Lecture 2

Safety: Patient and Clinical

Laboratory Practices
 Objectives
• Know the lab phase where most errors that impact patient safety occur
• Define the term nosocomial
• Per CDC, what 3 hospital areas show the highest rate of infections
• List 2 Bloodborne pathogens mentioned in the lecture.
• Know the purpose of the SDS (formerly known as MSDS).
• Know the purpose of Standard Precautions.
• List all “4” of the different Biosafety levels of clinical labs.
• Describe the difference between biohazard waste and radioactive waste.
• Describe safety measures for specimen handling and shipping/transportation
 Patient Safety

• 98% of the errors in the diagnostic process occur in the

preanalytic phase.

• Communications and mitigating patient risk are two main

areas of patient safety.
 The Joint Commission National Patient Safety
Goals 2022
1. Correctly identify a patient by the using the
patient’s name and birth date.
2. Improve staff communication to ensure
getting important test results to the right staff
person on time.
3. Prevent infection by using CDC or WHO
guidelines.
4. Use alarms safely ensure alarms on medical
equipment are heard and responded to on time.
5.
 ASCLS Patient Safety Indicators
● Preanalytical
● Patient identification
● Phlebotomy-associated negative events
● Specimen identification
● Order entry
● Specimen integrity
● Effective use of the clinical laboratory
● Analytical
● Verification of the accuracy of abnormal results
● Postanalytical
● Communication of test results
● Effective use of test results
● Outcomes of laboratory testing
 ASCLS Procedure to Evaluate Patient
Safety in Laboratory Testing
● Seven steps:
1. Determine areas of risk.
2. Collect data.
3. Determine the denominator to calculate the error
rate.
4. Capture data.
5. Data analysis
6. Design intervention.
7. Follow-up
 Communications
• The need for clear communication is imperative.
• Avoiding direct communication of an error that
harmed a patient is unacceptable.
• Medical euphemisms are commonly used in clinical
laboratories to describe medical errors that harm
patients. The use of euphemisms is a bad habit
thought to be rooted in the desire to avoid painful,
complex quality improvement issues as well as the extra
work that improvement strategies create.
• Taking time to communicate will help ensure patient
safety.
 Mitigating Patient Risk
● Preparation for information technology outages
1. Planned outages for updates or upgrades
2. Unexpected failures or impairments with an unknown length of
downtime
● The initial step toward managing IT downtime is to
have a clear activation and communications plan
with established guidelines for initiating downtime
protocols.
● Share protocols with patient care areas.
● A single laboratory contact creates an organized approach.
● Focus on reporting critical information.
● Clear communication throughout is essential.
● Conduct a critique after the outage.
 Laboratory Safety
• Most laboratory accidents are preventable by
exercising good technique, staying alert, and using
common sense.
• Laboratory safety includes Occupational Safety and
Health Administration (OSHA) standards and CDC
guidelines.
• Ergonomics is a safety issue.
 Safety Standards and Governing
Agencies (1 of 4)
• US Department of Labor’s Occupational Safety and
Health Administration (OSHA)
• Clinical and Laboratory Standards Institute (CLSI)
• Centers for Disease Control and Prevention (CDC),
part of the US Department of Health and Human
Services (DHHS), US Public Health Service
• College of American Pathologists (CAP)
• The Joint Commission (TJC)
 Safety Standards and Governing
Agencies (2 of 4)
• National Health Care Safety Network (NHSN)
• This new voluntary system integrates a number of
surveillance systems and provides data on devices,
patients, and staff.
• The NHSN expands legacy patient and health care
personnel safety surveillance systems managed by
the Division of Health care Quality Promotion (DHQP)
at CDC.
 Safety Standards and Governing
Agencies (3 of 4)
● The National Nosocomial Infections Surveillance
System of the CDC survey showed that the highest
rates of infection occurred in the burn ICU, the
neonatal ICU, and the pediatric ICU.
● Risk factors for the invasion of colonizing pathogens can
be categorized into the following three areas:
● Iatrogenic risk factors
● Organizational risk factors
● Patient risk factors
● Nosocomial infections are estimated to occur in 5% of all
acute care hospitalizations.
 Safety Standards and Governing
Agencies (4 of 4)
• Occupational Safety and Health Administration Acts and
Standards (OSHA)
• Occupational Safety and Health Act of 1970
• Hazard Communication Standard (1988)
• Safety officer: staff orientation and periodic updating
• Safety coaches are volunteers who assume additional job
responsibilities.
• OSHA-Mandated Plans
• All clinical laboratories must implement a chemical
hygiene plan (CHP) and an exposure control plan.
