U After the completion of this chapter, the students will
be able to:
> Define Medical/Clinical Laboratory Science.
> Determine the role of Clinical Laboratory in health care
system.
> Explain how to select appropriate laboratory tests.
> Define the reference ranges.
> Explain how to evaluate and interpret the Laboratory
results.
> Practice patient approach
+ Know different laboratory equipments and wares
w
08/07/2021 Amsalu M (BSC, MSC, DPHM)
Lecture outline
Introduction
Basic Medical Laboratory services
Role of the clinical laboratory
Selection of Laboratory Tests
Interpretation of Laboratory test results
Patient approach
Basic Laboratory equipments & wares
Amsalu M (BSC, MSC, DPHM)
“x. (0
Introduction Er
A laboratory is a facility that provides controlled
conditions in which scientific or technological research,
experiments, and measurement may be performed.
A medical laboratory or clinical laboratory
is a laboratory where tests are done on clinical specimens
in order to get information about the health of a patient as
pertaining to the diagnosis, treatment, and prevention of
disease.
AS
Without Reliable Laboratory Services:
= The source of a disease may not be identified correctly.
" Patients are less likely to receive the best possible care.
= Resistance to essential drugs may develop and continue to spread.
= Epidemic diseases may not be identified on time and with
confidence.
A
/
>
What Is Medical Laboratory SB 8
Y x
= Medical laboratory science is the use of clinical
laboratory tests to detect, diagnose, monitor and treat
disease.
= Blood, tissue and body fluids can be chemically
analyzed and examined for foreign organisms and
abnormalities.
= This information is then used by the medical team to
make decisions regarding a patient's medical care.
85% of all medical decisions are based on the results of
clinical laboratory testing.
Laboratory Tests eA
3
What are lab tests?
Laboratory tests are medical procedures that involve testing samples
of blood, urine, or other tissues or substances in the body.
Why does your doctor use lab tests?
Your doctor uses laboratory tests to help:
" Identify changes in your health condition before any symptoms
occur.
= Diagnose a disease or condition even before you have symptoms
" Plan your treatment for a disease or condition
= Evaluate your response to a treatment, or
= Monitor the course of a disease over time
Cont...
> Its function is to perform qualitative and quantitative
analysis of body specimens.
Q Urine
Q Blood,
Q Body fluids
Q Feces and other specimens.
> Produces reliable & objective evidence from which medical
decisions may be made.
> Up to 85% of clinical decision is based on laboratory
findings
Amsalu M (BSC, MSC, DPHM)
Listed below is a partial list of types of individual
clinical laboratories
Blood Bank/TM
Chemistry/ Immunoassay
Hematology and Coagulation
Urinalysis, uid Analysis and Medical Microscopy
Cytogenetics
Why do you need to learn clinical Laboratory
methods?
> In order to interpret laboratory results accurately
+ To know limitations of some laboratory tests
+ In order to perform some tests
> To know the usage of laboratory wares, instruments
and sterilization techniques
> To know the standard operational procedures of
some basic laboratory tests etc.
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Basic medical laboratory services
QThe assessment of patients may include the
evaluation of diagnostic investigations, which
continues throughout the patients course of care.
QThe accurate and timely reporting of laboratory
processes can play a major role in the health
outcomes for the patients.
Q So according to the standard there are two
laboratory services
1.Advanced diagnostic medical laboratory services
2.Basic diagnostic medical laboratory services
Amsalu M (BSC, MSC, DPHM)
Cont...
1. Advanced medical laboratory:
+ A medical laboratory facility which provides
all range of comprehensive ,specialized and
high caliber medical laboratory diagnostic
services.
2. Basic medical laboratory services:
+ Amedical laboratory facility which provides
routine and essential ranges of laboratory
tests.
08/07/202 Amsalu M (BSC, MSC, DPHM)
Role of clinical lab. in the health care system
+ Many infectious diseases and serious illnesses can only be
diagnosed reliably by using the laboratory.
Misdiagnosis or late diagnosis can lead to:
* Incorrect treatment with misuse and waste of drugs.
* increased morbidity and mortality.
* hospitalization and need for specialist care.
* patient dissatisfaction leading to negative responses to
future health interventions.
> The laboratory has an essential role in screening for ill
health and assessing response to treatment.
