Laboratory Medicine

The Cornerstone for Evidence

&
Data-Driven Medical Practice

i
Laboratory Medicine
The Cornerstone for Evidence
&
Data-Driven Medical Practice

ISBN 978- 9987 727 -40 7

2016 by Jeremia J. Pyuza

AUTHOR:
Jeremia J. Pyuza
Phones: +255783152962/+255754577574
Email: jeremiajpyuza@yahoo.com

Godwin Gunewe Publishers

P.O. Box 322, Mwanza-Tanzania.
Phone: +255784442128/+255752239825
All right reserved. No part of this publication may be reproduced in any
form without permission in writing from the author, except in the case of
brief quotations embodied in critical articles or reviews.

Printed in the United Republic of Tanzania

ii
 CONTENTS
Foreword...............iv
Acknowledgement...................vii
Dedication.........................ix

Chapter 1: Introduction to Laboratory Medicine...........1

Chapter 2: History and Contemporary Views Points on
Laboratory Medicine................................................13
Chapter 3:Track That Makes a Medical Laboratory Technician,
Technologist and Scientist..........................................48
Chapter 4: The Importance of Clinical Laboratory
Medicine....................................................................63
Chapter 5: Clinical Laboratory Medicine with Tanzania
National Health Vision 2025+...............................79
Chapter 6: Laboratory Personnel, Skills, Process and
Practices................................................................97
Chapter 7: Challenges facing clinical laboratory medicine
professionals and possible solutions.........................109
Chapter 8: Re-Engineering of Clinical Laboratory
Medicine.............................................................133
Chapter 9: Innovations in Laboratory Medicine and Excellence
in Service Delivery.........................145
Chapter 10: Future of Clinical Laboratory Medicine.........153

Bibliography..........................162

iii
 FOREWORD
Since early 1990s there has been a lot of socio-economic
changes as well as policy changed due to liberalization of
activities in Tanzania. In the same vein liberalization of education
was also in the main stream and quite a number of higher
education training institutions, particularly private universities
were opened. Until 1996 the country had only one medical
university, the Muhimbili University of Health and Allied
Sciences. The Evangelical Lutheran Church in Tanzania started a
medical university in Moshi known as the Kilimanjaro Christian
Medical University College (KCMUCo) in 1997 and since then
the medical universities have increased to eight.
Initially only medical students were enrolled by KCMUCo
and later in 1999 a diploma in laboratory sciences programme was
started. This was the second laboratory diploma programme in
the country after the one in Muhimbili Dar es Salaam. Soon after,
in 2001 the first programme of Bachelor of Science in Health
Laboratory Sciences in Tanzania was started at KCMUCo. Some
other Universities have also started diploma as well as bachelors
programme in their universities.
Health laboratory medicine has over the years been a very
strong tool in supporting clinicians in reaching a rational
diagnosis. Apart from diagnostic services, enormous
developments have taken place and the health laboratory is now
involved in a lot of other areas such as preventive medicine,
epidemiological surveillance, drugs and vaccines development,
and genetic bio-engineering.
Over the years enormous scientific innovations have taken
place and the health laboratory developments have moved with
the same pace. In the older days clinicians used to wait for days
or weeks to obtain patient results. With the scientific
developments, new equipment and techniques have been
developed which are more and more accurate and precise. Results
iv
are obtained rapidly, and often within a day. Multiple tests are
now performed using one equipment and only one sample, and
this has decreased a lot of errors during the specimen cycle. Other
tests are now obtained at the point of care, taking just a few
minutes.
The universities have greatly increased the number of
qualified staff in the country and thus have played a great role in
improving laboratory services in the country in diagnostic aspects,
disease surveillance and control, research and training. We now
need to improve and sustain the quality of the training and to
incorporate the technical developments taking place in this field.
This requires a critical eye from faculties, the students as well as
the alumni/alumnae
Jeremia J. Pyuza is a BSc Health Laboratory Sciences
graduate. As he was going through his training he was very
observant on what was happening in his training activities. The
text is based on what he has achieved so far and what he feels
about the field as a scientist. He feels that he should have been
more informed before joining the course so as to reap the
maximum out of his training, and that the young generation which
is expecting to join the health laboratory sciences should have a
gist of what is ahead of them. Students who are in training should
have a feel of what is expected of them during their training and
giving a perspective of what the laboratory is capable of doing.
To fill this gap, he felt that there was a need of writing this small
book. He has brilliantly been able to achieve his goal. It will also
serve the practicing staff, so as to match up with new
developments. The book has gone further in bringing up the
important relationship between health laboratory staff and
clinicians, and this indeed there is this missing link in Tanzania.
Clinicians and the laboratory personnel should consult each other
constantly, and at times work hand in hand to achieve tie best for
the patients they are serving.
It is not a technical book nor a reference book but a guide
to what is actually taking place in the health laboratory. It is but a
v
tool to pre-college and college students, faculty and instructors. I
am sure it will be of great help to prospective students before they
embark into this beautiful profession. It gives a broad
understanding of what lies ahead of them and also what is
expected of them. It is my sincere belief that it will stimulate
more students to join this noble profession.

Prof. Noel Sam (MD, M Med-Microbiology/Immunology, Dip-HIV/STDS).

KILIMANJARO CHRISTIAN MEDICAL UNIVERSITY COLLEGE(KCMU-Co).

vi
 ACKNOWLEDGEMENT
First of all, I would like to thank God the Almighty, for His
faithfulness to my life and particularly during this book writing.
Glory and Honor be to Him!
Secondly I am very delighted to thank Prof. Noel
Sam(KCMUCo),Dr. Amos Mwasamwaja (KCMC), Dr. Johnstone
Kayandabila (Arusha Lutheran Medical Centre), Dr. Elichilia Shao
(KCMC),Dr Deborah Endrew Mwaipopo (Intern-Doctor 2015/16-
Mbeya), My senior laboratory scientists, including Dr Balthazar
Nyombi PhD (Lab.scientist-KCMC), Mr. Edwin Nyale
(Lab.scientist- KCMC),Dr Elizabeth Wambui Muthondu(Resident-
KCMUCo-2012/16) Dr Maitseo Mwako-mohamad(Resident-
KCMUCo-2014/18) Mr. Ernest Obedi (Lab.scientist-DLT-
KILOSA), Mr. Pius Tarimo (Lab.scientist-KCMUCo), Dr. Jovine
Kitau PhD (Lab.scientist-KCMUCo), Ms Neema Kulaya
(Lab.scientist-KCMUCo),Mr Sixbert Mkumbaye (Lab.scientist-
KCRI) Mr. Enock Kessy (Lab.scientist-KCMUCo), Mr. Dominic
Ntekalejo (Lab.scientist-Misenye),Mr Tasilo T. Kamenya (Intern-
Lab.scientist- 2015/16 MUHIMBILI), Mr. Josephat Qaday
(Lab.scientist-Haydom Lutheran hospital), Mr Thadei Kavishe
(lab.scientist KCMC), Mr Denis Rweyemamu (lab.scientist KCMC)
and Mr. James Stanley Kimaro (Lab.scientist-KCMC),who kindly
took their time to read through this manuscript and make appreciable
comments.
I really appreciate a word of encouragement and motivation
from Dr Gilliard Masenga the executive director KCMC and Prof-
Egbert M.Kessi the Provost KCMUCo.
Thanks are also due to Ms Mercy Nkwama (MD student),
Miss Elizabeth Mbilli (MD Student), Mr. Noel G. Mdende (MD
Student), Emmanuel Mushi (MD Student), Mr. Faraja Magwesela
(MD student), Jimmy Wilfred (MD Student), Noella John (BSc HLS
Student), Mr. Octavian Ngoda (BSc HLS Student), Mr. Mololo Noa
(BSc HLS Student), Mr. Salvatory A. Samboti (BSc HLS Student),
Mr. Kongnso Edian (P&O student) from KCMUCo, who took their

vii
time to go through the manuscript and draw my attention to
typographic errors in it.
Countless number of thanks and appreciation to Rev.
Deogratus Msanya (Dean of students-KCMUCo), Miss Dorah
Elisonguo Mrema (Senior nurse at KCMC), Mr. Julius Kauki
(KCMUCo), Mrs. Yulitha J. Barnabas (Lab.scientist), Mr. Exavery
Mhanze, (Lab.scientist-Mbeya), Mr. Silverous Mwalongo
(Lab.scientist-Iringa), Mr Calcitus Nzota (Lab.scientist-Kilosa), Mrs
Esther Reuben Bugumba (Lab.scientist-Bugando Medical Centre),
Mr. Wilson Kaseha (Lab.scientist-HAI), Mr. Vincent Mgaya (former
leader of laboratory diagnosis services at ministry of health and
social welfare) for their cooperation throughout the preparation of
this book.
My special thanks and appreciation to my family members
Sarah Mhesa (my mother), Dr Modesta Mitao,Solomon Raymond,
Maria Raymod, Juliana Raymond and Nicolous Raymond for their
encouragement to me during the writing of this work.
Thanks are also due to all KCMC clinical laboratory,
attendants, technicians, technologist, Intern Lab Scientist (2015/16),
andscientist, graduates of Bachelor degree in Health Laboratory
Science, a class of 2015 and Medical students year one (MD 1
2015/16) for being challenging and cooperative to me during my
writing project.

viii
 DEDICATION
This book is dedicated to my late father Mr. Raymond Paul
Giisi, my late young sisters Agness and Rehema Raymond, my
mother Sarah Mhesa, my young brothers Mr. Solomon and
Mr.Nicolous Raymond, my young sisters Ms. Maria and Ms. Juliana
Raymond, and finally, to all health care practitioner especially
medical laboratory professionals.

ix
x
 CHAPTER ONE
INTRODUCTION TO LABORATORY MEDICINE

A cordial welcome to the world of clinical Laboratory

medicine is hereby made for all the clinical professionals and
stakeholders. Clinical laboratory medicine is the place where
interplay of the world of technology, science and mystery is greatly
appreciated. On the other side, the laboratory is the place where
technicians, technologists and scientists find answers to questions
that are both routine and confounding. For instance, does a particular
tissue sample contain cancer? What can the childs blood tell us
about her health? Is the yet unborn child developing normally? Does
a particular drug treat disease effectively? What are the possible
reasons which cause someone to die of a particular illness? Is the
donors blood compatible with the recipient?
Diagnosis of diseases, medical conditions and other risky
factors for developing a certain disease in the human being is one of
the skills and competences owned by the laboratory technician,
technologist or scientist. The scientists pillar stands on his or her
ability to diagnose the sample of the unseen patient and tell
physicians or patient the whole story about the disease. The mastery
of laboratory medicine has gone further nowadays as it has
participated in a number of the breakthroughs in medicine and
continued to shed light to clinical researchers and more brilliant
young scientists. Laboratory medicine has remained an outstanding
feature and major source of evidence-based medicine, providing
physician with confidence to interact with patients. Before we
embark into more details about laboratory medicine, it is fairly
important to have a brief understanding of laboratory medicine
concepts and hints. Some of the important concepts are:-
Laboratory is the place equipped with apparatus, equipment,
machines and reagents for performing tests, experiments, scientific
research, investigative procedures, preparation of reagents and
therapeutic materials. Therefore, laboratory medicine is one part of
the laboratory that is equipped with various biomedical instruments,
equipment, materials and reagents for conducting different
1
laboratory investigative activities by using biological specimens.
Clinical Laboratory medicine is a field in which laboratory
technicians, technologist and scientists provide testing of patient's
samples. These samples may be blood, urine, stools, cerebrospinal
fluid, sputum, pus or tissue. All samples are usually analyzed with an
intention of getting information about the health of a particular
patient. The analysis offers insights to the diagnosis, and
consequently treatment, management, monitoring, and follow-up.
Nevertheless, it contributes to control and preventive strategies of
the disease. The information obtained is a result of integration of
knowledge on using sophisticated biomedical instruments buoyed by
both theory and practices gained during studies.
Clinical Laboratory medicine can also be defined as any
facility that performs laboratory testing on specimens derived from
humans for the purpose of providing information for the diagnosis,
prevention, or treatment of disease, or impairment. Laboratory
medicine is the center of care for patients. Diagnosis made by
physicians are based on laboratory findings1. Laboratory data are
essential for clinicians to accurately assess the status of patients
health, make accurate diagnoses, formulate treatment plans, and
subsequently monitor the effects of treatment.
Therefore, a clinician must be able to trust the test results
from the laboratory in order to use them for clinical diagnosis and
treatment. As such the results must be accurate, reliable and timely2.
The most recent assessment suggests that the impact of
clinical laboratory medicine varies with the clinical department and
specialty for its application. In fact, the customary way of operation
of modern medicine would be impossible with subtraction of the
tests performed in the laboratory.
There are diversity of medical professions; there those which
have been working since time immemorial, example Medical
1
Woodcock S, Fine G, Mcclure K, Unger B, Rizzo-price P. The Role of Standards
and Training in Preparing for Accreditation. 2010;38892
2
Sustainable E, Testing Q, Infected P. Consultation on Technical and Clinical
Laboratory Testing Harmonization and Standardization Helping to Expand
Sustainable Quality Testing to Improve the Care and Treatment of People Infected
with and Affected by HIV / AIDS , TB and Malaria. 2008.

2
Doctor. Laboratory medicine is a young profession compared to
many other medical professions. There are number of reasons to
pursue and enjoy clinical laboratory medicine:-
1. Laboratory medicine is full of appreciative and grateful work. In
process of attaining professional skills and during work,
laboratory medicine is an evidence based practice, a person has
a chance to experience and observe what is actually heard and
learnt in theory as part of professional attainment. While others
are struggling to find proof, you are the one to prove and bring
confidence among colleagues.
2. Laboratory medicine is attained both theoretically and
practically. Education format and the learning mode provide
ever joyous feeling throughout the course; it involves clinical
laboratory rotations, there are programs like internship for
further exposition in laboratory practice before being conferred
amply authority to work independently.
3. As clinical laboratory medicine professional has an opportunity
to work and live anywhere as long as human beings do exist
there. One of the best need for every human being is good
health and laboratory medicine is an integral part of it.
Laboratory professionals have an opportunity to work in their
own private laboratory and in the ones established as part of
institutions.
4. Laboratory medicine professional has a great pathway towards
academic excellence. A lot of sponsors are ready to sponsor
human health professions, laboratory medicine being among. It
is known that there are very few sponsorships for degree
programmes but in laboratory medicine financial supports are
available from bachelors, masters, to PhD level.
5. As laboratory medicine professional person is given opportunity
to save and intervene peoples lives, It is an honor and trust to
be responsible for intervention of someone's life. Remember
that every sample brought in the laboratory decide the fate of
someones life and should be considered as patients.
6. The laboratory professional is responsible in combating and
eradication of diseases through early diagnosis for treatments
and control of diseases. Disease free conditions requires
laboratory participation in disease controlling process.

3
7. Practicing laboratory professionalism provides a room for
earning social acceptance due to services provided to people.
Apart from social acceptance it provides earning of money by
working either privately or as an employee. And employment
opportunities are not scrambled for like in other professionals.
8. For job security seekers, this is a nice opportunity because the
employment is not a challenge. Laboratory science is ever
growing field with high demand on human resource. For a
country seeking technological advancement working and
demand for human resources, is inevitable.
9. Laboratory medicine profession has a wide range of selection;
you can work as laboratory diagnosticians, researchers,
epidemiologists, lecturers/instructors, etc. Depending on your
interest and other life variables.
10. Laboratory medicine is facts-oriented field. Professionals talk
and report the careful scientific observations. Scientific proof is
the back born of any decision in modern medical practice.
Process of Laboratory Testing
Laboratory test being very important, can be requested by
different people mostly being physicians, clinicians, nurses and non-
medical personnel who are seeking for health checkup, monitoring
of treatment or diagnosis of diseases they suspect, such as malaria.
The process begins with the collection of a specimen which might be
blood, urine, sputum, tissue, or other biological matter from the
patient, which is then sent to the laboratory where it is uniquely
identified and examined if is appropriate for the test requested by the
health care provider. Some tests are manually performed and most of
tests are performed by using instruments.
Laboratories employ teams of licensed, highly skilled
medical professionals specially trained to perform the requested
analyses. Once the testing is complete, the lab issues a report with
the findings to the requesting clinician. And once the health care
provider receives the lab results decisions can be made as to most
appropriate treatment of the patient. To perform test which are
ordered, laboratory medicine is a section organized to facilitate
timely and quality practice

4
 Laboratory Sections
Laboratory sections are as follows:-
Clinical Chemistry section is responsible for determination of
different body level metabolites which include glucose, lipid,
proteins, together with hormones and enzymes in blood to see if a
patient had for example a heart attack or determination of level of
glucose/sugar in the blood for patient suspected with diabetes.
Microbiology section serves on identification of bacteria, fungus,
virus and other microorganisms infections. Information from
microbiology section is also used on selection of effective
antibiotics for treatment of diagnosed infection.
Serology section is the laboratory section which deals with
serological tests which are used for diagnostic identifications of
antibodies in blood serums aiming at diagnosis of certain disease.
Serologic testing can diagnose multiple illnesses, some to mention
are brucellosis, Hepatitis using hepatitis surface antigen, measles,
rubella, HIV, syphilis, fungal infections-pylori for peptic ulcers,
etc. Antibody levels referred as antibody titre, when reported by
laboratory technician, technologist or scientist tells clinician
whether an infection occurred recently or years ago. Sample
mostly used in serological test is whole blood where serum is
separated from other blood components one being clotting factors.
CSF is also among sample received and processed in the
serological clinical laboratory.
Hematology is a laboratory section for diagnosing blood related
disorders such as leukemia, sickle cell anemia, lymphomas,
coagulations factors and many other factors. If you have ever had
a blood test it was probably sent to Hematology section.

Parasitology section is where technician, technologist and
scientist diagnose the presence of parasitic infections such as,
malaria, roundworm, hook worms etc.
Molecular biology is a laboratory section involved in performing
specialized testing requiring extraction of DNA or RNA,
hybridization, amplification, or other analyses! of nucleic acids to
diagnose disease, predict prognosis of disease, guide therapy, or
evaluate susceptibility to diseases before disease. It is evident to
accurate and rapid diagnosis for diseases like hepatitis, HIV,
bacteria and other organism. Molecular biology laboratory is also
5
 involved in forensic medicine example finger print, parent
identification and embryological diagnosis of disease.
Blood Bank and Transfusion section is the one which deals with
services like blood grouping, cross-match, separation of blood into
different components such as red blood cells and platelets. Blood or
blood components is then given to a physician or a nurse to be
transfused into patients who are in need.
Diagnosis of diseases in laboratory sections relies on the
samples taken from patients or healthy individuals for the purpose of
annual examination, body checkup and screening purpose. Some
specimen are common to almost all departments while others are
specific to one section. The explained below, are some of the
samples received in the laboratories.

Laboratory Samples
Blood samples being most frequently received in most of
laboratories can be used in different laboratory sections to bring up a
picture of what is wrong within blood tissue. In clinical chemistry
section, blood plasma and serum can be used to measure parameters
like urea and creatinine for assessing kidney functional test, AST and
ALT for assessing liver functions along with High Density
Lipoprotein (HDL) and Low Density Lipoprotein (LDL) for
assessing arteriosclerosis-atherosclerosis3.
In hematology section, blood is used in diagnosing blood
related diseases such as anemia, hemostatic disorder, leukemia and
sickle cell anaemia. In serology component of blood which is serum
is used in diagnosis of disease through serological (antigen &
antibodies) tests. In microbiology section, blood can be used to
assess if there is any microorganism within blood, leading to
bacteremia etc.
Urine sample is used for diagnosis of diseases related to
urinary tract system such as urinary tract infections (UTI), urine
pregnancy testing, sexual transmitted disease and parasitic
infections. Stool samples are brought to the laboratory for diagnosis
of parasitic infections that can be intestinal pathogenic protozoa like

3
Pathology C, Hospital ES, Avenue C. Chemical Pathology Handbook. 2014

6
Entamoeba, Giardia, Balantidium, and helminthes like Schistosoma,
Manson, Ascaris and other enteric diseases.
Serous fluid is an ultra-filtrate of plasma and is produced and
reabsorbed at a constant rate. This fluid is contained in cavities of the
body that hold abdominal organs, lungs, and the heart and they are
lined by two membranes consisting of mesothelium cells. The fluid
is used for diagnosis of disease related to abdominal organs, lungs
and heart. Diseases which are likely to be diagnosed are
inflammatory disorders, malignancies, and different microorganism
infections4.
Synovial fluid is present within the synovial cavity is mostly
found in free-moving joints resulted of an ultra-filtrate of plasma
across the synovial membrane and has a chemical composition
similar to plasma. Indications for synovial fluid analysis include
arthritis (degeneration of the articular membranes) and other joint
diseases. Joint disorders may be classified as non-inflammatory,
inflammatory, septic, and hemorrhagic.
Seminal fluid is used for diagnosis of infertility cases,
qualification of donors for artificial insemination programs which
require a complete seminal analysis. The fluid also helps in
providing the necessary information for completeness of a
vasectomy, semen and sperm banking, and forensic studies in
sexually related crimes, such as rape and paternity allegations.
Gastric fluid is sample used in analysis and for the diagnosis
of digestive disorders or ulcers.
Sputum is used for diagnosis of diseases related to throats
and lungs, TB being the most common, with other diagnoses of
diseases depending on the needs.
Cerebralspinal fluid (CSF) is irreversible sample taken from spinal
cord and is used for diagnosis of pathologic diseases detected on
sample. Such conditions are subarachnoid or intracerebral
hemorrhages which might cause strokes or trauma, infections such as
meningitis from, (bacterial, fungal, parasitic, or viral), abscesses and
encephalitis. The fluid can also be used in diagnosis of malignant
processes such as primary brain tumors, metastatic tumors with a
4
Hubbard JD. A Concise Review of Clinical Laboratory Science. 2010

7
primary site elsewhere, or leukemia and lymphomas and multiple
sclerosis.
Body tissues are used for diagnosis of diseases like cancers.
Pus is used for identification of local bacterial infections. Being in
specialty, every skilled laboratory personnel performs tests
specifically sectional wise. Basically, there is a number of sections in
the clinical laboratory, some of them are clinical chemistry,
hematology, parasitology, microbiology, blood transfusion and
Molecular biology.
The cornerstone for evidence-based medicine which is the
result of efforts in Clinical Laboratory medicine, is strongly attracted
to people who have been interested in the dynamics of human body
functioning. Clinical laboratory provides knowledge and guidance
that help others by providing accurate test results which help a lot in
patient management. The field of Clinical Laboratory science,
applies scientific laboratory methods to diagnostic and therapeutic
problem of clinical medicine.
Well-trained and qualified medical laboratory scientists are
absolutely a necessary part of the health team in hospitals and in the
community in general. The life of a highly-skilled medical
laboratory scientist involves the use of most fashionable ideas or
style and technology in a fast paced environment. They use
sophisticated instruments and techniques while applying theoretical
knowledge to provide rapid, accurate, and reliable results that are
used by clinicians to saving the patient.

Let's Get Practical:

Have you ever visited the hospital for either a medical
checkup or treatment? Have you ever wondered who conducts the
detailed laboratory testing for your disease diagnosis, health
checkup, and annual examination, such as cholesterol and glucose
levels, and analyzes the results? Or who conducts specialized testing
for genetic disorders like sickle cell disease ? How about those who
identify an antibiotic resistant infection like Methicillin Resistant
Staphylococcus Aureus (MRSA) and determine which antibiotic is
required to save someone's life?
Well, if you thought that your sole attendant at the doctor's
8
office or in the hospital is only a physician or a nurse that would be
incorrect. Note that laboratory technicians, technologists or
scientists are also involved and play a very vital role. While
physicians initiate and facilitate access of patient to laboratory by
writing and sending request together with patients sample to the
laboratory, it's laboratory technician, technologist or scientist who is
responsible for all test outcomes. Medical laboratory professionals
provide up to 70 percent of patient information needed by physicians
to confirm their clinical diagnosis and therefore proceed with an
appropriate treatment plan5,6,7.
If you feel unwell and go to see a doctor or you become
admitted to hospital, there is high chance that the physicians will
take a sample which can be blood, tissue, urine, stool, sputum and
send it to laboratory for testing. From that aspect, the decision as to
whether you are ill or not will be obtained. Therefore, laboratory
diagnosis helps physician to understand disease which is primarily
responsible for your condition. All these information are given by
laboratory technicians, technologists and scientists accompanied
with scientific reasons8.
If a patient requires administrations of drugs, suggestions are
from laboratory technician, technologist or scientist on what drug
will be effective for treatment, which ones are resistant and which
are less toxic. Laboratory technician, technologist or scientist can
provide such sufficient answers. For a well-trained doctor, most of
basic foundation of knowledge and skills are basically laid in
laboratory medicine.
In a vision of todays world which rely on preventive
medicine rather than proactive medicine, laboratory medicine plays
a very vital role by proving screening tests for many diseases and
their risk factors. Doctors should have high level of confidence in
laboratory test results to aid in confirming their clinical diagnoses.
Patients history along with physical signs and symptoms are vital,

5
Ca NI, Ry ATO. Life Saving Medicine Starts Here.
6
Khosrow Adeli Simon Shorter. Public Relations Opportunities in Laboratory
Medicine:
7
Samson O. MEDICAL Science: The Engine Room of Modern Medicine
8
Williams A Cunningham ,The Revolution of Laboratory Medicine.
9
but most diagnoses need confirmation using laboratory tests.
In one of his famous statements, Sir Claude Bernard
(1865) who believed in revolution of medicine through
laboratory medicine said;
I consider hospitals only as the entrance to scientific
medicine; they are the first field of observation which a physician
enters but the true sanctuary of medical science is a laboratory. It is
only there, a physician can seek explanations of life in a normal and
pathological status by means of experimental analysis. I shall not
concern myself here with clinical side of medicine. I assume it as
known or as still being perfected in hospitals by methods of
diagnosis which Physics and Chemistry are constantly giving to
symptomatology.
By his opinion medicine does not end in hospitals as often
believed, but merely begins there. Apart from the hospital, critical
physician must go into laboratory and do experiment on patient
sample so as to seek what it has been observed to the patient,
whether about the action of drugs or about the origin lesion in organ
or tissue. Consequently he will achieve true medical science.
Laboratory medicine is a foundation of evidence-based
medicine and thus it is about integrating individual clinical expertise,
that is knowledge laid in physicians and the best external evidence
which involves knowledge laid in laboratory technician, technologist
and scientist. The philosophical origins of evidence-based medicine,
extend back to mid-19th century in Paris and earlier, and remained a
hot topic for clinicians, public health practitioners, purchasers,
planners, and the public9.
Despite its ancient origins, evidence-based medicine remains
a relatively young discipline whose positive impacts are just
beginning to be validated, and it will continue to evolve. This
evolution will be enhanced as several undergraduate, postgraduate,
and continuing medical education programs adopt and adapt it to
their learners' needs10.
Evidence-based medicine whose foundation is laid on
9
Collaboration C. Evidence-based medicine: What It is and What It is not.
1996;72:712
10
Ibid
10
laboratory medicine, is characterized by extreme care, great effort
which is readily observable in judicious use of current best evidence
in making decisions about the care of individual patients. The
practice of evidence-based medicine means integrating individual
clinical expertise with the best available external clinical evidence
from systematic research.
The laudable goal of making clinical decisions based on
evidence can be impaired by the restricted quality and scope of what
is collected as best available evidence11. Evidence-based clinical
practice guides healthcare practitioners to make informed patient
care decision12.
In the past years the role of clinical physician was relatively
straightforward with regard to laboratory testing. The physicians
would order a test and dutifully perform the study, regardless of
whether or not it seemed appropriate. The clinical laboratory was
working more or less as Hotel which save clients according to their
needs without reasoning, with the same reasons physicians were
provided any item, in any quantity they wanted. Now with mindset
of costs containment, things have changed in comparison to the years
back. Apart from cost issues, laboratory, technicians, technologists,
scientists in most of the developed and some of developing countries
have put forward strategies toward reasonable testing and
interpreting results obtained from laboratories for easiest use by
physicians.
With increase of laboratories and new laboratory tests,
physicians will face and continue to face expanded menu of tests,
and studies from which physicians must order wisely and interpret
results with an assistance of laboratory scientist, who is well
equipped in various disease processes that result in significantly
abnormal laboratory findings. Increasing complexity of clinical
laboratory science will force a physician to run the risk of being
incompletely informed or not informed about new tests in clinical
laboratory. Many physicians, most specifically junior doctors, will
seek out the necessary information and interpretative guideline to
11
Nierenberg AA. Promises, Pitfalls, and Pleasures of Practicing Evidence-Based
Psychiatry and Neurology. 2009; 6657
12
Medicine Better Health through Laboratory. 2013;13

11
make optimal and cost-effective use of laboratory tests and studies.
With massive innovation of science and technology, the use
of clinical laboratory has increased with high demand of relation
support and trust between clinicians and clinical laboratory scientist.
There is high need for bidirectional transfer of information among
clinical laboratory scientists and physicians for patient care
improvement. The understanding of clinical information by clinical
laboratory scientist will allow far better understanding of patients
and physicians need regarding laboratory tests. Moreover, if clinical
laboratory scientist understands the clinical problem, appropriate
screening and definitive testing procedures can be suggested, and it
will more efficiently result in the correct diagnosis. Most junior
doctors are comfortable with selecting tests from a small working
repertoire of common tests.
When results do not fit suspected diagnoses, doctors rely on
combination of patient presentation and their own diagnostic
instincts more than the laboratory results without asking more
questions on other extrinsic and intrinsic factors which may cause
unrelated results. On the other hand, clinical laboratory scientists
never use their own diagnostic instincts to reason on deviation of
results, instead, the most beneficial solution for this upcoming
problem is existence of laboratory consultation services which will
be as useful resource for the physician with need of effective and
consistent access to laboratory services. Laboratory professionals
should be in position of understanding clinical conditions in relation
to doctors and patient needs.
Having seen the introduction of laboratory medicine, we can
now be able to understand the foundation of what we see today in
laboratory enterprise. Now the next topic will give more details on
what happens in laboratory medicine.

12
 CHAPTER TWO
HISTORY AND CONTEMPORARY VIEW POINTS ON
LABORATORY MEDICINE

An understanding of history in any profession provides room for

critical thinking and allows a person to evaluate the position they hold in
the profession. Many people have been repeating the same mistakes made
by pioneers of their profession because they never read what occurred in
the past. You may remain celebrating the success which people
achieved years ago, with conclusions already in place.
To affect your profession effectively and positively, start with
maximizing your time management by not repeating the mistakes and
discoveries which have already been done by former members of your
profession but rather, think of new innovative ideas which will change your
profession at large.

