EA-99-284 - V.A., Department of, IL
December 15, 1999
Mr. John DeNardo, Director
Department of Veterans Affairs
Edward Hines, Jr. Hospital
Hines, IL 60141
|SUBJECT:||NOTICE OF VIOLATION
(NRC Inspection Report 030-01391/99001(DNMS))
Dear Mr. DeNardo:
This refers to the inspection conducted on September 27, 1999, with continued NRC review through November 8, 1999, at the Department of Veterans Affairs, Edward Hines, Jr. Hospital (VAMC Hines) in Hines, Illinois. The purpose of the inspection was to review the circumstances surrounding a reported brachytherapy misadministration. During the inspection, apparent violations of NRC requirements were identified, and are documented in the NRC inspection report sent to you by our letter dated December 1, 1999. In that letter, we indicated that NRC had sufficient information to proceed with enforcement action, however, you were given an opportunity to discuss the apparent violations at a predecisional enforcement conference or to address the apparent violations in writing. During the December 6, 1999, telephone conversation between Mr. L. Case of your staff, and Mr. G. Wright of my staff, VAMC Hines declined a conference and declined to provide additional written correspondence.
Based on the information developed during the inspection and the information provided in your report of misadministration dated October 5, 1999, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice).
The violations are indicative of weakness in the implementation of VAMC Hines quality management program (QMP). Specifically, ineffective training resulted in one individual failing to enter a treatment planning parameter into the console of the high dose rate (HDR) afterloader unit and a second individual failing to ensure the parameters were correctly entered and in accordance with the written directive prior to commencing treatment. As a result, an important factor was overlooked - the change in the starting point was not entered and dose was delivered to an unintended portion of the esophagus. It is likely that had the verification been performed, the misadministration would have been averted. Although we recognize that the misadministration did not likely cause any adverse effects to the patient, the violation is of concern because of the significant potential for serious patient treatment errors.
The QMP implementation weakness is further evidenced by another VAMC Hines employee, the therapist administering the treatment described above, failing to follow the two step patient identification procedure. Fortunately, there was no incident involved with this violation. Nonetheless, 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, the violations are categorized 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 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 based on the following corrective actions planned or taken: (1) the misadministration and its root cause were discussed with appropriate staff; (2) a memorandum of instructions was issued describing in detail the procedures to be followed by each staff member on keying in HDR skip treatments (Included in this instruction is a specific requirement for both individuals to inspect the pretreatment tape (GAMHUR card) against the data on the treatment record and the data on the screen before treatment); (3) the HDR planning and treatment record was revised to include signatures of individuals who checked the pretreatment tape against the data on the treatment record immediately before treatment; (4) the QMP was revised to include use of the pretreatment information from the simulated treatment to verify that the information not only agrees with the data entered into the console, but also agrees with the treatment data on the treatment record form; and (5) the QMP was revised to require methods of patient identification to be described in writing and signed by the individual identifying the patient.
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 problem constitutes escalated enforcement action that may subject you to increased inspection effort.
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 the inspection report and in your letter dated October 5, 1999. 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.
Docket No. 030-01391
License No. 12-01087-07
Enclosure: Notice of Violation
|Department of Veterans Affairs
Edward Hines, Jr. Hospital
|Docket No. 030-01391
License No. 12-01087-07
During an NRC inspection conducted on September 27, 1999, with continuing NRC review through November 8, 1999, 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 35.25(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 established by the licensee.
|A.||The licensee's quality
management procedure, dated July 15, 1994, Quality Management Program
for Teletherapy and Brachytherapy page 3, requires, in part, that
technologists, dosimetrists, or physicists entering treatment planning
parameters into the operating console of a remotely controlled afterloading
device will have their computer entries verified and documented, by
signature or initial, by a second technologist, dosimetrist, physicist
before commencing therapy.
Contrary to the above, on September 23, 1999, individuals under the supervision of the licensee's authorized user, did not follow the written quality management procedures established by the licensee in that treatment planning parameters entered into the operating console of a remotely controlled afterloading device were not verified and documented, by signature or initial, by a second technologist, dosimetrist, or physicist before commencing therapy. (01013)
|B.||The licensee's quality management procedure,
revised April 22, 1999, Quality Management Program for Teletherapy
and Brachytherapy page 2, requires, in part, that those administering
treatments will ask the patient to state their full name - first name
and last name. Additionally, they will ask the patient to state their
birth date. They will confirm both identifiers agree with the same
in the patient's chart.
Contrary to the above, on September 23, 1999, the identity of a therapy patient was not verified as required by the quality management program. Specifically, the therapist did not ask the patient to state their full name or date of birth. (01023)
These violations represent a Severity Level III problem (Supplement VI).
The NRC has concluded that information regarding the reasons for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence is already adequately addressed in the NRC inspection report and in a letter from Department of Veterans Affairs, Edward Hines, Jr. Hospital dated October 5, 1999. 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, 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 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.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 15th day of December 1999