02
Amsalu M (BSC, MSC, DPHM) 14
Cont...
“ The laboratory can help to reduce expenditure on drugs.
When laboratory is used:
P Drugs can be used more selectively and only when
needed.
P Reduce the number of times a patient may need to seek
medical care for the same illness.
P Prevent complications arising from advanced untreated
disease.
P Avoid hospitalization and further costly investigations.
Cont...
Laboratory also plays an important role in:
U Detecting and identifying the source of infection
U Participating in epidemiological surveys (inspecting
and examining diseases).
Q Application and evaluation of disease control
methods.
U Participating in health education.
U Participating in health planning
08/07/2021 Amsalu M (BSC, MSC, DPHM)
Without reliable lab support:
Patients less likely to receive the best possible care.
Resistance to essential drugs will continue to spread.
The etiology of disease may not be identified correctly.
Epidemics and spread of major communicable diseases
will not be checked reliably.
Valuable financial and human resource may not used
properly.
Amsalu M (BSC, MSC, DPHM) 18
+ Outcomes of clinical laboratory service
utilization?
>
Vv
VV V
08/07/202
Improvement in the quality of health system
Reduced disease transmission
Reduced health care costs
Greater patient satisfaction
Greater motivation of the health worker
E.t.c
Amsalu M (BSC, MSC, DPHM)
Selection Laboratory tests
U Selection of Laboratory tests depends on:
Q Value of the information provided
Q Cost of the test
Q The accuracy of tests
Q Availability of the necessary laboratory
materials
Q Availability of well trained & experienced
laboratory staff
Amsalu M (BSC, MSC, DPHM)
+ Types of diagnostic tests:
v Quantitative: classifies people as diseased or disease
free based on certain cutoff value or reference value.
Y Qualitative: classifies people as diseased and disease
free or positive and negative of a substance.
v Semi-quantitative: estimation
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+ Interpretation of Laboratory test result
+ Laboratory tests are performed for:
Q Purpose of diagnosing diseases
Q Monitoring therapy and epidemic.
» For the purpose of diagnosis — specific concentration of
different substances in disease & health conditions are
compared.
« For monitoring treatment — concentration of different
substances are compared with values obtained previously
from the same patient/reference range.
Amsalu M (BSC, MSC, DPHM)
Cont...
+ The ability of a diagnostic test to indicate a disease
is present or absent depends on its quality which is
described in terms of:
Q Precision
Q Accuracy
Q Sensitivity
Q Specificity
U Predictive value
Q Test efficiency
Precision & Accuracy
= Precision: measure of the agreement between results
of replicate analysis on the same sample
= Accuracy: closeness of measurements to the true
value
Sensitivity & specificity
Sensitivity:
Y” Analytical sensitivity: The ability to detect small differences in
concentration in a series of specimens.
Y” Diagnostic sensitivity: The incidence of true positive results obtained
when a test is used for patients known to have the disease or condition.
Disease
Yes No Total
Test results Positive TP FP TP + FP
Negative FN TN FN + TN
Total| TP + FP+ |TP+FP+FN+TN
FN TN
Amsalu M (BSC, MSC, DPHM)
Cont.-
A sensitive test should be chosen when there is
an important penalty for missing a disease.
= Specificity: Is the proportion of people without the
disease who have a negative test or it is the ability of a
test to identify non-infected individuals correctly.
» Specific tests are used to confirm (or rule out) a
diagnosis that has been suggested by other data
(when the test result is positive).
» Highly specific test are particularly needed when
false positive results can harm the patient physically,
emotionally, or financially.
08/07/2021 Amsalu M (BSC, MSC, DPHM) 27
Predictive values
= It describes the value of the test by taking in to account
the actual prevalence of the disease in a population
being tested.
= Two types: PPV & NPV
= Positive predictive value: is the frequency of infected
individuals among all persons with +ve test results.
= Negative predictive value: is the frequency of non-
infected individuals among all persons with -ve test
results.
Predictive value of a positive test = True positive x 100
(True positive + False positive)
Dede vo mga t= Te este m
(True negative + False negative)
08/07/2021 Amsalu M (BSC, MSC, DPHM)
Test efficiency (TE)
= It is the combination of sensitivity $ specificity that
determine the total effectiveness of the method.
