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Record keeping and quality control

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With the advent of highly standardized cell culture methods, culture hazards have become a much rarer cause for concern in the prenatal diagnosis laboratory. Due to the greater number of specimens processed by the average laboratory, a variety of quality‐control measures need to be followed to avoid mistakes ranging from culture mixups to diagnostic errors. The most common and potentially serious laboratory errors are human errors in labeling and cross‐contamination of samples. Labeling errors can occur at any stage where cells are transferred between vessels: in the amniocentesis procedure room, at culture initiation, feeding and subculture, harvest, slide making, and even microscope analysis. Cross‐contamination of cells between patient samples is most common at the time of cell culture harvest, especially for suspension harvests. For these reasons, quality control and quality assurance programs must include a nonpunitive recording system for all laboratory events. A regular review of those events should seek patterns of error that can be eliminated by continuing education of laboratory staff or (often more effective) process improvement directed at reducing the opportunity for human error.

Laboratory directors and supervisors should be familiar with the College of American Pathologists Laboratory General and Cytogenetics checklists and the American College of Medical Genetics Standards and Guidelines.665 Laboratories should also participate in a peer review system such as the CAP proficiency surveys.

Genetic Disorders and the Fetus

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