Developing a Quality Management System

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Developing a Quality Management System

• Viki Massey
• Quality Coordinator

A Joint Venture of London Health Sciences
Centre and St. Josephs Health Care London
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Todays Presentation

• LLSG profile
• Implementation Plan
• Outline Quality System Essentials
• Review Where are we?
• Outline the next steps

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London Laboratory Services Group

• Joint venture between LHSC and SJHC
• Pathology and Laboratory Medicine Program
• 9 disciplines
• 55 laboratories
• 4 campuses
• 500 employees

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What is a Quality Management System

• ISO 9000 defines a QMS as
• Management system to direct and control an
  organization with regard to quality

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Why Quality Management System?

• QMP-LS Quality Management Program Laboratory
  Services Ontario Laboratory Accreditation (OLA)
• Consistent with international trends and
  laboratory science
• We are committed to providing the highest level
  of care to the patient

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How to Implement a Quality Management System?
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LLSG Implementation Plan

• Quality Coordinator
• Discipline Task Teams
• Quality Team
• Develop Policies
• GAP analysis
• Map Processes
• Write procedures
• Quality Manual
• Communicate/Educate/Train
• Audit
• Accreditation

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Structure for a Quality system
Quality System Essentials Organization Personnel
Equipment Purchasing/Inventory Process
Control Documents/Records Occurrence
Mgmt Internal Assessment Process
Improvement Service and Satisfaction Facilities
and Safety Information Management
Path of Workflow
Pre-Analytic Analytic Post-Analytic Info Mgmt
Quality system essentials apply to all operations
in the path of workflow
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QSE Documents and Records

• Document Management System
• create
• identify
• change
• approve
• file
• distribute
• archive

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Hierarchy of Documents
Policy
What to do
Process
How it happens
Procedures
How to do it
Records
Forms
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Policy Development

• Quality Policies
• QSEs
• Map OLA requirements
• Policy statement
• Responsibility
• Supporting statements
• Supporting processes

• Operational Policies
• - included in procedures

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  The following sections are derived from the OLA
requirements. They determine the supporting
statements for the policy. There should be one
section and related statement for the major
categories defined in the requirements. Make a
broad statement about the Laboratory's intentions
for the sections below.  
SECTION
SUPPORTING STATEMENTS
 
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Process Mapping

• Address the path of workflow
• Describe how things happen here
• Flow Charts or Tables

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Procedure Development

• Identified from process mapping
• Templates developed based on NCCLS guidelines
• Used for analytical and non analytical procedures

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  NB SECTIONS NOT APPLICABLE TO A GIVEN
DOCUMENT ARE DELETED FROM THAT DOCUMENT
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Procedures

• Accessible
• Up to date
• User friendly- accurate, easy to follow

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QSE Process Control

• Laboratory processes and procedures
• Validation
• Establishing Reference Intervals
• Quality Control
• Internal and External QA
• Method Comparability
• Accreditation
•  

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QSE Occurrence Management

• Quality Control Corrective Action
• External and Internal Quality Assurance
• Turn Around Time (TAT) delay
• Discrepant Results
• Corrected Results
• Specimen Rejection Criteria
•  

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QSE Information Management

• Results Reporting
• Release of Results
• Computer Procedures
• Change Approval
• Computer QA
• Computer Security
• Computer Validation 

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QSE Purchasing and Inventory

• Inventory Control System
• External Services
• Purchasing Documents
• Material Resources

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QSE Safety

• Safety Officer, Safety Committee
• Safety Manual
• Audit and Inspections
• Reporting Incidents, Accidents, Illness
• Training
•  Personnel Responsibilities

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QSE Facilities

• Location and design
• Environmental Conditions
• Access
• Communication Systems
• Storage
• Computer Environment
•  

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QSE Equipment

• Equipment selection, calibration, verification,
  validation
• Inventory
• Equipment operation maintenance and records
• Defective Equipment
•  

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QSE Personnel

• Job Description and Qualifications
• Training
• Competence
• Continuing Education
• Personnel Records
• Performance Appraisal
•  

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QSE Organization

• License
• Mission Statement
• Accreditation
• Organizational Structure
• Resource Allocation
• Referral Laboratories
•  

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QSE Assessment

• Quality Indicators
• Internal Audits
• Management Review

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QSE Process Improvement

• Quality Improvement Activities
• Occurrence management
• Problem Solving

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QSE Service and Satisfaction

• Customer Satisfaction (Complaints)
• Internal and external 

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Where are We?

• Quality Team
• Quality policies developed
• Processes identified/mapped
• Procedures written
• Document Management System
• Quality Manual
• Web site for referral labs

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Where are We?

• Discipline Task Teams
• GAP analysis
• Processes mapped
• Procedures written
• Revisit requirements and close GAP

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Whats Next?

• Quality Team to continue to address QSE
• Discipline Task Teams to complete sections of OLA
  requirements
• Educate and train staff
• Perform self assessment

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Celebrate Success!
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Resource Material

• ISO documents
• 90012000
• 15189
• NCCLS documents
• GP26-A
• GP22-A
• HS1- A
• QMP-LS- OLA Consensus Requirements