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What agency provides guidelines for writing lab procedures and policies?
The Clinical and Laboratory Standards Institute (CLSI)
What agency(ies) mandate lab safety policies?
Center for Disease Control (CDC)
Occupational Safety and Health Administration (OSHA)
What is the chain of infection?
How microorganisms are transmitted
What is infection control?
Procedures put in place to control and monitor infections occurring within a facility
What is an infectious agent?
bacteria
fungi
parasites
viruses
What are the six elements of the chain of infection?
infectious agent
reservoir
portal of exit
means of transmission
portal of entry
susceptible host
What is a reservoir?
The location of potentially harmful microorganisms
What are some examples of a reservoir?
contaminated clinical specimens
infected patients
fomites
spores
What is the portal of exit?
The method in which an infectious agent exits the reservoir
What are some methods an infectious agent uses as a portal of exit?
through the mucus membranes of a reservoir’s mouth, nose and eyes
through blood and other body fluids
What is the means of transmission?
The way an infectious agent reaches a susceptible host after leaving the reservoir
What are some possible means of transmission?
direct contact: between the unprotect host and a patient, specimen or other contaminated object
airborne: inhaling aerosol particles circulating in the air or attached to dust particles
Droplets: inhaling aerosol droplets from the reservoir
Vehicle: Host ingests contaminated substance
Vector: from an animal or insect bite
What is the portal of Entry?
The means with which an infectious agent enters a new reservoir
What are some portals of entry?
sometimes the same as the port of exit ie through the mucus membranes of the mouth, nose and eyes
open wounds or breaks in the skin
What is a susceptible host?
Can be another patient during invasive procedures, visitors and healthcare professionals. Immunocompromised patients, infants and the elder are at increased risk
What is the most direct source of infection in the clinical laboratory?
Contact with patient specimens
What is PPE?
Personal protective equipment
gloves
lab coats
goggles
masks
What are some examples of practices used to break the chain of infection?
Proper hand hygiene
proper disposal of contaminated material
wearing PPE
Regular disinfection of work area
What does the Universal Precautions (UP) state and recommend?
That all patients are considered carriers of bloodborne pathogens. That gloves should be worn when handling and collecting blood and blood contaminated body fluids, wearing face shields when there is a possibility of samples splashing and that all sharps need to be disposed of in a puncture resistant container
What was originally excluded from UP?
Urine and body fluids not visibly contaminated with blood
What is the body substance isolation (BSI)?
Modification to UP to include all body fluids and moist body substances
What was a disadvantage of BSI?
It did not recommend hand sanitizing after removing gloves
What replaced both UP and BSI?
Standard Precautions
What are the SP guidelines?
Hand hygiene
Gloves
Mouth, eye and nose protection
Gown
Patient care equipment
Environmental control
Linen
Occupational Health and bloodborne pathogens: take care to prevent injuries when handling sharps
Patient placement
Respiratory hygiene/cough etiquette
What are engineering controls?
providing container sharps disposal and needles with safety devices
discarding needles with safety device activated and holder attached
labeling all biohazardous material and containers
What is the occupational exposure to bloodborne pathogens standard?
A law enforced by OSHA that requires control to be proved or mandated by the employer for all employees
What are work practice controls?
requiring all employees to practice SP and documenting training annually
prohibitng eating, drinking, smoking and applying cosmetics in work area
establishing a daily work surface disinfection protocol
Work places are required to prove what according to the Occupational Exposure to bloodborne pathogens standard law?
PPE
lab coats, gowns, face shields, and gloves
laundry facilities for non disposable protective clothing
Medical
Free HBV immunization
Follow up medical care to employees who have been accidentally exposed to blood borne pathogens
What Documentation is required according to the OEBPS law?
annual training in safety standards
evaluation and implantation of safer needle devices
Involving employees in selection and evaluation of new devices and maintaining that list and evaluations
sharp injury log and employee follow-up
If an accidental exposure occurs who must be notified first?
A supervisor
What is PEP?
Postexposure prophylaxis
What must occur within 24 hours of exposure?
A confidential evaluation to insure the proper PEP is initiated. If significant then HIV, HBV and HCV must be performed on employee and patient source alone with treatment and counseling.
Is wearing gloves a substitute for hand hygiene?
No
What are the symptoms associated with a latex allergy?
irritant contact dermatitis
delayed hypersensitivity reaction within 24-48 hours
immediate hypersensitive reaction
What are the requirements for lab coats in the clinical lab?
full length
fluid resistant
wrist cuffs
How should gloves be worn with lab coats?
Over cuffs
When must employees sanitize their hands?
before patient contact
after gloves are removed
before leaving work area
when hands have knowingly been contaminated
before going to break area
before and after using the bathroom
What does hand hygiene include?
Hand washing and alcohol based antiseptic cleansers
When are alcohol based cleanser recommend and when are they not?
When hands are not visibly contaminated. They are not recommended after contact with spore forming bacteria like Bacillus and C. diff
What biological waste does not have to be disposed of in a leakproof container labeled with a biohazard symbol/color?
Urine
How may urine be disposed?
In a sink with a Plexiglas countertop shield with care taken to avoid splashing. Then disinfected with 1:5 or 1:10 dilution of bleach.
When should lab countertops be disinfected?
After every shift and spill with a 1:10 dilution of bleach. Other products may be used as long as their effectiveness and contact time is known.
Should spills be moped or wiped?
No, absorbent powder or paper towels should be put on top to absorb as much as possible before disinfecting.
Should an attempt be made to neutralize chemicals when they come in contact with skin?
