preanalysis, analysis, postanalysis; point

of care testing; quality control; Biosafety

(pp2-10; 20-31; 33; 66-72; 73-83; 112-
129)
• Mzia Tsiklauri, Doctor of Medicine, Professor
LABORATORY DESIGN AND
SERVICE MODELS
• The functional design of a laboratory and its relationship
to other testing sites within a facility have separated
hematology, chemistry, microbiology, and blood bank
sections.
• In an effort to lower costs and respond more rapidly to
clinical needs, laboratories have employed both highly
automated “core” facilities.
• Based on current technology, tests that once were performed
in separate laboratory sections are now performed on a
single testing platform (single analyzer), on a workcell (two or
more linked instruments), or with the use of total laboratory
automation (workcell with preanalytic and postanalytic
processing).
• In conjunction with improved preanalytic sample handling
(e.g., bar coding, automated centrifuges, decapper), use of
highly accurate analyzers and timely postanalytic activities
(e.g., reporting laboratory results via networked computer
systems, the Internet, autofaxing) further contributes to
enhancing the quality of services provided.
The design of facilities is important regardless of the type of
laboratory and may best be accomplished by implementing
Six Sigma/Lean techniques to ensure the highest level of
productivity.
Location of the specimen processing area, patient
registration and data entry, specimen testing workflow,
short- and long-term storage, and laboratory information
system (LIS) connectivity requirements must be considered.
• Clinical laboratories are healthcare facilities providing a wide range
of laboratory procedures which aid the physicians in carrying out
the diagnosis, treatment, and management of patients.
• These laboratories are staffed by medical technologists (clinical
laboratory scientists) who are trained to perform various tests to
samples of biological specimens collected from its patients.
• Most of the clinical laboratories are situated within or near
hospital facilities to provide access to both physicians and their
patients.
•
Classifications of clinical laboratories reveal that these facilities can provide quality laboratory
tests that are significant for addressing medical and public health needs.

.
What kind of laboratories can be

• laboratory- can be government-owned 1. (public)

which is usually part of hospitals and medical centers
under the department of pathology or laboratory
medicine; or can be a 2. private facility as part of a
privately-owned medical/healthcare institution.
• According to function - can be general clinical
laboratories which provide common diagnostic
laboratory tests; or can be specific laboratories that
provide 3. disease-specific diagnostic laboratories we
can dothe confirmatory tests.
• According to test specialization - facilities can provide tests on a
particular field of interest listed below:
• Clinical Chemistry
• Clinical Microbiology
• Hematology
• Blood banking and Serology ( Immunohematology, Transfusion
Medicine)
Histopathology and Cytopathology
• Molecular Biology
 Molecular biology

Molecular biology, region of science concerned with studying the

chemical structures and processes of biological phenomena that
involve the basic units of life, molecules.
• The region of molecular biology is focused especially on nucleic
acids (e.g., DNA and RNA) and proteins—macromolecules that
are essential to life processes—and how these molecules
interact and behave within cells.
• Molecular biology appeared in the 1930s, having
developed out of the related region of biochemistry,
genetics, and biophysics; today it remains closely
associated with those sphere.
• Molecular biology is the branch of biology that studies
the molecular basis of biological activity.
• Living things are made of chemicals just as non-living
things are, so a molecular biologist studies how
molecules interact with one another in living organisms
to perform the functions of life.
The polymerase chain reaction (PCR) is a method widely
used to rapidly make millions to billions of copies (complete
or partial) of a specific DNA sample, allowing scientists to
take a very small sample of DNA and amplify it (or a part of
it) to a large enough amount to study in detail.
PCR was invented in 1983 by the American biochemist Kary
Mullis ; Mullis and biochemist Michael Smith, who had
developed other essential ways of manipulating DNA, were
jointly awarded the Nobel Prize in Chemistry in 1993.
• The region of molecular biology is focused especially on
nucleic acids (e.g., DNA and RNA) and proteins—
macromolecules that are essential to life processes—
and how these molecules interact and behave within
cells
Molecular Diagnostics Laboratory

