volume 27 issue 2 november 2011 in consent f m c f o f/media/files/mdu... · volume 27 issue 2...

JournalMDU

Volume 27 Issue 2 November 2011

ISSN 0952 9934

Consenta meeting of minds

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IN THIS ISSUE

02 MDU Journal Volume 27 Issue 2 November 2011

Medical editor Dr Udvitha Nandasoma

Editor Sarah Mouger

FEEDBACK Please write to:The Editor, MDUSL, 230 Blackfriars Road, London SE1 8PJ

or post on our website: the-mdu.com/feedback

The MDU Journal is published formembers of the MDU in the UK and theRepublic of Ireland. First published 1985.

The medico-legal advice in the MDUJournal is for general information only.Appropriate professional advice shouldbe taken before taking or refrainingfrom action based on it.

Opinions expressed by authors ofarticles published in the MDU Journalare their own and do not necessarily reflect the policies of the MedicalDefence Union limited.

The photographs used in thispublication are selected from stockimages, posed by models or have beenspecially commissioned by the MDU, unless otherwise stated.

MDU Services Limited (MDUSL) is authorised and regulated by theFinancial Services Authority in respect of insurance mediation activities only.MDUSL is an agent for the MedicalDefence Union Limited (the MDU). The MDU is not an insurance company.

The benefits of membership of the MDUare all discretionary and are subject tothe Memorandum and Articles of

Association. All MDU professionalindemnity insurance policies are issuedby SCOR UK Company Limited and byInternational Insurance Company ofHannover Limited.

MDU Services Limited is registered inEngland 395086. Registered office: 230Blackfriars Road, London SE1 8PJ.

MDUJournal

NEWS

04 ‘Fast track’ scheme notappropriateClinical negligence claims cannot becompared to RTAs

04 Self-prescribing risksEven antibiotics can be controversial

05 Advance decision by tattooNot a valid criterion

IN FOCUS

06 GMC Employment LiaisonAdvisersA new role

MEMBERSHIP NEWS

07 Bariatric surgery updateNew subscription category

07 Never unknowingly under-indemnifiedKeep the MDU up-to-date with yourworking circumstances

CONSENT

08 Consent at the cutting edgeConsent in adult surgical cases

11 Consent in clinical trialsThe complexities explained

14 Children – a special caseA medico-legal challenge

FEATURES

16 A small act with bigconsequencesThe repercussions of amending records

17 App consultationTelemedicine in practice

22 Wrong site, wrong sideAdvice on avoiding this error

FROM OUR FILES

18 The changing face of plasticsurgeryAnalysis of plastic surgery claims

24 Advice line dilemmasAssisting a criminal offence; consent in aminor without capacity

26 A finely balanced decisionCase study from our files
















November 2011 Volume 27 Issue 2 MDU Journal 03

Civil injustice

Ihave written before welcoming Lord JusticeJackson’s proposals for reform of civil negligencecosts and members will probably be aware that the main recommendations are now enshrined in the Legal Aid, Sentencing and Punishment of Offenders Bill currently before Parliament. The proposed changes would restore a greaterdegree of proportionality to costs in compensationclaims. The changes, if they get through, wouldmean that in cases we lose as defendants wewould no longer be required to pay claimants’solicitors costs uplift, which can be up to 100% on fees of as much as £400 per hour. Nor would we have to pay for after the event (ATE) insurance premiums, which are on average £6,200 in low value claims though we have seenpremiums as high as £50,000 or even £100,000 in some claims.

So far so good, but in transposing LordJustice Jackson’s changes into legislation,the Ministry of Justice also made changes tolegal aid that led to it watering down one ofthe main recommendations. Lord JusticeJackson’s report recommended thatdisbursement costs for experts’ reportsshould be funded by claimants or theirsolicitors, suggesting that money thatclaimants’ solicitors would otherwise use topay referral fees could be used for thispurpose. He proposed in his report ‘...thatthe payment of referral fees for personalinjury cases (currently running at aremarkably high level) be either banned orsubjected to a cap. Claimant solicitors maysee fit to re-allocate some part of thereferral fees thus saved towards payingdisbursements in unsuccessful cases.’

