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PPTC, Wellington, NZ
Laboratory Quality SystemsLaboratory Quality SystemsAssuring Quality in Assuring Quality in
Laboratory PerformanceLaboratory Performance
Introduction and Overview
John ElliotWHO Collaborating Centre
PPTC, Wellington, NZ
Laboratory Testing Laboratory Testing Impacts Nearly EveryoneImpacts Nearly Everyone
Accurate, reliable lab testing is essential to all aspects of health care
InfantInfantInfantInfant ChildChildChildChild TeenTeenTeenTeen AdultAdultAdultAdult SeniorSeniorSeniorSenior
PPTC, Wellington, NZ
How do we achieve QUALITY [excellent] performance in the
laboratory?
PPTC, Wellington, NZ
QUALITY is ACHIEVED BY:
• Determining the customer’s precise requirements
• Ensuring that all resources, facilities and skills required to meet the customer’s requirements are available
• Planning, documenting and implementing management procedures to ensure that the customer’s requirements are met consistently
• Ensuring that staff are trained and provided with the resources to do the job right the first time
PPTC, Wellington, NZ
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
PPTC, Wellington, NZ
PPTC, Wellington, NZ
QUALITY MANAGEMENT SYSTEM
Overview
PPTC, Wellington, NZ
QUALITY MANAGEMENT SYSTEM
Preanalytical
PPTC, Wellington, NZ
QUALITY MANAGEMENT SYSTEM
Analytical
PPTC, Wellington, NZ
QUALITY MANAGEMENT SYSTEM
Postanalytical
PPTC, Wellington, NZ
The Quality Assurance Cycle
•Data and Lab Management•Safety•Customer Service
Patient/Client PrepSample Collection
Sample Receipt and Accessioning
Sample TransportQuality Control
Testing
RecordKeeping
ReportingPersonnel CompetencyTest Evaluations
PPTC, Wellington, NZ
Advantages of a Systems Approach
• Ensure quality of overall process
• Detect and reduce errors
• Improve consistency within and between laboratories
• Contain costs
PPTC, Wellington, NZ
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 systemA headache may be caused by disorder of other components in the system
PPTC, Wellington, NZ
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
PPTC, Wellington, NZ
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
PPTC, Wellington, NZ
Steps in Development of Quality Systems Initiative
• Train the trainer
• Continued technical support for all elements
• Long-term, sustainable process
PPTC, Wellington, NZ
Organization of Training Materials
• Modular
• Designed for use by local staff
• Includes facilitator’s guide, content outline, PowerPoint presentation, exercises, supplementary materials, references
PPTC, Wellington, NZ
Framework
• Common definitions
• Importance of ISO philosophy
• Aim for simplicity
• Emphasis on performance, not process
• Convey importance of systems approach
PPTC, Wellington, NZ
ISO 9000 Family
• International Organization for Standardization
• Guidance for quality in manufacturing and service industries
• Has broad applicability, many kinds of organizations can use
PPTC, Wellington, NZ
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)
PPTC, Wellington, NZ
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
PPTC, Wellington, NZ
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
PPTC, Wellington, NZ
PPTC, Wellington, NZ
Comparison: NCCLS Quality System Model to
ISO 9001 Quality System Model * ISO 9001H
Quality System Essentials Clauses Organization 4.1 Management responsibility
4.2 Quality system 4.3 Contract review
Personnel 4.18 Training Equipment 4.11 Control of inspection, measuring, and
test equipment Purchasing and Inventory 4.6 Purchasing
4.7 Control of customer-supplied product Process Control (includes process validation, quality control, proficiency testing, process control, facilities, and safety)
4.4 Design control 4.8 Product identification and traceability 4.9 Process control 4.10 Inspection and testing 4.12 Inspection and test status 4.15 Handling, storage, packaging, preservation and delivery 4.20 Statistical techniques
Documents and Records 4.5 Document and data control 4.16 Control of quality records
Occurrence Management 4.13 Control of nonconforming product Internal Assessment 4.17 Internal quality audits Process Improvement 4.14 Corrective and preventive action Service and Satisfaction 4.19 Servicing
* 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.
