Clinical Risk Management in Italy State of the Art

1. Clinical Risk Management in ItalyState of the Art Riccardo Tartaglia, MD, Ph. D Clinical Risk Management and Patient Safety Centre Regione Toscana Firenze, 23 Ottobre 2004

2. WHEN did the problem arise? WHY is it important to act? WHO is involved? WHAT are our plans ? HOW can we enhance patient safety?

3. WHEN did the problem arise? The problem of medical errors has always existed but in these last 5 years it bursted • Rapid increase of insurance costs • The patient-doctor relationship has changed and expectations of cure both in quantity and quality have increased in recent years • Scientific literature reports a high number of deaths due to medical errors (Institute of Medicine, 2000)

4. WHY is it important to act? • Primum non nocere • The number of lawsuits has increased. In Italy there are about 12,000 per year (2002), but only 5000 healthcare professionals are condemned (CINEAS - Consortium for insurance engineering) • In Italy insurance costs have sensibly increased and, for example, in Tuscany these costs for hospitals are estimated about € 31.500.000 • CINEAS estimates between 15.000 and 50.000 the number of deaths due to medical errors in Italy • Patient injuried parties claim for an amount of 2.5 billions € in compensations

6. WHO is involved? The departments or wards with the highest number of lawsuits are: • Orthopaedics 16.5% • Oncology 13.0 • Surgery 10.6 • Gynaecology 10,8 (Cittadinanza attiva, Italy 2002)

7. WHAT are our plans ? • Promote a reporting and learning culture • Create a database of adverse events/alert reports (volontary incidents reporting) for an organization with memory • An organization based on memory through a Clinical audit as an educational instrument for clinical risk management • Information campaigns on specific issues for patient safety implementation (wrong site intervention, hospital infections, patient identification, and medication therapy) • Develop usable ICT for healthcare systems (electronic records, alert systems, wireless devices for therapies subministration, hospital information systems)

8. HOW can we enhance patient safety? • Involving healthcare top management • Promoting a reporting and learning culture through informational sensibilazation • Promoting clinical audits on sentinel and adverse events, unsure actions among all the areas involved • Ensuring the presence of Clinical Risk Managers in every hospital (doctors, nurses or other professionals with a specific training in human factor) • Training specific personnel in risk management • By means of the guidelines for patient safety enhancement promoted by the Italian Healthcare Ministry (cognitive approach)

9. A view on the Italian experiences • “Palmhospital” computerized Phisicians Order Entry by palmar vs HWP in 17 infective diseases wards of Lombardia Region • Regione Emilia Romagna, Regional Agency for Health: pilot study of voluntary reporting systems • Regione Toscana, Azienda Sanitaria di Firenze (4 hospitals in Florence): clinical audits as a method to improve patient safety (a voluntary reporting system) and two campaigns: cleaning hands for preventing hospital infections, and to avoid the trascription of therapy from clinical records to other forms (unified therapeutical form) • Certified clinical recordISO 9000 (Niguarda Hospital Milano) • Regione Lazio, Azienda Sanitaria di Roma: a voluntary reporting systems • Regione Veneto: hospital discharge record as an instrument to track errors

10. Knowing is not enough, we must apply Willing is not enough, we must do. Goethe

11. Thank you for your attention