Presentation on theme: "CLSI EP23™—Laboratory Quality Control Based on Risk Management"— Presentation transcript:
1 CLSI EP23™—Laboratory Quality Control Based on Risk Management James H. Nichols, PhD, DABCC, FACBChairholderEP23 Document Development CommitteeProfessor of Clinical Pathology, Microbiology and ImmunologyVanderbilt University School of MedicineMedical Director, Clinical ChemistryNashville, Tennessee, USA
2 Objectives Review key aspects of risk management. Describe the various types of control processes.Identify CLSI document EP23 as a resource for developing a laboratory quality control (QC) plan based on risk management.Use CLSI document EP23 to develop a quality control plan (QCP) based on risk management for a simple, moderate complexity device.
3 Would you walk underneath this piano? RiskWould you walk underneath this piano?
4 Risk Management Risk management is not a new concept; laboratories: Evaluate the performance of new devices.Troubleshoot instrument problems.Respond to physician complaints.Estimate harm to a patient from incorrect results.Take actions to prevent errors.Risk management is a formal term for what clinical laboratories are already doing every day.
5 Risk Management Definition Systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk (ISO 14971)
6 Risk DefinitionRisk – the chance of suffering or encountering harm or loss (Webster's Dictionary and Thesaurus. Ashland, OH: Landall, Inc.; 1993).Risk can be estimated through a combination of the probability of occurrence of harm and the severity of that harm (ISO/IEC Guide 51).Risk, essentially, is the potential for an error to occur that could lead to patient/staff harm.
10 Quality Control Advantages Disadvantages QC monitors the end product (result) of the entire test system.QC has target values: if assay recovers the target, then everything is assumed stable (ie, instrument, reagent, operator, sample).DisadvantagesWhen a problem is detected, one must go back and reanalyze patients since the last “good” QC.If results are released, then results may need to be corrected.Need to get to fully automated analyzers that eliminate errors up frontUntil that time, need a robust QC plan (QCP)
11 Types of Quality Control “On-Board” or Analyzer QC – built-in device controls or system checksInternal QC – laboratory-analyzed surrogate sample controlsExternal QC – blind proficiency surveyOther types of QC – control processes either engineered by a manufacturer or enacted by a laboratory to ensure result reliability
13 Quality Control Limitations No single QC procedure can cover all devices, because the devices may differ.QC practices developed over the years have provided laboratories with some degree of assurance that results are valid.Newer devices have built-in electronic controls, and “on-board” chemical and biological controls.QC information from the manufacturer increases the user’s understanding of device’s overall quality assurance requirements.ISO. Clinical laboratory medicine – In vitro diagnostic medical devices – Validation of user quality control procedures by the manufacturer. ISO Geneva, Switzerland: International Organization for Standardization; 2004.
14 Laboratory- Manufacturer Partnership Developing a quality plan surrounding a laboratory device requires a partnership between the manufacturer and the laboratory.Some sources of error may be detected automatically by the device and prevented, while others may require the laboratory to take action, such as analyzing surrogate sample QC on receipt of new lots of reagents.Clear communication of potential sources of error and delineation of laboratory and manufacturer roles for how to detect and prevent those risks is necessary.
16 CLSI Document EP23Laboratory Quality Control Based on Risk Management; Approved Guideline (EP23-A™)James H. Nichols, PhD, DABCC, FACB, Chairholder of the document development committeeEP23 describes good laboratory practice for developing a QCP based on the manufacturer’s risk mitigation information, applicable regulatory and accreditation requirements, and the individual health care and laboratory setting.
17 The ScenarioCLSI document EP23 provides guidance on developing an appropriate QCP that will:– Save time and money.– Use electronic and/or integrated QC features.– Use other sources of QC information.– Conform to one’s laboratory and clinical use of the test.
19 The Quality Control Toolbox Every QC tool has its strengths and weaknesses (there is no perfect QC tool).Implement a combination of tools in order to properly control a test.EP23 explains the strengths and weaknesses of the different QC processes.
