Laboratory Quality Systems Assuring Quality in Laboratory Performance - PowerPoint PPT Presentation

1 / 52
About This Presentation
Title:

Laboratory Quality Systems Assuring Quality in Laboratory Performance

Description:

Encourage all AAPI laboratories to use quality system concept ... Guidance for quality in manufacturing and service industries ... – PowerPoint PPT presentation

Number of Views:529
Avg rating:3.0/5.0
Slides: 53
Provided by: johne53
Category:

less

Transcript and Presenter's Notes

Title: Laboratory Quality Systems Assuring Quality in Laboratory Performance


1
Laboratory Quality SystemsAssuring Quality in
Laboratory Performance
  • Introduction and Overview
  • John Elliot

WHO Collaborating Centre
2
Laboratory Testing Impacts Nearly Everyone
  • Accurate, reliable lab testing is essential to
    all aspects of health care

3
How do we achieve QUALITY excellent performance
in the laboratory?
4
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

5
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

6
(No Transcript)
7
QUALITY MANAGEMENT SYSTEMOverview


8
QUALITY MANAGEMENT SYSTEMPreanalytical

9
QUALITY MANAGEMENT SYSTEMAnalytical

10
QUALITY MANAGEMENT SYSTEMPostanalytical

11
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
12
Advantages of a Systems Approach
  • Ensure quality of overall process
  • Detect and reduce errors
  • Improve consistency within and between
    laboratories
  • Contain costs

13
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
14
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

15
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

16
Steps in Development of Quality Systems Initiative
  • Train the trainer
  • Continued technical support for all elements
  • Long-term, sustainable process

17
Organization of Training Materials
  • Modular
  • Designed for use by local staff
  • Includes facilitators guide, content outline,
    PowerPoint presentation, exercises, supplementary
    materials, references

18
Framework
  • Common definitions
  • Importance of ISO philosophy
  • Aim for simplicity
  • Emphasis on performance, not process
  • Convey importance of systems approach

19
ISO 9000 Family
  • International Organization for Standardization
  • Guidance for quality in manufacturing and service
    industries
  • Has broad applicability, many kinds of
    organizations can use

20
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)

21
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

22
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

23
(No Transcript)
24
Comparison NCCLS Quality System Model to ISO
9001
25
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.
26
QUALITY ASSURANCEDEFINITION
  • All planned and systematic actions necessary to
    provide adequate confidence that goods or
    services will satisfy the customers needs.

27
QUALITY ASSURANCEanother 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

28
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.

29
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)

30
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.

31
Quality System
Quality Assurance
Quality Control
32
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

33
QUALITY SYSTEM MANUAL
what to do
Policies
how it happens
Processes
how to do it - (SOPs)
Procedures
34
IF IT IS NOT WRITTEN DOWN IT DID NOT HAPPEN!!!
35
Quality System Essentials
  • Organization
  • Management responsibility
  • Personnel
  • Training and competency assessment
  • Equipment
  • Installation and maintenance, calibration
  • Purchasing and inventory

36
Quality System Essentials
  • Process control
  • Validation/verification, quality control,
    proficiency testing, specimen management
  • Information management
  • Documents and records
  • Occurrence Management
  • Document and take corrective action

37
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

38
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
A culture committed to quality
Clearly defined responsibility accountability
39
Personnel
Retention
Human resource planning
Hiring
Performance management
Training
Supervision
40
Equipment Management
Selection
Acquisition
Installation initial calibration
Maintenance, service repair
Troubleshooting
Disposition
41
Purchasing and Inventory
Procurement
Receiving
Storage
Inventory management
Record keeping
42
Process Control
Standard operating procedures
Specimen management
External Quality Assessment
Quality control
43
Information Management
Information flow
Data collection management
Computer skills
Patient privacy confidentiality
44
Documents and Records
Standardized forms
Document distribution
Document approval
Document storage/retrieval
Document destruction
45
Occurrence Management
Written procedures for addressing errors
Corrective actions
Occurrence records
Occurrence reporting
46
Assessment
Internal audit or self evaluation
External evaluation
Improvement measures
47
Process Improvement
On-going data collection
Improvement measures
48
Service and Satisfaction
Monitoring Customer satisfaction
Process improvement
Rewards
49
Facilities and Safety
Testing and storage areas
Safety practice
Safety procedures records
50
WHO IS RESPONSIBLE FOR QUALITY?
To be responsible for Quality in YOUR LABORATORY
51
  • 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

52
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
Write a Comment
User Comments (0)
About PowerShow.com