EA-98-023 - MedCentral Health System
March 6, 1998
James Meyer, President
MedCentral Health System
335 Glessner Avenue
Mansfield, OH 44903
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report 030-00407/98001(DNMS))
Dear Mr. Meyer:
This refers to the inspection conducted on January 5 through 21, 1998 at the MedCentral Health System located in Mansfield, Ohio. The purpose of the inspection was to review a reported teletherapy misadministration and to determine whether activities authorized by the license were conducted in accordance with NRC requirements. The subject inspection report documenting our findings was sent to you by a letter dated January 29, 1998. As indicated in our letter, apparent violations were identified which involved teletherapy operations and the reported misadministration. You were given the option of participating in a predecisional enforcement conference or submitting a written response to the apparent violations. You chose to submit a written response dated February 26, 1998.
Based on the information developed during the inspection and the information provided in your February 26 response to the inspection report, 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 the subject inspection report. The violations involve failure to follow specific items of your quality management program (QMP), such as performance of second calculations by the technologists and second checks by the physicist to verify the correctness of the calculations. In addition, the violations include failure to perform reviews of modified written directives to ensure that all of the information is correct and on the record prior to administering the third patient treatment. As a result of these failures to fully implement the QMP, a misadministration occurred.
Although the misadministration did not appear to adversely effect the health of the patient and was properly reported to the NRC, the NRC is very concerned about the implementation of your QMP because these violations represent a breakdown in a program designed to reduce the probability of treatment errors. During the inspection, we learned that the QMP had been changed several times without appropriate NRC notification and apparently without conducting adequate personnel training. We believe that these factors contributed to the misadministration. The NRC expects each entity licensed by the NRC to use byproduct material responsibly by ensuring that the rules, regulations and license conditions are followed at all times. Failure to fully implement your QMP program and the resulting misadministration is a matter of significant regulatory concern to the NRC. 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 considered for a Severity Level III problem. Because your facility has not been the subject of escalated enforcement actions within the last two years or 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. Credit for corrective action is warranted because your actions were both prompt and comprehensive. These actions included, but were not limited to: (1) implementation of an improved check-off form used to document each step in the treatment series, (2) modifications were made to the QMP to clearly define the procedures for oral and written revisions to the written directive, and (3) appropriate staff is being or has been provided with training on the revised QMP procedures.
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 this Severity Level III problem constitutes escalated enforcement action, that may subject you to increased inspection effort.
The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violation and prevent recurrence and the date when full compliance will be achieved is already adequately addressed on the docket in Inspection Report 030-00407/98001(DNMS) and the letter from the licensee dated February 26, 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, its enclosure, and your response, if you choose to respond, will be placed in the NRC Public Document Room.
Original Signed by
James L. Caldwell for
A. Bill Beach
Docket No. 030-00407
License No. 34-02007-02
Enclosure: Notice of Violation
NOTICE OF VIOLATION
|MedCentral Health System
|Docket No. 030-00407
License No. 34-02007-02
During an NRC inspection conducted on January 5 and 6, 1998 with continuing NRC review through January 21, 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:
1. 10 CFR 35.25(a)(2) requires, in part, that a licensee that permits the use of byproduct material by an individual under the supervision of an authorized user shall require the supervised individual to follow the written quality management procedures (QMP) established by the licensee.
a. Part III of the QMP revised October 1997 titled "2nd Calculation," requires, in part, the primary technologist to perform a second calculation prior to the second treatment.
Contrary to the above, on December 11, 1997, a second calculation was not performed by a primary therapy technologist prior to a second teletherapy treatment. (01013)
b. Part IV of the QMP revised October 1997 titled "Physicist's Check," requires, in part, that after the second calculation has been performed, the calculations are checked by the physicist before the second treatment if the total number of treatments is equal to or less than ten or daily dose more than 300 rads.
Contrary to the above, the physicist did not check the calculations after the second calculation was performed and before the second treatment was given as required. Specifically, on December 13, 1997, the physicist rechecked the technologist's second calculation after three of the five fractionated treatments had been administered. (01023)
c. Part I of the QMP revised October 1997 titled "Pre-Treatment," requires, in part, that for all modified charts, the primary therapist should read the information in the chart and confirm that the modified prescription is signed and dated. If the above information is not complete, treatment should not be given.
Contrary to the above, on December 10, 1997, the primary therapy technologist did not follow the established written quality management procedure in that the technologist failed to ensure that the modified prescription was signed and dated by the authorized user prior to the treatment. (01033)
d. Part I of the QMP revised October 1997 titled "Pre-Treatment," requires, in part, that for all modified charts the primary therapist should read the information in the chart.
Contrary to the above, on December 10, 1997 the primary therapy technologist did not read the chart. (01043)
2. 10 CFR 35.32(e) requires, in part, that the licensee to furnish quality management program modifications to the appropriate NRC Regional Office within 30 days of making the changes.
Contrary to the above requirement, the licensee modified its quality management program on December 15, 1995, and again in October 1997 and the licensee failed to furnish the modifications to the NRC Regional Office within 30 days after the modifications were made. (02053)
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 violation and prevent recurrence and the date when full compliance will be achieved is already adequately addressed on the docket in Inspection Report 030-00407/98001(DNMS) and a letter from the licensee dated February 26, 1998. 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" 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 to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, D.C. 20555-0001.
Because your response, should you choose to send one, will be placed in the NRC Public Document Room (PDR), 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. 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 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
Dated at Lisle, Illinois
this 6th day of March 1998