NL-08-1405, Report of Unsatisfactory Performance Testing

Report of Unsatisfactory Performance Testing

ML082620348
Person / Time
Site:	Hatch, Vogtle, Farley
Issue date:	09/12/2008
From:	Ajluni M Southern Nuclear Operating Co
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
NL-08-1405
Download: ML082620348 (12)

Text

Southern Nuclear Operating Company, Inc.

Post Office Box 1295 Birmingham, Alabama 35201-1295 Tel 205,992.5000 SOUT¶HERN ZIý*

COMPANY TM September 12, 2008 Energy to Serve Your World" Docket Nos.: 50-321 50-348 50-424 NL-08-1405 50-366 50-364 50-425 U. S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, D. C. 20555-0001 Edwin I. Hatch Nuclear Plant Joseph M. Farley Nuclear Plant Vogtle Electric Generating Plant Report of Unsatisfactory Performance Testingq Ladies and Gentlemen:

Southern Nuclear Operating Company (SNC) operates the Joseph M. Farley Nuclear Plant, the Edwin I. Hatch Nuclear Plant, and the Vogtle Electric Generating Plant. The requirements of 10 CFR Part 26, Appendix A, Paragraph 2.8, include submittal of blind performance test specimens to a Department of Health and Human Services (HHS) certified laboratory for testing. Specimen 54282327 was provided to Kroll Laboratory Specialists (Kroll) located in Gretna, Louisiana on August 12, 2007. Specimen 54282327 was prepared and certified by ElSohly Laboratories, Incorporated (ElSohly) as a blind performance test specimen spiked with amphetamine at limits of detection (LOD).

The requirements of 10 CFR Part 26, Appendix A, Paragraph 2.8(e)(4) requires reporting of unsatisfactory performance testing incidents within 30 days. There were two separate and distinct unsatisfactory performance testing incidents associated with specimen 54282327 summarized as follows:

1. Kroll originally performed testing on specimen 54282327 at NRC cutoff levels. The SNC-required cutoffs for this specimen were at LOD. As a result, the blind performance specimen was initially reported out negative.

2. ElSohly provided blind performance specimen 54282327 to SNC certified to contain amphetamine only. Based on the test results from Kroll and subsequent verification testing, the specimen was determined to be positive for both amphetamine and methamphetamine.

Kroll performed an investigation of the events that led to the unsatisfactory performance testing incident described in item 1 above. The findings of this investigation are provided in Enclosure 1.

U. S. Nuclear Regulatory Commission NL-08-1405 Page 2 Similarly, ElSohly performed an investigation of the events that led to the unsatisfactory performance testing incident described in item 2 above. The findings of this investigation are provided in Enclosure 2.

In addition to the investigations performed by Kroll and ElSohly, SNC requested an independent review of the incident and the corresponding corrective action by Dr. Larry A. Broussard, Toxicology Consultant. Dr. Broussard's findings are provided in Enclosure 3. In summary, Dr. Broussard's investigation determined corrective actions taken by both Kroll and ElSohly are appropriate and, when fully implemented, will preclude recurrence of similar incidents.

This letter contains no NRC commitments. If you have any questions, please advise.

Sincerely, M. J. Ajluni Manager, Nuclear Licensing MJA/TWS/daj

Enclosures:

1. Kroll Laboratories - Investigation of Unsatisfactory Testing Results

2. ElSohly Laboratories - Investigation of Unsatisfactory Testing Results

3. Dr. Larry A. Broussard - Investigation of Unsatisfactory Testing Results cc: Southern Nuclear Operating Company Mr. J. T. Gasser, Executive Vice President Mr. J. R. Johnson, Vice President - Farley Mr. D. R. Madison, Vice President - Hatch Mr. T. E. Tynan, Vice President - Vogtle Mr. D. H. Jones, Vice President - Engineering RType: CFA04.054; CHA02.004; CVC7000; LC# 14835 U. S. Nuclear Regulatory Commission Mr. L. A. Reyes, Regional Administrator Mr. K. D. Feintuch, NRR Project Manager - Farley Mr. R. E. Martin, NRR Project Manager - HatchL.7 Mr. R. A. Jervey, NRR Project Manager - Vogtle Mr. E. L. Crowe, Senior Resident Inspector - Farley Mr. J. A. Hickey, Senior Resident Inspector - Hatch Mr. G. J. McCoy, Senior Resident Inspector - Vogtle

Edwin I. Hatch Nuclear Plant Joseph M. Farley Nuclear Plant Vogtle Electric Generating Plant Report of Unsatisfactory Performance Testing Enclosure I Kroll Laboratories - Investigation of Unsatisfactory Testing Results

KROLL 1111 Newton Street Gretna, LA 70053 504 361 8989 X237 Fax 504 361 8235 www.kroll.com Memo To: April Nai Brockson Date: 7 September 2008 From: David Green, Ph.D., DABCC, FACB

Subject:

Results of investigation regarding specimen ID 54282327 Specimen ID 54282327 was received on August 12, 2008 and screened positive for amphetamines.

