Regulations chapter 2 Flashcards
(130 cards)
1
Q
- According to CLIA and CAP regulations,
which one of the following individuals is
considered to be a director of a clinical molecular
laboratory?
A. Dr. A, a member of the corresponding
academic society
B. Dr. B, appointed by the institute as the
director laboratory
C. Dr. C, board certified in the corresponding
specialty
D. Dr. D, listed on the laboratory’s CAP and
CLIA certificate as the lab director
E. All of the above
F. None of the above
A
D. Dr. D, listed on the laboratory’s CAP and
CLIA certificate as the lab director
2
Q
- A scientist plans to develop a Sanger
sequencingbased test for the FAS (TNFRSF6)
gene to assist diagnosis of autoimmune
lymphoproliferative syndrome in a clinical
molecular laboratory. There are no commercially
available FDA-cleared/approved assays for it.
According to the Clinical Laboratory
Improvement Amendments (CLIA) regulations,which one of the following descriptions most
appropriately describes this test?
A. Waived test
B. Nonwaived test
C. Moderate-complexity test
D. High-complexity test
E. None of the above
A
D. The laboratory-developed Sanger sequencing
assay for the FAS gene is a high-complexity test
system.
3
Q
- A scientist plans to develop a quantitative
PCRbased test for pathogenic variants in the
NPM1 gene to assist in the diagnosis of acute
myeloid leukemia (AML) in a clinical molecular
laboratory. There are no commercially available
FDA-cleared/approved assays for it. According to
the Clinical Laboratory Improvement
Amendments (CLIA) program, which one of the
following descriptions most appropriately
describes this test?
A. Waived test
B. Nonwaived test
C. Moderate-complexity test
D. High-complexity test
E. None of the above
A
D. The laboratory-developed quantitative PCR
assay for the NPM1 gene is a high-complexity test
system.
4
Q
- A scientist plans to validate a quantitative HIV-1
RNA assay for viral load assessment with the
Bayer VERSANT HIV-1 RNA 3.0 Assay (bDNA), a
FDA-approved commercially available assay, in a
clinical molecular laboratory. According to the
Clinical Laboratory Improvement Amendments
(CLIA) program, which one of the following
descriptions most appropriately describes this test?
A. Waived test
B. Nonwaived test
C. Moderate-complexity test
D. High-complexity test
E. None of the above
A
D. HIV-1 RNA quantitative PCR assay is a highcomplexity
test system.
5
Q
- A scientist developed a quantitative PCR-based
test for pathogenic variants in the NPM1 gene to
assist in the diagnosis of acute myeloid leukemia
(AML) in a clinical molecular laboratory. He used
the data published in a peer-reviewed article,
since there were no commercially available FDAcleared/
approved assays for it. The validation
was done as planned, and the summary was
written. Who has the authority to review and
approve the validation, according to the College
of American Pathologist (CAP)’s regulations, if
applicable?
A. Clinical Laboratory Improvement
Amendments (CLIA)
B. College of American Pathologist (CAP)
C. The chair of the department
D. The laboratory director
E. The supervisor of the laboratory
F. All of the above
G. None of the above
A
D. According to the College of American
Pathology (CAP) All Common Checklist dated
July 28, 2015, COM.40000, “There is a summary
statement, signed by the laboratory director (or
designee who meets CAP director qualifications) prior
to use in patient testing, that includes the
6
Q
A scientist planned to validate the bioMe´rieux
THxID BRAF assay, an FDA-approved
commercially available assay, to detect
somatic mutations in order to guide the
therapy of metastatic melanoma in a clinical
molecular laboratory. The protocol received
from bioMe´rieux was for 20-μL total volume for
each reaction. To save money, the scientist
decided to use 10 μL for each reaction. Which
validation stringency should he follow for the
validation, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?
A. Follow the validation procedure for FDAapproved
assay.
B. Follow the validation procedure for FDAapproved
assay, and add analytical sensitivity
and specificity.
C. Follow the validation procedure for FDAapproved
assay with both 20-μL and 10-μL
reactions.
D. Follow the validation procedure for a
laboratory-developed assay.
E. None of the above.
A
D. Follow the validation procedure for a
laboratory-developed assay.“If an FDA-cleared/
approved test is modified to meet the needs of the user or
if the test is developed by the laboratory (LDT), both
analytical and clinical performance parameters need to
be established.
7
Q
A scientist reviewed last month’s data in a
clinical molecular laboratory and found that the
failure rate of the KRAS test was 10% higher
than that for the previous 6 months and for the
same month last year. Which one of the
following is the most appropriate term used to
define the nature of this monthly review of
failure rate, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?
A. Quality assurance
B. Quality control
C. Quality improvement
D. Quality planning
E. All of the above
F. None of the above
A
A. Quality assurance (QA) is a way of preventing
mistakes or defects in the process of testing clinical
samples and avoiding problems when delivering the
results to customers, which is the part of quality
management focused on providing confidence that
quality requirements will be fulfilled.
8
Q
A scientist reviewed last month’s quality control
data in a clinical molecular laboratory and
found that the failure rate of the KRAS test was
10% higher than that for the previous 6 months
and for the same month last year. Which one of
following actions should he take to resolve the
problem, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?
A. Quality assurance
B. Quality control
C. Quality improvement
D. Quality planning
E. All of the above
F. None of the above
A
C. Quality improvement (QI) is a formal approach
to the analysis of performance and systematic
efforts to improve it. This question is a good
example. The initial finding was the high failure
rate based on the data gathered through the
quality assurance program. Further investigation
found that the reaction volume at the end of
procedure became very low (from 20 μL to 5 μL).
So the laboratory worked on two plans to solve
the problem. This troubleshooting process is
called quality improvement (QI).
9
Q
A clinical molecular genetic scientist has been
working in a start-up company for 2 months. He
has been purchasing reagents and writing policies
and procedures for this new laboratory. Which
one of the following should be included in his
quality management plan for the clinical
laboratory, according to the College of American
Pathologist (CAP)’s regulations, if applicable?
A. Calibrating the pipette at least once a year
B. Checking the quality of new lots and new
shipments of reagents against old ones
C. Having a written quality management plan
D. Maintaining discontinued procedures for at
least 2 years
E. Participating in the CAP Proficiency Test (PT)
F. All of the above
G. None of the above
A
F. All of the above
10
Q
A courier picked up a peripheral-blood sample
(lavender) from an outreach draw station for
BCR-ABL1 quantitative testing at the main
hospital. He checked the identifiers of the sample
on the requisition form and the tube to make sure
the identity of the sample matched. At a
minimum, how many identifiers have to be on
the tube for a collected peripheral-blood sample,
according to the College of American Pathologist
(CAP)’s regulations, if applicable?
A. At least one
B. At least two
C. At least three
D. At least four
E. None of above
A
B. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.4049, “All primary
specimen containers are labeled with at least two
patient-specific identifiers.” And according to the
CAP All Common Checklist dated July 28, 2015,
COM.06100, “All primary specimen containers
are labeled with at least two patient-specific
identifiers.”
Therefore, at least 2 identifiers have to be on
the tube for a collected peripheral blood sample
according to the College of American Pathologist
(CAP)’s regulation.
11
Q
A courier picked up a peripheral-blood sample
(lavender) from a local obstetrician/gynecologist
(Ob/Gyn) practice for cystic fibrosis testing in the
main hospital. He noticed the patient’s name was
donor BJ. And the only usable identifier on the
requisition form and the tube was patient’s
medical record number. Which type of deficiency
would an on-site College of American Pathologist
(CAP) inspector find it to be, according to the
College of American Pathologist (CAP)’s
regulations, if applicable?
A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. None of above
A
E. This is not a deficiency. According to the College
of American Pathologists (CAP) All Common
Checklist dated July 28, 2015, COM.06100, “All
primary specimen containers are labeled with at
least two patient-specific identifiers.” However, it
also states “In limited situations, a single
identifier may be used if it can uniquely identify
the specimen.
12
Q
A scientist just finished validation of a HER2
FISH assay with archived formalin-fixed,
paraffin-embedded (FFPE) tissue samples in a
clinical molecular laboratory at a hospital.
According to procedure, he sends samples to the
cytology laboratory in the same hospital for
hybridization, then takes the slides back for analysis. How should the clinical molecular
laboratory perform proficiency test on this HER2
FISH assay, according to the College of American
Pathologist (CAP)’s regulations, if applicable?1
A. Enroll in the College of American Pathologist
(CAP) HER2 immunohistochemistry (IHC)
proficiency test.
B. Enroll in the College of American Pathologist
(CAP) HER2 FISH proficiency test.
C. Perform an alternative HER2 FISH proficiency
test.
D. All of the above.
E. None of the above.
A
C. According to the College of American
Pathologists (CAP) All Common Checklist dated
July 28, 2015, COM.01300, “Proficiency testing
for HER2 (ERBB2) is method specific. If the
laboratory performs HER2 (ERBB2) testing by
multiple methods, the laboratory must
participate in PT for each method. . . If the
laboratory sends its FISH (or ISH) slides for
hybridization to another facility, the laboratory
must perform an alternative assessment of the test
twice annually and may not participate in formal
(external) PT.”
13
Q
A scientist in a clinical molecular laboratory of a
hospital just finished validation of a HER2 FISH
assay with archived formalin-fixed, paraffinembedded
(FFPE) tissue samples. According to
procedure, she sends samples to the cytology
laboratory in the same hospital for hybridization,
then takes the slides back for analysis. Therefore,
the clinical molecular laboratory must perform an
alternative assessment of the HER2 FISH assay
instead of the CAP formal proficiency test. At a
minimum, how frequently should the laboratory
perform the alternative assessment of the HER2
FISH assay, according to the College of American
Pathologist (CAP)’s regulations, if applicable?
A. Every quarter
B. Semiannually
C. Annually
D. Biennially
E. None of the above
A
B. According to the College of American
Pathologists (CAP) All Common Checklist dated
July 28, 2015, COM.01300, “Proficiency testing for
HER2 (ERBB2) is method specific. If the
laboratory performs HER2 (ERBB2) testing by
multiple methods, the laboratory must participate
in PT for each method. . . If the laboratory sends
its FISH (or ISH) slides for hybridization to
another facility, the laboratory must perform an
alternative assessment of the test twice annually
and may not participate in formal (external) PT.”
14
Q
A clinical molecular laboratory in a hospital
received specimens for proficiency test of a BRAF
assay from the College of American Pathologist
(CAP) last week. The specimens were treated as
regular clinical samples, and were signed out in
the electronic reporting system in the laboratory.
Who should sign the Proficiency Test (PT)
Attestation Statement according to the College of
American Pathologist (CAP)’s regulations, if
applicable?
a. The laboratory director or designee
b. All individuals involved in the testing process
c. All staff in this laboratory
d. The quality control office of the hospital
A. a, b, and d
B. a, c, and d
C. a and b
D. a and c
E. a, b, c, and d
A
C. The laboratory director or designee
and all individuals involved in the testing process
should sign the Proficiency Test (PT) Attestation
Statement according to CAP’s regulation.
15
Q
A clinical molecular laboratory in a hospital
received specimens for a proficiency test of a
BRAF assay from the College of American
Pathologist (CAP) last week, which was 3 months after test was launched. The specimens were
treated as regular clinical samples and were
signed out in the electronic reporting system in
the laboratory. At a minimum, how frequently
should proficiency tests (PT) of this assay be done
according to the Clinical Laboratory Improvement
Amendments (CLIAs) 1988?
A. Annually
B. Biennially
C. Twice a year
D. Three times a year
E. None of above
A
C. According to the College of American
Pathology (CAP) All Common Checklist dated
July 28, 2015, COM.01500, “For test for which
CAP does not require PT, the laboratory at least
semi-annually exercises an alternative performance
assessment system for
16
Q
A director of a CAP/CLIA-certified clinical
molecular laboratory received specimens for a
proficiency test (PT) of a BRAF assay from the
College of American Pathologist (CAP). One of
the samples showed unacceptable results. Which
type of deficiency would this discrepancy be,
according to the College of American Pathologist
(CAP)’s regulations, if applicable?
A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. None of above
A
E. This is not a deficiency according to the College
of American Pathologist (CAP)’s regulations.
However, the laboratory must have written
procedures for the proper handling, analysis,
review, and reporting of proficiency testing
materials.
17
Q
A CAP inspection team comes to the molecular
pathology laboratory in the department of
pathology of a hospital for an on-site inspection.
The team member for the molecular laboratory
finds that the CYP2C19 test is on the test menu of
the laboratory, but not on the current College of
American Pathologist (CAP) activity menu. The
director explains that the test was developed 6
months ago, and he has not had a chance to add
it to the CAP activity menu. Which type of
deficiency would this discrepancy be, according
to the College of American Pathologist (CAP)’s
regulations, if applicable?
A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. None of above
A
B. This is a Phase I deficiency according to the
College of American Pathologist (CAP)’s
regulations. In the College of American Pathology
(CAP) All Common Checklist dated July 28, 2015,
COM.01200, it states “The laboratory’s current
CAP Activity Menu accurately reflects the testing
performed.” If the laboratory failed to inform
CAP the change of the test menu, it would be a
phase I deficiency. In the situation described in
the question, “the inspector should contact the
CAP (800-323-4040) for instructions and record on
the appropriate section page in the Inspector’s
Summation Report (ISR) whether those tests were
inspected or not inspected.”
18
Q
A clinical molecular scientist reviewed last
month’s quality control data in the laboratory,
and found that the detection rate of the KRAS test
was 50% lower than it had been in the previous 6
months and in the same month last year. He
started to investigate the reason while sending the
samples to a reference laboratory. During
investigation, the laboratory received CAP
proficiency test (PT) specimens for this test. One
of the ideas was to send the specimens to the
reference laboratory as clinical samples. Which
type of deficiency would it be if the laboratory sent the CAP specimens to a reference laboratory,
according to the College of American Pathologist
(CAP)’s regulations, if applicable?
A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. None of above
A
C. Under CLIA’88 regulations, there is a strict
prohibition against referring proficiency testing
(PT) specimens to another laboratory with a
different CLIA number, even if the second
laboratory is in the same health care system. If a
laboratory refers College of American Pathology
(CAP) PT specimens to another laboratory in any
circumstances, it is a Phase II deficiency.
19
Q
A clinical molecular laboratory in a hospital
received specimens for proficiency test (PT) of a
BRAF assay from the College of American
Pathologist (CAP) last week, which was 3 months
after test was launched. The specimens were
treated as regular clinical samples and were
signed out in the electronic reporting system in
the laboratory. How long should the primary
records of the proficiency test (PT) be retained,
according to the Clinical Laboratory Improvement
Amendments (CLIA) 1988?
A. At least 1 year
B. At least 2 years
C. At least 3 years
D. At least 4 years
E. At least 5 years
F. At least 10 years
A
B. According to the College of American
Pathology (CAP) All Common Checklist dated
April 21, 2014, COM.01700, “Primary records
related to PT and alternative assessment testing
are retained for two years (unless a longer
retention period is required elsewhere in this
checklist for specific analytes or disciplines).
