ML21055A850

Public Meeting Summary

ML21055A850
Person / Time
Site:	Palo Verde
Issue date:	02/24/2021
From:	Nicholas Hernandez Division of Reactor Safety IV
To:	Ryan Lantz Division of Reactor Safety IV
Scott L
References
Download: ML21055A850 (55)

Text

February 24, 2021 MEMORANDUM TO: Ryan E. Lantz, Director Division of Reactor Safety Region IV THRU: Gregory E. Werner, Chief Operations Branch FROM: Nicholas A. Hernandez, Operations Engineer Division of Reactor Safety

SUMMARY

OF PUBLIC MEETING CONDUCTED FOR PALO VERDE NUCLEAR GENERATING STATION On February 11, 2021, representatives of Palo Verde Nuclear Generating Station met with U.S.

Nuclear Regulatory Commission (NRC) personnel on a teleconference meeting to discuss the apparent violation identified in NRC Inspection Report Number 05000528/2020011, 05000529/2020011, 05000530/2020011, dated December 15, 2020, (NRCs Agencywide Documents Access and Management System [ADAMS] Accession No. ML20324A079). The predecisional enforcement conference was held at the request of the licensee and was characterized as an NRC Category 1 public meeting. The telephonic and web-based predecisional enforcement conference was at the request of the NRC because of the COVID-19 pandemic and the social distancing posture of the agency. The list of attendees is provided as an enclosure to this summary (Enclosure 1).

The NRC representatives, led by the Director, Division of Reactor Safety, discussed the apparent violation that was described in the subject inspection report and provided an overview of the NRCs Traditional Enforcement Process, as shown in the NRC Presentation (Enclosure 2).

The Senior Vice President for Site Operations and Director for Nuclear Regulatory Affairs led the presentation of Palo Verde Nuclear Generating Stations response to the apparent violation, as shown in the attached presentation (Enclosure 3). The licensee participants stated that Palo Verde Nuclear Generating Station accepted that a violation of NRC requirements occurred but did not agree that the significance was a Severity Level III violation due to perceived very low risk involved with the error and because the individual would have still received a reactor operator license. Therefore, the licensee determined that the significance level should be Severity Level IV versus Severity Level III. The supporting facts and circumstances of the violation, as detailed in the NRC inspection report, were not disputed.

CONTACT: Gregory E. Werner, OB/DRS (817) 200-1159

R. Lantz 2 The discussion of the timeline, causal analyses, and corrective actions described by licensee representatives during the presentation provided enough information so there were minimal clarifying questions from the NRC staff.

During the business portion of the meeting, NRC staff informed the licensee participants that the primary objectives of the predecisional enforcement conference was to get information from the licensee on the significance of the finding evaluated through the Traditional Enforcement Process and gain their perspective on the apparent violation. NRC staff also maintained that no final decisions would be made during the meeting. All information presented during the meeting, and prior to the meeting, would be considered and assessed to make a final decision and that determination would be communicated to the licensee as soon as possible. The NRC also informed the licensee that they had appeal rights in the event that they did not agree with the final determination.

In accordance with 10 CFR 2.390 of the NRCs Agency Rules of Practice and Procedure, a copy of this conference summary and enclosures (Enclosure 1, 2, and 3) will be made available electronically for public inspection in the NRC Public Document room or in the NRCs Agency-wide Documents Access and Management System, accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html.

Docket No. 50-528/50-529/50-530

Enclosures:

1. Attendance List - Public

2. NRC Presentation - Public

3. Licensee Presentation - Public

R. Lantz 3

SUMMARY

OF PUBLIC MEETING CONDUCTED FOR PALO VERDE NUCLEAR GENERATING STATION FEBRUARY 24, 2021 DISTRIBUTION:

SMorris, RA JMonninger, DRA AVegel, DRP MHay DRP RLantz, DRS GMiller, DRS DCylkowski, RC MHaire, RIV/OEDO VDricks, ORA LWilkins, OCA SLingam, NRR AMoreno, RIV/OCA BMaier, RSLO AAgrawal, IPAT JDixon, DRP FSanchez, DRP PVossmar, DRP CPeabody, DRP NCuevas, DRP ELantz, DRP ADonley, DRP YDubay, DRP BCorrell, IPAT LFlores, IPAT RGrover, IPAT R4Enforcement ADAMS Accession Number: ML21055A850 OFFICE RIV/DRS/OB RIV/DRS/OB Name NHernandez / NAH GWerner / GEW Date 02/24/21 02/24/21 OFFICIAL RECORD COPY