HISTORY OF LABORATORY MEDICINE

Berger once said in his article of medical diagnosis and the birth of
clinical laboratory that, the laboratory medicines contribution to modern
medicine has just recently been recognized by historians. Physicians have
recognized laboratory medicine as something more than an addition of
another resource to medical science and it has been appreciated as the basis
of evidence-based medicine and a seat of medicine, where clinicians prove
what they observe in their patients.
It is difficult to exactly tell when and where medical laboratory
science began. However early historical references have shown that there
was examination of body fluids in the time of Hippocrates. One could not
talk about the field of medical laboratory science without also talking about
the medical specialty of pathology, which is and will remain the core
course of clinical laboratory medicine1
Back to history; early laboratory practitioners were physicians or
pathologists, or both. Before the discovery of the microscopy and other
laboratory techniques, the laboratory medicine had already begun when
the ancient Greek physician Galen2 and Hippocrates started the practice of
1
Kranek MLSO, Louise M. Medical Laboratory Sciences Text Books. 2013;2211
2
Copeland DD. Polishing the Crystal Ball:emerging trends in contemporary
cinical laboratory medicine 2007;68(2):1018
13
examining patients specimens. The oldest known test on body fluids was
done on urine, in ancient times before 400 BC, when urine was poured on
the ground and observed to see whether it attracted insects. If it did,
patients were diagnosed with boils3.
The ancient Greeks also saw the value in examining body fluids to
predict a disease. At around 300 BC, Hippocrates promoted the use of the
mind and senses as diagnostic tools, a principle that played a big part in his
reputation as the Father of Medicine4. The central Hippocratic doctrine
of humeral pathology attributed all diseases to disorders of fluids of the
body.
To obtain a clear picture of a disease, Hippocrates advocated a
diagnostic protocol that included tasting the patients urine, listening to the
lungs, and observing skin color and other outward appearances and this
level of attention is still paid even in todays laboratory practice by looking
at the color of urine, the smell, its specific gravity, and many other things,
to get as much information as possible from the specimen provided from
the patients.
Beyond that, the physician had to understand the patient as an
individual. Hippocrates related the appearance of bubbles on the surface
of urine specimens to kidney disease and chronic illness. He also related
certain urine sediments, blood and pus in urine to disease. The first
description of haematuria or the presence of blood in urine, by Rufus of
Ephesus surfaced at around AD 50 and was attributed to the failure of
kidneys to function properly in filtering the blood. Even now, we are still
using these criteria of blood in the urine as indicative of problems caused
by a traumatized urinary system or kidney infection.
The ancient Greeks attributed all diseases to disorders of bodily
fluids called humors, and during the late middle Ages period between 5th to
15th centuries, doctors routinely performed cryoscopy, the determination of
the freezing point of a fluid, usually blood or urine, compared with that of
distilled water for disease diagnosis. Later, the microscope revealed not
only the cellular structure of human tissue, but also the organisms that
cause disease.
More sophisticated diagnostic tools and techniques such as the
thermometer for measuring temperature and the stethoscope for examining

3
Berger BD. A Brief History of Medical Diagnosis and The Birth of The Clinical
Laboratory. 2000;
4
The Lewin-group. Laboratory Medicine: A National Status Report Laboratory
Medicine 2008.
14
the heart were not in widespread use until the end of the 19th century.
Years back treatment relied almost entirely on history taking and physical
examination5.The clinical laboratory would not become a standard fixture
of medicine until the beginning of the 20th century.
The extraordinary advances in science and technology that
characterized the 20th century had so transformed the practice of clinical
medicine that now, history taking and physical examination have
increasingly given way to a practice of medicine dominated by the use of
medical technology, particularly laboratory medicine.
Three distinct periods in the history of medicine are from the
middle ages to the 18th century, when bedside medicine was prevalent;
then between 1794 and 1848 came hospital medicine6; and from that time
forward, laboratory medicine serves as bedside and pre-bedside medicine
mostly focused to pre-bed medicine.
Physicians began to study pulse, blood pressure, body temperature
and other physiological indicators, even though simple practical
instruments to measure these signs were not developed until the end of the
18 century. The use of precise measurements in diagnosis became standard
in medicine in the early 1900s. Standardized eye tests, weight and height
tables, and IQ tests were all part of a movement to identify statistical norms
of human physiology and behavior which have contributed significantly to
the understanding of normal and abnormal values which are used in
laboratory medicine.
The first hospital laboratory in Britain, which was set up at Guys
Hospital, was organized into clinical wards7. Two of these wards were
designated for medical student rotations and had a small laboratory
attached for clinical work. By 1890, most laboratory procedures in the
United States were performed by the physician with a microscope in his
home or office. In 1898, Sir William Osler, a Canadian physician and
professor, was one of the first well-known authors in the clinical laboratory
literature.
An increasing number of useful laboratory tests were discovered in
the second half of 1800s, and by the turn of the century, specific chemical
and bacteriological tests for disease emerged rapidly. In the 1880s, the
organisms responsible for tuberculosis, cholera, typhoid and diphtheria

5
Berger BD. A Brief History of Medical Diagnosis and The Birth of The Clinical
Laboratory. 2000;
6
Biittner B. The Origin of Clinical Laboratories *). 1992;30(10):58593
7
Biittner B. The Origin of Clinical Laboratories *). 1992;30(10):58593
15
were isolated; and by the mid-1890s, lab tests had been introduced to
detect these diseases. The spirochete that causes syphilis was identified in
1905, while the Wassermann test for syphilis was introduced in 1906.
Advances in the analysis of urine and blood gave physicians
additional diagnostic tools and moved the profession from treating patients
as if they were witchdoctors to scientific based medicine. These
innovations were the result of progress in basic science that made it
possible to duplicate successful applications more rapidly than ever before.
The earlier advances in immunization, such as smallpox
vaccination, had been purely empirical discoveries and were not quickly
repeated. Microbiology for the first time enabled physicians to link
disease-causing organisms, symptoms and lesions systematically. The
principles that Pasteur demonstrated in the development of anthrax and
rabies vaccines now provided a rational basis for developing vaccines
against disease and served as medicines lodestar. Something to have in
mind is that we could not speak of laboratory medicine without discovery
of microscopy. It was about two thousand years later, when the first true
clinical laboratory opened in 1896 at Johns Hopkins Hospital8.
The first clinical laboratory opened at Johns Hopkins Hospital was
a twelve-foot-by-twelve-foot room equipped at a cost of 50 USA dollars9.
This clinical laboratory took around 11 years to construct and was
completed in 1889 under the directive of Dr. William Stewart Halsted, the
first chief of surgery at the Johns Hopkins Hospital. Full construction took
about three years more after opening the clinical laboratory10.
There is a big difference between the 1896 clinical laboratory and
todays Johns Hopkins clinical laboratory. Todays Johns Hopkins clinical
laboratory is huge, with a great number of people working in it, with very
advanced automated machines for diagnosis of diseases and millions of
tests conducted per year.
In Britain, France and Germany laboratory medicine passed
through three phases; the early phase which took place between 1790-1840
where the first concepts of clinical laboratories were simple bedside testing

8
Berger BD. A Brief History of Medical Diagnosis and The Birth of The Clinical
Laboratory. 2000;
9
A. Delwiche F. Mapping The Literature of Clinical Laboratory Science.
2003;30310.
10
L. Cameron J. Early Contributions to the Johns Hopkins Hospital by the
Other Surgeon: 2001;234(3):26778

16
methods for the examination of stones, urine, and blood; phase two was
age of institutionalization which took place between 1840-1855 where
qualitative and quantitative chemical analysis of urine, blood and other
materials as well as physiological and pathological chemical research and
training were conducted; phase three was the extension phase which took
place in between 1855-1890 when hospital laboratories, ward laboratories,
laboratories of hospital pharmacies, chemical departments of pathological
institutes came into existence11.
The discovery of epidemic disease-causing agents such as
tuberculosis, diphtheria, and cholera and the development of tests to detect
the presence of these epidemic strains throughout the end of the 19th
century propelled laboratory medicine to a position of importance by the
early 20th century. Now with power in hand we can say that clinical
laboratories are a facility for the biological, microbiology, serological,
chemical, immune-haematological, haematology, biophysical, cytological,
pathological examination of materials derived from the human body for
the purpose of providing information for the diagnosis, prevention or
treatment of disease or for the assessment of the health of human beings.
Historically, laboratory medicine includes procedures to determine,
measure or otherwise describe the presence or absence of various
substances or organisms in the body. Facilities for collecting or preparing
specimens and those that only serve as a mailing service without
performing diagnostic testing are not considered as laboratories. The
practice of laboratory medicine implies a broader scope of influence
beyond the activities in the laboratory, such as consultations with clinicians
to assist with test ordering and results interpretation and performance
measurement for quality improvement in the delivery of patient care.
In a small and growing scale, there are direct interactions by
laboratory scientists with patients or the public. By considering three
phases in the laboratory which are pre-analytical, analytical and post
analytical; we can then say that clinical laboratory is the testing service,
associated with practices of assessment, diagnosis, treatment, management
or prevention of health-related conditions utilized in patient care decisions
and improving public health.
The emergence of the germ theory of disease in the late 19th
century not only laid to rest the humeral theory of Galen but also laid down
a relationship between modern medicine and the laboratory medicine that

11
Biittner B. The Origin of Clinical Laboratories ). 1992;30(10):58593
17
has come and dominated western medicine in the 20th century and is
spreading more to developing countries.
The main idea on the development of a causal taxonomy of disease
was introduced by Kochs postulates in 1884. Kochs postulates provided
reasons for establishing an etiological link between a microbe and a
disease. The four postulates in modern form are:
(i) For a disease to occur there should be an etiology.
(ii)To prove that, an organism must be isolated from a diseased individual
and grown in culture.
(iii) The organism must produce the same disease when introduced into a
healthy individual.
(iv) The organism must be re-isolated from the experimentally infected
organisms.
Postulates 3 and 4 fall entirely into the domain of the experimental
laboratory. However, the requirements of the first 2 postulates provided
great reason and force to the emergence of the clinical microbiology
laboratory. This logic provided a strong tradition for clinical laboratory
measures in confirming a medical diagnosis at the end 19th century.
ASANTE BABU KOCH. To mention some the clinical laboratory
provided the culture of microbial pathogens, hemoglobin estimation,
counting of red and white blood cells, microscopic identification of some
parasites, clotting time in coagulation disorders, examination of sputum in
tuberculosis, simple immunological tests such as agglutination tests for
typhoid fever, and the demonstration of amino acid in liver disease12.
During the next first half of the 20th century there was an
explosion of advances in analytical techniques in clinical chemistry,
immunology, and blood banking as well as microbiology. With the
exception of the important therapeutic applications of blood banking, the
emphasis was almost entirely on the application of the methods of the
clinical laboratory in diagnosis.

Chronological Aspects of Some Important Discoveries

in Laboratory Medicine
Apart from the discovery of an important device in laboratory
medicine, the early Microscope in 16 Century by Zacharias Jansen,
followed by the invention of the real microscope by Antony Van

12
Copeland DD. Polishing the Crystal Ball: Will Happen to This Patient and.
2007;68(2):1018

18
Leeuwenhoek in 17th century, most diagnostically useful tests in clinical
chemistry were developed in the first 50 years of the 20th century: serum
phosphorus (1920), serum magnesium (1921), protein electrophoresis
(1926), erythrocyte sedimentation rate (1929), alkaline phosphatase (1930),
lipase (1932), amylase and acid phosphatase (1938), ammonia (1939),
creatinine phosphokinase (1954), lactate dehydrogenase (1955), and
alanine aminotransferase (1956).
The tests were useful but labor intensive and required manual
methods by skilled technologists using sophisticated instrumentation. They
were primarily applied in patients solely after a physicians thorough
evaluation and examination had narrowed the differential diagnosis to a
short list of possibilities. The introduction of the first automated clinical
chemistry analyzer by Technicon Corporation in 1959 was a watershed in
the application of these clinical analyses(13).

THE GLOBAL TRENDS OF LABORATORY MEDICINE

Laboratory medicine growth has been measured through two
ways:-

Development of Laboratory Medicine on Professional Aspects

The professional development on laboratory medicine started
when physicians and pathologists started to struggle for evidence based
medicine. Therefore, physicians and pathologist were pioneers and
practitioners of this field. Due to the importance which was growing and
increasing every-day, physicians started teaching people who were
working with them to diagnose the disease according to criteria which were
given and settled. In simple words physicians and pathologists were helped
by medical attendants to perform laboratory procedures. Moving on from
medical attendants whose education was informal, the need for people with
formal education who could work in laboratories permanently increased
and formal education started.
At first laboratory medicine was integrated into colleges and
universities which were offering medical doctor programs and a number of
graduates were produced to suit the need of laboratory medicine. The states
of career development differs from one place to another, and developed
countries were pioneers of having qualified people to work in high quality
and trusted laboratories compared to developing countries. In most of

19
African countries Tanzania being an example degree level medical
laboratory qualifications started just some few years back.
For example, the Bachelor of health laboratory science in Tanzania
started in 2004 at Kilimanjaro Christian Medical University College
(KCMUCo), followed by the introduction of the Bachelor of Medical
laboratory science at Muhimbili University of Health Allied Science
(MUHAS).Up to now the number of universities offering the same course
has increased. The number of graduates has increased from tens to
hundreds. The masters degree for medical laboratory scientists has been
introduced to almost all colleges and universities offering medical
laboratory science. Apart from masters degree, a number of PhD graduates
each year are rooted in laboratory medicine.
According to Desmond Burke regarding laboratory medicine in
21st century, the practice of physicians performing autopsies and
conducting bacteriologic analyses on body fluids as aids on solving clinical
problems spread from Paris to London, Dublin, and Edinburgh and later to
the United States. With the discovery of blood groups and the development
of chemical analyses of body fluids in the 1920s, the demand for laboratory
tests by community physicians grew to the extent that hospitals demanded
more full-time laboratory personnel (laboratory scientists). Since
pathologists were needed to perform autopsies, they became the natural
choice to assume responsibility for centralized laboratory work.
By the 1960s, the discipline had gained strength with the
development of strong academic departments of laboratory medicine at
several medical schools. By the 1980s, many of these departments had
become integrated with pathology and were designated departments of
pathology and laboratory medicine according to the USA system.
Currently, the number of laboratory professionals with high
qualifications is so large. Number highly qualified university graduates is
increasing ranging from Bachelor degrees to PhDs. The professional is
heading towards having laboratory consultants as long as the need for
interpretation of results increases due to the day-to-day innovation of new
tests.

Development of Laboratory Medicine on Technological Aspects

On technological aspects, the observation of laboratory historical
timeline gives us a clue that, we are here because people did their best in
science discoveries. The technological aspect we are speaking about can be
explained as follows:-

20
 In 300BC Hippocrates advocated examination of urine to diagnose
disease, in 1500 physicians began using urine color charts for visual
urinalysis, In 1500 BC Egyptians described excessive urination in the
Papyrus ember, At the same time Hindu doctors noted that bugs were
attracted to some patients urine, and in 1675, the British doctor Thomas
Wills tasted urine and found it sweet14.
In 1684 Anton van Leuwenhoek published the first drawings of
bacteria as seen under the microscope, in 1770 John Hill introduced a
method of obtaining specimens for microscopic study, in 1830 Gerardus
Mulder performed the first elemental chemical analysis of proteins the
same year J. J. Lister developed an achromatic microscope and introduces
dark-field microscopy. In 1852 K Vierordt developed a method for
performing accurate blood counts (hemo-cytometry) and G. G. Stokes
discovered fluorescence microscopy.
In 1854 John Snow linked the London cholera outbreak to Broad
Street Pump, Jules Duboscq developed the first visual colorimeter based on
Beers Law. In 1856 William Perkin prepared the first synthetic dye; in
1866 Voit established the first hygienic laboratory in Munich, in 1872
Oscar Brefeld developed the use of a gelatin medium for isolation of fungi
in pure culture. In1875 Corfield established the first public health
laboratory in England and in Osaka Japan, there was establishment
imperial Hygienic Laboratory
In 1886 Jaffe developed the alkaline picrate method for the
determination of creatinine, in 1890 The Royal College of Physicians and
Surgeons established a conjoint clinical laboratory in London with G. S.
Wood-head as the first director. In 1892 J. Dewar invented the vacuum
flask; Charles and William Mayo founded their clinic and hired colleagues
to perform laboratory testing.
The New York City Department of Health established the first
public diagnostic bacteriology lab in the U.S. under Hermann N. Biggs and
William H. Park; The Laboratory of Hygiene at the University of
Pennsylvania is opened in Philadelphia this was in 1892. In 1893 Hermann
M. Biggs established the Diagnostic Laboratory in New York City, in 1895
Franz Ziehl and Friedrich Neelsen introduced their modification of the
acid-fast stain for tuberculosis for diagnosis and the Pepper Laboratory was
established at the Pennsylvania General Hospital in the same year.
In 1896 C. W. Purdy published Practical Urinalysis and Urinary
Diagnosis; Ferdinand Widal developed the agglutination test for
14
Hicks JMB. Laboratory Medicine: Past, Present and Future 2006.
21
identification of the typhoid bacillus; in Great Britain, clinical laboratories
existed in Edinburgh, Leeds, Glasgow, and London by this date. In 1897
the first commercial clinical laboratory, the Clinical Research Association,
which received specimens by mail, was established in England 15. In 1962,
blood glucose testing strips were first introduced. In the late 60s and early
70s automated equipment began to replace manually preparing a blood
cell stain and counting each cell under a microscope, a process that
typically took 20-30 minutes.
More discoveries kept on coming in between until a very big
discovery which has come to define modern medicine, the polymerase
chain reaction (PCR). PCR was discovered in 1983 by Kary B Mullis. This
new technology has helped the production of unlimited copies of a
specific DNA sequence in a test tube. The discovery of this technology
has led to a revolution in Research, Diagnostics and Forensic medicine.

Molecular Diagnostic: The Fastest and Vital Tool Discovered

in Laboratory Medicine
Molecular diagnostics is the fastest growing field within laboratory
medicine. Molecular diagnostics gives clinical practitioners a better
knowledge and understanding of disease, and thereby better approaches to
treatment and therapy molecular diagnostics. It has led to better patient
care for easier diagnosis of infectious diseases & drug resistance testing
and disease prevention. It is also employing personalized medicine where
technology helps to treat disease according to the need of particular
patients16.
PCR has got enormous applications in clinical laboratory, some are
mentioned here below:-
1. Cancer diagnosis:-genetically and non-genetically caused cancer: -
example chronic myeloid leukemia caused by chromosomal
translocation and cervical cancer caused by human papilloma virus can
be easily diagnosed by PCR.
2. Diagnosis of inherited diseases and disorder example sickle cell anemia
and thalassemia.
3. Using single hair follicle or sperm, single cell PCR allows
investigations involving forensic medicine example identification of

15
Berger BD. A Brief History of Medical Diagnosis and The Birth of The Clinical
Laboratory. 2000;
16
Hicks JMB. Laboratory Medicine: Past, Present and Future 2006

22
 potential suspects whos DNA may match evidence left at crime scenes
or clear person wrongly accused of crime.
4. Useful tool in detection and diagnosis of infectious agents example
latent virus in tissue, bacterial infections example tuberculosis and
retroviral infection example HIV infection.
5. Useful tool on typing matching tissues or organs before transplant. On
other word matching donors with recipients during transplant process.
6. Also very useful in prenatal diagnosis of diseases and disorder using
chorionic villus samples or fluid taped from the amniotic sac.
7. From its discovery it has simplified the study of evolution, the study of
archeology and palenteology has been more simplified, even very small
amount remains can be studied using amplification technique.
8. According to new algorithm HIV patients are managed using viral load,
now PCR is the only tool for such activity. It is most useful tool to
determine viral load.

Advancement in molecular biology is aimed at achieving the

following:-
1. Combining all testing needed on one micro array chip. This is possible
due to Genomic studies.
2. Decreasing the Cost-per-test- of molecular biology to prevent
unnecessary costs.
3. Molecular biology will increase the flexibility of testing which means
that laboratories can meet increasing test demands.
4. Currently in most of under developed countries technological
advancement is slow, resulting in a long turnaround time for test.
Molecular biology has come up with the solution by helping laboratory
technicians, technologist and scientists to reduce the time for test
performance.
5. Molecular biology has also helped to reduce the space needed by
laboratories because one machine can perform a number of tests,
meaning that less bench space is required.

THE FUTURE OF MOLECULAR BIOLOGY

Proteomics
Proteomics is the large scale study of proteins, particularly their
structure and functions. The proteome is complex and varies from cell to
cell, and is constantly changing through its biochemical interactions with

23
the genome and the environment. The study of proteomics can lead to a
better understanding of the disease process. To catalog all human proteins
is a major challenge for scientists. There is an international collaboration to
achieve this goal that is being coordinated by the Human Proteome
Organization.

Pharmacogenics
Pharmacogenetic tests can predict whether a drug will be effective
or cause adverse or even deadly side effects

Nutrigenomics
It is the field that examines the response of individuals to
compounds in food using genomic and other related technologies
nutrigenomics research looks at how diet interacts with gene expression

Nanotechnology
It is a relatively new area of science, in which because of its
enormous potential, the US government is supporting research. It will be
used for sensors to detect biological agents, and will contribute to the
diagnosis and therapy of heart, lung and blood disorders by using
multiplexed diagnostic sensors to allow the rapid measurement of
biomarkers in blood, urine and breath. There are a huge number of future
possibilities from this technology. More innovations are expected as
scientists are searching for further advancements.

From the Above Technological Advancement We Can

Still Learn the Following:-
1. There is big interval between when the pioneers tried to diagnose
diseases using different means to the time when real and defined
diagnosis started.
2. Number of discoveries was very high in 19th century compared to any
other time in the laboratory medicine timeline.
3. The first laboratory started to operate in 19th century, and from there we
have seen a lot of changes happening pushing out un-experimental
medicine and ushering in evidence-based medicine.
4. Africa has not participated in the big discoveries which happened in
laboratory medicine. From here we can now link the development of
laboratory medicine in Africa corresponding to less innovations which
have been contributed by African continent.

24
5. Laboratory medicine is still growing in the aspect of science because
every now and then we witness great changes which are happening and
all of them have a big contribution toward patients care.
6. The creation and development of laboratory medicine was the answer to
a fundamental need for medicine to understand and to diagnose human
disease17.
7. Great respect for the basic sciences, physics and chemistry and later
biochemistry were the leading goals18.
8. There was a deep interest of science in medicine, and hospitals became
the centers of knowledge building, and medics were science oriented.

Growth of Laboratory Medicine

The trend in growth of laboratory medicine can be explained with
reference to developed countries and developing countries. Laboratory
medicine growth can be applied in developed countries down to developing
countries. In most developed countries laboratory medicine is valued as an
important asset, for instance laboratory testing is performed for 98% of
hospital admissions in the USA19. There is an emphasis on the use of
laboratory tests for proof of clinical diagnosis, and the plans to eradicate
disease are engineered by good laboratory practices.
Since the discoveries of laboratory medicine there has been more
innovations in the field technology, particularly the use of automated
machines in sample processing rather than manual sample processing.
Laboratory medicine has got patents in developed countries and developing
countries. For many developing countries, the infrastructure, competent
personnel, machinery and equipment and policies to improve this very
important arm of medicine is still lacking. In developed countries people
are further on in terms of science and technology, competent laboratory
personnel, high utilization of laboratory information for patient
management and the laboratories are independently accredited.
Accreditation provides a basis for physicians to trust the results because
they rely on the procedures which are be assessed. On the other hand
clinicians know the meaning of what is produced by laboratory services.

17
Izazovi, Evropski M, Korita I, Blaton V. Challenges of Laboratory Medicine:
European Answers. 2011;30(4):2738
18
Ibid
19
Woodcock S, Fine G, Mcclure K, Unger B, Rizzo-price P. The Role of
Standards and Training in Preparing for Accreditation. 2010;38892

25
 Trying to assess in terms of policies and plans, developed countries
are advanced in comparison to developing countries, because their annual
budget prioritizes laboratory medicine as the main arm in health care
provision. This is quite different to developing countries where laboratory
medicine is given the surplus to implement its plan. Furthermore in most
developing countries the money for developing laboratory medicine has
been mainly from donors.
In term of laboratory utilization, in most developed countries,
people are utilizing laboratory medicine to prevent unnecessary costs
incurred during treatments of diseases which are actually not confirmed by
laboratory investigations. Laboratory diagnoses are important because
clinical diagnoses sometimes are wrong, hence wrong drugs are prescribed.
Wrong drugs provided to patients might cause harm and antibiotics may
cause drug resistance for later use. In many developing countries the
situation is different because most of health care provision does not take
laboratory medicine as its key arm.
Commitment among laboratory personnel is key indicator and a
good beginning for the improvement of services. Commitment differs
much among workers in developing countries and developed countries. In
most developed countries laboratory personnel are actively updating their
career, through attending workshops and, seminars and they have started
thinking of having consultations from laboratory professionals. This is
quite different from laboratory personnel working in developing countries,
because people attend meetings, with the intention of making money rather
than improving knowledge and furthering their career.
In most developing countries, laboratories were considered as the
arm of health care provisions mostly following the big burden of HIV,
Tuberculosis, and Malaria. It is true and well known that these diseases
require special attentions for treatment monitoring and monitoring disease
prognosis. Therefore, the existence of HIV, Tuberculosis, and Malaria has
provided room for development and existence of most laboratories in
developing countries. For developed countries the initiation and use of
laboratory medicine was a long time ago and the coming of HIV was not
the reason for them to be active although there has been increasing demand
according to the needs of HIV diagnosis.
Developed countries have high provision of rapid, accurate and
affordable laboratory services compared to developing countries. The
reasons for this difference might range from low science and technology
budgets, poor policies on the improvement of laboratory services and

26
existence of vested interests and power which does not provide room for
other health department work and improvements. Along with these, are low
understanding and negligence of health policy makers on the importance of
laboratory medicine.
Education and training improve the quality of test results and
engender trust from the physicians. In developed countries education and
training are given priority and people are updated regularly. The matter is
different in developing countries where sponsors for education are from
abroad and governments play a very minimal role to educate and upgrade
their people especially for postgraduate studies. This has led to high
number of accredited laboratories in developed countries in comparison to
developing countries.
Accreditation is the external validation of actual performance of a
laboratory by a recognized authority. The instruments which are used in
laboratory medicine are almost the same everywhere in the world. What
differs are the skills on utilization of instruments, knowledge behind
utilization and how to interpret the results.
Functional national laboratory medicine departments are the key
organ for organizing and improving laboratory services in developed
countries. In the USA for example, there are structured organizations
which usually monitor the progress of laboratory services. Furthermore in
most of developing countries there are only symbolic national laboratory
medicine departments and for that reason, they are not functioning to
improve the quality of laboratory medicine.
In most of the third world countries, plans which are implemented
are the product of developed countries. The implementation and
application of ideas which originate from individuals who are not from the
particular environment, are often different. For that reason, most of
developing countries are implementers of ideas from developed countries
rather than ideas born in them.
In developed countries most diseases are already well studied and
diagnosed. The reasons might be due to well-constructed laboratories with
sufficient reagents, machines, and the availability of laboratory personnel.
Low science and technology on other hand, are threats in most of
developing countries because most infectious diseases are not yet well
understood and diagnosed. More diseases are coming up every day. There
is recurrence of diseases like Ebola, whose incidence is rising and
thousands of people have died.

27
 According to the report of a meeting which was held in South
Africa 2012, it showed that less than 10% of clinical decisions in Africa are
based on laboratory results compare to 70% in the United States.

Laboratory Medicine in Africa

African countries are leading third world countries, on the other
hand, they are still very far away from the implementation of sufficient
health care to all people. The changes which are now seen in laboratory
medicine are due to diseases like HIV, Tuberculosis, and Malaria. The
three diseases mentioned have led to the attention which is now seen in
African countries. Most laboratories have been built and established to
tackle HIV, Tuberculosis and Malaria.
We can term it as HIV, malaria, Tuberculosis laboratory era.
Misdiagnosis, over-diagnosis, inadequate or inappropriate treatment, drug
resistance, and increased mortality are still the burden to most of African
countries. For example of the 4,670 patients admitted and treated for
Malaria in Tanzania hospitals, fewer than 50% actually had malaria, as
confirmed by blood smear. Similarly, a study in Ghana found that 40% of
patients with a clinical diagnosis of Malaria actually had bacterial sepsis
and the correct diagnosis of Malaria leads to better treatment20.
In Africa, South Africa is the country which has stepped further in
laboratory medicine, in comparison to other African countries because it
contributes to almost 91% of accredited international and recognized
standard laboratories in Africa. Other countries which are trying are Kenya
(n=8), Namibia (n=7), Botswana (n=6), Ghana, Nigeria (n=2), and
Tanzania (n=1)21. South Africa has reached this stage because of it
economic status and seriousness in provision of health care to her people.
More money has been allocated to build capacity in laboratories to contain
diseases. Other countries in Africa are trying to cope with this situation but
things are still not in place. For example 5 of 954 laboratories are
accredited in Uganda22. Policy makers, clinicians, and the public frequently
fail to understand the essential work of laboratories in the prevention and
treatment of disease.

20
Nkengasong JN, Nsubuga P, Nwanyanwu O, Roscigno G, Bulterys M.
Laboratory Systems and Services are Critical in Global Health: Time to End the
Neglect 2010;36873
21
Schroeder LF, Amukele T. Medical Laboratories in Sub-Saharan Africa That
Meet International Quality Standards. 2014;7915
22
Ibid
28
 In most of African countries, availability of laboratories and access
to reliable diagnostic testing is severely limited and misdiagnosis
commonly occurs. Undesirably, allocation of resources to diagnostic
laboratory testing has not been a priority in health care systems for
resource-limited countries. Most of the improvement which is taking place
in laboratory medicine has been of low effort from the mother countries but
a huge effort has been made by developed countries. As indigenous health
planners, we are blinded on how to make laboratory medicine the seat for
evidence-based medicine.
In African countries there is a rise of unreliable and inaccurate
laboratory diagnostic testing which has led to unnecessary expenditures of
resources to the countries which are already plagued by resource shortages.
Most highly qualified people in health teams still promote the perception
that laboratory testing is unhelpful, and compromises patient care. Each
year in sub-Saharan Africa, approximately 12 million people die and for
the majority of individuals, the cause of deaths are largely uninvestigated23.
For example, most doctors are prescribing drugs to patients without having
any laboratory test to prove their clinical diagnosis.
About 90% of investigated deaths which occur in Africa are
attributed to infectious diseases which could be easily diagnosed within
laboratories for timely treatment and monitoring of patients. Till this
moment, African countries are still challenged by the task of developing
affordable and sustainable laboratory infrastructures to support the
diagnosis of infectious disease.
Other challenges are lack of laboratory consumables, lack of basic
essential equipment, limited numbers of skilled personnel, lack of
educators and training programs, inadequate logistical support, de-
emphasis of laboratory testing, insufficient monitoring of test quality,
decentralization of laboratory facilities and no governmental standards for
laboratory testing for improving patient clinical outcome and no clear
policy on eradication of public health problems.
In July 2009, several African countries, donors, the World Health
Organization (WHO), and laboratory implementing partners met in Kigali-
Rwanda to launch a program for strengthening laboratory management.
The aim was to accelerate national laboratory services toward
accreditation in the African region. Before the 2009 meeting in Kigali, the

23
Petti CA, Polage CR, Quinn TC, Ronald AR, Sande MA. Laboratory Medicine
in Africa: A Barrier to Effective Health Care. 2006;42:37782
29
need to strengthen laboratory networks, systems, and services in
developing countries was highlighted in 2008 by several landmark events.
These include the January 2008 Maputo Declaration for
strengthening laboratory health systems, the April 2008 Lyon statement on
the need for developing countries to establish practical quality management
systems; and in September 2008, the Yaound resolution issued by the
WHO Regional Office for Africa (AFRO) that recognized the neglected
state of the laboratory health systems and the need to strengthen them, as a
priority, to fight multiple diseases.
The recent focus on strengthening health systems and the emphasis
on laboratory systems suggest that the opportunity has presented itself for
the international community to act now, act collectively24, but act
differently to ensure sustainability of global health efforts to enhance
laboratory networks and systems25.
To implement the process of laboratory strengthening there is the
recent and significant increase in funding for global health development,
from the US Presidents Emergency Plan for AIDS Relief, President
Obamas Global Health Initiative, the World Banks laboratory
strengthening efforts in East Africa, and other bilateral donors which offers
a monumental opportunity to act now, act decisively, to end the neglect of
laboratory systems and services in global health which is a good start
towards efforts to improve the quality of laboratory services.
In this regard, the Kigali meeting, which launched the laboratory
management tool called Strengthening Laboratory Management toward
Accreditation (SLMTA) and the newly established WHO-AFRO
accreditation process, was a landmark event that laid a road map for
strengthening laboratory systems in Africa leading to the accreditation and
improvement of many laboratories in Africa, for example in
Botswana262728. However, to achieve this goal, the international community

24
Nkengasong JN. A Shifting Paradigm in Strengthening Laboratory Health
Systems for Global Health Acting Now, Acting Collectively, but Acting Differently.
2010;35960
25
Petti CA, Polage CR, Quinn TC, Ronald AR, Sande MA. Laboratory Medicine
in Africa: A Barrier to Effective Health Care. 2006;42:37782
26
Ntshambiwa K, Ntabe-jagwer W, Kefilwe C, Samuel F, Moyo S, Hospital SM.
Translating A National Laboratory Strategic Plan Into Action Through SLMTA in
A District Hospital Laboratory In. 2014;15
30
must act collectively, with strong leadership from the countries, to end the
neglect of laboratory systems29.
With the support that African countries are getting from developed
countries, they still need to perform the following duties to make
laboratories the basis and engine for modern medicine.
1. Put forward more strategic efforts to build laboratory capacity,
involving private sector, commercial and public sector plans on
addressing health care crises.
2. The current inequity in funding for laboratory diagnostics must be
addressed through encouraging funding agencies to balance the
allocation of resources.
3. Greater emphasis should be placed on laboratory diagnostics and
supportive infrastructure for the more efficient provision of services.
4. More emphasis on making people aware and raising knowledge on the
critical importance of basic laboratory tests for impacting the clinical
and political priorities of laboratory personnel, clinicians, health care
policy makers, and donor organizations.
5. Public efforts should be more unified to address regionally defined
needs, for sustainability and effectiveness.
6. Public officials and health care professionals must be made aware of the
necessity of laboratory services to improve patient care.
7. In the short term, there should be an increased focus on providing basic
laboratory testing by accurate and reproducible methods30.

