ࡱ> npghijklm_ bjbj .bb HHHHH\\\8td \l(l((((()))$O$QH5))55$HH((4uVGVGVG5H(H(VG5VGVGz`(0X%v6&j0N/8b/``&/Hd )-VGz0<28)))$$FX)))5555/))))))))) : Iris Automated Urinalysis: iRICELL Procedure SW version 7.0 Template (North American) Overview PageTopic3 Purpose 3-4 Materials Reagents Supplies Equipment5 Sample Information: [Patient Preparation, Specimen Type, Specimen Rejection Criteria, Specimen Volume, Specimen Handling/Transport, Specimen Stability] Safety Precautions6 Quality Control 7Running QC: iChemVELOCITY analyzer 8 Running QC: iQ200 analyzer 9 Preparing Patient Specimens Logging on to the System10 Enabling Edit-Free Release and Setting the Particle Verification Range (PVR) 11 Enabling Auto-Release Exceptions 12 Operating the iRICELL System 13-14 Locating Auto-Released results Performing On-Screen Verification of Results 15-16 Assaying Diluted Specimens 17-18 Performing a Search 18 Creating a Consolidated Patient Report 19 Creating a Urine Culture Candidates Report Creating a No Urine Culture Indicators Observed Report 20 Accessing Consumables Traceability Handling an Expired Consumables Alarm21 Changing the lot number and expiration date of Chemistry QC Utilizing the HELP menu Enabling and Disabling Automatic Bacteria Grading 22 Restoring Settings Saving and Emailing Settings Enabling the Detailed Audit Trail  Overview continued PageTopic23 Adding Signature line to patient report Calculations 24-25 Interpretation/Results/Alert values Supplemental Material26-27 Reference Intervals 27 Method Performance Specifications Result Reporting References Related Procedures Appendices 28-29Appendix A: Theory of Operation and Principle 30-31Appendix B: Clinical Significance of Urine Chemistry Results 31-32Appendix C: Limitations and Interferences 33-34Appendix D: Expected Results 35Approval Signatures Iris Automated Urinalysis: iRICELL Procedure SW version 7.0 Procedure (North American)  Purpose This procedure template provides instructions for the Iris Automated Urinalysis: iRICELL. NOTE: The following procedure template is designed to assist laboratories in developing their own working laboratory procedure. This procedure template does not supersede the Operators Manual or product inserts. Areas requiring facility-specific input are bolded, underlined and are preceded by XXX. Search for XXX using the Find function: Click on Edit. Choose Find from the dropdown menu or Choose Ctrl+F. Type XXX into the box next to Find and click on Find Next. The program will take you to the first XXX. Edit the section to insert the information specific to your facilitys laboratory. Materials/ EquipmentConsumables and Part NumberStoragePackaging and UseiChemVELOCITY ConsumablesiChemVELOCITY Strips [800-7212](Room temperature. (Stable unopened until expiration date on bottle. (Open vial stability=5 days Bottle of 100 strips; 1 each. Use daily.iChem Wash Solution and Wash Filter [800-7704](Room temperature. (Stable unopened until expiration date on bottle. (Open bottle stability=3 months4 bottles/case; 5.5ml/test. Use daily.IRISpec CA/CB/CC [800-7702](Refrigerate 2-8 C. (Unopened stability= date on bottle. (Bring poured aliquot to room temperature before use. (Open stability= 15 days. (XXX Record open and/or expiration date on bottle.9 bottles (3 bottles of each control); 2 ml of each per day. Use daily.iChemVELOCITY CalChek Kit: Strips [800-7703](Room temperature (Stable unopened until expiration date on bottle. (Open stability=CalChek strips are single use only.2 vials/kit; 1 vial /quarter; single use. Use quarterly.iChemVELOCITY CalChek Kit: Reagents [800-7703](Room temperature (Stable unopened until expiration date on bottle. (Open tube stability=8 hours2 sets/kit; 1 set/quarter; single use. Use quarterly. Materials/ EquipmentConsumables and Part NumberStoragePackaging and UseiQ200 ConsumablesIQ Lamina [800-3102](Room temperature. (Unopened stability= date on bottle. (Change filter when replacing first bottle from a new case of 4.4 bottles/cs; 7000 mL/bottle; 14mL/test. Use daily.Iris System Cleanser [800-3203](Room temperature (Unopened stability= date on bottle. 4 bottles/cs 475 mL/bottle; 3ml/test. Use daily.Iris Diluent [800-3202](Room temperature (Unopened stability= date on bottle. 4 bottles/cs 475 mL/bottle; 3 ml/test. Use daily.iQ Calibrator [800-3103]( Refrigerate 2-8 C. ( Unopened stability= date on bottle. (Open bottle stability=24 hours4 bottles/cs 125 mL/bottle; 2ml/test. Use monthly.iQ Control/Focus Set [800-3104]( Refrigerate 2-8 C. (Unopened stability= date on bottle. (Open bottle stability=30 days 1 bottle ea Pos/Neg; 2 bottles of Focus; 125 mL/bottle; Lot-specific Barcodes: Positive control, Negative control; Focus reagent; 3ml of Control/test; 6 ml of Focus/test. Use daily.Dilution Code labels [800-3211]N/A1 set; 1 each /test as needed. Use as needed.16x100mm polystyrene tubes [660-0036] or polystyrene plastic tubesN/ABox of 200; 1 each/test. Use daily. SamplePatient Preparation: Give patient instructions to collect a clean catch urine specimen in a clean and/or sterile container. Specimen Type: A freshly voided urine sample collected by the clean catch method is the specimen of choice. First morning urine yields the most meaningful results. A clean catch urine is recommended to prevent the possibility of a positive leukocyte test caused by leukocytes external to the renal-urinary system. Specimen Rejection Criteria: Reject grossly bloody specimens for the iChemVELOCITY chemistry analysis; dilute grossly bloody specimens for iQ200 microscopy analysis. XXX Add any facility-specific specimen rejection criteria [Example: No Gray Top tubes are acceptable; specimens received several days after collection are unacceptable]. Specimen Volume: The specimen volume placed on the iRICELL must be at least 4 mL. If testing on the iChemVELOCITY urine chemistry analyzer alone, the minimum volume is 2 ml. If testing on the iQ200 urine microscopy analyzer alone, the minimum volume is 3 ml. Specimen Handling/Transport: Specimens should be delivered to the laboratory as soon as possible after collection. Do not add disinfectant or detergent to the specimen. Do not centrifuge the specimen. XXX Add any facility-specific specimen handling/transport issues. XXX Add information about any preservative transport tubes that are utilized. Specimen Stability: Urines, kept at room temperature, are stable for one hour. If the specimen is not processed within one hour after collection, cap the container tightly and store at 2 - 8 C. Specimens must be at or brought to room temperature before analysis. XXX Add any additional specimen stability information; describe how facility maintains specimen integrity (ex: preservative tubes). Special safety precautions Use Universal Precautions