Laboratory Testing Flashcards
T/F majority of all medical decisions are based on laboratory data
True (75%)
T/F Physicians, dentists, mid level practitioners but not osteopaths can order lab tests
False - all, including osteopaths can order lab tests
The law enacted in 1988 that specifies that all labs performing tests on which patient decisions will be made must be certified and licensed is _ . Who issues these certificates?
CLIA (clinical laboratory Improvement amendment) - Certified by Centers for medicaid and medicare services (CMS)
T/F A facility that does only one waived test does not require a CLIA license
False - all patient assoc testing requires CLIA
T/F Labs that perform research on unidentified patient samples, labs that do forensic testing and substance abuse testing labs must all have a CLIA license
False - these are all exceptions to CLIA
A test that has been cleared by the CDC and FDA for home use and have an insignificant risk of erroneous results are classified as _
Waived tests
The fastest growing segment of lab testing performed “near the patient” and not in a hospital or reference laboratory is _
Point of care testing
T/F Point of care testing must only be performed using unprocessed human specimens
True
What type of testing has the following 2 advantages?
- Rapid testing
- Source of revenue for physician’s offices?
Point of care testing
What are the 2 types of non-waived testing?
Moderately complex and highly complex
T/F Both moderately and highly complex non-waived testing requires no expertise beyond automation to interpret
False. That only applies to moderately complex non-waived testing
What are the 2 types of CLIA certificates that can be obtained for waived testing? These tests can be done in physician offices
1) Certificate of waiver and 2) certificate of provider performed microscopy
What are the 3 types of CLIA certificates that apply to non-waived testing? These tests are done in hospital and reference labs
Certificate of registration, certificate of compliance, certificate of accreditation
T/F CLIA specifically outlines the requirements to be a lab director in a physician’s office?
False - But at least 1 person must be designated for oversight and decision making
T/F only pathologist can be lab directors of highly complex labs
False - a non-pathologist can, has to meet 1 of the following
• One year lab training or
• Two years experience directing or supervising highly
complex testing
What is the organization that accredits many physician offices and focuses a lot on laboratory education?
COLA
T/F Provider performed microscopy can only be performed by physicians and dentists
False - mid level providers can also perform this testing
T/F A major advantage of waived testing is that they are usually cheaper than using a hospital chemistry laboratory
False - these tests are usually more expensive
T/F Waived testing is performed only on whole blood or urine samples that don’t require processing
True - this is a requirement
T/F - Dialysis centers, cancer centers, patient transport services, family medicine clinics all use point of care testing
True
T/F Lyme disease, HIV and Hep C are all examples of diseases where point of care testing is used
True
T/F Because of complexity of point of care testing, patient misidentification is a major problem
False - since done while the patient is
there, reduces misidentification of samples, or inappropriate sampling
T/F CLIA allows physician offices to alter manufacturer’s instructions provided that they document the changes for inspection
False - No changes are allowed to test instructions as provided by the manufacturer
T/F CLIA non compliance can be punished by hefty fines, suspensions and license revocation, but not imprisonment
False - Any person convicted of intentional violation may be imprisoned
