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20,758

100%

13,697

100%

and health departments. All of these laboratories are frequent sources of biosurveillance data.

Over 58% of the 186,734 laboratories registered with CMS only perform simple tests. These simple tests, often referred to as waived tests, usually are based on commercially available test kits determined by the FDA to be sufficiently simple to perform that there is little risk of operator error. Laboratories that perform waived tests must enroll in the CLIA program, pay certification fees, and follow the manufacturers' test instructions. However, laboratories that perform only waived tests do not undergo inspections or need to comply with other CLIA requirements for larger laboratories. Laboratories that perform tests that use a microscope to examine specimens that are not easily transportable during the course of a patient visit are required to enroll in a CLIA program, pay applicable fees, and maintain certain quality and administrative requirements. These laboratories, known as provider-performed microscopy providers (PPMPs), represent 22% of the registered laboratories and are not subject to routine inspections. The remaining clinical laboratories must either be accredited by 1 of 6 approved clinical laboratory accrediting organizations (American Association of Blood Banks,American Osteopathic Association, American Society of Histocompatibility and Immunogenetics, College of American Pathologists; Commission on Office Laboratory Accreditation, Joint Commission on Accreditation of Healthcare Organizations) or obtain a compliance certificate directly from CMS.

In August 2004, these six organizations had accredited 15,667 (8.7%) laboratories, and CMS had certified 20,758 (11.5%) laboratories. The balance of the clinical laboratories (144,022) were either waived test providers or PPMPs (Centers for Medicare and Medicaid Services, 2004). Accreditation of clinical laboratories helps ensure that laboratories meet or exceed clinical standards established by governmental and nongovernmental associations. CMS, insurance companies, and healthcare plans require laboratories to be certified or accredited by these organizations for reimbursement of laboratory services.

Table 8.3 shows the annual test volume of the 20,758 clinical laboratories that were certified by CMS in August 2004. Over 84% of these laboratories perform fewer than 25,000

tests per year. Only 125 of these laboratories performed 500,000 or more tests per year. These 125 laboratories represent only 0.6% of all laboratories, yet they perform approximately 20% of all tests.

Two state health departments have developed and currently administer state clinical laboratory improvement programs that CMS deems equivalent to the CMS program. Laboratories in Washington and New York must meet the standards of these state programs. Approximately 25 additional states have laboratory licensure programs. They receive funding from CMS to implement the federal CLIA program. In states that do not have clinical laboratory regulatory programs, the laboratories must choose between accreditation through one of the six approved organizations or submitting to inspection and certification by CMS.

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