SMILE GENERAL INVESTIGATION CHECKLIST/FORM

SSMMIILLEE GGEENNEERRAALL IINNVVEESSTTIIGGAATTIIOONN CCHHEECCKKLLIISSTT//FFOORRMM

SSUURRVVEEYY IINNFFOORRMMAATTIIOONN –– EEXXTTEERRNNAALL QQUUAALLIITTYY AASSSSUURRAANNCCEE ((EEQQAA))Note: Please complete the report and submit it to SMILE and your PNL within 30 days. Site/Laboratory Name: New York EQA Provider and #: CAP 99772255 Survey Name: FH9-A 2012 Analyzer Name/Model: Sysmex XE

Date Survey Received: 2 Feb 2012 Date Analysis Performed: 10 Feb 2012

Date Survey Results Submitted: 15 Feb 2012 Date Evaluations Available: 2 March 2012 Previous Survey Problems (If yes, explain): No

Investigation Performed By: Mark Date: 11 April 2012

Unacceptable EQA Panel: Date of Repeat testing:

Specimen Number Analyte Reported Result

Repeated Result Intended Result/Peer Group

FH9-01 Monocyte % 8.2 No samples 8.36-14.56 FH9-02 5.6 retained for 7.76-12.03 FH9-03 7.0 testing 8.35-12.47 FH9-04 6.7 7.43-13.24 FH9-05 5.6 9.3-13.85

RROOOOTT CCAAUUSSEE AANNAALLYYSSIISSPPRREE--AANNAALLYYTTIICCAALL EERRRROORRSS:: YES NO N/A

1. Were proficiency testing materials received in the laboratory without delay?Please describe any delivery issues.Comments:

2. Were specimens shipped and stored appropriately according to temperature requirements?Comments:

3. Did all EQA vials arrive intact (i.e. no missing, broken or leaking specimens)If not, did you contact the provider and SMILE?Comments:4. Did you prepare/reconstitute/dilute EQA specimens as indicated by the kit instructions?Comments:5. If there were special instructions provided in the kit, were they followed?

(Can be indicated by this symbol ) Comments:6. Were the correct tests performed on the correct specimen(s)?Comments:7. Was routine maintenance of instruments/equipment performed as scheduled (daily, weekly,monthly, etc.)?Comments:8. Did you check lot numbers and storage conditions of kits, reagents, and materials used toperform testing on samples?Comments:

9. Were expiration dates verified before sample testing (Controls, reagents, etc.)?Comments:

AANNAALLYYTTIICCAALL EERRRROORRSS:: YES NO N/A

11. Did you review the current and past EQA event for bias, shifts and trends? If present, wereinvestigations performed and what were the outcomes?Comments: Negative bias on this survey.2. Did you evaluate the instrument/method for any problems prior to or after the EQA event?Describe any problems identified.Comments:3. Was the calibration at the time of the EQA event reviewed for acceptability?If not acceptable, comment:4. How do you establish your Quality Control (QC) mean and ranges? Comments:

Lab established Use manufacturer’s Not applicable

5. Were all QC levels for this analyte within acceptable range(s) on day the survey was run?Comments:6. Are Westgard QC rules used? If so, which ones?Comments:7. Were QC/Levey Jennings charts reviewed for any trends, shifts and/or bias?Comments: A negative bias was noted for monocytes% on IQC but since all were within 2SD no action taken.8. Does your laboratory track precision by monitoring Coefficient of Variation (CV) for thisanalyte?If yes, was your CV acceptable at the time of the survey?Comments:9. If manual calculation was performed for this analyte was it checked for accuracy? (dilutions,formula)Comments:10. Was instrument or reagent manufacturer contacted?Comments: Requested service on instrument on 6 April 201211. Are questionable results reviewed by supervisor/pathologist before reporting?Comments:

