Introduction to quality systems Flashcards

1
Q

What is a standard?

A

a level of quality or attainment

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2
Q

Why are standards important?

A

Consistency in testing
High quality results
Cost effectiveness
Patient safety

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3
Q

Quality Standards used in Canada:

A

ISO (International Organization for Standardization) 9000 series– 15189; 2007

CLSI – Clinical and Laboratory Standards Institute

AABB – American Association of Blood Banks

CAP – College of American Pathologists

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4
Q

Most common hospital accreditation body in Canada:

A

Now includes: IQMH – Institute of Quality Management in Healthcare. Rebranded as Accreditation Canada Diagnostics

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5
Q

Quality Control

A

Operational process control techniques

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6
Q

Quality Assurance

A

Planned and systematic activates

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7
Q

Quality Management System

A

Systematic process-oriented approach to quality

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8
Q

Quality Cost Management

A

Measurement system economic aspect

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9
Q

Total Quality Management

A

Management approach centered on sustained high-quality

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10
Q

What is a Quality Management System?

A

A Quality Management System (QMS) can be described as a “set of essential building blocks needed for a laboratory’s work operations to fulfill stated quality objectives”

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11
Q

Quality documents

A

Policies, processes, procedures

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12
Q

Quality Manual

A

Describes what the QMS is and contains all polices that define the work and responsibilities

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13
Q

Path of workflow

A

Pre-examination/examination/post-examination

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14
Q

Policy

A

Statements of the organization’s intentions and/or commitments
Answers the question “What do we do?”
The compilation of the stated policies is the purpose of the Quality Manual

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15
Q

Process

A

List of activities required to accomplish the intent of the policy
Sequence of the events in order to obtain a successful outcome
Identifies who is responsible for each piece

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16
Q

Procedure:

A

Instructions on how to do an activity

17
Q

What is a Quality Manual?

A

Communication to personnel, customers and external assessors

Provides reference to the organization’s policies, processes and procedures

Defines how the organization functions and meets the identified requirements

Serves as a procedure manual for management

18
Q

What is thePath of Workflow?

A

The Path of workflow is made up of processes from three phases of workflow:
Pre-examination
Example of process: sample collection
Examination
Example of process: method selection
Post-examination
Example of process: final reports

19
Q

QSE: Organization and Leadership

A

Management Involvement – must have commitment/support from the top down

Quality Planning – mission, vision, policy development

Quality Manager – responsibility and authority to oversee compliance

Quality Steering Group – participate in and oversee implementation of the QMS

Communication Plan – useful in achieving internal and external communication of essential information

20
Q

QSE: Customer Focus

A

Identification of customer and user expectations
Capacity to meet customer expectations
Measuring customer and user satisfaction
Recording and managing complaints

21
Q

Document Management System:

A

Identification and control
New document review/approval process
Change processes
Review of documents
Storage and retention

22
Q

Record Management System:

A

Creation of records
Review/storage
Changes
Maintenance
Access
Retention
Disposal

23
Q

QSE: Personnel Management

A

Job Qualifications
Orientation
Training
Competency Assessment
Continuing Education
Performance evaluation

24
Q

QSE: Process Management

A

Analysis, design, documentation
Flowcharts or process maps
Procedures
Records
Process validation/verification
Process control
QC/Statistical Data
Change Management

25
Q

QSE: Assessments

A

Internal Assessments:
Quality Indicators
Internal audits
Quality audits
Benchmarking against internal sources

External Assessments:
Accreditation surveys
Proficiency testing
Benchmarking against external sources

26
Q

QSE: Continual Improvement

A

Participation in Quality Improvement activities:
Identifying opportunities for improvement
Preventative and Corrective Action
Problem Resolution Process - PDCA
Quality Improvement Tools
Periodic Reporting

27
Q

QSE: Nonconforming Event Management

A

Non-conforming event management
Investigation of non-conforming events
Classification, analysis and trending of data/information
Root cause analysis
Management review

28
Q

QSE: Information Management

A

Planning for information needs
Confidentiality of information
Security for data access
Integrity of data transfers/transmissions
Downtime procedures

29
Q

QSE: Equipment Management

A

Selection and Acquisition
Installation and Validation
Maintenance and Calibration
Troubleshooting, Service and Repair
Decommission and Disposition
Files/Records

30
Q

QSE: Supplier and Inventory Management

A

Selection based on requirements
Purchase of materials or services
Evaluations
Inspection/Verification
Storage
Inventory management
Identification/tracing materials and services

31
Q

QSE: Facilities and Safety Management

A

Facility design and modification
Space allocation
Facilities use and maintenance
Communication system

Safety programs
Biosafety/Fire prevention/ hazardous waste/Emergency management

32
Q

An overall Quality Policy includes (4 parts)

A

Information on the organization’s customer-focus intent
Management’s statement of the standard of service
Management’s commitment to compliance with all applicable requirements and standards
A commitment to good professional practice, quality services and compliance with QMS

33
Q

Cost of providing high quality:

A

Proficiency testing program
Accreditation fees
Running qc samples regularly
Infrastructure to support quality initiatives
Professional development andcontinuingeducation

34
Q

Costs associated with lack of quality:

A

Failure to produce quality results
Cost of running repeat samples – reagents. Consumables, staffing
Cost of misdiagnosis and mistreatment
Costs of poor workmanship – loss of reputation

35
Q

What is Ethics?

A

Doing good and not causing harm to the patients we serve

Issues that deal with moral conduct, duty, and personal judgment

CSMLS Code of Professional Conduct

36
Q

Areas of concern:

A

Collection of information from patients
Collection of samples
Performing tests
Reporting results
Storage and retention of records
Access to records
Use of samples
Financial information

37
Q
A