These include all instrument tapes, work cards,
computer printouts, evaluation reports, evidence
of review, and documentation of follow-up/
corrective action.”
20
Q
A start-up clinical molecular genetics laboratory
in the state of Arizona welcomed its first on-site
inspector on a Monday morning. There were only
two tests in this laboratory—factor V Leiden and
factor II. The director shared with the inspector
that he used an alternative approach for the
proficiency test (PT) in order to save money.
Which type of deficiency would it be, according
to the College of American Pathologist (CAP)’s
regulations, if applicable?
A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. None of above
A
C. This is a Phase II deficiency according to the
College of American Pathologist (CAP)’s
regulations. According to the CAP All Common
Checklist dated July 28, 2015, COM.01300, “The
laboratory participates in the appropriate
required proficiency testing (PT)/external
quality assessment (EQA) program accepted by
CAP for the patient testing performed.”
21
Q
A start-up clinical molecular genetics laboratory
in the state of Arizona welcomed its first on-site
inspector on a Monday morning. There were only
two tests in this laboratory—BRAF and EGFR.
The director shared with the inspector that he
used an alternative approach for the proficiency
test (PT) in order to save money. Which type of
deficiency would it be, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?
A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. None of above
A
E. This is not a deficiency according to the College
of American Pathologist (CAP)’s , “For tests for which CAP does not
require PT, the laboratory at least semi-annually
exercises an alternative performance assessment
system for determining the reliability of analytic
testing.”
BRAF and EGFR molecular assays fall into this
category, which requires alternative assessment.
According to COM.01500, “Appropriate
alternative performance assessment procedures
include participation in an external PT program
not required by CAP;
22
Q
According to the Centers for Disease Control and
Prevention (CDC) classification of biohazardous
waste, the risk group 1 agents are:
A. Agents that are not associated with disease in
healthy adult humans.
B. Agents that are associated with serious or
lethal human disease for which preventive or
therapeutic interventions may be available
(high individual risk but low community risk).
C. Agents that are associated with human disease
that is rarely serious and for which preventive
or therapeutic interventions are often available.
D. Agents that are likely to cause serious or lethal
human disease for which preventive or
therapeutic interventions are not usually
available (high individual risk and high
community risk).
A
A. In a research laboratory, this would include
solid waste generated from any work with human
or nonhuman primate blood, tissue, or cells and
microbiological agents that may cause human
illness. The Basis for the Classification of
Biohazardous Agents by Risk Group (RG) is as
follows:
* Risk Group 1 (RG1): Agents that are not associated
with disease in healthy adult humans.
23
Q
According to the Centers for Disease Control and
Prevention (CDC) classification of biohazardous
waste, the Risk Group 4 agents are:
A. Agents that are not associated with disease in
healthy adult humans.
B. Agents that are associated with serious or
lethal human disease for which preventive or
therapeutic interventions may be available
(high individual risk but low community risk).
C. Agents that are associated with human disease
that is rarely serious and for which preventive
or therapeutic interventions are often available.
D. Agents that are likely to cause serious or lethal
human disease for which preventive or
therapeutic interventions are not usually
available (high individual risk and high
community risk).
A
D. In a research laboratory, this would include
solid waste generated from any work with human
or nonhuman primate blood, tissue, or cells and
microbiological agents that may cause human
illness. The Basis for the Classification of
Biohazardous Agents by Risk Group (RG) is as
follows:
* Risk Group 4 (RG4): Agents that are likely to cause
serious or lethal human disease for which preventive
or therapeutic interventions are not usually
available (high individual risk and high community
risk)
24
Q
According to the Centers for Disease Control and
Prevention (CDC) classification of biohazardous
waste, the Risk Group 2 agents are:
A. Agents that are not associated with disease in
healthy adult humans.
B. Agents that are associated with serious or
lethal human disease for which preventive or
therapeutic interventions may be available
(high individual risk but low community risk).
C. Agents that are associated with human
disease that is rarely serious and for which
preventive or therapeutic interventions are
often available
D. Agents that are likely to cause serious or lethal
human disease for which preventive or
therapeutic interventions are not usually
available (high individual risk and high
community risk).
A
B. In a research laboratory, this would include
solid waste generated from any work with human
or nonhuman primate blood, tissue, or cells and
microbiological agents that may cause human
illness. The Basis for the Classification of
Biohazardous Agents by Risk Group (RG) is as
follows:
* Risk Group 2 (RG2): Agents that are associated
with human disease that is rarely serious and for
which preventive or therapeutic interventions are
often available.
25
According to the Disease Control and Prevention
(CDC) classification of biohazardous waste, the
risk group 3 agents are:
A. Agents that are not associated with disease in
healthy adult humans.
B. Agents that are associated with serious or
lethal human disease for which preventive or
therapeutic interventions may be available
(high individual risk but low community risk).
C. Agents that are associated with human disease
that is rarely serious and for which preventive
or therapeutic interventions are often available.
D. Agents that are likely to cause serious or lethal
human disease for which preventive or
therapeutic interventions are not usually
available (high individual risk and high
community risk).
C. In a research laboratory, this would include
solid waste generated from any work with human
or nonhuman primate blood, tissue, or cells and
microbiological agents that may cause human
illness. The Basis for the Classification of
Biohazardous Agents by Risk Group (RG) is as
follows:
* Risk Group 3 (RG3): Agents that are associated with
serious or lethal human disease for which preventive
or therapeutic interventions may be available (high
individual risk but low community risk).
26
Human immunodeficiency virus (HIV) spreads
through certain body fluids and attacks a person’s
immune system by destroying CD4-positive T
cells. This makes it harder and harder for the body
to fight infections and other diseases. Currently, no
effective cure exists for HIV. But with proper
medical care, HIV can be controlled. According to
the Centers for Disease Control and Prevention
(CDC) classification of biohazardous waste, to
which risk group does the HIV-1 virus belong?
A. Risk Group 1
B. Risk Group 2
C. Risk Group 3
D. Risk Group 4
E. Risk Group 5
C. HIV-1 and 2 viruses are in the risk group 3
27
The Ebola virus causes an acute and serious
illness that is often fatal if left untreated. Ebola
virus disease (EVD) first appeared in 1976 in two
simultaneous outbreaks, one in what is now,
Nzara, South Sudan, and the other in Yambuku,
Democratic Republic of Congo. The latter
occurred in a village near the Ebola River, from
which the disease takes its name. According to
the Centers for Disease Control and Prevention
(CDC) classification of biohazardous waste, to
which risk group does the Ebola virus belong?
A. Risk Group 1
B. Risk Group 2
C. Risk Group 3
D. Risk Group 4
E. Risk Group 5
D. Ebola virus is in the Risk Group 4
28
According to the Centers for Disease Control and
Prevention (CDC) classification of biohazardous
waste, to which risk group do hepatitis B,
cytomegalovirus (CMV), EpsteinBarr virus (EBV),
and herpes simplex types 1 and 2 viruses belong?
A. Risk Group 1
B. Risk Group 2
C. Risk Group 3
D. Risk Group 4
E. Risk Group 5
B. Hepatitis B, cytomegalovirus [CMV, EpsteinBarr
virus (EBV)], and herpes simplex types 1 and 2
viruses are in risk group 2
29
Rabies virus has a nonsegmented and negativestranded
RNA genome. Rabies disease is most
often transmitted through the bite of a rabid
animal such as raccoons, skunks, bats, and foxes.
According to the Centers for Disease Control and
Prevention (CDC) classification of biohazardous
waste, to which risk group does rabies virus belong?
A. Risk Group 1
B. Risk Group 2
C. Risk Group 3
D. Risk Group 4
E. Risk Group 5
B. Rabies virus is in risk group 2
30
An ACMG board-certified molecular geneticist
started a job as a director in a commercial
laboratory. He planned to review all the
procedures and policies in the laboratory in the
first 2 months. He found that one of the procedures
stated that a designee of the director would review
and assess instrument and equipment maintenance
and function-check records semiannually. He felt it
was wrong. How frequently should he or his
designee review and assess instrument and
equipment maintenance and function check
records, according to the College of American
Pathologist (CAP)’s regulations, if applicable?
A. At least monthly
B. At least quarterly
C. At least twice a year
D. At least annually
E. At least biennially
A. According to the College of American
Pathology (CAP) All Common Checklist dated
July 28, 2015, COM.04200, “Instrument and
equipment maintenance and function check
records are reviewed and assessed at least monthly
by the laboratory director or designee.”
31
An ACMG board-certified molecular geneticist
started a job as a director in a commercial
laboratory. He planned to review all the
procedures and policies in the laboratory in 2
months. He found that one of the procedures
stated that a designee of the director would check
the 20 thermal cyclers against each other once a
year. He noticed that 10 of the thermal cyclers
were from Applied Biosystems (ABI), 5 were
from Eppendorf, and the remaining 5 were from
Thermo Fisher Scientific. Which one of the
following statements is correct, according to the
College of American Pathologist (CAP)’s
regulations, if applicable?
A. He should check the thermal cyclers from the
same manufacturer against each other at least
once a year.
B. He should check all 20 thermal cyclers against
each other at least once a year.
C. He should check the thermal cyclers from the
same manufacturer against each other at least
twice a year.
D. He should check all 20 thermal cyclers against
each other at least twice a year.
E. None of the above.
D. According to the College of American
Pathology (CAP) All Common Checklist dated
July 28, 2015, COM.04250, “If the laboratory uses
more than one nonwaived instrument/method to
test for a given analyte, the instruments/methods
are checked against each other at least twice a year
for comparability of results.” It also states, “This
requirement applies to tests performed on the
same or different instrument makes/models or by
different methods.” Please also be aware that “This
comparison is required only for nonwaived
instruments/methods accredited under a single
CAP number.”
32
An ACMG board-certified molecular geneticist
started a job as a director in a commercial
laboratory. He planned to review all the
procedures and policies in the laboratory in the
first month. He found that one of the
procedures stated that a designee of the director
would check the 20 thermal cyclers against each
other once a year. He noticed that 10 of the
thermal cyclers were from Applied Biosystems
(ABI) and the rest were from Eppendorf or
Thermo Fisher Scientific. How frequently should
he or a designee check the thermal cyclers
against each other for comparability of results in
the laboratory, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?
A. At least monthly
B. At least quarterly
C. At least twice a year
D. At least annually
E. At least biennially
C. According to the College of American
Pathology (CAP) All Common Checklist dated
July 28, 2015, COM.04250, “If the laboratory uses
more than one nonwaived instrument/method to
test for a given analyte, the instruments/methods
are checked against each other at least twice a year
for comparability of results.”
33
A newly ACMG board-certified molecular
geneticist started a job as a director in a
commercial laboratory 2 months ago. While he
reviewed the procedures and policies, he found
that the laboratory used a triplet primer PCR
assay without methylation-sensitive
confirmation for the fragile X test. Before taking
any action on it, the laboratory received
specimens from the College of American
Pathologist (CAP) for proficiency testing on
fragile X. One of the specimens was homozygous
for allele 30. Since the gender of the specimen
was unknown, the director was concerned about
whether there was a gross deletion or a
mutation in the primer region leading to allelic
drop. He called a director at another institute to
discuss the result before finalizing it. Which type
of deficiency would it be if they discussed the
results, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?
A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. None of above
C. It would be a Phase II deficiency. According to
the College of American Pathology (CAP) All
Common Checklist dated July 28, 2015,
COM.01800, “Results must be reported by
personnel within the laboratory. There is a strict
prohibition against interlaboratory
communications about proficiency testing
samples or results until after the deadline for
submission
34
Dr. A, a newly board-certified molecular
geneticist, started to work for a hospital 10 days
ago. He planned to review all the procedures
and policies in the laboratory in the first 2
months. He found that some of the procedures
had not been reviewed for more than 5 years.
How frequently should the technical policies and
procedures be reviewed by the current laboratory director or designee in a clinical
molecular genetics laboratory, according to the
College of American Pathology (CAP)
regulations, if applicable?
A. At least monthly
B. At least quarterly
C. At least twice a year
D. At least annually
E. At least biennially
F. At least once in 5 years
E. According to the College of American
Pathology (CAP) All Common Checklist dated
July 28, 2015, COM.10100 “There is
documentation of review of all technical policies
and procedures by the current laboratory director
or designee at least every two years.”
35
Dr. A, a newly board-certified molecular
geneticist, started to work for a hospital 10 days
ago. He planned to review all the procedures and
policies in the laboratory in the first 2 months. He
found that some of the procedures had not been
reviewed for more than 5 years. Which type of
deficiency would it be, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?
A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. None of above
C. It would be a Phase II deficiency.
36
Dr. B, a director of a clinical molecular genetics
laboratory in an academic center, validated a
clinical next-generation sequencing (NGS) panel
for somatic mutations in solid tumors. When
should the procedure for this new test be
reviewed and approved, according to the College
of American Pathologist (CAP)’s regulations, if
applicable?
A. It should be reviewed and approved 30 days
before implementation.
B. It should be reviewed and approved 15 days
before implementation.
C. It should be reviewed and approved before
implementation.
D. It should be reviewed and approved within 1
month after implementation.
E. None of above.
C. According to the College of American
Pathology (CAP) All Common Checklist dated
July 28, 2015, COM.10200, “The laboratory
director reviews and approves all new technical
policies and procedures, as well as substantial
changes to existing documents, before
implementation. This review may not be delegated
to designees in laboratories subject to the CLIA
regulations. Paper/electronic signature review is
required. A secure electronic signature is
desirable, but not required.”
37
Dr. B, the only director of a clinical molecular
genetics laboratory in an academic center,
validated a clinical next-generation sequencing
(NGS) panel for somatic pathogenic variants
in solid tumors. By whom should this procedure
for the new test be reviewed and
approved, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?
A. BJ, the supervisor of the laboratory
B. Dr. B
C. Dr. C, the chair of the department
D. Dr. D, the chief medical officer of the hospital
E. College of American Pathologist (CAP)
F. All of the above
G. None of above
B. Dr. B
38
JJ, a technologist in a clinical molecular genetics
laboratory, came to Dr. E, the director, to
complain about the speed of the computer. The
laboratory support team assessed the situation
and suggested the purchase of a new remote
drive or the deletion some files in the current
hard drive to free some space. Dr. E decided to
delete some of the discontinued procedures.
How long should the discontinued procedures
be maintained in a clinical molecular genetics
laboratory, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?