PPOOSSTT AANNAALLYYTTIICCAALL EERRRROORRSS:: YES NO N/A 1. Were the results correctly transcribed from the instrument print-out/ worksheets to the EQAResult Form?Comments:2. Did you verify that the electronic results submitted matched the EQA result form (i.e. was theprovider website checked for accuracy of results submitted?)Comments:3. Were the correct instrument/method/reagent reported on the EQA Result Form?Comments:4. Were the correct units reported?Comments:5. Were results reported with correct decimal place?Comments:6. Were your results graded in the appropriate peer group?Comments:7. Did you select the correct result code for photographic images and/or microscopicexaminations?Comments:INVESTIGATIVE ACTIONS AND ROOT CAUSE: Briefly discuss what actions were taken in this investigation and what you believe is the primary cause of this EQA problem. The monocyte% was showing a negative bias on all 3 levels of the IQC, no immediate action was taken as results were still within range. Daily IQC checks between manual and automated differential counts are done and this too was within acceptable range. However, as was noted from the results of the FH9-A survey, significant differences between the monocyte% of the Sysmex XE and XT analyzers were noted. The biomedical engineer was called in to run calibrator material on the XE and do a sensitivity adjustment on the monocytes. See attachments for LJ Charts of monocytes % after sensitivity adjustments on the 6th April, comparison of monocyte% between XE and XT after sensitivity adjustment and job card referring to sensitivity adjustment as performed by Biomedical engineer. Was Personnel training/competency reviewed? Staff education or re-training conducted, as appropriate? Comments: Hematology staff was re-trained to note any biases, trends or shifts even if within acceptable limits. Corrective action log was added to QC log.

Type of Error:

Methodological Survey evaluation problem x Technical Other (explain) Clerical

Study Impact: Were study participant results assessed for adverse effects? If applicable, review participant results, amend results and notify the following---physicians, study staff and network representatives. Comments: Study participants that had results during this time period were reviewed. Repeat testing showed all results within normal range so no adverse effect on participants was noted. FUTURE PREVENTATIVE MEASURES/ ACTIONS: Briefly discuss how you will prevent this problem from occurring in the future. Calibrator material I run on the Sysmex XE analyzer every 6 months with service. If it is found that parameters are within the specified target range of the calibrator, no adjustment is made. In the future we will access parameters for biases, trends or shifts on our QC charts to decide if adjustments are required.

PREPARED BY: Name/Title Date Signature

Mark 11 April 2012

FOR SMILE USE ONLY.

SMILE Review: Acceptable and complete Investigation. Investigation is incomplete. See comments.

Comments:

Name/Title: Date: 14 April 2012 Cinderella FOR NETWORK USE ONLY.

PNL Review: Acceptable and complete Investigation. Investigation is incomplete. See comments.

Comments:

Name/Title: Date: 15 April 2012 Prince Charming

Table for supporting documents:

Attachment# Description of attachments

Service report, QC charts and post QC results

Service Report- Site/Caller Summary:

Site 0060600449 Site Name: Address: Zip I City: PO Box: IPO Box Zip: l Country:

Caller Salutation: Title: First Name: Last Name: Phone: 021 421 9338 Fax: 021 4252907

Case Summary

Case Case Title: Assay Performance Call Type: Service Report SA-Code: ServVisit Em'cy Severity: Normal Priority: Medium Date of Order: Date: 06.04.2012

Instrument Summary

Instrument Instrument Family: Hematology Instrument Line: XE-2100 Serial Number: IPart Number: I Part Description: Hemato Analyzer XE-2100, Contract:

Instrument Problem Description Instrument Error: Problem description: Customer requests optimisation of Monocyte populations. Research log: Cleaned SRV and piercer needle, ran scs1000 verfication checks, performed whole

blood senstivity adjustments, unit checked and tested ok, customer monitored unit ok. Spare parts/Reagents used ldent-No.

Manufact.

Description Invoice Type Quantity

No. FSE: Customer Signature:

Full Name:

Page t /1

Item Patient 10:

Sample No.: 5142886 Rack: 4 Tube:3 11/04/2012 12:16:12 Dr.: Ward:

Name: Comments:

Positive

Birth: Sex: Inst.lD:XT-1800i-1

MCHC 33.9 [g/d ] PLT 333 [1 09/L] RDW-SD 46. 6 [fl]

P-LCR PCT

11.1 - [%] 0.28 [%]

NEUT 4.73 LYMPH 1.20 [109/L] 19.3 - % MONO 0.22 [109/L] 3.5 -[o&; c EO 0.06 [109/L] 1.0 o] BASO NRBC IG

0.00 0.01

[109/L] [109/L] [1 09/L]

0.0 0.2

[%] [/1OOWBC] [%]

HPC# [1 03/ul] RET IRF LFR MFR

[%] [%] [%] [%]

[10 6/ul]

HFR [%] RET-He [pg] IPF [%]

Vl

[f1b

/:';

Comments: Negative

WBC 6.21 [109/L]

HGB 3.9 [g/d] l

DIFF

.<I

lnst.lD: XE-21 00-1

··

RBC 1.33- [1012/L] .·. HCT 0.115 - [UL] .. . MCV 86.5 - ··-·. MCH 29.3 g] sse IMI NRBC

u

RDW-CV 14.5 +l%1 ....