The MDU agreed with that recommendationand suggests it still has considerable merit,especially in the light of the government’s 9 September announcement that it will banthese referral fees.

However, because the government nowproposes to remove legal aid for clinicalnegligence claims, claimants’ solicitors andothers are concerned that patients whobelieve they have been negligently damagedmay not be able to pay for the expert

reports they need in order to determine ifthey have a case. Any suggestion ofclaimants’ solicitors funding these costs has somehow disappeared and thegovernment proposes instead that losingdefendants will fund these fees, and thecosts of any ATE premiums claimants takeout to cover such costs.

This would be the worst of all worlds fordefendants. In effect it would mean thatwhen claimants take out ATE insurance, weas defendants would end up paying the costof their reports in all cases, regardless of theoutcome. Where we successfully defended aclaim, we would not pay the insurancepremium; however, we would pick up thiscost in cases we lost because the insurerswould, as they do now, load all premiums inorder to recover costs from cases whereclaimants do not succeed and no ATEpremium is payable. We would have nocontrol over ATE premiums or the costscharged by experts and yet our memberswould be expected to foot the bill. Thatcannot be right or fair and it is against thespirit of the Bill’s other proposals on civilclaims that aim to restore fair and equalaccess to justice.

The MDU is resisting such proposals andcontinues to make representations to the

Ministry of Justice, co-ordinating ourcomments with other clinical negligencedefendants. And we were heartenedrecently to see additional comments fromLord Justice Jackson who suggested in aspeech on 5 September to the CambridgeLaw Faculty¹ that legal aid should beretained for clinical negligence claims inorder to cover the costs of experts’ reports.

We welcome Lord Justice Jackson’s carefullyconsidered and constructive solution. Itwould achieve the g overnment’s policy aimof ensuring that vulnerable and negligentlydamaged patients are not prevented fromseeking compensation and it would restorefairness. MDU members and the NHS morewidely should not be expected to pay fordisproportionate costs over which they haveno control. We hope the government givesserious consideration to Lord JusticeJackson’s proposal.

Dr Christine TomkinsChief executive

EDITORIAL

1 http://www.judiciary.gov.uk/media/speeches/2011/jackson-lj-speech-legal-aid-costs-review-reforms

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The MDU receives a number of calls eachyear from doctors who face investigationsrelating to the self-prescribing of drugs –and not just those drugs that might beexpected to raise concerns such as opiatesand anti-depressants. When it comes toself-prescribing, even antibiotics can becontroversial.

Since the GMC’s guidance Good practicein prescribing medicines was published in2008, the MDU has been notified ofseveral cases in which the member wasbeing investigated for self-prescribing. Thedrugs involved included benzodiazepines,antibiotics, opiates, anti-depressants,steroids, nicotine preparations, cardiacmedication and appetite suppressants. Inover half of the cases, the doctor faced aGMC fitness to practise panel and otherswere subject to a disciplinary investigationby their employer.

GMC guidance is very clear that doctorsshould seek independent advice wheneverthey or someone with whom they have aclose personal relationship requiresprescription medication. Doctors whochoose to self-prescribe must be preparedto explain and justify their decision; failureto do so may lead to their fitness topractise being called into question.

NEWS


Should low-value clinical negligence claims betreated in the courts in the same way as roadtraffic accidents?

The MDU believes not and has questioned theviability and fairness of the Ministry of Justice’s(MoJ) proposal to introduce a fast-track schemefor clinical negligence claims in the county courts,similar to the one which has been successfullyapplied in road traffic accident (RTA) cases.

In its response to the MoJ consultation Solvingdisputes in the county courts, the MDU set out itsview that clinical negligence claims aresignificantly more complex than RTA cases, notleast because claims are generally brought againstindividual doctors and the professional andpersonal repercussions for those involved may befar wider.

Dr Matthew Lee, MDU director of professionalservices, explains: ‘These factors affect how theMDU defends clinical negligence claims, whichmeans they are unlikely to fit into the ‘fast track’scheme model. For example, in RTAs it is usuallystraightforward to determine whether thedefendant was at fault and the effect this had onthe claimant. This is rarely true of clinicalnegligence cases, where expert evidence may beneeded to determine whether a clinician’streatment fell short of accepted standards and togauge the impact on the patient of anynegligence.’

