Flags, Codes and Messages on the COULTER® LH 750/755

Flags, Codes and Messages on the COULTER® LH 750/755
Flags, Codes, Messages Rev. F (October 2009) Flags, Codes and Messages on the COULTER® LH 750/755 Rev. F (October 2009) Miami Education Center Miami Education Center

What’s the difference between a Flag, a Code and a Message?
Flags, Codes, Messages Rev. F (October 2009) Flags Letters or Symbols that appear to the right of a result Codes Symbols that appear in place of results Messages Word messages provide additional information Suspect Definitive Decision (Reflex) Rules Flags are Letters or Symbols that appear to the right of a parameter result. Examples are R flag, H or L flag, asterisk flag. Codes are symbols that appear in place of parameter results Examples are ---- Total Voteout, …. Incomplete Computation, ++++ Over Range Messages are words (or text) with additional information pertaining to sample results. The LH 750 has three different types of word messages. The three types are: Suspect messages are generated by the instrument’s internal algorithm. Examples are platelet clumps, cellular interference. Definitive messages are generated when sample results exceed your lab’s action limits. These are defined by your lab’s protocols. Examples are anisocytosis, large platelets, neutrophilia. Decision (Reflex) Rules help automate and streamline the laboratory review processes. If for example, a laboratory has a review policy that “if the WBC is > 20 thousand, then perform a manual diff” , a decision rule can be created to prompt this process. Rev. F (October 2009) Miami Education Center Miami Education Center

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Flags, Codes, Messages Rev. F (October 2009) COULTER® LH 750 FLAGS Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The * Flag Result does not meet the counting threshold for MCV (i.e. less than 50 fL) There could be interference causing the reported result to be falsely low Red background on the Workstation screen Suspect message (RBC Interference) R on all RBC parameters, all Plt parameters and Retic # Do not report RBC results Let’s start with the asterisk flag. This flag is applicable to MCV only. This rarely occuring flag is displayed when the MCV result does not meet the instrument’s counting threshold, meaning the MCV result is less than 50 fL. When the asterisk flag is present for the MCV, there could be interference causing the reported RBC result to be falsely low. For example, if the RBC population shifts to the left, there may be a significant numbers of cells or particles falling below 36fL. Since anything smaller than 36fL is excluded from the count, the resulting RBC may be falsely low. In addition to the asterisk flag on the MCV parameter, the MCV is highlighted in red on the Workstation screen and the sample appears with the suspect message RBC Interference. All RBC and Platelet parameters appear with an R flag, as well as the Retic absolute number. Do not report RBC results. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The * Flag What could you do? Review RBC Histogram Review the morphology from the smear Do a spun hematocrit Perform a manual RBC count Review according to your lab’s policy What could you do for an MCV asterisk flag? Review RBC Histogram Review the morphology from the smear Could do a spun hematocrit Perform a manual RBC count Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The + Flag Result exceeds linearity (reportable) range The LH 700 Series reportable ranges: WBC to x 103 cells/µL RBC to 8.00 x 106 cells/µL Hgb to 25.0 g/dL Plt to 3000 x 103 cells/µl The + appears on results between the linear and operating range The single plus flag. A single plus flag next to a result means the result exceeds the reportable range of the instrument for that parameter. The reportable range is the same as the linearity range. Linearity is defined as the ability of an instrument to recover expected results (reference values or calculated values) for such parameters as WBC, RBC, Hgb, and Plt at varying levels of concentration of these parameters within specified limits. The LH 700 series reportable ranges are: WBC to four hundred thousand RBC to eight million Hgb to twenty-five Plt to three million As part of their implementation process, most labs verify the instrument’s linear range. The reportable values may be slightly different from the manufacturer stated ranges. A single plus flag appears on a result which is above the linear (or reportable) range, but below the operating range (which we will discuss in a few slides). Operating and reportable ranges are found in the online Help on the LH workstation. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The + Flag What could you do if a parameter result has a single plus? Perform a dilution of a sample aliquot. Run the sample in the predilute mode using the dilution factor made. If you get a single plus on a parameter result: Perform a dilution of a sample aliquot . Run the sample in the predilute mode using the dilution factor made. Dilute an aliquot of the sample and run it using the predilute function. When using the predilute function remember to enter your dilution factor in the pop-up window on the Workstation. As a reminder, the dilution factor is the number used to multiply the results. The factor is NOT a ratio. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) Operating and Reportable Ranges This is a screen capture from the LH750 online Help. This gives you a better understanding of the differences between the reportable range and the operating range of the instrument. The Operating Range reflects the range of values over which the instrument displays, prints and transmits results. The reportable range identifies the values where the instrument is accurate, and reflects the range studied in accuracy testing. In this slide, notice the instrument Reportable Range for the WBC is to The instrument Operating Range for WBC is 0.00 to Any result between the Reportable range and the Operating range has a single plus flag next to that result. For example, a WBC count of is above the Reportable Range, but under the Operating range, so it will have a single plus flag next to the WBC result and also the suspect message, WBC Exceeds Linearity, displays. If the WBC result is above the Operating range, (above nine hundred thousand) the instrument displays a code instead of a numeric result. The WBC result is replaced with (meaning over range) code. Rev. F (October 2009) Miami Education Center Miami Education Center

The H/L, aH/aL, cH/cL Flags
Flags, Codes, Messages Rev. F (October 2009) The H/L, aH/aL, cH/cL Flags These are flags that appear based on your laboratory’s reference, action and critical limits Can set up multiple sets of these ranges based on age and location (optional) in the Workstation Each set then has subsets for Male (Def.), Female, Action, Critical and Definitive Messages Review according to your lab’s policy The reference, action and critical flags. These flags appear based on your laboratory’s established ranges. High and low flags are generated if a result exceeds your Reference Ranges. On the LH 700 series, the reference ranges are the subsets, of normal male and female values. The male category is the default limit If the demographic information of gender for a sample is not available on the LH, the instrument uses the male default. Action Limits define the low and high limits for samples that require action by your laboratory. Critical Limits define the low and high limits for samples that are critical and require immediate action by your laboratory. They are sometimes called panic values. Multiple flagging sets of these ranges can be setup based on age with location optional in the Workstation. Each of those sets, contains subsets for Male, Female, Action, Critical and Definitive Messages. Rev. F (October 2009) Miami Education Center Miami Education Center

The H/L, aH/aL, cH/cL Flags
Flags, Codes, Messages The H/L, aH/aL, cH/cL Flags Rev. F (October 2009) The ranges for these flags are set up under System Setup…Patient…Flagging Limits This is an example illustrating a few of these flags. When a reference (or normal) range is exceeded, the result is highlighted with a Yellow background and contains an H or L flag. If Action or Critical Limits are exceeded, the result is highlighted with a Red Background. In this example the RDW contains an aH flag. Since this result exceeds the laboratory definable action limit, it is highlighted with a red background. Triggering this action limit also generates the definitive message, Anisocytosis. Definitive messages reflect the values entered for action limits. A unique definitive message can be selected to appear when an action limit is exceeded. If the MCH low action limit is exceeded, the definitive message, hypochromia appears. Monocytosis is for high monocyte absolute number. You can view a complete list of definitive messages in HELP. The ranges for these flags are setup in the LH workstation by selecting System Setup from the command center, then the Patient icon, and then the Flagging Limits tab. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The D Flag Indicates the result triggered a Delta Check as defined by your laboratory Review according to your lab’s policy Set up under System Setup…Patient… Decision Rules Next is the D or Delta Check Flag. It indicates the result triggered a Delta Check as defined by your laboratory. A Delta Check is a verification performed on sample results to determine if the current result on a specific patient id # is within limits of the last result obtained on that same patient id #. Your lab defines the criteria used for these checks. The D flag indicates the result was significantly different from a previous result on the same patient as defined by your laboratory. Review according to your lab’s policy. Set up a Delta check rule under System Setup. Click on the Patient Button and then choose the Decision Rules tab. Delta check rules may also be setup at the Host/LIS level, but if done there, no D would appear at the instrument. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The D Flag This is an example of the D Check Flag. On the parameter tab, the result highlights with a Red Background and a D flag appears next to the result reminding you that the Delta check rule was triggered. The rule message is displayed on the Demographic Tab inside the rule messages box. For this example it shows “Review Delta Check”. This message also prints on the Sample Report in the Comments section. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The E/e Flags The E shows a result that has been manually edited An E will also appear if the Sample ID (tube barcode) is edited The e shows a result that has been recalculated from a manually edited parameter Next we discuss the edit flags. An upper case E indicates that a result or sample ID has been manually edited. The lower case e flag indicates that a result has been recalculated from a manually edited parameter. To edit results, select the “Edit this sample” button located on the specific toolbar. Demographics and/or comments may also be added to the sample on the edit this sample screen. Use the save edit button to save the edited result. This button is active only after you leave the field being edited. Press tab or click in another field to make the save edit button accessible. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The E/e Flags Results are edited by selecting the “Edit this sample” button located on the specific toolbar Demographics and/or comments may also be added on this screen To save the edit, select the “save” icon on the specific toolbar Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The E/e Flags This slide shows an edited sample. Three edits were performed on this sample. Note inside the blue circle, the sample ID has an upper case E Flag beside it, indicating that the sample ID has been edited. Also notice the WBC count was manually edited as indicated by the upper case E flag next to the result. The absolute numbers for WBC parameters results for the differential have a lower case e beside them, because they were automatically recalculated from the edited WBC value. Another area to note in this example, is the Hemoglobin result. This parameter, too, was manually edited and the upper case E flag shows next to the result. Since Hemoglobin measurement is used to calculate the MCH and the MCHC, those results were automatically recalculated and a lower case e shows beside them. Finally, at the bottom of the screen, notice the Comment area circled in Green. This is the area of the edit screen where comments may be added. LIS systems usually offer editing capabilities also. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The P Flag The instrument detected a partial aspiration error (break in the flow of blood during sample aspiration) OR The blood detectors are disabled Next, let’s discuss the Partial Aspiration flag. A P flag next to the parameter results means the instrument detected a partial aspiration error or break in the flow of blood during sample analysis or the blood detectors are disabled. Note: Do not disable the blood detectors unless performing Carryover or during troubleshooting. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The P Flag Why do you think this sample gave a P flag? Hemoglobin is less than 4 g/dL What should you do? Check sample to verify no clots and rerun in the Manual aspiration mode This is an example of a sample with partial aspiration flags. All of the results are highlighted with a Red Background and a P flag. Take a moment to study these results to determine a reason for the aspiration error. {Note to speaker: Be sure to Pause before revealing the answer.} This sample flags with Partial Aspiration because the Hemoglobin result is less than 4 g/dL. What should you do for this particular sample? Check the sample to verify no clots are present and rerun using the manual aspiration mode. In the manual mode, the sample pathway does not use the front blood detector, therefore the blood detectors will not trigger a partial aspiration flag. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The P Flag This example does not have an obvious reason for the P flag. What should you do? Check sample for proper blood volume in the tube Check for clots Ensure blood detectors are enabled Rerun in Automatic mode This is another example of the Partial Aspiration Flag. Take a moment to study these results to determine a reason for the aspiration error. {Note to speaker: Be sure to Pause before revealing the answer.} In this example, there is no obvious reason for the P flag. The Hemoglobin is 14.1. What should you do for this particular sample? Check the sample for proper blood volume in the tube. Check for clots. Ensure the blood detectors are enabled. Rerun this sample in the Automatic mode. Take these steps at the Command Center on the LH Workstation if you want to prevent Partial Aspiration sample results from transmitting to the host: Select Run Configuration, under Automatic Output choose the LIS Tab, choose the Except Radio Button and then Enable the Partial Aspiration check box. All sample results except Partial Aspirations will transmit to the LIS. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The P Flag What to Do for persistent P flags Troubleshoot for leaks, kinks or plugs along the sample flow path Ensure the aspiration lines are clean Check for needle plugs If your instrument persists with P flags, perform the following: Troubleshoot for leaks, kinks, or plugs along the sample flow path, Ensure the aspiration lines are clean and Check for needle plugs. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The R Flag Review results before reporting according to your lab’s protocol This flag is generated in response to suspect messages The next flag is the R Flag. The R or review flag means review the parameter result according to lab protocol before reporting the results. The R flag is generated in response to suspect messages. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The R Flag Cellular Interference R appears next to WBC when the separation between the WBC populations is poorly defined RBC Interference MCV*, all RBC, Plt, and Retic # parameters will have R Low Event # (<800 WBC events) R appears next to all diff % & #, NRBC % & # display incomplete computation (....) when this message appears Platelet Clumps R appears next to Plt parameters These are the suspect messages causing R flagging. if Cellular Interference: R appears next to WBC when the separation between the WBC populations is poorly defined. if RBC Interference: MCV*, all RBC, Plt, and Retic # parameters will have R If Low Event # , meaning <800 WBC events were counted for the differential, then R appears next to all diff % & # and NRBC % & #. If Platelet Clumps: R appears next to Plt parameters Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The R Flag Verify Diff or WBC >1.5 and MO% >20 R appears next to differential and NRBC percentages and absolute numbers Verify Retic R appears next to Retic %, Retic #, IRF, and MRV WBC Exceeds Linearity Uncorrected WBC > 400. A plus sign (+) appears next to the WBC and an R appears next next to the RBC, Hgb, Hct, MCV, MCH, MCHC, RDW and the diff % & # These are more suspect messages causing R flagging. if Verify Diff or WBC >1.5 and MO% >20: R appears next to differential and NRBC percentages and absolute numbers if Verify Retic: R appears next to Retic %, Retic #, IRF, and MRV if WBC Exceeds Linearity: uncorrected WBC > 400. A plus sign (+) appears next to the WBC and an R appears next next to the RBC, Hgb, Hct, MCV, MCH, MCHC, RDW and the diff % & #. NRBC% % NRBC # display incomplete computation (....) when this message appears Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The R Flag This example shows an R flagged Plt Note the abnormal Plt histogram This is an example of an R flagged Platelet. In this case it was caused by the suspect message Platelet Clumps. (Note: it is also possible to have an R flagged platelet without a suspect message.) Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) COULTER® LH 750 CODES Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages The ( ) Code Rev. F (October 2009) Total voteout of the parameter Can appear for CBC parameters Means that two of the three aperture values do not agree No average histogram appears for the affected parameter You may review the individual aperture results on the CBC Data tab The first code we are going to discuss is the ( -----)Total Voteout Code. This code appears for counted parameters such as RBC, WBC, and Plt and means that two of the three aperture values do not agree. No average histogram appears for the affected parameter. You may observe the individual aperture results on the CBC Data tab. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The ( ) Code This is an example of a total vote out of the platelet parameter. The first thing you may notice, is that the individual aperture results for the platelet parameter are highlighted with a yellow background. This indicates that two of the three aperture counts do not agree. Notice also the average result for the platelet parameter is highlighted with a Red background and there is no numeric result, only dashes indicating the total voteout. The stoplight on the Command Center is yellow alerting the operator that a voteout has occurred. Placing the cursor over the yellow stoplight will bring up the message. Finally, inside the red circled area, there is no average histogram for the Platelet parameter. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The ( ) Code What to Do Rerun the sample Ensure baths contain diluent Ensure apertures are not blocked. Clear Aperture key F01 (Clear Apertures) F09 (Zap Apertures) Use F03 to ensure Mixing Bubbles are present. A lack of mixing bubbles can cause increased voteouts. What can be done for a total voteout code? If only one sample result has a voteout, rerun the sample. If total voteouts are received on several samples, it could be an instrument problem. You can try the following: Ensure baths contain diluent Ensure apertures are not blocked by checking the aperture bath functioning. Clear Aperture key F01 (Clear Apertures) F09 (Zap Apertures) Use F03 to ensure Mixing Bubbles are present. A lack of mixing bubbles can cause increased voteouts. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The (+++++) Code The result exceeds the instrument’s operating range. The next Code is the (+++++) meaning Over the Operating Range. It means the parameter result exceeds the instrument’s operating range. Rev. F (October 2009) Miami Education Center Miami Education Center

