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.

Accepted Answer

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

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 ____________.

Accepted Answer

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 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.

Accepted Answer

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

Question 4

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

Accepted Answer

The purpose of quality assurance is to monitor for the residual risk of errors not designed out of a POC device by the manufacturer.Total quality management is accomplished through a combination of appropriate training, external quality control, proficiency testing, competency assessment, and validation of devices prior to use in patient care.

Question 5

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

Accepted Answer

External controls are sensitive to device malfunction, reagent storage and stability, and operator technique.

Question 6

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

Accepted Answer

To the laboratory, participation in POCT offers the potential for decrease in preanalytical errors, particularly in patient ID and delays in transportation.To patients, POCT at the bedside and during an office visit provides improved convenience, less trauma, and a sense of patient-focused care.To administration, there are financial savings to the institution through faster diagnosis, therapeutic action, and decreased length of stay.

Question 7

Which of the following is not considered an analytical interference?

Accepted Answer

Interstitial fluid contamination is considered a problem encountered during the preanalytical phase of specimen collection.

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:

Accepted Answer

Competency must be checked at least annually.

Question 9

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

Accepted Answer

Most errors with point-of-care testing occur before analysis, in the preanalytical phase of testing.

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.

Accepted Answer

Internal controls may enhance detection of random errors, because they are performed with each test, whereas external controls detect the sum of all processes in the testing system and do not require prior knowledge of a potential error.

Question 11

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

Accepted Answer

Point-of-care testing (POCT) is clinical laboratory testing conducted close to the site of patient care.

Question 12

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

Accepted Answer

POCT is testing is conducted by non-laboratory medical personnel and by patient self-testing.

Question 13

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

Accepted Answer

Trichomonas is part of the CLIA '88 Waived Tests.

Question 14

Which of the following statements is not true regarding POCT?

Accepted Answer

POCT represents a different methodology than central laboratory testing.Therefore, results from POCT devices may not match central laboratory results for the same test.

Question 15

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

Accepted Answer

Analytes like blood gases, electrolytes, glucose, coagulation, and hemoglobin/hematocrit demonstrate rapidly changing levels-faster than the turnaround time for results from a central laboratory-and are important tests for consideration as POCT.

Question 16

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

Accepted Answer

Gram stains are sometimes performed as POCT and are classified as high complexity.

Question 17

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

Accepted Answer

Hypervolemia, hypovolemia, and poor peripheral circulation are all physiological factors that can affect the specimen.

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