Assuring Quality in Laboratory Performance Introduction Laboratory Quality Systems

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					Assuring Quality in Laboratory Performance
Introduction Laboratory Quality Systems

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

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Emphasis for CDC Global AIDS Program
• • • • •

Surveillance Prevention activities – VCT, MTCT Care and treatment Blood safety Opportunistic infections – STI, TB

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Achieving high performance of laboratories
• Lab assessment in GAP-supported countries

indicates quality assurance deficits • Many GAP-supported countries have begun efforts to improve quality assurance programs • Requests for training and assistance often focus on quality assurance issues

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The Quality Assurance Cycle

Patient/Client Prep Sample Collection Reporting •Data and Lab Management •Safety •Customer Service Personnel Competency Test Evaluations

Sample Receipt and Accessioning

Record Keeping

Quality Control
Testing

Sample Transport

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Systems Approach
• Ensure quality of overall process • Detect and reduce errors • Improve consistency within and between

laboratories • Contain costs

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GAP Laboratory Quality Systems Initiative
• Encourage all GAP countries to use quality

system concept • Provide assistance in development of national quality systems • Provide training materials for use locally • Provide long-term technical 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 national 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 process

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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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Organization of Training Materials
• Modular • Designed for use by local staff • Includes facilitator’s guide, content outline,

PowerPoint presentation, exercises, supplementary materials, references

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Timeline
• First workshop, 17 African countries invited:

Botswana, July 28 – August 1 • Initial training modules in preparation • Workshop for Asian GAP countries: 2004 • On-going activities – long-term project

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Quality….
• • • • • •

Quality Assurance Quality Control Quality Improvement Quality Indicators Quality System Quality Management
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Total Quality Management
• First described Feigenbaum in 1957 • Since 1980’s, important management theory

in industry and business • W. Edwards Deming,14 points for quality improvement • Joseph Juran, 85/15 rule

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TQM Philosophy
• Derived from earlier concepts of:

Quality control – applies statistical methods to monitor specific service outcomes Quality assurance – applies a framework for establishing quality standards

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TQM Definition
• Not limited to standard setting and quality • •

• •

control Is concerned with all aspects of organizational management, continuous effort Concentrates on processes as well as products Centered on quality, long-term success User satisfaction a priority
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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 9001:1994 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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Other Sources for Standards
• NCCLS – National Committee for Clinical

Laboratory Standards • National standards • Organizational standards • CLIA – Clinical Laboratory Improvement Amendments

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Quality Management
• All activities of the overall management

function that determine quality policy objectives, implement them by means such as quality planning, quality control, quality assurance, and quality improvement within the system (NCCLS)

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Quality System
• Organizational structure, resources,

processes and procedures needed to implement quality management (ISO, NCCLS)

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Quality Assurance
• Planned and systematic activities to provide

adequate confidence that requirements for quality will be met (ISO)

• Includes IQC, EQA, pre-analytic phase, test

standardization, post-analytic phase, management, and organization (WHO, 1992)
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Quality Control
• 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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Stages of Quality - Hierarchy

QUALITY MANAGEMENT

QUALITY SYSTEM
QUALITY ASSURANCE QUALITY CONTROL

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Quality System
Quality Assurance

Quality Control

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The Quality Assurance Cycle

Patient/Client Prep Sample Collection Reporting •Data and Lab Management •Safety •Customer Service Personnel Competency Test Evaluations

Sample Receipt and Accessioning

Record Keeping

Quality Control
Testing

Sample Transport

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Quality System Essentials
• NCCLS : Quality System Model for Health

Care (HS1-A) • NCCLS: Application of a Quality System Model for Laboratory Services (GP26-A2) • Model uses 12 essentials, based on the 20 quality system elements in ISO 9001 • Simplifies, uses language more familiar to laboratories
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Comparison: NCCLS Quality System Model to ISO 9001
Quality System Model * Quality System Essentials
Organization 4.1 4.2 4.3 4.18 4.11 4.6 4.7 4.4 4.8 4.9 4.10 4.12 4.15 4.20 4.5 4.16 4.13 4.17 4.14 4.19

ISO 9001H Clauses
Management responsibility Quality system Contract review Training Control of inspection, measuring, and test equipment Purchasing Control of customer-supplied product Design control Product identification and traceability Process control Inspection and testing Inspection and test status Handling, storage, packaging, preservation and delivery Statistical techniques Document and data control Control of quality records Control of nonconforming product Internal quality audits Corrective and preventive action Servicing

Personnel Equipment Purchasing and Inventory Process Control (includes process validation, quality control, proficiency testing, process control, facilities, and safety)

Documents and Records Occurrence Management Internal Assessment Process Improvement Service and Satisfaction

* NCCLS. Quality System Model for Health Care; Proposed Guideline, Document GP26-A. Wayne, PA: NCCLS, 1999. ? ISO. ISO 9001. Quality systems ? model for quality assurance in design, development, production, installation and servicing. ISO Standards Compendium, 6th ed. Geneva, Switzerland: International Organization for Standardization, 1996.

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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, 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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