Quality Assurance (QA)

& Quality Control (QC)

Dr. Muhammad Nadeem A. Khan

Professor of Pathology
Islamic International Medical College
Rawalpindi
Learning Objectives
• Define quality assurance or assessment
• Define quality control
• Describe the types and importance of quality control in Chemical lab
• Discuss the procedure with steps of Internal QC in a chemical pathology lab
• Discuss the procedure and steps of External QC in Chemical pathology lab
• Discuss following terms
• Accuracy
• Precision
• Systematic Errors
• Random Errors
Quality Assurance/Assessment (QA)
• An all-inclusive system monitoring the accuracy of test results

• It includes all steps before, during and after the testing processes
• Initial ordering of the test results
• Collection of a patient's specimen
• Analysis
• Transmittal of the results to the final destination

• A QA Program includes the laboratory personnel, the phlebotomy team and the
data processing staff and the purpose of QA is the detection, elimination and
control of errors
Quality Control
• QC is very important subset of QA
• QC is the periodic, systematic monitoring of the analytical process using
statistical techniques and standardized materials to demonstrate that a
process is operating appropriately
• The purpose of performing QC is to detect problems with the analytical
process early enough to prevent its consequences
5

What is the purpose of a QC?

• The simplest & most straightforward way to check the
reproducibility of a method is by including control specimens
in the run.
• These are samples for which the correct answer is known
• If the results with the controls are the expected results, we can
feel confident about the assay
Difference Between QA and QC:
• The aim of quality control is simply to ensure that the results
generated by the test are correct.
• While quality assurance is concerned with much more; that is
‘the right test is carried out on the right specimen, and that
the right result and right interpretation is delivered to the right
person at the right time at right cost.’
TYPES OF Quality Control
Internal QC (IQC)
• A control is a material which has a known value and which
is used for the assessment of precision of the laboratory
results.
• CLIA states that at least two levels controls should be run in
a day.
External QC(EQC)
Establishment of an IQC System
• Two or three levels of control material are usually used e.g.
Level 1 (low/abnormal), Level 2 (medium/normal) & Level 3
(high/abnormal)*
• QC measures:
• “Accuracy” – how close results are to the true value
• “Precision” –i.e. how reproducible are the results
• Correct following of QC procedures ensures that patient
results obtained from the laboratory instruments are valid
9

Is QC only applicable to quantitative lab test methods?

• No! QC is applicable to all types of laboratory test methods:

• Qualitative (i.e., results are reported only as “positive” or
“negative”)
• Semi-quantitative [i.e., results are reported using a relative scale
(e.g., 1+, 2+, 3+, 4+ or <50 mg/dL, 50-100 mg/dL; 100-150 mg/dL;
>150 mg/dL) that provides a rough estimate of the quantity of an
analyte that may be present]
• Quantitative [i.e., provide a more exact value for the quantity of
analyte present (e.g., 126 mg/dL)]
10

How is QC performed for qualitative methods?

• By testing the device/instrument with 2 control samples:

• one containing an analyte conc that gives negative result &
• another control sample that gives a positive result
• If either of the expected results is not obtained, then the
method fails QC and patients’ samples cannot be tested
by that method until the cause of the failure is determined
and corrected, and repeat QC testing performed
11

Point of Care HIV Test

• Example of a Qualitative control

control

+ -
12

How is QC performed for semi-qualitative

methods?
• By testing control samples
containing analyte
concentrations that are intended
to provide a specific reading with
regard to an arbitrary scale
relevant to the method.
13

How is QC performed for quantitative methods?

• By testing control samples containing known (or fixed)
amounts of the analyte the test method compares the values
obtained to a pre-established range of acceptable values.
• Values on control samples that fall within this range indicate
that the method is “in control,” while values that fall outside
this range indicate that the method is “out-of-control.”
 [AAFP Reprint No. 283, Items
14 D1a-j]

More on the QC of quantitative laboratory test

methods
• Because analytical errors can occur within a run and across several
different runs on different days, a control chart is used to monitor QC
values over time to detect any adverse trends in QC data that suggest the
method/instrument is not performing adequately.
[AAFP Reprint No. 283, Items D1a-j]
15
Example of a Control Chart (solid line indicates mean of data set;
dotted lines indicate mean  2SD limits)

Mid-Level Glucose Control Material

Glucose concn, mg/dL

132
130
128
126
124
122
120
118
116
1 6 11 16 21
Work Day of the Month
 [AAFP Reprint No. 283, Items
16 D1a-j]

How are control ranges established?

