[Federal Register Volume 59, Number 3 (Wednesday, January 5, 1994)]
[Notices]
[Pages 610-615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-125]
[[Page Unknown]]
[Federal Register: January 5, 1994]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-01244, License No. 06-00819-03, EAs 92-241 and 93-016]
Yale-New Haven Hospital, New Haven, Connecticut; Order Imposing
Civil Monetary Penalties
I
Yale-New Haven Hospital (Licensee), New Haven, Connecticut, is the
holder of Byproduct Material License No. 06-00819-03 (License), issued
by the U.S. Nuclear Regulatory Commission (NRC or Commission). The
License was most recently amended on September 15, 1993. The License
authorizes the Licensee to perform diagnostic and therapeutic
procedures with radioactive material as well as research in accordance
with the conditions specified therein. This is a broad scope license.
The License was most recently renewed on August 13, 1985, and was due
to expire on August 31, 1990 but was extended by the NRC pending staff
action on the Licensee's renewal request. Based on the Licensee's
application to renew the License dated June 17, 1990, and pursuant to
10 CFR 30.37(b), the existing License has not expired and continues in
effect.
II
Between December 3, 1992, and January 27, 1993, the NRC performed
two inspections of licensed activities at the Licensee's facility. The
inspections were conducted to review two incidents involving
therapeutic misadministrations and a failure to control licensed
material that occurred between November 30 and December 1, 1992, and on
January 21, 1993. During the inspections, five violations of NRC
requirements were identified. A written Notice of Violation and
Proposed Imposition of Civil Penalties (Notice) was served upon the
Licensee by letter dated April 26, 1993. The Notice states the nature
of the violations, the provisions of the NRC's requirements that the
Licensee had violated, and the amount of the civil penalties proposed
for the violations.
The Licensee responded to the Notice on June 10, 1993. In its
response, the Licensee denies Violations II.A and II.B set forth in the
Notice; questions the Severity Level classification for Violations I.A,
I.B, and I.C; and requests reduction of the civil penalties.
III
After consideration of the Licensee's response and the statements
of fact, explanation, and argument for mitigation contained therein,
the NRC staff has determined, as set forth in the Appendix to this
Order, that the violations did occur, the Severity Level
classifications were appropriate, and the penalties proposed for the
violations designated in the Notice should be imposed.
IV
In view of the foregoing and pursuant to section 234 of the Atomic
Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205,
It is hereby ordered that:
The Licensee pay civil penalties in the amount of $10,000 within
30 days of the date of this Order, by check, draft, money order, or
electronic transfer, payable to the Treasurer of the United States
and mailed to the Director, Office of Enforcement, U.S. Nuclear
Regulatory Commission, ATTN: Document Control Desk, Washington, DC
20555.
V
The Licensee may request a hearing within 30 days of the date of
this Order. A request for a hearing should be clearly marked as a
``Request for an Enforcement Hearing'' and shall be addressed to the
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission,
Washington, DC 20555, with a copy to the Commission's Document Control
Desk, Washington, DC 20555. Copies also shall be sent to the Assistant
General Counsel for Hearings and Enforcement at the same address and to
the Regional Administrator, NRC Region I, 475 Allendale Road, King of
Prussia, Pennsylvania 19406.
If a hearing is requested, the Commission will issue an Order
designating the time and place of the hearing. If the Licensee fails to
request a hearing within 30 days of the date of this Order, the
provisions of this order shall be effective without further
proceedings. If payment has not been made by that time, the matter may
be referred to the Attorney General for collection.
In the event the Licensee requests a hearing as provided above, the
issues to be considered at such hearing shall be:
(a) Whether the Licensee was in violation of the Commission's
requirements as set forth in Violations II.A and II.B in the Notice
referenced in section II above, and
(b) Whether, on the basis of such violations and the other
violations set forth in the Notice of Violation that the Licensee
admitted, this Order should be sustained.
