IR 05000482/2015010

NRC Inspection Report 05000482/2015010

ML15350A424
Person / Time
Site:	Wolf Creek
Issue date:	12/16/2015
From:	Anton Vegel Division of Reactor Safety IV
To:	Heflin A Wolf Creek
References
EA-15-170 IR 2015010
Download: ML15350A424 (15)

Text

ber 16, 2015

SUBJECT:

WOLF CREEK GENERATING STATION - NRC INSPECTION REPORT 05000482/2015010

Dear Mr. Heflin:

This letter refers to the inspection conducted from September 14, 2015, to December 16, 2015, for the Wolf Creek Generating Station. The purpose of the inspection was to review the information that you identified during internal audits earlier this year and subsequently provided to the NRC regarding the submittal of complete and accurate information for licensed operator medical conditions for your licensed operators. The enclosed report presents the results of this inspection. The inspector discussed the preliminary findings with Ms. L. Rockers, Licensing and other members of your staff at the conclusion of the in-office inspection. A final exit briefing was conducted telephonically with Mr. C. Reasoner, Site Vice President, on December 16, 2015.

Based on the results of this inspection, two related apparent violations of NRC requirements were identified that are being considered for escalated enforcement action in accordance with the NRC Enforcement Policy. The current Enforcement Policy is included on the NRCs Web site at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html.

The apparent violations are associated with Wolf Creeks submittal of an operators license application that was not complete and accurate in all material respects and the failure to notify the NRC within 30 days of a change in an operators medical condition. These apparent violations are described in detail in the enclosed report. The NRC notes that, upon identifying the issue, Wolf Creek took the appropriate immediate corrective actions by notifying the NRC of the operators medical condition and requesting an amendment to the operators license. On July 15, 2015, the NRC issued an amendment to the operators license with the appropriate medical restriction. With the issuance of this amendment, full compliance was restored.

The NRC acknowledges the diligence of your staff in identifying this issue. Specifically, the new Medical Review Officer demonstrated attention to detail and a strong questioning attitude in identifying this long standing issue. However, this issue is being considered for escalated enforcement to reinforce the importance of the role that the Medical Review Officer has for ensuring that operators are medically fit to perform their duties and that issues that may impact an operators ability to perform licensed duties are appropriately reported to the NRC. The circumstances surrounding the apparent violations, the significance of the issues, and the need for lasting and effective corrective actions were discussed with members of your staff during an inspection exit meeting on December 16, 2015. As a result, it may not be necessary to conduct a pre-decisional enforcement conference in order to enable the NRC to make an enforcement decision. In addition, since you identified the apparent violations, and based on our understanding of your corrective actions, a civil penalty may not be warranted in accordance with Section 2.3.4 of the Enforcement Policy. The final decision will be based on you confirming on the license docket that the corrective actions previously described to the NRC staff have been or are being taken.

Before the NRC makes its enforcement decision, we are providing you an opportunity to respond, in writing, to the apparent violations addressed in this inspection report within 30 days of the date of this letter or request a Pre-decisional Enforcement Conference (PEC). If a PEC is held, the NRC will issue a press release to announce the time and date of the conference; however, the PEC will be closed to public observation since the apparent violations involve personal privacy information. Please contact Vincent Gaddy, Chief, Operations Branch at 817-200-1159 within 10 days from the issue date of this letter to notify us of your intentions.

If we have not heard from you within 10 days, we will continue with our enforcement decision.

If you choose to request a PEC, the conference should be held in our office in Arlington, Texas, within 30 days of the date of this letter. This conference will afford you the opportunity to provide your perspective on these matters and any other information that you believe the NRC should take into consideration before making its enforcement decision. The decision to hold a PEC does not mean that the NRC has determined that a violation has occurred or that enforcement action will be taken. This conference would be conducted to obtain information to assist the NRC in making an enforcement decision. The topics discussed during the conference may include information to determine whether a violation occurred, information to determine the significance of a violation, information related to the identification of a violation, and information related to any corrective actions taken or planned. In presenting your corrective actions, you should be aware that the promptness and comprehensiveness of your actions will be considered in assessing any civil penalty for the apparent violations. The guidance contained in the enclosed excerpt from NRC Information Notice 96-28, Suggested Guidance Relating to Development and Implementation of Corrective Action, may be helpful.