POW 8.4 - fl MPV 8.3 - [fl]

[109/L] 76.2 + f%1 ;:.

..::.·.:.... ,· SFL >

l<.bT DC

PLT-0 u v..o..

SFL SFL

I :Jt I

U\_ ,..··....

RBC PLT •'

...

BALO 01 I

·.; -. <. . rt·.

• I ..... .., .:). -· .·.

WBC IP Message(s) RBC/RET IP Message(s) PLTIP Message(s)

Item Patient 10:

Sample No.: 5142886 Rack: 4 Tube:3 11/04/2012 12:16:12 Dr.: Ward:

Name: Comments:

Positive

Birth: Sex: Inst.lD:XT-1800i-1

NEUT 4.71 [10"9/L] 75.3 + LYMPH 1.20 [10"9/L] 19.2 - MONO 0.26 [10"9/L] 4.2 EO 0.07 [10"9/L] 1.1 BASO 0.01 [10"9/L] 0.2 IG 0.01 [10"9/L] 0.2

. . . ....-"· ,.,...

()

c

Count DIFF WBC/BASO -' "-

WBC 6.25 [10"9/L] RBC 1.28 - [10"12/L] HGB 3.8 - [g/dl]

VI

- , ..

HCT 0.117 [L/L] ·;. ._:l <¥"· -- . ... ·""' MCV 91.4 [fl] MCH 29.7 [pg] MCHC 32.5 [g/dl] PLT 369 [10"9/L] ROW-SO 43.8 [fl]

. :... <;<;( u VI "-

RDW-CV 13.9 [%] POW 9.0 [fl] .' - MPV 8.5 - [fl] .·r:···:;,

P.,LCR 14.0 [%] sse PCT 0.31 [%]

BALO

f %%%1 [%]

[%fill [% [%]

PLT

I !'

WBC IP Message(s) RBC IP Message(s)

PLT IP Message(s) Anemia

Item Patient 10:

Sample No.: 5142894 Rack: 4 Tube: 1 Dr.: Birth:

11/04/2012 12:14:42 Ward:

Name: Comments:

Positive

Sex: Inst.lD:XT-1800i-1

PCT 0.17 [%] "

a· u

r

. .

MCH

..

II

I

.

Comments: lnst.ID: XE-21 00-1

Positive Morph. DIFF WRrfRA O

V...I. WBC 8.96 [1 09/L] RBC 3.18 [1 012/L] HGB 9.1 [g/dL] HCT 0.267 [UL] . :.. MCV 84.0 - [fl 28.6 g] sse MCHC 34.1 [g/dL] PLT 183 [1 09/L] IMI NRBC RDW-SD 52.5 [fL] RDW-CV 17.2 +(%1 .... PDW 10.1 fL u

MPV 9.4 [fL] P-LCR 20.1 [%] . '

NEUT 5.71 * [109/L] 63.7 * 4 ;;.:·,.....: LYMPH 2.38 [1 09/L] 26. 6 %

[1 09/L] . ·.

7.8 .fo/rf; SFL EO 0.13 * [109/L] 1.5 o] oc BASO 0.04 [1 09/L] 0.4 [%] .l{.C' l' PLT-0 NRBC [1 09/L] [/1OOWBC] u

IG 0. 06 [1 09/L] 0.7 [%] HPC# [1 03/uL] RET [%] [1 06/uL] IRF [%] LFR [%] MFR [%] HFR [%] RET-He [pg] SFL SFL

IPF [%]

lj /\ 11 - "

I .:; I

· II ;. .''fJ ." Jl {'' ·: .

BALO .,..".:.'.) . : WBC IP Message(s) RBC/RET IP Message(s) PLTIP Message(s) Left Shift?

Item Patient 10:

Sample No.: 5142894 Rack: 4 Tube: 1 Dr.: Birth:

11/04/2012 12:14:42 Ward:

Name: Comments:

Positive

Sex: Inst.lD:XT-1800i-1

WBC 8.78 [10"9/L] RBC 3.06 [10"12/L] HGB 9.0 [g/dL] HCT 0.262 [LIL] MCV 85.6 - [fL] MCH 29.4 [pg] MCHC 34.4 [g/dL] PLT 194 [10"9/L] ROW-SO 50.9 [fL] ROW-CV 16.8 + [%] POW 10.4 [fL] MPV 9.8 [fL] P-LCR 22.2 [%] PCT 0.19 [%] NEUT 5.55 * [10"9/L] 63.2 * LYMPH 2.28 * [10"9/L] 26.0 * f%%1 MONO 0.78 * [10"9/L] 8.9 * [%] EO 0.14 * [10"9/L] 1.6 * [% BASO 0.03 [10"9/L] 0.3 [% IG 0.08 [10"9/L] 0.9 [%]

.