Confirmation testing revealed the presence of amphetamine and methamphetamine. Due to a technical issue the sample was retested essentially producing identical amphetamine and methamphetamine results.

However, the certifying scientist committed an administrative error by comparing the results to the standard FFD cut-off levels and reported the sample as Negative on August 14, 2008.

On August 15, 2008 April Brockson contacted Kroll client services to letme know this sample was a double blind and was reported in error. Upon review of the data it was noted that the sample though below the standard cut-off levels, contained significant amounts of both amphetamine and methamphetamine. The report was corrected and both the MRO and April Brockson were notified.

On August 18 we were notified that the sample should only contain amphetamine, further April Brockson was able to provide additional material for our investigation. The sample was retested and again revealed the presence of both amphetamine and methamphetamine. A small portion of the sample was submitted to an independent SAMHSA certified laboratory which corroborated the reported results. The remainder of the sample was forwarded to Dr. ElSohly's laboratory as directedby April Brockson.

The Kroll certifying scientist was counselled to carefully compare the GCMS result to the client requested panel and not to assume the standard FFD cut-off to be correct. Further, Kroll intends to launch our new reporting system prior to 2009 which will automatically perform the result value to cut-off level comparison which will avoid future errors.

• C Companies El - 1

Edwin I. Hatch Nuclear Plant Joseph M. Farley Nuclear Plant Vogtle Electric Generating Plant Report of Unsatisfactory Performance Testing Enclosure 2 ElSohly Laboratories - Investigation of Unsatisfactory Testing Results

ElSohly Laboratories, Incorporated 5 Industrial Park Drive e I Oxford, MS 38655 TEL 662-236-2609 FAX 662-234-0253 www.elsohly.com AMENDED REPORT Report on the investigation of the composition of blind QC specimen with ID SSN 574-80-4291 (Gabriel T. Irvin)

The above referenced specimen was submitted to the Southern Nuclear as being part of amphetamines batch A-2481 which contains amphetamine only at approximately 450 ng/mL.

The specimen was submitted to Kroll and Kroll reported both amphetamine and methamphetamine at approximately 300 and 425 ng/mL respectively.

At the request of Southern Nuclear Kroll repeated the analysis and got the same result.

The split was later sent to Kroll and upon analysis Kroll again found both amphetamine and methamphetamine. A portion of the split was submitted by Kroll to another laboratory where again it was found to contain amphetamine and methamphetamine. A second portion of the split was submitted to our laboratory for analysis.

Here is what we did at ELI:

1. We checked the records for batch A-2481 and the raw analytical data and verified that it actually contained amphetamine only.

2. We reanalyzed the reference sample we have in house from A-2481 and found it to contain amphetamine only, at the level of initial certification.

3. We requested an aliquot from the sample in question to analyze in-house.

4. Kroll sent an aliquot form the split sample to our laboratory for analysis.

5. In the meantime we started investigating any possibility of the sample in question being submitted from a different amphetamines batch than A-2481.

6. We found out that we do have a newer batch (A-3219) that is prepared as an LOD batch which contains both amphetamine and methamphetamine at levels comparable to those reported by Kroll for the specimen in question.

7. We decided to analyze a sample from A-3219 in parallel with the aliquot received from Kroll for SVT values to see if the matrix matches for these two samples and also against the reference sample from A-2481.

8. The results were as follows:

E2 - 1

The data shows that the specimen in question actually matches very well with A-3219 and quite different from A-2481.

9. We then investigated how was it possible for a specimen to be labeled as part of A-2481 when in actuality it was from A-3219. We found out that, the two amphetamine batches were stored side by side in the refrigerator (in bulk) and therefore there is a possibility that at the time of preparing the specimen in question for shipping, the laboratory technician pulled A-3219 and aliquoted from it instead of A-2481.

Although, we have no real evidence that this is what happened, it appears that, that possibility is certainly conceivable.

This is the first occurrence of bottling from the wrong container ever happening in our laboratory.

1O.We have therefore implemented the following procedure to be followed by the laboratory personnel in filling blind QC orders.

