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CHAPTER 6 -The MSDS describes the effects of overexposure or

exceeding the threshold limit value of allowable
Safety in the Immunology-Serology Laboratory exposure for an employee in an 8-hour day. The MSDS
Safety Standards and Agencies also describes protective personal clothing and
equipment requirements, first aid practices, spill
• U.S. Department of Labor, Occupational information, and disposal procedures.
Safety and Health Administration (OSHA)
• Clinical and Laboratory Standards Institute
(CLSI)
-a nonprofit educational organization that
provides a forum for the development, promotion,
and use of national and international standards
• Centers for Disease Control and Prevention
(CDC),
-part of the U.S. Department of Health and
Human Services Public Health Service
• College of American Pathologists (CAP)
• The Joint Commission (TJC)
The primary purpose of OSHA standards is to ensure
Figure 1: Hazardous Materials Classification
safe and healthful working conditions for every U.S.
worker. To ensure that workers have safe and Prevention of Transmission of Infectious Disease
healthful working conditions, the federal government
passed the Occupational Safety and Health Act of According to the CDC concept of Standard
1970 and, in 1988, expanded the Hazard Precautions, all human blood and other body fluids
Communication Standard to apply to hospital staff. are treated as potentially infectious for human
immunodeficiency virus (HIV ), hepatitis B virus (HBV
In 1991, OSHA mandated that all clinical laboratories ), and other blood-borne microorganisms that can
must implement a chemical hygiene plan and an cause disease in human beings.
exposure control plan. As part of the chemical
hygiene plan, a copy of the material safety data sheet Blood is the most important source of HIV, HBV, and
(MSDS) must be on file and readily accessible and other bloodborne pathogens in the occupational
available to all employees at all times. setting can be present in extraordinarily high
concentrations in blood, but HIV is usually found in
-The MSDS describes hazards, safe handling, storage, lower concentrations.
and disposal of hazardous chemicals. Information is
provided by chemical manufacturers and suppliers HBV may be stable in dried blood and blood products
about each chemical and accompanies the shipment at 25° C for up to 7 days.
of each chemical.
HIV retains infectivity for more than 3 days in dried
-Each MSDS contains basic information about the specimens at room temperature and for more than 1
specific chemical or product, including its trade week in an aqueous environment at room
name, chemical name and synonyms, chemical temperature.
family, manufacturer’s name and address,
Both HBV and HIV may be transmitted indirectly.
emergency telephone number for further information
about the chemical, hazardous ingredients, physical Viral transmission can result from contact with
data, fire and explosion data, and health hazard and inanimate objects, such as work surfaces or
protection information. equipment contaminated with infected blood or
certain body fluids. If the virus is transferred to the

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skin or mucous membranes by hand contact Generic sources of sodium hypochlorite include
between a contaminated surface and nonintact skin household chlorine bleach.
or mucous membranes, it can produce viral
Concentrations of 1:10 to 1:100 free chlorine are
exposure.
effective, depending on the amount of organic
The likelihood of infection in health care workers after material present on the surface to be cleaned and
exposure to blood infected with HBV or HIV depends disinfected.
on the following factors: • Concentration of HBV or
HIV; viral concentration is higher for HBV than HIV While wearing gloves, all work surfaces should be
•Duration of the contact. cleaned and sanitized at the beginning and end of the
shift with a 1:10 dilution of household bleach.
• Presence or skin lesions or abrasions on the hands Instruments such as scissors or centrifuge carriages
or exposed skin of the health care worker should be sanitized daily with a diluted solution of
bleach. It is equally important to clean and disinfect
• Immune status of the health care worker for HBV work areas frequently during the workday and before
Safe work practices for Infection control and after each shift.

OSHA requires laboratories to have a personal Studies have demonstrated that HIV is inactivated
protective equipment (PPE) program. The rapidly after being exposed to common chemical
components of this regulation include the following: germicides at concentrations much lower than used
in practice. Diluted household bleach prepared daily
• A workplace hazard assessment, with a written inactivates HBV in 10 minutes and HIV in 2 minutes.
hazard certification Disposable materials contaminated with blood must
• Proper equipment selection be placed in containers marked “Biohazard” and
properly discarded.
• Employee information and training, with written
competency certification Disposal of Infectious Laboratory Waste

• Regular reassessment of work hazards Containers for waste

The risk of nosocomial transmission of HBV, HIV, and OSHA has defined infectious waste as blood and
other bloodborne pathogens can be minimized if blood products, contaminated sharps, pathologic
laboratory personnel are aware of and adhere to wastes, and microbiological wastes. Infectious waste
essential safety guidelines. is packaged for disposal in color-coded containers
and labeled as such with the standard symbol for a
Protective Techniques for Infection Control biohazard.
-Selection and Use of Gloves Infectious waste (e.g., contaminated gauze squares
and test tubes) must be discarded into proper
-Facial Barrier Protection and Occlusive Bandages
biohazard containers with the following features:
-Laboratory Coats or Gowns as Barrier Protection
1. Conspicuously marked “Biohazard” with the
READ: universal biohazard symbol