Morph. Count DIFF WBC/BASO

A:

.-...,.,.. ;b'

:-·. .

·""··· · . u VI "-

; <;<;(

.·....a. _.

·:.;.

sse

BC l . PLT

BALO WBC IP Message(s) RBC IP Message(s)

PLTIP Message(s) Anemia

Left Shift? Atypical Lympho?

Item Patient 10: Sample No.: 5142904 Rack: 4 Tube: 2 11/04/2012 12:15:27

Dr.: Ward: Name: Comments:

Positive

Birth: Sex: lnst.ID:XT-1800i-1

A'

/!;' I

. f

WBC 15.58+ [10 9/L] ,A

RBC 2.80 [10 12/L] HGB 7.5 [g/dL] ( .

HCT 0.223- [UL] ··.. .. ·. MCV 79.6 - [fl .....· MCH 26.8 g] sse MCHC 33.6 [g/dL] PLT 125- [10 9/L] IMI NRBC RDW-SD 52.3 [fL] u

RDW-CV 17.9 + F'ol PDW 11.5 fL MPV 9.6 [fL] P-LCR 22.6 [%] PCT 0.12 - [%] NEUT 11.01 * [10 9/L] 70.6 * l%1 LYMPH 1.38 * [1 09/L] 8.9 * %

.... c.:

"...'.

MONO 3.14 * [10 9/L] 20.2 jofJ; Sfl

EO 0.02 * [1 09/L] 0.1 o] BASO 0.03 [10 9/L] 0.2 [%] Kb··l

DC

PLT-0 NRBC [1 0 9/L] [/1OOWBC] u

IG 0.41 [10 9/L] 2.6 [%] HPC# [10 3/uL] RET [%] [10 6/uL] IRF [%] LFR [%] MFR [%] HFR [%]

"...'.

RET-He [pg] Sfl SFL

IPF [%] RIB:C. ·"

PLT .': .;:·. I I I

II

: I \ I I I

I I I!

I .: BALO I II . .:..'!]{... ·.-::- ,:•,'· ' ) .. ·:.q-···

WBC IP Message(s) RBC/RET IP Message(s) PLTIP Message(s) Monocytosis IG Present Left Shift? Atypical Lympho?

Item Patient 10: Sample No.: 5142904 Rack: 4 Tube: 2 11/04/2012 12:15:27

Dr.: Ward: Name: Comments:

Positive

Birth: Sex: lnst.ID:XT-1800i-1

MPV 9.7 [fL] P-LCR PCT

23.1 0.14 -

[%] [%]

NEUT 11.26 * [10"9/L] 70.2 * LYMPH 1.42 [10"9/L] 8.9 - MONO 3.26 + [10"9/L] 20.3 + EO 0.04 * [10"9/L] 0.2 * BASO 0.06 [10"9/L] 0.4 IG 0.46 [10"9/L] 2.9

M '

c

Diff. Morph. DIFF WBC/BASO Count -' "V-i

;

WBC 16.04 + [10"9/L] RBC 2.74 [10"12/L] .

7.3 -

HGB [g/dL] .

HCT 0.224 [LIL] MCV 81.8 - [fL]

.

.·.: ,.-· • •• J • ·'-';.:..

<;«;(

MCH 26.6 [pg] u...... "-

MCHC 32.6 [g/dL] PLT 142 [10"9/L] ROW-SO 51.5 [fL] RDW-CV 17.7 + [%] :{,.- POW 11.2 [fL] ... ...·...... ....

sse

(%%%) [%]

[%1m [% [%] I ;

PLT

BALO WBC IP Message(s) RBC IP Message(s) PLTIP Message(s)

Neutrophilia Monocytosis IG Present

Anemia

Left Shift?

Material:control Mode:closed

XE-2100 Quality control !instrument ID Level(Lot) Lot NEoxp. oay loateFroiil' Number Of Plots:19 rxE:2100-1 Leve11(New)QC-207008JLO I31/05/2012 02/04/2012 11/04/2012

Print Date:11/04/2012 Time:16:34:24

UL

................ LL

r-- --

UL=

I Targ.= LL=

46.3 SO=

33.1 Mean=

19.9 CV=

1.65 33.61 4.9

UL - ===--====--==-== = UL= 20.6 SO=

11.5 Mean=

1.281 10.9

LL

2.4

-

CV= --

11.-7

UL LL UL - LL - UL - LL UL - LL UL LL UL LL UL LL UL LL -

0000000000000000111 2334455667778899001 /////////////II//// 0000000000000000000 4444444444444444444

2 - 1

14.3 SD= 0.77 - - -- 1.63 SO= 1.36 Mean=

1.09 CV=

1.37 SD=

0.98 Mean=

ll=

c. -

XE-2100 Qualiy con rol

Prinoa e:11/04/2012 Time:16:34:56

. . ...

