The New EP23 ‒ Laboratory Quality Control Based on
Risk Management,Approved Guideline
Luann Ochs, MS
Senior Vice President – Operations
Clinical and Laboratory Standards Institute
Objectives
• Describe the various types of control processes.
• Identify CLSI document EP23-A as a resource for developing a laboratory quality control (QC) plan based on risk management.
• Review key aspects of risk management.
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Today’s Quality Control
• Advantages– QC monitors the end product (result) of the entire test system.– QC has target values: if assay recovers target, then everything
is assumed stable (instrument, reagent, operator, sample).
• Disadvantages– When a problem is detected, one must go back and reanalyze
patients since last “good” QC.– If results are released, then results may need to be corrected.– For Point of Care devices, does traditional QC work for every
test?
• Need to get to fully automated analyzers that eliminate errors up front– Until that time, need a robust QC plan (QCP)
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Types of Quality Control
• “On-Board” or Analyzer QC – built-in device controls or system checks
• Internal QC – laboratory-analyzed surrogate sample controls
• External QC – blind proficiency survey
• Other types of QC – control processes either engineered by a manufacturer or enacted by a laboratory to ensure result reliability
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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.
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, and helps the laboratory determine the right combination of tools: The Right QC
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CLSI Document EP23
• Laboratory Quality Control Based on Risk Management; Approved Guideline
• James H. Nichols, PhD, DABCC, FACB, Chairholder of the document development committee
• EP23 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.
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The Scenario
• CLSI 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.
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Developing a QCP
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MEASURING SYSTEM INFORMATION
Medical Requirements forthe Test Results
Regulatory andAccreditationRequirements
Test System Information- Provided by the Manufacturer- Obtained by the Laboratory
Information AboutHealth Care andTest Site Setting
PROCESSRisk Assessment
OUTPUTQuality Control Plan
PROCESSPost-implementation Monitoring
Measuring System Information
• Gather information from several sources:– Medical requirements for the test results
• Allowable performance specifications via physicians– Regulatory and accreditation requirements
• Clinical Laboratory Improvement Amendments – Test/test system information
• User’s manual, reagent package insert, literature• Prior laboratory data
– Health care and testing site settings• Temperature conditions, operator training programs
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Developing a Process Map
• Break down all phases of the test/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.
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Process Map
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Developing a Process Map (cont’d)
• Compile this information. • A process map or a fishbone diagram is one example.
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Incorrect Test Result
1 Samples
2 Operator
3 Reagents
5Measuring
System
4Laboratory Environment
Sample Integrity
Sample Presentation
- Lipemia- Hemolysis- Interfering subtances- Clotting- Incorrect tube
- Bubbles- Inadequate volume
Operator Capacity
Operator staffing
Atmospheric Environment
Utility Environment
- Training- Competency
- Short staffing- Correct staffing
- Dust- Temperature- Humidity
- Electrical- Water quality- Pressure
Reagent Degradation- Shipping- Storage- Used past expiration- Preparation
Quality Control Material Degradation- Shipping- Storage- Used past expiration- Preparation
Calibrator Degradation- Shipping- Storage- Used past expiration- Preparation
Instrument Failure
Inadequate Instrument Maintenance
- Software failure- Optics drift- Electronic instability
- Dirty optics- Contamination- Scratches
Identify Potential Hazards
The Risk Assessment
• Once the process map is created, examine it for places where errors could occur.
• Five major areas: – Samples– Operator– Reagents– Laboratory environment– Measuring system
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Key Process Steps
Think about what steps can be taken to reduce errors “unrelated” to the actual testing
of the sample.
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PREPARATIONPre-analytical
Pre-examination
TESTINGAnalytical
Examination
RESULT REPORTINGPost-analytical
Post-examination
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.
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Perform the Risk Assessment
• “Risk Assessment” and “Risk Management” are formal terms for what you’re already doing.
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Risk Definition
• Risk – 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.
Life is a Continual Risk Assessment
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You assess risk every day,
all the time, usually without even
thinking about it.
In the Laboratory
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You do this every day!
Assess the Risk of Harm Due to Failures
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Defective IVD:Hazard
Incorrect ordelayed
test result:Hazard
Incorrect ordelayed medical
treatment:HazardousSituation
Injury or death:Harm
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 likelihood of that failure occurring, and the severity of consequences if it occurs.– Do this for each identified failure.– Use all of the information gathered in order to make
these assessments.
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Risk Assessment Worksheet
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Frequency (1 – 5) Example(Sometimes called “Probability”)
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Common Terms
Rating Example (ISO 14971)
Practical Example
Frequent 5 ≥ 1/1,000 More than 1x/week
Probable 4 < 1/1,000 and ≥1/10,000
Once every few months
Occasional 3 < 1/10,000 and ≥1/100,000
Once a year
Remote 2 < 1/100,000 and ≥1/1,000,000
Once every few years
Improbable 1 < 1/1,000,000 and
≥10,000,000
Unlikely to ever happen
The laboratory must decide – and it may be different for different tests!
Severity (1 – 5) Example
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Common Terms
Rating Possible Description(ISO 14971)
Catastrophic 5 Results in patient deathCritical 4 Results in permanent injury of life-
threatening injurySerious 3 Results in injury or impairment
requiring professional medical intervention
Minor 2 Results in temporary injury or impairment not requiring professional
medical interventionNegligible 1 Inconvenience or temporary discomfort
Detectability (1 – 5)
What is the likelihood that the control process detects or prevents the failure?
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Common Terms
Rating Example
Low 5 Control is ineffective 4 Control less likely to detect the
failure 3 Control may or may not detect the
failure 2 Control almost always detects the
failureHigh 1 Control can detect the failure
Risk Acceptability Matrix
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Probability of Harm
Negligible Minor Serious Critical Catastrophic
Frequent Unacceptable Unacceptable Unacceptable Unacceptable Unacceptable
Probable Acceptable Unacceptable Unacceptable Unacceptable Unacceptable
Occasional Acceptable Acceptable Unacceptable Unacceptable Unacceptable
Remote Acceptable Acceptable Acceptable Unacceptable Unacceptable
Improbable Acceptable Acceptable Acceptable Acceptable Unacceptable
Severity of Harm
Criticality
• Multiply Frequency x Severity x DetectabilityExample: Probable (4) x Catastrophic (5) x High likelihood to detect failure (1) = 20
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Criticality Result
Low <10
Mid 10 – 20
High >20
Higher criticality numbers must have quality control actions in place.
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.
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Monitor QCP 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.
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Monitor QCP 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.
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Summary
• 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.
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EP23 Companion Products
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Risk Assessment WorksheetImplementation Workbook
Plus – More fully worked examples coming soon
www.clsi.org