He continued: ‘While it is in the interests of MDUmembers that their claims are resolved as early aspossible, it makes no sense to settle them unlessthere are compelling grounds to do so. This is allthe more important because doctors may also beheld accountable for the incident that gave rise tothe claim at other tribunals, including the GMC.

‘It is essential that doctors’ ability to defendthemselves is not fettered by a quest forefficiency.’

What are your views on the proposed ‘fast-track’ scheme? Send your comments towww.the-mdu.com/feedback.

‘Fast track’approach notappropriate

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Email name caution The increasing use of email communication within the NHSand with external organisations can cause problems whererecipients have similar names. Inaccurate addressing ofemails may result in the wrong person receiving confidentialinformation.

Today’s doctors are likely to have a number of work emailaccounts, including their employer’s organisation accountand NHSmail. Most email addresses use the individual’s nameas the identifier and if there are several people in theorganisation with the same name, then numbers, symbols orextra letters are often added to distinguish them.

In busy clinical practice it is very easy to forget to include theadditional number/letter in the address. In one case, an emailcontaining confidential patient information was sent [email protected] instead of to [email protected] former was an administrator in the south of Englandwhile the intended recipient was a consultant in an acutetrust in the north.

The NHS Connecting for Health website has furtherinformation about NHSMail which it stresses is the ‘only NHSemail service secure enough for the transmission ofconfidential patient information’. Members are advised toseek specialist IT advice about ensuring the security of emailsystems, and to take extra care when typing in an emailaddress. All breaches of patient confidentiality should bereported to your organisation’s data controller.

Self-prescribing risks

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NEWS

IN BRIEF

Doctors ‘make the bestmanagers’

A study¹ of US hospitals has found a correlation between highperformance and leadership by doctors. Of the 100 top-rankedhospitals each specialising in cancer, digestive disorders and cardiaccare and surgery, between 34% and 51% had medically-qualifiedchief executives. Nationally, by comparison, only 235 out of 6,500US hospitals are led by doctors.

¹ Social Science and Medicine, Volume 73, Issue 4, Aug 2011, pp535-539

Suicide and chronic illnessThere is one death by suicide approximately every two hours inEngland. A study by Demos¹ investigating the reasons behindsuicides in 29 PCTs during 2009 found that in 10% of cases,chronic illness was an associated factor – much higher thanpreviously thought. The report called for public policy change toidentify patients with chronic illness as ‘high suicide risk’ andprovide better medical, practical and psychological support to this group.

¹ The Truth about Suicide, Bazalgette et al, Demos 2011

CQC prosecutionA doctor in independent practice has been prosecuted by the CareQuality Commission (CQC) for carrying out cosmetic surgeryprocedures without being registered to do so, and fined £2,500.The CQC had conducted an unannounced inspection of thepremises after a tip-off from a member of the public. MDUmembers in independent practice are reminded to register allregulated services with the CQC and notify it of all locations inwhich they practise.

Conscientious objectorsNearly half (45%) of respondents to a survey¹ of 1437 UK medicalstudents believe in the right of doctors to refuse to treat a patientwho wants a termination of pregnancy or contraceptive services, isunder the influence of drugs or alcohol, wants an intimateexamination or is of the opposite sex. Of the reasons given for theobjections, the majority were not connected to religious belief.While doctors have a right to refuse to participate in proceduresrelating to termination of pregnancy, GMC guidance is clear thatthere are no grounds for conscientious objection to providingnecessary medical care to a patient who is awaiting or hasundergone a termination (Good Medical Practice, para 26).

¹ Conscientious objection in medical studies, Journal of Medical Ethics, July 2011

iMDU on the roadDemand from doctors for the MDU’s expertise inmedical law and ethics is higher than ever. In 2010,the MDU spoke to doctors at 2066 events andpractice seminars on more than 80 separate topics.Confidentiality, consent and complaints are the mostpopular, but MLAs also present on such diversesubjects as the medico-legal aspects of familyplanning, living will and advance directives, urologicalinjuries in obstetrics and gynaecology surgery and riskmanagement in spinal surgery.

