Unannounced inspections by CAP
Automation in the laboratory
Regulatory agencies, accreditation requirements, quality assurance
new method validation
method comparisons
laboratory quality management plan
specimen collection and handling
reference ranges and critical value determinations
publically reported laboratory measures
Updates to CLIA, and other federal regulations
HIPPA
Laboratory Safety
Patient Safety
Critical values; Joint Commission recommendations for reporting
Informatics
IT issues - patient armbands, sample barcoding, laboratory automation
Consultations
Coding and Billing
Basic statistics used in internal QC, PT evaluation, reference range
development, etc.
Baysean statistics-sensitivity, specificity, PPV, NPV
The influence of prevalence on the positive and negative predictive values of
assays
|
Example 1: The impact of molecular diagnostics that are not 100% specific for
the detection of Neisseria gonorrhoeae in low prevalence scenarios (i.e. the
likelihood that a positive result will be false positive result). |
| Example 2: As above, the impact of using the rapid respiratory virus EIA when the prevalence of disease is low (e.g., summertime in Ohio). |
Regulatory agencies, accreditation requirements, quality assurance
new method validation
method comparisons
laboratory quality management plan
specimen collection and handling
reference ranges and critical value determinations
publicly reported laboratory measures