Chapter 05: Performance Improvement in the Microbiology Laboratory

Mahon: Textbook of Diagnostic Microbiology, 6th Edition

MULTIPLE CHOICE

1. Quality control is designed to

a. ensure the medical reliability of laboratory data.
b. check media
c. check reagents
d. monitor incubator and refrigerator temperatures
ANS: A
Checking media, checking reagents, and monitoring incubator and refrigerator temperatures
are all included in quality control. Each of these choices represents only a part of quality
control, whereas the first choice encompasses all the activities one would do in a quality
control program.

OBJ: Level 1: Recall

2. Actual laboratory testing is called a(n)

a. preanalytic activity.
b. analytic activity.
c. postanalytic activity.
d. research activity.
ANS: B
The analytic activity is the actual running of the laboratory test. Preanalytic activity is what
happens before a laboratory test is run. Postanalytic activity is what happens after a laboratory
test is run. Research is a term that applies to a series of focused experiments conducted to test
a hypothesis.

OBJ: Level 1: Recall

3. All of the following activities will directly affect the quality of a laboratory test, except
a. preanalytic.
b. analytic.
c. accreditation.
d. postanalytic.
ANS: C
Accreditation is a peer review of the policies and procedures of a laboratory that may
indirectly affect the quality of a laboratory test. Laboratory professionals have found that the
preanalytic, analytic, and postanalytic activities directly affect the quality of a laboratory test.

OBJ: Level 1: Recall

4. In January 2004, The Joint Commission (TJC) implemented performance measurements for
organizational systems that are critical to patient safety, quality of care, treatment, and
services. This new initiative is called
a. performance improvement.
 b. quality control.
c. quality assurance.
d. shared visions new pathway.
ANS: D
The new TJC initiative, shared visionsnew pathway, focuses on performance measurement of
organizational systems that are critical to patient safety, quality of care, treatment, and
services. Quality control consists of processes pertaining to the quality of analytic testing.
Performance improvement is a process that consists of setting performance standards,
measuring the standards against some criteria, then improving processes that fall short of the
standards. Quality assurance is a comprehensive system that takes the preanalytic, analytic,
and postanalytic processes into consideration when determining the quality of laboratory data.

OBJ: Level 1: Recall

5. All of the following activities are included in a laboratory quality control program, except
a. air quality.
b. temperatures.
c. media.
d. antimicrobial susceptibility testing.
ANS: A
The air quality in a laboratory is not routinely tested. A quality control program focuses on
procedures, equipment, and policies that affect how well laboratory tests are performed, the
quality of submitted specimens, and test results.

OBJ: Level 1: Recall

6. The morning technician arrives at the microbiology laboratory and goes around checking
daily temperatures. This person will check temperatures daily on all of the following
equipment, except
a. centrifuges.
b. incubators.
c. heating blocks.
d. refrigerators.
ANS: A
A centrifuge is not typically a temperature-dependent piece of equipment.

OBJ: Level 2: Interpretation

7. Thermometers used in the laboratory must be calibrated before they are put into use. This is
accomplished by
a. sending to the National Institute of Standards and Technology (NIST) to determine
its accuracy.
b. checking against an NIST thermometer.
c. measuring the grades to make sure they are the standard size and accurate.
d. using a colored dye.
ANS: B
A thermometer calibration is conducted by comparing the NIST thermometer reading to the
laboratory thermometer’s reading. Any variation is noted on the certificate of calibration.
 OBJ: Level 1: Recall

8. Preventive maintenance on an instrument includes all the following, except

a. disinfecting the surface of the instrument.
b. oiling and cleaning the instrument.
c. replacing filters.
d. recalibrating instruments.
ANS: A
Disinfecting the surface of an instrument is usually done as a daily activity and is generally
not considered preventive maintenance. All the other choices are preventive maintenance
activities that will keep an instrument in top shape and functioning at the proper level so as to
increase its lifetime and keep it producing quality results.

OBJ: Level 1: Recall

9. Commercial media must have quality control testing performed by the manufacturer. Because
of high failure rates, all of the following media must be retested by the hospital laboratory,
except
a. Campylobacter media.
b. selective media for pathogenic Neisseria.
c. trypticase soy agar with 5% sheep blood.
d. chocolate.
ANS: C
Trypticase soy agar with 5% sheep blood does not have a high failure rate, so the hospital
laboratory need not retest it.

OBJ: Level 1: Recall

10. Media that do not need to be retested by the hospital laboratory must still undergo observation
for all of the following, except
a. moisture.
b. sterility.
c. breakage.
d. organism colony characteristics.
ANS: D
When a laboratory is not required to retest prepared media, it still must observe media for
moisture, sterility, breakage, and appearance. Results of media observation must be recorded
and must include lot numbers.

