IR 05000327/1993048

Insp Repts 50-327/93-48 & 50-328/93-48 on 931006-08. Violation Noted.Major Areas Inspected:Qualifications of Acting Lab Supervisor,Use of Expired Stds in Alcohol breath-analysis Equipment & Testing Lab Procedures

ML20059K962
Person / Time
Site:	Sequoyah
Issue date:	11/09/1993
From:	Mcguire D, Tobin W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II)
To:
Shared Package
ML20059K927	List: IR 05000327/1993048 ML20059K924 ML20059K947
References
50-327-93-48, 50-328-93-48, NUDOCS 9311160255
Download: ML20059K962 (6)

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UNITED STATES

[pnro%, NUCLEAR REGULATORY COMMISSION 3* f% REGloN11

$ E, 101 MARIETTA STREET, N.W., sUTTE 2900 5 ;y ATLANTA. GEORGIA 30323-0199 o, a

%, ...../

Report No /93-48 and 50-328/93-48

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Licensee: Tennessee Valley Authority 6N 38A Lookout Place 1101 Market Street Chattanooga, TN 37402-2801 Docket No and 50-328 License Nos. DPR-77 and DPR-79 Facility Name: Sequoyah I and 2 Inspection Conducted: October 6-8, 1993 Inspector: h k William J. T Q Senior Safeguards Inspector

// 99 ~ Mt6 ' Signed Approved by: (L David R. McGuire, Chief

//!Of3 Dat'd Signed Safeguards Section Nuclear Materials Safety and Safeguards Branch Division of Radiation Safety and Safeguards

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SUMMARY l Scope:

This special, unannounced inspection was conducted in the area of the licensee's Fitness For Duty Program; specifically, the qualifications of an '

" acting" laboratory superviscr, the use of expired standards in the alcohol breath-analysis equipment, and testing laboratory procedure Results:

One violation (93-48-01) was identified relative to a lack of procedures for breath-alcohol analysis. Another issue, using expired alcohol standards, is under NRC review for further actio PDR ADOCK 05000327 G PDR

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Persons Contacted

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l Licensee Employees '

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• Andrews, Manager of Quality Assurance  :

• R. Driscoll, Manager of Nuclear Assurance  !

• R. Fenech, Site Vice President E. Gregg, Medical Technician  :

, *P. Hamilton, Fitness For Duty Coordinator l *C. Kelly, Manager of Nuclear. Security

• J. Maciejewski, Service General Manager ,

• R. Miller, Quality Assurance Auditor

• B. Schofield, Manager of Corporate Licensing  !

• J. Setliffe, Site Nuclear Security Manager >

• S. Spencer, Licensing Coordinator l

, *R. Thompson, Manager of Nuclear Personnel Branch j

• R. Thompson, Site Licensing Manager -

• K. Whittenberg, Public Affairs Officer ..

Other Individuals (Contacted Telephonically) l D. Collier, Chemist, Intoximeter In .!

A. Flores, Chemist, U. S. Department of Transportation  !

R. Forrester, Vice President, Intoximeter, In i J. Frank, Supervisor, U. S. Department of Transportation l G. Frezonski, Vice President, U. S. Alcohol Testing Inc. . ,

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C. Rice, Technician, National Highway Safety Administration U. S. Nuclear Regulatory Commission j

• Holland, Senior Resident Inspector

• P. Kellogg, Section Chief  :

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• Attended exit meeting Fitness For Duty l Laboratory Supervisor -

Between October 1992 and October.1993, the licensee's Central i Medical Laboratory in Chattanooga, Tennessee was supervised by an .

" acting" superviso NRC Part 26, Appendix A, Subpart i Licensee Testino Facility Personnel (a) " Day-to-Day Management of Operations" requires, in part that, "Any licensee testing . .

facility shall have an-individual to be responsible for day-to-day operations and to supervise the testing technicians. This individual (s) shall have at~least a bachelor's degree in the chemical or biological sciences or medical technology or

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L equivalent. He or.she shall have training and experience in the j theory and practice of the procedures used in the licensee testing .l facility, resulting-in his or her thorough understanding of quality control practices and procedures: the review,-

interpretation, and reporting of test results; and proper remedia'

actions to be taken in response to detecting aberrant test or quality control results."

