AEP-NRC-2013-80, Unit 2 - Report of Drug and Alcohol Testing Errors in Accordance with 10 CFR 26.719(C)(1)

Unit 2 - Report of Drug and Alcohol Testing Errors in Accordance with 10 CFR 26.719(C)(1)

ML13261A147
Person / Time
Site:	Cook
Issue date:	09/13/2013
From:	Gebbie J P Indiana Michigan Power Co
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
AEP-NRC-2013-80
Download: ML13261A147 (5)

Text

INDIANA Indiana Michigan Power MICHIGAN Cook Nuclear Plant POWER One Cook Place Bridgman, MI 49106 A unit of American Electric Power India naMichiga nPower.com September 13, 2013 AEP-NRC-2013-80 10 CFR 26.719 Docket No. 50-315 50-316 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, D.C 20555-0001 Donald C. Cook Nuclear Plant Unit 1 and Unit 2 REPORT OF DRUG AND ALCOHOL TESTING ERRORS IN ACCORDANCE WITH 10 CFR 26.719(C)(1)

In accordance with the criteria established by 10 CFR 26.719(c)(1), Indiana Michigan Power Company (I&M), the licensee for Donald C. Cook Nuclear Plant Units 1 and 2, is submitting the following report regarding a rejection of a test results report provided by I&M's contracted vendor, South Bend Medical Foundation (SBMF).On August 14, 2013, SBMF received a urine specimen, Identification Number L868944, from I&M for testing. The individual who received and opened the leak-resistant bag containing the specimen failed to document in real time the condition of the specimen bottle seals (i.e. at the time of receipt)as required by SBMF protocol and the National Laboratory Certification Program (NLCP). Although scientifically valid test results were obtained and negative, failure to document the condition of the tamper seals requires the certifying laboratory to report the specimen as "Specimen Rejected: Tamper-evident seals were not verified as intact at time of receipt of specimen." Upon notification of the rejected specimen, I&M began an investigation and conducted a re-test (Specimen Identification Number L868958) of the same donor on August 16, 2013. The test results were negative.

SBMF Technical Director of Toxicology conducted an internal investigation with their toxicology staff confirming the rejected specimen and notified I&M of the results on August 19, 2013. By letter dated August 23, 2013, SBMF's Technical Director of Toxicology notified I&M of the summarized actions to be taken by SBMF Toxicology staff to prevent recurrence.

This letter from SBMF is included as the enclosure to this submittal.

This event was entered into I&M's Corrective Action Program. There are no commitments contained in this submittal.

A U.S. Nuclear Regulatory Commission AEP-NRC-2013-80 Page 2 Should you have any questions, please contact Mr. Michael K. Scarpello, Regulatory Affairs Manager, at (269) 466-2649.Sincerely, Joel P. Gebbie Site Vice President RAW/amp Enclosure c: J. T. King -MPSC, w/o enclosure S. M. Krawec -AEP Ft. Wayne, w/o enclosure MDEQ -RMD/RPS, w/o enclosure NRC Resident Inspector C.D. Pederson -NRC Region III T.J. Wengart -NRC Washington DC Enclosure to AEP-NRC-2013-80 Letter dated August 23, 2013 RE: Corrective Actions Pursuant to the Matter of Specimen ID No.: L868944 1V I DEPARTMENT OF AW "FORENSIC TOXICOLOGY PRENTISS JONES, JR., Ph.D., D-ABFT 2Tox(coIgOlCO Chemist (NRCC)Techniral Direcicr SOUTH BEND MEDICAL FOUNDATION PAUL F. MOORMAN Technicai Manager 53(W North Li.rsyv~u lih tiCV;r1 SOIll1l BOW. I N 466111 10('N (574) 23,-1-176i

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August 23, 2013 Tammy Bond Cook Nuclear Plant One Cook Place Bridgman, MI 49106 RE: Corrective Actions Pursuant to the Matter of Specimen ID No.: L868944

Dear Ms. Bond:

In response to your email of Wednesday August 21, 2013 9:29, we are providing a summary of the corrective actions taken to prevent recurrence of the type of error that resulted in the rejection of Specimen ID No.: L868944.The following was communicated to South Bend Medical Foundation (SBMF) Toxicology staff: 1 It is the responsibility of the individual that opens the leak-proof specimen bag to contemporaneously annotate the condition of the tamper-evident seals when signing for receipt of a forensic specimen.2. (NEW) Prior to creating an aliquot from an unopened specimen bottle or specimen tube (includes blood ethanol specimens), the individual that breaks the tamper-evident seal MUST verify that the condition of the tamper-evident seal on the specimen(s) has. been annotated on the CCF.3. (NEW) The person breaking the tamper-evident seal is culpable (i.e., at fault or to be blamed) if at some later point it is determined that the condition of the tamper-evident seal was not recorded.4. NOTE: This protocol does not remove the responsibility or fault from the person that received the specimen; rather, the fault is shared between the receiving individual and the person that breaks the tamper-evident seal.5. If it is determined that the condition of the tamper-evident has not been recorded on the CCF prior to breaking the tamper-evident seal, have the individual that received the specimen verify the condition of the tamper-evident seal and ask that person to annotate the condition of the tamper-evident seals on the CCF.

6. If it is determined that the condition of the specimen bottles seals has not been recorded on the CCF prior to breaking the tamper-evident seal and the individual that received the specimen is unavailable, use Ancillary Chain of Custody form 950114 and the"Tamper-evident seal" stamp to record the condition of the tamper-evident seal.7. The SOP that corresponds to receiving specimens is being revised to reflect the aforementioned changes.Ms. Bond, we believe mandating a verification of the tamper-evident seals subsequent to the verification check performed during the initial receipt of the specimen minimizes the potential that a specimen will be handled in a manner as was the case for Specimen ID No.: L868944.If you have questions regarding what is herein contained please contact us.Prentiss Jones Jr., Ph.D., D-ABFT Toxicological Chemist (NRCC)Technical Director of Toxicology