Dated at Rockville, Maryland, this 27th day of December 1993.
For the Nuclear Regulatory Commission.
James Lieberman,
Director, Office of Enforcement.
Appendix--Evaluations and Conclusion
On April 26, 1993, a Notice of Violation and Proposed Imposition
of Civil Penalties (Notice) was issued for violations identified
during two NRC inspections. The Licensee responded to the Notice on
June 10, 1993. The Licensee denied Violations II.A and II.B;
questioned the Severity Level classification of Violations I.A, I.B,
and I.C; and requested reduction of the civil penalties. The NRC's
evaluations and conclusions regarding the Licensee's requests are as
follows:
Restatement of Violations--Section I
I.A. Condition 23 of License No. 06-00819-03 requires that
licensed material be possessed and used in accordance with
statements, representations, and procedures contained in an
application dated December 13, 1984.
Item 7 of that application, dated December 13, 1984, states that
the Hospital Radioisotope Committee has the responsibility of
establishing and enforcing the Hospital's Radiation Safety Program
to ensure the safety and welfare of hospital personnel and property
as well as protecting the surrounding community from the potential
hazards of sources of ionizing radiation used at the hospital.
A procedure of the Hospital's Radiation Safety Program entitled,
``Procedure for Nursing Care of Patients Containing Radioactive
Sources for Therapy'', requires, in part, that ``during nursing care
procedures, the nurse must check all materials used by the patient .
. . for radioactive sources that may have become dislodged,'' and
that ``everything used by the patient (except dishes) must be saved
and monitored before disposal.''
Contrary to the above, the Hospital Radioisotope Committee did
not enforce the Hospital's Radiation Safety Program to ensure safety
and welfare of hospital personnel and property as well as protecting
the surrounding community from the potential hazards of all sources
of ionizing radiation used at the hospital. Specifically, on
November 30 and December 1, 1992, nurses on the ninth floor of Yale-
New Haven Hospital removed linen pads from a brachytherapy patient's
room without first checking the pads for radioactive sources which
may have become dislodged and failed to survey the linen pads before
disposal.
B. 10 CFR 20.207(a) requires that licensed materials stored in
an unrestricted area be secured against unauthorized removal from
the place of storage. 10 CFR 20.207(b) requires that licensed
materials in an unrestricted area and not in storage be tended under
constant surveillance and immediate control of the licensee. As
defined in 10 CFR 20.3(a)(17), an unrestricted area is any area
access to which is not controlled by the licensee for purposes of
protection of individuals from exposure to radiation and radioactive
materials.
Contrary to the above, on December 1 and 2, 1992, licensed
material consisting of a 35 millicurie cesium-137 brachytherapy
source was located, at various times, in unrestricted areas, namely,
a hallway on the ninth floor of the hospital, the laundry collection
area of the hospital, and a contractor's laundry facility; and at
those times, the brachytherapy source was not under the constant
surveillance and immediate control of the licensee.
C. 10 CFR 20.105(b) requires, in part, that except as authorized
by the Commission in 10 CFR 20.105(a), no licensee allow the
creation of radiation levels in unrestricted areas which, if an
individual were continuously present in the area, could result in
his receiving a dose in excess of 2 millirems in any one hour or 100
millirems in any seven consecutive days.
Contrary to the above, on December 1 and 2, 1992, the licensee
allowed the creation of radiation levels, at various times, in
unrestricted areas, namely, in a hallway on the ninth floor of the
hospital, in the laundry collection area of the hospital, and a
contractor's laundry facility, such that if an individual were
continuously present in the area, he could have received a dose in
excess of 2 millirems in any one hour or 100 millirems in any seven
consecutive days.
