NRC-10-0011, Reply to Notice of Violation EA-09-267

Reply to Notice of Violation EA-09-267

ML100470675
Person / Time
Site:	Fermi
Issue date:	02/10/2010
From:	Plona J DTE Energy
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
EA-09-267, IR-09-011, NRC-10-0011
Download: ML100470675 (8)

Text

Joseph H. Plona Site Vice President 6400 N. Dixie Highway, Newport, MI 48166 Tel: 734.586.5910 Fax: 734.586.4172 DTE Energy*

EA-09-267 February 10, 2010 NRC-10-0011 U. S. Nuclear Regulatory Commission Attention: Document Control Desk Washington DC 20555-0001

References:

1) Fermi 2 NRC Docket No. 50-341 NRC License No. NPF-43

2) NRC Letter to Detroit Edison, Fermi Power Plant, Unit 2 - Notice of Violation, NRC Inspection Report No. 05000341/2009011 (DRS),

dated January 15, 2010

Subject:

Reply to Notice of Violation EA-09-267 Reference 2 transmitted Notice of Violation EA-09-267. The violation discusses a licensee identified violation of 10 CFR 50.9, "Completeness and Accuracy of Information" relating to missed licensed operator medical testing.

In Reference 2 the NRC requested a response within 30 days to the Notice of Violation.

The enclosure to this letter provides the required response.

No new commitments are being made in this submittal.

Should you have any questions or require additional information, please contact Mr. Rodney W. Johnson of my staff at (734) 586-5076.

Sincerely, Enclosure

USNRC NRC-10-0011 Page 2 cc: NRC Project Manager NRC Resident Office Reactor Projects Chief, Branch 4, Region III Regional Administrator, Region III Supervisor, Electric Operators, Michigan Public Service Commission

USNRC NRC-10-0011 Page 3 bcc: M. S. Caragher W. A. Colonnello J. T. Conner J. M. Davis J. W. Davis R. W. Johnson J. H. Plona G. A. Strobel C. M. Walker Electronic Licensing Library (ELL) (200 TAC)

Information Management (140 NOC)

Michigan Department of Environmental Quality Radiological Protection and Medical Waste Section NRR Chron File NSRG Administrator (200 TAC)

J. P. Flint D. G. Coseo

Enclosure To NRC-10-0011 Fermi 2 NRC Docket No. 50-341 NRC License No. NPF-43 Reply to Notice of Violation EA-09-267

Enclosure to NRC-10-0011 Page 1 Reply to Notice of Violation EA-09-267 Violation Summary from Inspection Reports 2009010 and 2009011 On August 13, 2009, Detroit Edison self-identified that two American National Standards Institute (ANSI) Standard requirements for physical examinations of licensed operators were no longer being administered by Fermi medical personnel. Specifically, olfactory and tactile testing had been deleted by a procedure change implemented in May 1999. Although all licensed operators were subsequently tested and found to have passed the olfactory and tactile tests, this failure had regulatory significance because the incomplete and inaccurate information was provided under a signed statement to the NRC and impacted numerous licensing decisions.

Since May 1999, the NRC issued and renewed numerous operator licenses based on each NRC Form 396 signed by the facility licensee stating that the licensed operator (and operator license applicant) had received a complete medical examination following the criteria provided in ANS/ANSI 3.4-1976. Because the licensee inappropriately certified on each NRC Form 396 that the requirements of ANS/ANSI 3.4-1976 were met, incorrect licensing actions were taken by the NRC. As such, the information provided to the NRC in the license renewal applications (and initial license applications) was material to the NRC licensing actions, and the licensee's failure to provide complete and accurate information to the NRC in the license renewal applications (and initial license applications) is a violation of Title 10 of the Code of Federal Regulations (10 CFR) 50.9.

Reply to Items in the Cover Letter of Reference 2

1. What actions were taken in 2004 in response to NRC Information Notice (IN) 2004-20, "Recent Issues Associated with NRC Medical Requirements for Licensed Operators," which, in part, reminded facility licensees that licensed operators and the personnel who perform and interpret their medical examinations need to be familiar with the regulatory requirements and guidelines (it should be noted that this IN specifically described an instance in which a facility licensee had not conducted some tests required in the ANSI standard for any of its licensed operators).

Response

A Level 4 corrective action program Condition Assessment Resolution Document (CARD) was issued on December 17, 2004 to review NRC Information Notice 2004-20 concerning NRC medical requirements for Licensed Operators; however, the CARD evaluation cited adequate procedures and training and was closed with no action taken as a result of the review. Level 4 CARDs are evaluated by the assigned individual and do not require supervisor or manager's review before closure. Additionally, at the time the CARD was issued in 2004, the CARD procedure did not require a completion of an action plan by a certain date. In 2005, the CARD procedure was revised to require that an action plan be developed for all CARDs within 30 days of the assignment date.

