Yampa Valley Medical Center

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1 Yampa Valley Medical Center PROCEDURE TITLE: Chemistry - Piccolo Version Number: 2 Next Review Date: 01/28/2018 Procedure for: Laboratory Originating Source: McCartin, Rachel (Laboratory Section Head (BB/Chem/Hemo/Micro)) Approved by: Hopfenbeck, James, Medical Staff, 01/28/2016 Effective Date: 01/28/2016 Purpose The Piccolo xpress Chemistry Analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood. Each patient test utilizes single-use disposable reagent discs composed of multiple reaction cuvettes containing test-specific lyophilized reagent beads. The chemical reactions carried out within each cuvette are designed to produce a reaction that absorbs light at known wavelengths. Reaction products in the cuvettes are then measured photometrically. Only the Comprehensive Metabolic Panel (CMP) reagent discs will be utilized. Each of these reagent discs test for the following analytes: Alanine aminotransferase (ALT) Albumin Alkaline phosphatase (ALP) Aspartate aminotransferase (AST) Calcium Chloride Creatinine Glucose Potassium Sodium Total bilirubin Total carbon dioxide Total protein Blood Urea Nitrogen (BUN) Specimen Requirements 1. Lithium heparinized whole blood is the only acceptable specimen. The tube must be at least 1/2 full.

2 2. A sample size of µl is required. 3. Specimens must be analyzed within 60 minutes of collection. 4. Do not refrigerate or shake the sample. 5. Invert the tube gently to mix (8-10 times) before running sample. Reagents 1. Reagent discs: a. No preparation needed. b. Store the discs in the refrigerator at a temperature at 2 to 8 C. This keeps the disc reagents stable until the expiration date. Do not allow cartridges to freeze. c. The discs are meant to be used straight from the refrigerator. d. Do not allow discs sealed in their foil pouches to remain at room temperature longer than 48 hours prior to use. e. A disc not used within 20 minutes of opening the pouch should be discarded. f. Run reagent disc within 10 minutes of applying the sample. g. Handle discs only by their edges to avoid smudges on the optical surfaces. h. Hold discs flat after introducing the sample or control to avoid spillage. i. Example of a reagent disc: bar code ring cuvettes sample port diluent container sample fill line 2. Piccolo External Liquid Assayed Controls Levels I and II. a. Piccolo liquid qc material is prepared from human serum to which purified biochemical material, chemicals, drugs, preservatives, and stabilizers have been added. This material must be handled with the same precautions used with patient specimens. b. Store the liquid qc in the freezer. Controls are stable until the expiration date when stored unopened at -20 C. c. Thaw controls on counter at room temperature for 1 hour d. After thawing, invert the control vial gently to mix.

3 e. Do not refreeze or refrigerate controls once cap has been opened. Discard after use. Quality Control The piccolo xpress includes quality control features such as optical sensing and electronic feedback systems, to ensure that accurate results are reported. The analyzer performs tests on both internal components and the reagent discs whenever the power is turned on and/or a reagent disc is inserted. Additionally, the analyzer continues to perform tests during analysis. Messages on the display or on the result printout warn of analyzer malfunctions and possible errors or explain why no results are reported. 1. Intelligent Quality Control (iqc) The piccolo xpress hardware performs an iqc test whenever power is turned on. iqc ensures that all optics, flash, and circuit board components are functioning properly and verifies the memory functions. The analyzer performs this analysis only when the iqc confirms that all components are functional. A hardware malfunction message appears on the display if any component malfunctions. 2. Quality Control During Analysis During an analysis, the analyzer s internal components and the reagent disc are checked to ensure the accuracy of the results. a. piccolo xpress Analyzer The analyzer s photometer takes readings with the light path obstructed and unobstructed to determine the appropriate light intensity range, and then checks that the range is within specification, before analysis begins. It also continually checks the performance of the motor, flash, and optics during analysis as well. b. Reagent Disc The analyzer performs several tests on the reagent disc during the analysis. These checks confirm: calibration factors

