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{{Adams
#REDIRECT [[IR 05000387/2012005]]
| number = ML13168A020
| issue date = 06/17/2013
| title = IR 05000387-13-008, 05000388-13-008, 08/28/2012 to 04/5/2013, Susquehanna Steam Electric Station, Units 1 and 2, NRC Follow-up to Unresolved Item 05000387-12-005, 05000388-12-005-05, Concerns Regarding PPLs Program for Conducting Biennial M
| author name = Miller C G
| author affiliation = NRC/RGN-I/DRS
| addressee name = Rausch T S
| addressee affiliation = PPL Susquehanna, LLC
| docket = 05000387, 05000388
| license number = NPF-014, NPF-022
| contact person =
| document report number = IR-13-008
| document type = Inspection Report, Letter
| page count = 21
}}
 
{{IR-Nav| site = 05000387 | year = 2013 | report number = 008 }}
 
=Text=
{{#Wiki_filter:UNITED STATES  NUCLEAR REGULATORY COMMISSION    REGION I  2100 RENAISSANCE BOULEVARD, SUITE 100 KING OF PRUSSIA, PENNSYLVANIA 19406-2713 June 17, 2013 EA-12-216
 
Mr. Timothy Senior Vice President and Chief Nuclear Officer
 
PPL Susquehanna, LLC
 
769 Salem Blvd, NUCSB3 Berwick, PA 18603-0467
 
SUBJECT: SUSQUEHANNA STEAM ELECTRIC STATION - NRC IP 92701 FOLLOWUP INSPECTION REPORT 05000387/2013008 AND 05000388/2013008
 
==Dear Mr. Rausch:==
On April 5, 2013, the U. S. Nuclear Regulatory Commission (NRC) completed an inspection at PPL Susquehanna LLC's (PPL) Susquehanna Steam Electric Station, Units 1 and 2 (SSES).
 
The enclosed inspection report presents the inspection results, which were discussed with you and other members of your staff during a preliminary exit meeting on [[Exit meeting date::May 13, 2013]], and again during a final exit meeting on [[Exit meeting date::May 22, 2013]].
 
This inspection examined activities conducted under your license as they relate to safety and compliance with the Commission's rules and regulations and with the conditions of your license.
 
The inspectors interviewed personnel, reviewed selected procedures and records, event evaluations, root causes, relevant performance history, and corrective actions planned and completed to assess the significance and potential consequences related to these issues.
 
Based on the results of this inspection, two apparent violations (AV) of NRC requirements were identified related to licensed operator medical examinations and incorporating appropriate restrictions into individual operator licenses. The AVs are described in detail in the enclosed inspection report. The NRC notes that PPL has taken appropriate immediate corrective actions such that the apparent violations do not represent an immediate safety concern. However, the apparent violations are being considered for escalated enforcement action in accordance with the NRC Enforcement Policy. The current Enforcement Policy is included on the NRC's Web site at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html.
 
The circumstances surrounding these apparent violations, the significance of the issues, and the need for lasting and effective corrective action were discussed with members of your staff at the aforementioned inspection exit meeting on [[Exit meeting date::May 22, 2013]]. As a result, the NRC does not require a pre-decisional enforcement conference (PEC) in order to make an enforcement decision. However, before the NRC makes its enforcement decision, we are providing you an opportunity to provide your perspective on these matters, including the significance, causes, and corrective actions, as well as any other information that you believe the NRC should take into consideration by: (1) requesting a PEC to meet with the NRC and provide your views in person; (2) responding to the apparent violations in writing; or, (3) accepting the violations as characterized in the enclosed inspection report and notifying us of that decision within 10 days. If you choose to request a PEC, the meeting should be held within 30 days of the date of this letter, and will be open for public observation. The NRC will issue a press release to announce the time and date of the conference. If you choose to provide a written response on these
 
matters, it should be sent to the NRC within 30 days of the date of this letter. Your response may reference or include previously docketed correspondence, if the correspondence adequately addresses the required response. You should clearly mark the response as a
"Response to Apparent Violations in Inspection Report Nos. 05000387; -388/2013008; EA-12-216," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555-0001 with a copy to the Regional Administrator, Region I, and a copy to the NRC Senior Resident Inspector at SSES.
 
Please contact Donald Jackson, Chief-Operations Branch, NRC, Region I, Division of Reactor Safety, at 610-337-5306 within 10 days of the date of this letter to let him know whether you are interested in attending a PEC or providing a written response. You may also elect to accept the violations as characterized in this letter and the inspection report, in which case the NRC will proceed with its enforcement decision. Please be advised that the number of violations and characterization of the AVs described in the enclosed inspection report may change as a result of further NRC review.
 
In addition, this report documents one NRC-identified associated finding of very low safety significance (Green). If you disagree with the cross-cutting aspect assigned to the finding in this report, you should provide a response within 30 days of the date of the inspection report, with the basis for your disagreement, to the Regional Administrator, Region I, and the NRC Senior Resident Inspector at SSES.
 
In accordance with Title 10 of the Code of Federal Regulation (10 CFR) Part 2.390 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response (if any) will be available electronically for public inspection in the NRC Public Document Room and from the Publicly Available Records (PARS) com ponent of NRC's document system, Agencywide Documents Access and Management System (ADAMS). ADAMS is accessible from the NRC Website at http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room).
 