A. At least 1 year
B. At least 2 years
C. At least 5 years
D. At least 7 years
E. At least 16 years
F. At least 23 years
G. Forever
B. At least 2 years
39
Dr. J, a clinical molecular geneticist, called Dr. G,
an oncologist in the same hospital, about a
patient’s abnormal PML/RARA quantitative
results. What information should be recorded in
the patient’s record for this communication,
according to the College of American Pathologist
(CAP)’s regulations, if applicable?
a. Patient ID
b. Date of the phone call
c. Time of the phone call
d. Laboratory individual responsible for the
phone call
e. Person notified in the physician office (first
and last name)
f. Test results
g. Recommendations
h. “Read-back” of the results
A. a, b, d, e, and h
B. a, b, d, e, f, and h
C. a, b, c, d, e, f, and h
D. a, b, d, e, f, and h
E. a, b, c, d, e, f, g, and h
F. None of above
C. a, b, c, d, e, f, and h
recommendation is not necessary for preliminary
results.
40
Dr. D, a director of a clinical laboratory in
Wisconsin, found that a lot of restriction
enzymes in the laboratory had passed the
expiration date. It would be a huge waste to
throw them away, so he tested the enzymes with
positive controls, negative controls, and 10
previous patient samples. All the results were
correct, so he decided to keep using those
enzymes clinically. Which type of deficiency
would this decision be, according to the College of American Pathologist (CAP)’s regulations, if
applicable?
A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. None of above
C. This is a Phase II deficiency
41
Dr. A, an ACMG board-certified molecular
geneticist, started a job as a senior director in a
commercial laboratory 2 months ago. When
reviewing the procedures and policies in the
laboratory, he found that the laboratory only
checked new reagent lots against old reagent lots,
but not against new reagent shipments in the
same lot. The manager explained that it was done
that way in order to save money. Dr. A changed
the procedure to check new reagent lots and new
shipments against old reagent lots and old
shipments. Why did Dr. A make the change,
according to the College of American Pathologist
(CAP)’s regulations, if applicable?
A. Because it is a Phase 0 deficiency if the
laboratory doesn’t check new shipments in the
same lot.
B. Because it is a Phase I deficiency if the
laboratory doesn’t check new shipments in the
same lot.
C. Because it is a Phase II deficiency if the
laboratory doesn’t check new shipments in the
same lot.
D. Because it is a Phase III deficiency if the
laboratory doesn’t check new shipments in the
same lot.
E. Because it makes Dr. A feel more
comfortable to have both new lots and new
shipments checked.
F. None of above.
C. It would be a Phase II deficiency if the
laboratory does not check new shipments
42
Dr. A, an ACMG board-certified molecular
geneticist, started a job as a senior director in a
commercial laboratory 2 months ago. He
observed the staff performing each test. When he
was observing JJ, a technologist, setting up a
quantitative PCR reaction for BCR-ABL1, JJ
found that the reagents in the kit were not
enough for this run. JJ took out another kit with
a different lot number from the freezer. The new
lot was checked and verified. JJ pipetted the
remaining reagents from the old kit to the new
kit and explained to Dr. A that this was a new
policy in the laboratory to save money. Dr. A
stopped JJ and changed the procedure
immediately. Why did Dr. A stop JJ and make
the change to the procedure, according to the
College of American Pathologist (CAP)’s
regulations, if applicable?
A. Because it is a Phase 0 deficiency to mix kit
components from different lots.
B. Because it is a Phase I deficiency to mix kit
components from different lots.
C. Because it is a Phase II deficiency to mix kit
components from different lots.
D. Because it is a Phase III deficiency to mix kit
components from different lots.
E. Because Dr. G did not feel that it was right to
mix kit components from different lots.
F. None of above.
C. It would be a Phase II deficiency if JJ used
reagents from kits within different kit lots,
according to the College of American Pathologist
(CAP)’s regulations. According to the CAP All
Common Checklist dated July 28, 2015,
COM.30500, “If there are multiple components of
a reagent kit, the laboratory uses components of
reagent kits only within the kit lot unless
otherwise specified by the manufacturer.” And
laboratories should have “Written policy defining
allowable exceptions for mixing kit components
from different lots.”
43
Dr. G, an ACMG board-certified molecular
geneticist, started a job as a senior director of a
clinical molecular pathology laboratory in a
hospital 2 months ago. He started to observe the
staff to performing each test. When he was
observing BJ, a technologist, as he set up a
quantitative PCR reaction for BCR-ABL1, a man
put an Eppendorf thermal cycler on the bench,
and told BJ it was fixed. BJ explained to Dr. G
that the Eppendorf thermal cycler had had a
problem and that a clinical engineer took it a few
days ago. While they were talking, Emily, another
technologist, walked in with her PCR plate. Emily
started to set up her PCR in the newly fixed
thermal cycler. Dr. G suggested that Emily use
other thermal cyclers in the laboratory. Why did
Dr. G suggest the use of other thermal cyclers in
the laboratory, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?1
A. It is a Phase 0 deficiency to use newly fixed
instruments/equipment before performance
verification.
B. It is a Phase I deficiency to use newly fixed
instruments/equipment before performance
verification.
C. It is a Phase II deficiency to use newly fixed
instruments/equipment before performance
verification.
D. It is a Phase III deficiency to use newly fixed
instruments/equipment before performance
verification.
E. Dr. G felt that using newly fixed instruments/
equipment before performance verification did
not feel right.
F. None of above.
C. It would be a Phase II deficiency if Emily uses
the newly fixed thermal cycler before
performance verification, according to the College
of American Pathologist (CAP)’s regulations.
According to the CAP All Common Checklist
dated July 28, 2015, COM.30550, “The
performance of all instruments and equipment is
verified upon installation and after major
maintenance or service to ensure that they run
according to expectations.” It also states,
“Performance verification is necessary after
repairs or replacement of critical components of
an instrument or item of equipment.”1
44
A start-up CAP/CLIA-certified clinical
molecular genetics laboratory has only two
technologists, one part-time on-site supervisor,
and one part-time off-site director. The
technologists validated a BRAF assay with
formalin-fixed and paraffin-embedded (FFPE)
tissue samples. The supervisor approved the
validation summary and sent it to the director. Before the director replied, the husband of the
supervisor, a physician in the same hospital, sent
a FFPE sample for the BRAF test. How should the
laboratory treat this sample, according to the
College of American Pathologist (CAP)’s
regulations, if applicable?1
A. Set up the sample for the BRAF test while
waiting for the director to approve the
validation for the final report.
B. Set up the sample for the BRAF test,
giving the preliminary results to the
ordering physician while waiting for the
director to approve the validation for the final
report.
C. Set up the sample for the BRAF test, reporting
it out before the director approves the
validation.
D. Hold the sample while waiting for the director
to approve the validation.
E. Explain to the ordering physician that the
method for the BRAF test has not been
validated in this laboratory.
F. None of above.
E. The lab staff should explain to the ordering
physician that the method for the BRAF test has
not been validated in this laboratory, and the lab
could not accept clinical specimens for this test
yet. According to the College of American
Pathologist (CAP) All Common Checklist dated
July 28, 2015, COM.40000, “There is a summary
statement, signed by the laboratory director (or
designee who meets CAP director qualifications) prior
to use in patient testing, that includes the
evaluation of validation/verification studies and
approval of each test for clinical use.
45
Dr. Z has been validating the FDA-cleared/
approved quantitative COBAS AmpliPrep/
COBAS TaqMan CMV test from Roche Molecular
Systems for cytomegalovirus (CMV) in a clinical
molecular pathology laboratory in Florida. He
gathered all the data to write the validation
summary. What components should he include in
the validation summary, according to the College
of American Pathologist (CAP)’s regulations, if
applicable?
a. Analytical accuracy
b. Analytical precision
c. Analytical sensitivity
d. Analytical specificity
e. Cross-contamination
f. Interferences
g. Reportable range
A. a, b, c, and d
B. a, b, and g
C. a, b, f, and g
D. c, d, f, and g
E. a, b, c, d, e, f, and g
F. None of the above
C. The College of American Pathologist (CAP)
has clearly different validation requirements for
FDA-cleared/approved and non-FDA-cleared/
approved tests. Non-FDA-cleared/approved tests
include laboratory-developed tests (LTDs) and
modified FDA-cleared/approved tests. According
to the CAP All Common Checklist dated July 28,
2015, COM.40000, “For an FDA-cleared/approved
test, a summary of the verification data must
address analytical performance specifications,
including analytical accuracy, precision, interferences,
and reportable range, as applicable.” It also states
that the summary statement must include a
written assessment of the validation/verification
study, including the acceptability of the data. The
summary must also include a statement
approving the test for clinical use with an
approval signature such as, “This validation
study has been reviewed, and the performance of
the method is considered acceptable for patient
testing.”
46
Dr. Y has been validating the FDA-cleared/
approved quantitative COBAS AmpliPrep/
COBAS TaqMan CMV test from Roche Molecular
Systems for cytomegalovirus (CMV) in a clinical
molecular pathology laboratory in Florida. And
he planned to use the assay on cerebrospinal fluid
(CSF) specimens, too, which was not been
approved or cleared by the FDA. He gathered all
the data to write the validation summary. What components should he include in the
validation summary according to the College of
American Pathologist (CAP) regulations, if
applicable?
a. Analytical accuracy
b. Analytical precision
c. Analytical sensitivity
d. Analytical specificity
e. Cross-contamination
f. Interferences
g. Reportable range
A. a, b, c, and d
B. a, b, and g
C. a, b, f, and g
D. c, d, e, f, and g
E. a, b, c, d, e, f, and g
F. None of the above
E. The College of American Pathologist (CAP) has
clearly different validation requirements to FDAcleared/
approved and non-FDA-cleared/
approved tests. No-FDA-cleared/approved tests
include laboratory-developed tests (LTDs) and
modified FDA-cleared/approved tests. According
to the CAP All Common Checklist dated July 28,
2015, COM.40000, “for modified FDA-cleared/approved tests or LDTs, the summary must
address analytical sensitivity, analytical specificity,
and any other parameter that is considered
important, to assure that the analytical
performance of a test (e.g., specimen stability,
reagent stability, linearity, carryover, and crosscontamination,
etc.), as appropriate and
applicable.”
47
A clinical molecular pathology laboratory
decides to discontinue its CYP2C19 test used to
predict therapeutic response to clopidogrel
(commonly known as Plavix) as an antiplatelet
agent for cardiovascular disorders, because it is
an extremely low volume test. How long should
the laboratory keep the procedure for the
CYP2C19 test after discontinuation, according to
the College of American Pathologist (CAP)’s
regulations, if applicable?
A. At least 1 year
B. At least 2 years
C. At least 5 years
D. At least 7 years
E. At least 16 years
F. At least 23 years
G. Forever
F. According to the College of American Pathology
(CAP) All Common Checklist dated July 28, 2015,
COM.10500, “When a procedure is discontinued, a
paper or electronic copy is maintained for at least
2 years, recording initial date of use, and
retirement date. For genetic testing, in order to
meet the requirements of some states relating to
the testing of minors (under the age of 21), it is
recommended that laboratories retain procedures
(paper or electronic) for at least 23 years (to cover
the interval from fetal period to age 21).”
Therefore, the laboratory should keep the
procedure for the CYP2C19 test for at least 23
years after discontinuation.
48
A clinical molecular pathology laboratory in
Florida has been offering a quantitative
cytomegalovirus (CMV) test with the FDAcleared/
approved COBAS AmpliPrep/COBAS
TaqMan CMV assay from Roche Molecular
Systems for more than 2 years. Last month the
laboratory moved from the main hospital to a
remote facility with the rest of the department of
pathology. Which of the following parameters
should be included in the verification after the
move, according to the College of American
Pathologist (CAP)’s regulations, if applicable?
a. Analytical accuracy
b. Analytical precision
c. Analytical sensitivity
d. Analytical specificity
e. Cross-contamination
f. Interferences
g. Reportable range
A. a, b, c, and d
B. a, b, and g
C. a, b, f, and g
D. c, d, e, f, and g
E. a, b, c, d, e, f, and g
F. None of the above
B. In the College of American Pathologist (CAP)
All Common Checklist dated July 28, 2015, there
is chapter dedicated to “Method Performance
Specifications,” which clearly states, “The method
performance specifications must be validated or
verified in the location in which patient testing
will be performed. If an instrument is moved, the
laboratory must verify the method performance
specifications (i.e., accuracy, precision,
reportable range) after the move to ensure that the
test system was not affected by the relocation
process or any changes due to the new
environment (e.g., temperature, humidity, reagent
storage conditions, etc.). The laboratory must
follow manufacturer’s instructions for instrument
set up, maintenance, and system verification.”
49
A clinical molecular pathology laboratory used a
CYP2C19 assay to predict therapeutic response
to clopidogrel (commonly known as Plavix) as
an antiplatelet agent for cardiovascular
disorders. Two years ago, the laboratory
discontinued the test because of low volume.
Recently, the data from the send-outs indicated
the increase of volume for CYP2C19. The
laboratory is considering bringing the assay
back. Which one of the following requirements
must be met in order to put the test back into
production, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?
A. PT or alternative assessment performed within
30 days prior to restarting patient testing
B. Method of performance specifications verified,
as applicable, within 30 days prior to
restarting patient testing
C. Competency assessed for analysts within 12
months prior to restarting patient testing
D. All of the above
E. None of the above
D. According to the College of American
Pathologist (CAP) All Common Checklist dated
July 28, 2015, COM.40100, “When a test is put
back into production, the following requirements
must be met:
* PT or alternative assessment performed within 30
days prior to restarting patient testing.
* Method performance specifications verified, as
applicable, within 30 days prior to restarting
patient testing.
* Competency assessed for analysts within 12 months
prior to restarting patient testing.”
Also, a “test is considered to be taken out of
production when (1) patient testing is not offered
AND (2) PT or alternative assessment, as
applicable, is suspended. It does not apply to
situations where a proficiency testing challenge is
not performed due to a temporary, short-term
situation, such as a reagent back order or an
instrument breakdown. In those situations, the
laboratory must perform alternative assessment
for that testing event.”
Therefore, all the choices listed in the question
are the requirements, which must be met in order
to put the test back into production.
50
A clinical molecular pathology laboratory has
been offering an FDA-approved quantitative
HIV-1 RNA test for 1 year. However, the test has
been suspended for a month, and the laboratory
cannot participate in the most recent CAP
proficiency test (PT) because of an instrument
breakdown. Which one of the following
requirements must be met in order to put the
test back into production, according to the
College of American Pathologist (CAP)’s
regulations, if applicable?
A. PT or alternative assessment performed within
30 days prior to restarting patient testing
B. Method of performance specifications verified,
as applicable, within 30 days prior to
restarting patient testing
C. Competency assessed for analysts within 12
months prior to restarting patient testing
D. Perform alternative proficiency test (PT)
assessment
E. All of the above
F. None of the above
D. According to the College of American Pathologist (CAP) All Common Checklist dated
July 28, 2015, COM.40100, intermittent testing
“does not apply to situations where a proficiency
testing challenge is not performed due to a
temporary, short-term situation, such as a reagent
back order or an instrument breakdown. In those
situations, the laboratory must perform alternative
assessment for that testing event.” The quantitative
HIV-1 RNA test is one of the PT required tests.
The laboratory should perform alternative
assessment for the test.
Therefore, alternative proficiency test (PT)
assessment must be performed in order to put the
test back into production.
