Deepening Topics QM - Implementation

Stages of QM implementation Top management QM-constitution Targets of clinic Training of QM-Team leaders Targets of departments Current state analysis Training of QM-responsibles Procedures Therapeutic standards Optimisation Training of internal auditors QM-manual Certification

Documentation in QM-Systems QM-Manual SOPs Standards Other QM-Documents (Methods, Directives, Forms, Checklists, Reports etc.)

SOP - Structure Purpose, targets, quality indicators Scope Co-applying documents Abbreviations, terms and definitions Responsibility Procedure Distribution Amendments

Structure of guidelines complying to BÄK/KBV I Targets: Indications and contraindications Patient group Procedure: Workflow (Flow-Chart) What is essential / superfluous/ obsolete Monitoring of development (MEASURES!) Recommendation: outpatient or stationary Results: Summary of the known results of the recommended or not recommended procedure

Structure of guidelines complying to BÄK/KBV II Proof and selection criteria: Scientific evicende Evidence based Medicine Benefit, side effects, costs Summary of the recommendations of the guideline Planning of the implementation Informations on usage of the guideline and efficacy Period of validity, responsibility for updating Informations on the elaboration of the guideline: authors consensus procedure

Targets of a Treatment Standard Patient wishes and Patient expectations P Optimal Diagnosis and Therapy of disease Optimising outcome minimising risks Current state of medical and nursing quality Legislation and Authorities Safety Aspects Treatment Standard S E Patient rights, Drugs, Medical Devices, Hygienic requirements Evidence based Medicine Medical guidelines

Example of a Treatment Standard I Surgical Procedure Disease, Purpose, Targets, Quality indicators Indications and Contraindications Alternative procedures Preoperative Diagnostic Typical complication possibilities Surgical procedure e.g. anaesthesic procedure, preoperative planning, bedding, instruction for the surgery, dressing, instruments, consumption material, implants, needs of time, costs and earnings

Example of a Treatment Standard II Surgical Procedure Post-treatment Documentation Hints and Remarks Co-applying Documents Responsibilites, Qualifications Abbreviations, Terms and Definitions Time of validity, Responsibility for updating Procedure as Workflow (Flow-Chart) Distribution Amendments

Example of a Diagnostic Standard Target Quality indicators Abbreviation, terms and definitions Diagnostic procedure Scientific evidence Literature Co-applying documents Alternatives Costs Distribution Amendments

6 documented standards required in ISO Control of documents Control of records Audits Control of nonconforming products and service Corrective action Preventive action

Steps toward systematic QM 1. Analyse and structure the processes 2. Define SOP 3. Compile QM-manual + Text

Failure mode and effects analysis FMEA Conceive potential failures in beforehand, control these and take preventive action Prepare for thinkable occurance of failures and effects Systematic minimizing occurance of failures in process Failure effect minimizing action and prevention Failure assessment – Discussion with rating scales Note: Prepare for the unexpected. It often happens in stress situations, when preventive walls fall! QM is not an instrument only for the good seasons, it shows its unique strength in stress situations!

10 steps of FMEA I Listing of potential failures Collect thinkable failure effects and reasons Estimate ocurrence probability in rating scale 1-10 Estimate impact of effects in rating scale 1-10 Estimate detection probability in rating scale 1-10 Calculate the risk priority number (Multiply the values of steps 3 – 5)

10 steps of FMEA I Develop corrective actions Assess the risk priority number again taking in consideration the effects of possible corrective actions Compare the two risk priority numbers Decide for measures with the greatest potential to reduce the risks

FMEA Collect potential risk with brain storming Assess the effects: Probability of Ocurrance (1=unlikely, 2-3=very sparsely, 4-6=sparsely, 7-8=moderate, 9-10=high) Impact of effects (1=hardly recognizable, 2-3=unimportant, 4-6=moderate severe, 7-8=severe effects, 9-10=extremely severe effects) Probability of Detection (1=high, 2-5=moderate, 6-8=sparsely, 9=very sparsely, 10=unlikely) O x I x D = RPN (risk priority number) (1=no, 125=medium, 1000=high Priority)

FMEA am Beispiel Allgemeinchirurgie Possible Failure O x I D = RPN* Not documented patient informed consent 8 7 448 Mix-up in Patient 1 10 Indication assessment too late 5 9 3 135 Doctor not available 2 18 Oxygen mask not connected 100 Fall of patient in post-anaesthesia care 90 *Note: Necessity for taking action also in case of high single assessment >7

Occurrance probability Risk-graph Occurrance probability Often 6a 6b 6c 6d probably 5a 5b 5c 5d occasionally 4a 4b 4c 4d conceivable 3a 3b 3c 3d unlikely 2a 2b 2c 2d unthinkable 1a 1b 1c 1d   negligible minor critical catastrophic Extent of damage   = acceptabler region = ALARP-region (As Low as Reasonably Practicable) = inaceptable region