What type of laboratory can perform tests needed in an emergency situation quizlet?

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The operation of a POL can have a significant impact on the health of the patients who depend on the medical practice for care. Accurate patient specimen testing is a primary concern. A quality assurance program is designed to monitor the quality of the patient care a medical laboratory provides. It also helps to ensure laboratory worker safety. An effective quality assurance program should be a written plan that includes both internal and external reviews of procedures. It serves to assess the quality of the tests performed in a clinical laboratory based on a set of written standards and procedures.
Clinical Laboratory Improvement Amendments

In response to public concern over the accuracy of laboratory tests, Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). This law placed all laboratory facilities that conduct tests for diagnosing, preventing, or treating human disease or for assessing human health under federal regulations administered by the Health Care Financing Administration (HCFA) and the CDC. State governments may implement their own standards, which must be at least as stringent as federal standards. If your state has its own standards, your office will operate under those standards. The state health department provides information about which standards to follow in a given locale.

CLIA '88 has had a major impact on office laboratories. Because of the complexity of the regulations and the expense required to meet them, many doctors have closed their laboratories or sharply reduced the number of tests they perform. Several attempts have been made to change the federal legislation, including an effort to exempt POLs from the regulations. As the healthcare debate continues, you may see changes in laboratory operations as a result of changes in CLIA '88 regulations.

As updated and implemented in 1992, CLIA '88 standards apply to four areas of laboratory operation: standards, fees, enforcement, and accreditation programs. Most of the regulations relate to laboratory standards. The specific standards that must be met depend on the test. Tests have been divided into these three categories, based on complexity: Certificate of Waiver tests, tests of moderate complexity, and tests of high complexity.

Certificate of Waiver Tests The Certificate of Waiver tests, as listed in Table 45-2, are laboratory tests defined as follows:

The tests pose an insignificant risk to the patient if they are performed or interpreted incorrectly.

The procedures involved are simple and accurate to such a degree that the risk of obtaining incorrect results is minimal.

The tests have been approved by the Food and Drug Administration (FDA) for use by patients at home.

If laboratory management decides to perform these tests only, the office may apply for a Certificate of Waiver. When the certificate is granted, the laboratory is exempt from meeting various CLIA '88 standards that apply to the other two test categories. Such laboratories, however, are subject to the following: (1) random inspections to ensure that laboratories operating under a Certificate of Waiver are performing only those tests that qualify for the waiver and (2) investigation of the laboratory if there is any reason to believe the laboratory is not operating safely or if there have been complaints against the laboratory. See the Caution: Handle with Care feature Operating a Reliable Certificate of Waiver Laboratory for more information about good lab practice.

Tests of Moderate Complexity Tests of moderate complexity make up approximately 75% of all tests performed in the laboratory. Among these tests are blood cell counts and cholesterol screening. Test procedures falling into this category include studies involving bacteriology, mycobacteriology, mycology, parasitology, virology, immunology, chemistry, hematology, and immunohematology.

A laboratory that performs moderate-complexity testing must be run by a pathologist who has an MD or PhD degree. Technicians performing the tests must have training beyond the high school level as defined by CLIA '88 regulations. All personnel must participate in a quality assurance program for laboratory procedures, and the laboratory is subject to periodic unannounced inspections and proficiency testing.
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Tests of High Complexity Tests of high complexity include more complicated tests in the specialties and subspecialties, including tests in clinical cytogenics, histopathology, histocompatibility, and cytology, and any test not yet categorized by the CMS. Manufacturers' guidelines for testing products are often the best source for discovering a test's CMS determination. The CMS publishes a directory of all moderate- and high-complexity tests.

Like a laboratory that conducts moderate-complexity tests, a laboratory that conducts high-complexity tests is subject to inspection, proficiency testing, and participation in a quality assurance program, and it must be headed by a medical doctor or a scientist who has a PhD degree. Testing procedures can be performed only by qualified laboratory personnel whose training exceeds that provided by high schools and meets the requirements of CLIA '88 regulations. Medical assistants will need additional training and education to perform moderate- and high-complexity tests.
Components of Quality Assurance

Every quality assurance program must include the following components, in a measurable and structured system, to satisfy CLIA '88 requirements:

Quality control.

