moderately complex test

moderately complex test

A test defined by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as one requiring basic lab knowledge and training for personnel performing the test. Moderately complex tests (MCTs) may require reagent preparation, limited pre-treatment of specimens, quality control, calibration, proficiency testing, some skill in troubleshooting and maintaining equipment, and some skill or judgement in interpretation of results. Most MCTs are relatively simple and, because they are portable, may be adapted for alternative site testing.
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Currently, Moderately Complex test kits are available for albumin, amylase, calcium, ALP, creatinine, fructosamine, GGT, LDH, magnesium, AST, total bilirubin, total protein, BUN, uric acid, inorganic phosphorus, CPK, Chemistry Panel 1 (BUN, GLU, CRE, CAL), Chemistry Panel 2 (ALB, ALP, T-BIL, ALT, AST) and a lipid panel strip which includes total cholesterol, HDL, and triglycerides.
As an example, Kay explained a moderately complex test that five years ago took seven reagents, 15 steps and 20 minutes for results.
Lab workers who perform any moderately complex test must have earned at least a high school degree, which for the next five years will also constitute the minimum educational qualification for employees who perform most highly complex tests.
The bill would further exempt individuals performing moderately complex tests in hospital, reference lab, and POL settings, provided that the lab director has certain practices and procedures in place and the individual performing the tests holds one of the following certifications: CMA(AAMA), RMA(AMT), or COLT(AMT).
With these agreements, we will take a big step toward the launch of our 'sample-to-result' molecular diagnostic system, including a differentiated menu of moderately complex tests that address urgent clinical decisions," commented Mike Whelan, group vice president of Beckman Coulter's High Sensitivity Testing Group.
In addition to the daily QC, any laboratory that carries out moderately complex tests is required to perform calibration verification (CV) on its instrument.
However, when the final rules for CLIA '88 were first published (57FR7165), there was disagreement over whether the rules exempted moderately complex tests, as well.
The Clinical Laboratory Improvement Act (CLIA) states calibration verification is only required for "modified" moderately complex tests.
The Triage BNP Test, which is approved for use in laboratories certified to perform moderately complex tests, can be used at the point-of-care to enable efficient and accurate diagnosis of patients who are experiencing shortness of breath or other symptoms associated with CHF.
Until now, the Osteomark NTx Point-of-Care device was available only for professional use by physician offices certified to perform CLIA moderately complex tests.
While no one is quite sure how many POLs were performing moderately complex tests before CLIA '88 was implemented, we know only 40% of POLs now are doing moderately complex tests.
The Health Care Financing Administration (HCFA) explained its offset to the inspection requirements of CLIA this way: "Because physicians have extensive medical training greater than that required by these regulations for personnel performing moderately complex tests, and because these tests are done in the context of a patient examination, we believe there is assurance that accuracy of testing can be maintained despite the lack of routine inspections.