ISO 9001:2008-BASED QUALITY SYSTEM IN A HOSPITAL PHARMAY Ana Alvarez Diaz Hospital Pharmacy Department Ramon y ajal University Hospital Madrid. Spain SUMMARY 1. BASI IDEAS 2. QMS IMPLEMENTATION PROESS 3. HOW QMS HAS INFLUENED OUR PD 4. STRENGTHS OF OUR QMS 1
Road to the EXELLENE STAKEHOLDERS ORGANISATIONS PROESSES PRODUTS ISO 9001:2008 ISO 9004 QUALITY ONTROL QUALITY ASSURANE TOTAL QUALITY EXELLENE ISO: PROESS Series of activities required to transform inputs into outputs : Organized in a logical way, Provide an added value to each output, Generate an expected pre-specified result, which is intended to be satisfactory to the client 2
ISO: ONTINUOS IMPROVEMENT YLE PDA P = Plan D = Do = heck A = Act AT 4 3 HEK PLAN 1 2 DO RAMON Y AJAL UNIVERSITY HOSPITAL (Pharmacy Service) 1080 beds: 100% POE Unit-Dose Distribution System 30% ADDs 2 mill. lines validates Almost 2800 T samples dispensed (86 new T) > 50,000 dispensations to outpatients > 13,000 Parentaral Nutritions Almost 33,000 ytostatics 3
Utilization of medicines is a high complexity process MISSION: providing maximum safety and quality STRATEGI LINE QMS Efficiency Safety Patient care - Enhance motivation of the staff - Optimaze the performance of the staff as a team IMPLEMENTATION PROJET INFORMATIVE MEETING 2008 Dec 2007 OPERATIONAL PHASE QUALITY OORDINATOR QUALITY OMMITEE 4
IMPLEMENTATION PROJET QUALITY OMMITEE FOLLOW-UP MEETINGS/3 months PROESS MAP PROESS LEADERS Oct 2008 DOUMENTATION IMPLEMENTATION PROJET INFORMATIVE MEETING Ap 2009: EXTERNAL AUDIT 2008 Dec 2007 OPERATIONAL PHASE Ap 2009 QUALITY OORDINATOR QUALITY OMMITEE Fb 2009: INTERNAL AUDIT 5
HOW HAS THE QMS INFLUENED OUR DEPARTMENT? 1.- THE PROESS-BASED APPROAH 2.- MEASURING THE PERFORMANE OF THE PROESSES 3.- DEVELOPING STRATEGIES FOR ONTINUOUS IMPROVEMENT 1.- THE PROESS-BASED APPROAH BEFORE: Operational prodecures not uniform Not always focused on client satisfaction No appropiate assignment of tasks No quality indicators 6
1.- THE PROESS-BASED APPROAH AFTER: Documentation NEEDS EXPETATIONS ATIVITIES RESPONSIBLES PRODUTS SERVIES RESOURES Servicio de FARMAIA STRATEGIS PROESSES GESTIÓN DE RELAIÓN ON GESTIÓN DE REURSOS REURSOS LOS LIENTES HUMANOS Y MATERIALES EONÓMIOS EVALUAIÓN Y MEJORA DE LA ALIDAD PLANIFIAIÓN DE REVISIÓN POR ANÁLISIS MEJORAS Y OBJETIVOS LA DIREIÓN DE DATOS SATISFAIÓN DE LOS LIENTES SEGUIMIENTO DE PROESOS Y SERVIIOS (INDIADORES) R E Q U I S I T O S L I E N T E PERSONAL SANITARIO (Médicos y Enfermería AUTORIDADES SANITARIAS PAIENTES PERSONAL SANITARIO (Médicos y Enfermería PROMOTOR ELABORAIÓN FÓRMULAS MAGISTRALES N. PARENTERALES Y M.ESTÉRILES ITOTÓXIOS GESTIÓN GESTION ADQUISIIONES DISPENSAIÓN SELEIÓN Dispensación de Productos elaborados en el Servicio de Farmacia ADQUISIIÓN D. a través de REEPIÓN VALIDAIÓN PREPARAIÓN DISTRIBUIÓN Dosis Unitaria SOLIITUD/ORDEN MÉDIA y/o REVISIÓN REEPIÓN/ INSPEIÓN Dispensación de Estupefacientes ALMAENAMIENTO DE MEDIAMENTOS Dispensación desde REEPIÓN VALIDAIÓN ALMAENAMIENTO Y P. SANITARIOS PREPARAIÓN DISTRIBUIÓN Almacén General SOLIITUD y/o REVISIÓN DE MEDIAMENTOS D. Directa a Pacientes REEPIÓN VALIDAIÓN PREPARAIÓN DISPENSAIÓN Externos ORDEN MÉDIA Prescripción - Solicitud GESTIÓN DE LA FÁRMAOTERAPIA INFORMAIÓN SEGUIMIENTO Muestras REEPIÓN GESTIÓN DE MUESTRAS PARA INVESTIGAIÓN LÍNIA ALMAENAMIENTO Y ONSERVAIÓN OPERATIONAL PROESOS PROESSES OPERATIVOS GESTIÓN DEL RIESGO PAIENTES PERSONAL SANITARIO (Médicos y Enfermería). AUTORIDADES SANITARIAS PAIENTES PERSONAL SANITARIO (Médicos y Enfermería). S A T I S F A I Ó N L I E N T E E INVESTIGADORES Prescripción ENSAYOS LÍNIOS REEPIÓN SOLIITUD/ORDEN MÉDIA VALIDAIÓN y/o REVISIÓN PREPARAIÓN, si procede DISTRIBUIÓN o DISPENSAIÓN INVESTIGADORES y PROMOTOR ONTROL ZONA ASÉPTIA GESTIÓN APLIAIONES INFORMÁTIAS SUPPORTING PROESS OMPRAS/VERIFIAIÓN EVALUAIÓN PROVEEDORES GESTIÓN ALMAENES MANTENIMIENTO EQUIPOS ALIBRAIÓN/VERIFIAIÓN ONTROL DOUMENTAIÓN ONTROL REGISTROS AUDITORÍAS INTERNAS ONTROL NO ONFORMIDADES: Servicios, SG, Reclamaciones clientes AIONES ORRETIVAS Y PREVENTIVAS 7
