ELECTIVES MODULES. Implement. Electives. Setup. Troubleshooting. Basics

ELECTIVES MODULES Implement Electives Setup Troubleshooting Basics This document is not intended to replace the information in your Instrument Instructions for Use Manual (IFU). Information in the Instructions for Use Manual supersedes information in any other manual. E-1 of 52

You will see the following symbols used throughout the learning modules. Important information you should know. Techie-type information you may be interested in knowing. Do these steps now! Timely Tip You reached the goal! I do not understand Questions Resources, Help E-2 of 52

COURSE MAP ELECTIVES XM Analysis XB Analysis Additional QC Setup Additional QC Review Extended Quality Control Repeatability & Carryover These modules are elective. You may perform them in any order desired. If a topic is not applicable to your lab situation, you do not need to do it at all. E-3 of 52

PERSONAL PROGRESS SUMMARY Name Setup Date Initial Apps Repeatability & Carryover Extended QC Additional QC Setup Additional QC Review XB Analysis XM Analysis E-4 of 52

OBJECTIVES REPEATABILITY AND CARRYOVER Given an operating DxH 800 and access to System HELP Perform a Repeatability study, verify and print results Perform a Carryover study, verify and print results Why Is It Important? Regulatory agencies may require that repeatability and carryover studies be performed periodically. These studies may also be used for troubleshooting instrument problems. Resources DxH 800 System System HELP For Repeatability: 2 EDTA specimens from the same donor For Carryover: 1 EDTA specimen and three empty EDTA tubes E-5 of 52

E-6 of 52

INFORMATION/PRACTICE Note: Both the Repeatability and Carryover procedures may be a requirement of regulatory agencies. These procedures may be used at any time to verify the performance of CBC, Diff and Retic parameters. We will perform these procedures for CBC parameters for the purposes of this module. Repeatability (aka Reproducibility or Precision) Step Action 1 Open System HELP. 2 Select Chapter 11 Quality Assurance. 3 Expand Repeatability. Note You may perform Repeatability studies in either cassette presentation or single-tube presentation. 4 Select Repeatability in Cassette Presentation 5 Read the information and then follow the steps to perform the study using CBC test mode. Obtain two EDTA specimens from the same donor. Carryover 6 Print the results of your Repeatability study. Carryover is the discrete amount of analyte carried by the measuring system from one specimen reaction into subsequent specimen reactions, thereby erroneously affecting the apparent amounts in subsequent specimen. (NRSCL8-A 1998, Clinical Laboratory Standards Institute) Carryover is expressed conventionally as a percentage of the concentration of the analyte in the first specimen that is carried into the subsequent specimen. Step Action 1 Open System HELP. 2 Select Chapter 11 Quality Assurance. 3 Select Carryover. E-7 of 52

4 Read the information and then follow the steps to perform the Carryover procedure. Obtain one EDTA specimen and three empty EDTA tubes. You may obtain diluent from the instrument for each of the empty tubes by using the single-tube presentation icon and selecting the Dispense Diluent button. 5 Print the results of your Carryover study. You reached the goal! Please continue to the Skill Check on the next page. E-8 of 52

REPEATABILITY AND CARRYOVER SKILL CHECK 1. Show facilitator the printout from the Repeatability study. 2. Show facilitator the printout from the Carryover study. Facilitator sign-off E-9 of 52

E-10 of 52

OBJECTIVES EXTENDED QC Using an operating DxH 800 and System HELP: Enable/disable Extended QC rules for control files Define Random Error, Systematic Error and Single Measurement Error Use Extended QC Limits Review control files with Extended QC, recognizing the flagging and how to respond to the flagging Print summary reports Why Is It Important? Extended QC is an optional quality assurance method that can be used to review control files. It is used to determine if an analyzer is working as predicted within a defined range. The Extended QC rules are derived from the German Quality Control Guidelines for the medical laboratory, known in Germany as Rili-BÄK (or Rili-BAEK). The Rili-BÄK (Guidelines of the Federal Chamber of Physicians), was first published in 1987. In 2003, the guidelines were extended to include hematology and in 2008 to include singlemeasurement error. Resources DxH 800 System System HELP Control file data E-11 of 52

