CLIA '88 Flashcards
What does CLIA stand for?
Clinical Laboratory Improvement Amendments
What does Subpart M in CLIA ‘88 cover?
Personnel
What does Subpart H in CLIA ‘88 cover?
Participation in Proficiency Testing
What does Subpart T in CLIA ‘88 cover?
Consultations
What does Subpart K in CLIA ‘88 cover?
Quality Systems for Non-Waived Tests
What changes have to reported to CMS within 30 days?
change in: Ownership Name Location Director or Technical Supervisor
What changes have to be reported to CMS within 6 months?
- performing a test not included in your certification specialty
- any deletions or changes in tests in a specialty or sub-specialty included on the certification of compliance.
Name the three categories of tests described by CLIA ‘88?
- waived tests
- tests of moderate complexity
- tests of high complexity
What type of CLIA issued certificate is required for laboratories performing tests of moderate or high complexity as an initial certificate before the lab applies for the next level of certificate?
Certificate of Registration
What type of CLIA issued certificate is required for laboratories performing waived tests only?
Certificate of Waiver
What type of CLIA issued certificate is required for laboratories performing PPM tests only?
Certificate for PPM procedures
What type of CLIA issued certificate is given to laboratories that meet all requirements?
Certificate of Compliance
What CLIA issued certificate replaces the Certificate of Registration?
Certificate of Compliance
What CLIA issued certificate suggests that your laboratory will be inspected by State CMA inspectors?
Certificate of Compliance
If your laboratory has a Certificate of Compliance, who is likely to inspect your laboratory?
State CMA inspectors
What CLIA issued certificate states your laboratory meets the standards of private non-profit accreditation programs?
Certificate of Accreditation
What two CLIA issued certificates are essentially the same, but just recognize two different inspection methods?
Certificate of Compliance (state CMA) and Certificate of Accreditation (private HHS approved accreditation programs)
How long is a CLIA issued certificate valid?
2 years
For waived testing, test system instructions must be written at what level?
no higher than 7th grade
PPM
Provider Performed Microscopy
Name a few examples of PPM procedures. (9)
- wet mounts (vaginal, cervical, skin)
- potassium hydroxide (KOH) preparations
- pinworm
- fern test
- post-coital direct
- urinanalysis
- fecal leukocyte exam
- semen analysis
- nasal smears for eosinophils
Successful participation in PT is considered what percentage passing?
80%