• A copy of the safety data sheet (SDS) must be on file and
readily accessible and available to all employees at all
times.
 OSHA-Mandated Plans
• Chemical Hygiene Plan
• The core of the OSHA safety standard
• Hazard Communication Standard
• Requires that the chemical manufacturer, distributor, or importer
provide SDSs, formerly material safety data sheets
(MSDSs), for each hazardous chemical to downstream users to
communicate information on these hazards
• Occupational Exposure to Bloodborne Pathogens
• Requires that laboratories:
• Develop, implement, and comply with a plan that ensures the
protective safety of laboratory staff to potential infectious bloodborne
pathogens
• Manage and handle medical waste safely and effectively
 Hazard Communication Standard
Major changes to the standard in 2022 include:
• Hazard classification
• Provides specific criteria to address health and physical hazards
as well as classification of chemical mixtures
• Labels
• Chemical manufacturers and importers must provide a label that
includes a signal word, pictogram, hazard statement, and
precautionary statement for each hazard class and category.
• Safety data sheets
• SDS information is mostly the same as the MSDS, except the
SDSs are required to be presented in a consistent, user-friendly,
16-section format.
 Exposure Control Plan (1 of 2)
● The OSHA-mandated program, Occupational Exposure to
Bloodborne Pathogens, requires that laboratories:
● Manage and handle medical waste in a safe and effective
manner
● Develop, implement, and comply with a plan that ensures
the protective safety of laboratory staff to potential infectious
bloodborne pathogens
● All employees who handle hazardous material and waste
must be trained to use and handle these materials.
Chemical hazard education sessions must be presented to
new employees and conducted annually for all employees.
● Each laboratory is required to evaluate the effectiveness
of its plan at least annually and to update it as necessary.
 Exposure Control Plan (2 of 2)
● The CDC also recommends safety precautions
concerning the handling of all patient specimens,
known as Standard Precautions.
● OSHA has also issued guidelines for the laboratory worker
in regard to protection from bloodborne diseases spread
through contact with patient specimens.
● CDC provides recommendations for treatment after
occupational exposure to potentially infectious material.
● These agencies are working to reduce the risk of
exposure of health care workers to bloodborne
pathogens.
 Biohazards
• Denotes infectious materials or agents that present
a risk or even a potential risk to the health of humans
or animals in the laboratory
• Risk is defined as the probability that a health effect will
occur after an individual has been exposed to a specified
amount of a hazard.
• Bioterrorism agents are divided into categories A, B,
and C.
• Biosafety levels 1, 2, 3, and 4
• Risk assessment is an important part of biosafety.
Laboratories should perform a risk assessment to determine
if there are certain procedures or specimens that may
require higher levels of biocontainment.
 Avoiding Transmission of Infectious
Diseases (1 of 2)
• Laboratory-acquired infections
• Most frequent routes of exposure and accidental inoculation
are inhalation, percutaneous inoculation, contact
between mucous membranes and contaminated
material, and ingestion.
• Bloodborne pathogens
• An occupational exposure is a percutaneous injury
(e.g., needlestick or cut with a sharp object) or contact
by mucous membranes or nonintact skin (especially
when the skin is chapped, abraded, or affected with
dermatitis or the contact is prolonged or involves an
extensive area) with blood, tissues, blood-stained body
fluids, body fluids to which Standard Precautions apply, or
concentrated virus.
 Avoiding Transmission of Infectious
Diseases (2 of 2)
● The likelihood of infection after exposure to
blood infected with hepatitis B virus (HBV) or
human immunodeficiency virus (HIV) depends
on a variety of factors:
● The concentration of HBV or HIV virus; viral
concentration is higher for HBV than for HIV.
● The duration of the contact
● The presence of skin lesions or abrasions on the
hands or exposed skin of the health care worker
● The immune status of the health care worker for HBV
● Most exposures do not result in infection.
 Safe Work Practices for Infection
Control (1 of 2)
• Personal protective equipment (PPE)
• Selection and use of gloves
• Facial barrier protection (masks/ face shields) and
occlusive bandages
• Laboratory coats or gowns as barrier protection
• Other factors
• Nail care
• Shoes
• Electronic devices
• Handwashing
• Decontamination of work surfaces, equipment, and
spills
 Safe Work Practices for Infection
Control (2 of 2)
● Decontamination of work surfaces, equipment,
and spills
● Disinfection describes a process that eliminates
many or all pathogenic microorganisms, except
bacterial spores, on inanimate objects.
● In health care settings, objects usually are disinfected
by liquid chemicals or wet pasteurization.
● Disinfecting solutions include hypochlorites.
● Disinfecting procedure is used on nondisposable equipment.
