Module 1-QS Overview

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

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How do we achieve QUALITY [excellent] performance in the

laboratory?

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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

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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

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Advantages of a Systems Approach

• Ensure quality of overall process

• Detect and reduce errors

• Improve consistency within and between laboratories

• Contain costs

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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

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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

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, sustainable process

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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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Framework

• Common definitions

• Importance of ISO philosophy

• Aim for simplicity

• Emphasis on performance, not process

• Convey importance of systems approach

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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

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

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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.

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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.

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QUALITY ASSURANCEDEFINITION

All planned and systematic actions necessary to provide

adequate confidence that goods or services will satisfy the

customer’s needs.

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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.

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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)

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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

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PoliciesPolicies

ProcessesProcesses

ProceduresProcedures

QUALITY SYSTEM MANUALQUALITY SYSTEM MANUALQUALITY SYSTEM MANUALQUALITY SYSTEM MANUAL

“what to do”

“how it happens”

“how to do it” - (SOPs)

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

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Quality System Essentials

1. Organization– Management responsibility

2. Personnel– Training and competency assessment

3. Equipment– Installation and maintenance, calibration

4. Purchasing and inventory

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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

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Personnel

RetentionHuman resource

planningHiring

Performancemanagement

Training Supervision

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Equipment Management

Maintenance,service & repair

Selection AcquisitionInstallation &

initial calibration

Troubleshooting Disposition

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Purchasing and Inventory

Inventorymanagement

Procurement Receiving Storage

Recordkeeping

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Process Control

ExternalQuality

Assessment

Standard operating

procedures

Specimenmanagement

Qualitycontrol

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Information Management

Informationflow

Data collection& management

Computerskills

Patient privacy &confidentiality

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Documents and Records

Documentstorage/retrieval

Standardizedforms

Documentdestruction

Documentdistribution

Documentapproval

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Occurrence Management

Written procedures for

addressing errors

Correctiveactions

Occurrencerecords

Occurrencereporting

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Assessment

Internal audit or self

evaluation

External evaluation

Improvementmeasures

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Process Improvement

On-goingdata

collection

Improvementmeasures

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Service and Satisfaction

Monitoring Customer

satisfaction

Process improvement

Rewards

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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