Variations, Errors, and Quality

VARIATIONS, ERRORS, AND QUALITY
RESIDENT’S WEEKLY REPORT (TUESDAY)

LEARNING OBJECTIVES
1. Determine the FACTORS THAT AFFECT THE ACCURACY of laboratory test results.
2. Describe the CLASSIFICATIONS OF ERRORS and its impact.
3. Explain the significance of TOTAL ANALYTICAL ERROR.
4. Determine the QUALITY SYSTEM ESSENTIALS of an operational clinical laboratory.
5. Characterize the STAGES OF QUALITY SYSTEMS.

GUIDE QUESTIONS
1. What are the factors that constitute an accurate laboratory result?
2. How are errors classified?
3. How are outcomes of errors classified?
4. What is the total analytical error?
5. What are quality system essentials?
6. Explain the hierarchy of quality in the clinical laboratory.

HENRY’S CLINICAL DIAGNOSIS AND MANAGEMENT 23RD
EDITION STATES:
“ The purpose of a clinical laboratory test is to evaluate the

pathophysiologic condition of an individual patient to assist with
diagnosis, to guide or monitor therapy, or to asses risk for a
disease or for progression of a disease.”
FACTORS THAT CAN AFFECT ACCURACY OF
LABORATORY RESULTS
TO TEST OR NOT….THAT IS THE QUESTION
 What is my reason for requesting this test? E.g. am I investigating symptoms and signs? Am I monitoring a disease or effect of a
medicine? Is this a screening test?
 Has this test already been done? Does it need to be repeated? If so, when?
 Will the test improve patient (or in some cases, family or partner) care?
 Is this the right test or combination of tests for the clinical situation?
 Is it the right time to do the test?
 How should the sample be taken?
 How should the sample be stored and transported?
 How will the test result be interpreted?
 How will the test result influence patient management?
 What will be the consequences of a false positive result?
FACTORS
Biological Variations
Individual Variations
Analytical Variations
BIOLOGICAL VARIATIONS
Advancing age Biological rhythms

• Comorbidities • Circadian rhythm
• Polypharmacy • Diurnal variations
Menstrual cycle Pregnancy

• Hormonal evaluation • Physiologic changes
INDIVIDUAL VARIATIONS
Diet and
Tobacco
nutritional Caffeine Alcohol Exercise
smoking
status
ANALYTICAL VARIATIONS
Transport of
Collection Storage Hemolysis
samples
LABORATORY ERRORS
“Failure of a planned action to be completed as intended, or use of

a wrong plan to achieve an aim, occurring at any part of the
laboratory cycle, from ordering examinations to reporting results
and appropriately interpreting and reacting to them.”
- ISO 2016
CLASSIFICATIONS OF ERRORS
1. Errors exclusively within the laboratory.

1. Pre-Analytical: Acceptance of improper specimens; Mismatch during analysis.
2. Intra-Analytical: Failure of the diagnostic system; Analytical interference; Procedures not followed; Undetected failure in QC
3. Post-Analytical: erroneous validation of analytical data; Failure in reporting; Excessive TAT
2. Laboratory errors caused by organizational problems outside the laboratory.

1. Wrong identification of patient at bedside
2. Sample mismatch during phlebotomy performed by non-laboratory personnel
3. Wrong procedure for specimen collection
4. Errors in specimen transport to the laboratory
3. Errors at the laboratory-clinical interference.

1. Appropriateness of test request
2. Appropriateness of test interpretation
3. Appropriateness of test utilization
THREE PHASES IN THE LABORATORY
Pre-Analytical
• Patient assessment, test order • Ordering test on the wrong patient

entry, request completion, • Ordering a wrong test
patient identification • Misidentifying the patient
• Specimen collection, transport, • Inappropriate collection container
and receipt in the laboratory • Improper labeling of containers
Analytical
• Preparation of specimen for

testing • Equipment malfunction
• Results interpreted and verified • Sample mix-up/ interchange
• Undetected failure in QC
by the technologist
• Procedures not followed
• Accuracy, precision, sensitivity,
specificity, and linearity
Post-Analytical
• Results released to the clinician,

interprets and makes diagnostic and • Failure in reporting
therapeutic decisions.
• Erroneous validation of analytical
• Ultimate check on the consistency of
pre- and analytical quality data
• Verifying results, feeding them into • Improper data entry
LIS, communicating them to the
clinicians…
TYPES OF ERRORS
Systematic Errors/ Determinate Random Errors/ Indeterminate

 Change in the mean of the control values  Any deviation away from an expected result.
 Trend/Shift  QC results: any positive or negative deviation
 Cause: Analytical Procedure or Instruments away from the calculated mean
 Cause: Unknown or unpredictable changes
 Identifiable error that can either be avoided or
corrected.  Cannot be totally eliminated but can be
 Results: All are too high or too low reduced
SYSTEMATIC ERRORS
 Arise from some faulty step in the analytical process

 Fault is repeatedly done every time the determination is performed.
 Dependent on the analyst.