due to the potential presence of pathogenic material. XXX Describe any facility-specific special safety precautions here. Quality ControlAssay QC once every 24 hours for both chemistry and microscopy modules. QC material for microscopy module: iQ Positive Control iQ Negative Control iQ Focus reagent. QC material for chemistry module: IRISpec CA/CB/CC controls Dipsticks: Sticks are checked for reactivity and accuracy once every 24 hours by running the CA/CB/CC control material. XXX State additional facility-specific testing [Example: Test control material additionally when a new shipment/new lot number of iChemVELOCITY test strips is received.] Parallel testing between the old shipment or lot number and the new shipment or lot number ensures that the system is operating within acceptable criteria. XXX State your facilitys specifics for parallel testing Upper limits, lower limits and target values are encoded within the lot-specific barcodes for the Positive, Negative and Focus iQ control material. Criteria for Acceptable Control Results: Quality control material results must fall within the ranges provided by the manufacturer of the material. Refer to the section below for corrective action(s) if the values fall outside of the published limits. Note: The system will lock out patient testing for microscopy when microscopy controls fail and patient testing for chemistry when chemistry controls fail.  Running QC: iChemVELOCITY system  Follow the activities in the table below to run QC on the iChemVELOCITY. Before you beginMake sure that only unexpired reagents are used Expired reagents will cause an ALARMStepAction1Remove an iChemVELOCITY control rack. Pour 2 mL of the CA, CB and CC control into 3 separate 16x100mm glass (or polystyrene plastic) tubes. Return tightly capped controls to the refrigerator immediately. Allow aliquots to warm to room temperature. Use aliquots within one hour of pouring. 2Place the CA control in position 8. [color coded on bottle and tube position as RED] Place the CB control in position 9. [color coded on bottle and tube position as BLUE] Place the CC control in position 10. [color coded on bottle and tube position as YELLOW]3Place the rack on the right side of the iChemVELOCITY sampler touching the edge nearest the operator. Note: The rack will automatically advance forward [blue MEASURE light will appear].4 Control results will automatically print on the Quality Review screen as CA, CB and CC.5Look at QC results. IfThenQC FailedLook at the result printout to see why the control failed. Adjust positions, if necessary. Re-pour and re-run all controls. If results are still not acceptable check strips loaded in instrument for discoloration. If discolored, discard and add new strips and repeat. If results are still not acceptable, notify your local distributor, your Iris Product Specialist or Iris Clinical Support. XXX include other facility-specific information required when QC fails. Example: Contact Supervisor. Running QC: iQ200 analyzer.  Follow the activities in the table below to Run QC on the iQ200 analyzer. Before you beginIf control is refrigerated, bring control set to room temperature before use. Make sure that only unexpired reagents are used Expired reagents will cause an ALARMStepAction1Place appropriate barcode labels on 16x100mm glass (or polystyrene plastic) tubes [Positive, Negative, Focus]. Mix iQ Positive control and iQ Focus by holding the bottle upside down and giving five hard sharp shakes followed by five gentle inversions.2Pour the following into 16x100 mm glass (or polystyrene plastic) tubes and place in the iQ200 QC rack: Position 1: 3ml of Iris Cleanser Position 2: 3ml of Iris Diluent Position 3: 3ml of Iris Diluent Position 4: Leave Empty Position 5: 6 ml of Focus reagent Position 6: 3 ml of Positive Control Position 7: 3 ml of Negative Control Control rack must be run immediately after pouring focus and controls.3Place the rack on the iQ200 sampler. Press the START button located at the upper left corner of the iQ200, if the instrument is in the standby mode (green light). If in measure mode (blue light), the rack will be detected and processed automatically.4Review results under: Quality Review screen QC StatisticsIfThen QC FailedLook at message code to see why the control failed. Note: If control failed due to an identification error or QC out of order, resolve this error. Pour fresh aliquots and re-run control. If results are still not acceptable, notify Iris Clinical Support. XXX include other facility-specific information required when QC fails; Example: Contact Supervisor or Lead. Preparing Patient Specimens:  Follow the activities in the table below to Prepare Patient Specimens StepAction1Bring Samples to room temperature2Label an empty 16 x100mm glass tube (or polystyrene plastic) with patient identifier. Apply the barcode to the tube so that the start of the barcode (not the label edge) is approximately inches from the top of the tube. Note: This leaves room for the dilution label should it be required.3Mix sample thoroughly by inversion. 4Pour 4ml of well-mixed specimen into labeled tube.5Put the sample tube in position number 1 on the sample rack Note: The racks black barcode should be facing to the right. The tubes barcode should face the instrument.6Load up to 10 samples in each rack in consecutive positions.    Logging on to the iRICELL:  Follow the activities in the table below to Log on to the iRICELL: StepAction1Access the Instrument Screen. Click on the Logon button.2Click on the down arrow. Select your identifier (Do Not type in your identifier). Press tab.3Enter your password.4Click on OK. Note: The current users name will now appear at the top of the Instrument screen. Enabling Edit-Free Release and Setting the Particle Verification Range (PVR)  Follow the activities in the table below to Enable Edit-Free Release and Set the Particle Verification Range (PVR). Before you BeginIt is recommended to consult with an Iris Product Specialist or Clinical and Customer Care Specialist before altering a setting. StepAction1Access the Instrument Screen Click on the Logon button. Log on as a Manager2Go OFF LINE Click YES at the Confirm window3Select SETTINGS4Select Urine Auto-Release5Select Enable Auto-Release Note: The following will also be automatically enabled: Enable Automatic Bacteria Grading [Enabled to allow automatic bacteria grading] Review When Linearity is Exceeded [Enabled to prompt user to review any images exceeding manufacturers linearity]6If Automatic Bacteria Grading is not desired, uncheck the box If Review when linearity is exceeded is not desired, uncheck this box7User-defined Abnormal Thresholds will automatically populate in the PVR box. Enter the Minimum and