The 2005 National French Adverse Event Study: ENEIS
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11.05.2006 SCIENTIFIC CONFERENCE : PATIENT SCIENTIFIC CONFERENCE : PATIENT SAFETY AND QUALITY ASSURANCE SAFETY AND QUALITY ASSURANCE The 2005 National French Adverse The 2005 National French Adverse Event Event Study Study : ENEIS : ENEIS Anne Farge - Broyart Ministry of Health Hospitalization and health care organization department Madrid - May 11 th 2006
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The 2005 National French Adverse Event Study: ENEIS. Anne Farge – Broyart. Presentation of the National Study of Adverse Events (Madrid, Ministry of Health and Consumer Affairs, 2006)
Transcript of The 2005 National French Adverse Event Study: ENEIS
11.05.2006
SCIENTIFIC CONFERENCE : PATIENT SCIENTIFIC CONFERENCE : PATIENT SAFETY AND QUALITY ASSURANCESAFETY AND QUALITY ASSURANCE
The 2005 National French AdverseThe 2005 National French Adverse Event Event StudyStudy : ENEIS: ENEIS
Anne Farge - BroyartMinistry of HealthHospitalization and
health care organization department
Madrid - May 11 th 2006
11.05.2006
The Adverse Event (AE) French national study
A first national study- The Ministry of Health needed data on serious adverse events to
implement patient safety policy- The department of Research, Studies, Evaluation and Statistic
(DREES) set up the study called “ENEIS”Objectives of ENEIS
- To estimate the incidence of serious adverse events (AE) in medical and surgical activities in public and private hospitals
- To assess the patient clinical situation and the active errorsDesign
Prospective assessment of AE by senior nursing and doctor external investigators with ward staffCoordination
A regional network - Committee on coordination and clinical evaluation anquality in Aquitaine (CCECQA ) with 6 regional teams
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Incidence of AE during hospitalization
6,6 AEs / 1000 days (1 every 5 days in a 30 bed ward)
37% preventable
32,9149 7,0 [5,8 ; 8,3] Surgery
37,2255 6,6 [5,7 ; 7,5]Total
43,4106 6,2 [4,9 ; 7,5] Medicine
% PreventableAEs
Total AEsNumber ‰ [CI 95%]
11.05.20060 5 10 15 20 25 30 35 40 45
Respiratory tract
Digestive tract
Heart
Vessels
Nephro-urologic system
Skin
Multi-organ disorder
Psychological disorder
Electrolytic disorder
Nervous system
Locomotor system
Genitourinary system
Ophtalmologic system
ENT system
Pain
Haematological disorder
Psychiatric disorder
Endocrine system
Stomatologic disorder
Preventable
Non preventable
Number of AE identified during hospitalization according to preventability and to anatomic location
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Inhalation pneumopathy during anaesthetic induction for oesophagal diverticulum in a man 48 yrs
4
Pneumothorax in a male patient 51 yrs hospitalised for pneumonectomy (aspergillosis on tubercular sequellae) occurring subclavian catheterisation
5
Stomach lesion during nephrectomy via celioscopy, requiring subsequent open surgery in woman 59 yrs
4
Perforation of the colon during colonoscopy in a man 73 yrs 4 Dissatisfaction of patient 57 yrs and hospitalisation for endoscopic retrograde cholangiopancreatography under general anaesthetic delayed on account of a leak in the endoscope discovered once the patient was anaesthetised
6
Patient 79 yrs dissatisfied after discharge was delayed; patient hospitalised for spontaneous haematoma of the left intracranial haemorrhage, waited 25 days for a control scan which was never actually performed. Communication problem between hospitalisation departments and imagery departments.
4
Lumbar pain in connection with second lumbar vertebra fracture non diagnosed in emergency unit, delay in diagnosis and corset fitted, man 20 yrs.
4
Hospitalisation for acute sigmoiditis and varicose ulcer treatment in a female patient 96 yrs. Intense systematic pain during care procedures despite preventive treatment (15mg morphine in subcutaneous administration).
