Laboratory Quality Systems Assuring Quality in Laboratory Performance

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Laboratory Quality SystemsAssuring Quality in
Laboratory Performance

• Introduction and Overview
• John Elliot

WHO Collaborating Centre
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Laboratory Testing Impacts Nearly Everyone

• Accurate, reliable lab testing is essential to
  all aspects of health care

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How do we achieve QUALITY excellent performance
in the laboratory?
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QUALITY is ACHIEVED BY

• Determining the customers precise requirements
• Ensuring that all resources, facilities and
  skills required to meet the customers
  requirements are available
• Planning, documenting and implementing management
  procedures to ensure that the customers
  requirements are met consistently
• Ensuring that staff are trained and provided with
  the resources to do the job right the first time

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QUALITY is ACHIEVED BY cont

• Ensuring that all activities are undertaken
  correctly
• Ensuring that when things go wrong, effective
  corrective action is taken to avoid repetition of
  errors
• Undertaking regular reviews and audits of all
  processes
• Total and organised commitment from management

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QUALITY MANAGEMENT SYSTEMOverview


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QUALITY MANAGEMENT SYSTEMPreanalytical

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QUALITY MANAGEMENT SYSTEMAnalytical

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QUALITY MANAGEMENT SYSTEMPostanalytical

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The Quality Assurance Cycle
Pre-Analytic
Patient/Client Prep Sample Collection
Personnel Competency Test Evaluations
Reporting

• Data and Lab Management
• Safety
• Customer Service

Post-Analytic
Sample Receipt and Accessioning
Record Keeping
Sample Transport
Quality Control Testing
Analytic
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Advantages of a Systems Approach

• Ensure quality of overall process
• Detect and reduce errors
• Improve consistency within and between
  laboratories
• Contain costs

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A Systems Approach to Quality

• Considers all components within a system
• Identifies the connection and relationship
  (e.g., cause and effect) among the components

Example the human body system A headache may be
caused by disorder of other components in the
system
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AAPI Laboratory Quality Systems Initiative

• Encourage all AAPI laboratories to use quality
  system concept
• Provide training and materials for use locally
• Provide technical assistance and support for
  quality system development and implementation

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Steps in Development of Quality Systems Initiative

• Develop framework for common approach
• Training materials CDC/APHL workgroup
• Workshops
• Present framework
• Provide information on training
• Encourage development and implementation of
  quality systems plan

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Steps in Development of Quality Systems Initiative

• Train the trainer
• Continued technical support for all elements
• Long-term, sustainable process

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Organization of Training Materials

• Modular
• Designed for use by local staff
• Includes facilitators guide, content outline,
  PowerPoint presentation, exercises, supplementary
  materials, references

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Framework

• Common definitions
• Importance of ISO philosophy
• Aim for simplicity
• Emphasis on performance, not process
• Convey importance of systems approach

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ISO 9000 Family

• International Organization for Standardization
• Guidance for quality in manufacturing and service
  industries
• Has broad applicability, many kinds of
  organizations can use

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ISO Documents - Laboratory

• ISO 90011994 Quality Systems Model for QA in
  design, development production, installation, and
  servicing
• ISO/FDIS 15189 Quality management in the
  clinical laboratory (1998)
• ISO/IEC 17025 General requirements for the
  competence of testing and calibration labs (1998)

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NCCLS A Quality System Model for Health Care
(HS 1-A)

• Lays out quality system model
• Has applicability to all health care systems,
  including laboratory
• Describes 12 quality system essentials
• Applies quality design consistent with ISO 9000
  series

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NCCLS Quality System Model for Laboratory
Services (GP 26-A2)

• Laboratory application document for quality
  system
• Provides how-to, examples
• Assists lab in improving processes
• Describes path of workflow
• Relates to HS1-A

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Comparison NCCLS Quality System Model to ISO
9001
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Quality System Definition

• Organizational structure, resources, policies,
  processes and procedures needed to implement
  quality management
• (ISO, NCCLS)

In other words all activities which contribute
to quality of testing, directly or indirectly.
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QUALITY ASSURANCEDEFINITION

• All planned and systematic actions necessary to
  provide adequate confidence that goods or
  services will satisfy the customers needs.

