[Federal Register Volume 59, Number 210 (Tuesday, November 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27005]
[[Page Unknown]]
[Federal Register: November 1, 1994]
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NUCLEAR REGULATORY COMMISSION
Abnormal Occurrences for Second 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 (AOs)
(i.e., unscheduled incidents or events that the Commission determines
are significant from the standpoint of public health and safety).
During the second quarter of CY 1994, the following incidents at NRC
licensees were determined to be AOs and are described below, together
with the remedial actions taken. The events are also being included in
NUREG-0090, Vol. 17, No. 2, (``Report to Congress on Abnormal
Occurrences: April-June 1994''). This report will be available at NRC's
Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC
20037 about three weeks after the publication date of this Federal
Register Notice.
Other NRC Licensees
(Industrial Radiographers, Medical Instructions, Industrial
Users, etc.)
94-8 Multiple Medical Brachytherapy Misadministrations at Deaconess
Medical Center in Billings, Montana
One of the AO reporting guidelines notes that a therapeutic
exposure which affects two or more patients at the same facility
(regardless of any health effects) can be considered an AO.
This report documents two misadministrations involving
brachytherapy procedures performed at the licensee's facility in
September and November 1993, which are related to nine other events
identified at another NRC-licensed medical facility, because the events
are the result of a common root cause.
Date and Place--September and November 1993; Deaconess Medical
Center; Billings, Montana.
Nature and Probable Consequences--On March 22, 1994,
representatives from Northern Rockies Cancer Center (NRCC), Deaconess
Medical Center (DMC), and St. Vincent Hospital and Health Center
(SVHHC) notified the NRC Region IV office of a misadministration
involving a brachytherapy treatment performed at DMC on September 24,
1993 (Preliminary Notification of Event or Unusual Occurrence PNO-IV-
94-010; March 23, 1994; Docket No. 030-02389). The event was not
discovered until March 20, 1994, during the course of a thorough review
of a select group of treatments performed at DMC and SVHHC under
treatment plans developed at NRCC. The three licensees participated in
the telephonic notification because NRCC provides brachytherapy
planning services to both DMC and SVHHC, and the potential cause of the
misadministrations involved errors in treatment plans developed at
NRCC. (NRCC is jointly owned by DMC and SVHHC.) The licensees reported
that based upon initial information developed by the physics staff at
NRCC, it appeared likely that additional brachytherapy treatment errors
had occurred at both DMC and SVHHC.
The following day, March 23, 1994, the licensees reported an
additional brachytherapy misadministration at DMC, and nine other
incidents due to the same error that resulted in administered doses
greater than prescribed (one at DMC and eight at SVHHC) (Preliminary
Notification of Event or Unusual Occurrence PNO-IV-94-010A; March 24,
1994; Docket No. 030-02389). The misadministrations reported by DMC
involved administration of radiation such that the doses received by
the patients exceeded the prescribed doses by 21 and 24 percent. In
each case, the patient had received radiation by external beam as well
as ``boost'' doses administered via brachytherapy. The overdoses noted
above pertain only to the brachytherapy component of each treatment.
During the initial telephonic report, NRCC staff explained that
during a recent routine treatment setup a new staff member identified
errors in a dose table generated by a Theratronics Theraplan L
treatment planning system. Following considerable review of treatment
plans and data generated using the treatment planning system, the
physics staff at NRCC, with assistance from Theratronics, concluded
that the data in a software file used to compute dose tables for
cesium-137 (Cs-137) sources were deleted and were later replaced with
data which did not properly characterize the Cs-137 sources used by DMC
and SVHHC. The computer-generated dose tables that were computed using
erroneous data were in error by as much as 20 to 25 percent. The errors
were not detected because an incorrect reference dose table was used to
verify and adjust the output of the treatment planning algorithm and
individual patient treatment plans.
An NRC inspection was conducted at the facility on March 28 through
April 1 and April 5 through 29, 1994. In addition, the events were
reviewed by regional and headquarters NRC staff accompanied by
personnel from the Idaho National Engineering Laboratory on April 6
through 8, 1994, to examine generic aspects of the root causes and
contributing factors.
The physics staff at NRCC promptly corrected the data in the
Theraplan L software and recalculated the doses received by the
patients. Based upon a review of the recalculated doses conducted by
the authorized users and an independent medical consultant contracted
by NRCC, the authorized users have determined that no long-term adverse
health effects beyond those normally expected for this form of
treatment are anticipated for the patients. The licensee has been
informed that an NRC medical consultant will review each case in order
to provide an independent assessment of the potential consequences of
the overdoses.
The patients involved in the misadministrations were notified both
orally and in writing.
Cause or Causes--The inspection disclosed that the root cause of
the misadministrations was a failure to conduct independent (manual)
verification checks of treatment plans that were adequate to determine
the accuracy of computer-generated dose tables (Letter from Leonard J.
