Exam 16: Quality Assurance and Quality Control in the Molecular Laboratory

A battery-operated pipetting device has stopped working. Which of the following describes the first course of action for the technologist using this pipet?

A woman calls and asks that the results of her husband's HIV viral load assay be faxed to her. She gives the technologist her husband's name and medical record number along with the date the specimen was collected and her fax number. She states that she is calling for her husband and has his approval. Which of the following is the correct course of action for the technologist?

A fax report of patient results is received in error. What should be done?

Which is used to calibrate an instrument that measures analyte in saline?

Controls run in a capillary gel electrophoresis instrument have been consistently unacceptable. Low signal strength is evidence that the laser is not functioning properly. Which of the following is the correct course of action for the technologist in charge of this piece of equipment?

Which of the following controls can distinguish between a true negative in a nucleic acid amplification assay from a false negative in which amplification failed in the specimen?

Which test method is best for a fixed tissue specimen?

Which of the following does not have to be documented in a procedure description that is written according to CLSI guidelines?

Which of the following controls defines the lower limit of reproducible and accurate detection of a molecular target?

Which is not intended for diagnostic use?

The temperature in a refrigerator that is used to store patient specimens and reagents should be checked how often?

Whole blood was sent to the laboratory for viral load determination of HIV (an RNA virus). It was received on a Saturday morning, and the technologist working in the receiving section of the laboratory put the tube in the refrigerator at 2^o-8^oC. The molecular technologist came on Monday morning and collected the specimens that had been sent to the laboratory over the weekend. What will likely be required on Monday morning?

Which of the following organizations provides oversight and governs the use the radioactive materials in the clinical laboratory?

The ability of a molecular-based assay to detect only the analyte and not other targets is called which of the following?

An assay that detects an analyte associated with a particular disease only in patients who have that disease and not in patients who do not have the disease has which of the following?

An unlabeled specimen arrives in the laboratory with an accompanying requisition. The requisition is properly filled out. How should you proceed?

A lavender-top tube labeled "John Smith" is received in the molecular biology laboratory. The tube is attached to a requisition stamped "John Doe," with today's date, requesting testing for t(9:22). Which of the following describes the proper course of action for the technologist who receives this specimen?

The analysis of external specimens to assess technologist competency and assay performance is which kind of testing?

Probes, primers, antibodies, and other test components that detect a specific target, such as a cell surface protein or DNA mutation, without claims to clinical significance are classified as what type of reagents?

The delivery of accurate voltage and current by an electrophoresis power supply should be checked how often?