Maximum Ranges for RBCs , SQEPS and WBCs.8Enter any user-defined exceptions to Auto-Release under Exceptions [Refer to Enabling Auto-Release Exceptions]  Enabling Auto-Release Exceptions  Follow the activities in the table below to Enable Auto-Release Exceptions Before you BeginSuggested Auto-Release criteria are listed in Appendix E of this procedure. The Auto-Release function is suggested for specimen results falling below the abnormal threshold (normal or negative). It is recommended to consult with an Iris Product Specialist or Clinical and Customer Care Specialist before altering a setting. StepAction1Access the Instrument Screen Click on the Logon button. Log on as a Manager2Go OFF LINE Click YES at the Confirm window3Select SETTINGS4Select Urine Auto-Release5Enable Auto-Release Exceptions by selecting the Enable this screen checkbox [Note 10 screens are available for 10 different sets of exception criteria]6Choose appropriate column to set up auto-release exception criteria [Prevent Auto-Release if all selected particles are greater than zero or Prevent Auto-Release if any checked particle exceeds its threshold.] Note: The user-defined abnormal threshold is commonly selected for the value entered in the threshold window.Choose the demographic group [Location or Age]to whom the Auto-Release Exceptions criteria will apply7Press OK [Note: Press Next if more criteria will be entered]8Press OK again to return to the Instrument screen Note: Specimens not meeting the criteria to prevent auto-release will be auto-released and will be found on the Found List [Exception: Flagged specimens will display on the Work List].  Operating the iRICELL System  Follow the activities in the table below to Operate the iRICELL System Before You BeginEach iRICELL System will be set up with parameters that are unique to each facility. For facilities that report out Sperm, it is recommended to enable the optional Sperm Present and/or Previous Sample Had Sperm Flags. For those who do not report out Sperm, it is recommended to set the Minimum to Auto-Classify to prevent automatic classification. For both activities, refer to the iQ200 Operators Manual, your local distributor, your Iris Product Specialist, your Clinical and Customer Care Specialist or the Iris Diagnostics Call Solutions Center.StepAction1Ensure that sufficient supplies and consumables are loaded. 2Load up to 10 samples in each rack in consecutive positions. 3Place rack(s) on right hand side of the iChemVELOCITY. Ensure that the notch of the rack base is placed onto the Sampler track ridge. Note: The instrument will automatically advance the rack.4THE REMAINDER OF THE PROCESSING IS PERFORMED AUTOMATICALLY ON THE SYSTEM: The sample rack will be moved along the sample transport tray to the barcode reader. After the barcode is read, the probe mixes the sample, aspirates an aliquot, analyzes the SG, color, clarity and dispenses the sample onto a test strip. When the sample processing is complete, the sample rack will be automatically transferred, via the bridge, to the iQ200 Analyzer. If the specimen does not need to be run on the iQ200 Analyzer, remove the rack from the instrument at this point. If the rack is to be run on the iQ200 Analyzer, allow the rack to transfer across the bridge. After the rack is transferred via the bridge to the iQ200 Analyzer, the sample rack will be moved along the iQ200 Sampler to the barcode reader. The iQ200 Analyzer barcode reader reads the specimen barcode. If a microscopic examination is to be done (as determined by the user-defined criteria), the probe will mix the sample, aspirate an aliquot and perform the microscopic examination. If a microscopic examination is not to be performed, the tube will be passed. After sample processing is complete, unload the sample racks from the left side of the iQ200 Analyzer. 5Note: Completed, auto-released results will appear on the Found List. Verify any pending, flagged results on the Work List as follows in next section of this document. Locating Autoreleased Results  Follow the activities in the table below to Locating Autoreleased Results Note: The majority of results will have been auto-released. Results can be printed to the printer, the LIS or the screenStepAction1Click on the Search button to access the Found List 2Specimens results will appear as user defined.3No further action is necessary Performing On-Screen Verification of Results  Follow the activities in the table below for Performing On-Screen Verification of Results Note: If the auto-release feature has been enabled, the majority of results will have been auto-released. Verify results only for those specimens not auto-released [i.e. specimens appearing on the Work List]. Verify only Yellow-colored categories Verify using FULL EDITBefore You BeginGreen and Red colored categories will be autoreleased Yellow categories require on-screen reviewStepAction1Click on the Work List button located on the top right part of the instrument screen to bring up all unreleased samples. Note: Samples may be sorted by Specimen ID, Date-Time, Rack/Pos or Status by header at the top of the row. (Clicking a second time will reverse the order.)2Highlight the specimen to be verified as follows: Click on Specimen Identifier: Click on the Specimen button. Verify consolidated Chemistry and Microscopy results.3Clear flags that are displayed before results are verified or deleted as follows: To Review Flagged Specimen: Click Review Flagged Specimen button. Click Accept. To Delete Specimen results (if the result must be discarded): Click Delete Flagged Specimen button. Click Accept. Continued on next page Performing On-Screen Verification of Results continued StepAction continued4Verify auto-classified particles as follows: Click on Edit Note: You will be directed to the first yellow particle categoryIfThenThe classification of the particle is acceptable, Continue the verification by clicking on the right arrow to move forward. Note: The Yellow category will appear.The classification is not acceptable, Reclassify the misidentified particle(s) as follows: Determine whether or not reclassification will make a clinical difference. Reclassify particles only when it will make a clinical difference. Click on the particle type that the image(s) should be classified into (use right-hand button). Click on the image(s) to be moved. Press the forward arrow to proceed to the next category. Note: If all images of a category are misclassified, click on the particle type and then click on the right arrow to move to the next category.5Press ACCEPT to release the results when verification is complete.6Return to the microscope for the following: Oval fat bodies (to view using polarized light) Fat (to view using