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QUALITY ASSURANCEanother definition

• The right result, at the
• Right time, on the
• Right specimen, from the
• Right patient, with result interpretation
  based on
• Correct reference data, and at the
• Right price

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EXTERNAL QUALITY ASSESSMENT (EQA)

• EQA REFERS TO A SYSTEM IN WHICH THE PERFORMANCE
  OF A LABORATORY IS ASSESSED
• PERIODICALLY AND RETROSPECITIVELY
• BY AN INDEPENDENT OUTSIDE AGENCY TO INDICATE TO
  THE LABORATORY STAFF WHERE THERE MAY BE
  SHORTCOMINGS AND HENCE INDICATES A NEED FOR
  IMPROVING AND/OR CHANGING IQC PROCEDURES.

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Quality Control Definitions

• Operational techniques and activities used to
  fulfill requirements for quality (ISO)
• Internal quality control (IQC) set of
  procedures for continuously assessing laboratory
  work and the emergent results immediate effect,
  should actually control release of results (WHO,
  1981)

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INTERNAL QUALITY CONTROL (IQC)

• IQC REFERS TO THE SET OF PROCEDURES UNDERTAKEN BY
  THE LABORATORY STAFF FOR THE
• CONTINUOUS AND IMMEDIATE
• MONITORING OF LABORATORY WORK IN ORDER TO DECIDE
  WHETHER THE RESULTS ARE RELIABLE ENOUGH TO BE
  RELEASED.

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Quality System
Quality Assurance
Quality Control
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IMPLEMENTATION of the QUALITY SYSTEM

• Planning what is to be done
• Documenting the plan
• Implementing the plan
• Periodically auditing procedures to ensure the
  plan is still working and being used
• Reviewing the plan periodically to confirm its
  continuing effectiveness

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QUALITY SYSTEM MANUAL
what to do
Policies
how it happens
Processes
how to do it - (SOPs)
Procedures
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IF IT IS NOT WRITTEN DOWN IT DID NOT HAPPEN!!!
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Quality System Essentials

• Organization
• Management responsibility
• Personnel
• Training and competency assessment
• Equipment
• Installation and maintenance, calibration
• Purchasing and inventory

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Quality System Essentials

• Process control
• Validation/verification, quality control,
  proficiency testing, specimen management
• Information management
• Documents and records
• Occurrence Management
• Document and take corrective action

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Quality System Essentials

• Internal assessment
• Process improvement
• Revise process based on information gathered
• Service and satisfaction
• Health care providers, patients
• Facilities and Safety
• Design for proper flow and ergonomics
• Safety of staff, others, environment

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Organization

• Support from the top level of the organization
• Involve all persons in the organization
• Conform with any regulatory requirements

Quality policy standards
Sufficient resources
A culture committed to quality
Clearly defined responsibility accountability
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Personnel
Retention
Human resource planning
Hiring
Performance management
Training
Supervision
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Equipment Management
Selection
Acquisition
Installation initial calibration
Maintenance, service repair
Troubleshooting
Disposition
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Purchasing and Inventory
Procurement
Receiving
Storage
Inventory management
Record keeping
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Process Control
Standard operating procedures
Specimen management
External Quality Assessment
Quality control
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Information Management
Information flow
Data collection management
Computer skills
Patient privacy confidentiality
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Documents and Records
Standardized forms
Document distribution
Document approval
Document storage/retrieval
Document destruction
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Occurrence Management
Written procedures for addressing errors
Corrective actions
Occurrence records
Occurrence reporting
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Assessment
Internal audit or self evaluation
External evaluation
Improvement measures
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Process Improvement
On-going data collection
Improvement measures
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Service and Satisfaction
Monitoring Customer satisfaction
Process improvement
Rewards
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Facilities and Safety
Testing and storage areas
Safety practice
Safety procedures records
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WHO IS RESPONSIBLE FOR QUALITY?
To be responsible for Quality in YOUR LABORATORY
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• LABORATORY MANAGEMENT MUST COMMIT TO MEETING
  QUALITY NEEDS, ESTABLISH POLICIES, PROCESSES AND
  PROCEDURES
• EVERY STAFF MEMBER IS RESPONSIBLE FOR THE QUALITY
  OF THEIR WORK.
• EVERY STAFF MEMBER MUST BE AWARE OF THE QUALITY
  OBJECTIVES AND POLICIES OF THE LABORATORY

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Sources of Laboratory QS Guidance and Information

• World Health Organization (WHO)
• International Organization for Standardization
  (ISO)
• NCCLS
• CDC guidelines
• Professional accrediting organizations
• National standards regulations