1. No two batches of the same drug class be stored in the same refrigerator housing bulk materials for bottling.

2. Implement a second check of the batch number on the container used in preparing positive specimens against the paperwork by another laboratory person.

3. Ascertain that the data base has no records for additional specimens when a particular batch is actually exhausted.

With these measures in place we believe that similar incidences would not occur in the future.

Submitted by:

Ma oud A. EISt*Iy, Ph.D., BCFE, BCFM President Laboratory Director September 5, 2008 E2 - 2

Edwin I. Hatch Nuclear Plant Joseph M. Farley Nuclear Plant Vogtle Electric Generating Plant Report of Unsatisfactory Performance Testing Enclosure 3 Dr. Larry A. Broussard - Investigation of Unsatisfactory Testing Results

Larry A. Broussard, Ph.D.

Toxicology Consultant 8 Melrose Dr. Destrehan, LA 70047 September 10, 2008 Mr. Paul Bizjak and Ms. April Brockson Medical Services Coordinator Southern Nuclear Operating Company Safety & Health Department P.O. Box 1295 Birmingham, AL 35201 Re: Investigation of drug testing incident involving Specimen 9522639 (Donor ID C080453) at Kroll Laboratory.

Dear Mr. Bizjak and Ms. Brockson:

Upon your request I have investigated the following incident concerning a specimen submitted to Kroll Laboratory:

Reporting of Positive results for amphetamine (314 ng/mL) and methamphietamine (424 ng/mL) on a blind LOD sample (Batch 2481;' -supplied by ElSohly Laboratories with a certificate of analysis verifying that the sample-containled amphetamine at a concentration of 43.9 ng/mL and no methamphetamine.

My preliminary and onsite investigation at Kroll included the following actions:

1. Review of email correspondence concerning the incident and subsequent telephone conversations with Ms. Brockson during which it was decided that I would investigate the incident as soon as possible and in the meantime the LOD sample program would be suspended and other samples would be sent to LabCorp instead of Kroll.

2. Site visit of Kroll Laboratory Specialists on August 26, 2008 (described below) and completion of this report.

Discussion of site visit to laboratory on August 26, 2008:

I visited the lab and met with Dr. Green, the laboratory director. During this visit I reviewed the following paperwork:

" SOP procedure for amphetamine/methamphetamine confirmation to verify that the laboratory's method is not one of the methods which have the potential for generating methamphetamine in the presence of large amounts of pseudoephedrine

" SAMHSA PT sample results for amphetamine and methamphetamine for the past 4 cycles to verify that the laboratory has not experienced any problems with amphetamine and/or methamphetamine testing of these specimens (which are known to contain potential interfering compounds)

E3- 1

" Chain of custody, screening data and electronic reports for previously submitted samples from the same pool (see Table 1 for further information on these specimens)

• All of the data for the testing of the specimen in question

" Data for re-analysis of remainder of sample that was sent to Kroll when there was none of the original sample remaining

" E-mail from Baptist Hospital in Little Rock (a SAMHSA-certified laboratory) reporting results of testing of the aliquot of the sample sent to Kroll when there was none of the original sample remaining

" Proof that remainder of aliquot would be sent to Dr. ElSohly's lab which should arrive by 8/27/08.

Table of Results of Samples tested at Kroll and Baptist (1 sample only)

Sample Date Amphet Methamp Screening Creat pH Reported GCMS GCMS value 53316074 2/6/08 488 818 45.6 7.3 H080835 54087180 3/27/08 452 842 44.7 7.1 V080689 54580267 7/7/08 468 815 41.6 7.4 F080893 54282327 8/14/08 314 424 1225 41.1 6.7 C080453 corrected Remaining aliquot 344 420 1339 41.9 6.8 from corporate C080453 reanalyzed At Kroll Remaining aliquot 8/26/08 293 419 from corporate C080453 reanalyzed At Baptist Comments:

Variance in creatinine values is not sufficient to determine that the samples came from the same or different performance testing pool.

Variance in pH may not be sufficient evidence that sample 54282327 is different from the previous 3 samples.

The most compelling arguments for sample 54282327 being different from the previous 3 samples are the screening and GCMS data but if methamphetamine had been added to this sample it would also explain these results.

Second visit to lab:

After our telephone conversation following my initial visit I revisited the lab the following morning (8/27/08) to review the screening and accessioning data for the sample in question and other samples either having been received or analyzed with the sample in question.

