Module 1-QS Overview

Laboratory Quality Systems
Assuring Quality in Laboratory Performance

Introduction and Overview
John Elliot
WHO Collaborating Centre
PPTC, Wellington, NZ
Laboratory Testing Impacts Nearly Everyone
Infant
Child
Teen
Adult
Senior
Accurate, reliable lab testing is essential to all aspects of health care

How do we achieve QUALITY [excellent] performance in the laboratory?
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
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
QUALITY MANAGEMENT SYSTEM

Overview

Preanalytical

Analytical

Postanalytical
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
Advantages of a Systems Approach

Ensure quality of overall process Detect and reduce errors Improve consistency within and between laboratories Contain costs
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
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
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
Steps in Development of Quality Systems Initiative

Train the trainer
Continued technical support for all elements

Long-term, sustainable process
Organization of Training Materials

Modular
Designed for use by local staff Includes facilitators guide, content outline, PowerPoint presentation, exercises, supplementary materials, references
Framework
Common definitions Importance of ISO philosophy Aim for simplicity Emphasis on performance, not process Convey importance of systems approach
ISO 9000 Family

International Organization for Standardization Guidance for quality in manufacturing and service industries Has broad applicability, many kinds of organizations can use
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)
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
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
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.PPTC, Wellington, NZ
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.
QUALITY ASSURANCE
DEFINITION
All planned and systematic actions necessary to provide adequate confidence that goods or services will satisfy the customers needs.
QUALITY ASSURANCE
another definition
at the on the from the with result interpretation based on Correct reference data, and at the Right price
The right result, Right time, Right specimen, Right patient,
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.
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)
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.
Quality System
Quality Assurance
Quality Control
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
QUALITY SYSTEM MANUAL

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

1.
Organization
Management responsibility
2.
Personnel
Training and competency assessment
3.
Equipment
Installation and maintenance, calibration
4.
Purchasing and inventory

5.
Process control
Validation/verification, quality control, proficiency testing, specimen management
6.
7. 8.
Information management
Documents and records Occurrence Management
Document and take corrective action

9. Internal assessment
Revise process based on information gathered
10. Process improvement
11. Service and satisfaction

Health care providers, patients
12. Facilities and Safety

Design for proper flow and ergonomics Safety of staff, others, environment
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
Clearly defined responsibility & accountability
A culture committed to quality

Personnel
Human resource planning Hiring Retention
Training
Supervision
Performance management
Equipment Management
Selection Acquisition Installation & initial calibration
Maintenance, service & repair
Troubleshooting
Disposition
Purchasing and Inventory

Procurement Receiving Storage
Inventory management
Record keeping
Process Control
Standard operating procedures Specimen management
Quality control
External Quality Assessment
Information Management
Information flow Data collection & management
Patient privacy & confidentiality
Computer skills
Documents and Records

Standardized forms Document approval Document distribution
Document storage/retrieval
Document destruction
Occurrence Management
Written procedures for addressing errors Corrective actions
Occurrence records
Occurrence reporting
Assessment
Internal audit or self evaluation External evaluation
Improvement measures
Process Improvement
On-going data collection Improvement measures
Service and Satisfaction

Monitoring Customer satisfaction Process improvement
Rewards
Facilities and Safety

Testing and storage areas Safety practice
Safety procedures & records
WHO IS RESPONSIBLE FOR QUALITY?
To be responsible for Quality in YOUR LABORATORY
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
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

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Laboratory Quality Systems

Assuring Quality in Laboratory Performance

Laboratory Testing Impacts Nearly Everyone

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

How do we achieve QUALITY [excellent] performance in the laboratory?

QUALITY is ACHIEVED BY:

QUALITY is ACHIEVED BY: [cont]

QUALITY MANAGEMENT SYSTEM

QUALITY MANAGEMENT SYSTEM

QUALITY MANAGEMENT SYSTEM

QUALITY MANAGEMENT SYSTEM

The Quality Assurance Cycle

Sample Receipt and Accessioning

Record Keeping Quality Control Testing Sample Transport

Advantages of a Systems Approach

A Systems Approach to Quality

AAPI Laboratory Quality Systems Initiative

Provide training and materials for use locally

Steps in Development of Quality Systems Initiative

Steps in Development of Quality Systems Initiative

Continued technical support for all elements

Organization of Training Materials

ISO 9000 Family

ISO Documents - Laboratory

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

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

Comparison: NCCLS Quality System Model to ISO 9001

ISO 9001H Clauses

Quality System Definition

The right result, Right time, Right specimen, Right patient,

EXTERNAL QUALITY ASSESSMENT (EQA)

PERIODICALLY AND RETROSPECITIVELY

Quality Control Definitions

INTERNAL QUALITY CONTROL (IQC)

CONTINUOUS AND IMMEDIATE

IMPLEMENTATION of the QUALITY SYSTEM

QUALITY SYSTEM MANUAL

IF IT IS NOT WRITTEN DOWN IT DID NOT HAPPEN!!!

Quality System Essentials

Purchasing and inventory

Quality System Essentials

Quality System Essentials

10. Process improvement

11. Service and satisfaction

12. Facilities and Safety

Clearly defined responsibility & accountability

A culture committed to quality

Maintenance, service & repair

Purchasing and Inventory

External Quality Assessment

Patient privacy & confidentiality

Documents and Records

Service and Satisfaction

Facilities and Safety

Safety procedures & records

WHO IS RESPONSIBLE FOR QUALITY?

To be responsible for Quality in YOUR LABORATORY

Sources of Laboratory QS Guidance and Information

Professional & accrediting organizations

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