Implementing Risk ManagementQualityin HealthCare 1995;4:129-134 ImplementingRiskManagement Essentials ofclinical riskmanagement RogerVClements Aimsofclinicalriskmanagement Risk management

Quality in Health Care 1995;4:129-134

Implementing Risk Management

Essentials of clinical risk management

Roger V Clements

Aims of clinical risk managementRisk management may broadly be defined asthe reduction of harm to an organisation, byidentifying and, as far as possible, eliminatingrisk. The aims of clinical risk management are(a) to reduce the frequency of adverse eventsand harm to patients, (b) to reduce the chanceof a claim being made, and (c) to control thecost of claims that are made. The primaryfocus is on malpractice, which causes financiallosses but also affects the reputation andmorale of a trust and its staff. Clinical riskmanagement also involves the continuing careof the injured patients and swift settlement ofjustified claims. Proper analysis of risk manage-ment reporting systems and an audit of clinicalcomplaints also offer invaluable opportunity toimprove quality in a way which is securelyfocused on the welfare of the patient. Improve-ment of quality must be the highest priority,for only by this means can the exposure tolitigation finally be eliminated.

In the new National Health Service (NHS)emphasis is rightly on both quality and price.When malpractice results in harm to patientsquality is obviously affected, but malpracticealso affects the overall cost of care. The providerunit must, firstly, recoup the cost of medicalmalpractice through its contracts, and there-fore successful claims will skew prices. But ina more subtle way poorly handled medicalmalpractice may damage the reputation of theprovider unit, affect the willingness of localpractitioners to refer patients, deter patients,and ultimately reduce the size of contractsthat are offered. A unit with an effective riskmanagement system, on the other hand, willsave money and enhance its reputation. Moneyis saved not only by improvement of quality butalso by early settlement of claims which cannotbe resisted, thus keeping money out ofthe handsof lawyers. The early reporting of adverse

events makes possible an economic defencewhere there is no fault.

Implementing risk managementThe principles of industrial and commercialrisk management (see Dickson, p 751) can beapplied to the clinical arena:* Identification* Analysis* Control* Funding.Funding is at present largely outside thecontrol of individual provider units, though thecreation of a central fund (see below) may gosome way towards providing the opportunityfor prudent financial management. However,identification and analysis of risks and the stepstaken to reduce and control risks are at theheart of clinical risk management.

Several key issues must be addressed whena risk management system is established, andthese will be discussed in turn:* Leadership and responsibility* Developing a risk management team* Practical issues of implementation* Cultural changes required* Continuing care of the injured patient* Ethical dilemmas* Support for staff involved in litigation.

LEADERSHIP AND RESPONSIBILITY ROLE OF THE

MEDICAL DIRECTOR

In most large provider units the broaderaspects of risk management (financial aspects,commercial aspects, fire, buildings, etc) will bethe responsibility of a steering group led by thefinance director. That group is not appropriateto deal with clinical risk, which should have aseparate management group which liaisesboth with the general risk management groupand with other quality initiatives within theprovider trust.

Risk management must have a high profilein the perspective of the management board.There must be commitment to the concept ofclinical risk management at board level, backedup by a written strategy. There must be anexecutive director of the board charged withpersonal responsibility for risk management.This will almost certainly be the medicaldirector, whose role is to provide a medicalperspective to board decisions, who should bein a position to influence the medical environ-ment both within and outside the provider unitin line with those board decisions. In the NHSManagement Executive's document on riskmanagement2 the medical executive director is

Aims ofclinical risk management* Reducing and, as far as possible, elimatingharm to the patient

* Dealing with the injured patient:Continuity of careSwift compensation for the justifiedclaimant

* Safeguarding the assets of the organisation:FinancialReputationStaff morale

* Improving the quality of care

Harley Street,London WIN lDGRoger V Clements

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not once mentioned. Nevertheless that personcan influence complaints monitoring, qualityinitiatives deriving from complaints, riskmanagement, clinical audit, and claims manage-ment. Clinical risk management will thereforeprimarily be the responsibility of the medicaldirector, although the directors of finance,nursing, and quality will work closely with himor her. Representatives from the clinicaldirectorates may be incorporated in a riskmanagement steering group, although this canmake the group rather cumbersome. Howeverthe directorates link in with the central depart-ment, the role of the clinical director isparamount.