51
Dr. Z, a director of a clinical molecular pathology
laboratory, wants to validate the FDA-cleared/
approved Cystic Fibrosis 139-Variant Assay.
However, the laboratory has Illumina MiSeq
instead of Illumina MiSeqDx. Dr. Z decides to
validate the assay with Illumina MiSeq (MiSeqDX is the instrument for the FDA-cleared/approved
Cystic Fibrosis 139-Variant Assay). Which of the
following parameters should Dr. Z include in the
verification, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?1
a. Analytical accuracy
b. Analytical precision
c. Analytical sensitivity
d. Analytical specificity
e. Cross-contamination
f. Interferences
g. Reportable range
A. a, b, c, and d
B. a, b, and g
C. a, b, f, and g
D. c, d, e, f, and g
E. a, b, c, d, e, f, and g
F. None of the above
E. The College of American Pathologist (CAP) has
clearly different validation requirements for FDAcleared/
approved and non-FDA-cleared/
approved tests. Non-FDA-cleared/approved tests
include laboratory-developed tests (LTDs) and
modified FDA-cleared/approved tests. According
to the CAP All Common Checklist dated July 28,
2015, COM.40000, “for modified FDA-cleared/
approved tests or LDTs, the summary must
address analytical sensitivity, analytical
specificity, and any other parameter that is
considered important, to assure that the analytical
performance of a test (e.g., specimen stability,
reagent stability, linearity, carryover, and crosscontamination,
etc.), as appropriate and
applicable.”
52
Which one of the following efforts is used to
verify or establish analytical accuracy, according
to the College of American Pathologist (CAP)’s
regulations?1
A. Using reference materials or other materials
with known concentrations or activities
B. Comparing results to an established
comparative method
C. Repeating measurement of samples at varying
concentrations or activities within-run and
between-run over a period of time
D. Testing the lower detection limit of an assay
E. A and B
F. A, B, and C
G. C and D
H. None of the above
E. According to the College of American
Pathologist (CAP) All Common Checklist dated
July 28, 2015, COM.40300, “Where current
technology permits, accuracy is established by
comparing results to a definitive or reference method,
or may be verified by comparing results to an
established comparative method. Use of reference
materials or other materials with known
concentrations or activities is suggested in
establishing or verifying accuracy.” And
“Precision is established by repeat measurement
of samples at varying concentrations or activities
within-run and between-run over a period of
time.” A lower detection limit establishes the
analytical sensitivity of a test.
53
Dr. Y, a director of a clinical molecular pathology
laboratory in Florida, decided to validate a
quantitative cytomegalovirus (CMV) assay with
the FDA-cleared/approved COBAS AmpliPrep/
COBAS TaqMan CMV test from Roche Molecular
Systems. He planned to use the assay on
cerebrospinal fluid (CSF) specimens, too, which
was not been approved or cleared by the FDA.
How many samples should Dr. Y include in
this validation according to the College of
American Pathologist (CAP)’s regulations, if
applicable?1
A. At least 5 samples
B. At least 10 samples
C. At least 20 samples
D. At least 40 samples
E. At least 60 samples
F. None of the above
C. At least 20 samples
54
Dr. Y, a director of clinical molecular pathology
laboratory in Florida, decides to validate an assay for hereditary hemochromatosis (HH). There is
no-FDA-cleared/approved assay available for
HH. How many samples should Dr. Y include in
this validation, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?1
A. At least 5 samples
B. At least 10 samples
C. At least 20 samples
D. At least 40 samples
E. At least 60 samples
F. None of the above
C. At least 20 samples
55
The most recent College of American Pathologist
(CAP) All Common Checklist, dated July 28,
2015, states that a laboratory must make the
summary of the analytical performance
specifications for each method available to
clients and the inspection team upon request.
Which one of the following is a client, according
to this statement?1
A. Health care entities
B. Licensed independent practitioners
C. Patients
D. Patient’s family members
E. A and B
F. A, B, and C
G. A, B, C, and D
H. None of the above
E. According to the College of American
Pathologist (CAP) All Common Checklist dated
July 28, 2015, COM.40700, “Clients include
healthcare entities, other laboratories, and licensed
independent practitioners. This requirement does
not apply to patients or their authorized
representatives.”
56
In the most recent College of American
Pathologist (CAP) All Common Checklist, dated
July 28, 2015, a new chapter named
“Individualized Quality Control Plan (IQCP)”
was added. Which one of the following
statements regarding this plan is correct?1
A. This IQCP is a quality control plan lower
than the standard defined in the CLIA
regulation.
B. This IQCP is a quality control plan lower than
the standard defined in the CAP checklist.
C. This IQCP is a quality control plan higher
than the standard defined in the CLIA
regulation.
D. This IQCP is a quality control plan higher
than the standard defined in the CAP
checklist.
E. A and B.
F. C and D.
G. A and D.
H. B and C.
I. None of the above.
E. According to the College of American
Pathologist (CAP) All Common Checklist dated
July 28, 2015, an individualized quality control
plan (IQCP) is “approved by the laboratory
director for nonwaived testing to reduce external
control analysis to a frequency less than the limits
defined in the CLIA regulations and CAP checklists.”
Therefore, IQCP is a quality control plan lower
than the standard defined in the CLIA regulation
and CAP checklists.
57
In the most recent College of American
Pathologist (CAP) All Common Checklist,
dated July 28, 2015, a new chapter named
“Individualized Quality Control Plan (IQCP)” was added. Which one of the
following statements regarding this plan is
correct?1
A. This IQCP allows a laboratory to perform
quality control less frequently than indicated
in the manufacturer’s instructions.
B. This IQCP allows a laboratory to perform
quality control less frequently than CAP
accreditation requirements.
C. FISH testing is not eligible for use of an
IQCP.
D. IQCP can be used in any US state.
E. IQCP does not apply to waived tests.
F. All of the above.
G. None of the above.
E. According to the College of American
Pathologist (CAP) All Common Checklist dated
July 28, 2015, an individualized quality control
plan (IQCP) is applied to nonwaived tests.
58
In the most recent College of American
Pathologist (CAP) All Common Checklist, dated
July 28, 2015, a new chapter named
“Individualized Quality Control Plan (IQCP)”
was added. If an IQCP plan is in use in a
laboratory, which one of the following should
the laboratory do, according to this CAP
regulation?1
A. Identify all tests using an IQCP in the
laboratory.
B. Check the eligibility of those tests using this
CAP checklist.
C. Complete the CAP form for all tests using an
IQCP.
D. Assess the risks for each IQCP test/device/
instrument.
E. Write a quality control plan for IQCP with
approval from the laboratory director.
F. Reassess and reapprove the quality control
annually.
G. All of the above.
H. None of the above.
G. According to the College of American
Pathologist (CAP) All Common Checklist dated
July 28, 2015, an individualized quality control
plan (IQCP) may be used by a clinical laboratory
for eligible nonwaived tests. First, a laboratory
should identify all tests using an IQCP. Second,
check on the eligibility of IQCP, according to CAP
and state regulations. Third, complete the CAP form
for IQCP, which may be downloaded from the
CAP website (http://www.cap.org) through the
e-LAB Solution Suite (COM.50200). Fourth, assess
the risk of IQCP for a test/device/instrument
(COM.50300). Fifth, write a quality control plan,
with approval from the laboratory director prior
to implementation (COM.50400). Six, monitor
ongoing quality data, including quality control and
instrument/equipment maintenance and function,
etc., at least monthly (COM.50600). Finally,
reassess and reapprove the quality control plan
annually (COM.50600).
Therefore, all the choices listed in the questions
are required for IQCP.
59
In the most recent College of American
Pathologist (CAP) All Common Checklist, dated
July 28, 2015, a new chapter named
“Individualized Quality Control Plan (IQCP)”
was added. If an IQCP plan is in use in a
laboratory, how frequently should the director
reassess and reapprove the quality control plan
for the IQCP?1
A. At least monthly
B. At lease semiannually
C. At least annually
D. At least biennially
E. At least every 5 years
F. None of the above
C. According to the College of American
Pathologist (CAP) All Common Checklist dated
July 28, 2015, COM.50600, “Ongoing quality
assessment monitoring is performed by the
laboratory to ensure that the quality control plan
is effective in mitigating the identified risks for
the IQCP, and include . . . reapproval of the
quality control plan by the laboratory director or
designee at least annually.”
60
In the most recent College of American
Pathologist (CAP) All Common Checklist, dated
July 28, 2015, a new chapter named “Individualized Quality Control Plan (IQCP)”
was added. If an IQCP plan is in use in a
laboratory, how frequently should the director
review quality control and instrument/
equipment maintenance and function for the
IQCP?1
A. At least every week
B. At least every 2 weeks
C. At least monthly
D. At lease semiannually
E. At least annually
F. At least biennially
G. None of the above
C. According to the College of American
Pathologist (CAP) All Common Checklist dated
July 28, 2015, COM.50600, “Ongoing quality
assessment monitoring is performed by the
laboratory to ensure that the quality control plan
is effective in mitigating the identified risks for
the IQCP, and include . . . Review of quality
control and instrument/equipment maintenance
and function check data at least monthly.”
Therefore, the director should review of quality
control and instrument/equipment maintenance
and function for the IQCP at least monthly.
61
In the most recent College of American
Pathologist (CAP) All Common Checklist, dated
July 28, 2015, a new chapter named
“Individualized Quality Control Plan (IQCP)”
was added. Dr. Z, a director in a clinical
molecular genetics laboratory, identified one test
for IQCP. There was no special indication in the
manufacturer’s instruction for using external
control material samples. How frequently must
the external control material samples be
analyzed, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?1
A. At least every 5 business days
B. At least every 14 days
C. At least every 31 days
D. At least every 3 months
E. At least every 6 months
F. None of the above
C. According to the College of American
Pathologist (CAP) All Common Checklist dated
July 28, 2015, COM.50500, “External control
material samples must be analyzed at least every
31 days and with new lots and shipments of
reagents or more frequently if indicated in the
manufacturer’s instructions.” Therefore, in this
case, the laboratory must follow CAP regulations
to analyze external control material samples at
least every 31 days unless new lots and
shipments of reagents come in.
62
In the most recent College of American
Pathologist (CAP) All Common Checklist, dated
July 28, 2015, a new chapter named
“Individualized Quality Control Plan (IQCP)”
was added. Dr. Z, a director in a clinical
molecular genetics laboratory, identified one test
for IQCP. The manufacturer’s instruction
indicated that it was better to use external
control material samples every week. How
frequently must the external control material
samples be analyzed, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?1
A. At least every week
B. At least every 2 weeks
C. At least every 31 days
D. At least every 3 months
E. At least every 6 months
F. None of the above
A. According to the College of American
Pathologist (CAP) All Common Checklist dated
July 28, 2015, COM.50500, “External control
material samples must be analyzed at least every
31 days and with new lots and shipments of
reagents or more frequently if indicated in the
manufacturer’s instructions.” Therefore, in this case,
the laboratory must follow the manufacturer’s
instruction to analyze external control material
samples at least every 5 business days (a week).
63
How frequently should a director of a clinical
molecular laboratory review the maintenance and
function check records of centrifuges, according to the College of American Pathologist (CAP)’s
regulations, if applicable?1
A. Biennially
B. Annually
C. Semiannually
D. Quarterly
E. Monthly
E. According to the College of American
Pathology (CAP) All Common Checklist dated
July 28, 2015, COM.0420, “Instrument and
equipment maintenance and function check
records are reviewed and assessed at least monthly
by the laboratory director or designee.” And “The
review of the records related to tests that have an
approved Individualized quality control plan
(IQCP) must include an assessment of whether
further evaluation of the risk assessment and
quality control plan is needed based on problems
identified (e.g., trending for repeat failures, etc.).”
64
How frequently should a director of a clinical
molecular laboratory review the maintenance and
function check records of thermal cyclers,
according to the College of American Pathologist
(CAP)’s regulations, if applicable?1
A. Once every 5 years
B. Biennially
C. Annually
D. Semiannually
E. Monthly
E. According to the College of American
Pathology (CAP) All Common Checklist dated
July 28, 2015, COM.04200 “Instrument and
equipment maintenance and function check
records are reviewed and assessed at least monthly
by the laboratory director or designee.” And “The
review of the records related to tests that have an
approved Individualized quality control plan
(IQCP) must include an assessment of whether
further evaluation of the risk assessment and
quality control plan is needed based on problems
identified (e.g., trending for repeat failures, etc.).”
65
Which one of the following samples may be used
to compare a new lot against an old lot for
quantitative nonwaived tests, according to the
College of American Pathologist (CAP)’s
regulations, if applicable?1
A. Patient specimens
B. Reference materials provided by the
manufacturer
C. Proficiency testing materials with peer
groupestablished means
D. QC materials with peer groupestablished
means
E. QC materials used to test the current lot
F. All of the above
F. According to the College of American
Pathology (CAP) Common Checklist dated July
28, 2015, COM.30450, “New reagent lots and/or
shipments are checked against old reagents lots
or with suitable reference material before or
concurrently with being placed in service.” It also
states, “For quantitative nonwaived tests, patient
specimens should be used to compare a new lot
against the old lot, when possible. Manufactured
materials, such as proficiency testing (PT) or QC
materials may be affected by matrix interference
between different reagent lots, even if results
show no change following a reagent lot change.
The use of patient samples confirms the absence
of matrix interference.
66
Which one of the following tests is NOT
considered to be a laboratory-developed
test (LDT) according to the College of
American Pathologist (CAP)’s regulations, if
applicable?1
A. An unmodified FDA-cleared/approved test.
B. A modified FDA-cleared/approved test.
C. The test is performed by the clinical laboratory
in which the test was developed.
D. The test was developed and launched by the
clinical laboratory in 2005.
E. The test is performed by the clinical
laboratory, while the test procedure was
created by another laboratory.
A. According to the College of American
Pathology (CAP) All Common Checklist dated
July 28, 2015, “For the purposes of interpreting
the checklist requirements, a laboratorydeveloped
test (LDT) is defined as follows: A test
used in patient management that has both of the
following features:
* The test is performed by the clinical laboratory in
which the test was developed wholly or in part;
AND
* The test is neither FDA-cleared nor FDAapproved.”
If a laboratory has made a modification to
manufacturer’s instructions for an FDA-cleared/
approved test, the test is developed in part in this
laboratory. Therefore, modified FDA-cleared/
approved tests may be considered as LDT tests by this
definition.
67
According to the US Food and Drug
Administration (FDA) regulations, a laboratorydeveloped
Sanger sequencing assay for Gaucher
disease is a(n):
A. High-complexity test
B. Moderate-complexity test
C. Low-complexity test
D. FDA-cleared test
E. Waived test
A. CLIA regulates laboratory testing and requires
that clinical laboratories obtain a certificate before
accepting materials derived from the human body
for the purpose of providing information for the
diagnosis, prevention, or treatment of any disease
or the impairment of, or assessment of the health
of human beings. The type of CLIA certificate a
laboratory obtains depends upon the complexity
of the tests it performs. CLIA regulations describe
the following three levels of test complexity:
waived tests, moderate-complexity tests, and
high-complexity tests.
