ML16138A562
| ML16138A562 | |
| Person / Time | |
|---|---|
| Site: | Davis Besse  |
| Issue date: | 05/17/2016 |
| From: | O'Brien K Division of Reactor Safety III |
| To: | Boles B FirstEnergy Nuclear Operating Co |
| References | |
| 3-2015-009, EA-16-022 IR 2016008 | |
| Download: ML16138A562 (7) | |
See also: IR 05000346/2016008
Text
UNITED STATES
NUCLEAR REGULATORY COMMISSION
REGION III
2443 WARRENVILLE RD. SUITE 210
LISLE, IL 60532-4352
May 17, 2016
Mr. Brian D. Boles
Site Vice President
FirstEnergy Nuclear Operating Co.
Davis-Besse Nuclear Power Station
5501 N. State Rte. 2, Mail Stop A-DB-3080
Oak Harbor, OH 43449-9760
SUBJECT: DAVIS-BESSE NUCLEAR POWER STATION - NRC INSPECTION REPORT
05000346/2016008; INVESTIGATION REPORT NO. 3-2015-009 AND
APPARENT VIOLATION
Dear Mr. Boles:
This letter refers to the investigation completed on January 29, 2016, by the U.S. Nuclear
Regulatory Commission's (NRCs) Office of Investigations (OI) at your Davis-Besse Nuclear
Power Station facility. The purpose of the investigation was to determine whether a licensed
operator deliberately failed to comply with a condition of his license that required him to take
medications as prescribed by his physician to maintain medical qualifications. Based on the
results of its investigation, the NRC preliminarily determined that the licensed operator
deliberately failed to comply with a condition of his license, and failed to provide the facility
licensee with information, that was complete and accurate in all material respects, for the
submittal of required updates on the operators medical condition.
Based on results of the investigation, the NRC identified an apparent violation that is
being considered for escalated enforcement action in accordance with the NRCs
Enforcement Policy. The current Enforcement Policy is included on the NRCs website
at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The apparent
violation involved the failure to provide information that was complete and accurate in all
material respects on an NRC Form 396 submitted to the Commission in accordance with a
licensed operators license condition, as required by Title 10 of the Code of Federal Regulations
(CFR) 50.9(a). A Factual Summary, included as an Enclosure to this letter, provides a summary
of the factual basis for the apparent violation.
Before the NRC makes its enforcement decision, we are providing you with the opportunity to:
(1) provide a written response to the NRC; (2) request a Predecisional Enforcement Conference
(PEC), or (3) request Alternative Dispute Resolution (ADR). 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 information related to an OI report will be discussed and the
report has not been made public. A PEC should be held within 30 days and an ADR session
within 45 days of the date of this letter.
B. Boles -2-
If you decide to submit a written response to this apparent violation, it should be clearly
marked as a Response to Apparent Violation in NRC Inspection Report 05000346/2016008;
EA-16-022, and should include: (1) the reason for the apparent violation, or, if contested, the
basis for disputing the apparent violation; (2) the corrective steps that have been taken and the
results achieved; (3) the corrective steps that will be taken; and (4) the date when full
compliance will be achieved. Your response may reference or include previously docketed
correspondence, if the correspondence adequately addresses the required response.
Additionally, your response should be sent to the NRCs Document Control Center,
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, with a copy mailed to
Kenneth G. OBrien, Director, Division of Reactor Safety, Region III, U.S. Nuclear Regulatory
Commission, Suite 210, 2443 Warrenville Road, Lisle, IL 60532-4352, within 30 days of the date
of this letter. If an adequate response is not received within the time specified or an extension
of time has not been granted by the NRC, the NRC will proceed with its enforcement decision or
schedule a PEC.
If you choose to request a PEC, the conference will afford you the opportunity to provide your
perspective on the apparent violation and any other information that you believe the NRC
should take into consideration before making an 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: (1) information to determine whether the violation occurred;
(2) information to determine the significance of the violation; (3) information related to the
identification of the violation; and (4) 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 would be considered in assessing any civil penalty for the
apparent violation.
You may also request ADR with the NRC in an attempt to resolve the willful apparent violation.