The inspector reviewed TVA records relative to the education, f'

training, certification and qualification of this " acting" supervisor. While he did not possess a bachelor's degree in the ,

required sciences or technologies, the " acting" supervisor was experienced and certified in medical laboratory technology. This supervisor is a licensed Medical Technologist and a General . ,

Medical Supervisor certified by the State of Tennessee Medical !

Laboratory Board. The licensee accepted his two years of college and 35 years of experience as being the " equivalent" of a degre ;

This " acting" supervisor was an interim appointment pending the !

selection _of a permanent candidate who did possess a bachelor's ,

degre There were no violations of regulatory requirements noted in this are ; Standards for Alcohol-Breath Analysis )

i NRC Part 26, Fitness For Duty Program, subpart 26.24 Chemical *

Testina (g) requires, " Tests for alcohol must be administered by ,

breath analysis using breath-alcohol analyses devices meeting '

evidential standards described in Section 2.7(0)(3) of Appendix 1 A." Section 2.7(0) Additional reauirements for . . . Licensee's :

Testina Facilities (3) Instruments and Eauipment requires, '

" Alcohol-breath analysis equipment shall be. an evidential [ sic]

grade breath-alcohol analysis device of a~ brand and model that !

conforms to National Highway Traffic Safcty Administration (NHTSA) -'

standards (49FR48855) and to any applicable State statutes."

Additionally, Section 2.8 Ouality Assurance and Quality Control, paragraph B, Licensee's Testina Facility Ouality Control '

Reauirements for Initial Tests requires, "In addition, the manufacturer required performance test for the breath analysis equipment shall be conducted as set forth in the manufacture's specifications." Intoximeter Inc., the manufacture of the i licensee's breath analysis equipment requires, in its Supervisor's '

Manual, that ". . . standards are accurately mixed and fresh, not- ,

depleted . . ." (Page 33, Simulator paragraph a.) and, ". . . the '

process of calibration involves running known, good standards at l the values required . . ." (Page 37, Fine Tuning and Full q Calibration) .  !

Through onsite and offsite interviews, review of supply requisitions, shipping documents, laboratory test records, handwritten logs and notations, the inspector was able to_ recreate

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a chronology of an event which occurred in late July, .1992, l relative to the licensee's use of expired alcohol solutions in its !

alcohol-breath analysis equipment (Intoximeter 2000 and 3000). ;

On July 23, 1992, a laboratory technician at the Sequoyah Medical f Station discovered that an expired alcohol solution had been ;

provided to the technician from the TVA Central Laboratory in i Chattanooga. The solution, which expired sometime-in June, 1992, >

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was identified as Lot No. 17211, a reagent' concentration of alcohol (.04 percent) for use in the breath-alcohol analysis by i the Intoximeter 200 l In accordance with NRC's Part 26, the licensee conducts a I preliminary breath-alcohol analysis (using an Intoximeter 3000 i that requires a .1 percent reagent standard) and, if the  !

preliminary analysis is positive, then a confirmatory breath- {

alcohol analysis (using an Intoximeter 2000 that requires a .04 !

percent alcohol reagent standard is performed). NRC requires a ]

.04 breath-alcohol cutoff leve !

A reconstruction of documentation reveals that the licensee notified Intoximeter Inc. on August 11, 1992 of the need for both l!

.1 percent reagents and .04 percent reagents. The vender, j Intoximeter Inc., shipped tot No. 2027 (a .1 percent reagent for ;

use in the preliminary breath-alcohol analysis Intoximeter 3000) l on August 11, and, shipped Lot No. 2976 (a .04 percent reagent for !

use in the confirmatory breath-alcohol analysis Intoximeter 2000) :

on August 13. Both Lots arrived in Chattanooga the day after !

being shippe Documentation at the Sequoyah Medical Facility reveals that both l Lot No. 2976 and Lot No. 2027 had arrived onsite and were in use !

by August 19. Also, dated "92-8-19", is a notation that the expired Lot No. 17211 (.04 percent solution for the confirmatory Intoximeter 2000) had been " dumped".