68
An ACMG board-certified molecular geneticist
started a job as a director in a commercial
laboratory. He planned to review all the
procedures and policies in the laboratory in 2
months. He found that the quality management
procedure stated that a designee of the director
would review this procedure biennially. How
frequently should a clinical molecular laboratory
review its quality management procedure,
according to the College of American Pathologist
(CAP)’s regulations, if applicable?2
A. At least monthly
B. At least quarterly
C. At least twice a year
D. At least annually
E. At least biennially
D. According to the CAP Laboratory General
Checklist dated July 28, 2015, GEN.16902, “For
laboratories that have been CAP accredited for
more than 12 months, the QM plan is
implemented as designed and is reviewed
annually for effectiveness
69
An ACMG board-certified molecular geneticist
started a job as a director in a commercial
laboratory. He planned to review all the
procedures and policies in the laboratory in 2
months. He found that the quality management
procedure stated that the competency
assessment records should be kept for 1 year. How
frequently should a clinical molecular laboratory
retain the competency assessment records?2
A. At least 1 year
B. At least 2 years
C. At least 5 years
D. At least 10 years
E. At least 20 years
B. According to the CAP Laboratory General
Checklist dated July 28, 2015, GEN.20377,
“Competency assessment records must be
retained for at least 2 years.”
70
An ACMG board-certified molecular geneticist
started a job as a director in a commercial
laboratory. He planned to review all the
procedures and policies in the laboratory in 2
months. He found that the quality management
procedure stated that the quality control records
should be kept for 1 year. How frequently should
a clinical molecular laboratory retain the quality
control records?2
A. At least 1 year
B. At least 2 years
C. At least 5 years
D. At least 10 years
E. At least 20 years
B. According to the CAP Laboratory General
Checklist dated July 28, 2015, GEN.20377,
“Competency assessment records must be
retained for at least 2 years.” The following
records must be retained for at least 2 years:
specimen requisitions (the patient chart or
medical record is included only if it was used as
the requisition), patient test results and reports
(both original and corrected), instrument
printouts, accession records, quality control
records, instrument maintenance records,
proficiency testing records, and quality
management records.
Therefore, a clinical molecular laboratory
should retain the quality control records for at
least two years.
71
In which one of following circumstances must a
clinical molecular laboratory notify CAP?2
A. Investigation of the laboratory by a
government entity or other oversight agency
B. Discovery of actions by laboratory personnel
that violate national, state, or local regulations
C. Change in laboratory test menu
D. Change in location, ownership, or directorship
of the laboratory
E. All of the above
F. None of the above
E. According to the CAP Laboratory General
Checklist dated July 28, 2015, GEN.26791,
72
Dr. G has been the only director of a genetics
laboratory in a small hospital for more than 30
years. His name has been listed on the
laboratory’s CAP and CLIA certificate as the lab
director. Yesterday he announced that he would
retire in 4 month and that his last day would be
June 30. Which one of following statements is
appropriate, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?
A. The laboratory should notify CAP
immediately.
B. The laboratory should notify CAP before May
30.
C. The laboratory should notify CAP before June
15.
D. The laboratory should notify CAP any time
before Dr. G’s last day.
E. There is no need to notify the CAP about this
change.
F. None of the above.
B. According to the CAP Laboratory General
Checklist dated July 28, 2015, GEN.26791, “The
CAP terms of accreditation are listed in the
laboratory’s official notification of accreditation.”
And “The policy must include notification of
CAP regarding change in location, ownership or
directorship of the laboratory; notification must
occur no later than 30 days prior to the change(s);
or, in the case of unexpected changes, no later
than 2 working days afterwards.”
Therefore, the laboratory should notify CAP
regarding change in the directorship of the
laboratory before May 30.
73
Dr. G, a director of a clinical molecular genetics
laboratory in an academic center, validated a
clinical exome-sequencing test in the laboratory.
Which one of following statements is
appropriate, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?2
A. Dr. G should notify CAP immediately.
B. Dr. G should notify CAP 30 days before
launching the test.
C. Dr. G should notify CAP 15 days before
launching the test.
D. Dr. G should notify CAP any time before
launching the test.
E. There is no need to notify the CAP about this
change.
F. None of the above.
D. According to the CAP Laboratory General
Checklist dated July 28, 2015, GEN.26791, “The
CAP terms of accreditation are listed in the
laboratory’s official notification of
accreditation.” And “The policy must include
notification of CAP regarding change in laboratory test menu (notification must occur prior
to starting new patient testing).”
Therefore, Dr. G should notify CAP before
launching the test.
74
How frequently should a director review the
quality management (QM) plan in a clinical
laboratory according to the College of
American Pathologist (CAP)’s regulations, if
applicable?2
A. At least biannually
B. At least annually
C. At least biennially
D. At least once every 5 years
E. At least once every 10 years
B. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.16902, “For Laboratories
that have been CAP accredited for more than 12
months, the QM plan is implemented as designed
and is reviewed annually for effectiveness.” And
“Appraisal of program effectiveness may be
evidenced by an annual written report, revisions
to laboratory policies and procedures, or revisions
to the QM plan, as appropriate.”
Therefore, a director should review the quality
management (QM) at least annually.
75
Dr. A, a director of a clinical molecular genetics
laboratory, received a phone call from Dr. G, an
oncologist in the same institute. Dr. G asked Dr.
A to add a JAK2 test for a specimen that was sent
2 days ago for a BCR-ABL1 quantitative test. Dr.
A checked with laboratory staff and confirmed
that no specimens were received for a BCR-ABL1 quantitative test in the past 2 days. After checking
with laboratory support team, he found that the
bone marrow specimen had been sent to a
reference laboratory for TB test by mistake. What
should Dr. A do at this point as part of the
quality management program, according to
College of American Pathologist (CAP)’s
regulations, if applicable?2
A. Dr. A should perform root-cause analysis.
B. Dr. A should send a gift and a letter to Dr. G
to apologize.
C. Dr. A should take 2 weeks off to avoid Dr. G.
D. Dr. A should ask Dr. G for another specimen
and promise no charge.
E. Dr. A should get the specimen back from the
reference laboratory for the ordered tests.
F. None of the above.
A. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.20208, “Any problem
that could potentially interfere with patient care
or safety must be addressed. Clinical, rather than
business/management issues, should be
emphasized. The laboratory must record
investigation and resolution of these problems.
Laboratories must perform root-cause analysis of
any unexpected event involving death or serious
physical or psychological injury, or risk thereof
(including ‘near misses’ and sentinel events).
Laboratories must be able to demonstrate
appropriate risk-reduction activities based on
such root-cause analyses.” It is an appropriate
response for Dr. A getting the specimen back
from the reference laboratory for the ordered
tests. It is good patient care, but not part of
quality management plan.
Therefore, Dr. A should perform root cause
analysis.
76
Dr. Z, a clinical molecular genetic scientist, has
been working for a start-up company in the state
of California for 2 months. He has been applying
for CLIA and CAP certificates for the laboratory
while registering with the Centers for Medicare
and Medicaid Services (CMS). Which one of the
following types of CLIA certificate must Dr. Z
obtain for this laboratory?2
A. Certificate of Accreditation
B. Certificate of Compliance
C. Certificate of Registration
D. Certificate of Waiver
E. All of the above
F. None of the above
A. CLIA regulates laboratory testing and requires
that clinical laboratories obtain a certificate before
accepting materials derived from the human body
for the purpose of providing information for the
diagnosis, prevention, or treatment of any disease
or the impairment of, or assessment of the health
of human beings. The type of CLIA certificate a
laboratory obtains depends upon the complexity
of the tests it performs. CLIA regulations describe
the following three levels of test complexity:
waived tests, moderate-complexity tests, and
high-complexity tests.
77
According to the American Pathologist (CAP)’s
regulations, a US-regulated clinical molecular
laboratory should have a procedure to report
device-related adverse patient events to the FDA
and to the device manufacturer if the event is
death. How soon must the reports be submitted
to the FDA?2
A. As soon as practical, but no later than 5 days
from the time medical personnel become
aware of the event
B. As soon as practical, but no later than 10 days
from the time medical personnel become
aware of the event
C. As soon as practical, but no later than 15 days
from the time medical personnel become
aware of the event
D. As soon as practical, but no later than 20 days
from the time medical personnel become
aware of the event
E. As soon as practical, but no later than 1 month
from the time medical personnel become
aware of the event
B. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.20351, “The laboratory
has a procedure for reporting device-related
adverse patient events, as required by FDA.” And
“When information reasonably suggests that any
laboratory instrument, reagent or other device has
or may have caused or contributed to a patient
death or serious patient injury, the FDA requires
hospitals and outpatient diagnostic facilities,
including independent laboratories, to report the
event. If the event is death, the report must be
made both to FDA and the device manufacturer.
If the event is serious patient injury, the report
must be submitted to FDA. Reports must be
submitted on FDA Form 3500A as soon as
practical but no later than 10 days from the time
medical personnel become aware of the event.”
78
A US-regulated clinical molecular laboratory
should have a procedure to report device-related adverse patient events to the FDA and to the
device manufacturer if the event is death. If the
FDA investigates a laboratory performance,
which other regulatory or oversight agency must
the laboratory notify?2
A. Centers for Medicare and Medicaid Services
(CMS)
B. Clinical Laboratory Improvement
Amendments (CLIA) of 1988
C. College of American Pathologist (CAP)
D. Occupational Safety and Health
Administration (OSHA)
E. US Department of Health and Human
Services
F. All of the above
G. None of the above
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.26791, “The CAP terms
of accreditation are listed in the laboratory’s
official notification of accreditation. The policy
must include notification of CAP regarding . . .
Investigation of the laboratory by a government
entity or other oversight agency, or adverse
media attention related to laboratory
79
A US clinical molecular laboratory should have a
procedure to report device-related adverse patient
events to the FDA and to the device manufacturer
if the event is death. If the FDA investigates a
laboratory’s performance, how soon must the
laboratory notify the College of American
Pathology (CAP)?2
A. No later than 8 hours
B. No later than 2 working days
C. No later than 5 working days
D. No later than 2 weeks
E. No later than 1 month
F. None of the above
B. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.26791, “The CAP terms
of accreditation are listed in the laboratory’s
official notification of accreditation. The policy
must include notification of CAP regarding . . .
Investigation of the laboratory by a government
entity or other oversight agency, or adverse
media attention related to laboratory
performance; notification must occur no later than
2 working days after the laboratory learns of an
investigation or adverse media attention. For
laboratories subject to US regulations, this
notification must include any complaint
investigations conducted or warning letters
issued by any oversight agency (i.e. CMS, State
Department of Health, The Joint Commission,
FDA, OSHA). For non-US laboratories, this
notification must include discovery of actions by
laboratory personnel that violate national, state or
local regulations.”
80
According to the College of American Pathology
(CAP) regulations, a clinical molecular laboratory
should report device-related adverse patient
events to the FDA and to the device manufacturer
if the event is death. Also, the laboratory must
submit an annual report of device-related deaths
and serious injuries to the FDA if any such event
was reported during the previous year. How long
must the laboratory keep the records of the FDA
MDR (medical-device reporting) reports if
applicable?2
A. 1 year
B. 2 years
C. 3 years
D. 4 years
E. 10 years
B. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.20351, “The laboratory
(or parent institution, as appropriate) must
submit an annual report of device-related deaths
and serious injuries to FDA, if any such event
was reported during the previous year. Annual
reports must be submitted on Form 3419 (for
hospital-based laboratories only, or an electronic
equivalent) or Form 3500 (for non-hospital-based
laboratories) by January 1 of each year. The
laboratory or institution must keep records of
MDR reports for 2 years.”
81
ZZ, a technologist on probation, broke a tube of
patient blood in a clinical molecular genetics
laboratory. He quickly cleaned up the area with
bleach without telling anyone. The next day BJ, a
technologist, rotating in the wet lab worked in the
same area with bare feet because her new high
heel shoes hurt her so much. BJ cut her foot on a
piece of glass and got stitches at the employee
health center. One month later, BJ was diagnosed
with HIV-1 infection when she tried to donate blood. Then ZZ confessed to the accident and the
director found that the broken tube of blood was
from a patient with HIV-1 infection. Occupational
Safety and Health Administration (OSHA) started
to investigate the incident. Which one of
following statements is appropriate, according to
the College of American Pathologist (CAP)’s
regulations, if applicable?2
A. The laboratory should notify CAP
immediately after the adverse incident.
B. The laboratory should notify CAP within 30
days after OSHA started the investigation.
C. The laboratory should notify CAP within 15
days after OSHA started the investigation.
D. The laboratory should notify CAP within 2
days after OSHA started the investigation.
E. There is no need to notify the CAP about this
investigation.
F. None of the above.
D. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.26791, “The CAP terms
of accreditation are listed in the laboratory’s
official notification of accreditation. The policy
must include notification of CAP regarding Investigation of the laboratory by a government
entity or other oversight agency, or adverse
media attention related to laboratory
performance; notification must occur no later than
2 working days after the laboratory learns of an
investigation or adverse media attention. For
laboratories subject to US regulations, this
notification must include any complaint
investigations conducted or warning letters
issued by any oversight agency (i.e. CMS, State
Department of Health, The Joint Commission,
FDA, OSHA). For non-US laboratories, this
notification must include discovery of actions by
laboratory personnel that violate national, state or
local regulations.”
82
How often must a director of a clinical molecular
laboratory review policies and procedures,
according to College of American Pathologist
(CAP)’s regulations, if applicable?2
A. At least once every 10 years
B. At least once every 5 years
C. At least once every 4 years
D. At least once every 2 years
E. At least annually
D. According to the CAP Laboratory General
Checklist dated July 29, 2013, “Document control
requirements apply to all policies, procedures and
forms (including quality management documents)
and activities that are subject to CAP
accreditation. The document control system must
ensure . . . that policies and procedures are
reviewed at least biannually by the laboratory
director or designee.”
83
Dr. G, a director in a clinical molecular
pathology laboratory in Massachusetts,
validated the FDA-cleared/approved Cystic
Fibrosis 139-Variant Assay with Illumina
MiSeqDx a month ago. Previously the laboratory
used xTAG Cystic Fibrosis 60 Kit v2 from
Luminex Molecular Diagnostics. Dr. G reviewed
and approved the new assay and discontinued
the old one. How long should the laboratory
keep the discontinued procedure for the cystic
fibrosis test?2
A. A minimum of 23 years
B. A minimum of 12 years
C. A minimum of 5 years
D. A minimum of 2 years
E. A minimum of 1 year
A. According to the College of American
Pathology (CAP) All Common Checklist dated
July 28, 2015, COM.10500, “When a procedure is
discontinued, a paper or electronic copy is
maintained for at least 2 years, recording initial
date of use, and retirement date. For genetic
testing, in order to meet the requirements of some
states relating to the testing of minors (under the
age of 21), it is recommended that laboratories
retain procedures (paper or electronic) for at least
23 years (to cover the interval from fetal period to
age 21).”
