EA-98-194 - Altoona Hospital
May 14, 1998
Dr. Warner F. Rhyner
Senior Vice President
620 Howard Avenue
Altoona, Pennsylvania 16603
|SUBJECT:||NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL
- $2,750 (NRC Inspection Report No. 030-03150/98-001)
Dear Dr. Rhyner:
This refers to the NRC inspection conducted on March 9 and 10, 1998, at your facility in Altoona, Pennsylvania, to determine whether activities authorized by your license were conducted safely and in accordance with NRC requirements. As described in the NRC inspection report sent to you on March 27, 1998, three apparent violations of NRC requirements were identified during the inspection. On April 30, 1998, a predecisional enforcement conference was conducted with you and Dr. Michael Vince, Radiation Safety Officer (RSO), to discuss the apparent violations, their causes, and your corrective actions. A copy of the enforcement conference report is enclosed.
Based on the information developed during the inspection, and the information provided during the conference, two violations of NRC requirements are being cited. The violations are described in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The violations involve: (1) the failure by your staff, on a number of occasions in 1997, to either prepare and use, or complete correctly, a written directive prior to the administration of iodine-131 to patients at the facility, contrary to your Quality Management Program (QMP); and (2) the failure to maintain appropriate security of the hot laboratory within which was located approximately three hundred millicuries of technetium-99m.
The NRC is particularly concerned with the first violation since a Notice of Violation was issued to you for a similar violation on February 21, 1997, after your RSO informed the NRC, in January 1997, of his identification of numerous instances in 1996 where written directives were not completed, yet iodine-131 was administered to patients. Although the RSO, when informing the NRC in early January 1997 of this finding, stated that full compliance had been achieved, only 22 days later, on January 29, 1997, another patient was administered a treatment without a written directive being completed. Subsequently, six other instances occurred during the remainder of 1997.
Although these failures to complete a written directive did not, in any case, result in a misadministration at the facility, these occurrences represent a substantial failure to implement the QMP required by 10 CFR 35.32. This failure was substantial given the number of occurrences and the repetitive nature of them, and the fact that the first recurrence happened in January 1997 so soon after you informed the NRC that the problem had been corrected. In addition, although you noted, at the enforcement conference, that training had previously been provided to the technicians regarding the need for written directives, these findings demonstrate that your training did not preclude recurrence of the violation. Furthermore, although you committed, in your March 5, 1997 response to the February 1997 Notice of Violation, to conduct quarterly audits of iodine-131 whole body scans to ensure continued compliance, you did not meet that commitment since only one such audit was conducted in the past year. Therefore, this violation is classified at Severity Level III in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation or problem. Because your facility has not been the subject of an escalated enforcement action 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. Your corrective actions included (1) monthly audits of all whole body scans to assure that written directives have been completed; (2) preparing a duplicate copy of each written directive for placement in the patient's file, as well as a newly created file for all written directives, to ensure they are not misplaced; (3) plans to have only a physician order iodine for scans; and (4) plans to provide tests to technicians to ensure that they fully understand requirements. While these actions are acceptable, credit for corrective actions is not warranted because they were not considered sufficiently comprehensive to warrant such credit. Specifically, you did not perform a thorough root cause analysis as to why the technicians did not ensure written directives were completed. In addition, your actions did not address the need for more active involvement by your authorized users who have the ultimate responsibility for authorizing such use. Also, your corrective actions were not timely, due to your failure to institute the quarterly audits that you had committed to in your March 5, 1997 letter. As a result, you missed opportunities for timely identification and subsequent correction of these numerous failures to comply with the QMP requirements.
Therefore, to emphasize the importance of appropriate management attention to the QMP, in general, and the need for written directives, in particular, I have been authorized to propose a civil penalty in the amount of $2,750 in this case.
In addition to this violation, a second violation is described in Section II of the enclosed Notice and involved the failure to maintain appropriate security of the hot lab at the facility in which approximately three hundred millicuries of technetium-99m were located during the inspection. This violation is classified at Severity Level IV because it did not create substantial potential for radiation exposure in excess of regulatory limits.
Further, one other apparent violation identified during the inspection and discussed in the inspection report, related to the training of technicians, is not being issued on the basis that the training had been provided.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and its enclosures, will be placed in the NRC Public Document Room (PDR).
|ORIGINAL SIGNED BY:
WILLIAM L. AXELSON
|FOR :Hubert J. Miller
Docket No. 030-03150
License No. 37-11826-01
1. Notice of Violation and Proposed Imposition of Civil Penalty
2. Enforcement Conference Report
Commonwealth of Pennsylvania
NOTICE OF VIOLATION
PROPOSED IMPOSITION OF CIVIL PENALTY
|Docket No. 030-03150
License No. 37-11826-01
EAs 98-194 and 98-202
During an NRC inspection conducted on March 9 and 10, 1998, two violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the NRC proposes a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282 and 10 CFR 2.205. The violations and associated civil penalty are set forth below:
|I.||VIOLATION ASSESSED A CIVIL PENALTY
|10 CFR 35.32 (a) (1) (iv) requires, in part, that a written directive
be prepared prior to administration of quantities greater than 30
microcuries of I-131.
|Contrary to the above, the licensee administered I-131 in quantities
greater than 30 microcuries to patients without preparing a written
directive. Specifically, during 1997, seven patients were administered
3 millicuries each of I-131, and the written directive as specified
in the licensee's Quality Management Program was not prepared. (01013)
|This violation is classified at Severity Level III (Supplement VI).|
| Civil Penalty - $2,750.
|II.||VIOLATION NOT ASSESSED A CIVIL PENALTY
|10 CFR 20.1801 requires that the licensee shall secure from unauthorized
removal or access licensed materials that are stored in controlled
or unrestricted areas.
|Contrary to the above, on March 10, 1998, the licensee did not secure
from unauthorized removal or limit access to approximately 100 millicuries
of Tc-99m located in the Hot Lab, an unrestricted area, nor did the
licensee control and maintain constant surveillance of this licensed
|This is a Severity Level IV violation (Supplement VI).|
Pursuant to the provisions of 10 CFR 2.201, Altoona Hospital is required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. If an adequate reply is not received within the time specified in this Notice, an Order or a Demand for Information may be issued as why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violation listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.
In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.
Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.
The response noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region I.
Because your response 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 King of Prussia, Pennsylvania
this 14th day of May 1998