Mike Devlin, head of MDU advisory services, said: ‘It’simportant that members understand and can applymedical law and ethics to their every day practice asthis can help pre-empt the sort of problems that leadto complaints and claims.’

For more information on seminars and talks, and to request a seminar, please visit the-mdu.com/education, or contact our salessupport team on [email protected] or on 020 7272 1569/1570.

Advance decision bytattooAn 81-year old woman had the words ‘do notresuscitate’ tattooed on her chest to prevent doctorstrying to revive her if she was unable tocommunicate her wishes¹. It was, she said, addedinsurance alongside her existing advance decision.

While a tattoo would be highly unlikely to meet thecriteria for a valid advance decision to refuse life-sustaining treatment, it demonstrates the patient’sdetermination to make her wishes known.Misunderstanding or mistaken assumptions in thisarea can cause bitter disputes between hospitalsand families. In one case, a man threatened legalaction against a trust, alleging doctors had put ‘donot attempt cardio-pulmonary resuscitation’(DNACPR) on his terminally ill wife’s notes againsther wishes. In another, a woman complained shewas only told about a DNACPR notice on herfather’s notes when she asked why doctors had nottried to resuscitate him.

Anxious and upset families can readily misinterpret aDNACPR order as an indication that doctors aregiving up on a patient. In cases where CPR is notregarded as clinically appropriate, it is important toexplain the reasons fully and reassure relatives thatthe patient will be given any other care that isappropriate and necessary. The GMC’s Treatmentand care towards the end of life: good practice indecision making (2010) provides detailed guidanceon DNACPR decisions.

1 Do not resuscitate tattooed on Norfolk pensioner, BBC News,6 Sept 2011.

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In recent months a number ofdoctors have been referred tothe GMC as a result of havingbreached the restrictions ofworking within an ApprovedPractice Setting (APS).

Legislation and GMC guidance on the issueare clear. UK graduate doctors andinternational medical graduates (except forthose eligible for entry in the specialist or GPregister) are required to work solely in an APSfor a minimum of 12 months after beinggranted registration.

The 12-month period runs from the date ofstarting work, not from the date of registration.

Activities such as issuing private prescriptions,or foundation year doctors assistingconsultants in independent sector operations,or the provision of medical services anywhereoutside of the APS (such as at music festivalsor sporting events) would constitute a breachof APS restrictions. Doctors working in an APSshould prospectively seek advice from theGMC and their medical defence organisationif there is any doubt as to whether work theypropose to undertake might lie outside therestrictions.

Importantly, and perhaps less well known, isthat these restrictions are not automaticallylifted by the GMC at the end of the 12-monthperiod. Doctors must apply to the GMCconfirming that they have satisfactorilycompleted 12 months’ practice in an APSbefore the restrictions are lifted¹.

Failing to take the active step of having APSrestrictions lifted will mean that they remainactive on a doctor’s GMC registration. Doctorsmay be the subject of a GMC investigation ifthey act outside the restrictions, such as byissuing private prescriptions. A breach orfailure to comply with the restrictions may betreated as misconduct and may result in actionbeing taken against the doctor’s registrationby the GMC.

1 Link to GMC website for applying to lift APSrestrictions: http://www.gmcuk.org/doctors/registration_applications/release_from_aps_p1.asp

The GMCplansto introduce EmploymentLiaison Advisers (ELAs) in early2012. These are new postscreated as a result of a needidentified in the white paperTrust Assurance and Safetyfor a way of improving liaisonbetween the GMC andhealthcare bodies. Most MDUmembers are unlikely to comeacross ELAs in person, butELAs may become involved inan individual doctor’s case ifthey are advising an employeras to whether concerns abouta doctor would trigger areferral to the GMC.