Enclosure to NRC-10-0011 Page 2

2. Why appropriate action was not taken in response to IN 2004-20 to identify the lack of olfactory and tactile testing.

Response

This was a missed opportunity for the station in that the review did not identify gaps in our processes. The fact that the station had no problems in the licensed operator medical program for several years yielded a false conclusion that the station had no issues in this area.

The Fermi Operating Experience (OE) Program has undergone extensive improvement since 2004. Additionally, the OE program was revised in August 2009 to include corrective action program level guidance and management oversight of the process. NRC Information Notice (IN) and Regulatory Information Summary (RIS) documents are required to be assigned Level 3 CARDs. Level 3 CARD evaluations and actions require review by the responsible manager of the group performing the operating experience review. The OE program also now includes specific instruction on the evaluation to address the potential for event occurrence at Fermi 2.

3. The corrective actions taken and planned at this time to assure all information submitted to the NRC is complete and accurate in all material respects.

Response

Immediate corrective actions included promptly procuring test kits and testing all active Licensed Operators prior to performing further licensed duties. All operators have been successfully tested with no required changes to licenses.

Long term corrective actions added rigor to the Licensed Operator Medical qualification process. The station procedure and forms were revised to match the ANSI Standard requirements. Human factors improvements were made that resulted in clearly stated ANSI criteria that are traceable from the medical form to the NRC form. The physician's signature was identified as a certification that the exam is in accordance with ANSI standard. A Nuclear Training signature was added signifying review of documentation and determination of the need for a license change. Other human performance barriers were added to the procedure including embedded commitments to preclude inadvertent omission of requirements during procedure changes. Finally, a single point process owner was established. The program is now owned by the Nuclear Training Manager.

Other barriers were strengthened. The Quality Assurance (QA) audit guide was revised to ensure medical certifications were checked during QA audits. A Medical Job Familiarization Guide (JFG) was created for the physician, site nurse, and medical administrative assistant to ensure knowledge of the ANSI Standard and NRC Regulations related to Licensed Operator Medical topics. Completion of the JFG is entered into the site qualification database.

Enclosure to NRC-10-0011 Page 3 Reply to Notice of Violation

1. The reason for the violation.

Response

A Root Cause Evaluation (RCE) Team was assembled to investigate the event, determine root causes, and make recommendations to prevent recurrence. The Root Cause Team identified two root causes. The first root cause identified that the procedure governing the performance of Licensed Operator physicals was not adequate in ensuring that the elements required for medically certifying and monitoring Licensed Operators were implemented. The second root cause identified a lack of understanding of the significance of missing olfactory and tactile tests and the impact on station Operator Licenses.

Additionally, a contributing cause identified that there was a lack of clear ownership and understanding of roles and responsibilities concerning Licensed Operator medical certifications.

2. The corrective steps that have been taken and the results achieved.

Response

Immediate corrective actions included promptly procuring test kits and testing all active Licensed Operators prior to performing further licensed duties. All operators have been successfully tested with no required changes to licenses.

Long term corrective actions added rigor to the Licensed Operator Medical qualification process. The station procedure and forms were revised to match the ANSI Standard requirements. Human factors improvements were made that resulted in clearly stated ANSI criteria that are traceable from the medical form to the NRC form. The physician's signature was identified as a certification that the exam is in accordance with ANSI standard. A Nuclear Training signature was added signifying review of documentation and determination of the need for a license change. Other human performance barriers were added to the procedure including embedded commitments to preclude inadvertent omission of requirements during procedure changes. Finally, a single point process owner was established. The program is now owned by the Nuclear Training Manager.

Other barriers were strengthened. The Quality Assurance (QA) audit guide was revised to ensure medical certifications were checked during QA audits. A Medical Job Familiarization Guide (JFG) was created for the physician, site nurse, and medical administrative assistant to ensure knowledge of the ANSI Standard and NRC Regulations related to Licensed Operator Medical topics. Completion of the JFG is entered into the site qualification database.

Enclosure to NRC-10-0011 Page 4

3. The corrective steps that will be taken.

Response

Corrective actions to test operators, improve procedures, improve human performance barriers, and strengthen ownership of the program have been completed. An effectiveness review in accordance with the Fermi 2 corrective action program will be completed in approximately one year.

4. The date when full compliance will be achieved.

Response

Detroit Edison is currently in full compliance.