CLIA '88 Test Complexities Flashcards
Criteria of waived complexity tests
tests cleared by FDA for home use, negligible likelihood of erroneous results, or no reasonable risk of harm to patients if performed incorrectly
Quality control of waived complexity tests
none required other than to follow manufacturers’ directions
proficiency testing for waived complexity tests
not required
testing personnel (minimum qualifications) for waived complexity tests
none specified
Provider-performed microscopy (PPM) criteria
certain microscopic exams performed by provider during patient’s visit
examples of provider-performed microscopy (PPM)
direct wet mount, KOH prep, urine sediment
quality control of provider-performed microscopy (PPM)
required when controls are available; otherwise, reference materials fulfill requirement
proficiency testing provider-performed microscopy
PT not specifically required, but labs must verify accuracy of testing twice annually. Can be through PT, split samples, or blind testing
testing personnel for provider-performed microscopy (PPM)
Physician, midlevel practitioner or dentist
criteria for moderate complexity tests
score of less than or equal to 12 on 7 criteria
quality control for moderate complexity tests
2 levels of external controls each day of testing
proficiency testing for moderate complexity tests
required
testing personnel minimum qualifications of moderate complexity tests
high school diploma or equivalent & training for testing performed
criteria of high complexity tests
score > 12 on 7 criteria
quality control for high complexity tests
2 levels of external controls each day of testing