Enclosure 1 Public Meeting Attendees February 11, 2021 Participants Affiliation Jaime Rodriguez NRC APS Common Facility Arizona Public Service (APS)

David Crockett NRC David Cylkowski NRC Gregory Werner NRC Jaime Rodriguez NRC Jeremy Groom NRC Michael Hackett NRC Nicholas Hernandez NRC Peter Jayro NRC Ryan Lantz NRC Dilbert Elkington APS Ben Overton Thomas Thor Associates Brian Hughes NRC Christopher Bristow APS Christopher Hartsock Duke Energy Christy Arder APS Craig Stewart American Nuclear Insurers Cynthia Heny El Paso Electric Company David Jones NRC Dusty Lowdermilk APS Eric Lantz NRC Eric Shells El Paso Electric Company Esther Andrews APS George Marengo APS Hannah Garcia South Texas Nuclear Project Ivan Kingsley Sonalysts Jane Accomando Morgan Lewis Jeannie Bell APS Jessica Goldman El Paso Electric Company Jill Hanks APS Joe Allison APS John Dixon NRC John Monninger NRC Jose Henzie STARS Alliance JR Steely APS Enclosure 1

Juanita Billingsley APS Lorraine Weaver Member of the Public Luis Salcon Office of Congressman Raul Grijalva Matt Euden Member of the Public Matt Euten Member of the Public Matt Swan APS Maurie Deeanie APS Nicole Good STARS Alliance Patricia Vossmar NRC Paul Bury STARS Alliance Robin Ritzman Curtiss-Wright Ryan Knappenberger Cronkite News Scott Morris NRC Sean Dornstife APS Shelley Clark South Texas Nuclear Project Taylor Rodgers Office of Senator Mark Kelly Zachary Branum Arizona Corporation Commission 2

NRC Virtual (via WebEx)

Pre-Decisional Enforcement Conference Palo Verde Nuclear Generating Station USNRC Region IV Thursday, February 11, 2020 Category I Public Meeting Enclosure 2 To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Meeting Logistics

• Operation of WebEx

• Please MUTE cellular phones

• Scheduled break (15-minute)

• NRC caucus (Team Meetings)

• Public Question Session (Press *1 on phone to raise hand, then wait for the Moderator to acknowledge you)

To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

MEETING AGENDA Topic Participants NRC Opening Remarks and Introductions Ryan Lantz Palo Verde Nuclear Generating Licensee Opening Remarks and Introductions Station Predecisonal Enforcement Conference Process Jeremy Groom Agen NRC Summary of Event and Requirements Nick Hernandez Summary of Dispositioning Process & Outcome Greg Werner and Apparent Violation Palo Verde Nuclear Generating Licensee Presentation Station Questions and Discussion All Conference Participants Break and NRC Caucus (via Teams Meeting) NRC and Conference Participants Questions and Discussion All Conference Participants Palo Verde Nuclear Generating Licensee Closing Remarks Station NRC Closing Remarks Ryan Lantz Public Question and Answer Session Public Attendees To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

NRC Principal Participants Ryan Lantz, RIV DRS Jeremy Groom, Director Team Lead, ACES Gregory Werner, RIV Nicholas Hernandez, RIV DRS/OB Chief DRS/OB To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Palo Verde Nuclear Generating Station Opening Remarks / Introductions To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Todays Meeting

• No Final Decision on safety significance or enforcement action will be made today.

• Our NRC Inspection Report provided our current understanding and perspective on the issue.

• As this is an Open meeting, no specific information should be mentioned as this violation does pertain to a medical condition (ex. Name of individual, name of condition, name of medical device)

• We Want Your Perspective

• Any additional details NRC should consider

• Whether violations occurred

• Perceived significance of the violations

• Corrective actions implemented and/or Planned Timeline To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Public Meeting Disclaimer

• This is a Category 1 Public Meeting.