• By assaying a control material (sample) for a particular
analyte a minimum of 20 times in 20 different runs of patients’
samples (e.g., 1 run per day x 5 days/week x 4 weeks/month =
20 runs/month), thus providing 20 values for the analyte.
• Determine the mean and standard deviation (s) of the data
set.
• Determine the lower limit (LL) of the control range by
calculating the value corresponding to the mean – 2s.
• Determine the upper limit (UL) of the control range by
calculating the value corresponding to the mean + 2s.
[AAFP Reprint No. 283, Items D1a-j]
17
Example to Illustrate the Determination of a Control Range for
the Analyte: Glucose

Run on Glucose Run on Glucose Summary

Day Value, mg/dL Day Value, mg/dL Statistics
1 123 11 124 mean = 123.2 mg/dL
2 122 12 126 s = 2.48 mg/dL
3 124 13 130 LL = mean – 2s = 118 mg/dL
4 126 14 124 UL = mean + 2s = 128 mg/dL
5 121 15 125 Acceptable Range for this
control/analyte:
6 125 16 122
118-128 mg/dL
7 120 17 123
8 121 18 121
9 123 19 122
10 119 20 123
[AAFP Reprint No. 283, Items D1a-j]
18
Example of a Control Chart (solid line indicates mean of data set; dotted lines
indicate mean  2s limits)

Glucose concn, mg/dL Mid-Level Glucose Control Material

132
130
128
126
124
122
120
118
116
1 6 11 16 21
Work Day of the Month
 [AAFP Reprint No. 283, Items
19 D1a-j]

Example of a Control Chart

• In the previous slide, note that the values appear to be evenly distributed around the
mean and that at least one of these 20 values was outside the limits corresponding to
the mean – 2s and the mean + 2s [i.e., on day 13, the control value of 130 mg/dL
exceeded the upper limit (128 mg/dL) for this control].
• When laboratory methods/instruments remain stable over time the distribution of control
values around a properly established and valid mean should be evenly distributed and
at least 1 out of every 20 values should exceed the lower or upper acceptable limit for
the control.
• This is because only random error is occurring; there is no systematic error affecting the
method/instrument.
External QC (EQC) or Proficiency Testing (PT)
Introduction/Definition
• “A system of objectively checking laboratory results by
means of an external agency including comparison of a
laboratory's result at intervals with those of other
laboratories”.
• The main objective is establishment of trueness or accuracy
International External Quality Assurance Scheme
Available in Pakistan
There are multiple bodies which provide PT samples:
a. NEQAPP (National External Quality Assurance Program of)- Pakistan
b. CAP (College of American Pathologists)- US
c. Randox RIQAS (UK)
d. Biorad EQAS (US)
e. NEQAS (UK)
f. CDC (Centre of Disease Control) provide surveys only for dried blood
spot analytes
g. ERNDIM provide surveys for biochemical genetics laboratories
National External Quality Assurance Programme in
Pakistan (NEQAPP)
• Designed specifically for the country’s needs
• Economical
• Useful in establishing national quality goals
• Fulfilling the requirement of accreditation by Pakistan National
Accreditation Council
• Started in 1996, now nearly 200 Laboratories in Pakistan are
participating
• Programs are available for Chemical Pathology, Microbiology,
Hematology and Histopathology
Delta Check
Introduction:
• First described in 1974.

• It compares the current test result with a previous result from the
same test obtained over a short period of time for the same patient.
• Lab can define its own period. For example, at AKU laboratory they
take 1 month as the Delta Time.
• Pre-analytical errors that are not detectable with QC can be
identified.
Delta Check Alert
• A “delta check” failure or alert occurs if there is a discrepancy
in the patient results.
• When the difference between a patient’s present lab result
and their previous result exceeds a predefined limit within a
predefined length of time, delta alert is shown.
Main Goals of Delta check
• Delta checks are useful quality improvement measures that
can help the lab identify possible patient-specific errors. There
are two main goals:
• Detection of real changes in patient condition or disease state
• Identification of test quality issues or patient identification
problem
Types of Analytical Errors

Errors in the Total Test Process

• Pre-analytical: 62%
• Analytical: 23%
• Post-analytical: 15%
Random Error
Imprecision of the test system causing a scatter or spread of control
values around the mean
Causes of Random Error:
• Air bubbles in reagents
• Improperly mixed reagents
• Air bubbles in reagent lines, sampling or reagent syringes
• Improperly fitting pipette tips
• Clogged or imprecise pipette
• Fluctuations in power supply
• Change in Environmental conditions e.g. room temperature
• Pipetting error
Systematic Error
• Systematic change in the test system may result in a
displacement of the mean from the original value.
• Systematic error of an analytic system is predictable and
causes shifts or trends on control charts that are
consistently low or high.
Causes of Systematic Error:
• Change in reagent or calibrator lot numbers