4 expiration date all reagent beads are present timing of fluid movement through the disc diluent and sample mixing sufficient sample has been applied to the disc reagent beads dissolve when mixed with diluted sample Each reagent disc contains reagents to detect exposure to extreme conditions such as temperature and humidity. The message QC OK is printed on the result printout when results from these reagents are within the expected ranges. Otherwise, no results are printed, and a run canceled message is shown on the display. The analyzer monitors the performance of the reactions. For rate chemistries, the analyzer confirms that the reactions are linear with time that the slope is within range, and whether the substrate has been depleted. In endpoint chemistries, the analyzer verifies the flatness (completeness) of the endpoints. c. Sample Samples are checked for physical interference. The analyzer estimates the sample indices, hemolysis, lipemia, and icterus using absorbance readings for the sample at 340 nm, 405 nm, and 467 nm. This information is then compared to pre-established limits for hemolysis, lipemia, and icterus for each method. When all three indices are below these limits for the method, the result for that method is printed on the result card. When even one index exceeds the limit, the result for the method is suppressed and the error condition displayed as HEM, LIP, or ICT. Printing Daily iqc Each day of patient testing, immediately after the first patient test, an iqc report must be printed, manually reviewed(check instrument iqc with the ranges listed), and placed in the Piccolo binder under the Daily iqc tab. To print an iqc report: 1. From the Home screen, press the folder icon(recall Screen) button. 2. Press the Last Disc button. Or 3. Press the, keys to select the first patient record

5 4. Press Print button. 5. Press the iqc button to select iqc records. 6. The iqc report is printed. Stick the iqc printout to the Daily iqc sheet under the Daily iqc tab in the Piccolo binder. 7. Press the Home button return to the standby mode. Running External Liquid Quality Control Two levels of external liquid quality controls must be tested as follows: At least every 30 days Whenever the laboratory conditions have changed significantly, e.g. Piccolo is moved to a new location or changes in temperature control When training or retraining of personnel is indicated With each new lot of reagent disc s To perform external liquid quality control testing (located in white chemistry freezer): 1. Thaw the controls on counter at room temperature for 1 hour. 2. After thawing, invert the control vial gently to mix (10-15 gentle windshield wiper motions). 3. Use a micropipette to dispense approximately µl of liquid qc into the reagent disc sample port. 4. Press Analyze on the touchscreen to open disc drawer and insert the loaded reagent disc into the instrument. 5. Enter your operator ID. 6. Select Control. 7. Enter the control lot number from the liquid QC bottle. Use for dashes in lot numbers. 8. When test is complete, the result will print. 9. Manually check the results with the package insert located under the Control Package Insert tab in the Piccolo binder. 10. If any results fall outside of target range, that level of liquid qc must be reran with a new reagent disc. 11. Stick the liquid qc printout to the data collection form controls sheet under the Control Data tab in the Piccolo binder. 12. Repeat above steps for level 2 of the liquid qc. 13. Print out the control iqc for both levels of controls when finished. 14. Manually review the control iqc with the ranges listed on printout. 15. Stick results on the data collection form controls iqc sheet under the Control iqc tab. 16. Discard liquid QC when done. 17. Both levels of liquid qc must have all results within the target ranges. Contact the Chemistry designee if results do not fall within target range on the second attempt. Document all action taken on a corrective action report and place with the data collection forms control sheet under the Control Data tab in the Piccolo binder.

6 Patient Testing Procedure 1. Using proper personal protective equipment, collect a green-top lithium heparin tube; make sure to gently mix before running. 2. Remove a reagent disc from the refrigerator. 3. Use a micropipette to slowly dispense approximately 100 µl of patient specimen into the reagent disc sample port. 4. Start the test within 10 minutes of transferring the sample into the reagent disc. 5. Press Analyze on the touchscreen to open disc drawer and insert the loaded reagent disc into the instrument. 6. Press Close. 7. Enter your operator ID. 8. Select Patient. 9. Select male or female. 10. Enter patient s age. 11. Enter the chemistry barcode number using the numeric keys when prompted and press Done. 12. The analyzer then checks the disc type, and begins processing the sample. 13. When the sample is finished processing, the analyzer stores the results and show that the analysis is complete. 14. The analyzer automatically prints the results of the analysis. 15. Press OPEN to open disc drawer and discard the reagent disc from drawer. 16. When finished press CLOSE to close drawer and return the analyzer to standby mode. 17. Examine the results paying particular attention to the indices printed near the bottom of the results. The HEM index must be less than 3+. All 3+ HEM specimens must be recollected and reran. 18. Manually enter results in Meditech (see reporting results section below). 19. Stick the printed patient results on the patient sample log under the Patient Sample Log tab in the Piccolo binder.