Molecular Diagnostics Laboratory manipulations of nucleic acids are

susceptible to obstruction various stages, including specimen collection
and processing.
Introduction of inhibitory substances and contamination with false-
positive signals are among the significant obstacle.
• Blood specimens for nucleic acid testing are generally collected into
EDTA (Ethylenediaminetetraacetic acid) anticoagulant to inhibit
enzymes that might break them down.
• Heparin is a poor choice for anticoagulant in this application because it
can be coextracted with DNA and inhibits DNA polymerase in
polymerase chain reactions (PCRs).
• This process must be optimized for specimen type to recover high-
quality nucleic acids with good quantitative yield.
Hemin(iron-containing porphyrin) from hemolysis in plasma
or serum can also inhibit DNA polymerase.
RNA is labile in blood or tissues, so these specimens must be
stored appropriately by rapid freezing in liquid nitrogen if the
extraction will be delayed.
Extraction of nucleic acids from clinical specimens such as
plasma (e.g., for viral load measurement), blood cells (e.g.,
for genetic testing), or tissues (e.g., for analyzing mutations in
tumors) involve lysing cells and separating nucleic acids from
proteins and lipids.
• Liquid nitrogen has also been used as a method for
cooling concrete for over twenty years.
• Liquid nitrogen (LN) is an inert cryogenic fluid with a
temperature of − 196 °C [− 320 °F].
• The uses of nitrogen are expanding as progress is made in
the possibilities for efficient storage and transport of this
substance
Nitrogen was first liquefied on April 15, 1883, by Polish physicists
Zygmunt Wróblewski and Karol Olszewski.
• We must avoid contamination of specimens with target
nucleic acids from other specimens or with the specimens that
have been analyzed previously.
• Accordingly , laboratories practicing nucleic acid amplification,
especially polymerase chain reaction (PCR), should have
separate areas with strict rules about personnel movements
between them.
laboratory network

• Different levels the network of laboratory network operate

in a coordinated and supervised by authorities.
• 1. Peripheral laboratories - provide routine screening,
diagnostic (e.g. conventional and rapid diagnostic tests)
and follow up tests for patients; usually situated in the
community where people can access its services.
• 2. Intermediate-level laboratories - can be at the district,
provincial and regional-level facility, they carry out
management and supervisory tasks under specific areas of
jurisdiction (particularly provincial and regional
laboratories)
3. National reference laboratories - also known as the central level,
which performs management of the laboratory network official
control under Regulation those for assisting the validation of
methods of analysis, listed in Regulationin terms of policy and
program implementation, training and development, monitoring and
evaluation and research;
• these facilities also provide a range of routine and highly-specialized
laboratory testing, including the introduction of new diagnostic
tests.
• Method validation is a process that is used to demonstrate the
suitability of an analytical method for an intended purpose.
• Validation procedures have been developed by a variety of
industrial committees, regulatory agencies, and standards
organizations for purposes of quality control and regulatory
compliance.
• In the past, the value of clinical laboratories as an integral part of
the healthcare system was not well realized.
• Throughout time, more physicians have recognized the need for
laboratory tests to confirm their diagnoses and to support the
monitoring of their patients as to its response to therapy.
Laboratory networks were developed across countries and
states to foster good coordination and collaboration among
clinical laboratories within the specified geographic areas.
Quality management systems within these laboratories have
also become significant issues recently, including the
standardization of laboratory services, strengthening of
laboratory systems and the development of new and rapid
diagnostic tools.
Clinical laboratories

Clinical laboratories perform testing in a logical manner.

