ML20012A118

Forwards Compuchem Labs,Inc 900214 Rept of Unsatisfactory Performance Testing Incident on 900126.Util Medical Review Officer Reported Incident to Util on 900206.Rept Indicates That Administrative Error Responsible for Incident

ML20012A118
Person / Time
Site:	Fort Calhoun
Issue date:	03/01/1990
From:	Gates W OMAHA PUBLIC POWER DISTRICT
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
LIC-90-0170, LIC-90-170, NUDOCS 9003080308
Download: ML20012A118 (23)

Text

Omaha Public Power District 1623 Harney Omaha, Nebraska 68102 2247 402/E36 4000 1

March 1, 1990 LIC 90-0170 U. S. Nuclear Regulatory Commission Attn: Document Control Desk Mail Station PI-137 .!

J L Washington, DC 20555

Reference:

Docket No. 50-285  ;

o Gentlemen:  ;

SUBJECT:

Report of Unsatisfactory Performance Testing Pursuant to 10 CFR 26, Appendix A, Subpart B. Section 2.8(e)(4), please find attached a report of an unsatisfactory performance testing incident (Attachment  !

I). The incident was reported to Omaha Public Power District (OPPD) on

february 6,1990, by the OPPD Medical Review Officer with respect to testing

• which was conducted on January 26, 1990.

The attached report from the testing laboratory, Compuchem Laboratories, Inc. i was signed by M. A. Peat, Ph.D., Director, Compuchem Laboratories, Inc. The  !

report indicates that an administrative error in posting data was responsible i for the incident. The report has been reviewed and found acNptable by OPPD's -

Medical Review Officer (Attachment II), and OPPD concurs.

If you have any questions, please contact me. {

Sincerely,  !

e

,.,k8 W N.W '

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,k Og' W. G. Gates Division Manager  !

l. oo Nuclear Operations  :

h oo WGG/pje i 8"

m Attachments SA*

c: LeBoeuf, Lamb, Leiby & MacRae R. D. Martin, NRC Regional Administrator, Region IV A. Bournia, NRC Project Manager P. H. Harrell, NRC Senior Resident Inspector

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.* Western Dimion . 600W North Mar 6,et Boulevard - Sacramento, CA 95t.34

, kN. Phone (916) 641 7779 - (800) $62 6550. Fax (916) 923 1938 February 14, 1990 l

i-  !

Mr. Robert H. Guy  !

Manager, F ,,loyment & Labor Relations Omaha Public Power District c 444 S. 16th Street-Mall Omaha, NB 68102-2247 .

l

Dear Bob:

l:' Please find enclosed my report on the' false negative incident  !

and attachments thereto. l I am sure that a comparison of our original results with the re-analysis results is favorable but if you have any further questions, please contact me.

I have contacted Dr. Mike Walsh of NIDA and informed him of this i and am sending him a copy of the enclosed report. i It was a pleasure meeting you in Omaha and I look forward to talking with you in the near future.

Yours sincerely, ,

! /

Mich'ael A. Peat, Ph,D.

' Director  !

i Enclosures  ;

b. cc: Dr. Walsh  !

Dr. Olnhausen J. Spink

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MKHM MBORATORIES, K.

Western Division 600W North Market Boulevate . Sacrarnento, CA 95834 enone <eisi s4i.777e . <soo> ser ssso . r ax isici 823.ie38 REPORT

, 02/14/90 INVESTIGATION:

On January 26, 1990 we received a number of specimens from OPPD.

These specimens included, as we were later notified, blind controls inserted by Physicians Clinic of Omaha, Nebraska.

The specimens were analyzed by our Standard Operating Procedure which includes preliminary screening by enzyme multiplied immunoassay (EMIT) and confirmation of presumptive positives by gas chromatography-mass spectrometry. In addition to these procedures, fluorescence polarisation immunoassay (TDx) is used to re-screen an EMIT positive amphetamine sample.

Included in the batch of specimens received were specimens with the identification # HOO137756 (given laboratory accession number 11417144) and a second specimen with identification #

EIB648298 (given laboratory accession number 11417532). Both of those specimens were originally reported as negative to OPPD.

