Sin t

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ENQual Complaint registration and risk
management for specific groups in Spain
Susana Lorenzo MD, MPH, PhD Quality
Manager Fundación Hospital Alcorcón
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2002 National health service desegregated
Autonomous Communities
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Cultural changes in health care risk

• New diagnosis and therapeutic methods 5
  incidence of toxic reactions and important
  accidents (1955).
• Illnesses consequence of medicine progress
  (1956).
• 20 of hospitalized patients undergo health
  complications. 4,7 were important (1964).

Barr DP. Hazards of modern diagnosis and therapy
- the price we pay. JAMA 1955 159 1452.Moser
RH. Diseases of medical progress. N Engl J Med
1956 255 606.Schimmel EM. The hazards of
hospitalization. Annals of Internal Medicine
1964 60(1) 100-110.
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ADVERSE EFFECTS HOSPITAL HEALTHCARE

• New York1State, 1984.
• 3,7 hospitalized patients AE. 13,6 deaths
  (98.000 deaths/year).
• Half preventable. Many avoidable.
• Colorado Utah2, 1992.
• 2,9 hospitalized patients AE. 6,6 deaths
  (44.000 deaths/year).
• Half preventable. Many avoidable.

1Brennan TA, Leape LL, Laird NM, et al. Incidence
of adverse events and negligence in hospitalized
patients Results of the Harvard Medical Practice
Study I-II. NEJM 1991 324 370-84.2 Thomas EJ,
Studdert DM, Burstin HR, et al. Incidence and
types of adverse events and negligent care in
Utah and Colorado. Med Care 2000 38 261-71
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Risk management patients
Alicante research multicentric project
Madrid research project anesthesia
Salamanca monitoring project
Barcelona monitoring project
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http//www.dsp.umh.es/proyectos/idea/index.html
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OBJETIVES

• To identify and define hospital healthcare AE.
• To determine the incidence of AE in 13 services
  of 8 hospitals.
• To analyze the patients and healthcare
  characteristics associated to AE.
• To estimate the impact of AE distinguishing
  avoidable and non-avoidable AE.

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DESIGN

• Cohort Prospective Multicentric Study.
• Qualitative study.
• Nested study
• diagnostic test evaluation Screening Guide.
• Effectiveness of the studies to detect AE in
  Obstetrics.
• AE Impact on newborn Obstetrics
• AE in colorectal cancer.
• surgeons opinion on AE in practice
• .../...

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Aragón - Hospital C. Universitario Lozano Blesa
(Zaragoza) - Servicio de Cirugía General -
Servicio de Psiquiatría - Hospital Miguel Servet
de Zaragoza - Servicio de Cirugía General -
Servicio de Psiquiatría
Ámbito del estudio
Comunidad Valenciana - Hospital General
Universitario de Alicante - Servicio de
Ginecología y Obstetricia - Servicio de Cirugía
General - Hospital C. Universitario de San Juan
de Alicante - Servicio de Cirugía General -
Hospital de San Vicente del Raspeig de Alicante.
Comunidad Canaria - Complejo Hospitalario
Materno Insular de Gran Canaria - Servicio de
Ginecología y Obstetricia
Madrid - Hospital Universitario 12 de Octubre -
Servicio de Cirugía General - Servicio de
Psiquiatría - Servicio de Medicina Interna
Andalucía - Hospital Universitario Virgen de las
Nieves (Granada) - Servicio de Cirugía General
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OPERATIVE DEFINITION
Every accident or incident in the Medical
Record that might have caused harm to the
patient, linked to health care conditions or to
the patient ones.
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STUDY ESTRATEGY
SAMPLE 1.000 medical record
AE Screening Guide
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Medical record screening 200
Modular Questionnaire MRF2
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ADVERSE EVENTS 40
Analysis Moment every 2 days and discharge.
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SCREENING GUIDE

1. Previous hospitalization lt12 meses antes (si gt65
   años 6 meses)
2. Neoplasic Treatment Previous to hospitalization
3. Trauma during hospitalization
4. Drug adverse reaction during hospitalization
5. Temperature gt38.3ºC the day before discharge
6. transfer from general unit to special care unit
7. Transfer to another acute hospital
8. Second surgery during hospitalization
9. Treatment or intervention due to damage during an
   invasive procedure
10. New neurological Deficit at discharge
11. AMI, CVA o PTE during or after an invasive
    procedure
12. Cardio/respiratory Stop
13. Damage or complication related to abortion,
    amniocentesis or labor.
14. Death
15. Opened Surgery not foreseen or hospitalization
    for surgical intervention
16. Damage or complication related to ambulatory
    surgery or invasive procedure that caused
    hospitalization or emergency evaluation
17. Adverse Effect.
18. Notes in the medical record that might suggest
    litigation
19. Nosocomial Infection.

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Piloting of MRF2

• Aim - to test and comment on quality of form
• - not to conduct an AE study
• 12 teams took part in the piloting of the MRF2
• (Britain, Italy, France, Spain, Australia, New
  Zealand, Japan USA)
• Completed new forms and evaluation questionnaires
• Instructions - to take time to understand review
  process and interpret definitions correctly

Maria Woloshynowych, PhD Clinical Safety Research
Unit Imperial College London. Measuring Errors
and Adverse Events in the UK. Valencia - 16
May 2003.
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(No Transcript)
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AnesthesiaCommunication and analysis of critical
incidents
Antonio Bartolomé Ruibal Área de Anestesia,
Reanimación y Cuidados Críticos Fundación
Hospital Alcorcón
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Anesthesia patient security Model or myth?
Muertes relacionadas con la anestesia (Por 10.000
anestesias)
Modified from Lagasse RS. Anesthesia safety
Model or myth? Anesthesiology 2002 97 1609-17.
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Anesthesia patient security Model not myth

• Non traditional research techniques
• critical Incident
• ASA Closed Claims Study
• Australian Incident Monitoring Study
• Technology
• Standards and guidelines
• Human factor and system focus

Gaba DM. Anesthesiology as a model for patient
safety in health care. BMJ 2000 320 785-8.
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Critical Incident

• (...) This study was one of a few pivotal events
  responsible for the dramatic success in promoting
  anesthesia patient safety (...)
• Pierce EC. Looking back on the anesthesia
  critical incident studies and their role in
  catalysing patient safety. Qual Saf Health Care
  200211282-3.

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Communication and analysis of critical incident
system

• Fundación Hospital Alcorcón 1999.
• CQI
• Anonymous communication and voluntary of critical
  incidents.
• Root analysis.
• Improvement actions.
• Does not need negative publicity

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Results1999-2003

• 44311 anesthetic procedures
• 446 critical incidents (1 )

Definitions According to Lunn JN. Anaesthesia
1985 40 79.
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Improvement actions

• New protocols (6)
• Modification of previous protocols (2)
• IC Modification (1)
• Hazardous material discharge (4)
• New material (4)
• equipment repair (2)
• equipment modification (3)
• Sessions (16)
• Alerts (13)

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Claim management. Madrid Regional Service.
Order 605/2003 21 april Suggestions and Claim
Hospital Public Service

• lt 30 days
• any client can use it
• where, reception procedure
• answering procedure
• follow up and evaluation commision
• annual follow up