PHARMAY Department STRATEGI PROESSES HUMAN AND MATERIAL RESOURES FINANIAL RESOURES EVALUATION AND IMPROVEMENT OF QUALITY PLANIFIATION IMPROVEMENT OBJETIVES MANAG. REVIEW DATA ANALYSIS LIENT SATISFATION FOLLOW UP PROESSES AND SERVIES OPERATIONAL PROESSES ENVIROMENTAL ASEPTI AREA MAINTENANE OF EQUIPMENT ALIBRATION/ VERIFIATION PROVIDERS QUALIFIATION STORE IT SUPPORTING PROESSES DOUMENTATION REORDS INTERNAL AUDITS NON-ONFORMITY PREVENTIVE AND ORRETIVE ATIONS OPERATIONAL PROESSES AQUISITION SELETION AQUISITION REEPTION STORAGE OMPOUNDING NON STERILE PRODUTS PARENTERAL NUTRITION YTOTOXIS DISPENSING INPATIENTS NAROTIS STOK OUTPATIENTS PHARMAOTHERAPY INFORMATION FOLLOW UP LINIAL TRIALS DISPENSING RISK MEDIATION ERRORS ADVERSE DRUG REATIONS 8
DOUMENTATION PROESSES (Strategic, Operational and Supporting) SPEIFI PROEDURES STANDARD OPERATING PROEDURES P D EXTERNAL DOUMENTATION QUALITY REORDS DOUMENT MANAGER Pharmacy Department 2.- MEASURING THE PERFORMANE OF THE PROESSES P D Nonconformities Follow-up meetings Quality commitee meetings Indicators 9
# ERRORS 03/05/2013 DISPENSING TO OUTPATIENTS Rate of medication errors that affected outpatients ( ) 80 70 60 50 69 55 BARODE SANNER ( 60%) PERMANENT PERSONNEL ( 80%) 40 30 20 10 0 2007 2008 33 2009 2010 2011 POE 2012 7 2 2 2,64 2,12 0,73 0,15 0,04 0,13 ELABORATION OF YTOTOXIS Microbiological monitoring of samples of preparations Visual quality control check of the finished product Indicators: To ensure sterility of the enviroment and product To avoid errors in the preparations 10
ELABORATION OF YTOTOXIS Errors detected BEFORE dispensing Errors in cytotostic detected AFTER dispensing : SENTINEL EVENT TRAEABILITY SYSTEM Right: 2011: 3 ERRORS DOSE DILUENT VOLUME PATIENT 3.- DEVELOPING STRATEGIES FOR ONTINUOUS IMPROVEMENT A P D lient satisfaction Indicators Audits omplaints Nonconformities 11
3.- DEVELOPING STRATEGIES FOR ONTINUOUS IMPROVEMENT A P D NONONFORMITIES REORD EFFIAY VERIFY ANALYSIS DATE TO IMPLEMENT ORRETIVE ATIONS 3.- DEVELOPING STRATEGIES FOR ONTINUOUS IMPROVEMENT A P D OPPORTUNITIES FOR IMPROVEMENT BARODE FOR OUTPATIENTS ADD FOR NAROTIS at Ph Dept. THERAPEUTI PROTOOLS POE SYSTEM DOUMENTAL MANAGER FOR QMS 12
3.- DEVELOPING STRATEGIES FOR ONTINUOUS IMPROVEMENT QUALITY OBJETIVES A P D TRAEABILITY YTOSTATIS ENTRALISED PREPARATION IV SOLUTION emar (Hospitalization and Emergengy) IMPROVEMENT ATIONS IN ADDs (HFMEA) SAFE USE MEDIATIONS (Oncology, Internal Medicine and Haematology) IMPROVE MEDIATION ADMINISTRATION (HFMEA) Design a MEDIATION REONILIATION programme STRENGTHS OF OUR QMS Guidance from Hospital Quality Unit Straightforward and of our own Involvement of Ph Dept. personnel Process approach Reformulation of activities Redistribution of workloads Monitoring of process keypoints ontinuous improvement 13
With an ISO 9001:2008-based QMS All activities necessary for each process are identificated Activities are systematized Activities are performed as efficiently as possible The efforts to produce even more better results are endless THANK YOU!! 14