INTRODUCTIO

N TO CLINICAL
CHEMISTRY
KATUAH, JMZ
MALAMULO COLLEGE OF HEALTH
SCIENCES
@2022
Basic Principles of Clinical Chemistry and Laboratory Medicine

• 1.1. Introduction and definition of terms

• 1.2. History of Laboratory medicine
• 1.3. Reasons for performing a laboratory test
• 1.4. Contribution of epidemiology in the Clinical Chemistry
field
• 1.5. Applications of Molecular Diagnostics in Clinical
Laboratory
• 1.6. Ethical issues in laboratory medicine
• 1.7. Confidentiality and conflict of Interest
 Clinical Chemistry
• Is a basic science that utilizes the specialty of chemistry to
study human beings in various stages of health and disease.

• It is an applied Science where analyses are performed on

body fluids or tissue specimens to provide important
information for the diagnosis or treatment of disease.

• Clinical chemistry is a quantitative science that is concerned

with measurement of amounts of biologically substances in
body fluids
 Clinical chemistry….
• As a service, the clinical chemistry section produces objective
evidence from which medical decisions may be made

• Clinical chemistry is also known as chemical pathology, clinical

biochemistry or medical biochemistry
• Clinical chemistry links the knowledge of general chemistry, organic
chemistry and biochemistry with an understanding of human
physiology
Definition of terms
 Some Terms used in clinical chemistry
• Catalyst – A catalyst is a substance that increases the rate of a
chemical reaction without being chemically changed in the
reaction. It lowers the activation energy needed for the reaction.
• Rate of reaction – The rate of a chemical reaction is how quickly
(per second) products are formed or how quickly reactants are
used up.
• Electrolyte – a mineral or element that conducts electricity due
to the presence of free ions
• absolute zero - Absolute zero is 0K. It is the lowest possible
temperature. Theoretically, at absolute zero, atoms stop moving.
Conti…
• accuracy - Accuracy is a measure of how close a measured value is to
its true value. For example, if an object is exactly a meter long and
you measure it as 1.1 meters long, that is more accurate than if you
measured it at 1.5 meters long.
• acid - any chemical that gives off protons or H+ in water.
• base - A base is a compound that produces OH- ions or electrons in
water or that accepts protons
• buffer - A liquid that resists change in pH when an acid or base is
added. A buffer consists of a weak acid and its conjugate base
Conti…
• calorimetry - Calorimetry is the study of heat flow. Calorimetry may
be used to find the heat of reaction of two compounds or the heat of
combustion of a compound, for example.
• dilution - Dilution is when a solvent is added to a solution,
making it less concentrated.
• electrolyte - An electrolyte is an ionic compound that dissolves in
water to produce ions, which can conduct electricity.
• endpoint - The endpoint is when a titration is stopped, typically
because an indicator has changed color.
Conti..
• enzyme - An enzyme is a protein that acts as a catalyst in a
biochemical reaction
• precision - Precision is how repeatable a measurement is.
More precise measurements are reported with more significant figures.
• solute - The solute is the substance that gets dissolved in a solvent.
Usually, it refers to a solid that is dissolved in a liquid. If you are
mixing two liquids, the solute is the one that is present in a smaller
amount.
• solvent - This is the liquid that dissolves a solute in solution.
Technically, you can dissolve gases into liquids or into other gases, too.
 Scope of Clinical Chemistry
• Instrumentation
• The development of instrumentation has determined much
of the progress of clinical chemistry.
• Instruments fulfill two functions:
• (1) to enable an analysis to be made which is not
otherwise possible
• (2) to enable it to be made faster, more accurately, on
smaller quantities, or more cheaply than by alternative
methods
 Quality Management