Callan, Regional Administrator, NRC Region IV, to Lane Basso, Chief
Executive Officer, Deaconess Medical Center, Docket No. 030-02389,
License No. 25-01051-01, dated May 26, 1994; and Letter from Samuel J.
Collins, Director, Division of Radiation Safety and Safeguards, to Mr.
Lane Basso, Chief Executive Officer, Deaconess Medical Center,
forwarding NRC Inspection Report 030-02389/94-01, Docket No. 030-02389,
License No. 25-01051-01, dated June 10, 1994). Several factors
involving clarity of instructions provided in the Theraplan user's
manual, and in prompts and data presented to treatment planning system
users in printed format and at the system console, were identified as
contributing factors to the inadvertent entry of and failure to detect
the erroneous data entered in program software for linear Cs-137
sources.
The inspection also disclosed significant weaknesses in DMC's
implementation of its quality management program (QMP) for
brachytherapy procedures. In addition, several apparent violations of
NRC requirements relating to DMC's QMP and its implementation were
identified. One apparent violation involved a failure to establish a
QMP in January 1992, as required, although the inspection confirmed the
DMC later established a QMP in May 1992. However, the QMP established
by DMC failed to meet the following requirements: (1) that written
directives are signed by authorized users and completed in accordance
with NRC regulations; (2) that final plans of treatment are in
accordance with the respective written directive; and (3) that each
administration of radiation is in accordance with the applicable
written directive. Other apparent violations included failures to (1)
conduct an annual review of the QMP during the calendar years 1992 and
1993, (2) train all individuals working under the supervision of DMC's
authorized users in the provisions of its QMP, (3) train nursing
personnel who cared for patients undergoing brachytherapy treatment in
accordance with the conditions of DMC's license, and (4) record all
required information in survey records related to brachytherapy and in
brachytherapy source usage records.
Actions Taken To Prevent Recurrence
Licensee--DMC voluntarily suspended its brachytherapy program until
certain corrective measures could be implemented. However, because the
findings of the inspection indicated significant, programmatic
weaknesses in DMC's QMP and its implementation, the NRC sought to
confirm with DMC staff the specific actions planned for completion
prior to resuming brachytherapy treatments. The licensee's proposed
corrective actions were documented in a Confirmatory Action Letter
(CAL) issued by the NRC on May 3, 1994 (Letter from Leonard, J. Callan,
Regional Administrator, NRC Region IV, to Lane Basso, Chief Executive
Officer, Deaconess Medical Center forwarding Confirmatory Action
Letter, Docket No. 030-02389, License No. 25-01051-01, dated May 3,
1994). As of the date of this report, the licensee has not yet
completed each of the actions described in the CAL and has continued
suspension of its brachytherapy program.
NRC--An enforcement conference was held with the licensee on June
28, 1994, to discuss the apparent violations described above and to
review the corrective actions taken by the licensee. NRC is continuing
its deliberations regarding any proposed enforcement action.
An NRC Information Notice has been drafted to inform other
licensees of the particulars of this case and of the importance of
conducting adequate checks of computer-generated treatment plans. NRC
has also discussed concerns related to the Theraplan treatment planning
system software, and related instructions provided by the manufacturer,
with representatives from the U.S. Food and Drug Administration (FDA).
FDA has recently cleared the software for the treatment planning system
to allow modifications of existing software to be imported into the
United States.
A medical consultant will review each misadministration and provide
NRC with an independent assessment of the overdoses and the potential
adverse health effects to patients.
* * * * * * *
94-9 Medical Brachytherapy Misadministration at Memorial Hospital in
South Bend, Indiana
One of the AO reporting guidelines notes that a therapeutic dose
that results in any part of the body receiving unscheduled radiation
can be considered an AO.
Date and Place--April 13, 1992; Memorial Hospital; South Bend,
Indiana.
Nature and Probable Consequences--On April 13, 1992, the first of
two brachytherapy treatments was begun. Each of the treatments was to
deliver 15 gray (GY) (1500 rad) to the patient's cervix. For the first
treatment, five cesium-137 (Cs-137) sources were to be loaded into a
treatment device, known as a Fletcher-suit applicator, which was placed
in the patient's vagina. The sources were placed into afterloaders by a
dosimetrist in preparation for placement in the applicator. The
afterloaders were then placed in the applicator by the treating
physician.
About eight hours later, the patient's care provider discovered a
Cs-137 source on the floor near the foot of the patient's bed. The
source was found after the care provider had changed the patient's bed
linen. The care provider recovered the source with long handled forceps
and placed it in a shielded container.
The treating physician and the licensee's Radiation Safety Officer
(RSO) were notified. They determined that one afterloader in the
applicator was empty and that the Cs-137 source had not been placed in
the applicator. The source was then placed in the afterloader and
loaded into the applicator to continue the patient's treatment.
The first treatment was then completed, giving the patient a dose
to the treatment site of 13.83 Gy (1383 rad), which was 8 percent less
than the intended dose. The second treatment was then performed on
April 27 and 28, 1992, without incident.