Just as within the trust as a whole themedical director's role is unique and central, soin each directorate the lead clinician must takeresponsibility for clinical risk management.Otherwise the programme will never carrysufficient weight and acquire the credibility tobecome effective. Unless the clinical directorowns the responsibility for clinical risk manage-ment, the directorate will not buy into theprocess.

DEVELOPING A RISK MANAGEMENT TEAMTwo new roles need to be created, that of aclaims manager and a risk managementcoordinator. These roles are very different butin small organisations they may effectively becombined in the same person.

Claims managerThe claims manager is the liaison with thesolicitor and the person who effectivelyinstructs solicitors on behalf of the trust. It isthe claims manager's responsibility to see thatthe day to day conduct of legal business suitsthe trust's agenda. Major decisions aboutsettling or defending claims will be com-municated to the solicitors through the claimsmanager, although he or she will not usually bethe person making the decisions. The decisionto defend or settle a claim must be a boarddecision, usually delegated to the medicaldirector. The medical director and claimsmanager must therefore work closely togetherin making sure that the solicitors act in the bestinterest of the trust.

Risk management coordinatorThe risk management coordinator has abroader function, including the day to dayresponsibility for the clinical incident reportingsystem and collecting data from it. These datamust be fed back to the directorates if they areto improve quality. The risk managementcoordinator should also have a key role inmaintaining the standards of the healthrecords. Administration of the complaintsprocedure might appropriately be delegated toeither the claims manager or the risk manage-ment coordinator. In most district generalhospitals of modest size (C50m turnover) theseroles can conveniently be assumed by onesenior manager, directly responsible to themedical director.Both the claims manager and the risk

manager will work most closely with the

medical director. This small group wouldadminister the reporting system and would relyon the medical executive director to liaise witheach of the clinical directorates and with otherboard members. Although the clinical directormust be responsible for effecting the culturechange and for driving the initiative, he or shewill depend on his service manager for the dayto day running of the reporting system.

PRACTICAL ISSUES OF IMPLEMENTATION:REPORTING SYSTEM

Central to any clinical risk management systemis an adverse outcome reporting system whichhas the confidence of all members of theorganisation. Adverse events are identifiedfrom staff reports, though this process may besupplemented by a systematic screening ofrecords. Reports of serious incidents are madebefore claims are initiated, and while memoriesare still fresh. The reports are used to create adatabase to identify common patterns andprevent future incidents. Ideally, patients andrelatives are also informed about adverseincidents and action is taken to minimise boththe physical and psychological trauma.Key elements in risk management pro-

grammes are educating clinicians about theirrole in risk management, formalising channelsof communication to enable early interventionwith patients and their families after adverseincidents, and establishing a strong organis-ational structure for dealing with the findingsof reviews of adverse events. The involvementand personal commitment of senior cliniciansare crucial. A first step must therefore be tointroduce a reporting system, but alongsidemust be an educational programme which willsecure interest and ultimately ownership.Implementation is best achieved by the

following steps.

(1) Identify key risk areasIn any provider unit the key risk areas willusually be self evident. In a district generalhospital they are likely to be the accident andemergency department (by volume the biggestrisk area); obstetrics, particularly in the labourward (by quantum the biggest risk area); andthe operating theatres.

(2) Take the message to those key areasThe risk management team takes the pro-gramme of education to the risk area. Forinstance, a half day seminar arranged in theaccident and emergency department isattended by the key healthcare providers(consultant staff, junior medical staff, seniornursing staff, and main users - for example,orthopaedics, gynaecology, paediatrics, etc).The principles of risk management areexplained with due emphasis on the advantagesto the quality of care which will accrue.

(3) Allow the healthcare providers to identifytrigger eventsDuring the seminar the healthcare providerscreate their own trigger list of incidents whichthey think are worth reporting to a risk manage-ment system. (Ifmembers ofthe department are

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to have ownership of the system they must

create their own list, then they are likely torespond to it.) They would also be encouragedto modify it with experience so that the listconstantly changes. The same process isrepeated in the labour ward and in theoperating theatres. The box shows the kind oflist of trigger events which might result for an

average labour ward. Imposition of this list onany labour ward is not intended; it is given onlyas an example.