84
Dr. G, a director of a clinical molecular pathology
laboratory in Massachusetts, validated the FDAcleared/
approved Cystic Fibrosis 139-Variant
Assay with Illumina MiSeqDx a month ago.
Previously, the laboratory had used xTAG Cystic
Fibrosis 60 Kit v2 from Luminex Molecular
Diagnostics. Dr. G reviewed and approved the
new assay and discontinued the old one. Which
regulatory or oversight agency must Dr. G notify
for the change?
A. Centers for Medicare and Medicaid Services
(CMS)
B. Clinical Laboratory Improvement
Amendments (CLIA) of 1988
C. College of American Pathologist (CAP)
D. Occupational Safety and Health
Administration (OSHA)
E. US Food and Drug Administration (FDA)
F. US Department of Health and Human
Services
G. All of the above
H. None of the above
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.26791, “The CAP terms
of accreditation are listed in the laboratory’s
official notification of accreditation. The policy
must include notification of CAP regarding . . .
Change in laboratory test menu prior to
beginning that testing or the laboratory
permanently or temporarily discontinues some or
all testing.”
85
Dr. J, a director of a clinical molecular
laboratory, reviewed last month’s quality control
(QC) data. He found that the failure rate of the
KRAS assay was 10% higher than it had been
for the previous 6 months and for the same
month last year. He temporarily discontinued
the KRAS assay in the laboratory and sent the
samples to a reference laboratory while
investigating the reason. Which regulatory or
oversight agency must Dr. J notify for the
change?2
A. Centers for Medicare and Medicaid Services
(CMS)
B. Clinical Laboratory Improvement
Amendments (CLIA) of 1988
C. College of American Pathologist (CAP)
D. Occupational Safety and Health
Administration (OSHA)
E. US Food and Drug Administration (FDA)
F. US Department of Health and Human
Services
G. All of the above
H. None of the above
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.26791 “The CAP terms
of accreditation are listed in the laboratory’s
official notification of accreditation. The policy
must include notification of CAP regarding . . .
Change in laboratory test menu prior to
beginning that testing or the laboratory
permanently or temporarily discontinues some or
all testing.”
86
A small clinical molecular laboratory in the state
of Florida is sold to LabCorp after 1 year of
negotiation. When must the College of American
Pathologist (CAP) be notified about this
change to comply with the CAP terms of
accreditation?2
A. No later than 60 days prior to the final date
B. No later than 30 days prior to the final date
C. No later than 2 weeks prior to the final date
D. No later than 2 working days afterward
E. No later than 2 weeks afterward
B. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.26791, “The CAP terms
of accreditation are listed in the laboratory’s
official notification of accreditation. The policy
must include notification of CAP regarding . . .
Change in laboratory directorship, location,
ownership, name, insolvency, or bankruptcy;
notification must occur no later than 30 days prior
to the change(s); or, in the case of unexpected
changes, no later than two working days
afterwards. Laboratories subject to US regulations
must also notify the US Department of Health
and Human Services.”
87
A small clinical molecular laboratory in the state
of Florida is sold to LabCorp after 1 year of
negotiation. The College of American
Pathologist (CAP) was notified about this
change 1 month before the change. Which
additional regulatory or oversight agency must
be notified to comply with the CAP terms of
accreditation?
A. Centers for Medicare and Medicaid Services
(CMS)
B. Clinical Laboratory Improvement
Amendments (CLIA) of 1988
C. College of American Pathologist (CAP)
D. Occupational Safety and Health
Administration (OSHA)
E. US Food and Drug Administration (FDA)
F. US Department of Health and Human
Services
G. All of the above
H. None of the above
F. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.26791, “The CAP terms
of accreditation are listed in the laboratory’s
official notification of accreditation. The policy
must include notification of CAP regarding . . .
Change in laboratory directorship, location,
ownership, name, insolvency, or bankruptcy;
notification must occur no later than 30 days prior
to the change(s); or, in the case of unexpected
changes, no later than two working days
afterwards. Laboratories subject to US regulations
must also notify the US Department of Health and
Human Services.”
88
It is time for an interim self-inspection in a
clinical molecular laboratory. Who in the
following list may the director of a clinical
molecular genetics laboratory choose for selfinspection,
according to the College of American
Pathologist (CAP)’s regulations, if applicable?
A. Residents
B. Technologists
C. Fellows
D. Supervisor of the cytogenetics laboratory next
door
E. All of the above
F. None of the above
E. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.23584, “The interim selfinspection
is an important aspect of continuing
education and laboratory improvement. The use
of a variety of mechanisms for self-inspection
(residents, technologists or others trained to perform
inspections) is strongly endorsed. Self inspection
by personnel familiar with, but not directly involved in, the routine operation of the
laboratory section to be inspected is a best
practice. Record of performance of the interim
self-inspection with correction of deficiencies is a
requirement for maintaining accreditation. The
laboratory must have a record to demonstrate
that personnel responsible for each laboratory
section have reviewed the findings of the interim
self-inspection.”
89
One of the directors in a CAP/CLIA-certified
clinical molecular genetics laboratory in New
York City received a phone call from a physician
to order fragile X test on a patient. When should
the laboratory solicit written or electronic
authorization for this verbal order, according to
the College of American Pathologist (CAP)’s
regulations, if applicable?2
A. Within 10 days
B. Within 15 days
C. Within 30 days
D. Within 2 months
E. Within 3 months
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.40932, “For laboratories
subject to US regulations, the laboratory solicits
written or electronic authorization for verbal
orders within 30 days. The laboratory must retain
the written authorization or documentation of
efforts made to obtain a written authorization. In
a managed office where the staff assistants are
not employees of the physician/clinician, the staff
should not sign a test requisition for the physician
without some type of provider services
agreement. This agreement must specify how the
clinician has accepted responsibility for the tests
ordered from the off-site laboratory. (This
situation is different from the hospital
environment, where the physician has personally
signed the order sheet.)”
90
Dr. A, a medical geneticist, saw a patient who
potentially had one of immunodeficiency
disorders. She ordered a next-generation
sequencing (NGS) panel for immunodeficiency
disorders from a reference laboratory. The
peripheral-blood sample was sent to the clinical
molecular genetics laboratory in the hospital to be
sent out. TM, a technologist, was the only staff
member trained to pack human specimens for
send-out. She was trained at the state health
department 6 years ago. How frequently would
recurring training be required for TM to keep her
active status, according to the College of American
Pathologist (CAP)’s regulations, if applicable?2
A. At least annually
B. At least biennially
C. At least every 3 years
D. At least every 5 years
E. None of the above
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.40515, “All personnel
who package infectious specimens for shipment
must satisfactorily complete training in these
requirements. Federal and international
regulations mandate the proper packaging and
transportation of infectious substances, also
termed ‘etiologic agents.’ It is the laboratory’s
responsibility to determine whether specimens
that are to be shipped are subject to the
regulations, or are exempt. For US laboratories,
specific requirements are set forth by the US
Public Health Service, the US Department of
Transportation and the US Postal Service. These
apply to domestic transportation by land, air or
sea, and to international air transportation.
Recurrent training is required every 3 years. The
laboratory should check with its local
department of transportation or state health
department for any recent revisions to these
requirements.”
91
How long should a clinical molecular laboratory
keep specimen requisitions, according to the
College of American Pathologist (CAP)’s
regulations, if applicable?2
A. A minimum of 10 years
B. A minimum of 5 years
C. A minimum of 4 years
D. A minimum of 2 years
E. A minimum of 1 year
D. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.20377, “The following
records must be retained for at least 2 years:
specimen requisitions (including the patient chart
or medical record only if used as the requisition),
patient test results and reports (both original and
corrected), instrument printouts, accession
records, quality control records, instrument
maintenance records, proficiency testing records,
and quality management records.”
92
How frequently should the operating speeds of
centrifuges be checked in clinical molecular
genetics laboratories, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?2
A. At least once every 5 years
B. At least biennially
C. At least annually
D. At least semiannually
E. At least monthly
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN. 41017 “The operating
speeds of centrifuges are checked at least annually
as needed for the intended use, and this is done
in a safe manner. For centrifuges having a safety
mechanism preventing the opening of the lid
while in operation, the checks of rpm should be
performed only by an authorized service
representative of the manufacturer or an
appropriately trained clinical engineer.”
93
How frequently should a clinical molecular
laboratory monitor refrigerator/freezer
temperature, according to the College of American
Pathologist (CAP)’s regulations, if applicable?2
A. Every day, including weekends and holidays
B. Every work day
C. Twice a day, including weekends and
holidays
D. Twice a day, but only on work days
E. Once a week
A. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.41042, “Refrigerator/
freezer temperatures are checked and recorded
daily using a calibrated thermometer” And “Daily
means every day (7 days per week, 52 weeks per
year). The laboratory must define the
acceptable temperature ranges for these units. If
temperature(s) are found to be outside the
acceptable range, the laboratory must record appropriate corrective action, which may include
evaluation of contents for adverse effects.”
94
”How frequently should a director of a clinical
molecular laboratory review and approve the
content and format of patient reports?2
A. At least once every 5 years
B. At least biennially
C. At least annually
D. At least semiannually
E. At least monthly
B. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.41067, “An individual
meeting CAP laboratory director qualifications
reviews and approves the content and format of
paper and electronic patient reports at least every
two years.” And “The laboratory director (or a
designee who meets CAP qualifications for
laboratory director) must review and, at least
every two years, approve the content and format
of laboratory patient reports (whether paper or
computer screen images) to ensure that they
effectively communicate patient test results, and
that they meet the needs of the medical staff.”
95
How long must a clinical molecular laboratory in
a local hospital retain patient charts, according to
the College of American Pathologist (CAP)’s
regulations, if applicable?2
A. Permanently
B. At least 23 years
C. At least 10 years
D. At least 5 years
E. At least 2 years
F. None of the above
A. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.41300, “The length of
time that reported data are retained in the
laboratory may vary; however, the reported
results must be retained for that period
encompassing a high frequency of requests for
the data. In all circumstances, a hospital
laboratory must have access to the patient’s
chart where the information is permanently
retained.”
96
A clinical molecular laboratory went paperless 2
years ago. Patients’ electronic charts have been
stored in a cloud-based computing system. There
is a written procedure to address patient
confidentiality during transfer of data to external
servers. How frequently must the laboratory audit compliance with the procedures, according
to the College of American Pathologist (CAP)’s
regulations, if applicable?2
A. At least once every 5 years
B. At least biennially
C. At least annually
D. At least semiannually
E. At least monthly
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.41303, “The laboratory
ensures that internal and external storage and
transfer of data maintains patient confidentiality
and security.” And “Written procedures must
address patient confidentially during transfer of
data to external reference laboratories or other
service providers. This must include cloud-based
computing (e.g., for storage of confidential data),
as appropriate.” “The laboratory must audit
compliance with the procedures at least annually.” Therefore, the laboratory must audit
compliance with the procedures at least annually.
97
Dr. F, a director in a clinical molecular laboratory,
received a phone call from a patient who asked
for a copy of test results that were reported 2
years ago. She said she did not live in the area
anymore and could not find the ordering
physician. How should Dr. F address the patient’s
request, according to the College of American
Pathologist (CAP)’s regulations, if applicable?2
A. Provide final test results to the patient within
30 days after such a request.
B. Provide final test results to the patient within
15 days of such a request.
C. Provide final test results to the patient within
5 business days of such a request.
D. Apologize to the patient, then ask her to have
her current physician contact the laboratory.
E. None of the above.
A. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.41304, “Laboratories
subject to US regulations must provide final test
results to the patient or the patient’s personal
representative upon request. For completed tests,
these results must generally be provided no later
than 30 days after such a request.”
98
Dr. F, a director in a clinical molecular genetics
laboratory at an academic center, received a phone
call from a genetic counselor, BJ, from a private
practice. BJ asked for a copy of a patient’s test
result, which was ordered by a physician in a
nonaffiliated hospital. BJ faxed a copy of a medical
record release form signed by the patient to release
the result to Dr. F. Under the HIPAA Privacy Rule,
which one of the following individuals may have
access to a patient’s test results?2
A. The patient
B. The patient’s personal representative
C. Authorized persons responsible for using the
test reports
D. The laboratory that initially requested the test
E. All of the above
F. None of the above
E. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.41304 “Under the
HIPAA Privacy Rule, only the patient or a personal
representative, defined as an individual who has
authority under applicable law to make health
care decisions for the patient, can be given access
to a patient’s personal health data. Laboratories
must take reasonable steps to verify the identity
of the patient and the authority of a personal
representative to have access to an individual’s
protected health information. The Rule also
allows for the release of test reports to authorized
persons responsible for using the test reports and to
the laboratory that initially requested the test, if
applicable.”
99
The Health Insurance Portability and
Accountability Act (HIPAA) was passed by the
US Congress in 1996. What does HIPAA protect?
A. Patient health information privacy
B. Patient right to be treated equally
C. Patient informed consent
D. Patient protection and affordable care
E. All of the above
F. None of the above
A. HIPAA is the acronym for the Health
Insurance Portability and Accountability Act that
was passed by Congress in 1996. HIPAA provides
the ability to transfer and continue health
insurance coverage for millions of American
workers and their families when they change or
lose their jobs; reduces health care fraud and
abuse; mandates industry-wide standards for
health care information on electronic billing and
other processes; and requires the protection and
confidential handling of protected health information
100
“ObamaCare” was signed by President Barack
Obama in 2010. What does “ObamaCare” mean?
A. Patient health information privacy
B. Patient right to be treated equally
C. Patient informed consent
D. Patient protection and affordable care
E. All of the above
F. None of the above
D. The official name for “ObamaCare” is the
Patient Protection and Affordable Care Act
(PPACA), or Affordable Care Act (ACA) for
short. The ACA was signed into law by President
Barack Obama on March 23, 2010, in order to
reform the health care industry; it was upheld by
the Supreme Court on June 28, 2012.
ObamaCare’s goal is to give more Americans
access to affordable, quality health insurance and
to reduce the growth in US health care spending.
The Affordable Care Act expands the
affordability, quality, and availability of private
and public health insurance through consumer
protections, regulations, subsidies, taxes,
insurance exchanges, and other reforms (http://
obamacarefacts.com).
101
In a clinical molecular genetics laboratory the
turnaround time (TAT) in the written policy is 5
business days for a BCR-ABL1 test. Last week the
technologist who was responsible for this test
repeated the test on five samples four times to
obtain reportable results. The real TAT was 7
days for those five samples. If the College of
American Pathologist (CAP)required TAT on
this test is 10 days, did these five samples meet
the required TAT?2
A. Yes
B. No
C. Not sure
B. A laboratory’s written policy defines test
reporting turnaround time (TAT) in this
laboratory, which is subject to the College of
American Pathology (CAP) regulations. In this
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case, the TAT in the written policy of the laboratory is
acceptable according to CAP regulation, and it is the
official TAT in this laboratory. Those five samples
did not meet the laboratory-established TAT.
