NL-03-2313, Report of Unsatisfactory Performance Testing
| ML033210111 | |
| Person / Time | |
|---|---|
| Site: | Hatch, Vogtle, Farley  |
| Issue date: | 11/11/2003 |
| From: | Gasser J Southern Nuclear Operating Co |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| NL-03-2313 | |
| Download: ML033210111 (6) | |
Text
Jeffrey T. Gasser Southern Nuclear Vice President Operating Company. Inc.
40 Inverness Center Parkway Post Office Box 1295 Birmingham. Alabama 35201 Tel 205.992.7721 Fax 205.992.0403 S
SOUTHERNN November 11, 2003 COMPANY Energy to ServeYourWorld DocketNos.:
50-321 50-348 50424 NL-03-2313 50-366 50-364 50425 U. S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, D. C. 20555-0001 Southern Nuclear Operating Company Report of Unsatisfactory Performance Testing Ladies and Gentlemen:
In accordance with 10 CFR Part 26, Appendix A, Southern Nuclear Operating Company (SNC), the licensed operator for the Joseph M. Farley Nuclear Plant, the Edwin 1. Hatch Nuclear Plant and the Vogtle Electric Generating Plant, requires that test specimens be submitted to a Department of Health and Human Services (HHS) certified laboratory for testing. On September 2, 2003, SNC began using LabCorp in Research Triangle Park, North Carolina for this purpose.
Because SNC was a new client, LabCorp personnel were to enter a new profile for SNC with the required cut-off levels for the panel of drugs at the NRC testing levels. The cutoff level which LabCorp personnel entered for opiates was 2000 ng/ml. The required NRC cutoff level is 300 ng/ml. This mistake was discovered by SNC personnel on September 19, 2003. At that time, LabCorp was instructed by SNC personnel to retest all of the aliquots that were still available and SNC recollected those individuals for which the aliquots had already been discarded. No individual was inappropriately granted unescourted access to any plant site; however, SNC noted this as a programmatic error on the part of the HHS laboratory and requested an immediate investigation.
The findings of LabCorp are provided as an enclosure (letters dated September 25, 2003, September 30, 2003, October 6, 2003 and October 13, 2003). SNC has determined that this error was not systemic and that corrective actions have been taken to prevent reoccurrence. This letter satisfies the reporting requirements of 10 CFR Part 26, Appendix A, paragraph 2.8.
Should you have any further questions, please advise.
Jeffrey T. Gasser
Enclosure:
LabCorp Reports (4 pages)
U. S. Nuclear Regulatory Commission NL-03-23 13 Page 2 cc:
Southern Nuclear Operating Company Mr. J. D. Woodard, Executive Vice President Mr. J. B. Beasley, Jr., Vice President, Plant Farley Mr. H. L. Sumner, Jr., Vice President, Plant Hatch Mr. J. W. Averett, Vice President - Administrative Services Mr. D. E. Grissette, General Manager - Plant Farley Mr. G. R. Frederick, General Manager - Plant Hatch Mr. W. F. Kitchens, General Manager - Plant Vogtle Document Services RTYPE: CFA04.054; CHAO2.004; CVC7000; LC#13869 U. S. Nuclear Regulatory Commission Mr. L. A. Reyes, Regional Administrator Mr. F. Rinaldi, NRR Project Manager - Farley Mr. S. D. Bloom, NRR Project Manager - Hatch Mr. F. Rinaldi, NRR Project Manager - Vogtle Mr. T. P. Johnson, Senior Resident Inspector - Farley Mr. D. S. Simpkins, Senior Resident Inspector - Hatch Mr. J. Zeiler, Senior Resident Inspector - Vogtle
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Occupational Testing Services
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September 25, 2003 Ms. Billie Rooks Medical Services Superiior Southern Nudear RE:
Specimen Processing Procedures 5
VIA FACSIMILE NUMBER: 205-92MB
Dear Billie:
The drug testing accounts for Southern Nuclear's NRC testing program requirements were incorectly set up in the laboratorys computer system. As a result, specimens were screened for opiates at 2000 ng/mL instead of the NRC requirement of 300 ng/mL and the autonatic requirements of 6-MAM and dl methamphetalme analysis were initially omitted. All accounts, regulated and non-regulated, have been reviewed by management and the necessary corrections completed. This system issue was promptly identified and only specimens tested from September 5 t September 11h were initially tested at the higher cutoff levd. Eighty-one of the eighty-five specmens tested have been retested with the appropriate parameters for your accounts with either with the original Bottle A or Bottle B provided by you for the twenty-two specimens which had been discarded (as negatives are retained at our lab for 5 days).
listed below is a summary of the actions taken by LabCorp to correct this mistake.
Aoal num Number 001076 001098 001116 001135 001144 Total ndb-Effec-e Total Cancelled 14 3
0 0
Total Corected and Qq 11 0
9 0
61 9
0 0
0 62 1
Four specimens (Identification numbers v031226-0024180101, C030399-0024050262, C030400-0024050270, and C030401-0024050288) were cancelled as 'invalid' by Soutbern Nudear as Bottle B could not be submitted.
