Deck 21: Point-Of-Care Near-Patient Testing

Question 1

Any analytical system approved by the U.S.Food and Drug Administration to be sold as an over-the-counter test (i.e., in a store or pharmacy, without the need for a prescription) is automatically placed into the ______________ category of POCT testing.

A)waived
B)provider-performed microscopy
C)moderate-complexity
D)high-complexity

Answer 1

waived

Question 2

Tests performed by clinicians on their own patients, using samples that are so fragile it is impractical to send them to a central laboratory, are ____________.

A)waived
B)provider-performed microscopy
C)moderate-complexity
D)high-complexity

Answer 2

provider-performed microscopy

Question 3

Given that hemoglobin A1c levels are consistent for approximately 3 months, performance of POCT in the physician's office has been demonstrated to ______patient counseling and ______ hemoglobin A1c levels, improving both patient and physician satisfaction.

A)misdirect, decrease
B)enhance, increase
C)misdirect, increase
D)enhance, decrease

Answer 3

enhance, decrease

Question 4

The purpose of __________ is to monitor for the residual risk of errors not designed out of a POC device by the manufacturer.

A)quality control
B)quality assurance
C)external control
D)internal control

Question 5

_______________ is/are sensitive to device malfunction, reagent storage and stability, and operator technique.

A)quality control
B)quality assurance
C)external controls
D)internal controls

Question 6

Which of the following is considered a benefit to the clinical laboratory with point-of-care testing?

A)less trauma for the patient
B)financial savings
C)decreased preanalytical errors such as incorrect patient ID and delay in transportation
D)improved convenience

Question 7

Which of the following is not considered an analytical interference?

A)lipemia
B)drugs
C)interstitial fluid contamination
D)icterus

Question 8

In several states, such as California and Florida, training and/or licensure is required for waived testing.When personnel documentation is reviewed, all of the following criteria must be met except:

A)Staff responsible for testing and direction are identified.
B)Staff responsible for supervision are identified.
C)Adequate training specific to the device is required to perform the test.
D)Competency is checked at least every 18 months.

Question 9

Most errors with point-of-care testing occur at which of the following times?

A)before analysis, in the preanalytical phase
B)during analysis
C)at the time of reporting and recording of test results
D)none of the above

Question 10

______ may enhance detection of random errors, because they are performed with each test, whereas ______ detect(s) the sum of all processes in the testing system and does/do not require prior knowledge of a potential error.

A)quality control, external controls
B)internal controls, external controls
C)internal controls, quality control
D)quality control, internal controls

Question 11

_____________ is clinical laboratory testing conducted close to the site of patient care.

A)ex-vivo testing
B)point-of-care testing
C)in-vivo testing
D)diagnostic testing

Question 12

Which of the following do not perform point-of-care testing?

A)laboratory personnel
B)physicians
C)nurses
D)patients

Question 13

Which of the following is not considered a CLIA '88 Provider-Performed Microscopy test?

A)urine sediment examination
B)fecal leukocyte examination
C)trichomonas
D)fern testing

Question 14

Which of the following statements is not true regarding POCT?

A)POCT analyzers tend to have higher disposable and reagent costs than traditional laboratory systems.
B)Results from a POCT device will match results from a central laboratory for the same test.
C)Results of POCT can be seen and acted upon before any control checks or other external mechanisms of ensuring test result reliability can be applied to the result.
D)Most POCT errors are unintentional.

Question 15

Owing to faster turnaround time than results from a central laboratory, analytes like __________ are important tests for consideration as POCT.

A)blood gases
B)electrolytes
C)coagulation
D)all of the above

Question 16

Gram stains are sometimes performed as POCT and are classified as _____________.

A)waived
B)provider-performed microscopy
C)moderate-complexity
D)high-complexity

Question 17

Considering a patient's physiological status, which of the following factors can affect a specimen used for POCT?

A)hypervolemia
B)hypovolemia
C)poor peripheral circulation
D)all of the above