These violations are classified in the aggregate as a Severity
Level III problem. (Supplements IV and VI)
Civil Penalty--$2,500
Summary of Licensee Response to the Violations in Section I
The Licensee, in its response, states that the safety
significance of the loss of the source was minimal, noting that the
potential absorbed dose to any member of the general public as a
result of this incident was well below regulatory limits. Further,
the Licensee argues that the possibility of public exposure was
minimized by the hospital's prompt search for and discovery of the
source. The Licensee believes that personnel and members of the
public who may have been exposed to the source received only a
minimal dose as a result of this incident, noting that its
calculations indicate that the maximum dose to any exposed
individual was unlikely to have exceeded a total of 30 millirems.
While the Licensee recognizes that, under postulated worst case
conditions, the exposure rate at distances less than 2.4 meters
could have exceeded the NRC's applicable limits for the general
public, the Licensee argues that this exposure condition would only
have existed for very short periods of time, on the order of several
minutes, and with the bulk of the postulated exposure at a dose rate
well below NRC's standards for the general public. The Licensee also
notes that the source was located in linen that was removed from a
patient's room, and that since the linen is treated as a
biologically hazardous waste, it is highly unlikely that a person
would have any extended contact with the source once it had left the
patient's room.
The Licensee states that immediately upon discovery that a
source was missing, the Radiation Safety Officer, and the resident
physician who misplaced the source, conducted a search that promptly
located and safely recovered the missing source. The Licensee
further contends that despite this corrective action, the NRC chose
to treat the sequential consequences which flowed from the initial
failure as separate violations which could be treated in the
aggregate and escalated to a Severity Level III problem.
In addition, while the Licensee recognizes the NRC's authority
to cite for each separate violation, the Licensee believes that the
circumstances of the violations do not represent a programmatic
breakdown in its radiation safety program, and even when aggregated,
do not have the safety or regulatory significance to be considered a
Severity Level III problem.
The Licensee argues that the 100 percent escalation of the civil
penalty was not warranted since the Notice makes reference to an
incident that occurred in 1989. The NRC's enforcement policy states
that a licensee's prior performance normally refers to a period
within the last two years of the inspection at issue, or the period
within the last two inspections; whichever is longer.
The Licensee concludes by requesting that the NRC exercise its
discretion to reduce the civil penalty associated with the
violations in Section I of the Notice.
NRC Evaluation of the Licensee Response to Violations in Section I
While the NRC agrees that the doses to members of the general
public resulting from the loss of the source were small, the source
was, nonetheless, missing for a period of time in excess of twenty-
three hours. During that time, the source was in the hallway outside
the patient's room for at least seventeen hours, in a basement
laundry closet and in a laundry service truck for at least an hour
each, and on the floor of the laundry facility or in the laundry
washing machine for at least four and one half hours. None of these
locations was controlled by the Licensee for the purposes of
radiation protection. Therefore, since the radiation levels were in
excess of applicable levels for unrestricted areas for periods of
hours, this created a significant potential for an exposure in
excess of regulatory limits to personnel or members of the public,
and the NRC maintains that this is a significant lack of control of
licensed material.
As noted in Section C.1 of Supplement VI of the Enforcement
Policy, violations involving a failure to control access to licensed
materials for radiation purposes (as specified in the NRC
requirements) constitute Severity Level III violations. Therefore,
Violation I.B could have been individually classified at Severity
Level III. However, the NRC chose to aggregate the Licensee's
violation in failing to control licensed material with its root
cause (failure to survey--Violation I.A) as well as the effect of
the violation (the creation of radiation levels in excess of that
allowed in NRC regulations--Violation I.C) since the three
violations were all related to the one incident.
In view of the above, the assertion that Violations I.A, I.B,
and I.C were classified in the aggregate at Severity Level III
because they represent a programmatic breakdown is incorrect. In
addition, the Licensee's contention regarding corrective action,
involving the prompt location and recovery of the source are not
controlling in determining the severity level of the violation. The
severity level is determined by the safety or regulatory
significance of the violation. The Licensee's request for mitigation
of the civil penalty is discussed below.
