quality control: tips, troubleshooting, and · pdf filesysmex america inc. 1 quality control:...

XE-2100 QC Lecture

Sysmex America Inc. 1

Quality Control: Tips, Troubleshooting, and Tidbits

Nancy May, MBA, MT(ASCP)

Technical Integration Specialist

Agenda:

4 Tips

2 Troubleshootings Tools:– Detector Parameters

– XbarM

Tidbits

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XE-2100 QC Lecture


Tip #1: Print your QC immediately when you submit to Insight.

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XE-2100 QC Lecture


Reviewing QC Data

Baso problem (+ + + +) “Unconnected Dots”

Sample Aspiration Error “Missing Set of Dots”

Reviewing QC: Function Errors

XE-2100 QC Lecture


Reviewing QC: Barcode Errors

• QC data is not plotted.

• QC must be re-analyzed to plot QC data.

XE-2100 QC Lecture


Tip #2: If a point is just out of QC limits, have techs accept and rerun

according to lab protocol.

Tip #3: Do not use Login: adminfor everyday use.

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Delete Submitted Data

XE-2100 QC Lecture


Managing QC in Insight™

© Sysmex America, Inc. All rights reserved.Not to be copied or distributed without expressed, written consent of Sysmex America, Inc.

•Adding comments to any QC sample•Removing samples from their Mean and SD calculations without deleting those samples from the analyzer L-J charts

Insight Home Page

XE-2100 QC Lecture


Definitions

• XA = Anomalous Data – Data that falls outside Sysmex predetermined ranges for

that level of control.

– These ranges are approx. 80% of the Assay Sheet Ranges

– Short samples, samples run in the wrong QC files… samples that could skew the customer’s true Mean and SD

– These samples are EXCLUDED from the Peer Group’s Mean and SD, but are INCLUDED in the Customer’s Mean and SD

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XE-2100 QC Lecture


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Comments

• Comments can be added to ANY QC sample– Click on Manage Data for a particular sample

– Enter a comment, click on Save Comment

– Comments are printed on the Notes page of the Insight report

XE-2100 QC Lecture


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Manage QC Data– Select Managed or Not Managed

– Select a comment from the drop down menu or free text a comment

– Click on Save Comment

XE-2100 QC Lecture


Pre-Defined Comments

• Customers can choose to select a pre-defined comment

• Or they can enter a free text a comment

Comments

• Comments are printed on the Notes page of the Insight report. – They will be stored with the Insight data for a

minimum of 2 ½ years

XE-2100 QC Lecture


Questions??

Tip #4: Establish relevant/appropriate

historical limits.

XE-2100 QC Lecture


QC Chart without Limits

QC Input without Limits

XE-2100 QC Lecture


Calculating Historical Limits• Average “Historical CV’s” from Cumulative Insight reports on first 3

lot’s of control material.

• For a 3SD graph, multiply average CV% X 3 for each parameter.

• Enter new limits in QC, Target/Limit.

• Use Spreadsheet that calculates 3CV, displays interim limits and adds drift factor.

Historical Cumulative CV’sControl Levels

e-CHECK Drifting Parameters• Commercial controls cannot be completely stabilized over life of

product and still retain sensitivity to reagents.

• Parameters which decrease over time:Mono - 4% to - 11%

DIFF-Y - 15% to - 22%

IRF - 12% to - 23%

HFR - 13% to - 23%

MFR - 11% to - 22%

RBC-X - 5% to - 10%

HPC - 2% to - 6%

IG# - 3% to - 6%

IG% - 2% to - 4%

Source: Insight Report Guide (WI 2494 Rev 05, 3-06-2006)

XE-2100 QC Lecture


Parameters which increase over time:

MCV + 1% to + 2%

RDW-SD + 1% to + 2%

PLT-O + 2% to +16%

RET% + 6% to +15%

RET# + 6% to +15%

IMI# + 2% to +10%

IMI RF + 3% to + 4%

LFR + 8% to +21%

Source: Insight Report Guide (WI 2494 Rev 05, 3-06-2006)

Historic Limits Spreadsheet

XT Historical Limit Datae -CHECK LEVEL 3

LOT #1 LOT #2 LOT #3 3 Lot Limit% Limit%Parameter 7263 7207 7150 Average Average x 2 Average x 3 3 CV% Suggested

