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INTRODUCTION
FUNDAMENTAL CONCEPTS IN CLINICAL CHEMISTRY
When a person is SICK, diagnosis begins with physical
examination by a doctor. It may not be possible to diagnose
(detect) a disease only on the basis of physical examination. For
this, there are various diagnostic tests to confirm or deny a
suspected diagnosis. The clinical laboratory tests are extremely
useful to find out the causes of disease.

Physical & symptomatic

diagnosis by physicians needs
confirmation of laboratory tests
on patient’s specimens to reach
Dr. Elmutuz Elssaig (PhD) the final diagnosis to initiate
the treatment
Course Name: Clinical Chemistry-CR Tutorial Code: MLT407

CLINICAL CHEMISTRY LABORATORY WORK FLOW CYCLE

Clinical chemistry deals with the laboratory applications of The flow cycle includes the entire steps of laboratory test,
biochemical parameters of a patient to find the cause of a starting from test ordering by a doctor until reporting the
disease as well as the severity of the disease. These are based results.
on the biochemical parameters present in patient’s specimen
such as blood, urine, cerebrospinal fluids and distributed
along different organs such as liver, stomach, heart, kidneys,
brain as well as the endocrine system and peripheral fluids.

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Good Laboratory Practice (GLP) Standard Operating Procedures (SOPs)

GLP is a term used for a standard framework of regulations that ensures the quality
of a clinical laboratory in order to certify that the results of the tests obtained in the
a set of instructions,
laboratory are valid and acceptable. The components of GLP includes: a document which describes
systems, procedures or steps
the operations of a certain
1. Laboratory premises adhering to the requirements of safety which is written so that
work or job in order to
and cleanliness. other individuals can follow
ensure its quality
2. Equipments calibrated and checked for capacity, accuracy to complete the job safely
and precision with scheduled maintenance procedures.
3. Material and reagent facilities with proper inventory and
recorded expiry dates.
4. Qualified and certified professionals trained in Clinical Lab
Sciences who are well aware of ethical responsibilities. The purpose of a SOP is to
It also maximizes operational
5. Standard specimen transport and storage facilities. carry out the operations
and production
6. Performance of the study /tests in accordance to the correctly and always in the
requirements
Standard Operating Procedures (SOP). same manner.
7. Archiving of records and specimens.
8. Quality assurance programs in the laboratory.

2 types of SOPs
A SOP should be available at the
place where the work is • focuses more on technical
performed. The original should technical SOP
activities such as how to collect
be kept at a secured place while and a laboratory sample.
working copies should be
authenticated with stamps
and/or signatures of authorized
persons. • highlights on the administrative
administrative
processes such as reviewing
SOP. contract documentation.

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Standard Operating Procedures (SOPs)

 SOP is a document, which contains detailed, written instructions describing
Why Lab Safety ?
the stepwise process and technique of performing a test or procedure in the
laboratory. • Coming in contact with human blood or blood products (plasma, serum, etc.), or
 SOP helps to ensure uniformity, consistency and control over the processes with certain chemicals used in the laboratory, is potentially hazardous.
carried out. It ensures that the procedures are done in exactly the same way
each time irrespective of the operator. • Safety involves taking precautions to protect you and coworkers against
 SOP should contain information on who can perform the test, their infection, injury or poisoning.
qualification and training, how to carry out the test including pre-analytical,
analytical and post-analytical stages of test/procedure, laboratory conditions • Other people who may come in contact with testing by-products
required for the test/ procedure, routine care and maintenance of equipment,
precautions and safety instructions, trouble shooting measures, waste • Protect integrity of test products
disposal and linkage with reference laboratories.
 SOP should be simple and written in an easy to understand language and • Protect environment from hazardous material
must be followed exactly by all staff members to ensure high quality results.
It is important for the SOP document to be readily available in the working
area and is therefore also referred to as ‘laboratory bench work manual’.
SOPs are controlled documents and can be changed only with approval
of the laboratory quality manager and/or Head of the laboratory.

General Laboratory Safety Regulations

• Laboratory safety regulations are in place to protect those who • Common risks: electric shock, toxic vapors, radioactive
work in the laboratory as well as those who come to the materials, corrosive substances, poisons, and the risks
laboratory for specimen collection, laboratory results, or
of handling biological materials.
inspections.

• Regulations include guidelines for operating safety equipment • Maintaining a continuous concern for safety is an
and identifying, handling, and storing chemical hazards. additional challenge to the already demanding field of
clinical laboratory sciences.
• All clinical laboratory personnel, by the nature of the work they
perform, are exposed daily to a variety of real or potential
hazards.

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Apply Safety Practices Throughout Develop Personal Safe Work Habits

the Testing Process
• Before Testing (Pre-analytical) • Wash hands before and
– Specimen collection after entering the lab
– Specimen preparation • Change gloves frequently
– Specimen transport • Wear lab coat or apron
• Testing (Analytical) • Dispose of contaminated
– Testing sharps and waste
immediately after testing
• After Testing (Post-analytical)
– Disposal

Develop Safe Personal Work Habits Maintain Clean and Orderly Work Space

• Pipetting by mouth • Keep work areas uncluttered

and clean
is strictly forbidden
• Disinfect work surfaces daily
• Never eat, drink or • Restrict or limit access when
smoke at the test working
site • Keep supplies locked in a
safe and secure area
• Keep food out of the • Keep emergency eye wash
laboratory/testing units in working order and Biohazard
site refrigerator within expiry date

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General Safety measures/equipments are in place in Disposal of hazardous waste

all labs. The safe handling and disposal of chemicals and other materials requires a thorough
 Know the locations and operating instructions for the fire knowledge of their properties and hazards, to protect both the individual and the
extinguishers, fire blankets, fire alarms, fire hoses, first aid kit, environment when disposing of wastes
eye washes and showers. Wash eyes for at least 15 minutes • Potentially biohazardous material, such as blood or blood products
 Operating instructions should placed near each safty equipment and contaminated laboratory waste, cannot be discarded directly.
• All biomedical waste should be placed into a bag that is marked
with the biohazard symbol, and then placed into a leak-proof
container that is puncture-resistant.
• All sharp instruments, such as needles, blades, and glass objects
should be placed into special puncture-resistant containers prior to
placing them inside a bag for disposal.
Fire Blanket Eye wash station
Fire Alarm • Special attention should be given to the discarding of syringes,
Fire extinguisher needles, and broken glass that could inflict accidental cuts or
punctures.
Fire hose reel • During the disposal of needles, it should be recapped, bent, or
Safety shower
broken as possible to avoid its use again.

Segregation of Medical Waste

 These procedures apply to disposal of research-associated or clinical
materials having the potential for causing disease or adverse health effects
ESSENTIAL READING:
in humans.
 Segregation is important because each category of waste my require a
different treatment protocol to eliminate or reduce the risk of hazard
associated with its exposure

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Closing up you presentation asking for

questions: