[Federal Register Volume 59, Number 19 (Friday, January 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1870]
[Federal Register: January 28, 1994]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-09792, License No. 13-02752-08 EA 93-111]
Indiana University School of Medicine; Indianapolis, IN; Order
Imposing Civil Monetary Penalty
I
Indiana University School of Medicine (licensee) is the holder of
Byproduct Material License No. 13-02752-08 issued by the Nuclear
Regulatory Commission (NRC or Commission) on September 26, 1973. The
license was amended in its entirety on October 6, 1989, and is due to
expire on November 30, 1994. The license was most recently amended on
April 9, 1992. The license authorizes the licensee to possess Cobalt-60
sealed teletherapy sources for medical use described in 10 CFR 35.600
and for irradiation of blood and blood products in accordance with the
conditions specified therein.
II
An inspection of the licensee's activities was conducted on
December 14, 1992, through January 13, 1993. The results of this
inspection indicated that the licensee had not conducted its activities
in full compliance with NRC requirements. A written Notice of Violation
and Proposed Imposition of Civil Penalty (Notice) was served upon the
licensee by letter dated October 7, 1993. The Notice states the nature
of the violation, the provisions of the NRC's requirements that the
licensee had violated, and the amount of the civil penalty proposed for
the violation. The licensee responded to the Notice by a letter dated
October 29, 1993. In its response, the licensee disputes the validity
of the cited violation. Further, the licensee takes exception to the
NRC Staff's application of the civil penalty adjustment factors in the
areas of identification and licensee performance.
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 violation occurred as stated and that the penalty
proposed for the violation 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 a civil penalty in the amount of $5,000 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 the 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,
ATTN: 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 III, 801
Warrenville Road, Lisle, Illinois 60532-4351
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 the Notice referenced in Section II above,
and
(b) Whether, on the basis of such violation, this order should be
sustained.
Dated at Rockville, Maryland this 18th day of January 1994.
For the Nuclear Regulatory Commission.
James Lieberman,
Director Office of Enforcement.
Appendix
Evaluation and Conclusion
On October 7, 1993, a Notice of Violation and Proposed
Imposition of Civil Penalty (Notice) was issued for a violation
identified during an NRC inspection on December 14, 1992, through
January 13, 1993. Indiana University School of Medicine responded to
the Notice in a letter dated October 29, 1993. In its response, the
licensee disputes the validity of the cited violation. Further, the
licensee takes exception to the NRC Staff's application of
identification and licensee performance civil penalty adjustment
factors. The NRC's evaluation and conclusions regarding the
licensee's requests are as follows:
Restatement of Violation
10 CFR 35.32(a) states, in part, that each licensee shall
establish and maintain a written quality management program to
provide high confidence that radiation from byproduct material will
be administered as directed by the authorized user. Pursuant to 10
CFR 35.32(a) (1) and (3), the quality management program must
include written policies and procedures to meet specific objectives
that: (1) Prior to administration, a written directive is prepared
for any teletherapy radiation dose; and (2) final plans of treatment
and related calculations for teletherapy are in accordance with the
written directive.
10 CFR 35.2 defines a written directive as an order in writing
for a specific patient, dated and signed by an authorized user prior
to administration of radiation and containing, for teletherapy, the
following information: The total dose, dose per fraction, treatment
site, and overall treatment period.
Contrary to the above, as of January 13, 1993, the licensee's
quality management program for teletherapy dated January 16, 1992,
did not have a procedure for: (1) Ensuring the written directive
contained the total dose, dose per fraction, treatment site, and
overall treatment period and (2) verifying the dose calculations for
administrations of three fractions or less to confirm that the final
plans of treatment are in accordance with the written directive.
Consequently, on November 13, 1992, the licensee's authorized user
signed and dated a written directive for teletherapy treatment that
failed to include the overall treatment period and the licensee
failed to verify the dose calculations, since the treatment called
for less than 3 fractions, to ensure the final plans of treatment
were in accordance with the written directive.
Summary of Licensee's Response to the Violation
The licensee disputes the validity of the cited violation, the
assigned Severity Level, and the NRC root cause analysis, as
follows:
1. The licensee asserts that the proposed violation did not
cause the misadministration even though the written directive did
include the overall treatment period. In the written directive for
the patient treated November 13, 1992, the number of fractions is
written as ``2 fx'' which means the treatment period is to include
two fractions or treatments. This is the licensee's interpretation
of the overall treatment period. The licensee asserts that the term
``overall treatment period'' is not defined in the regulations or in
Regulatory Guide 8.33. According to the licensee, the presence or
absence of the documentation of the overall treatment period would
have no bearing on the initial interpretational error made by the
dosimetrist or the subsequent oversights by individuals who were
verifying the correctness of the treatment.
2. The licensee notes that the treatment was performed on an
emergency basis and that this fact causes the standard verification
procedure to change depending upon the availability of staff.