Sincerely,/RA/ Christopher G. Miller, Director Division of Reactor Safety Docket Nos. 50-387, 50-388
 
License Nos. NPF-14, NPF-22
 
===Enclosure:===
Inspection Report 05000387/2013008 and 05000388/2013008
 
===w/Attachments:===
Supplemental Information (Attachment 1)
 
cc w/encl: Distribution via ListServ
 
ML13168A020 SUNSI Review Non-Sensitive Sensitive Publicly Available Non-Publicly Available OFFICE RI/DRS RI/DRP RI/DRP RI/OE RI/DRS NAME JCaruso/TEH for DJackson/DEJ MGray MMcLaughlin CMiller DATE 05/30/2013 05/30/2013 06/06/2013 06/10/2013 06/17/2013 Distribution w/encl: (via e-mail)
W. Dean, RA (R1ORAMAIL Resource)
D. Lew, DRA (R1ORAMAIL Resource)
D. Roberts, DRP (R1DRPMAIL Resource) M. Layton, DRP (R1DRPMail Resource)
C. Miller, DRS (R1DRSMail Resource)
J. Clifford, DRS (R1DRSMail Resource) M. Gray, DRP S. Barber, DRP
 
A. Rosebrook, DRP A. Turilin, DRP P. Finney, DRP, SRI J. Greives, DRP, RI
 
S. Farrell, DRP, AA D. Huyck, RI OEDO RidsNrrPMSusquehanna Resource
 
RidsNrrDorlLpl1-2 Resource ROPreports Resource D. Jackson, DRS
 
T. Hedigan, DRS D. Holody, ORA M. McLaughlin, ORA G. Gulla, OE M. Halter, NRR
 
i Enclosure U. S. NUCLEAR REGULATORY COMMISSION REGION I Docket Nos.: 50-387, 50-388
 
License Nos.: NPF-14, NPF-22
 
Report Nos.: 05000387/2013008, 05000388/2013008
 
Licensee: PPL Susquehanna, LLC (PPL)
 
Facility: Susquehanna Steam Electric Station
 
Location: Berwick, Pennsylvania
 
Dates: August 28, 2012 through April 5, 2013
 
Inspectors: John Caruso, Senior Operations Engineer Division of Reactor Safety Tom Hedigan, Operations Engineer Division of Reactor Safety
 
Approved By: Christopher G. Miller, Director Division of Reactor Safety
 
ii    Enclosure
 
=SUMMARY OF FINDINGS=
IR 05000387/2013008, 05000388/2013008, 08/28/2012 - 04/5/2013; Susquehanna Steam
 
Electric Station; Units 1 and 2; NRC Follow-up to Unresolved Item 05000387/2012005, 05000388/2012005-05, Concerns Regarding PPLs Program for Conducting Biennial Medical Exams for Licensed Operators and Repor ting Changes in Medical Conditions Two regional inspectors conducted this inspection. The inspectors identified two apparent violations (AV) which are being considered for escalated enforcement action in accordance with the NRC Enforcement Policy. In addition, the in spectors identified an associated finding (FIN) of very low safety significance (Green). The significance of most findings is indicated by their color (Green, White, Yellow, or Red) using Inspection Manual Chapter (IMC) 0609, "Significance Determination Process" (SDP), dated June 2, 2011. Cross-cutting aspects are determined using IMC 0310, "Components Within Cross-Cutting Areas," dated October 28, 2011. All violations of NRC requirements are dispositioned in accordance with the NRC's Enforcement Policy, dated January 28, 2013. The current Enforcement Policy is included on the NRC's Web site at  http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The NRC's program for overseeing the safe operation of commercial nuclear power reactors is described in NUREG-1649, "Reactor Oversight Process," Revision 4.
 
A. Inspectors-Identified and Self-Revealed Findings
 
===Cornerstone: Mitigating Systems===
 
AV. The inspectors identified:  1) an apparent violation (AV) of Title 10 of the Code of Federal Regulations (10 CFR) 55.21, "Medical Examination;" Part 55.25 "Incapacitation because of disability or illness;"  Part 55.33, "Disposition of an Initial Application," for the failure of the licensee to restrict operators from performing licensed duties when they had disqualifying medical conditions; and 10 CFR 50.74, "Notification of change in operator or senior operator status," for PPL's failure to notify the NRC within 30 days of  changes in licensed operators' medical conditions; and, 2) a related finding of very low safety significance (Green) for PPL's failure to implement effective corrective actions to prevent this recurring AV.
 
Specifically, the inspectors identified that four licensed operators developed disqualifying medical conditions that were not properly evaluated by PPL staff in accordance with ANSI/ANS-3.4-1983, "American National Standard Medical Certification and Monitoring of Personnel Requiring Operator Licenses for Nuclear Power Plants."  Additionally, PPL did not restrict the operators from performing licensed duties or obtain NRC approval (by requesting conditioned licenses) to continue to perform licensed duties, which caused the operators to not meet the requirements of 10 CFR 55.33(a)(1). Additionally, the inspectors identified eight instances in which PPL failed to notify the NRC within 30 days of learning of changes in licensed operator medical conditions that involved permanent disabilities/illnesses as required by 10 CFR 50.74. This resulted in the operators performing licensed operator duties without properly restricted licenses. PPL has taken actions to correct these issues by formally notifying the NRC and requesting conditioned licenses, as necessary, training  the licensed operators and medical staff in the iii applicable requirements, and revising related procedures to provide additional guidance and require annual training. PPL entered this issue into their corrective action program. (CR-1709539)
 
The inspectors reviewed this issue in accordance with NRC IMC 0612, Appendix B, "Issue Screening" for traditional enforcement and as part of the Reactor Oversight process (ROP). Under the ROP, the inspectors also identified a related finding of very low safety significance (Green) involving PPL's failure to prevent this recurring AV.
 
Traditional Enforcement Basis for  AV:  The inspectors determined that PPL's failure to ensure that licensed operators met the license conditions associated with minimum medical qualifications prior to performing license activities and failure to notify the NRC of the changes within 30 days was a performance deficiency that was within PPL's ability to foresee and correct and should have been prevented. Specifically, the inspectors determined that four operators with disqualifying medical conditions continued to stand watch in the control room. Additionally, the NRC identified eight instances where changes occurred in licensee medical conditions that involved permanent disabilities and/or illnesses but were not reported within 30 days as required.
 
