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 environments. Ensure that single-use
Proper hand hygiene items are discarded properly.
Correct disposal of contaminated 6. Environmental control: ensure that the
materials hospital has adequate procedures for the
Wearing personal protective equipment routine care, cleaning, and disinfection of
(PPE) environmental surfaces, beds, bed rails,
The modification of UP for body substance bedside equipment, and other frequently
isolation (BSI) helped to alleviate this concern. touched surfaces.
BSI guidelines are not limited to blood borne 7. Linen: prevents skin and mucous
pathogens; they consider all body fluids and moist membrane exposures and clothing
body substance to be potentially infectious. contamination and avoids the transfer of
A major disadvantage of BSI guidelines is that they microorganisms to other patients and
do not recommend hand washing after removing environments.
gloves unless visual contaminants are present. 8. Occupational health and blood-borne
In 1996, the CDC and the Healthcare Infection pathogens: use self-sheathing needles or
Control Practices Advisory Committee (HIPAC) a mechanical device to conceal the
combined the major features of UP and BSi needle.
guidelines and called the new guidelines Standard 9. Patient placement
Precautions. 10. Respiratory hygiene/cough etiquette
Standard Precautions are as follows: The Occupational Exposure to Blood-Borne
1. Hand hygiene: includes both hand Pathogens Standard is a law monitored and
washing and the use of alcohol-based enforced by OSHA. Specific requirements of this
antiseptic cleaners. Sanitizing hands may OSHA standards include the following:
be necessary between tasks and ● Engineering controls
procedures on the same patient to a. Providing sharps disposal
prevent cross-contamination of different containers and needles with
body sites. safety devices.
2. Gloves: wear gloves (clean, non sterile b. Requiring discarding of needings
gloves are adequate) when touching the with the safety device activated
blood, bloody fluids, secretions, and the holder attached
excretions, and contaminated items. c. Labeling all biohazardous
3. Mouth, nose, and eye protection: A materials and containers.
specially fitted respirator (N95) must be ● Work practice controls
used during patient care activities related a. Requiring all employees to
to suspected mycobacterium exposure. practice Standard Precautions
4. Gown: wear a gown (a clean, non sterile and documenting training on an
gown is adequate) to protect skin and annual basis.
prevent soiling of clothing during b. Prohibiting eating, drinking,
procedures and patient care activities that smoking, and applying cosmetics
are likely to generate splashes or sprays of in the work area.
blood, body fluids, secretions, or c. Establishing a daily work surface
excretions. disinfection protocol.
5. Patient care equipment: handle used ● Personal protective equipment
patient care equipment soiled with blood, a. Providing laboratory coats,
body fluids, secretions and excretions in a gowns, face shields, and gloves
manner that prevents skin mucous to employees and laundry
membrane exposure, clothing facilities for non disposable
contamination, and transfer of protective clothing.
microorganisms to other patients or
 ● Medical Hand Hygiene
a. Providing immunization for the
hepatitis B virus free of charge. Hand contact is the primary method of infection
b. Providing medical follow-up to transmission. Alcohol-based cleaners can be used
employees who have been when hands are not visibly contaminated. They are
accidentally exposed to not recommended after contact with
blood-borne pathogens. spore-forming bacteria, including Clostridium
● Documentation difficile and Bacillus spp.
a. Documenting annual training of Hand washing procedure
employees in safety standards Equipment:
b. Documenting evaluations and Antimaicrobial soap
implementation of safer needle Paper towels
devices. Running water
Any accidental exposure to a possible blood-borne Waste container
pathogen must be immediately reported to a Procedure
supervisor. Evaluation of the incident must begin 1. Wet hands with warm water. Do not allow
right away to ensure appropriate postexposure parts of body to touch the sink
prophylaxis (PEP). 2. Apply soap, preferably antimicrobial
3. Rub to form a lather, create friction, and
Personal Protective Equipment loosen debris.
