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