Tip #1
When performing comparability studies, if the
analytes have different reportable ranges due to the
method and sample type, a method comparison is
still required. There is nothing in the guidance that
the instruments/methods must produce the same
results. The laboratory needs to define the
relationship between the different results
(acceptance criteria) and perform the comparison
twice yearly. CMS requirement 493.1281
Tip #2
Laboratories are not required to perform
comparability for waived instruments unless their
own policies state that they are to be done.
Tip #3
Laboratories should have records of action or
corrective action when the instrument comparability
criteria are not met.
COM. 04250
Comparability of Instruments and Methods -
Nonwaived Testing Phase II
If the laboratory uses more than one nonwaived
instrument/method to test for a given analyte, the
instruments and methods are checked against
each other at least twice a year for comparability
of results.
© 2016 College of American Pathologists. All rights reserved.
Summary
This requirement applies:
• To tests performed on the same or different
instrument makes/models or by different methods.
• Only for nonwaived instruments/methods
accredited under a single CAP number.
• NOT for calculated parameters or waived testing.
© 2016 College of American Pathologists. All rights reserved.
Additional reminders
• Quality control data may be used, but use of
human samples is preferred.
• If using quality control material:
– it must be the same instrument platform
– quality control and reagents must be of the same
manufacturer and lot number.
• The use of pooled patient samples is acceptable.
© 2016 College of American Pathologists. All rights reserved.
For Microbiology testing, this
requirement:
• Applies when two instruments (same or
different manufacturers) are used to detect the
same analyte.
• Does not apply to multiple analytical methods
(eg, antigen typing versus culture or detection
of DNA versus a biochemical characteristic)
designed to detect the same organism but not
the same analyte.
© 2016 College of American Pathologists. All rights reserved.
Single data collection systems
• Two or more detectors or incubation cells
connected to a single data collection, analysis and
reporting computer need not be considered
separate systems
• For example:
– multiple incubation and monitoring cells in a continuous
monitoring blood culture instrument,
– two identical blood culture instruments connected to a
single computer system, or
– multiple thermocycler cells in a real time polymerase
chain reaction instrument.
© 2016 College of American Pathologists. All rights reserved.