CV% CV% CV% CV% (+ 2 CV) (+ 3 CV) Drift + Drift Limits

RBC 1.0 0.9 0.9 0.93 1.9 2.8 4.3HGB 0.9 0.7 0.7 0.77 1.5 2.3 4.2HCT 1.0 1.1 1.0 1.03 2.1 3.1 5.8MCV 0.8 0.7 0.7 0.73 1.5 2.2 1.0 3.2 4.3MCH 0.6 0.6 0.6 0.60 1.2 1.8 4.8MCHC 1.1 0.8 0.9 0.93 1.9 2.8 5.3PLT 1.7 1.6 1.8 1.70 3.4 5.1 10.9RDW-SD 1.4 1.0 1.4 1.27 2.5 3.8 1.0 4.8 5.5RDW-CV 0.8 0.6 0.6 0.67 1.3 2.0 3.4WBC 1.8 1.6 1.5 1.63 3.3 4.9 8.8NEUT% 1.8 1.7 1.7 1.73 3.5 5.2 8.0LYMPH% 2.4 2.1 1.9 2.13 4.3 6.4 8.0MONO% 6.8 6.2 4.9 5.97 11.9 17.9 5.5 23.4 20.0EO% 7.0 6.0 6.5 6.50 13.0 19.5 25.0BASO% 0.7 0.7 0.7 0.70 1.4 2.1 2.1NEUT# 2.4 2.4 2.4 2.40 4.8 7.2 9.8LYMPH# 2.5 2.4 2.2 2.37 4.7 7.1 11.0MONO# 7.7 6.7 5.1 6.50 13.0 19.5 5.5 25.0 21.9EO# 7.2 6.0 6.5 6.57 13.1 19.7 25.0BASO# 1.9 1.8 1.6 1.77 3.5 5.3 9.0PLT-O 4.7 2.8 3.4 3.63 7.3 10.9 8 18.9 19.1RET# 7.5 7.0 6.9 7.13 14.3 21.4 7.5 28.9 37.1RET% 7.4 6.9 6.8 7.03 14.1 21.1 7.5 28.6 36.2IRF 15.3 16.0 12.8 14.70 29.4 44.1 11.5 55.6 63.4MPV 0.6 0.6 0.8 0.67 1.3 2.0 4.0DIFF-X 8.0DIFF-Y 68.0BASO-X 15.0BASO-Y 21.0RBC-O 29.0HFR 217.0MFR 120.0LFR 56.0RBC-X 64.0RBC-Y 17.0

Facility Name: Northern Nevada Medical Center

Address: 2375 E. Prater Way

City, State, Zip: Sparks, NV 89434

Instrument: XT-2000

Serial Number: 13357

Mode Open/Closed?: Closed

Manufacturer Defined Limits for Detector Control/Service Parameters are defined as a variation from target values and will not be changed lot to lot.

These values are entered into the analyzer's control files.

For further information please refer to:Sysmex Customer Bulletin 61-1075: Insight Program Modification

XE-2100 QC Lecture


Westgard website

• When should you use a multirule QC procedure?

• Not always! Sometimes a single rule QC procedure gives you all the error detection needed while at the same time maintaining low false rejections. This generally means eliminating the 12s rule because of its high false rejections and considering others such as 12.5s, 13s, and 13.5s which have acceptably low false rejection rates. The remaining issue is whether adequate error detection can be provided by these other single rule QC procedures. If medically important errorscan be detected 90% of the time (i.e., probability of error detection of 0.90 or greater), then a single rule QC procedure is adequate.

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Westgard, cont.

• In general, you will find that single rule QC procedures are adequate for your highly automated and very precise chemistry and hematology analyzers, but you should avoid using 2s control limits or the 12s control rule to minimize waste and reduce costs……..

• To figure out exactly when to use single rule or multirule QC procedures, you will need to define the quality required for each test, look at the precision and accuracy being achieved by your method, then assess the probabilities for false rejection (Pfr) and error detection (Ped) of the different candidate QC procedures. Aim for 90% error detection (Ped of 0.90 or greater) and 5% or less false rejections (Pfr of 0.05 or less). With very stable analytical systems that seldom have problems, you may be able to settle for lower error detection,say 50%.