E-12 of 52

INFORMATION/PRACTICE Enable/Setup Extended QC Step Action 1 Open System HELP 2 Select Chapter 9 Setup. 3 Expand Quality Control. 4 Expand Commercial Controls. 5 Select Extended QC Setup. 6 Read this information. 7 Enable Extended QC. There are four tabs, CBC, Diff, Retic, BFC. 8 9 Select the CBC tab. Note there are entries for WBC, RBC, HGB, HCT and PLT. These are the default limits. The default limits, as well as adding values for any of the other parameters and tabs are editable. Additional Comments Once you enter limits, they apply to any lot number or level of control for 6C, Retic-X or Body Fluid. You may also add a Parameter ID of your choice for each parameter used. Choose the button Additional Information if you want to add comments to any of the reports. E-13 of 52

Extended QC Limits Note: If you use auto-stop for controls, any Random Error, Sytematic Error or Single Measurement Error applies and will trigger the auto-stop function. Random Error Random Error is Extended QCs measurement of imprecision (lack of repeatability). This is expressed as the maximum allowable coefficient of variation (CV%). The method is considered out of control if the CV falls outside the Random Error Limits. If the control file has an N 2 and N < 20, and the CV exceeds the Random Error limit, the CV value for that parameter highlights in Yellow in the statistics section of the QC summary results screen. If the control has an N 20, and the CV exceeds the Random Error limit, the CV value for that parameter highlights in Red in the statistics section of the QC summary results screen. The user must acknowledge the alert. The event posts to the QC tab in the Event Logs. Systematic Error Systematic Error is Extended QCs measurement of bias. A systematic error (bias) is defined as the deviation of the mean from the target value. The method is considered out of control if the deviation falls outside the Systematic Error Limits. absolute Delta Diff The formula for the Systematic Error Limit is: 100 Target Value If the control file has an N 2 and N < 20, and the deviation exceeds the Systematic Error Limit, the Delta Diff for the parameter highlights in Yellow in the statistics section of the QC summary results screen. If the control has an N 20, and the deviation exceeds the Systematic Error Limit, the Delta Diff for the parameter highlights in Red in the statistics section of the QC summary results screen. The user must acknowledge the alert. The event posts to the QC tab in the Event Logs. The Delta Diff used in the formula is the absolute difference between the current lab mean and the target value. Single Measurement Error % (SM%) Single Measurement Error is Extended QCs measurement of inaccuracy, as compared to an established limit. SM% is defined as the deviation of a single measurement from the target value. Each control run is evaluated using the following formula: ( Target Value Total Error Limit) TargetValue ± for that parameter. 100 E-14 of 52

If the result is outside of the upper or lower range, the user is notified by highlighting the result in Yellow on the parameter itself. The laboratory may choose to evaluate target value as either the BCI Assigned Value or the Mean-to-Lab Target Value. Troubleshooting Basic troubleshooting remains the same as any other QC routine. If you have SM% Error (a result is out of range), repeat the control. If the result is still out of range, try a new vial. Also verify the proper handling and mixing of the control vials per the manufacturer s insert sheet. If you have Systematic (bias) Error for a parameter, you may need to verify calibration. If you have Random (imprecision) Error, verify repeatability using a patient sample. If this fails, you need to contact the manufacturer. Other Information Sources www.westgard.com/lesson53.htm www.ajcp.com (The Quality of Laboratory Testing Today-an assessment. 2005080316.pdf) Printing Reports If you select the manual print icon while in a control file, there will be a choice in the drop-down box for Extended QC Report. You reached the goal! Please continue to the Skill Check on the next page. E-15 of 52

E-16 of 52

EXTENDED QC SKILL CHECK 1. Show your facilitator the screen where you enable/disable Extended QC. 2. Point to the values you can change. 3. Define these terms: Random Error Systematic Error SM % Facilitator sign-off E-17 of 52

