Quality Assurance

Question 1

What is the ultimate goal of overall management of quality processes and outcomes?

Answer 1

Customer satisfaction

This goal emphasizes the importance of delivering high-quality services to meet client needs.

Question 2

Define Quality Management.

Answer 2

Financial aspect of Quality

It includes managing resources and processes to ensure high-quality outcomes.

Question 3

What is a Quality system?

Answer 3

System to maintain and improve lab processes to meet quality goals

This system is crucial for achieving consistent quality in laboratory testing.

Question 4

What do Quality Assurance policies and procedures help fulfill?

Answer 4

Quality requirements

QA monitors QC data and seeks to improve processes.

Question 5

What does Quality Control ensure?

Answer 5

High quality test results

Regular operational activities are performed to maintain this quality.

Question 6

Why is Quality important in laboratory work?

Answer 6

Produces accurate, precise, reliable, and timely results

It reduces the risk of error, thereby minimizing harm to patients.

Question 7

What percentage of lab errors impact patient health?

Answer 7

12.5%

This statistic underscores the critical nature of quality management in healthcare.

Question 8

List some negative consequences of lab errors.

Answer 8

• Delay in correct diagnosis
• Unnecessary treatment
• Failure to provide proper treatment
• Additional testing

These consequences can lead to increased costs and poor patient outcomes.

Question 9

What can a quality management system be defined as?

Answer 9

Coordinated activities to direct and control an organization with regard to quality

This definition is based on standards set by ISO and CLSI.

Question 10

What are the components of a quality management system?

Answer 10

• Quality Planning
• Quality Control
• Quality Assessment
• Quality Improvement

These components work together to enhance laboratory performance.

Question 11

Where do the majority of lab errors occur in the workflow path?

Answer 11

Pre-Analytical (32-75%)

This stage includes patient and sample identification issues.

Question 12

What are some factors contributing to pre-analytical errors?

Answer 12

• Mismatched requisitions/tubes
• Wrong ID band on patient
• Wrong collection container or site
• Timing of collection
• Patient preparation issues

Attention to detail in these areas can help detect errors early.

Question 13

What are some errors we cannot control in pre-analytical processes?

Answer 13

• Age and gender
• Environment (altitude)
• Patient condition or disease
• Stress

These factors can affect test results but are beyond the laboratory’s control.

Question 14

What is the level of accuracy required in laboratory measurements?

Answer 14

As high as possible given limitations

Even a small error rate can lead to significant issues in laboratory testing.

Question 15

What is the definition of a policy in the context of a laboratory?

Answer 15

A written statement of overall intentions and directions endorsed by management

This includes regulations and laboratory requirements.

Question 16

Define Process in laboratory quality management.

Answer 16

Inter-related resources and/or activities that transform inputs into outputs

It involves multiple people and spans across time.

Question 17

What is a Procedure?

Answer 17

A specified way to perform an activity

It provides specific instructions for tasks and is usually performed by one person.

Question 18

Who plays a role in updating procedures?

Answer 18

Students or New Grads

Their fresh perspective can be valuable in improving protocols and reference materials.

Question 19

What is the focus of Lean Six Sigma methodology?

Answer 19

Process improvement as a means to meet a set standard.

Question 20

What does quality improvement aim to achieve?

Answer 20

New levels of performance not otherwise realized through quality control.

Question 21

What are the key factors for quality improvement?

Answer 21

• Culture: relentless pursuit of improvement toward excellence
• Infrastructure: coalition of senior members from organization
• Methodology: waste elimination and variation reduction
• Metric: LEAN and Six Sigma

Question 22

What does DMAIC stand for in quality management?

Answer 22

• Define
• Measure
• Analyze
• Improve
• Control

Question 23

What is the first step of the DMAIC methodology?

Answer 23

Define: end-users of services or products, their needs & expectations, project boundaries, process.

Question 24

What is the purpose of the Measure phase in DMAIC?

Answer 24

Collect data, determine defects, assess satisfaction.

Question 25

What does the Analyze phase of DMAIC involve?

Answer 25

Examine data to identify root causes of error.

Question 26

What is the goal of the Improve phase in DMAIC?

Answer 26

Fix problems and prevent future ones with creative solutions.

Question 27

What is the purpose of the Control phase in DMAIC?

Answer 27

Continuous monitoring of new plans.

Question 28

What does PDCA stand for in quality management?

Answer 28

* Plan * Do * Check * Act

Question 29

What is LEAN focused on?

Answer 29

Eliminating non-value-adding steps and reducing cycle time.

Question 30

What is Six Sigma focused on?

Answer 30

Reducing variation and error.

Question 31

True or False: Medical errors are less frequent than previously thought.

Answer 31

False.

Question 32

What are the basic tenets of Lean?

Answer 32

* Value: any action or process a customer would be willing to pay for * Minimum waste: eliminate anything that does not provide value * Customer Need: perform only what is needed * Employee Engagement: give the workers authority to make changes * Continuous Quality Improvement (CQI): continually improve, stop if something goes wrong.

Question 33

What are the potential types and forms of risk that could affect an organization?

Answer 33

Events ranging from minor disruptions to catastrophic events.

Question 34

What is the risk management process aimed at?

Answer 34

Continual improvement to lessen an organization's exposure to loss.

Question 35

What are the steps in identifying and analyzing risk?

Answer 35

* Analyze reported incidents * Conduct surveys * Perform audits/inspections * Look for holes in management system or processes * Run statistics of potential exposures common in organization.

Question 36

What actions may be initiated after identifying risk exposures?

Answer 36

* Find a way to avoid exposure * Find ways to reduce potential loss * Find ways to prevent occasion to occur * Segregate the loss of exposure * Transfer the risk (contractual arrangement).

Question 37

What can lead to potential liability from legal action?

Answer 37

* Actions arising from alleged product failures * End users misuse of product * Inappropriate actions of employees * Alleged health, safety and security violations or negligence.

Question 38

What are the 12 Quality System Essentials (QSEs)?

Answer 38

* Organization * Customer focus * Facilities and Safety * Personnel * Purchasing and Inventory * Equipment * Process Management * Documents and Records * Information Management * Non conforming Event Management * Assessments * Continual Improvement

Question 39

What does the 'Customer Focus' QSE describe?

Answer 39

Laboratory’s identification of its customers and their expectations.

Question 40

What is the significance of 'Personnel' in QSEs?

Answer 40

Obtaining and retaining adequate number of well trained and competent lab staff.

Question 41

What does the 'Equipment' QSE entail?

Answer 41

Selection and installation of equipment, maintenance, calibration, problems to ensure equipment performs as expected.

Question 42

What is described in the 'Process Management' QSE?

Answer 42

Laboratory’s path of workflow to optimize effectiveness and efficiency.

Question 43

What does the 'Documents and Records' QSE cover?

Answer 43

Creation, management, and retention policy for QSE and workflow.

Question 44

What is the focus of the 'Continual Improvement' QSE?

Answer 44

Mechanisms for identifying opportunities for improvement and a strategy for continual improvement.

Question 45

Fill in the blank: The process for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) forms a vital part of the ______.

Answer 45

[quality assurance system]