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S Arulkumaran Professor & Head Division of Obstetrics & Gynaecology St.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 limit Failure of brakes Untrained driver Driver slept New territory Faulty/new tracks Faulty/new signals No 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)

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

• 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 patients www.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


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

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

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

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 improve quality of service”

Clinical Governance
Accreditation of Services Professional revalidation

Guidelines Education & Training Audit
Risk management Patients’ complaints

Research & Audit

Evidence based medicine Patient’s wishes/ request Facilities Available/ Knowledge experience

Consultation – not confrontation

Cost effective Health care

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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