Quality and Compliance

Question 1

Which of the following is a component of a quality

management system?

Answer 1

B. Organizational structure

Question 2

Question 2: Which of these organizations is a regulatory agency?

Answer 2

D. Food and Drug Administration (FDA).

Question 3

Question 3: If a unit is released for distribution, which of the follow-
ing is a reportable event to the FDA?

Answer 3

E. Arm preparation was not properly performed.

Question 4

Question 4: Quality assurance (QA) includes which of the following?

Answer 4

B. Review all red cell antigen typing records on a weekly basis.

Question 5

Question 5: For sentinel events, which of the following is true?

Answer 5

C. Failure to submit a root cause analysis for a reported sentinel
event may result in denial of accreditation by The Joint Commis-
sion.

Question 6

Question 6: Juran’s Quality Trilogy is a quality management

approach that focuses on which three processes?

Answer 6

E.

Planning, control, and improvement.

Question 7

Question 7: Which of the following is true about Joint Commission
hospital accreditation requirements?

Answer 7

C. The transfusion of blood and blood components is considered
a high-risk process.

Question 8

Question 8: If a donor’s units from two previous and separate dona-
tions tested negative for the K1 antigen, units from that donor may
be labeled as negative for the K1 antigen. Which quality system
essential does this statement represent?

Answer 8

C. Process control.

Question 9

Question 9: A laboratory purchases a new plasma freezer and is in
the process of equipment qualification. The lab checks that the
freezer control alarms are triggered when the temperature goes
beyond the established range. This testing is an example of which
aspect of equipment qualification?

Answer 9

C. Operational qualification (OQ).

Question 10

Question 10: A laboratory intends to begin using a new automated
analyzer.The device is expected to run 100 specimens per hour
with a turnaround time of less than 30 minutes per specimen and a
failure rate of 1%. Which of the following processes demonstrates
that the device meets customer specifications?

Answer 10

C. PQ.

Question 11

Question 11: At the blood collection center, a potential blood
donor is deferred because he had sex with a man last week. Unfor-
tunately, the costs associated with recruitment and initial screening
of this donor cannot be recovered via collection of a transfusable
product. How may a donor center best minimize these costs of
quality?

Answer 11

A. Donor education with initial recruitment materials.

Question 12

Question 12: A blood center’s quality functions are overseen by an
individual who should report directly to:

Answer 12

E. Executive management.

Question 13

Question 13: The struggle to create the ideal standard operating
procedure (SOP) is best described as a balance between what two
constructs?

Answer 13

B. Service and production.

Question 14

Question 14: The individual designated to oversee a facility’s qual-
ity functions must have authority to:

Answer 14

B. Initiate corrective action for processes that do not comply with
requirements.

Question 15

Question 15: According to AABB’s Standards for Blood Banks and
Transfusion Services, how often should customer feedback be
sought?

Answer 15

E. Not defined.

Question 16

Question 16: Which of the following statements about quality func-
tions and operational staff are true?

Answer 16

A. They should not audit work they have performed.

Question 17

Question 17: Which regulation requires an independent quality unit
with the responsibility and authority to control essential processes?

Answer 17

D. A federal regulation.

Question 18

Question 18: For competency assessment (CA), which is true?

Answer 18

D. CAs must be performed at least annually after the employee’s
first year.

Question 19

Question 19: If a laboratory technologist has been working in a
given laboratory for just over 3 years, what is the minimum number
of CAs that should be in his or her file?

Answer 19

E. Five.

Question 20

Question 20: On the first day of employment, a new employee
reports to the blood bank and a bench technologist is assigned to
handle his training. For 7 weeks, he first watches the technologist
work and then performs those same tasks under the trainer’s supervi-
sion. He passes the CA and is allowed to work without supervision.
Does this training approach comply with current good manufacturing
practice (cGMP) requirements for employee training?

Answer 20

C. No, because he was not given cGMP training.

Question 21

Question 21: Which of the following is true about critical supplies
or services?

Answer 21

B. The quality system should include processes to ensure that
incoming supplies are acceptable.

Question 22

Question 22: What should be done first when equipment is mal-
functioning?