After reporting, we were notified that specimen #11417144 was a false negative for opiates and specimen #11417532 was a falso negative for amphetamines.

l A review of the analytical data showed that both of these specimens in fact screened positive for the drug classes indicated above and that the false negative reports were due to L an administrative error in posting data to the Laboratory Management System (LMS).

The opiate sample was originally screened by EMIT; normally EMIT data is transferred automatically to the LMS; in this case, because of a malfunction in this transfer process, the samples L

had to be posted manually. Attachment A shows clearly that saiaplc #11417144 was positive for opiates when compared to the cut-off. The absorbance reading for the unknown was 340.76 and that of the cut-off was 279.06. SubseqGent gas chromatography-mass spectrometry analysis showed this sample to contain 438.9 ng/mL of morphine and 713.7 ng/mL of codeine.

Sample 11417532 was screened initially by EMIT and found to be positive for amphetamines; the data for this analysis is shown in Attachment B. The sample was then re-screened by TDx. This I procedure requires a manual posting of data to the LMS and as with the opiate sample above, this sample was entered as negative although it was clearly positive by TDx. The TDx data are shown in Attachment C. Subsequent GC-MS analysis showed 2555.4 ng/mL of methamphetamine and 978.8 ng/mL of amphetamine.

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i COMPUCHEM l lABORATORES,INC. i l

Page 2  ?

1 CORRECTIVE ACTION:  ;

The original procedure called for manual posting to be done by  !

i the final reviewer after an initial review by the operator and a second review by the Quality control Section. To correct the problem mentioned above we have now added a fourth level of review for manually posted data. This involves the generating of a screening summary report and a comparison of that report l with the originally entered data by a Laboratory certifying Official independent of the final reviewer. Modifications of i the Standard Operating Procedure are included in Attachment D. i The appropriate entries have been printed in bold.  ;

We are currently investigating the reason for upload failure '

from the EMIT instrumentation and will inform you as soon as possible of remedios to this problem. Meanwhile I am confident .

that implementation of the new SOP will avoid any re-occurrence of the problem. At the request of OPPD we have re-analyzed all specimens received on the 26th of January for that client.

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OATA' ENTRY BY ATE -

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P'RE/ARED BY /

/DATE OPERATOR l DATE REVIEWED BY DA-;

I CAROUSEL NO. q) CAROUSEL NO. ' yg CAROUSEL NO.

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(( BAR CODE # hf' BAR CODE # ((* BAR CODE # DRUGS REQUIR C1 NEGATIVE - C1 NEGATIVE C1 NEGATIVE

1. NEGATIVE

_ ALL C2 LOW C2 LOW

• C2 LOW C3 LOW 60j l C3 LOW THC C3 LOW  ; 22

'11417151' 42 34i7326 N CO'c j 2 , LOW t

5 23 '11417169' 43 11417334 0 ) AMP 3 LOW 24

'11417177 44 '11417342' .

f/ OPl Wh BAR<ij 5

11417011 < 25 11417185 45 11417359 6

• 11417029 2e 11717193' 4s '11417367 B2P'-

7 11417037 27 1141720i' 47 '11327897' p.syPCP I e '11417045' 28 '11417219'

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48 114173755 uio' 9 11417052' 29 '11417227' 49 '11417383' _ uOu

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'11327855'e ao '11417235I 50 11417391' 11- '11417060' 31

'I141724T 51

'11417409' 12 11417078' 32 52 '11417417'

'11327871' -

13 11417086' 33

'11417250' 53

'11417425' 14' 41327863' 34 "1141726f 54

'Il41743F 15

' E 4' 35 11417276 55 'III17441' 16 11417102 36 11417284' 5e 11327905

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'11417110' 37 11417292' 57 '11417458' 18 '

l 11417128' 38 '1141730d' 58 i141746f 19

'11417136' 39 11327889' 59 "11417474' 20 '11417144'- 40

'11417318 60 11417482 1

CONTROL 21 CONTROL 41 CONTROL ChFORM . 3000-2 06-08-89 K.L.M.

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' I' - 01 ; N:GATIVE ! '52.67 :  ? 00 pass  ! -115.93 :

C(, 0: ' OUT  ! 279.93 ! l OC oess  ! 0.33 !

(,3 03 : C07 r 250.t? : i oc pees  ! 0.57 '

,{ t Oa i CUT l 279.09 1 I OC pass  ! -0.51 !