 Recognize and correct the errors
 Two methods to identify existence of systematic errors:

 Standard methods: analyze the sample by a completely different analytical procedure that is known to involve
no systematic errors.
 Run several analyses of a reference material of known accepted concentration of analyte (Levy-Jennings
Charts and Westgard Rules)
LEVY JENNINGS CHART
A visual
indication of the
laboratory
working
condition
Y-axis:
Control
Results
X-axis: Date or time

WESTGARD MULTI-RULE
• Reduce costs
• Maintains high level of
certainty that the
analytical process is
functioning properly.
• Diminish False
Rejection rate without
compromising quality
1 3S RULE VIOLATION
One control measurement

exceeds three standard
deviation
Identifies unacceptable
random error or possibly the
beginning of a large
systematic error
1 2S RULE VIOLATION
One control result that falls

outside of two standard
deviation
• “Warning Rule”
• Alerts technologist to
possible problems
2 2S RULE VIOLATION
Two out of three control

materials exceeds the two
standard deviation IN THE
SAME DIRECTION
• Detects Systematic
Error
R4S RULE VIOLATION
2 control materials
• One value exceeds +2
• One value exceeds -2
(opposite direction)
Indicates Random Error

only
• Requires control data from
10X RULE VIOLATION previous runs
• Last 10 values for the

same control level are on
the SAME SIDE of the
mean within 1SD
• Detects Systematic Error

• Accuracy problem
• Indicates a shift or a trend
• Requires control data from
4 1S RULE VIOLATION previous runs
• 4 consecutive SAME
SIDE of the mean within
1SD
• Detects Systematic Error

• Accuracy problem
• Indicates a shift or a trend
7T RULE
Seven control values trend

in the same direction
(progressively higher or
lower).
Systemic Error
REJECTION RULE VIOLATED
 Stop testing  Check:

 Identify and correct problem  Out of control reagents
 Repeat test on patient samples and  Reached its onboard stability or
controls nearing it
 Don’t report results until problem  Reached its open vial stability
solved and controls indicate proper period/ nearing it
performance.  Latest callibration
TOTAL ANALYTICAL ERROR
• Represents the overall error in a test result that is attributed to imprecision (%CV) and inaccuracy (%Bias)
• Combination of systematic errors and random errors.
𝑇𝐸= % 𝐵𝑖𝑎𝑠+(1.96 𝑥 % 𝐶𝑉 )
 1974 by Westgard et.al

 To improve the practice of judging method performance (vs. accuracy
and precision)
 Maximum analytical error that can be tolerated and still detect clinically
useful differences in results (maintaining the clinical utility of the test)
 Problem: some analyst argued that there were additional components of

errors that should be considered (interferences/ random errors)
 Solution (Krouwer): direct estimation of TAE obtained by using a
comparison with a reference methods (EP21A by the Clinical Laboratory
Standard)
APPLICATION TOOLS
 Sigma metrics
 Tolerance limits corresponds to the
laboratory limits for ATE and
facilitates calculation of a sigma
metric to characterize test quality
 Higher sigma = better quality
APPLICATION TOOLS
 Method decision chart

 Graphical tool for evaluating the
quality of a laboratory test on the
sigma scale\
 For example, an HbA1c method with
a bias of 1.0% and CV of 1.5% is
shown as point A in Figure 3 and falls
on the line corresponding to 4 sigma.
APPLICATION TOOLS
 Sigma SQC selection graph

 Monitor and evaluate systems,
including charting procedures.
APPLICATION TOOLS
 Chart of Operating
specifications
 Relates the precision and bias
observed for a method to the
desires SC, employing the same
format as the method decision
chart
WHAT IS LABORATORY QUALITY?
“Laboratory quality can be defined as accuracy, reliability and

timeliness of reported test results.”
“coordinated activities to direct and control an organization with
regard to quality”
PATH OF WORKFLOW
12 LABORATORY QUALITY SYSTEM ESSENTIAL
KEY MESSAGES
 A laboratory is a complex system and all aspects must function properly to achieve quality.
  Approaches to implementation will vary with the local situation.
  Start with changes that can be easily accomplished and have the biggest impact.
  Implement in a stepwise process but ultimately, all quality essentials must be addressed.
LOCAL LITERATURE

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VARIATIONS, ERRORS, AND QUALITY

RESIDENT’S WEEKLY REPORT (TUESDAY)

2. Describe the CLASSIFICATIONS OF ERRORS and its impact.

3. Explain the significance of TOTAL ANALYTICAL ERROR.

4. Determine the QUALITY SYSTEM ESSENTIALS of an operational clinical laboratory.

5. Characterize the STAGES OF QUALITY SYSTEMS.

1. What are the factors that constitute an accurate laboratory result?

2. How are errors classified?

3. How are outcomes of errors classified?

4. What is the total analytical error?

5. What are quality system essentials?

6. Explain the hierarchy of quality in the clinical laboratory.

“ The purpose of a clinical laboratory test is to evaluate the

Advancing age Biological rhythms

Menstrual cycle Pregnancy

“Failure of a planned action to be completed as intended, or use of

1. Errors exclusively within the laboratory.

2. Laboratory errors caused by organizational problems outside the laboratory.

3. Errors at the laboratory-clinical interference.

• Patient assessment, test order • Ordering test on the wrong patient

• Preparation of specimen for

• Results released to the clinician,

Systematic Errors/ Determinate Random Errors/ Indeterminate

 Arise from some faulty step in the analytical process

 Dependent on the analyst.

 Two methods to identify existence of systematic errors:

X-axis: Date or time

One control measurement

One control result that falls

Two out of three control

Indicates Random Error

• Last 10 values for the

• Detects Systematic Error

• Detects Systematic Error

Seven control values trend

 Stop testing  Check:

 1974 by Westgard et.al

 Problem: some analyst argued that there were additional components of

 Method decision chart

 Sigma SQC selection graph

“Laboratory quality can be defined as accuracy, reliability and

  Approaches to implementation will vary with the local situation.

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