7 Results and Reporting The figure at the right shows the contents of a typical results print- out. The heading of the results printout includes information such as the reagent disc type, test date and time, sample type, sample ID number, alternate ID number, gender, age, operator ID number, disc lot number, and analyzer serial number. The test results section of the card is printed in four columns: chemistry name, analyte con- centration, reference range, and specified units, as shown at right. The results printout has an adhesive backing so it can easily be placed into the patient's file. Each reagent disc contains reagents to detect exposure to extreme conditions such as temperature and humidity. The message QC OK is printed on the results when results from these reagents are within the expected ranges. Otherwise, no results are printed, and the analyzer opens the disc drawer. Results outside the reference range are indicated in the results by an asterisk (*) printed next to the analyte concentration. Results outside the dynamic range are indicated in the results by a less than symbol (<) printed next to the lowest value of the dynamic range, or a greater than symbol (>) printed next to the highest value of the dynamic range. For example, the dynamic range of glucose is mg/dl. A sample concentration of glucose below this range would be printed as <10 mg/dl, and a concentration above this range would be printed as >700 mg/dl. Results outside the dynamic range should be reported as being below or above the value indicated. The symbols ~~~ are printed in place of numbers when a result cannot be determined that is, when the result is suppressed. A result may be suppressed due to improper mixing of a reagent bead with

8 diluted sample, a nonlinear reaction, an endpoint of a particular reaction not reached, or a concentration outside the analyzer s capabilities. When a chemistry is suppressed (~~~), the analyzer prompts the operator to print an error report. Call Abaxis Technical Support with the error report or spin down and wait to run on the Vitros 5,1 when it is back up and operating. HEM, LIP, or ICT is printed in place of the analyte concentration if hemolysis, lipemia, or icterus, respectively, has adversely affected the results. LIP is also printed if both lipemia and icterus have been affected. HEM is also printed if hemolysis and icterus, hemolysis and lipemia, or hemolysis, lipemia, and icterus have affected a particular analyte. Examine the sample indices to determine if more than one interferent is affecting a particular result. The sample indices are included at the bottom of the results printout. These indices indicate the degree of hemolysis, icterus, and lipemia found in the sample. Hemolysis, icterus, and lipemia are measured on a scale of 0 (clear), 1+ (slight), 2+ (moderate), and 3+ (gross). If the sample is identified as hemolytic, collect a new sample and run another reagent disc. If the new sample is hemolytic, the specimen can be spun down and run on the Vitros 5,1 when it is back up and operating (result the specimen with a comment to the degree of hemolysis the sample contains). Samples with hematocrit in excess of 60% packed red cell volume may appear on the result card as HEM. These specimens can be spun down and run on the Vitros 5,1 when it is back up and operating. For grossly lipemic samples or for icteric samples, the specimen can be spun down and run on the Vitros 5,1 when it is back up and operating. Stick the printed patient result card to the Patient Result Form in the Piccolo binder. Manually enter the results into Meditech. Make sure to change method to Piccolo. Go to each result and hit edit (bottom of screen) then change method then choose Piccolo. Patient results displaying a > or < next to the result indicate results outside of the established analytical measurement range. Result any analyte with a > or < and the number in Meditech, e.g. AST >2000.

9 Review the patient results for any critical values (which would be flagged in Meditech once results are entered). All established critical results as defined by the medical staff require direct notification of a member of the patient s care team (defined as a healthcare professional immediately responsible for the care of the patient, including requesting physician, covering physician,attending physician, physician assistant, charge nurse, nurse or nurse practitioner, in the emergency department the ED tech). When calling and receiving results the process will include: the two patient identifier verification, date and time and Read Back Verify (RBV). The technologist will document in the Meditech system, the time, date and the RN, physician, or caregiver who was called with the critical result. In addition, the technologist will document that the critical results were read back to them by adding a comment Critical result read back. in the critical value comment in the Meditech system. Calibration Verification The piccolo xpress chemistry analyzer is self-calibrating. The bar code on the reagent disc contains the required information to perform its calibration when ever a reagent disc is run. Additionally, each reagent bead used in the disc is calibrated to a reference method and/or reference material. Analytical Measurement Range (Linearity) ALT ALB ALKP AST CA CL CREA GLUC K NA TBIL tco2 TP BUN Analyte AMR U/L g/dl U/L U/L mg/dl mmol/l mg/dl mg/dl mmol/l mmol/l mg/dl 5-40 mmol/l 2-14 g/dl mg/dl

10 Results exceeding the Piccolo s measurable range are displayed as either a greater than (>) or less than (<) symbol. Any result for a particular test that exceeds the Piccolo s measurable range is to be resulted with a > or < sign. If dilution is necessary, the sample will have to be spun down and ran on the Vitros 5,1 when it is back up and operating. Troubleshooting For additional troubleshooting assistance see section 7 in the Piccolo Xpress Chemistry Analyzer Operator s Manual in the Piccolo binder. Or call technical support at References 1. Piccolo xpress Chemistry Analyzer Operator s Manual, Piccolo Comprehensive Metabolic Reagent Disc, Piccolo Xpress-Waived Testing, Key Points to Remember