20 Examples of Quality Control Tools Intralaboratory QCInterlaboratory QCIntegrated (built-in) QCMeasuring system function checksElectronic system checksCalibration checksRepeat testing of patient samplesMonitoring aggregated patient resultsImplausible valuesDelta checksCorrelation of multiple analytes in same sample
22 Gather Information for the Risk Assessment Gather information from several sources:– Regulatory and accreditation requirementsClinical Laboratory Improvement Amendments Test/test system informationUser’s manual, reagent package insert, literature– Health care and testing site settingsTemperature conditions, operator training programs– Medical requirements for the test resultsAllowable performance specifications via physicians
23 Developing a Process Map Break down all phases of the test or test system into steps, so that weak points can be identified.Each step can be analyzed to find potential failure modes that could present significant risk to patients.Process can then be further analyzed to see if controls can be put into place to avoid the failures.
25 Key Process StepsView the preexamination (preanalytical), examination (analytical), and postexamination (postanalytical) areas of the laboratory.Think about what steps can be taken to reduce potential errors “unrelated” to the actual testing of the sample.
26 Where Is the Risk in the Process? What could possibly go wrong?
28 Hazard or Risk Identification Some areas to consider for weaknesses in the process:Testing personnel training and competencyReagent/calibrator/parts procurement and storagePatient sample acceptabilitySystem startupSystem calibrationLoading and testing of patient samplesProper device functionTest result review
30 Perform the Risk Assessment Identify the potential failures and their causes.– Review the process map, fishbone diagram, manufacturer’s instructions, etc.Assess each potential failure.Where a failure could occur, add an element to the QCP that will reduce the possibility of that failure, making residual risk acceptable.– For some types of failures, the manufacturer’s information may already have a quality check in place.
31 Perform the Risk Assessment (cont’d) Construct a table; see which types of errors are detected and which ones are not.– If not detected, it must be included in the QCP.For each possible failure, assess the possibility of that failure.– Do this for each identified failure.– Use all of the information gathered in order to make these assessments.
32 Assemble the Quality Control Plan Use the information gathered earlier to assess all of the identified risks and their control measures.Construct the QCP.Include each of the identified QCP actions in the QCP.
34 Monitor Quality Control Plan for Effectiveness Verify that the QCP that is put in place actually works.Continue to monitor errors and control failures.If an error occurs:– Take the appropriate corrective action.– Investigate the cause of the error.– Once the cause is understood, evaluate whether any changes need to be made in the QCP.
35 Monitor Quality Control Plan for Effectiveness (cont’d) Review any complaints that the laboratory receives from health care providers.– These complaints may include pointing out another source of QC “failure” that must be addressed.For patient safety, the QCP should be reviewed and monitored on an ongoing basis to ensure that the QCP is optimal.
36 Don’t Be Discouraged—Risk Management Is Documenting Much of What We Already Do!
37 Polling Question #1 What is a QCP? The frequency of liquid controls for a testA form that defines required specifications of materials from suppliersA document that describes the practices, processes, and sequences of specified activities to control the quality of a particular measuring systemNone of the above
38 A laboratory director wants to develop a QCP The ScenarioA laboratory director wants to develop a QCP– Incorporates the right QC processes for the specific test– Uses adequate QC to control for their potential error sources– Follows manufacturer’s instructionsA unit-use blood gas analyzer will be used as the example.
42 Blood Gas and Electrolytes Generic unit-use blood gas/lytes analyzer in a same-day surgical centerLow volume: tests/dayNeed for daily liquid QC uses two kits ($10 each) and adds to turnaround time (TAT).Adoption of nontraditional QC through EP23 would improve cost, test, and labor efficiency.
43 Blood Gas and Electrolytes Portable clinical analyzer for in vitro quantification of various analytes in whole bloodAnalyzers and cartridges should be used by healthcare professionals trained to use the system according to the facility’s policies and procedures.
