Chapter 1

Susceptible host - can be another patient during

Biologic Hazards invasive procedures, visitors, and health-care
personnel when exposed to infectious specimen or
Infection control - All health-care facilities have needlestick injuries.
developed procedures to control and monitor Susceptible host:
infectious occurring within their facilities. Immunocompromised patients
The chain of infection requires a continuous link
Newborns and infants
between an infectious agent, a reservoir, a portal
of exit, a means of transmission, a portal of entry, Elderly
and a susceptible host.
Table 1-1 TYPES OF SAFETY HAZARDS
Infectious agents:
Bacteria TYPE SOURCE POSSIBLE INJURY
Fungi
Parasites Biologic Infectious Bacterial, fungal,
Viruses agents viral, or parasitic
Reservoir - is the location of potentially harmful infections
microorganisms, such as a contaminated clinical
specimen or an infected patient Sharps Needles, Cuts, punctures, or
Fomites - equipment and other soiled inanimate lancets, blood-borne
objects. broken glass pathogen exposure
- They will serve as reservoirs, particularly if
Chemical Preservatives Exposure to toxic,
they contain blood, urine, or other body and reagents carcinogenic, or
fluids. caustic agents
The infectious agents must have a way to exit the
reservoir to continue the chain of infection. This Radioactive Equipment Radiation exposure
can be through the mucous membrane of the and
radioisotopes
nose, mout, eyes, and in blood, or other body
fluids. Electrical Ungrounded Burns or shock
Once the infectious agent has left the reservoir, it or wet
must have a way to reach a susceptible host. equipment;
Means of transmission include: frayed cords
1. Direct contact: the unprotected host
Fire/ explosive Open flames, Burns or
touches the patient specimen, or a organic dismemberment
contaminated subject (reservoir) chemicals
2. Airborne: inhalation of dried aerosol
particles circulating on air currents or Physical Wet floors, Falls, sprains, or
attached to dust particles heavy boxes, strains
patients
3. Droplets: the host inhales material from
the reservoir (e.g., aerosol droplets from a
patient or an uncapped centrifuge tube,
or when specimen are aliquoted or
spilled)
4. Vehicle: ingestion of a contaminated
substance (e.g., food, water, specimen)
5. Vector: from an animal or insect bite
Portal of entry - can be the same as portal of exit,
which includes the mucous membrane of the nose,
mouth, and eyes, breaks in the skin, and open
wounds.
Major importance in the laboratory
Proper hand hygiene
Correct disposal of contaminated
materials
Wearing personal protective equipment
(PPE)
The modification of UP for body substance
isolation (BSI) helped to alleviate this concern.
BSI guidelines are not limited to blood borne
pathogens; they consider all body fluids and moist
body substance to be potentially infectious.
A major disadvantage of BSI guidelines is that they
do not recommend hand washing after removing
gloves unless visual contaminants are present.
In 1996, the CDC and the Healthcare Infection
Control Practices Advisory Committee (HIPAC)
combined the major features of UP and BSi
guidelines and called the new guidelines Standard
Precautions.
Standard Precautions are as follows:
1. Hand hygiene: includes both hand
washing and the use of alcohol-based
antiseptic cleaners. Sanitizing hands may
be necessary between tasks and
procedures on the same patient to
prevent cross-contamination of different
body sites.
2. Gloves: wear gloves (clean, non sterile
gloves are adequate) when touching the
blood, bloody fluids, secretions,
excretions, and contaminated items.
3. Mouth, nose, and eye protection: A
specially fitted respirator (N95) must be
used during patient care activities related
to suspected mycobacterium exposure.
4. Gown: wear a gown (a clean, non sterile
gown is adequate) to protect skin and
prevent soiling of clothing during
procedures and patient care activities that
are likely to generate splashes or sprays of
blood, body fluids, secretions, or
excretions.
5. Patient care equipment: handle used
patient care equipment soiled with blood,
body fluids, secretions and excretions in a
manner that prevents skin mucous
membrane exposure, clothing
contamination, and transfer of
microorganisms to other patients or
environments. Ensure that single-use
items are discarded properly.
6. Environmental control: ensure that the
hospital has adequate procedures for the
routine care, cleaning, and disinfection of
environmental surfaces, beds, bed rails,
bedside equipment, and other frequently
touched surfaces.
7. Linen: prevents skin and mucous
membrane exposures and clothing
contamination and avoids the transfer of
