with 
the patient.
    The licensee notified the patient's referring physician, who was 
also the attending neurosurgeon, immediately after the event. The 
radiation oncologist informed the patient of the event the following 
day and subsequently provided a copy of the report submitted to the 
NRC.
    Cause or Causes--This misadministration was caused by human error, 
in that the licensee staff failed to verify that the treatment plan 
used was for the patient being treated. Contributing factors included: 
(1) The patient's name was not on each page of the computer-generated 
treatment plan; (2) the clipboard obscured the patient's name on the 
first page of the treatment plan; and (3) the licensee treated two 
patients with similar treatment plans.
Actions Taken To Prevent Recurrence
    Licensee--Based on the cause and contributing factors of the 
misadministration, the licensee immediately implemented measures to 
ensure that patient-specific parameters are confirmed and verified 
prior to initiation of treatment. The measures included: (1) 
Independent verification of the treatment plan to ensure that it 
corresponds to the couch on the Gamma Knife unit; (2) labeling each 
page of the computer treatment plan with the patient's name; (3) 
placing the treatment plan in the standard pink-colored patient-
specific binder; (4) ensuring that the outside of patient-specific 
binders have large lettering indicating the patient's name; (5) 
ensuring that all patient-specific binders contain all medical 
information for the patient; (6) use of clipboards to hold verification 
forms that do not cover up the patient's name at the top of the forms; 
and (7) training of applicable staff regarding the cause and 
contributing factors of the misadministration and the measures to 
ensure that patient-specific parameters are confirmed and verified 
prior to initiation of treatment.
    NRC--The licensee was cited for violations that included failure to 
verify that the treatment parameters implemented were for the patient 
being treated.
    This event is closed for the purpose of this report.

02-3 Extremity Exposure in Excess of Regulatory Limits at Pacific 
Radiopharmacy, Limited, in Honolulu, Hawaii

    Date and Place--March 26, 2002; Pacific Radiopharmacy, Limited, 
Honolulu, Hawaii.
    Nature and Probable Consequences--During a routine, unannounced 
inspection conducted by the NRC on March 6, 2002, an inspector observed 
a radiopharmacist drawing 3700 megabecquerels (MBq) (100 millicurie 
(mCi)) bulk doses of technetium-99m (Tc-99m) utilizing a vial shield 
without a shielded top. The inspector observed that the radiopharmacist 
used his left index finger to hold the vial containing the Tc-99m in 
the shield when he inverted the vial to draw a dose. After questioning 
the individual, the inspector determined that this was the individual's 
routine practice. The inspector then informed the licensee that this 
practice may contribute to unnecessary exposure to the individual's 
finger and that the licensee should perform an evaluation to determine 
if the individual's extremity monitor (finger badge) was indicative of 
the actual dose received as a result of this handling practice. 
Following the inspection, a licensee consultant calculated the exposure 
to the individual's left index finger to be 7000 mSv (700 rem) for 
calendar year 2001. The exposure was reported to the NRC Operations 
Center on March 26, 2002. In addition, the licensee's consultant 
calculated the exposure to the individual's left index finger to be 
1400 mSv (140 rem) from January 1, 2002, through March 13, 2002. The 
exposure was reported to the NRC Operations center as a 30 day report 
on March 28, 2002. The radiopharmacist's extremity exposure was chronic 
and not acute, occurring over the entire calendar year. The inspector 
viewed the individual's left index finger and did not identify any 
visible skin reddening.
    Cause or Causes--Licensee management and the Radiation Safety 
Officer failed to effectively train Pacific Radiopharmacy employees on 
NRC requirements for the safe handling of radionuclides and failed to 
provide effective oversight of its radiation safety program.
Actions Taken To Prevent Recurrence
    Licensee--The licensee has obtained additional vial shields with 
shielded tops, placed them at the second drawing station, and has 
required the radiopharmacist to use them. The licensee also reviewed 
the adequacy of the radiation safety officer's oversight of the 
radiation safety program, determined it to be inadequate, and has 
replaced the radiation safety officer with another individual. The new 
radiation safety officer conducts unannounced inspections of the 
radiopharmacy to ensure compliance with their procedures requiring the 
use of vial shields with shielded tops during dose drawing procedures.
    On March 29, 2002, the NRC issued Confirmatory Action Letter (CAL) 
4-02-003 to the licensee associated with the extremity exposure in 
excess of regulatory limits. On April 8, 2002, the licensee responded 
to the CAL with corrective actions which included: (1) Removing the 
radiopharmacist from working with radioactive materials throughout the 
remainder of calendar year 2002; (2) contracting with a local 
consultant to provide safety training, conduct random unannounced 
audits, and provide Radiation Safety Officer (RSO) services; and (3) 
replacing its current RSO with the new consultant and requiring the RSO 
to attend quarterly board meetings to provide safety reports to the 
board.
    NRC--In addition to issuance of CAL 4-02-003, NRC staff also met 
with licensee representatives in a Predecisional Enforcement Conference 
on October 10, 2002, to discuss the inspection findings. Enforcement 
action is currently pending.
    This event is closed for the purpose of this report.