In conclusion, the violations were properly classified in the
aggregate as a Severity Level III problem.
Restatement of Violations--Section II
II.A. 10 CFR 35.32(a) requires, in part, that each licensee
shall establish and maintain a written quality management program to
provide high confidence that byproduct material or radiation from
byproduct material will be administered as directed by the
authorized user. Pursuant to 10 CFR 35.32(a)(4), the quality
management program must include written policies and procedures to
meet the objective that each administration is in accordance with
the written directive.
Contrary to the above, as of November 30, 1992, the licensee's
quality management program did not include written policies and
procedures to meet the objective that each administration was in
accordance with the written directive. In particular, the licensee
did not establish written procedures to identify if a brachytherapy
source was not properly implanted or inadequately secured against
accidental removal. As a result, on November 30, 1992, during a
therapy procedure that involved a gynecological implant of four
cesium-137 sources, one source was either not implanted as required
or it was implanted properly but inadequately secured because the
source came out of the applicator and lay undetected in the
patient's bed. As a result, the dose administered to the patient was
less than that prescribed by the physician and the patient received
a radiation dose to the leg, an area not intended to receive
radiation.
B. 10 CFR 35.32(a)(4) requires, in part, that each licensee
shall establish and maintain a written quality management program to
provide high confidence that byproduct material or radiation from
byproduct material will be administered as directed by the
authorized user. The quality management program must include written
policies and procedures to meet the specific objective that each
administration is in accordance with the written directive.
On January 27, 1992, the licensee implemented a quality
management program for the use of byproduct material. Section 3 of
the quality management program entitled ``Policies and Procedures
for Brachytherapy'', paragraph 3.1.3 of the ``High Dose Rate Remote
Afterloading Devices'', requires, in part, that the treatment site
be confirmed with the written directive and treatment plan by the
administering person before administration of the treatment dose.
Contrary to the above, on January 21, 1993, the authorized user
physician failed to follow the quality management program in that
during a brachytherapy patient treatment with a high dose rate
remote afterloader, the treatment site was not confirmed by the
authorized user physician, causing the patient to receive 700 rads
to the rectum, instead of the vagina, as prescribed in the written
directive.
These violations are classified in the aggregate as a Severity
Level III problem (Supplement VI).
Civil Penalty--$7,500
Summary of Licensee Response to Violations in Section II
In its response, the Licensee denies that it violated the
requirement to establish and maintain a written QMP, noting that it
established a written QMP based upon the NRC's own guidance
published in Regulatory Guide 8.33 on January 27, 1992, and as
required by 10 CFR 35.32(a)(4). The Licensee further states that the
written quality management policy and procedures were distributed to
all authorized users for comment on January 21, 1992, and no
comments were received from the authorized users on this final
version, and the same version was presented to NRC Region I in a
letter dated January 27, 1992.
The Licensee also notes that in addition to giving each
authorized user a copy of the written quality management policy and
procedures, the radiation safety officer conducted formal training
for the members of the radiation therapy staff on March 5, 1992,
detailing the requirements of the QMP, and both physicians involved
in the alleged violations attended this presentation. The Licensee
further states that both physicians understood that the written
directive needed to be verified during the application process.
Nonetheless, despite the existence of a comprehensive QMP and
related training, these events occurred.
With respect to the first incident, the Licensee also states
that the resident physician followed the established procedures and,
therefore, reasonably concluded that he had successfully placed the
sources in the applicator during the loading process, and he and the
dosimetrist identified the correct sources as they were moved from
the transportation shield. The Licensee stated that in the process
of moving one of the four sources and its applicator to the patient,
the source inadvertently slipped unnoticed from the applicator, and
that since the resident missed the source in its fall under the
patient, he had no opportunity to identify the error once the
applicator was placed into the Fletcher Suit Device (FSD). Since the
resident wholly believed he had fulfilled the written directive, the
Licensee submits that he had satisfied the requirements of the QMP
regardless of his error.