There will be 14 ELAs, all GMC staff, who willdevelop working relationships with MedicalDirectors and Responsible Officers throughoutthe UK. Their role will be primarily to adviseNHS bodies about the role of the GMC, theappropriate thresholds for referring doctors inindividual cases, and providing advice tosupport the implementation of revalidation.They will also support employers withrevalidation after it is introduced later in2012.

Referrals of doctors to the GMC by publicbodies have increased dramatically recently.The MDU believes there is a problem withhealthcare bodies’ inappropriate referrals to

the GMC, though it is difficult to quantify itsextent. On average over the last five years,the GMC closed 40% of complaints at initialassessment, referred around 30% to thedoctor’s employer (most of which were notpursued by the GMC) and investigated theremaining 30%. Applying these percentagesto the 7,153 complaints the GMC receivedduring 2010, it suggests that a substantialnumber are likely to be or have beeninappropriate. Providing ELAs to assisthealthcare bodies to understand why andwhen it is appropriate to refer doctors to theGMC could help to prevent the real distresscaused by inappropriate referrals and is to be welcomed.

Some members may have concerns about the potential for ELAs’ involvement in localdisciplinary matters. For example, wouldhealthcare bodies be tempted to seek advicefrom ELAs about handling cases whereconcerns about a doctor clearly do notsuggest impaired fitness to practise? These are confidential cases and must beconsidered through statutory local proceduresin which the GMC has no role.

Niall Dickson, chief executive of the GeneralMedical Council, said: ‘This new service willenable us to completely change the way wework with medical directors. There aresignificant changes coming, including theintroduction of revalidation, and our newadvisers will help make sure we have thestrongest relationships in place that will benecessary to make this a success.’

Mary-Lou NesbittHead of governmental and external relations

GMCEmployment

Liaison Advisers

No automaticlifting of APSrestrictions

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In Focus



Bariatric surgeryupdate

Acomprehensive analysis ofoutcomes from 8710bariatric surgical operations

conducted in 86 hospitals between2008 and 2010 has revealed thatobserved in-hospital mortality rateafter primary surgery was 0.1%and the recorded surgicalcomplication rate for primaryoperations was 2.6%.

The findings are published in the First RegistryReport of the National Bariatric SurgeryRegister¹, the first such survey since theregistry was introduced.

The report’s authors conclude that the lowermortality and post-operative complication rateassociated with bariatric surgery comparedwith other types of planned operation,indicates that bariatric surgery in the UK andIreland has a relatively good safety profile.

However, it is not always the case that a lowerclinical risk translates into a lower indemnityrisk. For example, breast augmentation carriesa lower clinical risk than major vascular surgerybut results in a far higher incidence of notified

claims. There are complex reasons forthis, among them the issue of patientexpectations.

The registry does not collect dataabout litigation; however, the MDUhas been monitoring bariatricsurgery claims in recent years. Ourown data shows that the MDUincurs significantly higher costson behalf of surgeonsundertaking bariatric surgery inthe independent sector than forsurgeons who are not involved inthis field. Regrettably this issomething that must be taken intoconsideration by the MDU’s

actuaries and underwriters whensetting subscriptions.

From April 2012 a new subscriptioncategory will be introduced for members

who undertake bariatric surgery in theindependent sector. To ensure that you have inplace appropriate indemnity for all of yourwork it is therefore very important to informthe MDU membership department if youundertake any bariatric surgery notindemnified by NHS bodies or anotheremployers’ indemnity scheme.

1 The United Kingdom National Bariatric Surgery Registry:First Registry Report to March 2010. Prepared by NBSRData Committee and Dendrite Clinical Systems, 2011

Never unknowinglyunder-indemnifiedFor many MDU members, the calculation oftheir annual subscription is based on theclinical specialty in which they work and, if noother indemnity is in place, their earnings fromthat work.

As a mutual organisation owned by ourmembers, the MDU needs to ensure that eachmember is contributing appropriately and fairlyto the subscription income collected. Thismoney is used to provide the benefits ofmembership, including the provision of insuredindemnity for clinical negligence claims and alldiscretionary benefits.

We are aware that our members lead busylives and keeping the MDU up to date may getoverlooked when working circumstances orearnings change. As a result MDU membersmay unknowingly find themselves under- orover-indemnified for the work they do.

