risk management in obstetrics s arulkumaran professor & head division of obstetrics &...
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RISK MANAGEMENT IN OBSTETRICS
S ArulkumaranProfessor & Head
Division of Obstetrics & GynaecologySt.George’s Hospital Medical School
University of London
Some Definitions
Risk: The potential for unwanted outcome (Wilson)
Chance or possibility of loss or bad consequence
(Oxford dictionary)
Clinical Risk Incident: Injury or harm to a patient
as a result of care or treatment
Near Miss: An incident where there is a potential
for harm or injury to a patient
Serious Clinical Incident
a situation in which one or more patients are
involved in an incident which is likely to have:
1. An adverse effect on patients
2. Cause a major disruption to service
3. Attract press/media attention
4. Lead to a legal claim
Whose fault is it?
Speed limitFailure of brakesUntrained driverDriver sleptNew territoryFaulty/new tracksFaulty/new signalsNo speed check
Contingent Liability by Speciality(CNST, 1997)
Speciality
Accident & Emergency
Anaesthetics
General Surgery
Gynaecology
General Medicine
Paediatrics
Obstetrics
Orthopaedics
Cardiac Surgery
Others
TOTAL
Value £million
2.3
2.9
2.1
1.2
1.6
2.9
59.1
1.6
1.5
6.0
81.2
Medical Negligence in the UK
Potential claims £2.8bn in 1998
Obstetrics - largest claims - £1.4bn
Handicapped child - sadness for life
38% of claims handled by defence unions
Potential Problem Areas : Obstetrics (1)Antenatal• Pre-natal diagnosis
Labour/Delivery• Meconium stained liquor• CTG interpretation/fetal blood sampling• Decisions to “wait and see”• Use of oxytocic drugs• Management of previous LSCS• Inappropriate use of forceps• Shoulder dystocia• Analgesia
Potential Problem Area : Obstetrics (2)
Postnatal
Rubella immunisation
Anti-D immunoglobulin
Guthrie result
Contraceptive advice
Potential Problem Areas : Gynaecology
• Complications of surgery
• Failed sterilisation
• Delay in diagnosis
• “Lost” IUCD
• Retained foreign bodies
Why Do Risks Occur?
• System failures
• Short cuts
• Communication breakdowns
• Ill-defined responsibilities
• Inadequately trained staff
• Inadequate policies/procedures/guidelines
• Poor interagency/interdepartmental working
• Dishonesty
Harvard Study : Hospital Adverse Events
• Study of >30,000 hospital records
• Acute care setting - New York hospitals
• 51 hospitals randomly selected
Adverse events identified in the treatment of 3.7%
Approximately 28% of these considered to have
resulted from negligent care or treatment
NHS ERRORS: FACTS AND FIGURES
• An estimated 850,000 adverse incidents and errors occur every year in the NHS, affecting one in ten admissions
• A third of adverse incidents lead to patient disability or death
• Adverse events cost approximately £2bn a year in hospital stays alone
• Clinical negligence cost the health service more than £400m a year
bma news 1.3.03.
Error Producing Conditions(William, 1988)
Condition
Unfamiliarity with task
Time shortage
Information overload
Misperception of risk
Poor feedback from system
Inexperience
Poor instructions
Inadequate checking
Disturbed sleep patterns
Hostile environment
Risk Factor
x17
x11
x6
x4
x4
x3
x3
x3
x1.6
x1.2
National Patient Safety Agency-NPSA
NPSA targets – end of 2005• Cut the number of incidents in obstetrics and
gynaecology that result in litigation by 25 %• Cut the number of serious prescribed drug errors
by 40 %• Eliminate suicides by hanging from shower and
curtain rails among mental health patientswww.npsa.org.uk www.doh.gov.uk/buildsafenhs
Clinical Risk Management : Aims (1)
To reduce/eliminate harm to patients
Improve quality of care
Deal effectively with the injured patient:
• explanations/apology
• provide continuity of care
• swift compensation
Clinical Risk Management : Aims (2)
To protect the Trust:
• staff morale/supporting staff
• reputation
• financial resources
To meet clinical governance initiatives
To achieve CNST standards
Risk Management Process (1)
Identification of Risk
Analysis of Risk
Control of Risk
Funding of Risk
Risk Management Process (2)
Organisation of service
Professional competence
Equipment
Record keeping
Communication
Risk Management Group
• Lawyer with medical litigation experience - Chair• Senior Midwife - collected adverse events/ statements -
Co-ordinator• Clinical Director of Obstetrics and Gynaecology• Director of Midwifery• Consultant Anaesthetist and Paediatrician• Consultant Obstetrician and Senior Registrar• Hospital Legal Officer
Tasks of Risk Management Group
• Review based on list of adverse events - cases of possible litigation
• Advice on general management policies
• Support for staff and patients
• Staff give a report when events are fresh
• Not called to give evidence - supportive and not inquisitorial
• Identifies unsatisfactory practices
Identification of Risk• Encourage incident reporting
• Should have an open organisational (proportionate blame) culture
• Research and sharing of evidence based practice
• Incident may be trivial - recurrences need remedial action
• Open discussions of “near miss incidents”
Events That Need Reporting
• Admission to NNICU for severe birth asphyxia
• Neonatal convulsions
• Shoulder dystocia
• Intrapartum stillbirth
• Birth trauma
• Undiagnosed congenital malformation
Investigation of Adverse Events – (RCA)
Poor outcome
Near miss events
1. Identify incident
2. Interview participants : ensure confidentiality• all involved : may include non-clinical staff, parents• explain purpose of interview• ask to provide a detailed description of sequence of
events• special reference to own role and anyone they came into
contact with
Investigation of Adverse Events (2)
• Use open questions• establish reasons why action taken/not taken• anything different with benefit of hindsight? Any
suggestions for improvements• follow up references to changes in pace, emotions• clarify any contradictions• notes may act as a distraction at early stage - can prevent
description of thinking behind action• follow up interview with access to casenotes for accuracy
THE RISK MANAGEMENT PROCESSIdentify healthcare risk
Review current practices (AUDIT)
Establish goals that will eliminate/reduce risk
Develop action plan to meet goals
Educate/train staff on desired changes
Monitor changes (AUDIT)
Have changes reduced risk frequency/severity?
