Abnormal Occurrences for First Quarter CY 1994; Dissemination of Information

NUCLEAR REGULATORY COMMISSION

Abnormal Occurrences for First Quarter CY 1994; Dissemination of

Information

Section 208 of the Energy Reorganization Act of 1974, as amended,

requires NRC to disseminate information on abnormal occurrences (i.e.,

unscheduled incidents or events that the Commission determines are

significant from the standpoint of public health and safety). During

the first quarter of CY 1994, the following incidents at NRC licensees

were determined to be abnormal occurrences (AOs) and are described

below, together with the remedial actions taken. The events are also

being included in NUREG-0090, Vol. 17, No. 1, (``Report to Congress on

Abnormal Occurrences: January-March 1994''). This report will be

available at NRC's Public Document Room, 2120 L Street NW. (Lower

Level), Washington, DC 20555 about three weeks after the publication

date of this Federal Register Notice.

Nuclear Power Plants

94-1 Inoperable Main Steam Line Isolation Valves at Perry Nuclear

Power Plant

One of the AO reporting guidelines notes that a major reduction in

the degree of protection to public health and safety from a major

degradation of essential safety-related equipment can be considered an

AO.

Date and Place--March 1992; Perry Nuclear Power Plant, a General

Electric-designed boiling water reactor (BWR), operated by Cleveland

Electric Illuminating Company and located about 11 kilometers (7 miles)

northeast of Painesville, Ohio.

Nature and Probable Consequences--The main steam isolation, leakage

control and outboard drain valves in three of four main steam lines

penetrating containment failed to meet the Technical Specifications

limiting condition of operation (LCO) for leak tightness.

For many BWRs, the LCO for leakage of each main steam isolation

valve (MSIV) is 0.326 standard cubic meters (11.5 standard cubic feet)

per hour. Because it is difficult to measure the leakage of each valve

individually, a maximum combined allowed leakage is specified for the

inboard and outboard MSIVs, and the associated control and drain

valves. This LCO is 0.71 standard cubic meters (25 standard cubic feet)

per hour. During testing at Perry in 1992, the leakages through the

MSIVs were approximately 12 times allowable. Due to a history of poor

performance and multiple main steam line valve leakage, a detailed

analysis of the 1992 MSIV leakage was performed. The analysis is

required obtaining detailed information from the licensee; a number of

calculations, reviews, and subsequent reanalyses; and multiple meetings

among the staff to determine the impact on safety.

MSIVs are designed to close and limit the release of radioactivity

to the environment in the unlikely event of an accident. When the Perry

facility was issued an operating license, there was reasonable

assurance that the MSIVs would operate as intended, and the potential

off-site doses resulting from postulated accidents, which includes

assumptions regarding fuel damage and fission product release, would be

below the guideline values for release to the general public. Because

of the excessive leakage, the NRS staff, using conservative

assumptions, calculated the potential off-site doses to the general

public that might result from a postulated loss-of-coolant accident.

Using the very conservative licensing basis calculational

methodologies, the calculated dose exceeded the guidelines for release

to the general public. A more realistic calculation using the new

approach presented in draft NUREG-1465, ``Accident Source Terms for

Light-Water Nuclear Power Plants'' (U.S. Nuclear Regulatory Commission,

NUREG-1465, ``Accident Source Terms for Light-Water Nuclear Power

Plants,'' Draft Report for Comment, June 1992) showed that the

potential off-site doses would not exceed the limits for release to the

general public; however, additional measures would be needed to

minimize exposure of control room personnel.

Cause or Causes--The licenses determined the reason for the

excessive MSIV leakage during the 1992 tests to be excessive friction

from oxide buildup, which caused end-of-stroke angular misalignment

resulting in non-360-degree seat contact (Licensee Event Report 50-440/

92-006-01, ``Local Leak Rate Test Results Exceed Allowable Primary

Containment Leakage for Main Steam Lines A, B, and D,'' August 14,

1992). The reason for the difficulty of the Perry MSIVs to meet test

leakage limits is design geometry. The MSIVs are ``Y'' pattern valves

with the valve stem at 45 degrees to the piping axis. To seat properly,

translational motion of the poppet at the moment of impact must change

from the direction of the stem to a direction parallel to the axis of

the pipe. Seating is made more difficult because of the large size of

the valves (66 centimeters [26 inches] diameter) and the weights

involved (4500 kilograms [10,000 pounds]).