AFRICAN SOCIETY FOR LABORATORY MEDICINE (ASLM),

PLAN AND STRATEGIES TOWARD STRENTHENING
LABORATORY MEDICINE BY 2020+
From 2008 African countries have put forward ways for improving
healthcare in Africa. This will be achieved through strengthening
laboratory services building on advances in professional laboratory

27
Nkengasong JN. A Shifting Paradigm in Strengthening Laboratory Health
Systems for Global Health Acting Now, Acting Collectively, but Acting Differently.
2010;35960
28
Woodcock S, Fine G, Mcclure K, Unger B, Rizzo-price P. The Role of
Standards and Training in Preparing for Accreditation. 2010;38892
29 29
Petti CA, Polage CR, Quinn TC, Ronald AR, Sande MA. Laboratory
Medicine in Africa: A Barrier to Effective Health Care. 2006;42:37782
30
Petti CA, Polage CR, Quinn TC, Ronald AR, Sande MA. Laboratory Medicine
in Africa: A Barrier to Effective Health Care. 2006;42:37782
31
medicine practices, science and networks. The plan and strategies are
centered around Laboratory testing as pivotal in disease diagnosis,
epidemiological surveillance, outbreak investigations, initiation and
monitoring of treatment, as well as research development31.
It has been known for a long time that Medical laboratories in
Africa are underdeveloped and cannot meet the testing demands of rapidly
growing health delivery services in the 21st century. By recognizing this
the WHO Resolution AFR/RC58/R2 came up with the aim of
strengthening public health laboratories in the African region. The 2008
Maputo Declaration on Strengthening of Laboratory Systems agreed with
ASLM to address the challenges by working collaboratively with
governments, national, regional and international organizations,
implementing partners, the private sector and other agencies to achieve the
following goals by 2020+.
1) Africa should encourage professional development by encouraging
upgrading of education for laboratory personnel and further enrollment
of students to study laboratory medicine courses to meet the demand of
future laboratory workforce development. This will help Africa to
achieve the Millennium Development Goals for the Health Strategic
Direction. According to the World Health Organization Regional Office
for Africa (WHO/AFRO), Africa has less than one laboratory
professional per 10,000 citizens in year 2010s. Expansion of effective
healthcare health services to new areas requires a viable workforce. The
major workforce gaps that ASLM has to focus on include development
of standards for training and career development in order to increase
productivity and retention. Initiatives like I TECH Foundation have
contributed a lot of efforts to sponsor students taking medical
laboratory science.
2) To raise the number of accredited laboratories and achieve a
transformation towards quality of diagnostic services laboratory,
accreditation is compulsory. Fewer than 400 laboratories in Africa are
accredited to international standards and 90% are in South Africa32.
Accredited laboratories provide accurate, timely results that will be used
to make impactful medical and public health decisions for patients and
the community. ASLM has focused on laboratory system strengthening,

31
ASLM. ASLM2020: Strategies and Vision to Strengthen Public Health
Laboratory Medicine in Africa. 2008;
32
WHO. WHO Guide for the Stepwise Laboratory Improvement Process Towards
Accreditation in the African Region, 2013
32
 improved planning and policies and the expansion of the WHO/AFRO
Stepwise Laboratory Improvement Process towards Accreditation
(SLIPTA), purposely to increase the number of accredited laboratories.
3) To develop strong, harmonized regulatory systems for diagnostic
products that guarantee patient safety and help assure accurate
laboratory results by the African National and Regional Regulatory
Environments. Although some changes are happening, Africa currently
lacks strong national and regional regulatory systems to prevent the use
of poor quality diagnostic products. Working with governments and
other organizations both within countries and across regions as a pan-
African body, ASLM has now focused on strengthening regulatory
standards, systems for new product validation, standardized testing
protocols and promoting regulatory harmonization through advocacy,
consensus-building, mobilization and technical assistance. ASLM is
intending at raising regulatory standards for diagnostic products to
stringent international levels (as defined by the Global Harmonization
Taskforce) in 25 countries (50% of the countries in Africa) and to
enable harmonized regulation of diagnostics in the 5 economic regions
of Africa by 2020.
4) Strengthening the African Network of National Public Health Reference
Laboratories. The aim is to strengthen national laboratory networks and
promote South-South cooperation and collaboration because the
National Public Health Reference Laboratories play a key role in
training, assuring quality and developing laboratory capacity throughout
the healthcare system in their respective countries. Linking these
laboratories in a regional network is critical to increase research
capacity, quality management systems, disease detection and
sustainability of health programmes throughout Africa. Consequently, it
is intended that by 2020, at least 30 countries will have developed
national public health reference laboratories that participate in an
African Network of National Public Health Reference laboratories.
To achieve the goals which have been proposed by ASLM there
should be clear participation and sign-up from colleges, universities,
working areas and ministries of health all over African countries, including
Tanzania.

LABORATORY MEDICINE IN EAST AFRICA

Laboratory medicine in East African countries has progressed. The
East African countries comprising Tanzania, Kenya, Uganda, Burundi and

33
Rwanda have some similarities in the issues facing laboratory medicine. In
all these five countries there is a challenge of staff shortage. Presently there
is general increase in production of medical laboratory personnel with
higher qualifications, an increasing preference for degree qualifications,
and a more positive view from patient/clients about medical laboratory
personnel although they are often assumed to be doctors. There is further
improvement of Laboratory medicine looking forward towards the process
of accreditation. Medical laboratory personnel are getting good salaries,
and retention of workers and employment in the private sector has
developed. In all the five countries there is a private sector that is active in
production, employment and retention. The movement from public to
private is high among professionals in the region33.
Existences of similarities are accompanied with differences which
are found across the five countries of this region. The countries have
moved in different stages in terms of regulation. Tanzania appears to be the
most advanced in professional integrity in the region compared to other
countries in the region because Tanzania has a Health Laboratory
Practitioners Act and council to register and regulate the standards and
practice of the profession of health laboratory professionals. It also has in
place a private health laboratories regulation act and board to regulate the
practice of public laboratories.
On other hand Kenya has the KMLTTB to register and regulate
medical laboratory professionals. In Uganda, the registration and regulation
of Medical laboratory personnel is under the umbrella of allied Health
Professionals Council (AHPC) thus, giving no room for the development
of the laboratory professional. The setup in Rwanda is similar to that of
Uganda where the regulation of medical laboratory workers falls under the
Allied Health Professionals Order Rwanda. Tanzania and Uganda have
current policies and strategic plans for laboratory services. The medical
laboratory policy and strategy for Kenya lapsed in 2010 and is currently
under review. Having the overview on the development of laboratory
medicine we still find that laboratory medicine is still not effective in most
of East Africa34.
Associations of MLPs can play a significant role to enhance
professional status of laboratory personnel. In East Africa things are not
working that way which way but rather moving very slowly without any

33
Nafula M V. Study on Human Resource for Health issues in relation to Medical
Laboratory Personnel Kenya Report. 2012;(September)
34
Ibid
34
courage or vision. For example MELSAT in Tanzania has not yet
harmonized and integrated the curriculum for monitoring the quality of
education provided at the level of universities. This has caused the use of
curriculum which does not optimally suit the current goals of laboratory
medicine.
The report from Kenya has shown that Medical Laboratory
Personnels in four countries which were involved in report have
associations, though they are still at different levels of maturity. In Kenya
the association is known as The Association of Kenya Medical Laboratory
Scientific Officers (AKMLSO), In Uganda its known as the Uganda
Medical Laboratory Technology Association (UMLTA). These are mature
associations with well-established constitutions and structures. Tanzania
has a Medical Laboratory Scientists Association of Tanzania (MELSAT)
and Rwanda Association of Biomedical Laboratory Technologist
(RABITEC) which are struggling to get up to the level of the Kenya and
Uganda associations.
In the East African region, Kenya has managed to introduce
selection criteria for students that go beyond academic grades in laboratory
medicine. This has included the involvement of stakeholders in Reviewing
of Curriculum; National Registration Examinations, Performance Based
Pay by private laboratories which links annual staff bonuses to revenue
generated by laboratory services; Fast Tracking of Promotions in the Public
Sector; Stakeholder involvement in Policy Formulation & Strategy
Development; Inspection of both Public and Private Medical Laboratories;
Registration of mono discipline laboratory workers; and the Establishment
of standalone labs35.
Tanzania has attempted to replicate Kenyas policies but pertaining
to the curriculum review or higher education things are not well organized,
since every university has its own curriculum. The existence of different
curriculums within the same country provide room for disunity among
junior professionals because they have been trained in a different
methodology to tackle the same challenge within the country.
The Medical Laboratory Practitioners Week in Tanzania has the
potential to increase performance and raise the profile of MLPs. Uganda
applies key performance indicators on monitoring laboratory service
delivery and the support provided by private employers towards the

35
Nafula M V. Study on Human Resource for Health issues in relation to Medical
Laboratory Personnel Kenya Report. 2012.
35
continuous professional development of Medical Laboratory Personnel and
these actions provide reference examples of best practices.
Best practices that cut across the region are the adoption of the
SLIPTA approach to accreditation and the standardization of curricula in
Kenya and Tanzania. East African countries still face the same problems
which are similarly faced by most of African countries as mentioned earlier
in the part of laboratory medicine in Africa.

LABORATORY MEDICINE IN TANZANIA

Before starting the discussion of laboratory medicine in Tanzania
the following are reflective questions for laboratory personnel.
Is there a National Policy and Strategic Plan for clinical laboratories in
Tanzania? If yes what is in there? What have you done so far to meet
policy and planning objectives and if No what is your role?
As a relevant stakeholder have you ever thought of conducting a
situation analysis of the current state of laboratories in Tanzania?
Do you know exactly how many laboratories are registered in Tanzania?
Do you know who heads these laboratories?
How many laboratories are accredited?
What standards are employed for accreditation?
What is the government standard for laboratory performance?
Every laboratory technicians, technologist and scientist should be
motivated to answer these questions in order to improve laboratory
medicine because the above questions open a new responsibility to think
and act differently as laboratory professionals.

Laboratory Medicine in Tanzania

Laboratory medicine services in Tanganyika, currently Tanzania,
were established in the late 19th century during the German administration.
In 1897, the first Government Health Laboratory was established at Ocean
Road Hospital in Dar-es-Salaam which was formerly known as St.
Elizabeth Hospital. Prof. Robert Koch, the German Scientist visited and
worked in the laboratory on several occasions while investigating Malaria,
sleeping sickness and other endemic disease, which were a major health
problem in the country.
It was in Africa that Robert Koch embarked on his journey to
Stockholm to receive the Nobel Prize in physiology or medicine 1905.
Ocean Road Laboratory in Dar-es-Salaam was therefore the first site of a
health laboratory in Tanzania and it was opened to treat mostly Germans
36
during their colonial administration in Tanganyika. Despite the big
contribution by laboratory medicine in diagnosis, treatment, management
of patient, its development is not at expected level.
The development of laboratory medicine is very meager in
comparison to that of other health professionals, for example medical
doctors, nurses, and pharmacy, which are more established than laboratory
medicine professionals.
These other professions are more advanced in terms of self-
organization, focus and orientation, and in terms of end-goals. The
development of faculty members is also more established due to well-
organized curriculum which is better suited to their professional goals.
From the differences which currently exist, we can trace the
historical and inherited causes of this retarded growth in aspects of
laboratory medicine.

Historical Reasons Hindered Development

Of Laboratory Medicine
1. Laboratory personnel who were involved in planning for laboratory
medicine were not given enough chance to plan for the development of
the profession, instead they had to be followers of other professional
ideas. The ideas which are not owned by practitioners are not productive
because the mission to reach the desired vision is not owned.
2. Laboratory professionals were not given opportunity by the other health
professionals. Medical doctors or physicians, being the pioneers of this
professional did not think of developing laboratory medicine. This is
well explained with high number medical doctor graduates at
universities working with medical laboratory attendants some years
back aiming at producing the desired effects to patients.
3. Personal observation shows that up to year 2000 most doctors were
requesting laboratory diagnosis from people who could not think to
their level. For example, doctors were requesting a test from medical
attendants who could not even understand the pathophysiology of
disease in relation to the result obtained from laboratory tests.
4. Personal observation still shows that other health professionals see more
potential in laboratory medicine than people within laboratory medicine
itself. This has prevented a number of programs taking place within
laboratory medicine, for example most laboratories have been headed
by people outside that professional and as a result, and they are less
concerned about the professional development.

37
5. Little involvement of laboratory personnel in planning and
implementing planned activities, as so far most laboratory personnel
have been passive members of the health care team. Research done to
evaluate laboratories in Kenya shows that, laboratory medicine was not
even considered as one of health cadres among cadres mentioned in
health professional report. This shows how much planners and policy
makers do not know about laboratory medicine.
6. Specifically in Tanzania the laboratory medicine curriculum was
formulated to let laboratory personnel work as robots rather than
independent entities which can work with reason in mind on why
everything is done. There were reasons for the delay in the bachelor
degree in Tanzania. There are number of reasons why the masters of
laboratory medicine came earlier before the existence of the bachelor of
laboratory medicine. If lack of staff was the reason for the delay then
who were the lecturers for doctors who specialized in Microbiology,
parasitology and Hematology as core areas of laboratory medicine?
Teaching of laboratory medicine has been present for a very long time.
The delay of this program was caused by people who could not agree if
laboratory medicine could be raised to this level.
7. With regards laboratory personnel, success needs bright people around
you with a desire to meet certain goals, specifically professional goals,
but we seem to be less aware on that area. From that simple example,
previously employee in laboratory medicine had lower qualifications
than is required, At least things are now changing because in the current
situation health professionals are now equally distributed in terms of
education levels.

Back to the historical development of laboratory medicine in

Tanzania, laboratory services continued to grow countrywide and the
Ocean Road Laboratory became the Central Pathology Laboratory (CPL)
in early 1960s under the Ministry of Health. The laboratory services have
been part of the health facilities for the diagnosis of diseases and their
management. According to data which was published in 2009 Tanzania has
over 1172336 laboratory facilities most of them being health centers and
dispensaries. They are owned by government and private institutions.
Some of these laboratories provide services free of charge while others,

36
Massambu C, Mwangi C. My Harmonisation and Standardization of Tests and
Equipment In Industry of Health and Social Welfare in Diagnostic Services
Section Ation, Public Health Lab Reg al Lab. 2009;
38
especially independent laboratory facilities, charge for the services
provided and the cost are very high.
The majority of the totally independent and privately owned
laboratory facilities are typically located in areas where the population is
dense that is, in towns and cities. This is different compared to rural areas
because people in towns and cities can afford laboratory services much
better in comparison to rural areas and this is mainly because most people
in the urban areas are financially better off and have a general awareness
about the importance of a medical laboratory in diagnosis. However in
private laboratory facilities, a request for laboratory investigation is not
necessarily requested by a clinician, but a patient him/herself can visit the
laboratory and request the services she/he needs.
The laboratory services in Tanzania form an integral part of the
national health system. The entire network of laboratory services contribute
effectively to quality health care services through diagnosis of diseases and
in so doing assists the community to take measures for disease prevention.
Following global trends, Tanzania supports the principles of primary health
care to increase accessibility of health services. It implements the policy
towards increasing the effectiveness and accessibility of laboratory
services,
1. The Ministry of Health has emphasized the need to improve the
handling, appropriate processing and production of accurate results of
specimens.
2. It has issued medical laboratory guidelines in an attempt to improve
laboratory services.
3. It has further reacted to the concept of integrated health services by
developing appropriate human resources for laboratory services to meet
some of the health needs of the population.
4. The roles of medical laboratory services in this process has become
clear in the Agenda for Action where the health laboratories are
challenged to improve medical laboratory health care services. This
policy had included the capacity building to meet prospective needs and
demands of the population.
The Government of Tanzania has put emphasis on the primary
health care approach as the only way to improve and maintain the health of
the Tanzanian population. However, the primary health services delivery is
faced with difficulties in delivering comprehensive and quality laboratory

39
services, particularly handling, processing of specimens and production of
accurate results37.
Currently, Tanzania has implemented many initiatives around
laboratory medicine, many of which have been driven by high emphasis
from outside countries. The campaign toward the eradication of HIV,
Malaria and TB has promoted a significant amount of development of
laboratory medicine in Tanzania.

TREND OF EDUCATION IN LABORATORY MEDICINE

Education is the knowledge acquired by learning and instructions.
Based on the aspect of laboratory medicine; education is the scientific
knowledge based on analysis of human specimens for the diagnosis of
disease and prediction of its occurrence. Education in laboratory medicine
is both theoretical and practical. The theoretical part of this education gives
room for scientists to reason and provides opportunities to interact with
other minds through writing, listening and talking. This helps disseminate
knowledge which other people have developed in the field you are dealing
with.
It is the theoretical part which gives somebody the reasons behind
the practical aspect on how things are done. The practical part defines what
you are going to perform in the field. It applies theory to perform practical
procedures which can be manual or machine oriented. Both practical and
theoretical parts of knowledge involve learning and instruction delivered
by experts in respect to the course and subject somebody is taking.
Lets see a little history on developmental changes which took
place in laboratory medicine with reference to the USA and Tanzania.

United States of America

In the USA it was in late 1800s and 1900s when laboratory
education came into existence. Laboratory medicine took place within
hospitals where young women were typically taught how to perform basic
laboratory tests under the directives of a pathologist38. More formalized
education programs began to appear after World War I. However, there
was no professional recognition or oversight of these programs at the time.
These early programs required a high school education for acceptance, and

37
Shayo L. The Fourth Tanzania National Health Research Priorities. 2013-2018,
2013
38
E.Walz S. Education & Training in Laboratory Medicine in The United States.
1940;(3):13
40
the quality of training was variable. A few college-level laboratory
instructional programs arose in 1918 in response to an increase in both the
number of clinical laboratories and the number of laboratory tests being
developed and offered.
In the USA an organization of pathology was formed, to oversee
and standardize the training programs for laboratory technicians in 1922.
Shortly thereafter, a subcommittee was charged with formally defining the
profession and creating a registry of those trained according to the
standards set forth by the Society. This subcommittee became the ASCPs
Board of Registry in 1928, and two years later, the first certificates were
awarded to more than 400 laboratory technicians. In the USA laboratory
professionals were divided into technicians and technologists.
Technicians must have graduated from high school and received
approximately 18 months worth of instructive and clinical training in the
laboratory. Technologists possessed a degree similar to what we refer as a
laboratory scientist in Tanzania. Degrees were offered from university and
comprised at least one year of basic sciences and a years of hands-on
clinical training from a recognized laboratory.
To date, laboratory medicine professionals who are performing the
bulk of the testing in laboratories in the U.S. are classified as technicians
with associates degrees, or technologists with bachelors degrees39.
During the 1930s and 1940s, the ASCP Board of Registry
performed a number of important tasks that further formalized laboratory
training programs.
a) They surveyed existing training programs; using the gathered data to
develop recommendations for curricula (didactic and clinical), program
duration, and qualifications of teaching faculty in both hospital-based
and university based training programs.
b) The Board of Registry raised the criteria for applying for registration,
and generated a list of approved schools.
c) The work of the ASCP, the, Board of Registry and a newly established
professional organization for the bench-level laboratorial (the
American Society of Clinical Laboratory TechniciansASCLT), all
helped to advance the status of the laboratory technician.

World War II impacted the profession by increasing the need for

technicians in the public health realm and in military hospitals. Another
type of training subsequently arose. The ASCP continued to oversee U.S.
39
Ibid
41
education programs in laboratory medicine until the early 1970s. At that
time, more autonomy was desired by laboratory professionals, and the
professional organization, American Society for Medical Technologists
(ASMT, formerly ASCLT), helped develop an independently operated and
governed board to oversee laboratory education.
The National Accrediting Agency for Clinical Laboratory science
(NAACLS) was established in 1973, and remains the premier accrediting
body for laboratory education programs in the U.S., both within hospitals
and universities. Although other organizations have entered the realm of
registering or certifying Laboratory professionals over the years, only three
remain (ASCP, American Association of Bio analysts AAB, and
American. Medical Technology AMT),with the ASCP continuing as the
primary source of independent, professional certification of laboratories.

Tanzania
In Tanzania the situation was similar to the USA and the first
clinical laboratory here in Tanzania started in 1897 at Ocean Road. In
1904, Robert Koch visited Tanzania for the first time and researched about
different diseases using the Ocean Road clinical laboratory. From 1897-
1929 people who were working in the laboratory were the German then
British because when the Germans left colonial activities, the British were
the ones who took power.
Under this response services were limited mostly to foreigners.
The history of foreign workers was broken down when the first Tanzanian
joined clinical laboratory medicine services. The first Tanzanian to join the
clinical laboratory services was Mr. Yohana Mnkande in 1929. This was
a man who worked hard and opened the way to Tanzania medical
laboratory practitioners.
Till 1929 only informal education was provided and it this
continued until to 1945. In between training was in a form an
apprenticeship, that is attending short periodic on the job training courses.
Most of the trained staff were Microscopicist and laboratory auxiliaries and
a few laboratory assistants. The trained laboratory assistants where
required to work with other health professionals who had higher
qualification of education. For instance, medical doctors with a specialty in
the respective discipline were working with laboratory assistants,
something which reduced quality for patient care and management.
The formal three years Training of laboratory assistants
certificate, started at Ocean Road in 1945/46. Then this was the start of a

42
race in medical laboratory education. In 1967/68 the course was upgraded
to the diploma in Medical Laboratory technology, with those who qualified
in this new system being medical laboratory technicians. In 1971 the
training activities in medical laboratory were shifted from Ocean Road to
Muhimbili national hospital.
From Muhimbili national hospital medical laboratory education
moved to other health allied colleges where certificates in medical
laboratory were offered and later on diplomas were offered from other
colleges and universities. The title for laboratory personnel with diploma
level qualifications was later legally changed to Technologist in 1997.
Laboratory personnel who were informally trained in the cadre of
laboratory services remained as laboratory attendants.
The specialization Diploma Training which was mono-specialty
stated in 1970/1971. The mono-specialty changed to the advances Diploma
in 1993. At the level of mono-specialty people were trained in one core
specialty being Microbiology, parasitology, clinical chemistry etc. There
was the existence of many years in between before the start of the degree
program in Tanzania. This caused a delay in the growth of laboratory
medicine in aspects of both human resources and technology.
Many of the people who had the diploma opted to change to the
Medical doctor program. The degree program started at KCMC in 2004,
and this come as a solution to the long term gap that existed in this
profession. Arrogance was the key factor for delay of this degree program
in Tanzania, the training of pathologists started at Muhimbili late 1970 to
early 1980 and was covered by four major courses, which were
Microbiology, Parasitology, Clinical chemistry and Hematology. Provision
for mono-specialty studies to some universities is a remaining problem
because graduates are not given enough chance to work as general clinical
laboratories practitioners. Positions of leadership cannot be met because
during training graduates are not given opportunity to know some of the
things concerning laboratory medicine.
Currently degree graduates of Medical laboratory science have the
opportunity to pursue masters in a number of specialties. All courses which
are taken as basic courses and core courses are there for specialization
when a person wants to study further. Examples of masters programs are
Masters in Microbiology and Immunology, Biochemistry or Clinical
chemistry, Parasitology and Entomology, Hematology and Blood
transfusion, Anatomy, Physiology, Histopathology and Cytopathology.
Furthermore, graduates can specialize on Forensic Medicine and

43
Toxicology, Epidemiology and Biostatistics, Clinical Research, Laboratory
management, Public health and other many masters degrees depending on
the countries policies. An organization for medical laboratory scientists by
the name Mel SAT started in 1985.

CHALLENGES FACING EDUCATION IN CLINICAL

LABORATORY MEDICINE
Currently most of the syllabi and curricula for medical laboratory
students do not suit the needs of laboratory technicians, technologist and
scientists. Medical laboratory students require skills in pathophysiology of
diseases which in turn helps the understanding of abnormal results of
respective diseases but to most colleges and universities such a very
important skill is not given to the student. We are now heading for
laboratory consultation, where a laboratory scientist will not only process
specimen and release the result but also interpret the results according to
the laboratory findings to save the clients needs, but little attention has
been paid to combat the problem of knowledge and interpretation.
It is a boring topic to discuss the importance of clinical skills to
medical laboratory scientists because most of us believe that working as
robots is something which does not apply to the current status of the health
system. Still yet arrogant behavior of some medical professionals has
contributed a lot to insufficient patient care. There is no linking of
knowledge between the clinical aspect and the laboratory aspect and this
has been set aside purposely.
In most developed countries laboratory technicians, technologist
and scientists have been actively engaged in understanding the clinical
aspects of patients. For example, a book called Clinical Laboratory
Science which was written back in 1980s, has explained inevitable
changes in laboratory medicine by including clinical aspects not as a matter
of medical laboratory scientists assuming physician work but rather to
ensure a common mind on understanding treatment, management, follow-
up of patients and how they relate to efficient work done in the laboratory.
Despite that effort, most of our colleges still find no reason to
include such aspects in their Medical laboratory course. No matter how
much this thing is important, no one is handling it. To-date, the number of
tests are overwhelming physicians in terms of interpretation, something
which will require a solution from the medical laboratory specialist.
Laboratory medicine is essential and a key step toward a successful
medical education and is the foundation toward utilization of laboratory in

44
diagnosis of diseases. Statistics shows that, in most medical schools,
laboratory medicine is covered as only case discussion during clinical
rotations40.
Very few colleges and universities have incorporated laboratory
medicine as part of the curriculum; Kilimanjaro Christian Medical
University College being among many universities has incorporated it on
the third year of medical school. Under-exposure of medical students (MD)
in laboratory medicine has generated a number of worse clinical impacts.
Some are mentioned here below:-
1. Most junior doctors are incapable of identifying potential useful tests
which bring up the most diagnostic information hence delay services to
patients.
2. Physicians who are new in the field find it very difficult to identify the
appropriate sequence in which tests should be requested.
3. Interpretation of laboratory results is a challenge which has cost to
patients because students are not aware of what exactly is wrong due to
an inability to understanding results.
4. Most laboratory tests have limitations which are easily covered during
clinical laboratory rotation. For medical students with no capability of
rotating through the clinical laboratory, they fail to evaluate the
limitations of tests because of being theory oriented.
5. Medical students fail to recognize the link of pathophysiology in their
patients with laboratory findings.
6. Ordering unnecessary tests which in turn results in high costs to the
patient and long hospital stays if a condition not well handled.

Again clinical rotation for medical students to the clinical

laboratory has a number of advantages which in turn may help to save
patient lives. The following are some of those advantages:-
1. It helps a medical student to identify easily which tests are potentially
useful and to bring up the most diagnostic information.
2. It helps a medical student to familiarize themselves with the laboratory
environment which can have an impact on understanding the limitation
and errors which can happen in laboratory processes, namely the pre-
analytical, analytical and post analytical phase.

40
Patrick C.J.Ward, Ilene B, Harris.M, Desmond Burke CH.
Systematic_Instruction_in_Interpretive_Aspects_of Laboratory Result, 1976;
45
3. Interpretation is critical to successful diagnosis, and medical students
exposed to laboratory department will be better placed to interpret what
the test result means.
4. Medical laboratory rotations expose medical students to understanding
laboratory test limitations which is a big challenge posed in todays
medical practices because of confounders of the test results.
5. Medical laboratory rotations help in identifying appropriate orders and
sequences to follow during ordering of the test. There are number of
tests which might be required for diagnosis of disease but there should
be a way of ordering tests which may prevent cost and traumatization of
the patient.
6. It helps to familiarize student with evidence-based medicine because the
pathophysiology and theory are confirmed with the use of laboratory
analysis.
7. One of challenges facing the health care system is the interface between
health workers. The presence of medical laboratory rotations provides
room for development of friendships and close working relationships.
8. The Medical laboratory has a high impact on preventing the ordering of
unnecessary laboratory tests which at the end reduces unnecessary cost
for patients.

If all necessary educational requirements will not be provided

sufficiently to both medical laboratory science students and medical
students, laboratory services will not be effective in the provision of health
care support. Services will develop further if the issue of education is
addressed sufficiently.
To this very point, we have some important fundamentals
about the history and contemporary viewpoints on laboratory
medicine. Conclusively, I will further emphasize on what is written
in the opening verses of this chapter, specifically, on the importance
of understanding the history of laboratory medicine.
Now the question is, why the history of laboratory medicine?
The history of laboratory medicine helps us to draw into attention the
critical distance which laboratory medicine has moved to-date. It
helps us to know and understand the foundation of the subject. It
goes further and tells us what can go wrong in laboratory medicine.
History of laboratory medicine helps us to draw into attention
the relationship between laboratory medicine and other health

46
professions without forgetting the society as a whole. It reminds us
of the important contributions made by the founders of this very
noble profession.
Again, the history of laboratory medicine tries to make young
and vibrant scientists humble, eager to learn, more motivated and
stimulated to follow the path and have further advancement in the
career.
History of laboratory medicine reminds us on the speed with
which we should move to meet the needs of laboratory customers.
Such customers are physicians, nurses, patients and all those in need
of medical laboratory services.
At last the history of laboratory medicine improves
reasoning, critical thinking, and structure ability to understand both
the present and the future of our own profession.

47
 CHAPTER THREE
TRACK THAT MAKES A MEDICAL LABORATORY
TECHNICIAN, TECHNOLOGIST AND SCIENTIST.

Becoming a laboratory technician, technologist or scientist,

it begins by studying and passing well in science subjects, during
your primary school to secondary school studies, then enrolling in
one of the following avenues being certificate, Diploma, Bachelors
degree of medical laboratory science. Depending on the level of
program studied, students take courses in computer application,
laboratory management, quality system, biosafety, physiology and
anatomy. Apart from those, they undergo courses such as pathology,
communication skills, biochemistry, biostatistics, epidemiology, and
research methodology.
Furthermore, laboratory animals, microbiology and
immunology, parasitology, clinical chemistry, hematology,
histopathology (histotechnology) and Blood transfusion are also
studied. And in some universities, pharmacology is taught for the
sake of producing competent laboratory scientists, with
understanding of pharmacology principles, how drugs function and
how they affect laboratory results, the skills of which are gained both
theoretically and practically.
Organization of courses are organized differ from one
college/university to another, because some of basic courses are
taught in one institution but not in the other. The main reason for
this, is the absence of clear organization which can harmonize
curriculum throughout the country. Power on what to do about
curriculum has been left to colleges and universities respectively
without clear directives from Ministry of health or Medical
Laboratory Scientist Association of Tanzania.
The above mentioned courses are divided into basic courses
whose exposition takes place mostly at the first year of study others
are core courses which are exposed mostly from second year of
study depending on a curriculum of a specific college or university,
which is directly linked to laboratory medicine.
The number of years of study are three for both diploma and

48
Bachelor degree with addition of one year of internship at Bachelor
degree level. Depending on the country laws and regulations, there
should be registration to the laboratory board, which provides
mandate to work independently. The path by which people become
laboratory scientists, differ from one country to another though most
of core courses are similar in most of the countries.
On aspects of basic courses and the number of years at school
there are slight differences from one country to another. I will
actually discuss in a nutshell, courses required to make one a
professional laboratory technician, technologist or scientist from
ground of basic and core courses in respect to Tanzania situation,
though major courses including clinical chemistry, hematology,
microbiology and immunology, parasitology, blood transfusion,
histopathology, forensic medicine or science and toxicology are
almost the same all over the world.

