ML20045F505

Discusses Rept of Unsatisfactory Performance Testing. Findings & Supporting Documents by Skbl,Elsohly,Compuchem & Doctors & Physicians Lab Encl.Encl Withheld

ML20045F505
Person / Time
Site:	Vogtle
Issue date:	07/02/1993
From:	Mccoy C GEORGIA POWER CO.
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
Shared Package
ML19303F693	List: ML20045F505
References
LCV-0045, LCV-45, NUDOCS 9307070374
Download: ML20045F505 (3)

Text

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C. K. McCoy Georgia Power mPvxaus von sea & e emexu m m Docket Nos. 50-424 LCV-0045 50-425 U.S. Nuclear Regulatory Commission Attn.: Document Control Desk Washington, DC 20555 Vogtle Electric Generating Plant Report of Unsatisfactory Performance Testina Gentlemen:

In accordance with 10 CFR 26 Appendix A, paragraph 2.8, Georgia Power Company requires that blind performance test specimens be submitted to the HHS-certified laboratory used to confirm the presumptive positive on-site screens. On May 7, 1993, a known positive, blind performance sample was forwarded for confirmation testing from the Southern Nuclear Operating Company (Southern Nuclear) screening facility at Vogtle Electric Generating Plant (VEGP) to SmithKline Beecham Clinical Laboratories (SKBL) located in Atlanta, Georgia. (Southern Nuclear is the Fitness-for-Duty contractor for Georgia Power Company.) On May 17, 1993, the sample was reported as negative by the Medical Review Officer. An investigation of  !

the discrepancy was begun immediately upon receipt of the Medical Review Officer report.

The subsequent investigation determined that no error occurred, rather an interference on the M/Z 91 amphetamine fragment could not be resolved.

Therefore, the sample was reported as negative by SKBL. -

Federal regulation requires the use of three fragments in determining an amphetamine positive result; however, which three fragments are not specified. SmithKline Beecham Clinical Laboratories uses the 91,118. and 140 ton fragments in confirmation. The blind performance specimen obtained by Southern Nuclear from Elsohly Laboratories, Incorporated (ElSohly) was validated to contain amphetamine but not specifically validated for the 91 ion fragment. Methamphetamine was detected at the appropriate level, and amphetamine was detected'at the 118 and 140 ion fragments. However, the 91 ion fragment could not be determined due to a compound, possibly a phenylamine compound, interfering with the test.

Since the third required ion fragment could not be determined, SKBL ruled i the specimen as negative for amphetamine. The specimen did test positive on two initial screenings by Syva EMIT method and Abbott TDX methods.

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-U.S. Nuclear Regulatory Commission Page 2 l During the May 1993 Southern Nuclear Corporate Quality Services audit of 'l SKBL. it was noted that- SKBL had recently made a modification in the gas  :

chromatography mass spectrography on amphetamines which was designed to  :

increase the specificity of amphetamine. ElSohly has made no changes in

- protocol in the development of the blind performance specimens. In  ;

addition, an aliquot of the performance sample was prepared by SKBL and  ;

sent to Compuchem Laboratories, located in Research Triangle, North .

Carolina, to perform a repeat test which confirmed the same negative i results based on the 91 ion fragment.

During this investigation, Southern Nuclear has experienced two more unsatisfactory performance testing events. On May 27, 1993, a second positive amphetamine sample (from the same batch as the event referenced .

above) prepared by ElSohly was submitted from VEGP to SKBL for confirmation. The sample was reported as negative on June 7, 1993.

Southern Nuclear asked that an aliquot of the sample be sent to Doctors &

Physicians Laboratory located in Leesburg, Florida, for confirmation.

This aliquot was reported as positive on June 18, 1993. Doctors &

Physicians Laboratory does not use the 91 ion fragment for amphetamine confirmation.

The other unsatisfactory event concerned a false negative report from SKBL on a THC blind performance sample from Southern Nuclear's Joseph M. Farley Nuclear Plant screening site. The investigation on all three events is '

complete. A report on the THC blind performance test event will be transmitted by Southern Nuclear to the NRC in accordance with the regulations. '

Southern Nuclear has taken the action to increase the number of blind performance samples to SKBL, from all four sites, from 10 percent to 20 per(ent for the next 60 days. In addition, Southern Nuclear has asked l SKBL to repeat 25 percent of all negative samples submitted during the next 30 days. There was no Southern Nuclear programmatic breakdown that resulted in this error. The normal process would have initiated an informal investigation if a presumptive positive sample had been dispositioned as negative at SKBL. If the future sample tests' imply that additional action may be warranted, the NRC will be so advised. 1 Enclosed are the findings and supporting documents by SKBL, E1Sohly, Compuchem, and Doctors & Physicians Laboratories. This letter is '

considered to satisfy the reporting requirements of 10 CFR 26 Appendix A, paragraph 2.8 for both the amphetamine blind performance sample events.

.j Sincerely yours, ,

C. K. McCoy [

'CKM/JMG Enclosures ,

LCV-0045 t

s' ~e U.S. Nuclear Regulatory Commission Page 3

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cc: Georoia Power Company J. B. Beasley, General Manager - Plant Vogtle U. S. Nuclear Reaulatory Commission. Washinaton. DC ,

D. S. Hood, Licensing Project Manager - Vogtle U. S. Nuclear Reaulatory Commission. Reaion II ,

S. D. Ebneter, Regional Administrator ,

B. R. Bonser, Senior Resident Inspector - Vogtle 1

k l

i 9

LCV-0045