Abaxis Piccolo Chemistry Analyzer Department of Clinical Laboratories The Ohio State University Wexner Medical Center Laboratory: Document Type: Original Date Adopted: EVD Laboratory Procedure New Document Author: Karen L Scott and Erica Stone Document Owner: Karen L Scott Previous Document: POC-39 Revision 1 Adapted for EVD Testing Acknowledgement / Required Copy Holders*: All EVD laboratory testing volunteers, and other deemed applicable staff members Approval*: Point of Care Chemistry Division Director The Ohio State University Wexner Medical Center Medical Director *Approval and Acknowledgements* Refer to QPulse system and Document Details report for laboratory directors(s)’ electronic signature approval, employee acknowledgment and effective date. Revision 1 Page 1 of 8 DATE PRINTED: 2/9/16 DO NOT STORE BLANK FORMS. Print current version from QPulse. Abaxis Piccolo Chemistry Analyzer Department of Clinical Laboratories The Ohio State University Wexner Medical Center 1. PRINCIPLE: 1.1. The Piccolo Xpress™ chemistry analyzer provides quantitative in-vitro determinations of clinical chemistry analytes in lithium-heparinized whole blood, heparinized plasma, or serum. 1.2. Piccolo Liver Panel Plus 1.2.1. The Piccolo Liver Panel Plus is used with the Piccolo Xpress chemistry analyzer. The panel utilizes dry and liquid reagents in vitro quantitative determinations of alanine aminotransferase, albumin, alkaline phosphatase, amylase, aspartate aminotransferase, gamma glutamyltransferase, total bilirubin, and protein in heparinized whole blood. 1.2.2. The Piccolo Liver Panel aids the physician in determining liver function. 1.2.3. Alanine Aminotransferase (ALT): ALT catalyzes the transfer of an amino group from L-alanine to alpha-ketoglutarate to form L-glutamate and pyruvate. Lactate dehydrogenase catalyzes the conversion of pyruvate to lactate. Concomitantly, NADH is oxidized to NAD+. The rate of change of the absorbance difference between 340 nm and 405 nm is due to the conversion of NADH to NAD+ and is directly proportional to the amount of ALT present in the sample. 1.2.4. Albumin: Dye binding techniques are the most frequently used methods for measuring albumin. Bromcresol purple, when bound with albumin, changes from a yellow to blue color. The absorbance maximum changes with the color shift. Bound albumin is proportional to the concentration of albumin in the sample. This is an endpoint reaction that is measured as the difference in absorbance between 600 nm and 550 nm. 1.2.5. Alkaline Phosphatase (ALP): Alkaline phosphatase hydrolyzes p-NPP in a metalion buffer and forms p-nitrophenol and phosphate. The amount of ALP in the sample is proportional to the rate of increase in absorbance difference between 405 nm and 500 nm. 1.2.6. Amylase (AMY): The substrate, 2-chloro-p-nitrophenyl alpha D-maltotrioside (CNPG3), reacts with p-amylase in the patient sample, releasing 2-chloro-p-nitrophenol (CNP). The release of CNP creates a change in color. The reaction is measured bichromatically at 405 nm and 500 nm. The change in absorbance due to the formation of CNP is directly proportional to alpha-amylase activity in the sample. 1.2.7. Aspartate Aminotransferase (AST): Karmen/Bergmeyer technique of coupling malate dehydrogenase (MDH) and reduced nicotinamide dinucleotide (NADH) in the detection of AST in serum. Lactate dehydrogenase (LDH) is added to the reaction to decrease interference caused by endogenous pyruvate. AST catalyzes the reaction of L-aspartate and alpha-ketoglutarate into oxaloacetate and L-glutamate. Oxaloacetate is converted to malate and NADH is oxidized to NAD+ by the catalyst MDH. The rate of absorbance change at 340 nm/405 nm caused by the conversion of NADH to NAD+ is directly proportional to the amount of AST present in the sample. 