QUALITY MANAGEMENT Suzanne Kamel-Mohamed PhD, MBA, MT (ASCP) Associate Clinical Laboratories Consultants Sanford, Florida www.clinicallabconsultants.com

LABORATORY QUALITY Accuracy Reliability Timeliness

High LEVEL OF ACCURACY IS REQUIRED At first glance, 99% accuracy is good; however, the resulting 1% error can become quite large as in a system where many events occur, such as laboratory testing.

NEGATIVE CONSEQUENCES OF LABORATORY ERROR Examples: Failure to provide the proper treatment No treatment Delay in correct diagnosis and treatment Additional and unnecessary testing Increased cost (labor and supplies) Death of patient

Achieving Excellent Laboratory Performance and Minimizing Errors How? A quality management system is Essential

QUALITY MANAGEMENT SYSTEM Processes and procedures that are well coordinated to achieve excellency in lab performance

Laboratory Processes ISO Standards CAP Standards pre-examination, post-examination CAP Standards pre-analytic analytic post-analytic processes

COMPLEXITY OF LABORATORY PROCESSES An error in any part of the cycle can produce a poor laboratory result. A method of detecting errors at each phase of testing is needed if quality is to be assured.

THE PATH OF WORKFLOW The entire set of operations that occur in testing It begins with the patient and ends in reporting and results Is a key in quality management system.

QUALITY MANAGEMENT SYSTEM MODEL This quality management system model was developed by the Clinical Laboratory Standard Institute (CLSI) It is made of12 Quality system Essentials (QSE) It is fully compatible with ISO standards It Assures accuracy and reliability throughout the Path of Workflow

Quality system Essentials Organization Laboratory Structure and Management Mechanism of implementing and monitoring Personnel Qualified and Competent, motivated staff Equipment Quality equipment , properly functioning and maintained Purchasing and Inventory Quality reagents and supplies Reduce production interruption due to shortage of reagents and supplies

Quality system Essentials Process Control Quality control for testing Sample collection, handling, and processing Method verification and validation. Information Management Test result reporting. Data confidentiality, Accessibility to the laboratory staff and to the health care providers.

Quality system Essentials Documents and Records Documents and Records are accurate, accessible and properly maintained Occurrence Management Detect and handle occurrences properly, and take corrective actions to avoid reoccurrence Assessment Internal Assessment External Assessment Process Improvement The primary goal in a quality management system is continuous improvement of the laboratory processes, and this must be done in a systematic manner.

Quality system Essentials Customer Service It is essential that clients of the laboratory receive what they need. The laboratory should understand who the customers are, and should assess their needs and use customer feedback for making improvements. Facilities and Safety Security Containment Safety Ergonomic

QUALITY MANAGEMENT SYSTEM MODEL WITH ALL 12 QSEs In the quality management system model all twelve QSEs must be addressed to assure accurate, reliable, and timely laboratory results, and to have quality throughout the laboratory operations.

KEY MESSAGES A laboratory is a complex system and all aspects must function properly to achieve quality. Approaches to implementation will vary with each lab situation. Start with changes that can be easily accomplished and have the biggest impact. Implement in stepwise process but ultimately, all quality essentials must be addressed.

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