● Disposable labware or supplies that have come in contact
with blood should be autoclaved or incinerated.
 General Infection Control Safety
Practices
• Pipetting safeguards: automatic devices
• Safety manual
• Sharps safety and needlestick prevention
• Use of the special sharps container permits quick disposal of a
needle without recapping and safe disposal of other sharp
devices that may be contaminated with blood.
• Do not recap, bend, break, or otherwise manipulate any
sharp needle or lancet device by hand.
• Transport and handling of diagnostic specimens
• Specimens should be transported to the laboratory in
plastic leakproof bags. Protective gloves should always be
worn for handling any type of biological specimen.
• Zika: within the United States as Category B Biological
substances
Laboratory Safety Practices (1 of 2)
• All devices in contact with blood and capable of
transmitting infection to the donor or recipient must be
sterile and nonreusable.
• Food and drinks should not be consumed in work
areas or stored in the same area as specimens.
Containers, refrigerators, or freezers used for specimens
should be marked as containing a biohazard.
• Specimens needing centrifugation should be capped
and placed into a centrifuge with a sealed dome.
• Rubber-stoppered test tubes must be opened slowly and
carefully with a gauze square over the stopper to
minimize aerosol production.
Laboratory Safety Practices (2 of 2)
• Autodilutors or safety bulbs should be used for pipetting.
Pipetting of any clinical material by mouth is strictly
forbidden.
• No tobacco products can be used in the laboratory.
• No manipulation of contact lenses or teeth-whitening
strips should be done with gloved or potentially
infectious hands.
• No lipstick or makeup should be applied in the
laboratory.
• All personnel should be familiar with the location and use
of eyewash stations and safety showers.
 Specimen-Handling and Shipping
Requirements
• Proper handling of blood and body fluids is critical to the
accuracy of laboratory test results, and the safety of all
individuals who come in contact with specimens must be
guaranteed.
• If a blood specimen is to be transported, the
shipping container must meet OSHA requirements
for shipping clinical specimens. Shipping containers
must meet the packaging requirements of major
couriers and US Department of Transportation
hazardous materials regulations.
• Zika precautions
 Prevention of Disease
Transmission (1 of 4)
• Immunization
• Hepatitis B
• Influenza
• Measles
• Mumps
• Rubella
• Varicella
 Prevention of Disease
Transmission (2 of 4)
• Optional immunizations
• Hepatitis A
• Meningococcal disease
• Pertussis
• Typhoid
• Vaccinia
• Other immunizations
• Other vaccine-preventable diseases include
diphtheria, pneumococcal disease, and tetanus.
 Prevention of Disease
Transmission (3 of 4)
• Screening tests
• Tuberculosis: Purified protein derivative (PPD,
Mantoux) skin test
• Rubella
• Hepatitis B surface antigen
• Prophylaxis, medical follow-up, and records of accidental
exposure
• Hepatitis B virus exposure
• Hepatitis C virus exposure
• Human immunodeficiency virus
 Prevention of Disease
Transmission (4 of 4)
• Respirators or masks for tuberculosis control
• Protection from aerosols
• Biosafety cabinets
• Negative-pressure isolation rooms
• Additional laboratory hazards
 Additional Laboratory Hazards
• Chemical hazards
• Electrical hazards
• Fire hazards
• Labware hazards
• Infectious waste
 Chemical Hazards
• Specific hazardous chemicals
• Sulfuric acid, nitric acid, acetic acid, hydrochloric acid, sodium
hydroxide, phenol, carbon tetrachloride, trichloroacetic acid,
ethers
• Select carcinogens
• Carcinogens are any substances that cause the development of
cancerous growths in living tissue.
• Protective measures
• When any potentially hazardous solution or chemical is
being used, protective equipment for the eyes, face, head,
and extremities, as well as protective clothing or barriers,
should be used. Volatile or fuming solutions should be used
under a fume hood. In case of accidental contact with a
hazardous solution or a contaminated substance, quick
action is essential.
 Electrical Hazards
• Shock or fire can result from electrical apparatus. OSHA
regulations stipulate that the requirements for grounding
electrical equipment published in the National Fire
Protection Association’s National Electrical Code must
be met. Some local codes are more stringent.
• All electrical equipment must be Underwriters
Laboratories approved.
• Regular inspection of electrical equipment decreases the
likelihood of electrical accidents. Grounding of all electrical
equipment is essential. Personnel should not handle
electrical equipment and connections with wet hands, and
electrical equipment should not be used after liquid has
been spilled on it. Any equipment used in an area where
organic solvents are present must be equipped with
explosion-free fittings.
