Assuring Quality in Laboratory Performance

1
Assuring Quality in Laboratory Performance

• Introduction
• Laboratory Quality Systems

2
Accurate, reliable lab testing essential to all
aspects of health care
3
Emphasis for CDC Global AIDS Program

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

4
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

5
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
6
Systems Approach

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

7
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

8
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

9
Steps in Development of Quality Systems Initiative

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

10
Framework

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

11
Organization of Training Materials

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

12
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

13
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 1980s, important management theory in
  industry and business
• W. Edwards Deming,14 points for quality
  improvement
• Joseph Juran, 85/15 rule

15
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

17
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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Other Sources for Standards

• NCCLS National Committee for Clinical
  Laboratory Standards
• National standards
• Organizational standards
• CLIA Clinical Laboratory Improvement Amendments

20
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)

21
Quality System

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

22
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)

23
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
25
Quality System
Quality Assurance
Quality Control
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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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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
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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

31
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