-Guidelines for Handwashing and Hand Antisepsis in 2. Universal color—orange, orange and black, or red
Health Care Settings
3. Rigid, leakproof, and puncture resistant.
-Specimen-Processing Protection (Cardboard boxes lined with leakproof plastic bags
are available.)
-Additional Laboratory Hazards
4. Used for blood and other potentially infectious
Decontamination of Work Surfaces, Equipment, body fluids, as well as disposable materials
and Spills contaminated with blood or fluid
Sodium hypochlorite solutions are inexpensive and
effective broad-spectrum germicidal solutions.

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Final Decontamination of Waste Materials
Terminal disposal of infectious waste should be by
incineration; an alternate method is terminal
sterilization by autoclaving.
READ:
-Disease Prevention
-Basic First aid Procedures

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Quality Control
CHAPTER 7 It consists of procedures used to detect errors that
result from test system failure, adverse
Quality Assurance and Quality Control
environmental conditions, and differences between
Clinical Laboratory Regulatory and Accrediting technologists, as well as the monitoring of the
Organizations accuracy and precision of test performance over
time.
• Clinical Laboratory Improvement
Amendments of 1988 It monitors the accuracy and reproducibility of results
using control specimens. The diagnostic usefulness
• International Organization for of a test and its procedure is assessed by using
Standardization; ISO 15189 statistical evaluations, such as descriptions of the
Nonanalytical Factors Related to Testing Accuracy accuracy and reliability of the test and its
methodology.
• Qualified Personnel
Accuracy describes how close a test result is to the
• Established Laboratory Policies true value.
• Laboratory Procedure Manual Precision describes how close the test results are to
one another when repeated analyses of the same
• Test Requisitioning
specimen are performed.
• Patient Identification, Specimen
Procurement, and Labeling
• Preventive Maintenance of Equipment
• Appropriate Testing Methods
• Inaccurate Results
Errors Related to Phase to Testing
Errors occurring during the analytical phase of testing
in clinical laboratories are now relatively rare.
Currently, most laboratory errors are related to the
preanalytical and postanalytical phases of testing.
Pre-Analytical Errors The CV can be used to compare the standard
deviations of two samples. Standard deviations
Incorrect test request cannot be compared directly without considering the
Specimen obtained from wrong patient mean.The CV can be used to compare a day’s work
with that of a similar day or to compare test results
Specimen procured at wrong time from one laboratory with the same type of test results
Specimen collected in wrong tube or container from another laboratory. The coefficient of variation
(%) is equal to the standard deviation divided by the
Blood specimens collected in wrong order mean, as follows:
Incorrect labeling of specimen
Improper processing of specimen
Post-Analytical Errors Figure 2:CV Formula

Recording results inaccurately

Verbally reporting results for wrong patient
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The sensitivity of a test is defined as the proportion of laboratory analyses. With a properly designed control
subjects with the specific disease or condition who system, it is possible to monitor testing variables. If
have a positive test result. the control value in a determination is out of the
acceptable range (out of control), one or more of the
following factors may be responsible:

1. Deterioration of reagents or standards

Figure 3: Sensitivity Formula
2. Faulty instrument or equipment
The specificity of a test is defined as the proportion of 3. Dirty glassware
subjects without the specific disease or condition
who have a negative test result. 4. Lack of attention to timing or incubation
temperature

5. Use of a method not suited to the needs and

facilities of the laboratory

6. Use of poor technique by the technologist doing

Figure 4: Specificity Formula
the test
To assess the predictive value (PV ) for a test, the
7. Statistics: a certain percentage of all
sensitivity, specificity, and prevalence of the disease
determinations will be statistically out of control.
in the population being studied must be known. The
prevalence of a disease is the proportion of a READ:
population who have the disease. The incidence is
-Reference Range Statistics
the number of subjects found to have the disease
within a defined period, such as 1 year, in a -Testing Outcomes
population of 100,000
-Validating new procedures
Monitoring Quality

Proficiency testing (PT) is incorporated into the CLIA

requirements. In addition to the use of internal QC
programs, each laboratory should participate in an
external PT program as a means of verification of
laboratory accuracy. Periodically, a laboratory tests a
specimen that has been provided by a government
agency, professional society, or commercial
company.

A QC program for the laboratory uses a control

specimen, a specimen with a known value that is
similar in composition to the patient’s blood. A
control specimen must be carried through the entire
test procedure and treated in exactly the same way
as any unknown specimen; it must be affected by all
the variables that affect the unknown specimen.
Control specimens are used because repeated
determinations on the same or different portions (or
aliquots) of the same sample will not give identical
values. Many factors can produce variations in

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