Actions Taken to Prevent Recurrence

Licensee--In the early 1980s, Atwood & Morrill, suppliers of the

MSIVs, and the BWR Owners Group recognized the need for better

maintenance and for modification of the MSIVs. Modifications included

improved poppet nose guides to overcome eccentricity during seating and

poppet anti-rotation devices. During the 1992 refueling outage, these

modifications were installed by the licensee on the six (out of eight)

MSIVs which have had leakage problems (Licensee Event Report 50-440/92-

006-01, ``Local Leak Rate Test Results Exceed Allowable Primary

Containment Leakage for Main Steam Lines A, B, and D,'' August 14,

1992). Based on leakage tests performed in 1993 and 1994, the

modifications were successful in significantly reducing MSIV leakage.

NRC--NRC is closely monitoring the licensee's program and progress

in reducing the leak rate through the MSIVs.

* * * * *

Other NRC Licensees (Industrial Radiographers, Medical Institutions,

Industrial Users, etc.)

94-2 Medical Brachytherapy Misadministration at Hospital Metropolitano

in Rio Piedras, Puerto Rico

One of the AO reporting guidelines notes that a therapeutic

exposure to any part of the body not scheduled to receive radiation can

be considered an abnormal occurrence.

Date and Place--December 11, 1993; Hospital Metropolitano; Rio

Piedras, Puerto Rico.

Nature and Probable Consequences--On December 9, 1993, at 5:20

p.m., a patient began a gynecological low-dose-rate brachytherapy

treatment. The patient was prescribed a treatment of 3000 centigray

(cGy) (3000 rad) by a 48-hours exposure to approximately 2.3

gigabecquerel (61.3 millicurie [mCi]) of cesium-137 (Cs-137).

On December 11, 1993, at approximately 7:30 a.m. (about 10 hours

before the end of the prescribed treatment), the patient intervened

with the procedure by removing the implant containing three Cs-137

sources of approximately 730 megabecquerel (20.4 mCi) each, and placed

it next to her thigh. Shortly after removing the implant, the patient

showed the device to the floor nurse. The nurse recognized the implant

and understood the need for concern. She did not take the device from

the patient but reported the situation to her supervisor. The patient

apparently returned the device next to her thigh beneath the bed linen.

At the time of being informed, the nursing supervisor was

experiencing difficulty with another patient, and was involved in shift

turnover. Due to these distractions, the supervisor failed to realize

the urgent nature of the situation and did not make required

notifications.

On several occasions that morning, other licensee personnel entered

the patient's room without realizing that the radioactive source was

exposed because it was covered by bed linen; the patient did not notify

any additional staff members that she had removed the implant.

Approximately 2\1/2\ hours after the estimated time of the source

removal, the attending physician attempted to perform a routine check

of the implant and discovered that it had been removed and placed next

to the patient's thigh.

After properly accounting for and storing the sources, the

physician examined and interviewed the patient. Based on discussions

with the patient and review of the exposure received, the attending

physician terminated the treatment. This decision was based on the

physician's determination that the treatment received was clinically

adequate and his concern that the patient was a threat to herself and

others.

The actual dose delivered to the intended treatment site was

calculated to be 2270 cGy (2270 rad). The written directive was revised

to reflect the lower dose delivered. The licensee's evaluation of the

incident indicated that assuming the implant remained in the same

location for three hours, the maximum dose to the skin of the patient's

thigh (the wrong treatment site) was 572 cGy (572 rad). The licensee

reported that no adverse effects to the patient are expected.

The patient was notified verbally at the time the misadministration

was discovered and then notified in writing on January 13, 1994.

Cause or Causes

The initial cause of the misadministration was the patient's

removal of the implant which was compounded by the failure of the two

nurses to follow emergency procedures. The nurses' failure to respond

to the emergency resulted in approximately 2\1/2\ hours of unnecessary

exposure.