The inspectors determined that Traditional Enforcement (TE) applies because the issue impacted the NRC's ability to perform its regulatory function. Namely, the NRC relies upon PPL to ensure all licensed operators meet the medical conditions of their licenses.
 
10 CFR 55.25 requires that if, during the term of the individual operator license, the operator develops a permanent physical or mental disability that causes the operator to fail to meet the requirements of 55.21 of this part, the facility licensee shall notify the Commission, within 30 days of learning of the diagnosis, in accordance with 10 CFR 50.74(c). PPL failed to properly identify that operators had disqualifying medical conditions and also did not restrict the operators from performing licensed duties. These issues are being characterized as an apparent violation in accordance with the NRC's Enforcement Policy, and its final significance will be dispositioned in separate future correspondence.  (Section 4OA2.1)
 
ROP Green Finding Basis:  Since 2008, PPL has been issued three Severity Level (SL) IV violations and one SL III violation related to the medical qualifications of their licensed operators. PPL procedure, NDAP-QA-0702, "ACTION REQUEST AND CONDITION REPORT PROCESS," Revision 39, defines a Significant Condition Adverse to Quality (SCAQ) as a condition determined to be significant enough to warrant a root cause analysis and actions to prevent recurrence.  (For significant conditions adverse to quality, the causes of the deficiency shall be determined and corrective actions shall be taken to preclude recurrence). NDAP-QA-0702 Attachment M, lists "a Severity Level III or greater NRC Notice of Violation (NOV)," as an example of a SCAQ. Following the 2009 SL III NOV, PPL failed to identify the causes of the condition that led to the SCAQ, and the extent of cause and condition reviews were ineffective to identify additional issues. The inspectors determined that PPL's failure to implement adequate corrective actions to prevent this recurrence in response to these previous violations was an associated performance deficiency that was within PPL's ability to foresee and correct and should have been prevented.
 
iv The performance deficiency is more than minor because, if left uncorrected, having operators stand watch with disqualifying medical conditions has the potential to lead to a more significant safety concern. The inspectors evaluated this finding using IMC 0609,
Attachment 4, "Initial Characterization of Findings," and IMC 0609, Appendix A, "The Significance Determination Process (SDP) for Findings At-Power," Exhibit 2, "Mitigating Systems Screening Questions."  All questions in Exhibit 2 were answered "no" and therefore this associated finding was determined to be of very low safety significance (Green). This issue is indicative of current performance and is determined to have a cross-cutting issue in the area of Problem Identification and Resolution - Evaluation P.1(c), related to thorough evaluation of problems. Specifically, PPL's reviews following the issuance of similar violations in 2009 and 2011, did not identify the additional cases discovered in 2012, and PPL's root cause evaluation completed in 2012, did not identify a root and several contributing causes, which were subsequently identified by the NRC inspectors.  (Section 4OA2.1)
 
AV. The inspectors identified an AV of 10 CFR 50.9, "Completeness and Accuracy of Information," related to PPL's failure to provide information to the NRC regarding medical examinations of licensed operators that was complete and accurate in all material respects. Specifically, PPL submitted three NRC licensed operator renewal applications and one initial license application, each of which certified the medical fitness of the applicants and that no restricting license conditions were necessary. However, the applicants, in fact, each had medical conditions that did not meet the minimum standards of 10 CFR 55.33(a)(1) and required license conditions to be in place in order for the operators to perform licensed activities. PPL entered this issue into their corrective action program.  (CR-1709540)
The inspectors determined that PPL's failure to provide complete and accurate information to the NRC was a performance deficiency that was within PPL's ability to foresee and correct and should have been prevented. The inspectors determined that TE applies, as the issue impacted the NRC's ability to perform its regulatory function.
 
Specifically, the NRC issued new and/or renewed licenses to the operators based on information that was not complete and accurate in all material respects. The performance deficiency was screened against the ROP per the guidance of IMC 0612,
Appendix B, "lssue Screening."  No associated ROP finding was identified and no cross-cutting aspect was assigned. This issue constitutes an apparent violation in accordance with the NRC's Enforcement Policy, and its final significance will be dispositioned in separate future correspondence.  (4OA2.1)
 
===B. Licensee-Identified Violations===
 
No violations of significance were identified.
 
=REPORT DETAILS=
 
{{a|4OA2}}
==4OA2 Follow-up Inspection==
{{IP sample|IP=IP 92701|count=1}}
 
===.1 Review of Unresolved Item===
 
====a. Inspection Scope====
The inspectors documented an unresolved item (URI) on February 13, 2013, in NRC Integrated Inspection Report 05000387/2012005 and 05000388/2012005 related to PPL Susquehanna, LLC's (PPL) process for conducting biennial medical exams for licensed operators and reporting to the NRC changes in operators' medical conditions. The issues were documented in a URI because the NRC physician had not completed his review of the medical records. In addition, between August 2012 and April 2013, the
 
inspectors reviewed additional medical submittals and associated corrective actions to ensure compliance with NRC requirements.
 
Since 2008, PPL has been issued three Severity Level (SL) IV violations and one SL III violation related to the medical qualifications of its licensed reactor operators. As a result of these, and other licensed operator reporting issues (some licensee-identified),
PPL staff completed a detailed evaluation of these repetative problems, PPL staff reviewed the medical records of all of its licensed operators and, as a result, on July 20, 2012, submitted ten medical updates to the NRC. Four of the ten updates
 
involved permanent changes in medical conditions that had not been previously submitted within the required 30 days. The other six submittals involved conditions that PPL initially stated were being provided to the NRC "for information only."  However, the NRC independently identified (i.e., as a result of reviews conducted by the NRC contract physicians) that three of these six "Information Only" submittals actually involved operators with permanent changes in medical conditions. These medical conditions did not meet the minimum standards to conduct licensed activities and, therefore, the affected operators should have been removed from licensed activities or conditions added to their licenses before being permitted to continue watch standing. In addition, in December 2012, PPL submitted updates to the NRC for three other individuals that had medical conditions (sleep apnea) that had not been reported in a timely manner as required. Based on questioning of the Medical Review Officer (MRO) and examining physician, NRC inspectors in consultation wi th NRC contract physicians determined that the individuals did not have the requisite knowledge of the American National Standards Institute/American Nuclear Society (ANSI/ANS) 3.4-1983, "American National Standard Medical Certification and Monitoring of Personnel Requiring Operator Licenses for
 
Nuclear Power Plants."
 
