Implementation of ISO-qualitymanagement and clean room in theclinicCarl SpiessensLeuven University Fertility CenterLeuven, Belgium
ISO 9001• ISO 9001: general quality management system• ISO 17025: specifies the general requirements for thecompetence to carry out tests and/or calibrations,including sampling.• ISO 15189: medical laboratories (particularrequirements for quality and competence)• ISO 15224: ISO 9001 for health care
Principles• Focus on the patient• Process-based approach• Continuous improvement• Decision making based on facts
What is needed?• Motivation of all collaborators• Support from the hospital management• QMS
Quality Management System (QMS)• Primary process• General management:– Setting targets– External communication– Research
QMS• Logistics:– Personnel, training– Internal communication– Suppliers and supplies– Materials, working environment• QMS:– Management of the QMS– Evaluation, analysis and improvement
QMS: concept• Procedures:– Who ?– What ?– When ?• Instructions:– How ?• Documents and forms
Handling errors and complaints• ‘Check’ part of the PDCA cycle• Should not focus on ‘WHO’ ?• Should focus on ‘HOW’ could it happen and‘HOW’ do we prevent it in the future?
SMART• S• M• A• R• Tspecificmeasurableacceptablerealistictime-bound
Key Performance Indicators (KPI)• Evaluation of success• Process-based– Clearly define the process to be monitored– Measure only the monitored process– Keep it simple, avoid extra work• KPI clinic /lab/…• KPI operational/financial/safety/….
Risk management• Risk analysis: process-based• Risk index= impact x probability of occurence• Risk management: avoid – reduce – accept
ED 2004/23/EC• Objective: Define standards for quality andsafety for human tissues and cells intended forhuman application to ensure a high level ofprotection of human health.• Technical requirements in ED 2006/17/EC andED 2006/86/EC.
Traceability• ED requires full traceability• Implementation– 2-Dimensional barcode system/software control– Important risk reduction– Preparing dishes is more time consuming
QMS• ED requires a QMS• Implementation– ISO 9001 QMS– KPI?– Benchmarking?– Protocol drift
Storage conditions• ED requires continuous monitoring of criticalparameters• Implementation– Link all critical devices to central system formonitoring.– Separate containers issue
Equipment and materials• ED requires registration of all relevant data ofproducts and materials in contact with tissuesand cells• Implementation– Relevance?– Administrative overburden– CE marking?
Facilities• ED requires specifies air quality• Implementation– Evidence based??– High cost / extra workload– Benefits?
Conclusion• QMS is a must• ISO 15224• EU directive:– Strong focus on safety– Effect on effectiveness?– Negative effect on efficiency