Actions Taken to Prevent Recurrence

Licensee--The licensee determined that the nursing supervisor's

failure to make the required notifications was due to the lack of

familiarity with established radiation safety procedures to which he/

she had been trained. The licensee's investigation of the event

revealed that the lack of familiarity with radiation safety procedures

was caused by the infrequent handling of patients undergoing therapy

with licensed materials (Letter from Hospital Metropolitano, to Hector

Bermudez, Senior Inspector, NMI Section, NRC Region II, Forwarding a

Misadministration Report dated December 29, 1993, and an Addendum to

the Misadministration Report dated January 11, 1994, Docket No. 030-

11155, Licensee No. 52-16033-01). The licensee held a Radiation Safety

Committee meeting in which the incident and corrective actions to

prevent recurrence were discussed.

The licensee decided to dedicate one floor of the hospital for all

therapies involving NRC-licensed materials. This will provide

additional controls to allow the licensee to better ensure that nurses

assigned to the floor are kept current and familiar with operating and

emergency procedures. The licensee is also evaluating the need to

increase patient awareness regarding non-intervention of procedures.

The licensee is revising its procedures for responding to

radiological emergencies involving patients undergoing

radiopharmaceutical or sealed source therapy. As a minimum, the

procedures will define what is a radiological emergency and will

provide examples of situations which must be considered radiological

emergencies or which could result in misadministrations. The licensee

also committed to developing and implementing a retraining program

based on the revised emergency procedures for all hospital employees

who may be involved in handling patients receiving radiation therapy.

NRC--A special inspection was conducted on December 15 and 17,

1993, to review the circumstances surrounding the misadministration and

the licensee's Quality Management program. A Confirmatory Action Letter

(CAL) was issued to the licensee on December 30, 1993 (Letter from J.

Philip Stohr, Director, Division of Radiation Safety and Safeguards,

NRC Region II, to Hospital Metropolitano, Attn: Mr. Victor Marrero,

Administrator, forwarding a Confirmatory Action Letter, CAL No. 2-93-

14, Docket No. 030-11155, License No. 52-16033-01, dated December 30,

1993). The CAL confirmed that the licensee would revise its emergency

procedures and implement a training program, based on new procedures,

for all licensee employees who may handle patients undergoing radiation

therapy. An NRC medical consultant has been retained to perform a

clinical assessment of this misadministration. The medical consultant's

report is expected to be available in time to discuss his findings in

the second quarter AO Report. As of the issuance of this report, NRC is

pursuing escalated enforcement action against the licensee.

* * * * *

94-3 Teletherapy Misadministration at Triangle Radiation Oncology

Associates in Pittsburgh, Pennsylvania

One of the AO reporting guidelines notes that a therapeutic

misadministration that affects two or more patients at the same

facility, regardless of any health effects, can be considered an

abnormal occurrence.

Date and Place--December 20, 1993; Triangle Radiation Oncology

Associates; Pittsburgh, Pennsylvania.

Nature and Probable Consequences--On December 20, 1993, Triangle

Radiation Oncology Associates in Beaver, Pennsylvania, notified NRC of

two potential teletherapy misadministrations that occurred between

December 13 and 17, 1993, at the licensee's Pittsburgh, Pennsylvania,

facility. The potential misadministrations were identified during a

review of patient records on December 17, 1993, when the licensee

observed calculation errors involving the depth of the dose given to

each of the two patients.

Both cases involved breast treatments where the original treatment

plan prescribed 28 treatments of 180 centigray (cGy) (180 rad) from a

cobalt-60 teletherapy source (using 2 parallel opposed fields) for a

total absorbed dose of 5040 cGy (5040 rad). The primary breast

treatments were concluded on December 10, 1993. The physician wrote

separate written directives for each patient to receive an additional

1000 cGy (1000 rad) to the scar in 5 treatments of 200 cGy (200 rad)

per day. One of the written directives indicated that the absorbed dose

was to be delivered at dmax, the maximum extension of the

teletherapy unit, which, as stated by the physicist, is typically a

depth of 0.5 centimeter (cm) (0.2 inch). The other written directive

did not indicate a depth; however, the physician stated that the

intended depth was dmax.