microorganisms to other patients and
environments.
8. Occupational health and blood-borne
pathogens: use self-sheathing needles or
a mechanical device to conceal the
needle.
9. Patient placement
10. Respiratory hygiene/cough etiquette
The Occupational Exposure to Blood-Borne
Pathogens Standard is a law monitored and
enforced by OSHA. Specific requirements of this
OSHA standards include the following:
● Engineering controls
a. Providing sharps disposal
containers and needles with
safety devices.
b. Requiring discarding of needings
with the safety device activated
and the holder attached
c. Labeling all biohazardous
materials and containers.
● Work practice controls
a. Requiring all employees to
practice Standard Precautions
and documenting training on an
annual basis.
b. Prohibiting eating, drinking,
smoking, and applying cosmetics
in the work area.
c. Establishing a daily work surface
disinfection protocol.
● Personal protective equipment
a. Providing laboratory coats,
gowns, face shields, and gloves
to employees and laundry
facilities for non disposable
protective clothing.
 ● Medical
a. Providing immunization for the
hepatitis B virus free of charge.
b. Providing medical follow-up to
employees who have been
accidentally exposed
blood-borne pathogens.
● Documentation
a. Documenting annual training of
employees in safety standards
b. Documenting evaluations and
implementation of safer needle
devices.
Any accidental exposure to a possible blood-borne
pathogen must be immediately reported to a
supervisor. Evaluation of the incident must begin
right away to ensure appropriate postexposure
prophylaxis (PEP).
Personal Protective Equipment
PPE used in laboratories includes gloves,
fluid-resistant gowns, eye and face shields, and
plexiglas countertop shields. When a specimen is
collected, gloves should be changed between
every patient. A variety of gloves types are
available, including sterile and non sterile,
powdered and unpowdered, and latex and
nonlatex.
Reactions to latex include irritant contact
dermatitis, which produces patches of dry, itchy
irritation on the hands; delayed hypersensitivity
reactions resembling poison ivy that appear 24 to
48 hours after exposure; and rue, immediate
hypersensitivity reactions often characterized by
facial flushing and breathing difficulties. Any
symptoms of latex allergy should be reported to a
supervisor because true latex allergy can be
life-threatening.
Disposable coats are placed in containers for
biohazardous waste, and nondisposable coats are
placed in designated laundry receptacles.
A variety of protective equipment is available:
Mask and goggles
Full-face plastic shields that cover the
front and sides of the face
Mask with attached shield
Plexiglas countertop shields
Hand Hygiene
Hand contact is the primary method of infection
transmission. Alcohol-based cleaners can be used
when hands are not visibly contaminated. They are
to not recommended after contact with
spore-forming bacteria, including Clostridium
difficile and Bacillus spp.
Hand washing procedure
Equipment:
Antimaicrobial soap
Paper towels
Running water
Waste container
Procedure
1. Wet hands with warm water. Do not allow
parts of body to touch the sink
2. Apply soap, preferably antimicrobial
3. Rub to form a lather, create friction, and
loosen debris.
4. Rinse hands in a downward position to
prevent recontamination of hands and
wrists.
5. Obtain a paper towel from the dispenser.
6. Dry hands with a paper towel.
7. Turn off the faucet with a clean paper
towel to prevent contamination.
Biologic Waste Disposal
All biological waste, except urine, must be placed
in appropriate containers labeled with the
biohazard symbol.
The waste is then decontaminated following
institutional policy:
Incineration
Autoclaving
Pick-up by a certified hazardous waste
company
Disinfection of the sink using a 1:5 or 1:10 dilution
of sodium hypochlorite should be performed daily.
Sodium hypochlorite dilutions stored in plastic
bottles are effective for 1 month if protected from
light after preparations. The same solution also can
be used for routinely disinfecting countertops and
accidental spills. The solution should be allowed to
air-dry on the contaminated area.
Absorbent materials used for cleaning countertops
and removing spills must be discarded in biohazard
containers.
Sharp Hazards
Sharp objects in the laboratory, including needles,
lancets, and broken glassware, present a serious
biologic hazard, particularly for the transmission of
blood-borne pathogens. All sharp objects must be
disposed of in a puncture-resistant, leak-proof
container with the biohazard symbol.
Chemical spill kits containing protective apparel,
nonreactive absorbent material, and bags for
