On September 27-28, Joseph Campos, Alice Weissfeld, David Sewell and Suzanne Leous attended the Clinical Laboratory Improvement Act Advisory Committee Meeting (CLIAC) at the Centers for Disease Control and Prevention (CDC) in Atlanta. CLIA-related issues and updates were provided to CLIAC by federal agencies including the Food and Drug Administration (FDA), the Health Care Financing Administration (HCFA) and CDC. Specifically, waived tests classification, test systems currently not regulated under CLIA, regulation of genetic testing, and workforce issues were considered by the Committee.
CLIAC spent a majority of their meeting discussing the topic of waived test classification, now that the waiver process resides within the FDA. FDA staff Joseph Hackett and Clara Sliva informed CLIAC that twenty-seven representatives of industry, professional societies, government and others, presented testimony at the August public workshop on the waiver issue. FDA will continue to interact with stakeholders and will decide whether to rescind the 1995 proposed rule on waiver classification. If the rule is rescinded, FDA will proceed with negotiated rulemaking or move to a process known as "negotiated guidance" to achieve consensus among interested parties before publishing a new rule. CLIAC drafted a letter to Secretary Shalala requesting an opportunity to provide advice on the process used for making waiver determinations. A subgroup of Committee members was charged with shaping an appropriate response to FDA regarding waived tests classification.
Related to the waiver issue was an interesting presentation by HCFA regarding trends in the classification of laboratories. HCFA reported that out of a total of 163,882 registered laboratories (not including labs in CLIA-exempt states), physician office laboratories (POLs) have increased by 4205 over a period of seven years; the current number of POLs is 95,005. Only sixteen percent of laboratories are HCFA certified and ten percent of laboratories are HCFA accredited, while twenty-two percent are classified as provider-performed microscopy (PPM) and fifty-two percent are waived laboratories. This means that seventy-four percent of laboratories have no government oversight.
A HCFA-generated survey focusing on the deficiencies in HCFA certified laboratories has been completed in two states (Ohio and Colorado). The results thus far show that greater than 50% of laboratories experience testing problems. The top three deficiencies cited were failure to follow the manufacturer's instructions, lack of quality assurance programs, and a lack of quality control (2 levels per day of testing). Eight additional states will be surveyed in the remaining states where HCFA regional offices are located and HCFA will analyze the impact of laboratory deficiencies on patient care.
Test systems currently not regulated under CLIA as well as the regulation of genetic testing were also discussed. A report by the CLIAC subgroup on unregulated tests defined the type of testing/specimens involved, reported the appropriateness of CLIA standards for these tests, and discussed oversight available for non-regulated testing. Currently, these issues do not generally impact microbiology except for H. pylori breath testing. A summary of public comments on genetic testing and reports from the Secretary's Committee on Genetic Testing and the CDC Genetic Laboratory Forum were presented. A CLIAC subgroup was formed and charged with developing a laboratory perspective response to this complex issue.