Where a member is under-indemnifiedproblems may be encountered if they later

seek medico-legal assistance with a matterarising from the under-indemnified period.They may also find themselves in breach oftheir professional obligation to have in placeadequate indemnity for all their work.

If you believe the information we hold aboutyour working circumstances (which can befound on your renewal notice) could beincorrect it may be possible to correct ourrecords retrospectively to ensure you areadequately indemnified for the work you areand have been doing. Please contact themembership helpline on 0800 716376 if youwould like to discuss this further, or [email protected].

Olympics reminderDoctors who have been selected as medical‘Games Makers’ for next year’s Olympics areadvised to check their indemnity. The London2012 Organising Committee of the OlympicGames (LOCOG) has confirmed that all primaryand emergency care at venues for spectatorsand athletes will be provided outside of theNHS and so will not fall within NHS indemnity.Adequate individual indemnity arrangementsare therefore required.

For MDU members, the professional indemnitypolicy of insurance¹ will cover this workproviding you meet the following criteria:

• You are an official LOCOG volunteer (orGames Maker).

• You are in active MDU membership andhave paid a subscription for clinical work.

• You hold a current GMC licence topractise.

• You are not restricted to working in anapproved practice setting (unless you havebeen notified that the Games environmentis to be given approved practice setting).

• You are not entering into any formalarrangement to provide care for individualathletes or teams.

• You will be working within the limits ofyour competence.

If you can answer yes to all of these, you donot need to let the MDU know that you areacting as a volunteer. For all other questionsabout volunteer or sports medicine indemnity,please email [email protected].

www.the-mdu.com/2012

1 Subject to the terms and conditions of the policyunderwritten by SCOR UK Company Limited andInternational Insurance Company of Hannover Limited.


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Adult patientsawaiting surgeryhave to absorb avast amount of

complex information at atime when they are anxiousand vulnerable. Dr RuthGibson, MDU medico-legaladviser, examines a doctor’sresponsibilities – andchallenges – in ensuringtheir patients’ consent isinformed and valid.

Seeking a patient’s consent to surgery ortreatment may be seen as a routine part ofpractice, but failure to take proper consentor, more often, failure to properly recordthe consent process can leave doctorsvulnerable to criticism.

When a procedure has an adverse outcomeor does not fulfil the patient’s expectationsa common statement in claims orcomplaints is that they were not fullyinformed of the risks beforehand. In fact,allegations that consent was not properlyobtained are often a feature of claimsnotified to the MDU.

If MDU members are in any doubt aboutobtaining consent – either generally, or fora particular patient – the MDU medico-legaladvice line is a useful place to go for help.Our experience shows the following

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CONSENT


at thecuttingedge

Issues ofconsent areamong the

most commonethical questionsmembers askthe MDU. In ourlead feature, theMDU Journallooks at consentin three areas ofclinical practice.

News





questions arise most frequently, and thisarticle explains the main issues involved withthese, and other, topics.

• Who can obtain consent?

• When should consent be obtained?

• What information is needed during a‘cooling off’ period?

• What if a patient does not seem tounderstand the procedure?

Who can obtain consent?

Historically, obtaining consent used to bedelegated to the most junior member of theteam. But times have changed and the GMCmakes it clear in its publication Consent:doctors and patients making decisionstogether (2008) that it is the responsibility ofthe doctor undertaking the investigation orproviding the treatment to discuss it with thepatient¹. However, given the pressures thathospital doctors work under, it may notalways be practicable for every doctor toobtain consent for every procedure that he orshe carries out. One option is to delegate thistask to someone else, and this is commonpractice.

In delegating the consent process, you mustbe personally satisfied that the person towhom you delegate the task is suitablytrained and qualified and has sufficientknowledge of the procedure in order toobtain valid informed consent¹,². You maylater be called upon to justify your decision toask someone else to obtain consent on yourbehalf and you will remain responsible formaking sure that the patient has been givenenough time and information to make aninformed decision.

When should consent beobtained?

The Department of Health publicationReference guide to consent for examinationand treatment states that the clinicianproviding the treatment or investigation isresponsible for ensuring that the patient hasgiven valid consent ‘well in advance’ of thestart of treatment³.

