Minimising risk in gynaecological surgery

www.elsevier.com/locate/rigp

Reviews in Gynaecological Practice 5 (2005) 152–158

Minimising risk in gynaecological surgery

Juhi Siddiqui, Derek Tuffnell *

Bradford Teaching Hospitals NHS Trust, Maternity Unit, Smith Lane, Bradford BD9 6RJ, UK

Received 28 February 2005; accepted 23 May 2005

Available on
line 5 July 2005
Abstract

Gynaecological surgery involves risks, predominantly to the woman, though potentially to the staff. This article considers how risks in

gynaecological surgery can be avoided or reduced as well as how to learn lessons from adverse events. To do this, the background to risks in

healthcare and the theory of reducing error by taking an organisational rather than individual approach to identification and prevention will be

discussed. No individual is perfect and punishment does not reduce error. This approach demonstrates that reducing risk requires a

combination of prospective and reactive measures.

Having established the basic principles, we consider the approach to gynaecological surgery that minimises risk by ensuring adequate

assessment, explanation of risk and that the surgeon and the surgical team are appropriately trained to undertake the task and deal

appropriately with problems that arise. The reactive element of reducing risk is to acknowledge adverse outcome as it occurs and to have in

place a system to report with a trigger list of events relevant to gynaecological surgery. Then, the root causes which are generally

organisational rather than individual are identified to improve practice by learning from the analysis.

# 2005 Elsevier B.V. All rights reserved.

Keywords: Risk management; Patient safety; Root cause analysis; Gynaecology; Surgery

1. Introduction

Every gynaecological operation inherently carries a

certain amount of risk. Risk can be defined as ‘the

likelihood, high or low, that somebody or something will

be harmed by a hazard, multiplied by the severity of the

potential harm’ [1]. Risk management aims to proactively

identify, assess and treat risks leading to the prevention of

foreseeable adverse events [2]. Adverse health care events

are defined as ‘events or omissions arising during clinical

care and causing physical and psychological injury to a

patient’ [1]. Initially, the focus of risk management was

somewhat defensive—its purpose to protect the hospital

from litigation. Now, a more positive and broader view is

that it is one approach to improving safety and quality of

care [3]. This should be integrally involved with appro-

priateness and acceptability of treatment [4]. This review

will encourage the reader to take a more positive approach

* Corresponding author. Tel.: +44 127 4364520; fax: +44 127 4366690.

E-mail address: [email protected] (D. Tuffnell).

1471-7697/$ – see front matter # 2005 Elsevier B.V. All rights reserved.

doi:10.1016/j.rigp.2005.05.002

by considering how to identify and treat risks in

gynaecological surgery starting pre-operatively and con-

sidering the operation and post-operative course. This will

be done by considering known risks and then evaluating

lessons from adverse events.

2. Background

In the UK, the concept of risk management has been

around for at least 10 years. The establishment in 1995 of the

Clinical Negligence Scheme for Trusts’ (CNST) has led to

the introduction of risk management standards. The

Department of Health document, An Organisation with a

Memory recommended a reduction of 25% in the number of

cases of negligent harm in Obstetrics and Gynaecology by

2005 [1]. This document along with Building a Safer NHS

for Patients, highlighted research, which suggested that

about 10% of patients admitted to UK acute hospitals suffer

some kind of patient safety incident and up to half could

have been prevented [5]. The National Patient Safety

J. Siddiqui, D. Tuffnell / Reviews in Gynaecological Practice 5 (2005) 152–158 153

Agency (NPSA) was formed following these publications,

and estimated that over 850,000 incidents either harm or

nearly harm hospital inpatient in the UK each year, with

44,000 of these incidents proving fatal, half of which were

preventable.

It states that ‘the best way of reducing error rates is to

target systems failure, rather than take action against

individual members of staff’ [6].

It recommends that we need to tackle two myths

identified by Leape:

� T
he perfection myth: if people try hard enough, they will
not make any errors.

� T
he punishment myth: if we punish people when they
make errors, then they will make fewer of them [7].

