ML14176A132
| ML14176A132 | |
| Person / Time | |
|---|---|
| Site: | South Texas  |
| Issue date: | 06/12/2014 |
| From: | Shelton T South Texas |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| NOC-AE-14003144 | |
| Download: ML14176A132 (5) | |
Text
Nuclear Operating Company South Texas Project Electric Generating Station PO. Box 289 Wadsjwrth. Texas 77483 An A June 12, 2014 NOC-AE-14003144 10 CFR 26.719 Attention: Document Control Desk U. S. Nuclear Regulatory Commission Washington, DC 20555-0001 South Texas Project Units 1 and 2 Docket Nos. STN 50-498, STN 50-499 Report of Unsatisfactory Blind Testinq Results in Fitness for Duty Program In accordance with 10 CFR Part 26.719 (c) (1), STP Nuclear Operating Company (STPNOC) is reporting unsatisfactory blind performance testing results from Laboratory Corporation of America (LabCorp) for the STPNOC Fitness For Duty (FFD) Program.
On May 14, 2014, LabCorp reported a negative result to STPNOC for a dilute-negative blind sample. STPNOC contacted the lab on May 14, 2014, and requested LabCorp perform an investigation and Condition Report 14-9093 was generated. The cause was determined to be inadequate testing of a software upgrade at the vendor lab. LabCorp has taken action to correct the software. However, since STPNOC has experienced issues with LabCorp. STPNOC has decided not to use LabCorp in the future. Problems included 2 human errors requiring reports to the Nuclear Regulatory Commission in 2007 as well as 3 untimely reporting of lab test results as required by 10 CFR 26.169 in 2013. The LabCorp report sent to STPNOC related to this event is attached.
If you have any questions, please contact Robyn Savage at (361)-972-7438.
There are no commitments in this letter.
Tina R. Shelton General Manager, Human Resources, Organizational Development & Knowledge Transfer
Attachment:
LabCorp Report On Dilute Negative Blind Specimen from STP STI: 33885924
ý_AL
NOC-AE-14003144 Page 2 cc:
(paper copy)
(electronic copy)
Regional Administrator, Region IV U. S. Nuclear Regulatory Commission 1600 East Lamar Boulevard Arlington, TX 76011-4511 Balwant K. Singal Senior Project Manager U.S. Nuclear Regulatory Commission One White Flint North (MS 8 B13) 11555 Rockville Pike Rockville, MD 20852 NRC Resident Inspector U. S. Nuclear Regulatory Commission P. O. Box 289, Mail Code: MN116 Wadsworth, TX 77483 A. H. Gutterman, Esquire Morgan, Lewis & Bockius LLP Balwant K. Singal U. S. Nuclear Regulatory Commission John Ragan Chris O'Hara Jim von Suskil NRG South Texas LP Kevin Polio Cris Eugster L. D. Blaylock CPS Energy Peter Nemeth Crain Caton & James, P.C.
C. Mele John Wester City of Austin Richard A. Ratliff Texas Department of State Health Services Robert Free Texas Department of State Health Services
Attachment NOC-AE-14003144 LabCorp Report on Dilute Negative Blind Specimen from STP
Laboralory CorporaUon of AMedca 7207 N. Gessner Road Houston, TX 77040 (713) 561-4738 May 23, 2014 South Texas Project ("STP") Nuclear Operating Company P.O.Box 289 Wadsworth, TX 77483 Attn: Lisa Matula Re: SPID 037407444, dilute negative blind specimen from STP
Dear Ms. Matula:
In reference to your condition report 14-9093, the following is the Laboratory Corporation of America Holdings' ("LabCorp") written response with regard to the requirement according to 10CFR Part 26.719(c)(1).
Issue:
A negative result was reported on specimen number 0374074444. Upon receiving notification from STP staff that the result reported was for a Dilute Negative blind specimen, LabCorp conducted the following investigation.
Investigation:
The report sent to STP had a value of creatinine 15.6 mg/dL and negative for all drugs; LabCorp laboratory information system (LIMS) is programmed to reflex to specific gravity for any specimen with a creatinine value that is less than 20 mg/dL.
Laboratory had completed and entered the result for the required specific gravity (SG) on 5/14/2014 at 8:11 AM with a value of 1.0022. The report sent to STP at 8:25 AM should have reported as "Dilute Negative". However, the report did not have the SG result and therefore did not have the "dilute" comment.
After the notification'from STP, the laboratory determined that the LIMS did not contain the SG value. The Houston Laboratory immediately contacted the Information Technology (IT) Department to conduct further investigation as to why the result was not captured.
LabCorp updated the LIMS software on April 27h to adopt several enhancements. Prior to the implementation of the software upgrade, user testing was conducted and the software was validated and approved before going "LIVE".
Based on the findings, the laboratory manually posted the results and issued an amended report to STP on 5114/14..
The IT Department identified the root cause of the problem that resulted in the result not being captured as a software bug in the Re-apply profile process that incorrectly deleted the SG result. Without the SG result, the "dilute" was not reported and only the creatinine result appeared on the report along with negative results for drugs.
==
Conclusion:==
The Laboratory confirmed the test results and entered them properly on the LIMS.
After the software updates, a software bug was found that deleted the SG result.
The condition under which this issue occurs is rare and not isolated to a specimen type.
Actions taken:
An Amended report with the SG result and the "dilute negative" was released on the same day of STP notification. This was accomplished by reviewing and manually reposting the results The IT Department was contacted immediately. IT initiated a plan to identify the problem and correct it by the next software update release.
The Laboratory reviewed all STP specimens received from April 11h to May 14h, that is two weeks prior to the software updates and found that all results reported were accurate with the exception of the specimen in question (0374074444)
The Laboratory immediately placed all specimens from STP on an additional "Review hold" pending the software bug is corrected in the LIMS.
The software bug associated with the Re-Apply Profile that caused the dropping of SG was corrected after testing and loaded into LIMS on May 22, 2014.
Following the software corrections on May 22nd, the laboratory will continue to review STP specimens on "Review hold" for a few more weeks.
If you have any questions or need further clarification, please contact me at (713) 561-4738.
Sincerely, Prabhakaran Koteel, Ph.D.
Director/RP