As described above, such a treatment plan would typically have been

calculated by the teletherapy technologist at the Pittsburgh facility

and communicated by telephone to the teletherapy physicist at the

Beaver facility to be checked. However, this procedure changed when the

computer at the Pittsburgh facility was taken out of service on

December 1, 1993.

On December 9, 1993, the teletherapy technologist hand wrote a

paraphrased request of the written directive for the two breast-

treatment patients needing scar booster dose calculations. Rather than

writing dmax, the technologist stated the tumor dose at a depth of

5 cm (2 inch) and sent the request, via facsimile transmission, to the

teletherapy physicist at the Beaver facility. Hand calculations were

performed for 200 cGy (200 rad) treatments at a 5 cm (2 inch) depth,

checked by a certified physicist, and sent back to the technologist,

via facsimile transmission, on December 9, 1993.

The patients were treated from December 13 to 17, 1993, and

received doses of 1300 and 1320 cGy (1300 and 1320 rad) respectively,

rather than the 1000 cGy (1000 rad) intended. This resulted in

misadministrations of 30 and 32 percent greater than the intended dose.

The licensee's physician stated that no adverse clinical effects are

expected as a result of the overexposures.

After the initial report, the licensee told NRC in subsequent

telephone conversations that a recalculation of the dose averaged over

the entire tumor volume did not exceed 30 percent and, therefore, the

licensee no longer thought the definition of a misadministration

applied in this case.

NRC performed a special inspection on December 28 and 29, 1993, to

review the potential misadministrations. Information gathered during

this inspection, including the calculations of the administered doses,

was given to an NRC scientific consultant to evaluate. The scientific

consultant, in his report to NRC, stated that ``the dose prescription

was to dmax (i.e., 0.5 cm [0.2 inch] depth on the central axis)

and a misadministration can only be judged by considering the dose

given to this point. * * * clearly in both cases a misadministration

has taken place.'' On March 25, 1994, the licensee was informed that

the doses to both patients were deemed to be misadministrations. The

licensee submitted its report of misadministrations in a letter dated

April 7, 1994.

After receiving the scientific consultant's report, an NRC medical

consultant was retained to perform a clinical evaluation of the

patients. The medical consultant is still reviewing the potential

health effects to the patients. The consultant's report is expected to

be completed in time to update this writeup in the next AO report to

Congress.

The referring physician was notified and determined that, based on

medical judgment, informing the patients of the misadministrations

would be harmful.

Cause or Causes--The technologist incorrectly transposed the

treatment depth on the facsimile used to prepare the treatment plan.

The technologist failed to make reference to dmax and entered the

depth value incorrectly as 5.0 cm (2 inch) instead of the intended 0.5

cm (0.2 inch).

Actions Taken to Prevent Recurrence

Licensee--The licensee implemented a requirement for a stamp to be

placed on all written directives that prompts a clear documentation of

key treatment parameters such as site, method, daily dose, fractions,

total doses, depth of calculation, spinal blocks, other blocks, and

date. Previously, key parameters had been informally handwritten

directives on patients's treatment charts. The licensee also formalized

its requirement to include the written directive for all dosimetry

calculation requests from the Beaver facility, and revised its ``weekly

chart check'' procedure to increase chart reviews from once a week to

twice a week, as was the practice prior to December 1, 1993.

NRC--NRC is reviewing the licensee's April 7, 1994,

misadministration report and the findings of the December 28 to 29,

1993, NRC inspection. Once the NRC medical consultant's report is

received, enforcement action will be considered.

* * * * *

94-4 Lost Reference Sources at Brooks Air Force Base in San Antonio,

Texas

One of the AO reporting guidelines notes that any serious

deficiency in management or procedural controls in a major area can be

considered an abnormal occurrence.

Date and Place--1993; Armstrong Laboratory, Brooks Air Force Base

(AFB); San Antonio, Texas.

Nature and Probable Consequences--As prescribed by the licensees's

Compliance Accountability and Control Procedures, in 1993, the licensee

performed an audit of all licensed sources at Armstrong Laboratory.

