QC and Changing Lots

Transcription

1 QC and Changing Lots Back to the Basics Karen Hoffman MT(ASCP) Senior Technical Integration Specialist Laboratory Solutions Services Sysmex America, Inc. Objectives On completion of this training you should be able to: Describe how to change the lot of QC Describe proper mixing and handling instructions for e-check QC Material Explain how to utilize XbarM to troubleshoot 1

2 Inputting a New Lot Number Setting the Variable Target on the New Lot 2

3 We don t want to use the same Targets as the previous lot. We have new Values. Parallel New and Current Lots (Gather at least 10 Data points for NEW lot) The New Lot will have a running mean since there is not a set target. Current New 3

4 Compare Your Mean to the Range of Means on the Assay Sheet Auto-Setting Targets Select all runs 4

5 Select all Parameters Only Auto-Set the TARGET! 5

6 Quiz Time: Why do we Auto-Set the Target? This looks Beautiful!! 6

7 Change New Lot to Current Lot Print Current lot LJ Charts and Data Submit Current Lot to Insight Verify data is Saved before changing lot Use Change Lot program (saves data, deletes Current lot, and moves New Lot to Current Lot all in one step) When the lot has been changed from New to Current, it turns Blue 7

8 e-check Information Storage and Stability (Package Insert) 84 day closed vial product life Store vials at 2-8ºC Open vial stability is 7 days Instructions for Use (Package insert) Bring to room temperature (18-25ºC) for at least 15 minutes. Mix by end to end inversion until cell button in bottom of vial is completely suspended. Other helpful hints: Do not use mechanical rocker or mixer. Do not leave out of refrigerator > 30 min. Reviewing QC Data Baso problem ( ) Unconnected Dots Sample Aspiration Error Missing Set of Dots 8

9 Reviewing QC: Function Errors Reviewing QC: Barcode Errors QC data is not plotted. QC must be re-analyzed to plot QC data. 9

10 Patient Moving Averages (XbarM) A Tool for Troubleshooting Patient Moving Average 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 10

11 Patient Moving Average I can t use this my patients are too abnormal! All your patients represent the normal patient population of your facility Excluded automatically from XbarM ID number zero Commercial QC Calibration data Background counts Data over linearity (@) or unreliable (*) Data reported with an analysis error Data displayed as **** or ---- Establishing XbarM Targets Set batch size Ideal size allows collection of 6 points/24 hours Collect at least three months of data when running live Use interim limits during data collection Autoset XbarM targets and limits after collecting sufficient data 11

12 If QC is out, how can you use the XbarM? Can XbarM help Troubleshoot Flagging? 12

13 XbarM Troubleshooting Flowchart XbarM Out of LImits Check patient population (Dialysis run, pediatric run, oncology run, ER's) If NO, If YES, Run Patients Monitor XbarM Check Maintenance Log Daily/Weekly Shutdown? Calibration? Part Replacement? Check Reagent Log. New Lots? Reagent Changes? XbarM Shifts & Trends? 1) Run Patient Specimen from Before shift/trend 2) Run Commerial QC Always follow your facility procedure! If both IN Run Patients & Monitor XbarM If Either is Outside Expected Range Call Sysmex TAC SYSMEX If another Point OUT, Call Sysmex TAC SYSMEX Document all Actions On Action Log. Troubleshooting XbarM Remember XbarM is a weighted average program Part of the batch mean from the previous batch is used to determine the mean for the current batch It may take a few good batches after corrective action for the XbarM graph to return to normal 13

14 Quick Quiz!!! Result Concern? QC - OK Xm - OK QC - OK Xm - Not OK QC - Not OK Xm - OK QC - Not OK Xm - Not OK Thank You! 14