The licensee investigated the incident and concluded that the
source had fallen on the floor while it was being placed in the
afterloading device by the dosimetrist. The incident was not reported
to NRC because the radiation dose to the treatment site differed by
only 8 percent from the intended dose. This variance would not require
reporting as a misadministration.
During an NRC inspection on May 4 and 5, 1994, the inspector
reviewed the circumstances surrounding the treatment incident. The
inspector evaluated the routine radiation surveys of the patient's room
that were done after the radiation sources were placed in the
applicator. The surveys showed that it was unlikely that there was an
unshielded Cs-137 source on the floor of the room.
Further inquiry by the inspector led to the determination that the
source likely fell from the afterloader while it was being placed in
the applicator. The physician reported having difficulty in placing the
afterloader in the applicator, and, according to the treatment chart,
the patient had reported that she felt a small metal object fall next
to her skin during the source placement.
As a result, the source may have been next to the skin of the
patient's thigh for about 7.5 hours resulting in a radiation dose of up
to 10.34 Gy (1034 rad), according to the licensee's calculation.
An NRC medical consultant was retained to evaluate the case and
concluded that the radiation dose to the patient's thigh could result
in some later damage to the tissue of the patient's thigh.
Because this incident resulted in a radiation dose to the wrong
treatment site, this constitutes a misadministration.
The licensee notified the patient and the patient's physician of
the misadministration on May 6, 1994. However, the licensee did not
provide a written report to the patient until June 27, 1994, after NRC
inquired about patient notification.
Cause or Causes--The incident apparently was the result of the
source falling out of the afterloader as it was being placed in the
applicator. The physician reported some difficulty in placing the
sources and apparently did not observe the source when it fell.
Actions Taken To Prevent Recurrence
Licensee--The licensee has revised its procedures for placing the
radiation sources, including use of a pillow under a patient's pelvis
in difficult situations. Its investigation of any future incidents will
also include an evaluation of radiation doses to unintended treatment
sites.
NRC--The NRC inspection during May 4 and 5, 1994, identified two
violations of NRC requirements. They were (1) failure of the licensee's
Radiation Safety Committee and RSO to adequately investigate a possible
misadministration to include consideration of possible radiation doses
to the wrong treatment sites; and (2) failure to provide a written
report to the patient within 15 days of the discovery of a
misadministration. A Notice of Violation (Letter from Roy J. Caniano,
Chief, Nuclear Materials Safety Branch, NRC Region III, to George
Soper, Senior Vice President, Memorial Hospital, forwarding Notice of
Violation and Inspection Report 030-17335/94001, Docket Nos. 030-17335
and 030-191173, License Nos. 13-18881-01 and 13-18881-02, dated July
15, 1994) was issued to the licensee on July 15, 1994, There was no
Civil Penalty involved.
* * * * * * *
94-10 Teletherapy Misadministration at Jewish Hospital, Washington
University Medical Center, in St. Louis, Missouri
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 as an AO.
Date and Place--April 22, 1994; Jewish Hospital, Washington
University Medical Center; St. Louis, Missouri.
Nature and Probable Consequences--A patient was being treated for
cancer of the brain. The written prescription directed that a 3000
centigray (cGy) (3000 rad) total absorbed dose be delivered in a series
of 10 treatments of 300 cGy (300 rad) each. Each treatment was to
consist of 150 cGy (150 rad) from the left side, and 150 cGy (150 rad)
from the right side. The eyes were to be shielded during the
treatments. The patient's first treatment on April 21, 1994, was
delivered without incident in accordance with the prescription.
On April 22, 1994, the licensee informed NRC that after
administering the first treatment to the patient, the physicians
decided to include the patient's right eye orbit into the whole brain
treatment field for subsequent treatment fractions. The radiation
therapist was verbally instructed of the change, but the written
directive was not changed.
The first portion of the second treatment was properly delivered
using the modified treatment plan. However, the radiation therapist
erroneously changed the treatment angle for the second portion of the
treatment. The error meant that the left eye orbit received the
radiation dose instead of the right eye orbit. Consequently, the left
eye orbit erroneously received a dose of approximately 150 cGy (150
rad) and the right eye orbit received 150 cGy (150 rad) less than
intended. The licensee stated that the patient received an explanation
of the event and that the error did not affect the treatment. The
entire treatment was completed on May 6, 1994, without further
incident. The patient subsequently died as a result of the cancer. The
NRC consultant determined that the misadministration had no impact on
the patient's death.
Cause or Causes--Failure of the authorized physician to prepare a
change in the written directive, and failure to effectively supervise
the administration of the treatment.
Action Taken To Prevent Recurrence
Licensee--The licensee's corrective actions included (1) policy
changes to clarify the radiation therapists' responsibility when
treatment plan changes are made; (2) retraining staff on quality
management program (QMP) procedures; (3) requiring that on the first
day of treatment the setup is supervised by a physician; (4) modifying
the written directive form used for documenting written directives and
subsequent revisions; and (5) reviewing and revising the current QMP
and submitting the changes to NRC for review.