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• 169.31 :  ! necetiva .116.29 t

&! 07 i FAMALE  ! 167.GB 1  ! neeetave  ! 111.94 !

7t 98 t  ? AMPLE  ! 156.90 ! I acostsve 1 -112.6 ,

dt 09 !  ? AMDI.E f 156.99 n.qetave '

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'ssp(! 15 i  ? AMPLE  : 16F.69 I I neoetaue  ! 110.71 )

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@ 17 1 4 AMPLE i 199.60 '  ! neoetawe f -111,00 i f f '10 t 5 AMPLE

157 39  : i necottue  ! -111.61  :

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SCREENIN3 TRAIN MAP O S EOulRED: THC COC AMP OPi BAR BZP PCP _ MTD MOU ALL  !

I CAROUSEL NO. Qll CAROUSEL NO.

45 c^aousEtNO. CARousEtNO.

k[' BAR CODE # k[' BAR CODE # k[' BAR CODE # N ' BAR CODE #

C1. NEGATIVE C1 NEGATIVE C1 NEGATIVE C1 NEGATIVE C2 tow C2 C2 C2 tow tow tow C3 tow C3 C3 C3 tow tow tow 62 11417490' 82 '11417664' 102 122 ,

63 '11417508' 83 '11417672' 103 123 ,

64 '11417516' 84 '11327939' 104 124 h 65 '11417524' es '11417680' 105 125

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'1141754T 'T1417722' 69 '11417557' 89 11417714' 109 129 .

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70 11417565' 90 '11417730' ilo 130 71 'T1417573' 91 '11327947' 111 131 72 '11417581' 92 '11417748' 112 132 73 '11417599' 93 '11417755' 113 133 74 U 1417607' S4 114 134 75 '11417615' 95 115 135 76 11417623' 96 its 136 b 77 '11417631' 97 117 137 78 '11327921' 98 its the 79 11417649' 99 119 T39 80 '11417656' 100 120 140 61 CONTROL 81 CONTROL 101 CONTROL 121 CONTROL CW FORM 3000-2 9/8/87 S.J.E..

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TDI E 2EENING ll.e

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INITIAL REVIEWERi i l e,

HOME TRAY _# /W/ /M DATE ~ k C' -

ANALYST _ FINAL REVIEWER <

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DATE /"M*f8 DATE bh 94 4

CAROUSEL: CAROUSEL: CAROUSEL:

SEQ -

• Ring Sample

1. ng/mL Ring Sample ng/mL Ring Sample ng/mL. '

. # ID # ID # ID 1 s.osJ 474.W ,

2 ,e nSt..?? ,I 3 A4W 34,fo.S3 4 fl M M'+r 1;f.fv s b IWiMW f.77 6 Ilh"S3 #f -

f' 7 INI}M MI 8 }M09 6 9 10 WT /fVD./t., -

10 9 Ml} 733.9/

11 Il 4l M32- M[

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TDx TRAIN MAP .

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POS # RING #1 RING #2 RING #3 RING #4 RING #5 RING $6 ,

CARO: CARO:

CARO:y) CARO: CARO: CARO:

i tow 2 MED .

3 HIGH 4

T1397775 5 11417797 6

7 11417193 g 11417409 9 11417805 lo 11417813 11 11417532 12 . ,

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F-DATEi 01/29/90 W

!- TIME 09:48:40 ,

L F. SERIAL #i 13411 OP IDi 884

l. RGT LOT # 32650 ASSAY: ANPHET/METH U CAROUSELi 1 e

SPLVOL= 9.00 REPS = 1

.GA!!# 20 CALIB.DATE 12/21/89 CALIB. TIME 12:12:55 COHC= HG/ML ,

' STORED THRESHOLD = 8000.00 SAMPLES LOC CONC NET P BLK !

1 476.44 (T 182.81 215.34 2 1456.79 <T 165.04 226,45 2

' 3 3690.53 <T 149.20 4

216.75

' 339.54 <T 187.35 316.23 5 6.79 <T 209.87-6 359.12 HI >=T 132.70 7 234.01 HI >=T 112.76 173.19 0 8 HI

>=T 113.17 178.66 9 1940.16 <T 160,11 10 323.17 733.41 <T 176.37 338.32 11* H1- > =T2 112.43 178.82 '

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POSTING OF URINE TDX DATA  :

i After completing a final data review of the urine TDx data, they are to be posted in the Laboratory Management System (LMS).  ;

1) Access the Screening Menu (Drugs of Abuse Menu, selection

1. 3). .