PPTC, Wellington, NZ
QUALITY ASSURANCEDEFINITION
All planned and systematic actions necessary to provide
adequate confidence that goods or services will satisfy the
customer’s needs.
PPTC, Wellington, NZ
QUALITY ASSURANCEQUALITY ASSURANCEanother definitionanother 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
PPTC, Wellington, NZ
EXTERNAL QUALITY ASSESSMENT EXTERNAL QUALITY ASSESSMENT (EQA)(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.
PPTC, Wellington, NZ
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)
PPTC, Wellington, NZ
INTERNAL QUALITY CONTROL INTERNAL QUALITY CONTROL (IQC)(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.
PPTC, Wellington, NZ
Quality System
Quality Assurance
Quality Control
PPTC, Wellington, NZ
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
PPTC, Wellington, NZ
PoliciesPolicies
ProcessesProcesses
ProceduresProcedures
QUALITY SYSTEM MANUALQUALITY SYSTEM MANUALQUALITY SYSTEM MANUALQUALITY SYSTEM MANUAL
“what to do”
“how it happens”
“how to do it” - (SOPs)
PPTC, Wellington, NZ
IF IT IS NOT WRITTEN DOWN IF IT IS NOT WRITTEN DOWN IT DID NOT HAPPEN!!!IT DID NOT HAPPEN!!!
PPTC, Wellington, NZ
Quality System Essentials
1. Organization– Management responsibility
2. Personnel– Training and competency assessment
3. Equipment– Installation and maintenance, calibration
4. Purchasing and inventory
PPTC, Wellington, NZ
Quality System Essentials
5. Process control– Validation/verification, quality control, proficiency
testing, specimen management
6. Information management
7. Documents and records
8. Occurrence Management– Document and take corrective action
PPTC, Wellington, NZ
Quality System Essentials9. Internal assessment
10. Process improvement• Revise process based on information gathered
11. Service and satisfaction• Health care providers, patients
12. Facilities and Safety• Design for proper flow and ergonomics• Safety of staff, others, environment
PPTC, Wellington, NZ
Organization
• Support from the top level of the organization• Involve all persons in the organization• Conform with any regulatory requirements
A culture committed to quality
Quality policy & standards
Clearly definedresponsibility
& accountability
Sufficientresources
PPTC, Wellington, NZ
Personnel
RetentionHuman resource
planningHiring
Performancemanagement
Training Supervision
PPTC, Wellington, NZ
Equipment Management
Maintenance,service & repair
Selection AcquisitionInstallation &
initial calibration
Troubleshooting Disposition
PPTC, Wellington, NZ
Purchasing and Inventory
Inventorymanagement
Procurement Receiving Storage
Recordkeeping
PPTC, Wellington, NZ
Process Control
ExternalQuality
Assessment
Standard operating
procedures
Specimenmanagement
Qualitycontrol
PPTC, Wellington, NZ
Information Management
Informationflow
Data collection& management
Computerskills
Patient privacy &confidentiality
PPTC, Wellington, NZ
Documents and Records
Documentstorage/retrieval
Standardizedforms
Documentdestruction
Documentdistribution
Documentapproval
PPTC, Wellington, NZ
Occurrence Management
Written procedures for
addressing errors
Correctiveactions
Occurrencerecords
Occurrencereporting
PPTC, Wellington, NZ
Assessment
Internal audit or self
evaluation
External evaluation
Improvementmeasures
PPTC, Wellington, NZ
Process Improvement
On-goingdata
collection
Improvementmeasures
PPTC, Wellington, NZ
Service and Satisfaction
Monitoring Customer
satisfaction
Process improvement
Rewards
PPTC, Wellington, NZ
Facilities and Safety
Testing andstorageareas
Safety practice
Safety procedures& records
PPTC, Wellington, NZ
WHO IS RESPONSIBLE FOR WHO IS RESPONSIBLE FOR QUALITY?QUALITY?
To be responsible for Quality in YOUR LABORATORY
PPTC, Wellington, NZ
• 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
PPTC, Wellington, NZ
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