Points of Discussion
• Types of Laboratories
• Medical Laboratories
• Departments (Clinical – Administrative)
• Types of Staff
• Workflow Processes
• Types of Analysis
• Laboratory Information System (LIS)
Types of Laboratories
• Hospital Laboratories
• Private (Community) Laboratories
• Reference Laboratories
• Research Laboratories
• Molecular Diagnostics or Cytogenetics and Molecular Biology
• Or so called Clinical Laboratories.
• Definition; is a laboratory where tests are done on clinical specimens
in order to get information about the health of a patient that are
related to the diagnosis, treatment, and prevention of diseases.
Types of Administrative Departments
Finance and Accounting
Types of Staff
• Clinical Biochemist
• Pathologist assistant (PA)
• Biomedical Scientist (BMS) in the UK
• Medical Laboratory Scientist (MT, MLS or CLS) in the US
• Medical Laboratory Technologist (MLT) in Canada,
• Medical Laboratory Technician (MLT in US)
• Medical Laboratory Assistant (MLA)
• Phlebotomist (PBT)
Types of Analysis
• Manual Analysis:
1) Low rate Samples
2) Small Private Laboratories
3) Confirmatory Testing
• Automated Analysis:
1) High Rate Samples
2) High Accuracy Results (Low Human Intervention)
3) Other Activities During Analysis
Laboratory Information System (LIS)
• Low Effort – Less Time
• Validation and Control
• Reports and Statistics
• Inventory Control
• ISO 189 – International Standards Organization (ISO); USA.
Particular Requirements for Quality and Competence.
• Joint Commission (JCAHO); USA.
• College of American Pathologists (CAP); USA.
• American Association of Bioanalysts (AAB); USA.
• Clinical Laboratory Improvement Amendments (CLIA); USA.
• NATA (Austraia)
• COFRAC (France)
Points of Discussion
• What is Quality?
• What is Quality Control?
• Importance of Quality Control
• Terms and Definitions
• Types of Quality Control
What is Quality?
• Definition (1):
The standard of something as measured against other things of a similar
• Definition (2):
The degree of excellence of something.
• Definition (3):
A distinctive attribute or characteristic possessed by someone or something.
What is Quality Control?
• It is a process by which entities review the quality of all factors
involved in production. This approach places an emphasis on three
1) Main Elements: Controls, Job Management, Processes, ..etc.
2) Competences: Knowledge, Skills, Experience, ...etc.
3) Soft Elements: Personnel, Organizational Structure, Structure, ..etc.
• Quality Control in Medical Laboratories; is a statistical process used to
monitor and evaluate the analytical process that produces patient
Importance of Quality Control
• Meeting Standards (Internal or Laws)
• Maintaining Quality Standards
• Monitoring Errors and Mistakes
• Satisfying Customers
• Building Good Reputation
• Analysis and Improvement
Terms and Definitions
• Errors vs. Mistakes
• Precision vs. Accuracy
• Repeatability vs. Reproducibility
• Random Errors (RE)
• Systematic Errors (SE)
• Gross Errors (GE)
Errors vs. Mistakes
Non-conforming results with
Non-conforming results with “no
This category includes all the
“wrong” laboratory measures due
to non-human action.
This category contains all the
human errors e.g. mixing up
Classification of Errors ad Mistakes:
• Pre-Analytical Stage
• Analytical Stage
• Post-Analytical Stage
Pre-Analytical Stage Errors and Mistakes
Inappropriate specimen (e.g. wrong specimen-anticoagulant ratio).
Wrong anticoagulant (e.g. sodium citrate in place of EDTA).
Improper conservation method.
Inappropriate patient’s preparation (e.g. wrong diet).
Mistakes in patients’ identification.
Analytical Stage Errors and Mistakes Ex.:
Expired reagents which may lead to erroneous results.
Expired controls or calibrators.
Calibration curve time-out elapsed.
Failure in sampling system.
Failure in aspiration system of reagents.
Changes in analyzer’s photometric unit / flow cell / measuring unit.
Any other analyzer’s failure.
Post-Analytical Stage Errors and
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.
Precision vs. Accuracy
The closeness of agreement
between independent test results
obtained under stipulated
The closeness of the agreement
between the result of a
measurement and a true value of
Repeatability vs. Reproducibility
The degree of consensus between
successive measurements which have
been done on the same sample with
very similar conditions (same analyzer,
same user, same laboratory, same
methods, same lot of reagents) in a very
short time (e.g. same day).
It is approached by within run or
within day experiments.
The degree of consensus between
successive measurements achieved on
the same sample with different
conditions (e.g. different analyzer,
different user, different lot of reagents)
in a long time.
It is approached by between day
experiments, can be either intralaboratory or inter-laboratory.
Random Errors (RE)
Errors in measurement that lead to measurable values
being inconsistent when repeated measures of
a constant attribute or quantity are taken.
Systematic Errors (SE)
A component of error which, in the course of a number
of analyses of the same measurand, remains constant
or varies in a predictable way.
Gross Errors (GE)
Errors that make the measurement very far off of the
known/accepted value; can be defined as mistakes.
Types of Quality Control
• Internal Quality Control
• External Quality Control
Internal Quality Control
It concludes all SQC methods which are performed every day by the
laboratory personnel with the laboratory’s materials and equipment.
It checks primarily the precision (repeatability or reproducibility) of the
Terms in IQC
• Normal Distribution
• Mean or Average
• X-axis represents the values of a
• Y-axis the frequency of each value
(the number of each value’s
• It has a bell-shaped form with its
two edges approaching the x-axis.
Mode, Median, and Mean(Average)
1) Mode (Mo); the value with the highest frequency.
2) Median (M); the value which divides the variable’s observations in
two equal parts.
3) Mean (Average); the value which all the observations should have
if they were equal.
What is the Mode?
What is the Median?
What is the Mean?
External Quality Control
It concludes all SQC methods which are performed periodically (i.e.
every month, every two months, twice a year) by the laboratory
personnel with the contribution of an external center (referral
laboratory, scientific associations, diagnostic industry etc.).
It checks primarily the accuracy of the laboratory’s analytical methods.
Proficiency Test (PT)
External Quality Assessments Schemes (EQAS)
From the OSHA Laboratory Safety Guidance
Points of Discussion
1) Types of Hazards in Medical Laboratories.
2) Safety Signs in Medical Laboratories
Types of Hazards in Medical Laboratories
• Chemical Hazards
• Physical Hazards
• Biological Hazards
• Safety Hazards
• Carcinogens; cancer-causing agents.
• Toxins; those affecting the liver, kidney, and nervous system.
• Corrosives; a substance that causes a destruction of a substance in
• Sensitizers & Irritants; a substance that causes exposed people to
develop an allergic reaction in normal tissue after repeated exposure
to the substance.
• Labelling and Identification
• Safe Inventory
• Safe Handling and Transportation
• Material Safety Data Sheets (MSDS)
• Information and Training
• Exposure Determination
• Medical Consultations and Examinations
Material Safety Data Sheets (MSDS)
1. Name of the chemical;
2. Manufacturer’s information;
3. Hazardous ingredients/identity information;
4. Physical/chemical characteristics;
5. Fire and explosion hazard data;
6. Reactivity data;
7. Health hazard data;
8. Precautions for safe handling and use; and
9. Control measures.