Professional Documents
Culture Documents
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Risk Management
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Risk Management Definition
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Risk Definition
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What could go wrong?
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Sources of Laboratory Error
• Environmental:
– Temperature
– Humidity
– Light intensity
– Altitude
• Operator:
– Improper specimen preparation, handling
– Incorrect test interpretation
– Failure to follow test system instructions
• Specimen:
– Bubbles
– Clots
– Incorrect tube additive
• Analysis:
– Calibration factor incorrect
– Mechanical failure
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Managing Risk With
a Quality Control Process
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Quality Control
• Advantages
– 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).
• Disadvantages
– When 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.
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Types of Quality Control
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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.
ISO. Clinical laboratory medicine – In vitro diagnostic medical devices –
Validation of user quality control procedures by the manufacturer. ISO
15198. Geneva, Switzerland: International Organization for
Standardization; 2004.
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Laboratory-
Manufacturer Partnership
• Developing a quality plan surrounding a laboratory device
requires a partnership between the manufacturer and the
laboratory.
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Quality Control
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CLSI Document EP23
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Developing a QCP
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The Quality Control Toolbox
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Examples of
Quality Control Tools
• Intralaboratory QC
• Interlaboratory QC
• Integrated (built-in) QC
• Measuring system function checks
• Electronic system checks
• Calibration checks
• Repeat testing of patient samples
• Monitoring aggregated patient results
• Implausible values
• Delta checks
• Correlation of multiple analytes in same sample
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What Could Go Wrong?
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Gather Information
for the Risk Assessment
• Gather information from several sources:
– Regulatory and accreditation requirements
• Clinical Laboratory Improvement Amendments Test/test
system information
• User’s manual, reagent package insert, literature
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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.
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Process Map
Process Map
High-Level
Measurement Process
3 2
Measuring system
Startup/maintenance/ Operator training and
Examination ready
calibration compentency
4
Laboratory
environment
Reagents/calibrators/ 1
Start parts procurement and Samples received at
storage measuring system
Sample acceptability
is evaluated
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Measuring system
Yes No
error message or
malfunction?
Troubleshooting
performed and
corrective action taken
Yes
No
Results are
evaluated
Performance
verified?
Results are reported
No
Yes
Samples are
unloaded
and stored
Repeat
examination
required? End
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Key Process Steps
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Where Is the
Risk in the Process?
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Identify the Risks
1 2 4
Samples Operator Laboratory Environment
Sample Integrity Atmospheric Environment
- Lipemia Operator Capacity - Dust
- Hemolysis - Training - Temperature
- Interfering subtances - Competency - Humidity
- Clotting
- Incorrect tube
Utility Environment
Sample Presentation Operator staffing - Electrical
- Bubbles - Short staffing - Water quality
- Inadequate volume - Correct staffing - Pressure
Identify Potential Hazards Incorrect Test Result
Reagent Degradation
- Shipping Instrument Failure
- Software failure
- Storage
- Optics drift
- Used past expiration Calibrator Degradation - Electronic instability
- Preparation - Shipping
Quality Control Material Degradation - Storage
- Used past expiration Inadequate Instrument Maintenance
- Shipping
- Preparation - Dirty optics
- Storage
- Contamination
- Used past expiration
- Scratches
- Preparation
3 5
Reagents Measuring
System
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Hazard or Risk Identification
• Some areas to consider for weaknesses in the
process:
– Testing personnel training – System startup
and competency – System calibration
– Reagent/calibrator/parts – Loading and testing of
procurement and storage patient samples
– Patient sample – Proper device function
acceptability – Test result review
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Risk Assessment
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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 (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.
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Assemble the
Quality Control Plan
• Use the information gathered earlier to
assess all of the identified risks and their
control measures.
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What could go wrong?
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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.
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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.
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Don’t Be Discouraged—Risk
Management Is Documenting Much of
What We Already Do!
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Polling Question #1
What is a QCP?
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The Scenario
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Developing a
Quality Control Plan
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Polling Question #2
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Gather the Information
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Blood Gas and Electrolytes
• Generic unit-use blood gas/lytes
analyzer in a same-day surgical
center
• Low volume: 0 - 5 tests/day
• Need 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.
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Blood Gas and Electrolytes
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Blood Gas and Electrolytes
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Cartridge Operations
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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 channels
• Range of signals encompasses entire linear range
expected from blood analytes
• Next, 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.