The (+++++) Code Flags, Codes, Messages Rev. F (October 2009) What should you do if a parameter result has an over range code ? Perform a dilution of a sample aliquot. Run the sample in the predilute mode using the dilution factor made. If your result is a single + or another rerun using regular manual mode and do the math yourself. What should you do for results with an over range code? Dilute an aliquot of the sample and run it using the predilute function. When using the predilute function remember to enter your dilution factor in the pop-up window on the Workstation. As a reminder, the dilution factor is the number used to multiply the results. The factor is NOT a ratio. If the result of the predilute analysis is also over the operating range or presents a single plus flag indicating the result is over the reportable range, make a greater dilution and rerun using the regular manual mode, then do the math yourself. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) Carryover You need to be aware of carryover issues related to + and Blood-to-diluent Carryover on the LH 750 should meet these limits: WBC <2.0% RBC <1.0% Hgb <2.0% Plt <2.0% DIFF <200 events RETIC <600 events When a sample has a high count, even this amount of Carryover may be too high. Always verify the results of the sample that come after a high one by repeating it. Since we are talking about +, you need to be aware of carryover issues Blood-to-diluent Carryover on the LH 700 Series should meet these limits: WBC <2.0% RBC <1.0% Hgb <2.0% Plt <2.0% DIFF <200 events RETIC <600 events When a sample has a high count, even this amount of Carryover may be too high. Always verify the results of the sample that come after a high one by repeating it. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The (…..) Code An incomplete computation of a CBC parameter Can occur on calculated parameters due to the primary parameter used in the calculation having either: a voteout (-----) or exceeding operating range (+++++) For example, if the WBC has the voteout (-----) code, the diff absolute #s will appear as (…..) Next we will look at the ( …..) code – an incomplete computation of a parameter. This code occurs on calculated parameters because of a voteout or overrange result for the parameter used in the calculation. For example, if voteout appears for WBC, the diff absolute numbers and the NRBC absolute number results appear as ( …..) incomplete computation code since they are calculated from the white count and the WBC result is not available. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The (…..) Code What to Do Rerun the sample if the primary parameter has a voteout (-----) Make the necessary dilution if the primary parameter exceeds the operating range (+++++) Check other parameters, such as WBC, to ensure sufficient data was received for calculations. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The (:::::) Code May appear for Diff or Retic The instrument suspects a clog in the flow cell One of the following designations will appear on the dataplot. PC1 or PC2 or FC Note: this code may be misleading as there is not always a flow cell clog…… more on this in the Troubleshooting Basics 1 (TB1) module The last code is the (:::::)double dot code. This code only appears for the Diff or Retic results when the instrument detects a clog in the flow cell. In addition, to the double dot code, the diff or retic dataplot displays either PC1 or PC2 or FC possibly indicating a partial clog or full flowcell clog. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) The (:::::) Code This is an example of the double dot code. Notice in the parameter results area, the Diff percentage and absolute numbers are highlighted with a red background and have double dots instead of numeric values. The Diff Dataplot is also displayed on this screen. Note the PC1 message on the Y axis of the Diff data plot. Notice the count and time information near the bottom of the results. The low count displayed and increased time are indications of a partially clogged flowcell. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages The (:::::) Code Rev. F (October 2009) What To Do if One sample Repeat, if still no results, perform manual diff if Many samples Run Latron to troubleshoot F44, F45 Not all flow cell problems are clogs. They may be related to an individual sample. Possible causes are sample chemistry, hemolyzed sample, lipemic sample, or instrument malfunction. For a single sample result, you may re-run the sample. If the repeat, still has no results, perform a manual diff. For multiple sample results, it may be necessary to clear the clog. Try F44 up to three times. If still no results, try F45 up to three times. If that does not resolve the problem, refer to the Troubleshooting Basics module for more details. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) COULTER® LH 750 Suspect Messages Definitive Messages and Decision Rules Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) Suspect Messages Appear for sample results based on abnormal cell distribution or population System generates the message according to an internal algorithm using information from data plots or histograms Suspect messages appear for sample results based on an abnormal cell distribution or population. The system generates the messages according to an internal algorithm, a software program. Suspect messages appear in a separate area of the screen display and the sample report printout. A complete listing of the possible Suspect Messages is found in the on-line HELP of the instrument. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) Suspect Messages The LH 750 has the option of adjusting the sensitivity of certain differential suspect messages Should confirm abnormalities by microscopic review Review sample results per your lab’s protocol (e.g. confirm abnormalities by review) Laboratories may differ in their desired sensitivity to abnormal cell types with some laboratories requiring more sensitivity than others. Because sensitivity to abnormal cell types varies between laboratories, the LH 700 Series provides the laboratory with the ability to adjust the sensitivity of differential suspect messages to meet individual laboratory requirements. There are 3 levels of sensitivity which are operator adjustable on four of the differential suspect messages. By default, these are set to level 2. Truth table analysis helps a lab determine if sensitivities need adjusting. As with any flag, code, or message, review any suspect message according to your laboratory’s protocol. Abnormalities should be confirmed by microscopic review. Rev. F (October 2009) Miami Education Center Miami Education Center

Suspect Messages (“research”)
Flags, Codes, Messages Rev. F (October 2009) Suspect Messages (“research”) 13 suspect messages are considered “research” only Viewed only if the research button is selected Not required as part of your review protocol Can not be transmitted Print only when the research button is selected There are 13 suspect messages considered “research” only. Examples are Thalassemia and Low Opacity Lymph. They can only be viewed if the research data button on the specific toolbar in the Patient Results, Results and Graphics view is selected. It is not required that these messages be used as part of your review protocol. They cannot be transmitted. Research suspect messages print when the research data button is selected. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) Suspect Messages Sample result with 2 suspect messages This is an example of a sample result with two suspect messages in the Suspect/Definitive message box on the Parameters tab in the Results and Graphics screen. Note that these messages are red on screen. The color alerts you to their significance. This box displays on all of the other tabs (Demographics, CBC Data, Diff Data, and Retic Data). Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) Definitive Messages Appear based on action limits entered in System Setup, Patient, Flagging Limits Review according to your lab’s protocol Includes “H&H Check Failed” Is preset, cannot be adjusted Can be turned off/on at the Run Configuration Screen Definitive Messages are our next topic. Definitive messages such as Eosinophilia, Thrombocytopenia, and Lymphocytosis are laboratory-defined based on action limits developed by your lab. If results exceed these limits, the Workstation generates a message. Results that generate these messages may require review. Check your laboratory’s protocol for handling the particular message. H&H Check Failed is a preset definitive message. The formula used for this message is three times the hemoglobin equals the hematocrit plus or minus three. The formula cannot be adjusted, but the message can be disabled on the Run Configuration Screen. Rev. F (October 2009) Miami Education Center Miami Education Center

Decision (Reflex) Rules
Flags, Codes, Messages Rev. F (October 2009) Decision (Reflex) Rules Messages that appear with results based on rules entered by your lab Rules that can be thought of as “if-then” statements, e.g. If the WBC is ≥ 20.0, then “Perform a manual diff” The “then” part of the statement appears in the comments area on the sample results printout and on the Demographics tab in Rule Messages box Our last area is Decision (Reflex) Rules. These rules are used for identifying sample results in need of attention. This helps streamline the review process in your laboratory. Each laboratory establishes these rules specifically based on criteria used by that lab for error checking. Each rule ends with a statement of action for the operator. The action is determined by the sample results. These rules may also be used to automate your delta checking process. These rules can be thought of as “if – then” statements, for example, if the WBC is greater than or equal to 20.0, then “Perform a manual diff” The “then” part of the statement is the action required of the operator. The “then” statement appears with the sample results on the Demographics tab in the Rule Messages box. The Decision Rule Message also prints on the sample report in the comments area. An unlimited number of rules can be entered in the instrument, but a maximum of 20 will apply to one sample. The priority of the rules is operator adjustable. Rev. F (October 2009) Miami Education Center Miami Education Center

Decision (Reflex) Rules