102
A clinical molecular laboratory became
paperless 2 years ago. Patient’s electronic
charts have been stored in a cloud-based
computing system. There is a written
procedure to address patient confidentially
during transfer of data to external servers.
Electronic copies of reports from reference
laboratories have been stored in the same place.
The director of the laboratory received a
warning message to inform him that the server
is almost full. To save money, he decided to
delete some of archived reports, and stop
saving new reports from reference laboratories.
Which type of deficiency would it be if
it were one?2
A. Phase 0
B. Phase I
C. Phase II
D. Phase III
E. Not a deficiency
F. None of the above
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.41430, “For samples
referred to another laboratory, the original or an
exact copy of the testing laboratory’s report is
retained by the referring laboratory.” And “The
report may be retained on paper or in electronic
format. Exceptions to this requirement may be
made under special circumstances or for special
categories, such as drugs of abuse or employee
drug testing. The laboratory director may make
these exceptions.” Therefore, it is a Phase II
deficiency, if the laboratory fails to do so.
103
How frequently should a clinical molecular
genetics laboratory test its water quality to make
sure it is as claimed to be in each of its testing
procedures?2
A. At least once every 5 years
B. At least biennially
C. At least annually
D. At least semiannually
E. At least monthly
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.41500, “The laboratory
defines the specific type of water required for
each of its testing procedures and water quality is
tested at least annually.”
104
How frequently should the autoverification
process of documentation be tested after
initial validation, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?2
A. Annually
B. Biennially
C. Every 3 years
D. Every 4 years
E. Every 5 years
A. According to the College of American Pathology
(CAP) Molecular Pathology Checklist April 21,
2015, GEN.43875, “Autoverification is the process
by which patient results are generated from
interfaced instruments and sent to the LIS, where
they are compared against laboratory-defined
acceptance parameters. There is documentation
that the autoverification process was validated
initially, and is tested at least annually and
whenever there is a change to the system that could
affect the autoverification logic.”
105
Dr. G, a director of a clinical molecular
laboratory, plans to transfer the reports for
cystic fibrosis carrier tests from Cerner to
SunQuest. How many examples of reports must
Dr. G test for the interface before the
implementation?2
A. At least 1
B. At least 2
C. At least 10
D. At least 20
E. At least 30
. B. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.48500, “There is a
procedure to verify that patient results are accurately transmitted from the point of data
entry (interfaced instruments and manual input)
to patient reports (whether paper or electronic).”
And “At implementation of a new interface, or
change to an existing interface, validation of at
least 2 examples of reports from each of the
following disciplines, where applicable, satisfies
the intent of this checklist requirement.
Subsequently, at least 2 examples of reports from
at least 4 of these disciplines should be validated
every 2 years
106
Dr. A, an ACMG board-certified molecular
geneticist, started a job as a senior director in a
commercial laboratory 2 months ago. When he
reviewed the procedures and policies in the
laboratory, he found that the laboratory verified
two examples of reports every 4 years to ensure
the interface result integrity. Dr. A changed
the policy immediately. What did Dr. A change
the policy to, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?2
A. At least 4 examples of reports every 2 years
B. At least 4 examples of reports every 4 years
C. At least 2 examples of reports every 2 years
D. At least 10 examples of reports every
10 years
E. None of the above
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.48500, “There is a
procedure to verify that patient results are
accurately transmitted from the point of data
entry (interfaced instruments and manual input)
to patient reports (whether paper or electronic).”
And “At implementation of a new interface, or
change to an existing interface, validation of at
least 2 examples of reports from each of the
following disciplines, where applicable, satisfies
the intent of this checklist requirement.
Subsequently, at least 2 examples of reports from at
least 4 of these disciplines should be validated
every 2 years.
107
How many years of experience with highcomplexity testing must an individual have to be
qualified as a general supervisor of a clinical
molecular pathology laboratory if he or she has a
bachelor’s degree in a chemical, physical,
biological, or clinical laboratory science or
medical technology, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?2
A. At least 1 year
B. At least 2 years
C. At least 4 years
D. At least 10 years
E. At least 15 years
A. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.53600, “supervisors/
general supervisors who do not qualify as a
laboratory director or section director/technical
supervisor must qualify as testing personnel and
possess a:
* Bachelor’s degree in a chemical, physical,
biological or clinical laboratory science or
medical technology with at least one year of
experience with high complexity testing, or
* Associate degree in a laboratory science
or medical technology program with at
least two years experience with high
complexity testing, or
* Have previously qualified or could have
qualified as a general supervisor prior to 2/28/
1992”
Therefore, a general supervisor of a clinical
molecular pathology laboratory must have at
least 1 year experience with high complexity
testing if he/she has bachelor’s degree in a
chemical, physical, biological or clinical
laboratory science or medical technology.
108
According to the College of American Pathologist
(CAP)’s regulations, a technical consultant in
a clinical molecular laboratory must have at
least a(n):2
A. Doctoral degree (MD or PhD)
B. Master’s degree
C. Bachelor’s degree
D. Associate’s degree
E. High school diploma
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.53625, “The technical
consultant (including the laboratory director who
serves as a technical consultant) must be qualified
by education and experience by one of the
following combinations:
* MD or DO, licensed to practice medicine in the
jurisdiction where the laboratory is located (if
required), with certification in anatomic and/or
clinical pathology, or qualifications equivalent
to those required for board certification
* MD, DO, or DPM, licensed to practice in the
jurisdiction where the laboratory is located (if
required), with at least 1 year of training and/
or experience in nonwaived testing (The
technical consultant’s training and experience
must be in the designated specialty or
subspecialty area of service for which the
consultant is responsible.); or
* Doctoral or masters degree in a chemical,
physical, biological or clinical laboratory
science with at least 1 year of training and/or
experience in nonwaived testing (The technical
consultant’s training and experience must be in
the designated specialty or subspecialty area of service for which the consultant is
responsible.); or
* Bachelor’s degree in a chemical, physical,
biological or clinical laboratory science or
medical technology with at least 2 years of
experience in nonwaived testing (The technical
consultant’s training and experience must be in
the designated specialty or subspecialty area of
service for which the consultant is
responsible.).”
Therefore, a technical consultant in a clinical
molecular laboratory must have at
least bachelor degree
109
According to the College of American
Pathologist (CAP)’s regulations, a clinical
consultant in a clinical molecular laboratory
must have at least a(n):2
A. Doctoral degree (MD or PhD)
B. Master’s degree
C. Bachelor’s degree
D. Associate’s degree
E. High school diploma
A. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.53650, “Clinical
consultants must be a physician licensed to
practice medicine in the jurisdiction where the
laboratory is located (if required) or doctoral
scientist certified by a CLIA-approved board.”
Therefore, a clinical consultant in a clinical
molecular laboratory must have at least doctor
degree (MD or PhD).
110
A technologist was hired into a clinical
molecular laboratory 1 month ago and was trained
to run the BRAF V600E qualitative assay. How
frequently should this technologist be assessed for
competency on this test after the initial training,
according to the College of American Pathologist
(CAP)’s regulations, if applicable?2
A. At least once every 5 years
B. At least biennially
C. At least annually
D. At least semiannually
E. At least monthly
D. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.55500 “Prior to starting
patient testing and prior to reporting patient
results for new methods or instruments, each
individual must have training and be evaluated
for proper test performance as required in
GEN.55450. Thereafter, during the first year of an
individual’s duties, competency must be assessed
at least semiannually for nonwaived testing. After
an individual has performed his/her duties for
one year, competency must be assessed annually
for all duties. Retaining and reassessment of
employee competency must occur when problems
are identified with employee performance.”
Therefore, this technologist should be assessed
at least semiannually for competency on this test
after the initial training.
111
Dr. B, an on-site College of American Pathologist
(CAP) inspector, presented herself to the staff in a
clinical molecular genetics laboratory that she was
assigned to inspect. She asked the supervisor
whether new personnel had been hired in the
past 2 years. OB, a technologist, had been hired
into the laboratory 2 years ago. OB’s personnel
file showed that his initial training for the BRAF
V600E qualitative test was on January 1, 2012.
Which one of the following personnel files
indicated that OB was competent to perform the
BRAF V600E assay and fulfilled the minimal
requirement of the College of American
Pathologist (CAP)’s regulations?
A. OB’s competency was first assessed on June
30, 2012, and then on December 30, 2013.
B. OB’s competency was first assessed on
December 30, 2012, and then on December 30,
2013.
C. OB’s competency was first assessed on June
30, 2012, and then on June 30, 2013.
D. OB’s competency was first assessed on
December 30, 2012, and then on December 30,
2014.
E. All of the above.
F. None of the above.
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.55450, “There are
records that all staff has satisfactorily completed
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initial training on all instruments/methods
applicable to their designated job. The records
must show that training specifically applies to the
testing performed by each individual.”
GEN.55500 states, “During the first year of an
individual’s duties, competency must be assessed
at least semiannually. After an individual has
performed his/her duties for one year,
competency must be assessed at least annually.”
Therefore, if OB’s first competency was
assessed on 06/30/2012 and the second was on
06/30/2013, he was competent
112
Who must be assessed for competency in a
clinical molecular pathology laboratory, according
to the College of American Pathologist (CAP)’s
regulations, if applicable?2
A. Technologists
B. General supervisors
C. Technical consultants
D. Section directors
E. All of the above
F. None of the above
E. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.55450, “There are records
that all staff has satisfactorily completed initial
training on all instruments/methods applicable to
their designated job. The records must show that
training specifically applies to the testing
performed by each individual.” GEN.55525 states,
“The performance of section directors/technical
supervisors, general supervisors, and technical
consultants is assessed and satisfactory.”
Therefore, technologists (A), general
supervisors (B), technical consultants (C), and
(section directors) must all be assessed for
competency
113
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.55450, “There are
records that all staff has satisfactorily completed
initial training on all instruments/methods
applicable to their designated job. The records
must show that training specifically applies to the
testing performed by each individual.”
GEN.55500 states, “During the first year of an
individual’s duties, competency must be assessed
at least semiannually. After an individual has
performed his/her duties for one year,
competency must be assessed at least annually.”
Therefore, his competency assessment for the
BRAF V600E qualitative assay must be evaluated
at least annually from now on.A technologist was hired into a clinical molecular
laboratory 2 years ago. He has been competent to
perform the BRAF V600E qualitative assay for 1
year. How frequently must his competency for
the BRAF V600E qualitative assay be evaluated
from now on, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?2
A. At least once every 5 years
B. At least biannually
C. At least annually
D. At least semiannually
E. At least monthly
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.55450, “There are
records that all staff has satisfactorily completed
initial training on all instruments/methods
applicable to their designated job. The records
must show that training specifically applies to the
testing performed by each individual.”
GEN.55500 states, “During the first year of an
individual’s duties, competency must be assessed
at least semiannually. After an individual has
performed his/her duties for one year,
competency must be assessed at least annually.”
Therefore, his competency assessment for the
BRAF V600E qualitative assay must be evaluated
at least annually from now on.
114
Which one of the following should be included in
competency assessments, according to the College
of American Pathologist (CAP)’s regulations, if
applicable?2
A. Directly observing routine patient test
performance
B. Monitoring the recording and reporting of test
results
C. Reviewing intermediate test results or
worksheets, quality control records,
proficiency testing results, and preventive
maintenance records
D. Directing observation of performance of
instrument maintenance and function checks
E. Assessing test performance through testing
previously analyzed specimens, internal blind
testing samples, or external proficiency testing
samples
F. Evaluating problem-solving skills
G. All of the above
H. None of the above
G. According to the College of American Pathology
(CAP) Laboratory General Checklist dated July 28,
2015, GEN.55500, “Elements of competency
assessment include but are not limited to:
* Direct observations of routine patient test
performance, including, as applicable;
* Patient identification and preparation; and
specimen collection, handling, processing and
testing;
* Monitoring the recording and reporting of test
results, including, as applicable, reporting
critical results; * Review of intermediate test results or worksheets,
quality control records, proficiency testing results,
and preventive maintenance records;
* Direct observation of performance of instrument
maintenance and function checks;
* Assessment of test performance through testing
previously analyzed specimens, internal blind
testing samples or external proficiency testing
samples; and
* Evaluation of problem-solving skills.”
Therefore, direct observations of routine
patient test performance (A); monitoring the
recording and reporting of test results (B);
review of intermediate test results or
worksheets, quality control records, proficiency
testing results, and preventive maintenance
records (C); direct observation of performance
of instrument maintenance and function checks
(D); assessment of test performance through
testing previously analyzed specimens, internal
blind testing samples or external proficiency
testing samples (E); evaluation of problemsolving skills (F) are all elements of a test
system. And they all should be included in the
competency assessment
115
BJ, a technologist at a clinical molecular
laboratory, has been competent to perform the
BRAF V600E qualitative assay for 3 years.
However, he did not pass the competency
assessment for this assay this year. What should
be the next step for BJ, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?2
A. Layoff
B. Reassignment of duties
C. Reeducation and training
D. Supervisory review of work
E. None of the above
C. BJ must undergo reeducation and training.
According to the College of American Pathology
(CAP) Laboratory General Checklist dated July
28, 2015, GEN.57000, “If an employee fails to
demonstrate satisfactory performance on the
competency assessment, the laboratory has a plan
of corrective action to retrain and reassess the
employee’s competency.” And “If it is determined
that there are gaps in the individual’s knowledge,
the employee should be re-educated and allowed
to retake the portions of the assessment that fell
below the laboratory’s guidelines. If, after
reeducation and training, the employee is unable
to satisfactorily pass the assessment, then further
action should be taken which may include,
supervisory review of work, reassignment of
duties, or other actions deemed appropriate by
the laboratory director.”
Therefore, BJ should be re-educated and retrained to re-gain his competency for the assay.
116
Dr. B, an on-site College of American
Pathologist (CAP) inspector, presented herself to
the staff in a clinical molecular genetics
laboratory that she was assigned to inspect. She
asked JJ, the supervisor, how frequently the
laboratory’s safe work practices were
reviewed. JJ said they were reviewed biennially.
Dr. B cited Phase II deficiency on it. How
frequently should a clinical molecular
laboratory review its safe work practices to
reduce hazards, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?2
A. At least once every 5 years
B. At least biennially
C. At least annually
D. At least semiannually
E. At least monthly
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.73400 “There is
documented periodic review (at least annually) of
safe work practices to reduce hazards.” And
“Review must include bloodborne hazard control
and chemical hygiene. If the review identifies a
problem, the laboratory must investigate the
cause and consider if modifications are needed to
the safety policies and procedures to prevent reoccurrence of the problem or mitigate potential
risk.”