3. Background theory

Risk management is relatively new in healthcare. Other

industries, for example, nuclear power generation and

aviation, have implemented improvements, based on

models of causation of accidents, for many years. These

models can be applied to health care. Human errors

contribute to accidents in over 90% of cases. The

explanation for this is that equipment has become more

reliable. Unsafe acts come inmany forms—slips, lapses and

mistakes, errors and violations—which all have different

psychological origins.

An error can be defined as the failure of planned actions

to achieve their desired goal. Failure can occur in two ways:

(1) S
lips, lapses, trips and fumbles: which are execution
failures, i.e. the plan is adequate, but the associated

actions do not go as intended. Slips are related to

observable actions and are associated with attentional

failure. Lapses are more internal events and relate to

failures of memory.

(2) M
istakes: which are planning or problem solving
failures. The action may go entirely as planned, but

the plan is inadequate to achieve its intended outcome.

Mistakes can be further subdivided into two groups:

(i) R
ule-based mistakes: which relate to problems for
which the person possesses a prepackaged solution,

acquired as the result of training or experience. This can

be the misapplication of a good rule, the application of a

bad rule or the non-application of a good rule.

(ii) K

Fig. 1. Reasons stages of development of organisational accidents.

nowledge-based mistakes: which occur in new

situations where the solution to the problem has to be

worked out immediately. There is no rule available and

the wrong plan is made. A second distinction needs to be

made between errors and violations. Violations are

deviations from safe operating practices, standards or

rules. The deliberate violations are of interest to us.

Violations can be subdivided into three groups:

(i) R
outine violations: this is when corners are cut.
(ii) O
ptimising violations: when actions are taken for
personal rather than task related goals.

(iii) N
ecessary or situational violations: where breaching
the rules seems the only way to get the job done, where

the rules or procedures seem to be inappropriate for the

situation.

When considering the causes of adverse events, we must

also distinguish between active and latent failures.

Active failures are unsafe acts (errors and violations)

committed by clinicians who are caring for patients. There is

therefore potential for immediate adverse complications.

Latent failures are committed at the level of management,

where the adverse consequences may lie dormant for a long

time [4]. When they combine with local triggering like a high

workload or new staff, the effects of the managerial factors and

the clinician factors combine to produce adverse events [3].

Reason has represented the accident sequence diagram-

matically (Fig. 1). The direction of causality is from left to

right. The accident sequence begins with the negative

consequences of organisational processes (i.e. decisions

concerned with the planning, scheduling, forecasting, policy

making, etc.). The latent failures are then transmitted to the

workplace (operating theatre, the ward, etc.), where they

create the local conditions that promote the errors and

violations (understaffing and high workload). Many unsafe

acts are committed, but only very few of them will penetrate

the defences to produce damaging outcomes. This model

shows that the likelihood of an unsafe act being committed is

influenced both by the nature of the task and by the local

workplace conditions [4].

Similar techniques are to analyse the causes of serious

adverse health care events, e.g. the technique of root cause

analysis suggested by the National Patient Safety Agency.

4. Prospective risk management

This is when we try to predict problems before

they happen. Problems are anticipated and measures put

J. Siddiqui, D. Tuffnell / Reviews in Gynaecological Practice 5 (2005) 152–158154

in place to prevent adverse events occurring. This can be

demonstrated with regard to gynaecological surgery. All

gynaecological procedures have their own predictable risks.

Once these risks are predicted, then assessments can be

made on how to reduce them. Major incidents are rare in

surgery and are usually dealt with promptly and effectively,

resulting in a satisfactory outcome. It is much more likely

that the small cumulative events which individually might

pass unnoticed, lead to a hazardous situation. It is the

identification and management of these risks that enable

surgery to be practised safely

An operation is only a single point in a pathway of care,

we should identify risks in the pre-, intra- and post-operative

period. These risks can then be analysed, to eliminate them

where possible. If they cannot be eliminated, they must be

reduced to a minimum. It is the clinical skills and

professional judgement of the whole surgical team that

influence quality of care received by patients. Organisational

and managerial aspects of care are also essential for the safe

conduct of surgical practice.

4.1. Pre-operative risk management

Pre-operative preparation can prevent, or at least limit,

adverse events intra-operatively. The following issues need

to be tackled even before reaching theatre.

