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)

1. Madrid - May 11 th 2006
SCIENTIFIC CONFERENCE : PATIENT
SAFETY AND QUALITY ASSURANCE
The 2005 National French Adverse Event
Study : ENEIS
Anne Farge - Broyart
Ministry of Health
Hospitalization and
health care organization department
11.05.2006

2. 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 errors
Design
Prospective assessment of AE by senior nursing and doctor external
investigators with ward staff
Coordination
A regional network - Committee on coordination and clinical evaluation an
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quality in Aquitaine (CCECQA ) with 6 regional teams

3. 11.05.2006

4. Incidence of AE during hospitalization
6,6 AEs / 1000 days
(1 every 5 days in a 30 bed ward)
37% preventable
Total AEs % Preventable
Number ‰ [CI 95%] AEs
Medicine 106 6,2 [4,9 ; 7,5] 43,4
Surgery 149 7,0 [5,8 ; 8,3] 32,9
Total 255 6,6 [5,7 ; 7,5] 37,2
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5. Number of AE identified during hospitalization according to
preventability and to anatomic location
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
Preventable
ENT system
Non preventable
Pain
Haematological disorder
Psychiatric disorder
Endocrine system
Stomatologic disorder
0 5 10 15 20 25 30 35 40 45
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6. AE during hospitalization and preventabibity
score
Inhalation pneumopathy during anaesthetic induction for oesophagal diverticulum in a man 48 4
yrs
Pneumothorax in a male patient 51 yrs hospitalised for pneumonectomy (aspergillosis on 5
tubercular sequellae) occurring subclavian catheterisation
Stomach lesion during nephrectomy via celioscopy, requiring subsequent open surgery in 4
woman 59 yrs
Perforation of the colon during colonoscopy in a man 73 yrs 4
Dissatisfaction of patient 57 yrs and hospitalisation for endoscopic retrograde 6
cholangiopancreatography under general anaesthetic delayed on account of a leak in the
endoscope discovered once the patient was anaesthetised
Patient 79 yrs dissatisfied after discharge was delayed; patient hospitalised for spontaneous 4
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.
Lumbar pain in connection with second lumbar vertebra fracture non diagnosed in emergency 4
unit, delay in diagnosis and corset fitted, man 20 yrs.
Hospitalisation for acute sigmoiditis and varicose ulcer treatment in a female patient 96 yrs. 4
Intense systematic pain during care procedures despite preventive treatment (15mg morphine
in subcutaneous administration).
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7. Incidence of hospital admission caused by
AEs
4% of admissions caused by AEs
45% Preventable
% Preventable
Total AEs
AEs
Number % [IC à 95%]
Medicine 95 4,5 [3,5 ; 5,6] 53,8
Surgery 96 3,5 [2,7 ; 4,3] 35,8
Total 191 3,9 [3,3 ; 4,6] 44,7
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8. AE leading to hospitalization and
preventabibity score
Demented female patient 85 yrs hospitalised for cognitive disorders. Recently instated 4
treatment for arthritic pain causing confusion; improvement after dose adjustment
Ischaemic CVA in a female patient 61 yrs under long-term anticoagulants (mitral prosthesis). 4
Preventive treatment dosage too low (INR=2,87 (expected value between 3,5 and 4,5)
from10 days prior to hospitalisation)
Hospitalisation of a child, on parents’ initiative, for pneumococcal meningitis on 4th day of 6
fever, following consultations with GP who diagnosed upper respiratory tract infection
Admission of female patient 80 yrs for confusion syndrome aggravated by 3 changes in 4
wards in 4 days. Initial hospitalisation for dislocated shoulder
Woman 22 yrs admitted to intense care for meningitis following subarachnoid anaesthesia 5
during childbirth
Infection of the operative site, abscess at port of entry and arthritis of the knee; septicaemia 4
following removal of osteo-synthetic material on the tibia in a male patient 48 yrs with no
particular comorbidity
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 5
home, female patient 78 yrs
Hospitalisation of a woman 76 yrs for haematemesis and melaena in connection with grade 5
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
Acute pancreatitis and partial colic necrosis following endoscopic sphincterectomy for 4
choledocolitheasis in a man 33 yrs
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9. Main exposure or mechanism
% of hospital stays Incidence density of
arising from at least AE during
one preventable AE hospitalisation
n n
% ‰
32 56
Invasive procedure 0,76 1,40
23 0,58
- among them, surgical procedure 1,00
39
44 30
Healthcare product 0,90 0,70
36 0,78
- among them, medications 0,48
22
18 17
Care-related infection 0,37 0,41
6 0,16
- among them, wound infection 0,02
1
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10. Type of active error (% of AE)
All AE Preventable
(n=450) 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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11. Contributory factors (45 root cause analysis)
Clinicalprotocol/policy
Communication w ith patient/familiy
Workload, staff supervision
Delay/availability of information
Reporting, coordination
Equipment/supply
Facing unexpected situation
Betw een w ards coordination
financial shortage
Definition of responsability
Know ledge, attitude
Task planification
Safety culture
Building
Weakly associated
Stress
Strongly associated
Betw een HCO coordination
Outside area of expertise
Conflicts
0 2 4 6 8 10 12 14 16 18 20
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12. Contributary factors as pathways for
occurrence of preventable AE
Prev
AE
Individual clinical team tasks environment organisation institution
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13. Key points
40% of AE
preventable
2/3 of the AE during a
hospital stay
What?
Who ?
Where?
seriousness : 40% of Patient : 2/3 with
AE = only prolongation complex medical
of hospitalization status
≥1 AE occured in 2/3
of the wards for a
seven 7 days 11.05.2006

14. http://www/drees/publica/indexpub.htm
11.05.2006

15. Next steps
A national serious adverse events reporting
system to build
- A mandatory system : law of August 9th 2004 (loi de santé
publique)
- Hospital and primary care
- A three year experimentation period before implementation
October 2005 : a meeting on serious health
adverse events and reporting system
http://www.sante.gouv.fr/htm/dossiers/risques_etabs/accueil.htm
11.05.2006