During this audit, the licensee identified four missing strontium-90

(Sr-90) reference sources of approximately 14.8 megabecquerel (400

microcurie) each. The licensee conducted an extensive physical search

for the sources and reviewed all radioactive material permits issued to

other organizations at Brooks AFB. When the disposition of the Sr-90

sealed sources could not be determined, the licensee reported the loss

of the four sealed sources to NRC by telephone on September 22, 1993.

The licensee informed NRC that the United States Air Force (USAF)

Inspector General would review this incident. The licensee suspected

that the sources had been inadvertently discarded and transported to a

sanitary landfill.

The licensee evaluated possible radiation exposure to members of

the general public and concluded that unless the sources were removed

from the container, the radiation levels from the sources would be near

background level. Furthermore, unless a deliberate effort was made to

open the source capsules, an individual handling the sources would

receive less exposure than allowed by regulatory limits for the general

public.

Cause or Causes--During 1991, the timeframe during which the

sources were apparently lost, a number of individuals were responsible

for the radiation safety program at Brooks AFB. These individuals were

temporary or part-time Radiation Safety Officers (RSOs), and had

extensive, temporary duties at other sites.

The results of the USAF Inspector General's investigation

determined that ``programmatic issues started to plague radiation

safety at Brooks AFB after the dismantling of the base/clinic program

and the inception of additional duty RSOs.'' The report explained that

in 1986, the radiation safety function and responsibility was

transferred to the base clinic at Brooks AFB. Almost simultaneously, a

Joint Military Medical Command (JMMC) was established and the base

clinic became a part of JMMC. JMMC was a medical command established to

service all branches of the Armed Forces in the San Antonio, Texas,

area. With this action, the radiation safety program was managed by an

organization that was not responsible to any management level at Brooks

AFB. Furthermore, the report stated that JMMC dismantled the clinic's

radiation safety program, and ``requested that all organizations

previously under the clinic's program establish and run their own

radiation safety program.'' Exacerbating the problem was the

appointment of the additional duty RSOs, who had ``limited to general

knowledge of radiation safety,'' and no directives or other guidance to

assist them. Additionally, ``the additional duty RSOs received little

management oversight after they had been appointed to the RSO

position.''

The investigation concluded that from 1986 through 1991, there had

been a lack of commitment to management oversight, and a serious

disregard for radiation safety issues.

Actions Taken to Prevent Recurrence

Licensee--In 1991, Armstrong Laboratory was placed under a new Air

Force Command. The Command committed to increased management oversight

of the radiation safety programs. Additionally, physical inventory

procedures were revised.

NRC--NRC conducted an inspection (Letter from Dwight D.

Chamberlain, Acting Director, Division of Radiation Safety and

Safeguards, NRC Region IV, to Lt. Colonel Joseph J. Donnelly, chief of

USAF Radioisotope Committee Secretariat, forwarding Inspection Report

No. 030-28641/93-10, Docket No. 030-28641, License No. 42-23539-01AF,

dated January 19, 1994) at Brooks AFB on December 21, 1993, to review

the circumstances associated with the loss of licensed material, after

receiving a written report from the licensee on December 10, 1993. NRC

also held an Enforcement Conference with the licensee on February 3,

1994, to review the findings of the inspection and to determine

enforcement action.

On February 11, 1994, NRC issued a Notice of Violation (Letter from

L.J. Callan, Regional Administrator, NRC Region IV, to Department of

the Air Force, USAF Radioisotope Committee, forwarding Notice of

Violation, Docket No. 030-28641, License No. 42-23539-01AF, dated

February 11, 1994) for violations involving (1) a failure to secure

licensed material and (2) failure to include in one USAF permit a

requirement to conduct a periodic physical inventory of all licensed

materials.

These violations were categorized as a Severity Level III and a

Severity Level IV, respectively (Severity Level I through V range from

the most significant to the least significant, respectively). No civil

penalty was assessed because of the Air Force's discovery of this

violation and the promptness and comprehensiveness of the corrective

actions. The licensee has responded in writing to the Notice of

Violation and no additional actions are required.

* * * * *

94-5 Medical Brachytherapy Misadministration at the University of

Cincinnati in Cincinnati, Ohio

One of the AO reporting guidelines notes that a therapeutic

exposure to a part of the body not scheduled to receive radiation can

be considered an abnormal occurrence.