= It is used to determine the over all ability of the test
method to eliminate false positives & false negatives.
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«< Example: In a population of 2% prevalence of a given
disease, 4,000 specimens were tested by two different test
kits & the result shows the following:
= Test kit A: 80 positives (70 from infected individuals &
10 from non-infected individuals) & 3920 negatives (3910
from non-infected individuals & 10 from infected group).
= Test kit B: 90 positives (60 from infected & 30 from non-
infected individuals) & 3910 negatives (20 from infected
& 3890 from non-infected group).
3 Calculate: Specificity, Sensitivity, PPV, NPV & TE for
3 Compare the two kits with justifications; which one is
better for screening & which one is better for
SC, DPHM)
“Reference intervals (RIs)?
= Ris were first brought as ‘Normal values/ ranges’
= RI is the interval between, & including, two reference
limits (upper & lower limits) of a given analyte
covering 95% of the population.
= Ris are used to determine whether a disease is present
or absent or to know if the patient is at risk for future
disease states
= Every laboratory should have its own RIs
02 Amsalu M (BSC, MSC, DPHM) 32
“What are the factors that can affect RIs?
Q Race
Q Altitude
Q Gender
Q Age
Q Living condition
Q Feeding practice
Q Etc
08/07/2021 Amsalu M (BSC, MSC, DPHM)
Patient approach
Identifying Yourself
« Greet your client
« Be friendly
« State your name
« State your purpose
Amsalu M (BSC, MSC, DPHM)
Client Identification
> The most important step in specimen collection is
client identification
> Misidentification of a client can be grounds for
dismissal
+ When identifying a client, ask them to state his or
her full name
> NEVER SAY: “ARE YOU MRS SMITH?”
Amsalu M (BSC, MSC, DPHM)
Inpatient or Ward Contact
Before entering a patient’s room
> Always knock before entering
> Greet patient in a friendly manner
> Always make your presence know before
proceeding into the room and pulling back the
curtain
Amsalu M (BSC, MSC, DPHM)
Identifying Yourself
State your name, where are from and the purpose of
you visit
If a patient is sleeping, wake gently
Speak softly
Never turn on a bright light
Never attempt to draw blood from a sleeping patient
Amsalu M (BSC, MSC, DPHM) 37
Unconscious Patient
Identify yourself and inform the patient of your
intent
Ask caregiver to identify the patient
Compare this information to the identification
bracelet
Continue to speak to the patient
Ask for help in holding the patient because they
can sense pain but can not control their reactions
Amsalu M (BSC, MSC, DPHM)
Doctors and Visitors
If a doctor is with a patient, don’t interrupt but come
back latter
If the blood work is needed immediately, excuse
yourself and explain why you are there
If visitors are present, it is best to ask them to step
out of the room
If a patient is not in the room, find out where they
are.
Amsalu M (BSC, MSC, DPHM)
Inpatient or Ward Identification
+ Emergency Room patients:
— should have a identification band on, can be
asked directly if conscious or put a temporary
band on
— Always make sure all information matches
+ Young children:
— confirmed by parents or relatives
Amsalu M (BSC, MSC, DPHM)
Cont...
It is very important for healthcare professional to
ensure that specimens are drawn from the correct
patient
Ask the patient to state his/her full name, birth date
or identification number
Compare the information given with the
information on the patient’s identification bracelet
Report any error before drawing the patient
Amsalu M (BSC, MSC, DPHM)
Cont...
Any discrepancy between ID band and request slips should
be verified
ID bracelet missing on wrist, check ankle
If band is not on patient but on the wall, bed or night table the
patient Can Not be Drawn
A new band must be issued and placed on the patient
Amsalu M (BSC, MSC, DPHM) 42
Bed Sde Manner
+ Gain the client’s or patient’s trust and confidence
» Put the client/patient at ease
+ Use a cheerful and pleasant manner
+ A phlebotomist who has a professional appearance and
behaves in a professional manner will convey confidence to
the client
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Handling Difficult Gients
+ Remain calm and professional
¢ Treat the client in a caring manner under any circumstances
+ Never force a client to do anything that they do not want to
do
08/07/202 Amsalu M (BSC, MSC, DPHM)
If the Client Objects
+ The client has the right to refuse
« Never force a client
+ You may try to convince them how important the
procedure is