View source for PLA-6791, Reply to Notice of Violation, EA-11-244, PLA-6791

{{Adams
| number = ML113420338
| issue date = 12/08/2011
| title = Reply to Notice of Violation, EA-11-244, PLA-6791
| author name = Kearney F
| author affiliation = PPL Susquehanna, LLC
| addressee name = 
| addressee affiliation = NRC/NRR, NRC/Document Control Desk
| docket = 05000387, 05000388
| license number = 
| contact person = 
| case reference number = EA-11-244, PLA-6791
| document type = Letter type:PLA, Notice of Violation
| page count = 6
| project = 
| stage = Other
}}

=Text=
{{#Wiki_filter:Faber A. Kearney                  PPL Susquehanna, LLC Site Vice President                    769 Salem Boulevard Berwick, PA 18603 DEC 0 8 2011                                    Tel. 570.542.2904 Fax 570.542.1504 fakearney@pplweb.com U. S. Nuclear Regulatory Commission Attn: Document Control Desk Mail Stop OP1-17 Washington, DC 20555 SUSQUEHANNA STEAM ELECTRIC STATION REPLY TO A NOTICE OF VIOLATION; EA-11-244                                            Docket Nos. 50-387 PLA-6791                                                                                    and 50-388

==Reference:==
I) Letter from NRC (P. G. Krohn) to PPL (T. S. Rausch), "Susquehanna Steam Electric Station -NRC Integrated Inspection Report 0500038712011004 and 05000388/2011004 and Notice of Violation," dated November 8, 2011.
In accordance with 10 CFR 2.201, PPL Susquehanna, LLC (PPL) hereby submits the Reply to a Notice of Violation EA-11-244 for the Susquehanna Steam Electric Station, Unit 1 and Unit 2.
By letter dated November 8, 2011 (Reference 1), the Nuclear Regulatory Commission (NRC) cited PPL for being in violation of 10 CFR 55.25 "Incapacitation Because of Disability or Illness," for failing to notify the NRC of a known permanent change in medical status of a licensed operator, and 10 CFR 55.3, "License Requirements," for failing to ensure that an individual license holder, in the capacity of a reactor operator, met the medical prerequisites prior to performing licensed operator duties.
PPL accepts the violation. As discussed in the attached Enclosure, PPL has taken prompt action to return to compliance with 10 CFR 55.25 and 10 CFR 55.3.
No regulatory commitments are contained in this letter.
Should you have any questions regarding this submittal, please contact Mr. John Petrilla III, Acting Manager- Nuclear Regulatory Affairs at (570) 542-3796.
Sincerely,

Document Control Desk PLA-6791 Copy: NRC Region I Mr. P. W. Finney, NRC Sr. Resident Inspector Mr. R. R. Janati, DEP/BRP Mr. B. K. Vaidya, NRC Project Manager

Enclosure to PLA-6791 Page 1 of4 Enclosure PPL Susquehanna, LLC Reply to Notice of Violation EA-11-244 Restatement of the Violation During an NRC inspection conducted during the third quarter of 2011, a violation of NRC requirements was identified. Below is a description of the violation.
10 CFR 55.3, states that a person must be authorized by a license issued by the Commission to perform the functions of an operator or senior operator as defined in this part.
10 CFR 55.21 requires, in part, that a licensee shall have a medical examination by a physician every two years. The physician shall determine that the applicant or licensee meets the requirements of 10 CFR 55.33(a)(1). 10 CFR 55.33(a)(1) states, in part, that the applicant's medical condition and general health will not adversely affect the performance of assigned job duties or cause operational errors endangering public health and safety. 10 CFR 55.33(b) states, in part, if an applicant's general medical condition does not meet the minimum standards under 10 CFR 55.33(a)(l) the Commission may approve the application and include conditions in the license to accommodate the medical defect.
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. On the Form 396, PPL certified that it used the guidance in ANSI!ANS 3.4-1983, "Medical Certification and Monitoring of Personnel Requiring Operator Licenses for Nuclear Power Plants."
10 CFR 55.23(b) states that when the certification requests a conditional license based on medical evidence, the medical evidence must be submitted on NRC Form 396 to the Commission and the Commission then makes a determination in accordance with 10 CFR 55.33.
ANSIIANS 3.4-1983, section 3 states, in part, that the primary responsibility for assuring that qualified personnel are on duty rests with the facility operator. The health requirements set forth herein are considered the minimum necessary to determine that the physical condition and general health of the individual are not such as might cause operational errors endangering public health and safety. The specific health requirements and disqualifying conditions are described in