E-18 of 52

OBJECTIVES Using the System HELP: Demonstrate how to set up and use lab limits Demonstrate how to set up a Patient Control ADDITIONAL QC SETUP Why Is It Important? Using lab limits allows your lab to more closely monitor control results and take quick action to correct out-of-limits situations. As part of a lab s Quality Assurance program, a patient control may be used in addition to a commercial control. Resources DxH 800 System System HELP A set of lab limits for COULTER 6C Cell Control An EDTA specimen E-19 of 52

E-20 of 52

INFORMATION/PRACTICE Lab Limits Step Action 1 Open System HELP 2 Select Chapter 9 Setup. 3 Expand Quality Control. 4 Expand Commercial Controls. 5 Select Lab Limits. 6 Read information and then go to the Lab Limits screen. 7 Select BCI, Retic-X, Level II. Enter the following limit: Retic % 0.9 Note: This limit is used for classroom purposes only. You will establish your own limits for your lab. 8 Now go to the setup control area, highlight Retic-X, Level II and select the Edit Control button. a. Select to use Lab Limits as your target range. (You may always Restore Original Values (Mfg. Ranges) if you need to do so.) b. Select either Mean as Assigned Target (the running mean) or Restore Assigned Values. 9 Open your Retic-X, Level II, file data. You should see the lab limit now applied to your data, as long as there are at least two runs in the file. E-21 of 52

Set Up a Patient Control File Step Action 1 Create lab limits for Patient, CBC, Normal and enter the following: WBC 0.5 MCH 1.2 PLT 25 RBC 0.15 MCHC 1.7 MPV 2.0 HGB 0.6 RDW 1.5 HCT 2.5 RDW-SD 3.5 MCV 3.0 2 Open System Help 3 Select Chapter 9 Setup. 4 Expand Quality Control. 5 Expand Commercial Controls. 6 Select New Patient Control. 7 Read information and then perform the steps required to create a Patient Control. Be sure to enable the lab limits you just created. a. You may enter the Specimen ID for the patient you want to use and have the system populate the fields (the easy method however, there should only be one set of results, no reruns), OR b. Type in the assigned values and the range. 8 Run the specimen. The results will appear in the control file. A patient control requires only one run to be able to activate it. 9 Now go back to the setup screen and select the Mean-To-Lab Target radio button. You reached the goal! Please continue to the Skill Check on the next page. E-22 of 52

ADDITIONAL QC SETUP SKILL CHECK 1. Show the facilitator the Lab Limits applied to the control run. 2. Show the facilitator the Patient Control file with at least one run in it. Facilitator sign-off E-23 of 52

E-24 of 52

OBJECTIVES ADDITIONAL QC REVIEW Given an operating DxH 800 System and using the System HELP Delete data from control files/delete control files Download control data for IQAP Export data from control files for electronic storage Why Is It Important? An understanding of the levels of deletion of control material allows you to remove unwanted or old data. Using the IQAP program gives your lab a means of peer review with other users of DxH 800 and BCI controls. Using the export feature to electronically archive control data is a convenient means to use for long-term storage of data. Resources DxH 800 System System HELP CD-R or flash drive Web version of IQAP manual E-25 of 52

E-26 of 52

INFORMATION/PRACTICE Delete Control Data Delete Runs From a File Step Action 1 Open System Help 2 Select Chapter 4 Quality Control. 3 Expand Overview. 4 Select Delete Control File Records. 5 Read the information in this section. 6 Go to any of your control data files and select the Delete button. 7 Be sure you understand the differences between the three choices given. Selected Run - to delete the selected run only. All Runs in Current Filter - to delete all the runs in the current filtered view. All Runs in Current Control File - to delete all runs in the current control file, regardless of the filter applied to the view, if any. Delete the Entire File Step Action 1 When you no longer need the control data information, you may delete the entire file. Note 2 3 Please do not delete any of the BCI Control files that are set up in the classroom. The following two steps are for observation only. From the Control Setup Screen, highlight a control level and then locate the Delete button. Do not click on the button. If selected, the entire file would disappear. There is no way to reverse this action. E-27 of 52