Date and Place--January 7, 1994; University of Cincinnati;

Cincinnati, Ohio.

Nature and Probable Consequences--On January 14, 1994, NRC was

notified by telephone of a misadministration involving a leaking

iodine-125 (I-125) brachytherapy implant seed. On January 7, 1994, 16

I-125 seeds, each ranging from 370 to 1110 megabecquerel (MBq) (10 to

30 millicurie [mCi]) activity, were implanted in the brain of a 30-

year-old male patient. Following the explant procedure on January 14,

1994, the licensee identified radioactive contamination in the surgical

room and bathroom used by the patient. Personnel from the licensee's

radiation safety office identified the contamination to be I-125 and

confirmed that at least one seed was leaking. Further analysis by the

licensee determined that one seed was damaged during the implant

procedure by a surgical staple. The seed originally contained 758 MBq

(20.5 mCi) of I-125 and, based on an assay of the explanted source, the

licensee estimated that the loss was approximately 74 MBq (2.0 mCi).

Thyroid monitoring of the patient's visitors and hospital employees

involved in the care of the patient was performed by the licensee. One

of the licensee's employees was determined to have received a committed

dose equivalent to the thyroid of 50 microsievert (Sv) (5

millirem [mrem]). In addition, a visitor was determined to have

received a committed dose equivalent to the thyroid of 540 Sv

(54 mrem), or a total effective dose equivalent of 160 Sv (1.6

mrem), which is less than the annual limit for members of the general

public of 1000 Sv (100 mrem).

Through patient monitoring, the licensee estimates that

approximately 5 percent of the free I-125 was taken up in the patient's

thyroid. (In a normally functioning, unblocked thyroid, approximately

25 percent of the free iodine would be taken up in an individual's

thyroid.) The licensee estimates that the uptake would result in a

radiation dose to the thyroid of approximately 300 centigray (300 rad).

The licensee does not expect any adverse medical effects to the patient

as a result of the misadministration. An NRC medical consultant

concluded that the non-radioactive iodinated contrast agent used during

an imaging procedure performed on the patient prior to the implant

blocked the absorption of the I-125. He also concluded that exposure to

the radiation levels described has resulted in an increased probability

of developing thyroid tumor(s) in the future.

The licensee notified the referring physician, the patient, and the

patient's family of the misadministration.

Cause or Causes--The seed leaked after being inadvertently crushed

by a surgical staple used to secure the catheters during the implant

procedure.

Actions Taken to Prevent Recurrence

Licensee--For future procedures, the licensee plans to ensure that

the implanted seeds are located further down the catheter in order to

reduce the likelihood of seed damage from surgical staples. The

licensee also plans to examine each I-125 seed for leakage following

each explant procedure.

NRC--NRC dispatched two inspectors on January 16, 1994, to monitor

the licensee's decontamination efforts and to obtain more details on

the misadministration. NRC also obtained the services of a medical

consultant to review the medical implications of the incident. A

followup NRC inspection (Letter from W.L. Axelson, Director, Division

of Radiation Safety and Safeguards, to Donald Harrison, M.D., Senior

Vice President and Provost for Health Affairs, University of

Cincinnati, forwarded Inspection Report No. 030-02764/94001, Docket No.

030-02764, License No. 34-06903-05, dated March 10, 1994) was conducted

from February 7 to 11, 1994. On March 16, 1994, NRC held a telephone

Enforcement Conference with the licensee to discuss the safety

inspections conducted in January and February 1994, at the University

of Cincinnati.

A Notice of Violation was issued by NRC on March 25, 1994, which

imposed a fine of $5000 for a violation not associated with this

misadministration. In the Notice of Violation, NRC determined that the

inadvertent opening of the I-125 sealed source did not constitute a

violation of the University of Cincinnati's license.

* * * * *

94-6 Medical Brachytherapy Misadministration at Keesler Medical Center

at Keesler Air Force Base in Biloxi, Mississippi

One of the AO reporting guidelines notes that a therapeutic

exposure to a part of the body scheduled to receive radiation such that

the actual dose received is greater than 1.5 5imes the prescribed dose

can be considered an abnormal occurrence.

