#06-5558 Accrd Manual V7 - COLA

CYTOLOGY>721. EAre there procedures to process slides which can not be successfully screened by instruments?Instruments used to screen slides may produce flags to alert personnel that a problem has been detectedwith the slide itself, such as wrong type or size coverslip or a broken slide. Flags may also be triggered byabnormal results. Such circumstances require further action and review by laboratory staff.Slides which can not be successfully screened by instruments must be processed in accordance with instrumentmanufacturer’s instructions, as applicable, and laboratory defined procedures. If this procedureinvolves reprocessing on the instrument, the presumed reason for the initial failure should be documentedand confirmed by a rapid manual review of the slide. In cases where the slide is examined and reported manually,a record of the presumed reason for the instrument screening failure should also be documented.CLIA workload limits relative to automated or semi-automated screening devices can be found at 744-754.722. EAre corrective actions taken and documented when tolerance limits for the instrument are exceeded and whenslides cannot be successfully screened?It is important that the laboratory review and understand the limitations of an instrument used in the screeningprocess. Tolerance limits are defined by the manufacturer as the operating or performance limitations forthe technology, as approved by the FDA.723. EDoes the cytology laboratory meet the general laboratory equipment and analytic systems requirements forCOLA accreditation?The laboratory must have written procedures, verify performance specifications; and perform maintenanceand function checks, calibration and calibration verification procedures, and control processes as appropriatefor its automated and semi-automated instruments.Specimen Collection and ManagementThe laboratory shall have and must follow policies and procedures for the collection and handling of specimens.724. EAre the preferred methods of slide preparation described?The cytology laboratory should provide its customers with specific information on the preferred methods forthe submission of gynecologic cytology material such as submission in liquid media or on glass slides andshould address methods of fixation for material on glass slides. Methods for submission of non-gynecologicfluid samples, such as possible malignant effusions, should also be addressed.725. EIs the laboratory’s accepted method of slide labeling described?Cytology slides must be labeled with the patient’s name and with an additional form of identification suchas patient number or date of birth.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FOR MORE INFORMATION CONTACT COLA PHONE 800.981.9883 | FAX 410.381.8611 | ON-LINE www.cola.org83