Clinical Laboratories

There are more than 186,000 clinical laboratories in the United States in which clinical laboratory scientists, pathologists,

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TABLE 8.1 Clinical Laboratory Tests that Contribute to the Diagnosis of Anthrax

Type of Test

Specimen

Expected Result

Nonspecific White blood count Cerebrospinal fluid (CSF) analysis Presumptive Growth on sheep blood

Colony morphology

Gram stain Hemolysis Motility Sporulation

Confirmatory Capsular stain

Gamma phage Direct fluorescent antibody (DFA) Polymerase chain reaction (PCR) Time-resolved fluorescence (TRF) Molecular characterization

Whole blood CSF

Blood, CSF, lesion Bacterial growth

Bacterial growth Bacterial growth Bacterial growth Bacterial growth

Bacterial growth

Bacterial growth Bacterial growth

Bacterial growth

Bacterial growth

Bacterial growth

Elevated count Normal

Growth within 24 hours

Gray-white colonies, flat or convex, ground glass appearance Large Gram-positive rods Clear hemolysis Motile

Visual spores with malachite green stain

Visual capsules with M'Faydean stain Lysis by gamma phage Positive fluorescence

Positive PCR

Positive TRF assay

Positive match with control materials

The Centers for Medicare and Medicaid Services (CMS) registers all clinical laboratories in the United States that examine materials derived from the human body for diagnosis, prevention, or treatment. CMS administers the program for the Secretary of Health and Humans Services in conjunction with the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). CMS regulates laboratories and establishes criteria for other organizations, such as state health departments, that also regulate laboratories to ensure compliance with the federal Clinical Laboratory Improvement Act (CLIA). CLIA was first enacted by Congress in 1967 and set guidelines for large independent laboratories. In 1988, Congress amended CLIA 67 to expand the type of laboratories that must comply; CLIA 88 further established quality standards for laboratories to ensure accuracy, reliability, and timeliness of test results.

In August, 2004, 186,734 laboratories were registered with the CMS (Centers for Medicare and Medicaid Services, 2004). Table 8.2 shows the distribution of these laboratories by type. More than 55% of these laboratories are located in physician offices. Skilled nursing facilities (7.9%), hospitals (4.6%) ,and home health agencies (4.4%) accounted for an additional 20% of laboratories. The remaining clinical laboratories are found in community health clinics, health maintenance organizations, blood banks, industrial facilities, medical technologists, and laboratory technicians perform 7 billion or more diagnostic tests annually (Centers for Medicare and Medicaid Services, 2004). The American Society for Clinical Pathology (ASCP) currently certifies more than 280,000 laboratory professionals who primarily work in clinical diagnostic and research laboratories. Clinical laboratory services in the United States are delivered either by commercial clinical laboratories or by "in-house" laboratories at healthcare facilities (hospitals, clinics, physician offices), departments of health, veterinary hospitals, and clinics. Individual veterinarians and physicians and the staff within their offices also conduct laboratory testing and produce results that are important for biosurveillance.

Professional laboratorians provide services that include simple, rapid screening tests; more advanced diagnostic tests; and complex confirmatory analyses. Clinicians use the information provided by laboratories to establish diagnoses and to make treatment decisions on virtually every patient. The demand for testing is increasing as the population ages and requires more health care, including analytical services. New tests are frequently introduced that improve diagnosis and care. The emergence of new diseases, the threat of bioterrorism, and the need for better biosurveillance systems have increased the demand for qualified laboratory professional in all fields, especially infectious disease testing. Although the demand for more laboratory professionals is increasing, the number of established laboratory professional training programs is decreasing.

TABLE 8.2 Clinical Laboratories Registered by Center for Medicare and Medicaid Services (CMS) by Type of Facility, August 2004

Type of Laboratory

Number

Percentage

Ambulatory surgical centers

3,229

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