ML20062K576

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Responds to Violations Noted in Insp Repts 50-327/93-48 & 50-328/93-48.Corrective Actions:Interim Procedures for Calibr & Verification of Alcohol Breath Analysis Equipment Written,Approved for Use & Issued on 931011
ML20062K576
Person / Time
Site: Sequoyah  Tennessee Valley Authority icon.png
Issue date: 12/10/1993
From: Fenech R
TENNESSEE VALLEY AUTHORITY
To:
NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
NUDOCS 9312230004
Download: ML20062K576 (5)


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lanrmw VMey Au*mty Post Offee Box 2OJO Secty-Damy hsmsee 37347000 flobert A Fenech Vce Prycent. Dequoysh f eat Pmnt December 10, 1993 U.S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, D.C. 20555 Centlemen:

In the Matter of

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Docket Nos. 50-327 Tennessee Valley Authority

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50-328 SEQUOYAH NUCLEAR PIANT-(SQN) - NRC INSPECTION REPORT NOS. 50-327, 328/93 REPLY TO NOTICE OF VIOLATION (NOV) 50-327, 328/93-48-01 contains TVA's response to Douglas M. Collins' letter.to

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Mark O. Medford dated November 10, 1993, which transmitted the subject NOV concerning the use of inadequate alcohol testing-procedures in TVA's Fitness for Duty Program. Commitments made in response to the NOV are contained in Enclosure 2.

In the cover letter accompanying the NOV, TVA was-requested to describe its efforts to ensure the use of valid. alcohol solutions during-breath alcohol. testing. Upon~ identification of the. issue,.the alcohol. solutions in stock were inspected to verify that there was no expired solution in; storage. An interim verification and calibration procedure issued on October 11, 1993, in response to the findings on.which the'NOV'is based..

includes requirements to check the. solution's preparation and/or-expiration date before use and to not use solutions over one y, ear.old.

At TVA's request, the solution vendor has agreed to mark each solution bottle with an expiration date.

In addition, TVA-is considering whether-to arrange for monthly direct shipments of fresh solution'to the collection sites by the vendor as an additional-means to' eliminate stocking large quantities of alcohol solution in a central location.

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December 10,.1993 i

i The identification of concerns regarding the specimen collection and f

analysis process resulted in the initiation of reviews of the Fitness for Duty Program, including a comprehensive assessment performed by a contractor with expertise in fitness for duty issues. Those reviews are ongoing. As indicated in the NOV response, TVA intends to develop and

-implement a comprehensive action plan based on the results of those reviews. Accordingly, it is our intention to revise and update this NOV

-response to include the results of the ongoing reviews and the corrective actions that are init;ated.

Information regarding the status of these reviews will also be provided in TVA's Fitness for Duty Program i

Performance Data report for the period of July 1-December 31, 1993.

Questions regarding this response may be directed to Russell R. Thompson, SQN Compliance Licensing Manager at (615) 843-7470. Questions regarding the TVA Fitness for Duty Program may be directed to Ralph E. Thompson, Fitness for Duty Program Manager at (615) 751-2000.

Sincerely, skbb<ft{?,b-'~~

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Robert A. Fenech Enclosures cc (Enclosures):

Mr. D. E. LaBarge, Project Manager U.S. Nuclear Regulatory Commission i

One White Flint, North 11555 Rockville Pike Rockville, Maryland 20852-2739 NRC Resident Inspector k

Sequoyah Nuclear Plant

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2600 Igou Ferry Road ~

-l Soddy-Daisy, Tennessee 37379-3624 Regional Administrator U.S. Nuclear Regulatory Commission i

Region 11 l

101 Marietta Street, NW, Suite 2900 Atlanta, Georgia 30323-2711 J

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.9-1 RESPONSE TO NRC INSPECTION REPORT.

