Question 1

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

Accepted Answer

A)   Discard the pipet, and order a new one.
B)   Call the manufacturer to request that a technical support representative make a service call.
C)   Change or charge the batteries.
D)   Put the pipet back in the drawer and get a new one. C

Question 2

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?

Accepted Answer

A)   Fax the results as requested.
B)   Tell the woman that her husband can get his test results from his physician.
C)   Contact the husband to verify that this request is acceptable with him.
D)   Report the results by telephone. B

Question 3

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

Accepted Answer

A)   Call the sender immediately.
B)   File the report with quality-assurance documents.
C)   Discard the report in a standard waste receptacle.
D)   Read the report to others in the laboratory. A

Question 4

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

Accepted Answer

A)   An unknown patient sample diluted in saline
B)   A reference standard diluted in saline
C)   A positive control diluted in water
D)   A reference standard diluted in water

Question 5

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?

Accepted Answer

A)   Call the manufacturer, ask that a replacement laser be shipped, remove the old laser, and insert the new laser when it arrives.
B)   Scan eBay for a compatible laser, purchase the laser, and replace the old laser with the newly purchased laser.
C)   Request a service visit from the manufacturer's technical support team who can safely replace the old laser with a new laser.
D)   Tag the instrument for removal and disposal, and order a new instrument from the manufacturer.

Question 6

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?

Accepted Answer

A)   Positive
B)   Negative
C)   Sensitivity
D)   Amplification

Question 7

Which test method is best for a fixed tissue specimen?

Accepted Answer

A)   Long-range PCR
B)   Southern blot
C)   Standard PCR
D)   PFGE

Question 8

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

Accepted Answer

A)   Sequence of primers
B)   Credentials of technologist performing the assay
C)   Acceptable ranges of product sizes
D)   Probe purification conditions

Question 9

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

Accepted Answer

A)   Positive
B)   Negative
C)   Sensitivity
D)   Amplification

Question 10

Which is not intended for diagnostic use?

Accepted Answer

A)   IVD reagents
B)   RUO test kits
C)   FDA-approved test kits
D)   FDA-cleared reagent sets

Question 11

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

Accepted Answer

A)   Hourly
B)   Daily
C)   Biweekly
D)   Weekly

Question 12

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 2o-8oC. 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?

Accepted Answer

A)   RNA isolation and viral load testing as requested
B)   Request for blood redraw
C)   HIV antibodies testing after forwarding the tube to the serology laboratory
D)   Transfer of the blood into a tube containing guanidine isothiocyanate

Question 13

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

Accepted Answer

A)   National Fire Protection Association
B)   Nuclear Regulatory Commission
C)   Clinical Laboratory Improvement Amendments
D)   American Society for Clinical Laboratory Science

Question 14

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

Accepted Answer

A)   Clinical specificity
B)   Clinical sensitivity
C)   Analytic sensitivity
D)   Analytic specificity

Question 15

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?

Accepted Answer

A)   Analytic specificity
B)   Analytic sensitivity
C)   Clinical specificity
D)   Clinical sensitivity

Question 16

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

Accepted Answer

A)   Proceed with testing.
B)   Do not proceed with the test and notify the supervisor.
C)   Cancel the test and discard the tube.
D)   Label the specimen yourself and proceed with the test.

Question 17

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?

Accepted Answer

A)   Perform the test as requested, and report the results for John Doe.
B)   Change the labeling on the requisition to match that of the tube, and perform the test.
C)   Notify the laboratory supervisor.
D)   Call the nursing unit to ask whether John Doe or John Smith is correct, and make the change.

Question 18

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

Accepted Answer

A)   Proficiency
B)   Quality control
C)   Quality assurance
D)   Competency

Question 19

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?

Accepted Answer

A)   FDA cleared
B)   IVD
C)   RUO
D)   ASR

Question 20

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

Accepted Answer

A)   Daily
B)   Weekly
C)   Monthly
D)   Yearly

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