CLIA Regulations: Competency,
Proficiency Testing (PT), and Inspections
2. Monitoring the recording and reporting of test results (post-analytical phase) - ANS--can be
accomplished by reviewing patient records in a lab information system (LIS), hard copy reports,
or patient medical records
-specific elements, such as critical value documentation, accurate RR, corrected reports, and
accurate patient demographics are important to the quality of patient data and should be
monitored
3. Review of intermediate test results or worksheets, QC records, PT results, and preventive
maintenance (PM) records - ANS--a method to document the review of the elements mentioned
in the standard must be used to ensure that all staff are maintaining quality in the lab
4. Direct observation of performance of instrument maintenance and function checks - ANS--in
addition to the review of documentation, a specified individual is also responsible to watch staff
perform instrument maintenance and function checks, which are critical to analyzer performance
- ensures that all steps are performed according to the writing procedures
5. Assessment of test performance through testing previously analyzed specimens, internal
blind testing samples or external PT samples - ANS--this requires the assessor to prepare
unknown samples to be incorporated into the daily workload
6 requirements for competency - ANS-1. direct observations of routine patient test performance,
including patient preparation, if applicable, specimen handling, processing, and testing
6. Assessment of problem solving skills - ANS--problems encountered include inadequate or
mislabeled specimens, troubleshooting instrumentation or reagent performances, and customer
complaints
AABB inspection - ANS--announced
According to CLIA - ANS--one (1) accrediting body (CMS or those approved by CMS) can
inspect the lab and the lab would be in compliance with CLIA
-If you are accredited by other accrediting bodies you are subject to additional inspections to
meet the criteria the set for the laboratory
Any non-waived test system must be addressed in a competency program - ANS--this includes
PPM and moderate- and high- complexity testing
, CAP inspection - ANS--unannounced
-may ID 10 dates on which the inspection may not occur
CLIA inspection - ANS--announced
CLIA inspectors - ANS--are trained to look for Medicare violations, and Medicare inspectors
check to be sure that a physician has a CLIA certificate for every procedure for which it bills.
CLIA PT - ANS--labs conducting moderate and high complexity testing must participate in PT for
certain analytes ("regulated analytes")
-PT offers each lab performing non-waived tests a way to measure performance and verify its
accuracy and reliability of its testing
-PT is not required for any test that is waived - but labs performing waived testing can enroll in
PT
CLIA-exempt and accredited labs - ANS--must permit validation and complaint inspections
COLA inspection - ANS--announced
Common Deficiencies found in inspections: - ANS--the failure to document to temperatures of
refrigerators
-failure to perform a Gram-positive and Gram-negative control for each and every Gram stain
-failure to perform quality control (QC) testing
-failure to have a protocol for quality assurance (QA)
i.e. telling what action is to be taken if the medium fails a QC test (Microbiology)
-failure to have a job description for all the "positions" in the laboratory even if all of them are
filled
-failure to have proper laboratory requisition forms for ordering the tests
Competency - ANS--the ability to accomplish a task successfully
-in the lab, this means testing the right sample in the correct way to produce the best result
possible for patient care
-must encompass all phases of testing: pre-analytic, analytic, and post-analytic
-it is ok for a lab to develop an effective competency program
-don't at least twice a year during the 1st year the individual performs patient testing and
annually thereafter
-if a new test method or a change in instrumentation, all testing personnel must be reevaluated
before reporting patient results
Consequences of Unsuccessful PT - ANS--If your laboratory has never had an unsuccessful
performance for any PT analyte, subspecialty, or specialty, the CLIA regulations, under certain
circumstances, permit technical assistance and training to take place, rather than a more
serious sanction.
Proficiency Testing (PT), and Inspections
2. Monitoring the recording and reporting of test results (post-analytical phase) - ANS--can be
accomplished by reviewing patient records in a lab information system (LIS), hard copy reports,
or patient medical records
-specific elements, such as critical value documentation, accurate RR, corrected reports, and
accurate patient demographics are important to the quality of patient data and should be
monitored
3. Review of intermediate test results or worksheets, QC records, PT results, and preventive
maintenance (PM) records - ANS--a method to document the review of the elements mentioned
in the standard must be used to ensure that all staff are maintaining quality in the lab
4. Direct observation of performance of instrument maintenance and function checks - ANS--in
addition to the review of documentation, a specified individual is also responsible to watch staff
perform instrument maintenance and function checks, which are critical to analyzer performance
- ensures that all steps are performed according to the writing procedures
5. Assessment of test performance through testing previously analyzed specimens, internal
blind testing samples or external PT samples - ANS--this requires the assessor to prepare
unknown samples to be incorporated into the daily workload
6 requirements for competency - ANS-1. direct observations of routine patient test performance,
including patient preparation, if applicable, specimen handling, processing, and testing
6. Assessment of problem solving skills - ANS--problems encountered include inadequate or
mislabeled specimens, troubleshooting instrumentation or reagent performances, and customer
complaints
AABB inspection - ANS--announced
According to CLIA - ANS--one (1) accrediting body (CMS or those approved by CMS) can
inspect the lab and the lab would be in compliance with CLIA
-If you are accredited by other accrediting bodies you are subject to additional inspections to
meet the criteria the set for the laboratory
Any non-waived test system must be addressed in a competency program - ANS--this includes
PPM and moderate- and high- complexity testing
, CAP inspection - ANS--unannounced
-may ID 10 dates on which the inspection may not occur
CLIA inspection - ANS--announced
CLIA inspectors - ANS--are trained to look for Medicare violations, and Medicare inspectors
check to be sure that a physician has a CLIA certificate for every procedure for which it bills.
CLIA PT - ANS--labs conducting moderate and high complexity testing must participate in PT for
certain analytes ("regulated analytes")
-PT offers each lab performing non-waived tests a way to measure performance and verify its
accuracy and reliability of its testing
-PT is not required for any test that is waived - but labs performing waived testing can enroll in
PT
CLIA-exempt and accredited labs - ANS--must permit validation and complaint inspections
COLA inspection - ANS--announced
Common Deficiencies found in inspections: - ANS--the failure to document to temperatures of
refrigerators
-failure to perform a Gram-positive and Gram-negative control for each and every Gram stain
-failure to perform quality control (QC) testing
-failure to have a protocol for quality assurance (QA)
i.e. telling what action is to be taken if the medium fails a QC test (Microbiology)
-failure to have a job description for all the "positions" in the laboratory even if all of them are
filled
-failure to have proper laboratory requisition forms for ordering the tests
Competency - ANS--the ability to accomplish a task successfully
-in the lab, this means testing the right sample in the correct way to produce the best result
possible for patient care
-must encompass all phases of testing: pre-analytic, analytic, and post-analytic
-it is ok for a lab to develop an effective competency program
-don't at least twice a year during the 1st year the individual performs patient testing and
annually thereafter
-if a new test method or a change in instrumentation, all testing personnel must be reevaluated
before reporting patient results
Consequences of Unsuccessful PT - ANS--If your laboratory has never had an unsuccessful
performance for any PT analyte, subspecialty, or specialty, the CLIA regulations, under certain
circumstances, permit technical assistance and training to take place, rather than a more
serious sanction.