4.1.1. Is an operation the appropriate treatment?

As all surgery carries risks, have other alternatives been

considered, e.g. MirenaTM intra-uterine system rather than a

hysterectomy.

4.1.2. Has the woman been given appropriate

information to give consent?

The recent RCOG guidelines on ‘obtaining valid

consent’ state that before seeking a woman’s consent for

treatment, intervention or operation, you should ensure

that she understands the nature of the condition for which it

is proposed, its prognosis, likely consequences and risks of

receiving no treatment, as well as any possible treatments.

The information should be provided at a time and in a

manner that is appropriate. This should be seen as an

ongoing process from the time of the initial consultation

through to the day of surgery. The signing of the form is one

part of this process. It is commonly suggested this should be

undertaken in the presence of the doctor who intends to

supervise or carry out the procedure. The more important

element is that the patient has appropriate information and

has chosen in the light of the information to proceed with

surgery. In order to have appropriate information, she needs

to be aware of serious or frequently occurring risks and the

fact she has been given this information should be

documented.

Good practice principles should be taken into account

when taking consent. Patients should be treated with

courtesy and respect and their dignity should be maintained

at all times. The scope of the authority given by the patient

should not be exceeded, except in an emergency. Even then

the opinion of other specialists or experienced colleagues

should be sought. Prior consent should be sought to treat any

problem that may arise, especially if the diagnosis or

treatment options are uncertain. It should be elucidated

which procedures the patient would prefer further discussion

about before proceeding.

Occasionally, there is unexpected pathology such as

endometriosis or suspected cancer discovered intra-opera-

tively, for which further surgery is indicated. It is unwise to

proceed with any additional surgical procedures without

discussing it with the woman first, unless complications of

surgery occur which are themselves life-threatening.

Oophrectomy at the time of hysterectomy for unexpected

disease should not be performed without previous informed

consent. Therefore, the possible need for oophrectomy

should be discussed with all women undergoing hyster-

ectomy and their preferences recorded.

With regard to sterilisation, all doctors providing women

with advice on permanent forms of contraception should be

aware of the current guidelines issued on sterilisation [8].

There is an increasing onus on the clinicians to provide as

full as possible information prior to surgery particularly in

an elective environment.

4.1.3. Is the womans’ condition optimal?

This is most pertinent at the extremes of age or if there are

significant co-morbidities. This question should be answered

by the surgeon, the anaesthetist and the physician. Avoidable

risks, such as obesity and smoking should be tackled if

possible [9]. In emergencies, the patient should be

adequately resuscitated and fluid management optimised.

Sometimes, a judgement on balance of risk, such as with a

ruptured ectopic has to be made. Is there benefit or risk by

delay to give fluids and start transfusion?

4.1.4. Is the surgeon adequately trained?

Doctors in training, by definition, lack the knowledge,

skills and experience of fully trained specialists. Learning

through mistakes is not an option where human lives are

concerned. Supervision is the way to learn safely. Whatever

the level of seniority, the quality of consultant supervision

seems to be one of the most important factors in determining

job satisfaction for trainees [10]. Doctors traditionally have

worked in an ‘apprenticeship’. Firstly watching, assisting,

then performing the operation under supervision and then

performing it alone. It has always worked well but it can take

years of apprenticeship to experience uncommon events.

Airline pilots train for hours using simulators but simulators

in medicine are relatively new. They have been used in

laparoscopy and hysteroscopy. Emergency training course

such as MOET and ALSO are more common for emergency

obstetric situations. Emergency behaviour and teamworking

skills are, however, equally applicable in gynaecological

emergencies as well as routine surgery.


The shorter working hours and training time mean that

specialists will probably not be as experienced as those that

have trained previously [10].

This means it is very important to identify and tackle a

poorly performing trainee. Usually, this would need to

involvement of the postgraduate dean. Theywould then need

remedial training if necessary in a supernumerary capacity

[10]. Problem trainees should be tackled sooner rather than

later, however, difficult the issues. Assessments should be

non-judgemental, transparent and fair.

Even consultants should ask themselves whether they are

the right person to do the operation. It is imperative that

the surgeon works ‘within his or her sphere of expertise’. As

there has been a trend towards sub-specialisation, with

advanced laparoscopic and hysteroscopic techniques, cross

referral between consultants should be encouraged. It is not

appropriate for newer techniques to be adopted without

evidence of training or specific expertise even at consultant

level.

