Arterial Blood Gas Analysis Radiometer ABL80 Audience .

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University of Texas Medical BranchPulmonary Function LabPolicy 04-01 Radiometer ABL80Effective Date:Revised Date:Review Date:Nov 90May 14May 14Arterial Blood Gas Analysis – Radiometer ABL80AudienceAll personnel in the Pulmonary Function Clinic.PolicyThe purpose of this policy is to define the usage of the Radiometer ABL80 FLEXCO-OX for the analysis of arterial blood gas samples. It will include specimenrequirements, wet section of analyzer, sensor calibration, solution, quality control,values, and limitations.PrincipleThe ABL80 is a portable, automated analyzer that measures pH, blood gases andoximetry. It uses a three-electrode system to measure quantitatively pH, PCO2,and PO2 in blood samples. On the basis of the measured values the analyzercalculates seven derived parameters: plasma and standard bicarbonate, oxygensaturation and oxygen content, total CO2, actual and standard base excess.Blood gas analysis is used to assess the oxygenation, ventilation, and acid-basestatus of a patient. Other parameters that are derived from these three parametersare used in the assessment of oxygen content and oxygen delivery.The optical system is based on a 128-wavelength spectrophotometer with ameasuring range of 478-672nm. The spectrophotometer is connected via anoptical fiber to a combined hemolyzer and measuring chamber.Specimen CollectionUnder routine conditions, blood gas sampling will be done with the patientbreathing room air unless specified by the requesting physician. In these cases,the conditions under which the blood gas sample was drawn will be documentedon the blood gas/pulmonary function report. If the patient arrives in thePulmonary Function Laboratory using supplemental oxygen, and a blood gas withthe patient breathing room air is needed, the patient will be taken off of theoxygen for no less than 15 minutes before the blood gas sample is drawn.The specimen will be obtained from the radial artery only, using a pre-packaged 3cc syringe with 100 units of lyophilized lithium heparin and a 22 GA x 1-inchneedle. The amount of blood required is 1-3 cc’s.Handling Conditions: A blood gas sample will be run within 5 minutes ofobtaining the sample. If the sample cannot be analyzed within 5 minutes, thesample will be placed on ice until such a time that it can be analyzed. All airbubbles will be expelled from the sample immediately. Blood samples that arebeginning to or have already coagulated are unacceptable for analysis.Precautions: Those patients receiving anticoagulant therapy must be observedclosely. No substances in normal blood will interfere with pH and PCO2measurements. Blood from patients anaesthetized with nitrous oxide or halothanePage 1 of 13

University of Texas Medical BranchPulmonary Function LabPolicy 04-01 Radiometer ABL80Effective Date:Revised Date:Review Date:Nov 90May 14May 14may give unreliable PO2 values due to the influence of these anesthetic gases onthe PO2 electrode. Patients who have received lipid therapy will have anabnormally high blood lipid content, which causes some interference in pHmeasurements. Samples from such patients should be labeled so that thesecontaminants can be taken into account in the interpretation on the results.Wet SectionDefinitionThe wet section of the analyzer is where all samples and solutions are transportedfor measurement, calibration and rinseContents of wet sectionThe main components of the wet section are: Sensor cassette Internal tubing Peristaltic pumps for sample aspiration, calibration and waste Valve / manifold assembly Solution pack HemolyzerSolutionsAll solutions for the ABL80 FLEX analyzer are contained in the solution pack.GasesGas tanks are not necessary with the ABL80 FLEX CO-OX analyzer.The multiple levels of solutions are tonometered and sealed ingastight disposable pouches, without a gas phase. This eliminates theneed for gas tanks, and temperature or barometric pressurecorrections.The table below describes the functions of the main parts of the ABL80 FLEX wet section.ItemPartInlet probe1Waste drain luerLuer which receives waste fluids from the inlet probe during flushcycles.Main waste lineInternal tubing, which provides the pathway for waste fluidtransport to the waste pouch contained in the solution pack.Cassette measuringchamberThe area of the cassette which contains the sensor array and wherethe actual measurements occur for pH, blood gases, electrolytes and234FunctionThe point of introduction for the sample into the sensor cassette. Italso provides a pathway for calibration/QC solution to be flushed tothe waste drain.Page 2 of 13