To validat the changes, specimen identification numbers 0296775334 and 0296775360 are being monitored as of the writing to ensure the correct procedures are being followed. I apologlze for any inconvenience this may have caused Southern Nuclear. If you require any furher information, please do not hesitate to contact me direct at 800-833-3933, ext. 3645.
Sincerely, etsMI I
Associate Vice President
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Laboratory Corporation of AmericaO Holdings i.<
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-. Occupational Testing Services 1904 Alexander Dve Research Tdangle Park, North Carolina 27709 Telephone: 800-833-3984 September 30, 2003 919-572-6900 Ms. Billie Rooks -
Medical Services Supervisor Southern Nuclear VIA FACSIMILE NUMBER: 205-992-5568 RE:
Specimen Processing Procedures Follow-Up
Dear Billie:
As you know, this letter is in follow-up to our communication of September 25, 2003.
On September 10, 2003, Southern Nuclear specimens were identified as being initially tested with an opiate cut-off level Inconsistent with the NRC requirements. After the NRC opiate cut-off level was entered into the system, we proceeded to edit the specimens to apply the correct opiate cut-off level. The specimens were tested at the correct opiate cut-off level but the system applied the original (incorrect) opiate cut-off level (2000 ng/mL) and re-reported the incorrect results. A thorough investigation of this process determined that the system did not correctly edit the test. Therefore, where appropriate, system enhancements have been implemented. The specimens In question were edited to delete the incorrect opiate cut-off level (2000 ng/mL) and correctly accept the 300 ng/mL cut-off level and appropriately report the test results.
LabCorp immediately contacted Southern Nuclear when we realized this process had occurred.
If you require any further information regarding this matter, please do not hesitate to contact me at the number Indicated above or Mitzi Allison at the number above, ext.
Sincerely, Assoit Vitchell Associat Vice President
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PO Box 12652 Occupational Testing Services 1904 Alex~nder Drive Research Triangle Park Not Carolina 27709 Telephone: 800-833-3964 October 6, 2003 919-572-6900 Ms. Billie Rooks Medical Services Supervisor Southern Nuclear VIA FACSIMILE NUMBER: 205-992-5568 RE:
Specimen Processing Procedures Follow-Up
Dear Billie:
As you know, this letter Is in follow-up to our communication of September 25, 2003.
On September 10, 2003, Southern Nuclear specimens were identified as being initially tested with an opiate cut-off level inconsistent with the NRC requirements. After the NRC opiate cut-off level was entered Into the system, we proceeded to edit the specimens to apply the correct opiate cut-off level. The specimens in the lab were tested at the correct opiate cut-off level but the system applied the original (incorrect) opiate cut-off level (2000 ng/mL) and re-reported the incorrect results (reports for each specimen indicated this was "an amended report). A thorough Investigation of this process determined that the system did not correctly edit the test. Therefore, where appropriate, system enhancements have been implemented. The specimens in question were edited to delete the incorrect opiate cut-off level (2000 ng/mL) and correctly accept the 300 ng/mL cut-off level and appropriately report the test results. LabCorp immediately contacted Southern Nuclear when we realized this process had occurred.
If you require any further information regarding this matter, please do not hesitate to contact me at the number indicated above or Mitzi Allison at the number above, ext.
3125.
Sincerely, Betsy Mitchell Associate Vice President
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1904 Alexander Drive Research Triangle Park. North Carolina 27709 October 13, 2003 Telephone: 800-833-3984 919-572-5900 Ms. Billie Rooks Medical Services Supervisor Southern Nuclear VIA FACSIMILE NUMBER: 205-992-5568 RE: Specimen Processing Procedures Follow-Up
Dear Billie:
As previously explained, this letter Is sent In follow-up to LabCorp's correspondences dated September 25, 2003, September 30, 2003 and October 6, 2003 and your request for additional information. On September 10, 2003, Southern Nuclear samples were Identified by Southern Nuclear as having been tested for opiates at cut-off levels inconsistent with NRC requirements. Standard editing procedures were Implemented on September 11, 2003 to apply the appropriate opiate cutoff levels within Southern Nuclear's NRC profile. The samples were then re-tested at the correct cutoff levels on the same day; however, the original results were re-reported as 'an amended report."
A thorough investigation determined service weaknesses in two areas. First, Southern Nudear's account record was set-up with the incorrect testing parameters.
Second, reporting logic did not recognize Southern Nuclear's corrected testing profile when components within the profile had been adjusted to appropriate NRC levels.
This situation has been reviewed with appropriate staff and, where appropriate, action taken.
In addition, additional training emphasizing the consequences of Incorrect account set-up will be given to all members of the account set-up team.
Our IS tean reviewed the programming logic within the editing and reporting routines. As a result, our procedure has been enhanced to create an entirely new and separate profile with the appropriate cutoff to prevent the reporting logic from "missing' the applied changes and triggering an amended report of the original results.
If you require any further Information regarding this matter, please do not hesitate to contact me at the number Indicated above or Mitzi Allison at the above number, ext. 3225.
Sincerely, Betsy Associate Vice President