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

Which test method is best for a fixed tissue specimen?

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?

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?

What is required for incorporating an FDA-approved test into a laboratory?

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

An outbreak of Salmonella has occurred in the community. Molecular-based assays will be performed to determine if multiple isolates of Salmonella taken at hospital X are related to each other and part of the outbreak. Laboratory technologists have accumulated 10 different cultures growing Salmonella and suspect that there may be more isolated in the next few days. How should these organisms be handled until the molecular-based assays can be performed in about 3 days?

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?

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?

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?

Which is the proper way to report a threonine-to-methionine mutation at amino acid position 790?

Which of the following organizations has established standards used by laboratory professionals when developing, implementing, and performing molecular-based laboratory tests?

An unlabeled bottle of clear liquid is found on a shelf. A sign on the shelf says, "Tris-EDTA Buffer, pH 8.0." What is the proper course of action?

A blood sample is received in the laboratory for factor V Leiden analysis. What precautions are appropriate?

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

Which is not intended for diagnostic use?

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

What is the proper way to handle raw data from a completed test run?