University of Texas Medical BranchPulmonary Function LabPolicy 04-01 Radiometer ABL80Effective Date:Revised Date:Review Date:Nov 90May 14May 14glucose.Cassette luerThe fluid connection port between the analyzer and the sensorcassette.Pinch valveValve used in the measurement of co-oximeter parametersHemolyzerUltrasonic hemolyzer which contains the hemolyzed sample in acuvette during measurementLiquid sensorSenses the location of the sample in the pathway, ensuring thesample has successfully been transported through the hemolyzerSpectrometerUses a photodiode array to measure the wavelengths of the sampleand create an absorption spectrumSample pumpProvides the pumping mechanism to transport fluids through thehemolyzer and across the cassette sensor arrayVent valveInternal valve that controls the flow of waste fluids into the wastepouch contained in the solution pack.Waste pumpPump that transports waste fluids to the waste pouchValvesInternal valves that control the selection and flow of solutions fromthe solution pack to the sensor cassetteManifoldInterface between the solution pack, valves and the analyzer wetsectionFluid port luerThese luers penetrate the valves of the sealed pouches in thesolution pack to provide fluid flow.Solution packContains five sealed pouches, four solution pouches and a wastepouch.Solution pouchesFour pouches with precision-tonometered electrolyte solutions anddyes.Waste pouchPouch to collect and contain all waste fluids in the system.56789101112131415161718SensorDefinitionThe term sensor refers to an individual sensor as part of the sensing arraywithin a sensor cassette. The electrical signal from each sensor is measuredby proprietary analog electronics contained within the analyzer unit.Measuring PrinciplesThere are four different measuring principles employed in sensors in the ABL80 FLEXCO-OX analyzer.Page 3 of 13

University of Texas Medical BranchPulmonary Function LabPolicy 04-01 Radiometer ABL80 Effective Date:Revised Date:Review Date:Nov 90May 14May 14Potentiometry: The potential of a sensor chain is recorded using a voltmeter,and related to the concentration of the sample (the Nernst equation). Thepotentiometric measuring principle is applied in the pH and pCO2 sensors.Amperometry: The magnitude of an electrical current flowing through a sensorchain is proportional to the concentration of the substance being oxidized orreduced at an electrode in the chain. The amperometric measuring principle isapplied in the pO2 sensors.Conductometry: Specific impedance of a sample as measured by twoconducting electrodes held at a constant voltage is directly proportional to theconductive properties of that sample. The conductometric measuring principle isapplied in the Hct electrodes and the air-in-sample detection (SC) electrodes.Spectrophotometry: Light passes through a cuvette containing a hemolyzedblood sample. The specific wavelengths absorbed and their intensity generatesan absorption spectrum used to calculate oximetry parameters.The first three measuring principles are described in detail in ABL80 FlexReference Manual. Spectrophotometry is described above in Principle. Indepth sensor and electrode descriptions and functions are available insection 4 in the ABL 80 Flex Reference Manual.Manual Quality Control ReagentsQUALICHECK 5 Control Solution is recommended by Radiometer for optimalperformance of analyzer. All manual QC solutions will be scanned into theanalyzer and solution ID fields entered. Solutions include S7730QUALICHECK5 Level 1, S7740 QUALICHECK5 Level 2, S7750QUALICHECK5 Level 3, S7760 QUALICHECK5 Level 4Sensor CalibrationSensor calibration is the process of relating sensor electrical outputs to knownanalyte values. The calibration line slop (sensitivity) of each sensor is derivedfrom the electrical values (end points) obtained by measuring two solutions withdifferent analyte concentrations.The ABL 80 FLEX CO-OX automatic quality control system calibration processincludes the measurement of three solutions with different analyte concentrations.These three measure values are used in different combinations of two points eachto establish three two-point calibration lines for each anaylte. One calibration lineis consistently used to report sample results. All three calibration lines are usedtogether to evaluate system linearity.SensitivitySensor sensitivity describes the slope of the calibration line derived from a 2-pointcalibration. The sensitivity limits for the calibration are set for each sensor.The following table lists the sensitivity limits for each sensor:Page 4 of 13

University of Texas Medical BranchPulmonary Function LabPolicy 04-01 Radiometer ABL80Effective Date:Revised Date:Review Date:Nov 90May 14May 14LimitsParameterSensitivity RangeUnitpH40.0 – 65.0mV/pH unitCO30.0 – 75.0mV/decade pCO0.002 – 0.052nA/mmHgO222Calibration LevelsAll ABL80 FLEX analyzers are equipped with a solution pack. This pack containsprecision-tonometered fluids. The tonometry calibration gas mixture is of a knowncomposition.Gas 1 has a composition of:O2 25%CO2 8%.N2 BalanceGas 2 has a composition of:O2 24%CO2 15.5%.N2 Balance Gas 3 has a composition of:O2 0%CO2 3%.N2 BalanceThe determination of pCO2 is also dependent on the pH values. Solution 1 has an approximate pH value of 7.40Solution 2 has an approximate pH value of 7.00Solution 3 has an approximate pH value of 7.60 The partial pressure of CO (pCO ) and the solution pH values are known and contained22in the solution pack smart chip. System Cycle Calibration is performed during a System Cycle.ScheduleCalibration is performed every 8 hours, with the ability to increase frequency upto every 2 to 4 hours, if desired. A System Cycle is also performed followingpower-up if the analyzer has been turned off for more than 10 minutes or if turnedoff without following the appropriate power down process as described in theoperator manual.Blank CalibrationIn the ABL80 FLEX CO-OX analyzer a blank (zero) calibration of the COOximeter is performed, using clear solution, during every System Cycle andsensor cassette installation.Page 5 of 13