Targ.=

29.3

Ul UL= 35.2 SD"' J:":"14l Mean= 30.3

ll -- - --- ll= 23.4 CV= 3.8

Ul Ul=

Targ.=

-:--::-

15.8

9.9

4.0

SD= 1.031 Mean= 09 CV= 11.4 -- - - SD= 0.94

Mean= 10.71

ll ---- -------- - ---- ----- ----- -ll= 5.2 CV= 8.8

UL LL -- - - --- UL LL -

Ul= 1T,arg.=

t : Targ.=

I_ LL=

84.2 SO= 0.651

67.4 Mean= 67.9

50.6 CV= 1.0

15.2- -S-D-=- - -0-.44-11

11.7 Mean= 11.6

s_.2 c_v_= 3.81

..!...:.!!..._ CV=- - UL .. . I Ul= 3.75 SO=

0.083

3.26 Mean= 3.25 LL ------ --- --

ll -- -- - -- -- Ul

UL=

Targ.=

LL= --- Ul=

'

2.28 SO= 0.108

1.90 Mean= 1.971

1.52 CV= 5. 5

1.02 SD= 0.0601

0.64 Mean= 0.59 ,, - : -- - _ -- ---------- _ ------ --- ----- ----- ---- _ _ _ I Tar: UL -- ---- ----- --- - --- ---- --- - - -- - ---- --- --- - -- -- - !Tar:

CV= 10 .21 1.02 SD= 0.068

0.68 Mean= 0.70

UL - & 5.46 SD= ----o.lo91

ll - 0.34 CV= 9 .71

Targ.= 4.37 Mean= 4.421

Ll _ L _L_L= 3._28_ cv_=_ 2 . 00000000000000001111 233445566 77788990001 ll//ll//////l/111/11 00000000000000000000 44444444444444444444

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Instrument ID 1 Level(Lot)I LOt NO. 1 Exp. Day Date From TO XE-2100-1 1 Level3(New)I QC-207008121 31/05/2012 02/04/2012 ll/04/2012i

I I

Material:control Number of Plots:20 Mode:closed UL - ----------- ,--------- -------- --------- -

XE-2100 Quality Control

Print Date:ll/04/2012 Time:16:35:20 UL= 31.2 SD= 0.74

Targ.= 26.0 Mean= 26.3

LL= 20.8 CV= 2.8

}UL LL UL LL ----------- UL -----------

LL --- -------- UL --- - ----- -- LL UL

--- --...-\--.J-'-3'!-)- - n----- (;, UL= 14.6 SD= 1.10

Targ.= 9.7 Mean= 9.2

LL= 4.8 CV= 12.0

UL= 17.0 SD= 0.87

Targ.= 11.3 Mean= 11.3

LL= 5.6 CV= 7.7

UL= 89.0 SD= 0.72

Targ.= 71.2 Mean= 71.5

LL= 53.4 CV= 1.0

UL= 15.0 SD= 0.64

Targ.= 12.0 Mean= 12.6

LL= 9.0 CV= 5.1

UL= 10.63 SD= 0.382

Targ.= 9.24 Mean= 9.26

LL ----------- ------------ -- --------------- UL ----------- ----------- ---------- ------ - - !l •••• LL UL LL UL LL --- -------- UL ------ ----- ----------- ---------------------- --- ---- -------------- -- -·- -- LL

LL= 7.85 CV= 4.1

UL= 5.45 SD= 0.197

Targ.= 4.54 Mean= 4.58

LL= 3.63 CV= 4.3 1

UL= 2.54 SD= 0.174

Targ.= 1.69 Mean= 1.60

LL= 0.84 CV= 10.9

UL= 2.97 SO= 0.144

Targ.= 1.98 Mean= 1.97

LL= 0.99 CV= 7.3

UL= 15.54 SD= 0.353

Targ.= 12.43 Mean= 12.45

LL= 9.32 CV= 2.8

SMILE –Investigation Form for Qualitative/Quantitative Testing

QC Chart Error Ex.doc Page 16

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SMILE –Investigation Form for Qualitative/Quantitative Testing

QC Chart Error Ex.doc Page 17

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