Organizations Flashcards
Centers for Medicare and Medicaid Services (CMS)
- enforces CLIA
- proxy through CAP and JCAHO to inspect and accredit for CLIA certification
Clinical Laboratory Improvement Amendments (CLIA)
CLIA certification required for repayment for Medicare/Medicaid testing
College of American Pathologists (CAP)
- CMS proxy
- regulate proficiency testing for labs
Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
- CMS proxy
- regulate proficiency testing for labs and hospital
- more recognized by nurses than clinical labs
CLIA requirements for Waived Tests
Only requirement - follow manufacturer’s written instructions
- changes invalidates test
- changes makes test a high complexity test
CLIA requirements for Moderate Complexity Tests
Accuracy
Precision
Reportable range
Reference interval
CLIA requirements for High Complexity Tests
Accuracy Precision Reportable range Reference interval Analytical sensitivity (detection limit) Analytical specificity (interference and recovery)
Non-waived tests are divided into
Moderate Complexity Test
High Complexity Test
CAP requirements for Waived Tests
None, except verification of reference range if practical (manufacturer’s document)
CAP requirements for Moderate Complexity Tests
Accuracy Precision Reportable range Reference interval Sensitivity Specificity (interferences)
Define Individualized Quality Control Plans (IQCP)
Standards that must be followed and risk factors checked in order to use an analyzer’s internal QC
Define Equivalent Quality Control (EQC)
2 levels of external QC checks everyday
IQCP vs EQC - which one is more expensive?
EQC
CAP proficiency testing rules (4)
- test samples as you would any patient sample
- do not communicate results or share with other labs
- do not send test out if you normally do
- must not test sample in multiple labs
CAP proficiency testing - cannot fail how many consecutive surveys? Cannot fail how many surveys per year?
2
2
CAP proficiency testing - what do you do if you fail testing?
Document corrective action
-keep records for 2 years
Which organizations have different requirements for moderate and high complexity testing and which group them together?
CLIA and JCAHO = different for moderate/high complexity
CAP = same for moderate/high complexity
Why might we want to do a EQC over an IQCP
IQCP cannot account for human/tech error
-a lot of POC devices have internal QC that cannot account for tech error = pre-analytical error
JCAHO requirements for Waived Tests
Require evidence of data for:
Accuracy
Precision
Reportable Range
Verify:
Reference Range
JCAHO requirements for Moderate Complexity Tests
Accuracy
Precision
Reportable Range
Reference Range
CAP requirements for High Complexity Tests
Accuracy Precision Reportable range Reference interval Sensitivity Specificity (interferences)
JCAHO requirements for High Complexity Tests
Accuracy Precision Reportable range Reference interval Analytical sensitivity Analytical specificity (interferences)
Same requirements for modified moderate complexity or in-house tests
Which organization administers Proficiency Testing? How many samples do they send per year for testing? What is the passing score?
CAP
3 sets of 5 samples
80% (4 out of 5 samples must pass)
-except blood bank, which is 100%
Proficiency Testing is also a form of this type of QC check
External QC
