ML20065C973

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Responds to Violation Noted in Insp Repts 50-327/93-48 & 50-328/93-48.Corrective Actions:New Controlled Medical Procedure to Be Implemented by 940501
ML20065C973
Person / Time
Site: Sequoyah  Tennessee Valley Authority icon.png
Issue date: 04/01/1994
From: Powers K
TENNESSEE VALLEY AUTHORITY
To:
NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
NUDOCS 9404060150
Download: ML20065C973 (6)


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. Tennessee va!@y Autnonty, Post Oft,ce Box 2000. Sodcty Darcy. Tennessee 7379 1

April 1, 1994 4

U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 In the Matter of

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Docket Nos. 50-327-Tennessee Valley Authority

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50-328 SEQUOYAH NUCLEAR PLANT (SQN) - NRC INSPECTION REPORT NOS. 50-327, 328/93 SUPPLEMENT. REPLY TO NOTICE OF VIOLATION (NOV) 50-327, 328/93-48-01 In accordance with TVA's letter dated December 10, 1993, a supplemental' response-to the subject NOV and the-results of the completed-evaluations are described in Enclosure 1.

Commitments made in response.to this supplement are contained in Enclosure 2.

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

Sincerely,,

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Ken Powers Site Vice President Sequoyah Nuclear Plant Enclosures cc: See page 2 9404060150 940402:

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U.S. Nuclear' Regulatory Commission Page'2

~ April 1, 1994 cc (Enclosures):

Mr. R. V. Crienjak, Chief U.S. Nuclear Regulatory Commission-Region II 101 Marietta Street, NW, Suite 2900 Atlanta, Georgia 30323-2711 Mr. D. E. LaBarge, Project Manager U.S. Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, Maryland 20852-2739 NRC Resident Inspector Sequoyah Nuclear Plant 2600 Igou Ferry Road Soddy-Daisy, Tennessee 37379-3624 i

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?W ENCLOSURE 1.

SUPPLEMENTAL 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 1

CORRECTIVE STEPS THAT HAVE BEEN TAKEN AND THE RESULTS ACHIEVED TVA has reviewed the open issues from the referenced inspection; report-and provides the following supplemental information:

A.

Expired verification solution--Based on information supplied by the.

equipment vendor and solution representatives and a review'of test-data, it has been determined that while solution'wasLused-beyond-its normal expiration date, the solution was within the manufacturer's.

chemical specification and produced valid test results.

It is therefore concluded that the solution met the manufacturer's requirements of being " fresh and not depleted."

B.

Use of the solution in the wrong breath analysis device--The vendor manual sintes that "a' separate protocol may therefore be expected to exist which supersedes this section (of the. factory manual), with f actory approval'." TVA had in place a verification program, developed by a factory-certified technician and approved by-the.

factory, which allowed TVA to use'O.04 percent solution-in.the. breath analysis device. Therefore, TVA's use of solutions.was correct.

C.

Positive alcohol' test--TVA has' investigated the circumstances surrounding a positive alcohol test. at Browns ' Ferry Nuclear Plant (BFN) on-August 13, 1992.

Interviews with medical personne11and'a review of the test data do not support the' contention.that-the' medical technologist was " apprehensive".orithat the technologist had any reason to be so.

Regarding'the possible delivery,of. replacement solution to BEN on August 13 by the Chattanooga-Lab. Manager, a review of invoices for solution indicates that an 0.10 percent' solution'may:

have been available for delivery to BEN on' August 13,.but the'needed 0.04 percent solution did not arrive from'the vendor until August 14.

All indications are that the' positive test on August 13 was a good and valid test.

TVA conducted a comprehensive audit of its Fitness for Duty-(FFD) program, using the services of Bensinger DuPont and Associates.- TVA's

. Nuclear Security organization conducted a separate review of specific issues. These reviews have result'ed in a number of additional,'but related, FFD issues being identified. Corrective actions for these issues have been included in the overall corrective action plan forfthe_

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FFD program.