NRC--NRC Region III conducted an inspection from May 2 through June
9, 1994, to review the misadministration. NRC also contacted a medical
consultant to review the incident. Significant violation of NRC
requirements were identified during the inspection. The violations
included (1) failure to make a written revision to a written directive
prior to administering a revised teletherapy dose to a patient; (2)
failure to review the written prescription; (3) failure to verify that
details of the administration of the verbally revised dose were in
accordance with the written directive and plan of treatment; (4)
failure to follow the written QMP procedures established by the
licensee; and (5) failure to include in written directives the overall
treatment period. On July 11, 1994, NRC Region III issued a Notice of
Violation (NOV) with a Severity Level III violation with no fine
assessed (Letter from W.L. Axelson, Director, Division of Radiation
Safety and Safeguards, to Walter Davis, Jr., Assistant Dean and Chief
Facilities Officer, Washington University Medical Center, forwarding
Inspection Report No. 030-15101/94001, Docket No. 030-15101, License
No. 24-00063-10, dated July 11, 1994). The NOV requires the licensee to
document the specific actions taken and any additional actions planned
to prevent recurrence.
* * * * * * *
94-11 Medical Brachytherapy Misadministration at The Queen's Medical
Center in Honolulu, Hawaii
One of the AO reporting guidelines notes that administering a
therapeutic radiation dose greater than 1.5 times that intend from a
sealed source should be considered an AO.
Date and Place--May 2, 1994; The Queen's Medical Center; Honolulu,
Hawaii.
Nature and Probable Consequences--A patient was prescribed to
receive two treatments of 1000 centigray (cGy) (1000 rad) to the
patient's right eye using a strontium-90 (Sr-90) eye applicator. The
treatment plan called for the two treatments to be scheduled one week
apart. The first treatment was properly delivered on April 25, 1994, by
keeping the source in contact with the patient's right eye for 18
seconds. On May 2, 1994, when the patient returned for the second
treatment, the same physician treated the patient, but a different
oncology nurse assisted. The physician did not refer to the written
directive or to the dose-rate information available with the eye
applicator, although he had used other applicators in the past. He also
did not discuss the procedure with the oncology nurse prior to the
second treatment. At the end of the desired 18-second period, the nurse
raised her voice and paused at the count of ``18'' (as she had been
trained) without saying ``stop'' as the physician expected. As a
result, the treatment continued until 32 seconds had passed, when the
physician realized that the desired time must have elapsed. As a
result, the patient received 1778 cGy (1778 rad) to the right eye
during the second treatment, rather than the prescribed 1000 cGy (1000
rad).
The Radiation Safety Officer reported the misadministration to the
NRC Operations Center at 8:37 p.m. on May 2, 1994. The referring
physician was also notified on the same day. The patient was notified
of the event during follow-up examinations by the referring physician
on May 5 and May 14, 1994. No clinical damage was observed by the
referring physician, and none is expected. The patient will be examined
during subsequent follow-up visits to the medical center.
The NRC staff retained a medical consultant to evaluate the
potential medical effects on the patient as a result of the
misadministration. The medical consultant stated that dosimetry for Sr-
90 eye applicators is difficult, due to calibration factors, clinical
factors, and treatment technique. The consultant will send an update on
the dosimetry and calibration in the near future. The medical
consultant stated that the increased unintended dose is within the
range of normal treatments. He indicated that the medical consultant
stated that the increased unintended dose is within the range of normal
treatments. He indicated that the medical consequences of the
misadministration would be negligible.
Cause or Causes--Part of Title 10 of the Code of Federal
Regulations states that licensees must establish and maintain a written
quality management program (QMP) to provide high confidence that each
administration is in accordance with the written directive. However, at
the time of the treatment, the licensee did not have a written
procedure to require that staff members confirm that the planned
administration will be as specified in the written directive.
Consequently, neither the physician nor the oncology nurse referred to
the written directive, nor did they discuss the procedure before it
took place. Inconsistent training given to the oncology nurses in the
method of timing treatments was also a contributing factor.
Actions Taken To Prevent Recurrence
Licensee--The licensee revised the QMP procedures to prevent
recurrence of similar misadministrations. The new procedure specifies
that prior to the procedure, the staff will determine that the eye
applicator is as specified in the written directive. It also states
that the staff must seek guidance prior to continuing if they do not
understand any aspect of the written directive.
NRC--NRC Region IV conducted an inspection at The Queen's Medical
Center on May 16-17, 1994, to review the circumstances associated with
the misadministration and its probable cause(s). The NRC staff is
currently reviewing the inspection results for possible violations, and
enforcement action is pending.
