1. Ireland Army Community Hospital CLSI Quality Series

2. Set of documents designed for healthcare managers who wish to improve their Quality system through quality management activities - HS1-A2 A Quality System Model for Healthcare - GP26-A3 Applications of a Quality System Model for Laboratory Services - GP 22 Continuous Quality Improvement - GP27 Using Proficiency Testing to Improve the Clinical Laboratory - GP2 Development and Control, Lab documents - C24 Statistical Quality Control

3. CLSI Quality Series Patient Clinician Assessment of patient Clinician Action on result Laboratory Services Paths of Workflow Documents and Records Organization Personnel Equipment Purchasing & Inventory Process Control Information Management Occurrence Management Assessment Process Improvement Customer Service & Satisfaction Facilities & Safety

4. CLSI Quality Series Preanalytic Processes >>> Analytic Processes >>> Postanalytic Processes Test Ordering>> Specimen Collection>>Transport>>Specimen Receipt/Processing>> Clinical Laboratory Key Processes Testing>>Results Review/FU>>Interpretation>> Result Reporting & Archiving>>Specimen Mgmt

5. CLSI Quality Series Quality Manual System Level Procedures Instructions Records, Forms Reports Description of system Commitment to Quality Definition of policy Authority and Responsibilities The Documented Quality System Flows and Controls System Implementation

6. CLSI Quality Series Intended for: primarily for Lab directors, managers, and supervisory personnel Goal: systematic implementation of Quality management approaches TQM- customer oriented, team focused decision making, anticipatory planning CQI- ongoing quality improvement

7. CLSI Quality Series Why: systematically maximize efficiency, effectiveness, and adaptability 1. licensing and certifying agencies 2. demands to handle more volume with fewer resources 3. changing trends

8. CLSI Quality Series Quality System Essentials: coordinated management activities to direct and control an organization with regard to quality The quality system must be managed with a focus on Continuous Quality Improvement

9. CLSI Quality Series QSEs Document and Records: creation, review, approval change control master file retention, storage and retrieval Organization: org chart, leadership review, strategic planning Personnel: hiring, training, competency Equipment: selection, calibration, maintenance Purchasing & Inventory: vendor selection, receiving & inspection, vendor evaluation Process control: design, validation, QC, PT Information Management: data issues, security, pat. related info

10. CLSI Quality Series Occurrence Management: detection, documentation and remedial action investigation and analysis Internal & External assessment: external assessment, quality indicators, internal audit, quality reporting Process Improvement: preventive action, corrective action Customer Service: needs & satisfaction assessment Facilities and safety: design, safety surveillance

11. CLSI Quality Series Quality Management, Why it Fails Three identifiable phases to implementation 1. Startup: struggle to learn (all levels) Commitment vs Involvement Justification and Timing Too much focus on short term activities 2. Alignment: must align organizational systems and practices 3. Integration: quality - how we do things, not something we do

12. CLSI Quality Series Leadership: “Determine the direction Set the Pace Applaud the spirit”