The inspectors determined that PPL's root cause analysis (RCA) did not identify either as a root or contributing cause that the MRO and examining physician at Berwick Hospital were not provided adequate training and oversight nor did the root cause assign corrective actions to address these issues. PPL staff responded to the inspectors' concern and initiated a Level 3 Evaluation (CR 1597808) on October 5, 2012, and assigned corrective actions (CRA 1600109) to include training of the MRO and nurse.
 
The training for the MRO was completed on November 14, 2012, and for the site nurse on December 10, 2012. NDAP-QA-0723, "PPL-Susquehanna NRC Operator and Medical Notification Process", Revision 2, dated March 27, 2013, added a requirement in Section 4.9.1.c to provide annual refresher training to the MRO and nurse and also for them to attend the  annual medical conference hosted by the industry. However, the inspectors observed that the procedure revision did not address initial training if a new MRO or nurse is hired. PPL staff initiated CR 1688211 to address this issue. Additionally PPL hired a contract company with specialized knowledge of the NRC requirements in this area to oversee its licensed operator medical program. The inspectors concluded that the corrective actions implemented by the licensee addressed the problem.
 
====b. Findings====
===.1
 
=====Introduction:=====
===
The inspectors identified: 1) an Apparent Violation (AV) of 10 CFR 55.21, "Medical examination," Title 10 of the Code of Federal Regulations 10 CFR 55.25, "Incapacitation because of disability or illness," for the failure of the licensee to restrict operators from performing licensed duties when they had disqualifying medical conditions and 10 CFR 50.74, "Notification of change in operator or senior operator status," for failure to notify the NRC within 30 days of a change in medical condition; and, 2) a related Green ROP finding consistent with the guidance in IMC 0612, Appendix B, "Issue Screening" for PPL's failure to implement effective corrective actions to prevent this recurring AV.
 
=====Description:=====
The inspectors identified four licensed operators that developed disqualifying medical conditions that were not properly evaluated by PPL staff in accordance with ANSI/ANS-3.4-1983, "American National Standard Medical Certification and Monitoring of Personnel Requiring Operator Licenses for Nuclear Power Plants."  Additionally PPL staff did not restrict the operators from performing licensed duties or obtain NRC approval (by requesting conditional licenses) to continue to perform licensed duties, which caused the operators to not meet the requirements of 10 CFR 55.33(a)(1).
 
Eight additional instances were identified (four identified by PPL and four identified by NRC) in which PPL staff failed to notify the NRC within 30 days of learning of changes in licensed operator medical conditions that involved permanent disabilities and/or illnesses as required by 10 CFR 50.74. This resulted in the operators performing licensed operator duties without properly conditioned licenses. ANSI 3.4, Section 5.3 Disqualifying Conditions, states in part, "A history or other indication of any disqualifying condition shall be considered disqualifying unless adequate supplemental findings demonstrate that no disqualifying condition exists-  The presence of any of the following conditions, unless adequately compensated by the methods specified in
 
subsections-  shall disqualify the individual."  The four most significant examples of operators with disqualifying conditions are described below:
 
===1. The first example involved an operator who, on October 25, 2011, reported to PPL medical personnel that he had been diagnosed as having asthma/chronic obstructive pulmonary disease (COPD), which is listed as a potentially disqualifying medical ===
 
condition in ANSI/ANS 3.4, Section 5.3.1, "Respiratory."  On July 20, 2012, PPL submitted an NRC Form 396 to the NRC that described the pulmonary medication the operator was required to take and requested a conditioned license for the
 
additional medication required to treat the condition. The NRC contract physician reviewed the NRC Form 396 and requested additional information regarding the operator's medical status. Subsequently, PPL submitted an updated NRC Form 396 on December 12, 2012, and requested that the operator's license be conditioned to prohibit him from solo operations and require a 6 month medical update, due to PPL's determination that the operator's medical condition could result in sudden incapacitation. However, PPL should have restricted the operator from licensed duties and requested a conditioned license upon first learning of the operator's condition in October 2011, but did not.
 
2. The second example involved an operator who was diagnosed on June 4, 2012, as having coronary artery disease, which is listed as a potentially disqualifying medical condition in ANSI/ANS 3.4, Section 5.3.2, "Cardiovascular."  On July 20, 2012, PPL submitted an NRC Form 396 to the NRC "for information only", that described the operator's medical condition, but did not include a request for a conditioned license (i.e., individual had a history of chest discomfort, licensee noted in remarks cardiac stress test indicated cardiac abnormality - a cardiac evaluation with a cardiologist was recommended). The NRC contract physician reviewed the NRC Form 396 and requested additional information, including a cardiology evaluation to ascertain the
 
operator's cardiac status. Subsequently, PPL staff submitted an updated NRC Form 396 on November 21, 2012, requesting that the operator's license be conditioned to prohibit him from solo operations and require a 6 month medical update, due to PPL's determination that the operator's coronary artery disease with multiple risk factors put him at high risk for sudden incapacitation. However, the inspectors determined PPL should have restricted the operator from licensed duties and requested a conditioned license upon first learning of the operators's condition in June 2012, but did not.
 