* * * * *
94-12 Medical Sodium Iodide Misadministration at Stamford Hospital in
Stamford, Connecticut
One of the AO reporting guidelines notes that administering a
radiopharmaceutical other than the one intended which results in any
part of the body receiving unscheduled diagnostic radiation, and the
actual dose to the wrong body part, is five times the upper limit of
the normal range of exposures prescribed for diagnostic procedures
involving that body part, can be considered an AO.
Date and Place--May 17, 1994; Stamford Hospital; Stamford,
Connecticut
Nature and Probable Consequences--On May 19, 1994, the licensee
notified the NRC Operations Center that on May 17, 1994, a patient was
administered 37 megabecquerel (MBq) (1 millicurie [mCi]) of sodium
iodide iodine-131 (I-131) for a whole body scan when no such study was
prescribed. The licensee identified this misadministration during
review of the scan by the authorized user.
A patient was scheduled by a referring physician to have a ``whole
blood red cell mass'' test, correctly known as a ``red blood cell
volume'' test. This test involves withdrawing an amount of blood from
the patient, and labeling the patient's red blood cells in vitro with
the radionuclide chromium-51 having a nominal activity of 1.02 to 3.7
MBq (30-100 microcurie [Ci]). This is followed by reinjection
of the labeled red blood cells into the patient, and measurement of
radioactivity in blood samples withdrawn from the patient 10 to 30
minutes later. The referring physician contacted the patient's Health
Maintenance Organization (HMO), as the HMO requires that it place the
order with Stamford Hospital. The HMO wrongly contacted the central
booking area for Nuclear Medicine at Stamford Hospital, rather than the
Clinical Laboratory which performs this test as authorized in Part
35.100 of Title 10 of the Code of Federal Regulations. The central
booking secretary, and the HMO secretary, in an attempt to fit the
procedure into one of those listed under Nuclear Medicine, converted
the prescribed ``Whole Blood Red Cell Mass'' test into ``Whole Body I-
131 Scan,'' a scan that uses 37 MBq (1 mCi) of I-131. The central
booking secretary then printed the name of the referring physician at
the bottom of the form for ``Consultation for Nuclear Medicine,'' and
sent it to the Nuclear Medicine Department where it was received on May
13, 1994. A nuclear medicine technologist (NMT) looked at the form and
saw that it was for ``total red cell mass,'' but since the NMT knew the
referring physician, the NMT assumed that this was a new test using I-
131 to determine ``total red cell mass.'' The NMT ordered the requested
37 MBq (1 mCi) I-131 capsule, which was administered on May 16, 1994.
The patient was scanned on May 17, 1994, and May 18, 1994, the
authorized user (AU), who is also the Radiation Safety Officer (RSO),
read the films. The AU immediately noticed the error and notified the
referring physician, who notified the patient.
The licensee estimated that the patient received a whole body dose
equivalent of 4.7 millisievert (470 millirem) and a thyroid absorbed
dose of 800 centigray [cGy] (800 rad). NRC was notified within 24 hours
of the discovery of the misadministration. The licensee submitted a
written report of the misadministration to NRC Region I on May 31,
1994.
Cause or Causes--The licensee had failed to establish a quality
management program (QMP) for administering quantities of I-131 and
iodine-125 (I-125) greater than 1.11 MBq (30 Ci) which would
require written directives and failed to instruct supervised
individuals in NRC requirements of a QMP.
Actions Taken To Prevent Recurrence
Licensee--The licensee now requires that (1) all requests for
diagnostic or therapeutic procedures be in writing and sent via
facsimile transmission from the referring physician's office; (2) all
administrations above 1.11 MBq (30 Ci) of I-131 be done only
by written order from the AU/RSO or other AU's authorized to do so; (3)
all diagnostic and therapy requisitions will be reviewed by a
radiologist, and designated as approved or not approved; (4) all
technologists will be trained in regard to the clinical diagnosis for
which each test is applicable; (5) the central booking staff will meet
with the RSO and will be informed that the clinical diagnosis must
match the test being requested, and that any deviation from the match
or any diagnosis that they don't understand must be challenged and
brought to the attention of the radiologist; and (6) the RSO and
physicist will review the QMP annually and discuss it at the Radiation
Safety Committee meeting and with the entire nuclear medicine staff.
NRC--NRC Region I conducted a special inspection on May 23 and 24,
and June 1 and 6, 1994, to investigate the circumstances of the
misadministration. An NRC inspection report (Letter from Charles W.