4.1.5. Is this the right time of day to operate?

Whatever the work pattern, between the hours of 03:00–

07:00, everybody is at their lowest ebb and help is hard to

access. If work is necessary, it should be performed by staff

competent to do it. ‘Who operates when II’, the report of a

confidential enquiry into peri-operative deaths (CEPOD)

[11] has shown that there is increased reluctance by

trainees to involve senior staff members in the night. There

then may be inappropriate pre-operative management, an

inappropriate operation and deaths related to surgery.

Many operations have been performed out of hours

because of inadequate scheduled sessions for non-elective

surgery. The main emergency gynaecological operation

that is relevant is ectopic pregnancy. CEPOD states that

during the day and evening, most women with an ectopic

pregnancy will have an operation performed or supervised

by a consultant. During the night, it is more likely that the

operation will be performed by a more junior grade of

surgeon. At all times, it is likely that the anaesthetist will

be a junior. Surgery for an ectopic pregnancy is only

required at night if there is evidence that the patient is

bleeding. If patients operated on at night are genuinely

more acute than those operated on during the day, it might

be expected that the surgical and anaesthetic staff would be

of senior grades. Most evacuation of retained products of

conception were operated by juniors, although this was

generally in the day or evening when senior help is most

likely to be available [10].

Due to the European Working Time Directive, there has

been a reduction in experience, reduction in the number of

shifts and a reduction in continuity of care. There is a debate

whether some non-essential surgery can take place during

extended hours [10]. Unfortunately, the problem of how to

cover emergencies out of hours, provide safe supervision for

trainees whilst ensuring rest and reasonable work/life

balance for all doctors has not yet been resolved.

4.1.6. Are there adequate facilities, equipment and

support staff?

CEPOD recommends that all emergency patients should

havepromptaccess to theatre, critical care facilities andappro-

priately trained staff, 24 haday, everydayof theyear. It should

be ensured that all essential services (including emergency

operating rooms, recovery rooms, high dependency units

(HDU)and intensive care units (ITU)) areprovidedona single

site wherever emergency/acute surgical care are delivered.

All operating theatres should have sufficient numbers of

trained recovery staff available whenever theatres are in use

[10]. Appropriate operating assistance, nursing and operat-

ing department assistants should be available and should be

familiar with the equipment. It should be anticipated what

kind of equipment is needed for each case.

4.2. Intra-operative risk management

Complications in surgery are inevitable and cannot

always be anticipated. Some problems will only become

known during the procedure. This is especially the case if

disease processes have distorted the anatomy. It is more

likely damage to adjacent organs will occur because of

difficulty in demonstrating the anatomy. Again, this is more

likely to happen to a more junior surgeon or to someone who

is operating outside his sphere of expertise.

There are risks to the patient from diathermy injury. This is

whensomeor all of the current is concentratedonanareaother

than the intended site, leading to thermal damage to tissue.

Endogenous burns can be created from within the tissue and

can be a result of the plate being poorly applied. In open

surgery, anyunusedelectrodes should be stored in an insulated

quiver. In minimal access surgery, these electrodes often

remain in situ. If theseelectrodes are incontactwith thepatient

and are accidentally activated, unintentional burns can occur.

Insulation failure can cause the current to activate another

metal instrument or inadvertently directly burn tissue [12].

Lifting and handling of patients when moving them from

trolley to table is a peri-operative risk. We should be aware

that especially with gynaecological patients in lithotomy

position for long periods of time, that there is an increased

chance of injuries. There are also peri-operative risks to the

surgeon from needlestick and sharps injury frompatients with

potentially lethal infectious diseases. If an adverse event does

occur, then it is important that all personnel firstly recognise

the event, act appropriately within their sphere of expertise,

calling for help if needed. The documentation needs to be

clear onhow the complicationwas recognised andwhat action

was taken, who was called when and what time they arrived.

All entries should include the time, date, position and

signature, preferably with a personal stamp for clarity.

4.3. Post-operative complications

Even despite the best of care, post-operative complica-

tions may still occur. Recognition of the complications and


prompt action to remedy the situation is imperative.