• At a Category I meeting, the public is invited to observe the meeting and will have one or more opportunities to communicate with the NRC after the business portion, but before the meeting is adjourned.

To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

SIGNIFICANCE = Severity Level To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Civil Penalty Assessment NRC Enforcement Policy Considers:

Enforcement History Whether the licensee identified the issue Adequacy of corrective actions To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

POSSIBLE OUTCOMES

• No Action

• Notice of Violation (NOV)

• NOV with Civil Penalty ($)

• Order To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

APPEAL RIGHTS

• Any NRC action may be challenged

• Civil Penalties and Orders provide hearing rights To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

PVNGS Incomplete and Inaccurate Medical Form 396 on an operator license application Application submitted September 19, 2019 Error Identified and NRC informed on August 4, 2020 NRC issued a Choice Letter to PVNGS on December 15, 2020 (ML20324A079; EA-20-128)

To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Applicable Requirements

• ANSI/ANS-3.4-1983 , section 5, Health Requirements and Disqualifying Conditions,

• Section 5.2.2, The examinee shall be free of the following conditions that are considered by the designated medical examiner as significantly predisposing to incapacity for duty,

• Subsection 4 - any condition that may result in sudden or unexpected incapacitation

• 01DP-0EM13, Licensed Operator Medical Examinations, Section 2.5.6, states, in part, that PVGS Health Services Personnel verifies that medical restrictions identified during the medical examination are indicated on the most current NRC Form 396.

• 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.

To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Applicable Requirements

• Title 10 CFR 55.23 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.

To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Applicable Requirements Per our understanding, the licensee failed to meet the NRC requirement of 10 CFR 50.9 for failure to provide information that was complete and accurate in all material respects. Specifically, as required by 10 CFR Part 55, the licensee failed to identify that the applicant had a medical condition requiring the use of a medical device to be free from the risk of incapacitation. This failure ledthe NRC to issue an operator license without a necessary restricting condition to use the medical device as prescribed.

To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Apparent Violation

• Contrary to the earlier discussed requirements, on September 19, 2019, the licensee provided information to the NRC that was not complete and accurate in all material respects. Specifically, the licensee submitted a licensed reactor operator application with an NRC Form 396 that certified the medical fitness of the applicant and that there was only one medical condition that required a restricting license condition. This information was inaccurate in that the applicant had a second issue that required a therapeutic device to control 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 use a therapeutic device as prescribed to maintain medical qualifications.

Based, in part, on the inaccurate information, the NRC issued the applicant an operator license without the required restricting license condition on November 12, 2019.

To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Dispositioning the Issue:

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

• A non-willful compromise (see 10 CFR 55.49, Integrity of Examinations and Tests) of an application, test, 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 Predecisional 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,."

To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Dispositioning the Issue:

• Based on this example, the NRC has preliminarily determined that the violation appears to be Severity Level III because Palo Verde Nuclear Generating Station failed to report a condition that would have required the addition of a license restriction.

• In this case, the NRC incorrectly issued an initial operator license without a required license restriction to use a therapeutic device, as prescribed, to maintain medical qualifications, which is similar to Section 6.4.c.4.(a). It is important to note, that the NRC would NOT have issued a license without a specific restriction for this individual.

To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Palo Verde Nuclear Generating Station Presentation Agenda To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

NRC and PVNGS Staff Q&A Session To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

NRC Predecisional Enforcement Conference with Palo Verde Nuclear Generating Station NRC Caucus in Session Returning Shortly To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Conference Closing Remarks

• Licensees Closing Remarks

• NRCs Closing Remarks

• Next Steps / Expectations

• Conclusion of the business portion of todays Predecisional Enforcement Conference

• The platform is now OPEN to questions from our public attendees PLEASE press *1 on your phone and await the Moderator to announce you.

To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Any Questions from the Public Attendees?

(Please press *1 on your phone to raise your hand and await the Moderator)

To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

Public Feedback To hear the audio portion of this presentation, dial 1-888-603-7036 and enter participant code # 6660483.

APS Presentation Pre-Decisional Enforcement Conference Licensed Operator Medical Apparent Violation February 11, 2021 Enclosure 3

We are a Continuous Learning Organization "We freely take ownership of issues and see them through to resolution. We ensure that the actions we take are sustainable for the long term."

