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Developing a Quality Management System Viki Massey Quality Coordinator A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London Today’s Presentation LLSG profile Implementation Plan Outline Quality System Essentials Review: Where are we?

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Developing a quality management system l.jpg

Developing a Quality Management System

VikiMassey

Quality Coordinator

A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London


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Today’s 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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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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Quality Policies

QSE’s

Map OLA requirements

Policy statement

Responsibility

Supporting statements

Supporting processes

Operational Policies

- included in procedures

Policy Development


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POLICY STATEMENT:

PURPOSE:

This policy provides the direction for the processes and procedures to….

RESPONSIBILITY

(use those that apply)

Program Leader/Discipline Leader/Section Head is responsible for

Lab Manager is responsible for

Technical Specialist/Coordinator is responsible for

Staff members are responsible for

Other:

References:

·NCCLS document HS1-A Vol.22, No.13- A Quality System Model for Health Care; Approved Guideline

·QMP-LS- Ontario Laboratory Accreditation Requirements

·Others:

Supporting

Documents

List the processes that support this policy:

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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What Happens

(List the steps)

Who’s responsible

Procedure (or another Process)

Results

1)

2)

3)


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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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PURPOSE

This procedure gives instructions……

POLICY

EQUIPMENT

MATERIALS

SPECIMEN

SPECIAL SAFETY

QUALITY CONTROL

PROCEDURE

LIMITATIONS

INTERPRETATION

CALCULATIONS

REFERENCE RANGE

RESULTS REPORTING

REFERENCES

RELATED DOCUMENTS

APPENDICES

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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What’s 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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Resource Material

  • ISO documents:

  • 9001:2000

  • 15189

  • NCCLS documents:

  • GP26-A

  • GP22-A

  • HS1- A

  • QMP-LS- OLA Consensus Requirements


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