1.2.8. Gamma Glutamyltransferase (GGT): The addition of sample containing gamma glutamyltranferase to the substrates L-gamma-glutamyl-3-carboxy-4-nitroanilide and glycylglycine (gly-gly) causes the formation of L-glutamylglycylglycine (glu-gly-gly) and 3-carboxy-4-nitroaniline. The absorbance of this rate reaction is measured at 405 nm. The production of 3-carboxy-4-nitroaniline is directly proportional to the GGT activity in the sample. 1.2.9. Total Bilirubin (TBIL): In the enzyme procedure, bilirubin is oxidized by bilirubin oxidase into biliverdin. The final reaction is the conversion of biliverdin into various purple compounds. Bilirubin is quantitated as the difference in absorbance between 467 nm and 550 nm. The initial absorbance of this endpoint reaction is determined from the bilirubin blank cuvette and the final absorbance is obtained from the bilirubin test cuvette. The amount of bilirubin in the sample is proportional to the difference between the initial and final absorbance measurements 1.2.10. Total Protein (TP): In the biuret reaction, the protein solution is treated with cupric [Cu(II)] ions in a strong alkaline medium. Sodium potassium tartrate and potassium iodide are added to prevent the precipitation of copper hydroxide and the autoreduction of copper, respectively. The Cu(II) ions react with peptide bonds between the carbonyl oxygen and amide nitrogen atoms to form a colored Cu-Protein complex. The amount of total protein present in the sample is directly proportional to the absorbance of the Cu-protein complex. The total protein test is an endpoint reaction and the absorbance is measured as the difference in absorbance between 550 nm and 850 nm. Revision 1 Page 2 of 8 DATE PRINTED: 2/9/16 DO NOT STORE BLANK FORMS. Print current version from QPulse. Abaxis Piccolo Chemistry Analyzer Department of Clinical Laboratories The Ohio State University Wexner Medical Center 1.3. Piccolo MetLac 12 Panel 1.3.1. The Piccolo® MetLac 12 Panel reagent disc, used with the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN) in lithium heparinized whole blood. 1.3.2. Albumin: Bromcresol purple (BCP) is the most specific of the dyes in use. Bromcresol purple, when bound with albumin, changes from a yellow to blue color. The absorbance maximum changes with the color shift. Bound albumin is proportional to the concentration of albumin in the sample. This is an endpoint reaction that is measured as the difference in absorbance between 600 nm and 550 nm. 1.3.3. Calcium (CA): Spectrophotometric methods using Arsenazo III has a high affinity for calcium and is not temperature dependent as is CPC. Calcium in the patient sample binds with arsenazo III to form a calcium-dye complex. Ca2+. The endpoint reaction is monitored at 405 nm, 467 nm, and 600 nm. The amount of total calcium in the sample is proportional to the absorbance. 1.3.4. Chloride (CL-): Deactivated α-amylase is reactivated by addition of the chloride ion, allowing the calcium to re-associate with the enzyme. The reactivation of α-amylase activity is proportional to the concentration of chloride ions in the sample. The reactivated α-amylase converts the substrate, 2-chloro-p-nitrophenyl-α-D-maltotrioside (CNPG3) to 2-chloro-p-nitrophenyl (CNP) producing color and α-maltotriose (G3). The reaction is measured bichromatically and the increase absorbance is directly proportional to the reactivated α-amylase activity and the concentration of chloride in the sample. 1.3.5. Creatinine (CRE): Methods using the enzyme creatinine amidohydrolase eliminate the problem of ammonium ion interference found in techniques using creatinine iminohydrolase. In the coupled enzyme reactions, creatinine amidohydrolase hydrolyzes creatinine to creatine. A second enzyme, creatine amidinohydrolase, catalyzes the formation of sarcosine from creatine. Sarcosine oxidase causes the oxidation of sarcosine to glycine, formaldehyde and hydrogen peroxide (H2O2). In a Trinder reaction, peroxidase catalyzes the reaction among the hydrogen peroxide, 2,4,6-tribromo-3hydroxybenzoic acid (TBHBA) and 4-aminoantipyrine (4-AAP) into a red quinoneimine dye. Potassium ferrocyanide and ascorbate oxidase are added to the reaction mixture to minimize the potential interference of bilirubin and ascorbic acid, respectively. Two cuvettes are used to determine the concentration of creatinine in the sample. Endogenous creatine is measured in the blank cuvette, which is subtracted from the combined endogenous creatine and the creatine formed from the enzyme reactions in the test cuvette. Once the endogenous creatine is eliminated from the calculations, the concentration of creatinine is proportional to the intensity of the red color produced. The endpoint reaction is measured as the difference in absorbance between 550 nm and 600 nm. 1.3.6. eGFR (calculated): Serum creatinine is routinely measured as an indicator of renal function. Because creatinine is influenced by age, gender and race, chronic kidney disease (CKD) may not be detected using serum creatinine alone. Thus, the National Kidney Disease Education Program strongly recommends that laboratories routinely report an estimated Glomerular Filtration Rate (eGFR) when serum creatinine is measured for patients 18 and older. Routinely reporting the eGFR with all serum creatinine determinations allows laboratories to help identify individuals with reduced kidney function and help facilitate the detection of CKD. Calculated eGFR values of <60 mL/min are generally associated with increased risk of adverse outcomes of CKD. Calculation of the eGFR is performed by the Piccolo using the patient’s age, gender and race. The Piccolo method for creatinine is traceable to the IDMS reference method for creatinine so that the following form of the MDRD equation for calculating the eGFR can be used. 1.3.7. Glucose (GLU): Modified version of the hexokinase method. The reaction of glucose with adenosine triphosphate (ATP), catalyzed by hexokinase (HK), produces glucose-6-phosphate (G-6P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) catalyzes the reaction of G-6-P into 6-phosphogluconate and the reduction of nicotinamide adenine dinucleotide (NAD+) to NADH. The absorbance is measured bichromatically at 340 nm and 850 nm. The production of NADH is directly proportional to the amount of glucose present in the sample. Revision 1 Page 3 of 8 DATE PRINTED: 2/9/16 DO NOT STORE BLANK FORMS. Print current version from QPulse. Abaxis Piccolo Chemistry Analyzer Department of Clinical Laboratories The Ohio State University Wexner Medical Center 1.3.8. Lactate (LAC): In the Abaxis method, lactate (LAC) is oxidized by lactate oxidase (LOX) to pyruvate and hydrogen peroxide (H2O2). Peroxidase catalyzes the reaction of H2O2, 4aminoantipyrine (4-AAP) and 3,5-dichloro-2-hydroxybenzenesulfonic acid (DHBSA) to form a red quinoneimine dye. The rate of formation of the red dye is proportional to the LAC concentration in the sample. The reaction is measured bichromatically at 515 nm and 600 nm. 1.3.9. Magnesium (MG): Magnesium from the sample activates HK, which in turn catalyzes the breakdown of glucose to form glucose-6-phosphate (G-6-P) and ADP. G-6-P reacts with nicotinamide adenine dinucleotide phosphate (NADP+) to form reduced nicotinamide adenine dinucleotide phosphate (NADPH) and 6-phosphogluconate in the presence of glucose-6-phosphatedehydrogenase (G-6-PDH). This is a first-order rate reaction. The rate of production of NADPH is directly proportional to the amount of magnesium present in the sample. Absorbance is measured bichromatically at 340 nm and 405 nm. 1.3.10. Phosphorus (PHOS): The most applicable enzymatic method for the Abaxis system uses sucrose phosphorylase (SP) coupled through phosphoglucomutase (PGM) and glucose-6-phosphate dehydrogenase (G6PDH). Using the enzymatic system for each mole of phosphorus present in the sample, one mole of NADH is formed. The amount of NADH formed can be measured as an endpoint at 340 nm. 1.3.11. Potassium (K+): In the coupled-enzyme reaction, pyruvate kinase (PK) dephosphorylates phosphoenolpyruvate to form pyruvate. Lactate dehydrogenase (LDH) catalyzes conversion of pyruvate to lactate. Concomitantly, NADH is oxidized to NAD+. The rate of change in absorbance difference between 340 nm and 405 nm is due to the conversion of NADH to NAD+ and is directly proportional to the amount of potassium in the sample. 