Flags, Codes, Messages Rev. F (October 2009) Decision (Reflex) Rules You may create an unlimited number of rules A maximum of 20 rules can apply to one sample result The priority of the rules can be changed Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) Summary BCI suggests using all available flagging options to optimize the sensitivity of instrument results based on your patient population. All flagging options include: Reference Ranges (H/L), Action (aH/aL) & Critical (cH/cL) limits Definitive messages Suspect messages Parameter codes Decision rules/Delta checks System alarms Avoid using single messages or outputs to summarize results. Beckman Coulter suggests using all available flagging options to optimize the sensitivity of instrument results based on your patient population. All flagging options include reference ranges (H/L), action and critical limits, definitive flags, suspect flags, parameter codes, delta checks, decision rules and system alarms. Beckman Coulter recommends avoiding the use of single messages or outputs to summarize specimen results or patient conditions. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) COULTER® LH 750 Corrected and Uncorrected WBC Counts Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) WBC Correction The following slides will present some examples of the WBC correction feature on the LH 700 Series The following slides will present some examples of the WBC correction feature on the LH 750. Rev. F (October 2009) Miami Education Center Miami Education Center

Causes of Cellular Interference
Flags, Codes, Messages Rev. F (October 2009) Causes of Cellular Interference Unlysed RBCs Platelet Clumps Giant Platelets NRBCs Malarial parasites Fragmented WBCs Cryoglobulins Agglutinated WBCs Precipitated elevated proteins Cellular interference may be caused by a multitude of things, for example: unlysed RBCs, Platelet Clumps, Giant Platelets, NRBCs, malarial parasites, fragmented WBCs, cryoglobulins, agglutinated WBCs, and precipitated elevated proteins. If the instrument detects statistically significant interference of any of these, the WBC count is corrected and the suspect message, Cellular Interference, always displays. Cellular Interference never displays for any other event. Whenever the cellular interference message displays, review the smear to determine the cause of the cellular interference and ensure correction is appropriate. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) WBC Correction WBC histogram showing significant interference to the WBC count WBC Correction As shown in this example, the LH 750 instrument corrects the WBC count when statistically significant cellular interference is detected in a sample. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) WBC Correction WBC histogram showing poorly defined cell populations As shown in the above example, there are times that both the uncorrected and the corrected WBC count will be flagged with an R flag and a red background on the workstation. Whenever this is observed, the separation between the WBC populations is poorly defined. When this occurs, your laboratory follows your policy for verifying the WBC count. There will be an R and a red background if the separation between the populations is poorly defined. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) WBC Correction If the algorithm determines that the particles are not significant, then no correction is made. No suspect message posted. No need to review. In this example, there is a small population in the lower counting threshold (35fL) area for the WBC histogram. If the algorithm determines that population is not statistically significant to the WBC count, no correction is made. No suspect message is posted and there is no need to review. Rev. F (October 2009) Miami Education Center Miami Education Center

WBC Correction– Example 1
Flags, Codes, Messages Rev. F (October 2009) Results: WBC = 2.8, NRBC% = 0.0 Avg. WBC and uncorrected count are equal Smear Review: 1 NRBC/100 WBC Review WBC Histogram: Example 1 Reviewing this WBC histogram, we see a population around the 35fL mark. The Average WBC and the Uncorrected WBC count are equal and no suspect message is present. The average WBC count is 2.8 and the NRBC% is 0.0. Smear review noted 1 NRBC per 100 WBC. You may be wondering why the instrument did not make a correction to the WBC. The 2.8 WBC count does not need correction because most of the population in the interference area is smaller than 35fL in size, therefore it is not included in the WBC. It does not interfere with the WBC count. There is no NRBC enumeration because the Enumerated NRBC parameter is only reported from 2% or greater. In other words, if the NRBC% is less than 2%, it will be reported as a 0.0. CLSI (Clinical Laboratory Standards Institute H20-A2) defines an abnormal NRBC proportional count as greater than 2%. This guideline furnished the basis for enumerating NRBC only if 2% or greater were found by the instrument method. Should you correct the WBC? No, since the population was <35 fL, it never interfered with the WBC. Could review smear. Enumerated NRBC is only reported from 2% or greater. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) WBC Correction– Example 2 Results: WBC = 7.6 Avg.WBC = 7.6 uncorrected count = 8.3 Suspect Msg: Cellular Interference, NRBC Review WBC Histogram: Smear Review: 5 NRBC/100 WBC Enumerated NRBC – Disabled Should you correct the WBC? No, it’s already corrected. WBC correction operates independently of the NRBC parameter. Review smear. NRBC Example 2 Review of this WBC histogram shows a cell population at the 35fL area. The suspect/definitive message box contains the suspect messages, Cellular Interference and NRBC. The Uncorrected WBC count is 8.3 and the average WBC count is 7.6. It is the average WBC count that transmits to the Host/LIS system. A manual smear review found 5 NRBC per 100 WBC. In this example, the Enumerated NRBC parameter is disabled. When the Enumerated NRBC parameter is disabled, if NRBC are present, the instrument displays the NRBC suspect message. If the NRBC parameter is enabled, as it was in example 1, then the NRBC% & # display and no NRBC suspect message appears. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) WBC Correction– Example 3 Results: WBC = 8.6, NRBC% = 9.8 Avg.WBC = 8.6 uncorrected count = 9.5 Suspect Msg: Cellular Interf. ,Plt Clumps Review WBC Histogram: Enumerated NRBC – Enabled Smear Review: 11 NRBC/100 WBC Should you correct the WBC? No, it’s already corrected. Review smear. Example # 3 The Uncorrected WBC count is 9.5 and the average WBC count is 8.6. The NRBC enumeration is reported as 2%. Two suspect messages, Cellular Interference and Platelet Clumps are found in the suspect and definitive message box. Review the WBC histogram. In this example, the NRBC parameter is enabled. Smear review found 2 NRBC per 100 WBC. Review of the WBC histogram shows it crossing the lower counting threshold for WBC above the baseline. The instrument corrected the WBC because of significant interference at the 35fL area, possibly platelet clumps and/or NRBC. Review the smear to determine the cause of the cellular interference. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages WBC Correction– Example 4 Rev. F (October 2009) Results: WBC = 25.1, NRBC = 6.9% Avg.WBC and uncorrected count are the same Review WBC Histogram: Enumerated NRBC – Enabled Smear Review: 7 NRBC/100 WBC Should you correct the WBC? NRBCs were not included in the count as they are <35 fL. Review smear. Example # 4 The average WBC count is NRBC enumeration is 6.9% The Average WBC and the Uncorrected WBC counts are equal and no suspect is message present. Review the WBC histogram. In this example, the NRBC parameter is enabled. Review of the smear finds 7 NRBC per 100 WBC. Review of the WBC histogram shows a small population at the 35fL mark. Most of the NRBC population seen on this histogram were not included in the count, because they were less than 35fL in size, they were never counted as WBC. The population of cells sitting at 35fL were not statistically significant to the count. Review the smear per your lab’s protocol. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) WBC Correction– Example 5 Results: WBC = 8.5R, NRBC% = 5.0 Avg. WBC = 8.5R and uncorrected WBC = 9.3 R Suspect Msg: Ly Blasts, Cellular Interf. Review WBC Histogram: Enumerated NRBC – Enabled Smear Review: 44 NRBCs/100 WBC Should you correct the WBC? Yes, most of these NRBCs are >35 fL in size and fall in the Lymph area. Example # 5 The Uncorrected WBC count of 9.3 and the average WBC count of 8.5 are both R flagged and have red backgrounds, alerting the operator that the separation between the WBC populations is poorly defined. NRBC enumeration is 5.0%. Three suspect messages, Cellular Interference, Lymph Blasts and Verify Diff are found in the suspect and definitive message box. Review the WBC histogram. In this example, the NRBC parameter is enabled. Review of the smear finds 44 NRBC per 100 WBC. Review of this WBC histogram shows a population at the 35fL mark. Most of these NRBC are > 35fl in size. They are falling in the Lymph area and are being counted as WBC. Therefore, the WBC is falsely elevated. Both the corrected and uncorrected WBC are R flagged. You could verify the WBC by a smear estimate or a manual WBC. Follow your lab policy. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) WBC Correction– Example 6 Results: WBC = 9.7, NRBC% = 2.9 Suspect Msg: Platelet Clumps Review WBC Histogram: Enumerated NRBC – Enabled Smear Review: 3 NRBC/100 WBC, Clumped Platelets Should you correct the WBC? No correction is necessary. Review smear. Example # 6 The Uncorrected WBC count and the average WBC count are the same NRBC enumeration is 2.9%. The suspect message, Platelet Clumps, is found in the suspect and definitive message box. Review the WBC histogram. In this example, the NRBC parameter is enabled. Review of the smear finds 3 NRBC per 100 WBC. Review of the WBC histogram shows a small population at the 35fL mark. In this example, the algorithm determines that the population at the 35fL mark is not statistically significant to the WBC count, therefore no correction to the WBC is necessary. Review the smear per your lab’s protocol. Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes, Messages Rev. F (October 2009) THE END Rev. F (October 2009) Miami Education Center Miami Education Center

Flags, Codes and Messages on the COULTER® LH 750/755

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Flags, Codes and Messages on the COULTER® LH 750/755

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