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Agenda Apparent Violation Background - Matt Kura Summary of Root Cause - Tom Weber Key Corrective Actions Direct Cause - Jeff Fearn Root Cause - Jeff Fearn/Dallan Lott Contributing Cause - Mike McLaughlin Regulatory Significance - Tom Weber Closing Remarks - Todd Horton 3

Overall Timeline Medical Review Officer Completes Annual Physical Final Certification Form with Identifies Missing Missing Medical Restriction Medical Restriction Operator Receives Independent Health Care Pre-NRC Exam Physical from Professional Completes APS Submits Operator Receives Medical Review Officer Preliminary 396 Form from Corrected 396 Form pre-Licensed Final Certification Form to NRC and NRC Operator Initial Amends and Issues Training (LOIT)

APS Submits 396 Form Corrected Operator Physical Operators Personal to NRC with Missing License Physician Sends Requested Medical Restriction NRC Biennial Medical Information to Palo Requalification Verde Health Services NRC Issues Operator License Inspection with Missing Medical Restriction 2018 2019 2020 4

Root Cause Review Team Composition Multidiscipline representatives from:

Organizational Effectiveness Health Services Nuclear Training Nuclear Regulatory Affairs Security Problem Statement On September 19, 2019, the Palo Verde Generating Station submitted an initial license application to the NRC which was missing a required medical restriction. This resulted in a Reactor Operator with a license without a required restriction, contrary to the requirements of 10 CFR 50.9 and 55.33(a)(1).

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Root Cause Review Analysis Methods Used Interviews Detailed Sequence of Events Task Analysis Swim Lane Process Diagram Organizational Effectiveness Analysis Why Staircase 6

Root Cause Review Direct Cause The direct cause of Palo Verde Generating Station submitting to the NRC an initial license application, containing a missing medical restriction is due to the medical review officer (MRO) not checking the correct number of restrictions on the medical certification form.

Root Cause The root cause of the initial license application containing a missing medical restriction was ineffective program ownership, which enabled Palo Verde to submit incomplete information to the NRC.

Contributing Cause Contributing to the initial license application containing a missing medical restriction was the dilution of knowledge with the multiple turnovers of the Regulatory Analyst Nurse position.

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Root Cause Review Extent of Condition A review of the remaining Licensed operators that were part of the 2019 class was completed and no other medical restrictions were missing from an operators license.

A review was also done of the other 117 currently licensed operators and no additional medical restrictions were found to be missing from an operators license.

Extent of Cause Change processes were reviewed and determined that no ineffective program ownership condition existed in these areas applicable to regulatory submittals requiring prior NRC review and approval.

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Root Cause Review Safety Culture There were four safety culture traits that were found to contribute to the causes identified by the Level 1 evaluation.

Questioning Attitude Leadership Safety Values and Actions Continuous Learning Problem Identification and Resolution Corrective actions identified for the root and contributing causes include components addressing the above safety culture traits.

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Key Corrective Actions - Direct Cause Immediate Actions Restored compliance by submitting corrected license application paperwork to the NRC including a revised NRC Form-396 and a Medical Review Officer (MRO) letter.

Received updated NRC operator license.

Brief Health Services staff to address immediately needed changes.

Performed stand-down with Health Services staff to discuss the significance of the missing medical restriction and the importance of diligence and a thorough review of regulatory documentation and NRC communications.

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Key Corrective Actions - Root Cause Eliminate the single point vulnerability for the Centralized Managed Oversight position by developing a knowledge transfer and retention plan.

Combine 01DP-0EM13, Licensed Operator Medical Examinations and 40DP-0OP09, Operator Licensing and Requalification Process into a new procedure 15DP-0LC01 to formally streamline and clarify responsibilities and accountabilities.

Update responsibilities in new procedure 15DP-0LC01, Operator Licensing and Requalification Process to identify the Nuclear Training organization as the owner for Operator Licensing and Requalification.

Include identification of the leader position for oversight responsibilities Requiring periodic reviews of program effectiveness 11

Key Corrective Actions - Root Cause Revise training (NLR20, License Responsibilities) lesson plan to include the Operating Experience from relevant condition reports to reinforce standards and expectations for how Operators review their own license-related documentation.