University of Texas Medical BranchPulmonary Function LabPolicy 04-01 Radiometer ABL80Effective Date:Revised Date:Review Date:Nov 90May 14May 14DriftThe system can be configured to display a drift value for any parameter whosedrift value falls outside the acceptable drift criteria between System Cycles. Seechapter 9 in operator manual for enabling. When enabled and at least oneparameter drift value is outside the acceptable criteria, a Drift tab will appear onthe System Cycle results screen.Inactivation If the calibration fails, the system will not allow the use to perform sampleanalysis unless the failed parameter is inactivated. The analyzer can be configuredto automatically inactive and re-activate failed parameters.ProcedureFor complete operating procedure, see Chapter 4: ABL80FLEX CO-OXOperators Manual.Measurements:Sample Volume -Operating ConditionsFor each analysis, the ABL80 requires a sample volumeof 105μl of bloodTemperature All measurements and calibrations carried out at 37 C 0.2 CAnalysis/Cycle time140 secondsSolutionThe ABL80 FLEX analyzer utilizes a solution pack for all calibrations, QC, and flushprocedures and for the collection of waste fluids. The solution pack contains four foilpouches each filled with calibration solution. These pouches provide multiple solutionlevels for sensor calibration. Additionally, solution 1 is used for sample flushingprocedures. A fifth pouch provides a receptacle for the collection of all waste fluids.Expiration DateThe shelf-life expiration date for the solution pack is found on the pack label. Theexpiration date is labeled with an "Install By" symbol () followed by a date in yearmonth-day format (e.g. 2006-04-23). A solution pack may be installed up to thisexpiration date and be used on the analyzer for up to 30 days beyond this date or until oneor more calibration fluids are fully consumed, whichever occurs first.StorageThe solution pack storage temperature range for all versions (except REF 944-341) is 5 C to 25 C (41 to 77 F). The solution pack storage temperature range for REF 944-341is 2 C to 25 C (36 to 77 F). The storage and operating altitude range is sea level to2290 meters. When stored at this temperature and altitude, the solution pack is stablethroughout the shelf-life period, if the protective tape over the fluid ports remains intact.Beyond this date, the solutions will remain stable and may be used for up to themaximum allowed number of days, when properly installed onto the analyzer.SolutionsThe four solutions contained in the pouches of the solution pack are used for calibrationand quality control of all analytes. During sample analysis and quality controlmeasurements this solution also acts as a flush, removing the sample from the sensorPage 6 of 13

University of Texas Medical BranchPulmonary Function LabPolicy 04-01 Radiometer ABL80Effective Date:Revised Date:Review Date:Nov 90May 14May 14cassette measuring chamber. This solution is also used to manually flush the measuringchamber when using the Rinse function.Pouch Volume1234Volume440 mL220 mL220 mL220 mLCycles230110110110PouchCompositionThe solution composition includes organic buffers and inorganic salts which provide thefollowing substances with approximate concentrations as given below:SubstanceUnitspHpCOpO2mmHgSolution 1Solution 2Solution 37.406.907.6035751515045mmHg2 mmol/L145104160 mmol/L48.52.52 mmol/L1.092.260.55cNacKcCaSolution 4210–All solutionsaremmol/Lbuffered for stability1147913016cClcGlummol/L0All solutionsare bufferedfor stability.Hct%1512563ResultsPreprogrammed Values:TEMP – Temperature in C. Results are indicated at 37 C unless adifferent value is entered. pH, pCO2, and pO2 are then corrected to the keyed-invalue.Measured Values:pH – pH ScalepCO2 – Carbon Dioxide Partial Pressure (mmHg)pO2 – Oxygen Partial Pressure (mmHg)tHb – Total hemoglobin (g%)sO2- Oxygen Saturation in Blood (%)FO2Hb – Fraction of Oxyhemoglobin (%)Page 7 of 13