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XE-2100 QC Lecture


WEBINAR: Control Rule Simplification of High Precision Sysmex Hematology Analyzers

• Fall 2010 Webinar by Dr George S. Cembrowski, MD, PhD

• Use 14.5S Rule for all parameters except HCT 13.5S

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Questions??

XE-2100 QC Lecture


Troubleshooting Tools

Detector Parameters

Patient Moving Averages (XbarM)

Significance of Detector Control Parameters

• Detector Control Parameters provide information on the performance of the analyzer but are not reported and have no inherent medical utility.

XE-2100 QC Lecture


e-CHECK QC Parameters

• Up to 48 Parameters (C + D + R + N)

12 CBC Parameters (RDW-CV, RDW-SD, PLT-O)

14 DIFF Parameters (%, #, NRBC #, %)

4 Retic Parameters (RET %, RET #, IRF, Ret-He)

16 Detector Control Parameters

2 HPC, IPF

• 16 Detector Control Parameters

Parameter Detector Method Used

MPV RBC/PLT (DC/Sheath flow)

Diff-X, Diff-Y DIFF (Optical Flow)

Baso-X, Baso-Y WBC/BASO (Optical Flow)

NRBC-X, NRBC-Y NRBC (Optical Flow)

IMI #, IMI-DC, IMI-RF IMI Channel (RF/DC)

RBC-O, LFR, MFR,HFR, RBC-X, RBC-Y Retic (Optical Flow) *

WBC Detector Control Parameters

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DIFF - X (NEUT)

DIF

F-

Y BA

SO

-Y

BASO - X (WBC)

IMI DC

IMI -

RF

NRBC - X

NR

BC

-Y

XE-2100 QC Lecture


RBC & Retic Detector Control Parameters

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RBC - X

RB

C-

YRBC-OPLT-ORBC-XRBC-YLFR,MFR,HFR

MPV

RBC-I, & PLT-I, MPV

Detector Control ParametersMPV Measures platelet volume, very low MPV may indicate

platelets below lower discriminator

BASO-X, BASO-Y Distinguishes WBC’s from RBC ghosts, and WBC’s from Basophils

Flags affected: Lyse Resistance

WBC Abn Scattergram

DIFF-X, DIFF-Y Monitors accuracy for diff % and # number

Flags affected: WBC Abn Scattergram

NRBC

Left Shift

Aty lymph

Abn lymph/L-Blast

Plt Clumps

XE-2100 QC Lecture


Detector Control ParametersNRBC-X, NRBC-Y Ensures separation of NRBC population from RBC ghosts and

WBC populations.

Flags affected: NRBC, NRBC Abn Scattergram

IMI#, IMIDC, IMIRF Monitors immature gran accuracy and precision of IMI detector.

Flags affected: Left Shift,

Blasts,

Immature Grans

Plt Clumps

RBC-X Mean fluorescence channel of mature RBC’s in Retic scattergram on horizontal axis

May affect IRF

RBC-Y Mean channel for mature RBC’s in Retic Scattergram on vertical axis.

Questions??

XE-2100 QC Lecture


Patient Moving AverageXbarM

• QC tool developed by Dr. Brian Bull in 1974.

• Algorithm is based on the inherent stability of patient results in a general hospital population.

• Monitors stability over time of:

– Instrumentation

– Reagents

– Technique

Advantages of the Patient Moving Average

• Inexpensive, simple to use

• Utilizes unfixed patient blood

• Incorporated into current Hematology analyzers

• Real time QC

XE-2100 QC Lecture


Xm - Modification of Bull’s Xb

Used to monitor Patient Moving Average

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Definition

• Bull’s AlgorithmN

XM(i)=XM(i-1)+SGN{ SGN[X(j,i)-XM(i-1)*i=0

l X(j,i)-XM(i-1) l} *F N

F={ SGN [X(j,i-XM (i-1)] l X(j,i)-XM(i-1) l}2

i=0 N

Patient Moving Averages X-bar-M

Effective in checking hour-by-hour changes in instrument and reagents

Parameters remain stable once characteristics of population established

Does not include:ID number zeroCommercial QC dataCalibration dataBackground countsData that exceeds linearity range (@)Data that is unreliable data ( *)Data reported with analysis errorData displayed as “****” or “----”