With respect to the second incident involving the High Dose Rate
Afterloading (HDR) device, the Licensee states that the physician
who prepared the written directive was the same physician who placed
the applicator in error. Since he was the prescribing physician, the
Licensee contends that there is no doubt that he understood the
intent of the written directive. The Licensee states that while the
physician did not visually confirm or verify the placement, he fully
believed that he had correctly placed the applicator, based on his
sense of touch during the physical examination, knowledge of
anatomy, the feel and depth of the applicator insertion, and by
asking the patient if she felt comfortable after the placement.
Since the physician fully believed that he had carried out the
written directive, the Licensee submits that it had fulfilled the
requirements of the QMP notwithstanding his error.
NRC Evaluation of Licensee Response to Violations in Section II
The NRC does not dispute, in general, that the Licensee
established and maintained a QMP, or that it provided training to
authorized users. However, with respect to the first incident, the
NRC maintains that the Licensee's QMP did not include written
policies and procedures to provide high confidence that the QMP
would meet the objective that each brachytherapy administration is
in accordance with the written directive. 10 CFR 35.32(a) requires,
in part, that each licensee shall establish and maintain these
written policies and procedures to provide high confidence that the
radiation from byproduct material will be administered as directed
by the authorized user. Therefore, it is incumbent upon the Licensee
to establish written procedures that provide high confidence in the
delivery process of therapeutic radiation and the accurate
administration of the prescribed dose. In this case, the Licensee
did not establish adequate written procedures, as required, to
effectively implement their QMP and procedures to verify whether
brachytherapy sources were properly inserted in accordance with the
written directive. In particular, the QMP was inadequate in that it
did not require visual or other verification of proper insertion of
the sources while they were being inserted. The Licensee stated that
it established a QMP based on requirements in 10 CFR 35.32. 10 CFR
35.32(a)(4) requires that each administration be in accordance with
the written directive. The licensee's QMP did require that a means
be employed of verifying sources are positioned properly. However,
the licensee had not established such a procedure to meet this
objective by directing the physician to verify proper insertion of
the source or sources (e.g., by visual inspection). In this
instance, visual verification of the sources in the applicator would
have been an acceptable means. The QMP did not have any procedure to
ensure, nor did the physician confirm, that the administration of
the dose was in accordance with the written directive. Therefore,
the QMP did not provide high confidence that radiation from
byproduct material would be administered as directed pursuant to 10
CFR 35.32(a).
With respect to the second incident, although the authorized
user fully understood the intent of the written directive, the
individual did not confirm or verify the proper placement of the
applicator, which had not been placed into the correct organ, with
the treatment site specified in the written directive and treatment
plan. The Licensee stated that it established a QMP based on
requirements in 10 CFR 35.32. 10 CFR 35.32(a)(4) requires that each
administration be in accordance with the written directive but did
not describe how this should be done. The licensee's QMP did require
the treatment site be confirmed with the written directive. Visual
verification of the source insertion into the proper organ would
have been an acceptable means. As in violation IIA, the QMP appears
inadequate in that it did not require visual or another specific
procedure for verification of proper insertion of the sources while
they were being inserted. The QMP did not have any specific
procedure to ensure, nor did the physician confirm, that the
administration of the dose was in accordance with the written
directive. Therefore, the QMP did not provide high confidence that
radiation from byproduct material would be administered as directed
pursuant to 10 CFR 35.32(a).
The NRC realizes that confirmation of a treatment site by the
Licensee may be accomplished in a number of ways. However, it is the
responsibility of the Licensee to establish effective procedures to
meet the performance-based objective of the QMP required by 10 CFR
35.32(a)(4), and provide high confidence that the intended
therapeutic radiation is administered to the designated treatment
site as prescribed by the physician authorized user. In this case,
simple visual confirmation could have prevented the error and would
have provided higher confidence than the physician's method of
feeling to locate the treatment site.