BASIC COURSES
Basic courses are courses which are fundamental on laying a
foundation for someones professional studies. They provide
principal and easy understanding of core course which sometimes
are referred to as main and professional courses. They are organized
in such a way that student will grasp ideas of what he/she is going to
do for next course of study. Here below are some of the basic
courses in attaining medical laboratory science profession.

Computer Application
Despite some difficulty with ever-changing science and
technology, computer skills provide essential knowledge and skills
that will enable a graduate to accommodate technological
advancement characterized of high degree of challenges. Computer
skills form the foundation for continuous learning and applicability
in ever-changing innovations. Laboratory is currently running into
computerized environment which in turn requires potentials
computer skills.

49
Biosafety and Ethics
The Laboratory is a dangerous place if rules and principles
will not be adhered to. To become a laboratory scientist, you should
have skills which provide a comprehensive overview of biological
safety in the research laboratory, clinical diagnostic laboratory,
forensic laboratory, biotechnology laboratory, industrial laboratory
and hospital environment in general. This basic course enables a
graduate to appreciate the importance of laboratory safety and take
necessary steps against unsound laboratory practices, and also
provide up-to-date knowledge of health and safety regulations.
Apart from biosafety, ethics are very essentials in any clinical
medical laboratory because they are key to patients right and moral
conduct in hospital environment. Laboratory ethics open the mind of
medical laboratory scientists and students on ethical and legal
questions posed by contemporary medical research and work. They
also provide basic concepts and language of laboratory which
provide an opportunity for graduates to develop skills in the
application of laboratory ethics to clinical cases and having an
understanding on guiding principles with regards to ethics both at
work and research activities.

Biomedical Instrumentation
The present challenge in most of laboratories in Tanzania is,
the incompetency in repair and maintenance of most of the available
machines which are characterized by frequent breakdowns. Most of
biomedical engineers are coming from abroad, something which
hinders the effectiveness of laboratory activities. With recognitions
of this challenge, most universities are offering biomedical
instrumentation as part of medical laboratory course which presently
requires some improvement to reach the real standard. This can be
justified by the lack of qualified teachers in biomedical engineering.
Many instruments in clinical laboratories require regular
maintenance, and this marks an important need for this course. The
exposure to this course provides the basic principles of different
instruments/equipment used in the health industry if experts will be
involved in the teaching of this course.
The practical component of this course is always intended on
50
imparting skills on use, servicing and maintenance of
instruments/equipment. Another purpose of this course is to
understand the operational and methodological principles of the most
common equipment used in health laboratories which require
servicing.
Laboratory Management and Quality Systems
A laboratory scientist graduate without necessary skills on
management and quality system has got no qualification toward
current emphasis of laboratory medicine as cornerstone for evidence
based medicine. Graduates exposed to quality assurance courses
have high opportunity to work under bioscience industry standards
that require employees to know how to run a safe laboratory,
maintain accurate documentation and use well-designed processes.
Accreditation matters so as to improve the quality of laboratory
results, then skills on quality standards helps graduate to ensure
quality products are generated.
In the process of providing quality services there is always
company of good management. Management skills are very
necessary and basic for laboratory scientist. A laboratory scientist
can work on laboratory management by provision of laboratory
services which includes customer care, relationship among hospital
staffs, and control of quality operations, teaching and counselling.
The skills enable graduates to know the management of a
health laboratory and how to apply necessary financial, personnel
and material management regulations for efficient and effective
health laboratory services. Skills on management also promote
administrative competence including knowledge of the operations of
laboratory organizations in health care and of control and evaluation
of operations.

Physiology
Power of medical laboratory scientist is laid under cognitive
power of understanding the normal functions and activities of living
organisms and their parts, including all physical and chemical
process. Physiology concentrates on how organism, organ system,
Organ cells and organ molecules carry out the chemical and physical
activities. Physiology knowledge is very helpful in understanding the
51
number of parameters in laboratory in response to physiological
condition; it also lays down the basics for the core subjects like
chemical pathology also known as clinical chemistry, pathology, and
hematology. Physiology also enables scientists to understand the
function of systems in the human body. It is designed to help
students understand the fundamentals of cellular and systems
physiology.

Anatomy
Under this course students are exposed to an understanding
of structure of organisms and their parts. Studying of anatomy
includes appearance and position of various organs of the body, the
materials from which they are composed, their locations of different
organ of the body and their relationship with each other. It is much
more concerned with size, shape, position, structure, blood and nerve
supply. Anatomy can be taught either regionally or systemically.
Every sample used in clinical laboratory medicine is collected from a
certain anatomical site.
Allocation of anatomical site has great significance in
understanding some helpful information, for instance, knowing
anatomical site helps to identify the normal flora of that site which in
turn prevents mix-up and difficult in diagnosing etiological agent of
disease. The use of tissues in pathology laboratory helps in diagnosis
of disease because tissues differ with respect to anatomical position.
Actually Anatomy helps a lab scientist focus on understanding the
body structures.

Biochemistry
One of the areas of laboratory is clinical chemistry whose
basic foundation is Biochemistry. Biochemistry forms a bridge
between biology and chemistry by studying how complex chemical
reactions and chemical structures give rise to life and lifes
processes.
It provides an understanding of array of techniques in
biochemistry which help in understanding of diseases at the ground
of chemical substance within the body of an organism and to
studying the role of glucose, lipids, vitamins, and proteins in health
and disease conditions. Experiments designed to colleges and
52
universities on understanding the chemistry in living organisms
acquaint the laboratory scientist with the basic skills necessary to
perform biochemical studies, which later on link to clinical
chemistry.

Laboratory Animal Science

Exposition of this course to medical laboratory scientist is
very important because one of the role of scientist is scientific
research which sometimes involves experiments on animals, it is
hard to speak on development of todays medicine without big
contributions done through experimental animals. The results from
animal studies have served as the basis for many key clinical trials
and will lead to future therapeutic inventions.
Established animal models, as well as others that will be
developed in the future, help address increasingly challenging new
questions in biomedical science. Animal-based research has
significantly contributed to the advancement of scientific knowledge
in general and to biomedical progress specifically.
Studies on animals have provided basic information on animal
biology and physiology; this information, in turn, has important
relevance to human biology. Animal models of human disorders have
added invaluable information about many aspects of the
pathophysiology, treatment, and diagnosis of human diseases1.
Experiments on animals, has helped scientists to come up
with vaccination of different diseases. This is always designed for
providing students with basic training in laboratory animal science; it
is an introduction to the use of animals in biomedical research and
impartation of knowledge to students on the use of laboratory
animals in science and ethical implications.

Research Methodology
Existence of science which is enjoyable with its fruits is due
to ongoing studies which have taken place and those which are
taking place. The ongoing research opens up our minds on the
number of things whose sources, prevention, cure and even

1
Hau J, Hoosier GL Van. Handbook of Laboratory Animal. 2003

53
management, we are not yet aware of. The course of research
methodology provides basic ideas and knowledge on how to conduct
scientific research. Research course explores specific areas of
conducting excellent research.
Research methodology opens the minds of laboratory
scientists on recognition of scientific intentional deception resulting
into injury to another person, peer interaction, proper conduct and
reporting of misconduct. It introduces the basic skills required to
conduct independent research in health sciences and encourages the
development of the abilities to think critically and independently.

Biostatistics and Epidemiology

Epidemiology is the study of health and illnesses in human
populations 2. It is primarily concerned with identifying the
important factors or variables that influence a health outcome of
interest. It is also concerned with providing a methodological basis
for the study and control of population epidemics. Laboratory plays a
vital role on all the above mentioned functions of epidemiology and
on studying the distribution of disease by just applying means
available in laboratory.
Laboratory also has major impacts on public health concern,
it is highly involved in processes like screening asymptomatic
disease, water analysis, and food analysis which is upcoming
challenge. On other hand, basic concepts on statistical methods and
their application help on solving problems arising in the health and
biomedical sciences.
Epidemiological data are important in provision of
information about causes of diseases, for identifying risk factors
which provide adequate health care, and planning disease
prevention. Epidemiology records data about incidence, occurrence,
mortality and morbidity.

The above mentioned courses are the basic courses which are
taught to bring sense of basic human science which is of critical
importance for someone to work effectively in the field of laboratory
2
David G. Kleinbaum, Kevin M. Sullivan NDB. Pocket guide for epidermiology.
2007

54
medicine. The challenges remain on teaching methodologies,
organizations of courses toward successful delivery of laboratory
medicine skills and knowledge, number of expert lecturers and time
duration for undertaking medical laboratory science course, which is
so limited on comparison to number of courses allocated in the
curriculum.

CORE COURSES
Core courses are the ones organized and taught so as to make
someone acquire professional skills. They mostly reflect what
someone will be doing after graduating. Here below are core courses
in attaining medical laboratory science profession, though they may
slightly differ from one country to another or university to another.

Pathology
Laboratory medicine is changing to meet challenges which
have been in the field of laboratory medicine and seen to appear
more fluently in working environment. Understanding of underlying
causes of diseases and their pathophysiology is the key future of
good laboratory practice, result interpretation and consultation
services. We expect the laboratory scientist in developing countries
to provide services with same or more quality as the laboratory
scientists in developed countries in the near coming future. It is high
time for evolution of consultations services whose mother root is
pathology.
Pathology helps laboratory scientists learn the basic
principles of disease processes (General Pathology) and apply these
principles to the study of particular diseases in various tissues,
organs and systems of the body (Systemic Pathology).Pathology
provides the picture which helps in correlating the pathological
changes with the clinical picture under observation and scientific
analysis of patients or samples using medical laboratory disciplines
at microscopic levels.
Appreciation of the role of pathology is done by applying
experimental medical research. Pathology is therefore a study of
abnormal functions of the body which are caused by the number of
disease conditions or simply study of diseases. This study provides

55
understanding of the processes of diseases, their causes, clinical
effects, etc. As a medical discipline, pathology deals with a
performance and interpretation of laboratory procedures, leading to
diagnosis.

Forensic Medicine and Toxicology

This is newly initiated course to most of universities in
Tanzania. To date there some of universities that have not yet
included this very valuable course. The lab scientists are exposed to
forensics forensic medicine and toxicology course aiming at
providing graduate students with the basic knowledge, understanding
and basic professional skills of the medico-legal aspect of medical
practice. It also involves intervention of major toxicological
problems as well as medical-legal problems facing the professionals
after graduating, mostly during their general medical practices as
laboratory scientists.
The course provides awareness of relevant legal/court
procedures applicable to the medico-legal/medical practice, way of
preserving and dispatch specimens in medico-legal/postmortem
cases and other concerned materials to the appropriate Government
agencies for necessary examination. It gives knowledge on how to
manage medico-legal implications, diagnosis and principles of
therapy of common poisons. In addition to the above brings out
awareness of general principles of environmental, occupational and
preventive medicine.

Parasitology and Entomology

We are living in the world, full of organisms which are
causative agent (etiology) of diseases. Speaking of tropical countries,
the leading causes of deaths among the population are parasitic
infections, specifically, by malaria parasites. Malaria is killer disease
which has cost a lot of peoples lives, money, time and social-
psychological touches. Apart from malaria, there are other parasitic
infections for example, ascaris, hookworms, toxoplasma,
Entamoeba, Leishmania, Drancuculus, Trichnella and Trichomonas
which have led to high morbidity, mortality, physical disability and
other much worse effects.

56
 Now, to become laboratory technician, scientist or
technologist, one of the core courses undertaken is parasitology.
Parasitology exposes a laboratory technicians, scientist or
technologist on three major groups of organisms which are parasitic
protozoa, parasitic helminthes (worms), and those arthropods that
directly cause disease or act as vectors of various pathogens.
Knowledge and skills on the arthropods and parasites is important
for diagnosis, prevention, and the control of parasitic infections and
to understand the host response to infection. So far the skills gained
are very important for the research in malaria, filariasis and
helminthes, which has resulted to decrease of death.
Entomology course exposes a medical laboratory science
student to behavioral and characteristics of organisms responsible for
transmission of diseases, some of which are mosquitoes, bug lice,
mites, blackflies, fleas, ticks and midges. This has helped much for
the control of diseases transmitted though arthropods and other
related organisms

Molecular Biology and Biotechnology

Modern medicine is characterized by accurate results, quick
and less expensive. To cope with demand, molecular biology and
biotechnology is the intensive tool to meet the needs. Being
laboratory scientist, one is to be provided with opportunity to work
in molecular diagnosis laboratory. Competency on the aspect of
molecular biology and biotechnology is of essence to graduates.
Molecular biology course mainly performs specialized
testing requiring the extraction of DNA or RNA, hybridization,
amplification, or other analysis of nucleic acids to diagnose a
disease, predict the prognosis of a disease, guide therapy, or evaluate
the susceptibility to a disease before it is evident3. The course
integrates classical cell biology concepts with current molecular
biology for a unified view of cell function.
Prepare graduate for further studies or professional activities
in the industry or the public sector. understanding of the structures

3
Washington VA, Space VA, Criteria P, Version S. Veterans Heath
Administration - Pathology and Laboratory Medicine Services. 2008;124

57
and functions of cells, the basis of inheritance, the structures of
nucleic acids and their manifestation example proteins;
demonstrating how the discoveries of basic science can lead to
practical application and appreciating the impact of genetic
engineering on industry.

Clinical Chemistry
A disease condition in the body of living organism causes
number of changes on the body metabolites and physiological
activities; the changes happening in the body can be measured using
chemical analysis in blood, cerebrospinal fluids, urine, peritoneal
fluids etc. Becoming a laboratory scientist requires skills about
chemical pathology.
The course equip graduates with skills on biochemical
analyses with emphasis on principles, practice, techniques,
instrumentation, and quality control.
Fundamental concepts of the correlation of clinical laboratory
chemistry results to organ pathophysiology are core concern on this
course4. Graduates are well equipped with physiological basis for the
test, the principle and procedure for the test, and the clinical
significance of the test results, including quality control and normal
values.
The course has been designed to meet necessary skills which
include basic chemical laboratory techniques, chemical laboratory
safety, electrolytes, and acid-base balance, proteins, carbohydrates,
lipids, enzymes, metabolites, endocrine function, electrophoresis,
urinalysis, and toxicology. Graduates are well trained on automated
and manual methods which will enable measurement of chemical
analysis.

Microbiology and Immunology

Microorganism (the unseen organism using naked eye) are
the major causes of diseases, and on other side they are the leading
causes of disease complications. For instance, if an injured person
will not be in position of caring the injured part of his body, he may
end up suffering from a number of diseases complicated by bacteria,

4
Pathology C, Hospital ES, Avenue C. Chemical Pathology Handbook. 2014;
58
parasites, fungus or virus. The very food eaten and water drunken are
contaminated with microorganisms which in turn cause diseases.
The drugs which are offered for treating diseases are
becoming resistant to most of microorganisms, and this provides a
reason for laboratory scientists to undergo microbiology course.
On aspects of immunology, our bodies react positively to any
foreign substances (antigens) which can harm them, and fight by
producing antibodies against specific infections. The studying of
this, has a lot to do with diagnosis of diseases which can evoke
immune response.
Immunology provides theories and processes related to
natural body defenses inclusive of basic antigen-antibody reactions,
complement action, cellular response, humoral immune response,
and clinically significant diseases.
Clinical procedure theories and practical in immunology and
serology are also presented as well as clinical significance of these
procedures. Serology is therefore a branch of medical science that
deals with serums in which antibodies against specific etiology agent
can be identified with respect to immunological response.
Then a laboratory technicians, technologist or scientist is
exposed to principles concerning laboratory techniques used to
safely isolate and identify pathogenic bacteria, parasites, fungi and
virus.
Microbiology courses covers comprehensive study of the
classification, etiology, pathogenicity, laboratory identification,
diagnosis, and treatment of bacterial, fungal, viral and parasitic
infections5. Emphasis is placed on techniques and methods used to
identify and isolate bacterial, fungal, virus and parasitic pathogens.
Clinical practicum consists of microscopic, biochemical, and
immunological procedures to identify pathogens from clinical
specimens aiming at provision guide for patient treatment and
management.
Hematology
Blood is the fluid (red in vertebrates) that is pumped

5
Schools BH, Rock L. Baptist Health Schools - Little Rock School of Medical
Technology: School Specific Section. 2015;

59
throughout the body by the heart and contains plasma, blood cells,
and platelets. Blood is the most submitted sample in almost every
laboratory in the world for most laboratory sections apart from histo-
pathology laboratory where tissues and cell are primary samples.
The reason is explained by its important functions within
human body and valuable diagnostic components which are essential
for diagnosis of diseases. Information from my personal study which
is not published shows that blood as a sample is the most received
sample in clinical laboratory.
It is therefore very important course which a laboratory
technician, scientist or technologist should undertake to become
competent for diagnosing a disease and disorder related to blood.
The course starts with introduction to blood cells structure and
function, hematopoiesis (formation of blood cells), cell enumeration
(cell counting), differentiation, and hemostasis.
A graduate is also equipped with basic and advanced
techniques, quality control manual and automated procedures,
normal and pathological conditions with manifestations and
complications of blood related diseases and disorders.
Medical laboratory science students are well equipped with
skills on hematopoiesis and hemostasis with a strong emphasis on
clinical applications6. Proficiency in routine and specialized
procedures utilized in todays clinical laboratories is emphasized.
Thus, hematology aims at in-depth examination of normal
blood cell physiology and morphology followed with understanding
of the etiology, clinical symptoms, laboratory diagnosis and
treatment of the major hematologic disorders. Graduates are well
informed of pathophysiology of the anemia, leukemia, and other
blood cell diseases. Coagulation disorders, fibrinolysis and
thrombolytic therapy are also covered.

Blood Bank or Immunohematology

One of the major services found in laboratory medicine is
blood banking and transfusion medicine. The term transfusion
service usually refers to a facility located in a laboratory, organized

6
Ibid

60
principally to store, cross-match and issue blood for transfusion to
patient. Blood transfusion section is very busy requiring critical care
and attention. A laboratory technician, technologist or scientist is
principally responsible for provision of blood bank and
immunohematology services.
To become competent in this area a laboratory technician,
technologist or scientist student has to undergo studies so as to
understand services given by this section. Theoretical aspects of the
immune response and its relationship to the diagnosis of disease and
immunohematology are basic starting point. Understanding of
ABO/Rh grouping, direct anti-globulin testing, antibody screening
and compatibility testing are also very important. The course also
covers blood and component selection, hemolytic disease of the
newborn, etc.

Histotechnology
According to National society of histo-technology definition,
histology is a science dealing with the structure of cells and
formation into tissue and organs. Person desiring to become
laboratory technician, technologist or scientist should be equipped
with the stages of being expert at this area.
Histotechnology laboratory is designed for preparation and
staining of microscopic slide for microscopic examinations with
many other functions related to pathology.
The key objectives for this course is to enable student to
understand each tissues microscopic anatomy, ultra-structural
anatomy, unique physiology, relationship to other cell types and its
position in characteristic organs or organ system; being able to
justify the significance of clinical histology and cytology tests to
diagnosing disease; and being able to know how to perform basic
histology and cytology tests independently and identify key cell
findings.
The above basic and core courses may change at any time to
suit the need for professionals. It can be either course contents or
new item to existing curriculum. Changes happen in accordance with
principles and policies of particular universities.
The standard of education for laboratory medicine students
should be a pillar and leading cause of improvement. Extraordinarily
61
breakthrough in medicine will not be appreciated in most of African
countries and the world at large if participation of medical laboratory
students and other health professions is poor, pertaining clinical
research and other professional development strategies which
include curriculum development, curriculum review, and curriculum
improvement to suit the needs of the specific course.

62
 CHAPTER FOUR
THE IMPORTANCE OF CLINICAL LABORATORY
MEDICINE

Laboratory medicine provides incredible and continuous

patient and community care. In addition to providing objective data
about patient health, laboratory medicine enables early assessment of
disease risk, use of preventive and less invasive treatment, selection
of appropriate treatment, and monitoring treatment. If used
appropriately, it helps to inform patient management decisions.
Laboratory testing can contribute to optimizing use of health care
resources and decrease short-, medium-, and long-term costs of
care1.
According to the Lewin-group report which was given out in
USA and personal experience, clinical laboratory medicine has
number of rules and applications. As we are still exploiting
laboratory medicine, lets have a look on rules and applications of
laboratory medicine as important components of disease prevention,
treatment, and control and see how clinical laboratory medicine
contribute to that.

Screening for Risk Factors of Developing Specific Disorders

Screening tests are very important in todays world especially
with the advantages they provide as they can be conducted on
asymptomatic individuals to check for risk factors and other
indicators of developing or latent disease, especially for children and
young adults. Such testing can prevent the impact of diseases and
medical conditions that appear later in life.
Screening tests for adults can detect certain common diseases
which when identified early, can be monitored and treated more

1
The Lewin-group. Laboratory Medicine: A National Status Report Laboratory
Medicine. 2008.

63
easily. An easy example of a disease which can be screened are heart
disease by measuring cholesterol level. A lot of diseases can be
prevented through screening and by this way we minimize deaths
and cost on treating them Example cervical cancer by doing pap-
smear.

Screening to Determine Individual Risk

Genetic testing involves the analysis of chromosomes, DNA,
ribonucleic acid, genes, or gene products to detect heritable or
somatic variations related to genes or health. When we look at a
practical side, genetic testing is used to determine whether an
individual is a carrier of a disease or a condition or has a heightened
risk of developing a disease years or decades later. It also can be
used for diagnostic or prognostic purposes and as a predictive tool to
assess an individuals drug metabolism. The main types of genetic
testing include the following:-
1. Carrier Identification
This is used to determine whether an individual possesses a
potentially harmful gene that can be passed on to progeny. Maternal
serum screening is used to determine whether a fetus is at risk of
having specific genetic conditions and to detect open neural tube
defects and certain chromosomal abnormalities. Current prenatal
diagnosis is targeted at specific diseases and/or mutations rather than
determining the general genetic make-up of the fetus.

2. Newborn Screening
This is most often used to determine whether a newborn has a
medical condition that requires immediate treatment, e.g.
phenylketonuria, and congenital hypothyroidism.

3. Late-onset Disorder Testing

This is used to determine an adults susceptibility or
predisposition to complex diseases such as cancer, heart disease, just
to mention but a few. The increasing role of genetic testing is due in
a great measure of advances in understanding the role of genetics
and molecular biology in disease development. Genetic tests are now
64
available although their expenses are high. Many diseases are known
or thought to be caused by inherited or spontaneous acquired DNA
alterations, like sickle cell anemia, hemophilia and Down syndrome
respectively. Further details are beyond the scope of this book.

Diagnosis
Laboratory tests are critically important for accurately
diagnosing a disease in its earliest stages, having power of
determining disease severity, assessing the likelihood of recovery,
and evaluating the potential for adverse outcomes. Accurate and
early diagnosis allows clinicians and patients to better evaluate the
benefits and risks of various treatment options. Begin treatment
promptly in the case of contagious conditions and prevent a disease
from spreading to others. Laboratory tests are used by clinicians and
increasingly patients, to inform prevention and treatment decisions
and related courses of action. Early-stage detection via laboratory
testing is established for such diseases and conditions like breast
cancer, malaria and typhoid2.
Along with an individuals signs, symptoms, personal
history, and family history, laboratory tests are used to arrive at or
eliminate possible diagnoses. A laboratory test used for including
(ruling in) a disease or condition indicates that it may be present; if
the test results are abnormal excluding (ruling out) a disease or a
condition allows the clinician to consider alternative diagnoses and
make more efficient use of resources rather than continuing with
treatment which is not specific.
Gynecologists recommend that young women receive Pap
tests every year beginning not later than the age of 21 years. Women
over the age of 30 who have no new risk factors and those with
normal results for three consecutive years are advised to get retested
every two-to-three years. By personal observation, it shows that at
KCMC many women attend clinic for checkup and if anything

2
Leary JJO. Pathology 2026: The Future of Laboratory Medicine and Academic
Pathology. 2006;

65
wrong is suspected they are referred to Pathology/Histopathology
department for more checkup. Broad use of the Pap test as a
screening tool to detect pre-invasive lesions is credited with
reduction in the annual incidence rate and it has saved thousands of
women. When diseases are identified at an early stage or before
symptoms have appeared, patients and their health care providers
can take measures to prevent or reduce the risk of developing the
disease or condition, including increased medical monitoring,
lifestyle changes and, when needed, medical interventions. Similarly,
early measures may minimize the severity of the disease and its
effects on mortality, morbidity, and quality of life. These measures
also can diminish downstream health care. For instance, early
detection of incipient colorectal cancer using fecal-occult blood
testing is associated with more successful treatment and increased
survival.

Measure/Assessment of Degree of Severity of Disease

Laboratory tests can be used to determine the degree to
which the disease has progressed/reached and the severity of the
disease. Laboratory tests, including studies of blood, urine, bodily
fluids, and bodily tissues, play a major role in the staging of
diseases; this is describing the severity of a disease based on the
extent to which it has spread throughout the body. Tests to determine
the extent and severity of a disease can be the same or different from
those for Diagnosis3. For example, measurements of HbA1c and
glucose are used to diagnose diabetes and to monitor blood sugar
control in diabetic individuals. We can also monitor disease like HIV
by measuring viral load, this helps physicians to decide on how to
care for patients.

3
Leary JJO. Pathology 2026: The Future of Laboratory Medicine and Academic
Pathology. 2006;

66
 Preventing Drug Resistance and Selection of Drug of Choice
According to WHO, drug resistance occurs when micro-
organism such as bacteria, fungi, parasite and viruses change
themselves in the way that renders the medications failure on
treating the same disease which was treated before. The fatality of
the antimicrobial resistance is like a walking bomb which has
exploded in many areas of the world to a state of being resistant to
multiple antimicrobials. It has affected the regime for treating
tuberculosis, HIV, Malaria, Gonorrhoea, and other many bacterial
infections.
Though drug resistance is termed as natural phenomena but
human being play the major role to facilitate its spread. There are
key issues about antimicrobial resistance:-
First of all antimicrobial resistance prevents the efforts
toward prevention and treatment of increasing range of infections
caused by the virus, parasites, fungus and bacteria. Secondly, it is
now causing high tension to the government, policy makers,
hospitals, and other potential agents. Thirdly we are expecting an
increase in requirements of more extreme drugs near future which
will be more costly, and might be more toxic as compared to the one
we use. Fourthly drug resistance puts at risk the best efforts which
have been reached by the health system.
The impacts of drug resistance go further to worsened
clinical conditions or outcome, consume more health resources, and
lastly death becomes an option to these innocent people.
Accompanied with other means of controlling and preventing
drugs resistance, clinical laboratory medicine contributes to high
percentages on preventing, reducing and controlling drug resistance
through application of proper microorganism diagnosis, culture and
sensitivity tests as well as suggestions of best drugs to use.
This highlights the importance of accurate laboratory tests in
slowing increase in the prevalence of medication-resistant strains of
disease causing bacteria. While antibiotics have little or no effects on
treating many upper respiratory infections including viral infections.
Symptoms of viral infections often resemble those caused by Group
A streptococcus and pose a challenge on diagnosis using clinical
67
signs and symptoms. Clinicians in Tanzania and other parts of the
world often prescribe antibiotics for viral infections. There is now a
high antibiotic resistance on treating Group A streptococcus; now
accurate diagnosis of Group A streptococcus using laboratory
testing is a key component for preventing inappropriate use of
antibiotics by use of antimicrobial susceptibility testing to determine
the ability of antimicrobial agents to inhibit the growth or kill
pathogenic bacteria, thereby helping to optimize treatment and
reduce the risk of antibiotic-resistant organisms.
Note that clinical microbiology laboratory especially in the
part of culture and sensitivity, plays a vital role on;
1. Preventing drug resistance and drug selection. Example, it is
estimated that more than 95% of patients with multidrug resistant
TB globally are not treated with appropriate second-line drugs,
because they are not checked for drug resistance, as mainly, only
cultures are done4.
2. Formulation of policies on what drugs to use as antibiotic with
respect to hospital settings.
3. Access to the raise of any kind of resistance for example beta-
lactamase organisms.

Informing on Prognosis of Patients

Once a diagnosis is made and the severity of the disease has
been determined, laboratory test results can contribute to projecting
the cause of a disease, including estimating the likelihood that an
individual will recover from a disease or medical condition. Routine
laboratory tests ordered upon hospital admission of patients
following myocardial infarction that measure white blood cell,
creatinine, glucose, lactate dehydrogenase, and platelet counts are
predictive of the likelihood of mortality. For diseases like kidney
diseases, prognosis of patients can be measured through use of
clinical chemistry panel where urea and creatinine are assessed.

4
PSHSPD. The United Republic of Tanzania: Ministry of Health and Social Welfare,
Primary Health Services Development Programme. 2007;200717

68
Laboratory medicine can predict for future adverse health outcomes
following recovery from a disease, such as recurrent stroke or cancer
relapse.
Monitoring General Treatment Effectiveness
Laboratory medicine tests play a tremendous role in
monitoring and evaluating the efficacy of other medical treatments.
They can assist clinicians in deciding whether to modify a specific
course of treatment in order to optimize outcomes, including
maximizing the therapeutic impact. For instance, tests to measure
viral load, CD4 count, complete blood count, and blood chemistry
tests are commonly used to assess treatment response in patients
with HIV. Some laboratory tests used to monitor treatment
effectiveness are the same as those used to make the initial disease
diagnosis. A very common instance of this involves tests to measure
thyroid stimulating hormone in the diagnosis and monitoring of
thyroid disease. Laboratory testing is also important in monitoring
patients following surgery to measure precisely the success and
effectiveness of a procedure. Laboratory tests help to detect levels of
human chorionic gonadotropin in women with trophoblastic disease,
which involves abnormal growth of cells inside a womans uterus.
These tests are conducted regularly following surgery to determine
whether or not further treatment is required.

Managing Acute Medical Conditions

Acute conditions are those that appear suddenly and follow a
short, severe course. In this text I mean persisting for several days or
weeks and have the potential to be completely resolved. Most of
acute care is relatively short-term. In acute care settings such as the
intensive care unit (ICU) or the emergency department frequent
laboratory tests can be used to monitor quickly and accurately an
individuals status and response to medical interventions. The five
most commonly ordered types of laboratory tests in ICUs include
basic metabolic panels example tests are glucose, calcium,
electrolytes, arterial blood gas profiles, complete blood counts,
partial thromboplastic time, and measures of magnesium levels. The
basic metabolic panels, are commonly ordered in hospital emergency
69
rooms because the results can indicate several acute problems,
including kidney failure, insulin shock or diabetic coma, respiratory
distress, or heart rhythm changes particularly in critical care settings.
Any intervention that shortens or improves the efficiency of care can
dramatically affect patient outcomes and health care costs. There is
great emphasis on providing quick and accurate laboratory test
results for individuals in critical care settings. For the sake of seeing
this happening, many hospitals maintain designated laboratory
usually close to operating rooms, critical care units, or the
emergency department, although its not yet implemented in most
hospitals in Tanzania and Africa at large. Laboratory tests for certain
critical conditions can be conducted using point-of-care testing
technology, which allows clinicians to obtain laboratory results in
proximity to the patient. Measurements of glucose and oxygen
saturation levels at the point-of-care allow clinicians to determine
changes in a patients status rapidly and frequently. In critical care
settings, nurses often perform point-of-care testing technology
(POCT). Particularly in the emergency room, performing point-of-
care testing technology (POCT) has the potential to facilitate
decision making and allow for more effective assessment of patients.
While acute care is often provided in hospital settings such as the
emergency department-ICU, it can also be provided in other related
care settings like primary care sites. As in critical care, laboratory
testing in non-critical primary care is vital to timely and accurate
diagnosis. For instance, testing for urine leukocyte esterase and
nitrites to detect urinary tract infections, testing for H pylori to detect
gastrointestinal disorders, and testing for C-reactive protein to detect
bacterial infection are all commonly used in acute care provided in
primary care settings. Perform point of care testing technology
(POCT) is growing in use for non-critical acute care to provide rapid
diagnosis and rule out other tests. Whereas urine specimen culture
testing requires 24 hours to complete, urine dipstick tests provide a
means of rapidly detecting the presence of bacteria in urine and
urinary tract infections which will lead to further diagnosis.
Specimen for culture and antimicrobial resistance susceptibility tests
are usually conducted in a laboratory, while dipstick tests contain
70
specially treated plastic strips that change color when exposed to
infected urine and can be conducted in a doctors office or at home.
In many cases, negative urine dipstick tests alone can exclude the
presence of infection then the dipstick techniques require
confirmation from main laboratory because of interference factor
which can occur in the physicians office.