XE-2100 QC Lecture


Installing X Series: Xm Settings

• Xm must be turned ON

• Set Xm batch: Sysmex recommends 20

• During implementation:

Interim limit or 0 - 999

Assign Variable Target for Xm

How to set XBarM limits

• QC Settings

– LJ, %, 3SD (only for auto-setting XbarM limits)

XE-2100 QC Lecture


QC System Settings

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Limit SettingRatio (%) & 3SD

Control MethodL-J Control

Establish historical limit & autoset target• File holds 300 pts, each pt = mean of 20 pats = 6000

patients. Click and drag on all 300 pts.

• Select [Target / Limit] key.

• Click & drag to highlight all parameters.

• Select [Auto Setting] & √ Target and Limit and [OK] to auto set target and 3 CV limit.

• Only time you will have Limit selected.

XE-2100 QC Lecture


QC Troubleshooting Tool

Concern?

Commercial QC - OK Xm - OK

Commercial QC - OK Xm - Not OK

Commercial QC - Not OK Xm - OK

Commercial QC - Not OK Xm - Not OK

No Problem

Population Shift or Reagent

Control problem

Systematic Error

XE-2100 Xm Flowchart - RBC parameters

CellpackCellsheath

RBC/PLT

CellpackSulfolyser

HGB

Ret-Search II(Diluent & Dye)

Ret % & #, RBC-O, RBC-X & YIRF, LFR, MFR, HFR

Check reagent log. Has a reagent beenchanged that coincides with Xm going out.

Check if reagent is running lowor almost outdated.

Check maintenance log for any recentcalibration or part replacement. If XE has beencalibrated in the last 7 days, leave a messagefor supervisor. Targets may need adjusted.

If YES,run XE

Check if parameters that are out arerelated to patient population being run.

i.e.) Dialysis run, pediatric run,oncology run, ER's

Each time Xm alerts as out, check Xm chart. Document each timeXm is out on QC log. Proceed after ___ Xm points are out.

XE-2100 QC Lecture


XE-2100 Xm Flowchart - RBC parameters (cont)

If another point is out, callhotline. 1-888-8SYSMEX

Run XE-2100 - Monitor Xm

Patient control &commercial control in.

Document all actionson action log.

Call Hotline

Patient control or commercialcontrol out for same parameter.

Run the patient control fromcurrent and previous shift.Run commercial controls.

1) Clog removal2) Clean RBC Aperture

3) Clean SRV

RBC/PLT

1) Clean SRV

HGB

Check maintenance log. Has maintenance been doneor not done recently? Perform maintenance.

XE-2100 Xm Flowchart - WBC parameters (cont)

Stromatolyser-NR(Diluent & Dye)

nRBC #, nRBC-X & Y

If another point is out, callhotline. 1-888-8SYSMEX

Run XE-2100 - Monitor Xm

Patient control &commercial control in.

Document all actionson action log.

Call Hotline

Patient control or commercialcontrol out for same parameter.

Run the patient control from current andprevious shift. Run commercial controls.

Check maintenance log. Has maintenance beendone or not done recently? Perform maintenance.1) Clog removal, 2) Clean IMI detector aperture,

3) Remove flow cell air bubbles, 4) Rinse Flowcell.

Document any reagent changeon onboard reagent log.

Stromatolyser-4DLStromatolyser-4DS

Diff parameters, Diff-X & Y

Stromatolyser-IM

IMI #

Stromatolyser-FB

WBC, Baso # & %, Baso-X & Y

Check reagent log. Has a reagent been changedthat coincides with Xm going out? Check ifreagnet is running low or almost outdated.

XE-2100 QC Lecture


Questions??

Tidbits• PLT Clumping? flag

• ISLH Consensus Rules-

www.islh.org

PLT rule: <100 or >1000 and first time

• Pediatric Normal Ranges:

“Pediatric Reference Intervals”, 7th edition, www.aacc.org

XE-2100 QC Lecture


Thank you!

Questions?

quality control: tips, troubleshooting, and · pdf filesysmex america inc. 1 quality control:...

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