As demonstrated by the authorized user's failure to treat the
prescribed treatment site, the Licensee did not meet the objective
in 10 CFR 35.32(a)(4).
The NRC agrees that the Licensee had a QMP and that the
physician understood the intent of the written directive. The NRC
has determined, however, that the procedures may have been
inadequate in that the physician did not adequately confirm (or
verify) the placement of the applicator and that the QMP procedure
for confirmation (or verification) is vague and does not provide
high confidence that the objective will be met.
Accordingly, the NRC maintains that with regard to both
incidents, violations of the QMP occurred.
Summary of Licensee Response Requesting Mitigation of the Civil
Penalties
As a general comment to violations identified in Sections I and
II of the Notice, the Licensee contends that the civil penalties
should be reduced, noting that it has voluntarily conducted an
independent, formal, and comprehensive review of the hospital's
radiation safety program, and a panel of four experts conducted the
review on May 10 and 11, 1993. The Licensee also notes, as evidenced
by this formal review program, and other comprehensive measures
detailed in its incident reports dated December 22, 1992, January 4,
1993, and February 5, 1993, that it is committing significant
management and fiscal resources to address the concerns expressed in
the enforcement action. The Licensee believes that the remedial
actions that the NRC seeks to encourage will be realized without the
need for stringent enforcement in the form of proposed civil
penalties, and that this is consistent with the Enforcement Policy.
With respect to the violations in Section I, as stated above,
the Licensee notes that the NRC letter stated that 100 percent
escalation of the civil penalty was warranted based upon the
hospital's past enforcement history. Since the letter makes
reference to an incident which occurred in 1989, the Licensee
questions consideration of that action since the NRC's Enforcement
Policy indicates that a licensee's prior performance normally refers
to a period within the last two years of the inspection at issue, or
the period within the last two inspections, whichever is longer.
Since this license is a broad scope license that is inspected on a
yearly interval, the Licensee believes it is contrary to established
NRC practice to cite an incident occurring more than three and a
half years ago as a basis for escalation of the civil penalty.
Further, since the NRC's current Enforcement Policy has been
modified to provide for maximum flexibility and consideration of all
mitigating circumstances, the Licensee requests that the NRC
exercise its discretion to reduce the civil penalty associated with
the violations in Section I of the NOV.
With respect to the violations in Section II, the Licensee
states that the NRC's cover letter to the NOV indicates that all of
the adjustment factors set forth in 10 CFR Part 2, Appendix C, were
considered. Although the NRC increased the base civil penalty by 200
percent for ``past enforcement history and multiple examples,'' and
concluded that the remaining factors warranted no further
adjustment, the Licensee believes that, upon closer examination of
the circumstances, mitigation is warranted.
Regarding the ``multiple examples'' adjustment factor, the
Licensee notes that the NRC's Enforcement Policy makes it explicitly
clear that for this factor to be applicable, the multiple
occurrences should have the ``same root causes.'' The Licensee
contends that while the NRC indicated that the root cause of the two
incidents was inattention to detail by the treating physicians, this
is not the root cause of the cited violations. The Licensee notes
that the NOV states that the root cause of Violation II.A was
failure to have an adequate procedure in place consistent with the
program requirements in 10 CFR 35.32, whereas the second violation,
II.B, is stated by the NRC to arise from a different root cause,
namely, failure to follow an existing procedure established in
conformance with the program requirements of 10 CFR 35.32. The
Licensee further states that the fact that these violations derive
from different root causes is reinforced by the fact that the
specific corrective action for one violation would not necessarily
have prevented the other. Based on this information, the Licensee
believes that escalation of the base civil penalty under the
``multiple examples'' factor is inappropriate.