Agreement State Licensees

    The NRC determined that the following events, which occurred at 
Agreement State licensed facilities

[[Page 19236]]

during this reporting period, were significant enough for reporting as 
AOs:

AS 02-1 Loss of Package Integrity and Elevated Radiation Levels 
Measured at Federal Express Facility in Kenner, Louisiana

    Date and Place--January 2, 2002, Federal Express facility at New 
Orleans International Airport, in Kenner, Louisiana.
    Nature and Probable Consequences--A package containing iridium-192 
(Ir-192) with elevated surface radiation levels was discovered at the 
Federal Express facility located at the New Orleans airport. The 
package was identified as a routine shipment for Source Production and 
Equipment Company (SPEC), located in St. Rose, Louisiana. After being 
notified by Federal Express authorities, a representative of SPEC 
picked up the package from the Federal Express facility. While loading 
the package, known as the SAFKEG, onto his truck, the individual 
noticed that his survey meter was offscale and his pocket dosimeter 
showed a reading of 1.6 mSv (160 mrem). The SAFKEG was transported back 
to SPEC facilities and entombed in high-density concrete bricks in its 
secured warehouse. The individual's total exposure during these 
activities was later determined to be 3.45 mSv (345 mrem).
    The SAFKEG was shipped from a Swedish Company, Studsvik AB, and 
contained three vials loaded with a total of 1078 Ir-192 discs. The 
total activity was 366 terabecquerels (TBq) (9893 curies (Ci)). 
Shipping papers accompanying the package indicated that the Ir-192 was 
solid metal, in a Type B(U) package with a yellow radioactive III 
label, and a transportation index of 2 (radiation levels of 0.02 mSv/hr 
(2 mrem/hr) at one meter from the surface). Photographs taken by SPEC 
personnel, in St Rose, Louisiana, prior to the SAFKEG entombment 
confirmed that the appropriate U. S. Department of Transportation (DOT) 
labeling was affixed to the package. Surveys conducted at about the 
same time at 15 feet from the cask revealed measured radiation levels 
of 10 mSv/hr (1 rem/hr). The package remained entombed until a hot cell 
capable of remote inspection was constructed. After the SAFKEG's 
contents were removed, in the hot cell, and before it's shipment from 
the St. Rose facility, surveys for radiation levels and leak tests 
conducted for removable contamination showed no removable 
contamination.
    The SAFKEG was originally shipped by Federal Express. A Health 
Physicist/Consultant to Federal Express performed dose estimate 
calculations for personnel exposed to the package during its transit. 
Personnel monitoring devices were worn by the flight crews for both the 
flights; specifically, from Sweden to Paris and from Paris to Memphis. 
The First Officer for the Paris to Memphis flight received 0.05 mSv (5 
mrem) for the January-February 2002 monitoring period and 0.39 mSv (39 
mrem) for the November-December 2001 period. The consultant concluded 
that there were no excessive radiation levels from the SAFKEG on either 
flight. The consultant's calculations estimated the highest dose to any 
Federal Express employee at 20 mSv (2 rem). The French and Swedish 
regulatory agencies evaluated the portions of the event that occurred 
within their jurisdictions.
    Cause or Causes--On February 7, 2002, after construction of the hot 
cell, appropriate SPEC personnel opened the SAFKEG utilizing robotics. 
The tamper seal was intact; after it was broken, it was sealed in 
plastic and put aside. The interior shielded pot was removed and placed 
into a small lead shield. The shielding pot lid is normally secured 
with six allen head screws; however, one of the six screws was found 
loose. The plug assembly accessing the cavity containing the three 
vials of Ir-192 disks was removed, revealing that two of the three 
vials were open. The screw tops for the vials and a large number of Ir-
192 disks were visible along the lip of the inner cavity. It is 
presumed the screw tops became unscrewed during transportation, 
resulting in the elevated external radiation levels.
Actions Taken To Prevent Recurrence
    Licensee--The licensees involved in this occurrence are the package 
shipper, Studsvik AB, the package manufacturer, Croft, and the U.S. 
recipient, SPEC. The shipper and package manufacturer are pursuing 
corrective actions, but these have not been formalized as of the date 
of this report.
    The inner-shielded pot of the package remained in the hot cell of 
the SPEC facility at the time of this report. SPEC had no plans to 
attempt further decontamination of the pot.
    DOT--DOT issued a revision to the certificate of compliance (COC) 
requiring the type of radioactive material transported in the SAFKEG be 
contained in special form source capsules. This revision prohibits the 
use of the screw-top type vials that were used during this incident. 
The revised COC should prevent this type of occurrence in the future. 
DOT has discussed possible enforcement action as a result of this 
event.
    State Agency--The State of Louisiana had the lead role in the 
investigation of this event and has concluded its investigation.
    This event is closed for the purpose of this report.