The term ADR generally encompasses various techniques for resolving conflicts using a
neutral third party. The technique that the NRC has decided to employ is mediation.
Mediation is a voluntary, informal process in which a trained neutral (the mediator) works
with parties to help them reach resolution. If the parties agree to use ADR, they select a
mutually agreeable neutral mediator who has no stake in the outcome and no power to make
decisions. Mediation gives parties an opportunity to discuss issues, clear up
misunderstandings, be creative, find areas of agreement, and reach a final resolution of the
issues. Additional information concerning the NRC's program can be obtained at
http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The Institute on Conflict
Resolution (ICR) at Cornell University has agreed to facilitate the NRC's program as a neutral
third party. Please contact ICR, at 877-733-9415, within 10 days of the date of this letter, along
with notifying Mr. Orlikowski, if you are interested in pursuing resolution of this issue through
ADR. The ADR mediation session is normally held within 30 to 45 days of receipt of this letter,
dependent upon availability of a mediator.
Please contact Mr. Robert Orlikowski, at 630-829-9834, within 10 days from the issue date
of this letter to notify the NRC of how you intend to respond to the apparent violation.
B. Boles -3-
Please be advised that the number and characterization of apparent violations 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 10 CFR 2.390, Public Inspections, Exemptions, Requests for Withholding,
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 NRCs Public Document Room or from
the Publicly Available Records (PARS) component of the NRC's Agencywide 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).
If you have any questions concerning this matter, please contact Mr. Robert Orlikowski of my
staff at 630-829-9834.
Sincerely,
/RA/
Kenneth G. OBrien, Director
Division of Reactor Safety
Docket No. 50-346
License No. NPF-3
Enclosure:
Factual Summary of NRC Investigation
cc: Distribution via LISTSERV
FACTUAL SUMMARY OF OFFICE OF INVESTIGATIONS REPORT 3-2015-009
On February 9, 2015, the U.S. Nuclear Regulatory Commission (NRC) Office of
Investigations (OI), Region III Field Office, initiated an investigation to determine whether a
licensed reactor operator at the Davis-Besse Nuclear Power Station deliberately failed to
comply with a condition of his license and to report a change in a medical condition.
The NRC completed its investigation on January 29, 2016.
The licensed reactor operator received his reactor operator license in January 2012. Pursuant
to 10 CFR 55.33(b), the license included conditions to take all medications as prescribed by the
licensed operators physician to maintain medical qualifications and to wear corrective lenses
when performing licensed duties. In March 2012, the NRC amended the operators license to
include a condition to provide 3-month updates to the NRC on his medical condition, prognosis,
treatment, and ability to perform licensed activities. The operator was taking two medications to
control diabetes at the time the original license was issued.
The operator indicated that part of the initial training included reporting of an individuals medical
issues. The operator also stated that he had received continuing training several times since he
had received his license. During these continuing training sessions, it was stressed to report all
new medications that were prescribed, including any changes in medications or discontinuance
of any medications. The operator indicated during his interview that he understood the
condition of his license, as well as the need to report any changes in medication to the
licensees health center.
In January 2013, the operators personal physician prescribed the operator a blood pressure
medication. On January 2, 2013, the operator filled the prescription, obtaining a 3-month
supply. He did not refill the prescription and in August 2013, during a doctors appointment,
the operators blood pressure was high again. The physician prescribed the same blood
pressure medicine at a higher dose. The operator indicated that in August 2013, he notified
the Davis-Besse Health Center by telephone that he had been prescribed the blood pressure
medication. In November 2013, the operator filled the prescription for the higher dose. He
stated that he stopped taking the medication at some point in either November or December of
2013 because it caused side effects. He reported the cessation to his physician on
January 31, 2014, at which point his physician told him not to take it anymore.
In January of 2014, the operators physician prescribed a third medication for controlling his
diabetes. The operator stated he notified the Davis-Besse Health Center of this additional
medication he was taking. The operator filled the prescription in January for a 1-month supply
and then refilled the prescription again in March with a 1-month supply. The operator also
indicated that due to the high cost of the medicine, he stopped taking the third diabetes
medication after one month, and notified his physician on April 30, 2014.