Managing Chronic Medical Conditions

Laboratory medicine is a basic and fundamental component
in managing chronic diseases. There is big population and a lot of
people are having chronic diseases which they really need clear
attention. Chronic diseases are a growing concern in particular
developing countries due to adapting western life styles. Currently
millions of people live with chronic illnesses and about half of older
adults have at least two chronic medical conditions being Diabetes,
Hypertension and TB. Care for chronic illness accounts for very high
percent of laboratory tests in context to chronic diseases are and
useful tools for clinicians in understanding the status of the diseases,
informing treatment decisions, determining the urgency of care
required, managing symptoms, educating patients, and incorporating
lifestyle changes into the treatment regimen.
In certain instances, regular laboratory testing can prevent the
diseases from progressing or worsening. For example, patients with
Chronic Ischemic heart disease (IHD) and coronary artery disease
are at high risk for myocardial infarction Acute Coronary Syndrome.
Aggressive lipid management in individuals who have heart disease
helps to prevent heart attacks and reduces mortality rates. Regular
lipid testing of patients with heart disease helps physicians to adjust
a specific need of disease management regimens and provides a
means to motivate some patients to implement lifestyle changes.
Similarly, laboratory tests are a key component in the management
of chronic kidney disease, which can also lead to high blood
pressure, anemia, weak bones, nerve damage, and progression to
kidney failure. Laboratory tests that measure glomerular filtration
rate are used to assess the severity of chronic kidney disease and to
determine whether to initiate treatments.
71
 Disease management refers to the ongoing care associated
with chronic conditions. It is defined as a Proactive, multi-
component strategy for delivering health care services that aims to
reduce adverse medical events by maximizing patients adherence to
prescribed treatment and/or lifestyle changes. An important
component of the strategy is self-management, with patients being
responsible for day-to-day self-monitoring, decision-making, and
healthy lifestyle choices.

Therapeutic Drug Monitoring

Laboratory medicine tests are an essential constituent to the
management of medication and dosages for various conditions5.
Therapeutic drug monitoring refers to the measurement of specific
drugs or metabolites in the body by blood testing to inform
therapeutic regimens that maintain a target medication concentration
in the body. Maintaining an appropriate dosage is particularly
important for medications with a narrow therapeutic index that is,
drugs with smaller dosage ranges for optimum effectiveness
(optimum effectiveness and toxic effects) .Medications e.g. Digoxin
drugs that have a wider therapeutic index, such as antihypertensive
and antibiotics, can usually be prescribed based on pre-established
dosing schedules. Laboratory tests associated with therapeutic drug
monitoring are instrumental in establishing and maintaining the
medication dosage that will yield the optimum blood level range for
a specific individual. Calculations are based on optimum therapeutic
ranges developed through research and clinical testing of narrow
therapeutic index medications in addition to individual patient
testing. Therapeutic drug monitoring plays a vital role in ensuring
that treatments are fully effective and that the individual does not
experience any toxicity as a result of treatment.

5
Leary JJO. Pathology 2026: The Future of Laboratory Medicine and Academic
Pathology. 2006;

72
 Detection and Prevention of Medication Error
Laboratory medicine testing also provides a means to prevent
and detect medication errors. Medication error is an error occurring
in the medication-use process, such as wrong dosages prescribed,
wrong dosage administered, failure to administer a medication by the
provider, or patient failure to take the medication as prescribed. It
can compare the medication orders to major elements of the patients
history, including laboratory results. Clinicians are alerted when
medication orders conflict with a specific element in the patients
history. Increased pharmacy and laboratory inter-information
systems should further increase the ability of laboratory medicine to
aid in the prevention of medication errors. Review of laboratory test
results documented in a patients medical record aids in the detection
and identification of medication errors. An adverse drug reaction is
an effect resulting from the use of a medication in the recommended
manner. An adverse drug event is any injury due to medical harm,
including physical harm e.g. rash, mental harm (e.g. confusion), or
loss of function (e.g. inability to drive a car), whether used in the
recommended manner or not. An adverse drug reaction and events
may be preventable or not preventable.

Individualizing Drug Treatment and Reducing

Adverse Drug Reactions
As scientists study the human genome and gain
understanding of the genetic, behavioral, and environmental
determinants of disease and therapeutic response, laboratory tests
have power to act leveraged to individualize treatment protocols
based on individual patient traits. Pharmacogenomics uses
information from the human genome to understand the spectrum of
genes involved in drug response and studies the relationship between
gene-based markers and pharmacology. The term pharmacogenetics
refers to the study of particular inherited differences in drug
metabolism; laboratories will have important roles in studies to
identify and verify polymorphisms and clinical trials of
Pharmacogenomics-guided interventions pertaining this very
upcoming career in laboratory medicine. To see this we need now-
73
and-then changes in curriculum. Change to meet the needs of
modern medicine because as you can witness, most of medical
laboratory science schools offer no course relating to pharmacology
and pharmacogenomics.

Protecting the Blood Supply and Transplant Recipients

Blood and blood products are vital health care resources that
are required in a large number on medical procedures available in
our setting. Availability of safe blood and blood products is essential
for millions of people in the Tanzania by saving accident victims,
anemic pregnant mothers, anemic children, transplant recipients, and
patients undergoing a wide range of surgeries.
Health care industry relies on blood donations from
volunteers in order to meet this demand. In the most recent years, the
data available show that in Tanzania, centers for blood donation have
been allocated zone wise where blood is collected and distributed to
different hospitals, through clinical laboratory department. Clinical
laboratory medicine works to guarantee the safety of the blood
supply. Blood collection usually takes place at community blood
centers, hospital based donor centers, universities, colleges,
secondary schools, or mobile sites temporarily constructed for blood
donations. Following donation, the blood is taken to blood banking
laboratories and tested to determine blood type and detect the
presence of antibodies, bacterial contamination, and other agents that
could potentially cause adverse reactions in transfusion recipients.
Once testing is completed, donated blood that is free of infection is
stored for future use. Screening blood donations for the presence of
infectious disease is a high-value service provided by blood banks
within clinical laboratories. Laboratories screen donations for the
presence of HIV and hepatitis B and C viruses. Innovations in
laboratory testing have also allowed donated blood to be screened
for human T-lymph tropic virus types I and II, syphilis, West Nile
virus, Chagas disease, and other infections.
Clinical laboratories also conduct blood compatibility testing,
to determine whether a particular unit of blood can be safely
transfused into an individual. Pre-transfusion hem compatibility
74
testing includes identifying an individuals ABO blood group and Rh
type, both of which are determined by the presence or absence of
specific antigens on red blood cells, as well as testing blood for
unexpected red cell antibodies. Cross-matching determines whether
an individuals blood has antibodies that will react with the donors
cells. In the event that a cross-match indicates a reaction, laboratory
professionals identify the specific reacting antibodies and locate
alternate donor blood that lacks the antigen.
Compatibility testing, cross-matching, and other precautions
taken by clinical laboratories help prevent adverse transfusion
outcomes, which include acute hemolytic transfusion reactions,
febrile or hemolytic transfusion reactions, allergic reactions, volume
overload, and acute lung injury caused by transfusing incompatible
blood. ABO incompatibility is the most common cause of acute
hemolytic transfusion reactions, which usually result from antibodies
in the recipients plasma reacting to red blood cell antigens in the
donor blood.

Detecting Exposure to Illegal or Toxic Drugs

Exposure to illegal drugs, toxic substances, and incorrect use
of therapeutic drugs is a major causes of hospital emergency
department visits. Most of visits to the emergency department are
attributed by poisoning and toxic effects. Most emergency
department visits each year may also be attributed by abuse of
alcohol and other substances. In Addition to alcohol and drug abuse,
accidental or inadvertent contact with substances such as Organ
phosphorous compounds (used in pesticides), rodenticides, heavy
metals, and carbon monoxide can also contribute to significant acute
and chronic threats to health. Rapid and accurate laboratory testing
enables clinicians to identify specific toxic substances to which
patients have been exposed; that enables the treatment in relation to
specific problems to particular patients; this is per personal
observation.

75
 Position of laboratory Medicine in Health Care Improvement
For improvement of good health care, laboratory medicine is
grounded in six aims of quality, it should be remembered that
quality of services is laid in the following safety, effectiveness,
patient centered service, timeliness, efficiency and equitability, as
explained here below:-

1. Safety
Safety refers to protection of patients from harm, due to care
that is intended to help them, and protection of health care workers
from harm while providing care. Under this very basic right of both
patient and health care provider, Laboratory medicine contributes in
diminishing the risk of harm when patients and specimens are
accurately identified. Specimens are collected appropriately,
measures are taken to prevent specimen contamination; process
control measures are executed during analytic processes, and test
results are complete and understandable.

2. Effectiveness
Effectiveness refers to measures of how well health care
interventions (screening, diagnosis, treatment, etc.) achieve their
intended outcomes or other impacts. Under this very important need,
Laboratory medicine supports effectiveness when test ordering is
evidence-based, specimen collection follows science-based
procedures, specimen analysis and results reporting conform to well-
established standards, and testing results in improved patient
outcomes.

3. Patient-centered
Patient-centered care is respectful of and responsive to
individual patient values, preferences, and expressed needs, and
ensures that patient values guide decision making. Laboratory
medicine supports patient-centered care when test ordering reflects
patient preferences, including end-of-life care; specimen collection is
designed for patient's comfort and satisfaction, and test results are
understandable to and actionable by the patient and clinician. These
76
attributes can contribute to favorable patient experience of the health
system and quality of care.

4. Timeliness
Timeliness Laboratory care medicine minimizes unnecessary
delays that can result in emotional or physical harm. Timely
transport of specimens, decreased turnaround times in routine and
state testing, and timely notification of critical or abnormal values
are primary ways that laboratories support quality of care.

5. Efficiency
Efficiency refers to using of resources to optimize production
of desired results. Laboratory medicine contributes to health care
efficiency when waste is eliminated or reduced, including that
associated with inappropriate test ordering.

6. Equity
Equity of care ensures that quality does not vary because of
patient personal characteristics such as sex, race/ethnicity,
geographic location, or socioeconomic status. Laboratories
contribute to equitable care when they provide services in a manner
that is unbiased, accommodate the special needs of patients during
specimen collection, use reference intervals that account for
population differences, and present information according to the
language and literacy level of the patient.

GENERAL VALUE OF LABORATORY MEDICINE

Medical Laboratory has been structured to almost every level
of health facilities to perform the following duties:-
1. Investigate by referral or testing on site, important diseases and
health problems affecting the local community. Such
investigations usually include bacterial diseases, viral diseases,
parasitic diseases and other causes of illness.
2. Assist health care workers in deciding the severity of a patients
conditions.

77
3. Notify at an early stage of any laboratory results of public health
importance and send specimens for confirmatory tests to other
laboratories. This helps much in diseases prevention, especially
diseases which are epidemic.
4. Perform a range of special tests such as viral, histo-pathology,
cytological, immunological, forensic, genetic investigations. In
coordination to other tests such as pregnant women for anemia,
proteinuria, malaria, HIV and syphilis.
5. Laboratory medicine team promotes health care and assists in
community health education for diseases like cholera, Ebola, and
other infectious diseases.
6. Keep records, which can be used by health authorities in making
health policy and planning for epidemiological purpose. In facts
laboratory tests and results are recorded and it is easy to tell the
disease which is common in a particular environment.
7. Clinical laboratory performs a range of tests relevant to the
medical, surgical, and public health activities from dispensary to
national laboratory level.
8. Clinical laboratory processes blood transfusion from the donors or
from the center of blood donation. Being center for blood
donation, laboratory is involved in donation process.
9. Carry out important and appropriate research for the purpose of
lowering public health problem or burden. It is research which
makes sense out of scientists' brains and mark beginning of
changes.
10. Persons been in clinical laboratory professionals have
responsibility to contribute for the sphere of professional
competence and general wellbeing of the community6.
11. Laboratory scientists are also involved in provision of
consultation services and interpretation service on how to select
tests, sequence and interpretation of result from the laboratory to
other medical professionals.

6
Standard A, Procedures O. Revised 2009. 2009;

78
 CHAPTER FIVE
CLINICAL LABORATORY MEDICINE WITH
TANZANIA NATIONAL HEALTH VISION 2025+

The Tanzania Development Vision 2025+ has the main

objective of improving the quality of life for all Tanzanians, by
improving the quality of healthcare in the country. The strategy for
obtaining this goal requires laboratory participation, which will
ensure realization of the following health services goals:-
1) Access to quality primary health care for all. This goal will really
be effective if more laboratory diagnosis is included in primary
health care1. Primary health care will not be effective if empirical
treatment does not stop.
2) Access to quality reproductive health services for all individuals
of appropriate ages. The strategies to reproductive health
improvement are well accompanied with availability of good and
quality laboratory practices for monitoring different conditions
which are facing reproductive ages. It involves early detection of
pregnancy, Monitoring Hemoglobin level for pregnant women,
identification of sexual transmitted disease, diabetes and other
common diseases to reproductive age women. In general every
pregnant women requires good laboratory for health delivery
process.
3) Reduction in infant and maternal mortality rates by three quarters
of current levels, the reduction of all these conditions can be well
managed if expectant mothers will be in position of screening the
diseases and knowing the status before they get prepared for
having pregnancy and in doing so, laboratory plays a vital role 2.
Increase in maternal and infant mortality rate are mostly
accompanied with delay on diagnosis of disease during
pregnancy.
1
PSHSPD. The United Republic of Tanzania: Ministry of Health and Social
Welfare, Primary Health Services Development Programme. 2007;200717
2
Ibid

79
4) In the strategy of universal access to clean and safe water,
laboratory has a critical role on finding the safety of public
consumables which involves water, foods etc., and if that is the
case, laboratory has a great position on finding solutions to
hygienic conditions which will result in to prevention of diseases
related to unhygienic environmental conditions.
5) Life expectancy will increase as compared to the level attained by
typical middle-income countries. We can only attain high life
expectancy if we have the culture of screening our health every
now and then because it is a strategy to prevent advancement of
diseases which lead to incurable situations. All these can be done
by medical doctors relaying on laboratory diagnosis.
6) Food self-sufficiency and food security. Food sufficiency relays
much on technology and laboratory. Laboratories play very vital
role on issue of food security, specifically for food imported from
abroad,some of them are not user friendly. A number of
laboratories have been established to look at the standards. For
example TFDA laboratory.
7) Encourage the participation of community in the delivery of
health services. Every health professional has a primary goal of
educating people around him/her; that being a reason for every
laboratory technician, technologist and scientists to be responsible
for caring, educating and improving others health.

To meet the desired goals for 2025+ Tanzanian government has

put the following efforts toward growth of laboratory medicine:-
1.The government has encouraged the opening of more colleges and
universities to offer education on laboratory medicine.
2.It has tried to employ more laboratory personnel in different tiers
of health facilities to meet the needs of the country.
3.It has done a lot on provision of undergraduate education
sponsorship through HELSB, thus increasing the number of
people who are graduating in these courses.
4.Currently the number of clinical laboratories with the capability of
diagnosing diseases is increasing.

80
5.The government has also placed emphasis on buying durable and
quality laboratory machines used for diagnosis.
6.The Ministry of Health and Diagnostic Services has formulated the
National Quality Assurance document to be used all over the
country to ensure that its laboratories meet quality guidelines.
7.A mechanism has been put in place to monitor laboratory services
with support from CDC3, national reference laboratory, etc.
8.A number of efforts have been directed at developing a program of
international accreditation of laboratories in Tanzania.
In order for Tanzanias laboratory services to operate with the
sufficiency needed to meet the goals of 2025+, a quality laboratory
information system is needed to ensure better utilization of
laboratory data for a clear vision.

Transferring Tanzania Medical Laboratory Data From

Paperwork into The Laboratory Information System (LIS)
An operational laboratory information system (LIS), or
laboratory information management system (LIMS) is necessary
due to the large quantity of highly complex data, information, and
knowledge that laboratories accumulate, as well as the continued
demand for data to support public health surveillance through
effective disease prevention,4 5.
The increase of efficiency in time management, busy life,
peoples awareness and economic issue in healthcare services, has
led clinical diagnostic laboratories to look for tools that can improve
their efficiency, resulting in improved laboratory services and
increased profits.
Currently, most laboratories in Tanzania are heading toward
employing a new system of using computers in recording important

3
Hotel P. Post - Market Surveillance of Diagnostics Scheme - Earqas Meeting
Report. 2010;
4
Nyasulu PS, Paszko C, Mbelle N. A Narrative Review of the Laboratory
Information System and Its Role in Antimicrobial Resistance Surveillance in
South Africa. 2014;(August):6926
5
Search H, Journals C, Contact A, Iopscience M, Address IP. Information Systems
as a Quality Management Tool in Clinical Laboratories. 2007;012005
81
information about patients samples, and in some laboratories the
new systems are already in use. Though the concept of laboratory
information systems (LIS) is new in Tanzania, it is not so in
developed countries.
A laboratory information system (LIS) is a data processing
and dissemination technique used in the laboratory to deliver
accurate and understandable results within a reasonable timescale as
requested by clinicians and is a class of software that receives,
processes, and stores information generated by medical laboratory
processes6.
Most of Tanzanias laboratories are under construction,
though some regional and referral clinical laboratories are already
using it, to some extent, with numerous challenges. Advances in
technology have made LIS more sophisticated than ever, offering
clinical and non-clinical applications, Web-based connectivity, and
customizable configuration and rule-writing, scalability, and
modular units that can offer data handling for the most cutting-edge
laboratory techniques and testing7.
A laboratory information system (LIS) is a software program
that provides the IT functionality needed for a clinical laboratory.
Components of LIS offer basic needs for most modern laboratories,
components often included a LIS. It handles patient check-in, order
entry, results entry, patient demographics, specimen processing, and
some level of reporting ability. In addition, an LIS is able to route
test orders and results to various users and network locations.
The needs for LIS differ from one laboratory system to
another, depending on the procedures and processes conducted at
each particular level of laboratory. For example, specialized
laboratories, especially labs that use molecular-based techniques, or

6
Sara Al Hamdan. Evaluating the Importance of the Laboratory Information
System ( LIS ) in National Guard Health Affairs Hospital-Riyadh: Done by Sara
Al Hamdan , Supervised by Dr Basema Saddik Mph PhD, College of Public
Health and Health Informatics, King Saud Bin Abdul A. 2009;24
7
Terry BM, Michel ERL. Transferring Laboratory Data Into The Electronic
Medical Record: Technological Options for Data Migration. 2011;
82
high-resolution image capture, have highly specialized LIS
requirements compare to other laboratory.

Advantages of Laboratory Information System (LIS)

1. LIS helps to provide the easiest communication and sharing of
clinical data among health care providers. It can help to know
exactly where a sample is and what has been done about the
sample.
2. It improves accuracy and turnaround time of results. Paper
methods of laboratory information causes a number of delayed
diagnosis, management of patient and decrease in efficient of
patient care. Delayed results, of course, bring many unacceptable
consequences including death.
3. Automation of laboratory activities removes the element of
manual reporting, increases productivity and allows access to
retrospective data for analysis8.
4. LIS has opened the door for the utilization of laboratory data in
research activities in more comfortable and reliable ways. Data
obtained in LIS can be used in studying of epidemiological
studies and surveillance.
5. Data generated by LIS is used to understand the volume of tests
done, the time it takes to get results back to the patient and to
plan efficient service delivery to patients.
6. LIS has enabled easy dealing with huge volumes of data, both
internal and external to the laboratory9.
7. LIS simplifies issues of management for the laboratory director
(head of department), laboratory manager, quality control officer,
safety officer etc. This system has made follow up much more
efficient.
8. An appropriate information system is a valuable tool in quality
management in clinical laboratories, as it works against

8
Nyasulu PS, Paszko C, Mbelle N. A Narrative Review of the Laboratory
Information System and Its Role in Antimicrobial Resistance Surveillance in
South Africa. 2014,6926
9
Baltazar Chilundo, Sundeep Shay. Clinical Laboratory Information System in
Mozambique: The great challenge, 2001
83
 misdiagnosis and inappropriate treatment. Appropriate laboratory
information systems allows for quicker diagnosis, simple
analysis of quality tests, avoiding problems related to the
calculation and interpretation of test results, and identifying
problems in the processes, thereby ensuring delivery of results
within specified quality standards10.

Challenges Of Effective Adaptation of Laboratory

Information Systems (LIS)
Currently, there are a number of challenges faced in the
implementation of laboratory information systems, despite its
advantages which have been detailed earlier. These include the
following:
1. Particularly in Tanzania most university curricula of medical
laboratory science cover computer skills but without relevant
skills needed for laboratory information systems. This has posed
a number of challenges for graduates as they adapt to working
stations.
2. The operation of laboratory information systems is costly.
Components required to install LIS depend much on
computerization which involves very expensive hardware. In
addition there are charges for installation, as well as the use of the
internet, and ongoing maintenance.
3. LIS require IT personnel to run them, as the systems are incapable
of operating on their own. Though this is an excellent job creator
for IT personnel, it is another costly expense for the institutions
implementing LIS.
4. For laboratory information systems to work effectively a quality
adaptive workflow is crucial to prevent system failure.
5. When you start using LIS, there is downtime for installation or
operational maintenance, negatively impacting patient services.

10
Search H, Journals C, Contact A, Iopscience M, Address IP. Information Systems
as a Quality Management Tool in Clinical Laboratories. 2007;012005

84
6. The operation of laboratory information systems is complex and it
requires unique laboratory specialties who will easily
communicate with LIS language to ensure that the system is user
friendly.
7. For LIS to work effectively there must be clear interfaces between
laboratory staff and the clinical staff (nurses and physicians).
There are many errors which might happen within a system,
including instrumentation interfaces, which are the most common.
8. Another challenge is data storage. Most of the data which can be
stored in LIS system can be protected against invaders such as
viruses. On the other hand corrupted systems can cause massive
loss of patient data.
9. Funding is a huge challenge for most underdeveloped countries
when it comes to innovation in science and technology. Meeting
international standards with new LIS systems is quite expensive.
10. Due to importance of laboratory information systems in todays
world, there should be clear and defined strategies to meet the need
for effective provision of services. Strategies shall include re-
designation of curriculum to meet this very basic need for
laboratory improvement, and enough support for money to run or
initiate activity. Furthermore, well-defined plans and policies are
needed to meet the targeted goals.

LABORATORY MEDICINE AS CENTER

FOR CLINICAL RESEARCH
Studies conducted to answer specific scientific questions by
involving people or human samples is called clinical research.
Medical research laboratories perform basic research, and develop
new techniques and methodologies, that provide evidence on which
to base the formulation of policies and decisions on health and
development11.
Some of the laboratories engage research testing in order to
develop new assays and technologies, vaccines and drugs. Clinical

11
Cohen S, Africa. The Need for a Quality Standard for Assurance in Medical
Research Laboratories. 2014;3(1):19
85
research is the backbone for the existence of medicine. Clinical
research is conducted by clinical research scientists, which includes
laboratory scientists, medical doctors and other health cadres.

Need of Clinical Researches which are basically

conducted in Laboratory
1. Research helps to develop proper tools for the use of existing
knowledge.
2. Not only does research enable healthcare providers to diagnose
and treat diseases, but it also provides evidence for policies and
decisions on health and development.
3. Research laboratories, as part of the research process, assist in the
development of new technologies for monitoring disease and the
surveillance thereof, while diagnostic testing laboratories, on the
other hand, are directly involved in patient management through
laboratory testing and not considered a part of the research
process12.
4. Scientific research plays a vital role in efforts to maintain health
and combat diseases, that is, global threats to health security.
5. Through clinical research healthcare personnel learn and
understand how to improve human health.
6. Through clinical research the doors for discoveries of new
diagnostic methods can be obtained and hence clear the way to
go.
7. Clinical research, in the historical aspect, has led to important
medical discoveries that has made and will make our life better.
Discoveries of vaccines have prevented a lot of diseases such as
hepatitis B,pertussis,tetanus,polio,and diphtheria,even led to the
eradication of diseases such as small pox.
8. Clinical research has provided room for treatment of disease such
as cancer, tuberculosis, hypertension and Diabetes.
9. Current clinical research have led to the improvement of medical
procedures.

12
Ibid
86
10. Clinical research has provided room for the development of
academic careers people who are undergoing research activities as
part of their studies acquire different academic qualifications.
11. Clinical research is very helpful in the safety and effectiveness of
treatment, diagnosis, and prevention of a certain diseases of
interest.

There are number of areas to strengthen in research according

to the need and demands of our community and nation at large13. The
following are the areas of concentration:-
1.Increased interactions between basic science research and clinical
care research.
2.Increased participation in interdisciplinary research meetings,
centers, and institutes.
3.Create research focus groups that will interact with other
departments and schools.
4.Foster interactions and networking opportunities for faculty to
meet potential collaborators with other colleges and universities
both inside and outside of the country. This will increase
collaborative research opportunities.
5.Encourage all faculty to be part of a research team within the
department at specific hospitals to promote collaboration among
teaching staffs and laboratory medicine workers for teaching
hospitals.
6.Encouragement of accreditations of laboratories. Accreditation
allows people to make an informed decision when selecting a
laboratory.
7.Medical research is normally funded by external parties such as
government and various donors. In order for laboratory research
development to be accepted and funded by such sponsors, it is a
requirement that these laboratories be accredited to known

13
UCDAVIS. Department of Pathology and Laboratory Medicine. 2014;030
87
 international standards demonstrating confidence of reliability and
quality to these funders14.

Laboratory medicine plays a major role in the facilitation of

research activities. Clinical laboratory scientists are mostly involved
in designing and conducting research for accurate provision of
results relating to the specific purpose and need. For the purpose of
building capacity in clinical research there is high need for
developing laboratories at standards suitable for doing research.
Participation on provision of good and quality clinical
research is very important for laboratory personnel, as combating
diseases is the work of everyone in the medical field. It has been
long time since Germany started research activities in Tanzania.
Now we are finally realizing the role of laboratory personnel
participating in this science that is so important to life.
Previously, medical doctors were the most qualified people to
undergo research activities, but now graduates of laboratory
medicine and other health cadres are joining and doing very well in
research activities. The number of laboratory personnel who have
specialized in clinical research as their major specialty is growing
and PhD graduates are increasing in number. This is encouraging for
the future of laboratory medicine, leading to improved treatment, and
the management and control of diseases.
From the overview of clinical/health research history in
Tanzania, clinical research or health research started during colonial
government which was in quarter of 19th Century. The major focus
in clinical/health research, was on communicable diseases. Dr.
Robert Koch and Dr. Gustav Giemsa were among the first scientists
who will respectively be remembered for their contributions to the
diagnosis of tuberculosis and malaria.
After the First World War which was in 1914-1918,
Tanganyika became a British Protectorate under the United Nations
and the British continued with health research on specific disease

14
Cohen S, Africa. The Need for a Quality Standard for Assurance in Medical
Research Laboratories. 2014;3(1):19
88
problems to satisfy their need. It was during this postwar period that
institutionalized health research was initiated15.
Under the leadership of Dr. Frank Apted the British Colonial
Government started a Sleeping Sickness Service Unit in Tabora in
1922. The Unit was responsible for medical surveillance and
treatment of sleeping sickness cases (Human African
trypanosomiasis). In 1963 the Sleeping Sickness Unit was taken over
by the Ministry of Health of the Independent Tanganyika. The Unit
which is now Tabora Research Centre is therefore the oldest Medical
Research Unit in Tanzania.
In the Lake Victoria Zone, the British Colonial government
launched research on lymphatic filariasis with the establishment of
the East African Medical Survey at Malya in 1947. The following
year, (1948) a Filariasis Research Unit was opened in Mwanza. In
1954 the East African Medical Survey closed its offices in Malya
and moved to Mwanza. In the same year the two units merged and
acquired a new name, the East African Institute for Medical
Research, under the East African High Commission16.
Under the British Colonial and Welfare Scheme in 1949 an
East African Malaria Unit (EAMU) was established at Ubwari,
Muheza in northern Tanzania by Captain Dr. Bagster Wilson. In
1951, the Unit was moved to Amani in the East Usambara
Mountains and was renamed East African Malaria Institute (EAMI)
and became operational under the East African High Commission. In
1954, the EAMI was renamed the East African Institute of Malaria
and Vector Borne Diseases (EAIMVBD).
After independence in 1961, and prior to the establishment of
National Institute for Medical Research (NIMR), public health
research institutions in Tanzania were under the guidance of the East
African Medical Research Council (EAMRC), established in 1957.
Among the major objectives of the EAMRC included the recruitment

15
Shayo L. The Fourth Tanzania National Health Research Priorities, 2013-2018

16
Ibid
89
of and training of indigenous research personnel from the member
states of Uganda, Kenya and Tanzania.
The EAMRC was also mandated to coordinate, set health
research priorities, and submit research programmes, annual reports
and financial statements. In 1968, the East African Medical Research
Council established a Tuberculosis Investigation Unit (later National
Tuberculosis Reference Laboratory) in Dar-es-Salaam. In the mid-
1970s, the Medical Research Council of UK established
Helminthiasis Research Unit at Bombo Hospital in Tanga17.
Following the collapse of the East African Community
(EAC) in 1977, all the institutions established under the EAC were
rendered non-functional. These included all health research
institutions in the country, which were previously being administered
by the East African Medical Research Council.
The government of the United Republic of Tanzania,
therefore, decided to re-organize the health research centers into the
National Institute for Medical Research. NIMR was empowered to
take over all health research institutions in the country, which until
the demise of the East African Community in 1977, were
administered by the East African Medical Research Council18. From
the History of Health Research in Tanzania, there are reasons to
appreciate the work done by German and British colonial
government in Tanzania.

Roles Played by German and British Government in Clinical

Laboratory Medicine before Independence.
1. Clinical research on diseases such as malaria, filariasis,
helminthes resulted into decrease in mortality rate started during
colonial government.
2. The establishment of research centers opened the door for
indigenous education and understanding of diseases around,
which were a burden to social and economic life.

17
Shayo L. The Fourth Tanzania National Health Research Priorities, 2013-2018.
18
Ibid

90
3. The establishment of research centers has opened the room for
international collaboration, as scientists from Tanzania are now
working in collaboration of others from abroad.
4. Research which is conducted abroad, specifically that of
developed countries, do not have critical similarities which will
enable the tackling of problems we have in Tanzania, due to the
difference of people, exposure to diseases, etc. It is now a critical
moment to increase the strategies toward more research centers
within our country.
5. Apart from colonial activities, the Tanzania government has done
a good job of keeping NIMR ongoing as per plans which are
intended by national health plans.

