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What are the six quality aims for healthcare?
Safe
Effective
Patient-centered
Timely
Efficient
Equitable
What is “safe”?
Provide service which prevents harm to patients and improves healthcare outcomes ( e.g. diagnostic process, ensure continuous quality improvement, etc.)
What is “effective“?
“Use evidence-based knowledge to limit and prevent overuse, underuse and misuse of services“
What is “patient-centered”?
Respond to and be respectful of patient preferences, needs, and values
What is “timely“?
Reduce wait times and delays in providing service for patients, clinicians, and other healthcare professionals
What is “efficient“?
Avoid and reduce waste and inefficiencies (e.g., time, energy, ideas, supplies, equipment, etc.)
What is “equitable“?
Deliver care without variation due to gender, ethnicity, geographic location, and socioeconomic status
Who is responsible for Quality Assurance in the lab?
Lab managers/directors
Lab supervisors
Testing personnel
Phlebotomists
Other lab personnel
Other healthcare providers
Hospital administration
What is an Individualized Quality Control Plan (IQCP)?
Looks at TOTAL TESTING PROCESS
Requires continuous monitoring of laboratory quality
What is the purpose of the Individualized Quality Control Plan (IQCP)?
Identify & minimize risks that could potentially result in erroneous laboratory results
What is the required documentation for IQCP?
Risk Assessment
Quality Control Plan
Quality Assessment
What are policies?
Written statement of lab’s intent
Derived from external requirements or organizational mandate
Describes “what is done”
What are procedures?
Instructions for how to do an activity within the larger process
What are processes?
Written description of “who does what“ and “when”
What are Forms?
Means by which data, information, or results are captured from performance of a procedure
What are records?
Form with data, information, or result entered
What are internal assessments?
Competency testing
Monitor processes with quality indicators
Comparison of performance to similar measures
What are external assessments?
Participation in assessment conducted by external organizations
Proficiency testing
What are the four steps of quality improvement?
Plan
Do
Check
Act
What is a fishbone diagram?
Helps determine root cause using structured approach
Encourages group participation
Utilizes knowledge from different disciplines
Indicates possible variations in process
Indicates areas where more data should be collected
What is a reportable range?
the lowest that can be detected by analyzer and the highest that can be detected by analyzer
What is a Reference Range?
Range of normal values in patient population
What is assayed QC material?
most expensive
all the statistical work has been done
What is unassayed QC material?
cheaper
need to run more tests to get reference range
What is in-house QC materials
materials made at the lab
typically used in research labs
What is a systemic error?
continuous and/or consecutive errors
What is a random error?
one time error
What is a 1-2s violation?
value falls outside 2 standard deviations 1 time
What is a 1-3s violation?
value falls outside of 3 standard deviations 1 time
What is a 2-2s violation?
value that falls out of 2 standard deviations 2 times (consecutively)
What is a R-4s violation?
where 2 values are 4 standard deviations away from each other
What is a 4-1s violation?
values (consecutively) stays within 1 standard deviation 4 times
What is a 6x violation?
value (consecutively) stays on one side of the mean 6 times
What are the steps (IN ORDER) to perform when controls are out?
REPEAT — could be a random error
Inspect control material and reagent for problems (i.e. mold haha)
Run new control/ reagent
Review calibration
Contact manufacturer (DEF CON 5 everybody fucked up)
What is a trend?
Gradual change in mean
Indicates systemic error
What is a shift?
Abrupt change in mean
Indicates random error
What is a cofactor?
Nonprotein molecule needed for enzymatic activity
What is an isoenzyme?
Different forms of the same enzyme
What is a coenzyme?
Organic cofactor
What is an apoenzyme?
Enzyme without cofactors
What is a product?
Compound(s) formed
What is a haloenzyme?
Complete enzyme-cofactor complex
What is a substrate?
Reactant in enzymatic reaction
What are the functions of enzymes?
In vitro:
Used in the lab for enzymatic reactions when determining the concentration of an analyte
In vivo:
Quantitated by catalytic effect on substrate in rxn mixture
What are some qualities of first order kinetics?
E>S
Rate of rxn inc as more S is added
Rate of reaction proportional to S concentration
What are some characteristics of zero order kinetics?
S>>>E
Maximum velocity
Rate of reaction proportional to E concentration
How do COMPETITIVE inhibitors affect enzyme reactions?
KM increases
Vmax same
Reversible
How do NONCOMPETITIVE inhibitors affect enzyme reactions?
Vmax ecreases
Same KM
How do UNCOMPETITIVE inhibitors affect enzyme reactions?
Irreversible
KM decreases
Vmax decreases