Date and Place--January 13, 1994; Keesler Medical Center, Keesler

Air Force Base; Biloxi, Mississippi.

Nature and Probable Consequences--A patient was prescribed a lung

brachytherapy treatment delivered by an Omnitron 2000 high-dose-rate

(HDR) remote afterloader system. The prescribed tumor treatment plan

included 1000 centigray (cGy) (1000 rad) absorbed doses at 5 treatment

positions using a 144.3 gigabecquerel (3.9 curie) iridium-192 source

within a special needle. At the end of fifth and last treatment, the

source wire retracted 0.5 centimeter (cm) (0.2 inch) and stopped.

Alarms immediately alerted Keesler staff that the source remained

inside the patient's body. Licensee personnel followed emergency

procedures, entered the therapy room and removed the needle from the

patient. Once outside the patient's body, the radioactive source

retracted to the stored position.

The licensee determined that the source remained stuck at 0.5 cm

(0.2 inches) above the fifth position for approximately 2\1/2\ minutes.

The treatment plan called for the delivery of 1000 centigray (cGy)

(1000 rad) at 1cm from each of the 5 treatment positions. As a result

of the additional 2\1/2\ minutes exposure, the last treatment position

received 1732 cGy (1732 rad) absorbed dose, or 73.2 percent over the

prescribed dose. The treatment plan also predicted an 800 cGy (800 rad)

absorbed dose at 0.5cm (0.2 inch) from each of the 5 treatment

positions. The point 0.5 cm (0.2 inch) above the last treatment

position, where the movement of the source stopped, received

approximately 1400 cGy (1400 rad), or 75 percent greater than the

absorbed dose stipulated in the prescribed treatment plan. The failure

of the source to retract resulted in a single overexposure, causing an

overall absorbed dose of 75 percent greater than that prescribed, for

all the tissue surrounding the position 0.5cm (0.2 inch) above the last

treatment site.

The licensee reported that no adverse health effects to the patient

are expected. The patient was immediately notified of the

misadministration.

Cause or Causes

The patient had made a sudden move near the end of the treatment

causing the special needle to bend at the point where it extended

beyond the biopsy needle. The bend prevented the radioactive source

from retracting to the stored position, causing the misadministration.

Actions Taken to Prevent Recurrence

Licensee--The licensee immediately stopped the use of the HDR

device pending a complete check of the system by the manufacturer

(Letter from Omnitron International, Inc. to NRC Document control Desk,

forwarding a Report of HDR misadministration, Part 21- Reporting of

Defects and Noncompliance, Omnitron Report No. 102, dated January 19,

1994, Docket No. 030-26841, License No. 42-23539-01AF; and Letter from

Omnitron International, Inc. to John W. Lubinski, Mechanical Engineer,

Nuclear Material Safety and Safeguards, NRC Washington, D.C.,

forwarding a report of Inspection of Source Wire, dated April 6, 1994,

Docket No. 030-26841, License No. 42-23539-01AF). The licensee also

evaluated the practice of extending special needles beyond biopsy

needles and the probability of patient movement causing damage, and

decided to discontinue this practice (Letter from Department of the

Army, HQ AFMOA/SGPR, Brooks AFB, TX to NRC Region IV, forwarding the

15-Day Report of Misadministration at Keesler AFB, MS, dated February

1, 1994, Docket 030-26841, License No. 42-23539-01AF; and Letter from

Department of the Army, HQ AFMOA/SGPR, Brooks AFB, TX to NRC Region IV,

responding to a NRC Confirmatory Action Letter (dated January 18,

1994), dated March 8, 1994, Docket 030-26841, License No. 42-23539-

01AF).

NRC--A special inspection was conducted from January 19 to 21,

1994, to review the circumstances surrounding the misadministration and

the licensee's Quality Management program. A representative of the U.S.