• Total quality management in clinical

chemistry consists of efforts to establish and
maintain a climate of continued
improvements in the laboratory in order to
deliver high-quality services to health care
Importance of Quality Management
• quality management system help your lab provide patients
with the most accurate, precise and timely results
• Quality can improve efficiency and productivity within an
organization
• The quality system essentials are: organization, facilities and
safety, personnel, purchasing and inventory, equipment,
process management, documents and records, information
management, nonconforming event management,
assessments, and continual improvement.
 Laboratory Safety
• Laboratory safety practices include
• appropriate facilities and equipment
• adequate training
• Personal protective equipment
• Chemical management
• standard operating procedures
• waste handling
• proper laboratory practices
• safe working conditions
History of Lab Medicine
 Laboratory medicine
• The term laboratory medicine refers to the discipline
involved in the
• 1 . selection,
• 2. provision, and
• 3. interpretation of diagnostic tests
• Laboratory medicine includes clinical chemistry (including
toxicology and drug monitoring, endocrine and organ
unction testing and molecular genetics) and areas such as
microbiology, hematology, hemostasis and thrombosis,
blood banking (transfusion medicine), immunology and
identity testing
 History of Laboratory Medicine
• DISTANT PAST!
• First tests to know Diabetes
• Patient urinates on the floor. If the urine contains sugar,
ants will crawl to lick the urine.
• This test was used up to 20 years ago in some parts of
Africa
• IN 1970
• Slides were used!
• No automation
• No sophisticated quality control
• No laboratory information systems
Looking into the past…
Looking into the past…
Looking into the past…
Present day Lab Medicine………….
• In the 20th century phlebotomy was introduced as a
diagnostic tool
• PRESENT
• Point-of-Care Testing
• Molecular diagnostics
• Sophisticated equipment such as Tandem Mass
Spectrometry
• Consolidation of testing on a single platform
• Consolidation of reference laboratories
 History of clinical chemistry

• From the time of Hippocrates (C.460-C.375 B.C.) the crude

examination of body fluids including urine had been done
• Thomas Willis, in the second half of the 17th century did sweet
taste on urine to differentiate between the two types of diabetes.
• At the beginning of 20th centaury, Quantitative tests were carried
out in regard to sugar and urea of urine and a series of qualitative
tests for acetone, albumin, bile, and sugar were performed.
• The discipline of chemical pathology, earlier known as
pathological chemistry, arose from the attempt to apply chemistry
to medicine
Conti…
• Analyte : a chemical substance that is the subject of a chemical
analysis
• chemistry analyzers are medical laboratory devices used to calculate
the concentration of certain substances within samples of serum,
plasma, urine and/or other body fluids.
Why perform Laboratory Tests??

Why lab
tests??
 Reasons for performing lab tests
• Diagnosis (to rule in or rule out a diagnosis)
• Monitoring (the efficacy of a drug or treatment)
• Screening (to discover active substances/variables)
• Research (to understand the pathophysiology of a
particular disease)
• Providing a prognosis
• establishing and monitoring the severity of a
physiological disturbance
Sources of errors in clinical chemistry
laboratory
Errors
assignment 1
• In groups of 5, discuss what you think might be
sources of error in Clinical Chemistry
• Discuss how you can avoid such errors
• Write down your points and submit by the
beginning of class next week
• Enjoy
 Epidemiology and Clinical Chemistry
• Epidemiology is the study of the distribution and determinants of
health and disease conditions in defined populations
• Clinical epidemiology is the application of epidemiology principles and
methods to the clinical setting.
• In short, clinical epidemiology is generally focused on applied
decision-making, for the purpose of improving patient-level
outcomes.
• Clinical epidemiology is the application of the principles and methods
of epidemiology to conduct, appraise, or apply clinical research for
the purpose of improving prevention, diagnosis, prognosis, and
treatment of diseases in patients.
Epidemiology …..
• Epidemiology studies are conducted using human populations to evaluate whether there is a
correlation or causal relationship between exposure to a substance and adverse health
effects

• Epidemiological studies measure the risk of illness or death in an exposed population

compared to that risk in an identical,
unexposed population

• The movement toward evidence-based medicine and evidence-informed decision-making in

the clinical setting and in healthcare more generally is a direct derivative of the field of
clinical epidemiology.

