Quality Flashcards
primary standard
reference material that has a known amount of analyte and is used for calibrating an instrument or preparing standard curves
secondary standard
reference material in which the analyte concentration has been determined by reference to a primary standard
calibrator
(in hematology)
a cell suspension whose parameters have been determined by multiple reference labs by reference methods in order to certify their assigned value
when are calibrators used in hematology?
to adjust the parameters on the automated analyzer (Coulter/Sysmex)
in Hematology, the only CBC measurement that is based on a standard is …
hemoglobin measurement (cyan-methemoglobin std)
when are calibrations performed?
- at installation
- routine maintenance (every 6 mos min)
- after the replacement or repair of parts
- when instrumentation drift occurs
- when WC failure occurs with no obvious instrument malfunction
how are calibrators different from controls?
used to adjust instrumentation or develop a std curve
a control must be: (3)
- similar in composition to unknown samples
- analyzed in the same manner as unknowns going through the entire procedure like unknowns
- stable
this is performed on hematology analyers before calibration, every six months, or as needed for troubleshooting purposes
precision checks
- uses a patient sample with normal CBC and diff
what is a delta check?
the computer compares current results obtained on a patient with their most recent previous result
- if significantly different= failed the delta check
- check sample integrity, sample labeling, check pt history
- if everything checks, append a comment is appended, and recollection is suggested
criticals procedure
- review testing conditions = no instrument error messages
- previous criticals?
- check specimen (clot?)
- confirm result, if required (ex: manual PLT estimate)
- verbally report results
constant systematic errors
in the same direction and if the same magnitude for all results
proportional systematic errors
increase in magnitude as the concentration of the substance being measured increases
these result in a loss of accuracy; with a change in mean but not SD
systematic errors
results in shifts or trends on the control chart
these are accidental and indeterminate and lack any definite pattern
random errors
- decrease the precision of a method and are indicated by a large SD