Ireland Army Community Hospital

1. Ireland Army Community Hospital CLSI Quality Series

2. CLSI Quality Series 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. Patient CLSI Quality Series Laboratory Services Clinician Assessment of patient Clinician Action on result 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. Clinical Laboratory Key Processes CLSI Quality Series Result Reporting & Archiving>>Specimen Mgmt Preanalytic Processes >>> Analytic Processes >>> Postanalytic Processes Testing>>Results Review/FU>>Interpretation>> Test Ordering>> Specimen Collection>>Transport>>Specimen Receipt/Processing>>

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

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”