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Assessing Genetic Risks: Implications for Health and Social Policy
filing a certificate of registration with HCFA will be inspected every two years, and the laboratory's quality control and internal proficiency test system will be assessed. HCFA has a training program for laboratory inspectors—many of whom are sent by states—provided by the Department of Laboratory Medicine of the Johns Hopkins University School of Medicine. HCFA may soon deem other organizations (CAP, Joint Committee on Accreditation of Health Organizations, specific states) as capable of conducting its surveys and accrediting laboratories. State accreditation can supplant HCFA accreditation when a state's program is deemed equivalent or more stringent than the federal program.
Quality control under CLIA88 is funded by fees charged to laboratories. Compliance fees vary substantially from hundreds to thousands of dollars depending on how many different types of tests the laboratory performs, their complexity, and the volume of testing.
Genetic Tests Under CLIA88
Very few genetic tests are on the list of tests whose complexity has been defined under CLIA88. Those that are listed have been classified as of moderate complexity including sweat chloride for CF, creatine kinase, and alpha-fetoprotein (AFP) for tumor marker (Federal Register, 1992d). A test subspecialty called "clinical cytogenetics" has been established, but there is no other genetic test subspecialty under CLIA88. Moreover, no proficiency testing for cytogenetic laboratories is required, although well-established programs (e.g., New York State and CAP) have been operating for years. Proficiency tests are not required for any other genetic tests, either.
Few laboratories performing genetic tests as their sole or principal activity are yet complying with the CLIA88 regulations. Based on the committee's workshops and other information, it appears that few genetics laboratories have applied for certification from HCFA even though they provide genetic test information for clinical use. Committee staff also surveyed the directors of 12 genetics laboratories in academic centers to ask if their laboratory had applied for certification, and only I laboratory indicated that it had.
Research Laboratories and Tests for Rare Disorders
Research laboratories are covered under CLIA88 if they also provide tests on which clinical decisions are based. Some of these laboratories provide genetic tests as clinical services that are not directly related to the research they perform, and they may have limited expertise in performing or interpreting such tests. In many large academic hospitals, the central laboratory is not even aware of all the laboratories that provide services. This situation could be rectified either by having these laboratories obtain their own certificates from HCFA or by having them (and the tests they perform) listed under the central laboratory's certificate. Al-