Hehl, Director, Division of Radiation Safety and Safeguards, to Andrew
H. Banoff, Vice President, Ambulatory Services, Stamford Hospital
forwarding Inspection Report No. 030-01265/94-001, Docket No. 030-
01265, License No. 06-06697-02, dated June 15, 1994) was issued June
15, 1994, and identified the following five apparent violations: (1)
failure to establish a QMP for amounts of I-125 and I-131 greater than
1.11 MBq (30 Ci); (2) failure to conduct annual reviews of the
QMP; (3) failure to have records specifying the methods used to verify
patients identity which can be audited; (4) failure to have written
directives signed by the authorized user; and (5) failure to instruct
individuals in the QMP. An NRC medical consultant reviewed the
information in the NRC's inspection report, the licensee's 15-day
misadministration report, and the preliminary notification, and
conducted telephone interviews with the RSO/AU. The medical consultant
concluded that without an actual measurement of the thyroid uptake of
I-131 there was a moderate uncertainty in the estimate of the radiation
dose to the thyroid, and estimated a radiation absorbed dose of
approximately 530-to-1600 cGy (530-to-1600 rad). The medical
consultation further stated that it is unlikely that the
misadministration will result in a clinically detectable effect on the
patient's thyroid. The impact on the patient's health should be
negligible, with no expected long-term disability.
An enforcement conference was held with the licensee on June 24,
1994. The five violations were classified as a Severity Level III
problem and a Notice of Violation and Proposed Imposition of Civil
Penalty (Letter from Thomas T. Martin, Regional Administrator, to
Andrew H. Banoff, Vice President, Ambulatory Services, Stamford
Hospital forwarding Notice of Violation and Proposed Imposition of
Civil Penalty--$1,250, Docket No. 030-01265, License No. 06-06697-02,
dated July 11, 1994) for $1,250 was issued on July 11, 1994.
* * * * *
94-13 Medical Brachytherapy Misadministration at Blodgett Memorial
Hospital in East Grand Rapids, Michigan
One of the AO reporting guidelines notes that a therapeutic dose
that is greater than 1.5 times the prescribed dose can be considered an
AO.
Date and Place--June 14, 1994; Blodgett Memorial Medical Center;
East Grand Rapids, Michigan.
Nature and Probable Consequences--On June 15, 1994, the licensee
notified NRC that a misadministration occurred on June 14, 1994, during
the second of a series of three treatments to an eye surface lesion
using a strontium-90 (Sr-90) eye applicator. The misadministration
resulted in the patient receiving a total dose that was 53.6 percent
above the intended total dose.
The patient was to receive 25.5 gray (Gy) (2550 rad) in a series of
three equal treatments. The intended treatment time for each of the
three treatments was 19.1 seconds. The first treatment was performed as
intended. During the second treatment, the treatment time was misread
and the patient received treatment for 1 minute and 9 seconds. The
second treatment dose was 30.68 Gy (3068 rad) instead of the intended
8.5 Gy (850 rad). The third treatment was not administered. Therefore,
the patient's eye received a total dose of 39.18 Gy (3918 rad).
The patient and referring physician were notified of the incident
by the licensee. The licensee and the referring physician do not
anticipate any serious health consequences to the patient and have
conducted follow-up medical examinations.
Cause or Causes--The licensee reported that when the first
treatment fraction was performed on June 7, 1994, the treatment time of
19.1 seconds was erroneously recorded on the medical chart as 1.91
seconds. When it came time for the second treatment fraction to be
administered, the therapist made the assumption that the treatment time
was 1 minute 9 seconds. The physician did not verify the specific
details of the administration prior to administering the brachytherapy
dose, and did not confirm the treatment time. In addition, the licensee
failed to establish a written Quality Management Program (QMP) for the
Sr-90 eye application eye application, and the therapist was not
instructed in the licensee's QMP.
Action Taken To Prevent Recurrence
Licensee--The licensee reported that in the future the
brachytherapy quality management program (QMP) will be strictly adhered
to when performing eye applications, and a physics check will be done
before each treatment fraction. In addition, a source activity decay
chart for Sr-90 will be provided to the physicians for immediate
reference.
NRC--NRC Region III conducted an inspection from June 28 through
July 6, 1994, to review the circumstances of the misadministration. An
NRC medical consultant, retained to review the case, concluded that
chances are favorable that the patient will suffer no health
complications, but the risk of future complications is not zero.
On August 18, Region III issued a Notice of Violation (Letter from
John B. Martin, Regional Administrator, NRC Region III, to Randy
Oostra, Assistant Vice President, Blodgett Memorial Medical Center,
forwarding Notice of Violation, NRC Inspection Report No. 030-02008/
94001, Docket No. 030-02008, License No. 21-01424-03, dated August 18,
1994) to the licensee for the following violations: (1) treating a
patient with the Sr-90 eye applicator without preparation of a written
directive; (2) failure to establish and use a written QMP for the Sr-90
eye applicator; (3) investigation of the misadministration by the
Radiation Oncology Department instead of the Radiation Safety Officer
as required; (4) failure to maintain required records of the Sr-90
source usage; (5) failure to maintain the manufacturer's instructions
for the eye applicator as required. There was no Civil Penalty assessed
for the violations.
* * * * *
94-14 Medical Brachytherapy Misadministration that Required Medical
Intervention at The William W. Backus Hospital in Norwich, Connecticut
One of the AO reporting guidelines notes that a therapeutic dose
that results in an actual dose greater than 1.5 times the prescribed
dose can be considered an AO.
