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Deepening Topics. QM - Implementation . Stages of QM implementation. Top management. Targets of clinic. QM- constitution. Current state analysis. Training of QM-Team leaders. Targets of departments. Training of QM- responsibles. Procedures. Therapeutic standards. Optimisation.
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Deepening Topics QM - Implementation
Stages of QM implementation Top management Targets ofclinic QM-constitution Currentstateanalysis Training of QM-Team leaders Targets ofdepartments Training of QM-responsibles Procedures Therapeuticstandards Optimisation Training ofinternalauditors QM-manual Certification
Documentation in QM-Systems QM-Manual SOPs Standards Other QM-Documents (Methods, Directives, Forms, Checklists, Reports etc.)
SOP - Structure • Purpose, targets, qualityindicators • Scope • Co-applyingdocuments • Abbreviations, terms and definitions • Responsibility • Procedure • Distribution • Amendments
Structureofguidelinescomplyingto BÄK/KBV I • Targets: • Indications and contraindications • Patient group • Procedure: • Workflow (Flow-Chart) • Whatis essential / superfluous/ obsolete • Monitoring ofdevelopment (MEASURES!) • Recommendation: • outpatientorstationary • Results: • Summary of the knownresultsof the recommendedor not recommendedprocedure
Structureofguidelinescomplyingto BÄK/KBV II • Proof and selectioncriteria: • Scientific evicende • EvidencebasedMedicine • Benefit, sideeffects, costs • Summary of the recommendationsof the guideline • Planningof the implementation • Informations on usageof the guideline and efficacy • Periodofvalidity, responsibilityforupdating • Informations on the elaborationof the guideline: • authors • consensusprocedure
Targets of a Treatment Standard Optimal Diagnosis andTherapyofdisease Patient wishesand Patient expectations P Optimisingoutcomeminimisingrisks Currentstateofmedicalandnursingquality LegislationandAuthoritiesSafetyAspects Treatment Standard S E EvidencebasedMedicine Medical guidelines Patient rights, Drugs, Medical Devices, Hygienicrequirements
Example of a Treatment Standard I SurgicalProcedure • Disease, Purpose, Targets, Quality indicators • Indications and Contraindications • Alternative procedures • PreoperativeDiagnostic • Typicalcomplicationpossibilities • Surgicalprocedure • e.g. anaesthesicprocedure, preoperativeplanning, bedding, instructionfor the surgery, dressing, instruments, consumption material, implants, needsof time, costs and earnings
Example of a Treatment Standard II SurgicalProcedure • Post-treatment • Documentation • Hints and Remarks • Co-applyingDocuments • Responsibilites, Qualifications • Abbreviations, Terms and Definitions • Time ofvalidity, Responsibilityforupdating • Procedureas Workflow (Flow-Chart) • Distribution • Amendments
Example of a Diagnostic Standard • Target • Quality indicators • Abbreviation, terms and definitions • Diagnosticprocedure • Scientific evidence • Literature • Co-applyingdocuments • Alternatives • Costs • Distribution • Amendments
6 documented standards required in ISO • Controlofdocuments • Controlofrecords • Audits • Controlofnonconformingproducts and service • Correctiveaction • Preventiveaction
Steps toward systematic QM 1. Analyse andstructuretheprocesses 2. Define SOP 3. Compile QM-manual + Text
Failuremode and effectsanalysis FMEA • Conceive potential failures in beforehand, controlthese and takepreventiveaction • Prepareforthinkableoccuranceoffailures and effects • Systematicminimizingoccuranceoffailures in process • Failureeffectminimizingaction and prevention • Failureassessment – Discussionwithratingscales Note: • Preparefor the unexpected. Itoftenhappens in stress situations, whenpreventivewalls fall! • QM is not an instrumentonlyfor the goodseasons, itshowsitsuniquestrength in stress situations!
10 steps of FMEA I • Listing of potential failures • Collectthinkablefailureeffects and reasons • Estimateocurrenceprobability in ratingscale 1-10 • Estimateimpactofeffects in ratingscale 1-10 • Estimatedetectionprobability in ratingscale 1-10 • Calculate the riskprioritynumber (Multiply the valuesofsteps 3 – 5)
10 steps of FMEA I • Developcorrectiveactions • Assess the riskprioritynumberagaintaking in consideration the effectsofpossiblecorrectiveactions • Compare the tworiskprioritynumbers • Decideformeasureswith the greatest potential toreduce the risks
FMEA • Collect potential riskwithbrainstorming • Assess the effects: • ProbabilityofOcurrance(1=unlikely, 2-3=verysparsely, 4-6=sparsely, 7-8=moderate, 9-10=high) • Impact ofeffects(1=hardlyrecognizable, 2-3=unimportant, 4-6=moderate severe, 7-8=severeeffects, 9-10=extremelysevereeffects) • ProbabilityofDetection(1=high, 2-5=moderate, 6-8=sparsely, 9=verysparsely, 10=unlikely) • O x I x D = RPN (riskprioritynumber)(1=no, 125=medium, 1000=high Priority)
