Introduction to quality systems

Question 1

What is a standard?

Answer 1

a level of quality or attainment

Question 2

Why are standards important?

Answer 2

Consistency in testing
High quality results
Cost effectiveness
Patient safety

Question 3

Quality Standards used in Canada:

Answer 3

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

Question 4

Most common hospital accreditation body in Canada:

Answer 4

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

Question 5

Quality Control

Answer 5

Operational process control techniques

Question 6

Quality Assurance

Answer 6

Planned and systematic activates

Question 7

Quality Management System

Answer 7

Systematic process-oriented approach to quality

Question 8

Quality Cost Management

Answer 8

Measurement system economic aspect

Question 9

Total Quality Management

Answer 9

Management approach centered on sustained high-quality

Question 10

What is a Quality Management System?

Answer 10

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”

Question 11

Quality documents

Answer 11

Policies, processes, procedures

Question 12

Quality Manual

Answer 12

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

Question 13

Path of workflow

Answer 13

Pre-examination/examination/post-examination

Question 14

Policy

Answer 14

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

Question 15

Process

Answer 15

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

Question 16

Procedure:

Answer 16

Instructions on how to do an activity

Question 17

What is a Quality Manual?

Answer 17

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

Question 18

What is thePath of Workflow?

Answer 18

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

Question 19

QSE: Organization and Leadership

Answer 19

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

Question 20

QSE: Customer Focus

Answer 20

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

Question 21

Document Management System:

Answer 21

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

Question 22

Record Management System:

Answer 22

Creation of records
Review/storage
Changes
Maintenance
Access
Retention
Disposal

Question 23

QSE: Personnel Management

Answer 23

Job Qualifications
Orientation
Training
Competency Assessment
Continuing Education
Performance evaluation

Question 24

QSE: Process Management

Answer 24

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

Question 25

QSE: Assessments

Answer 25

Internal Assessments: Quality Indicators Internal audits Quality audits Benchmarking against internal sources External Assessments: Accreditation surveys Proficiency testing Benchmarking against external sources

Question 26

QSE: Continual Improvement

Answer 26

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

Question 27

QSE: Nonconforming Event Management

Answer 27

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

Question 28

QSE: Information Management

Answer 28

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

Question 29

QSE: Equipment Management

Answer 29

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

Question 30

QSE: Supplier and Inventory Management

Answer 30

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

Question 31

QSE: Facilities and Safety Management

Answer 31

Facility design and modification Space allocation Facilities use and maintenance Communication system Safety programs Biosafety/Fire prevention/ hazardous waste/Emergency management

Question 32

An overall Quality Policy includes (4 parts)

Answer 32

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

Question 33

Cost of providing high quality:

Answer 33

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

Question 34

Costs associated with lack of quality:

Answer 34

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

Question 35

What is Ethics?

Answer 35

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

Question 36

Areas of concern:

Answer 36

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