disposing of contaminated materials should be
available for cleaning up spills.
Chemical Handling
Chemicals should never be mixed together unless
specific instructions are followed, and they must
be added in the order specified.
Acid should always be added to water to avoid the
possibility of sudden splashing caused by the rapid
generation of heat in some chemical reactions.
Chemicals should be used from containers that are
of an easily manageable size.
Pipetting by mouth is unacceptable in the
laboratory.
Chemical Hygiene Plan
OSHA also requires all facilities that use hazardous
chemicals to have a written Chemical hygiene plan
(CHP) available to employees. The purpose of the
plan is to detail the following:
1. Appropriate work practices
2. Standard operating procedures
3. PPE
4. Engineering controls, such as fume hoods
and inflammables safety cabinets
5. Employee training requirements
6. Medical consultation guidelines
Each facility must appoint a chemical hygiene
officer, who is responsible for implementing and
documenting compliance with the plan.
Chemical Labeling
Hazardous chemicals should be labeled with a
description of their particular hazard, such as
poisonous, corrosive, flammable, explosive,
teratogenic, or carcinogenic.
The National Fire Protection Association (NFPA)
has developed the standard system for the
Identification of the Fire Hazards of Materials and
NFPA 704.
This symbol system is used to inform firefighters of
the hazards they may encounter with fires in a
particular area.
The diamond-shaped, color-coded symbol
contains information relating to health,
flammability, reactivity, and personal
protection/special precautions.
Each category is graded on a scale of 0 to 4, based
on the extent of concern.
Material Safety Data Sheets
The OSHA Federal Hazard Communication
Standard requires all the employees have a right to
know about all chemical hazards present in their
workplace.
Information contained in an MSDS includes the
following:
1. Physical and chemical characteristics
2. Fire and explosion potential
3. Reactivity potential
4. Health hazards and emergency first aid
procedures
5. Methods for safe handling and disposal
6. Primary routes of entry
7. Exposure limits and carcinogenic potential
Radioactive Hazards
Radioactivity may be encountered in the clinical
laboratory when procedures using radioisotopes
are performed.
The amount of radiation exposure is related to a
combination of time, distance, and shielding.
Persons working in a radioactive environment are
required to wear measuring devices to determine
the amount of radiation they are accumulating.
Electrical Hazards
Equipment should not operated with wet hands.
Designated hospital personnel minitor electrical
equipment closely; however, laboratory personnel
should continually observe for any dangerous
conditions such as frayed cords and overloaded
circuits, and report them to the supervisor.
Fire/Explosive hazards
The joint commission (JC) requires that all
health-care institutions post evacuation routes and
detailed plans to follow in the event of a fire.
When a fire is discovered, all employees are
expected to take actions in the acronym RACE:
Rescue - rescue anyone in immediate
danger
Alarm - activate the institutional fire
alarm system
Contain - close all doors to potentially
affected areas
Extinguish/evacuate - attempt
extinguish the fire, if possible or evacuate,
closing the door
2. Aim at the base of the fire
3. Squeeze handles
4. Sweep nozzle side to side
Quality Assessment
The term Quality Assessment (QA) refers to the
overall process of guaranteeing quality patient care
and is regulated throughout the total testing
system.
Quality system refers to all of the laboratory’s
policies, processes, procedures, and resources
needed to achieve quality testing.
In clinical laboratory, a quality assessment program
includes not only testing controls, referred to as
quality control (QC), but also encompasses
Pre examination variables (e.g., specimen
collecting, handling,and storage)
Examination variables (e.g., reagent and test
performance, instrument calibration and
maintenance, personnel requirements, and
technical competence)
Postexamination variables (e.g., reporting of
to
results and interpretation), and documentation
that the program is being meticulously followed.
QA program
Procedure manual
Internal quality control
External quality control
Electronic quality control
Calibration or calibration verification
Standardization
Proficiency testing (PT) more formally
known as External Quality Assessment
(EQA)
QA is the continual monitoring of the entire test
process from test ordering and specimen collection
through reporting and interpreting results.