2) Access the " Edit and Post Cobas Results" Menu (selection ,

1. 7). i

3) Enter the carousel number, train number and drug. Press  !

" Enter" (or the equivalent on your keyboard).

4) Cross-check the laboratory accession numbers shown on the LMS against those listed on the Screening Train Maps to ensure that all samples have been entered in the correct order. ,

5) Type in your employee number and whether the run status is OK, over-ride, or flag. Over-ride should be used if '

one of the statistical criteria has not been satisfied and the batch has been accepted. Flag should be used if the batch is to be realiquoted and reanalyzed for that drug.

6) Type in #5 for Instrument Number to indicate that analysis was completed by TDx.

7) Type in date and time, use the date and time from the analysis tape of the TDx.

M For temperature enter 37.0.

8)

9) Enter the TDX reading for the negative (N), LOW Abbott control (L) and 130% control (P).

I 10) The first six positions on the carousel and the first three on subsequent carousels are for QC samples on the EPOS and are not used in posting TDx data.

11) Enter the result for each samples by posting from the TDx working sheet. Samples with a result greater than the cut-off are coded as P.

Those with less than the Reviewed by: Nhb J Datet_ 2/M 9 v

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CCW - S.O.P.

cut-off as N, and those requiring reanalysis as R.

12) After position 12 press " Enter" (or the equivalent on your keyboard), this will upload all the data posted in steps 5 through 11. ,

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13) If any data already entered is to be corrected, press  !

F5 (left column) and this will highlight the fields required for steps 5 through 11.

14) Repeat step 11 for samples in positions 13 through 23.

Position 24 represents a QC sample and is not used in posting TDx data. -

i

15) Press " Enter" (or the equivalent on your keyboard) and then F2 (to confirm) on the prompt from the LMS.  !

16) Repeat steps 3 through 15 for subsequent carousels for each drug. Do not change any of the fields listed in ,.

steps 3 through 9 for subsequent carousels.

17) Once a drug has been entered, repeat the entire process '

(steps 5 through 16) for each additional drug analyzed in that train. . .

18) Once all the TDx data has been posted, press F8 to return to the Drugs of Abuse Menu. '

i

19) Access " Operations Reports" (Menu #9).

20) Access " Carousel Screen Summary" (Menu #4).

21) Type . in the Train Number and press " Enter" (or the equivalent on your keyboard) to print the Screening Summary Report. Include these printouts in the M

Immunoassay Train File together with the TDx working sheets and TDx printouts.

22) Transfer the file to another data reviewer.

h 23) The second reviewer should compare the Screening Summary E Report with the original TDX Working Sheets to ensure consistency.

l' 24) The second reviewer should sign and dat3 the screening Summary Report as verified.

Reviewed by: A C

Ak Datat 3 -I 4".fo L

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i 2QJ, TING OF URINE EMIT DATA i I

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If for some reason EPOS data fails to upload automatically, they are to be posted in the Laboratory Management System (LMS). .

1) Access the Screening Menu (Drugs of Abuse Menu, selection

1. 3).

2) Access the " Edit and Post Cobas Results" Menu (selection-

1. 7). -

f

3) Enter the carousel number, train number and drug. press

" Enter" (or the equivalent on your keyboard).

4) Cross-check the laboratory accession numbers shown on -

the LMS against those listed on the Screening Train Maps to ensure that all samples have been entered in the correct order.

5) Type in your employee number and whether the run status-is OK, over-ride, or flag. Over-ride should be used if one of the statistical criteria has not'been satisfied and the batch has been accepted. Flag should be used if .

the batch is to be realiquoted and reanalyzed for that drug.

6) Type in the instrument number, date and time from the EPOS printout if available. If not, type in the -

7 instrument number and the date and time that you are '

entering data.

7) For temperature enter 30.0.

l

8) From the EPOS printout enter the negative (N), calibrator (L) and the 50% control (P). ~

9) Enter in the first positions on the carousel as follows:

CS Negative from Cup -

1 Negative from Train 2 Calibrator from Cup 3 Calibrator from Cup 4 Calibrator from Train 5 Calibrator from Train Reviewed by: . ,

Date t _2 Ik ic)

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CCW - S.O.P.