Common complications are infections of the wound, chest

and urinary tract although prophylactic antibiotics should

reduce this. There also needs to be increased vigilance to

cleanliness and hand washing because of hospital acquired

infections, e.g. methicillin resistant Staphylococcus aureus

(MRSA).

Thrombo-embolic complications can be reduced by

adequate risk assessment prior to surgery. Age, weight and

pre-existing thrombophilias should be taken into considera-

tion when using prophylactic low molecular weight heparin

and TEDS stockings. With older patients, pressure sores can

occur and nursing staff need to be vigilant to avoid this.

If there is a significant adverse health care event, then

there needs to be early senior level involvement. The level of

care should also be decided, i.e. ward or HDU or ITU. It is

important to be aware that if a complication has occurred,

the chances of further complications may be increased.

Table 1

Adverse events that should be reported

Clinical incidents Organisational incidents

Damage to structures

(e.g. ureter bowel, vessel)

Complications of

anaesthesia

Delayed or missed diagnosis Delay following call

for assistance

Deep vein thrombosis Faulty equipment

Failed procedures

(e.g. abortion, sterilisation)

Interpersonal conflict

over case

ITU admission Potential service user

complaint

Omission of planned procedure Prescribing/administration

errors

Operative blood loss >500 ml Retained swab/instrument

Ovarian hyperstimulation Violation of local

protocol/guideline

Performance of unplanned,

unconsented procedures

(e.g. removal of ovaries at hysterectomy)

Pulmonary embolism

Unplanned return to theatre

5. Reactive risk management

This is how we learn from adverse events once they have

happened.

5.1. Communication

If an adverse health event has occurred, then open and

honest communication with both patients and the relatives is

imperative. Full explanation should be given, in the

appropriate language, of the likely sequelae. An opportunity

should be given to ask questions. It is also often helpful to

apologise that the adverse event has happened. This does not

necessarily imply fault. If appropriate pre-operative infor-

mation has been given, a phrase such as ‘I am sorry you had

bleeding during the operation. I know even though you were

told before the operation it can happen it is always

disappointing when it happens to you’ is both accurate and

appropriate.

Systems that yield information on adverse incidents

include the NHS untoward incident reporting scheme.

There are also databases of ongoing studies on a national

basis which aim to identify poor outcomes as previously

mentioned, e.g. CEPOD.

5.2. Clinical incident reporting

Clinical incident reporting is a useful risk management

tool in the NHS.

The NPSA has made the reporting of incidents

compulsory. Again, the NHS can learn from the mistakes

of other industries and utilise good practise principles in

incident reporting. To encourage staff to report incidents,

there must be a move away from a blame culture. Staff

should be educated as to the purpose of incident reporting.

They need to be clear when action may be taken as a result of

an incident form. We would not expect disciplinary action

should follow the reporting of an incident except in the

following situations: where there is a second occurrence

involving the same individual following education and/or

training; where the incident has resulted in a police

investigation; where in the view of the professional

registration body, the action is far removed from acceptable

practice; where there is failure to report an incident in which

a member of staff was involved.

Gynaecological events that could result in adverse effects

would include those recommended by the Royal College in

Table 1 [3].

However, local variation of these incidents is important,

particularly if there has been an area of concern raised such

as a number of vault haematoma after hysterectomy. The

addition of specific events can aid the early identification of

trends to consider whether a more detailed assessment of

cases should be made. Also, not all incidents need

investigation. A woman with a large fibroid uterus with

blood loss at hysterectomy of 600 ml may be reported but

would not be surprising. The initial investigation of an

adverse event usually starts with reviewing the case notes.

Often this identifies reasons for the event, such as a large

fibroid uterus, and no further action would be needed.

Sometimes, it is only when a pattern of events emerges, such

as repeated problems with laparoscopy equipment, that more

detailed investigation is needed. However, certain individual

events such as inappropriate oophrectomy would require

further assessment.

This initially involves talking to the staff and preparing

written reports. An initial summary of the principle events

(outline chronology) is made and care management

problems (CMP) are identified. Then, it needs to be decided

which section of the process needs to be examined. The

questions to be asked are: What happened? How did it


happen? Why did it happen? This then should identify the

contributory factors and specific factors to the case. Then,

during the analysis, it should ask, ‘What can we learn from

this and what changes should we make, if any?’

