Transcript Quality Management Program

A Quality Management
System
Viki Massey
Quality Coordinator
A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London
7/16/2015
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Objectives
Why Quality?
 What is a Quality System?
 How do we achieve Quality?
 The next steps
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Why Quality?

“ In the spirit of innovation and
collaboration, LLSG provides the health
care system with appropriate and
comprehensive diagnostic, therapeutic and
consultative services of the highest quality.”
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Why Quality?

To improve patient care

Technologists want quality
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QMP-LS - OLA
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What is Quality?

The totality of features and characteristics
of a product or service that bear on its
ability to satisfy stated or implied needs.
(The Free Online Dictionary of Computing)
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How to Achieve Quality?
QC
 EQA
 Best Practice
 Standards- NCCLS
- CAP
- GMP
- ISO
OLA
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OLA’s Goals
Establish best practice standards
 Define expected quality
 Uniform standards
 Recognition of excellence
 Consistency with international initiatives
 Connect with the stakeholders (internal and
external customers)

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The Quality Hierarchy
TQM
Quality
Management
Quality System
Quality Assurance
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Quality Control
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Goal of a Quality Management System
For the laboratory :
 to operate efficiently and effectively, meeting
regulatory requirements
 to be managed with the interests of the patient
 to ensure that everyone understands who is
responsible for doing what, when, why,where and
how
 to continually strive for improvement
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Stated Simply:
Say what you do, do what you say
 Standardize, standardize, standardize
 Measure and monitor those things that are
important to your customer
 Focus on the process
 Assess
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Quality System Essentials
•Organization
•Personnel
•Equipment
•Purchasing and
Inventory
•Process Control
•Documents and
Records
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•Information
management
•Investigation of nonconformities
•Assessment
•Process improvement
•Service and
satisfaction
•Facilities and safety
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Structure for a Quality system
Quality System Essentials
Organization
Personnel
Equipment
Path of Workflow
Pre-Analytic Analytic Post-Analytic Info Mgmt
Purch/Inventory
Process Control
Documents/Records
Information Mgmt
Occurrence Mgmt
Quality system essentials apply
to all operations in the path of
workflow
Internal Assessment
Process Improvement
Service and Satisfaction
Facilities and Safety
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QMP-LS Components of Quality
System
Quality Manager
 Implementation
Plan
 Quality Manual
 Quality Policy
Statement
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Quality System
Essentials
 Policies, processes,
and procedures
 Documents and
records
 Continual Quality
Improvement

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The next steps
LLSG Structure
Quality Coordinator
 Quality Team
 Discipline Quality Task Teams
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Organizational Chart
Vice President
Laboratory Manager
Medical Leader(s)
QMS*
Quality Coordinator
Special
Chem/Immuno
Transplant
Pulmonary
SRA&
Results
Reporting
Core
Lab
Special
Hematology
Surgical
Pathology
Autopsy
Services
Cytology
Molecular
Pathology
Blood
Transfusion
Microbiology
LIS
Discipline
Task
Team
Discipline
Task
Team
Discipline
Task
Team
Discipline
Task
Team
Discipline
Task
Team
Discipline
Task
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Discipline
Task
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Discipline
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Discipline
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Discipline
Task
Team
*Quality Monitoring Subcommittee
Additional Representatives:
•LRCC
•Regional Affiliates
•Corporate
•Non Technical Staff
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The First Steps
GAP analysis
 Develop Implementation Plan
 Quality Manual- Policies for each QSE
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Document !
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Document ! Document
!
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Challenges
Resources/Commitment
 Corporate Culture
 Early Gains
 Regional Involvement
 Software Packages
 Timeline
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Strengths
Leadership Support
 Staff Resources
 Some work already completed or underway
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Summary
Need an organized plan to implement QMS
 Use OLA requirements to develop QMS
 Develop Quality Manual addressing QSE
 Operationalize Quality Manual
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Resource Material
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ISO documents:
9001:2000
15189
NCCLS documents:
GP26-A
GP22-A
HS1- A
QMP-LS- OLA Consensus Requirements
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