Quality Control: Tips, Troubleshooting, and Tidbits

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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 2 Sysmex America Inc. 1

2 Tip #1: Print your QC immediately when you submit to Insight. 3 Sysmex America Inc. 2

3 Reviewing QC Data Baso problem ( ) Unconnected Dots Sample Aspiration Error Missing Set of Dots Reviewing QC: Function Errors Sysmex America Inc. 3

4 Reviewing QC: Barcode Errors QC data is not plotted. QC must be re-analyzed to plot QC data. Sysmex America Inc. 4

5 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: admin for everyday use. 9 Delete Submitted Data Sysmex America Inc. 5

6 Managing QC in Insight Adding comments to any QC sample Removing samples from their Mean and SD calculations without deleting those samples from the analyzer L-J charts Sysmex America, Inc. All rights reserved. Not to be copied or distributed without expressed, written consent of Sysmex America, Inc. Insight Home Page Sysmex America Inc. 6

7 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 14 Sysmex America Inc. 7

8 15 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 Sysmex America Inc. 8

9 17 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 Sysmex America Inc. 9

10 Pre-Defined Comments Customers can choose to select a predefined 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 Sysmex America Inc. 10

11 Questions?? Tip #4: Establish relevant/appropriate historical limits. Sysmex America Inc. 11

12 QC Chart without Limits QC Input without Limits Sysmex America Inc. 12

13 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. Control Levels Historical Cumulative CV s 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, ) Sysmex America Inc. 13

14 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, ) Historic Limits Spreadsheet Facility Name: Northern Nevada Medical Center Address: 2375 E. Prater Way City, State, Zip: Sparks, NV Instrument: XT-2000 Serial Number: Mode Open/Closed?: Closed XT Historical Limit Data e -CHECK LEVEL 3 LOT #1 LOT #2 LOT #3 3 Lot Limit% Limit% Parameter Average Average x 2 Average x 3 3 CV% Suggested CV% CV% CV% CV% (+ 2 CV) (+ 3 CV) Drift + Drift Limits RBC HGB HCT MCV MCH MCHC PLT RDW-SD RDW-CV WBC NEUT% LYMPH% MONO% EO% BASO% NEUT# LYMPH# MONO# EO# BASO# PLT-O RET# RET% IRF MPV DIFF-X 8.0 DIFF-Y 68.0 BASO-X Manufacturer Defined Limits for Detector Control/Service Parameters are 15.0 BASO-Y defined as a variation from target values and will not be changed lot to lot RBC-O These values are entered into the analyzer's control files HFR For further information please refer to: MFR Sysmex Customer Bulletin : Insight Program Modification LFR 56.0 RBC-X 64.0 RBC-Y 17.0 Sysmex America Inc. 14

15 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 1 2s rule because of its high false rejections and considering others such as 1 2.5s, 1 3s, and 1 3.5s 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. 29 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 1 2s 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 (P fr ) and error detection (P ed ) of the different candidate QC procedures. Aim for 90% error detection (P ed of 0.90 or greater) and 5% or less false rejections (P fr 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%. 30 Sysmex America Inc. 15

16 WEBINAR: Control Rule Simplification of High Precision Sysmex Hematology Analyzers Fall 2010 Webinar by Dr George S. Cembrowski, MD, PhD Use 1 4.5S Rule for all parameters except HCT 1 3.5S 31 Questions?? Sysmex America Inc. 16

17 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. Sysmex America Inc. 17

18 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 DIFF- Y BASO - Y DIFF - X (NEUT) BASO - X (WBC) NRBC- Y IMI - RF NRBC - X IMI DC 36 Sysmex America Inc. 18

19 RBC & Retic Detector Control Parameters RBC- Y RBC - X RBC-O PLT-O RBC-X RBC-Y LFR, MFR, HFR RBC-I, & PLT-I, MPV MPV 37 Detector Control Parameters MPV BASO-X, BASO-Y Measures platelet volume, very low MPV may indicate platelets below lower discriminator 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 Sysmex America Inc. 19