44 Blood Gas and Electrolytes System consists of:Portable clinical analyzerTest cartridges sealed in foil pouch for protection during storageQuality assurance materialsControl solutionsCalibration verification setData Management SystemServer class computerData management softwareWireless connectivity and LIS/HIS interfacesDeviceDeviceDeviceDevice
45 Blood Gas and Electrolytes Unit use cartridge contains all components to perform the testing– Calibrating solutionReagentsSample handling systemSensorsAnalyzer automatically controls all steps of the testing process:Fluid movementCalibrationReagent mixingThermal control
46 Cartridge OperationsCartridges are standardized to plasma core lab methods using multi-point calibration curves stored in the device memory that are stable over many lotsUpon insertion, a calibrant solution in the cartridge is passed across the sensors.Signals produced by the sensor’s responses to calibrant are measured – A one-point calibration adjusts the offset of stored multi-point calibration curve.Analyzer then moves sample over sensors, and the signal of the sensor responses to the sample are measured off the adjusted calibration curve
47 Polling Question #3What types of quality control processes can help laboratories manage their risk of errors for a blood gas/electrolyte test system?Liquid quality control samplesManufacturer checks and simulated internal electronic controlsStaff training and competencyAll of the above
48 Internal Control Processes Simulated internal QC - diagnostic check of the edge connector, internal electronics, and analyte circuitry.Internal QC simulates electronic signals produced by the sensors during a cartridge test.An isolated region of the internal circuit board sends a range of simulated sensor signals through the cartridge measurement channelsRange of signals encompasses entire linear range expected from blood analytesNext, conductivity out of the connector pins is measured, insuring no contamination is present in the edge connector which would interfere with the test.Signal measurements must fall within strict predetermined thresholds to pass.
49 Quality Control Recommendations Internal Simulated QC:Automatically performed by device every 8 hrsIf significant change in analyzer temp (cold to hot)Whenever performance of device in questionLiquid QC:Each shipment of cartridgesNew lots of cartridgesIf cartridges experience temperature shift >8°C (15°F)Periodically as required by facility policiesTemperature VerificationMonitored continuously during each patient test, but verification cartridge available and recommended annually, or as required by facility policy
50 Identify Weak Steps for Hazards or Risk of Error Create a Process MapIdentify Weak Steps forHazards or Risk of Error
51 Polling Question #4What are some common sources of error for a blood gas/electrolyte test system?Shipping and storage temperature of cartridgesOperator techniqueDevice failureAll of the above
52 Finding the Failure Points Hazard Identification
53 Process Map: Finding the Failure Points Work from the current package insertTest order – electronic or hardcopyTest collectionIncorrect collection – bubbles, sample exposure to airWrong tube type – calcium titrated, heparinized BG tubesIndirect phlebotomy – line draw contaminationUndermixing/overmixing – sample clots, hemolysisAnalytic delay – glucose, BG, pH, iCa, etc.AnalysisWrong sample volume loaded onto cartridgeIncorrect procedure, timing, result interpretationExpired reagentReagent exposure during shipmentDegradation during storageInfection ControlResult reporting errors
54 Conduct a Risk Assessment Identify Control Processes for Each Hazard That Maintain Risk at a Clinically Acceptable Level
55 Blood Gas and Electrolytes Risk Assessment Refer to Appendix A, CLSI document EP18 for a more comprehensive list of error sources.Work from the manufacturer’s current package insert.SamplesPhysician order – POCT possible w/o order, need written or electronic physician order before commencing test.Wrong tube type – train to use BG syringes/tubesLine contamination – train on preferred collection and techniques if catheter collection is only optionSample mixing – analyzer has clot detection, but will not detect hemolysis - train on proper mixing techniqueAnalytic delay – YES – train to analyze immediately, no longer than mins of collection
56 Blood Gas and Electrolytes Risk Assessment (cont’d) OperatorOperator lock-out – prevents use of analyzer by untrained operatorsSample volume detection – Analyzer detects inadequate sample volume and prevents overloading.Incorrect procedure, timing, result interpretation – analysis and result interpretation fully automated, clotted sample or bubbles will be detected by analyzer.Expired reagents – cartridges are bar-coded with lot number and expiration date, analyzer prevents use past expirationWireless Connectivity – data management automates reporting of result provided patient properly identified, train on proper patient ID, use barcoded wristbandsInfection control – train to clean and disinfect after each use
57 Blood Gas and Electrolytes Risk Assessment ReagentsTest exposure outside specifications (eg, temperature, humidity) during shipment – analyze liquid QC with each shipmentLot-to-lot variability – analyze liquid QC with each lotLiquid QC degradation – monitor refrigerator (2 to 8°C), bring to room temperature at least 30 minutes before use, discard within 30 days of opening bottleDegradation during storage – monitor storage conditions, room temp for 2 years). If refrigerated, bring to room temperature at least 30 minutes before use, (analyze liquid QC due to temp change). What about other QC frequency?