Enclosure to PLA-6791 Page 2 of4 Section 5.3, "Disqualifying Conditions," and Section 5.4, "Specific Minimum Capacities Required for Medical Qualification," of the ANSI standard.
10 CPR 55.25 states, in part, that if during the term of the license, the licensee develops a permanent physical or mental condition that causes the licensee to fail to meet the requirements of 10 CFR 55.21, the facility licensee shall notify the Commission, within 30 days of learning of the diagnosis. For conditions for which a conditional license (as described in 10 CPR 55 .33(b) of this part) is requested, the facility licensee shall provide medical certification on Form NRC 396 to the Commission.
Contrary to the above, PPL failed to notify the NRC within 30 days of a known permanent change in medical condition of a licensed operator and ensure that an individual license holder, in the capacity of an RO, met the conditions of his license prior to performing licensed operator duties. Specifically, biennial medical examinations conducted on April16, 2009 and April19, 2011 identified that an RO did not meet the health requirements stated in ANSI!ANS 3.4-1983, Section 5.4.5, "Eyes." Despite medical reviews on May 12, 2009 and May 9, 2011, PPL did not report this change in permanent medical condition to the NRC within 30 days nor did PPL request an amended license with a condition requiring corrective lenses until identified by the NRC during a review of the RO's license renewal application package submitted to the NRC on August 9, 2011. This resulted in the RO performing licensed operator duties from April2009 through August 2011 without a properly restricted license. It was noted that the RO had worn his corrective lenses since his medical examination in April2009.
This is an example of a Severity Level IV violation (Enforcement Policy Section 6.4).
Reason for Violation The failure to notify the NRC within 30 days of a known permanent change in medical condition of a licensed operator was documented in Condition Report (CR) 1450138.
The apparent cause evaluation for CR 1450138 identified the cause of the violation as inadequate process/procedures for implementation of the licensed operator medical examination program. Specifically, the process is fragmented and lacks suf~icient levels of review. This conclusion is based on the following:
* Training procedure NTP-QA-31.12, "Preparation and Submission of NRC Form 396 - Certification of Medical Examination by Facility Licensee and NRC Form 398 - Personal Qualifications Statement - Licensee," does not prescribe the

Enclosure to PLA-6791 Page 3 of 4 necessary actions to ensure that all operator license conditions/restrictions are properly identified and submitted to the NRC on NRC Form 396.
* Procedure NTP-QA-31.12 does not require a review of the operator's medical examination results against the current license to identify if a change to the operators license is required to be submitted on NRC.
* The Operations or Training departments are not required to review the Medical Review Officer's letter from the SSES Senior Staff Specialist- Health Services to determine if an NRC form 396 is required to be submitted.
* The preparation of an NRC Form 396 does not require a sufficient level of review to ensure accuracy.
Corrective Steps Taken and Results Achieved PPL completed a review (under Corrective Action 1462949) of medical records for all licensed operators to verify that all applicable medical conditions/restrictions identified since early 2008 were reported to the NRC on NRC Form 396. No discrepancies were found.
Date When Full Compliance Will Be Achieved PPL is in full compliance with the requirements of 10 CFR 55.25 and 10 CFR 55.3. On August 19, 2011, a revised NRC Form 396 was submitted to the NRC identifying the operator's visual acuity requiring "Corrective lenses must be worn when performing licensed duties" as a change in the operator's license conditions/restrictions.
Corrective Steps That Will Be Taken to A void Future Violations The following action from CR 1450138 was developed as part of the apparent cause evaluation:
* Develop a site level administrative procedure for implementation of the licensed operator medical examination process. The procedure shall include all of the medical requirements for licensed operators, including the applicable requirements from 10 CFR 55, NUREG-1021 Rev. 9, Supplement 1, "Operator Licensing Examination Standards for Power Reactors," ANSIIANS 3.4, "Medical Certification and Monitoring of Personnel Requiring Operator Licenses for Nuclear Power Plants," and Regulatory Guide 1.134, "Medical Evaluation of Licensed Personnel at Nuclear Power Plants." This procedure will replace the medical examination sections ofNTP-QA-31.12 and incorporate all of procedure OP-AD-010.

Enclosure to PLA-6791 Page4 of4 The new procedure will include the following:
* The operator medical examination process and responsibilities for implementation, tracking and reporting required information to the NRC in accordance with NRC Form 396.
* Require each licensed operator to acknowledge all license conditions/restrictions based on the current physical examination results.
* Require that the Operations Training Coordinator maintain a file of all the required forms needed to keep the process efficient.
* Include record retention requirements for SSES operator's licenses in the procedure.
* Include a requirement that when errors are identified that are related to processing operator medical examinations and/or NRC Form 396 reviews, the condition will be entered into SSES's corrective action program.
Why Corrective Steps for EA-09-248 Were Not Effective in Identifying This Issue Earlier The extent of condition performed under CR 1199349 for EA-09-248 was inadequate because it was limited to a CAP database search. An appropriate extent of condition should have included a review (since 2008) of medical records for all licensed operators to verify that all applicable conditions/restrictions were correctly reported to the NRC on NRC Form 396. This review would have possibly identified the performance deficiency documented in Notice of Violation EA-11-244.}}