Senior Management will reinforce in-person Palo Verde standards and expectations for Licensed Operators and the responsibility to own their license.

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Key Corrective Actions - Contributing Cause Revise new procedure 15DP-0LC01, Operator Licensing and Requalification Process to clarify requirement that the medical files shall be used as the information source document during reviews of the certification and NRC Form-396.

Create an Administrative Guide to support new procedure 15DP-0LC01 to provide structure and guidance for the Regulatory Analysts responsibilities during the physical examination process.

Ensures knowledge transfer, maintains consistent standards and reduces errors when completing medical paperwork validations.

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Key Corrective Actions - Contributing Cause Create a Job Familiarization Guide for the Regulatory Analyst Nurse position within Health Services to include roles and responsibilities, regulatory required tasks, importance of maintaining questioning attitude, attention to detail, required NRC forms for operator licensing program and industry training opportunities.

Conducted a briefing to Health Services staff to state that after completion of the first check by the Regulatory Analyst Nurse and prior to the operator leaving, the Occupational Health Physician, the Regulatory Analyst Nurse and the Operator shall all verify and be aligned that the medical information on the certification is complete and accurate. This includes the medical restrictions and conditions.

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Regulatory Significance APS acknowledges there is regulatory significance anytime inaccurate information is submitted to the NRC. However, mitigating circumstances exist in this instance:

The Operator had been appropriately implementing treatment notwithstanding the documentation error.

The ability of the Operator to perform required job duties was not adversely impacted by the error.

APS identified the error and promptly notified the NRC on August 4, 2020.

APS submitted amended 396 Form to NRC on August 6, 2020; NRC promptly issued a corrected License the same day.

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Regulatory Significance The NRC Enforcement Policy provides violation examples in Section 6.4 for guidance in making severity level determinations for Licensed Reactor Operators. Section 6.4.d contains examples for severity level IV.

The NRC Enforcement Policy Section 6.4.d.1(a) states that:

1. A nonwillful compromise (see 10 CFR 55.49) of an application, test, or examination required by 10 CFR Part

55. For example,

• (a) cases of inaccurate or incomplete information inadvertently provided to the NRC that do not contribute to the NRC making an incorrect regulatory decision as a result of the originally submitted information Severity Level IV Basis 1:

The PVGS example involves:

• A nonwillful compromise of an application

• Incomplete information inadvertently provided to the NRC

• The information did not contribute to the NRC making an incorrect regulatory decision as a result of the originally submitted information since when the NRC became aware of the omission and was provided the updated information, the regulatory decision granting the operator license did not subsequently change.

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Regulatory Significance The NRC Enforcement Policy Section 6.4.d.1(d) states that:

1. A nonwillful compromise (see 10 CFR 55.49) of an application, test, or examination required by 10 CFR Part

55. For example,

• (d) an individual operator who met ANSI/ANI 3.4, Section 5, as certified on NRC Form 396, required by 10 CFR 55.23, but failed to report a condition that would have required a license restriction to establish or maintain medical qualification based on having the undisclosed medical condition.

Severity Level IV Basis 2:

The PVGS example involves:

• A non-willful compromise of an application

• An inadvertent failure to report a condition that would have required a license restriction using the ANSI/ANS 3.4, Section 5

• The Operator was medically qualified regarding ANSI/ANS 3.4, Section 5, with respect to the undisclosed medical condition 17

Regulatory Precedent Date Accession # Violation Severity Level 5/11/2017 ML17130A766 SL III Problem- Complex Enforcement: Multiple deliberate violations NOV issued to SRO (not the Part 50 licensee) for violating 10 CFR 55.53(l) and 10 CFR 50.5(a)(2). The operator was not in compliance with the condition of the license that required the use of a CPAP machine.

3/16/2015 ML15075A328 SL III Problem - Complex Enforcement (two violations): Part 50 licensee failed to notify the NRC within 30 days after learning of a change in a ROs medical condition that involved a permanent disability / illness (sleep apnea) and did not request an amended license. Part 50 licensee subsequently submitted a licensed renewal application for the same RO that did not specify the subject medical condition that required a restriction (use of a CPAP machine).