Their guidance states that if a patient is notasked to signify their consent until just beforethe procedure is due to start, at a time whenthey may be feeling particularly vulnerable, theremay be real doubt as to its validity. In nocircumstances should patients be given routine

pre-operative medication before being asked fortheir consent to proceed with the treatment³.

Time to discuss risks

Patients sometimes complain that they feelthey were not allowed enough time to discusspossible risks and complications of theirsurgery in detail. Such allegations may castdoubt on whether consent has been properlygiven. Your patient should also be given timeto reflect before and after they have made adecision, especially if the information iscomplex or the intervention involvessignificant risk�.

There can be quite a significant delaybetween the time that consent was obtainedand the time of the procedure or treatment. Itis then important to review the details of theconsent that was obtained and a patientshould be asked if he or she still wishes toproceed. Time should be given to allow apatient to ask any additional questions. This is particularly important if ’significanttime has passed since the initial decision wasmade’, if ‘there have been material changes inthe patient’s condition’ or ‘new informationhas become available, for example about therisks of treatment or about the treatmentoptions’5.

A ‘cooling off period’ – that is, a reasonableinterval between obtaining consent and theprocedure itself – gives the patient a chanceto consider the matter further and take adviceshould they wish to. This interval is notdefined and will depend on the patient andthe procedure involved, whether it is major orminor and its urgency.

If, after considering carefully all the relevantinformation, the patient decides not to goahead with the surgery, their decision shouldnormally be respected, even if you think it isunwise or you do not agree with it.

Helping patients understand

Each patient is different: some want to knowvery little about what’s going to happen tothem while others want you to go throughevery possible risk and complication in minutedetail. Taking time to listen to your patient’sviews about their health and ascertainingwhat they wish to know is an essential part ofeffective patient communication.

You should share information in a way thatthe patient can understand and wheneverpossible in a place and at a time when theyare best able to understand and retain it�.

The ability of a patient to make a decisionabout whether to consent to a particulartreatment can depend on various things suchas capacity, the nature of the condition or thecomplexity of the decision. It is important totry and maximise their decision-making abilityby providing information in various ways. Apatient may not understand or retain all thenecessary information at one consultation.Discussion with other health professionals and family members may aid the patient’sunderstanding6.

An explanatory leaflet can be used to supportand reinforce any discussion but simplyproviding an information leaflet should not beseen as an alternative to a full and detailedconversation with the patient.

Questions of capacity

Concerns as to the ability of a patient tomake decisions relating to a particularprocedure can raise the question of whetherthe patient can in fact give valid consent totreatment. In England and Wales the law inrelation to adults who lack capacity to makedecisions on their own is laid down in theMental Capacity Act 20057. One of the fivestatutory principles that underpin the MCA isthe presumption that every adult patient hasthe capacity to make decisions about theircare, unless it is established that he or shelacks capacity7,8.

A patient can be found to lack capacity toconsent if he or she is unable to9:

• Understand the information relevant tothe decision, including information aboutthe reasonably foreseeable consequencesof deciding one way or another, or failingto make a decision.

• Retain that information.

• Use or weigh that information as part ofthe process of making a decision.

• Communicate his decision.

Assessment of the patient’s capacity must bedecision-specific. Does the patient havecapacity to make a particular decision about aparticular treatment at a particular time? Ifthere is doubt about a patient’s capacity thenit may be helpful to seek further involvementfrom others. Initially this could include inputfrom the multi-professional team and secondopinions from other specialties such aspsychiatry. Ultimately, it may be necessary toseek legal advice if a decision cannot bereached.


CONSENT

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Involving others

The ability of a patient to make decisions abouttheir treatment should be maximised. There arevarious ways this can be done, one of which isto involve other people in the discussion – forexample, the extended healthcare team, orfamily members (subject to the patient agreeingto their involvement). If the patient lackscapacity the views of anyone legally appointedto act on their behalf should be ascertained. InEngland and Wales this could be a person whohas a lasting power of attorney related tohealth and welfare or a court appointed deputy.