4. Rinse hands in a downward position to
PPE used in laboratories includes gloves, prevent recontamination of hands and
fluid-resistant gowns, eye and face shields, and wrists.
plexiglas countertop shields. When a specimen is 5. Obtain a paper towel from the dispenser.
collected, gloves should be changed between 6. Dry hands with a paper towel.
every patient. A variety of gloves types are 7. Turn off the faucet with a clean paper
available, including sterile and non sterile, towel to prevent contamination.
powdered and unpowdered, and latex and
nonlatex. Biologic Waste Disposal
Reactions to latex include irritant contact
dermatitis, which produces patches of dry, itchy All biological waste, except urine, must be placed
irritation on the hands; delayed hypersensitivity in appropriate containers labeled with the
reactions resembling poison ivy that appear 24 to biohazard symbol.
48 hours after exposure; and rue, immediate The waste is then decontaminated following
hypersensitivity reactions often characterized by institutional policy:
facial flushing and breathing difficulties. Any Incineration
symptoms of latex allergy should be reported to a Autoclaving
supervisor because true latex allergy can be Pick-up by a certified hazardous waste
life-threatening. company
Disposable coats are placed in containers for Disinfection of the sink using a 1:5 or 1:10 dilution
biohazardous waste, and nondisposable coats are of sodium hypochlorite should be performed daily.
placed in designated laundry receptacles. Sodium hypochlorite dilutions stored in plastic
A variety of protective equipment is available: bottles are effective for 1 month if protected from
Mask and goggles light after preparations. The same solution also can
Full-face plastic shields that cover the be used for routinely disinfecting countertops and
front and sides of the face accidental spills. The solution should be allowed to
Mask with attached shield air-dry on the contaminated area.
Plexiglas countertop shields
Absorbent materials used for cleaning countertops Chemical Labeling
and removing spills must be discarded in biohazard
containers. Hazardous chemicals should be labeled with a
description of their particular hazard, such as
Sharp Hazards poisonous, corrosive, flammable, explosive,
teratogenic, or carcinogenic.
Sharp objects in the laboratory, including needles, The National Fire Protection Association (NFPA)
lancets, and broken glassware, present a serious has developed the standard system for the
biologic hazard, particularly for the transmission of Identification of the Fire Hazards of Materials and
blood-borne pathogens. All sharp objects must be NFPA 704.
disposed of in a puncture-resistant, leak-proof This symbol system is used to inform firefighters of
container with the biohazard symbol. the hazards they may encounter with fires in a
Chemical spill kits containing protective apparel, particular area.
nonreactive absorbent material, and bags for The diamond-shaped, color-coded symbol
disposing of contaminated materials should be contains information relating to health,
available for cleaning up spills. flammability, reactivity, and personal
protection/special precautions.
Chemical Handling Each category is graded on a scale of 0 to 4, based
Chemicals should never be mixed together unless on the extent of concern.
specific instructions are followed, and they must
be added in the order specified. Material Safety Data Sheets
Acid should always be added to water to avoid the
possibility of sudden splashing caused by the rapid The OSHA Federal Hazard Communication
generation of heat in some chemical reactions. Standard requires all the employees have a right to
Chemicals should be used from containers that are know about all chemical hazards present in their
of an easily manageable size. workplace.
Pipetting by mouth is unacceptable in the Information contained in an MSDS includes the
laboratory. following:
1. Physical and chemical characteristics
Chemical Hygiene Plan 2. Fire and explosion potential
3. Reactivity potential
OSHA also requires all facilities that use hazardous 4. Health hazards and emergency first aid
chemicals to have a written Chemical hygiene plan procedures
(CHP) available to employees. The purpose of the 5. Methods for safe handling and disposal
plan is to detail the following: 6. Primary routes of entry
1. Appropriate work practices 7. Exposure limits and carcinogenic potential
2. Standard operating procedures
3. PPE Radioactive Hazards
4. Engineering controls, such as fume hoods
and inflammables safety cabinets Radioactivity may be encountered in the clinical
5. Employee training requirements laboratory when procedures using radioisotopes
6. Medical consultation guidelines are performed.
Each facility must appoint a chemical hygiene The amount of radiation exposure is related to a
officer, who is responsible for implementing and combination of time, distance, and shielding.
documenting compliance with the plan. Persons working in a radioactive environment are
required to wear measuring devices to determine
the amount of radiation they are accumulating.