===3. The third example involved an operator who exhibited persistent and deteriorating pulmonary function tests over several years, and who, as of November 2010, had ===
 
informed PPL that he had been prescribed the use of an inhaler for asthma, which is listed as a potentially disqualifying medical condition in ANSI/ANS 3.4, Section 5.3.1, "Respiratory."  On July 20, 2012, PPL submitted an NRC Form 396 to the NRC "for information only" that described the operator's medical condition, but did not include a request for a conditioned license. The submittal indicated persistent and deteriorating pulmonary function tests over the previous several years. The NRC contract physician reviewed the NRC Form 396 and requested additional information, including a full pulmonary evaluation. Subsequently, PPL submitted an updated NRC Form 396 on December 3, 2012, requesting that the operator's license be conditioned to prohibit him from solo operations and require a 6 month medical update, due to PPL's assessment that the operator was unable to perform fire brigade or emergency response functions and due to the operator's need for a prescribed inhaler because of the risk of an acute asthma attack that can cause sudden incapacitation. However, PPL should have restricted the operator from licensed duties and requested a conditioned license upon first learning of the operator's condition in May 2012, but did not.
 
===4. The fourth example involved an operator who had been taking medication since November 2011 for stress-related anxiety, which is listed as a potentially ===
 
disqualifying medical condition in ANSI/ANS 3.4, Section 5.3.8, "Mental."  On July 20, 2012, PPL submitted an NRC Form 396 to the NRC "for information only," that identified an additional medication for anxiety, but did not include a request for any additional changes in license conditions. The NRC contract physician reviewed the NRC Form 396 and requested additional info rmation, including documentation of a clinical assessment. Subsequently, PPL submitted an updated NRC Form 396 on December 4, 2012, requesting that the operator's license be conditioned to require a 12 month medical update, due to PPL's assessment that the operator's anxiety and depression required an annual psychological evaluation and monitoring. However, PPL should have restricted the operator from licensed duties and requested a conditioned license upon first learning of the operator's condition in May 2011, but did not.
 
The other four examples involve two reactor operators (RO) and two senior reactor operators (SRO) who had, on separate occasions between August 2007 and July 2011, been diagnosed with sleep apnea, required to wear corrective lenses, or prescribed medication for a non-disqualifying condition. Although these issues did not constitute medical conditions described in ANSI/ANS 3.4-1983 as disqualifying conditions, they did involve permanent disabilities and/or illnesses that were required to be reported to the NRC within 30 days and that required conditions to be added to the operators' licenses.
 
The Root Cause Analysis (RCA) that the PPL staff completed in 2012 identified a number of programmatic issues and ineffective corrective actions following the 2009 and 2011 NOVs. However, the NRC inspectors determined that PPL's RCA missed the following causes: 
 
The MRO did not receive formal training on the ANSI/ANS-3.4-1983 standard or NRC regulatory requirements. The MRO assumed responsibility in 2007; and at that time was not provided a turnover or training regarding ANSI or 10 CFR Part 55, but learned the responsibilities of the job over time. As a result, the MRO did not understand the ANSI/ANS standard he was certifying the examinations were being completed against.  (Root Cause)
PPL did not identify vulnerabilities in the Medical Examination process. Through interviews the inspector determined that the MRO did not perform the medical exams nor did he meet with or examine the licensed operators during the medical exam process. The exams were performed by another physician and his staff at Berwick Hospital, and subsequently records were faxed to the nurse for later review by the nurse and the MRO. As a result, NRC Form 396s, "Certification of Medical Examination by Facility Licensee" sent to the NRC had not been completed accurately in the past because the physician's name who performed the medical exams was not entered on part A of the form as required.  (Contributing Cause)
The inspectors determined Susquehanna Form 4294, "Licensed Operator Medical Requirements" was inaccurate. 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 pr ovided to the physician performing the medical exams at Berwick Hospital as a checklist to highlight ANSI disqualifying medical conditions.  (Contributing Cause)
The inspectors determined the doctor performing the medical examinations did not have knowledge of the ANSI/ANS-3.4-1983 standard or NRC regulatory requirements. The doctor at Berwick Hospital that had been performing the physical exams for many years had not been trained, nor did he have knowledge of the existence of either ANSI 3.4 or 10 CFR Part 55. Thus although the examinations were thorough and identified the deficient medical conditions, the doctor did not know which conditions were disqualifying (i.e., except for those listed on PPL Form 4294, which was incorrect) so that he could alert the MRO or PPL.  (Contributing Cause)
 
As a result, from 2009 until 2013, disqualifying medical conditions continued to be identified, but the conditions were not properly addressed. Subsequently, licensed operators with identified disqualifying medical conditions continued performing licensed operator duties without properly conditioned licenses that would ensure the disqualifying conditions were appropriately addressed. Specifically, three of the four operators identified by the NRC had cardiac or respiratory conditions with an increased potential for sudden incapacitation. In a high stress scenario where respiratory equipment was required, such as during a postulated main control room evacuation due to a fire, there was an increased potential that these operators may become incapacitated and unable to carry out risk significant operator actions. PPL staff corrected these issues by
 
submitting NRC 396 forms which led to modifica tions of their Part 55 licenses, revised procedures, and provided training of the licensed operators and medical staff.
 
=====Analysis:=====
The inspectors reviewed this issue in accordance with NRC Inspection Manual Chapter (IMC) 0612, Appendix B, "Issue Screening" for traditional enforcement and as part of the Reactor Oversight process (ROP). Under the ROP, the inspectors also identified a related finding of very low safety significance (Green) involving PPL's failure to prevent this recurring AV.
 
Traditional Enforcement Basis for AV:  The inspectors determined that PPL's failure to ensure that licensed operators met the license conditions associated with minimum medical qualifications prior to performing license activities and failure to notify the NRC of the changes within 30 days was a performance deficiency that was within PPL's ability to foresee and correct and should have been prevented. Specifically, the inspectors determined that four operators with disqualifying medical conditions continued to stand watch with no license restrictions. Additionally, eight submittals involved changes in licensee medical conditions that had not been reported within 30 days, as required.
 