1.3.12. Sodium (NA+): β-galactosidase is activated by the sodium in the sample. The activated enzyme catalyses the reaction ο-nitrophenyl-β-galactopyranoside (ONPG) to o-nitrophenyl and galactose. 1.3.13. Total Carbon Dioxide (tCO2): The enzymatic method, the specimen is first made alkaline to convert all forms of carbon dioxide (CO2) to bicarbonate (HCO3-). Phosphoenolpyruvate (PEP) and HCO3 then react to form oxaloacetate and phosphate in the presence of phosphoenolpyruvate carboxylase (PEPC). Malate dehydrogenase (MDH) catalyzes the reaction of oxaloacetate and reduced nicotinamide adenine dinucleotide (NADH) to NAD+ and malate. The rate of change in absorbance due to the conversion of NADH to NAD+ is directly proportional to the amount of tCO2 in the sample. 1.3.14. Blood Urea Nitrogen (BUN): Coupled-enzyme reactions are rapid, have a high specificity for ammonia, and are commonly used. In the coupled-enzyme reaction, urease hydrolyzes urea into ammonia and carbon dioxide. Upon combining ammonia with α-ketoglutarate and reduced nicotinamide adenine dinucleotide (NADH), the enzyme glutamate dehydrogenase (GLDH) oxidizes NADH to NAD+. The rate of change of the absorbance difference between 340 nm and 405 nm is caused by the conversion of NADH to NAD+ and is directly proportional to the amount of urea present in the sample. 2. SCOPE OF DOCUMENT 2.1 The Abaxis Piccolo Xpress chemistry analyzer is only for use in the EVD laboratory at UH 2.2 When the instrument is needed for a high risk patient, the critical events officer will notify the UH Laboratory Medical Director or the EVD Laboratory volunteer on call. 2.3 The EVD laboratory will be activated per the Critical Event Officer’s discretion. 3. RESPONSIBILITY: 3.1. The Point of Care coordinators and manager are responsible for maintaining the document and ensuring biennial review. 3.2. The Point of Care Chemistry Division Director is responsible for approving all changes, and reviewing at least biennial. The laboratory medical director is responsible for establishing and approving all changes before activating. 4. SPECIMEN COLLECTION: Revision 1 Page 4 of 8 DATE PRINTED: 2/9/16 DO NOT STORE BLANK FORMS. Print current version from QPulse. Abaxis Piccolo Chemistry Analyzer Department of Clinical Laboratories The Ohio State University Wexner Medical Center 4.1. Refer to Laboratory Policies and Procedures/Specimen Collection on OneSource for sample collection procedure: 4.2. Specimen requirements: 4.2.1. The minimum required sample size is 100 uL of heparinized whole blood or control material 4.2.2. Gently mix the whole blood before sampling. 4.2.3. Whole blood sample should be run immediately or within 60 minutes. 4.2.4. Use only lithium heparin vacutainer tubes 4.3. CAUTIONS: 4.3.1. Hemolysis may cause erroneously high results in K+ 4.3.2. Total Bilirubin results may be falsely decreased due to extended exposure to light, if the sample cannot be processed immediately; keep the sample out of the light. 5. SPECIAL SAFETY PRECAUTIONS: 5.1. Refer to the General EVD Policy. Follow all Medical Center Safety Procedures. 5.2. Warnings and Precautions: 5.2.1. For in vitro Diagnostic Use 5.2.2. The diluent container in the reagent disc is automatically opened when the analyzer drawer closes. A disc with an opened diluent container cannot be re-used. Ensure that the sample or control has been placed into the disc before closing the drawer. 