University of Texas Medical BranchPulmonary Function LabPolicy 04-01 Radiometer ABL80Effective Date:Revised Date:Review Date:Nov 90May 14May 14FCOHb – Fraction of Carboxyhemoglobin (%)FMetHb – Fraction of Methemoglobin (%)Calculated Values:Baro – Barometric Pressure (mmHg)HCO3 – Plasma Bicarbonate (mmol/L)TCO2 – Total CO2 in Plasma (mmol/L)SBE – Standard Base Excess in Blood (mmol/L)Blood Sample Measurements:Pre-operating Checks – Mix the blood sample with a suitable anticoagulant. Also,mix the sample contents immediately before measuring. Record relevant patientdata (i.e., patient temperature, time of sampling, external respiratory assistance,etc.).IMPORTANT: GLOVES MUST ALWAYS BE WORN WHEN OBTAININGOR ANALYZING BLOOD SAMPLES.Syringe Sample:1.Log into analyzer2.Check that the ABL80’s status is READY.3.Traffic light is displaying green or yellow light4.Touch screen to Menu, then Analysis- Aspiration screen appears.Parameters are pre-selected.5.When prompted, slide handle up to the first position.6.Guide inlet probe into the sample; ensure tip is fully immersed inthe sample.7.Select the Aspirate button to start the measurement.8.When prompted by the analyzer, remove the syringe and lowerinlet probe.9.Touch Scan on the screen and scan barcode on patient label.Additional sample information can be put on patient results query. Patient IDnumber is only required information for ABL80 FLEX CO-CO to process sample.A new sample may be introduced when the READY button displays.Calculations The ABL80 calculates the following values based on programmed and measuredvalues.HCO3 – Plasma Bicarbonate (mmol/L)TCO2 – Total CO2 in Plasma (mmol/L)SBE – Standard Base Excess in Blood (mmol/L)Quality ControlPage 8 of 13

University of Texas Medical BranchPulmonary Function LabPolicy 04-01 Radiometer ABL80Effective Date:Revised Date:Review Date:Nov 90May 14May 14Definition: Any measuring instrument used in diagnosis must be checkedroutinely to assure its reliability. RADIOMETER has specified the instrumentaccording to a set of accepted reference methods, which inform the operator aboutits performance characteristics, i.e., inaccuracy and imprecision. Quality control,then, is a method for verifying these specifications by making measurements inthe same way as sample measurements, but on a prepared material withpredetermined value ranges.The ABL 80 FLEX CO-OX analyzer provides automatic quality control analysisfor each parameter, measuring three level of quality control material for bloodgases. The analyzer also measures three levels of controls for all oximetryparameters.Auto QC: The Pulmonary Function Clinic currently uses the AutoQC3 SolutionPack for all reagents. These automatic quality control measurements areperformed during each System Cycle.The Pulmonary Function Clinic runs a minimum of one sample for eachlevel of control daily (the Pulmonary Function Clinic is in operation from8am to 5pm Monday through Friday only). The Laboratory’s QC programwill normally run for one year (i.e., same batch numbers for each controllevel) unless there is a manufacturing limitation on batch availability. Inany case, the program will not run for less than 6 months.Control RangesThe assigned value and control range for each parameter are level areentered automatically into the analyzer each time a new solution pack isinstalled. The values can be viewed and printed from the SystemInformation/Solution Pack tab.Acceptance CriteriaThe analyzer automatically assesses all automatic QC results and flagsany result that is outside the normal range.QC RecordsAll automatic quality control results are stored in the analyzer’s database.QC ResultsThe table of QC results include the follow information: Solution ID Lot Cycles Parameter QC #The quality control results from each System Cycle can be viewed in theSystem Data Logs.Page 9 of 13

University of Texas Medical BranchPulmonary Function LabPolicy 04-01 Radiometer ABL80Effective Date:Revised Date:Review Date:Nov 90May 14May 14Automatic QC plotThe QC plot displays result of all automatic quality control measurementsfor each parameter and each solution level. All QC results are displayed ina bias plot. The plot charts the difference between the measured value andthe assigned value for each parameter and each level. This plottingmethod allows for continual analysis and trending of analyte performancewhile eliminating variations due the solution lot changes.System Checks: Every 30 minutes the analyzer will perform a SystemCheck to verify the stability and proper function on the analyzer. Duringthe System Checks, the analyzer will activate the heater circuitry and airdetection system. Measurements will be taken on all sensor cassettesensors and a drift evaluation will be performed. Proper communicationwith the CO-oximeter will also be confirmed.Corrective ActionThe analyzer will automatically perform corrective actions when theresults of a System Check are not acceptable. The first phase of thiscorrective action is to flush the sensor cases and repeat the measurements.If repeat measurements are not acceptable, the system will automaticallyinitiate a System Cycle to fully evaluate the measurement system. Theevent log records these corrective actions by recording the event alongwith the ac

section 4 in the ABL 80 Flex Reference Manual. Manual Quality Control Reagents QUALICHECK 5 Control Solution is recommended by Radiometer for optimal performance of analyzer. All manual QC solutions will be scanned into the analyzer and solution ID fields entered. Solutions include S7730 QUALICHECK5 Level 1, S7740 QUALICHECK5 Level 2, S7750

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