Regarding the ``prior enforcement history'' adjustment factor,
the Licensee believes that the application of this factor was
inappropriate in this case, noting that the Quality Management rule
has become effective only recently, and there has been no
opportunity to develop an enforcement history for compliance with
this rule. Just as the Enforcement Policy recognizes that this
factor should not be applied where the Licensee has not been in
existence long enough to establish a performance history, the
Licensee contends that so too should this logic be applied in
establishing performance history for quality management violations.
On this basis, the Licensee contends that escalation of the base
civil penalty is unwarranted.
Regarding the other factors, the Licensee believes that, on
balance, the remaining adjustment factors warrant mitigation even
though none was applied. Regarding the ``identification'' factor,
the Licensee notes that the current Enforcement Policy streamlines
the applicability of this factor to situations where the Licensee
identified the violations and promptly reported them to the NRC. The
Licensee argues that, in both cases, following identification of the
violation, the hospital thoroughly evaluated the events and promptly
provided the NRC with the results in letters to the NRC Region I
office, dated December 22, 1992, January 4, 1993, and February 5,
1993. Based on this information, the Licensee believes that full
mitigation on this factor is warranted.
Regarding the ``corrective action'' factor, once the violations
were identified, the Licensee maintains it took prompt action to
bring the situations into compliance. Immediate corrective actions
were implemented to assure that fully safe conditions were restored
and that further noncompliance with the NRC's requirements was
halted. In addition, as evidenced by the NRC's inspection report
dated December 30, 1992, the Licensee maintains that it had already
developed proposed long-term corrective actions, ``at the time of
the inspection,'' which was the day after the incident was reported.
Given this information, the Licensee believes that further
mitigation due to this factor is warranted.
Finally, the Licensee maintains it had no prior opportunity to
identify the two specific violations, neither misadministration
resulted in doses to the patients that exceeded the prescribed doses
by more than 20 percent of the total prescribed doses, nor are they
believed to result in any significant detriment, and therefore, no
escalation is warranted for these factors. In summary, when the
circumstances surrounding the violations are fully considered, the
Licensee submits that significant mitigation of the proposed civil
penalty for Violation II is warranted.
NRC Evaluation of Licensee Response Requesting Mitigation of the
Civil Penalties
The NRC has evaluated the Licensee response and has determined,
as set forth below, that the Licensee has not provided an adequate
basis for any mitigation of the civil penalty. In determining the
amount of the civil penalty, the NRC considered the escalation and
mitigation factors set forth in the NRC Enforcement Policy.
With respect to the issues provided in the Licensee's response
as a basis for mitigation of the penalty, the NRC acknowledges that
the Licensee performed an independent assessment on May 10 and 11,
1993, to improve implementation of the radiation safety program.
However, this commitment was made only after these violations were
identified by the NRC as a result of inspections conducted on
December 3 and 4, 1992, and January 26 and 27, 1993, at the
Licensee's facility. Nevertheless, the NRC mitigated the base civil
penalty for corrective action for Violations I.A, I.B, and I.C by 50
percent, the maximum recommended under the enforcement policy. No
further mitigation is warranted under this factor.
With respect to the violations in Section I, the Licensee states
that the NRC, contrary to established practice in Section VI.B.2.(c)
of the Enforcement Policy, used an enforcement action which occurred
in 1989 as part of its inspection history to establish a basis for
the 100 percent escalation of the civil penalty for licensee
performance. The NRC agrees that prior performance normally refers
to the licensee's performance within the last two years of the
inspection at issue, or the period within the last two inspections,
whichever is longer. However, Section VI.B.2.(c) also states that
the base civil penalty may be escalated by as much as 100 percent if
the current violation is reflective of the licensee's poor or
declining prior performance. While the NRC did mention the escalated
action issued in 1989 in its April 26, 1993, cover letter to the
Notice of Violation, it also referred to an escalated action that
was issued in 1992, which is within the two year/two inspection
period. Viewed collectively, the past enforcement actions
demonstrate a declining trend in performance at the Licensee's
facility. Additionally, the escalated enforcement action issued in
1989 involved the Licensee's loss of control of a cesium-137 sealed
source and subsequent improper disposal. The Licensee's corrective
action for this incident was not broad and lasting, and did not
prevent recurrence of a similar violation described in Section I of
the Notice issued April 26, 1993, involving the loss of a cesium-137
brachytherapy sealed source. Based on the above, the NRC believes
that the 100 percent escalation for Licensee performances, was a
proper application of the Enforcement Policy in determining the
civil penalty amount of $2500 for the violations in Section I. As
for the Licensee's contention regarding identification of Violations
I.A, I.B, and I.C, the NRC in the Notice proposed 50 percent
mitigation, which is the maximum recommended under the enforcement
policy.
