Luc Lafrance

Transcription

1 An education oriented presentation of Mandatory Accreditation in Ontario Accreditation provided by OLA within Ontario and IQMH for out of province clients Luc Lafrance ISO model applies to all laboratories Special thanks to the Quality Management Program-Laboratory Services, Institute for Quality Management in Healthcare and Mrs Julie Coffey for permission to use some of the slides in this presentation. Quality Management: Coordinated activities to direct and control an organization with regard to quality (ISO 9000:2000) A laboratory system for the collection, examination and reporting of human samples that: Supports diagnosis, monitoring, prevention and management of disease states Generates information having clinical utility and optimal impact on health outcomes Meets pre-determined targets for accuracy, reproducibility, and traceability Strives to minimize error Is timely, safe, efficient, cost-effective Focuses on client satisfaction and continual improvement (Ontario Laboratory Accreditation)

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3 Acquiring Knowledge from the Masters of Quality Walter A. Shewhart W. Edwards Deming Joseph M. Duran Philip B. Crosby Kaoru Ishikawa Shigeo Shingo

4 Identification of a Leader Get your Leader educated in Quality Management System Build your plan

5 Bring your project to top management This is an important step in the implementation process Patient safety and Cost savings Institute of Medecine1999 report To Err Is Human Canadian Adverse Event Study Liability and Reputation Patient Safety

6 Potential Cost Savings It is difficult to calculate the costs of a quality management system. Prevention QMS/CQI Appraisal Investigatio n Internal Failure External Failure The Institute of Medicine estimates that the cost of system errors is between 17 and 29 BILLION per year. Cost of Quality Duran Model Top Management Commitment Selling the Project to the Laboratory Staff It is insufficient for Top Management to commit to support Quality. Support is not enough. Action is Required. W. Edwards Deming Out of the Crisis

7 QMS Create a Dependable System Procedures are done correctly the first time Standardize your processes Track occurrences and implement preventive measures System can catch mistake before they reach the patient Mistake-proof your laboratory Create a Sense of Urgency 2. Form a Guiding Coalition 3. Create a vision 4. Communicate the vision 5. Empower others to act on the vision 6. Create quick wins (low hanging fruit) 7. Build on the change 8. Institutionalize the Change 1. Change Management Small percentage will be open to change Most will be neutral to change Small percentage will be resistant to change Concentrate your efforts on the neutral Select a Quality Manager

8 A peer-review process by which an authoritative body ensures that laboratories meet explicit quality management criteria, in order to give formal recognition that the laboratory is competent to carry out examinations. Assemble a team Teamwork divides the tasks and multiplies the success (Ontario Laboratory Accreditation) Hire an accrediting body to grant your laboratory accreditation to ISO Internal Audit Audit against ISO requirements Audit against your accrediting body s requirements. Internal audit will provide you with your current baseline. GAP analysis A gap exists when you do not fully meet the requirements. Create a plan to address the GAP.

9 Documents are used to communicate What we do Why we do it Documents and Records Life Cycle How it happens How to do it Creation What the results were Documents are at the Foundation of the Quality Management System Laboratory Quality Manual Your most important document Approval Distribution Preservatio n

10 Map Your Processes Implementation of inter-related processes that create a failure resistant system in which it is difficult to do the wrong thing and easier to do the right thing. (Ontario Laboratory Accreditation) Implementation of the Quality System Essentials No particular order of implementation Human resources QSE Personnel Job qualifications Organization Personnel Equipment Job descriptions Orientation Purchasing & Inventory Documents & Records Process Improvement Process Control Occurrence Management Customer Service Information Management Assessment Facilities & Safety Training Professional development Competency assessment Continuing education

11 QSE Equipment QSE Purchasing and Inventory Acquisition Verification Troubleshooting Installation Maintenance Records Vendor Qualifications Supplies and Reagents Inventory Management QSE Process Control QSE Information Management Quality Control Method Verification Method Validation Requisitions Documents and Records Laboratory Reports Laboratory Information System

12 QSE Occurrence Management QSE Laboratory Assessment Identify the occurrence Document it Remedial actions Determine the extent of the problem (focus audit) Root cause analysis Corrective actions Effectiveness of the corrective actions Data evaluation Quality Indicators Internal Audits External Quality Assessment Management Reviews ISO Accreditation QSE Process Improvement QSE Facilities and Safety Opportunities for Improvement Customers Feedback Risk Assessment Plan-Do-Check-Act Cycle Laboratory Safety Transport Management Security Waste Management Emergency Preparedness

13 To monitor compliance in the pre-analytical, analytical and post-analytical phases, you need quality indicators. Pre-Analytical Quality Indicators Pre-Analytical Quality Indicators

14 Pre-Analytical Quality Indicators Analytical Quality Indicators Post-analytical Quality Indicators

15 Occurrences Quality Indicators The ultimate goal is to provide staff and clients of the service assurance that processes are consistently measured, monitored and improved. The system itself must be as failure resistant as possible. Documented policies, processes and detailed procedures will clearly define every aspect of the system. Regular monitoring will help identify opportunities for improvement and allow laboratory management to prioritize its continual improvement plans. The goal of implementing a quality management system should not be to meet accreditation requirements. Share your knowledge, it is a way to achieve immortality (Dailai Lama) (Ontario Laboratory Accreditation) Thank you