AS 02-2 Industrial Radiography Occupational Overexposure at Longview 
Inspection in Channahon, Illinois

    Date and Place--The Illinois Department of Nuclear Safety (the 
Department) was notified on January 15, 2002, by the licensee's RSO, 
that in June 2000, a radiographer experienced an overexposure and 
subsequent injury at a temporary job site near Channahon, Illinois.
    Nature and Probable Consequences--On January 15, 2002, the licensee 
reported a potential overexposure to a radiographer and a subsequent 
injury that could have resulted from the overexposure. The overexposure 
occurred in June 2000, and involved a 3.0 TBq (81.2 Ci), Ir-192 source 
at a temporary job site near Channahon, Illinois. The radiographer, 
believing that the source was secured following the radiographic 
exposure, approached the guide tube area and knelt down without looking 
at his survey meter. The radiographer's alarming rate meter was 
inoperable because of a low battery. After changing the radiography 
film for the next shot and unhooking the guide tube, he noticed the 
source drive cable was still in the guide tube and his survey meter 
showed an off-scale reading. He immediately cranked the source back 
into the shielded position. His self-reading pocket dosimeter was off-
scale. The radiographer did not inform the licensee of the incident. 
Approximately 2 weeks after the incident, the radiographer noticed skin 
redness in a 2-centimeter sized area of his left calf. Over the next 
year, the wound became ulcerated and would not heal. A physician 
examined the individual and concluded that it could have resulted from 
radiation. In January 2002, the licensee's RSO became aware of the 
condition and reported it to the Department. Prior to commencing an 
extensive investigation, the Department recommended that the licensee 
seek immediate assistance from Oak Ridge Radiation Emergency Assistance 
Center/Training Site (REAC/TS). The REAC/TS concluded that the injury 
could have resulted from the overexposure in June 2000. The Department 
performed interviews and extensive time-motion studies and concluded 
that the incident could have occurred as described by the radiographer. 
The estimated dose to the individual was 15,000 mSv (1,500 rem) to the 
extremity. The licensee's

