ULNRC-06126, Blind Specimen Test Results
| ML14182A587 | |
| Person / Time | |
|---|---|
| Site: | Callaway  |
| Issue date: | 07/01/2014 |
| From: | Maglio S Ameren Missouri |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation, Office of Nuclear Security and Incident Response |
| References | |
| ULNRC-06126 | |
| Download: ML14182A587 (7) | |
Text
~ rt WAmeren MISSOURI Callaway Plant July 01, 2014 ULNRC-06126 U.S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-0001 Ladies and Gentlemen:
DOCKET NUMBER 50-483 CALLA WAY PLANT UNIT 1 UNION ELECTRIC CO.
FACILITY OPERATING LICENSE NPF -30 BLIND SPECIMEN TEST RESULTS In accordance with 10CFR26.719(c)(3), enclosed is the documentation ofthe investigative findings and the corrective actions taken for an incorrect result on a blind specimen. A report from Clinical Reference Laboratory and an evaluation by the Callaway Medical Review Officer is included in the documentation of investigative findings.
Please contact Anna Lee at 573-676-4435 if any additional action is needed as a result of this information or if there are any questions.
This letter does not contain new commitments.
Enclosure PO Box 620 Sincerely, Scott A. Maglio Manager, Regulatory Affairs Fulton. MO 65251 AmerenMissouri.com STARS
- Alliance
ULNRC-06126 July 01, 2014 Page2 cc:
Mr. Marc L. Dapas Regional Administrator U.S. Nuclear Regulatory Commission Region IV 1600 East Lamar Boulevard Arlington, TX 76011-4511 Senior Resident Inspector Callaway Resident Office U.S. Nuclear Regulatory Commission 8201 NRC Road Steedman, MO 65077 Mr. Fred Lyon Project Manager, Callaway Plant Office ofNuclear Reactor Regulation U. S. Nuclear Regulatory Commission Mail Stop 0-8B 1 Washington, DC 20555-2738
ULNRC-06126 July 01, 2014 Page3 Index and send hardcopy to QA File A160.0761 Hardcopy:
Certrec Corporation 4150 International Plaza Suite 820 Fort Worth, TX 76109 (Certrec receives ALL attachments as long as they are non-safeguards and may be publicly disclosed.)
Electronic distribution for the following can be made via Other Situations ULNRC Distribution:
F. M. Diya D. W. Neterer L. H. Graessle B. L. Cox S. A. Maglio T. B. Elwood Corporate Communications NSRB Secretary STARS Regulatory Affairs Mr. John O'Neill (Pillsbury Winthrop Shaw Pittman LLP)
Missouri Public Service Commission
Enclosure to ULNRC-06126 Page 1 of 4
~~
~Ameren MISSOURI Callaway Plant AAFFD 14-0007 June 24, 2014 Mrs. Anna Lee Supervisor Access Authorization/Fitness for Duty Ameren Missouri PO Box 620 Fulton, MO 65251 RE: Investigation of Blind Performance Testing Error Clinical Reference Lab provided an investigative report to Callaway on 05/30/2014. This report did not address all of the questions that I had as Medical Review Officer. A telephone conference was held on 06/ I 0/2014 to address th~ follow-up questions. A report was issued back to Callaway on 06/ 17/20 I 4, which provided the required information to resolve this issue.
As Medical Review Officer, I am satisfied that the appropriate actions have been taken. If any further questions arise, please do not hesitate to give me a call at 573-676-430 I.
William P. Cravens, MD Callaway Energy Center Medical Review Officer cc:
A 160.000 I PO Box 620 Fulton, MD 65251 AmerenMissouri.com
Enclosure to ULNRC-06126 Page 2 of 4 cJ-"
OBALSE~~
- i. *'*-
CLINICAL REFERENCE LABQRATORY Memorandum for the Record RE:
Follow-up questions for misreported Blind Specimen 2021916468.
6/17/2014 CRL received follow-up questions from Dr. Cravens in response to the report issued on 5/30/2014. These questions are addressed below:
r I
- 1. Was CRL able to consistently duplicate (more than once) the inaccurate result using a known dilute control sample to validate the theory of the bubbles within the chamber causing the elevated specific gravity levels to assure that a root cause was obtair~.d?
CRL: Yes. Four replicates of a dilute specimen with a known specific gravity of 1.0016 were prepared at various volumes below the required minimum volume. One additional replicate of the dilute specimen was prepared at a volume above the ~q(jired minimum. Five replicates of a specimen with a normal specific gravity (1.0048) were placed in the sampling rack immediately preceding each of the dilute specimens. One additional normal replicate was placed at the end of the sampling rack. The specific gravity of each specimen was then measured using our automated system. Each of the low volume dilute specimens had inaccurate readings that were biased high. The values obtained were 1.0032, 1.0048, 1.0056, and 1.0056. The dilute specimen prepared with adequate volume read correctly with a value of 1.0016. The normal replicates prepared with adequate volume were all measured correctly with values of 1.0048, 1.0048, 1.0048, 1.0049, 1.0048, and 1.0048, respectively. This validates our theory regarding the root cause of the misreported blind.
- 2.