Hindrance of 2025+ National Health Vision

As we are looking forward to vision of 2025+ we should be
aware of the burden facing Tanzania and the world at large, and the
position of laboratory medicine to overcome it. The world is at risk
as it is facing an inflow of new threats and ancient foes (enemy). The
very air we breathe, water we drink, and foods we eat are under new
assaults.
Deadly diseases, once conquered, are becoming resistant to
even our most advanced medicines. This might be due to
misdiagnosis of diseases by health practitioners, taking drugs
without any clinical directives sometimes for the matter of antibiotic,
less laboratory participation on finding appropriate drugs for disease
by doing culture and sensitivity.
Rising rates of heart disease, cancer, and diabetes reflect the
impact of tobacco, alcohol, and poor diets. These can be combated
by early diagnosis and education to the community, something
which is still not done properly, especially in the third world
countries.
Today deadly contagious diseases, including those routinely
preventable through vaccination that erupt in one part of the world,
can be transported across the globe with the speed of a jet aircraft.
The Ebola virus and other plagues, once unknown to science, have

91
reached our shores, as we have seen outbreaks in most African
countries.
Biological and chemical weapons, with their potential for
massive death and destruction, pose daunting global challenges. In
almost every nation, public health workers can point to a recent
event that confirms this fact. This can be defended against if
teamwork will be implemented and laboratory medicine will work to
the standard that is required. We can now see west Nile Virus,
encephalitis, and other outbreaks are examples of how new diseases
and their vectors have found their way onto our shores, joining old
threats that have re-emerged in more virulent and drug-resistant
forms, such as drug-resistant strains of TB.
Food-borne diseases, such as those caused by Salmonella and
E. coli 0157:H7, are estimated to cause millions of illnesses, millions
of hospitalizations, and millions of deaths each year in the world,
with Tanzania being a particularly threatened country.
Due to environmental pollution, particularly water pollution,
the population was affected by a deadly strain of E. coli that had
contaminated the citys water supply and has led to an outbreak,
which has resulted in hospitalization, death and economic
drawbacks. Today, twenty percent of TB cases around the world are
resistant to the drugs used to treat the disease.
In the 1940s and thereafter, when penicillin was rightly
touted as a medical miracle, moderate doses of penicillin and other
drugs in its class cured all staphylococcus infections. By 1998, 9 out
of 10 staphylococcus infections 90 percent were resistant to
penicillin and its related compound. This is due to different sources
of information including CDC.
Forty percent of pneumococci are no longer susceptible to
penicillin. We have one antibiotic, vancomycin, left in our dwindling
arsenal of effective antibiotics against resistant staphylococcus
organisms, but it is expensive and already losing ground to rapidly
mutating strains.
The utilization of laboratories is the best way to eradicate the
overgrowing problem of drug resistance. Chronic diseases also pose
an increasing threat. Millions of people, Tanzanians included, live
92
each day with chronic disease. Heart disease, cancer, diabetes and
other chronic conditions are now responsible for high rates of deaths
occurring each year and for one-third of the years of potential life
lost.
These killers disproportionately affect women and
racial/ethnic minorities who cannot access early laboratory diagnosis
and treatment. They also present special challenges to an
overburdened public health system.
Heart disease is the leading cause of death in women 35 years
and older, claiming the lives of more than the time they die. When
trying to track silent killer diseases like cancer, the mortality rates
from cervical and prostate cancer are more than the previous day.
The reasons might be the lifestyle, environment, etc. and the notable
thing in Tanzania is late diagnosis, which is often a cause of poor
prognosis, and all of these are due to the lack of enough centers for
diagnosis. One of the speeches from Jakaya Mrisho Kikwete, the
president of Tanzania, at the end 2014 was to encourage people to
be having regular medical checkups, but our medical infrastructure
are still not well equipped.
Chronic diseases and high-risk behaviors also rob our
children of healthy futures. Automobile injuries, homicides, and
suicides account for a high percent of deaths among youth. The main
question over here is, what is your role as a health professional
(particularly Laboratory technician, technologist and scientist)?
Millions of school children today especially from most of the ward
secondary schools will die prematurely from tobacco use due to lack
of education on the effect of tobacco use. A high percent of teens are
overweight and at increased risk of high blood pressure, stroke, and
diabetes in their early life. Millions of teenage girls are becoming
pregnant every year and this has resulted in many drawback to the
economy and the governmental prosperity.
Continued progress against microbes and other causes of
disease is not guaranteed19. These trends are early, persistent alarms,

Price CP. Current and Future Challenges Technology Innovation in Laboratory

19

Medicine. 2006;20057

93
warning us that continued progress against microbes, chronic
diseases, and injuries is not guaranteed. Fueled by greater mobility
of people and goods around the world, infectious disease outbreaks
could become more common and, in many cases, more severe.
Most importantly, we cannot individually control our
exposure to many of these threats. Mentioned problems are
hazardous regardless of whether we are insured, rich or poor, or
under a doctors care. Progress against chronic diseases is not
guaranteed either.
Today the world faces an alarming epidemic of increasing
obesity especially among our young people and of physical
inactivity due to computerized lifestyles. These two trends (obesity
and physical inactivity) already contribute to cancer, heart disease,
and diabetes deaths each year. Unless our health system works
sufficiently, our future is in jeopardy.
For preventable outcomes; public healths infrastructure has
significant roles to play by documenting problems, monitoring
progress, advocating improved clinical screening and counseling,
and educating the public about healthy behaviors. Morbidity and
mortality from each of the above conditions could be substantially
reduced by a more effective public health system.
To be more effective in improving the nations health, we
need to build a better infrastructure, laboratory medicine being
primary. Our public health laboratories are old and unsafe and they
need to be re-structured to meet the challenges we face in the
healthcare system. Our state and local health departments do not
have the capacity to institute proven intervention strategies to
prevent behaviors and conditions that account for many deaths
including those caused by tobacco use, poor nutritional intake, lack
of health checkups of laboratory to know any changes, and lack of
exercise. Our public health physicians, laboratory scientist and
nurses are untrained in new threats like Ebola20, West Nile virus and
weapon zed microorganisms. It is vital that we take steps now to
20
Price CP. Current and Future Challenges Technology Innovation in Laboratory
Medicine is Outstripping The Ability of. 2006;20057

94
strengthen this infrastructure to embrace not just the essential
elements of disease prevention and surveillance but also new
strategies and tactics capable of addressing global challenges.
In short, we must ensure that every health agency has
capacity and is fully prepared. Also, every community is to be served
by an efficacious public health system. Everybody, play your part to
make the world the safe place.

Hindrance of clinical laboratory medicine to meet 2025+

national vision:-
1. Unawareness of clinicians of the possible consequences of
patients clinical features on the outcome of the tests leading
always lead to insufficient information provision to the laboratory
services this may lead to delay of laboratory staff to provide
result because they will request additional information.
2. Insufficient filling of request forms can cause confusion in the
laboratory, leading to unacceptable delays in sample taking and
testing.
3. Unawareness of laboratory staff on the effect of the presentation
of the test results; clinicians face problems as a result of non-
interpretable presentation formats.
4. Clinicians regularly cannot distinguish between an outcome that
could be corrected and an outcome that does not fit the patients
clinical picture; and may not identify mistakes made by the
laboratory personnel.
5. Despite test results, clinicians proceed with unnecessary or
incorrect treatment. This can also be caused by inadequate
knowledge of the national or global policies by clinicians and
laboratory services.
6. Clinicians are not using standard criteria for ordering tests, but
base their request behavior on their own rationality and 20% to
60% of the ordered tests are clinically unnecessary21.
7. Unawareness on the part of clinicians and laboratory staff on the
tests available.

21
Series EM. Good Clinical Diagnostic Practice. 2005
95
8. Attitude related to procedures performed by clinical and
laboratory staff; clinicians request tests or collect specimens that
need quick analysis without informing the laboratory staff in
advance leading to unreliable test results.
9. The results of tests are not always used for clinical decision
making. This may undermine the motivation of laboratory staff to
perform tests accurately, again when noticed by clinicians, it leads
to reduced confidence in test results.
10. Lack of motivation of laboratory staff in peripheral-level
laboratories feeling neglected and professionally isolated.
11. The laboratory worker analyzes specimens in a scientific manner
to create an outcome, the clinician also uses experience and
common sense to come to a diagnosis. Insight and understanding
in both groups about the different viewpoints may already
improve the interaction.
12. Hierarchy is strongly embedded in the health sector in
lower/middle income countries. The academically-educated
clinicians usually work at the management level in health
institutions, while laboratory staff is answerable to them.
13. Lack of confidence of clinicians in laboratory results, leads to
inappropriate use of test results. The lack of trust may constrain
the laboratory services as inefficient use of tests and their results
can lead to higher costs in an already resource-poor settings.

96
 CHAPTER SIX
LABORATORY PERSONNEL, SKILLS, PROCESS
AND PRACTICES

There is a great fitting together in working between

Laboratory technician, technologist and scientist with the
physicians, nurses, and patients as clients. Both physicians, nurses
and patients have uniqueness in the demands; Physicians and
nurses require more detailed information compared to patients.
Each client differ in problems, values, attitudes, and mostly in the
issue of expectations.
However, clients also differ in experience; and this is the
reason that laboratory personnel require skills that will be
supportive in the various laboratory undertakings. As laboratory
personnel, you must have ongoing learning on different
approaches to attend your clients. Currently, not all, technicians,
technologists and scientists lack skills on how they can work
efficiently with their customers. Apart from the general
knowledge gained in the class as practical and theory based
knowledge, laboratory personnel must also possess other
practical based knowledge and skills so as to enhance
effectiveness in laboratory undertakings.
In the process of working as laboratory personnel, there
are a number of skills that the laboratory personnel will require in
order to be effective. Then practicing of these skills is very crucial
for it fosters them to mastery.

Attending
Attending is the process whereby a person concentrates
with their clients both physically and psychologically with use of
professional acquired skills which remove any doubt. As a
laboratory technician, technologist and scientist, engaging in
effective attending does two things; it tells the client that you are
97
with him/her and sets you in a position of being very attentive and
it is hereby as scientists you can think big and hence a solution to
problems. Laboratory personnel must provide undivided attention
to take heed of what a client has, for the sake of improving the
services provided.

Listening.
Everyone needs to be listened carefully, it is from this, and
a client can expose confidently his /her problem. The aim of
listening skill is to ensure that laboratory personnel do not miss
any verbal clues from the client. Listening has been classified as
active, passive and interpretive. Active listening involves paying
full attentions to the clients. We ought not to be involved in any
other mental activities. This should be practiced mostly at the
level of receptions and laboratory interpretation of the results. In
developed countries this skill has been very useful for laboratory
consultants.
Laboratory personnel at this situation must listen and try to
repeat the words spoken by clients, this shows the speaker that
you were tentative in listening. Passive listening is kind of
listening without making any contribution, reacting to what is
being said or summarizing what speaker is saying. The listener
simply sits back and listens to the speaker.
Another kind of listening technique is called tough minded
listening, which is an act of listening while detecting the gaps and
conflict of clients opinions. As laboratory personal you ought to
aply any of listening techniques to attend your clients.

Reflecting.
Laboratory personnel require skills which clients will
notice they are with him/her. This shows that laboratory personnel
understand the need of clients being physicians, other health
practitioner and patients in general. Reflection provides room for
the department growth because as we take heed to what clients are
requesting is room for qualifying services. Another consideration
98
in reflecting is the degree to which clients acknowledge their
feelings.

Questioning
In laboratory, open-ended questions are most preferred.
These are questions that leave room for the clients to respond
freely. The clients are not restricted to a certain number of
answers or to a certain way of answering. Obviously, there are
other situations that will require the use of close ended questions.
When laboratory personnel will not be in position of tackling
questions from client's weakness will be identified and escaping
from questions shows how much you do not know your field. On
other hand, when clients fail to respond positively to questions
he/she asked by laboratory personnel, it is the responsibility of the
laboratory personnel to direct client on what to do. Open-ended
questions encourage clients to talk about themselves. They are
usually based on something the client has said and used to explore
the situations in depth. And this will provide room for solving
future problems. For we have clients who are still learning such as
Medical laboratory students, medical student (MD) it is better we
learn how we can tackle their questions and how we can ask
questions on whatever wrong they have done, remember being an
expert is not a one day activity.

Probing
Probing is the state of searching quality information to the
theoretical belief that is existing about laboratory. For the guides
of action plans, knowing what is going wrong, seeking for further
information or provokes further discussion along a certain line.
Probing should be done with high skill, probing can take the form
of questions, statements or injections.

Concreteness (specificity).
This refers to being straightforward and practical, without
resulting to theoretical abstractions in responding to the clients.
99
This involves process whereby a laboratory person guides the
client to give specific information and offering the client specific,
clear, and straight forward answers. Remember laboratory save
people of different aspects and they really do not know how it
works and what is there. There is need of straight forward answers
counteracted with practical aspects. As experts, show people
practically what you know and do not assume as political figure.

Focusing.
This skill enables laboratory personnel to concentrate
her/his attention to the clients needs.

Giving feedback.
This skill helps and maintain open and honest relationship
between the clients and the laboratory personnel. You are working
under the conditions in which feedback for whatever is happening
to patients results has to be given. Giving feedback provides no
room for a personal blaming. It is a matter of feedback which
causes miscommunication in among health care practitioner.

Immediacy.
Laboratory personnel should be having the skill of acting
immediately. This skill enables the laboratory personnel and the
client to deal with issues as they arise. This is very important
because postponement may lead to forgetting or the client may
lose curiosity in talking about the issue at a later date. It involves
using immediate examples arising from the here and now
interaction between the client and the laboratory personnel.
When immediacy is used effectively, can accomplish two
things, first, it can provide new perspectives. Secondly, what the
clients learn about themselves in their interactions with laboratory
personal can provide new perspectives on how they interact with
other people when speaking about laboratory.

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Advanced level empathy.
Empathy is very important for laboratory personnel because
it provides room for you to understanding and enters into
another's feelings with special example a doctor is coming from
ICU or Theatre in need of blood to save patient life. Then it is
very meaningful to understand his/her feeling and save
accordingly. To use more technical language, Collins says we are
empathizing with the driver. This skill enables the laboratory
personnel to perceive the events and experiences of a clients life
they are part of his own life (Roger, 1992). Advanced level
empathy focuses not only on problems but also resources we have
in laboratory. Empathy builds a good working relationship
between the laboratory personnel and the clients physicians and
patients. There are many ways of showing empathy; one, is by
providing clients with alternative way for something you can do,
and two, by giving someone room to express whatever she/he has
concerning laboratory.

Interpretation.
This skill involves explaining to the client what do results
mean, why samples have been rejected, why samples are not
collected at a particular time, or any other events mean. This is a
highly technical skill which requires clear and distinct knowledge
to the major sections of clinical laboratory. This has great
potential for enabling the client to understand whatever is done in
laboratory. Interpretations can be harmful if introduced before the
client is ready to understand what ever is happening in laboratory.

Problem-solving.
When a client comes to laboratory personnel with a
problem, his/her expectation is that the laboratory personnel will
solve it. It is, therefore, wise to listen adequately and take the role
of a facilitator to help the client solve the problem. Laboratory
personnel does not and cannot have direct and immediate answers
to the clients problem. He/she must, therefore, use the problem
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solving skill in order to solve the problem or lead the client into
solving the problem. Key steps in problem-solving are: listening
to and understanding the problem; coming up with alternatives;
analyzing the consequences of each alternative; and finally
choosing the best alternative and implementing it.

Decision-making.
The skill of decision making relies much on choosing best
alternative from among alternatives or options. It is Important that
a laboratory personnel possesses the skill of decision-making.
Having the decision-making skills also enables laboratory
personnel to train his/her clients to make decisions about their
patients in a better way. The key decisions-making steps are
almost similar to those of problem-solving. These steps include:
clear understanding of the situation/issue; gathering information
about the issue/situation; coming up with options; assessing the
options; and picking the best option.
In dealing with a client, a personnel needs to clearly
understand the clients need from the laboratory perspective. A
laboratory personnel must then gather as much information about
the issue/situation from other seniors within laboratory or by
reading. The laboratory personnel then comes up with options,
assesses them and then finally makes a decision.

Goal-setting.
Laboratory personnel should be having skills on how to
put in place clear and specific statements of what they want to do
or achieve within a laboratory. If no personal goals which have
been set, it is good for a personnel to adhere to group goals as per
every place of working has its goals. There are many benefits as
to why a laboratory personnel should set goals, the key being that
it focuses laboratory personnel to accomplish them at right time.
Laboratory personnel with goals are less likely to engage in
aimless work and behavior. Advantages of goal setting are:-

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 a) Goal-setting motivates the laboratory personnel to search for
strategies to accomplish the goals.
b) Meaningful goals will push laboratory personnel towards
action.

Goal-setting means that the laboratory personnel or the

client must know what they expect at the end of laboratory
services and activities.
Goals should be clear and specific. They should also be
measurable or have verifiable outcomes, be realistic, be within
ones ability to achieve, be substantive and also consistent with
his/her physicians, nurses, patients, students etc.

Review and evaluation.

It is incredible if a laboratory personnel will have skills for
evaluating every days activities, customer satisfaction, follow up
how well the client is doing and to determine whether a plan of
action was successful or not. Review is done on an ongoing basis
to ensure that the plan is on course.
Evaluation on the other hand, is done at the end of the
implementation of a plan to determine whether the intended
objectives/goals were achieved.
The laboratory personnel must also terminate by
encouraging the client to consult in case of major difficulties and
to wish him/her all the best.

THE LABORATORY PERSONNEL

Being among the laboratory personnel is being involved in
a dynamic process, meaning that it changes often depending on
the issues at hand, the environment, client and laboratory
personnel. New discoveries are happening every day and working
principles are changing accordingly to meet the health needs and
awareness to the community.

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 QUALITIES OF A GOOD LABORATORY PERSONNEL
The personality and character of the laboratory personnel
is one of the most important factors in service provisions.
Qualities and experiences of laboratory personnel have influence
toward clients care. This human dimension is one of the most
powerful determinants for the services provided. The laboratory
personnel, in order to promote the clients growth and change,
must continually struggle to live up to their own full potential.
This is the most powerful influence on the client.
The following are some qualities that a good laboratory personnel
should have:-

Self awareness
Laboratory personnel must be fully aware of themselves.
They need to be in touch with their own strengths and
weaknesses, capabilities and limitations, among other aspects of
self. In the areas of weaknesses they need seniors to help them
grow and have strength. Knowing limitations is also very
important because solving strategies can be allocated. This is very
important because it will help them separate themselves and their
issues from those of the client. At the same time, the laboratory
personnel will avoid attempting or engaging in an activity that
he/she is not very sure of or good at and instead seek assistance
from another professional Laboratory personnel should also
acquire skills in self-knowledge, because it permits one to feel and
communicate compassion.

Competency
A laboratory scientist must possess and manifest physical,
intellectual, emotional, social and moral qualities necessary to
help the client. Competence will generate confidence in self and,
more importantly, in the client. To become competent, laboratory
personnel must continually increase their knowledge and seek
diverse work experiences. They must develop new skills, try new
ideas and approaches, and able to evaluate their own
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effectiveness. For a laboratory personnel intending for provision
of good services, he/she really needs understanding of his/her
course, apart from that he/she needs knowledge and understanding
of other field working with. For example a laboratory personnel
should be aware of what doctors, nurses, pharmacy, and
physiotherapist do, this is very helpful in understanding needs for
your clients.

Psychological Stability
Psychological health for laboratory personnel is very
important to client; it is important that the laboratory personnel be
in good psychological health. A laboratory personnel with
psychological problems or instability can actually cause more
damage to physicians, nurses, and patients (clients). Laboratory
personnel with psychological problem cannot pay attention to the
clients needs and this is accompanied with high rate of
dissatisfaction. Laboratory personnel must, therefore;

1. Have their needs affirmed and met.

2. Beware of their Personnel biases and weak spots that can
affect their results.
3. Living and showing satisfaction with things as they have and
are doing in life of people.

Trustworthy
This means that the Laboratory personnel should be
persons who do not take advantage of other people, especially in
their moments of weakness. It should be remembered that we are
different and weaknesses do exist we need trust to bring more
people closer and make them learn from us. The laboratory staff
and clients often share a lot of professional and personal
information with hope of getting assistance. He/she places his/her
trust in the laboratory personnel. Untrustworthy laboratory
personnel may take advantage of his/her position to influence the
client or his/her personnel gain rather than for the gain of the
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client. Taking advantage of the client in this way may make the
clients position worse. Laboratory personnel at all times, must
observe confidentiality. This helps clients reveal more and helps
them develop a deeper sense of trust in themselves. It is important
for laboratory personnel verbally and non-verbally assure the
person that absolute confidentiality will be maintained.

Honesty
Laboratory personnel needs to be genuine. They should
give unvarnished feedback to the client. Whether the feedback
is positive or negative, they must remain honest laboratory
personnel. In return, the client will be honest. If the client finds
that laboratory personnel are honest, then he/she will also become
honest .This brings about harmonious environment for both sides.
It is honesty which opens doors of to both sides. It is honesty
which opens doors for success in any work. If a client by any way
finds that you are not honest, that become a big defeat for success.

Strength
Having strength or power in laboratory medicine relies
much on how much you know and how you use potentials you
have to meet clients needs. A laboratory personnel will need to
be strong to withstand the burdens facing people outside
laboratory. A laboratory personnel should also have the courage
to say and to perform what their deepest self says be helpful and
to stand by their observations. At the same time, laboratory
scientists will need to be strong and stand by his/her client when
necessary.

Warmth
This means that the laboratory personnel should be
inviting to the client. He/she should be a person who makes other
people around him/her comfortable. Warmth melts defenses and
invites sharing on experiences and burden in process of saving

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patients. When people receive warmth, it allows them to be warm
to themselves and others.

Active Responsiveness
Active responsiveness communicates personnel caring to
their clients.

Committed for Life-Long Learning

There is no way a laboratory technician, technologist or
scientist will become well oriented to the work and opportunity
he/she has if there will no commitment to life-long studying.

Professional Advocacy
As Laboratory personnel should be in position of speaking
something about laboratory medicine as a profession and the work
done within this professional.
From this aspect a laboratory personnel should be having
the following:-1

1) Ability to communicate effectively with officials from the

various governmental and regulatory agencies.
2) Ability to proactively work with Hospital
Administration/Health Research to promote the laboratory
professions. By doing the following:-
a. Leadership in publicity regarding clinical laboratory
medicine.
b. Salary surveys and appropriate interpretations for the
betterment of the profession.
c. Government Affairs and regulatory Compliance.
d. Collaboration with internal and external stakeholders to
make up laboratory medicine growth.

1
Clinical Laboratory Scientist/Medical Technologist of the future task List.

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e. Conduct relevant evidence-based research to advance the
practice field and/or patient outcomes.
f. Serve in non-technical hospitals, clinic committees such as
new employee orientation, customer satisfaction teams,
g. Proactively participate in institution-wide policy making
committees and task forces, product review, safety, space
utilization, compliance, etc.
h. Save as safety committees members in any level of his
working environment

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 CHAPTER SEVEN
CHALLENGES FACING CLINICAL LABORATORY
MEDICINE PROFESSIONALS AND
POSSIBLE SOLUTIONS

Medical laboratory, technicians, technologist and scientists

are highly skilled professionals who use state-of-the-art instruments
and biochemical, microscopic, molecular and immunological
techniques to analyze samples such as blood, urine, sputum, tissues
and other medical specimens.
Laboratory technicians, technologist and scientists use
knowledge and skills acquired in science, biotechnology and
laboratory medicine in general to provide essential information to
physicians and other health care professionals about the presence,
extent, or absence of disease, as well as effectiveness of treatment.
Working in a clinical laboratory requires very good technical skills
which should be attached with problem solving skills, data analysis
skills, computer skills and good oral and written communication
skills.
Medical laboratory technicians typically perform routine and
moderately complex tests whereas medical laboratory scientist and
technologist conduct more technically advanced and complex tests,
supervise other laboratory personnel or oversee laboratory
operation1.
Clinical laboratory sciences practitioners as mentioned above
are employed in hospitals, private reference laboratories and clinics,
blood centers, pharmaceutical companies, medical research,
biotechnology facilities etc.
Unlike many other health professions, clinical laboratory
sciences practitioners have little to no contact with patients, yet they
play a critical role in the delivery of health care services. Without
tests and procedures performed by Medical laboratory scientist,

1
L. Dyson S. The Clinical Laboratory Sciences Workforce. 2004.

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technologist and technician health care providers would have very
hard time making diagnoses, establishing treatment regimens or
monitor patient health status. The need for clinical laboratory
sciences practitioners is increasing day-to-day as we move to
medicine -based evidence and increase of more knowledge among
people on the importance of laboratory diagnosis and other medical
services is coming up.
The number of medical scientists and technologists is
expected to increase over this time period. This can be well
elaborated with high rise of science and technology which project to
new job opportunity and increase in centers for medical laboratory
education provision, being college and universities. Like other health
professions, there is growing demand for the clinical laboratory
workforce due to a number of other factors.

Other Factors Which Will Raise Demand of Laboratory

Technicians, Technologists and Scientists Include:-
1) Population growth and aging. Population growth increases the
demand for health facilities, clinical laboratory being among the
health facility has great opportunity to grow to meet the need of
her population. Aging also increases the need of clinical
laboratory for both early prevention, diagnosis, treatment and
management of elderly diseases such as diabetes and
hypertension diseases.
2) Changes in the health delivery and regulation of health care
system. There are major changes in delivery of clinical services.
It is now demanding more number of people coming and
working to meet standard and issue of quality which are
priorities. Quality requires more skilled people for its
maintenance and practice. The new health regulation which
requires clear provision of services and human resources is key
for good health provision.
3) Development of new tests for diagnosis, screening of diseases and
other health related conditions. Clinical laboratory is the key
place where innovation is taking place and development of new
techniques and methods are coming up every now and then. For
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 those techniques to work and become more advanced day to day
to meet the need of todays diagnostic setting, then all of these
require clear efforts on increasing human resource to work for
the efficiency of laboratory activities.
4) Increases in disease prevalence and patient acuity. In todays
world, patients are well educated and they really want to
understand everything pertaining the health care given to them
having this inner eye it gives reason on the need of skilled people
in laboratory to serve the community with high demand to meet
quality services. There is also increase in prevalence of diseases,
hypertensions and diabetes being among. This high prevalence of
diseases require skilled laboratory personnel in coordination to
other health professionals for clear intervention of cases.
5) Rise in outbreaks of diseases and other catastrophic events which
affect health care systems and personnel. When we see outbreaks
happen, the government finds the alternative way to deal with the
situation and according to current status, there is increase in
outbreaks specifically when there are catastrophic events which
actually demand a lot of laboratory scientists because through
laboratory investigations it will be easy to handle the situation
and its where we still see the high demand of personnel.
6) One of the policy to every country in the world is to meet the
minimum required number of health professionals to facilitate
eradication and control of diseases. To implement such a policy
laboratory technicians, technologist and scientist are among
health professionals who are of great help.
7) There is an increase on the number of hospitals and other health
care institutions. For them to work as per country policy there is
no way they can exist without presence of clinical laboratory. For
that reason there will be more demand for laboratory scientists
and technicians to work in newly opened hospitals and other
health institutions.

How to Make the Laboratory a more distinguished arena.

Laboratory professionals can differentiate themselves not
only by technical skills they have but rather by being involved in the
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creation, distribution and application of knowledge related to the
laboratory aspects of patient care. Such extra service should be
recognized and implemented in the business strategy.
Functions performed by Medical Laboratory health workers
are diagnostic testing, public health testing, pharmacovigilance,
monitoring of drug resistance, disease surveillance, medico-legal and
forensic services, blood transfusion services, monitoring and control
of vector borne diseases, research, training, counseling sales and
marketing.
Medical Laboratory technicians and technologists or
scientists are involved in all the above mentioned activities and
currently more involvement is seen in aspects such as medico-legal
and forensic services which were exclusively carried out by
pathologists. As a person working in laboratory you have an
opportunity of conducting every good step which involves patient
care.
Medical Laboratory Scientists have career opportunities2 in
hospital clinical laboratory, veterinary, regional and national testing
laboratories; biotechnology labs for example KCMC biotechnology
laboratory, pharmaceutical, chemical industries, local, National
health agencies like Tanzania Food and Drugs Authority (TFDA)
and Tanzania Bureau of Standards (TBS), research and teaching
institutions like Kilimanjaro Christian Medical University College,
advanced degrees in medicine, masters and doctoral degrees in
biomedical sciences.

CONTRIBUTION OF LABORATORY MEDICINE FOR

ECONOMIC GROWTH
Laboratory medicine has potential power toward economic
growth in all aspects of life. At individual, community and national
level. You can only appreciate this by considering the following;

2
UMDNJ. Program Overview.

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1. At individual level, a person with laboratory profession is in the
position of having a private laboratory which will open doors for
his/her economic growth.
2. Medical laboratory technician, technologist and scientists are
employed in governmental and non-governmental organizations
which in turn as employees, pay-tax for national development.
3. While the owner of the laboratory advances in economic aspect
he/she is in position of employing a number of workers who are
also benefiting from the same profession.
4. At community level, people around where a well-equipped
laboratory is centered, are provided with easy access of this
service and this gives room for people to concentrate on the other
economic activities rather than seeking service far away which is
costly in terms of money and time.
5. Laboratory provides early intervention of disease which is very
beneficial to the economy. There is also a low chance for long
hospital stays due to early intervention, this gives time to relatives
and family members to concentrate to other economic activities.
6. Through laboratory, a number of research activities are in place in
research centers, there are big interventions which are very
beneficial to economic growth personally and national wise.
Research provides answers to difficult questions which in turn
grows a national economy. For example, research has helped a lot
on understanding malaria which had cost the country a lot.
7. Laboratory diagnosis in hospital setting contributes a high percent
to total income gain for hospital. Mathematical patient diagnosis
is one of the places which incur a lot of costs which sometimes
hinder the possibility of patients treatments and care. Big
incomes from this department is the leading cause of errors
because people are so attracted to the advantages gained without
clear way forward of improvement and restructuring. In aspect of
private laboratory, tests are sometimes ordered for the sake of
making money, not clinically important.
8. Presence of laboratory requires reagents and machines, most of
which are imported; through that government authority collects

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 revenue from imported reagents and machines and raise our
economy.
9. Laboratory medicine provides critical diagnosis which helps to
provide the medicine for treating the diseases. Critical treatment
approved by laboratory, provides no room for having unnecessary
drugs which in turn prevent drug resistance and cost which is
positive feedback in terms of economy.
10. On early diagnosis through laboratory we can detect diseases
very early and this will have a number of advantages which are;
less costs will be incurred to intervene the disease. Reducing
mortality because the early the diagnosis the better the treatment
and management of disease which is again positive in term of
economy.

LABORATORY MEDICINE AS A PROFESSIONAL

AND CLINICAL ARENA
Laboratory diagnostics is the medical discipline devoted to
obtain, explore and employ knowledge about using various
techniques for analyzing the composition and properties of human
samples, interpretation of the results in relation to health and disease.
It is good to understand laboratory diagnostics or laboratory
medicine as both a clinical discipline and the separate medical
science.
These two fields of laboratory diagnostics are tightly bound
as in the case of other clinical sciences. It is a clinical picture from
the patient which gives somebody clues for testing or requesting tests
in the laboratory yet it is laboratory results which give physicians a
reason to believe or not, based on his/her observation.
Laboratory tests are used in various stages of the diagnostic
process in all fields of clinical medicine. Along with imaging
studies, electrophysiological and other procedures, laboratory
medicine remains the main source of information on the health status
of the patient. Advances in medical sciences and clinical practice
causes continuous increase in demand for laboratory testing related
to their panel, based to quantity and availability.