8/28/2013 ML13241A027 SL III Problem - Complex Enforcement (two violations): The first involved four licensed operators who each had permanent disabilities or illnesses specified as disqualifying conditions in ANSI/ANS 3.4, 1983, however they were not restricted from performing licensed operator duties or reported to the NRC within 30 days. The second violation involved four licensed operators who had permanent disabilities or illnesses that were not reported to the NRC within 30 days of the licensee learning of the medical issues.

11/23/2005 ML053290243 One SL III Violation and One SL III Problem - Complex Enforcement: (1) incomplete and inaccurate information in an August 2, 2004, letter that described corrective actions for a previous Severity Level III violation; (2) untimely information with regard to the medical status of NRC-licensed reactor operators; and (3) incomplete and inaccurate information with regard to three applications for new, renewed, or amended NRC-licensed reactor operator licenses.

9/29/2004 ML042740019 SL III Violation - Complex Enforcement: Ability of licensed operator to continue duties in doubt due to potentially disqualifying condition not communicated to the NRC. The NRC had not been informed of a cardiac condition experienced by an SRO. Had the medical information been complete and accurate at the time the license renewal was sought by the licensee, the NRC would have taken a different regulatory position by applying the appropriate restriction on to the SRO license.

5/6/2003 ML031270014 SL III Violation - Complex Enforcement: Involving multiple operators and a change of allowed operation to no-solo category upon review of omitted medical information. Incomplete and inaccurate information was submitted to the NRC as it did not include medical information already available to the licensee, that potentially disqualified two individuals applying for reactor operator licenses. Based on the additional information provided, the NRC determined that a restriction to each license was necessary and the licenses were modified to include restrictions for "no solo" operation.

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Regulatory Precedent Date Accession # Violation Severity Level 1/29/2019 ML19031B145 SL IV Violation - Single Issue: Failure of the licensee to notify the NRC of a change in a medical condition of a licensed operator. The operator had used the therapeutic device and taken the medication as prescribed and was not on shift during this time.

2/11/2013 ML13042A356 SL IV Violation - Single Issue: On February 23, 2012, the licensee submitted a completed NRC Form-396 for renewal of an SRO's operator license. The licensed SRO had been prescribed a CPAP device on March 26, 2010, and the license renewal did not include the license restriction, "shall use therapeutic device as prescribed to maintain medical qualifications."

7/25/2012 ML12208A054 SL IV Violation - Single Issue: Failure by the operator to disclose prescription for CPAP device to the licensee while enrolled in the licensed operator initial training program. Licensee notified the NRC within 6 days after being notified. The NRC concluded that the operators medical condition did not adversely affect the operators ability to safely operate the facility even though the operators license was incorrect.

5/10/2012 ML12132A026 SL IV Violation - Multiple Similar Issues: Part 50 licensee discovered that six operator licenses did not have medical restrictions for use of Continuous Positive Airway Pressure (CPAP) devices. Per NRC Enforcement Policy, Section 6.4, failing to include medical condition restrictions within operator licenses, which did not adversely affect their ability to safely operate the facility was categorized as an example of a SL IV violation.

5/10/2012 ML12131A422 SL IV Violation - Single Issue: On December 21, 2005, an employee was diagnosed with sleep apnea and prescribed a CPAP. The employee was issued an NRC initial operating license on March 2, 2011, without a requirement to use therapeutic devices as directed. On July 6, 2011, the operator notified the site nurse of a prescription for a CPAP device. On August 1, 2011, the licensee notified the NRC of the need to add this condition to the operator's license. On October 24, 2011, the NRC amended the operator's license to include the license condition.

10/29/2010 ML103020152 SL IV Violation - Single Issue: A licensed operator was placed in a no-solo status by the facility licensees medical review officer due to a permanent change in the individuals medical condition, and the licensee failed to notify the Commission within 30 days of learning of the change in medical condition as required. The SL IV violation was issued as an NCV.

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Regulatory Significance Conclusion APS acknowledges that medical information was omitted from the NRC Form-396 for the operator that should have been listed on their license. However:

The omitted information did not cause the NRC to change its position regarding whether the operator warranted an operator license.