There are three phases of the laboratory testing process that
each facility should follow.
Standard operating procedure ( SOP) manuals and job aids
are written for guidance for carrying out each step of the
phase: pre-analytical, analytical and post-
analytical.
While clinical laboratories, especially in the modern day, are
usually known for its laboratory machines and instruments
that do the majority of actual sample testing, these facilities
still heavily hope on the laboratory professionals that ensure
that results are accurate.
 Issues of Concern

Providing high-quality, diagnostic testing is the goal of all

clinical laboratories. To attain this goal, several issues and
problems are needed to be addressed which ultimately
underline the need for improving laboratory capacity.
• Addressing human and financial resources, training and
supervision, quality assurance, logistics and supply,
biosafety and equipment management and other relevant
laboratory aspects were found to be necessary to optimize
laboratory services provided to patients.
• In 2018, the World Health Organization developed and
released the Essential Diagnostics List (EDL).
• Using the EDL with essential medicines list (EML),
authorities can now focus their efforts so that people can
receive laboratory services they need the most.
Accreditation for clinical laboratories became common recently
with the emergence of international laboratory standards.
Several guidelines for laboratories have been developed to
regulate laboratory test procedures and maintain its quality.
• An example of laboratory accreditation is the ISO provided by
the International Organization for Standardization (ISO) which
focuses on meeting the requirements for quality and
competence of medical laboratories.
• Another example is biosafety guidelines around microbiological
agents such as bacteria, viruses, parasites, and other agents
and microbiological products.
The need for risk management in clinical laboratories was
highlighted to maintain the accuracy and safety of laboratory
tests.
The Clinical Laboratory Standards Institute (CLSI) developed a
guideline to introduce the principles of risk management
specifically in the clinical laboratory.
• From risk assessment to risk analysis, evaluation and control
down to the process of continuous quality improvement, the
clinical laboratory should and must be able to minimize errors
along its path of the workflow (i.e., pre-analytic, analytic and
post-analytic phases).
• Such significant risks identified, for instance, in specimen
collection and handling and the of remove laboratory wastes
must be taken into consideration by all clinical laboratories
Clinical Significance

As the challenges faced by the clinical laboratories

constantly arise, the most important value for each
healthcare professional is the recognition its significance
for the patient health.
• Health authorities at the global level including clinicians,
experts and other healthcare professionals at the local
level must recognizing that the existence of clinical
laboratories taking its hold within the most important
clients of healthcare.
Laboratory medicine and medical laboratory
analyzes play an important role in most
disciplines of clinical medicine.
Medical laboratory research is a set of
consistent processes, which begins with the
collection of material and ends with the
interpretation of the results of the analysis.
These processes are: pre-analytics,
analytics, post-analytics.
 Preanalytical, analytical or post-analytical phases.

An integral part of laboratory work.

