Deck 25: Quality Management

Question 1

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.

Answer 1

B

Question 2

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.

Answer 2

D

Question 3

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.

Answer 3

C

Question 4

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 5

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 6

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 7

Why might a laboratory adopt an individualized quality control plan (IQCP)?

A) To customize its QC program to its specific needs
B) To demonstrate where costs can be saved
C) To eliminate the need to perform daily quality control
D) To do all of these

Question 8

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 9

What phase is synonymous with "quality management?"

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

Question 10

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.

Question 11

Which of the following is not regarded as an instrument?

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

Question 12

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 13

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

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

Question 14

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 15

Calibrating equipment prior to use is considered which function of quality?

A) Quality assurance
B) Quality control
C) Quality improvement
D) Quality management

Question 16

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 17

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 18

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

Question 19

When a new shipment of reagents is received, 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

Question 20

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 21

Which of these should be evaluated during a risk assessment?

A) Airflow/ventilation
B) Competency of testing personnel
C) Equipment functioning
D) All of these

Question 22

Which of these is part of process control?

A) Performing routine QC of test methods and reagents
B) Performing proficiency testing and personnel competency checks
C) Using a manual or automated action to prevent the occurrence of errors
D) All of these.

Question 23

Which of these does NOT describe a flowchart?

A) Can be created on paper or with commercially available software programs
B) Displays actions required in a process using graphic symbols for ease of understanding
C) Is useless in obtaining better control of a process.
D) Shows where decision points are located within a process

Question 24

Copies of regulations and accreditation requirements are examples of:

A) documents.
B) forms.
C) results.
D) none of these.

Question 25

Which of these records may be reviewed during competency assessment for blood bank personnel?

A) Quality control records
B) Proficiency testing results
C) Maintenance records
D) All of these

Question 26

An outcomes of performing procedures and testing is called a:

A) document.
B) form.
C) result.
D) none of these.

Question 27

The use of different colored sera for blood bank reagents is an example of:

A) process control.
B) quality control.
C) standard operating procedures.
D) validation studies.

Question 28

Competency assessment for blood bank personnel includes all of these EXCEPT:

A) direct observation of patient test performance.
B) cross-training into other areas of the laboratory.
C) monitoring the recording and reporting of test results.
D) review of test results or worksheets.

Question 29

Daily testing the reactivity of blood typing reagents is considered which function of quality?

A) Quality assurance
B) Quality control
C) Quality improvement
D) Quality management

Question 30

Which of the following relationships is NOT considered a quality essential of an organization?

A) Blood bank personnel links to their families
B) Blood bank's link to the laboratory
C) Blood bank's link to the hospital.
D) Blood bank links to the hospital's quality function

Question 31

Which of the following is NOT an internal customer for the transfusion service?

A) Nurse administering blood products
B) Patient receiving blood products
C) Nursing assistant transporting blood products
D) Physician ordering blood products

Question 32

Laboratory safety training must include which of these for blood bank personnel?

A) Chemical hygiene
B) Emergency preparedness
C) Radiation safety
D) All of these

Question 33

Which of the following provides a framework for applying quality principles and practices in the blood bank?

A) Quality assurance program
B) Quality control and correction
C) Quality improvement process
D) Quality management system

Question 34

Testing all activities in a new process to ensure that the process will work in the live environment is a function of:

A) quality control.
B) standard operating procedures.
C) validation studies.
D) none of these.

Question 35

Which of these need NOT be evaluated during a risk assessment?

A) Patient opinion survey
B) Reagent storage conditions
C) Specimen labeling
D) Transmission of data to LIS

Question 36

What is a flowchart?

A) A tool that displays all the elements involved in a process
B) A tool that allows for greater understanding of specific steps in a process
C) A tool that explains the sequence of activities in a process in paragraph for
D) All of these.

Question 37

A quality framework in the blood bank ensures all of the following EXCEPT:

A) Application of quality principles and practices.
B) Blood bank operations are customized to individual staff preferences.
C) Compliance with regulatory body requirements
D) Review of each step from donor selection through transfusion outcomes.

Question 38

What is the purpose of a flowchart?

