RISK MANAGEMENT IN OBSTETRICS

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RISK MANAGEMENT IN OBSTETRICS

• S Arulkumaran
• Professor Head
• Division of Obstetrics Gynaecology
• St.Georges Hospital Medical School
• University of London

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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

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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

4

Whose fault is it?
Speed limit Failure of brakes Untrained
driver Driver slept New territory Faulty/new
tracks Faulty/new signals No speed check

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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

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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

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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

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Potential Problem Area Obstetrics (2)

• Postnatal
• Rubella immunisation
• Anti-D immunoglobulin
• Guthrie result
• Contraceptive advice

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Potential Problem Areas Gynaecology

• Complications of surgery
• Failed sterilisation
• Delay in diagnosis
• Lost IUCD
• Retained foreign bodies

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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

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Harvard Study Hospital Adverse Events

• Study of gt30,000 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

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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.

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Error Producing Conditions(William, 1988)

• Risk Factor
• x17
• x11
• x6
• x4
• x4
• x3
• x3
• x3
• x1.6
• x1.2

• 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

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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 patients
• www.npsa.org.uk www.doh.gov.uk/buildsafenhs

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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

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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

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Risk Management Process (1)

• Identification of Risk
• Analysis of Risk
• Control of Risk
• Funding of Risk

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Risk Management Process (2)

• Organisation of service
• Professional competence
• Equipment
• Record keeping
• Communication

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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

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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

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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

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Events That Need Reporting

• Admission to NNICU for severe birth asphyxia
• Neonatal convulsions
• Shoulder dystocia
• Intrapartum stillbirth
• Birth trauma
• Undiagnosed congenital malformation

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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

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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

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THE RISK MANAGEMENT PROCESS

• Identify 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

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Review of Records

• Compliance with agreed guidelines/protocols
• Administration of steroids if delivery lt34 wks
• Consultant presence - in potentially complicated
  CS, placenta previa, abruptio placenta, preterm
  lt32 wks, multiple previous CS
• Prophylactic antibiotics and thromboprophylaxis
  for CS
• Decision to delivery interval lt20mins - pH lt7.20,
  abruption, cord prolapse, scar dehisence,
  prolonged bradycardia gt10mins

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Risk Management Audit

• Cyclical
• Rectify shortcomings
• Show improvement in next audit cycle

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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.)

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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

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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

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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

32
Risk Control (2)

• Difficulty in adhering to protocols - remedial
  action to be taken
• Good and competent clinical practice
• Good communication
• Good record keeping

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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

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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

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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

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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

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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

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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

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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

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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

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Risk Management should be a mandatory agenda to
improvequality of service
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Clinical Governance

• Accreditation of
  Professional
• Services
  revalidation
• 
  Guidelines
• Education
  Training
• 
  Audit
• Risk management
  Patients complaints

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CLINICAL PRACTICE
Evidence based medicine
Facilities Available/ Knowledge experience
Patients wishes/ request
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Whose fault is it?
Speed limit Failure of brakes Untrained
driver Driver slept New territory Faulty/new
tracks Faulty/new signals No speed check

Mostly it is a System Failure
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THANK YOU