United States Nuclear Regulatory Commission - Protecting People and the Environment

EA-04-129 - William Beaumont Hospital

September 14, 2004

EA-04-129
NMED No. 040415

John Labriola
Senior Vice President and
  Hospital Director
William Beaumont Hospital
3601 West Thirteen Mile Road
Royal Oak, Michigan 48073

SUBJECT:   NOTICE OF VIOLATION
[NRC Special Inspection Report No. 030-02006/2004-01 (DNMS)]

Dear Mr. Labriola:

This refers to the special inspection conducted on June 10, 2004, at the William Beaumont
Hospital, Royal Oak, Michigan, with continuing in-office review through June 28, 2004, of a medical event which occurred on June 8, 2004. The event involved the unintended administration of 915 microcuries of liquid iodine-131 (I-131), instead of the prescribed 10 microcuries, to a patient for a thyroid uptake study. Your staff reported the event to the Nuclear Regulatory Commission (NRC) via telephone on June 8, and provided a written report on June 18, 2004. The NRC identified one apparent violation, for the administration of a dosage of I-131 which differed by more than 20 percent from the prescribed dosage. The inspection report was provided to you on July 22, 2004.

In the letter transmitting the inspection report, we provided you the opportunity to address the apparent violation identified in the report by either attending a predecisional enforcement conference or providing a written response before we made our final enforcement decision. In a letter dated August 11, 2004, you provided a response to the apparent violation.

Based on the information developed during the inspection, and the information that you provided in your June 18, 2004 report and your August 11, 2004 letter, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The violation involved administering a dosage of I-131 to a patient for a thyroid uptake study that was approximately 90 times larger than the 10-microcurie dosage prescribed by the authorized user physician. In summary, a radiopharmacy technologist prepared the dosage from a low specific activity I-131 bulk solution using a pipette that was used earlier in the day to prepare a dosage from a high activity bulk solution. Residual material in the pipette from the high activity solution resulted in the activity of this dose being much higher than expected. The technologist checked the dosage in the dose calibrator which indicated an activity of 0.915 millicuries (915 microcuries) and placed a label on the dose reading 0.915 millicuries. The technologist apparently incorrectly converted the units of measurement and believed that an activity of 9.15 microcuries of I-131 was present instead of the actual activity of 915 microcuries. A nuclear medicine technologist who picked up the dose from the pharmacy, also failed to identify its incorrect activity when reading the label indicating 0.915 millicuries, and administered it to the patient. While a dosage of this activity could be expected to result in some impairment of the function of the patient’s thyroid, the actual safety significance of this event was reduced because the patient was scheduled to receive a much larger therapeutic dosage the next day. Notwithstanding the circumstances of this event, we expect that your management oversight of the use of NRC licensed materials will ensure that during patient dose verification an appropriate level of attention will be applied by your staff to ensure that the patient receives the dose that was prescribed. Because of its potential safety significance, the administration of a dosage of liquid I-131 which differed from the prescribed dosage by more than 20 percent has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III violation.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $3,000 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit is warranted because your corrective actions were considered prompt and comprehensive. These corrective actions included, but were not limited to: (1) using new pipettes for each iodine-131 uptake dose; (2) changing computer software to allow the uptake doses to be checked against a standard, prescribed dosage; and (3) training nuclear medicine staff to ensure that prescribed doses are administered as directed by the authorized user.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized, after consultation with the Director, Office of Enforcement, 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 violation constitutes escalated enforcement action, that may subject you to increased inspection effort.

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance was achieved, is already adequately addressed on the docket in your June 18, 2004 event report and your August 11, 2004 letter. 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 addition, in your August 11, 2004 letter, you suggested several minor corrections to the content of our July 22, 2004 inspection report. We have addressed your suggested corrections in Enclosure 2.

In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response (should you choose to respond) will be made available electronically for public inspection in the NRC Public Document Room or from the NRC’s document system (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction. The NRC also includes significant enforcement actions on its Web site at www.nrc.gov; select What We Do, Enforcement, then Significant Enforcement Actions.

 

Sincerely,

  /RA/ Geoffrey E. Grant for

  James L. Caldwell
Regional Administrator

Docket No. 030-02006
License No. 21-01333-01

Enclosures:
1. Notice of Violation
2. Corrections to Inspection Report

cc w/encls:
Mr. John P. Hartwig, Chairman of the
  Board, William Beaumont Hospital


NOTICE OF VIOLATION

William Beaumont Hospital Docket No. 030-02006
Royal Oak, Michigan License No. 21-01333-01
  EA-04-129

During an NRC inspection conducted on June 10, 2004, with continuing in-office review through June 28, 2004, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

10 CFR 35.63(d) provides that unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent.

Contrary to the above, on June 8, 2004, the authorized user prescribed a dosage of 10 microcuries of liquid iodine-131 for a thyroid uptake study. However, the patient was administered 915 microcuries, a dosage which differs from the prescribed dosage by more than 20 percent.

This is a Severity Level III Violation (Supplement VI).

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance was achieved, is already adequately addressed on the docket in the licensee’s June 18, 2004 event report and the licensee’s August 11, 2004 letter. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein 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, EA-04-093,” and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555 with a copy to the Regional Administrator, Region III, within 30 days of the date of the letter transmitting this Notice of Violation (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, D.C. 20555-0001.

If you choose to respond, your response will be made available electronically for public inspection in the NRC Public Document Room or from the NRC’s document system (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. Therefore, to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the public without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.390(b) to support a request for withholding confidential commercial or financial information).

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 14th day of September 2004.

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