NOS. 50-327/93-48 and 50-328/93-48 DOUGLAS M. COLLINS' LETTER TO MARK 0. MEDFORD DATED NOVEMBER 10, 1993 Vinlation 50-327. 328/93-48-01 "10 CFR Part 26, Fitness for Duty Program, subparagraph 26.22 [ sic]

Writtenlolicy_anILIToredurca, states in part, 'Each licensee subject to this Part shall establish and implement written policies and procedures-designed to meet the general performance objectives and specific requirements of this Part. As a minimum, written policies and procedures a

must address fitness for duty through the following:

procedures to be utilized in testing for alcohol, including the quality controls used to ensure the test results are valid.'

i "10 CFR Part 26, Appendix A, subpart 2.7, LabEIatory and_Igsline Facility i

Analysis Procedurea, subparagraph (0) Additional Reauirements_lDr HHS Cettilledlahnratsrins_andlissnaen's_Iestine Facilitina, states in part,

' Procedure Manual. Each licensee's testing facility shall have a 4

procedure manual which includes preparation of standards and controls, l

calibration procedures, remedial actions to be taken when the test systems are outside of expiration dates.'

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" Contrary to the above, on October 7, 1993, the licensee's alcohol testing procedures did not address those quality controls used to ensure i

the tests results were valid, in that, the procedures did not include accurate preparation of standards, calibration, nor the action to be f

taken if the test system is outside of expiration dates.

i "This is a Severity Level IV violation (Supplement VII)."

Renann_for the Violatinn

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The violation resulted from a failure to establish adequate procedures for the' control of activities associated with alcohol testing. Reliance was placed on the skill and ability of the_ collection site personnel to l

implement the instructions contained in vendors' operating manuals for the alcohol breath analysis equipment in use.

CDrrec. tile _1tePE_ That Have Bren_IA);An_and the Results Achieved As an immediate corrective action, on Friday af ternoon, October 8,1993, testing was suspended-until interim procedures for alcohol testing could be established.

Interim procedures for the calibration and verification l

of the alcohol breath analysis equipment ~were written, approved for use, and issued on Monday, October 11, 1993. The procedures were subsequently reviewed and approved by authorized representatives of the vendors of the

-j alcohol-breath analysis equipment. Testing using these interim procedures was resumed on Tuesday morning, October 12, 1993.

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i On November 12, 1993, the Health Services and Nuclear Security organizations signed a " Division of Responsibilities for Administration of the Fitness for Duty Program" that defines the. role of-each organization in the TVA Nuclear Power Fitness for Duty Program. This document established Nuclear Security as the single organization.

responsible for the Fitness for Duty Program. Health Services implements.

specific portions of the program under the guidance and direction of Nuclear Security.

On November 13 and 20, 1993, collection site and testing facility personnel attended training sessions on the regulatory requirements affecting the Fitness for Duty Program.

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l Correntirelteps_Ihatlilue_Iaken_to Avoid Further Viola.t.ipna f

Internal reviews of the Fitness for Duty Program have been initiated by 1

the TVA Office of the Inspector General and the corporate Nuclear Assurance and Nuclear Security organizations. These reviews are expected i

to be completed by January 15, 1994.

l The identification lof additional areas of concern regarding the specimen f

collection and analysis process resulted in the initiation of an outside e

review of the overall Fitness for Duty Program. A three-person team from i

Bensinger, DuPont and Associates (BDA) completed a two-week, comprehensive review of the IVA Fitness for Duty Program on November 12, 1993. The BDA assessment included a review of implementing policies and procedures; fitness for duty training; the chemical testing program; activities of the Medical' Review Officers; the breath, blood, and urine specimen collection process as implemented at TVA collection site locations; the drug-testing quality assurance program; reporting and recordkeeping practices; and the performance of the Health'and Human Services certified contract laboratory used by TVA. BDA's final report is expected to be issued to TVA by December 20, 1993.

Based on the findings of the TVA internal reviews and the BDA assessment, a comprehensive action plan and corrective action implementation schedule will be developed by March 1, 1994. IVA will revise and update its response to the subject NOV to incorporate.the results of these reviews and to provide a schedule for the implementation of corrective actions by i

April 1, 1994.

i Datn3 hen EulLCompliance311helchicXnd Full compliance for the cited violation was achieved when the interim j

verification and. calibration procedure was issued on October 11, 1993.

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i Comilments 1.

Based on the findings of the TVA internal reviews and the BDA

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assessment, a comprehensive action plan and corrective action.

implementation schedule will be developed by March 1, 1994.-

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TVA will revise and update its' response to the subject NOV to incorporate the results of these reviews and to provide a' schedule

-j for the implementation of corrective actions by April 1, 1994.-

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