 Fire Hazards
● Fire safety
● Personnel need to be trained in the use of safety equipment and
procedures. Annual retraining is mandatory. Each laboratory
must have equipment to extinguish or confine a fire in laboratory
and on clothing. Safety showers are essential. Fire blankets
must be easily accessible in wall-mounted cabinets.
● An easy acronym for use of fire extinguishers is PASS: pull,
aim, squeeze, and sweep.
● Fire classification
● Class A: Ordinary combustibles
● Class B: Flammable liquids and gases
● Class C: Electrical equipment
● Class D: Powdered metal (combustible) material
● Class E: Cannot be extinguished
 Labware Hazards
• Caution must be used to prevent unnecessary or
accidental breakage.
• Most labware currently used is discarded when broken.
Any broken or cracked labware should be discarded in a
special container for broken glass, not thrown in the
regular waste container.
• Common sense should be used in storing labware,
with heavy pieces placed on lower shelves and tall
pieces placed behind smaller pieces.
• Shelves should be installed at reasonable heights;
labware should not be stored out of reach.
 Infectious Waste
• OSHA regulations apply to human blood, human
infectious waste, and human pathologic waste.
• States often expand the definition of medical waste or blood to
include animals.
• Biohazard containers
• Body fluid specimens, including blood, must be placed in well-
constructed biohazard containers with secure lids to prevent
leakage during transport and for future disposal.
• Biohazard bags
• Plastic bags are appropriate for disposal of most infectious
waste materials, but rigid, impermeable containers should
be used for disposal of sharps and broken labware.
 Final Decontamination of Waste
Materials (1 of 2)
• Most laboratories generate at least three major types
of waste streams:
• Nonregulated waste
• Regulated medical waste (RMW)
• Chemical waste
• The RMW is divided into two groups:
• Biohazard waste
• Biohazard sharps
• The control of infectious, chemical, and radioactive
waste is regulated by various government agencies,
including OSHA and the US FDA.
 Final Decontamination of Waste
Materials (2 of 2)
• Infectious waste
• Must be discarded in proper biohazard containers, which should
have the following characteristics:
• Conspicuously marked “Biohazard” and bear the universal
biohazard symbol.
• Display the universal color: orange, orange and black, or red.
• Rigid, leakproof, and puncture resistant; cardboard boxes lined with
leakproof plastic bags are available.
• Used for blood, certain body fluids, and for disposable materials
contaminated with blood and fluids.
• Radioactive waste
• The Nuclear Regulatory Commission regulates radioactive
waste disposal. Waste associated with the radioimmunoassay
(RIA) laboratory must be disposed of with special caution.
 Safety Audit (1 of 4)
• Laboratory coats. Clean coats must be separated from
coats that are being used.
• Fire extinguishers should be in date and not expired.
• Biosafety cabinets and hoods need to be certified
annually.
• Eyewash stations and safety shower equipment need to
be within 100 feet or no more than a 10-second walk
from hazardous chemicals.
• Chemicals must be inventoried annually.
• Safety data sheets need to be available as hard copy or
electronically within 5 minutes of a request.
 Safety Audit (2 of 4)
• Basic first-aid procedures
• The first priority should be removal of the accident
victim from further injury, followed by definitive action
or first aid to the victim.
• A rule to remember in dealing with emergencies in the
laboratory is to keep calm.
• Because many injuries may be extreme, and because
immediate care is critical with such injuries, all
laboratory personnel must thoroughly understand the
application of the proper first-aid procedures.
 Safety Audit (3 of 4)
• Alkali or acid burns on the skin or in the mouth.
Rinse thoroughly with large amounts of running tap
water. If serious, consult a physician.
• Alkali or acid burns in the eye. Wash out eye
thoroughly with running water for a minimum of 15
minutes. Help the victim by holding the eyelid open
so water can make contact with the eye. An eye
fountain is recommended, but any running water will
suffice. Use of an eyecup is discouraged. A
physician should be notified immediately, while the
eye is being washed.
 Safety Audit (4 of 4)
• Heat burns. Apply cold running water (or ice in water) to
relieve pain and stop further tissue damage. Use a wet
dressing of 2 tablespoons of sodium bicarbonate in 1 quart
of warm water. Apply bandage securely but not tightly. For
third-degree burns, consult a physician immediately.
• Serious cuts. Apply direct pressure to the wound area to
control the bleeding, using the hand over a clean
compress covering the wound. Call for a physician
immediately.
• Minor cuts. Wash the wound carefully and thoroughly with
soap and water. Remove all foreign material that projects
from the wound by careful washing, but do not gouge for
embedded material. Apply a clean bandage if necessary.