US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1234: Identify and document problems arising from breakdowns in communication between the laboratory and the authorised persons who order or receive test results

What does 1234 require?

The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results, for example missed critical value calls, misdirected reports, incomplete requisitions or client confusion about reference intervals, so that the causes can be assessed and corrected through the quality assessment process.