4
AE during hospitalization and preventabibity score
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Incidence of hospital admission caused by AEs
4% of admissions caused by AEs
45% Preventable
35,896 3,5 [2,7 ; 4,3] Surgery44,7191 3,9 [3,3 ; 4,6]Total
53,895 4,5 [3,5 ; 5,6] Medicine
% PreventableAEs
Total AEsNumber % [IC à 95%]
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AE leading to hospitalization and preventabibity score
Demented female patient 85 yrs hospitalised for cognitive disorders. Recently instated treatment for arthritic pain causing confusion; improvement after dose adjustment
4
Ischaemic CVA in a female patient 61 yrs under long-term anticoagulants (mitral prosthesis). Preventive treatment dosage too low (INR=2,87 (expected value between 3,5 and 4,5) from10 days prior to hospitalisation)
4
Hospitalisation of a child, on parents’ initiative, for pneumococcal meningitis on 4th day of fever, following consultations with GP who diagnosed upper respiratory tract infection
6
Admission of female patient 80 yrs for confusion syndrome aggravated by 3 changes in wards in 4 days. Initial hospitalisation for dislocated shoulder
4
Woman 22 yrs admitted to intense care for meningitis following subarachnoid anaesthesia during childbirth
5
Infection of the operative site, abscess at port of entry and arthritis of the knee; septicaemia following removal of osteo-synthetic material on the tibia in a male patient 48 yrs with no particular comorbidity
4
Displacement of a fracture of the radius in plaster in a child 10 yrs 4 Stiffness after total prosthesis of the knee, in connection with insufficient physiotherapy at home, female patient 78 yrs
5
Hospitalisation of a woman 76 yrs for haematemesis and melaena in connection with grade A oesophagitis, gastritis and stomal peptic ulcers following anti-inflammatory and anticoagulant treatment instated 2 weeks previously after intervention for dual malleolus fracture. Preventive treatment with proton pump inhibitors (PPI) initially prescribed but discontinued too early
5
Acute pancreatitis and partial colic necrosis following endoscopic sphincterectomy for choledocolitheasis in a man 33 yrs
4
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Main exposure or mechanism
% of hospital stays arising from at least one preventable AE
Incidence density of AE during
hospitalisation
n % n ‰ Invasive procedure 32 0,76 56 1,40
- among them, surgical procedure 23 0,58 39 1,00
Healthcare product 44 0,90 30 0,70
- among them, medications 36 0,78 22 0,48
Care-related infection 18 0,37 17 0,41
- among them, wound infection 6 0,16 1 0,02
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Type of active error (% of AE)
All AE (n=450)
Preventable AE (n=181)
No error 49 24
Failure to adequately implement care 18 35
Failure to choose appropriate care 8 17
Delay in implementing care 8 17
Don’t know 18 8
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Contributory factors (45 root cause analysis)
0 2 4 6 8 10 12 14 16 18 20
Conflicts
Outside area of expertise
Betw een HCO coordination
Stress
Building
Safety culture
Task planif ication
Know ledge, attitude
Definition of responsability
f inancial shortage
Betw een w ards coordination
Facing unexpected situation
Equipment/supply
Reporting, coordination
Delay/availability of information
Workload, staff supervision
Communication w ith patient/familiy
Clinicalprotocol/policy
Weakly associatedStrongly associated
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Contributary factors as pathways for occurrence of preventable AE
PrevAE
Individual clinical team tasks environment organisation institution
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Key points
WhatWhat??
40% of AE preventable
seriousness : 40% of AE = only prolongation
of hospitalization
≥1 AE occured in 2/3 of the wards for a
seven 7 days
Patient : 2/3 withcomplex medical
status
2/3 of the AE during ahospital stay
Who Who ??WhereWhere??
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http://www/drees/publica/indexpub.htm
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Next steps
A national serious adverse events reportingsystem to build- A mandatory system : law of August 9th 2004 (loi de santépublique)- Hospital and primary care- A three year experimentation period before implementation
October 2005 : a meeting on serious healthadverse events and reporting system
http://www.sante.gouv.fr/htm/dossiers/risques_etabs/accueil.htm
