waived testing Flashcards
What are waived testing procedures
- at home
- using kits that ae availalbe from number of manufactureres
- includes easy to follow isntruction and most come with b uilt in control
- includes:
● erythrocyte sedimentation rate (ESR)
● fecal occult blood testing
● microhematocrit
● strep screening
● urine pregnancy testing
● urine chemical screening
● point-of-care testing (POCT)
what are the levels of lab testing designated by the CLIA in 1988`
- waived tests, moderate complecity tests and high complixty testing, provider-performed microscopy
what are high complexity tests
- tests that require close attention to details
- require manual manpulation of high complexd equipment and reagenets (lab test chemicals) and that require interpretation and troubleshoot skills
- manual dna extraction procedures intricate special staining procuedre and operation of complex analyzer that require detailed setup or ieator interactions
what are moderate complexity tests
- faled btwn waived and high compleicty
- a few orcoedural step that aer not highly complexy but requre some forma training to perform
- include running automated instruments (little manual manipulatio of specimen or reagenet with minimal interpretation and tourbleshooting skiills)
what is certificate of accrediation?
- moderate and or high complex testing
- private not for profit accreditation program
what are certificate of compliance
moderate and or high complex testing
lab is in compliance with all applicable CLIA requirements
- labs r surveyed every other year
certificate of registration
- lab that applied for COA COC
- lab can perform moderate and or high complex testing until inspected for COA or COC
Certificate for Provider-Performed Microscopy Procedures
- lab where physician midlevel practitioner or dentist perform only microscopy procuedres q
certificate of waiver
- lab performs only waived tests
- must ably to department of health and human services, centers for medicare and medicaid services (CMS)
- submit to randsom inspection and investigatoon
- recommended to follow Clinical Laboratory Improvement Advisory Committee (CLIAC) suggestions for lab managements during before and after test
provider-performed microscopy procedures
(PPMPs)
● direct wet mounts
● potassium hydroxide (KOH) preparations
● pinworm examinations
● fern tests
● post-coital qualitative
● urine sediment examinations
● nasal smears for granulocytes
● fecal leukocyte examinations
● qualitative semen evaluation
what is lab management and personnel need to adher to ?
● Follow all applicable federal, state, and local regulations.
● Perform waived tests only.
● Follow the manufacturer’s instructions in the package insert.
● Do not make modifications to the instructions.
● Allow random inspections by authorized agencies, such as the CMS.
● Establish a laboratory safety plan that follows OSHA guidelines.
● Have a designated area that has adequate space and conditions.
● Have enough personnel in the lab and train them appropriately.
● Have written documentation of each test performed.
- follow standard operating procedures (SOPs)
what is ESR?
- rate at which RBC settle in whole blood
- measures distance in mL that RBC fall in 1 hr when allowed to settle in a calibrate dtube
- screens for presence of any inflammation
- number of plasma proteins such as albumin and globulin increases
- increase in plasma proteins may = rouleaux formation (RBC sticks together)
- several cells sticking together settls faster than a single RBC
What are the different methods to perform ESR
- Wintrobe
- Westergren
- Modified Westergren
tube and testing for ESR
- requires light blue top tube or their own speciality tube usually with a black stopper or top
- ESR procedure are done in less than 4 hours but if refrigerated up to 12 hours
what is required for ESR
● Specimen transfer pipets
● ESR kit
● ESR vials containing a premeasured amount of diluent (usually 0.9%
sodium chloride)
● Calibrated ESR tubes
● ESR testing rack