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Quality Control Recommendations
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Create a Process Map
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Polling Question #4
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Finding the Failure Points
Hazard Identification
1 2 4
Samples Operator Laboratory Environment
Sample Integrity Atmospheric Environment
- Lipemia Operator Capacity - Dust
- Hemolysis - Training - Temperature
- Interfering subtances - Competency - Humidity
- Clotting
- Incorrect tube
Utility Environment
Sample Presentation Operator staffing - Electrical
- Bubbles - Short staffing - Water quality
- Inadequate volume - Correct staffing - Pressure
Identify Potential Hazards Incorrect Test Result
Reagent Degradation
- Shipping Instrument Failure
- Software failure
- Storage
- Optics drift
- Used past expiration Calibrator Degradation - Electronic instability
- Preparation - Shipping
Quality Control Material Degradation - Storage
- Used past expiration Inadequate Instrument Maintenance
- Shipping
- Preparation - Dirty optics
- Storage
- Contamination
- Used past expiration
- Scratches
- Preparation
3 5
Reagents Measuring
System
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Process Map:
Finding the Failure Points
• Work from the current package insert
• Test order – electronic or hardcopy
• Test collection
– Incorrect collection – bubbles, sample exposure to air
– Wrong tube type – calcium titrated, heparinized BG tubes
– Indirect phlebotomy – line draw contamination
– Undermixing/overmixing – sample clots, hemolysis
– Analytic delay – glucose, BG, pH, iCa, etc.
• Analysis
– Wrong sample volume loaded onto cartridge
– Incorrect procedure, timing, result interpretation
– Expired reagent
– Reagent exposure during shipment
– Degradation during storage
• Infection Control
• Result reporting errors
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Conduct a Risk Assessment
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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.
• Samples
– Physician order – POCT possible w/o order, need written
or electronic physician order before commencing test.
– Wrong tube type – train to use BG syringes/tubes
– Line contamination – train on preferred collection and
techniques if catheter collection is only option
– Sample mixing – analyzer has clot detection, but will not
detect hemolysis - train on proper mixing technique
– Analytic delay – YES – train to analyze immediately, no
longer than 15-30 mins of collection
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Blood Gas and Electrolytes
Risk Assessment (cont’d)
• Operator
– Operator lock-out – prevents use of analyzer by
untrained operators
– Sample 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
expiration
– Wireless Connectivity – data management automates
reporting of result provided patient properly identified,
train on proper patient ID, use barcoded wristbands
– Infection control – train to clean and disinfect after each
use
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Blood Gas and Electrolytes
Risk Assessment
• Reagents
– Test exposure outside specifications (eg, temperature,
humidity) during shipment – analyze liquid QC with each
shipment
– Lot-to-lot variability – analyze liquid QC with each lot
– Liquid QC degradation – monitor refrigerator (2 to 8°C),
bring to room temperature at least 30 minutes before use,
discard within 30 days of opening bottle
– Degradation during storage – monitor storage conditions,
(stable @ 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?
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Polling Question #5
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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 each
– Shipment
– New lot
– Significant change in cartridge temperature (>8°C)
– Whenever question of test system performance
• Options for determining liquid QC frequency
– Peer publications – verify what others are already doing
– Develop QC rules based on six-sigma of test system
– Verify 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 system
• QC-lockout assists with compliance
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Blood Gas and Electrolytes
Risk Assessment (cont’d)
• Environment
– Incorrect collection – train staff anaerobic phlebotomy
– Compliance with documentation – risk bases on prior
issues with other testing noted at this location
(refrigerator monitoring, QC documentation, etc.)
• Clinical Application
– Immediate 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!
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Summarize the
Quality Control Plan
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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 order
– Proper patient identification
– Use BG syringes/tubes for specimen collection
– Arterial BG collection (preferred), or line draws as required
– Use anaerobic technique
– Mix specimens appropriately and analyze immediately
– Monitor refrigerator and room temperatures
– Clean and disinfect analyzers after each use *
(* Manufacturer recommendations) (** Mandated by accreditation regulations)
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Polling Question #6
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Implement the
Quality Control Plan
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Quality Control Plan
Implementation: BG/Electrolyte Monitors
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Risk Management will help you learn
about your processes and weaknesses
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Summary
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Now that you’ve survived this…
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