05000443/LER-2006-001
| Seabrook Station | |
| Event date: | |
|---|---|
| Report date: | |
| Initial Reporting | |
| 4432006001R00 - NRC Website | |
I. Description of Event
On January 31, 2006, during the annual audit of access authorization and fitness for duty programs, it was determined that a non-supervisory, station contract employee was incorrectly granted unescorted access to the protected area. During a review of the drug and alcohol test results at Seabrook Station, an independent technical specialist discovered that a test conducted on February 25, 2005 was reported by the laboratory on March 2, 2005 as a diluted specimen containing a confirmatory presence of marijuana with a level of 16 ng/ml. This value is above the NRC cut off level of 15 ng/ml for a marijuana confirmatory test. The Medical Review Office,- (MRO) directed an observed sample be conducted. The observed test was conducted on March 7, 2005 and returned as a negative test. The MRO ruled the overall tests as negative. With the tests being negative and the remaining elements of the access process in place, the individual was granted unescorted access on March 10, 2005. As a result of the audit review by the technical specialist, the first test being ruled negative was in error. A one-hour report (EN# 42297) was made to the NRC at 1708 on January 31, 2006, the individual's protected area access was suspended and the Medical Review Officer was suspended.
II. Cause of Event
The cause of the event was inadequate understanding by the Medical Review Officer of the specific guidance for declaring a drug test positive, including appropriate cutoff levels and level of detection (LOD) testing.
III. Analysis of Event
10 CFR 26, Appendix A, specifies initial screening cut off levels for each of the five drugs tested. If there is a presence of illegal drugs, an additional step is taken to test the drug in question to a more stringent screening method called Gas Chromatography/Mass Spectrometry (CG/MS), which has lower cut off levels assigned to each drug panel. For marijuana, the initial screening cut off level required by the NRC is 100 ng/ml; however, FPUFPLE Seabrook applies a stricter standard of 50 ng/ml. The cut off level for a marijuana confirmatory test (GC/MS) is set by the NRC at 15 ng/ml, which FPUFPLE Seabrook applies.
During an interview conducted by the FPL Medical Review Officer with the Seabrook MRO on February 6, 2006 it was evident that the Seabrook MRO may not have had a full understanding of the cut off levels. The Seabrook MRO stated that he routinely consulted the Fitness for Duty staff regarding threshold levels. Additionally, an uncontrolled copy of a cancelled procedure was still in place in the Medical Office. The cancelled procedure lists the initial drug screening cut off levels (marijuana metabolites — 50 ng/ml) but does not list the specific levels for a confirmatory test. If the MRO solely relied on this procedure, he may have been misled into thinking that the cut off level was 50 ng/ml instead of the required 15 ng/ml for confirmatory tests.
IV. Corrective Action The corrective actions taken for this event include:
- The individual was denied protected area access based on an interview conducted by the FPL MF:O since there, was no medical explanation for the positive results.
- A work review of the involved individual was conducted for the period of 3/11/05 to 2/1/06 with no adverse issues identified.
- A 100% review of the 2005 tests conducted at Seabrook (2,541 total), to include a review of all negative results. The results determined that there were no additional issues identified that would have irnpacted unescorted access.
IV. Corrective Action (Continued)
- A 100% review was conducted of 2004 diluted and positive tests as a result of one issue identified during the 2005 test review. No further issues were identified.
- Standardized the process for all positive and dilute specimens and documented in appropriate procedure.
- Revised Fitness for Duty procedure to provide the MRO with instructions for handling all non-negative specimens.
- Removed all uncontrolled manuals/procedures from the Medical Office.
- Reviewed procedure usage and use of controlled document requirements with fitness for duty and medical office personnel.
V. Addition al Information None Similar Events A review of the Condition Reporting System identified an instance where all regulatory requirements were not met prior to granting unescorted access to the Protected Area. An individual had not completed enhanced Behavior Observa':ion Training per NRC Order EA-02-261, Order for Compensatory Measures Related to Access Authorization. A review of the associated root cause evaluation determined that this condition is not related nor would the corrective actions have precluded this event.
Manufacturer Data None