The inspectors determined that Traditional Enforcement applies, as the issue impacted the NRC's ability to perform its regulatory function, because the NRC relies upon the licensee to ensure all licensed operators meet the medical conditions of their license.
 
10 CFR 55.25 requires that if, during the term of the license, the licensee develops a permanent physical or mental disability that causes the licensee to fail to meet the requirements of 55.21 of this part, the facility licensee shall notify the Commission, within 30 days of learning of the diagnosis, in accordance with 10 CFR 50.74(c). PPL failed to properly identify that operators had disqualifying medical conditions and also did not appropriately restrict the operators from performing licensed duties.
 
ROP Green Finding Basis:  Since 2008, PPL has been issued three SL IV violations and one SL III violation related to the medical qualifications of its licensed reactor operators.
 
PPL procedure, NDAP-QA-0702, "ACTION REQUEST AND CONDITION REPORT PROCESS," Revision 39, defines a Significant Condition Adverse to Quality (SCAQ) as a condition determined to be significant enough to warrant a root cause analysis and actions to prevent recurrence. For significant conditions adverse to quality, the cause of the deficiency shall be determined and corrective actions shall be taken to preclude recurrence. NDAP-QA-0702 Attachment M, lists "a SL III or greater NRC Notice of Violation (NOV)," as an example of a SCAQ. Following the 2009 SL III NOV, PPL failed to identify the cause of the condition which led to the SCAQ, and the extent of cause and condition reviews were ineffective to identify additional issues. The inspectors determined that PPL's failure to implement adequate corrective actions to prevent this recurrence was an associated performance deficiency that was within PPL's ability to foresee and correct and should have been prevented.
 
The performance deficiency is more than minor because, if left uncorrected, having operators stand watch with disqualifying medical conditions has the potential to lead to a more significant safety concern.
 
The issue was evaluated using IMC 0609, Attachment 4, "Initial Characterization of Findings," and IMC 0609, Appendix A, "The Significance Determination Process (SDP)for Findings At-Power," "Exhibit 2-Mitigating Systems Screening Questions."  All questions in Exhibit 2 were answered "no" and therefore this associated finding was determined to be of very low safety significance (Green). This issue is indicative of current performance and is determined to have a cross-cutting issue in the area of Problem Identification and Resolution - Evaluation P.1(c), "The licensee thoroughly evaluates problems such that the resolutions address causes and extent of conditions, as necessary. This includes properly classifying, prioritizing, and evaluating for operability and reportability conditions adverse to quality. This also includes, for significant problems, conducting effectiveness reviews of corrective actions to ensure that the problems are resolved."  Specifically, PPL's reviews following the issuance of similar violations in 2009 and 2011, did not identify the additional similar cases discovered in 2012, and PPL's root cause evaluation completed in 2012, did not identify a root and several contributing causes, which were subsequently identified by the NRC inspectors.
 
=====Enforcement:=====
10 CFR 55.3 requires, in part, that a person must be authorized by a license issued by the Commission to perform the function of a licensed reactor operator or a licensed senior reactor operator as defined in Part 55.
 
10 CFR 50.74(c) requires, in part, that each facility licensee notify the appropriate NRC Regional Administrator within 30 days of a permanent disability or illness as described in 10 CFR 55.25 involving a licensed operator or licensed senior reactor operator.
 
10 CFR 55.25 requires, in part, that if a licensed reactor operator or licensed senior reactor operator develops a permanent physical condition that causes the licensed
 
operator to fail to meet the requirements of 10 CFR 55.21, the facility must notify the NRC within 30 days of learning of the diagnosis. For conditions where a license condition is required, the facility licensee must provide medical certification on NRC Form 396, "Certification of Medical Examination by Facility Licensee."
 
10 CFR 55.21 requires, in part, that individual licensed reactor operators and licensed senior reactor operators shall have a medical examination by a physician every 2 years, and that the physician shall determine that the operator meets requirements of Section 55.33(a)(1).
 
10 CFR 55.33(a)(1) requires, in part, that an applicant's medical condition and general health will not adversely affect the performance of assigned operator job duties or cause operational errors endangering public health and safety. 10 CFR 55.33(b) states, in part, that if the general medical condition of an applicant for a reactor operator license does not meet the minimum standards under 10 CFR 55.33(a)(1), the Commission may approve the application and include conditions in the operator's license to accommodate the medical defect.
 
10 CFR 55.23 requires, in part, that an authorized representative of the facility licensee shall certify the medical fitness of an applicant for a reactor operator license by completing and signing an NRC Form 396, "Certification of Medical Examination by Facility Licensee."  On its Form 396s, facility licensees must certify, in part, the guidance that was used to determine the medical fitness of its reactor operator license applicants. PPL certified on its Form 396s that it used the guidance in ANSI/ANS 3.4-1983, "Medical Certification and Monitoring of Personnel Requiring Operator Licenses for Nuclear
 
Power Plants."
 
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 licensee. In addition, the health requirements set forth within the standard provide the minimum necessary to determine that the physical condition and general health of the licensed operators 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."
 
ANSI 3.4, Section 5.3 Disqualifying Conditions, states in part, "A history or other indication of any disqualifying condition shall be considered disqualifying unless adequate supplemental findings demonstrate that no disqualifying condition exists-The presence of any of the following conditions, unless adequately compensated by the methods specified in subsections- shall disqualify the individual."
 