58 Polling Question #5How should laboratories determine the optimal frequency of liquid quality controls?Refer to the manufacturer’s package insert recommendationsIdentify local and regional regulatory requirementsConduct a risk assessmentAll of the above
59 Liquid Quality Control Frequency Minimum – follow manufacturer recommendations and regulatory requirements (CLIA for BG analysis – one QC sample q 8 hr, two levels q 24 hrs, one QC w/ each pt sample unless calibration every 30 mins)Manufacturer recommends liquid QC with eachShipmentNew lotSignificant change in cartridge temperature (>8°C)Whenever question of test system performanceOptions for determining liquid QC frequencyPeer publications – verify what others are already doingDevelop QC rules based on six-sigma of test systemVerify in your facility:analyze 2 levels each day for several weeks, then reduce to every few days, weekly or monthly after more experience with test systemQC-lockout assists with compliance
60 Blood Gas and Electrolytes Risk Assessment (cont’d) EnvironmentIncorrect collection – train staff anaerobic phlebotomyCompliance with documentation – risk bases on prior issues with other testing noted at this location (refrigerator monitoring, QC documentation, etc.)Clinical ApplicationImmediate medical decisions – test results used to manage critical patients, higher risk since only one chance to get right result!Sample not stable – analyze immediately, presents higher risk since can’t be repeated!
62 Blood Gas and Electrolytes Quality Control Plan Analyze liquid QC.Each new shipment*Start of a new lot*After significant change in cartridge temperature (>8°C) *Whenever uncertainty about analyzer performance*Monthly (based on facility verification and experience with test)Note: Simulated multi-level quality control automatic every 8 hours and internal calibration with each test cartridge **Use checklist to document training/competency.Test only when electronic or written physician orderProper patient identificationUse BG syringes/tubes for specimen collectionArterial BG collection (preferred), or line draws as requiredUse anaerobic techniqueMix specimens appropriately and analyze immediatelyMonitor refrigerator and room temperaturesClean and disinfect analyzers after each use *(* Manufacturer recommendations) (** Mandated by accreditation regulations)
63 What should a laboratory do once a QCP is drafted? Polling Question #6What should a laboratory do once a QCP is drafted?Have a party; the laboratory has now proved the quality of its test.Nothing; once developed, the QCP is the end of the risk management process.Monitor its QCP for effectiveness, and modify the plan as needed.None of the above.
64 Monitor for Failure/Errors and Modify Quality Control Plan as Needed Implement theQuality Control PlanMonitor for Failure/Errors and Modify Quality Control Plan as Needed
65 Quality Control Plan Implementation: BG/Electrolyte Monitors Frequency of analyzer error codesLiquid QC failure ratesFrequency of specimen issues – hemolysis, clots, or other problemsNumber of physician complaints: results that don’t match clinical situationAny other unexpected error
66 Risk Management will help you learn about your processes and weaknesses
67 SummaryRisk management is something laboratories are already doing. EP23 simply formalizes this.A QCP is necessary for result quality, and each QCP is unique.A QCP is the industry standard. It depends upon the extent to which the device’s features achieve their intended purpose in union with the laboratory’s expectation for ensuring quality results.Once implemented, the QCP is monitored for effectiveness and modified as needed to maintain risk at a clinically acceptable level.