Factors affecting the usefulness of laboratory data may arise in
any of the preanalytical, analytical or post-analytical phases of
the testing cycle. Failures to consider these factors make
errors.
• If these errors occur prior to collection of blood or after
results have been produced, while still likely to be marked as
laboratory errors as the laboratory staffs.
• The clinical laboratory is a complex operation that must
smoothly integrate all three phases of the testing process:
preanalysis, analysis, and postanalysis.
• 1. Preanalysis refers to all the activities that take place before
testing, such as test ordering and sample collection.
• 2. The analysis stage consists of the laboratory activities that
actually produce a result, such as running a sample on an
automated analyzer.
• 3 postanalysis is patient result interpretation. Collectively, all
of the interrelated laboratory steps in the testing process
describe its workflow; this, in turn, occurs within the overall
design of a laboratory operation as described in its policies and
procedures.
• Yet the staff does have the responsibility to
educate those individuals who may have
caused them to ensure that such errors do
not occur.
• The quality of laboratory research can be
defined as the result of the analysis without
error. Laboratory error - this is any error that
occurred at any stage of the research.
• As a result of many studies, it was established
that the most frequent errors occur in the pre-
(45-60%) and post-analytical (25-47%) stages,
and the least frequently (7-15%) - in the
analytical phase.
The term preanalytics includes a set of
administrative and practical processes for
analysis: identification of containers, collection
of necessary material, processing, storage and
transportation to the laboratory immediately
before the start of research.
This procedure begins not with the collection of
material from the patient (for example, taking
blood from a vein), but earlier, when the
attending physician makes a decision to
prescribe a particular analysis, fills out the order
form, prepares the patient (for example,
stopping certain medications, fasting, etc. sh.).
Who is responsible for the preanalytics
process?
• The patient, who must take into account all the instructions
given orally or in writing by the doctor or laboratory
employees;
• A doctor who is required to correctly produce
documentation, create conditions for taking material,
provide written or verbal correct and timely instructions to
the patient before taking the material;
• A laboratory employee who must provide the doctor with an
accurate list of analyzes and all information necessary for
specific analyzes (what material should be taken, its storage,
transportation, supply of containers and other necessary
materials, order forms).
• In preparing a patient for phlebotomy, care should
be taken to minimize physiologic factors related to
activities that might influence laboratory.
• These include daily variation, exercise, fasting, diet,
ethanol consumption, tobacco smoking, drug
ingestion.
Diet. An individual’s diet can greatly affect laboratory test
results. Glucose and triglycerides, absorbed from food,
increase after eating. After 48 hours of fasting, serum bilirubin
concentrations may increase.
• Fasting for 72 hours decreases plasma glucose levels in
healthy women to 45 mg/dL (2.5 mmol/L), while men show
an increase in plasma triglycerides, glycerol.
• When determining blood constituents such as glucose,
triglycerides, cholesterol, and electrolytes, collection should
be done in the basal state.
• Eating a meal, depending on fat content, may elevate plasma
potassium, triglycerides, alkaline phosphatase.
Certain foods may affect serum or urine constituents.
Long-time vegetarian diets are reported to cause
decreased concentrations of low-density lipoproteins
(LDLs), very-low-density lipoproteins (VLDLs), total lipids,
phospholipids, cholesterol, and triglycerides.
Vitamin B12 deficiency can also occur, unless
supplements are taken .
• A high-meat or other protein-rich diet may increase
serum urea, ammonia levels.
• High-protein, low-carbohydrate diets, such as the
Atkins diet, greatly increase ketones in the urine and
increase the serum blood urea nitrogen (BUN).
Beverages rich in caffeine elevate plasma free fatty acids and
cause catecholamine release from the adrenal medulla and
brain tissue.
Ethanol ingestion increases plasma lactate, urate, and
triglyceride concentrations.
Elevated highdensity lipoprotein (HDL) cholesterol, γ-
glutamyl transferase (GGT), urate, and mean corpuscular
volume (MCV) have been associated with chronic alcohol
abuse.
• Serum concentrations of cholesterol, triglycerides,
lipoproteins are correlated with obesity.
• Plasma insulin concentration is also increased, but
glucose tolerance is impaired.
• In obese men, testosterone concentration is reduced.
Stress. Mental and physical stresses induce the production
of adrenocorticotropic hormone (ACTH), cortisol, and
catecholamines.
• Total cholesterol has been reported to increase with
mild stress, and HDL cholesterol to decrease by as much
as 15%.
• Hyperventilation affects acid-base balance and elevates
leukocyte counts, serum lactate, or free fatty acids.
• Pose of the patient during phlebotomy can have an effect on
various laboratory results.
• An upright position increases hydrostatic pressure, causing a
reduction of plasma volume and increased concentration of
proteins.
• Albumin and calcium levels may become elevated as one changes
position from supine to upright.
• Elements that are affected by postural changes (Pertaining to the
posture or position of the body, the attitude or carriage of the
body as a whole, or the position of the limbs (the arms and legs)
are albumin, total protein, enzymes, calcium, bilirubin,
cholesterol, triglycerides, and drugs bound to proteins.
• fist exercise can result in erroneous test results.
• Prolonged tourniquet application may also increase
serum enzymes, proteins, and protein-bound
substances, including cholesterol, calcium, and
triglycerides, as the result of hemoconcentration
when plasma water leaves the vein because of
back pressure.
After bed rest in the hospital, a patient’s
hemoglobin (Hb) can decrease from the original
admitting value enough to falsely lead a physician
to suspect internal hemorrhage or hemolysi.
This effect can be amplified by intravenous fluid
administration.
Patients should be advised to avoid changes in
their diet, consumption of alcohol, and exercise 24
hours before having their blood drawn for
laboratory testing.
age groups: newborn, childhood to puberty, adult, and elderly
adult .
In the newborn, much of the Hb is Hb F, not Hb A, as seen in
the adult. Bilirubin concentration rises after birth and peaks at
about 5 days. In cases of hemolytic disease of the fetus and
newborn (HDFN), bilirubin levels continue to rise. This often
causes difficulty in distinguishing between physiologic jaundice
and HDFN. Infants have a lower glucose level than adults
because of their low glycogen reserve.
With skeletal growth and muscle development, serum alkaline
phosphatase and creatinine levels, also increase.
The high uric acid level seen in a newborn decreases for the
first 10 years of life, then increases, especially in boys, until the
age of 16 .
• Gender. After puberty, men generally have higher
alkaline phosphatase, aminotransferase, creatine
kinase, and aldolase levels than women; this is
due to the larger muscle mass of men.
• Women have lower levels of magnesium, calcium,
albumin, Hb, serum iron, and ferritin.
Most serum components remain during adult life
until of menopause in women and middle age in
men.
Increases of about 2 mg/dL (0.05 mmol/L) per year
in total cholesterol and 2 mg/dL (0.02 mmol/L) per
year in triglycerides until midlife.
The increase in cholesterol seen in postmenopausal
women has been attributed to a decrease in
estrogen levels.
• Uric acid levels peak in men in their 20s but do not
peak in women until middle age. The elderly
secrete less triiodothyronine, parathyroid
hormone, aldosterone, and cortisol.
• After age 50, in men decrease concentration of
testosterone, and women have an increase in
pituitary gonadotropins, especially follicle-
stimulating hormone (FSH).
COMMON INTERFERENCES