Alcohol-breath testing records at the Sequoyah Medical Facility reveal that after the July 23 discovery of the expired alcohol solution, the licensee conducted 69 random or pre-badging tests using lot No. 17211. These tests were conducted July 29 and 30, as well as August 6 and 13. No "for cause" tests were performed during those four days. No " positive" results occurred using lot No. 17211. These daily test records also reflect that Lot N (the .04 percent solution for use with the confirmatory Intoximeter 2000) was erroneously used in the Intoximeter 3000, the preliminary breath-alcohol device. This can be substantiated from the serial number of the Intoximeter 3000 being identified as the analysis device using Lot No. 1721 The inspector learned that a medical technician at the Browns Ferry Medical Facility using expired alcohol solutions had conducted a "for cause" test of a contractor. This test occurred l

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in mid-August 1992. The resc1ts of that test were " positive" and-the contractor was terminated. The inspector was told that the new solutions arrived in tb afternoon of the day this test had ot urred, and that the Bro <ns Ferry technician was apprehensive about the earlier " positive". The inspector reviewed documentation that showed that at 10:10 a.m. on August 13 a Bechtel employee tested " positive" for alcohol'.

The inspector reviewed the circumstances of a situation involving a supervisor from the Central Laboratory who supposedly had instructed technicians at the licensee's facilities to discontinue using the newly provided alcohol solutions and to revert back to using the expired solutions. On September 14, 1992, the-laboratory technician, returning from several days of sick leave, discovered Lot No. 17211 had again been delivered to the Sequoyah Medical Facility. The technician's notes reflect that the technician realized the expired solution had been reissued and the technician, " dumped them all" without us In conclusion, the use of expired alcohol solutions in the wrong breath-alcohol analysis device appears to be contrary to Intoximeter manufacturer specifications and in violation of NRC requirements. This apparent violation is under review by NRC for further actio c. Testing Laboratory Procedures 10 CFR Part 26, Fitness For Duty Program, subparagraph 26.22-Written Policy and Procedures, 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 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 area valid " 10 CFR Part 26, Appendix A, subpart 2.7, Laboratory and Testina Facility Analysis Procedures, subparagraph (0) Additional Reouirements for HHS Certified Laboratories and Licensee's Testina Facilities, states in part, " Procedure Manual, Each licensee's testing facility shall have a procedure manual which includes preparation of standards and controls, calibration procedures, remedial actions to be taken when the test systems are outside of expiration dates."

While reviewing the licensee's alcohol-breath analysis techniques, the inspector review a one page typed list of instructions titled,

" Monthly Procedure, Intoximeter 3000 Breath-Alcohol Testing Equipment Beginning October 1, 1991." This unsigned, unnumbered document was apparently used by a technician to calibrate the preliminary breath alcohol analysis equipment (Intoximeter 3000)

on a monthly basis. The document had three technical changes pencilled in relative to the alcohol solution to be used, c -

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additionally, instructions were hand-written on the document. This j list of instructions was not used by the site technician when she !

verified the accuracy of the Intoximeter against known alcohol standards, prior to conducting the daily breath-analysis tes The inspector was informed that there was no such procedure, nor, )

was there a procedure for calibrating the confirmation breath-  :

alcohol analysis equipment (Alco-Analyzer-Intoximeter 2000). The .

inspector was advised that the available "Intoximeter 3000 i Supervisor's Manual" would be referenced if the technician experienced a problem, and, that a qualified technician was ,

available at the licensee's Central Laboratory in Chattanooga to ,

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The failure of the licensee to have quality control procedures which address preparation of standards, instrument calibration and actions to be taken in the event the standards have expired is considered a violation of 10 CFR Part 26.22 and Appendix A subpart 2.7 which require such procedures addressing such criteria i (No. 93-48-01).

When advised of the failure to have procedures, the licensee immediately stopped using those breath-alcohol analysis devices and instituted an interim procedure writing effor . Exit Interview The inspection scope and results were summarized via telephone on ,

October 21, 1993, with those persons indicated in Paragraph 1. The inspector described the areas inspected and discussed in detail the inspection results. The licensee stated that it had already amended its Fitness For Duty procedures and was currently conducting an internal .

evaluation of its chemical testing program to include an independent '

report appraisal. Proprietary informi. tion is not contained in this report. Dissenting comments were not received from the license l t

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