5.2.3. Used reagent discs contain human body fluids. Follow good laboratory safety practices when handling and disposing of used discs. See the Piccolo Xpress chemistry analyzer operator’s manual for instructions on cleaning biohazardous spills. Dispose of the disc in the biohazard sharps in the testing location 5.2.4. The reagent discs are plastic and may crack or chip if dropped. Never use a dropped disc as it may spray biohazardous sharps material throughout the interior of the analyzer. 5.2.5. Reagent beads may contain acids or caustic substances. The operator does not come into contact with the reagent beads when following the recommended procedures. In the event that the beads are handled (e.g., cleaning up after dropping and cracking a reagent disc), avoid ingestion, skin contact, or inhalation of the reagent beads. 5.2.6. Reagent beads and diluent contain sodium azide which may react with lead and copper plumbing to form highly explosive metal azides. Reagents will not come into contact with lead and copper plumbing when following recommended procedures. However, if the reagents do come into contact with such plumbing, flush with a large volume of water to prevent azide buildup. 6. REAGENTS/SUPPLIES: 6.1. Reagent Discs 6.1.1. Each Piccolo reagent disc contains dry test-specific reagent beads. A dry sample blank reagent (comprised of buffer, surfactants, excipients, and preservatives) is included in each disc for use in calculating results. A dedicated sample blank is included in the disc to calculate concentrations of creatinine, total bilirubin and total protein. Each disc also contains a diluent consisting of surfactants and preservatives. 6.1.1.1. MetLac 12 Panel – 07P02-16 6.1.1.2. Liver Panel Plus – 07P02-10 6.1.2. Storage Use 6.1.2.1. Store the reagent discs in their sealed pouches at 2-8ºC in the EVD Lab. Overflow storage is in the POC department. 6.1.2.2. Reagent discs may be used directly from the refrigerator without warming 6.1.2.3. Do not allow the discs to remain at room temperature longer than 48 hours prior to use. Place a new expiration date on the package when removing from the refrigerator. Revision 1 Page 5 of 8 DATE PRINTED: 2/9/16 DO NOT STORE BLANK FORMS. Print current version from QPulse. Abaxis Piccolo Chemistry Analyzer Department of Clinical Laboratories The Ohio State University Wexner Medical Center 6.1.2.4. Do not use a disc if it has been removed from the pouch for more than 20 minutes 6.1.2.5. Do not use a reagent disc if the pouch has been damaged 6.1.2.6. Do not use reagent disc beyond the expiration date. 6.2. Piccolo analyzer: 6.2.1. Operates at ambient temperature between 15-32ºC, with a relative humidity of 8-80%. 6.2.2. The piccolo Xpress™ chemistry system is compact and easy to transport. The system consists of a portable analyzer and single-use disposable reagent discs. The analyzer contains the following features and components: 6.2.2.1. A variable-speed motor to spin the disc 6.2.2.2. A photometer to measure analyte concentrations 6.2.2.3. Two microprocessors to control testing and analytical functions 6.2.2.4. A thermal line printer to print out results 6.2.2.5. A VGA color touchscreen for communicating with the analyzer 6.2.2.6. Optional data functions for more detailed analysis information 6.3. Piccolo 2 levels of controls: 6.3.1. Piccolo 2 levels of controls: (BRT) 6.3.2. The BRT controls are prepared from human serum to which biochemical material, chemicals, stabilizers and preservatives have been added. 6.3.3. The BRT controls are stored at <-15 degrees C, away from light, until the expiration date. 6.3.4. If the BRT is stored unopened at 2-8 degrees C, then the expiration date is 14 days from refrigeration. Label controls with new expiration dates 6.3.5. If the BRT controls are opened label the vial with a new expiration date and time of 24 hours from open. Store opened in the refrigerator 2-8 degrees C. 6.3.6. The BRT control must be thawed at room temperature for 1 hour before use. Once thawed, gently mix the control. 