On July 10, 2014, the operator signed a compliance package used to generate the required
Form 396 stating that he was taking his medications as prescribed. The explanation section
of the compliance package listed all four of the medications that the operators physician had
prescribed. Despite the fact that he was no longer taking two of the listed medications, the
operator signed the compliance package. Davis-Besse submitted the status report required by
the additional condition of the operators license on July 11, 2014. The status report indicated
that the operator was taking all of the medications that he had been prescribed when he was
not actually taking all of them.
Enclosure
In the licensees internal investigation, the operator stated that he mentioned to a licensee
Regulatory Compliance staff member that the medications were not correct, but was under the
impression there was not time to correct the form before it was due. The operator stated that
he signed the form with the intentions of getting the medication list corrected later. A review
of the NRC Form 396s submitted quarterly by the facility licensee was conducted for 2013
and 2014. This review determined that NRC Form 396s submitted by the facility licensee
on February 6, 2013, October 18, 2013, and February 17, 2014, also contained inaccurate
information regarding the prescribed medications listed on the Form 396 and the actual
medications taken by the operator at the time the forms were submitted.
On July 31, 2014, the operator completed a physical and noted that he was taking only two
medications. The medical center questioned the operator as to why he was not taking the
two additional medications listed on his medical record. The operator stated that he was
surprised by the questioning because he believed he had informed the medical center that
he was no longer taking the two medications in question. However, there is no record that
he informed the Health Center.
Based on the evidence gathered in the OI investigation, it appears a licensed reactor operator
deliberately provided false information to the facility licensee. This inaccurate information was
used by the facility licensee to complete NRC Form 396s that were submitted to the NRC.
Specifically, the operator deliberately provided incomplete or inaccurate information by signing
the forms attesting to the accuracy of the document listing the prescription medication he was
taking when he knew the list was inaccurate. The information in the document was material to
the NRC because it provided the basis for the operators medical qualification. Therefore, the
operator apparently violated Title 10 CFR 50.5(a)(2) that requires, in part, that an employee of a
licensee may not deliberately submit to the licensee information that the person submitting the
information knows to be inaccurate in some respect material to the NRC. His actions also
apparently caused the facility licensee to be in violation of 10 CFR 50.9(a).
2
B. Boles -3-
Please be advised that the number and characterization of apparent violations 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 10 CFR 2.390, Public Inspections, Exemptions, Requests for Withholding,
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 NRCs Public Document Room or from
the Publicly Available Records (PARS) component of the NRC's Agencywide 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).
If you have any questions concerning this matter, please contact Mr. Robert Orlikowski of my
staff at 630-829-9834.
Sincerely,
/RA/
Kenneth G. OBrien, Director
Division of Reactor Safety
Docket No. 50-346
License No. NPF-3
Enclosure:
Factual Summary of NRC Investigation
cc: Distribution via LISTSERV
DISTRIBUTION:
See next page
ADAMS Accession Number: ML16138A562
Publicly Available Non-Publicly Available Sensitive Non-Sensitive
NAME Baker:jw Orlikowski Holahan1 Vrahoretis2 Skokowski
DATE 04/26/16 04/27/16 05/06/16 05/06/16 05/06/16
OFFICE RIII
NAME OBrien
DATE 05/17/16
OFFICIAL RECORD COPY
1
OE Concurrence received from G. Gulla on May 6, 2016.
2
OGC Concurrence received from R Carpenter on May 6, 2016.
Letter to Mr. Brian B. Boles from Mr. Kenneth G. OBrien dated May 17, 2016
SUBJECT: DAVIS-BESSE NUCLEAR POWER STATION - NRC INSPECTION REPORT
05000346/2016008; INVESTIGATION REPORT NO. 3-2015-009 AND
APPARENT VIOLATION
DISTRIBUTION:
RidsNrrDorlLpl3-2 Resource
RidsNrrPMDavisBesse Resource
RidsNrrDirsIrib Resource
Cynthia Pederson
Lauren Casey
DRPIII
DRSIII
ROPassessment.Resource@nrc.gov