(4) Institute a reporting systemHaving established a list of the trigger eventslikely to give early warning of patient harm, therisk management department introduces a

system of reporting, which above all, must besimple.For example, one particular hospital uses a

double sided printed A4 sheet. It avoids largenumbers of boxes to tick and it avoids difficultquestions, simply requiring the identificationof the incident, the carers, and the onlookers,with a small space for free script to allow thereporter the opportunity to describe whathappened. The form is constantly underreview, has recently been modified, and willcontinue to be modified. Anyone can use theform. Staff of all grades and of all disciplinesfrom every profession are encouraged to reportadverse outcomes. This invevitably leads tomuch over-reporting of trivial incidents, whichis not discouraged. Nobody is dissuaded frommaking a report.Non-medical staff quickly see the advantages

of the adverse outcome reporting systemand seldom need much encouragement toimplement it. Without the doctors the riskmanagement programme will not be effective,and it is essential that the medical staff shouldunderstand what is in it for them. Reportingadverse outcomes or near misses to a riskmanagement reporting system should beassociated with reward not punishment.

(5) Monitor and analyse resultsThe forms are sent initially to the manager atlocal level - the service manager or equivalent.The service manager has the discretion todecide whether the incident is trivial and of noconsequence, when no further action need betaken. If the incident seems to be an important

indicator of a quality issue but is unlikely to

have harmed a patient on this occasion themanager will take local action but may notforward the form. Only those incidents whichrelate to harm which might potentially lead tolitigation need be sent to the central riskmanagement department. There they are

scrutinised again. Some will be rejected as

being important to quality but not to the riskof litigation. Only those important for the riskof litigation will be entered on to the database.The advantages of such a simple system are

that it allows:* The local manager to assess quality issues* Identification of clusters* Fuller investigation of the real exposure to

litigation.If the effect on quality is to be maximised theadverse outcome reporting system inherent inany clinical risk management programme mustfeed in to the other quality initiatives of thetrust. Unless the adverse reporting system is aneffective part of clinical audit it will not haveits maximum effect on quality. Identifying a

cluster of adverse outcomes may lead to thecorrection of a system or the counselling ofa staff member. It should not be used fordiscipline.

(6) Investigate, when appropriateWhen an incident is sufficiently importantto be entered on to the database a fullinvestigation will take place. The risk manage-ment department will require local managers toobtain statements from all healthcare providersinvolved with the patient. This enables theclinical director and the medical executivedirector to take an early view on whether an

action, if brought by the patient, could bedefended. When, months or years later, the"letter before action" arrives, the risk manage-ment department can instruct solicitors inan effective and timely manner without theunseemly and usually fruitless search throughthe archives for members of staffwho have longsince left not only the trust but usually thecountry.

CULTURAL CHANGE AND DIFFICULTIES OF

IMPLEMENTATION

A risk management reporting system willinevitably be resisted by doctors. Doctors per-ceive adverse outcome reporting as a threat totheir reputation and their professional integrity.To assure an effective clinical risk managementprogramme a major cultural change will beneeded to achieve acceptance by clinicians.

Conversely, patients' organisations perceiverisk management as a way of covering up whenthings go wrong. It is therefore important toestablish, from the very beginning that riskmanagement:0 Does not concern discipline* Does not lead to covering up when things gowrong

* Does not encourage "defensive" medicine* Does not involve creating complex causationarguments to defeat the plaintiff.

Risk management is about avoiding litigation- not about evasion.

Trigger events in a labour wardApgar score -5 at 5 minutesFetal malformation undiagnosed before birthInjury to the baby at time of birthBlood transfusion >3 unitsCaesarean section: decision to delivery interval>40 minutesThird stage or emergency hysterectomyFailed forceps deliveryUnscheduled return to operating theatreStillbirth or neonatal deathUnexpected or late admission to special carebaby unitThird degree tear

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In order to convince clinicians that riskmanagement works, the medical director initially(and subsequently each clinical director) mustexplain to colleagues the advantages that a riskmanagement programme can bring in qualityand price to the organisation. It is essential toeliminate the fear which adverse outcomereporting naturally generates. Doctors need tobe reassured that they will not be disciplinedfor reporting adverse outcomes even if fault isestablished. They need further to be reassuredthat one of the main advantages of a satis-factory risk management programme is thattheir reputations can more effectively beprotected when they are not at fault.