• Think of examples
2 Minutes Break
Ethics in Laboratory Medicine
 Introduction
• In the current time, ethical concerns exist everywhere whether it is a medical
field or life science.
• Lab Medicine and biomedical research, both fields are interconnected by
laboratory testing where new results, remaining patient’s blood sample, and
genetic testing, etc. are some of the major ethical issues that commonly exist.
• Ethical issues plays very crucial role in laboratory medicine.
• Therefore, it is required for laboratories to strictly follow ethical principles.
• The field of ethics involves ‘a set of principles of right conduct’ and bio-
ethics is well-defined as a branch of applied ethics that studies the
philosophical, social and legal issues arising in medicine and life sciences.
 Evolution of ethics
• Evolution of biologically-centered ethical guidelines in
medical or biomedical research has upgraded the
understanding of ethics over the years.

• Various guidelines and declarations evolved over the period,

including international and national are mentioned in the
coming slides
 Nuremberg Code, 1947….
• This code was the initiation of modern ethical morals.
• It introduced the discussion on rationale and explanation of
research risks or benefits analysis.
• Initially there was no ethical conduct for the research
involving biological subjects, the time before World War II.
• Nuremberg, during 1947, was the first to establish ethical
principles for such researches which delineates the necessity
of competent and trained staff, participant’s consent, and
circumstances under which research should be discontinued
 Declaration of Geneva, 1948
• It comes into existence soon after Nuremberg code which emphasized
guidelines for ethical issues related to clinical medicine.
• Soon after Nuremberg code, Declaration of Geneva was conscripted
and accepted by World Medical Association (WMA) in 1948.
• It was actually a physician’s oath that was proposed as an amendment
of Hippocratic Oath which was the assertion of physician’s
commitment towards his duty for humanity in medicine.
• Its concept is applicable to clinical medicine unlike Nuremberg code
 Declaration of Helsinki, 1964
• Revised 1983, 1989, 1996, 2000, 2008, 2013
• It is obliged to make individual rights as informed decisions, duties of
investigators and research participant’s welfare as well.
• It was developed by World Medical Association (WMA) which
includes the set of ethical moralities for conducting research
involving humans for medical community.
• Ten principles of Nuremberg code and Declaration of Geneva were
tied in a single document named as ‘Declaration of Helsinki’
 Belmont report, 1978–1979
• The Belmont Report was generated by the United States of America (USA)
National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research in 1978.
• It is one of the key work concerning ethics and healthcare research and
explains the ethical guidelines for experiments involving human participants.
• It has three basic principles includes the respect for participants, justice and
beneficence.
• In research these basic principles obliged to consider.
• It also saves the rights of participants in clinical and experimental researches.
• It also describes the approval of study by the Institutional ethical committee
and ensures that participant should at least get nominal care for their medical
condition
 CIOMS guidelines
• Council for International organizations of Medical Sciences], 1992–
1993, Revised 2002
• International ethical guidelines were announced by CIOMS for
epidemiological studies in 1991 and for researches involving human
participants were announced in 1993.
• It focusses on the pharmacovigilance, reporting of adverse drug effects
along with protection of research participants
• Pharmacovigilance is the science and activities relating to the
detection, assessment, understanding and prevention of adverse effects
or any other medicine/vaccine related problem.
 Principles of ethics

• From the declarations ,three ethical

principles are derived
• Respect for humans
• Beneficence
• Justice
 Respect for humans
• We must respect patient and their self-respect.
• There is freedom of decisions to the each participant of the
study.
• It is an obligation to respect the decisions made by people
concerning their own lives.
• This is respecting human dignity.
• We must not interfere with the decisions of competent adults,
and also actively empower others for whom we are
responsible.
 Beneficence
• It refers to our duties in the best interests of the
patients or research participants.
• The goal is to maximize benefits and minimize
harms
• The latter sometimes is called non-maleficence.
• Everyone must be fair and correct in all their
actions and must take positive steps to prevent
harm
 Justice
• It is an obligation to provide all participants with whatever they deserve.
• Basically, we have an obligation to treat all people equally, fairly, and
impartially.
• All individuals should have an opportunity to participate in research
unless contraindicated and we must not impose unfair burdens.
• All doubts of research participants should be cleared by concerned staff.
• We should make available all the safety concerns as demanded by
research participants.
Principles of ethics
 Codes of ethics

