ML20070E070
| ML20070E070 | |
| Person / Time | |
|---|---|
| Site: | San Onofre  |
| Issue date: | 07/12/1994 |
| From: | Marsh W SOUTHERN CALIFORNIA EDISON CO. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| NUDOCS 9407140045 | |
| Download: ML20070E070 (8) | |
Text
{{#Wiki_filter:1 p(W.g wm ,p Southem Califomia Edison Company ' 3 PARKER STHEET 4 tRVINE, CAUFORNIA 92718 July 12, 1994 wAuen c. uAnso m,,,_ ~ MANAGEFI OF NUCL F AFI ME,GUL. A FOftY AFF AIFtS ( 714 k 4 64 -440'3 U.S. Nuclear Regulatory Commission Document Control Desk H Washington, D.C. 20555
Subject:
Docket Nos. 50-361 and 50-362 Report of Unsatisfactory Blind Drug Performance Test Result San Onofre Nuclear Generating Station, Units 1,2 and 3 Pursuant to 10CFR26, Appendix A, Subpart B, Section 2.8(e)(4), this submittal summarizes Edison's investigation concerning unsatisfactory blind drug performance test results. Attachment 1 summarizes the occurrence which is attributable to the testing program of our HHS certified laboratory. Documentation - of this instance is provided as attachments 2 and 3. The corrective action. Identified in attachment 1 has been implemented. This event did not compromise employee sample testing, if you have any questions, please let me know. Sincerely,. 40& $ i - Attachments l cc: L. J. Callan, Regional Administrator, NRC Region IV i K. E. Perkins, Jr., Director, Walnut Creek Field Office, NRC Region IV J. A. Sloan, NRC Senior Resident inspector, San Onofre Units 2 & 3 M.' B. Fields, NRC Project Manager, San Onofre Units 2 and 3 < e v c m ',~, 940714o045 94o71,- - 0,j .] l PDR ADOCK 0500o361 i\\ P PDR
4-e 4
ATTACHMENT 1
SUMMARY
OF UNSATISFACTORY BLIND PERFORMANCE TEST RESULTS Propoxyphene GC/MS Testing Discrepancy On June 14,1994, a blind sample was reported negative by Nichols Institute Substance Abuse Testing Laboratory (NISAT) when it should have tested positive for propoxyphene. An investigation of the test discrepancy commenced June 15,1994. It was learned on June 16,1994 that NISAT had screened the sample positive by EIA (enzyme multiplied immunoassay technique) but had confirmed the sample negative by GC/MS analysis due to the absence of the urinary metabolite of propoxyphene, norpropoxyphene, in the sample tested (attachment 2). The blind sample provider, EISohly Laboratories, verified the presence of propoxyphene in the sample by repeated GC/MS analysis prior to sample shipment (attachment 3). It was determined that NISAT had changed the testing methodology such that the GC/MS assay being utilized, detected only the urinary metabolite of propoxyphene, which is norproxyphene, rather than the parent drug, propoxyphene. While it is acknowledged that the technique of identifying only a urinary metabolite rather than the parent drug is not incorrect, the SCE test panel as set forth in the purchase order, requires testing for propoxyphene at the levels of 300 ng/mi by EIA and 200 ng/ml by GC/MS. NISAT was instructed to continue GC/MS confirmation analysis for propoxyphene whenever any sample submitted by SCE screens positive for propoxyphene by EIA. Any change to testing methodology will be acknowledged in writing and will result in a change to the purchase order agreement between SCE and NISAT. I i i
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06-17-1994 11:06AM FROM TO 917143688120 P.02 /3 Nichols Institute C J SubstA%e Abuse Lat,orawies 7470 M4 sam Vailey Road $46 D'600. CA D2108 619/2974 202 800/446 4728 Toll Free June 16,1994 i Ms. Sharon Blue Southern California Edison / SONGS Mesa Bldg. #G48, Room i14 i J San Clemente, CA 92672 l Re: Specimen ID Number: SCE36489 Lab Accession Number: K4941332 1 i This specimen screened positive by EIA for the propoxyphene drug group and was subjected to confirmatory testing by GC/MS. The GC/MS assay for confinnation of propoxyphene is designed to detect norpropoxyphene, the primary urinary metabolite of propoxyphene. Because this specimen did not l contain norpropoxyphene, the GC/MS results were reported as negative. Upon notification from your staff that this was a blind QC specimen and that the results were expected to be positive, we determined that the specimen had been spiked with propoxyphene only. Nichols i Institute's screening results were consistent with SCE/ SONGS screening results as the EIA procedure for j propoxyphene will react positively to both propoxyphene and norpropoxyphene. However, the GC/MS procedure will only detect norpropoxyphene. We might suggest that you consult with your vendor of blind specimens about obtaining specimens which contain at least 9000 ng/mL of norpropoxyphene or a combination of 360 ng/mL of d-propoxyphene and at least 240 ng/mL of norpropoxyphene. Specimens spiked at either of these concentrations should produce a positive screen for the propoxyphene assay by EIA and a positive confirmation by GC/MS analysis. Please do not hesitate to contact me should you need any additional information. Si.crcly, Nina Green Director of Operations cc: Jim Callies Cynthia Bridges 1 vewce ca en i
i
r zw gyy 02/16/1931 05: 49 601-034-0253 EL50HL / L AhISkifS EE D'E-E EISohly Laboratories, Incorporated .dg a 5 Industrial Park Drive Oxford, MS 38655 TEL 601-236-2609 FAX 601234-0253 s N 1 P !li June 17,1994 i l ijh y M i ip Ms. Sharon L. Blue J.
- j FFD Administrator i
Y Southern California Edison Company i h j San Onofre Nuclear Generating Station .}, P.O. Box 128 San Clemente, CA 02674-0128 Ip
Dear Ms. Blue:
-{ Re: Blind Quality Control Specimen from Batch ELI X-0342, PPXY @ 736 ng/mL ) Thank you for your letter of June 17,1994, advising ttat a propoxyphene positive blind y] 'I sample from our' Batch ELI X-0342 screened positive by EIA but was reported from your j primary testing laboratory as negative for propoxyphene by GC/MS. i t i Batch X-0342 was prepared on July 23, 1993, and was certifiEl at ELI by triplicate [' GC/MS analysis at 736 ng/mL propoxyphene. Aliquots of the batch were submitted tt, lj, two other DHHS-certified laboratories, and on August 8,1993. MedExpress reported a er value of 610 ng/mL propoxyphene, and on July 27,1993, PDLA reported a value of 981 i[C-ng/mL propoxyphene. Subsequent GC/MS re-analyses at ELI indicate that on November 14,1993, this ba'.ch was analyzed positive for propoxyphene at 759 ng/mL, and on May ! }, 16, 1994, the batch was analyzed positive for propoxyphene at 729 ng/n.L. As you are ] aware, each shipment is re-screened at the time of shipment. On June 6,1994, the date 1 , qh: of the shipment of these specimens, our screening analysis indicated no problems with l j the specimens. It should be noted that two specimens were submitted to you in this l' shipment (393-23-5519 Emma B. Short, and 394-36-5872, Martha S. Northern). Since [ we do not know which of the specimens was reported as negative by the primary testing g laboratory, I would suggest that you look at the analysis of the second specimen in the q, 4 .q shipment to see what result was reported for it since both specimens were poured from h[ the same batch container at the same time, under the same conditions. 'J g j .. C s
l !'fi 2/idst d2/1 ns:49 601-234-0253 ELSOHLY LABORATORIES PAGE 03 '! M' ' i., -Q ! r, },' i, ig d' l}C [ .i v M, in answer to your question concerning whether or not the sample in questhn was spiked with norpropoxyphene, the answer is no We have been preparing blind quality control specimens to be used in the federally-mandate (1 program since its inception in the late ! [j'h 1980's, and we have always used propoxyphene (which is also secreted in the urine), and / lfl this is the first incident where a laboratory has failed to confirm the cresence of p', g propoxyphene. '1 h j4 Although norpropoxyphene is, in fact, a major metabolite of propoxyphene, 1 ' I' propoxyphene itself is also excreted in urine, and most laboratories confirm immunoassay-positive propoxphene specimens by GC/MS analysis for the parent drug propoxyphene or a combination of propoxyphene and norpropoxyphene. Therefore, a specimen which contains only propoxyphene would confirm by GC/MS 'under these conditions. If the laboratory uses only norpropoxyphene for confirmation, specimens containing propoxyphene would not be expected to confirm. Please let us know if we can provide you with additional information at any time. We shall be happy to work with you to resolve any discrepancies or to answer any questions you may have. With best regards. Sincerely, fahmo A. EISo Ph.D. President Laboratory Director 1 j 1 1 1 -}}