Taibah University

College of Applied Medical Sciences

(Quality Assurance in Medical Labs)

Lecture 2: QC Definitions & Materials
(v2.1)

Dr. Bandar Suliman, BMSc. MClinSc. DipQA PhD

Medical Scientist, RSci MIBMS, MT(ASCP)
Asst. Prof. Molecular Immunology & Oncology, Taibah University
Adjunct Research Fellow, Center for Cancer Research, Monash University
01 Feb 2014
Objectives:

By the end of this lecture, you should:

• Understand the difference between QC & QA
• Discuss the 3 steps of QC
• Analyse QC materials & their uses

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Definition of Quality:

• Quality is defined as:

“Meeting or exceeding customer's specification

based perspective”.

“The standard of something as measured

against other things of a similar kind”.

“The degree of excellence of something”.

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What is Quality?

• What defines Quality in Medical

Laboratories?

The Royal College of Pathologists in Australia:

Quality of testing relies on the "Ability to use
pathology tests to predict, pre-empt, diagnose
and monitor disease, and to determine and
monitor appropriate therapies"
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Quality Assurance:

• Quality Assurance is the total of all activities that

are performed to ensure the generation of reliable
and accurate results or data (Conformance to
Specifications)#

• Quality Assurance is a systematic and objective

evaluation and self-evaluation of how effectively a
laboratory test is performed as part of an ongoing
continuous improvement program.

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Quality Assurance:

• Quality Assurance includes all those activities both

in and outside the laboratory, performance
standards, good laboratory practice, and
management skills that are required to achieve and
maintain a quality service and provide for
continuing improvement.

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Quality Assurance :

QA has been defined by WHO as the total

process whereby the quality of laboratory
reports can be guaranteed.

• right result, at the

• right time, on the
• right specimen, from the
• right patient, with result interpretation based on
• correct reference data, and at the
• right price
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Quality Control :

• QC in the medical laboratory is a statistical

process used to monitor and evaluate the
analytical process that produces patient
results.

• Two major requirements:

1) Regular testing
2) Comparison of results

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Quality Control :

• QC in the medical laboratory is a statistical

process used to monitor and evaluate the
analytical process that produces patient
results.
How to ensure that these
requirements are
• Two major requirements:being done?
1) Regular testing
2) Comparison of results

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Quality Control :

Definition of Quality Control System:

• It is the system for recognizing and minimizing

analytical errors.

• It is one component of quality assurance system.

• It emphasize the need for an ongoing continuous

improvement program.

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Quality Control Systems:

A Quality Control System Should:

§ Ensure the reliability of each measurement

performed by a lab machine on a patient sample.

§ Be able to detect medically allowable errors.

§ Provide precise and accurate biochemical data for

short and long term medical decision making.

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QA vs. QC :

• Quality Assurance • Quality Control

makes sure you makes sure the
are doing the right results of what
things, the right you've done are
way. what you expected.

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Quality Control :

Pre-Analytical

Analytical

Post-Analytical
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Specimens Flowchart:

Patient data is Test is requested

Sample
entered into from in or out-
collection
the database patients clinics

Sample
Sample
Results handling and
processing
transportation

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Pre-Analytical:
Sample without order Duplicate order
Incorrect test Not readable
Ordering Incorrect time/date Incorrect priority
Typing error
Forgotten Failed
Incorrect tube Lost tube
Incorrect volume Incorrect temperature
Collection Incorrect treatment Patient state
Incorrect time/date Incorrect priority
Tube missing Patient missing
Insufficient clinical information
Missing/Incorrect patient ID
Identification Missing/Incorrect physician ID
Incorrect patient
Incorrect labeling

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Analytical:

Common analytical errors:

1. Expired reagents
2. Expired controls or calibrators
3. Calibration curve time-out lapsed
4. Failure in sampling system
5. Failure in aspiration system of reagents
6. Changes in analyzer’s photometric unit/flow
cell/measuring unit
7. Instrument’s failure

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Post-Analytical:

Common post-analytical errors:

1. Wrong matching between sample and

laboratory’s files
2. Wrong copy of results from the analyzer’s report
to the laboratory report (in cases of manual
transfer)
3. Delay in delivering the results to the physicians,
clinics or patients
4. Loss of the results

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Errors:
Is there a difference between errors?

Random
Errors

Systemic
Errors

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Errors:
Is there a difference between errors?

The higher the precision

Random of a laboratory
Errors instrument, the smaller
Precision the variability (SD) of
the results
=
MEAN is significantly
different from the real
value

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Errors:
Is there a difference between errors?

Systemic errors cause

the MEAN of many
independent
measurements to be
significantly different
from the actual (real) Systemic
value. Errors
=
Not accurate Accuracy

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Accuracy & Precision:

Is this Accurate?
Yes

Is this Precise?
Yes

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Accuracy & Precision:

Is this Accurate?
No

Is this Precise?
Yes

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Accuracy & Precision:

Is this Accurate?
No

Is this Precise?
No

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Accuracy & Precision:

Can results be accurate

but not precise?

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IF-AT Q2 (Group Work) :

2. What defines accuracy & precision?

A) The Mean only

B) The Mean & Range
C) The Mean & Standard Deviation
D) The Mean & Coefficient of Variation
E) All of the above

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Accuracy & Precision:

What defines accuracy & precision?

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Quality Control Materials:

QC Products:

1. A quality control product is a patient-like material

ideally made from human serum, urine or spinal
fluid.

2. They can be a liquid or freeze dried (lyophilized)

material and is composed of one or more
constituents (analytes) of known concentration.

3. They should be tested in the same manner as

patient samples

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Quality Control Materials:

QC Products:

4. A normal control product

contains normal levels for
the analyte being tested.

5. An abnormal control
product contains the
analyte at a concentration
above or below the normal
range for the analyte.

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Quality Control Materials:

QC Products:

6. Commercial QC products are always supplied

with documentation showing the actual data of
each of the analytes contained with in.

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Self-Test #2:

Self-Test #2

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IF-AT Questions:

3. What is the mean?

4. What is the SD?

5. What is the CV?

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What you should remember:

u What is the difference between QC & QA?

u What is the 3 steps of analytical processes
that QC should test?
u What are the types of errors?
u What are QC materials? and how to calculate
their means and SDs?

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© 2010 Bandars.com

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