Deck 23: Quality Management

Question 1

What is the main purpose of linking Current Good Manufacturing Practices (CGMPs) to process control?

A) To comply with the regulations
B) To build quality into the manufacturing process from the beginning to the end
C) To review and approve training programs and employee position descriptions
D) To approve raw test materials and in-house reagents

Answer 1

B

Question 2

Process improvement teams address all of the following issues except:

A) becoming "team players."
B) quality and reliability of service.
C) filing a grievance.
D) interdepartmental communication.

Answer 2

C

Question 3

When a new assay is implemented, what measure is taken to determine equivalency?

A) Lot to lot testing of new and old lot numbers of reagent
B) Work-flow reorientation
C) Daily quality control
D) Calibration

Answer 3

A

Question 4

Which of the following might lead to unacceptable quality control results?

A) A technician who has not worked in the area for several months
B) A deteriorated "Anti-A"
C) An uncalibrated serofuge
D) All of the above

Question 5

A standard operating procedure (SOP) is:

A) a statement of intent or course of action.
B) a description of resources and activities that transform inputs into outputs.
C) a set of directions for how to perform a particular task.
D) a form on which to record results.

Question 6

A physician complains that she has not received a test report from the blood bank. The remedial action is to:

A) complete the occurrence report form.
B) prepare a copy of the report for the physician.
C) locate the original report.
D) determine why the report was not delivered.

Question 7

Which of the following statements concerning equipment is true?

A) Requires software to function
B) Quality control is not needed for critical steps.
C) Frequency of testing is determined by manufacturer recommendations.
D) All equipment must be purchased from the manufacturer.

Question 8

How do internal assessments differ from compliance inspections?

A) Compliance inspections assess performance on quality indicators.
B) Internal assessments focus on meeting regulations.
C) Internal assessments are more frequent than compliance inspections.
D) Compliance inspections seek underlying causes of problems.

Question 9

Which statement concerning compliance programs is false?

A) Programs are designed to evaluate effectiveness of blood bank laboratories.
B) Programs provide an occasional opportunity to expose new and different problems.
C) Compliance is synonymous with organization-wide quality assurance.
D) Compliance inspections are conducted every 1 to 2 years.

Question 10

All of the following are transfusion service quality assurance indicators used to monitor patient care except:

A) labeling errors on specimens sent to the blood bank.
B) reason for return of blood products.
C) number of therapeutic units drawn.
D) turnaround time on antibody identification.

Question 11

Employee training takes place:

A) before procedures are validated.
B) after competence assessments.
C) before flowcharting the process.
D) after hiring and after implementing new procedures.

Question 12

Which of the following is used to determine if reagents and equipment are functioning prior to testing?

A) Critical control points
B) Control charts
C) Quality assurance
D) Quality control

Question 13

Which of the following is an example of an external customer?

A) A night-shift medical technologist
B) A blood donor
C) An intravenous nurse
D) Housekeeping employee

Question 14

Which continuous improvement cycle component ensures the finished product has met required specifications?

A) Improve
B) Assess
C) Implement
D) Plan

Question 15

What department evaluates and certifies employee credentials and determines the literacy of the employee?

A) Human Resources
B) Laboratory
C) Administration
D) Education

Question 16

What phase is synonymous with "quality management"?

A) Good manufacturing practice
B) Organization-wide quality assurance
C) Process improvement team
D) Quality control

Question 17

Blood collected in a red-top tube and a lavender tube was sent through a tube system to the STAT laboratory. The blood specimens were not labeled with any type of patient identification. The medical technologist called the emergency room (ER) to notify them of the problem. The ER nurse stated she wanted the tubes sent back to the ER and that she would label them. The stat laboratory technologist related the laboratory's policy on unlabeled specimens, saying that they would be discarded. At that point the disgruntled nurse said she would write up a(n) for the laboratory's refusal to analyze blood on an emergency patient.

A) employee evaluation
B) incident report
C) patient report
D) flow chart

Question 18

What is a function of the quality committee or quality council?

A) To provide solutions to recurring clerical errors
B) To provide counseling for departmental downsizing
C) To set priorities for quality improvements
D) To focus on computer upgrades and software implementation

Question 19

Which of the following is not regarded as an instrument?

A) Automated analyzer
B) Pipette
C) Washer
D) Cuvette

Question 20

As part of postemployment departmental training, a medical technologist was given 10 known blood samples to analyze for ABO specificity. This is referred to as:

A) recertification.
B) a competence assessment.
C) education.
D) a proficiency test.