Complex factors do not exist in this instance and therefore, a Severity Level IV violation would be more consistent with the NRC Enforcement Policy.

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Closing Remarks 21

Questions and Comments 22

Appendix A - Corrective Actions Cause Action Status Direct Cause: Submit a revised NRC 396 form and MRO letter to the NRC. Complete Action Intent: This action restored compliance by submitting corrected license application paperwork to the NRC, which resulted in a corrected license Medical Review Officer not being issued on 08/06/2020. Action was issued through level 3 evaluation 20-09888-001.

checking the correct number A briefing to Health Services to address immediate enhancement to process was drafted and presented. Complete Action Intent: Action was issued through level 3 evaluation 20-09888-01 with briefing given on 08/13/2020. Briefing statement: Effective immediately, of restrictions on the upon the completion of a regulatory physical the first checks shall be immediately completed. Upon completion of the first checks and prior to the medical certification form employee leaving the department the Regulatory Analyst RN, or designee, and the Occupational Health Physician, or designee, and the regulatory employee shall conference and review the certification together to verify that the certification includes all pertinent certification restrictions/conditions. The conditions may include but may not be limited to requirements for taking medications, use of a therapeutic device, use of corrective lenses or use of hearing aids to remain medically qualified. Prior to the regulatory employee leaving Health Services, all three people must agree that the certification is complete and accurate.

Complete a stand down with Health Services staff to discuss the significance of this event and the importance of diligence and Complete thorough review of regulatory documentation and NRC communications.

Action Intent: Action was issued through level 3 evaluation 20-09888-001 with stand down conducted on 08/21/2020.

Table of Abbreviations and Acronyms CARB Corrective Action Review Board NRC Nuclear Regulatory Commission CMO Centralized Oversight Management OE Operating Experience LOIT Licensed Operator Initial Training RA Regulatory Analyst MRO Medical Review Officer RAN Regulatory Analyst Nurse 23

Appendix A - Corrective Actions Cause Action Status Root Cause: Create a new procedure capturing the required content from 01DP-0EM13, Licensed Operator Medical Examinations and 40DP- Due 2/19/2021 0OP09, Operator Licensing and Requalification Process to combine procedures into a new single procedure. Review the evaluation Ineffective program attached to 20-14933-001 and consult with the CMO and RAN on formatting and required content. New procedure ownership will ownership be the Nuclear Training Department Director. Following creation and approval of the new procedure, cancel 01DP-0EM13 and 40DP-0OP09.

Action is referred to but not in the Root Cause, it was originally contained in previous Level 3 Evaluation. Added here for clarity.

Update responsibilities section within 15DP-0LC01, Operator Licensing and Requalification Process, to identify the Training Due 2/19/2021 organization as process owner for the Operator Licensing and Requalification Process. Also, include a responsible leader by job title and the oversight responsibilities.

Revise bullet under responsibilities which provides guidance to perform periodic internal audit or simple assessment of the licensed operator medical files to include a periodic review of CAP items for common causes or ineffective corrective actions. Also include steps to review external operating experience for site applicability.

Action Intent: Provide overall ownership of the license process and program and to monitor program health. NOTE: Procedures 01DP-0EM13 and 40DP-0OP09 were combined into a new procedure (15DP-0LC01) as directed per Level 3 AI 20-14933-002. (Above)

Revise NLR20 License Responsibilities lesson plan to include operating experience from CRs 20-08891, 20-09653, 20-09888, and 20- Due 3/19/2021 09927. Additionally, create two additional objectives on:

• What does your signature mean?

• Operator's responsibility for review of their license application and renewal of license. To include discussion on human performance tools, questioning attitude, and recent OE for errors on licenses, license application, and renewals.

Action Intent: Revises lesson plan for both CBT and future classroom training to set standards and expectations for how Operators review their licensing paperwork.

Revise LOIT TPD to reflect delivering NLR20 License Responsibilities, prior to license application Operator signature. This class will Complete also be delivered in person as classroom training conducted with a member of Senior Leadership to set and reinforce PVGS standards and expectation for license management for LOIT per Level 2 Evaluation 20-09888-007.

Action Intent: Revises lesson plan for both CBT and future classroom training to set standards and expectations for how Operators review their licensing paperwork.