Convincing the doctors is not easy; muchdepends on the individual leadership of clinicaldirectors and the personalities of the seniordoctors concerned. For instance, it may berelatively easy in the women's and children'sdirectorate, perhaps because they are alreadyfamiliar with the threat of litigation and theneed to change practice in order to avoid it,and in the accident and emergency depart-ment, the high volume part of the industrywhere errors seem to be more frequent, for avariety of understandable reasons, not least thepressure of work out of hours. Difficulty maybe encountered in the directorate of surgery.Part of the mythology of surgery is that thesurgeon is in complete control of the operationand therefore completely responsible for every-thing that happens. Surgeons may feelparticularly threatened by the idea that amember of the nursing staff should report anuntoward incident - causing them to bebrought to account. The pattern of responsemay vary but, whatever the personalitiesinvolved, it is essential that at the beginning keystaff in the major areas are targeted andpersuaded of the benefits, otherwise theprogramme will fail.

CONTINUING CARE OF THE INJURED PATIENT

An injured patient requires more, not less, carethan patients with a successful outcome. Para-doxically, it is precisely at the moment when anaccident happens that the caring seems to stop.At least that is how the patient perceives it.

Risk management means caring for thepatient after the injury. Care includes thefollowing:* Continuing to treat - or sometimes arranging

for alternative care if trust has broken down* An explanation of what happened* An explanation of why it happened* Remedial action where possible* Compensation when appropriate.Thus the advantages for the patient are clearcut: early investigation of the cause of harm; ifno fault, a clear explanation; and if fault, a clearexplanation and early settlement.A good clinical risk management system

does not disadvantage a patient with a justifiedclaim. It does of course withhold the paymentof damages from those who are not entitled tothem. That is only right. But it is also right thatthose patients should receive a full and earlyexplanation as to why they are not entitled todamages. Conversely, the patient who is

entitled to damages receives an early settle-ment without money needlessly passing intothe pockets of lawyers.A good provider unit should establish a

reputation for frank explanation and earlysettlement of cases with fault. A trust with sucha policy would quickly gain the reputation forvigorous and successful defence where therewas no fault, and the incidence of litigationagainst it would fall. Litigation is in the interestonly of lawyers. The plaintiff wants an earlyexplanation and settlement (when appropriate);good clinical risk management achieves this.

ETHICAL DILEMMAS

Occasionally, the caring team may becomeaware that the patient has been injured whilethe patient continues to believe that he or shehas had the best possible care. Under thosecircumstances the provider unit is obliged togive the patient a full explanation, consistentonly with the patient's best interest.Lord Donaldson has several times drawn

attention to the obligation placed on lawyers insuch circumstances.3Both branches of the legal profession have a salutaryrule of professional ethics requiring them to advisetheir client to consult another practitioner if theyconsider that they may have been in breach of theirduty of care and that this breach has led to loss ordamage on the part of their client.

He goes on to plead for a similar franknessfrom doctors.The position in relation to the medical profession is,or should be, in many respects the same. The dutyof care does not involve the doctor in making adefinitive judgement on his own professional con-duct and communicating that judgement to thepatient. Save in a clear case, he may be less likelythan the lawyer to be the person best able to decide.But, in contrast to the position of the lawyer, he hasa very special duty of disclosure.

Doctors who find themselves in such adilemma should find support from their seniormanagers for a full and honest disclosure to thepatient of the unsuspected accident. Caringdoes not stop when an accident occurs; part ofthat caring is to make sure that the patientunderstands what has happened and why.