Food and Drug Administration (FDA) also participated in this

inspection. No violations of regulatory requirements were identified

during the inspection, but NRC initiated the following actions: (1) A

Confirmatory Action Letter (Letter from James L. Milhoan, Regional

Administrator, Region IV, to Department of the Army, USAF Radioisotope

Committee, HQ AFMOA/SGPR, Brooks AFB, TX, forwarding a Confirmatory

Action Letter, CAL No. 4-94-01, Docket No. 030-28641, License No. 42-

23539-01AF, dated January 18, 1994) was issued to the licensee on

January 18, 1994, which prohibited the use of the HDR unit until

serviced by the manufacturer; (2) a medical consultant was contracted

to evaluate the clinical effects and to assess the events that led to

this misadministration; (3) the manufacturer was asked to analyze the

source wire involved in the misadministration for damage as a result of

the stresses experienced during this event; (4) Southwest Research

Institute was contracted to analyze the special needle for mechanical

failure; (5) a generic communication is being developed to notify other

HDR users of the results of the inspection and related research; and

(6) NRC is coordinating with FDA an evaluation of the generic

implications surrounding this event.

* * * * *

94-7 Medical Brachytherapy Misadministration at Alexandria Hospital in

Alexandria, Virginia

One of the AO reporting guidelines notes that a therapeutic

exposure to a part of the body not scheduled to receive radiation can

be considered an abnormal occurrence.

Date and Place--January 27, 1994; Alexandria Hospital; Alexandria,

Virginia.

Nature and Probable Consequences--On January 27, 1994, a patient

was scheduled to receive a 500 centigray (cGy) (500 rad) brachytherapy

treatment to the trachea using a Nucletron high-dose-rate (HDR) remote

afterloader system. A single catheter was used for this endobronchial

treatment and the licensee performed a routine simulated treatment.

During this simulation, the oncologist established a 3 centimeter (cm)

(1.2 inch) tumor treatment site and added a 1 cm (0.4 inch) margin on

both ends of the tumor site.

Normally, at this time the medial physicist and the dosimetrist

plot distances, measured in centimeters along the length of the

catheter shown in the simulation film, in order to program the HDR for

precise treatment at the prescribed treatment site. This step was not

performed and the procedure was initiated without the HDR being

properly programmed. The unprogrammed source was allowed to travel

beyond the treatment site into the left lung area where the catheter

ended. The treatment resulted in the prescribed 500 cGy (500 rad)

effective dose equivalent being delivered to the left lung instead of

the trachea target site. Prior to administering the dose, the treatment

plan and treatment console printout were reviewed by the dosimetrist,

the medical physicist, and the oncologist. All three individuals failed

to identify the failure to plot the treatment site. Immediately

following the treatment, the licensee's medical physicist realized that

the plotting and programming of the treatment site were not performed.

After discovery of the treatment error, the oncologist determined that

the patient should be treated again using the correct treatment

parameters.

The licensee has advised NRC that no adverse effects to the patient

are anticipated as a result of this misadministration. The licensee has

informed the patient of the misadministration.

Cause or Causes--The licensee's radiation therapy staff failed to

follow the licensee's normal protocol for treatment with the HDR remote

afterloader. The failure to administer the treatment as prescribed

resulted from performing the treatment planning and independent

verification in the vicinity of the HDR console, where there were a

number of distractions.

Actions Taken to Prevent Recurrence

Licensee--The licensee's corrective actions included immediate

retraining of all personnel involved in brachytherapy treatments and

the addition of a checklist for each step in the treatment process. The

licensee also added steps to its Quality Management program for HDR

brachytherapy. These steps now require the use of the treatment

planning computer with manual verification of the input parameter and

the use of the treatment parameter card generated by the planning

computer to program the HDR rather than programming the HDR treatment

parameters manually.

NRC--NRC conducted a special inspection from February 2 to 4, 1994,

to review the circumstances associated with the misadministration, the

licensee's Quality Management program, and the licensee's immediate

corrective actions. In addition, on February 25, 1994, NRC employed a

medical consultant to provide an assessment of the potential clinical

effects of this misadministration and the events that led to it.

The inspection report, medical consultant's assessment, and

enforcement actions for the misadministration are being completed.

Dated at Rockville, MD this 15th day of August, 1994.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Acting Secretary of the Commission.

[FR Doc. 94-20423 Filed 8-18-94; 8:45 am]

BILLING CODE 7590-01-M