[[Page 19237]]

radiation monitoring program revealed a whole body dose of 9.1 mSv 
(0.910 rem) assigned to the radiographer for the month of June 2000. 
The reading was within the normal range for this individual, based on 
licensee records.
    The radiographer underwent skin grafting on February 26, 2002. 
Based on the results of the medical treatment, no long-term adverse 
health effects are expected.
    Cause or Causes--The cause was identified as a failure to conduct a 
lockout survey of the camera after the source was retracted, the 
failure to conduct radiation surveys and the failure to utilize an 
operable alarming rate meter due to a low battery.
Actions Taken To Prevent Recurrence
    Licensee--The licensee terminated the radiographer's employment and 
incorporated the event into the annual refresher training at all 31 
Longview Inspection offices.
    State Agency--The Department conducted an investigation and 
concluded that the subsequent injury could have resulted from the 
overexposure. The Department imposed a suspension of the radiographer's 
certification for one year.
    This event is closed for the purpose of this report.



AS 02-3 Industrial Radiography Occupational Overexposure at McShane 
Industries in Baltimore, Maryland

    Date and Place--September 25, 2001, McShane Industries, Baltimore, 
Maryland. The NRC was informed of this event in September 2001; 
however, this event was not documented as an AO in the ``Report to 
Congress on Abnormal Occurrences, Fiscal Year 2001'' because of its 
investigation at that time.
    Nature and Probable Consequences--On September 25, 2001, a 
radiographer employed by Accurate Technologies Incorporated (ATI) of 
Tinton Falls, New Jersey, was overexposed while conducting industrial 
radiography in Baltimore, Maryland. (On December 20, 2001, the licensee 
changed its name to United Evaluation Services Incorporated.) The 
radiographer was using an Amersham 660A radiography exposure device 
(camera) when the sealed source containing 2.16 TBq (58.4 Ci) of Ir-192 
failed to retract into the shielded position inside the camera 
following the previous radiographic exposure. The radiographer thought 
that the source was completely retracted into the shielded position 
when he relocated the camera, crank, guide tube and its extension tube 
in preparation for next exposure. The radiographer did not use a survey 
meter and was not wearing a pocket dosimeter, a whole body badge, or an 
alarming rate meter. The radiographer changed the film and 
identification, then secured the tip of the guide tube on to a 
different pipe weld for the next exposure. While attempting to unlock 
the camera for the next exposure, the radiographer noticed that the 
self-locking device on the camera was not in the locked position. Using 
the crank, the radiographer retracted the source into the shielded and 
secured position inside the camera. On September 29, 2001, the 
radiographer experienced burning and itching sensations in his fingers. 
On October 1, 2001, the radiographer notified the RSO and visited a 
physician. The physician reported that, on October 1, 2001, the 
radiographer had erythema on his fingers and palms. On October 5, 2001, 
State Inspectors observed radiation burns and blisters on the 
radiographer's hands. At the request of the State of Maryland, the 
United States Department of Defense, Armed Forces Radiobiology Research 
Institute, analyzed a 30 milliliter blood sample obtained from the 
radiographer, using cytogenetic biological dosimetry techniques, and 
reported a mean whole body dose estimation of approximately 2,670 mGy 
(267 rad). The assistant radiographer on site during this incident was 
not exposed.
    Cause or Causes--The root cause of this radiation injury was 
identified as a failure by the radiographer to follow licensed 
radiation safety procedures, to comply with Maryland Regulations 
regarding radiation safety requirements for industrial radiographic 
operations, and to properly use required radiation detection and 
measurement devices. Specifically, the radiographer failed to wear an 
audible alarming rate meter or any type of dosimetry. He also failed to 
use a radiation survey meter. He inadvertently entered a very high 
radiation area caused by the Ir-192 sealed source that did not retract 
into the shielded position inside the camera. Finally, he failed to 
ensure that the source was secured in the shielded position prior to 
relocating the equipment from one location to another.
Actions Taken To Prevent Recurrence
    Licensee--On October 4, 2001, the licensee agreed to discontinue 
all licensed activities until the completion of the Departmental 
Investigation.
    State Agency--The licensee was cited for violations of Maryland 
Regulations for Control of Radiation. Specifically, the licensee was 
cited for exceeding occupational exposure limits; failure to conduct 
radiation surveys; failure to secure the device after the exposure; 
failure to wear and properly use a pocket dosimeter, alarming rate 
meter and film badge; failure to notify the Agency of an overexposure; 
failure to maintain a utilization log; failure to report a bankruptcy 
to the Agency; failure to notify the Agency before vacating premises; 
failure to authorize the RSO on the license; and several other 
associated violations. On October 25, 2001, the Agency issued a Cease 
and Desist Order to the licensee, prohibiting all industrial 
radiography activities in Maryland. ATI's Maryland radioactive 
materials license expired on December 31, 2001, and was terminated. The 
incident has been referred for escalated enforcement.
    This event is closed for the purpose of this report.