20 Detector Control Parameters NRBC-X, NRBC-Y IMI#, IMIDC, IMIRF RBC-X RBC-Y Ensures separation of NRBC population from RBC ghosts and WBC populations. Flags affected: NRBC, NRBC Abn Scattergram Monitors immature gran accuracy and precision of IMI detector. Flags affected: Left Shift, Blasts, Immature Grans Plt Clumps Mean fluorescence channel of mature RBC s in Retic scattergram on horizontal axis May affect IRF Mean channel for mature RBC s in Retic Scattergram on vertical axis. Questions?? Sysmex America Inc. 20

21 Patient Moving Average XbarM QC tool developed by Dr. Brian Bull in 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 Sysmex America Inc. 21

22 Xm - Modification of Bull s Xb Used to monitor Patient Moving Average Definition Bull s Algorithm N X M (i)=x M (i-1)+sgn{ SGN[X(j,i)-X M (i-1)* i=0 l X(j,i)-X M (i-1) l} *F N F={ SGN [X(j,i-X M (i-1)] l X(j,i)-X M (i-1) l} 2 i=0 N 34 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 zero Commercial QC data Calibration data Background counts Data that exceeds linearity range (@) Data that is unreliable data ( *) Data reported with analysis error Data displayed as **** or ---- Sysmex America Inc. 22

23 Installing X Series: Xm Settings Xm must be turned ON Set Xm batch: Sysmex recommends 20 During implementation: Interim limit or Assign Variable Target for Xm How to set XBarM limits QC Settings LJ, %, 3SD (only for auto-setting XbarM limits) Sysmex America Inc. 23

24 QC System Settings Control Method L-J Control Limit Setting Ratio (%) & 3SD 47 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. Sysmex America Inc. 24

25 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 Each time Xm alerts as out, check Xm chart. Document each time Xm is out on QC log. Proceed after Xm points are out. Check if parameters that are out are related to patient population being run. i.e.) Dialysis run, pediatric run, oncology run, ER's Check maintenance log for any recent calibration or part replacement. If XE has been calibrated in the last 7 days, leave a message for supervisor. Targets may need adjusted. If YES, run XE Check reagent log. Has a reagent been changed that coincides with Xm going out. Check if reagent is running low or almost outdated. RBC/PLT HGB Ret % & #, RBC-O, RBC-X & Y IRF, LFR, MFR, HFR Cellpack Cellsheath Cellpack Sulfolyser Ret-Search II (Diluent & Dye) Sysmex America Inc. 25

26 XE-2100 Xm Flowchart - RBC parameters (cont) Check maintenance log. Has maintenance been done or not done recently? Perform maintenance. RBC/PLT HGB 1) Clog removal 2) Clean RBC Aperture 3) Clean SRV 1) Clean SRV Run the patient control from current and previous shift. Run commercial controls. Patient control & commercial control in. Patient control or commercial control out for same parameter. Run XE Monitor Xm Call Hotline If another point is out, call hotline SYSMEX Document all actions on action log. XE-2100 Xm Flowchart - WBC parameters (cont) Check reagent log. Has a reagent been changed that coincides with Xm going out? Check if reagnet is running low or almost outdated. nrbc #, nrbc-x & Y Diff parameters, Diff-X & Y IMI # WBC, Baso # & %, Baso-X & Y Stromatolyser-NR (Diluent & Dye) Stromatolyser-4DL Stromatolyser-4DS Stromatolyser-IM Stromatolyser-FB Document any reagent change on onboard reagent log. Check maintenance log. Has maintenance been done or not done recently? Perform maintenance. 1) Clog removal, 2) Clean IMI detector aperture, 3) Remove flow cell air bubbles, 4) Rinse Flowcell. Run the patient control from current and previous shift. Run commercial controls. Patient control & commercial control in. Patient control or commercial control out for same parameter. Run XE Monitor Xm Call Hotline If another point is out, call hotline SYSMEX Document all actions on action log. Sysmex America Inc. 26

27 Questions?? Tidbits PLT Clumping? flag ISLH Consensus Ruleswww.islh.org PLT rule: <100 or >1000 and first time Pediatric Normal Ranges: Pediatric Reference Intervals, 7 th edition, Sysmex America Inc. 27

28 Thank you! Questions? Sysmex America Inc. 28