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 Big methodological and technological progress in laboratory
medicine over the past 2030 years has made laboratory medicine
different in a positive way3. Progress in science and technology has
brought ability of measuring concentrations of various substances in
body fluids and testing on the cellular and subcellular level,
including genetic material. Moreover, the analytical quality has
significantly improved.
There is also an increase in laboratory efficiency and
decrease in turnaround time. However, despite this progress, a
fundamental question still remains valid how to do it properly in
terms of performing laboratory tests and ensuring their accessibility,
meeting turnaround time, and their appropriate analytical quality? In
other words how should the laboratories perform their work
nicely?
Automation, consolidation, integration and centralization of
laboratory procedures and use of already manufactured reagents
have completely changed the nature of the work in diagnostic
laboratories from manual oriented to machine oriented. Currently,
laboratory staff must be familiar with often complex pre-analytical
phase of performed tests, analytical methodology, advanced
measurement techniques and equipment, various electronic devices
and information systems, which are used in daily practice.
The automation of measuring systems is developing very
dynamically and requires continuous updating of knowledge of
analytical methodology and features of particular analyzers
(maintenance and calibration, monitoring measurement system and
electronics, troubleshooting or error recognition, corrective action
and others). Thus, the contemporary laboratory scientist should be
also an expert in the field of advanced measurement techniques and
equipment.

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 The remaining professional knowledge and skills have also
become more complex. The pre-analytical phase properly
established for the continuously increasing number of performed
tests should be based on the knowledge of Laboratory Medicine as a
profession and clinical science. Now the issue is how to perform
both of them well.
Knowledge of clinical medicine is necessary for advisory
functions including explaining the causes of erroneous results, which
sometimes are obtained in laboratories. Moreover, the required
qualifications must include an appropriate body of knowledge of the
pathophysiology and diagnostics of diseases, allowing validation of
the results before reporting and advisory functions offered by
laboratories.
There are two key factors determining the respective
competence of laboratory staff professional training and
appropriate human resources management. The required scope of the
knowledge and skills is very wide and such high level of
professional qualifications is not necessary for every diagnostician
employed in given laboratory.
According to the common organizational approach there are
at least two categories of laboratory staff Laboratory technicians
who are actually familiar with analytical methodology equipment are
the operators or analyzers and are responsible for the proper
performing of tests. In most cases technicians are not involved in the
validation of the results or the consultative and advisory functions of
the laboratory. The next group comprises laboratory diagnosticians,
who are familiar with the pre-analytical and analytical phases as well
as with the pathophysiological, and diagnostic context of performed
tests and obtained results. Their duties usually include supervising
the work of technicians, validating the obtained results releasing the
lab reports and contact with physicians ordering the tests. It is
important and useful for both laboratory diagnosticians and
physicians to have technical support.
The exchange of information is often helpful for validation of
the results and their interpretation particularly in the case of
erroneous results and it requires both laboratory skills and clinical
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skills. On the other hand, doctors benefit by getting assistance in
interpreting the results or in the appropriate choice of laboratory
tests. Currently efficient laboratory service has to include the
advisory and consultative functions.
Laboratory diagnosticians have to be partners for physicians
in the diagnostic process. To achieve this, they must have an
appropriate level of professional qualifications including sufficient
medical knowledge. This is of importance as long as members of
laboratory staff with such qualifications must be in line with current
scientific and technological bases of laboratory medicine.
Thus, laboratory diagnostics is the medical profession based
on advanced analytical technologies, diagnostic expertise and
medical knowledge. Properly organized pre and postgraduate
training in all fields of laboratory medicine should ensure the
acquisition of appropriate professional knowledge and skills.
Moreover, laboratory diagnosticians should also have the
ability to continuously update professional knowledge and skills in
order to raise qualifications through constant participation in training
courses and medical research, like the way it is done in some
research centers of Tanzania. They should have ability in the
management of the laboratory medicine, taking individual and
collective responsibility for the profession along with its economic
and social aspects.

To meet these tasks and standards, under-graduate and

postgraduate education for laboratory diagnosticians should
ensure that:-
1. The study program includes basic and clinical science as well as
laboratory professional training4.
2. The basic contents are medically oriented, practical and adjusted
to the needs of clinical training in respect to human needs.

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3. The educational facility is adequately equipped with laboratories,
which must meet the quality standards for scientific and medical
diagnostics laboratories.
4. The clinical diagnostics training should be carried out in hospital
facilities by laboratory scientists who are familiar with Laboratory
medicine.

WHY IS LABORATORY MEDICINE TERMED AS A

PROFFESIONAL AND CLINICAL ARENA?
Laboratory diagnostics or laboratory medicine is also a
clinical science of a specific nature resulting from its location
across" all other clinical disciplines. Laboratory tests are an
essential diagnostic tool, or the subject of numerous experimental,
clinical and epidemiological studies. Laboratory medicine by its
nature integrates the basic science, technical performance and
clinical context for patient decision making but as science, it
provides a general role of selection of tests for specific research
tasks.
Laboratory medicine creates also the roles of analysis and
interpretation of the results and for evaluation of the diagnostic
performance of laboratory tests. The scientific nature of laboratory
diagnostics is best reflected in the evidencebased laboratory
medicine (EBLM). According to the classical definition EBLM is
the conscientious, explicit, and judicious use of current best
evidence in making wellinformed medical decisions. Thus, all
clinical practice guidelines developed for the use of laboratory tests
should be based on EBLM roles5.
Laboratory medicine is the clinical science using advanced
research tools and providing data relevant for clinical practice,
published in highly valued scientific journals. It should be
emphasized that progress in laboratory medicine, as in other clinical

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disciplines, is made not only through clinical studies, but also in
daily practice.
Diagnostic laboratories are a source of information that if
properly selected and analyzed can have high scientific value. For
this reason, the institutions performing research in the field of
laboratory medicine, in addition to cooperation with clinical units
should be integrated with diagnostic laboratories. Separation of such
institutions lowers the quality of both research and routine laboratory
testing.

WORKFORCE IN CLINICAL LABORATORY SCIENCE

Laboratories are found in all tiers of the health system being
central, regional and district, sub-district, wards even in some of
village dispensaries. At each tier, a range of tests are performed
according to national policies. National diagnostics policy defines
clearly number and kind of test performed by a particular laboratory
according to its level.
The capacity of laboratory service department, inclusive its
work force should be able to respond adequately to the requests
made by clinicians and this is primary need for all people in health
care system.
Depending on national policies and availability of staff in
low income countries laboratory services at primary health care level
are delivered by the laboratory technicians or laboratory assistants or
in case of absence of these cadres, tests are performed by locally
trained staff or by a different category of staff (nurses, health
assistants) trained on the job for specific laboratory tasks. We are
now moving further to having qualified personnel to work in
laboratory though some duties to be done by laboratory personnel
are still done by other health care providers who are clinicians,
nurses and attendants. The result on unskilled and shortage of
qualified laboratory staff is well documented in The Laboratory
Services and Supply Chain Assessment which was done very well in
Malawi (2009).
To-date, no published research which has already been done
in Tanzania, measuring existing problem. Instead many research
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report has describes insufficient laboratory staff for higher tiers in
the health system as the district level (laboratory technicians) and
tertiary/ academic level (laboratory scientist) etc.
In large hospitals or in independent laboratories that operate
continuously, the personnel usually work the day, evening, or night
shift and may work even weekends and holidays. Laboratory
personnel in small facilities may work on rotating shifts, rather than
on a regular shift. Due to lack of qualified/trained staff, shifts may be
taken by one member of staff more frequently resulting in tiredness
and less effective in working. It is very hard to get guidelines in
place for laboratory management or functioning managements
systems which show how everyone should rotate while maintaining
the quality of results for efficient patient care.
The competency, working environment and motivation of the
laboratory health workers are important determinants for well
provision of the laboratory services. It should be remembered that
under-competency of laboratory worker may pose a lot of risk during
work.

CHALLENGES FACING CLINICAL LABORATORY

MEDICINE PROFESSION
1. Laboratory functioning is considerably obstructed by inadequate
leadership and policy.
2. Factors constraining the expansion of necessary diagnostic testing
include a severe shortage of qualified laboratory personnel and
this is why, presently more funds are needed to sponsor people
who are willing to take position of enrollment in this profession.
3. The HIV/AIDS epidemic and other upcoming diseases like Ebola.
These diseases have influenced the need of the laboratory
workforce as described in the rapid situational analysis for scaling
up for universal access to HIV prevention, treatment and care. In
most African countries especially sub-Saharan analysis mentions
the tremendous increase in demands towards the health
workforce, for example the introduction of CD4 testing, viral load
for HIV patients and apart from that, Ebola is threat.

120
4. Having built laboratory capacity and accurate reliable testing,
ineffective delivery of results and physicians attitudes regarding
the value of laboratory testing persist as significant barriers to
laboratory use and management of antimicrobial resources.
5. Since the release of the World Health Report in 2006, attention
has been paid to the Human Resources for Health crisis in low
and middle income countries. Yet, little attention has been
provided to support staff, particularly medical laboratory staff
despite their services for proper diagnosis and treatment, which is
essential part of the health care system.
But shortage of laboratory staff is the key problem in the
implementation of quality laboratory services. This shortage was
also identified in an exploratory study carried out by the Royal
Tropical Institute (KIT) and the Kilimanjaro Clinical Research
Institute (KCRI), in Moshi region, Tanzania, in November 2011.
During this study staff shortages and education levels were
frequently mentioned by directors of health facilities, clinicians
and laboratory workers. This is opaque for proper implementation
of laboratory work and it is ongoing problem and still cause to
improper care to patients
Shortage of staff being problem, the performance of most
available workforce is often found to be sub-optimal and it is
attributed to the level of competence due to various factors
including low education levels.
6. Poor contribution of laboratory services to patient care is caused
by poor interface between laboratory health workers and clinical
health workers because in them there is less informations to each
other on how they work with both patients and samples given to
laboratory6,7. Lack of clear communication has caused lack of
good interactions among laboratory and clinical staff for optimal
medical care.
7. Inter-professional laboratory medicine clinical medicine
linkages for optimal health service delivery remains limited and

6
Series EM. Good Clinical Diagnostic Practice. 2005
7
Orikiiriza J. Conference theme: Accurate Laboratory Diagnostics: A Pillar For
Quality Care. 2012
121
 under researched especially in Africa which is opposed to health
reform system that calls for an integrated workforce that engages
diverse skills of health care cadres.
8. Despite strong commitment from the international community
for fighting major infectious diseases, weak laboratory
infrastructure remains a huge rate-limiting step8.
9. Facilities to strengthen the interdepartmental communication and
cooperation for clinicians and clinical laboratory health workers.
10. Despite the importance of laboratory testing in confirming
clinical diagnoses, conducting accurate infectious disease
surveillance, conducting reputable lab based research and direct
public health care policy but currently most of African clinical
laboratory, health care and research infrastructures are
insufficient to meet these needs and perhaps have been ignored.
To-date, the vast majority of financial resources from funding
organizations have been focused on disease prevention and
provision of care, whereas relatively little funding has been
allocated to build laboratory and research capability.
11. To-date there is less understanding on the cause of errors in the
laboratory which occur mostly during pre-analytical stage where
almost non-medical laboratory staff are involved. Currently,
there is no junction to both cadres to solve such problem.
12. Severely limited access to reliable diagnostic testing and
undervalued and/or under-utilization, has caused frequent
misdiagnosis resulting in inadequate treatment, increased
mortality rate and inability to determine the true prevalence of
diseases.
13. Tanzania being example, laboratories are equipped with a lot of
automated machines it will be good if every university with a
program of medical laboratory ensures that undergraduates
receives engineering techniques to rescue the status. This will

8
Birx D, Souza M De, Nkengasong JN. Laboratory Challenges in The Scaling Up of
HIV, TB, and Malaria Programs: The Interaction of Health and Laboratory
Systems, Clinical Research , and Service Delivery. 2009;84951

122
 have very positive reputation to the services provided because
the costs of requesting somebody from abroad are enormous and
it automatically hinders the efforts to reduce costs on services we
provide from laboratory.
14. Most of us encounter inappropriate testing requests, duplication
of requests and inappropriate use of direct laboratory testing
facilities where a point of care testing would adequately suffice.
15. Inadequate funding structures for laboratories are universally
encountered by all people in laboratory and when we look back
to history, the sponsor for people who were taking medical
laboratory science was not given but currently we have seen the
Higher Education Loans Board (HELSB) doing something for
further growth of this course.
16. It is common to see laboratory medicine services in
hospitals/trusts competing for residual finance with other
peripheral sectors within hospital, even though specific service
plans has to be in place for the laboratory9.
17. Clinical laboratory appears to be perceived as being peripheral,
almost serving no useful purpose to general hospital activity and
it is here where you can find conflict among people within health
department. It is clear that clinical laboratory budget advocacy
skills need significant sharpening if laboratories are to compete
with clinical discipline in our hospitals/trusts. The development
of directorate models has gone some way to addressing this, but
has not cured the problem.
18. The concept of tenure track promotion has not been embraced by
our system here in Tanzania and the world as a whole. Although
we encourage young scientific graduates to pursue research and
achieve higher degrees, the non-reward system hinders or
prevent the progress of significant career advancement in
laboratory medicine for most of our bright, highly qualified

9
Laposata M. Improving Test Selection and Test Results Interpretation: The
Diagnostic Management Teams at Vanderbilt Presentation of The Clinical
Problem.

123
 scientists. We are all aware of the migratory tendencies to
industry, research center like NIMR, KCRI, by such scientists,
who represent a huge intellectual loss to laboratory medicine in
the public sector. Politicians commonly repeat the same word
that laboratory scientist are the greatest resource and it is so true,
particularly in laboratory medicine, but the people in laboratories
often feel like undervalued and poorly supported.
19. The perception of medical laboratory by the general public.
Public fail to understand what medical laboratory is, what
laboratory scientist do or indeed the relevance of medical
laboratory to modern medicine. Though it has a lot do with
everything happening in modern medicine.
20. In the university level, pathology-related subjects have been
under pressure to be maintained in core curricula10. Indeed, the
traditional pathology department has disappeared from some of
our medical schools and is on the edge of extinction in others.
This has major implications for the future in our inability to
attract good clinical laboratory graduates to enter laboratory
medicine disciplines. Without direct exposure to pathology
subjects, pathology laboratories, pathologists, laboratory
scientists, medical students will be unable to make informed
decisions in relation to future careers in laboratory medicine as
we now see every day we insist of changes in the curriculum of
laboratory medicine.
21. The issue on how clinical laboratory scientists view themselves
and how they are viewed by health administrators also
constitutes a major weakness today because they never use the
advantages of each other to make clients happy.

10
Leary JJO. Pathology 2026: The Future of Laboratory Medicine and Academic
Pathology 2006.

124
22. Generally, medical laboratory scientists are not good at
marketing their skills base and tend to interact badly with the
media.
23. Health planners see laboratory medicine as low priority and
constantly criticize it for not thinking strategically and in a
business-like fashion. This is a valid criticism and it needs to be
addressed as we move forward into a more business- and
strategically laboratory medicine.
24. Medical staffing shortages, particularly with enough skills to
perform tests. For instance, most referral hospitals do not have
enough laboratory scientists, so they mostly depend on the intern
laboratory scientists, people who are still learning.
25. Some hospitals have highlighted problems with recruitment and
maintenance of staff, which for laboratory discipline in particular
may have serious repercussions in the future. Also, many
government employees desire to move into private institutions
where they mostly think, can find more favor.
26. To-date there is lack of clear- policy, confidence, quality
reagents, and physical infrastructure in most of government
laboratory. Government laboratories are still working under low
standards.
27. Government had put less emphasis on training people from
postgraduates level onward, instead, most of NGOS are
working hard to educate people of that level. This leaves a gap in
the ratio between numbers of specialized doctors to specialized
laboratory scientists.
28. There is less emphasis on improving curriculum to suit the
changes which are happening in todays life. For example, to-
date molecular diagnosis is ironic diagnosis, but most of
graduates are not well oriented to this very important tool for the
future clinical medicine.

125
29. Laboratory medicine is still challenged with a lot of inaccurate
laboratory results, long turnaround time11, expensive laboratory
tests, unreliable results, thus lacking early life saving ability.
30. Most of people who are working in health sectors are money
oriented in way that programs and plans settled are not aiming at
improving laboratory services but rather personnel or group
benefit.
31. Country has put forward less efforts on the agenda of research
activities as key operator toward science development and its
discoveries. So far, laboratory medicine is the homeland for
research activities if will not be given all necessary needs
research will remain at the same state while other countries
prosper further on that aspect. The government has not yet given
out a defined organ to run laboratory medicine in Tanzania, in
comparison to other health cadres. Laboratory medicine has got
no executives to direct its activities, apart from director of
laboratory services at Ministry of Health Social Welfare.
32. There is problem for having well-trained health professionals
who fail to recognize the reasons for not being in position of
containing diseases especially infectious disease reason being
underutilization of laboratory medicine and other diagnostic
services. Disease like Ebola samples were taken to Kenya.
Policy makers, politicians, clinicians, and the public in general
frequently fail to understand laboratory services in treatment and
prevention of diseases.
33. Most laboratories operate with limited funding and technical
deficiencies as a result, accreditation is still an alarming problem
as longer money allocated for enhancing are mostly from donors
rather than government. Remember that accreditation is a
warranty of quality services12.

11
Jones BA, Bekeris LG, Nakhleh RE, Walsh MK, Valenstein PN. Physician
Satisfaction With Clinical Laboratory Services. A college of American
Pathologists Q-Probes Study of 138 Institutions. 2009;133.
12
Hotel P. Post - Market Surveillance of Diagnostics Scheme - Earqas Meeting
Report. 2010;
126
34. Some laboratory personnel are not confident to carry out their
duties and are less creative on the matter of utilization of skills
they earn at school. People do not believe if they deserve being
laboratory scientists. Others enjoy their titles without working
hard to meet the carrier requirements.
35. Challenge on Growing complexity of science and technology,
some of which has advanced more rapidly than our ability to
integrate it into safe, effective, and efficient health care, longer
life expectancy, which has significantly increased the chronic
disease burden and the resources being devoted to chronic
disease care. This is found more in developed countries are not
developing countries.
36. A highly decentralized health care system that is often
bureaucratic, wasteful, and difficult to navigate underinvestment
and disparities in access to health information technology,
constraining the ability of technology to improve the quality of
care13.

SUGGESTED SOLUTIONS TO THE CHALLENGES FACING

CLINICAL LABORATORY MEDICINE PROFESSION
1. Effective collaboration between the lab scientists and clinicians
can promote quality, safer, and more comprehensive health care
services. Advanced practice laboratory models benefit many
consumers, including other primary care providers, patients, and
administrators as provided in the Strengthening Laboratory
Management towards Accreditation training model.
2. Good laboratory personnel and clinical interactions should be
characterized by mutually effective interaction with the aim of
improving service delivery, enriching knowledge exchange,
fostering a teamwork approach. This will come up with
innovative strategies to improve and sustain evidence-based
practices in health care delivery.

13
TheLewin-group. Laboratory Medicine: A National Status Report Laboratory
Medicine. 2008

127
3. Since clinicians interface with patients, engaging them through
regular meetings may serve to improve quality and better
utilization of laboratory services. Regular meetings will serve as
opportunities to improve on lab results quality and build trust.
However, a larger study assessing the role and impact of clinician
on laboratory service improvement is recommended.
4. Strategic track programs need to be developed for young
scientists and medical graduates in laboratory medicine
disciplines in order to retain and develop expertise in clinical
laboratory disciplines.
5. Clinicians need to actively collaborate with laboratory staff to
improve relevant research capacity aimed at improving laboratory
services and advocate for increased human resource in laboratory
medicine.
6. To integrate laboratory curriculum in routine medical school for
both undergraduate and postgraduate curricula as means of early
clinician sensitizations toward importance of laboratory medicine,
something which has started in some of universities, such as
KCMUCo.
7. It is essential to embark solid operational research to identify the
root causes of poor laboratory science in our country.
8. Medical laboratory scientists really need to learn how to easily
interact with media, as they can easily be attached to the
community and make it understand what is done by laboratory
personnel14.
9. Government officials and health care in our country should agree
on the importance of creating strong and reliable medical
diagnosis. Laboratory medicine being the most important.
10. Significant investment should be made in system of laboratory
medicine and ensure financial accountability, universal access to
efficient and accurate laboratory tests.
11. Tanzanian government together with other African governments
should agree on the building and development of comprehensive

14
Ibid

128
 laboratory which will be capable of handling diseases found in
our region.
12. Government should invest in retaining and recruiting medical
laboratory personnel who are skilled to the profession. The
quality which will be provided by faculty members will rise up
the standard and quality of laboratory medicine. Currently, most
qualified individuals are employed in private sectors, with access
to very few people.
13. Independent functional unit and department which has to deal
with development of laboratory medicine should be created at the
ministry of health and social welfare level. Through this, most of
important matters rising in laboratory medicine will be solved at
the right time.
14. Government and stakeholders have to prepare integrated national
laboratory strategies with clear policy and plans which can be
implemented at a particular moment in time range.
15. Funding; it is high time for the government to think of investing
enough amount of money for running laboratory activities,
investing in research activities, which is the way forward for the
development of science and technology.
16. Strategies in business modelling need to be pursued by every
laboratory medicine directorate in order to achieve the necessary
recurrent income and capital investment stream to maintain
activity and achieve strategic growth. Often, strategic growth is
sacrificed on the altar of expediency, which we should not
tolerate.
17. Effective leadership; laboratory professionals have to graduate
with leadership skills, pertaining to who they are going to work
with. In other health courses, students are taught leadership skills
which they find easy to apply after graduating. It is high time
now for laboratory graduates to acquire leadership skills during
studies and at work.
18. There should be bridging up of the gap which is existing between
clinicians and laboratory medicine staff, because the long time
existing gap has caused mistrust in laboratory results and
underutilization of laboratory services. This can be done through
129
 seminars, advertisement of professions to both clinicians and
community at large.
19. Insurance of high quality for laboratory tests and results in
general. This is only possible if the government will provide
training services, mentorship, and competency assessment to all
workers within laboratory medicine.
20. The Government should emphasize the development of its local
and indigenous partners working as technical staff because
asking for human resource from abroad is much costly in terms
of money and time. Currently, we have many colleges and
universities offering medical laboratory courses but we dont
have colleges and universities offering courses for engineering,
the equipment, instruments and machines within laboratory.
21. Government and stakeholders should think big for developing
standard and quality teaching centers. There is very high cost for
producing one medical professional who sometimes does not
qualify the need of our nation. There is also need for having
standard curriculum all over the country with the aim of
producing professionals with high quality, same vision and
grown on the same standard. The number of colleges and
university is still very small in comparison to population of
students who need to study this course.
22. In a training institutions, there is a high need for having lectures
and other facilitators who are aware of laboratory medicine and
they should be involved totally in curriculum development and
improvement. Students are aware of what they need in respect to
the career they are taking. That being a reason, they should be
involved in issue related to curriculum.
23. As we are currently heading to have health centers in every ward,
medical doctors will be posted to work over there. The
establishment of standard and quality health laboratories to all
levels of health facilities will encourage its utilization,
employment opportunities, and advocate the laboratory
medicine.

130
24. There is need to reduce the monopoly of vendors in the country
to increase the competition, thereby making price and service
options more competitive15 and easily available.
25. We should also open system platforms which will simplify
reagent specification and competitive bidding in accordance with
the procurement act of Tanzania.
26. Laboratory personnel should think of establishing and
strengthening laboratory leadership. Leadership structure is
critical for the effective operation and sustainability of laboratory
services. To-date, laboratory personnel do not know exactly who
is a laboratory leader at the top; is it a Pathologist or Laboratory
scientist.
27. We need consistent focus on our desired results. As long as a
laboratory personnel's task is to work and save patients to the
level and standard of high quality we really need unchanged
focus to goals we have planned. For example, we need
accreditation for the laboratory occupants, to be recognized
internationally and add trust to its users therefore, we have to
stay in defined focus and work hard.
28. We need undivided attention and desire for changes to happen
within laboratory discipline. If it is a matter of changing
curriculum to suit the needs of the career, the respective bodies
have to settle down and see how they can go about it, if it is the
matter of seriousness, there is a need for changes.
29. Creation of values to what you are doing and also create value
for others being smart in the way you are working in the
laboratory create a position for others to value your work and
potentials you have. You really need to value services and
produce the result of high quality as per international standard.
Effective team working with other health professionals, working
in a friendly manner and remain connected for reaching your
dreams.

15
Massambu C, Mwangi C. My Harmonisation and Standardization of Tests and
Equipment In Industry of Health and Social Welfare in Diagnostic Services
Section Ation, Public Health Lab Reg al Lab. 2009.
131
30. Laboratory personnel should seek for opportunities in
innovations, research and laboratory studies because through
that, more chances are opened for the career and personnel
growth.
31. As you become one of medical laboratory personnel, you are
already in something to do with your own life and other peoples
lives. You therefore need to accept and live your responsibility.
No way can changes be made in laboratory medicine without
accepting and living by the responsibilities you have. Most of the
time, people have so many excuses when it comes to what they
have to do and this has created room for some obligations to
remain unperformed.
32. The more you produce the desired result, patient care increases,
unnecessary cost is eliminated from patients and clients being
either physician or other people which in turn builds lifetime
trust in you. You need commitment to perform excellent
activities by pushing yourself to produce the best services as you
can.
33. Laboratory medicine is an ever-changing science which requires
lifelong learning for the purpose of being updated. Most of
laboratory personnel are interested in staying without learning
new things about their career which turns out to be very
dangerous for the survival of profession. A man learn through
two ways one being reading, and another being associated with
smart people. From the principle, medical laboratory personnel
should have the charisma of studying hard pertaining the field of
interest.
34. In order to strengthen the association of medical laboratory
personnel, there should be a well-organized well organized
system with capability of solving problems

132
 CHAPTER EIGHT
RE-ENGINEERING OF CLINICAL LABORATORY
MEDICINE

Although there are many strengths and opportunities, there

are also significant weaknesses and threats in all sections within
laboratory medicine. There is need for laboratory medicine to
redefine itself as a unitary discipline and redefine its position
within modern medicine, society and the world at large.
Clinical laboratory needs to develop greater advocacy
skills for the disciplines and establish Tanzania, East Africa,
Africa and the world, laboratory scientist organization for the
formulation of uniform strategies to develop carrier, forum to
formulate strategies for education, research, service development
and staff recruitment.
Clinical laboratory needs to improve or establish academic
career advancement programs, including tenure-track programs
for medical staff, medical trainees, and medical laboratory
scientists. There is also need to encourage improvement and
formation of centers of research excellence in laboratory medicine
based on the hub and spoke for the easy access of information
with quality, and well generated by qualified scientist.
Clinical laboratory needs to establish medical laboratory
fellowship training programs for medical and science trainees
within laboratory medicine disciplines. This has big impacts
because it will provide clear expositions for individuals to an
understanding of laboratory medicine.
In addition to all that, Clinical laboratory has the
responsibility of building more established industrially supported
student organizations such as TAMELASA and TAMSA for
133
medical and scientifically qualified graduates within laboratory
medicine. This is a key in terms of achieving team work, sharing
even after graduating.
Laboratories need to take a lead role in the bio-banking,
genome resource banking and national cancer genome survey
initiatives that have recently been launched throughout the world.
Most importantly, laboratory medicine needs to think like a
business!
For the sake of laboratory growth, corporate strategy in
laboratory medicine and hospitals should be based on;
1. Attracting external funding from the biotechnology sector,
national and international agencies.
2. Establishing international research and education networks.
3. Establish endowed studentships for BMLS, MD, MSc students
and PhD.
4. Establish endowed lectureships and professorships in
laboratory medicine with significant support from
biotechnology and industry partners.

Furthermore, clinical laboratory needs to examine

critically examining the role of private income generation and its
potential use as seed capital funding for strategic, academic,
technological and scientific development within laboratories.
Laboratory medicine departments should now be establishing as
business translation incubator units, in collaboration with hospital
institutions, universities and industrial/ biotechnology partners,
this is fundamental in relation to achieving growth within
laboratory medicine. It allows significant technology relocation
and access to innovations.

134
 We need urgent development in expertise specifically in
research, so as to cope with the exploitation of discovery.
Laboratory disciplines should now start providing essential core
facilities for medical schools in order to regain the initiative and
re-establish laboratory medicine as a fundamental discipline
within medical schools. However, in the final analysis, laboratory
medicine will just succeed based on its human resource.
We need to fashion the increase and rapidly progressively
step by step on a broad base effect in attracting and maintaining
people of excellence in service and academic laboratory medicine.
Mentoring programs for medical and science graduates within
laboratory medicine are extremely important on encouraging the
best, retaining the best and ensuring that the best seek academic
advancement for themselves and their discipline.
By employing this pyramidal effect we will see strategic
growth within laboratory medicine and protect a rich heritage that
has been passed on to all of us.
If laboratory medicine remains without altering the way it
is perceived, there is a risk of its marginalization. People will keep
complaining on how they perceive and nothing will happen. By so
saying:-
1. There is a need to change disciplines or parts of disciplines for
the sake of redefining who we are, what we are and what we
are doing.
2. There is also a high need to develop a strategic out-reach
education program and identify a national figure who will
serve as an advocate for laboratory medicine, its mission and
role.
3. There is need to target specific call for second-level education
in education programs organized by laboratory scientists.
4. There is a need to redefine laboratory medicine and support
the advancement of Laboratory medicine in Tanzania to an
135
 international level, making laboratory scientists more
accessible and available to clinical colleagues and other
healthcare workers.
5. The laboratory needs to be redefined in terms of its role in the
hospital, and the community as a Centre of diagnostics that is
important and pivotal to the requirements of the patient.
6. Engaged with the general public to explain what laboratory
medicine is or to contextualize its role in modern medicine.
7. There is high need for Laboratory medicine to attract, bright
medical and scientific graduates to work in the field, and this
may be in the future laboratory medicine.
8. We need to enroll a young vibrant scientific and medical staff
in laboratory medicine, who are highly motivated and
committed to excellence, with ability to work in challenging
situations.
9. We need to focus on availability of training opportunities to
enable laboratory personnel progress upward.
10. Involvement of stakeholders in review of curriculum, national
registration examinations, policy formulation and strategy
development. Inspection of both Public and Private Medical
Laboratories, registration of mono-discipline laboratory
workers, and the establishment of standard laboratories.

Quality in Laboratory Medicine

Laboratory as per history has now grown up and its
application to health system has increased very much. To meet
criteria it requires constant maintenance or if not, it sometimes
requires replacement of system so as to work effectively. Re-
engineering of laboratory medicine provides means on which
clients will get standard services to meet the desired outcome on
helping patients.
There are lots of clinical data which are very important for
research activities but they are not utilized to the standard

136
required. We also have issue of quality result which are generated
by quality sample whose great attention has been paid but more
efforts are needed. This topic will discuss just in short the issue of
quality in laboratory medicine and the latter as source of medical
data practices.

General Quality in Laboratory Medicine

Little is known on the importance of quality patient
samples for the laboratory test. How much do you know on what
causes a sample to be rejected? Its the duty of every medical
professional to understand causes of sample rejections and where
errors are likely to occur and then create systems to minimize the
possibility of errors.
Understanding the causes of errors helps on formulation of
system to minimize the likelihood of their recurrence1.
Implementing a quality system in a medical laboratory is the
exclusive means for improving service offered to patients,
clinicians, and other healthcare organizations23.
Every laboratory has criteria for a sample to be received or
not. Meeting criteria which are set by such a laboratory gives
room for further analysis of sample and vice versa is true. Such
criteria can be one or more of following unlabeled specimen;
absence of laboratory request form, mismatch of sample and
patient information, insufficient patient information, hemolysed
sample, and wrong container.

1
Hicks JMB. Laboratory Medicine: Past, Present And Future, 2010
2
Akinsete P Ibironke. Repositioning Our Clinical Laboratories For Effective And
Efficient Health Care Delivery.
3
Search H, Journals C, Contact A, Iopscience M, Address IP. Information Systems
as a Quality Management Tool in Clinical Laboratories. 2007;012005
137
 Other causes are inadequate sample, wrong specimen,
prolonged transport, clotted sample, and form without
specimen/sample submitted. Furthermore, leaking specimen
container, contaminated sample, requesting test which is not
conducted at laboratory, unpaid sample all may cause sample
rejections.
A rejected sample will not be analyzed. Therefore there is
a number of clinical impacts which can happen due to that.

