SAFETY AND QUALITY MANAGEMENT Flashcards
most significant hazard in the immunology lab
obtaining and testing specimen
the manner of how organisms are transmitted is called
chain of infection
6 elements in chain of infection
infectious agent reservoir portal of exit means of transmission portal of entry susceptible source
infectious agents examples
bacteria
fungi
virus
parasite
a place where the infectious agent can live and multiply
reservoir
means of transmission
direct contact droplets airborne vehicle vector
MOT:
host touches contaminated medium
direct contact
MOT:
host inhales infected aerosol droplets from px or specimen
droplets
MOT:
host inhales dried aerosol particulates circulating on the air current or dust particles
airborne
MOT:
host ingests contaminated food or water
vehicle
MOT:
animal or mosquito bite
vector
In the chain of infection, a contaminated specimen or an infected patient is considered a/an:
reservoir
T/F:
Portal of exit and entry can be the same
TRUE
mucous membranes of the eyes, nose, mouth,
PEx: + other body fluids
PEn: + breaks in the skin, open wounds
Most susceptible hosts include:
Patients with severe diseases, receiving chemotherapy, newborns and infants, elderly, immunocompromised
T/F:
Once the chain of infection is complete, the infected host becomes another source able to transmit the microorganisms to others
TRUE
most likely source of infection in serological testing
CONTACT with patient specimens
best way to prevent completion of chain of infection
prevent transmission
2 main organizations who formulated guidelines to which laboratories must strictly adhere to.
Centers for Disease Control and Prevention (CDC)
Occupational Safety and Health Administration (OSHA)
1 prevention of infection
handwashing
methods of hand hygiene
handwashing
use of alcohol-based antiseptic cleansers
T/F:
use of alcohol-based antiseptic cleansers may be done after contact with spore-forming bacteria
FALSE:
alcohol-based cleansers are not recommended for sanitation upon contact with spore-forming bacteria.
Handwashing is necessary.
T/F:
Wearing gloves is a substitute for hand sanitizing
FALSE
T/F:
A true latex allergy from gloves can be life threatening
TRUE
CDC developed standard precautions by combining recommendations of what procedures?
universal precautions (UP) body substance isolation (BSI)
All patients were assumed to be potential carriers of bloodborne pathogens.
Universal precaution
OSHA stands for:
Occupational Safety and Health Administration
T/F:
Each health-care institution is responsible for designing and implementing its own exposure control plan
TRUE
Which regulation by OSHA requires all employers to have a written BloodBorne Pathogen Exposure Control Plan?
Occupational Exposure to BloodBorne Pathogen Standard
Components of the OSHA Bloodborne Pathogen Exposure Control Plan
- engineering controls
- work practice controls
- personal protective equipment
- medical
- documentation
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Providing sharps disposal containers and needles with safety devices
Engineering Controls
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Requiring discarding of needles with the safety device activated and the holder attached
Engineering controls
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Labeling all biohazardous materials and containers
Engineering controls
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Requiring all employees to practice standard precautions
Work Practice Controls
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Prohibiting eating, drinking, smoking, and applying cosmetics in the work area
Work Practice Controls
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Establishing a daily work surface disinfection protocol
Work Practice Controls
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Providing laboratory coats, gowns, face shields, and gloves to employees and laundry facilities for non-disposable protective clothing
Personal Protective Equipment
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Providing immunization for the hepatitis B virus free of
charge
Medical
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Providing medical follow-up to employees who have been accidentally exposed to bloodborne pathogens
Medical
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Documenting annual training of employees in safety standards
Documentation
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Documenting evaluations and implementation of safer
needle devices
Documentation
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Involving employees in the selection and evaluation of new devices and maintaining a list of those employees and the
evaluations
Documentation
Which component of the OSHA Bloodborne Pathogen Exposure Control Plan?