• In Vivo
• Tobacco Smoking
• Tobacco smokers have high blood carboxyhemoglobin levels,
plasma catecholamines, and serum cortisol.
• Changes in these hormones often result in decreased numbers
of eosinophils, while neutrophils, monocytes, and plasma free
fatty acids increase.
• Chronic effects of smoking lead to increased Hb concentration,
erythrocyte (RBC) count, and leukocyte (WBC) count.
• Vitamin B12 levels may be decreased.
• Smoking also affects the body’s immune
response. Immunoglobulin (Ig)A, IgG, and IgM are
lower in smokers, and IgE levels are higher.
Decreased sperm counts and motility and
increased abnormal morphology have been
reported in male smokers when compared with
nonsmokers .
Analytical stage
• The analytical stage includes the technological
process of research, preparation of reagents and
instruments for research, accomplishment of the
analysis protocol, quality control procedures,
registration.
• Quality control at the analytical stage of research is
based on the use of control materials.
• Their analysis, the so-called control
measurements, makes it possible to draw a
conclusion about the reliability and reproducibility
of the results obtained in the laboratory.
Analytical stage
• It is a sample study in laboratories 13% of
the total number of errors occur on this
stage.
• Quality control of the analytical stage –
assessment results of measurements of
control samples.
Laboratory quality control research
• Analyzer control samples
• Intralaboratory control
• External control
What is Laboratory Quality Control?
• Laboratory quality control is all the measures put in
place to eliminate the risk of non-conforming results. It
involves systems that safeguard the accuracy, reliability
of lab results.
• It should be performed regularly and quality control
materials should be treated the same as samples.
• Laboratory quality control (QC) ensures that the lab
processes and operations run efficiently and guarantees
the production of accurate results.
• Failure quality control in a laboratory can lead to
several negative consequences, including the following:
• Time losses, as experiments and tests are repeated.
• Budget implications, as more reagents are needed to
carry out repeat tests and experiments.
• Loss of customer loyalty and satisfaction.
• not on time diagnosis or unnecessary treatments for
patients.
Intralaboratory control

• QC testing is performed within a laboratory to

monitor and ensure the reliability of test results
produced by the laboratory. Control materials
(usually liquid controls) are used to monitor the
test system and verify that quality patient test
results have been attained.
• A control is a stabilized sample with a
predetermined range of result values that
simulates a patient sample.
• Control samples are tested in the same way as patient
samples. If the results from testing a control sample are
not within the acceptable ranges, we assume there has
been a problem in the test procedure, equipment, or
the samples themselves.
• There are many criteria for rejecting a test based on
the control samples measurements; Patient results are
not reported until the cause of the problem has been
found, the problem resolved, and the controls retested
to verify that everything is working normally.
External control