According to the licensee, while neither the Quality Control/Quality
Assurance Program (QA/QCP) nor the Quality Management Program (QMP)
include specific procedures for verification when less than four
treatments are prescribed, no change in the subsequent chart
checking procedures would have resulted because the treatment in
question as an emergency.
The licensee also asserts that it verified the dose calculations
in that the prescribing physician/authorized user and two radiation
therapists attempted to verify that the treatment to be delivered
was in accordance with the written directive. According to the
licensee, while none of these individuals identified the
calculational error made by the dosimetrist, their failure to
identify the error was related to the wording of the written
directive rather than the failure to follow proper procedure.
3. The licensee challenges the categorization of the proposed
violation as a Severity Level III violation. The licensee asserts
that the misadministration occurred due to inconsistencies in the
format of the written directive, and that the QMP was followed and
the appropriate checks were made. According to the licensee, the
violation would be more appropriately categorized at Severity Level
IV since it does not represent a programmatic weakness in the
implementation of the QMP, the failure was isolated to the single
event, and the consequences were limited and did not adversely
affect the patient.
4. The licensee disagrees with the NRC's statement that, ``The
violation contributed to the occurrence of a misadministration on
November 13, 1992.''
NRC Evaluation of Licensee's Response to the Violation
This enforcement action focuses on the licensee's failure to
develop and implement an adequate QMP. As a result of the
misadministration, the NRC performed a detailed review of the
licensee's QMP during the followup inspection and enforcement
deliberations. The result of this detailed review was that the NRC
identified substantial deficiencies. The inspection determined that
the licensee's written QMP did not have procedures for: (1) Ensuring
that the written directive contained the total dose, dose per
fraction, treatment site, and the overall treatment period; and (2)
verifying the dose calculations for administrations of three
fractions or less to confirm that the final plans of treatment are
in accordance with the written directive. The licensee has not
provided any information to demonstrate that its written QMP
addressed these procedures. These deficiencies represent a
programmatic (as opposed to isolated) failure in the implementation
of the QMP; therefore, the violation was categorized at Severity
Level III in accordance with the NRC Enforcement Policy, Supplement
VI.C.6 (57 FR 5792).
NRC has defined the term ``overall treatment period'' in the
Statement of Considerations for the QMP rule (56 FR 34104).
According to the Statement of Considerations, ``the phrase `overall
treatment period' was added to emphasize that the treatments will
end after the specified number of weeks, unless the treatment period
is revised by the authorized user prior to continuing.'' Therefore,
the treatment period is a unit of time and not the number of
fractions as used in the licensee's definition.
The licensee argues that three different individuals (the
authorized user and two radiation therapists) attempted to verify
that the treatment to be delivered was in accordance with the
written directive, and that the failure to identify the error was
related to the working of the written directive rather than a
failure to follow proper procedure. However, the same authorized
user had created the written directive that same afternoon.
Therefore, it is extremely unlikely that his failure to identify the
error was related to the wording of his own written directive. The
licensee's QMP procedure required that the authorized user review
and initial the treatment chart to verify that he had reviewed the
written prescription and the calculated dose per fraction. As noted
in the inspection report, the information written on the patient
chart clearly indicated that the dose per fraction was incorrect. It
appears that the authorized user initialed the chart and that his
review was cursory or inadequate.
Moreover, the violation focuses on the fact that, while the
licensee's QMP requires that a physics staff member review the
accuracy of all dosimetric calculations for treatments that are
delivered in four or more fractions, it has no equivalent provision
for treatments that are delivered in less than four fractions. Had
such an independent review been required by the Licensee's QMP and
performed in this case, the error could have been avoided.
The Licensee's QMP waived review of dose calculations by the
physics staff member for extenuating circumstances such as staff
shortages and emergency treatments. Neither the QMP regulations nor
the accompanying regulatory guide suggest that this independent
review may be waived for staff shortages or emergent treatments,
such as those that must be performed after working hours. A footnote
to 10 CFR 35.32(a)(1) states, ``if, because of the emergent nature
of the patient's medical condition, a delay in order to provide a
written directive would jeopardize the patient's health, an oral
directive will be acceptable, provided that the information
contained in the oral directive is documented immediately in the
patient's record and a written directive is prepared within 24 hours
of the oral directive.'' Neither 10 CFR 35.32(a) nor the footnote
permit the waiving of the independent review of the dosimetric
calculations due to the emergent nature of a treatment. The
independent verification is especially important during times when
the licensee is more subject to error such as with staff shortages
and emergent treatments.
Based on the above, the NRC concludes that the violation did
occur as stated, and that there was not an adequate basis for a
reduction of the severity level.
Summary of Licensee's Request for Mitigation
1. Identification
The licensee asserts that the NRC improperly takes credit for
identifying the proposed violation of the QMP because the QMP was
submitted to the NRC approximately 1.5 years ago in accordance with
10 CFR 35.32(f)(2); and, since that submission, the licensee has
received no indication that the QMP was deficient. According to the
licensee, the ``less than four treatment'' deficiency was detected
concurrently by the NRC and the licensee as a result of this
misadministration; and therefore, escalation of enforcement based on
the NRC's claim of identifying the deficiency is inappropriate.