If you choose to provide a written response, 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 and should include for each apparent violation: (1) the reason for the apparent violation, (2) the corrective steps that have been taken and the results achieved, and (3) the corrective steps that will be taken. It should be clearly marked as a Response to Apparent Violations in Inspection Report No. 05000482/2015010; EA-15-170, and sent to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555-0001 with a copy to the Regional Administrator, Region IV, 1600 East Lamar Boulevard, Arlington, TX 76011-4511. In addition, please be advised that the number and characterization of the apparent violations described in the enclosed inspection report may change as a result of further NRC review. You will be advised by separate correspondence of the results of our deliberations on this matter.

In accordance with Title 10 of the Code of Federal Regulations 2.390, Public Inspections, Exemptions, Requests for Withholding, of the NRCs Rules of Practice, a copy of this letter, its enclosure, and your response (if any) will be available electronically for public inspection in the NRCs Public Document Room or from the Publicly Available Records (PARS) component of the NRCs Agency-wide Documents Access and Management System (ADAMS). ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room).

Sincerely,

/RA/

Anton Vegel, Director Division of Reactor Safety Docket No. 50-482 License No. NPF-42 Enclosure:

Inspection Report 05000482/2015010 w/Attachment: Supplemental Information cc w/encl: Electronic Distribution

SUMMARY OF FINDINGS

IR 05000482/2015010; 09/14/2015 - 12/16/2015; Wolf Creek Generating Station; Focused

Baseline Inspection Report.

This report covers a focused baseline inspection regarding a medical issue involving a licensed operator. Based on the results of this inspection, two related apparent violations of NRC requirements were identified that are being considered for escalated enforcement action in accordance with the NRC Enforcement Policy. The significance of most findings is indicated by their color (i.e., greater than Green, or Green, White, Yellow, Red) using Inspection Manual Chapter 0609, Significance Determination Process (SDP). Cross-cutting aspects were determined using Inspection Manual Chapter 0310, Aspects Within the Cross-Cutting Areas.

Findings for which the SDP does not apply may be Green or be assigned a severity level after NRC management review. All violations of NRC requirements are dispositioned in accordance with the NRCs Enforcement Policy, dated July 9, 2013. The NRCs program for overseeing the safe operation of commercial nuclear power reactors is described in NUREG-1649, Reactor Oversight Process, Revision 5, dated February 2014.

NRC-Identified Findings

and Self-Revealed Findings

Cornerstone: Mitigating Systems

• Apparent Violations. Wolf Creek Nuclear Operating Corporation (Wolf Creek) identified two apparent violations (AVs): (1) An apparent violation of Title 10 of the Code of Federal Regulations (10 CFR) 50.9, Completeness and Accuracy of Information; and (2) an apparent violation of 10 CFR 50.74, Notification of Change in Operator or Senior Operator Status. Specifically, on January 10, 2010, Wolf Creek submitted certified copies of an NRC operator license application that did not specify that the applicant required a restriction (to take medication as prescribed) in order to maintain medical qualifications. The NRC issued the renewed operators initial license on February 25, 2010, but without the necessary medical restriction (AV #1). From May 31, 2006, until July 9, 2015, Wolf Creek had several additional opportunities to identify that medication was required to compensate for a disqualifying medical condition and that a license condition was required during the licensees biennial licensed operator requalification program reviews and medical examinations. On July 9, 2015, a period that exceeded 30 days from when the condition was identified, the facility notified the NRC of the medical condition via a letter requesting amendment to the operators license to include the restriction (AV #2). On July 15, 2015, the NRC issued the license amendment with the new restriction. This issue was entered into Wolf Creeks corrective action program.

