EA-98-196 - Harper Hospital
April 10, 1998
Ms. Shirley Green
Vice President, Site Administrator
3990 John R. Street
Detroit, Michigan 48201
|SUBJECT:||NOTICE OF VIOLATION
(NRC Inspection Report 030-02045/98001(DNMS))
Dear Ms. Green:
This refers to the inspection conducted March 26 and 27, with continued NRC review through April 2, 1998, at Harper Hospital in Detroit, Michigan. The purpose of the inspection was to review the circumstances surrounding a reported misadministration. During the inspection, apparent violations of NRC requirements were identified. A copy of the NRC inspection report was mailed to you and sent by facsimile on April 8, 1998. You were given the opportunity to participate in a predecisional enforcement conference; however, in a telephone conversation between Gary Ezzell, Ph.D., and John Madera of this office on April 8, 1998, you declined a conference.
Based on the information developed during the inspection and the information provided in your April 6, 1998 report of misadministration, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report.
Violation A in the enclosed Notice is considered the primary cause of the misadministration and is indicative of a programmatic weakness in the implementation of your quality management program (QMP). Specifically, the written QMP failed to clearly address the verification procedures to be used to ensure that each administration is in accordance with a written directive. Although we recognize that the misadministration did not cause any adverse effect to the patient and all required notifications were made, the violation is of concern because such violations create the potential for serious errors in patient treatments. Incumbent upon each NRC licensee is the responsibility to ensure that all requirements of the NRC license are met and any potential violations of NRC requirements are identified and corrected expeditiously. Therefore, Violation A of the Notice is classified 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 $2,750 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.B.2 of the Enforcement Policy. Based upon the corrective actions taken following the inspection and those actions identified in your letter dated April 6, 1998, credit for Corrective Action was warranted. The corrective actions planned or taken include: (1) the individual responsible for the misadministration has received re-instruction reinforcing the need to have programs checked by another person; (2) the QMP will be modified by May 1, 1998, to clarify the instructions for checking calculations, programming, and all patient setup parameters; (3) the misadministration particulars has been discussed with all physics staff and each physicist will be required to read and understand the QMP and the physics policies; and (4) the QMP and related procedures will be reviewed at least annually.
Therefore, to encourage prompt and comprehensive correction of violations and in recognition of the absence of previous escalated enforcement action, 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 the Severity Level III violation constitutes escalated enforcement action that may subject you to increased inspection effort.
Violation B of the Notice addresses the failure to provide the NRC with a copy of your modified QMP. This violation is classified at a Severity Level IV.
The NRC has concluded that information regarding the reasons for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence are already adequately addressed in your letter dated April 6, 1998. 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, the enclosed Notice, and your response if you choose to respond, will be placed in the NRC Public Document Room.
Original Signed by
James Caldwell for
A. Bill Beach
Docket No. 030-02045
License No. 21-04127-02
Enclosure: Notice of Violation
NOTICE OF VIOLATION
|Docket No. 030-02045
License No. 21-04127-02
During an NRC inspection conducted on March 26 and 27, 1998, with continuing NRC review through April 2, 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:
A 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.
Pursuant to 10 CFR 35.32(a)(4), the QMP must include written policies and procedures to meet the specific objective that each administration is in accordance with a written directive, which is defined in 10 CFR 35.2.
Contrary to the above, the licensee's QMP failed to assure through its written policies and procedures that each patient setup on the High Dose Rate (HDR) afterloader is in accordance with the written directive. Specifically, HDR brachytherapy treatments administered on March 19 and 20, 1998, were administered to the wrong treatment site because the QMP procedures do not require that the treatment site be verified prior to the treatment. (01013)
This is a Severity Level III violation (Supplement VI).
B. 10 CFR 35.32(e) states the licensee may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased. The licensee shall furnish the modifications to the appropriate NRC Regional Office within 30 days after the modification has been made.
Contrary to the above, the licensee modified its quality management program in December 1997, and failed to furnish a copy of the modifications to the NRC Regional Office within 30 days after the modifications were made. Specifically, a copy was not provided until March 26, 1998. (01014)
This is a Severity Level IV violation (Supplement VI).
The NRC has concluded that information regarding the reasons for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence is already adequately addressed in a letter from Harper Hospital dated April 6, 1998. However, you are required to respond to the provisions of 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," 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, 801 Warrenville Road, Lisle, Illinois 60532-4351, within 30 days of the date of the letter transmitting this Notice of Violation.
If you contest this enforcement action, you should also provide a copy of your response 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 placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, it should not include any personal, privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. Under the authority of Section 182 of Act 42 U.S.C. 2232, any response shall be submitted under oath or affirmation.
Dated at Lisle, Illinois
this 10th day of April 1998