Negative Impacts of Sample Rejections

1. Rejected sample causes delay in diagnosis and management of
disease because the rejected sample requires recollection of
new sample which in turn, increase turnaround time with delay
of patient care.
2. Rejected samples lead to prolonged stay in the hospital. For a
patient whose sample has been rejected. For instance, a rejected
sample taken during morning will have to be retaken the next
day, it depend on the kind of sample4.
3. Patients stay longer than it is required and this brings about fear
to patients and relatives, causing lack of trust and confidence to
both medical staff and laboratory staff.
4. Rejected sample may be a source of conflict in between clients
(patients, clinicians, nurses and other laboratory users) and
laboratory worker. The reason for this to happen are viewed
under different perceptions between these two groups.
5. Cost increases to patients because the longer the patients stay in
the ward without clear diagnosis which leads to clear
management is key source for cost increase with reference to
cost incurred5.
4
Stark A, Jones BA, Chapman D, Well K, Krajenta R. Clinical Laboratory
Specimen Rejection Association With the Site of Patient Care and Patients
Characteristics Findings From a Single Health Care Organization. 2007;
5
Elbireer A, Gable AR, Jackson JB. Laboratory medicine in a resource-limited
country. 2010;41(7):42933.
138
6. Delay of laboratory results may cost somebodys life as long as
no clear diagnosis is seen, a patient may end up dying. There
are a number of diseases which requires more laboratory
attention.
7. Upon sample rejection some of samples will not be recollected,
that being the case, a patient will not get clear and good
services from people who are taking care of him or her.
8. Apart from other negative impacts, delay and sample rejection
cause financial consequences.

Classification of Sample Received in Clinical Laboratory

There two classifications of samples which are received in
the laboratory, which are reversible samples and irreversible
samples. Reversible sample are those samples which they can
easily be recollected after being rejected, and when are rejected,
they get discarded examples of such samples are blood, urine,
stool etc. Irreversible samples are those samples which cannot
easily be recollected because it is very difficult to collect and to
patient's side they are very painful, example CSF and many other
body tissues.
Understanding of negative clinical impacts which can be
seen if sample is rejected provide an idea on re-engineering
process. Its really high time to think and know how far we can go
to prevent this problem which is rising every day. Defined
solution to this upcoming problem is application of Quality
assurance.
Quality assurance is the means which is used to assure best
selection of test, best preparation of patients for extraction of
quality sample, best study of individual characteristics which
sometimes differ from one individual to another, best sample
collection and transportation. It also covers best handling and

139
preservation of samples in addition to best ways of receiving
protocol at laboratory reception site.
Quality of laboratory is important because clinical
laboratories affects up to 70% of clinical decisions. This is
according to a number of studies which were conducted by
different scholars6. Therefore study of the pre-analytical phase is
of emerging interest as evidenced by an increase in the number of
publications in recent years and from there re-engineering process
has started.
Thinking of re-engineering is the way which provides
means for laboratory profession on understanding important
things to be noted during pre-analytical, analytical and post-
analytical. Phases

LABORATORY MEDICINE AS SOURCE OF DATA

DRIVEN MEDICAL PRACTICE
Re-engineering of laboratory medicine is there to provide a
way on which scientists will be in position of extracting data
available in clinical laboratory. Laboratory medicine has a lot of
untapped potentials, clinical laboratory data being among.
Clinical laboratory data are among the most detailed,
objective, reliable, and useful measures of patient characteristics
contained in the medical record7. Clinical laboratory provides
important data for clinical diagnosis and epidemiological
reasoning. Therefore the main purpose of a clinical
laboratory is to serve clinicians and patients by providing results,

6
Elbireer AM, Ascp MT, Opio AA, Brough RL, Jackson JB, Manabe
YC.Laboratory medici in Sub-Saharan Africa: Uganda Case Study.
2011;42(12):71925.
7
Reynolds RE. clinics in laboratory medicine. 2008.
140
directly for clinical diagnosis or indirectly for epidemiological
decision-making through data available8.
About 94% objective data in medical records originated
from clinical laboratory medicine9. For easy utilization of clinical
laboratory medicine data, we need advance information
technology in clinical laboratory.

Reasons for Integrating Information Technology in Clinical

Laboratory Medicine
1. Information technology in laboratory medicine can lead to a
better understanding of unnecessary tests by comparing tests
ordered with medical usage and outcomes, and thereby
decreasing over-utilization which in turn reduces unnecessary
data within a laboratory information system10.
2. Information technology in laboratory medicine allows the
development of evidence-based protocols which are very
important during analysis and interpretation of laboratory data.
3. Information technology in laboratory medicine helps to an
understanding of the best laboratory tests for the diagnosis of
a disease, which is a key tool for controlling unnecessary
ordering of test specifically from junior health practitioners
who are not yet oriented about laboratory system.
4. Information technology in laboratory medicine is less time
consuming, easy data retrieval and utilization.

Importance of Data from Clinical Laboratory Medicine

1. Clinical laboratory data provides accurate and correct
estimation of people who are suffering from particular medical
conditions.
8
Baltazar Chilundo sundeep shay. Clinical Laboratory Information System in
Mozambique: The great challenge, 2001.
9
Khosrow adeli simon shorter. Public Relations Opportunities in Laboratory
Medicine.2012
10
Hicks JMB. Laboratory medicine: past, present and future. 2010.
141
2. Clinical laboratory data provide a picture for the existing
disease. The more the diagnosed diseases, the more diseases
present at a particular moment and area.
3. Clinical laboratory data have a room to be used for encouraging
funders to allocate money to the areas of burden, because what
is produced in laboratory provide evidence data for real
situations.
4. Laboratory data predict the future of health situation and hence
enable easy and attainable plans which can be used to combat
problem.
5. Laboratory data has big potentials on reduction of costs for
doing research at a particular population because the burden of
collecting data from the field is already covered.
6. Laboratory data are important for clinical diagnosis and
epidemiological reasoning.

Overview on Laboratory Data

Numerous studies based on laboratory data and in
aggregate with other clinical and experimental data have revealed
correlative and predictive patterns in laboratory data that have
improved our understanding of diseases, therapeutic response, and
health care delivery processes.
Additional useful patterns undoubtedly remain hidden in
the data, awaiting discovery by creative, prepared minds using
effective analysis techniques. Some pathologists abroad have
recognized this opportunity and laboratory personnel are still
wondering on the use of resource they have in their hands.
In Tanzania most of laboratories are still using manual
methods for registration of samples and releasing of results also
by manual methods. In some laboratories, sample registration is
computerized, through this it is easy to retrieve data. The
progressive increase in the amount of clinical data stored in

142
electronic form it will for the first time in history make possible to
carry out large-scale studies that focus on the interaction between
genotype, phenotype, and disease at a population level. Studies
involving clinical laboratory medicine data have extraordinary
potential to determine:-

1. The effectiveness of treatment and monitoring strategies.

2. Identify subpopulations at risk for disease for a particular
disease.
3. Define the real variability in the natural history of disease and
comorbidities.
4. Discover rational bases for targeting therapies to particular
patients, and
5. Determine the incidence and contexts of unwanted health care
outcomes.
Matching patient responses (phenotype) with gene
expression and known metabolic pathway relationships across
large numbers of individuals may be the best hope for
understanding the complex interplay between multiple genes and
the environment that underlies some of the most common and
debilitating health problems. Although serious issues remain to be
resolved before the large-scale secondary use of health data for
research can become routine.
Clinical laboratory databases contain perhaps the largest
available collection of structured medical data representing human
phenotypes of disease progression and response to therapy. Alone
and especially in combination with other clinical and
environmental data, laboratory databases have substantial value
for translational research, including correlative studies linking
gene expression with diseases11.
11
Reynolds RE. Clinics In Laboratory Medicine. 2008.
143
 For effective utilization of data from clinical laboratory
medicine there is need for advanced technology linking laboratory
skills, statistics and computer. Developed countries have gone far
in terms of technology, in comparison to developing countries that
being the case, integration of skills from different technologies
has enabled utilization of laboratory data for most research
activities. As a laboratory scientist in Tanzania, you have the task
to develop policies and strategies on how laboratory services will
be computerized for easy access of data.

Challenges for Clinical Laboratory Data Mining and

Utilization in Tanzania
Data mining is the means used to extract laboratory data
for the use in research and other activities. This method is good as
long as it helps finding data from laboratory to other departments
in hospital. However, there are challenges facing the process of
data mining:-
1. Data mining is a set of statistical approaches to data analysis
that are relatively technical and that need to be correctly
matched to an analysis task.
2. This specialized knowledge is generally outside the scope of
laboratories training.
Software tools for data mining by non-experts have been very
expensive and are often a poor fit for laboratory databases.

144
 CHAPTER NINE
INNOVATIONS IN LABORATORY MEDICINE AND
EXCELLENCE IN SERVICE DELIVERY

Excellence should be an outstanding feature of clinical

laboratory medicine. Excellence is deepened by criteria which
requires checkup of system on how it works. Criteria for performing
excellence in laboratory can be defined by number of key issues,
example leadership-for excellence performance; there should be a
good leader to manage and work in laboratory. Two; clear strategies
which at the end make goals attainment, three quality of results
which are provided to clients. Four; looking for customer/client
satisfactions and Fifth number of workforce to provide services at
laboratory. There are other qualifications to meet but the listed one
are of most important. Therefore, to make laboratory center of
excellence there should be key things to be considered.

The Following Below are Key Issues to Consider

Satisfaction of customer for quality and the responsibility of
everyone in the lab.
1. Availability of services, appropriate results, accuracy of results,
reproducibility of results, short turnaround time, availability of
clinical advice from laboratory on what to do with patients
results and cost-effectiveness.
2. Conducive Environment for both tests and workers in clinical
laboratory, clear organization of clinical laboratory, availability of
laboratory equipment according to standard of settings.
Conducive Environment for workers is very important and
keystone for laboratory growth.
3. Assessing Development changes within laboratory, should be the
basic goal of every working institutions or organization.
4. Updating knowledge, to cope with new innovations coming every
day involving new machines.

145
5. Having leaders and head of laboratory medicine who go beyond
others in term of implementation, planning, innovation, attention,
and problem solving.
6. Maintenance of quality because is the source of everything good
in laboratory.
Trust is the main agenda for good laboratory practices. If
laboratory users will be in a position of understanding laboratory, as
a where working environment are good which means that, people
working within are smart, quality are adhered, then they can easily
trust what we are doing, which on turn bring of bright future of
laboratory.

To ensure competent, effective laboratory services there is

necessity of the following:-

1. Clinical-effectiveness1
Clinical effectiveness is the key for today world for making
trust to customers we are saving. This can be achieved through;
a. The provision of direct patient care by medically qualified
laboratory medicine specialists.
b. The provision of rapid and accurate interpretive reports, which
allow patients to be referred to the appropriate clinical team for
further investigation and/or treatment, thus facilitating improved
clinical outcomes.
c. The provision of a clinical channel for communication between
groups and advisory service.
d. Participation in multidisciplinary clinical team meetings.
e. Participation in clinical audit projects.
f. The derivation and implementation of clinical practice guidelines.

1
Gruyter W de. Adding value to laboratory medicine: a professional
responsibility. 2013;51:2217.

146
2. Evidence-based Practice
Laboratory medicine need more specialized people to work
in Evidence-based medicine comprises the distillation of research
evidence, clinical expertise and patient values. The adoption of
evidence-based medicine is very basic for facilitation of consistent
practice and improve clinical outcomes. Laboratory medicine
specialists are trained to search and critically appraise the scientific
and clinical literature.
They are well placed to practice and contribute to the
development of evidence-based laboratory medicine. Every
laboratory medicine specialist has to ensure that, current laboratory
practice and clinical practice guidelines are consistent with the latest
evidence from the literature. This will involve acting as knowledge
manager in discussions with users of the service. A proactive
approach is required to ensure that laboratory medicine specialists
are part of the multidisciplinary team that prepares for hospital
objectives budget, and policy.

3. Novel Applications/Reactive Application

Up recently, medicine was reactive, being population focused
system-based and therapeutic2. The patient has been a passive
partner. However, we are now facing an exciting new direction as we
move to medicine which is predictive, personalized, preventive and
participatory one. This change of direction is based on individual
genome properties and so underpinned by modern molecular
laboratory medicine.
The growth of participatory medicine presents a great
opportunity for laboratory medicine to reinforce central role in
healthcare. We need to think of patients as individuals not as
population and in so doing, the importance of reference interval and
population-based action limits will diminish.
We need to think of wellness and risk stratification rather
than disease. We need to embrace a new range of methods and also

2
Gruyter W de. Adding value to laboratory medicine: a professional
responsibility. 2013;51:2217.
147
the bioinformatics that will be essential to interpret complex data and
algorithms from individual subjects3.

4. Cost-effectiveness
The challenges presented by the need, for the laboratory to be
cost-effective, tend to dominate thinking and are regarded by many
specialists as a barrier to implementing the other domains of added
value 45. However, all laboratory medicine specialists have a
responsibility to deliver a cost-effective service without
compromising quality.
There are areas in which cost-effectiveness can be addressed.
First, efforts can be made to contain or reduce the direct costs of
running the laboratory. It will include economizing scale from
laboratory networking and sharing of common equipment between
laboratory specialties, adjusting the skill mix of the staff to match the
increasing automated technology.
Second reducing unnecessary testing through demand
management and test request monitoring that every test ordered to
laboratory have clinical implication to patients, adopting a more
appropriate business model. At present in Tanzania, laboratory
medicine is often regarded as a production center with little or no
link between output and clinical effectiveness.
Inadequate reimbursement, fixed costs and very small
budgeting all create an environment where it is difficult for
laboratory medicine specialists to react to a rising workload, and also
bring in the added value that can make a difference to patients. A
business model based on laboratory medicine as a service Centre
would be more appropriate with funding linked to the contribution to
the care pathway6.
3
Ibid
4
Patricia Munch Danzon, Willard G.Manning, Jr. M susa. M. Factors affecting
laboratory test use and prices. 1983
5
Beastall G. Shaping the Future of Laboratory Medicine: The Great Debate
central role of Laboratory Medicine intenational clinical federation for clinical
biochemistry and laboratory medicine 2014
6
Gruyter W de. Adding value to laboratory medicine: a professional
responsibility. 2013;51:2217.
148
5. Educating Users and Others
For many years laboratory medicine has been considered as
the best kept secret in healthcare. The profession has produced
continuous quality improvement, introduced high international
standards of practice and succeeded in delivering a rapidly rising
workload for little or no increase in costs.
However laboratory medicine is taken for granted by many
users and peers. And largely unknown to the patient and the public.
Laboratory image of being dominated by machines, which are kept
running by a few scientist or technician engaged in research who
work out of sight of the rest of the healthcare team. Laboratory has a
role to play outside the laboratory and actively promote the
contribution of laboratory medicine to healthcare. Educating on what
we are doing is the best mechanism for its excellence.

6. Optimization of Operational Efficiency

Operational efficiency relates to the ability of a laboratory to
provide rapid results and reports which may affect further
investigation, management or discharge of the patient7. Currently we
see in Tanzania most of laboratory work have automated instruments
that improve workflow, informatics solutions that allow test results
to rapidly access by physicians.
Reducing medical errors and improvement of turnaround
time are all aspects of laboratory medicine that may contribute to
operational efficiencies. The following are the criteria that may be
used to assess operational efficiency; efficient patient sorting and
allocating services on the basis of their need for or likely benefit
from medical treatment (triage), patient waiting times and the length
of the patient journey, rate of re-investigation and re-admission of
samples if necessary, decrease on operational costs and optimization
of patient management
The optimization of patient management will depend to a
large extent on the laboratory provision of interpretive service.

7
UCDAVIS. Department of Pathology and Laboratory Medicine. 2014;030.
149
Interpretative services enables laboratory information to be
converted into knowledge for the benefit of the individual patient or
groups of patients. The early deployment of an appropriate
diagnostic test is also good technic for effective services.
The use of evidence-based clinical practice guidelines and
the effective application of clinical audit are examples of how
laboratory medicine can contribute to the optimization of patient
management. Criteria that may be used to assess operational
efficiency include; Reduction of unnecessary investigation and
treatment, reduction in time taken and money spent on patient
investigation, Improved patient outcome and/or improved quality of
life.

7. Influencing Patient Behavior and Other Effects

Laboratory services has to expand to the ability of providing
information to patients that will catalyze changes of lifestyle choices
or change their sense of satisfaction and well-being. Alteration of
diet or exercise, the use of prophylactic medicines self-monitoring;
and planning for retirement may all be affected by a patient knowing
result from laboratory investigation that highlights present or future
risk of disease.
Criteria that may be used to assess operational efficiency
include:- evidence of patient empowerment, information leading to a
sense of satisfaction or well-being, evidence of lifestyle
management8.
In nations with developed healthcare systems, laboratory
medicine specialists have been at the forefront of line delivering
services of the highest quality and they have been proud to embrace
external accreditation. In achieving this status, they have focused on
what goes on inside the laboratory. It is right time for laboratory
medicine specialists to look outside the laboratory, as part of the
multidisciplinary team that seeks to optimize clinical outcomes and
patient experiences in an efficient and cost-effective way.
8
Miles J, Ascp MT, Weiss RL. The Role of Laboratory Medicine in accountable
care Organizations. 2011.

150
8. Building Outreach Program to Extend Lab Services
Laboratory services for long time has been at utmost serving
physicians, nurses, and paramedical members and patient who are ill
and they have already come to hospital. It is essential to create an
integrated network for outreach programs which will provide room
for laboratory personnel to be known and affect society positively.
Their work shall be recognized by society specifically on treating
and managing chronic disease like hypertension and diabetes.

9. Employing Electronic Connectivity to Services Provided

Laboratories have the opportunity to be instrumental in
assisting physicians and other laboratory users to access important
informations at a right time. This is the way of demonstrating the
value of both patients and physician, this can be attained with
utilization of computerized system. Computerized laboratory have
high and good impacts to health care and diagnosis because of its
efficient means of getting solutions to challenge such as result
interface, turnaround time, and easy access to information pertaining
patients.

10. Understanding of The Laboratorys Role in The Big Picture

For laboratories to perform in an excellence manner within
hospitals or health systems, they should have a clear understanding
of the health systems clinical and financial objectives, including
plans for an accountable care organization. Successful laboratories
will align the laboratorys strategic objectives with those of the
larger organization such as community marketing, physician-
alignment strategy, or information technologies strategy.9
Moving beyond the hospitals bricks and mortar, well-
informed laboratories will also be aware of efforts from competing
laboratories to disrupt the integrated services of a hospital laboratory
or replace it in an accountable care organization. This will open

9
Miles J, Ascp MT, Weiss RL. The Role of Laboratory Medicine in accountable
care Organizations. 2011.
151
more door for the community understanding about laboratory
medicine.

11. Developing and Utilization of Management Tools

It is good if laboratory results will be utilized effectively.
Clinical utilization and management of results has the potential to
reduction and elimination of unnecessary expenditures 10. Test-
utilization review within a hospital organization can be performed by
a multispecialty medical committee, such as a laboratory scientists,
physicians, pharmacists, and nurses.
This committee can have the same scope and authority as a
traditional pharmacy and therapeutics committee to recommend the
appropriate use or availability of lab tests as well as review process
for referred test orders and protocols. Laboratory experts are
uniquely qualified to be involved in the development of
computerized physician order entry with clinical decision support
test algorithms, and clinical pathways.

10
Miles J, Ascp MT, Weiss RL. The Role of Laboratory Medicine in accountable
care Organizations. 2011.

152
 CHAPTER TEN
FUTURE OF CLINICAL LABORATORY MEDICINE

In the future, a clinical laboratory technician, technologist

and scientist will have an expanded role that builds on the current
defined Clinical Laboratory Science/Medical Technology Scope of
Practice. These future intellects will move into various arenas
consisting clinical and non-clinical aspects. On near future
laboratory scientist will assume additional roles that should be in the
Clinical Laboratory Science/Medical Technology domain. The
arenas which will most probably be encountered in the new
laboratory will be:

1. Consultation Services
The time has come where consultation or advice in laboratory
medicine practice settings is crucial in patients management. Thus
correlating laboratory data and patient status is required with a keen
eye from laboratory professional personnel due to the fact that the
advance tests innovated requires a highly qualified person to
interpret the result and provide any necessary inputs to help patient
meet a better health management.
If the laboratory scientist will not be used effectively,
clinicians might miss necessary information to help their clients 1.
The areas which will demand these consultations are physician
offices, Hospitals, Government (ministry of health and other health
care professions), Industry and Public health.
This new age of clinical laboratory will provide in-laboratory
interpretation of admission laboratory tests and the ordering
(according to an agreed rubric/algorithm) of follow up tests. For
instance, if a person is admitted with a microcytic hypochromic
anemia and a complaint of GI Bleeding, then iron studies are not
needed.

1
Doig K, Nca CLS, Clsp H. Future of the Laboratory workforce: Advanced
clinical practice 2006.
153
 However, if there is no clear-cut explanations then iron
studies should be ordered. Developing of clinical laboratory ordering
pathways and reflex testing algorithms to expedite quality clinical
care is needed2. It provides laboratory expertise to physicians in the
proper development of physician driven clinical pathways.
Developing new authoritative rule of conduct for tests based
on reading of scientific literature. For example, the clinical chemistry
supervisor should be the person who determines the availability of
troponins and the refusal to honor requests for older/outmoded tests.
Assists in development of triage (Sorting and allocating aid on the
basis of need for protocols) for appropriate departments such as the
emergency Room or Intensive Care Unit to produce the most
appropriate information as rapidly as possible.
Clinical laboratory is developing to serve as an enriched
partner on healthcare team that is available twenty four hours every
single day to assist physicians in bringing tests-ordered knowledge
to ward-rounds along with nurses and physicians, by communicating
the following to all the health team;
a) By providing the meaning of test results.
b) By helping in recommending of further testing pertaining the
patients condition.
c) Assessing patient conditions from a laboratory medicine
perspective.
d) By participation in rounds and patient care conferences to provide
the clinical laboratory perspectives and point of views.
e) To provide proper blood product utilization and currently a lot of
laboratory is doing this work.
f) Provide information for timing tests and consolidation of blood
collection.

2. Laboratory scientist will be in position of observing issues of

laws which is coming up in every health profession sector
It is inevitably that at very near future clinical laboratory
scientist will serve as patient advocate to explain the patient

2
Macmillan DH, Soderberg BL, Laposata M. Regulations regarding reflexive
Testing and Narrative Interpretations in Laboratory Medicine. 2001; 12932.
154
condition, medications and laboratory tests that will support legal
aspect of patient or any other medical professional. This will be
important to support family decision-making, medical legal issues
etc.

3. Clinical laboratory scientist will be more engaged to work

with hospital and medical quality groups to:-
a. Review laboratory data of oncology patients in team work
with Oncology Technical Specialist and to review other
laboratory data as Technical Specialist in other areas as
processing of all suspected samples of cancer are under
histopathology/pathology laboratory.
b. Serve on all facility medical practice committees to include,
but not be limited to, Infection Control, Medical Practices,
Quality Management, and Transfusion Committees.
c. Serve as Infection Control Coordinator (Epidemiologist) in
the laboratory and/or for the facility.
d. Present rich and superior in quality rounds concerning
laboratory utilization.
e. Provide expert testimony in legal situations, this is currently
being done in some places but not all.

4. Clinical laboratory scientists will be more engaged in

providing services in risk management and this will be done
by:-
a. Developing diagnostic and/or therapeutic laboratory protocols
for patients by disease category.
b. Reviewing charts for compliance and make recommendations
for action.
c. Developing clinical laboratory algorithms/ roles for patient
management.
d. Serving as Risk Managers.
e. Developing and coordinating direct access for testing.
For attaining the future of laboratory medicine on the aspect
mentioned in this main subtopic which is future of laboratory
medicine there is high need of setting goals and way to attain such
goals.
155
 The following should be goals aimed at:-
1. An aspiration of moving to higher degree level of education and
position Generic competencies for all clinical scientists which will
provide ability to provide interpretation of data and a diagnostic
(therapeutic) opinion, including any further action to be taken by
the individual responsible for the patient.
2. Understanding of the wider clinical situation relevant to the
patients presenting to his/her specialty.
3. Ability to develop/advises an investigation strategy taking into
account the complete clinical picture.
4. Understanding of the clinical applications of the specialty and the
consequences of decisions made upon his/her actions/advices.
5. Awareness of the evidence base that underpins the use of the
procedures employed by the service.
6. Specific competencies for clinical scientists must be laid on
understanding the underlying mechanisms of the pathology of
disease.
7. Must recognition and understanding the value of laboratory based
research and development in clinical laboratory in the practice of
clinical science.
8. Must be able to advice on choice of investigation, interpret data
and recommend further course of action within the wider context
of the clinical situation.
9. Must be able to relate data from other disciplines to the overall
clinical situation.
10. Must be aware the strengths and weaknesses of the evidence base
for commonly used procedures and investigations.
11. Must be able to Contribute on monitoring of patients as
appropriate within clinical laboratory.
12. Must have sufficient clinical knowledge to be able to
communicate effectively with clinical and other professional
colleagues.

156
Drivers to future clinical laboratory medicine according to
International Federation of Clinical Chemistry and Laboratory
Medicine are:-
a) Globalization which is characterized by instant global
communication which will enhance patients to have access to
services like online interpretation of laboratory results. This will
also easer communication among health professionals and it will
facilitate quality standard, good clinical application and good
laboratory practices3.
b) Technological advancement currently there massive
technological innovation which automatically has moved and will
move laboratory medicine to very new atmosphere laboratory
advancement. Talking of proteomic metabolism, Genomic,
automatic robotics, nanotechnology, bioinformatics and mass
spectrum.
c) Smarter working laboratory personnel have started and will work
with improved efficiencies, managed work load, and shared
resources.
d) Intergraded patients pathway which will actually involves
laboratory medicine, imaging (radiology), and endoscopy and
work together.

NEW ERA OF DOCTORATE IN CLINICAL LABORATORY

MEDICINE (DCLS)
This is an appropriate time at which we need people with
broad knowledge in laboratory medicine practices. We need broad
thinking on management of disease, prevention, screening, early
intervention of diseases and in critical issues. We need highly
qualified people who will be in position of having knowledge of
clinical laboratory and clinical medicine in general.
Medical doctors have been trained with ability to join other
paramedical position like microbiology and immunology. It is also
right time for laboratory professional to have opportunity especially
here in Tanzania to join other further degree which can make them
3
Beastall G. Shaping the Future of Laboratory Medicine: The Great Debate
central role of Laboratory Medicine intenational clinical federation for clinical
biochemistry and laboratory medicine 2014.
157
have chance on full participation on making clinical decision
pertaining the patients investigations, contributing on what should be
done during major round.
Number of laboratory test are ordered but with less
significance or no any significance application. For example, a
person may be suffering a different disease from the test ordered.
Unnecessary tests added to patient increases cost through this very
specialized program almost all raised problems will be solved.
Specialization which will lay ground in clinical specializations, will
help our societies a lot. According to the research which took place
in USA, DCLS has great important to covers the existing gap
between laboratory scientists and clinicians4.

Defining the Roles and Responsibilities of the DCLS

Categorization of the responsibilities of the DCLS are laid
mostly into four areas in which are;
1. Patient care management
2. Education and research applications
3. Health care policy development, and
4. Health care services delivery and access.

1. Patient Care Management

In the area of patient care management, the DCLS will play a
vital role in cost-effective laboratory. This will include test
utilization by providing input during clinical rounds with other
health professionals and developing and disseminating algorithms to
optimize testing5. A survey of the literature indicates a growing
concern for inappropriate laboratory test utilization with various
types of proposed solutions or interventions. This include peer
management, development of guidelines for test utilization in
different care units and the use of intelligent computer information
systems to reduce unnecessary testing in clinical laboratory.
With the increase in complexity testing, especially in the
field of molecular diagnostics, providing interpretation of test results
4
Nadder Teresi S. The development of the doctorate in clinical laboratory science
in the U.S.A 2008 24:16.
5
Ibid
158
to other health care professions as well as patients is essential in a
patient-centered health care system. Patient specific narrative
interpretation in laboratory reports has been advocated.
Based on a review of previous studies, there is inadequacy of
current laboratory advisory systems which include curbside
consultations, computer information systems, algorithms, and web-
based medical information. Due to different information from
various research we can suggest that physicians need expert advice
from the clinical laboratory staff on the selection of laboratory tests
and interpretation of test results on a case by case basis. The provider
of such services was further characterized as an expert in all areas of
the clinical laboratory who is readily available for consultation when
needed.
To provide quality services equivalent to that of anatomical
pathology and radiology, it is also to have interpretative services to
accompany complex evaluations. Various study n which physicians
were surveyed pertaining the outcome of utilizing their health
systems laboratory medicine interpretation service for complex
laboratory panels, 70% reported that the interpretation reports
prevented misdiagnoses and 60% reported reduced time to diagnosis.
The DCLS can assist the pathologists with these important
tasks, especially in rural communities where the number of
pathologists may be scarce. Key informants surveyed for the report
The Clinical Laboratory Workforce: The changing picture of supply,
demand, education, and practice endorse the new role for laboratory
practitioners as consultants on the health care team. The need for
such an advisor is also supported by reports from primary care
physicians that their increased scope of care is difficult to handle and
may affect the quality of care provided to their patients.
In addition, an emphasis has been placed on the need for
improvement in the treatment and monitoring of chronic illness and
preventative services. The DCLS can be a key resource in disease
prevention and management for these patients, subsequently
reducing the burden of practice among the primary care physicians.

159
2. Education and Research Applications
Realm of education, ultimately affects the quality of patient
care. DCLS will be in position of educating other health
professionals with regards to quality of specimen collections, point
of care testing, new test offerings and emerging technologies. As the
interface between the clinical laboratory and the clinician, the DCLS
would be an ideal candidate for instructing patients on point of care
devices and home testing kits.
The DCLS is also expected to make significant contributions
to research related to quality improvement and patient outcomes 6.
Most errors in the total laboratory process are due to pre-analytical
factors (up to 68%) and post-analytical factors (up to 47%). Thus to
increase the quality of laboratory medicine and increase patient
safety, efforts addressing these pre-and post- analytic errors have
been made through systematic evidence review methods.
Blood sample hemolysis, the effectiveness of barcoding to
reduce patient specimen errors, and effectiveness of practice to
reduce blood culture contamination. In deed this will increase the
participation of laboratory professionals in clinical research. As a
generalist with advance practice experience, the DCLS will have the
training to conduct such studies.
Engaging in clinical research to benefit the quality of
laboratory medicine will also well position the DCLS as valuable
participants in health care policy debates and in decision making
associated with laboratory services.
Give advice to a physicians on the diagnosis and monitoring
of the treatment of their patients.
1. Select and perform the most appropriate tests to be used.
2. Set protocols and maintain quality standards within the
laboratory.
3. Interpret the results of tests for other clinicians.
4. Propose hospital policies on the control of antibiotic usage and
antibiotic resistance.

6
Doig K, Nca CLS, Clsp H. Future of the Laboratory workforce: Advanced
clinical practice, 2006.
160
5. Participate in training programs for trainees and be responsible for
the assessment of the trainees using the record made in their
training logbook.
6. Collaborate with National Surveillance organizations and public
health authorities and provide services for the organizations.
7. Undertake research and development in the fields of Laboratory
Medicine.
8. This position would be helpful for clinicians -especially those in
training working at a teaching facility.
9. Will identify many unnecessary tests ordered would help to
reduce some costs to the laboratory, especially caused by
unnecessary tests.
10. Most of medical personnel sometimes are not sure what to order
to accomplish the best use of specimen and greatest informative
value to help their patients. Through this solution will be on
table.

161
 BIBLIOGRAPHY

1. A. Delwiche F. Mapping The Literature of Clinical Laboratory

Science. 2003
2. Akinsete P Ibironke. Repositioning Our Clinical Laboratories For
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