Did existing SOP define the required volume of aliquot required to be present in the sample for accurate testing to be achieved?
CRL: The existing SOP did define th~_re,quired volume, but did not require the technician to carefully check each specimen. The SOP has been revised to require a volume check of each specimen prior to the analysis.
- 3.
If so, was an extent of condition revfew done to determine whether the technician(s) who perform the aliquot procedure were aware of the 50P requirement.
- <l dtf;\\1,
CRL: Yes. The technicians were aware of the requirement. However, no mechanism was in place for carefully checking each specimen prior to analysis.
- 4.
If so, what programmatic corref:ti~*la-ctton was taken to reaffirm that the human performance issue is resolved going forward? 1.e., retraining of'aiiquot staff, retraining of refractometer operators, changes to SOP?
.. ;t,':..
CRL: The SOP has been modified to require a volume check of each specimen. Additional training is being provided to the aliquot accessioning staff regarding the minimum volume requirements. Additional training is being provided to the refractometer operators regarding the requirement to check the volume of each specimen prior to analysis.
lift I r<.*'j ~L iJ ;
.- ~
8433 QUlVIRA ROAD
- LENEXA, KANSAS 66215
- 913-492-3652 *
- stMJ44s~917
~---~...l.*iirlt
,1*' **'
Enclosure to ULNRC-06126 Page 3 of 4
- c; ' fl
- 5.
Did the investigation provide any indication of the extent of condition on how long this condition could have existed thus the risk of how many specimens may have been tested inaccurately?, i.e. new operator who did not follow procedure, long terrorDJ)era'.tor. who changed practices recently, etc. 7 CRL: The automated refractometer has been in use for approximately 2 Yi years. However, during this time period, most of the aliquots provided to the screening department have had more than enough volume present to meet the minimum requirement. On the occasions when we have performed follow-up specific gravity testing on a second, separate aliquot of a given specimen, we have generally not experienced difficulty in obtaining results that closely match the initial measurement. Results for our NLCP PT specimens have matched their expected values. We do not believe that the problem experienced with the misreported blind has been frequent in occurrence.
If you have further questions or concerns regarding this matter, please let us know.
Daniel Kolbow, Alt. Responsible Person 612812006
. ~~,~ **. JUN 1 7 2014
. ( - -.
~*,..
i ' Yt "'
Date Date Date f*_ **
2
Enclosure to ULNRC-06126 Page 4 of 4 CLINICAL REFERENCE LABQRATORY Memorandum for the Record 5/30/2014 RE:
Blind Specimen 2021916468 was mlsreported due to an inaccurate specific gravity value.
Investigation:
CRL received specimen 2021916468 on April23, 2014. It was processed as CRL accession# 39948097. The initial drug screen values were all negative. The Initial creatinine specimen validity value was 9.8 mg/dl. The specific gravity of the specimen was measured and a value of 1.0038 was obtained. The data was reviewed by a certifying scientist. The sample was reported as negative on 4/23/2014.
Dr. Cravens contacted CRL to notify us that this specimen was a blind that CRL had misreported as "negative" rather than "negative" and "dilute". Dr. Cravens requested testing oftihe specimen at another laboratory. CRL sent an aliquot of the specimen from bottle f. to Quest Diagnostics. On May 22, 2014, CRL retested the specific gravity of an aliquot of the specimen from bottle A and an aliquot of the specimen from bottle B. Duplicate readings of each were obtained. All four of these measurements had the identical specifiC gravity result value of 1.0011. The creatinine level was also retested. The value of 9.8 mg/dl obtained exactly matches the original value obtained in April. The original creatinine value appear~Jo have been accurate. The original specific gravity reading appears to be erroneous.
r'-J (_ f CRL utilized an automated refractometer to obtain the original specific gravity measurement for this specimen. In the course of the investigation, Screening Department personnel noted that bubbles within the chamber of this refractometer can cause erroneou~f!led readings. The bubbling can occur if the sample probe is not fully immersed in the specimen due to a 'i'o~all"quot volume.
Corrective Action:
To prevent future problems of this nature, the volume present in each specimen aliquot will be verified by the operator prior to testing. The volume present must be greater than the minimum required volume for the test If the aliquot volume is too low the specimen must be re-aliquoted or tested on a non-automated refractometer. The quality control samples run at the beginning of the batch will be tested at this minimum volume to ensure that the sample probe is working properly and Is fully immersed in the sample.
==
Conclusion:==
We have concluded that this blind failure is due to a sampling probe problem that can occur with low sample aliquot volumes. To prevent ~h}s,problem, CRL will require a probe check to be performed at the beginning of the batch using aliquoh 1
W~er! 1(9nlaining the minimum allowed sample volume for the quality control samples. The remaining ~~~e.s 111 the batch will be checked to ensure that the volume of specimen present exceeds the minir¥tun\\.volume requirement.
Daniel Kolbow, All Responsible Person Date tr'=
5*30 1'4 Kiml:ferty Erin, 6Ualily Control Officer Date Date
-~
.. ~.,
- "'~ ~
8433 QUIVIRA ROAD
- LENExi\\"; K.ANSAS 66215
---~