05000387/FIN-2012005-05
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Finding | |
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| Title | Concerns Regarding Ppls Program for Conducting Biennial Medical Examinations for Licensed Operators and Reporting Changes in Medical Conditions |
| Description | The inspectors identified an unresolved item (URI) related to licensed operator medical examinations and qualifications required by 10 CFR 55.53 and 10 CFR 55.21. Specifically, over a period of approximately four years, a number of licensed operators developed potentially disqualifying medical conditions which were not properly evaluated by PPL in accordance with ANSI/ANS-3.4-1983, American National Standard Medical Certification and Monitoring of Personnel Requiring Operator Licenses for Nuclear Power Plants. In addition, during this same time frame, there were a number of cases (i.e., both historical and current) where PPL potentially failed to notify the NRC of a change in medical condition within 30 days as required by 10 CFR 55.25. The inspectors concluded that there are a number of recently submitted submittals of PPL medical status updates that will require independent evaluation by the NRCs contract physicians before the NRC is able to determine whether the medical issues represented disqualifying conditions and; therefore, would constitute a violation of NRC requirements. In February 2012, PPL launched a root cause evaluation (CR 15167640) in response to a series of NRC findings from 2007 to present involving required NRC notifications not being made that affected license conditions of licensed operators. The root cause report was issued on April 17, 2012. As a result of this evaluation, on July 20, 2012, PPL submitted ten medical updates to the NRC. Four of the ten submittals reported permanent changes in medical conditions that were not submitted in a timely manner as required and six others were submitted to the NRC as Information Only. PPL later resubmitted three of the six Information Only submittals adding conditions to the licenses after follow-up questioning from the NRC contract doctor. Examples of license conditions included Solo Operations is Not Authorized and Shall Submit Medical Status Report Every 12 Months. In addition, PPL staff initiated CR 1597808 on July 12, 2012, when PPLs interviews conducted with the MRO and site nurse as part of a root cause corrective action (CRA 1567782) revealed they are not adequately familiar with regulatory responsibilities contained in 10 CFR 55.23, ANSI 3.4, and the NRC Medical FAQs. During the week of July 16, 2012, the inspectors conducted a follow-up interview with the Licensed Operator Requalification Training (LORT) supervisor who was assigned overall responsibility for follow-up to the root cause investigation and corrective actions. On July 17, 2012, the inspectors asked the LORT supervisor why neither the primary root cause (Susquehanna lacks a formal process to maintain NRC licensed operator status to ensure appropriate notifications are made) or causal factors pointed to the inadequate training and oversight of the MRO and examining physician or assigned corrective actions to address these issues. On July 18, 2012, PPL revised the root cause (CRA 1600109) to include training of the MRO and nurse as a root cause and assigned corrective actions to address this issue. On August 16, 2012, the MRO called the NRC inspectors to discuss questions that had been previously posed to PPL staff by the inspectors. The MRO stated that he was assigned to his position in 2008. The MRO stated that he was not given any turnover or training regarding ANSI 3.4 or 10 CFR 55 requirements and that he relied on the inhouse nurse for her experience and insights. Through this discussion, the inspectors identified that licensed operator medical examinations were coordinated by the site nurse but the examinations were actually conducted at the Berwick Hospital by another physician. The site nurse, the MRO of record, and the doctor that actually performed the medical examinations at Berwick Hospital were interviewed by the inspectors to determine their process for conducting these examinations and for notifying the NRC when a change in medical condition requires the operators license to be conditioned. The interviews also established their prior understanding of the ANSI standard and 10 CFR 55. As a result of their interviews the inspectors identified the following information which was not identified in PPLs Root Cause Analysis: The inspectors confirmed that the MRO was not provided a turnover or training regarding ANSI 3.4 or 10 CFR 55 but learned by on-the-job performance as discussed in the August 16 call with NRC inspectors. The inspectors identified that the MRO does not actually perform the operator medical examinations and, as a rule, he does not actually meet with or examine the licensed operators during the medical exam process. The exams were actually performed by a physician and his staff at Berwick Hospital and then the records were faxed back to the nurse for later review by the nurse and the MRO. The inspectors identified that the NRC Form 396s, Certification of Medical Examination by Facility