[Federal Register Volume 59, Number 19 (Friday, January 28, 1994)]
[Unknown Section]
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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