No
Should water be added to acid?
No acid should always be added to water in order to avoid splashing by the rapid generation of heat by some reactions.
What does OSHA require of facilities that used hazardous chemicals?
A chemical hygiene plan (CHP)
What is included in a CHP?
Appropriate work practices
Standard operating procedures
PPE
Engineering controls like fume hoods and flammables safety cabinets
Employee training requirements
Medical consultation guidelines
-all labs must appoint a chemical hygiene officer responsible for the implementation of the CHP
What should hazardous chemicals have?
A label with a description of their particular hazard
What does the diamond shaped NFPA label contain?
Health (Blue), Flammability (Red), Reactivity (Yellow) and specific hazards (white).
What are chemicals and regents that contain a hazardous ingredient in a concentration greater than 1% required to have?
A Safety Data Sheet (SDS)
What does a SDS contain?
physical and chemical characteristics
fire and explosion potential
reactivity potential
Health hazards and emergency first aid procedures
Methods for safe handling and disposal
Primary routes of entry
Exposure limits and carcinogenic potential
What is the globally Harmonized system (GHS)?
An international effort to standardize the classification of hazardous chemical and the symbols used to communicate that hazard and in the SDS.
What does a GHS label include?
GHS hazard pictograms, signal words and a GHS hazard statement.
What does RACE stand for?
Rescue : rescue anyone in immediate danger
Alarm: Activate the fire alarm
Contain: Close all doors to potentially affected area
Extinguish/evacuate: attempt to extinguish fire if possible or evacuate
What does PASS stand for?
Pull pin
Aim at base of fire
Squeeze handles
Sweep nozzle side to side
What does quality management (QM) refer to?
To the overall process of guaranteeing quality patient care.
What does quality management system (QMS) refer to?
To all of the lab’s polices. processes, procedures and resources needed to achieve quality testing.
In the clinical laboratory, QMS also includes?
quality controls
preexamination variables
examination variables
postexamination variables
documentation
What is a class A fire type and how is it extinguished?
Wood, paper or clothing fires, extinguished with water
What is a class B fire type and how is it extinguished?
Flammable organic chemicals and it is extinguished with dry chemicals, carbon dioxide, foam or halon
What is a class C type and how is it extinguished?
Electrical. Extinguished with dry chemicals, carbon dioxide or halon
What is a class D fire type and how is it extinguished?
Combustible metals. Extinguished with sand or dry powder. If fire created is type ABC, with dry chemicals
What is class K fire type and how is it extinguished?
Grease, oils and fats. Extinguished with liquid designed to prevent splashing and cool the fire
What is included in a QMS?
procedure manuals
internal quality control
external quality control
electronic quality control
calibration verification
standardization
proficiency testing
record keeping
equipment maintenance
safety programs
training
education and competency assessment of personnel
review of processes documentation
What is required by all accreditation agencies?
Documentation of QM procedures
What are preexamination variables?
Variables that occur before the actual testing of the specimen
What are some examples of preexamination variables?
test requests
patient preparation
timing
specimen collection
handling
storage
What should requisition forms include?
date and time of specimen collection
whether specimen was refrigerated
time specimen was received in lab and when testing was performed
tests requested
Area for specific instructions that might affect results
patient identification info
What time should all urine specimens be examined in and what should be done if this is not possible?
Within two hours and if not possible urine must be preserved.
When is a root cause analysis done?
When there is a problem with testing
What are examination variables?
Processes that directly affect the testing of samples
What are some examples of examination variables?
reagents
instrumentation and equipment
testing procedure
QC
preventive maintenance
access to procedure manuals
competency of testing personnel
All reagents must be labeled with?
date of preparation/opening
purchase/receive date
appropriate safety information
When should reagent strips be checked against a known positive and negative?
once a day at the minimum
each shift
when a new bottle is open
When should reagents be checked?
daily or when testing is performed
What does quality control (QC) refer to?
The materials, procedures, and techniques that monitor the accuracy, precision and reliability of a laboratory test
What are external quality controls?
Controls that are exposed to the same conditions as patients specimens.
What should a external control contain?
Concentrations at medically significant levels and be as much like human specimens as possible
How are external controls evaluated?
By establishing a mean and standard deviation through repeat measurements then seeing if result is within the established control range based on the established confidence interval
What are internal controls?
Internal monitoring systems built into the test system.
What are electronic controls?
Mechanical or electrical devices used in place of liquid QC specimens.
Do electronic controls verify the integrity of testing supplies?
No, they only verify the functional ability of a testing device
What is proficiency testing?
The testing of unknown samples received from an outside agency. They prove unbiases validation of the quality of patient test results.
What agency mandates comparison testing for laboratory accreduation?
Clinical Laboratory Improvement Amendments (CLIA)
What is an alternative CLIA QC option?
A individualized quality control plan (IQPC)
What does a IQCP consider?
The entire testing process and not just the frequency of QC and number of QC material
What does an IQCP require?
risk assessment
quality control plan
quality assessment
What are postexamiantion variables?
Processes that affect the reporting of results and correct interpretation of data
Reports may be?
Hand written or electronic
What must be present on a laboratory report?
patient first and last name
patient’s unique identification number
specimen collection date and time
specimen source
condition of unsatisfactory specimen
tests performed, results and reference range
date and time of final results
facility where test was performed
What is a delta check?
A QM procedure that compares patient’s test results with a previous result
What is specificity?
The likelihood of measuring the analyte desired
What is the sensitivity?
The lowest level of an analyte that a test can detect