Non disclosure: Nothing to disclose

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1 European Association of Hospital Pharmacists Congress Paris March , March Chris Hubers Senior Consultant Kerteza Non disclosure: Nothing to disclose Presentatie EA RvA/CCKL

2 Quality Organizational quality Professional quality Product quality Presentatie EA RvA/CCKL

3 Deming Cycle Dr. W. Edwards Deming Quality Assurance Continuous Improvement You ll get what you create! Presentatie EA RvA/CCKL

4 Agreement Possible to do what is written Enough flexibility Do not chain yourself to the procedure Do what you did before Agreements that work Presentatie EA RvA/CCKL

5 Quality system WHAT Reference (standard) + HOW Agreements (within the organisation) Examine In reality Quality system: why? Need for QS Customer Organisation itself Obligation Government Customers Presentatie EA RvA/CCKL

6 Quality system: why? Work becomes easier and quicker New collegue with / without SOP s Analyse trouble with / without log Responsibilities with / without manual Archive with / without index Tool for management Process control Quality Assurance Officer Officer coordinating the setting up, the implementation and maintenance of the quality system NO final responsibility for QS!!! Presentatie EA RvA/CCKL

7 Responsibilities in a quality system Management: multi stage follow up on working agreements ISO model (9001) JCI Standards for Hospitals Presentatie EA RvA/CCKL

8 Other standards Good Manufacturing Practice (GMP) Good Logistic Practice (GLP) Good Distribution Practice (GDP) Good Research Practice (GRP) National standards and legislation Professional standards Conceptual model ISO RESPONSIBILITY OF THE BOARD OF DIRECTORS Mission Statement Staff Strategy Documentation Process design Materials Equipment Continuous Improvement Policies Processes Infra structure Indicators RESPONSIBILITY OF THE BOARD OF DIRECTORS External parties and developments Presentatie EA RvA/CCKL

9 Risk model for processes POLICIES PRE- SCRIP- TION PICKING DISTRI- BUTION STORAGE ON WARD PREPA- RATION ADMI- NISTER MONI- TORING DISPO- SAL RESULTS QUALITY ASSURANCE CORRECTIVE ACTIONS Risks on results RESULTS: - Effect - Adverse effects - Correct patient - Correct medication - Correct dose I,I&N Critical Factors Indicators, incidents Near miss (I,I & N) REVIEW (INCL. SYSTEM) ROOT CAUSE ANALYSIS IMPROVEMENT PREVENTIVE ACTIONS Joint Commission International Standards for Hospitals Primary process pointed: patient centered Patient safety / risk management based From process to structure Tracer methodology used in external audit Tracer methodology used in organisation Presentatie EA RvA/CCKL

10 Joint Commission International Standards for Hospitals Standards Intent Measurable elements Joint Commission International Standards for Hospitals International patient safety goals: o Identification: two identifiers o Effective communication: read back o High alert medication o Correct side, correct procedure, correct patiënt o Prevention of infection: hand hygiene o Reducing harm caused to patients by falls Presentatie EA RvA/CCKL

11 Joint Commission International Standards for Hospitals Patient centered standards o Access to Care and Continuity of care (ACC) o Patient and Family Rights (PFR) o Assessment of Patients (AOP) o Care of Patients (COP) o Anesthesia and Surgical Care (ASC) o Medication Management and Use (MMU) o Patient and Family Education Joint Commission International Standards for Hospitals Health Care Organization Management Standards: o Quality Improvement and Patient Safety (QPS) o Prevention and Control of Infections (PCI) o Governance, Leadership and Direction (GLD) o Facility Management and Safety (FMS) o Staff Qualifications and Education (SQE) o Management of Communication and Information Presentatie EA RvA/CCKL

12 JCI and medication management IPSG 3: High alert medication Storage: sound alike / look alike Labeling List of high alert medication JCI and medication management MMU.1 Management Law and legislation MMU.2 Selection and procurement List of medication Medication not readily available Presentatie EA RvA/CCKL

13 JCI and medication management MMU.3 Storage Labeling Recall MMU.4 Prescribing and transcribing Authorisation Registration in patient record JCI and medication management MMU.5 Preparing and dispensing Review for appropriateness Right dose, right patient, right time MMU.6 Administration Qualification and authorisation Home medication Presentatie EA RvA/CCKL

14 JCI and medication management MMU.7 Monitoring effects Misses, near misses JCI and medication management Other standards related with pharmacy Laboratory (AOP.5) Hazardous materials (FMS.5) Water and medical gas (FMS.10) Qualification of staff (SQE) Presentatie EA RvA/CCKL

15 JCI and medication management Pharmacist is owner of medication process o Policies o Process design o Indicators o Involvement in audits o Involvement in data analysis and review Dialogue with management o Review results / indicators o Change in policies o Commitment in implementation Dialogue with management Committee Quality and Safety o Board o Management o Staff o Process owner on request (for instance two times a year medication management review) Presentatie EA RvA/CCKL

16 Dialogue with management Data review o Tracer Results o Developments o Indicators: Process Outcome Compliance Indicators (examples) Compliance staff (tracer data) Use of antibiotics Medication incidents en near misses Completeness of records.. Analysis Root cause analysis, Prospective risk analysis (HFMEA, Bow-tie, ) Presentatie EA RvA/CCKL

17 Ammount Percentage Procent Incidents with medication Medication incidents Q ,0 60,0 50,0 40,0 30,0 Severity % Q ,0 10,0 Divisie 0,0 (possible) damage (under investigation No damage (did not reach patient) Delivery of Cytostatica Request conform protocol Q Month Not conform Conform Perc. Presentatie EA RvA/CCKL

18 Information management and improvement Reports External: Developments Legislation Inspection Trends: Incidents Process owner Bench mark * Analysis results Retrospective analysis New demands/ methods/ best practices etc.) JCI Visitation Patient tracers * Check on policies and standards System tracers Prospective Risk analyses Patient Record Audits Reports Improvement plan Quality Assurance agency Periodic reports Focus tracers Commission quality and safety Correction Recommendations Annual report Cognos Indicator Registration intern Indicator Registration extern * Goals / references Governance Accountability Before accreditation Presentatie EA RvA/CCKL

19 After accreditation Presentatie EA RvA/CCKL