6.3.7. Do not use controls beyond their expiration date. 7. CALIBRATION / MAINTENANCE: 7.1. Calibration: 7.1.1. The Piccolo analyzer is calibrated by the manufacturer before shipment. 7.2. Maintenance: 7.2.1. Clean the filter every 6 months. Document the cleaning of the filter on the maintenance log 7.2.2. Clean the instrument surface each day of use with the 10% Sani-Bleach wipes. Document the cleaning of the instrument on the maintenance log. 7.3. Refer to the Point of Care Quality Policy for information on AMR verification and correlations. 8. QUALITY CONTROL: 8.1. External QC is performed (2 levels of control) 8.1.1. Each day of use 8.1.2. At least every 30 days 8.1.3. Whenever the lab changes conditions; move locations. 8.1.4. When patient test results do not match the clinical picture 8.1.5. For troubleshooting purposes 8.1.6. To verify new lot/new shipment of controls by performing the controls on shipment of lot of discs. 8.2. QC test procedure 8.2.1. Prepare QC sample 8.2.2. Gently swirl and add 100uL of control to the disc 8.2.3. Insert the pipette tip into the sample port and dispense 100uL of control into the disc 8.2.4. Press Analyze on the touch screen to open drawer 8.2.5. Place the disc in the instrument Revision 1 Page 6 of 8 DATE PRINTED: 2/9/16 DO NOT STORE BLANK FORMS. Print current version from QPulse. Abaxis Piccolo Chemistry Analyzer Department of Clinical Laboratories The Ohio State University Wexner Medical Center 8.2.6. Press Control on the analyzer screen 8.3. Document QC result on the Piccolo QC log 8.3.1. Compare the results with the BRT ranges and verify results are within range before patient testing 8.3.2. If QC fails, open a new vial of control, allow to thaw 1 hour and repeat testing 8.3.3. If repeat QC fails, call technical support 1-800-822-2947 8.3.4. Do not perform patient testing if QC fails 8.4. Internal Controls 8.4.1. The Piccolo performs iQC with each test. It is a series of automatic checks that verify the chemistry, optics, and electronic functions of the analyzer 8.4.2. The results obtained in the chemistry iQC testing are given at the bottom of the card, along with the minimum acceptable value. Any value above the minimum indicates that the disc was stored correctly and all chemistries in the disc were viable at the time of testing. 8.4.3. If the iQC fails, a hardware malfunction message appears on the display if and component malfunctions 8.4.4 If iQC fails call technical support, do not perform patient testing. 9. TEST PROCEDURE: 9.1. Use the reagent disc within 20 minutes after opening pouch. 9.2. Remove only one test disc from the refrigerator. Open only one reagent disc at a time. Reagents discs will expire after 20 minutes. (Do not remove or open more than one panel type at a time assay time is greater than 20 minutes) 9.3. Check the pouch to ensure it is intact before opening and have the patient sample ready before opening. 9.4. Use the BD blood vacutainer transfer device to pull off a sample into a syringe. 9.5. Dispense the 100 uL of the sample into the sample port on the center of the disc (line with arrows). Do not overfill. 9.6. Start the test immediately. 9.7. Immediately discard the syringe in the biohazard waste 9.8. Press the yellow ANALYZE on the instrument to open the door 9.9. Load the disc in the instrument 9.10. Press the blue CLOSE tab at the bottom of the touch screen, analysis begins 9.11. Manually Enter operator ID, Badge # 9.12. Select PATIENT on the touch screen 9.13. Type in the patient’s identifier, then press DONE 9.14. Testing takes approximately 14 minutes 9.15. When the run is complete, Press OPEN on the touch screen 9.16. Remove the disc and discard in the biohazard sharps container 9.17. Press CLOSE on the touch screen 9.18. Results will print. Keep the printed copy in the file 9.19. The instrument must be thoroughly wiped down with a bleach wipe after performing patient testing. 