AS 02-4 Intra Vascular Brachytherapy Misadministration (IVB) at Rhode 
Island Hospital, Providence, Rhode Island

    Date and Place--January 28, 2002; Rhode Island Hospital, 
Providence, Rhode Island.
    Nature and Probable Consequences--A patient was prescribed a dose 
of 8 Gy (800 rad) to the coronary artery during a Cordis Checkmate IVB 
procedure using 10 Ir-192 seeds, 8991 MBq (243 mCi). On January 31, 
2002, during a review of dosimetry and physician records, the licensee 
discovered that the diameter of the artery was used in the treatment 
plan calculation instead of the radius. This error resulted because the 
physicians (authorized users) using the CORDIS device were more 
familiar with the procedures for a NOVOSTE device also in use at this 
institution. The Novoste device uses the diameter of the artery in the 
dosimetry calculations whereas the Cordis device uses the radius. The 
authorized user provided the wrong dimension (diameter instead of 
radius) which led to an incorrect dose being calculated. As a result 
the patient received an actual dose of 14.6 Gy (1,460 rad) to the outer 
coronary artery site instead of the prescribed 8 Gy (800 rad). The 
licensee indicated that there will probably be no adverse health effect 
to the patient.
    Cause or Causes--As stated, the misadministration occurred due to 
human error in the use of the diameter of the artery instead of the 
radius of the vessel as required when using the Cordis system. The 
physicians' (authorized users) familiarity with the procedures for a 
Novoste device was a contributing factor.

[[Page 19238]]

Actions Taken To Prevent Recurrence
    Licensee--The licensee informed the State of Rhode Island the next 
day by telephone of the potential misadministration and provided a 
written report of the incident on February 14, 2002. In-service 
training has been conducted concerning the misadministration. In 
addition, the prescription form has been modified to indicate if the 
radius or the diameter of the vessel is being used for the treatment 
plan.
    State Agency--The Agency has been in contact with the licensee 
concerning this matter and the effectiveness of the corrective measures 
implemented. The licensee indicated that there will probably be no 
adverse health effects to the patient. To date there has been no 
recurrence of the problem.
    This event is closed for the purpose of this report.

AS 02-5 Strontium-90 Eye Applicator Brachytherapy at South Broward 
Hospital District in Hollywood, Florida