SUPPORT FOR STAFF INVOLVED IN LITIGATION

In return for active participation in riskmanagement, all clinical staff should feelsupported and protected by the system; theprogramme must offer support to the doctor,who often feels vulnerable and isolated whena patient is injured. Few doctors cope well withthe knowledge that they have harmed a patient.Practical help should include the following.* An opportunity to talk through the experi-ence with senior colleagues

* An inquiry process which is supportive, notconfrontational

* Readily available legal advice - for example,before appearing in a coroner's court

* Shared experience with those who have hada similar experience.Before crown indemnity, medical staff were

used to relying on their medical defenceorganisations for such support. The defence

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societies are still available to give informaladvice to individual doctors, but they are nolonger involved in litigation for hospital doctorsand that role should be increasingly subsumedby the risk management department. Similarlynurses and midwives tended to refer to theirunions for support in litigation. Although theunions were seldom involved directly in thelitigation process, the nurse or midwife oftenfelt protected by the union. A good riskmanagement department should be able toprovide just such support for all staff.The interests of the individual will not

necessarily always coincide directly withthose of the provider unit. Nor did they in thedays when doctors were "protected" by theirmedical defence organisations. There arecountless examples of litigation conductedprimarily for the benefit of the medical defenceorganisation, with doctors coming a poorsecond in the process, for they were never thefirst client of the lawyers conducting the action.Doctors tended to assume that the defencesocieties were exercising their paternalismbenignly in the interests of the individual;often, though, the societies were acting eitherin their own interests or in what they perceivedto be the interests of the profession as a whole.So with individuals and provider units a

conflict will occasionally arise. Doctors perceivethis conflict most starkly where the trust mightbe inclined to settle a case which, in their view,can be defended. They would be offended bythe admission of liability where they believenone exists. But whose reputation is stainedthereby? Doctors need to be reassured that inthese days of crown indemnity they are mostunlikely to be named in any suit. In any event,in NHS practice an admission of liability ismade on behalf of the provider unit, not by anindividual. The doctors whose reputation isharmed by malpractice are those whose casesattract publicity. They are doctors who aredefended in public - in the courts.A settlement with or without admission of

liability seldom attracts publicity in anypersonal sense. When doctors' names arepublished it is because the accusations havebeen made in open court and, substantiated ornot, the accusations can be repeated by thenewspapers without redress. The newspapersreport the action on the first day of the trial,seldom later. Plaintiff counsel speaks on thefirst day of the trial cataloguing the misdeedsof the doctor. Even if the doctor is fullyexonerated, even if the judge finds on thefourteenth day of the trial that no blameattaches, even if the decision goes for thedefence, nobody gets to know about it becauseby then the newspapers have lost interest."Doctor not guilty of negligence" is not news.So to safeguard the reputation of the medicalstaff, the simple answer is to keep them out ofcourt. Doctors should be reassured that thediscreet and early settlement of a case whichmight attract publicity, whether or not thecourt found for the plaintiff, may well be inthe interest not only of the trust but of theindividual doctor whose reputation is therebyprotected.

Response to litigationWhen a "letter before action" is received, therisk management team, led by the medicaldirector, should determine the response of thetrust. It will not always be appropriate toinstruct solicitors. In many cases the matter istrivial, the issues are clear cut, and an offer ofa very modest settlement may deflect apotentially costly legal action. It is important toremember the common experience of expertsand plaintiff solicitors - namely, that often theinjured patient seeks only an explanation andan apology and is not primarily motivated bymoney. Nevertheless, most "letters beforeaction" will need to be forwarded to the trust'slegal advisers so that the matter may be assessedand an appropriate response formulated.Under no circumstances should doctors ever beallowed to respond personally to a "letterbefore action." The skill and responsibility ofthe claims manager, supported by the medicaldirector, does not end with the handing over ofthe "letter before action": it must include theproper instruction of solicitors.

Traditionally, medical malpractice has beenhanded over by doctors to their medicaldefence organisations and by health authoritiesto their legal advisors, with virtually no inputthereafter. The matter was run at the speedconvenient to the lawyers and the defenceorganisations with the inevitable result thatactions were unnecessarily protracted andcosts escalated. That is not in the interest of theprovider unit, and it must be a priority of anyrisk management system to prevent it.