10) Enter the EMIT reading for each sample by posting from the EPOS printout or the EMIT Working Sheet. Samples with a reading greater than the calibrator are coded as P. Those with an absorption less than the calibrator as N, and those requiring reanalysis as R.

11) After position 12 press " Enter" (or the equivalent on  !

your keyloard), this will upload all the data posted in steps 5 tnrough 11. ,

12) If any data already entered is to be corrected, press F5 (left column) and this will highlight the fields i required for steps 5 through 11. e

13) Repeat step 11 for samples in positions 13 through 23.

Position 24 represents a QC sample and should have the 50% result.

14) Press " Enter" (or the equivalent on your keyboard) and

then F2 (to confirm) on the prompt from the LMS.

15) Repeat rteps 3 through 15 for subsequent carousels for t each drug. Do not change any of the fields listed in steps 3 through 9 for subsequent carousels,

16) Once a drug has been entered, repeat the entire process (steps 5 through 16) for each additional. drug analyzed ,

in that train, if necessary.

17) Once all the EMIT data has been posted, press F8 to >

return to the Drugs of Abuse Menu. '

18) Access " Operations Reports" (Menu #9).

19) Access " Carousel Screen Summary" (Menu #4).

20) Type in the Train Number and press " Enter" (or the equivalent on your keyboard) to print the Screening Summary Report. Include these printouts in the Immunoassay Train File together with the EPOS printouts and tapes.

21) Transfer the file to another data reviewer.

22) The second reviewer should compare the Screening Summary Reviewed by bd d/ Datei dM d LJ

l I

CCW - S.O.P.

Report with the original EPO8 Working Sheets to ensure consistency.

23) The second reviewer should sign and date the screening ,

Summary Report as verified.

I

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i Reviewed by 1 bd Date 2 l0 90 V

4 : .

ig t

I' ATTACHMENT 11

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1 t'

I' D

7 1

PHYSICIANS CLINICn .

4 February 16, 1990 Mr. Robert !!. Guy Manager - Employment & Labor Relations Omaha Public Power District ,

444 South 16 Street Mall Omaha, Nebraska 68102-2247  ;

Allergy & Inununology Ret False Negative lucident Reports ninho!..,v '

Iwnnainh.gy Deer Mr. Guys Isarm. Nni.e A Throat trannh l>ractice The reports from Dr. Michael A. Peat regarding the incidents of two i outrnenterniugy false negative blind samples on January 26, 1990 have been reviewed.  ;

liemainingroneni"#'

As you will recall, when we first became aware of these false

• Internal munne wheni i',.vehology negative blind samples and the confirmation of this was reviewed, we  ;

ohnicine. A o>necoh.gv immediately reported to you the circums tances surrounding this incident. As noted by Dr. Peat, the problem was not found to be at occupannnai mhcm" the level of the collection or referral source, but at the level of ophthahnology orthornhe surgerv the laboratory. Af ter discussion of this matter with you, you asked tha t we obtain a report from Dr. Peat regarding the circumstances l '"h " ' "C" I'hvutu1 Therapv surrounding this incident and that we review this report and convey '

our opinions to you. You had also requested that we have all of the l'la,.oc. th ennsinn ih.-

samples from the Omaha Public Power District that were submitted on A ilami surcer' that date, including the blind samples, be submitted for a second .

[," ',[ """'*"' screening and confirmation.

I have reviewed Dr. Peat's report and feel that his explanation of the problem has been fully explained and that the corrective measures instituted by their laboratory are acceptable to prevent recurrence of this problem. We have received a report ot all of the drug screens submitted on the date iu question and found them to be in accord with the original reports. The blind samples have also been confirmed to '

be correct.

I believe, therefore, that the steps taken should prevent a recurrence of similar problems in the future.

Sincerely, i llMG lb gency Orcle

.gfW,b N M b y"$'j,[$u4 Ronald W. Olnhausen, M.D.

Medical Director NNm S.142nd Street

, Millard, NE 68137 402'8954490- RWO/vmt l

14625 California Omaha, NE 65154 402'496 0610