Therefore, a clinical molecular laboratory
should review its safe work practices at least
annually to reduce hazards
117
For US laboratories subject to OSHA regulations,
all workplace fatalities must be reported to the
Occupational Safety and Health Administration
(OSHA). How soon should a clinical molecular
laboratory report the accident to OSHA?2
A. Within 4 hours
B. Within 8 hours
C. Within 24 hours
D. Within 2 days
E. Within 1 week
B. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.73600, “For US
laboratories subject to OSHA regulations, all
workplace fatalities must be reported to the
Occupational Safety and Health Administration
(OSHA) within eight hours and work-related inpatient hospitalizations, amputations, or losses of
an eye within 24 hours.”
Therefore, a clinical molecular laboratory
should report all workplace fatalities to OSHA
within 8 hours.
118
For US laboratories subject to OSHA regulations,
all work-related inpatient hospitalizations,
amputations, or losses of an eye must be reported
to the Occupational Safety and Health
Administration (OSHA). How soon should a
clinical molecular laboratory report the accident
to OSHA?2
A. Within 4 hours
B. Within 8 hours
C. Within 24 hours
D. Within 2 days
E. Within 1 week
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.73600 “For US
laboratories subject to OSHA regulations, all
workplace fatalities must be reported to the
Occupational Safety and Health Administration
(OSHA) within eight hours and work-related inpatient hospitalizations, amputations, or losses of
an eye within 24 hours.”
Therefore, a clinical molecular laboratory
should report the accident (all work-related inpatient hospitalizations, amputations, or losses of
an eye) to OSHA within 24 hours.
119
According to the College of American Pathologist
(CAP)’s regulations, how frequently must
sterilizing devices be monitored in a clinical
molecular pathology laboratory?2
A. Daily
B. Weekly
C. Biweekly
D. Monthly
E. Quarterly
. B. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.75000, “Each sterilizing
device must be monitored periodically with a
biologic indicator to measure the effectiveness of
sterility. Chemical indicators that reflect
sporicidal conditions may be used. The test must
be performed under conditions that simulate
actual use. One recommended method is to wrap
the Bacillus stearothermophilus spore indicator
strip in packaging identical to that used for a
production run, and to include the test package
with an actual sterilization procedure. Weekly
monitoring is recommended.”
Therefore, sterilizing devices must be
monitored weekly.
120
After new employees pass fire safety training,
how frequently should a fire safety review be
conducted, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?2
A. At least once every 5 years
B. At least biannually
C. At least annually
D. At least semiannually
E. At least monthly
C. According to the College of American
Pathology (CAP) Laboratory General Checklist
dated July 28, 2015, GEN.75400, “Fire safety
training is performed for new employees, with a
fire safety review conducted at least annually.
Fire safety training must be recorded for all
employees to show that they have been instructed
on use and response to fire alarms and to execute
duties as outlined in the fire safety plan. While fire exit drills are not required, physical evaluation of the escape routes must be
performed annually, to ensure that fire exit
corridors and stairwells are clear and that all fire
exit doors open properly (i.e., not rusted shut,
blocked or locked). Paper or computerized testing
of an individual’s fire safety knowledge on the
fire safety plan is acceptable; all personnel must
participate at least once a year.”
Therefore, a fire safety review should be
conducted at least annually.
121
According to the College of American Pathologist
(CAP)’s regulations, for laboratories subject to US regulations, chemicals that must be handled as
potential carcinogens include those defined by
OSHA as “select carcinogens.” The list of
OSHA-defined select carcinogens does NOT
include:2
A. Group 1 carcinogen listed by the IARC
B. Group 2A carcinogen listed by the IARC
C. Group 2B carcinogen listed by the IARC
D. Group 3 carcinogen listed by the IARC
E. A “known to be carcinogen” classified by the
NTP
F. A “reasonably anticipated to be carcinogen”
classified by the NTP
D. Agents classified by the International Agency
for Research on Cancer (IARC) are: Group 1
(Carcinogenic to humans); Group 2A (Probably
carcinogenic to humans); Group 2B (Possibly
carcinogenic to humans); Group 3 (Not classifiable as
to its carcinogenicity to humans); Group 4 (Probably
not carcinogenic to humans). (https://monographs.
iarc.fr/agents-classified-by-the-iarc/) According to
the College of American Pathology (CAP)
Laboratory General Checklist dated July 28, 2015,
GEN.76000, “For laboratories subject to US
regulations, chemicals that must be handled as
potential carcinogens include those defined by
OSHA as ‘select carcinogens.’ OSHA defines select
carcinogens as any substance that is:
* Regulated as a carcinogen by OSHA, has been
classified as “known to be carcinogenic” by the
National Toxicology Program (NTP), or listed
as a group I carcinogen by IARC.
* Has been classified as ‘reasonably anticipated to
be carcinogenic’ by the NTP or listed as a group
2A or 2B carcinogen by the IARC if it meets the
toxicological criteria listed in the January 31,
1990 Fed Register, pages 33193320.
OSHA also requires special containment
procedures for substances that are reproductive
toxins or are acutely hazardous.” Therefore, group
3 and group 4 agents are NOT OSHA-defined select
carcinogens.
122
According to the College of American Pathologist
(CAP)’s regulations, which one of the following
locations is appropriate to store strong acid and
bases?2
A. Storage above eye level
B. Storage near the floor
C. Storage containers of acids and bases together
D. Storage under sinks
E. Any one of the above
F. None of the above
B. According to the College of American
Pathology (CAP) Laboratory General
Checklist dated July 28, 2015, GEN.76700,
“Supplies of concentrated acids and bases are
stored safely. (1) Storage must be below eye
level. Storage near the floor is recommended. (2)
Strong acids and bases must not be stored
under sinks, where contamination by moisture
may occur. (3) Storage containers of acids and
bases should be adequately separated to prevent
a chemical reaction in the event of an
accident/spill/leak. (4) Bottle carriers are
used to transport all glass containers
larger than 500 mL that contain hazardous
chemicals.”
123
. Which one of the following individuals is
qualified to be a section director/technical
supervisor of a clinical molecular pathology
laboratory, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?4
A. A pathologist
B. An MD with an ACMG certification in clinical
molecular genetics
C. A PhD with an ACMG certification in clinical
molecular genetics
D. A technologist with an ASCP certification and
10 years of experiences in a molecular
pathology laboratory
E. A, B, and C
F. All of the above
G. None of the above
E. According to the College of American
Pathology (CAP) Molecular Pathology checklist
dated July 28, 2015, MOL.49650, “The section
director/technical supervisor of the molecular
pathology laboratory is a pathologist, board-certified
physician in a specialty other than pathology, or
doctoral scientist in a chemical, physical, or biologic
science, with specialized training and/or appropriate
experience in molecular pathology.” An individual
with qualifications described in choice D may be
a “bench testing/section supervisor”
(MOL.49655).
Therefore, a pathologist (A), a MD with an
ACMG certification in clinical molecular genetics
(B), and a PhD with an ACMG certification in
clinical molecular genetics (C) are qualified to be
a section director/technical supervisor of a clinical molecular pathology laboratory.
124
How many years of experience must an
individual have to be qualified to serve as a
bench testing supervisor of a clinical molecular
pathology laboratory if he or she has bachelor’s
degree in a chemical, physical, biological, or
clinical laboratory science or medical
technology, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?4
A. At least 1 year
B. At least 2 years
C. At least 4 years
D. At least 10 years
E. At least 15 years
C. According to the College of American
Pathology (CAP) Molecular Pathology checklist
dated July 28, 2015, MOL.49655, “Bench testing
supervision is the person in charge of bench
testing/section supervisor of the molecular
pathology laboratory, who is qualified as one of
the following:
* Person who qualifies as a section director/
technical supervisor
* Bachelor’s degree in a chemical, physical,
biological, or clinical laboratory science or
medical technology with at least 4 years of
experience (at least 1 of which is in molecular
pathology methods) under a qualified section
director.”
Therefore, this person has to have at lest 4
years of experience in order to serve as a bench
testing supervisor
125
According to the College of American
Pathologist (CAP)’s regulations, a technologist in
a clinical molecular laboratory must have at least
a(n):4
A. Certification as a clinical molecular genetics
technologist
B. Master’s degree
C. Bachelor’s degree
D. Associate’s degree
E. High school diploma
D. According to the College of American
Pathology (CAP) Molecular Pathology checklist
dated July 28, 2015, MOL.49660 “Personnel
performing the technical work of molecular
pathology have appropriate experience in
molecular pathology methods and qualify as high
complexity testing personnel with a minimum of
the following:
* Bachelor’s degree in a chemical, physical,
biological or clinical laboratory science or
medical technology; or
* Associate degree in a laboratory science or
medical laboratory technology from an
accredited institution, or equivalent laboratory
training and experience meeting the
requirements defined in the CLIA regulation
42CFR493.1489. The qualifications to perform high complexity testing can be assessed using
the following link: CAP Personnel
Requirements by Testing Complexity.”
Therefore, a technologist in a clinical
molecular laboratory must have at least an
associate degree.
126
For quantitative molecular tests, which one of
the following controls should be included in each
run, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?4
a. A no-template control
b. A wild-type control
c. A low-positive control
d. A high-positive control
e. An internal control
A. a, b, c, and d
B. a, b, c, d, and e
C. a and b
D. a, b, and d
E. a, b, d, and e
B. According to the College of American
Pathology (CAP) Molecular Pathology checklist
dated July 28, 2015, MOL.30440, “Quantitative
molecular tests require that the dynamic range of
the assay be defined and assay performance
tested with controls in each run including a
negative, low positive, and a high positive control.”
Usually a wild-type control is also used as a
negative control for cross-reaction between the
mutant and wild type. The internal control is used
to confirm the quantity and quality of the sample
for the assay.
Therefore, a no-template control (a), a wild
type control (b), a low positive control (c), a high
positive control (d), and an internal control (e)
should all be included in each run
127
Which of the following parameters should be
verified for FDA-cleared/approved tests during
assay validation in a clinical molecular
genetics laboratory, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?1
a. Analytical accuracy
b. Analytical precision
c. Analytical sensitivity
d. Analytical specificity
e. Reference range
f. Reportable range
g. Positive predictive value
h. Negative predictive value
A. a, b, c, and d
B. a, b, c, d, and e
C. a, b, c, d, and f
D. a, b, e, and f
E. a, b, c, d e, and f
F. a, b, c, d, e, f, g, and h
D. According to the College of American
Pathology (CAP) Molecular Pathology Checklist
dated July 28, 2015, “For unmodified FDAcleared/approved tests, the laboratory need only
verify accuracy, precision, reportable range, and
reference range.” This is also stated in CAP All
Common Checklist dated July 28, 2015,
COM.40000.
Therefore, analytical accuracy (a), analytical
precision (b), reference range (e), and
reportable range (f) should be verified for FDAcleared/approved tests during assay validation.
128
Which of the following parameters should be
verified for modified FDA-cleared/approved
assays during validation in a clinical molecular
genetics laboratory, according to the College of
American Pathologist (CAP)’s regulations,
if applicable?1
a. Analytical accuracy
b. Analytical precision
c. Analytical sensitivity
d. Analytical specificity
e. Reference range
f. Reportable range
g. Positive predictive value
h. Negative predictive value
A. a, b, c, and d
B. a, b, c, d, and e
C. a and b
D. a, b, and d
E. a, b, c, d, e, and f
F. a, b, c, d, e, f, g, and h
F. According to the College of American
Pathology (CAP) Molecular Pathology Checklist
dated July 28, 2015, “If an FDA-cleared/approved
test is modified to meet the needs of the user or if
the test is developed by the laboratory (LDT),
both analytical and clinical performance
parameters need to be established. Analytical
performance parameters include, precision, reference
range, reportable range, as well as analytical
sensitivity, analytical specificity, and any other
parameter that is considered important to assure
the analytical performance of a particular test
(e.g. specimen stability, reagent stability, linearity,
carryover, cross-contamination, etc., as appropriate
and applicable). The clinical validity, which
includes clinical performance characteristics, such
as clinical sensitivity, clinical specificity, positive and
negative predictive values in defined populations or
likelihood ratios, and clinical utility should also be
considered, although individual laboratories may
not be able to assess these parameters within their.....
Therefore, analytical accuracy (a), analytical
precision (b), analytical sensitivity (c), analytical
specificity (d), reference range (e),
reportable range (f), positive predictive value (g),
and negative predictive value (h) all should be
verified for modified FDA-cleared/approved
assays during validation.
129
A director planned to validate a quantitative
BCR-ABL1 TaqMan-based assay in a clinical
molecular genetics laboratory at a hospital. He
sent six peripheral-blood samples to a
commercial laboratory for this validation. For
one positive sample, the result from the
commercial laboratory was 86% translocationpositive. The technologists in the laboratory
repeated the sample three times in one run
and repeated the run three times. The results
for this sample were 66% 6 0.1% translocationpositive with all nine repeats. Which one of
the following statements regarding the results
is correct, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?4
A. The accuracy of the assay in this lab was high.
B. The precision of the assay in this lab was low.
C. The reproducibility of the assay in this lab
was high.
D. The analytical sensitivity of the assay in this
lab was low.
E. The analytical specificity of the assay in this
lab was high.
C. Intermediate precision expresses withinlaboratories variations, such as different days,
different analysts, different equipment, etc.
Repeatability expresses the precision under the
same operating conditions over a short interval
of time. Repeatability is also termed intraassay
precision. According to the College of American
Pathology (CAP) Molecular Pathology Checklist
dated July 28, 2015, MOL.31145, “The laboratory
must show recorded evidence that a test will
return the same result regardless of minor
variations in testing conditions that can cause
random error, such as different technologists,
instruments, reagent lots, days, etc. This is
usually determined by repeated measures of
samples throughout the reportable range, and
for a quantitative test, represented as the
coefficient of variation, whereas for a qualitative
test, represented as ratios of concordant
results.”...
Therefore, the accuracy of this assay was low
in this lab, the precision was high, and the
reproducibility was high.
130
A director planned to validate a quantitative
BCR-ABL1 TaqMan-based assay in a clinical
molecular genetics laboratory at a hospital. He
sent six peripheral-blood samples to a commercial
laboratory for this validation. For one positive
sample, the result from the commercial laboratory
was 86% translocation-positive. The technologists
in the laboratory repeated the sample three times
in one run and repeated the run three times. The
results for this sample were 85% 6 20%
translocation-positive with all nine repeats. Which
one of the statements below regarding the
results is correct, according to the College of
American Pathologist (CAP)’s regulations, if
applicable?4
A. The accuracy of the assay in this lab is high.
B. The precision of the assay in this lab is high.
C. The reproducibility of the assay in this lab is
high.
D. The analytical sensitivity of the assay in this
lab is low.
E. The analytical specificity of the assay in this
lab is high.
A. The accuracy of an analytical procedure
expresses the closeness of agreement between the
value that is accepted either as a conventional
true value or an accepted reference value and the
value found....
Therefore, the accuracy of this assay was high
in this lab, the precision was low, and the
reproducibility was low