2. Licensee Performance
The licensee asserts that the NRC improperly escalated the base
civil penalty by 100 percent for ``poor past performance'' and notes
that this was apparently due to a misadministration which occurred
in May of 1990, some 2.5 years before the most recent one. According
to the licensee, while the NRC claims that these two
misadministrations were ``similar'', the only similarities were that
they were both brain treatments and the dose per fraction was
doubled. The licensee notes that the dissimilarities include an
emergency treatment versus treatment during normal working hours, a
short-term versus a more conventional long-term treatment, and a
single port treatment versus a multiple port treatment. According to
the licensee, there appears to be no relationship between the causes
of the two misadministrations. The licensee indicates that this
escalation implies that the NRC's sole evaluation of past
performance relates to the number of misadministrations which have
occurred and been reported over an undefined period of time. The
licensee points out that the May 1990 misadministration was
discovered through its QA/QCP and, until January of 1992, most
licensees were not required to have any type of QMP; therefore,
comparing the licensee's performance to that of other licensees in
not appropriate (i.e., other licensees may have had
misadministrations which went undetected due to the fact that they
had no QMP).
The licensee asserts that while a QMP helps reduce the
possibility of misadministrations, normal statistical probabilities
would predict that the potential for misadministrations will
increase with the number of patient treatments due to human error.
In the licensee's particular instance, its Radiation Oncology
Department treated approximately 1418 patients including some 52,000
separate treatments with external beam therapy during the time
interval between the two misadministrations. Five hundred and
eighteen (518) of those patients (approximately 15,000 separate
treatments) were specifically treated with cobalt-60 teletherapy.
According to the licensee, one patient with two ports in error is a
very small percentage of the overall number of treatments and should
not be sufficient to escalate a civil penalty based upon ``poor past
performance.''
NRC Evaluation of Licensee's Request for Mitigation
1. Identification
Licensees may not expect, or rely on, NRC to identify safety
problems or violations for them. The Enforcement Policy provides
that the purpose of the identification factor is to encourage
licensees to monitor, supervise, and audit activities in order to
assure safety and compliance. By the licensee's own admission, it
did not detect the problems noted in the violation during the 1.5
years that its QMP has been in existence, nor is there any evidence
that the licensee identified the specific problems noted in the
violation before NRC did. For example, these problems are not noted
in the licensee's December 17, 1992 misadministration report, which
includes a section entitled, ``Improvements and Actions Taken to
Prevent Recurrence.''
Based on the above, the NRC concludes that 50 percent escalation
of the base civil penalty is warranted for NRC identification.
2. Licensee Performance
The NRC Enforcement Policy states that prior performance refers
to the licensee's performance normally (1) within the last two years
of the inspection at issue, or (2) the period within the last two
inspections, whichever is longer. On this case the period covered by
the last two inspections is applicable, i.e., two inspections prior
to the inspection at issue. The two previous inspections to be
considered are the inspection conducted on September 11, 1991, and
the inspection conducted on May 21-23, 1990.
The NRC did not compare the licensee's performance with other
licensees. The Enforcement Policy provides that the effectiveness of
previous corrective action for similar problems is a consideration
in assessing the licensee performance factor. The May 1990
inspection was conducted to review the circumstances surrounding a
teletherapy misadministration. The physicist performing the
treatment dose calculation misinterpreted the physician's written
prescription. The error continued undetected despite at least four
separate opportunities for the dosimetry and physician staffs and
several opportunities for the technologists to identify the problem.
In its misadministration report of May 24, 1990, the licensee noted
that loss of objectivity was a causative factor in that the various
QA checks had not been performed as an independent review. The
licensee's corrective action was to turn an existing requirement
that the authorized user initial the chart before the treatment
begins into a full QA check involving a review by the physician of,
among other things, the calculated dose per fraction. A memorandum
entitled ``Chart checking of treatment doses and calculations'' was
circulated to emphasize to physicians and other key personnel the
importance of vigilant and critically minded checking of doses and
dose calculations. Thus, the NRC concludes that the root causes of
the misadministrations are sufficiently similar to warrant
escalation for past performance.
The licensee also argues good past performance in that a very
small percentage of its treatments were misadministrations. On the
contrary, the NRC is concerned that the licensee was performing a
high volume of treatments with a deficient QMP.
Based on the above, 100 percent escalation of the base civil
penalty is warranted for poor licensee performance.
NRC Conclusion
Based on its evaluation of the licensee's response, the NRC
staff concludes that the violation did occur as stated, and that
neither an adequate basis for a reduction of the severity level nor
for mitigation of the civil penalty has been provided by the
licensee. Accordingly, NRC concludes that a civil monetary penalty
of $5,000 should be imposed by order.
[FR Doc. 94-1870 Filed 1-27-94; 8:45 am]
BILLING CODE 7590-01-M