polarized light) Trichomonas (to observe motility) Cellular Casts (only necessary when the operator cannot make a definite identification of the cell type using the iQ) Assaying Diluted Specimens  Follow the activities in the table below to Assay Diluted Specimens Before you BeginDilutions must be prepared for the iQ for the following specimens: Grossly bloody Mucoid Dense/Viscous Short Samples Note: Dilutions are run on the iQ200 urine microscopy analyzer only Do Not perform dilutions for the iChemVELOCITY urine chemistry analyzer. Identify specimens that require a dilution before placing specimen on the iRICELL. StepAction1Select dilution and corresponding dilution code (refer to Dilutions under Formed Particles or Fluid Type under Settings on the Instrument Screen). IfThenYou have barcodes Obtain a Dilution Rack Fix identical patient barcode onto two unlabeled tubes. Pour 3 ml urine into the first tube. Place the tube in the dilution rack and run on the Chemistry analyzer. Note: The rack will proceed to the iQ, but will not be aspirated. Remove the rack from the Chemistry analyzer. Label the matching second tube with the appropriate secondary barcode dilution label (fix label below the patient barcode). Prepare the dilution, in this tube, using Iris Diluent. Replace the undiluted sample that was used for the Chemistry analyzer with the diluted tube and place the specimen into a patient rack. Put rack on the iQ analyzer Press START to run the sample. Results will consolidate. If auto-release has been enabled, results will auto-release as the user has defined, unless flagged. Verify results only for non-autoreleased samples (refer to previous sections of this document). Assaying Diluted Specimens continued If continuedThen continuedYou do not have barcodes Obtain a dilution rack Click on Manual Orders Choose the patient rack and position number that will be used to run the assay. Identify the specimen ID, select URN, Dilution code and Work order=run. Put the sample into the correct position in Dilution rack number 23. Pour 3 ml urine into the corresponding unlabelled tube. Place rack on the right hand side of the Chemistry analyzer and run. [Note: the Dilution rack will not be aspirated by the iQ] The Chemistry Result will be displayed as ID_ERROR. After Chemistry has completed, remove rack. Perform appropriate dilution. Place the diluted sample in the patient rack and position number that was programmed [refer to second bullet). Place the rack on the iQ analyzer. Press START to run the sample. Consolidate results. If auto-release has been enabled, results will auto-release, as the user has defined, unless flagged. Verify results only for non-autoreleased samples (refer to previous sections of this document).  Performing a Search  Follow the activities in the table below to Perform a Search. StepAction1Access the Work List List Select SEARCH 2Clear all previous entries by Clicking Clear. To Search byThenSpecimen IDEnter specimen identifier Press OKSequence numberEnter desired Sequence number Press OKOperatorEnter Operator Log-in ID Press OKDate and Time Enter the specific date and time Press OK24 hoursSelect 24 hours Press OKTodaySelect Today Press OKLotSelect Lot number Select specific lot from lots displayed Select OK [Note: This function enables the user to search for Results Tied to a Specific Lot number]Last Name Enter the Last Name or range of last names. Press OKFirst NameEnter First Name or range of first names. Press OKAgeEnter in the specific age expressed in decimals (For example: 10 years and 5 months is entered as 10 and 5/12=10.42) Press OK Continued on next page Performing a Search StepAction continued LocationEnter Location Press OK Note: Location must match the LIS entry exactly.Urine Additional Criteria Enter Urine Culture Candidates or No Urine Culture Indicators Observed. Press OKSpecimens awaiting transmissionCheck Show Specimens Awaiting Transmission Only and only these specimens will appear Press OK.Released specimensCheck Show Released Specimens Only and only released specimens will appear. Press OK Note: Imported images appear as Released specimens.Incomplete SpecimensCheck Show Incomplete Specimens Only and only incomplete or specimens in progress will appear. Press OK Creating a Consolidated Patient Result Report  Follow the activities in the table below to Create a Consolidated Patient Result Report. StepAction1Perform a Search using desired criteria (as directed above)2Access the Found List3Click on RE-REPORT4Go to the Section listed All Rows5Click on Consolidated Report6Go to Destination section and Select Screen and/ or Printer7Click OK. Note: A Consolidated report will appear. This report is not sent to the LIS. Creating a Urine Culture Candidates Report  Follow the activities in the table below to Create a Urine Culture Candidates Report StepAction1Make certain that ASP is set properly. Refer to Setting ASP section below.2Perform a Search for Urine Additional criteria as indicated above selecting Urine Culture Candidates.3Access the Found List4Click on RE-REPORT5Go to the Section listed All Rows6Click on Urine Culture Candidates Report7Go to Destination section and Select Screen and/ or Printer8Click OK. Note: A Urine Culture Candidates report will appear. This report is not sent to the LIS. Creating a No Urine Culture Indicators Observed Report  Follow the activities in the table below to Create a No Urine Culture Indicators Observed Report StepAction1Make certain that ASP is set properly. Refer to Setting ASP section below.2Perform a Search for Urine Additional criteria as indicated above selecting No Urine Culture Candidates Observed.3Access the Found List4Click on RE-REPORT5Go to the Section listed All Rows6Click on No Urine Culture Candidates Observed Report7Go to Destination section and Select Screen and/ or Printer8Click OK. Note: A No Urine Culture Indicators Observed report will appear. This report is not sent to the LIS. Accessing Consumables Traceability  Follow the activities in the table below to Access Consumables Traceability StepAction1Log in as Manager2Go OFFLINE3Access Consumables4Select Traceability5View all reagents that have been automatically entered by the reagents barcode6Manually enter reagents that do not have barcodes as follows: Enter Reagent expiration date, start date, etc. Select ADD Select Update7Delete manually entered reagents as follows: Enter a Deletion Comment Select Update Note: The reagent will not disappear completely but will be removed from the queue. Handling an Expired Consumables Alarm  Follow the activities in the table below to Handle an Expired Consumables Alarm Before you beginIf an expired reagent or strip is run on the instrument, a red alarm will appear.StepAction1If