Instrument and equipment maintenance.

Proficiency testing.

Training and continuing education.

Standard operating procedures documentation.

Quality Control and Maintenance

A quality control program is one component of a quality assurance program. The focus of the quality control program is to ensure accuracy in test results through careful monitoring of test procedures. To be in compliance with quality control standards, a laboratory must follow certain procedures.

Calibration Testing equipment must be calibrated regularly, in accordance with manufacturers' guidelines. Calibration ensures the equipment is operating correctly. Each calibration must be recorded in a quality control log like the one shown in Figure 45-6. Calibration routines are performed on a set of standards. A standard is a specimen, like the patient specimens you would normally process with the equipment, except that the value for each standard is already known. If the equipment does not yield the expected results during the calibration procedure, it must be adjusted until the expected results are obtained. Calibration routines are run on the standards alone, never with patient samples. They are used exclusively to ensure that the equipment is performing according to manufacturers' specifications. Check the manufacturer's instructions to determine how often the equipment should be calibrated. Calibration of some equipment must be performed by trained service personnel.

Control Samples Control samples are similar to standards in that they are specimens like those taken from a patient and have known values. Unlike standards, however, control samples are used before each patient sample is processed. Using a control sample serves as a check on the accuracy of the test. If the control tests do not fall within the manufacturer's prescribed ranges, patient samples are not analyzed, preventing erroneous results.

The control samples for certain laboratory procedures show both normal (negative) and abnormal (positive) results. Generally, positive and negative control samples are used with tests that yield a qualitative test response (the substance being tested for is either present or absent).
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Other control samples—used for tests that yield quantitative test results (the concentration of a test substance in a specimen)—are formulated to show when results fall within a normal range. At least two control samples containing different concentrations of the test substance should be run for quantitative tests.

Reagent Control Control samples or standards are also run every time you open a new supply of testing products, such as staining materials, culture media, and reagents. Reagents are chemicals or chemically treated substances used in test procedures. A reagent is formulated to react in specific ways when exposed under specific conditions. One example of a reagent is the chemically coated strip used in blood glucose monitoring. A visual change on the reagent strip (also called a dipstick) occurs in the presence of glucose in a blood sample.

To ensure the quality of reagents, you should keep a reagent control log. If a defective reagent test is identified, it can be tracked to its source. A sample reagent control log is shown in Figure 45-7. Running controls on a routine basis gives you information about the equipment and the reagents used during the test. If a control consistently yields unexpected results (for example, a positive control yields a negative result), you should check the reagents first and then the equipment calibration.

Maintenance Testing instruments and equipment must be properly maintained and all maintenance procedures must be documented. Follow manufacturers' guidelines for performing instrument and equipment maintenance. A maintenance log provides a complete record of all work performed on an instrument or a piece of equipment (Figure 45-8).

TroubleshootingYou may need to investigate the cause of a problem with a piece of equipment or a test. To do this, you should take a systematic approach to rule out the cause of the problem. For more information regarding investigating equipment and test malfunctions, see the Caution: Handle with Care feature Troubleshooting Problems in a Physician's Office Laboratory.

Documentation A quality control program depends first on careful adherence to procedures designed to identify problems with equipment calibration, errors in testing procedures, and defective testing supplies. The second component of a quality control program is the careful documentation of all procedures. Besides maintaining the quality control log, the reagent control log, and the equipment maintenance log, you also will complete the following records as part of a quality control program:

Reference laboratory log, which lists specimens sent to another laboratory for testing.

Daily workload log, which shows all procedures completed during the workday.

Proficiency Testing

All laboratories that perform moderate- and high-complexity tests as identified by CLIA '88 must participate in a proficiency testing program. Proficiency testing programs measure test result accuracy and adherence to standard operating procedures. Generally, proficiency tests include two parts: (1) a control sample from the proficiency testing organization engaged by your laboratory and (2) forms that must be completed to record the steps in the testing procedure. The control sample is processed normally, under the same conditions as any patient sample. The results, the forms, and sometimes the control samples are returned to the proficiency testing organization, which then informs your office of whether it has passed or failed the test. A passing mark means that your laboratory can continue to perform that particular test. A failing mark can mean that your laboratory must discontinue that test and possibly other tests, too.

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