OBJ: Level 1: Recall

11. When a medium needs to be quality controlled because it was prepared in house or because it
is complex, all the following rules must be followed, except:
a. Only media not specified in Clinical and Laboratory Standards Institute (CLSI)
guidelines should be tested.
b. The medium should be tested for sterility and pH.
c. The organism selected for quality control testing should represent most fastidious
organisms for which the medium is designed.
 d. Testing techniques should be different for primary plating media than for
biochemical or subculturing media.
ANS: A
All in-house media must be tested for pH, sterility, and positive and negative reacting
organisms—that is, if a medium should inhibit a specific organism or group of organisms, it
should be tested with those organisms to ensure it “works.” CLSI guidelines give specific
guidance as to what type of quality control testing should be performed on media prepared in
house.

OBJ: Level 1: Recall

12. Reagents that should undergo quality control in the microbiology laboratory include all the
following, except
a. Optochin.
b. immersion oil.
c. -lactamase.
d. nitrate.
ANS: B
Immersion oil does not need quality control testing. All stains performed in a microbiology
laboratory along with Optochin, -lactamase, nitrate, bacitracin, catalase, coagulation, gelatin,
germ tube, hippurate, Kovac’s, oxidase, PYR, typing sera, Voges-Proskauer, and X & V strips
should undergo quality control testing in a microbiology laboratory.

OBJ: Level 1: Recall

13. In any susceptibility system, variables that can affect the results include the following:
1. Antibiotic potency
2. Inoculum concentration
3. Bactericidal level
4. pH
5. Anion content
a. 1, 2, and 3 are correct
b. 1, 3, 4, and 5 are correct
c. 1, 2, 3, 4, and 5 are correct
d. 1, 2, and 4 are correct
ANS: D
The factors affecting results include antibiotic potency, inoculum, concentration, and pH. The
bactericidal level of antibiotic and anion content does not affect susceptibility results. Other
factors affecting results include agar depth, evaporation, cation content, thymidine content,
instrument failure, temperature, moisture, and difficulty in determining endpoints.

OBJ: Level 2: Interpretation

14. Susceptibility testing of control organisms is usually conducted daily until precision can be
demonstrated with _____ or _____ _____ days of susceptibility testing using CLSI guidelines.
a. 20; 30; consecutive
b. 15; 20; consecutive
c. 30; 40; nonconsecutive
 d. 5; 10; consistent
ANS: A
Once the 20- or 30-day evaluation has been accomplished, quality control organisms may be
tested weekly instead of daily. All results should be kept as long as the antimicrobial agent is
used or at least 2 years after discontinuing the agent.

OBJ: Level 1: Recall

15. How can personnel competency be determined?

a. Asking an employee to explain how to do a test
b. Proficiency testing
c. Asking another employee to comment on someone’s competency
d. Assuming competency from one’s credentials
ANS: B
Proficiency testing consists of carefully designing samples and giving them to technicians as
unknowns for the purpose of identifying them. This will show how competent a technician is
at performing job tasks. Asking an employee how to do a test is not the same as having
someone perform the test. Performing a test involves motor skills and coordination that cannot
be measured by asking a person how a test is performed.

OBJ: Level 1: Recall

16. The following are provisions of CLIA 88, except:

a. Verify employee competency upon employment.
b. Determine an employee’s competency.
c. Reverify the employee’s competency monthly.
d. Reverify the employee’s competency annually.
ANS: C
To maintain quality in the laboratory, CLIA 88 mandated that an employee’s competency must
be verified upon employment, an employer must determine an employee’s competency, and
the employee’s competency must be reverified annually. It did not mandate reverifying an
employee’s competency monthly because this would be an impossible task—the time frame is
too short.

OBJ: Level 1: Recall

17. Quality control stock cultures are available from all of the following, except
a. American Type Culture Collection (ATCC).
b. commercial sources.
c. proficiency testing isolates.
d. Centers for Disease Control and Prevention (CDC).
ANS: D
CDC is a clearinghouse for knowledge concerning infectious diseases, but CDC does not
provide stock cultures to hospital laboratories.

OBJ: Level 1: Recall

18. Popular media choices for maintaining stock cultures include

 a. Tryptic soy agar deeps.
b. cornmeal.
c. Sabouraud dextrose.
d. Cystine tryptic agar with glucose.
ANS: A
TSA deeps is the only choice that is sugar-free. For best results, a stock culture should be
grown in a large volume of broth, then divided among enough small freezer vials to last a
year. Media selection for freezing is at the discretion of the individual laboratory, but it should
not contain sugars. If organisms use sugars while being maintained, acid by-products could
kill the organism over time. CTA, Sabouraud dextrose, and cornmeal all have sugar.