• External Quality Control is defined as the

monitoring and evaluation work made by an
external system/institution/organization with
specimens the content or concentration of
which is known or unknown in order to ensure
or improve the truth of laboratory test results.
Post-analytical stage

• recording results (up to 71% errors)

• Patient reporting
• interpretation of the results,
• forming a conclusion
Conditions for obtaining a reliable laboratory
information on post-analytical stage

• Assessment of biological and clinical validity•

• Accounting for the influence of interferents, incl.
medicines•
• Accounting for gender, age, ethnic, professional
factors•
• Accounting for the critical difference in results•
• Evaluation of clinical informativeness and the need
for urgent action
Recording results

• At this stage, about 71% of errors occur , of them:

transfer from analyzers - 43%
• incorrect result - 13%assigned to the wrong patient –
9%
• loss of result - 6%
• At this stage, about 29% of errors occur, of them:
verification of results -12%
• recalculations - 11%
• wrong comment – 6%
The analytical stage, errors arise during the process of
testing or experimentation.
This could be due to the use of the wrong test
reagents, the use of defective and non-calibrated
equipment, the use of the wrong proportions of
reagents, and general non-adherence to standard
operating procedures (SOPs).
These errors can be minimized by ensuring that:
• All laboratory equipment is well maintained and calibrated.
• A proper inventory is in place, outlining all reagents and their
validity to ensure no expired reagents are in use.
• All standard operating procedures are documented and
accessible.
• Actions are taken on staff that is continually non-compliant
with the SOPs use.
• Errors can be introduced in the post-analytical stage through
incorrect calculations, recording, and interpretation of results.
 TIME OF COLLECTION
Sometimes, samples have to be collected at a specific time.
Failure to follow the planned time schedule can lead to
erroneous results and misinterpretation of a patient’s condition.
The most common tests in this category are the ASAP and stat
collections. ASAP means “as soon as possible,” and stat is an
American medical term meaning “immediately” (from the Latin
statim).
The exact definitions of these terms vary from one laboratory to
another. Stat specimens are collected and analyzed immediately.
They are given the highest priority and are usually ordered from
the emergency department and critical care units .
Tubes also come in various sizes for adult and pediatric
patient populations. Draw volume is determined by the
internal vacuum within the sealed tubes (e.g., 3.5, 4.0, 4.5,
or 8.5 mL).
• By using anticoagulants, plasma (obtained by
centrifugation) or whole blood can be analyzed.
• Plasma contains fibrinogen, which is missing from serum.
Many laboratories have converted from glass to plastic
collection tubes to minimize exposure to biohazardous
material (e.g., blood) and broken glass.
This change from glass to plastic has required a
modification in the order of draw.
• Glass or plastic tubes with additives, including gel
tubes, are drawn after the citrate tube (blue top) to
avoid interference with coagulation measurements.
• Glass or plastic serum tubes, without a clot
activator or gel separator, may be drawn before the
coagulation tubes are drawn, consistent with
Clinical and Laboratory Standards Institute (CLSI)
guidelines (GP41-A6) (Ernst & Calam, 2004).
Laboratory Analytical Instruments

• Analytical lab instruments surround a wide range of

instrumentation whose principle purpose is to
qualitatively and quantitatively analyze samples;
• The wide range of available equipment also allows
for a wide range of testing methods and their
respective applications.
Analyzer of gases and electrolytes
Diagnostica Stago
Category: Coagulation
Biochemical analyzer Cobas 311
Biosafety In The Laboratory

