Preanalytic Testing

The CLIA has requirements that cover the preanalytic phase of testing. These include the use of requisition forms with correct identification of the patient, the patient -s age and gender, the test to be performed, the date and time of sample collection, the name of the ordering provider or the person to whom results should be reported, the type of specimen (e.g., blood), and any other additional information needed to produce a result. All of these are critical pieces of information that should be provided to the laboratory. Many so-called "laboratory errors" actually arise at the time of sample collection, and specimen misidentification is one of the most common types of error in the testing process.

In addition to the patient -s age and gender, orders for molecular genetic testing should include relevant information about suspected diagnosis, clinical findings, and especially the family history. Many experienced clinical geneticists and genetic counselors will include a pedigree diagram on a requisition form for tests for inherited disorders. This practice is highly desirable and provides much useful information to the laboratory. As an example of the importance of this information, current practice guidelines in obstetrics and gynecology in the United States encourage the offering of prenatal testing to expectant Caucasian mothers to determine if they are carriers of mutations for cystic fibrosis. A recommended panel of mutations to be tested by clinical laboratories covers approximately 80 to 85% of all mutations in this population. In general, a negative screening test for these mutations reduces the risk of being a cystic fibrosis carrier from 1 in 30 to 1 in 141, and the laboratory would report these figures, or, if a mutation were identified, would report the specific mutation. However, these figures are based on the assumption that there is no family history of the disorder in the patient's family. If there is such a history, the risk of being a carrier (both before and after testing) is substantially higher. It is therefore essential that the ordering physician inform the laboratory if there is a family history.

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Project Management Made Easy

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