Table 1-2 Types of Fires and Fire Extinguisher

Fire Type Extinguishing Type/Comp Extinguisher

Material osition of
Fire

Class A Wood, paper, Class A Water

The acronym PASS can be used to remember the clothing
steps in the operation:
1. Pull pin Class B Flammable Class B Dry
 organic chemicals, Nonmatching labels and requisition forms
chemicals carbon Contaminated specimens with feces or toilet
dioxide, paper
foam, or Containers with contaminated exteriors
halon Insufficient volume of urine
Improperly transported or preserved specimens
Class C Electrical Class C Dry Delay between time of collection and receipt in
chemicals, the laboratory
carbon
Examination variables are the processes that
dioxide, or
halon directly affect the testing of specimens. They
include reagents, instrumentation and equipment,
Class D Combustible None Sand or dry testing procedure, QC, preventive maintenance
metals powder (PM), access to procedure manuals, and
competency of personnel performing the tests.
Class ABC Dry
chemicals External Quality Control - used to verify the
accuracy (ability to obtain the expected result) and
Class K Grease, oils, Class K Liquid precision (ability to obtain the same result on the
fats designed to same specimen) of a test and are exposed to the
prevent same conditions as the patient samples.
splashing
Food and Drug Administration (FDA) standards
and cool in
the fire require that the control material test negative for
HIV and hepatitis virus.
Standard mean is the average of all data points
Preexamination variables occur before the actual
Standard deviation is a measurement statistic that
testing of the specimen and include test requests,
describes the average distance each data point in a
patient preparation, timing, specimen collection,
normal distribution is from the mean.
handling, and storage.
The CV indicates whether the distribution of values
TAT is defined as the amount of time required from
about the mean is in a narrow versus broad range
the point at which a test is ordered by the
and should be less than 5%.
health-care provider until the results are reported
Control ranges are determined by setting
to the health-care provider.
confidence limits that are within +-2 SD or +-3 SD
The form should include space for recording:
of the mean, which indicates that 95.5% to 99.7%
1. The actual date and time of specimen
of the values are expected to be within that range.
collection
Trend that is a gradual changing in the mean in
2. Whether the specimen was refrigerated
one direction
before transporting
Shift is an abrupt change in the mean.
3. The time the specimen was received in
Internal Quality Control consists of internal
the laboratory and the time the test was
monitoring systems built into the test system and
performed
are called internal or procedural controls.
4. Test are quested
External Quality Control uses a mechanical or
5. An area for specific instructions that
electrical device in place of a liquid QC specimen.
might affect the results of the analysis
EQC verifies the functional ability of testing
6. Patient identification information
devices, but it does not verify the integrity of the
All urine specimens should be examined within 2
testing supplies.
hours
PT or EQA is the testing of unknown samples
received from an outside agency, and provides
Table 1-4 Criteria for Urine Specimen Rejection unbiased validation of the quality of patient test
results.
Unlabeled containers
The Clinical Laboratory Improvement
Amendments (CLIA) mandates comparison testing
for laboratory accreditation.
Postexamination variables are processes that
affect the reporting of results and correct
interpretation of data.
Electronic transmission is now the most common
method for reporting results.
Summary 1-1 Quality Assessment
Preexamination
Patient misidentification
Wrong test ordered
Incorrect urine specimen type
collected
Insufficient urine volume
Delayed transport of urine to the
laboratory
Incorrect storage or preservation of
urine
Examination
Sample misidentification
Erroneous instrument calibration
Reagent deterioration
Poor testing technique
Instrument malfunction
Interfering substances present
Misinterpretation of quality control
data
Postexamination
Patient misidentification
Poor handwriting
Transcription error
Poor quality of instrument printer
Failure to send report
Failure to call critical values
Inability to identify interfering
substances
Study questions:
1. The current routine infection control
policy developed by CDC and followed in
all health-care settings is: Standard
Precautions
2. Quality assessment refers to: Quality of
specimens and patient care
3. During laboratory accreditation
inspections, procedure manuals are
examined for the presence of: critical
values, procedure reference and
procedure for specimen preservation
4. As supervisor of the urinalysis laboratory,
you have just adopted a new procedure.
You should: Put a complete, referenced
procedure in teh manual
5. Indicate whether each of the following
would be considered 1.) preexamination,
2) examination, 3) postexamination factor
by placing the appropriate number in the
blank:
a. Reagent examination date - 2
b. Rejecting a contaminated
specimen - 1
c. Constructing a Levy-Jennings
chart - 2
d. Telephoning a positive Clinitest
result on a newborn - 3
e. Calibrating the centrifuge - 2
f. Collecting a timed specimen - 1
6. The testing of sample from an outside
agency and the comparison of results
with participating laboratories is called:
Proficiency testing
7. A color change that indicates that a
sufficient amount of patient’s specimen or
reagent is added correctly to the test
system would be an example of: Internal
QC
8. What steps are taken when the results of
reagent strip QC are outside of the stated
confidence limits? : check the expiration
date of the reagent strip, run a new
control, open a new reagent strips
container.
9. When a new bottle of QC material is
opened, what information is placed on
the label?: The data and the laboratory
worker’s initials
10. When a control is run, what information is
documented? : The lot number,
expiration date of the control and the
test results