Transcript Introduction To The COLA Quality Management Systems Program

The COLA Quality Management Systems Program
Introduction
COLA
Quality Management Systems
Program
An ISO 15189:2003 Accreditation Program
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Global community standards
• We are all part of a global economy
• Standards and management of quality
apply world-wide
• International & domestic operations to
achieve and maintain accepted levels
of quality
• Uniform standards across borders with
a minimum of confusion and concern
over quality
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ISO: International Organization for Standardization
A world-wide federation of national
standards bodies using ISO technical
committees
• Define standards for quality management
systems
• ISO 9000 series = fundamentals and
vocabulary
• ISO 9000:2000 = requirements for QMS
• Origins in manufacturing organizations with
manufacturing terminology
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ISO: Growth from manufacturing to medical
Medicine realized the
advantages of applying
quality management system
practices to laboratory
operations
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ISO: Growth from manufacturing to medical
ISO technical committee sought to
1. Standardize & interpret the ISO 9000 into
language more familiar to healthcare
organizations
2. Retain the core essence of the ISO 9000 quality
principles
ISO 15189:2003: Particular Requirements
for Quality and Competence in Medical
Laboratories
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Quality System Essentials
Foundation of the COLA QMS
accreditation program is the concept of
Quality System Essentials (QSE)
• Essential components of quality
• Defines all aspects of the laboratory
operation
• Basis of compliance with regulations
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Quality System Essentials
• QSEs are the “Infrastructure for Quality
Management’s Procedure Manual”
• Management sets policies and designs
processes for each QSE
• Both management and staff follow
procedures in the QSEs
• QSEs are everyone’s responsibilities
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The 12 Quality System Essentials
• Organization
• Facilities and Safety
• Process Control • Purchasing & Inventory
• Personnel
• Occurrence Management
• Assessments
• Information Management
• Equipment
• Customer Satisfaction &
Service
• Documents &
Records
• Process Improvement
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Workflow Analysis: Path of Workflow
• Operational aspect defines how a
particular service or product is provided
• Sequence of activities from the initiation
of a request through the provision of
laboratory products or services
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CLSI GP26
Preanalytic
Analytic
Postanalytic
Test Ordering Specimen Collection Transport Receipt/Processing
Testing Results Review and Follow-Up Interpretation
Result Reporting and Archiving  Specimen Management
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Quality Management System: Laboratory Model
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The COLA QMS Accreditation Program: Epilogue
Goals of QMS Accreditation Program
• Built-in standards of quality
• Continuous systems for quality
assessment, improvement, and feedback
• Maintenance of Quality Standards
Resulting in
• Enhances patient care
• Integrated Incident Management
• Optimized operational efficiency
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