    Date and Place--January 4, 2002; South Broward Hospital District, 
Hollywood, Florida.
    Nature and Probable Causes--A patient was prescribed radiation 
treatment for pterygium in his left eye. The patient was to receive a 
total dose of 30 Gy (3,000 rad) in three 10 Gy (1,000 rad) fractions 
spaced approximately a week apart. Due to human error, the third and 
final fraction, given on January 4, 2002, was 24.84 Gy (2,484 rad) 
instead of the prescribed 10 Gy (1,000 rad).
    The prescribed dose was to be administered via a 3M Company Model 
6D1A eye applicator using a 973 MBq (26.3 mCi) strontium-90 (Sr-90) 
source. The written directive called for each fraction to consist of a 
treatment duration of 44 seconds to deliver a 10 Gy (1,000 rad) dose. 
The correct fractionated dose was administered as planned on December 
20, 2001, and December 28, 2001. A routine administration of the eye 
applicator required one person to time the event with a stopwatch while 
the authorized user administered the dose. The nurse and the authorized 
user became distracted in conversing with the patient and lost track of 
the time. The stopwatch used was the old style that simply counted time 
up and the nurse lost focus in trying to make the patient more 
comfortable and at ease. The authorized user had to remind the patient 
to gaze in a certain direction to treat the affected area. As a result, 
the third fractionated treatment time was 109 seconds instead of the 
prescribed 44 seconds resulting in a dose of 24.84 Gy (2,484 rad).
    The patient was counseled about the slight increase in late effects 
including cataract formation and scleral scar tissue formation.
    Cause or Causes--The State found and the licensee agreed that the 
misadministration occurred due to human error and the failure of staff 
to attend to details as required in licensee's procedures.
Actions Taken To Prevent Recurrence
    Licensee--The licensee has identified and made changes in their 
procedures for use of the Sr-90 ophthalmic applicator. The facility 
purchased a digital stopwatch that has a large display, counts time 
down and not up, audiblizes the time in the last 10 seconds, and alarms 
at the end of treatment. In addition, the nurse has been counseled and 
all personnel have received training in the revised procedures using 
the new stopwatch.
    State Agency--The Florida Bureau of Radiation Control performed an 
on-site investigation on February 7, 2002, to review the licensee's 
corrective actions, which were found adequate by the State. The State 
also determined that while the patient was informed verbally of the 
misadministration, the licensee did not inform the patient in writing 
as required. The licensee was cited for failure to notify the patient 
in writing within 15 days.
    This event is closed for the purposes of this report.

AS 02-6 Industrial Radiography Occupational Overexposure at Technical 
Welding Laboratory, Inc. in Houston, Texas

    Date and Place--April 10, 2002, Technical Welding Laboratories 
Inc., Houston, Texas.
    Nature and Probable Consequence--On April 10, 2002, a radiographer 
received an overexposure calculated at 0.70 Sv (70 rem) due to handling 
his radiographic equipment with the source in an unshielded condition.
    The exposure occurred while conducting radiography using an 
Amersham 660 radiography exposure device (camera) containing a 1.30 TBq 
(35 Ci) cobalt-60 (Co-60) radiography source. At the conclusion of a 
radiograph, the radiographer cranked the source to the shielded 
position without conducting a survey and then repositioned the source 
guide tube for the next radiograph. When he attempted to crank out the 
source for the next radiograph, the radiographer realized the source 
had not been retracted to its fully shielded position and was contained 
at the end of the guide tube. The radiographer notified the Radiation 
Safety Officer and returned to the office. The licensee then notified 
the State of Texas. While being interviewed for the event, the 
radiographer stated that although the camera's automatic locking 
mechanism was inoperable while performing radiography, he did not stop 
work and proceeded to complete the job. Subsequently, the licensee 
hired a consultant to check the equipment's operability and found no 
problem. The equipment was placed back in service with no repair 
necessary.
    The radiographer was sent to a doctor, underwent blood tests and 
participated in a chromosome aberration study. Although the blood tests 
results were negative, the chromosome aberration study indicated a 
radiation exposure ranging from 0.70 Sv (70 rem) to 1.52 Sv (152 rem) 
with a 95-percent confidence level. In addition, due to the 
radiographer's difficulty in performing a good reenactment, a dose 
calculation of the exposure was difficult, however a consultant 
determined that an exposure of 0.70 Sv (70 rem) did occur. Although the 
radiographer stated that he could have possibly touched the end of the 
guide tube where the source was located, no erythema or blistering of 
the hand, as expected with an incident of this type was seen. A second 
consultant conducted calculations for a possible extremity exposure 
which resulted, in a possible 2.01 Sv (201 rem) exposure to the right 
hand.
    Cause or Causes--It was determined that the cause of the 
overexposure involved the radiographer's failure to: (1) Wear his 
alarming rate meter; and (2) wear a personnel monitoring device.
Actions Taken To Prevent Recurrence
    Licensee--The licensee terminated the radiographers employment and 
reviewed the incident with other radiographers employed by the company. 
A licensee consultant evaluation of the equipment determined that the 
camera was functioning properly.
    State Agency--The licensee and radiographer were cited for not 
performing a lockout survey after a radiographic exposure, not using an 
alarming rate meter during radiographic operations; not using a 
collimator during radiographic operations and not using an individual 
monitoring device during radiographic operations. The licensee was also 
cited for allowing an individual to receive an exposure in excess of 
regulatory limits.
    The licensee has since terminated its license and the radiographer 
no longer