the alarm indicates that an expired Chemistry control or strip was run: Check under Chemistry QC to make certain that the correct information has been added. Correct information if incorrect (refer to Changing the lot number and expiration date of Chemistry QC) Re-run control or strip2If the alarm was due to another consumable: Obtain an unexpired consumable Re-run Changing the lot number and expiration date of Chemistry QC  Follow the activities in the table below to Change the lot number and expiration date of Chemistry QC StepAction1Select Consumables2Select Chemistry QC3Enter Strip lot and Expiration date listed on the urine chemistry strips5Select Next6Enter Chemistry control CA lot and expiration date listed on the reagent box7Select Next8Enter Chemistry control CB lot and expiration date listed on the reagent box9Select Next10Enter Chemistry control CC lot and expiration date listed on the reagent box11Select OK Utilizing the HELP menu  Follow the activities in the table below to Utilize the HELP menu StepAction1Access Instrument Screen2Select ? icon3Operators Manual will appear as a PDF5Click on PDF to open the manual6Find topic desired and click on Table of Contents Note: The operator will be directed to the appropriate section Enabling Automatic Bacteria Grading  Follow the activities in the table below to Enable Automatic Bacteria Grading StepAction1Log-in as a Manager2Access SETTINGS3Access Urine Auto Release4Select Enable Auto release5Enable Automatic Bacteria Grading will automatically be enabled Restoring Settings Follow the activities in the table below to Restore Settings StepAction1Log on as a Manager2Select SETTINGS3Select View Log4Select Restore to Restore settings from a user-defined location or device [ex: USB]5Select Restoreto Restore settings to a user-defined location or device [ex: USB] Saving and Emailing Settings Follow the activities in the table below to Save and Email Settings StepAction1Log on as a Manager2GO OFFLINE3Select SETTINGS4Select View Log5Select SAVE AS6Name file to desired location [ex: Desktop] Note: File will be saved as a .slf file7Click SAVE8Access the file under which the file was saved9Right click and rename the file with a .xml extension10Email the file to Global Service for troubleshooting in this format Enabling the Detailed Audit Trail Follow the activities in the table below to Enable the Detailed Audit Trail Note: The detailed Audit Trail will capture any change made to the system and record the name of the Operator who made the changes Enabling this function required to Edit Chemistry results Before You BeginDo Not Enable this Option without consulting with an Iris Product Specialist or Clinical and Customer Care Specialist before altering a setting. StepAction1Log on as a Manager2GO OFFLINE3Select SETTINGS4Select Specimen5Check Enable Detailed Audit Trail Adding Signature line to patient report Follow the activities in the table below to Add Signature line to patient reportStepAction1Log on as a Manager2GO OFFLINE3Select SETTINGS4Access Laboratory Information5Add text to be displayed on the patient report [Ex: Signature line or Approved by] Note: The patient report or any re-reported patient report will include the selected message. Calculations  None Interpretation/ Results/Alert values  INTERPRETATION OF RESULTS: Glucose, protein, and ketones are reported semi-quantitatively as XXX State Semiquantitative grading or mg/dL or SI units. Bilirubin is reported semi-quantitatively as negative, XXX State Semiquantitative grading or mg/dL or SI units. Leukocytes are reported as a value XXX Leu/L. Urobilinogen is reported semi-quantitatively as XXX State semiquantitative grading or mg/dL or SI units. pH is reported in quantitative units. Blood is reported semi-quantitatively as XXX State semiquantitative grading or mg/dL or SI units. Nitrite is reported semi-quantitatively as XXX State semiquantitative grading or mg/dL or SI units. Specific Gravity is reported by refractive index quantitatively with a value to 3 decimal places, ranging from 1.000 to >1.060. in 0.001 increments. Clarity is reported as XXX clear, turbid or extremely turbid. These can be changed to meet the laboratory terminology. Color is reported as a color: colorless, yellow, orange, brown, red, violet, blue, green and Other by the iChemVELOCITY. Each color is also reported as light and dark. XXX Indicate here if the facility has user-defined criteria to confirm any specific color. RBCs and WBCs are reported XXX usually reported as cells per HPF. Indicate user-defined reporting format here. WBC clumps are reported XXX usually reported qualitatively. Indicate user-defined reporting format here. Renal, transitional, and cells are XXX usually enumerated per HPF. Indicate user-defined reporting format here. Squamous epithelial cells are reported XXX usually reported per LPF. Indicate user-defined reporting format here. Bacteria are usually reported XXX usually reported qualitatively. Indicate user-defined reporting format here.  Interpretation/ Results/Alert values Continued Crystals are reported XXX usually reported qualitatively or per HPF. Indicate user-defined reporting format here. All casts are reported XXX usually by type and enumerated per LPF. Indicate user-defined reporting format here. Yeast is reported XXX usually reported qualitatively or per HPF. Indicate user-defined reporting format here. NOTES: Iris recommends confirming any suspicious Sperm result that may have medicolegal implications by manual microscopy of the original specimen. XXX State the conditions under which manual microscopy will be performed. XXX State the conditions under which results require confirmatory testing. XXX Enter any user-defined procedure utilized for confirmatory testing. XXX State any result that would be considered a Critical result and policy for notification. XXX Enter Alert Values.  Reference Intervals  Chemistry Results Specific Gravity XXX pH XXX Leukocyte Esterase XXX Leukocytes/ul Nitrite XXX mg/dL Protein, Qualitative XXX mg/dL Glucose XXX mg/dL Ketones XXX mg/dL Urobilinogen XXX mg/dL Bilirubin XXX mg/dL Blood XXX mg/dL Color XXX Clarity XXX Microscopy Results WBC XXX/HPF RBC XXX/HPF Bacteria XXX Epithelial Cells XXX/HPF Squamous Epis XXX/LPF Transitional Epis XXX/HPF Renal Epi XXX/HPF Casts XXX/LPF Hyaline Casts XXX /LPF Broad Casts XXX /LPF Granular Casts XXX/LPF Cellular Casts XXX/LPF WBC Cast XXX/LPF RBC Cast XXX/LPF Waxy Cast XXX/LPF Fatty Cast XXX/LPF Epi Cell Cast XXX/LPF Crystals XXX/HPF Calcium Oxalate Cry. XXX/HPF Amorphous Crystals XXX/HPF Uric Acid Crystals XXX/HPF Triple Phosphate Cry. XXX/HPF Calcium Carbonate Cry. XXX/HPF Calcium Phosphate Cry. XXX/HPF Leucine Crystals XXX/HPF Cystine Crystals XXX/HPF Tyrosine Crystals XXX/HPFReference Intervals ContinuedMiscellaneous Particles Yeast XXX/HPF WBC Clumps XXX/HPF or XXX Oval Fat Body XXX/HPF Trichomonas XXX/HPF Sperm XXX/HPF or Present/Absent Mucus XXX  Method performance specifications pH is measured from 5.0 to 9.0 in 0.5 increments. Specific Gravity is measured via refractive index from 1.000 to >1.060 in 0.001 increments. Instrument linearity for microscopic particles is from 0-1000/uL, 0-182/HPF, or 02857/LPF. *Refer to iChemVELOCITY Urine Chemistry Strips for dipstick analytical sensitivity and report ranges. *Refer to Limitations and Interferences in the Appendix C of this procedure.  