Biosafety in the Laboratory is of practical guidelines for

handling of biohazardous material.
It discusses high- and low-risk biological agents
(including the highest-risk materials handled in labs
today), presents the "seven basic rules of biosafety," of
dangerous materials, covers waste disposal in detail,
offers a checklist for administering laboratory safety.
Biosafety In The Laboratory
• The materials consist of infectious agents, as well as
substances actually or potentially contaminated with
them.
• A large number of laboratory workers handle such
materials as part of their daily routine.
• The persons at risk are primarily the laboratory workers
themselves, but the risks may extend to others: students,
and maintenance workers who must enter laboratories,
sanitation workers, and all who work in or pass through
building areas communicating to the laboratory.
Safe Handling of Infections Agents
• Infection is caused by pathogens ('bugs') such as
bacteria, viruses, protozoa or fungi getting into or
onto the body.
• It can take some time before the microbes multiply
enough to trigger symptoms of illness, which
means an infected person may accidentally be
spreading the disease during this incubation
period.
• Infection control in the workplace aims to prevent
pathogens from coming into contact with a person
in the first place.
• Employers are forced under the Occupational
Health and Safety Act 2004 to provide a safe
workplace for their employees, including the
provision of adequate infection control procedures
and the right equipment and training.
Transmission of infection
• Infectious agents can be spread in a variety of ways, including:
breathing in airborne germs – coughs or sneezes release
airborne pathogens, which are then inhaled by others
• touching contaminated objects or eating contaminated food –
the pathogens in a person's feces may be spread to food or
other objects, if their hands are dirty.
• skin-to-skin contact – the transfer of some pathogens can occur
through touch, or by sharing personal items, clothing or objects.
• contact with body fluids – pathogens in saliva, urine, feces or
blood can be passed to another person's body via cuts or
abrasions, or through the mucus membranes of the mouth and
eyes.
Assumption of risk
• The basis of good infection control in the
workplace is to assume that everyone is
potentially infectious.
• Proper procedures have to be followed at all
times. Every workplace should have an
appropriate first aid kit, with at least one staff
member trained in first aid.
• Equipment such as gloves, gowns, eye goggles and
face shields should be provided if necessary.
Workplace infection control – personal
hygiene practices
• Infection control procedures relating to good personal hygiene
include:
hand washing – the spread of many pathogens can be
prevented with regular hand washing.
Thoroughly wash hands with water and soap for at least 15
seconds after visiting the toilet, and after touching clients or
equipment. Dry hands with disposable paper towels.
• unbroken skin – intact and healthy skin is a major barrier to
pathogens. Cover any cuts or abrasions with a waterproof
dressing.
• gloves – wear gloves if you are handling body fluids or
equipment
• containing body fluids, if lab. workers are
touching someone else's broken skin or mucus
membrane, or performing any other invasive
procedure.
• Wash hands between each client and use fresh
gloves for each client where necessary.
• personal items – don't share towels, clothing,
razors, toothbrushes, shavers or other personal
items.
• The spread of hepatitis B virus (HBV), hepatitis C virus
(HCV), human immunodeficiency virus (HIV), and
tuberculosis (TB) has focused the responsibility on each
health care organization to protect its employees,patients,
and the general public from infection.
• The Centers for Disease Control and Prevention (CDC) and
the Occupational Safety and Health
• Administration (OSHA) have provided guidelines for safe
handling of body fluids and human tissues for all patients,
beginning with Universal Precautions.
• Blood, all other body fluids, and any unfixed tissue samples are
considered potentially infectious for various blood-borne
pathogens.
• In the laboratory, individuals should avoid mouth pipetting;
consumption of food; smoking; applying cosmetics; potential
needlestick situations; and leaving unprotected any skin,
membranes, or open cuts.
• Aerosol contamination may be due to inoculating loops
(flaming a loop), spills on laboratory counters, expelling a spray
from needles, and centrifugation of infected fluids.
The CDC has refined its recommendations for Universal
Precautions on several occasions, including in 1987 with
a set of rules known as Body Substance Isolation (Siegel
et al, 2007), and in 1996, with an approach known as
Standard Precautions; yet, as recent experience with
Ebola demonstrates, laboratory safety, especially with
respect to biologic hazards, requires constant vigilance
and the flexibility to adopt evolving recommendations.
ERGONOMIC HAZARDS
• Ergonomic hazards are physical factors in the environment
that may cause musculoskeletal injuries.
• These injuries may evolve from environmental factors such
mechanical pressure, vibrations, or compressive forces on the
arms, hands,neck, or back.
• Human error may also be a causative factor when individuals
push themselves beyond their limits or when productivity
limits are set too high.
• Although the ergonomics program standard was passed into
law
• Among laboratory personnel, cumulative trauma disorders
are usually related to repetitive pipetting, keyboard use, or
resting their wrists/arms on sharp edges, such as a laboratory
counter.
• These actions can cause carpal tunnel syndrome
(compression and entrapment of nerve from wrist to hand),
tendonitis (inflammation of tendon), or tenosynovitis
(inflammation or injury to synovial sheath)
• Employees must wash their hands after removal of gloves,
after any contact with blood or body fluids, and between
patients. Gloves should not be washed and reused because
microorganisms that adhere to gloves are difficult to
remove (Doebbeling et al, 1988). Masks, protective eyewear,
or face shields must be worn to prevent exposure from
splashes to the mouth, eyes, or nose. All protective
equipment that has the potential for coming into contact
with infectious material, including laboratory coats, must be
removed before leaving the laboratory area and must never
be taken home or outside the laboratory (such as during
lunch or personal breaks).
• Laboratory coats must be cleaned onsite or by a professional. It
is helpful for all employees to know what areas (offices,
conference rooms, lounges, etc.) and equipment (telephones,
keyboards, copy machines, etc.) are designated as laboratory
work areas because they can be potentially contaminated.
• Avoid contamination by not wearing soiled gloves when in these
areas or when using nonlaboratory equipment.
• Use of medical safety devices will help reduce the 600,000 to
800,000 needlestick injuries each year (NIOSH, 1999; Sharma et
al, 2009).
• Box 1-7 outlines some common materials that can be used for
decontamination (CLSI, 2005).
URINE AND OTHER BODY
FLUIDS COLLECTION

