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A Quality Management System

Viki Massey Quality Coordinator

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

Objectives

Quality Management System


- What - Why - Goals/Benefits - Structure

Ontario Laboratory Accreditation (OLA) Implementation Plan Accreditation Process

What is a Quality Management System

ISO 9000 defines a QMS as:

Management system to direct and control an organization with regard to quality

Why Quality Management System?


QMP-LS: Quality Management Program Laboratory Services; Ontario Laboratory Accreditation Consistent with international trends and laboratory science Providing the highest level of care to the patient

LPTP to OLA

1974 -Laboratory Proficiency Testing Program (LPTP) 1992-1994- Laboratory Review Quality Improvement Model 2000- Quality Management ProgramLaboratory Services (QMP-LS) Ontario Laboratory Accreditation (OLA)

Ontario Laboratory Accreditation


Mandatory

for all Ontario laboratories Peer accreditation Based on a process approach Review of policies and processes Standards of practice

Building Blocks of OLA


ISO

9000; ISO 17025; ISO 15189 NCCLS- A Quality System Model for Health Care Ontario Law Generally accepted standards of laboratory practice

The Benefits of a QMS


Encourages

active and effective

leadership Involves and empowers staff Staff will clearly understand their responsibilities Ensures consistency Focuses on root cause of problems

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

Stated Simply:

Say what you do (document) Do what you say Standardize, standardize, standardize Measure and monitor those things that are important to your customer Focus on the process Assess

Structure for a Quality system


Quality System Essentials
Organization
Personnel Equipment Purchasing/Inventory

Path of Workflow

Pre-Analytic Analytic Post-Analytic Info Mgmt

Process Control
Documents/Records Occurrence Mgmt Internal Assessment Process Improvement Service and Satisfaction Facilities and Safety Quality system essentials apply to all operations in the path of workflow

Information Management

LLSG Implementation Plan

Quality Coordinator Discipline Task Teams Quality Team Policies drafted GAP analysis Mapping Processes Quality Manual Communication/Education/Training Audit Accreditation

Accreditation Process

Institution
Meet Essential Requirements (614) Meet Good Practice Recommendations (66) Submit Quality Manual

QMPLS
Review Quality Manual Appoint Accreditation Team

Accreditation Team

Interview Observe Check list of requirements Assess compliance Recommend accreditation

Summary

Need an organized plan to implement QMS Use OLA requirements to develop QMS Develop Quality Manual addressing QSE Operationalize Quality Manual Prepare for accreditation assessment visit

Additional Information
Can

be found at these Web Sites: - www.qmpls.org - www.lhsc.on.ca/lab/qmanage/qmsys.htm