OBJ: Level 1: Recall

19. Which of the following is an example of a mission statement for an institution?

a. “The AFMS Flagship—Comprehensive Healthcare…On Time…On Target”
b. “Working Together for a Healthy America”
c. “Your Total eLearning Solution”
d. “Will Answer Questions Correctly 95% of the Time”
ANS: B
An organization’s vision and mission statements must be clearly emphasized so that all
employees become involved and understand that each one of them has a role in the mission,
and that they must strive to make performance improvement part of their everyday life to
achieve the organization’s mission. The first and third choices are vision statements, whereas
the last choice is an objective.

OBJ: Level 2: Interpretation

20. All the following are components of TJC recommendations for establishing performance
monitors, except
a. plan.
b. design.
c. do.
d. assess.
ANS: C
The components of the recommendations are plan, design, measure, and assess.

OBJ: Level 1: Recall

21. Customers of a laboratory include all the following, except

a. patients.
b. insurers.
c. doctors.
d. accrediting organizations.
ANS: D
Anyone who looks to the laboratory for service is a customer. Accrediting organizations are
not expecting services from a laboratory, so they cannot be considered a customer. Doctors,
nurses, insurers, and patients are all customers.
 OBJ: Level 1: Recall

22. Multiple unlabeled specimen have been sent to the laboratory from multiple in-patient
locations. The laboratory manager decides corrective action needs to occur. What should be
constructed to evaluate and correct the problem?
a. Find fault with the nurse causing the problem.
b. Provide training for the nurse responsible for the problem.
c. Empower a facilitator.
d. Make a cross-functional team.
ANS: D
When patient outcome is less than desirable, the process must be evaluated and corrected. The
focus is on the process, not the individual. The primary rule to follow is to refrain from finger
pointing or fault finding. Preanalytic and postanalytic activities usually take place outside the
laboratory and require a cross-functional team to evaluate and correct the problem.

OBJ: Level 3: Synthesis

23. When is a broken process fixed?

a. When the problem is prevented from happening again.
b. When everyone is happy with the process.
c. When the process becomes seamless.
d. When the hospital administrator determines that the cross-functional team is no
longer needed.
ANS: A
A process is fixed only when the problem is prevented from happening again. It is not fixed
just because the reason something went wrong is explained.

OBJ: Level 1: Recall

24. What is benchmarking?

a. Identifying a problem to be fixed
b. Seeking an industry’s or profession’s best practices to imitate and improve
c. Explaining why a problem occurred
d. Asking the CEO’s opinion and going with his or her idea
ANS: B
Benchmarking is seeking an industry’s or profession’s best practice to imitate and improve.
Benchmarking was initially practiced in business and industry, but it has now become an
important part of the hospital quality management program.

OBJ: Level 1: Recall

25. When performing tests in the microbiology laboratory, the detection limit of a test refers to the
_____ of that test.
a. analytic specificity
b. analytic sensitivity
c. clinical sensitivity
d. clinical specificity
ANS: B
 The analytic sensitivity of a test refers to its ability to detect a particular analyte or a small
change in its concentration. Analytic sensitivity is usually defined as the 0.95 confidence level
(±2 SD) and may be referred to as the detection limit. Analytic specificity is a test’s ability not
to react with substances other than the one of interest. Clinical sensitivity is the proportion of
specimens that test positive from people who are known to have the disease. Clinical
specificity is the population of specimens that test negative from those known to be disease
free.

OBJ: Level 1: Recall

26. A technician is performing a chemistry test on a control sample. The technician gets the
following values for the control: 4.3, 4.3, 4.3, 4.2, 4.4, 4.3, 4.2, and 4.4. The actual value is
4.3. These results are said to be
a. systematically inaccurate.
b. sensitive.
c. accurate.
d. bias.
ANS: C
The degree of conformity of a measurement to a standard or true value is accuracy. Bias is the
mean difference of test results from an accepted reference method caused by systematic
errors.

OBJ: Level 3: Synthesis

27. A test is performed on a group of 10 patients. Six patients have a disease, and four are free of
the disease. If six patients (all known to have the disease) of this group test positive for the
disease, we say that the clinical sensitivity of this test is
a. 60%.
b. 40%.
c. 50%.
d. 100%.
ANS: D
Clinical sensitivity is the proportion of positive test results obtained when a test is applied to
patients known to have the disease. Thus, it is the frequency of positive test results in patients
with the disease. If six patients in our group are known to have the disease and all six test
positive, then the clinical sensitivity of the test is 100%.

OBJ: Level 3: Synthesis

28. A group of 10 patients are to be tested: six are known to have a disease and four are disease
free. If the four disease-free patients tested negative for this disease, what would the clinical
specificity of this test be?
a. 100%
b. 60%
c. 40%
d. 50%
ANS: A
 Clinical specificity is the proportion of negative results obtained when a test is applied to
patients known to be free of disease. Thus it is the frequency of negative test results in patients
without the disease. So if there are four patients in this group and they all test negative with
this test, then the clinical specificity is 100%—all negative individuals tested negative with
this test.

