Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period.
The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992 established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR 493 (September 1, 1992). This notice announces the second of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. This notice also includes deletions and corrections to the list of test systems, assays and examinations published on February 28, 1992. Additional lists of test systems, assays and examinations as well as deletions and corrections will be published periodically. On or before September 1, 1992, a complete list of all laboratory test systems, assays and examinations, categorized by complexity, will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on that final list will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation, applications will be taken to categorize (or recategorize) other laboratory test systems, assays and examinations following the procedures delineated in 42 CFR 493.17(d). After September 1, 1992, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.
D001322:Autoanalysis / Q000145:classification / Q000295:instrumentation; D019411:Clinical Laboratory Techniques / Q000145:classification* / Q000592:standards; D007753:Laboratories / Q000331:legislation & jurisprudence* / Q000592:standards; D014481:United States; D014492:United States Public Health Service