Result reportingComplete auto-release process. Perform verification of results as listed above for those not auto-released. Note: Results are released to the LIS (or middleware) when the operator clicks on the Accept button. XXX Describe laboratory-specific process to report results here using criteria from Interpretation/Results/Alert Values section above. XXX Enter auto-release criteria if applicable.  ReferencesiChemVELOCITY Operators Manual Iris iQ200 Operators Manual iChemVELOCITY urine chemistry strip insert Fundamentals of Urine and Body Fluid Analysis, Nancy A. Brunzel, 2nd edition, 2004. Urinalysis and Body Fluids, Susan King Strasinger, 5th edition, 2008. GP16-A2: CLSI Urinalysis and Collection, Transportation, and Preservation of Urine Specimens; Approved Guideline-Second Edition  Related procedures Iris Automated Urinalysis: iRICELL System Maintenance Procedure  AppendicesTheory of Operation. Clinical Significance. Limitations and Interferences. Expected Values. APPENDIX A PRINCIPLE AND THEORY OF OPERATION: INTENDED USE:The iRICELL is an in-vitro diagnostic system. Distinguished by throughput, the workcell includes the iRICELL 2000 (iQ( 200 ELITE plus the iChemVELOCITY) and the iRICELL 3000 (iQ( 200 SPRINT plus the iChemVELOCITY). The workcell is composed of the Automated Urine Chemistry Analyzer module [The iChemVELOCITY], the iQ( Series Automated Urine Microscopy Module [iQ Series], results/analysis processor, computer monitor, mouse and keyboard. The iRICELL provides a fully integrated, automated chemical and microscopic analysis of urine. This procedure provides instructions for performing a complete urinalysis using the iRICELL. THEORY OF OPERATION:The iChemVELOCITY performs the chemistry panel, determines the specific gravity, color and clarity of a urine specimen. The chemistry panel is performed using a test strip, which detects the presence of 9 elements glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, and leukocytes by wavelength reflectance. Specific gravity is determined by measuring the refractive index. Color is measured by transmitted light and clarity is measured by scattered light. The iQ Series performs the microscopic portion of the urinalysis and provides a quantitative or qualitative count of formed elements such as cells, casts, crystals, and organisms. The iQ Series photographs particles as they are passed in front of a digital camera. The images are classified, counted and stored for verification by the user. The workcell consists of a computer that is interfaced with an approved chemistry analyzer and the iQ Series modules. At the workcell, results of the chemistry profile and the microscopic analysis are collated, compared to user-defined criteria for auto-release, and stored for auto-release or verified. The majority of specimens can be autoreleased if user-defined criteria are entered. The user can verify results including the images of the formed elements. As needed, the user may sub-classify or verify results. After verification the results may be sent to the host computer or printed. PRINCIPLE: iChemVELOCITY URINE CHEMISTRY SYSTEMThe iChemVELOCITY is a urine chemistry analyzer that measures the chemical constituents of the urine using iChemVELOCITY strips, which are read by a dual wavelength reflectance system. The iChemVELOCITY strips consist of a plastic strip containing nine (9) pads impregnated with chemicals specific for the determination of a particular constituent. The nine analytes measured are: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes esterase, ascorbic acid and a color compensation pad. A color compensation pad is included on the strip to compensate for the natural color of urine and its effect on the color of the reaction pads. Test strips are placed onto a strip conveyor system by a mechanical extractor. The sample probe mixes the sample, aspirates an aliquot of urine and dispenses it onto each reagent pad. At defined wavelengths, the iChemVELOCITY analyzes the color changes and the intensity of reflected light from the reaction pads. These measurements are used to calculate clinically meaningful results.  PRINCIPLE: iQ200 MICROSCOPY SYSTEMThe microscopic portion of a routine urinalysis is performed on the iQ200 Analyzer. The iQ200 Analyzer auto-identifies and processes specimens by mixing, sampling and analyzing the data obtained from the sample. Approximately 1mL of the mixed specimen is aspirated and is sandwiched between enveloping layers of a suspending fluid. This fluid or lamina is positioned exactly within the depth of focus and field of view of the objective lens of a microscope that is coupled to a video camera. The iQ Lamina is used to position the formed elements in the best orientation that presents the particles with their largest profile facing the direction of view. The camera captures five hundred pictures per sample. The flash of a strobe lamp illuminates each field. The pictures are digitized and sent to the instrument processor. Individual particle images are classified into one of 12 categories using size, shape, contrast and texture. The auto-classified categories are RBCs, WBCs, WBC clumps (WBCC), hyaline casts, unclassified casts (UNCC), squamous epithelial cells, non-squamous epithelial cells (NSE), bacteria, budding yeast, unclassified crystals (UNCX), mucus, and sperm. Any images that do not classify into any one of these 12 categories are placed in the UNCL category. The particle concentration is calculated using the number of images, normalization factor and the volume scanned. User defined criteria for the auto-release of results is checked and results are sent either directly to the host computer and/or printer or to the system monitor for verification. Only non-autoreleased specimens will appear on the system screen for verification. During the verification process, individual images may be displayed. The operator may manually reclassify digital images when necessary and in accordance with the laboratorys policy. Unclassified crystals (UNCX), unclassified casts (UNCC), and non-squamous epithelial cells (NSE) may be further sub-classified during the verification process. XXX State here if there are any criteria for your facility that must be met to allow results to be reported. (Example: If XXX are not sub-classified, the accession will fail and cannot be verified in the LIS.) Once the verification process has been completed and ACCEPT has been chosen, the results will be sent to the LIS, screen or printer.  