The escalation/mitigation factors for the violations in Section
II were applied consistent with the Policy. Regarding the ``multiple
examples'' factor, the violations both involved the failure to meet
the specific objective that each administration is in accordance
with the written directive. The QMP was inadequate in that it did
not contain procedures that provide high confidence in the delivery
process of therapeutic radiation and the accurate administration of
the prescribed dose. The administering physician's inattention to
detail was the root cause and primary contributing reason for the
occurrence of both misadministrations at the facility within a short
period. In violation II.A, the physician failed to observe that one
of four sources fell into the patient's bed, while in violation
II.B, the physician failed to use any visual means to verify correct
insertion of the sources. Had either physician paid adequate
attention while inserting the sources, or if the Licensee's QMP had
provided specific procedures to verify correct source insertion,
these violations would likely have been averted. Therefore, based on
the fact that both events were due to the same root cause,
escalation on this factor was warranted.
With respect to the ``prior performance'' factor, while there is
no history in the quality management area given its recent
implementation, the Licensee's poor and declining overall
performance in the radiation safety area of the medical program
warrants escalation of the penalty on this factor, as set forth
above.
Regarding the ``identification'' factor, the NRC maintains that,
while the two misadministrations were self disclosing, the
associated quality management violations were identified by the NRC.
In both events, the Licensee did not identify the failure of the QMP
to include written policies and procedures to meet the objective
that each brachytherapy administration is verified to be to the
proper treatment site in accordance with the respective written
directive. In each case, the NRC identified the failure to establish
adequate written procedures to ensure the Licensee's proper
placement of brachytherapy source(s) at the prescribed treatment
site. Therefore, on balance, no adjustment by the NRC on this factor
was warranted.
With respect to the ``corrective action'' factor, the actions
taken in response to these violations were not considered
sufficiently prompt and comprehensive to warrant mitigation because
they were initially narrowly focused on the specific events, rather
than on root causes, the QMP and improvements necessary to increase
management oversight. The Licensee did implement additional training
and instruction in the loading and placement of brachytherapy
sources and applicators. However, the Licensee did not perform an
extensive and comprehensive root cause analysis of the two
misadministrations. The corrective actions were narrowly focused and
primarily directed at the performance of visual checks and
examinations of the sources and applicators before implantation. The
corrective actions did not include a comprehensive review of the QMP
procedures to determine what written modifications might be
necessary to ensure compliance with the failed objective and program
areas of concern. Additionally, the corrective actions failed to
address what changes in management oversight and involvement would
be incorporated into the Licensee's QMP to prevent recurrence of
similar events and improve supervision of brachytherapy activities.
Following the second event and discussions with NRC, a more
comprehensive approach was adopted. However, on balance, no
adjustment on this factor is warranted.
NRC Conclusion
The NRC concludes that the Licensee has not provided an adequate
basis for mitigating any portion of the civil penalties.
Accordingly, the NRC has determined that monetary civil penalties in
the amount of $10,000 should be imposed.
[FR Doc. 94-125 Filed 1-4-94; 8:45 am]
BILLING CODE 7590-01-M