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  • t Listed below are the significant findings from these reviews. Other good practice deficiencies were identified and are being addressed as part of the overall improvement program.

Incomplete Alcohol Test An error by a medical technologist resulted in an incomplete random alcohol test being conducted on June 25, 1993, at BFN.

The initial breath test registered an 0.048 percent blood-alcohol count. The medical technologist failed to note or record this as a positive; therefore, no confirmatory test was conducted. This was detected during a review of alcohol tests conducted from January 1992 to December 1993. A review of the event does not indicate any intent by the technologist to circumvent 10 CFR 26.

A review of medical, personnel, attendance, and local criminal history information for the person tested does not indicate any type of drug or alcohol abuse. The investigation did identify the fact that the medical procedures do not require any type of second-party verification of negative test results. No other examples of this problem have been identified; therefore, this is considered to be an isolated event. As an enhancement to the program, the improvement program will include a second-party verification of alcohol negatives.

IYA Medical Lab Ouality Control The TVA review and the audit by Bensinger Dupont identified quality control issues within the onsite screening laboratory.

TVA'made the decision to'stop screening onsite and to send all specimens directly to the contract lab of the' Department of Health and Human Services (DHHS).

TVA's review of the onsite laboratory has documented 19 occasions over a 12-month period where some specimens were processed when the equipment indicated that the quality control readings were outside of the expected norms. This involved a total of 858 specimens.

A review of these specimens by the vendor of the testing equipment, the DHHS contract lab, and TVA's medical staff verified that'there were no confirmed positives as a result of these quality control readings.. The review for false negatives indicates that 2 of the 858 could be classified as potential false negatives.

The DHHS laboratory manager, an expert in forensic toxicology, reviewed the data and believes that neither of the two specimens would have been confirmed positives. He has further stated that even if both specimens had been actual false negatives, the " potential error rate would appear to be small compared to the maximum acceptable rate" (within federal laboratory guidelines).

TVA has stopped using its Central Medical Lab to perform FFD testing; therefore, the issues associated with onsite screening have been appropriately addressed.

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-lnadnguate or Incomplete Procedures and InstruC11Dns.

The audits and reviews identified certain areas in which inadequate or-incomplete procedures and instructions existed.

Instructions provided to the individual being tested were either inadequate or fragmented.

The breath analysis program did not have adequate procedures.

There were inadequate procedures governing recordkeeping.-

The onsite screening laboratory's standard operating practice was deficient in a number of areas.

The quality assurance procedures and practices of the onsite-screening laboratory were deficient.

Corrective actions for these audit findings have been developed and are a part of the overall corrective action program documented by Significant Correccive Action Report (SCAR) CHSCA-930002.

Quality Asaurnace Audits The audit results indicate that the previous. annual-program audits were somewhat ineffective at identifying issues in the medical area. Nuclear Assurance has developed an audit plan that requires a' separate FFD audit, which will include FFD technical experts on the audit team.

CORRECTIVE STEPS THAT WILL BE TAEEN TO AVOID FURTHER VIOLATIONS-TVA has' developed an extensive corrective action plan to address.these

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additional issues and to implement ~a. number of good practice recommendations that were identified during the various reviews. Many-key actions, such as the elimination of the fragmentation in the management of the FFD program, the closure of the onsite screening.

laboratory, and the retraining of key personnel, have already taken place. A new controlled medica 1' procedure system will be implemented'by May 1, 1994. Corrective actions tracked by SCAR CHbCA-930002 will be completed by December 30, 1994.

DATE WHEN FULL COMPLIANCE WILL BE ACHIEVED With the implementation of interim measures described in the violation response dated December 10, 1993, TVA is in compliance with 10 CFR. Part 26.

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ENCLOSURE 2 COMMITMENTS 1.

A new controlled medical procedure system will be implemented by May 1, 1994.

2.

Corrective actions tracked by SCAR CHSCA-930002 will be fully

. completed by December 30, 1994.

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