Regulatory Agencies & Compliance
This agency sets the gold standard for laboratory quality in the US.
CLIA/CMS
Where is POCT performed?
At or near the patient
Name three phases of testing in a laboratory setting
Pre-analytic, analytic, post-analytic
What is the primary goal of customer service in the laboratory?
Meeting customer needs
New York State follows standards from this organization in addition to CLIA
NYSDOH
Name a common waived POCT
Glucose or Strep or INR or COVID or hCG
What does QC monitor in the analytical phase?
Testing
DAILY DOUBLE
A mislabeled sample is what type of error?
This voluntary accreditation organization uses peer review in its inspections
CAP
POCT improves patient and physician what?
Satisfaction
What is the first element of an IQCP?
Risk assessment
NCE stands for Non-Conforming what?
Event
Quality System Essentials are components of the QSM. How many QSE's are there?
12
Name two voluntary accrediting agencies for labs besides CAP
AABB, ISO, or CLSI
DAILY DOUBLE
Besides CLIA, what daily QC oversight does waived POCT require?
What should careful inventory management prevent?
Waste
Proficiency Testing compares results between laboratories to ensure test what?
(Accuracy) (Reliability is also acceptable)
Explain "deemed status" regarding CLIA and how it applies to New York.
CMS grants "deemed status" to states like New York whose standards meet or exceed CLIA, allowing the state to handle oversight
Who provides mandatory oversight for all POCT programs
The Laboratory
Besides Organization and Leadership, name another Quality System Essential
Customer Focus or Facilities/Safety or Personnel or Equipment or Process or Documents/Records or Information Management or NCE Management or Assessments or Continual Improvement) (Accept any of these)
Besides audits, name a tool used for continual improvement in the lab
Quality Indicators