US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
Subpart H: participation in proficiency testing for nonwaived testing (sections 493.801 to 493.865), with Subpart I program approval as context – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 821-865: Meet the specialty and subspecialty proficiency testing criteria: for each microbiology, immunology, chemistry, hematology, gynecologic cytology and immunohematology event, the laboratory must identify or quantify the challenges to the program's target within the stated acceptance limits, and unsuccessful performance in two of three consecutive events is unsuccessful participation

What does 821-865 require?

Sections 493.821 to 493.865 set, for each specialty and subspecialty, what the laboratory must do with the PT challenges and how performance is scored. Bacteriology, mycobacteriology, mycology, parasitology and virology laboratories must identify organisms, and for bacteriology perform susceptibility testing, to the extent they do for patients, with a passing score of 80 percent per event (90 percent for ABO grouping and D typing, and 100 percent for compatibility testing in immunohematology); syphilis serology and general immunology, routine chemistry, endocrinology, toxicology and hematology analytes are scored against the program's target values and acceptance limits with 80 percent required; and gynecologic cytology is tested at the individual level with a passing score of 90 percent and remedial action and retesting for individuals who fail. A laboratory that fails to attain the passing score in two of three consecutive events, or fails an event with a score of zero for nonparticipation, has participated unsuccessfully for that specialty, subspecialty or analyte and is subject to the consequences in sections 493.803 and 493.807. The laboratory must report PT results for each challenge the way it would report a patient result, including reporting organism identification to its routine level.

Maintained by Gerard Blokdyk

Other controls in Subpart H: participation in proficiency testing for nonwaived testing (sections 493.801 to 493.865), with Subpart I program approval as context – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.