Maintaining a sharps injury log including the type and brand of safety device, location and description of the incident, and confidential employee follow-up
Documentation
How long before postexposure prophylaxis is initiated upon confirmation of infection in evaluation of a laboratory accident?
within 24 hours
most frequent encountered exposure in the laboratory that places laboratorians in danger of contracting viruses
needlesticks
In administering postexposure prophylaxis, what tests are conducted in the sample of the patient?
HBV, HCV, HIV
For instances of significant exposure, what could replace patient consent to proceed with testing?
physician order/court order
In laboratory accidents, when the patient tests positive for HIV, what medications and PEP are given?
PEP using zidovudine (ZDV)
one or two additional anti-HIV medications
In laboratory accidents, when the patient tests positive for HIV, when is the employee retested after administration of medication?
at intervals of 6 weeks, 12 weeks and 6 months
In laboratory accidents, when the patient tests positive for HBV, what medication or treatment is given for unvaccinated employees?
Hepatitis B immune globulin (HBIG)
HBV vaccine
In laboratory accidents, when the patient tests positive for HBV, what medication or treatment is given for vaccinated employees?
tested for immunity
PEP
In laboratory accidents, when the patient tests positive for HCV, what PEP is given?
No PEP is available
In case of needlestick injuries, any exposed employee should be counseled to report any
symptoms related to viral infection that occur within _______ of the exposure.
12 weeks
T/F:
All biological waste must be placed in appropriate containers labeled with the biohazard symbol
FALSE
except urine
most commonly used disinfectant for contaminated nondisposable equipment
1:10 dilution of sodium hypochlorite
what material should bleach be stored in
plastic
DOT stands for:
Department of Transportation
IATA stands for:
International Air Transport Association
Under DOT and IATA regulations, all diagnostic specimens require _________.
triple packaging
Inclusions in triple packaging
primary container (watertight with positive screw-on cap)
primary container wrapped with enough absorbent material
secondary container (leakproof)
when was the Needlestick Safety and Prevention Act signed into law?
2001
When was the Needlestick Safety and Prevention Act revised by OSHA?
June 2022
(all blood holders with needles attached should be immediately discarded into sharps container after the device’s safety feature is activated
how should acid and water be combined?
add acid to water
what to do when skin or eye gets in contact with chemicals?
flush area with water for 15 minutes then seek medical attention
(do not try to neutralize chemicals spilled on skin)
Safety Data Sheet is required for chemicals and reagents containing hazardous ingredients in a concentration of _________.
greater than 1%
Chemical Hygiene Plan include:
appropriate work practices SOPs PPE engineering controls employee training requirements medical consultation guidelines
Many kits used in the immunologic testing often contain what preservative
sodium azide
exposure to radiation is dependent on the combination of what three elements
time, distance, shielding
disposal of medical radioactive waste is regulated by the
Nuclear Regulatory Commission (NRC)
actions to be taken once a fire is discovered
Rescue
Alarm
Contain
Extinguish/Evacuate
Steps in opening a fire extinguisher
Pull pin
Aim at the base of the fire
Squeeze handles
Sweep nozzle side to side
symbol system for hazardous material and classification
NFPA 704
Hazardous Materials Classification:
BLUE
Health Hazard
Hazardous Materials Classification:
RED
Fire Hazard
Hazardous Materials Classification:
WHITE
Specific Hazard
Hazardous Materials Classification:
YELLOW
Reactivity
refers to the overall process of guaranteeing quality patient care
Quality Management
continual monitoring of the entire test process from test ordering and specimen collection through reporting and interpreting results
Quality Management
Normally, QA records are maintained for how long?