A) Facilitates understanding of resources when planning a new process
B) Reveals problems (i.e., missing actions) in a current process
C) Shows how process inputs are converted into outputs
D) All of these

Question 39

Which of the following is not part of an individualized quality control plan (IQCP)?

A) New instrument validation
B) Quality control plan
C) Quality assessment
D) Risk assessment

Question 40

Quality assessment monitors include reviews of all of these EXCEPT:

A) Corrected report communications.
B) Personnel competency records.
C) Turnaround time reports.
D) Vendor selection process.

Question 41

The cost incurred for proficiency testing and periodic licensure or accreditation inspections is what type of cost?

A) Internal evaluation costs
B) External evaluation costs
C) Internal failure costs
D) External failure costs

Question 42

The cost incurred with customer product recalls is an example of what type of cost?

A) Internal evaluation costs
B) External evaluation costs
C) Internal failure costs
D) External failure costs

Question 43

Examples of documents include:

A) written policies, procedures and instructions.
B) process flowcharts and forms.
C) manufacturers' package inserts and operator manuals.
D) all of these.

Question 44

The cost incurred when discarding donated blood units is an example of what type of cost?

A) Internal evaluation costs
B) External evaluation costs
C) Internal failure costs
D) External failure costs

Question 45

52, Using the DOE tool occurs at what stage of the DMAIC process?

A) Analyze
B) Control
C) Define
D) Improve

Question 46

An action taken to reduce or eliminate the potential for a nonconformance is what type of action?

A) Corrective
B) Disciplinary
C) Preventive
D) Remedial

Question 47

Which of the following statements is true?

A) Remedial action occurs over time.
B) Remedial action does not uncover the real cause of the nonconformance.
C) Remedial action does not require further investigation.
D) All of these are true.

Question 48

The cost of good quality (COGQ) does NOT include which of these?

A) Appraisal costs
B) Conformance costs
C) Nonconformance costs
D) Prevention costs

Question 49

The process of define, measure, analyze, improve, and control (DMAIC) is known as which process?

A) IOS System
B) FQM System
C) LEAN
D) Six Sigma

Question 50

Conformance costs may include:

A) preventive maintenance.
B) quality management activities.
C) validation activities.
D) all of these.

Question 51

Ensuring that the implemented changes are sustained occurs at what stage of the DMAIC process?

A) Analyze
B) Control
C) Define
D) Improve

Question 52

Understanding the cause and effect relationships occurs at what stage of the DMAIC process?

A) Analyze
B) Control
C) Define
D) Improve

Question 53

A Pareto chart is used at what stage of the DMAIC process?

A) Analyze
B) Control
C) Define
D) Measure

Question 54

An action taken to identify and eliminate the cause of a nonconformance is what type of action?

A) Corrective
B) Disciplinary
C) Preventive
D) Remedial

Question 55

Using a SIPOC diagram occurs at what stage of the DMAIC process?

A) Analyze
B) Control
C) Define
D) Measure

Question 56

Which of these costs is a cost of poor quality (COPQ)?

A) Appraisal costs
B) Conformance costs
C) Nonconformance costs
D) Prevention costs

Question 57

Examples of forms include:

A) instrument printouts.
B) manual or electronic worksheets.
C) tags, stickers, or labels.
D) all of these.

Question 58

A good document control process does all of these EXCEPT:

A) eliminates the need to document all changes or corrections to procedures.
B) ensures that only the latest approved copies of documents are available for use.
C) links a facility's policies, processes, and procedures to each other.
D) notifies appropriate parties of the change and document the notification.

Question 59

The cost incurred for calibration materials and reagents is an example of what type of cost?

A) Internal evaluation costs
B) External evaluation costs
C) Internal failure costs
D) External failure costs

Question 60

An error has occurred during a test procedure, which was found to be caused by the technologist using a copy of the procedure that was being used at the time of her training. What should be put in place to ensure this type of mistake is not made again.

A) Corrective disciplinary action
B) Document control process
C) Instrument validation
D) Quality control checks

Question 61

Both the blood bank and the entire medical laboratory use which of the following?

A) Quality management systems
B) Continuous improvement systems
C) Essentials quality indicators
D) All of these