Instruction here carries the ordinary Englishmeaning. The medical executive directorshould expect from his or her lawyers exactlywhat any individual instructing solicitor has aright to expect - namely, competent technicaladvice and compliance with the client's wishes.This means that when an in house investigationhas determined that a matter is no longerdefensible the lawyers should be instructed tosettle it. Expert opinions can often bedispensed with when the in house opinion isclear and decisive. When the matter is to bedefended the medical director should ensurethat his or her clinical colleagues are involvedin the choice of expert and are kept informed,throughout the conduct of the case, so thatthey can be ofmaximum help to the legal team.In some respects, this is the most difficultculture change to achieve, for it threatenstraditional practices of two professions - thelawyers as well as the doctors! Although it isessential that defensible claims should bevigorously defended, the facts of medicolegallife must be clearly understood:* Quantum (that is, damages) increases, inabsolute terms, with time. The later a claimis settled or lost, the greater quantum is likelyto be, leaving aside inflation and the costs ofthe action

* Failure to settle quickly an indefensible claimcan only add further to the anger of theinjured patient (or family) and so damagefurther the reputation of the trust

* Costs accumulate on both sides. If a claim isindefensible the plaintiff will continue to

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incur costs (ultimately payable by thedefendant) assembling evidence to proveliability until that liability is admitted

* The admission of liability at the door of thecourt almost always represents a massivewaste of public money. Seldom have thefacts of the case changed; seldom is thereany different reason for assessing a case asindefensible on the day of settlement than onany of the preceding days, weeks, or monthsthat have passed since the first intimation ofa legal action.

Vacillation puts money into the pockets oflawyers. Incidentally, it usually increases, inreal terms, the quantum paid to the plaintiff.An effective team of claims manager andmedical director should have as their primaryobjective the prevention of any unnecessarycosts paid to lawyers in both sides.

When claims should be settledThere will be times when it becomes clear tothe medical director that the potential cost ofdefending an action will greatly exceed anypossible quantum. It may be appropriate forhim or her to advise the finance director that,even though there may be a chance ofdefending the action, settlement would bewiser. Settlements at the door of the courtoccur, mostly, because the defendants took arealistic view of the case only when their mindswere finally concentrated by the need toproduce evidence in court. The prospect of alengthy court battle, only to lose, suddenlyseems unattractive. Tragically, by the time thatmoment arrives many thousands of pounds incosts have already been spent by both sides,costs which will have to be borne by theprovider unit. Not only that but (except in theCourt of Appeal) costs orders against plaintiffsreceiving legal aid are not enforced and successafter many days in court may prove somethingof a pyhrric victory if the costs incurred by thedefendants exceed the plaintiffs (disappointed)expectations of quantum!

Care is required in these matters. The unitmust not get the reputation for being an easypushover, willing to settle any case wherequantum is modest. Some cases have to bedefended, ifnecessary in open court. In makingsuch decisions the medical director and his orher trust board colleagues need to considerhow best to preserve their assets, not onlyfinancial assets but also reputation and staffmorale.

It has been suggested that creating a centralfund may reduce the ability of local providerunits to make such decisions in their owninterests - may insist on cases where there ismedical "merit" being defended even thoughit makes no financial sense to do so. This wasstrongly hinted at by Brian Marsden, deputydirector of finance and corporate information,of the NHS Executive at the conference onprevention and control of clinical negligence atthe Royal College of Surgeons in May 1994.

It is recommended that Trusts should have primeresponsibility for handling the majority of claims.They would use solicitors from a nationwide panelapproved by the Fund - with the Fund managerbeing consulted before a claim is settled and havingdiscretion to take over management of any claimconsidered novel, or likely to create precedent, or tobe costly.4

Interference, to prevent trusts settling smallclaims expeditiously and cheaply would be amistake. Save only for the most exceptionalcircumstances, such decisions should belong tothe local provider unit.

1 Dickson G. Principles of risk management. Quality in HealthCare 1995;4:75-9.

2 NHS Management Executive. Risk management in the NHS.London: Department of Health, 1993.

3 Lord Donaldson. Foreword. In: Clements RV, ed. Safepractice in obstetics and gynaecology: a medicolegalhandbook. Edinburgh: Churchill Livingstone, 1994.

4 Marsden B. Funding clinical negligence claims inprevention and control of clinical negligence. Clinician inManagement 1994;3(suppl 1):4.

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