Licensee, sent to the NRC had not been completed accurately in the past since the physicians name that had actually performed the medical examinations was not entered on the part A of the form as required. The inspectors identified that, in April 2010, Susquehanna Form 4294, Licensed Operator Medical Requirements, was incorrectly revised by the MRO (i.e., the revisions did not accurately reflect disqualifying conditions as indicated in ANSI/ANS- 3.4-1983). This Form was given to the physician actually performing the medical examinations at Berwick Hospital as a checklist to highlight ANSI disqualifying medical conditions. The inspectors identified that the doctor at Berwick Hospital, who had been performing the physical examinations for the past twenty years, had not been trained on either ANSI 3.4 or 10 CFR 55. The licensed operator medical issues identified in the past four years (i.e., both current as well as historical) appear to be associated with PPLs failure to properly train and provide oversight for their MRO and the Berwick examining physician regarding compliance with the requirements of ANSI/ANS-3.4-1983 and 10 CFR 55. The medical issues identified during this time frame appear to be related to a lack of knowledge and inadequate oversight. The inspectors noted the following guidance applies: ANSI/ANS-3.4-1983, states in part, 3. Health Evaluation Responsibility, 3.1 General Aspects. The primary responsibility for assuring that qualified personnel are on duty rests with the facility operator. The health requirements set forth herein are considered the minimum necessary to determine that the physical condition and general health of the individual are not such as might cause operational errors endangering public health and safety. The designated medical examiner shall be conversant with this standard and should have a general understanding of activities required of a nuclear reactor operator. Susquehanna Procedure, NTP-QA-31.12, Revision 5, Preparation and Submission of NRC Form 396 - Certification of Medical Examination by facility Licensee and NRC Form 398 - Personal Qualifications Statement - Licensee, section 6.3.11, states in part, The Consulting Physician reviews the results against the medical standards set forth in ANSI/ANS 3.4 -1983...completes the medical section of Form NRC- 396 for employees seeking Initial Licensure and Six-Year License Renewal or any change in medical condition. Consulting Physician may also request a waiver or a specifically limited approval when an employee\\\'s general medical condition does not meet the minimum standard, i.e., wear corrective lenses. These requests are documented on Form NRC-396 and other medical history and pertinent medical documentation are attached. NRC Form 396, Certification of Medical Examination by Facility Licensee, Part A, Medical Examination Information, provides the physicians name, license number, and most recent biennial medical examination date for the applicant that was examined and states in part, I certify that in reaching this determination the guidance in the ANSI standard...was followed, and that documentation is available for review by the NRC. In addition, page two of the Instructions for NRC FORM 396, states in part, ...the physician has the ultimate responsibility for certifying that the medical examination was conducted in accordance with the ANSI standard and the applicant meets the medical requirements. The inspectors concluded that PPLs failure to properly identify potentially disqualifying medical conditions resulted in failure to notify the NRC of these changes in medical conditions within 30 days, and in some cases may have affected the operators ability to comply with operator license conditions that should have been in affect while standing watch. This was a performance deficiency within PPLs ability to foresee and correct and should have been prevented. The NRC has issued conditioned individual operator licensees which address the potentially disqualifying conditions for the operators. PPL has recently submitted several PPL medical status updates for the cases in question that will require independent evaluation by the NRCs contract physicians. The inspectors determined that these concerns represent a URI. Completion of an independent evaluation by the NRC contract doctors is required before the NRC is able to determine whether medical issues represented disqualifying conditions and, therefore, would constitute a violation of NRC requirements. |
| Site: | Susquehanna  |
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| Report | IR 05000387/2012005 Section 4OA2 |
| Date counted | Dec 31, 2012 (2012Q4) |
| Type: | URI: |
| cornerstone | Mitigating Systems |
| Identified by: | NRC identified |
| Inspection Procedure: | IP 71152 |
| Inspectors (proximate) | C Miller J Caruso T Hedigana Bolgera Rosebrook C Lally J Caruso J Furia J Greives J Richmond M Gray P Finney R Edwards R Rolph |
| INPO aspect | |
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Finding - Susquehanna - IR 05000387/2012005 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Finding List (Susquehanna) @ 2012Q4
Self-Identified List (Susquehanna)
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