iChemVELOCITY DIPSTICK CHEMICAL REACTIONS: BilirubinThis test is based on the coupling of bilirubin and diazonium salt in an acidic medium. A pinkish tan color proportional to bilirubin concentration is generated.UrobilinogenThis test is based on the coupling reaction of urobilinogen with a stable diazonium slat in buffer. A pink to red color proportional to the urobilinogen concentration is generated.KetoneThis test is based on Legals method in which the test pad contains sodium nitroprusside and glycine in an alkaline medium. A violet color proportional to methylketone is generated.Ascorbic AcidThis test is based on Tillmans reaction in which the presence of ascorbic acid leads to the decolorization of the pad from gray-blue to orange. GlucoseThis two-step enzymatic reaction uses glucose oxidase, peroxidase and a chromogen. Glucose oxidase catalyzes the formation of gluconic acid and hydrogen peroxide via the oxidation of glucose. Peroxidase then catalyzes the reaction of hydrogen peroxide with a chromogen via the oxidation of chromogen to colors ranging between green and gray-blue.ProteinThis test is based on the protein error of pH indicators on the green color developed from the presence of protein. This dye-binding is particularly strong with albumin. BloodThis pseudo-enzymatic test contains organic peroxide and a chromogen. The peroxidase effect of hemoglobin and myoglobin causes a color change to green.pHThis test contains a mixed indicator which assures a marked change in color between pH5 and pH9. Colors range from orange through yellow and green to cyan.NitriteThis test is based on modified Griess reaction in which nitrite in the urine reacts with amide to form a diazonium compound. The subsequent coupling reaction yields a pink color in the presence of nitrite. Some Gram positive and non nitrite-forming bacteria are not detected in this test.LeukocytesThis enzymatic test pad contains an indoxyl ester and a diazonium salt. Granulocyte esterases react with indoxyl ester and diazonium salt to generate a violet color. APPENDIX B CLINICAL SIGNIFICANCE OF URINE CHEMISTRY RESULTS: Glucose:The presence of glucose in the urine called glucosuria is caused by hyperglycemia or renal condition. Diabetes mellitus is the most common disease resulting in hyperglycermia. Renal conditions causing dysfunction of tubular reabsorption of glucose occur in many conditions including pregnancy. Protein: The presence of protein in urine is often the first indicator of renal disease, but its appearance in the urine doesnt always signify renal disease. Although proteinuria may indicate nephritic syndrome, multiple myeloma, glomerulonephritis, and pre-eclampsia, a transient mild proteinuria can be present after exposure to cold, strenuous exercise, high fever, dehydration, or an acute phase of a severe illness. The strip is primarily sensitive to albumin. Bilirubin:The appearance of urinary bilirubin can be a sign of liver disease or extra-or intra-hepatic biliary obstruction. Urobilinogen: The normal urine has a small amount of urobilinogen (less than or equal to 2.0 mg/dL). The strip is unable to detect a decreased amount, which may appear in infants, patients on antibiotic therapy, or patients with obstructive disease. Increased amounts appear in hemolytic anemias and liver dysfunction. pH:Along with the lungs, the kidneys are the major regulator of acid-base balance. Freshly voided urine has a pH of 5.0 6.0. The pH of urine can be controlled by dietary regulation and medication.Blood:A positive reaction for blood may indicate red cells, hemoglobin, or myoglobin present in the urine. Hematuria can be seen due to bleeding as a result of trauma or irritation (renal calculi, glomerulonephritis, tumors, toxic or chemical exposure). Hemoglobinuria occurs when there is lysis of red cells in the urinary tract, intravascular hemolysis or transfusion reactions. Very dilute or extremely alkaline urine can also lyse the cells. Myoglobinuria indicates muscular destruction that may appear in hypothermia, convulsions, and extensive exertions. Ketones: Ketonuria appears when there is an increased use of fat instead of carbohydrate as a source of metabolism. Conditions of ketonuria include diabetes mellitus, vomiting, inadequate intake of carbohydrates due to starvation, weight reduction, or pregnancy.  APPENDIX B continued CLINICAL SIGNIFICANCE OF URINE CHEMISTRY RESULTS: Nitrite: Bacteria, specifically gram negative organisms, are detected by this nitrite reducing reaction. In order for the reaction to take place there must be adequate dietary nitrates, and the urine must be in the bladder at least four hours for the bacteria to react with nitrate for a positive reaction. Unusually colored urine due to medication or dyes can interfere with this reaction. Leukocytes: The presence of white blood cells in the urine is an indicator of inflammation. Lysed and intact WBCs are detected because both may have produced esterase. Specific Gravity: Specific gravity is a measure of the dissolved substances present in the urine. Specific gravity is one measure of the concentrating and diluting ability of the kidneys and hydration status of the patient. The specific gravity is obtained by measuring the refraction angles of light passing through a triangle prism. An LED emits a beam of light through a slit and a lens. The refractive index changes according to the specific gravity of the sample, the higher the specific gravity the greater is the angle of measurement. The change in the angle of the light is reported as the specific gravity. The result is automatically corrected for elevated protein or glucose concentrations as measured by the test strip. Color: Color variation can indicate the presence of a disease process, metabolic abnormality, or an ingested food or drug, or the variation simply due to excessive physical activity or stress. The color of the specimen is measured by transmitted light. The colors obtained are colorless, yellow, orange, brown, red, violet, blue, green and other, including light and dark of each. Clarity: Substances that cause urine turbidity may be pathologic or non-pathologic. The clarity or turbidity of a urine specimen is measured by passing a beam of light through the sample and measuring how the light is scattered. The amount of scattered light increases as the specimen becomes more turbid. The amount of clarity is reported as clear, turbid or extremely turbid.  