• Improperly prepared reagents

• Deterioration of reagents or calibrators
• Inappropriate storage of reagents or calibrators
• Variation in sample or reagent volumes due to pipette
misalignments
• Variation in temperature of reaction chambers
• Deterioration of photometric light source
• Variation in procedure between technologists
Difference Between Precision and Accuracy
Precision: refers to the ability to get the same (but not necessarily ‘true’)
result time after time. The degree of fluctuation in the measurements is
indicative of the imprecision of the assay.
Accuracy: The closeness of measurements to the true value is indicative of
the accuracy of the assay. An accurate result is one that is the ‘true’ result
31

What is a “critical value”?

• A value for an analyte that has such potentially serious
medical consequences for the patient if it were not acted
upon in an appropriate time period
• Procedures should be in place that make the laboratory
duty-bound to report such a result immediately to the
physician who requested the test for that analyte or an
appropriate representative (e.g., a nurse on the ward
where the patient is located; an on-call physician).
32

Summary
• The quality of the results produced by a laboratory are directly related to
the ongoing effort made to assure that quality.
• QA requires a broad approach that involves all links in a chain beginning
with test selection, ordering, and QC and continuing through to the
correct interpretation of the results of the test(s) in the treatment and
management of the patients for whom the test(s) were ordered.
33 [AAFP Reprint No. 283, Items D1a-j]

Thanks!
MCQ
A clinical laboratory manager is working on the measures like
reducing turnaround time, improvement for specimen and
patient identification, and test utility. Which of the following
term best describes the
processes:
a. Quality Assurance
b. Quality Control
c. Quality Improvement
d. Quality Laboratory Processes
e. Quality Planning
MCQ

Which of the following is most common cause of a random

error ?
a. Change in reagent or calibrator lot numbers
b. Deterioration of reagents or calibrators
c. Fluctuation in power supply
d. Improperly prepared reagents
e. Wrong calibrator values
Interpretation
Random errors in any laboratory can be described as an error that cannot
be predicted in terms of its direction or in terms of its magnitude. It’s a
‘mutinous’ error. On the other hand, systemic error is usually preceded by a
similar error with some variation in the magnitude but in the same direction.
MCQ
Basic statistics is essential for running a quality control
programme in a laboratory. In statistical terms, normal data
means:
a. Labs own generated values
b. Result of disease free subjects
c. Result of healthy individuals
d. Symmetrical distribution
e. Values within reference values
Normal data
• This is the type of data, called symmetrical, normal or
Gaussian.
• It is characterised by equal distribution of data on both sides
of mean.
• The other type is non-symmetrical or skewed data.
• In QC, the data is almost always symmetrical.
MCQ
Which one of the following aspects best describes an
External Quality Assessment Scheme (EQAS)?
a. Detection of imprecision
b. Detection of random error
c. Inter-laboratory comparison
d. Prevention of post-analytical errors
e. Prevention of pre-analytical errors
• External Quality Control is also called External Quality
Assessment (EQA) or Proficiency Testing (PT).
• The hallmark of EQA programmes is ‘Inter-laboratory
Comparison’ of results of QC material sent to these labs by
the EQA agency.
MCQ
Result of glucose level of 23.7 mmol/L was forwarded to a Chemical
Pathology Resident. Although satisfied with internal quality control and EQAS
results, she was hesitant to authorize it. She searched the Lab Information
System to find any previous results of the same patient but failed to find any.
Then she called the Medical Ward where the patient was admitted. The
Resident Medicine told her that the patient is a known diabetic and is
admitted with a gangrene right foot. Which of the following procedures she
has carried out to rule out any pre-analytical errors?
a. Auto-Verification
b. Delta Check
c. Lean Management
d. Proficiency Testing
e. Quality assurance
Per-analytical errors cannot be rectified by any internal or
external QC programme. These errors should be suspected if a
patient result is unusually high or low. The Pathologist
predetermines the values of each analyte for creating alert
called ‘delta value’. Whenever the results of an analyte cross
this delta value compared to previous results of the same
analyte, delta failure occurs and results are not reported. The
technologist or resident should verify this result by
counterchecking from the previous record of the patient or
from the ward or patient himself/herself. This procedure is called
‘Delta Check’. This is an important component of ‘Patient
Safety’ in clinical labs, too.