[[Page 19239]]

works in the industrial radiography industry.
    This event is closed for the purposes of this report.

AS 02-7 Diagnostic Misadministration at Cedars-Sinai Medical Center in 
Los Angeles, California

    Date and Place--May 29, 2002, Cedars-Sinai Medical Center in Los 
Angeles, California.
    Nature and Probable Consequences--A patient was erroneously 
administered 111 MBq (3 mCi) of iodine-131 (I-131) for a neck scan 
instead of receiving a diagnostic uptake scan of 7.4 MBq (0.2 mCi) of 
iodine-123 (I-123). This resulted in a dose of 30.8 Gy (3,087 rad) from 
the I-131 to the patient's remaining thyroid tissue, rather than 0.07 
Gy (7 rad) that would have resulted from the prescribed I-123.
    The elderly patient was from another country, had some language 
difficulties, and had no medical records. The patient had a scar on her 
neck, and answered affirmatively when the referring physician (who was 
not an endocrinologist) asked if she had a thyroidectomy. Because there 
were no medical records, and because she had symptoms indicating a 
potential thyroid dysfunction, the referring physician ordered a 
``thyroid scan,'' and in the referral noted that the patient had a 
thyroidectomy. A temporary scheduling clerk at the administering 
hospital noted the thyroidectomy information and, after conferring with 
a nuclear medicine technologist (NMT), scheduled a dosage of 111 MBq (3 
mCi) of I-131 for the patient. When the patient arrived at the 
licensee's facility, the NMT received confirmation from the patient 
that a scar on the patient's neck was the result of a thyroidectomy, 
the NMT proceeded to administer the scheduled neck scan with I-131. 
Neither the temporary scheduling clerk nor the NMT consulted with the 
authorized user or the referring physician to confirm their use of 111 
Mbq (3 mCi) of I-131 instead of 7.4 MBq (0.2 mCi) of I-123. It was 
determined later that the patient had only a partial thyroidectomy, 
with approximately 50 percent of her thyroid mass remaining. The dose 
to the patient's remaining thyroid tissue 30.87 Gy (3,087 rad) from the 
I-131, instead of 0.07 Gy (7 rad) had I-123 been administered. Because 
of a possible reduction of thyroid function, the patient's physician 
will follow her medical needs.
    Cause or Causes--The misadministration occurred due to human errors 
and inadequate procedures. The patient had language barriers that 
impeded clear communication with medical providers and licensee staff 
failed to consult the authorized user to obtain clarification from the 
referring physician. Finally, training and written instructions were 
not adequate to have prompted the temporary scheduling clerk or the NMT 
to seek appropriate assistance to resolve the dosage scheduled and 
administered.
Actions Taken To Prevent Recurrence
    Licensee--Corrective actions taken to prevent recurrence included 
modifying the Nuclear Medicine Department procedures and ensuring that 
scheduling for all I-131 administrations, no matter what the activity, 
are performed by the Thyroid Treatment Coordinator or by the Chief, 
NMT.
    State Agency--The California Department of Health Services has 
reviewed and approved the licensee's corrective actions. The State is 
considering enforcement actions.
    This event is closed for the purposes of this report.

    Dated in Rockville, Maryland, this 14th day of April, 2003.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 03-9605 Filed 4-17-03; 8:45 am]
BILLING CODE 7590-01-P