Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 1 QM - Implementation Deepening Topics

Dr. Erwig PinterQKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 1

QM - Implementation

Deepening Topics


Stages of QM implementation

ProceduresTraining of QM-responsibles

Targets of clinic

Training of QM-Team leaders

Optimisation

Top management

Targets of departments

Therapeutic standards

Training of internal auditors

Current state analysis

QM-constitution

QM-manual

Certification


Documentation in QM-Systems

Other QM-Documents(Methods, Directives, Forms,

Checklists, Reports etc.)

SOPsStandards

QM-Manual


1. Purpose, targets, quality indicators2. Scope3. Co-applying documents4. Abbreviations, terms and definitions5. Responsibility6. Procedure7. Distribution8. Amendments

SOP - Structure


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 I


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

Structure of guidelines complying to BÄK/KBV II


Patient wishes and Patient expectations

P Optimal Diagnosis and

Therapy of disease

Optimising outcome

minimising risks

Patient rights, Drugs, Medical Devices,

Hygienic requirements

Current state of medical and

nursing quality

Evidence based Medicine

Medical guidelines

ESTreatment Standard

Legislation and Authorities

Safety Aspects

Targets of a Treatment Standard


Surgical Procedure1. Disease, Purpose, Targets, Quality indicators 2. Indications and Contraindications3. Alternative procedures4. Preoperative Diagnostic5. Typical complication possibilities6. 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 I


Surgical Procedure7. Post-treatment 8. Documentation 9. Hints and Remarks10.Co-applying Documents11.Responsibilites, Qualifications12.Abbreviations, Terms and Definitions13.Time of validity, Responsibility for updating14.Procedure as Workflow (Flow-Chart)15.Distribution 16.Amendments

Example of a Treatment Standard II


1. Target2. Quality indicators3. Abbreviation, terms and definitions4. Diagnostic procedure 5. Scientific evidence6. Literature 7. Co-applying documents8. Alternatives9. Costs10.Distribution11.Amendments

Example of a Diagnostic Standard


Control of documents Control of records Audits Control of nonconforming products and service Corrective action Preventive action

6 documented standards required in ISO


Steps toward systematic QM

1. Analyse and structure the processes

2. Define SOP

+ Text

3. Compile QM-manual

VI Anlagen-verzeichnis

V 21 QM-Elemente

IV Abkürzungen

III Aufbau desQMH

II BeschreibungKrankenhaus

I Revisions-verzeichnis

Qualitätsmanagement-Handbuch

Krankenhaus

Verantwortung RA S V PA

E2

D5

D2

D4

I2

D3

M6

M3

I4

D6

R4

A = Arzt, S = Schwester, V = Verwaltung , PA = PatientenaufnahmeE = Entscheidung, D = Durchführung, M = Mitwirkung, I = Info, R = besonderes Risiko

2

3

4

6

5

1

7


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:1. Prepare for the unexpected. It often happens in stress

situations, when preventive walls fall!2. QM is not an instrument only for the good seasons, it shows its

unique strength in stress situations!

Failure mode and effects analysis FMEA


1. Listing of potential failures2. Collect thinkable failure effects and reasons3. Estimate ocurrence probability in rating scale 1-104. Estimate impact of effects in rating scale 1-105. Estimate detection probability in rating scale 1-106. Calculate the risk priority number (Multiply the

values of steps 3 – 5)

10 steps of FMEA I


7. Develop corrective actions8. Assess the risk priority number again taking in

consideration the effects of possible corrective actions

9. Compare the two risk priority numbers10.Decide for measures with the greatest potential to

reduce the risks

10 steps of FMEA I


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


FMEA am Beispiel Allgemeinchirurgie

Possible Failure O x I x D = RPN*

Not documented patient informed consent

8 7 8 448

Mix-up in Patient 1 10 1 10

Indication assessment too late 5 9 3 135

Doctor not available 2 9 1 18

Oxygen mask not connected 1 10 10

100

Fall of patient in post-anaesthesia care 2 5 9 90

*Note: Necessity for taking action also in case of high single assessment >7


Risk-graph

Occurrance probability

Often 6a 6b 6c 6d

probably 5a 5b 5c 5doccasionally 4a 4b 4c 4d

conceivable 3a 3b 3c 3d

unlikely 2a 2b 2c 2d

unthinkable 1a 1b 1c 1d negligible minor critical catastroph

ic

Extent of damage

= acceptabler region = ALARP-region (As Low as Reasonably Practicable) = inaceptable region