EA-98-523 - Sinai Hospital
December 18, 1998
Senior Vice President Administration
6767 West Outer Drive
Detroit, MI 48236
|SUBJECT:||NOTICE OF VIOLATION
(NRC Inspection Report 030-00252/98001(DNMS))
Dear Ms. Regling:
This refers to the inspection conducted on October 28 through November 9, 1998, at Sinai Hospital (Sinai) in Detroit, Michigan. The inspection was conducted to review the circumstances surrounding a reported cobalt-60 teletherapy misadministration. Three apparent violations of your quality management program (QMP) were identified and considered for escalated enforcement action. These apparent violations are described in the inspection report sent to you by letter dated November 27, 1998. A predecisional enforcement conference was held on December 16, 1998, in the NRC Region III office to discuss the apparent violations, the root causes, and the corrective actions planned or taken.
Based on the information developed during the inspection, the information provided in Sinai's letters dated October 30 and November 16, 1998, and the information provided during the conference, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The violations involve: (1) failure to assure that the treatment was in accordance with the written directive by checking dose calculations within three working days of initiation of treatment, (2) failure of the treating therapists to compare the written directive with the calculations each day of treatment, and (3) failure of the staff to perform weekly chart checks to verify treatment parameters were in accordance with the written directive.
The misadministration occurred when a patient received in one week a dose that was twice the prescribed weekly dose. An error occurred when incorrect dose information was used in the dose calculation. If Sinai's staff had fully implemented Sinai's QMP, the incorrect dose per fraction would not have continued through the seventh day of treatment and the misadministration likely would not have occurred. The fact that a number of staff were involved with this treatment over a period of several days and no one noticed the error until the eighth day, indicates a significant programmatic weakness in the implementation of the QMP. Although we recognize that the misadministration did not cause any adverse effects to the patient and all required notifications were made, the violations are of concern to NRC because, if allowed to continue, more serious consequences could potentially arise with future patient treatments.
Therefore, these violations are classified in the aggregate in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 as a Severity Level III problem.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is normally considered for a Severity Level III problem. Because your facility has been the subject of escalated enforcement actions within the last two inspections,(1) the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Since your staff identified the violations and exercised considerable effort to determine the root cause, credit for identification is warranted. The NRC has also determined that credit is warranted for the corrective actions taken and/or planned. The actions include: (1) dosimetry calculations will be logged in a separate binder by the person performing the task; (2) the therapists will verify the physician's written directive with that information entered in the treatment verification system; (3) chart checks will be scheduled to be completed before Friday of each week and the site specialist will insure that they are completed before the end of the work week; (4) the therapy staff will be reminded of the department's procedure for documenting calculation checks in the chart and of the policy that treatments are not to be given beyond the specified number of fractions without a documented check and this point will be included in the annual QMP in-service training sessions; (5) the supervisory staff will conduct random quality assurance audits to ensure compliance; and (6) all therapy staff have been informed of the incident and everyone who works with the cobalt-60 teletherapy unit has received refresher training on the contents and implementation of the QMP.
Therefore, to encourage prompt identification and comprehensive correction of violations, I have been authorized not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level III problem constitutes escalated enforcement action that may subject you to increased inspection effort.
During the conference your staff provided a written statement addressing apparent inaccuracies in the subject inspection report. We have reviewed the noted inaccuracies and concluded that no revision to the attached Notice was warranted. We will address these statements in the conference summary report to be provided to you by separate correspondence.
The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance will be (was) achieved is already adequately addressed on the docket in Inspection Report 030-00252/98001(DNMS). Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response, if you choose to provide one, will be placed in the NRC Public Document Room.
|Original Signed By
|James L. Caldwell
Acting Regional Administrator
Docket No. 030-00252
License No. 21-00299-06
Enclosure: Notice of Violation
NOTICE OF VIOLATION
During an NRC inspection conducted on October 28 through November 9, 1998, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:
10 CFR 35.32(a) requires, in part, that the licensee establish and maintain a written quality management program (QMP) to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user.
|A.||The licensee's written QMP revised September 9, 1994,
in the paragraph titled "Treatment Plan/Calculation(s) Check," requires
that dose calculations be checked within three working days after
the administration of the first teletherapy dose.
Contrary to the above, on October 8 and 9, 1998, dose calculations
were made by the physicist and the dosimetrist, respectively, and
neither calculation was checked within three working days after
administration of the first teletherapy dose. (01013)
|B.||The licensee's written QMP, revised September 9, 1994, in the paragraph
titled "Execution of the Written Directive," requires that before
administering each teletherapy dose, the specific details of the administration
be verified. For example, the dose per fraction shall be confirmed
by the person administering the teletherapy treatment to verify agreement
with the latest written directive and plan of treatment.
Contrary to the above, on October 12, 13, 14, 15 and 16, 1998,
the persons administering the teletherapy treatments did not verify
agreement with the latest written directive and plan of treatment.
Specifically, the dose per fraction was not verified before administering
each teletherapy dose. (01023)
|C.||The licensee's QMP, revised September 9, 1994, in the paragraph
titled "Weekly Chart Checks," requires that the treatment charts of
all patients undergoing treatment in Radiation Oncology be checked
by a qualified person on a weekly basis to detect mistakes that may
have occurred in the daily and cumulative teletherapy dose administrations
from all treatment fields, or in connection with any changes in the
written directive or plan of treatment.
Contrary to the above, during the week of October 12, 1998, and on several occasions during the months of August, September and October 1998, all treatment charts of patients undergoing treatment in Radiation Oncology were not checked by a qualified person on a weekly basis. (01033)
These violations represent a Severity Level III problem (Supplement VI).
The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence and the date when full compliance will be achieved is already adequately addressed on the docket in Inspection Report 030-00252/98001(DNMS). However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description herein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region III, 801 Warrenville Road, Lisle, Illinois 60137, within 30 days of the date of the letter transmitting this Notice.
If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.
If you choose to respond your response will be placed in the NRC Public Document Room (PDR). Therefore to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 18th day of December 1998
1. A Severity Level III violation was issued on September 21, 1994 (EA 94-168) for a violation of a QMP procedural requirement.