Laboratory Management Introduction PDF

Laboratory Management Introduction to Laboratory Quality Management System A.Y 2024-2025 | 2nd Term THE QUALITY MANAGEMENT SYSTEM COMPLEXITY OF A LABORATORY SYSTEM...

Laboratory Management Introduction to Laboratory Quality Management System A.Y 2024-2025 | 2nd Term THE QUALITY MANAGEMENT SYSTEM COMPLEXITY OF A LABORATORY SYSTEM PATH OF WORKFLOW Achieving a 99% level of quality means accepting a 1% error rate. In France a 1% error rate would mean everyday ▪ 14 minutes without water or electricity ▪ 50,000 parcels lost by postal services ▪ 22 newborns falling from midwives’ hands ▪ 600,000 lunches contaminated by bacteria ▪ 3 bad landings at Orly Paris airport Essential to all aspects of health care are laboratory reports that are Accurate Reliable, and Timely Why is the Path of Workflow essential to consider in health LABORATORY ERRORS COST IN laboratories? The entire process of managing a sample must be considered: Time ▪ The beginning: sample collection Personal Effort ▪ The end: reporting and saving of results Patient Outcomes ▪ All processes in between. QUALITY MANAGEMENT SYSTEM DEFINITION LABORATORY TESTS ARE INFLUENCED BY ▪ Laboratory environment Coordinated activities to direct and control an organization with ▪ Knowledgeable staff regard to quality (ISO,CLSI). ▪ Competent staff ▪ Reagents and equipment All aspects of the laboratory operation need to be addressed to ▪ Quality control assure quality; this constitutes a quality management system. ▪ Communications ▪ Process management ▪ Occurrence management ▪ Record keeping L.S  TWELVE QUALITY SYSTEM ESSENTIALS INFORMATION MANAGEMENT Set of coordinated activities that function as building blocks for ▪ Confidentiality quality management. ▪ Requisitions ▪ Logs and records ORGANIZATION ▪ Reports ▪ Computerized laboratory information systems (LIS) DOCUMENTS RECORDS Creation Collection Revisions and review Review Control and distribution Storage Retention OCCURENCE MANAGEMENT ▪ Complaints ▪ Mistakes and problems ▪ Documentation ▪ Root cause analysis PERSONNEL ▪ Immediate actions ▪ Corrective actions ▪ Human Resources ▪ Preventive actions ▪ Job qualifications ▪ Job descriptions LABORATORY ASSESSMENT ▪ Orientation ▪ Training INTERNAL EXTERNAL ▪ Competency assessment Quality indicators Proficiency testing (EQA) ▪ Professional development Audit program Inspections ▪ Continuing education Audit review Accreditations PROCESS IMPROVEMENT EQUIPMENT ▪ Acquisition ▪ Opportunities for improvement (OFIs) ▪ Installation ▪ Stakeholder feedback ▪ Validation ▪ Problem resolution ▪ Maintenance ▪ Risk assessment ▪ Calibration ▪ Preventive actions ▪ Troubleshooting ▪ Corrective actions ▪ Service and repair CUSTOMER SERVICE ▪ Records ▪ Customer group identification PURCHASING AND INVENTORY ▪ Customer needs ▪ Customer feedback ▪ Vendor qualifications ▪ Supplies and reagents FACILITIES AND SAFETY ▪ Critical services ▪ Contract review ▪ Safe working environment ▪ Inventory Management ▪ Transport management ▪ Security PROCESS CONTROL ▪ Containment ▪ Waste management ▪ Quality control ▪ Laboratory safety ▪ Sample management ▪ Ergonomics ▪ Method validation ▪ Method verification L.S  The foundation of international Implementing Quality Management does not guarantee an medical laboratory quality ERROR-FREE laboratory. management. But it detects errors that may occur and prevents them from Medical laboratories- particular recurring. requirements for quality and competence. Laboratories not implementing a quality management system guarantees UNDETECTED ERRORS. CLSI QUALITY DOCUMENTS LABORATORY QUALITY MANAGEMENT SYSTEM HS1-A2 A Quality Describes quality system model, 12 Coordinated activities to direct and control an organization with Management System essentials regard to quality. ISO 9000:2000 Model for Health Care Aligns to IS0 15189 and parallels ISO INNOVATORS OF QUALITY 9000 A Brief History of Quality Management Applies to all healthcare system ❖ Quality management is not new. GP26-A3 Application Describes laboratory application of of Quality quality system model INNOVATOR DATE CYCLE Management System Walter A. Shewhart 1920s Statistical Process Model for Laboratory Relates the path of workflow to the 1891-1967 Control Services quality system essentials W. Edwards Deming 1940s Continual 1900-1993 Improvement Assists laboratory in improving Joseph M. Juran 1950s Quality Toolbox processes 1904-2008 (103 years) Relates to HS1-A2 and ISO 15189 Philip B. Crosby 1970s Quality by Requirement Robert W. Galvin 1980s Micro Scale Error IN SUMMARY Reduction Quality management is not new. Quality management grew from the good works of STANDARDS ORGANIZATION innovators who defined quality over a span of 80 years. ISO CLSI Quality management is as applicable for the medical International Organization for Clinical and Laboratory laboratory as it is for manufacturing and industry. Standardization Standards Institute (formerly known as NCCLS) KEY MESSAGES A laboratory is a complex system and all aspects must Guidance for quality Standards, function properly to achieve quality. in manufacturing and guidelines, and best Approaches to implementation will vary with local situation. service industries. practices for quality Start with the easiest, implement in stepwise process. in medical laboratory Ultimately, all quality management system elements must testing. be addressed. Broad applicability; Detailed; applies used by many kinds specifically to of organizations. medical laboratories. Uses consensus Uses consensus process in process in developing developing standards. standards. ISO DOCUMENTS- LABORATORY ISO 9001:2000 Model for QA in design, development Quality Management production, installation, and servicing. System Requirements ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. ISO 15189:2007 Quality Management in the Clinical Laboratory L.S