Overview to a Laboratory Quality Management System

Presented By: Henry Julius

Welcome

Welcome to the Overview to a Laboratory Quality Management System

Module

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Module Objectives

At the end of this module, participants will be able to: Discuss the importance of Accreditation; Explain the importance of a quality management system; Describe the Path of Work Flow Concept; List the quality management system essential elements; Summarize each quality management system essential element.

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Why Accreditation?

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Global trend – Free market – allowing free movement of goods across countries

Quality of goods (test results) is considered the most significant non-tariff barriers to trade in the global free market

Accreditation of laboratories, using common standards (ISO) is seen as the most effective way of dealing with this trade barrier

The Implementation and Management of the ISO standards in an organisation is accomplished by means of a Quality Management System (QMS)

What is a Quality Management System?

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Set of key quality elements that must be in place for an organization’s work operations to function in a manner as to meet the organization’s stated quality objectives

Such a system provides the means to direct and control the

organization with regard to quality.

What is a Quality Management System?

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The foundation of a quality management system provides a platform for continuous improvement

The following outcomes are greatly enhanced: Ability to reduce or eliminate medical error; Customer requirements; The potential for successful governmental and

accreditation assessments; and Sustainable attainment of quality objectives

Importance of Laboratory Results

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Essential to all aspects of health care are laboratory results that are

Accurate, reliable, and timely

If inaccurate results are provided, the consequences can be very significant: Unnecessary treatment; treatment complications Failure to provide the proper treatment Delay in correct diagnosis Additional and unnecessary diagnostic testing.

The Quality Assurance Cycle

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Quality System Essentials (QSEs)

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QSEs are: Foundational building blocks – Infrastructure Must be well defined and documented

If not Breakdown in communications Medical errors

Excellent Performance in the Laboratory

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When all of the laboratory procedures and processes are organized into an understandable and workable structure, managing them become a reality.

The quality model used here organizes all of the laboratory activities into twelve quality system essentials.

Summary: A Systems Approach to Quality

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QSE Pre-analytical Analytical Post-analytical

Quality system essentials apply to all operations in the path of workflow

QSE: Organisation

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Managements Involvement Actively involve in QMS Visible in their participation Quality Planning – leadership in

developing QSEs Quality Manager

Delegated responsibilities & authorities Reports to the level at which

decisions are made Formal training in QMS Trained Auditor Negotiation skills

Quality Steering group

WHO: Training Toolkit

QSE: Personnel

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Recruitment

Orientation

Job description

Qualification

Appraisal system – KPA

Training & Competency

CPD

QSE: Documents & Records

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All policies, processes and procedures must be documented

Training & Competency

Brief Summary – Flow Chart

Detailed Step by step instructions

These records provide evidence

QSE: Documents & Records (continued…)

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The Quality Manual Procedure Manuals

SOPs Records

Examination request; Worksheets; Patient files; Equipment Calibration & Maintenance.

QSE: Equipment

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Selection Criteria

Acquisition Space; Energy; Future disposal.

Installation Installation Certificate Validation versus verification

Identification Asset numbers (otherwise stated).

Service and Repair SOP for Equipment Breakdown; Must be documented; Must be verified after repairs that it

meets required standard.

QSE: Equipment (continued…)

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Calibration Maintenance Schedule; Verification after Calibration; Labeled to indicate calibration stickers.

Equipment Files and Records (Equipment book of life)

Name of equipment and ID number; Date place in service; Installation records Service records; Calibration records; Routine Maintenance; Current location; Manufactures’ manuals.

QSE: Purchasing & Inventory

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Uninterrupted availability of reagents, supplies, and services is needed; The organization or service should set expectations, and build and maintain good

relationships with providers of materials and services. Procurement dept. is part of the QMS

QSE: Purchasing & Inventory

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Identification of critical materials and services

Vendor qualification & Evaluation

ISO 9001 compliant

Tender process

History with the Vendor

Own Auditing

Purchase agreements and review (Contract Review)

Inspection and testing of received materials

Storage and handling of materials

Inventory management

QSE: Process Control

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ID the Processes in the Path of the Workflow Development of Flow charts Process Validation Verification (Before implementation of after changes of Methods

/ equipment ) SOP development & Maintenance Monitoring of Processes

QSE: Laboratory Information Management

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Control of Information – Incoming and Outgoing

Management of downtime Access & Security

Access levels appropriately defined Password controlled - Changed at regular intervals Audit trail Good Firewalls & Anti-viruses Verification & Validation of critical software

QSE: Laboratory Information Management

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Example of Information systems in the NHLS

Lab Trak (TrakCare) DISA ORACLE Q-pulse Thusano CDW

QSE: Occurrence Management

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Identify systematic problems;

Gain Management’s commitment to remove it;

Non-conformance;

Remedial Actions

Corrective Actions

Trend Analysis

________________________

Preventative Actions

QSE: Assessment

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Self-assessment (within the same department)

Internal Audit (one department audits another)

QAD audit

DOH Audit

External Audit e.g. SANAS, WHO, DAIDS etc.

Bench Marking

EQA

QSE: Customer Service

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The laboratory needs to assess the satisfaction of its customers, and patients with the quality of its services on an ongoing basis;

Actively seek feedback. Identify the customer;

Determine the Customers’ respective needs;

Structure work operations and procedures

to meet the need of the customers’ satisfaction;

QSE: Facilities & Safety

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Compliance with the Occupational Health and Safety Act (OSHACT)

HSR / HSR committees

Patient Safety Design, Space Allocation, and Access

Environment Monitoring

Storage Space and Storage Conditions

Fire Drills

Risk Assessments

QSE: Process Improvement

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The laboratory should use information from any of the following sources to identify areas in any part of its path of workflow where improvement is needed:

Customer satisfaction Audits ; Non Conformance / Corrective Action S.W.O.T analysis Bench marking Management Review

Summary

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An active quality management system ensures laboratories meet all client requirements.

Customer service is an integral part of a quality management system and meeting customer needs is a primary goal of the laboratory.

Personnel are the most important resource in the laboratory. The principal element for a successful quality management

system is Managerial commitment. The QSEs must be well defined and documented or there

will be breakdown in communications and medical errors. If QSEs are not well defined, unnecessary costs are incurred

due to inefficiencies and ineffective human resources.

Summary

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An equipment management program will address equipment selection, preventive maintenance and procedures for troubleshooting and repair.

A laboratory will have a system to monitor and plan for purchasing and inventory which includes analyzing needs, developing forms and procedures, and maintaining an inventory.

Documents are essential for assuring accuracy and consistency in the laboratory.

The goal of process control is to identify errors and eliminate them before reporting patient results.

Assessment is important in monitoring the effectiveness of the laboratory quality management system.

A good information management system will ensure all data is well managed.

Quality counts.

References & Links

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WHO: Quality Management Toolkit ISO 15189:2007: Quality management in the clinical laboratory GP26-A3: Application of Quality Management System Model for Laboratory Services HS1-A2 A Quality Management System Model for Health Care A Quality Management System Model for Health Care; Approved Guideline—Second

Edition; HIS-A2 Vol 24 No. 37 Application of a Quality Management System Model for Laboratory Services;

Approved Guideline—Third Edition; GP26 A3 Vol 24 No. 36

References

Wrap Up

Participants are now able to: Discuss the importance of Accreditation; Explain the importance of a quality management system; Describe the Path of Work Flow Concept; List the quality management system essential elements; Summarize each quality management system essential element.

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Questions

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