Electrical Hazards 2. Aim at the base of the fire
3. Squeeze handles
Equipment should not operated with wet hands. 4. Sweep nozzle side to side
Designated hospital personnel minitor electrical
equipment closely; however, laboratory personnel Quality Assessment
should continually observe for any dangerous
conditions such as frayed cords and overloaded The term Quality Assessment (QA) refers to the
circuits, and report them to the supervisor. overall process of guaranteeing quality patient care
and is regulated throughout the total testing
Fire/Explosive hazards system.
Quality system refers to all of the laboratory’s
The joint commission (JC) requires that all policies, processes, procedures, and resources
health-care institutions post evacuation routes and needed to achieve quality testing.
detailed plans to follow in the event of a fire. In clinical laboratory, a quality assessment program
When a fire is discovered, all employees are includes not only testing controls, referred to as
expected to take actions in the acronym RACE: quality control (QC), but also encompasses
Rescue - rescue anyone in immediate Pre examination variables (e.g., specimen
danger collecting, handling,and storage)
Alarm - activate the institutional fire Examination variables (e.g., reagent and test
alarm system performance, instrument calibration and
maintenance, personnel requirements, and
Contain - close all doors to potentially
technical competence)
affected areas
Postexamination variables (e.g., reporting of
Extinguish/evacuate - attempt to
results and interpretation), and documentation
extinguish the fire, if possible or evacuate,
that the program is being meticulously followed.
closing the door
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 3. During laboratory accreditation
Amendments (CLIA) mandates comparison testing inspections, procedure manuals are
for laboratory accreditation. examined for the presence of: critical
Postexamination variables are processes that values, procedure reference and
affect the reporting of results and correct procedure for specimen preservation
interpretation of data. 4. As supervisor of the urinalysis laboratory,
Electronic transmission is now the most common you have just adopted a new procedure.
method for reporting results. You should: Put a complete, referenced
procedure in teh manual
5. Indicate whether each of the following
Summary 1-1 Quality Assessment
would be considered 1.) preexamination,
Preexamination 2) examination, 3) postexamination factor
Patient misidentification by placing the appropriate number in the
Wrong test ordered blank:
Incorrect urine specimen type a. Reagent examination date - 2
collected b. Rejecting a contaminated
Insufficient urine volume specimen - 1
Delayed transport of urine to the c. Constructing a Levy-Jennings
laboratory chart - 2
Incorrect storage or preservation of d. Telephoning a positive Clinitest
urine
result on a newborn - 3
Examination e. Calibrating the centrifuge - 2
Sample misidentification f. Collecting a timed specimen - 1
Erroneous instrument calibration 6. The testing of sample from an outside
Reagent deterioration agency and the comparison of results
Poor testing technique with participating laboratories is called:
Instrument malfunction Proficiency testing
Interfering substances present 7. A color change that indicates that a
Misinterpretation of quality control sufficient amount of patient’s specimen or
data reagent is added correctly to the test
system would be an example of: Internal
Postexamination QC
Patient misidentification 8. What steps are taken when the results of
Poor handwriting reagent strip QC are outside of the stated
Transcription error confidence limits? : check the expiration
Poor quality of instrument printer date of the reagent strip, run a new
Failure to send report
control, open a new reagent strips
Failure to call critical values
container.
Inability to identify interfering
9. When a new bottle of QC material is
substances
opened, what information is placed on
the label?: The data and the laboratory
Study questions: worker’s initials
10. When a control is run, what information is
1. The current routine infection control documented? : The lot number,
policy developed by CDC and followed in expiration date of the control and the
all health-care settings is: Standard test results
Precautions
2. Quality assessment refers to: Quality of
specimens and patient care