Once the interviews and analysis are completed, a

composite is made, detailing the whole incident from start to

finish. The report and implications should then be fairly easy

to compile. The final report will summarise the chronology,

identify the care management problems and their con-

tributory causes, giving most emphasis to general con-

tributory factors. The positive points of the care should also

be emphasised. Action plans should then be created with

time-scales for each one of the general factors requiring

attention so that progress can be monitored [13].

5.3. Root cause analysis

TheNPSA states that we should encourage staff to use root

cause analysis to learn how and why incidents happen. Root

cause analysis refers to the structured investigation of a

problem to identify its true cause and therefore understand the

actions necessary to eliminate the problem. This really takes

the process described above and ensures that the underlying

causes rather than the superficial causes are identified.

For instance, if we consider a woman admitted for

hysterectomy and discover that post-operatively, she

develops a deep vein thrombosis, we could consider the

case at a number of levels. It may be that sometimes

clinicians may just consider that ‘these things happen’. This

would not be the best response! At the next level, we may

consider that the houseman was an idiot because they did not

prescribe the heparin that would have avoided the problem.

Whilst this may be correct, it is a superficial approach. Root

cause analysis would work on the principle that all of us are

idiots at some point and that the system we work in should

prevent these type of errors.

A full root cause analysis would identify that the woman

was admitted to a non-gynae ward, the houseman had not had

an induction, so did not know what was expected. They were

also no guidelines for thromboprophylaxis in place and no

care pathway which identified to staff the need to consider

thromboprohylaxis. The approach therefore considers the

system rather than the individual. The response to this event

would then involve an action plan to avoid, as much as

possible, women on inappropriate wards. An induction

programme would be put in place for medical and nursing

staff and a training programme based upon the new guideline

on thromboprophylaxis and the new hysterectomy care

pathway.

This demonstrates that a structured investigation process

aims to assist in the identification of the root cause of a

particular event. The investigative principles focus on

problem solving not blame. They should be system and

process based not on individuals. The interfaces between

cause and effect should be assessed. They should identify

actual and potential failures. The investigations should be

undertaken by individuals and teams, but the lead

investigator should be trained and empowered.

The information should then be collected from direct

observation, documentation and interviews. These investiga-

tions should identify the immediate and underlying causes of

an incident by determiningwhy, if any, failures occurred. This

should provide the foundations for improvement strategies.

The root cause is the failure in a process, that if

eliminated, would prevent an adverse patient incident from

recurring. When establishing causation, the sequence of

events should be determined. Thus, the causal factors are

identified (conditions that created the incident). The

improvements should be monitored and assessed. This

should be automatic and ongoing. It should be ascertained

what worked and why [14,15].

A further example in our unit followed the ‘loss of a fetus’

after a 14-week miscarriage. The fetus was placed in the

sluice whilst the nurse attended to the womans other needs.

When the nurse returned to the sluice, the fetus and container

had been disposed off. A detailed analysis revealed that there

were no facilities or appropriate containers for fetuses on the

ward. The staff tended to use containers that would normally

be disposed of in the sluice. There was no secure area to

place a fetus on the ward and because the nurse was caring

for the woman, she did not have the chance to communicate

to other staff about the presence of the fetus. Following this

incident, clearly identifiable containers were made available

for a fetus to be placed in whilst care was ongoing. A

designated area was identified on the ward and all staff given

information about the development of the new practice. This

approach identified a way to prevent further occurrences

rather than attributing blame for the occurrence already past.

6. Conclusion

Risk management is a fairly new process, which is often

met with scepticism by many surgeons. It offers an

opportunity to learn from our failures, to prevent the same

problem occurring, again and again. In gynaecological

surgery, the prospective techniques can help ensure surgery

is performed on women who are appropriately informed, by

the right surgeon with the necessary equipment and

staff. Using root cause analysis to review adverse events

can be a powerful method of identifying problems within

the conditions and systems in which we work to act as an

impetus to achieve change and improve outcomes.

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http://www.clinicalrisk.com/

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Minimising risk in gynaecological surgery