NO : re-establish goals YES : continue to monitor
Review of Records
Compliance with agreed guidelines/protocols; Administration of steroids if delivery <34 wks Consultant presence - in potentially complicated CS,
placenta previa, abruptio placenta, preterm <32 wks, multiple previous CS
Prophylactic antibiotics and thromboprophylaxis for CS Decision to delivery interval <20mins - pH <7.20,
abruption, cord prolapse, scar dehisence, prolonged bradycardia >10mins
Risk Management Audit
Cyclical
Rectify shortcomings
Show improvement in next audit cycle
Surgical Morbidity
• Cystotomy• Ureter injury• Vesico-vaginal fistula• Bowel injury (full thickness)• Haemorrhage - return to OR
- transfusion
- haematoma• Reoperation (includes such things as drainage of abscess,
reimplantation of ureter etc.)
Associated Morbidity
• Infection - requiring antibiotics, but excluding UTI (Pyelonephitis included)
• Bowel : Ileus/Obstruction• Thromboembolism• Readmission - within 6/52 or related to the original
surgery• ICU
Risk Analysis
Analysis of reported incidents and outcome of
audits - determines:-
Severity of risk
Likelihood of recurrence
Cost benefit analysis
Prioritisation
Additional funding to contain risk
Risk Control (1)
• General and specific action plans
• Multidisciplinary and known to all staff
• Include in staff induction programmes
• Protocols and guidelines accessible to staff and in different work areas
Risk Control (2)
• Difficulty in adhering to protocols - remedial action to be taken
• Good and competent clinical practice
• Good communication
• Good record keeping
Organisation of Service (1)
Adequate staffing level
• 1.5 midwives to 1 woman in labour if not all the time - majority of time
• Experienced obstetrician, paediatrician and anaesthetist available within delivery unit or at short notice
Organisation of Service (2)
• Designated consultant to delivery unit. Overall responsibility for guidelines/ protocol development, standard setting and audit
• Multidisciplinary team to resolve major clinical problems
• Clear professional responsibilities in intrapartum care
Medical Equipment
Adequate to provide care (eg ventilators)
Checked and maintained regularly
Staff know how to use them and resolve problems
Equipment updated especially with increased services
Additional equipment
Professional Competence
Induction programme is mandatory
Supervised clinical care for period of time
Skill in adult and neonatal resuscitation
Training in interpretation of CTG
Emergency drill for PPH, shoulder dystocia
Review of statistics/case discussions/
educational activities
Communication (1)
Verbal if not adequate - written information
Different languages - interpreters
Definitive explanation and consent
(written if risks +)
e.g. screening and diagnostic tests, operative deliveries
Communication (2)
Honest explanation by involved Senior Clinician when things go wrong
Communication with on-call staff - streamlined
High risk areas - personnel handover at the senior level
Lines of communication and command should be clear
Record Keeping
• Legible, accurate annotated date/time, signature• Complete and contemporaneous• Mother and baby notes stored for 25 years• CTG - electronic archival - fades and gets misplaced• Photocopies of notes and CTGs - certified and kept• Policy decisions regarding place and format of storage -
obstetricians should be involved
Success of Clinical Risk Management
• No immediate dividends
• Difficult to quantify
• Avoidance of adverse outcome and medico legal claims
• Prime motive of risk management - improvement of quality of care
• Culture of openness, clinical competence, professional development, good practice and communication
“Risk Management should be a mandatory agenda to improvequality of service”
Clinical Governance
Accreditation of ProfessionalServices revalidation Guidelines
Education & Training
Audit
Risk management Patients’ complaints
CLINICAL PRACTICE
Research & Audit
Cost effectiveHealth care
Consultation – notconfrontation
Evidence based medicine
Patient’s wishes/request
FacilitiesAvailable/Knowledgeexperience
Whose fault is it?
Speed limitFailure of brakesUntrained driverDriver sleptNew territoryFaulty/new tracksFaulty/new signalsNo speed check
Mostly it is a System Failure
THANK YOU