• Professional personnel of a medical laboratory are bound by the

ethical codes of their respective profession.
• A code of ethics may be described as an expression of basic values –
the principles and standards by which we should conduct ourselves.
• Several laboratory professional societies and organizations have
developed codes of ethics, with common principles of conduct which
act as guidelines to professional members of those organizations .
 Codes of ethics
• The International Federation of Biomedical Laboratory Science
(IFBLS) suggests
• to maintain strict confidentiality of patient information and test results;
• safeguard the dignity and privacy of patients and above all be accountable
for the quality and integrity of clinical laboratory services being provided.
• In same line, the American Society of Clinical Pathologists (ASCP)
has also advised laboratory staff to
• treat patients and colleagues with respect,
• care and thoughtfulness; perform duties in an accurate, precise, timely and
responsible manner;
• safeguard patient information as confidential, within the limits of the law.
Ethical issues in the Lab
 Confidentiality
• Confidentiality in health care refers to the obligation of
professionals who have access to patient records or
communication to hold that information without telling or
disclosing to anyone.
• Medical Privacy refers to the legal protection of personal
medical information from being shared on a public platform.
• Ensuring privacy can promote more effective communication
between physician and patient, which is essential for quality of
care, enhanced autonomy, and preventing economic harm,
embarrassment, and discrimination
What is confidentiality and why is it important?

• One of the most important elements of confidentiality

is that it helps to build and develop trust.
• It potentially allows for the free flow of information
between the client and worker and acknowledges that
a client's personal life and all the issues and problems
that they have belong to them.
 Examples of breach of confidentiality
• Here're some examples of ways you could break patient/therapist
confidentiality:
• Sharing confidential information about a client with a
family member or friend.
• Talking about confidential information somewhere you
can be overheard.
• Leaving your computer containing confidential
information open to others.
• Read about legal implications and effects of breach of confidentiality
• Make short notes
Conflict of Interest
 Conflict of interest
• A conflict of interest occurs when an entity or individual
becomes unreliable because of a clash between personal
interests and professional duties or responsibilities.
• Such a conflict occurs when a company or person has a
vested interest—such as money, status, knowledge,
relationships, or reputation—which puts into question
whether their actions, judgment, and/or decision-making
can be unbiased.
• When such a situation arises, the party is usually asked to
remove themselves, and it is often legally required of them.
 Medical conflict of interest
• Medical Conflict of interest describes a situation in
which a health officer is or appears to be at risk of
acting in a biased way towards patients because of
personal interests.
• Decisions are always biased or there is a favor towards
a personal interest
•Let us discuss the case below
 Case study
• A former editor of the New England Journal of Medicine observed
that “[p]hysicians have been conflicted about their dual roles as
professionals and businessmen for millennia, but this dilemma has
sharpened in recent years as income from the practice of medicine
has faltered” (Kassirer, 2001, p. 159). The dilemma is particularly
evident, first, in the growth of physician ownership of (or other
business arrangements with) outpatient diagnostic or treatment
centers and specialty hospitals to which they refer patients and,
second, in the increase in expensive in-office ancillary equipment
(e.g., equipment used for imaging and other diagnostic services
ordered by the physician owner). As described by Pham and Ginsburg
(2007)
 The scenario

• Lucy Dickens is an osteopath who runs a clinic where she also rents
out treatment rooms on a sessional basis to other healthcare
practitioners. One of these is an acupuncturist, who pays Lucy a 25%
share of any patient fees she receives when working at the practice.
•Molecular Techniques
application in Chemistry will
be discussed later
Questions