Export IQAP Data When you are ready to submit your control data to IQAP: Step Action 1 Review your control files to be sure the runs you want to submit are included in the statistics. 2 3 From the Control Setup Screen, highlight a control level or levels and then select the Export IQAP button. Under Control Data to Export, choose Selected DxH Control Lots. 4 Under Data Export Grouping, choose Use Multiple Shifts. 5 Under Destination, there are three choices to continue: a. Transfer to BCI this would be directly through the PROService connection. b. CD Recorder (G:\) - This process may take several minutes. Then, use the CD to upload your data to the eiqap website. c. Local drive (E:\).This process copies the files to the E drive. You could then open Windows Explorer and drag and drop to a USB flash drive. (Use File, Eject before removing the flash drive). Then, use the flash drive to upload your data to the eiqap website. eiqap Submission Electronic uploading of your control data files via the internet is done using eiqap. You must have an IQAP account set up first. Then you will be asked if you want to use eiqap. If you do, you will be given a code and instructions to set up your internet account. Once you have the data from the previous exercise, you will log in to the internet site for eiqap. Follow screen instructions to upload your data. The advantage to the internet upload is that you will have access to the pool data in as little as 24 hours. You will access and print your own reports via a.pdf format. The internet site provides access to the download for Adobe Acrobat Reader if you do not have it already. E-28 of 52

There are separate Administrator and User functions within your account. Once you enroll all eligible hematology instruments in your laboratory, you access your data through your eiqap account. Mail-in IQAP diskette While the transition to e-iqap takes place, the mail-in system will continue. You mail the data in a provided envelope and receive a printed report in 3-4 weeks. Eventually, the mail-in system will be phased out. You will receive notification and a timetable for this as the time approaches. Export Controls Note: before using this method, check with your regulatory requirements to verify that this is an acceptable way to store and retrieve data. From the Control Data screen, choose More Options, then Export. Select runs or the entire file to save to a CD or local drive. This will be in a.csv that can be access via a spreadsheet program such as Microsoft Excel. The other format available, INF.dat, is a raw data file format that you might send to BCI for troubleshooting purposes. You reached the goal! Please continue to the Skill Check on the next page. E-29 of 52

E-30 of 52

ADDITIONAL QC REVIEW SKILL CHECK 1. Delete a control run chosen by your facilitator. 2. Show facilitator the control data exported using the spreadsheet program provided. Facilitator sign-off E-31 of 52

E-32 of 52

OBJECTIVES XB ANALYSIS Given an operating DxH 800 System and using the System HELP: Demonstrate how to set up XB target values and limits Review XB data in your System Give at least three examples of results that would be excluded from an XB batch Why Is It Important? XB Analysis is a cost-free quality control method that monitors instrument performance by tracking the MCV, MCH, and MCHC parameters of all patient samples. It is a very sensitive indicator of instrument problems. Resources DxH 800 System System HELP E-33 of 52

E-34 of 52

INFORMATION/PRACTICE What is XB Analysis? "Weighted Moving Average" of patient sample results Originally created by Dr. Brian S. Bull Uses RBC indices (MCV, MCH, MCHC) Small batches of samples (20 samples) Compares batch results to lab "target values" automatically Batch results are in control if batch mean is within 3% of the target value An on going method of monitoring automated hematology instruments No additional cost (uses patient sample results) Why Use The RBC Indices? MCV, MCH and MCHC are fairly stable parameters Stable for individual patient from day to day Stable for "patient population" over time "Target values" or mean vales can be established for your patient population What Is A Target Value? An average value, for each parameter, calculated from large numbers of patient results Target values should reflect the entire patient population of the laboratory Include all ages and disease states Dr. Bull's Target Values MCV = 89.0 MCH = 30.5 MCHC = 34.0 Suggested starting values to use until laboratory values are established Based on general population across the nation E-35 of 52

After Data is Collected Collect printouts of XB batches Calculate the mean and %CV for each of the XB parameters Verify the lab's means do not exceed Bull's target values by more than 3% Verify the %CV is less than 1.5% Use the calculated means as the new target values Enter the new values in the XB setup screen Non-Random Sampling Batch may go outside the ±3% limits, because the batch is biased Each subsequent batch should move closer to the target and be back "in control" within 3 to 4 batches Make a note that the "batch was out due to non-random sampling" by adding a comment in the Batch Mean Table. Batch Results Go "Out" and Stay Out There is a change in the patient population One or more new type of patient is added to the patient population One or more types of patient is no longer a part of the patient population Seasonal changes of the patient population (hospitals or clinics in resort areas) Instrument problem Can be a gradual change that may indicate a part going bad over time or a calibration drift Will go back "in control" after calibration Will go back "in control" after part is replaced Can be a sudden change that indicates an instrument problem Will go back "in control" after problem is fixed E-37 of 52

Troubleshooting When a Batch is "Out" Know which parameter is out Look at the batch results "Out" parameters are flagged with H or L Know where the parameter comes from MCV: Derived from the RBC Histogram MCH: Hgb x 10 RBC MCHC Hgb x 100 Hct where the Hct = RBC x MCV 10 As you can see, two of the XB parameters are calculated using other RBC results Troubleshoot those things that can affect the parameters used in the calculations What to Look for When XB Parameters are "Out" MCV LOW MCV HIGH MCH LOW MCH HIGH MCHC LOW MCHC HIGH MCV dec inc --- --- inc dec RBC --- --- inc dec inc dec Hgb --- --- dec inc dec inc Hct dec inc --- --- inc dec Practice Step Action 1 Open Help. 2 Select Chapter 9 Setup. 3 Expand Quality Control 4 Select XB E-38 of 52

5 Read the sections on XB. 6 Review the screens associated with XB setup. 7 8 Review the screens associated with XB review by selecting Status Icon Be able to find the Current Batch, Previous Batches and the Batch Means Tables and Levy-Jennngs graphs. You reached the goal! Please continue to the Skill Check on the next page. E-39 of 52

E-40 of 52

1. Show facilitator the XB setup screen. 2. Show facilitator the XB review screen. XB ANALYSIS SKILL CHECK Facilitator sign-off E-41 of 52

E-42 of 52

OBJECTIVES XM ANALYSIS Given an operating DxH 800 System and using System HELP: Show where to enable/disable XM parameter groups Demonstrate where to set up XM target values and limits for a parameter group Review XM data in the System Manager Give at least five examples of results that would be excluded from an XM batch Why Is It Important? XM Analysis is a cost-free quality control method that monitors instrument performance using an Exponentially Weighted Moving Average of CBC, Diff and Reticulocyte parameters of all patient samples. It compares these averages with target means and limits. The use of XM is an option decided upon b the laboratory. Resources DxH 800 System System HELP XM Analysis Overview Setting up XM Analysis Reviewing XM results XM Statistics Table E-43 of 52

E-44 of 52

INFORMATION/PRACTICE What is XM Analysis? Exponentially Weighted Moving Average (EWMA) of patient sample results. The first form of weighted moving average statistical analysis in Hematology was X B, originally created by Dr. Brian S. Bull. Note Although both XB and XM are ways to monitor moving averages, the EWMA used in XM and the Bull s algorithm used in XB are different. Uses any of four XM parameter groups: CBC, Diff, Retic, Retic Calc. Batch size can be configured independently for the four parameter groups from 2-1000. XM is most effective with larger batch sizes (250+). Compares batch results to target means and limits. An on-going method of monitoring automated hematology instruments. No additional cost (uses patient sample results). XM provides a way to monitor calibration stability within a method or instrument. It also provides a way to monitor calibration uniformity between methods and instruments. What is a Target Value An average value, for each parameter, calculated from large numbers of patient results. Target values should reflect the majority of the patient population of the laboratory. Target values include all ages and disease states. The value may be static (fixed) or moving (auto-updated with each new batch mean when auto-update is enabled) Note If you use auto-update continually, the batches will never be flagged out of range. However, auto-update works independently for both Target and Limits. You may select auto-update ON for Target and OFF for Limits. In this case, the batches will be evaluated. E-45 of 52

Where to Enable XM You may access the XM Setup screen by selecting: Menu>Setup>Quality Control OR From the XM Data Screen, choose the XM setup button This screen allows you to: Enable/disable the different XM Parameter groups Set the batch size for each group Select Location exclusions (if used) Select the Reporting Options you wish Select the Alerts you wish to use Enable/disable Auto Stop E-46 of 52