The inspector determined that Wolf Creeks failure to provide complete and accurate information to the NRC in the operator license application and to notify the NRC of a change in a licensed operators status for a condition was a performance deficiency. This performance deficiency was known by the licensee and within its ability to foresee and correct and should have been prevented. The inspector determined that traditional enforcement applies, as the issue affected the NRCs ability to perform its regulatory function. Namely, the NRC relies upon Wolf Creek to ensure all licensed operators meet the medical conditions of their licenses. If, during the term of the individual operator license, an operator develops a permanent physical or mental disability that causes the operator to fail to meet the requirements of 10 CFR 55.21, Medical Examination, the licensee shall notify the NRC within 30 days of learning of the diagnosis, in accordance with 10 CFR 50.74(c).

Additionally, the NRC issued a renewed operator license to the applicant based on information that was not complete and accurate in all material aspects. The performance deficiencies were screened against the Reactor Oversight Process per the guidance of Inspection Manual Chapter 0612, Appendix B, Issue Screening. No associated Reactor Oversight Process finding was identified and no cross-cutting aspect was assigned. These issues constitute apparent violations in accordance with the NRCs Enforcement Policy and their final significance will be dispositioned in separate future correspondence.

REPORT DETAILS

OTHER ACTIVITIES

Cornerstones: Initiating Events, Mitigating Systems, Barrier Integrity, Emergency Preparedness, Public Radiation Safety, Occupational Radiation Safety, and Security

4OA2 Problem Identification and Resolution

Review of Corrective Action Program Documents

a. Inspection Scope

The inspector reviewed one corrective action program document that identified an issue related to the medical qualification of licensed operators. The inspector reviewed this document to evaluate the effectiveness of corrective actions related to the medical qualifications. The list of specific documents that were sampled and reviewed by the inspector is listed in the Attachment to this report.

b. Findings

Introduction.

The licensee identified two apparent violations. The first, an apparent violation of 10 CFR 50.9, Completeness and Accuracy of Information, for Wolf Creeks failure to submit complete and accurate information regarding an application for an operators license. The second is an apparent violation of 10 CFR 50.74, Notification of Change in Operator or Senior Operator Status, associated with Wolf Creeks failure to notify the NRC within 30 days of a change in a licensed operators medical condition.

Description.

On May 31, 2006, a licensed reactor operator reported to the licensees Medical Reviewing Officer (MRO or licensee physician) that he had been prescribed medication. The MRO did not recognize that this condition warranted NRC notification or that prescribed medication required a license restriction. During subsequent annual physicals conducted in June 2006, June 2007, May 2008, and May 2009 the operator again disclosed the use of medication. However, the MRO never recognized that this was a reportable condition or that it required a license restriction.

On January 10, 2010, Wolf Creek submitted NRC-Form 396 (Certification of Medical Examination by Facility Licensee) with the reactor operators renewal application requesting an operating license with one restricting license condition for wear corrective lenses. The form did not request a license restriction for take medication as prescribed and this medication is required for fitness for duty reasons in accordance with the American National Standards Institute (ANSI)-3.4-1983 medical standard that Wolf Creek is using to meet the medical requirements for licensed operators. On February 25, 2010, the operator was granted a renewed operating license that contained the license restriction regarding corrective lenses, but no condition for taking medication as prescribed. Subsequent to the issuance of the renewed operating license, the operator received annual physicals in May 2010, April 2011, April 2012, March 2013, March 2014, and February 2015 where the reactor operator again disclosed the use of medication, and the MRO did not recognize that it was a reportable condition or that it required a license restriction.

Wolf Creek signed a new contract in 2015 with a different medical company that uses a different doctor (MRO) and nurse. This new medical staff identified this issue on May 4, 2015, during a review of several licensed operators medical files for medications. As a result of this review, the new medical staff found this licensed reactor operators medication was never reported to the NRC, nor was his license ever amended for taking this medication. Wolf Creek subsequently reported this condition to the NRC on July 9, 2015, and also reported that the operator had been taking his medication as prescribed.

On July 9, 2015, Wolf Creek submitted a letter to the NRC with a revised NRC Form 396 that reflected a new restriction to take medication as prescribed. On July 15, 2015, the NRC issued a license amendment with the new restriction. As stated on NRC Form 396, the overriding purpose of licensed operator medical qualification is that the individual would not be expected to cause operational errors endangering public health and safety. The guidance contained in industry consensus standards, specifically versions of ANSI/American Nuclear Society (ANS)-3.4 forms the basis in reaching this determination. Wolf Creek is committed to ANSI/ANS-3.4-1983, Medical Certification and Monitoring of Personnel Requiring Operator Licenses for Nuclear Power Plants.