Date and Place--June 21, 1994; The William W. Backus Hospital;
Norwich, Connecticut.
Nature and Probable Consequences--NRC Region I was notified by the
licensee on June 21, 1994, of a therapeutic misadministration that had
occurred at its facility earlier that day. The misadministration
involved a patient who was prescribed to receive a prostate implant of
112 iodine-125 (I-125) seeds have a radionuclide activity per seed of
between 15.9 and 17.0 megabecquerel (MBq) (0.43 and 0.46 millicurie
[mCi]), but who instead was implanted with 112 I-125 seeds having an
activity of 166 MBq (4.49 mCi) each.
Following the preplanning dosimetry performed at Yale-New Haven
Hospital (YNHH), a written directive was prepared by an authorized user
and was sent via facsimile transmission to The William H. Backus
Hospital on June 16, 1994, by the dosimetrist from YNHH. (YNHH is under
contract with The William W. Backus Hospital to provide radiation
oncologists, dosimetrists and health physicists, and two of the
physicians from YNHH are listed as authorized users on The William W.
Backus Hospital's NRC license). The Chief Nuclear Medicine Technologist
(NMT) received the directive and called Medi-Physics in Arlington
Heights, Illinois, to place the order for the required I-125 seeds. The
package containing the seeds arrived at The William W. Backus Hospital
on June 17, 1994, and was received by one of the NMTs, who was not the
same individual who had ordered the seeds. The NMT opened the package
after making the required radiation surveys. In accordance with the
licensee's established procedure, information on the packing slip that
accompanied the package was compared with the information that was
posted on the lead ``pig'' that contained the seeds. The verified
information included the number of seeds (112), activity per seed (166
MBq [4.49 mCi] per seed), and total activity (18,600 MBq [502.88 mCi]),
and was entered into the sealed source inventory log book by the NMT.
On June 21, 1994, the dosimetrist from YNHH arrived at The William
W. Backus Hospital to assist in the implant procedure. The same
dosimetrist had performed the preplanning dosimetry, and had prepared
the written directive that was signed by the authorized user. The
dosimetrist took the package after reviewing the documentation, but
failed to notice that the activity of the seeds was 10 times higher
than the prescribed activity. The dosimetrist made entries into the log
book before removing the container from the nuclear medicine hot lab,
and the entries documented that 112 seeds with activity of 166 MBq
(4.49 mCi) each were taken to the operating room.
The implant procedure was completed between 10 and 11 a.m. on June
21, 1994, in the presence of the authorized user, who at the completion
of the procedure documented that 112 I-125 seeds with total activity of
1840 MBq (49.73 mCi) were implanted. Following the implant procedure,
the required radiation surveys were made by the dosimetrist and the
dose rate of 1 microcoulomb per kilogram (4 milliroentgen) per hour at
1 meter (39 inch) from the patient was recorded by the dosimetrist.
The patient was moved to the recovery area, and the dosimetrist
returned to the nuclear medicine department to complete the
documentation required by the licensee's procedure. At this time, the
dosimetrist noted discrepancies between the entries made in the log
book by the NMT at the time of receipt of the package, and those made
by himself earlier that morning. The dosimetrist assumed that these
were clerical errors, and therefore ``corrected'' two of the three sets
of entries in the log book by drawing lines across them and entering
the ``correct'' figures as 16.6 MBq (0.449 mCi) per seed and 1860 MBq
(50.288 mCi) total, respectively.
The dosimetrist realized the possibility of an error when it was
noted that the packing slip also indicated that each seed had an
activity of 166 MBq (4.49 mCi). The dosimetrist contacted the Chief
NMT, and together they both called Medi-Physics to verify the activity
of the seeds. Upon confirmation by Medi-Physics that each seed had an
activity of 166 MBq (4.49 mCi), the surgeon was notified of the error.
(The surgeon was also the patient's referring physician.) Unable to
contact the authorized user who had supervised the implant procedure,
the surgeon consulted with a second authorized user (also from YNHH)
and the two agreed that a surgery to explant as many seeds as possible
was the most appropriate approach under the circumstances. This
involved removal of the patient's prostate gland where a majority of
seeds were located. The patient and his family were informed of the
misadministration, and the patient was brought back to the operating
room and prostatectomy was completed at approximately 4:00 p.m.
The licensee was able to explant 69 of the 112 seeds that were
implanted, leaving 43 seeds still remaining inside the patient's body.
During the explanting procedure, one of the I-125 seeds was ruptured.
The patient was administered prophylactic potassium iodide to block the
possible uptake of I-125 by the patient's thyroid. The licensee also
collected the fluids and the tissue that may have been contaminated.
Approximately 5 liters (5.28 quarts) of fluid were collected and
appeared to be contaminated with approximately 1.85 MBq (0.050 mCi) of
I-125. The personnel who were present in the operating room during the
surgery were also monitored for possible uptake, and the results
indicated no internal contamination of these personnel.
