exam 1 Flashcards
QM in the lab
framework for managing and monitoring activities to address quality standards and achieve organizational goals
Quality assurance
ensuring that plans, policies and procedures across the entire path of specimen workflow are followed.
- assessing the info gathered during QC activities & identifying & eliminating problems
are quality assurance and quality assessment the same thing?
yes
Quality Control
focuses on analytical, usually monitoring and recording the daily performance of lab equipment, as well monitoring testing reagent lot #s and expiry dates
internal controls are used within labs to…
ensure quality testing results
statistical QC
involves running specimens controls with known values
purpose is to detect error in the procedure by comparing control results to expected values
non statistical QC
does not monitor actual production of test results, but it supports the ability to ensure our test results are valid
(documenting daily temperatures)
trouble shooting:
F- figure out what’s going on
I- isolate the cause
R- resolve the problem
E- evaluate the solution
D- document all steps and outcomes
specimen integrity
before either specimen POC testing or specimen loading on an instrument, it is imperative to ensure sample integrity
hemolyzed
damaging of intact RBCs
fluid portion serum/plasma will appear clear red due to RBCs been lysed and the release of hemoglobin into fluid oortion
icteric
specimens can be identified by abnormal yellow-brown colour of the specimens plasma/serum
due to an increase of bilirubin the blood
lipemic
both serum/plasma will appear foggy and have a white hue due to presence of fats and lipids suspended in the fluid portion of blood
specimen collection is part of which workflow in the lab
pre analytical
preparing QC material is a part of which workflow in the lab
analytical
specimen storage in walk in fridges is part of which workflow in the lab
post analytical
when a lab profession prepares and runs QC material on a set schedule, what i type of QC are they performing
internal statistical QC
what range on the standard bell curve is selected most often for the limit of control ranges in the clinical lab
+/- 2 SD
in the acronym FIRED used for troubleshooting, what does the E stand for
evaluate
which workflow do most lab errors happen
pre analytical
asking patient to identify themself is what workflow
pre analytical
accessioning is part of what workflow
pre analytical
specimen storage is part of what workflow
post analytical
examples of pre analytical
test ordering
specimen collection
specimen transport
specimen receipt and processing
examples of analytical
test performance
review of test results
interpretation of test results
examples of post analytical
test result reporting
specimen management
QC is typically what workflow
analytical
non statistical QC
involves procedures that maintain and improve performance of analytical methods
examples of non statistical QC
daily temps
maintenance and troubleshooting on lab equipment
room temp and humidity
statistical QC is
the use of specimen controls and QC charts to monitor the performance of analytical methods and assess the validity of patient test results
statistical QC in the lab involves
running specimen controls with known values
what is a control range
is the acceptable range of QC values that accounts for normal day to day variations
acronym FIRED for troubleshooting the F stands for?
figure out what’s going on
acronym FIRED for troubleshooting the I stands for?
isolate the cause
acronym FIRED for troubleshooting the R stands for?
resolve the problem
acronym FIRED for troubleshooting the D stands for?
document all steps and outcomes
pre analytical
activities that take place from the time the lab tests are ordered to the time the specimens are processed and delivered to the testing laboratory
analytical
activities involved in performing a test, verifying the reliability of the test results and interpreting the findings
post analytical
activities involved in reporting and archiving results as well as retention of specimens
QA
ensures that plans, policies and procedures across the entire path of specimen workflow are followed
statistical WC control are samples with ** concentration of analytes and are carried through the *** run of the test procedure exactly like a patient sample
known, analytical
matrix
a control should be the same matrix as the patient samples so that it behaves the same as a patient specimen in the test method
lyophilized
freeze dried
control range
the acceptable range of QC values that accounts for normal day-to-day variations
confidence interval
the control range 95% of the time, it is also know and a 95% CI
during hemolysis the plasma/serum will appear…
clear and red due to red cells being lysed and the release of hemoglobin into the fluid portion
how does icteric happen
due to an increase in bilirubin in the blood which can be caused by increased destruction of red cells
how does lipemic happen and can be cleared by?
due to the presence of fats or lipids suspended in the fluid portion of the blood
can be cleared by ultracentrifugation prior to testing
what tube top has strict volume requirements and must be followed?
NaCit
reasons why POC testing is gaining popularity
smaller volume of patient specimen required
staffing shortages
portability
accessibility for rural communities
reduced TAT
convenience
examples of non instrument POC test
pregnancy tests
urine reagent strips/dipsticks
blood glucose reagent strips/dipsticks
infectious mononucleosis
examples of handheld automated POC tests
glucose
hemoglobin
cardiac markers
prothrombin time with INR
MLA role in POC testing
responsible for the calibration and QC for both the non instrument and handheld tests
