MICRC$COpE
A Publication of MEDQUEST, Laboratory Services of The Moses H.Cone Memorial Hospital
July 1995
CLIA '88: Round Two!
Congratulations! Most of you have survived your first CLIA
on-site survey and, from all indications, found the process to
be not nearly as traumatic as you had anticipated. The thrust
has been, as promised, to educate. It has been gratifying for
us to see the positive outcomes of the accreditation process,
including quality aspects, staff confidence, and pride in a job
well done.
CLIA has been the subject of much debate for most of the
past 12 months, but only recently have there been any
changes published regarding standards. For any of you who
have followed the official comments, there were really no
surprises. Following is a summary of the most noteworthy
issues.
Inspection Tidbits:
The most frequently cited deficiency
involved nonenrollment in appropriate
proficiency testing, followed by failure to
perform and/or document required quality
control procedures (particularly in the area
of microbiology); lack of a written quality
assurance program; and failure of the
medical director to carry out certain basic
responsibilities (such as reviewing QC / PT
records, and ensuring that the training/experience of their staff is well documented).
COLA Changes:
For those of you who had your COLA
survey fairly recently, we have just received
clarification on several issues.
• It will not be required that you check
calibrations on room thermometers or
hygrometers. Other thermometers
(refrigerators/incubators) are still required to be NBS/NIST traceable, or
must have calibration checked using a
certified standard.
Documentation, at least once each day
of patient testing, that internal
(procedural) controls worked will satisfy
CLIA's QC requirements. Some offices
seem more comfortable documenting
this with each patient test, and also
running external controls with each new
kit. No one will fault you for going the
extra mile to ensure good lab results!
COLA no longer requires that you
subscribe to PT for nonregulated tests.
These are moderate and high complexity
tests which probably aren't commonly
done in physician offices. They would
still require checking against another
method (internal PT) twice annually.
It's a little confusing, so don't hesitate to
call us if you need clarification.
MICRC$COpE
A Publication of MEDQUEST, Laboratory Services of The Moses H.Cone Memorial Hospital
July 1995
CLIA '88: Round Two!
Congratulations! Most of you have survived your first CLIA
on-site survey and, from all indications, found the process to
be not nearly as traumatic as you had anticipated. The thrust
has been, as promised, to educate. It has been gratifying for
us to see the positive outcomes of the accreditation process,
including quality aspects, staff confidence, and pride in a job
well done.
CLIA has been the subject of much debate for most of the
past 12 months, but only recently have there been any
changes published regarding standards. For any of you who
have followed the official comments, there were really no
surprises. Following is a summary of the most noteworthy
issues.
Inspection Tidbits:
The most frequently cited deficiency
involved nonenrollment in appropriate
proficiency testing, followed by failure to
perform and/or document required quality
control procedures (particularly in the area
of microbiology); lack of a written quality
assurance program; and failure of the
medical director to carry out certain basic
responsibilities (such as reviewing QC / PT
records, and ensuring that the training/experience of their staff is well documented).
COLA Changes:
For those of you who had your COLA
survey fairly recently, we have just received
clarification on several issues.
• It will not be required that you check
calibrations on room thermometers or
hygrometers. Other thermometers
(refrigerators/incubators) are still required to be NBS/NIST traceable, or
must have calibration checked using a
certified standard.
Documentation, at least once each day
of patient testing, that internal
(procedural) controls worked will satisfy
CLIA's QC requirements. Some offices
seem more comfortable documenting
this with each patient test, and also
running external controls with each new
kit. No one will fault you for going the
extra mile to ensure good lab results!
COLA no longer requires that you
subscribe to PT for nonregulated tests.
These are moderate and high complexity
tests which probably aren't commonly
done in physician offices. They would
still require checking against another
method (internal PT) twice annually.
It's a little confusing, so don't hesitate to
call us if you need clarification.