The patient was transferred to YNHH on June 23, 1994, in order that
a more precise localization of the remaining seeds could be made by the
use of equipment available at that facility. At YNHH three-dimensional
scans were taken, and on June 27, 1994, the patient was again operated
on and an additional 15 seeds were explanted. This left 28 seeds still
remaining in the patient. The remaining seeds appeared to be scattered
in the lower pelvic region and the licensee decided that further
mitigating surgery at this time was not warranted. The patient appeared
to be in stable condition. Preliminary dose calculations by the
licensee indicated that the remaining seeds would cause the body tissue
to receive a radiation dose of the same order of magnitude as would
have been received by the surrounding organs and tissue if the
originally planned seeds were permanently implanted. The patient was
discharged from YNHH on July 4, 1994.
Cause or Causes--There was a misunderstanding in communication
between the Chief NMT who ordered the seeds, and the representative of
Medi-Physics who received the order. The Chief NMT and the NMT were not
familiar with the magnitude of the radionuclide activities that are
used in prostate implant procedures. The NMT did not inform the Chief
NMT as to the activity received. The Chief NMT was confused by the two
telephone calls that were received from Medi-Physics subsequent to
placing of the order, but failed to act to clear the confusion. The
licensee did not have any procedure that required a comparison of the
material ordered and the material received. The YNHH dosimetrist failed
to notice that the activity of the seeds was 10 times higher when he
logged out the seeds. The licensee did not have a procedure that
required an independent verification of the activity that was being
loaded into the implant needles. The authorized user relied totally on
the dosimetrist and did not verify the activity of the seeds. Dual
control (by the licensee and YNHH) of the radiation safety program
related to brachytherapy procedures caused the YNHH to assume that the
Chief NMT was familiar with the ordering of the radioactive material
and did not need additional training.
Actions Taken To Prevent Recurrence
Licensee--The licensee made a commitment to voluntarily suspend its
brachytherapy program until written authorization is granted by NRC to
resume the program. This commitment was documented in a Confirmatory
Action Letter (Letter from Charles W. Hehl, Director Division of
Radiation Safety and Safeguards, to Brian J. Smithwick, Vice President
and Chief Executive Officer, The William W. Backus Hospital, forwarding
Confirmatory Action Letter 1-94-010, Docket No. 030-01287, License No.
06-11734-02, dated June 23, 1994). The licensee was considering a
requirement that radioactive sources be assayed prior to implantation,
and that the implant sources be ordered in writing from the supplier.
NRC--NRC Region I dispatched an inspection team, which arrived at
the facility at approximately 2:00 p.m. on June 22, 1994, to review the
circumstances surrounding the misadministration. An NRC medical
consultant was engaged to assess the effects of the misadministration
on the patient. The medical consultant reviewed the events and the
mitigating actions that the licensee has taken to minimize the impact
of the misadministration on the patient. The consultant advised NRC
that the licensee's actions appeared appropriate. On June 23, 1994, NRC
Region I, in consultation with the NRC Office for Nuclear Material
Safety and Safeguards (NMSS) and the NRC Office for Analysis and
Evaluation of Operational Data, upgraded its inspection effort to an
Augmented Inspection Team (AIT). NMSS contacted the U.S. Department of
Energy's Idaho National Engineering Laboratory (INEL), who formed a
team of consultants to provide technical support to the AIT. The AIT
and INEL support consultants returned to The William W. Backus Hospital
on June 28, 1994 and also to YNHH. NRC Region I issued a press release
on June 23, 1994, and the AIT held a public exit meeting with the
licensee at The William W. Backus Hospital on July 7, 1994. NRC has
received the information gathered on the incident by INEL support team
and incorporated this information in the AIT report issued to the
licensee on August 4, 1994 (Letter from Charles W. Hehl, Director,
Division of Radiation Safety and Safeguards, to Michael T. Moore,
President and Chief Executive Officer, The William W. Backus Hospital,
forwarding NRC Augmented Inspection Team (AIT) Report No. 030-01287/94-
001, Docket No. 030-01287, License No. 06-11734-02, dated August 4,
1994). In a letter to the licensee dated August 10, 1994, NRC indicated
that its review of the AIT report noted two apparent violations: (1) 10
CFR 35.32(a); and (2) 10 CFR 35.25(a) (Letter from Charles W. Hehl,
Director, Division of Radiation Safety and Safeguards, to Michael T.
Moore, President and Chief Executive Officer, The William W. Backus
Hospital, forwarding NRC Inspection Report No. 030-01287/94-001, Docket
No. 030-01287, License No. 06-11734-02, dated August 10, 1994). NRC
will discuss these apparent violations at an Enforcement Conference
scheduled for August 24, 1994.
Dated at Rockville, MD this 26th day of October, 1994.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Acting Secretary of the Commission.
[FR Doc. 94-27005 Filed 10-31-94; 8:45 am]
BILLING CODE 7590-01-M