Where to Set Up Targets Select the Parameter Details button at the bottom of the screen to access the target set-ups. For each XM group, by selecting the appropriate tab you may: Initially, you may want to select auto-update for both target and limits until you accumulate enough of your own data. If you deselect Auto-Update Target, then you may type in your own target value. If you deselect Auto Update Limits, then you may type in your own Low Limits and High Limits. You may select to use 2SD or 3SD for your Limits. Note If you use auto-update continually, the batches will never be flagged out of range. However, auto-update works independently for both Target and Limits. You may select auto-update ON for Target and OFF for Limits. In this case, the batches will be evaluated. E-47 of 52

What Does an "Out of Control" Batch Indicate? "Out of Control" batches may indicate: An instrument problem A reagent problem A sample handling problem A calibration problem A change in the patient population Establishing Laboratory "Target Values" Before collecting data ensure the following: Instrument is clean Instrument is calibrated There are no instrument problems Sufficient data collected (recommend at least six months) How Do You Get Started? Enable XM on the Run Configuration screen for each data set required Configure your requirements in System Setup, QA, XM tab You might want to use the auto-update feature during the data collection phase, then switch to static values for some or all of your parameters when you are satisfied with your target and limit values. For example, you could leave auto-update on for the target and turn auto-update off for the limits. Another consideration for those who want to use both XB and XM: if you leave a target blank and turn auto-updat off for a parameter, you will not get a value or graph for that parameter. In other words, you can use this to disable parameters within a parameter group that you do not want to monitor. So, if you are using XB, you can turn off MCV, MCH and MCHC in XM. You may want to use historically established means and limits to begin or run samples to collect batches of patient samples You might want to set to a large batch (250-1000+) for the data collection. E-48 of 52

Collect data to reflect entire patient population (all ages and disease states). Consider that you need an adequate N in a reasonable time frame, a relatively homogenous population over time (or else your mean may drift) and no excessive biological variation within the time frames (you might see a difference in means between in-hospital tertiary care patients in the AM vs. normal patients from doctor s offices/external clinics in the PM. Results from at least six months of data should be collected to find your laboratory's target values Include all types of patients (oncology, presurgical, OB, dialysis, outpatients and so forth) After Data is Collected Compare means and limits calculated using auto update to establish static values or to make adjustments to previously entered historic values. What Makes a Batch "Out of Control"? Instrument problem Seasonal changes (change in patient population) One or more types of patients added or removed from mix of patient population Batch of patients is biased by several abnormal patients of a certain type (oncology, neonatal and so forth) Each subsequent batch should move closer to the target and be back "in control" within 3 to 4 batches Make a note that the "batch was out due to non-random sampling" Consider adjusting limits to more adequately reflect your population Batch Results Go "Out" and Stay Out: There is a change in the patient population One or more new type of patient is added to the patient population One or more types of patient are no longer a part of the patient population Seasonal changes of the patient population (hospitals or clinics in resort areas) E-49 of 52

Instrument problem Can be a gradual change that may indicate a part going bad over time or a calibration drift Will go back "in control" after calibration Will go back "in control" after part is replaced Can be a sudden change that indicates an instrument problem Will go back "in control" after problem is fixed Troubleshooting When a Batch is "Out" Practice Know which parameter is out Look at the batch results "Out" parameters are flagged with H or L Know where the parameter comes from Is it a directly measured parameter? Is it a derived parameter (derived from a histogram)? Is it a calculated parameter? Refer to System Help Chapter 2 Operation Principles, select Parameter Measurement, Derivation and Calculation. Step Action 1 At any DxH 800 System Manager, review XM set up options. 2 Using the data we have in XM, review the screen data. Note The XM data in our classroom is not typical for a laboratory. We present the data for observation and study purposes only. You reached the goal! Please continue to the Skill Check on the next page. E-50 of 52

XM SKILL CHECK 1. Show facilitator the XM Setup screen. 2. Show facilitator the XM Data Review screens. 3. How many batches are available for review? 4. Name the four XM parameter sets. 5. What size range can you set a batch equal to? Facilitator sign-off E-51 of 52

E-52 of 52