5/13/2021

Chapter 7
Laboratory Quality Management
Systems

Introduction to Quality
Reliable and accurate test results in a timely manner
Laboratory standards
Compare performance to a standard
Set by ISO (manufacturing standards)
Set by CLSI
Quality management systems
Systematic approach – consider all processes
Every aspect of the lab is related to quality
Staffing shortages, reliable instruments, space
Must be able to detect errors before results are sent out

Introduction to Quality
Elements of QMS:
Facilities and safety
Customer service
Process improvement -CQI
Documents and records
Occurrence management
Assessment – lab proficiency testing
Purchasing and inventory
Process control – sample mgmt., QC, method validation
Information management
Equipment
Personnel
Organizational structure

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Facilities and Safety Overview

Employee responsible for safety
Follow safety protocols
PPE
Management responsible for identification of risks
Create appropriate training
Safe work environment
Document safety training

Instruments
Properly performing instruments yield accurate results
Selection of instruments
Not too large, not too small
Reagent cost, ancillary cost
Maintenance, tech support
Testing menu
Preparation for use (done by manufacturers)
Calibration
Parallel testing
Precision studies

Instrument Maintenance
Preventive maintenance
Manufacturer determined
Troubleshooting equipment problems
Backup analyzer or testing methods
Random errors
Variety of sources
Instrument service contracts
Equipment maintenance documentation

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Purchasing and Inventory

Inventory management: efficient and cost-effective
Responsibilities of management
Purchase agreements and delivery
How much to order (have enough but not go bad)
Responsibilities of staff
Receipt and stocking
Put newer stock in back of shelves, keep lots together

Process Control: Preanalytical

Phase
Most laboratory errors (up to 68%) occur in the preanalytical
phase (period from order to ready for testing)
Controllable variables
Preventable errors – majority of errors
Ordering the right test on the right patient
Uncontrollable variables
Diurnal variations
Physiologic factors

Process Control: Preanalytical

Phase
Precollection
Patient identification (2 identifiers)
Errors can cause the need for redraws
Collection
Proper specimen collection – right tubes, right order of draw, …
Proper tube labeling
Hemolysis
Clerical errors
Processing
Lab check-in time and info
Sample rejection
Centrifugation, aliquotting,…
Transport, storage, and retention

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Process Control: Analytical Phase

Instrument function
Many analytical phase errors occur as a result of a mechanical malfunction of
the instrument. These include the aspiration of the sample, the dispensing of
reagents, the age of the lamp or ISE module, as well as the function of the
various pumps that are often contained in automated analyzers.
Reagent and calibration quality
Storage, calibration frequency
Technical competence
Annual assessment of lab techs
Ancillary equipment
Heat blocks and water baths
Refrigerators and freezers
Centrifuges

Control Materials
Contain a specific amount of analyte; tested just like patients
Tests validity and reliability of instrument and operator
Always uses at least a normal and abnormal level, daily
Buy enough to last months
Forms of control materials
Same material as sample (serum, plasma,…)
Frozen, lyophilized or liquid
Assayed vs. unassayed controls
Assayed controls come with predetermined ranges set for
each analyzer type; generally range is adjusted in each lab
Unassayed controls need their range set by the lab, cheaper

Control Materials
Lot-to-lot correlations for control materials
Parallel testing
20 times in 20 days, minimum, run alongside patient tests
Set mean, SD stays same
New reagent lot
Patient correlation
Run controls
Frequency of analysis
After maintenance
Each new reagent lot/new reagent calibration
Once per 24 hrs, or once per shift
Calibrator materials
Set the calibration curve (signal into result)
Calibrations set the limits of testing (linearity)
Calibrations are run every 6 months minimum
Each new lot of reagent has to be calibrated
Run for troubleshooting out of range QC

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Quality Control
Essential part of QMS
Determines whether patients can be tested on the analyzer
Goal of QC
Detect, evaluate and correct errors before results are
reported
Has to fall within control limits
Determines accuracy and precision
Accuracy = validity
Precision = reproducibility

Quality Control
Statistics
Mean
Normal distribution
Standard deviation (amount of variation around the mean)
Confidence intervals (1SD-68%, 2SD-95%, 3SD-99%)
𝑠
Coefficient of variation (𝑥ҧ )x100
Monitors precision
<5%
Reference ranges
Decision limits
95% of normal people fall in the normal range
Therapeutic ranges for drugs
Established by manufacturers (needs 100s of normal samples)
Verified by labs for their population (20 normal samples)

Method Evaluation
Many methods and tests are available
Must evaluate:
Cost of testing
Time required for testing
Quality of results
Accuracy and precision
Diagnostic specificity: ability of the test to detect the absence
of a disease, % of people without the disease whose test will
be negative (true negatives, false positives)
Diagnostic sensitivity: ability to detect a disease in someone
that has the disease, % of people who have the disease whose
test is positive (true positives, false negatives)
Linear regression is used to correlate 2 methods

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Analysis of Quality Control

Random error
Infrequent
Can be positive or negative (too high or too low)
Systematic error
Consistently shift values in one direction (pos/up or neg/down)
Trend: 6 control results in a row going up or down, indicates gradual
deterioration
Shift: sudden change, 6 or more results on one side of the mean (up or
down from the mean)
Both are seen on the Levey-Jennings chart

Analysis of Quality Control

Levey-Jennings chart

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Analysis of Quality Control

Youden plot: looks at normal and abnormal QC together;
spread of data should be equal

Analysis of Quality
Control
Westgard rules

Analysis of
Quality Control
Westgard rules

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Analysis of Quality
Control
Corrective actions

External Quality Control

Proficiency testing
External organization like CAP sends unknown samples
No consultations
Performed by same testing personnel
Performed with routine testing
Tests lab performance on all the tests offered and compares to
peers
Repeated failures of proficiency testing can result in loss of
ability to perform and bill for a test

Process Control: Postanalytical

Phase
Interpreting test results
reference ranges are always reported with patient results
the meaning of abnormal results is not always well
understood
Reporting test results (autoverify)
LIS systems
Flagged results
Delta checks
Critical values

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Assessment & Audits

Assessment determines effectiveness of QMS
Demonstrates meeting necessary requirements
Accreditation standards
Internal Audits
Meeting current standards?
Policies working?
External Audits
Accreditation agencies
Continuous quality improvement cycle
Plan, monitor, corrective actions, evaluate

Personnel
Most valuable resource
Participate in training
Maintain records of professional development
Competency and competency assessment
Required by accreditation agencies
Details the expectations and the past performance of an
employee
Documentation that the employee can perform their job

Customer Service
Meeting customers’ requirements
Laboratory customers include:
Patients
Physician and office staff
Nursing staff
Public health agencies
Assessment : surveys

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Occurrence Management and

Process Improvement
Errors and near misses
Proactive process
Occurrence has a negative impact
Continuous process improvement
PDCA
Tools: lean and 6-sigma
Quality indicators
Contribution to patient care

Documents and Records

Policies, processes, and procedures
Procedure manuals (electronic or paper)
Procedures must contain certain information
Operating procedures detail how to perform the test
Quality manual contains the QMS
Records are generated by laboratory processes
Instrument printouts - keep 2 years
Patient records – much longer

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