E3 - 2

Dr. ElSohly's investigation:

I discussed the incident both before and after Dr. ElSohly investigated his process of preparing and shipping the blind performance samples. He presented a possible scenario which seems to be the most probable explanation of Kroll receiving a sample containing methamphetamine and amphetamine. His explanation was that the sample received at Kroll matched the composition of a sample prepared in his laboratory and that it was possible that his personnel mislabeled the specimen sent to the corporate office.

Although there is not 100% proof that this occurred it certainly seems to be the most logical explanation.

I have reviewed his final report including the action listed below taken to prevent occurrence of the scenario which seems to have caused this incident:

1. No two batches of the same drug class be stored in the same refrigerator housing bulk materials for bottling.

2. Implement a second check of the batch number on the container used in preparing positive specimens against the paper work by another laboratory person.

3. Ascertain that the data base has no records for additional specimens when a particular batch is actually exhausted Initial Reporting Problem by Kroll:

I investigated the fact that the sample was originally reported as negative with LOD cutoffs listed on the report. This happened as a result of the following set of circumstances:

• The sample originally appeared on a computer generated worklist with the correct LOD cutoff level.

" Due to a technical issue with the batch it had to be rerun.

" Rerun batches at Kroll are hand written and not generated by the computer and the cutoff level must be handwritten on this rerun batch.

• The Certifying Scientist for the failed batch committed an error and wrote the standard cutoff for this specimen.

" The Certifying Scientist who released the rerun batch used the handwritten cutoff of 500 and not the LOD cutoff. This is why it was released as a negative originally.

I have reviewed Dr. Green's report which includes a summary, explanation of the incident (as described above) and the following corrective action taken:

1. The Kroll certifying scientist was counseled to carefully compare the GCMS result to the client requested panel and not to assume the standard FFD cut-off to be correct.

2. Kroll intends to launch our new reporting system prior to 2009 which will automatically perform the result value to cut-off level comparison which will avoid future errors.

Conclusions During my visits, I reviewed all of the laboratory documentation of this incident including testing data and reports issued. I have summarized some of this documentation in the table on page 1 of this report. I have also reviewed all of the ongoing and final reports from Dr. El Sohly and Dr. Green, ConcerningDr. El Sohly's investigationand corrective action implemented Ifeel that the corrective action is appropriateand will prevent this type of errorfrom happening in the future.

E3 - 3

All representatives and employees of Kroll that I talked to were helpful, candid, and forthcoming with any information I requested. Combined with Dr. ElSohly's investigation and probable explanation it is safe to assume that the testing performed at Kroll on the specimen in question was accurate and that the specimen contained amphetamine and methamphetamine.

Unfortunately although the investigation validates the accuracy of the analytical testing process it reveals the failure of the testing process to detect all possible clerical/administrative errors. The original error of reporting the specimen as negative was due to failure by Certifying Scientists (CS) at 2 steps in the process. The original CS committed the error of recording the incorrect cutoff on the handwritten worklist but the CS who signed the report and released the result electronically should have performed checks to insure that the cutoffs were appropriate. The correct procedure should include cross-checks such as checking the electronic report and CCF to verify that LOD cutoffs were to be applied to this sample. As part of their corrective action the certifying scientist was counseled which is a generally accepted part of any appropriate corrective action plan involving a clerical error.

The most significant part of Kroll's corrective action plan is "to launch the new reporting system prior to 2009 which will automatically perform the result value to cut-off level comparison." In my opinion this corrective action is appropriateand would preventfuture errors of the kind causing this incident. Of course there will be a delay before this system is implemented and the diligence of the testing personnel in following procedure to compare the result to the requested panel will be the primary means of preventing the error until the system is implemented.

To summarize my conclusions I agree that the corrective actions implemented by ElSohly Laboratories, Inc and Kroll are appropriate. I do not have any other suggested recommended action other than to stress that the implementation of the new reporting system by Kroll is the essential element to theirplan and the corrective action will not be complete until the system is implemented. Until that time the current system is the same as that in place when the error occurred. Finally even though this incident revealed problems involving the supplier of the blind performance specimens and the laboratoryperforming the testing it did validate the purpose and value in the blindperformance program-i.e. to detect potential problems in the entire process. It caused all parties involved to critically evaluate theirprocesses and resulted in implementation of plans which will strengthen the drug testingprogram.

I hope that this report sheds further light on this incident and helps you when making decisions about the company's drug-testing program. I look forward to the continuation of our relationship even though we all wish incidents such as this one would never happen. Please feel free to call me if you have any questions about this report.

Sincerely, Larry A. Broussard, Ph.D., DABCC E3 - 4