Develop knowledge transfer and retention plan for the Centralized Managed Oversight position. Due 2/19/2021 Action Intent: Eliminate single point vulnerability for the position.

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Appendix A - Corrective Actions Cause Action Status Contributing Cause: Revised procedure 01DP-0EM13, Licensed Operator Medical Examinations, for clarity. Complete

• Add step 2.3.5 "Reviews the medical examination physical and verifies any medical restrictions identified during the medical Dilution of knowledge with examination are included on the exam certification form (PV E-1160)"

the multiple turnovers of the

• Change step 2.3.2 to "Reviews most recent medical examination physical and verifies that medical restrictions identified during Regulatory Analyst position the medical examination are indicated on the Licensed Operator's most current NRC Form 396 and match the medical in a six-month window restrictions on the NRC license."

• Change step 2.4.5 to "Reviews the Licensed Operator's most recent medical examination physical and compares it to the current NRC License and NRC Form 396."

• Change step 2.4.6 to " Approves any medical correspondence and reviews the most recent medical examination physical and the 396 Form for a new medical condition, a change in a current medical condition, or recommended restrictions based on a new or current medical condition.

Action Intent: Action was issued through level 3 evaluation 20-09888-001. Action was to clarify expectations that the medical files would be used as the information source document during reviews of the certification and NRC Form 396. Action did not include the new expectation in the instructional section of the procedure.

Include in procedure 15DP-0LC01, Operator Licensing and Requalification Process, the following: Due 2/19/2021

• Step 4.2.1 B.3 Ensure all medical information such as but not limited to restrictions, conditions, and required prescription use are listed on the current medical examination certification match the Operators health history form and any Regulatory Medical Update form(s) contained in the Operators medical files.

• Step 4.2.1 C.4 Ensure all medical information such as but not limited to restrictions, conditions, and required prescription use are listed on the current medical examination certification match the Operators health history form and any Regulatory Medical Update form(s) contained in the Operators medical files.

• Step 4.6.3 NRC Form 396 A.1 Ensure all medical restrictions listed on the current medical certification are compared and validated against the previous medical exam certification and license prior to listing the medical conditions and restrictions on the NRC Form 396.

Update procedure to reference new admin guide.

Action Intent: Action is to place the current standard for completing the first and second checks into the instructional section of the procedure to make it align with the changes made to the roles and responsibilities section of the procedure made in PCR 20-09888-004. This will help drive knowledge transfer, keep consistent standards, and reduce errors when completing the validations of the medical paperwork.

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Appendix A - Corrective Actions Cause Action Status Contributing Cause: (cont.) Update PV form PV- E0604, Operator Medical NRC Form 396 Routing Form, under Medical Review Officer, Occupational Health Complete Physician, Health Services.

Dilution of knowledge with Action Intent: Action was issued through level 3 evaluation 20-09888-01. Action was to clarify expectations that the medical files would be used as the the multiple turnovers of the information source document during reviews and approvals.

Regulatory Analyst position Create a Job Familiarization Guide for the Regulatory Analyst Nurse role within Health Services. Include role and responsibilities, Complete regulatory required tasks, importance of questioning attitude and attention to detail, required NRC forms for operator licensing in a six-month window program, and potential industry training opportunities.

Action Intent: Action is to replace Level 8 AI 20-02061-004 which is due 12/31/2020.

Create admin guide to support 15DP-0LC01, Operator Licensing and Requalification Process. Include clear instructions for the tasks Due 2/19/2021 and responsibilities of the steps within the license process.

Action Intent: Provide structure and guidance for the Regulatory Analyst responsibilities during the physical examination process.

Provide What Does Your Signature Mean training for Health Services individuals, including MRO and RA. Complete Action Intent: Raises awareness within the organization to know and understand the information within documents prior to signing.

Revise form PV-E1160 PVGS Health Services Final Certification of Medical Examination Form. Change Additional Complete Comments/Recommendations: to Amendments/Additional Comments/Recommendations:

Action Intent: Provides process improvement by including an area for Health Services individuals to update the certification for when information has been received which could impact the certification.

Effectiveness Review: Perform an assessment of the licensing submittal process to validate effectiveness of actions taken. Due 7/30/2021 26