2 years
T/F:
A procedure manual may be in the form of paper or digital
TRUE
provides the basis for all testing in the laboratory
procedure manual
defined as anything that can be changed or altered
variable
defined as the amount of time required between the point which a test is ordered by the health care provider and the results are reported to the healthcare provider
TAT
processes that directly affect the testing of specimens
Examination variables
Reagents should be checked against how many levels of commercial control solutions on each shift?
two
When should reagents be checked against commercial control solutions
minimum once a day
each shift or;
whenever a new reagent is opened
Deionized water used for reagent preparation is quality controlled by checking its ph and purity meter resistance every when?
weekly
Who is responsible for signing and dating new procedures and all modification of procedures before they are used?
laboratory director
refers to the materials, procedures and techniques that monitor the accuracy, precision, and reliability of a laboratory test
Quality control (WC)
these procedures are performed to ensure that acceptable standards are met during the process of patient testing
QC
these controls are used to verify the accuracy and precision of a test
External controls
the ability to obtain the expected result
accuracy
the ability to obtain same results on the same specimen
precision
T/F:
The control material is exposed to the same conditions as the patient samples
TRUE
referred to as the ability to maintain both precision and accuracy
Reliability
FDA standards require that control material test negative for _______.
HBV, HIV
refers to the spread in the values that indicate the ability to repeat the analysis and obtain the same value
Gaussian distribution
refers to the average of all data points
control mean
a measurement statistic that describes the average distance each data point in a normal distribution is from the mean
standard deviation (SD)
SD expressed as a percentage of the mean; this indicates that whether the distribution of values about the mean is ina narrow versus broad range and should be less than 5%
coefficient of variation (CV)
refers to the limits between which the specified proportion or percentage of results will lie
Confidence intervals
in plotting control values, changes in accuracy of results are indicated by a ______, defined as the gradual changing in the mean in one direction that may be caused by a gradual deterioration of reagents or deterioration of instruments performance
trend
in plotting control values, changes in accuracy of results are indicated by a ______, defined as an abrupt change in the mean that may be caused by a malfunction of the instrument or a new lot number of reagents
shift
In conducting QC procedures, values are plotted on what type of control charts for visualization of control values
Levey-Jennings
internal controls are also termed as __________.
procedural contols
are used to monitor the sufficient addition of a patient specimen or reagent, instruments’ and reagents’ interaction and proper migration of samples in test strips.
Internal controls
These controls verify the functional ability of a testing device, but does not verify the integrity of testing supplies
Electronic control
the testing of unknown samples received from an outside agency
External Quality Assessment (EQA)
External Quality Assessment is also called __________.
proficiency testing
processes that affect the reporting of results and correct interpretation of data
Post-examination variables
most common method for reporting results
electronic/automated
this organization stipulates that all labs that perform testing on human specimens for the purposes of diagnosis, treatment, monitoring, or screening must be licensed and obtain a certificate form the CMS.
Clinical Laboratory Improvement Amendments (CLIA)
CMS stands for
Centers for Medicare and Medicaid Services
three categories of laboratory tests according to CLIA
waived
provider-performed microscopy procedures (PPMP)
nonwaived testing
Nonwaived testing is separated into the categories of _____ complexity with regard to requirements for personnel performing the tests.
High and moderate
which CLIA Test classification pertains to tests considered easy to perform by following the manufacturer’s instructions that have little risk of error
Waived
which CLIA Test classification pertains to microscopy tests performed by a physician, mid-level practitioner or a dentist
Provider-Performed Microscopy Procedure
which CLIA Test classification pertains to tests that require documentation of training in test principles, instrument calibration, periodic proficiency testing, and on-site inspections
Moderate complexity tests
which CLIA Test classification pertains to tests that require sophisticated instrumentation and a high degree of interpretation
High complexity tests
designed to coordinate activities to direct and control an organization with regard to quality and the reduction of medical errors
Quality Management System
basis of a quality management system (QMS)
Quality system essentials (QSEs)
how many QSEs are there?
12
What tool is being utilized by the lean system?
6S: sort straighten scrub safety standardize sustain
focuses on the elimination of waste to allow a facility to do more with less and at the same time increase customer and employee satisfaction
Lean System
primary goal is to reduce variables and decrease errors to a level of 3.4 defects per 1 million opportunities
Six Sigma
6 Sigma Methodology
Define goals and current processes
Measure current processes and collect data
Analyze the data for cause-and-effect information
Improve the process using the data collected
Control the correction of concerns displayed in the data