Based on this standard, the medication prescribed to the licensed operator would require a condition on his license for take medication as prescribed. Based on medical documentation from the operators treating physician, the operators medical condition has been adequately controlled since his original diagnosis. The operators condition is and has been stable, and his diagnosis has not interfered with his ability to perform his licensed operator duties.

Analysis.

Wolf Creeks failure to submit complete and accurate information in a license application to the NRC regarding the applicants medical condition and the failure to notify the NRC within 30 days of a change in a licensed operators medical condition and request a condition be placed on the operators license are performance deficiencies that were reasonably within the licensees ability to foresee and prevent. These performance deficiencies adversely affected the regulatory process, because the NRC used the inaccurate information as a basis for an incorrect regulatory decision.

Specifically, the NRC renewed a reactor operators license which did not include the necessary restriction on the operators license to take medication as prescribed, a condition required to ensure the applicant was medically qualified. Because the regulatory process was affected, traditional enforcement was applicable.

Section 6.4.c.4 of the NRC Enforcement Policy describes an example of a Severity Level III violation that involves:

A non-willful compromise (see 10 CFR 55.49, Integrity of Examinations and Tests)of an application ... or examination required by 10 CFR Part 55, or inaccurate or incomplete information inadvertently provided to the NRC, subsequently contributes to the NRC making an incorrect regulatory decision, such as the following:

(a) In the case of initial operator licensing, contributes to an individual being granted an operator or senior operator license, or

(b) In the case of operator requalification, contributes to an individual being permitted to perform the functions of an operator or senior operator, or

(c) contributes to a medically unqualified individual performing the functions of a licensed operator or senior operator.

Based on this example, the NRC has preliminarily determined that these violations appear to be Severity Level III because Wolf Creek failed to report a condition that would have required the addition of a license restriction. In this case, the licensed operator required a license restriction to take medication, as prescribed, to maintain medical qualifications. The apparent violations affected licensed operator requalification in 2010.

In accordance with Inspection Manual Chapter 0612, Appendix B, Issue Screening, these performance deficiencies were also evaluated for significance under the Reactor Oversight Process. During the period between receiving his prescription from his personal physician and the amending of his license to include this restriction, this individual took the prescribed medication to address his disqualifying medical condition.

No operational issues resulted from this individuals performance. As a result, there is not a more than minor Reactor Oversight Process violation; therefore, no cross-cutting aspects are assigned to the apparent violations.

1. Title 10 CFR 50.9, Completeness and Accuracy of Information, requires, in part,

that information provided to the NRC by a licensee shall be complete and accurate in all material respects.

Title 10 CFR 55.21 requires, in part, that individual licensed operators and licensed senior operators shall have a medical examination by a physician every 2 years and that the physician shall determine that the licensee meets the requirements of Section 55.33(a)(1).

Title 10 CFR 55.33(a)(1) requires, in part, that an applicants 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.

Title 10 CFR 55.33(b) states, in part, that if the applicants general medical condition does not meet the minimum standards under 10 CFR 55.33(a)(1), the NRC may approve the application and include conditions in the license to accommodate the medical defect.

Title 10 CFR 55.23, Certification, requires, in part, that to certify the medical fitness of the applicant, an authorized representative of the facility licensee shall complete and sign 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 applicants 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 applicants license should be conditioned with restrictions.

Contrary to the above, on January 10, 2010, Wolf Creek staff provided information to the NRC that was not complete and accurate in all material respects. Specifically, Wolf Creek staff submitted an NRC licensed operator application with an NRC Form 396 that certified the medical fitness of the applicant and that the only necessary restricting license condition was for corrective lenses. This information was inaccurate in that the applicant had a medical condition that does not meet the minimum standards of 10 CFR 55.33(a)(1) and that requires a restricting license condition to take medication, as prescribed, to maintain medical qualifications. Compliance was restored on July 9, 2015, when Wolf Creek submitted a letter to the NRC with a revised NRC Form 396 indicating the new restriction to take prescribed medication. On July 15, 2015, the NRC issued a license amendment with the new restriction. This issue was entered into Wolf Creeks Corrective Action Program as Condition Report CR 00097771.