Contrary to the above, between 2010 and 2012, PPL allowed eight licensed reactor operators to continue to perform licensed operator duties after learning that they had permanent disabilities or illnesses (four of which involved conditions specified as disqualifying conditions in ANSI/ANS 3.4-1983), and without requesting amended licenses with conditions to account for the medical issues. Additionally, PPL did not notify the NRC within 30 days of learning of the permanent disabilities or illnesses. PPL entered this issue into their corrective action program (CR-1709540), and submitted requests for license amendments.  (AV 05000387, 388/2013008-01, Failure to Restrict Operators from Performing Licensed Duties with Medically Disqualifying Conditions and Failure to Notify the NRC Within 30 Days of Discovering Changes
 
in Medical Conditions)
 
===.2
 
=====Introduction:=====
===
The inspectors identified an Apparent Violation (AV) of 10 CFR 50.9, "Completeness and Accuracy of Information," related to PPL's failure to provide information to the NRC regarding medical exam inations of licensed operators that were complete and accurate in all material respects. Specifically, PPL submitted three NRC licensed operator renewal applications and one initial license application, each of which certified the medical fitness of the applicants and that no restricting license conditions were necessary. However, the applicants, in fact, each had medical conditions that did not meet the minimum standards of 10 CFR 55.33(a)(1) and required license conditions to perform licensed activities.
 
=====Description:=====
Between July and December 2012, the PPL staff submitted thirteen medical records for licensed operators to the NRC for either "information only" or to report a change in license condition. The inspectors determined that four of these cases also involved the submittal of operator license applications that were not complete and accurate in all material respects (i.e., one initial license application and three operator renewal applications). The following provides a summary of details on these four license applications: 
 
A licensed operator informed the facility licensee, PPL that he had a change in medical status on October 25, 2011. PPL submitted a letter to the NRC on July 20, 2012, requesting a new license condition be added to the operator's license requiring the operator to take medication as prescribed. PPL in the letter stated, "the licensee made the facility aware of the change in status on October 25, 2011 and it was previously not reported to the NRC office by the facility."  PPL submitted another letter on December 21, 2012, requesting to change the license restriction to a "No Solo" and 6 month medical update. PPL subsequently submitted a license renewal for this operator and his license was renewed on January 6, 2012. The NRC Form 396 submitted by PPL for the renewal was not accurate and complete in that it did not contain the change in medical status. If the additional information had been included, the NRC could have conducted further inquiry to clarify the individual's medical status; and the license could have been conditioned properly.
 
Three additional operators (one initial license and two license renewals) had sleep apnea and had been prescribed the use of a Constant Positive Airway Pressure (CPAP) machine for several years. Their licenses were not conditioned to use the therapeutic device as prescribed.
 
One operator was issued an initial RO license on February 9, 2011; however, he had a significant history of sleep apnea. PPL sent a letter to the NRC on February 7, 2013, requesting a new license condition be added to the operator's license requiring the use of a therapeutic device as prescribed to maintain medical qualifications.
 
The NRC renewed two additional operator licenses based on inaccurate and incomplete information. The first operator (a licensed SRO) was issued a renewal on January 10, 2012; however he had first been diagnosed with sleep apnea in 2010.
 
PPL sent a letter to the NRC dated December 21, 2012, requesting a new license condition be added to the operator's license requiring the use of a therapeutic device as prescribed to maintain medical qualifications. The second operator (a licensed SRO) was issued a renewal on January 6, 2012; however he was diagnosed with sleep apnea on August 16, 2007. PPL sent a letter to the NRC dated January 7, 2013, requesting a new license condition be added to the operator's license requiring the use of a therapeutic device, as prescribed, to maintain medical qualifications.
 
The licensed operator medical issues identified above are associated with PPL's failure to properly train and provide oversight for their medical review officer (MRO) and the Berwick examining physician regarding compliance with the requirements of ANSI/ANS-3.4-1983 and 10 CFR Part 55. The NRC determined that these issues do not involve willfulness or careless disregard, but rather are related to a lack of knowledge and inadequate oversight.
 
=====Analysis:=====
The inspectors determined that PPL's failure to provide complete and accurate information to the NRC was a performance deficiency that was within PPL's ability to foresee and correct, and should have been prevented. The inspectors determined that Traditional Enforcement applies, as the i ssue had the potential to impact the NRC's ability to perform its regulatory function. Specifically, PPL did not provide information to the NRC that was complete and accurate in all material respects, in that it submitted three NRC Form 396s for renewal and one initial license application which certified that the applicants met the medical requirements of ANSI/ANS 3.4-1983. Subsequently, the NRC made a licensing decision based on this information that was not complete and accurate in all material respects. The performance deficiency was screened against the ROP per the guidance of IMC 0612, Appendix B, "lssue Screening."  No associated ROP finding was identified and no cross-cutting aspect was assigned.
 
=====Enforcement:=====
10 CFR 50.9 requires, in part, that information provided to the Commission by a licensee shall be complete and accurate in all material respects.
 
10 CFR 55.21 requires, in part, that individual licensed reactor operators and licensed senior reactor operators shall have a medical examination by a physician every 2 years, and that the physician shall determine that the operator meets requirements of Section 55.33(a)(1). 10 CFR 55.33(a)(1) requires, in part, that an applicant's medical condition and general health will not adversely affect the performance of assigned operator job duties or cause operational errors endangering public health and safety.
 
10 CFR 55.33(b) states, in part, that if the general medical condition of an applicant for a reactor operator license does not meet the minimum standards under 10 CFR 55.33(a)(1), the Commission may approve the application and include conditions in the operator's license to accommodate the medical defect.
 
10 CFR 55.23 requires, in part, that an authorized representative of the facility licensee shall certify the medical fitness of an applicant for a reactor operator license by completing and signing an NRC Form 396, "Certification of Medical Examination by Facility Licensee."  NRC Form 396, when signed by an authorized representative of the facility licensee, certifies that based on the results of the physical examination, including information furnished by the applicant, the physician has determined that the applicant's physical condition and general health are such that the applicant would not be expected to cause operational errors endangering public health and safety, and documents whether the applicant's license should be conditioned with restrictions.
 