APPENDIX C LIMITATIONS AND INTERFERENCES: ANALYTECAUSES OF FALSE NEGATIVE RESULTS CAUSES OF FALSE POSITIVE RESULTSBilirubinElevated concentrations of nitrite may inhibit the reaction. Bilirubin is light sensitive and prolonged exposure of urine specimens to light may result in diminished or false negative valuesSome urine specimens may contain impurities such as food dyes and therapeutic pigments to produce a yellowish or reddish discoloration of the test pad that may lead to the interference. Elevated Urobilinogen concentrations may slightly enhance the response to this test pad. UrobilinogenThis test is inhibited by elevated concentrations of formaldehyde and nitrite e"10 mg/dl. Prolonged exposure to light may lead to diminished or false negative values. Food dyes and medications that have an intrinsic red color in acidic medium such as red beets, azo dyes, phenazopyridine and p-aminobenzoic acid may produce false positive results.KetonesElevated concentrations of phenylpyruvic acid may interfere with the test pad and produce a variety of colors. Phthaleins and anthraquinone derivates exhibit a red color in alkaline medium and this may mask the response. Large amounts of levodopa and medications containing sulfhydrl groups may produce atypical color reactions.N/AAscorbic AcidNo interferences reportedNo interference reported. GlucoseAscorbic acid concentrations of up to 50 mg/dL did not interfere with glucose assay test results (no false negative results). Acetoacetic Acid concentrations of up to 200 mg/dL did not interfere with glucose assay test results (no false negative results). High specific gravity, acidic pH values and gentisic acid may inhibit color formation.Cleaning agents such as hypochlorite and peroxide may lead to false positive results.ProteinFood dyes such as red beets and therapeutic pigments such as methylene blue and pyridium may mask the coloration of the test pad. Interference may occur with high specific gravity. Interference may also occur with disinfectants, wetting agents and blood substitutes (quaternary ammonium compounds, polyvinylpyrolidone, chlorohexidine). APPENDIX C LIMITATIONS AND INTERFERENCES continued ANALYTECAUSES OF FALSE NEGATIVE RESULTS CAUSES OF FALSE POSITIVE RESULTSBloodReducing agents such as ascorbic acid, uric acid, glutathione and gentisic acid may cause false negative results. Samples with a pH of 5 may interfere with this test. High concentrations of nitrite can delay the reaction.Preservatives (formalin) and cleaning agents such as hypochlorite may result in false positives.pHNo interferences reported.No interferences reported.NitriteA negative response in the presence of bacteriuria may be caused by the following: non-nitrite producing microorganisms, low nitrate diet, antibiotic therapy, strong diuresis, or insufficient urinary retention time in the bladder. Food dyes and therapeutic pigments such as red beets and pyridium may cause false positive responses. LeukocytesHigh concentrations of protein, glucose, cephalexin and gentamicin may diminish the color response. The test can be negative in the presence of visible leukocytes if they have not lysed and/or are not granulocytes. False positive results may occur in the presence of preservatives such as formaldehyde and formalin. Test results may be positive in the absence of observable cells if the granulocytes have lysed.Specific GravityN/A-measured by RefractometerN/A-measured by RefractometerColorN/A measured by scattered lightN/A measured by scattered light APPENDIX D EXPECTED RESULTS: BilirubinIn normal urine, no detectable level of bilirubin should be obtained. Positive results require further investigation. Performance Characteristics: The test is specifically developed for bilirubin. Biliverdin does not react with this test pad.UrobilinogenIn normal urine, urobilinogen is usually present at concentration up to 1 mg/dl. A result of 2 mg/dl represents the transition from normal to abnormal state and the specimen should be further investigated for possible liver disease and hemolytic disorders. Performance characteristics: The diazonium-based test is more specific for urobilinogen than Ehrlichs reagent based- test. Test strips cannot determine the absence of urobilinogen, which may be significant in biliary obstructionKetoneDetectable amounts of ketone do appear in the urine of normal specimens. Positive ketone values may result from the following conditions:starvation, dietary imbalance, diabetes mellitus, eclampsia, insulin dosage monitoring, vomiting and other metabolic disorders. Performance Characteristics: The test does not measure B-hydroxybutric acid and is only slightly sensitive to acetone.Ascorbic AcidAscorbic acid is found in various food supplies and dietary supplements. Concentrations of ascorbic acid greater than 20 mg/dl can be expected to cause strong interference with glucose, blood, and nitrite. Performance Characteristics: The oxidized form, dehydroascorbic acid, does not react with this test pad.GlucoseA small amount of glucose (up to 20 mg/dl) may be present in normal urine. The detectable sensitivity of this test has been adjusted to exclude the minute amount of glucose. Therefore, any positive response should be further evaluated. Performance Characteristics: The test pad doe not react with other reducing sugars such as fructose and galactose.BloodNormal urine contains no detectable hemoglobin or intact red blood cells. Any positive results should be further evaluated. Performance Characteristics: 0.015 mg/dl bloodpHThe normal pH of urine can vary between pH 4.5and pH 8.0. Performance Characteristics: pH values are determined to within 0.5 unit over the range from 5.0 to 9.0. NitriteNormal urine contains no detectable nitrite. However, a negative result does not rule out a urinary tract infection. Performance Characteristics: This test is specific for nitrite. Results may depend on the ability of bacteria to reduce nitrate to nitrite, the number of bacteria and the retention time of the urine in the bladder.LeukocytesA normal urine specimen should not produce a positive result. The test can be negative in the presence of observable leukocytes if they are not lysed/and or are not granulocytes (example:lymphocytes). The test may be positive in the absence of observable cells if the granulocytes have lysed. Performance Characteristics: Leukocyte test detects the presence of esterase in the granulocytic white blood cells. The test result is most frequently accompanied by the presence of bacteria that may or may not produce a nitrite positive reaction. 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