(AV 05000482/2015010-01, Incomplete and Inaccurate Medical Information Resulted in Issuance of a Renewed Operator License Without a Required Medical Restriction)

2. Title 10 CFR 55.3, Licensee Requirements, requires, in part, that a person must be

authorized by a license issued by the Commission to perform the function of a licensed operator or a licensed senior operator as defined in Part 55.

Title 10 CFR 50.74(c), Notification of Change in Operator or Senior Operator Status, 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, Incapacitation Because of a Disability or Illness, involving a licensed operator or senior operator.

Title 10 CFR 55.25 requires, in part, that if a licensed operator or licensed senior operator develops a permanent physical condition that causes the licensee to fail to meet the requirements of 10 CFR 55.21, Medical Examination, 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.

Title 10 CFR 55.21 requires, in part, that individual licensed operators and senior 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), How to Apply.

Title 10 CFR 55.33(a)(1) requires, in part, that an applicants 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), Disposition of an Initial Application, states, in part, that if the general medical condition of an applicant does not meet the minimum standards under 10 CFR 55.33(a)(1), the NRC may approve the application and include conditions in the license to accommodate the medical defect.

Contrary to the above, from June 30, 2006, (this date is 30 days from the date the operator informed the licensee of his medication prescription) until July 9, 2015, (a period greater than 30 days), Wolf Creek failed to notify the NRC of a permanent disability of a licensed operator. Specifically, Wolf Creek staff was informed in May 2006 that the operator was taking prescribed medication for a medical condition.

Wolf Creek did not report this permanent medical condition to the NRC when they submitted NRC Form 396 as part of the licensed operator renewed license application in January 2010, nor did they request an amended license with a condition to account for the medical issue until July 9, 2015. The condition was reported to Wolf Creek by the operator as part of each subsequent annual medical examination and licensed operator requalification program which provide several additional opportunities to report the condition and request a license condition. Compliance was restored on July 9, 2015, when Wolf Creek submitted a letter to the NRC with a revised NRC Form 396 indicating the new restriction to take prescribed medication. On July 15, 2015, the NRC issued a license amendment with the new restriction. This issue was entered into Wolf Creeks Corrective Action Program as Condition Report CR 00097771.

(AV 05000482/2015010-02, Failure to Report a Permanent Change in a Licensed Operators Medical Status and Request a Condition be Placed on the Operators License)

4OA6 Meetings, Including Exit

Exit Meeting Summary

On December 16, 2015, the inspector presented the preliminary inspection results to Mr. C. Reasoner, Site Vice President, and other members of the licensees staff. The licensee acknowledged the results as presented. While some proprietary information was reviewed during this inspection, no proprietary information was included in this report.

4OA7 Licensee-Identified Violations

No findings were identified.

SUPPLEMENTAL INFORMATION

KEY POINTS OF CONTACT

Licensee Personnel

C. Reasoner, Site Vice President

J. McCoy, Vice President, Engineering

P. Black, HR Specialist, Human Resources

N. Good, Acting Supervisor, Licensing, Regulatory Affairs

C. Hafenstine, Manager, Regulatory Affairs

R. Hobby, Licensing Engineer, Regulatory Affairs

E. McIntyre, Manager, Human Resources

L. Stone, Licensing Engineer, Regulatory Affairs

J. Pearson, Supervisor, Human Resources

NRC Personnel

D. Dodson, Senior Resident Inspector, Wolf Creek Generating Station

LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED

Opened

05000482/2015010-01 AV Incomplete and Inaccurate Medical Information Resulted in Issuance of a Renewed Operator License Without a Required Medical Restriction

05000482/2015010-02 AV Failure to Report a Permanent Change in a Licensed Operators Medical Status and Request a Condition be Placed on the Operators License Attachment