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Quality Systems in the Clinical Laboratory. Susan Blonshine RRT, RPFT, FAARC. Why Quality Systems?. Consistent services High quality Cost-effective. Selected Key Definitions. ISO: International Standards Organization

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Quality Systems in the Clinical Laboratory


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    1. Quality Systems in theClinical Laboratory Susan Blonshine RRT, RPFT, FAARC

    2. Why Quality Systems? • Consistent services • High quality • Cost-effective

    3. Selected Key Definitions • ISO: International Standards Organization • Quality System: The organizational structure, resource, processes, procedures needed to implement quality management • Quality System Essentials - those elements which must be applied to all operations in the service’s path of workflow

    4. Selected Key Definitions • Path of Workflow - as it relates to the processes involved in the pre-, during and post- phases of delivery of services with the laboratory as an example • Policy: What to do - states intent and direction • Process: How it happens - describes activities that transform intent into action • Procedure: What To Do - work instructions

    5. Stages of QualityNCCLS Approved Guideline - GP26A Quest Diagnostics Incorporated

    6. Origins • ISO 9000 - “Family of Quality Standards” • ISO 9001 - defines 20 quality system elements that any business should use to manage its operations: • Manufacturers and Service Industries • GMP - International

    7. Origins • FDA Mandate for Blood Banks - CGMP: • ISO 9001: • Standards Applications • Model for Quality Assurance • Segue To Laboratory Applications • ISO/IEC DIS 17025 • [General Requirement for Competency of testing and calibration] • ISO/DIS 15189 • [Quality Management in the Clinical Laboratory]

    8. Healthcare ApplicationNCCLS GP 26-A • Harmonization/Standardization • JCAHO Interest • Infrastructure - Launching Pad: • ISO 9000 Quality System Certification

    9. Organization Personnel Equipment Purchasing and Inventory Process Control Documents and Records Occurrence Management Internal Assessment Process Improvement Service and Satisfaction Quality System Essentials

    10. Comparison: NCCLS Quality System Model to ISO 9001

    11. Comparison: NCCLS Quality System Model to ISO’s 17025 and 15189

    12. Subsequent Quality ModelsApplications • NCCLS HS4-P A Quality System Model for Respiratory Care • A Quality System Model for Imaging Services

    13. Model for a Quality System • Quality system essentials • Path of workflow • Adding the patient to the system • Documentation • Policies • Processes • Procedures

    14. Model Structure For a Quality System • Organization • Personnel • Equipment • Purchasing and Inventory • Process Control • Documents/Records • Occurrence Management • Internal Assessment • Process Improvement • Service and Satisfaction

    15. The Laboratory Service As An Example Laboratory Path of Workflow

    16. Integrated Paths of Workflow Quality System Essential Pretest Test ing Post-test Therapeutic intervention (e.g., split-night study) Pre-analytical Analytical Post-analytical Information Management Organization Personnel Equipment Purchasing/ Inventory Process Control Documents/ Records Occurrence Management Internal Assessment Process Improvement Service and Satisfaction Quality system essentials apply to all operations in the path of workflow Integrated Path of Workflow

    17. Adding the patient to the Quality System

    18. Linking Quality System To The Patient

    19. Path of Workflow • Pre-analytical • Analytical • Post-Analytical • Information Management

    20. HIV TestingPath of Workflow

    21. InitialPhases of Implementation • Establishment of management commitment • Identification of the laboratory service's path of workflow • Development of the quality manual

    22. QSE: Organization • Establishment of management commitment • Identification of the laboratory service's path of workflow • Development of the quality manual

    23. QSE: Documents & Records • Development of the system for controlling documents and records • Analysis and validation of processes, development of SOPs and implementation of process controls

    24. Quality System Documentation Hierarchy

    25. Document Control THIS MEANS - There is defined document structure There are defined formats There is a defined document revision process There is a defined review process There is a defined retention process Quest Diagnostics Incorporated

    26. QSE : Equipment • The Equipment Management Plan • Equipment Selection • Equipment Installation

    27. Equipment Selection • Management Plan • List of acceptable vendors • Develop product-evaluation matrix • Evaluate equipment • Determine acceptable limits of accuracy and precision

    28. Equipment Selection • Management Plan • Consider database options • Consider quality control and calibration routines • Consider computer standards • Identify warranty and service agreements • Perform on-site evaluation • Correlate old and new equipment

    29. EquipmentInstallation • Develop installation manual • Validate equipment function • Perform biomedical checks • Validate reference values selected

    30. QSE : Process Control • Develop flowcharts for processes • Process Validation • Identify and Write Standard Operating Procedures • Process Control • Quality Control • Proficiency Testing

    31. AdditionalPhases of Implementation • QSE: Personnel • Training and competence assessment programs • QSE: Purchasing and Inventory

    32. AdditionalPhases of Implementation • QSE: Occurrence Management • QSE: Internal Assessment • QSE: Process Improvement • QSE: Service and Satisfaction

    33. QSE : Personnel • Job qualifications and descriptions • Training and Competence Assessment Programs

    34. QSE: Personnel

    35. Training and Competence Assessment Programs • Orientation and Training • Training Guides • Competence Assessment • Documentation of Training and Competence Assessment

    36. QSE:Purchasing and Inventory • Purchasing • Inventory

    37. QSEOccurrence Management System • Uniform documents for capturing information • Immediate action and investigation • Investigation and corrective action

    38. QSE : Internal Assessment • Quality Indicators • GP-26 appendix • Key elements • Internal Auditing • The Quality Audit

    39. QSE: Process Improvement • Identification of Opportunities for Improvement • Problem resolution process • Periodic reporting

    40. QSE : Service and Satisfaction • Internal • Physicians • Staff • Nurses • Other caregivers

    41. QSE : Service and Satisfaction • External • Patients • Physicians • Clinics • Accrediting bodies • Regulatory groups • Public Health

    42. Organization Personnel Equipment Purchasing and Inventory Process Control Documents and Records Occurrence Management Internal Assessment Process Improvement Service and Satisfaction Quality System Essentials

    43. Staff Benefits • Staff are more process focused • (think globally) • Increased accountability • (clear definitions) • Improved training • (customer/employee satisfaction) • Develops team attitude • (removes departmental barriers)

    44. Keys to Success • Ability • Agility • Skating to where the puck is going to be Wayne Gretzky Hockey Star New York Rangers

    45. NCCLS Documents • NCCLS • 940 West Valley RoadSuite 1400Wayne, PA 19087-1898610-688-0100