Contrary to the above, on four occasions in December 2012, PPL provided information to the NRC that was not complete and accurate in all material respects. Specifically, on December 23, 2010, PPL submitted an NRC Form 396 for one licensed operator initial application and on December 6, 2011, PPL submitted an NRC Form 396 for three NRC licensed operator renewal applications, each of which certified the medical fitness of the applicants and that no restricting license conditions were necessary. However, the applicants each had medical conditions that did not meet the minimum standards of 10 CFR 55.33(a)(1) and required license conditions to be able to perform licensed activities. PPL entered this issue into their corrective action program (CR-1709540), and submitted correct license amendment requests.  (AV 05000352, 353/2013008-02, Failure to Provide Complete and Accurate Medical Information for Licensed Operator Applications)
 
{{a|4OA6}}
==4OA6 Meetings, Including Exit==
 
===Exit Meeting Summary===
 
On May 22, 2013, the inspection team discussed the inspection results with Mr. Jon A. Franke, Site Vice President Susquehanna and members of his staff. The inspection team confirmed that proprietary information reviewed during the inspection period was returned to PPL.
:  Supplemental Information 
 
=SUPPLEMENTAL INFORMATION=
 
==KEY POINTS OF CONTACT==
 
===Licensee Personnel===
: [[contact::A. Alley]], Medical Review Officer
: [[contact::J. Franke]], Site Vice President Susquehanna
: [[contact::J. Goodbred]], Jr., Assistant Programs Manager (i.e., Formerly Operations Manager)
: [[contact::C. Goff]], Training Director 
: [[contact::D. Geraghty]], Operations Training Manager
: [[contact::M. Gosekamp]], Change Management Manager
: [[contact::K. Griffith]], Licensed Operator Requalification Program Lead 
: [[contact::J. Helsel]], Nuclear Plant Manager
: [[contact::A. Jardine]], Operations Manager
: [[contact::J. Jennings]], Nuclear Regulatory Affairs Supervisor 
: [[contact::G. Kanouse]], Medical Doctor, Berwick Hospital 
: [[contact::C. Parks]], Site Nurse
: [[contact::H. Strahley]], Assistant Operations Manager-Training 
: [[contact::R. Streeper]], Formerly Operations Training Manager 
: [[contact::J. Tripoli]], Manager Nuclear Regulatory Affairs
 
==LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED==
 
Opened: 
: 05000387, 388/2013008-01            AV    Failure to Restrict Operators from Performing Licensed Duties with Medically Disqualifying Conditions and Failure to Notify the NRC Within
Days of Discovering Changes in Medical
 
Conditions
(Section 4OA2.1)
: 05000387, 388/2013008-02            AV  Failure to Establish and Implement Written Procedures for Operating Plant Equipment Failure
to Provide Complete and Accurate Medical
Information for Licensed Operator Applications
(Section 4OA2.1)
Closed: 
: 05000387, 388/2012005-05            URI Concerns Regarding PPLs Program for Conducting Biennial Medical Examinations for Licensed
 
Operators and Reporting Changes in Medical
Conditions (Section 4OA2)
 
Attachment
==LIST OF DOCUMENTS REVIEWED==
==Section 4OA2: Followup Inspection==
 
===Condition Reports===
(CRs)
: (* denotes NRC identified during this inspection)
: 1592588
: 1592590
: 1592591
: 1593293
: 1593296
: 1594635
: 1597808
: 1598122
: 1598286
: 1600109
: 1610073
: 1617148* Documents: ANSI/ANS-3.4-1983, "American National Standard Medical Certification and Monitoring of Personnel Requiring Operator Licenses for Nuclear Power Plants" Form 4294 (4/2010) Licensed Operator Medical Requirements Licensed Operator Medical Examination Requirements and Guidelines Training, Revision 0
: NDAP-QA-0723,
: PPL-Susquehanna NRC Operator License and Medical Notification
: Process, Revision 1
: NTP-QA-31.12, Preparation and Submission of NRC Form 396-Certification of Medical Examination by Facility Licensee and NRC Form 398-Personal Qualifications Statement-
: Licensee, Revision 5
: OP-AD-010, Control of Licensed Operator License Status, Restrictions, and
: Requirements, Revision 6
: Investigations and Assessments
: Root Cause Analysis for
: CR 1516764, Revision 0, Revision 1
: Evaluation for
: CR 1597808, Revision 0
: Attachment
==LIST OF ACRONYMS==
 
CFR Title 10 of the
Code of Federal Regulations
: [[ADAMS]] [[Agencywide Document and Access Management System]]
: [[ANS]] [[American Nuclear Society]]
: [[ANSI]] [[American National Standards Institute]]
: [[AV]] [[Apparent Violation]]
: [[CAP]] [[Corrective Action Program]]
: [[CFR]] [[Code of Federal Regulations]]
: [[COPD]] [[Chronic Obstructive Pulmonary Disease]]
: [[CPAP]] [[Constant Positive Airway Pressure]]
: [[CR]] [[Condition Report]]
: [[CRA]] [[Correction Action]]
: [[EOP]] [[Emergency Operating Procedure]]
: [[FIN]] [[Finding]]
: [[IMC]] [[Inspection Manual Chapter]]
: [[MRO]] [[Medical Review Officer]]
: [[NRC]] [[Nuclear Regulatory Commission]]
: [[PARS]] [[Publicly Available Records]]
: [[PEC]] [[Pre-decisional Enforcement Conference]]
: [[PPL]] [[]]
: [[PPL]] [[Susquehanna,]]
: [[LLC]] [[]]
: [[RCA]] [[Root Cause Analysis]]
: [[RO]] [[Reactor Operator]]
: [[ROP]] [[Reactor Oversight Process]]
: [[SDP]] [[Significance Determination Process]]
: [[SL]] [[Severity Level]]
: [[SRO]] [[Senior Reactor Operator]]
: [[SSES]] [[Susquehanna Steam Electric Station]]
TE Traditional Enforcement
: [[URI]] [[Unresolved Item]]
}}

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