OBJ: Level 3: Synthesis

29. Incidence is
a. the frequency of a disease at a designated single point in time in the population
being tested.
b. the number of new cases of disease over a period of time.
c. proportion of negative test results in a population known to be free of disease.
d. positive results in patients with the disease.
ANS: B
Incidence is defined as the number of new cases of disease over a period of time. Prevalence
is the frequency of a disease at a designated single point in time in the population being tested.
Clinical specificity is the proportion of negative test results in a population known to be free
of the disease. Clinical sensitivity is the positive results in patients with the disease.

OBJ: Level 1: Recall

30. A test can have both a positive and a negative predictive value (NPV). All the following
elements are needed to compute the positive and NPV of a test, except
a. sensitivity of a test.
b. specificity of a test.
c. type of disease being tested.
d. prevalence of the disease being tested.
ANS: C
The predictive value of a test is the probability that a positive result (positive predictive value,
PPV) accurately indicates the presence of an analyte or a specific disease. The formula is

where PPV = positive predictive value

P = prevalence of disease being tested
Se = sensitivity of test
Sp = specificity of test

OBJ: Level 1: Recall

31. Assume that a certain test for group A Streptococcus has reported sensitivity and specificity of
90% and 98%, respectively, and the estimated prevalence for group A Streptococcus infection
in acute pharyngitis is 5%. What is the PPV of this test?
a. 99.5%
b. 30%
c. 90%
d. 70.3%
 ANS: D

PPV = positive predictive value

P = prevalence of disease being tested
Se = sensitivity of test
Sp = specificity of test

OBJ: Level 3: Synthesis

32. Usually, negative test results are more reliable in predicting

a. the absence of disease.
b. the presence of disease.
c. the sensitivity of a test.
d. the specificity of a test.
ANS: A
Usually, with tests, the NPV is higher than the PPV. This shows that tests can more accurately
predict the absence of disease. The sensitivity and specificity of a test do not predict the
presence or absence of a disease.

OBJ: Level 1: Recall

33. The efficiency of a test indicates

a. the percentage of patients who test positive for the disease.
b. the percentage of patients who are correctly identified as having or not having the
disease.
c. the percentage of patients who test negative for the disease.
d. the number of patients tested for a disease.
ANS: B

Test efficiency =
TP = number of patients with true-positive
TN = number of patients with true-negative
FP = number of patients with false-positive
FN = number of patients with false-negative

OBJ: Level 1: Recall

34. Screening is
a. used for only particular test analytes.
b. not practical in a hospital laboratory.
c. used for testing large populations of patients.
d. when a high incidence of a disease is found in a population.
ANS: C
Screening is used for testing large populations of patients. Generally, screening tests have high
clinical sensitivity and NPV. Positive results with such tests generally require confirmation
with a more specific test.
 OBJ: Level 1: Recall

35. Confirmation is used after

a. careful consideration by the doctor to do the test.
b. a test that has a low predictive value.
c. a test that has a low specificity.
d. obtaining a positive screening result.
ANS: D
Confirmation is the process of repeating a screening test using a test that is more sensitive and
specific to ensure accuracy for the initial screening result. Confirmatory tests help seek out
false-positive screening tests.

OBJ: Level 1: Recall

36. When choosing a test to perform in your laboratory, an in-house verification is always
performed. Verification of a test
a. serves to establish that the performance parameters of the test are satisfactory.
b. lets technicians actually perform the test.
c. lets physicians perform the test.
d. allows laboratory management to view positive results.
ANS: A
A test must be verified by a laboratory to ensure that it will work as described on the package.
A test must perform up to specifications in a laboratory or it is not worth using. Although
having technicians perform the test in-house shortens the turnaround time for results, the test
is evaluated for its performance. Physicians are not allowed to perform tests in a clinical
laboratory. Laboratory management does not need to see positive test results. Laboratory
management will evaluate the test on its in-house performance.

OBJ: Level 1: Recall

37. Test validation is the ongoing process of providing information that a test is performing
correctly. The components of validation include all the following, except
a. quality control.
b. specimen requirements.
c. proficiency testing.
d. instrument calibration.
ANS: B
Specimen requirements do not assess the functioning of a test. Quality control, proficiency
testing, and instrument calibration evaluate test functioning on a continual basis.

OBJ: Level 1: Recall

38. All of the following provide guidelines to ensure the continual correct performance of tests,
except
a. accrediting agencies.
b. regulatory agencies.
c. CDC.
d. manufacturers.
ANS: C
CDC does not publish recommendations in regard to continual test validation. CDC is a
clearinghouse for infectious disease knowledge.

OBJ: Level 1: Recall