10. REPORTING RESULTS 10.1. Manually enter the results in Labsprod using MEM 10.1.1. EVDMET (Met lac panel) 10.1.2. EVDLIV (liver panel) 10.1.3. EVDPLO (Piccolo left over tests) 10.2. Refer to master listing chart / laboratory guide to services for reference intervals, Analytical measurement range (technical range), and reportable range (reportable range) CRR 10.3. Refer to Critical Result / Critical Value policy for critical values 10.4. Notify a nurse or physician of all critical results according to hospital policy and as stated in the Lab Admin Rapid Communication of Laboratory Results Procedure 10.5. To recall results on Piccolo Revision 1 Page 7 of 8 DATE PRINTED: 2/9/16 DO NOT STORE BLANK FORMS. Print current version from QPulse. Abaxis Piccolo Chemistry Analyzer Department of Clinical Laboratories The Ohio State University Wexner Medical Center 10.5.1. 10.5.2. 10.5.3. 10.5.4. From the Home Screen, press RECALL icon Press Last Disc Scroll through the results If you need printed results, Press Print 11. LIMITATIONS: 11.1. The only anticoagulant recommended for use with the Piccolo blood chemistry analyzer is lithium heparin. Abaxis has performed studies demonstrating that EDTA, fluoride, oxalate, and any anticoagulant containing ammonium ions may interfere with analytes in the Piccolo MetLac 12 Panel reagent disc. 11.2. Samples with hematocrits in excess of 62-65% packed red cell volume may give inaccurate results. 11.3. Amylase is secreted by several glands as well as by the pancreas. Only pancreatic amylase is of clinical interest. Contamination of a sample with nonpancreatic amylase will cause artificially elevated results. 11.4. Warning: Extensive testing of the Piccolo Xpress chemistry analyzer has shown that, in very rare instances, sample dispensed into the reagent disc may not flow smoothly into the sample chamber. Due to the uneven flow, an inadequate quantity of sample may be analyzed and several results may fall outside the reference ranges. The sample may be re-run using a new reagent disc. 12. REPORTABLE RANGES: 12.1. Refer to the Master Testing List (POC) for Technical Ranges, Reportable Ranges, and Reference Ranges. 13. TROUBLESHOOTING 13.1. Error Messages: The analyzer can display warning and error messages when problems occur. These messages include an internal error code that will assist Abaxis Technical Support in diagnosing the problem. Record the error message and/or print an error report before calling Abaxis Technical Support at 800-822-2947 13.2. Electrostatic Discharge: If the analyzer experiences an electrostatic discharge while running a sample, it may “freeze up.” If this happens, cancel the analysis then power the analyzer off and back on again. This should restore the analyzer to operating condition. 13.3. Technical Support: If the troubleshooting recommendations contained in this section do not correct the problem with the analyzer or the reagent discs, please contact Abaxis Technical Support call 800-8222947 or email technicalsupport@abaxis.com 13.4. Disc Cancellations: If the disc cancels, record the following information or print an error report and contact Abaxis Technical Support at 800-822-2947: Lot number, Product name, 4-digit error code, Specimen type and sample. 14. INTERFERING SUBSTANCES: 14.1. Interfering substances from hemolysis, lipemia, and icterus are semi-quantitatively assessed in each sample by absorbance readings at 340nm, 405 nm and 467nm. 14.2. The degree of any potential interference is printed by the results for any affected tests. 14.3. Flag HEM- Hemolysis (+1-+10) 14.4. Flag LIP- Lipemic (+1-+10) 14.5. Flag ICT- Icterus (+1-+10) 14.6. If results are flagged with HEM, LIP, or ICT, or suppressed completely, replace the result with the modifier INFS “Interfering substance”. 15. REFERENCES: 15.1. Abaxis Piccolo Chemistry Analyzer Operation Manual 16. RELATED DOCUMENTS 16.1. Refer to QPulse for related Laboratory Policies, Procedures, and Master Forms Revision 1 Page 8 of 8 DATE PRINTED: 2/9/16 DO NOT STORE BLANK FORMS. Print current version from QPulse.