The purpose of this article is to review current principles and criteria for obtaining Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) waiver, identify existing point-of-care (POC) coagulation and hematology technologies, and analyze regulatory challenges regarding CLIA-waiver for those and future devices. CLIA ’88 documentation requires tests performed by laboratories with a Certificate of Waiver to be so simple that the likelihood of erroneous results by the user is negligible, or poses no unreasonable risk of harm to the patient if performed incorrectly as determined by the Secretary of Health and Human Services. “Simple” means that the test uses unprocessed samples, has a direct read-out of test results, does not have specifications for user training, and includes instructions for confirmatory testing when advisable.
Answer:
Explanation:
Hematology laboratories count the WBCs and RBCs in a sample of a patients blood. In general these types of counting tests with numerical results are known as a complete blood count (CBC), also known as a full blood count (FBC).
Explanation:
A blood test that gives information about the cells in a person's blood is referred to as a complete blood count (CBC), also known as a full blood count (FBC).
This test provides details of the amounts of white blood cells, red blood cells and platelets, the concentration of hemoglobin in the blood, and the hematocrit, which is the percentage of the blood that is made up of red blood cells.
Answer:
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a. specimens must be collected in a particular order