Answer 22

B. Evaluate the potential clinical impact.

Question 23

Question 23: Which of the following is true about agreements with
providers of supplies or services?

Answer 23

C. The contracting facility assumes responsibility for ensuring that the contractor complies with all applicable product standards
and regulations.

Question 24

Question 24: If a blood bank has developed a novel crossmatch
process that is different from the package insert, what must be done
before implementation?

Answer 24

A. Submit a variance request to the FDA.

Question 25

Question 25: For equipment used in the collection, processing, test-
ing, or storage of blood components and human cells, tissues, and
cellular and tissue-based products, which of the following is required?

Answer 25

D. Documentation of OQ.

Question 26

Question 26: How many times may a blood bank fail crossmatch
proficiency testing (PT) before it is at risk for mandated cessation of
crossmatch testing?

Answer 26

C. After a second failure within three challenges, the laboratory is
at risk.

Question 27

Question 27: A facility uses an FDA-approved antisera for red cell
antigen testing. Staff have established they can use the antisera at a
1:1 dilution without affecting the sensitivity of the test. Which of the
following is true?

Answer 27

D. The establishment must validate the diluted antisera, then apply for an FDA variance from the manufacturer’s instructions.

Question 28

Question 28: Which of the following is true about critical supplies?

Answer 28

B. A contract is required, even if the outside supplier is at the same institution.

Question 29

Question 29: For documents and records, which of the following is
true?

Answer 29

C. Documents provide information on what should happen.

Question 30

Question 30: During investigation of an error, which process will
help determine the optimal preventive action(s) to take?

Answer 30

D. Pareto chart.

Question 31

Question 31: Which of the following events is a biological product
deviation (BPD) that must be reported to the FDA?

Answer 31

A. An Rh-positive Red Blood Cell (RBC) unit is incorrectly labeled
as Rh negative and issued to an Rh-positive patient. The unit is
returned to the blood bank.

Question 32

Question 32: What is the relationship between compliance and

quality?

Answer 32

A. Quality > Compliance.

Question 33

Question 33: A product recall would be required in which of the
following situations?

Answer 33

B. A lot of Rh Immune Globulin (RhIG) is incorrectly labeled with
a potency of 250 IU/dose when the actual does is 204 IU.

Question 34

Question 34: For compliance with cGMP requirements for perform-
ing QA, which of the following is true?

Answer 34

-PT is not an acceptable form of assessment.
-An assessment should focus on one process.
-Self-assessment tools are not adequate for performing assess-
ments.
-Assessments may be internal or external.
E. All of the above.

Question 35

Question 35: A 56-year-old man experiences severe unexpected
bleeding after minimally invasive surgery and receives one RBC
unit. Shortly after onset of the transfusion, he develops a fever, his blood pressure drops, and he begins to ooze from his incision sites.
A transfusion reaction workup reveals that he received an ABO-
incompatible unit. Despite supportive measures, he develops dis-
seminated intravascular coagulation (DIC) and acute circulatory
collapse, leading to his death. Which of the following is correct?

Answer 35

C. The transfusion center is always responsible for reporting a
transfusion-associated death.

Question 36

Question 36: Which of the following is true about FDA licensure
and registration?

Answer 36

E.Hospital blood banks must be registered if they collect or manufacture blood components.

Question 37

Question 37: Which of the following characteristics of blood products
should a blood center quality management team be concerned with?

Answer 37

D. Safety, quality, identity, potency, and purity.

Question 38

Question 38: Which of the following statements is true about PT?

Answer 38

C. PT is required only for CLIA-regulated tests.

Question 39

Question 39: A facility discovers that technologists have been dis-
pensing blood components without first issuing them in the infor-
mation system, as required by operating policies, processes, and
procedures. These errors were discovered when the units could not
be accounted for during inventory reconciliation. On reviewing
these errors, management decides that at the end of each shift, a
technologist must review the retained compatibility slip copies for
all components issued and, if necessary, correct the computer sta-
tus. This is an example of:

Answer 39

B. Remedial action.