• Collection of urine for analytic testing must follow a carefully

prescribed procedure to ensure valid results.
• Laboratory testing of urine generally falls into three categories:
chemical, bacteriologic, and microscopic examinations. Several
kinds of collection are used for urine specimens: random, clean
catch, 24 hour, and catheterized.
• Random specimens may be collected at any time, but a first-
morning-is optimal for constituent concentration, because it is
usually the most concentrated and has a lower pH caused by
decreased respiration during sleep.
• Random urine specimens should be collected in a chemically
cleanreceptacle, either glass or plastic.
A clean-catch midstream specimen is most desirable for bacteriologic
examinations. Proper collection of a clean-catch specimen requires
that the patient first clean the external genitalia with an antiseptic
wipe; the patient next begins urination, stops midstream, and
discards this first portion of urine, then collects the remaining urine in
a sterile container.
A urine transfer can be transported to the laboratory.
• The system consists of an adapter that attaches to a yellow
evacuated sterile tube. The vacuum draws the urine into the
sterile tube.
• The adapter assembly must be treated like a needle
assembly system and be discarded into a biohazard
container.
• A similar product is available for cultures; it uses a sterile
gray-top tube containing 6.7 mg/L of boric acid and 3.335
mg/L of sodium formate , along with the adapter device
described previously (BD Vacutainer).
One can avoid problems in collecting 24-hour specimens by giving
patients complete written and verbal instructions with a warning that
the test can be invalidated by incorrect collection technique.
The preferred container is unbreakable, measures 4 L
(approximately), is plastic, and is chemically clean, with the correct
preservative already added.
The test is used to check kidney function. A 24-hour urine collection is
done by collecting the urine in a special container over a full 24-hour
period.
The container must be kept cool until the urine is returned to the lab.
Urine Storage and Preservation

• Preservation of a urine specimen is essential to maintain its

integrity.
• Unpreserved urine specimens are subject both to microbiologic
decomposition and to inherent chemical changes.
• To prevent growth of microbes, the specimen should be refrigerated
promptly.
• HENRY’S „Clinical Diagnosis AND Management BY Laboratory
Methods“

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