The Mental Capacity Act 2005 sets out howsuch decisions must be approached. Decisionsabout treatment of a patient who lacks capacityshould be made in their best interests10. It isimportant to consider the views of others whohave information about the patient’s wishes,feelings and values, such as family members orothers involved in looking after the patient11.

On the record

Records can provide crucial evidence if there is adispute about consent. Keep clear, detailed,contemporaneous notes of conversations thatyou have with your patients about the consentprocess. As part of an investigation into acomplaint or claim, reference will be made tothe medical records and it is important to beable to demonstrate that a particularcomplication or risk was in fact clearly explainedto the patient. A signed consent form in itselfmay not be enough to demonstrate that apatient gave full valid and informed consent.

Forms detailing the consent process also needto be adequately detailed and up to date. GMCguidance states that the medical record or aconsent form ‘should include informationdiscussed, any specific requests by the patient,any written, visual or audio information given tothe patient and details of any decisions thatwere made’¹². This form should always be partof the medical records and carefully checkedbefore any procedure begins. There may betimes where a patient’s medical conditionchanges, leading to a change in the proposedtreatment plan. It would be appropriate in thesecircumstances to discuss things again with thepatient and ask the patient to sign a newconsent form.

All discussions of possible risks andcomplications with the patient should be clearlydocumented in their medical records or on theconsent form. Specific pro formas may be usedfor certain procedures so that specific risks andcomplications can be listed separately, with anadditional space for any further comments tobe noted. It can be difficult to defend clinicalnegligence claims where a patient says theywere not told of a risk and there is nodocumentation to support the doctor’s viewthat he or she did in fact explain the risks of theprocedure in detail.

The consent process can pose particularproblems for doctors. The needs of eachprocedure and each patient may be differentand must be assessed on their own merits. TheMDU is pleased to advise members who may beuncertain about aspects of the consent processor have specific queries about an individualcase.


CONSENT

References

1. GMC Consent: Patients and doctors makingdecisions together June 2008 – para 26

2. GMC Good Medical Practice Nov 2006 -para 54

3. Department of Health Reference guide toconsent for examination and treatmentMay 2009 – para 31


5. GMC Consent: Patients and doctors makingdecisions together June 2008 – Para 52

6. GMC Consent: Patients and doctors makingdecisions together June 2008 – para 66-69

7. Mental Capacity Act 2005, section 1(2)


9. Mental Capacity Act 2005, section 3 (1)

10. Mental Capacity Act 2005, section 1 (5)

11. Mental Capacity Act 2005, section 4


The Mental Capacity Act 2005 applies toEngland and Wales. In Scotland the Adults withIncapacity (Scotland) Act 2000 applies.

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Consent






CONSENT

Consent is central to theparticipation of patientsin research. Dr YvonneMcCombie, MDUmedico-legal adviser,discusses some areasthat require specialconsideration in thecontext of clinical trials.

Consent inclinical trials

Doctors involved in clinical trials have a number oflegal obligations, not least ensuring that the trial isproperly authorised and approved¹. However, one ofthe key legal obligations is to obtain written consentfrom each participant.

It is well recognised that consent is fundamental to apatient’s participation in a clinical trial. The latestGMC guidance Good Practice in Research andConsent for Research (2010) sets out what isexpected from doctors involved in seeking consentfrom patients invited to participate in research.Among the principles governing consent in clinicaltrials are:

1. That patients should be informed of, and doctorsshould respect, their right to decline to take partin research and to withdraw from the researchproject at any time.

2. That information is shared with patients. Theamount shared will depend on their individualcircumstances and must be explained to them in away that they can understand, supported byaccurate written material or visual or other aids.

3. The clinician responsible for seeking consent mustunderstand the research project including what itwill involve and any anticipated benefits andforeseeable risks. If the task is delegated tosomeone else, that person must also understandthe project and possess sufficient skills andcompetence to seek consent.

4. Any consent should be clearly recorded alongwith the key elements of the discussion.

5. It is a legal requirement to obtain written consentfrom participants in clinical trials of investigationalmedicinal products.

6. Children or people lacking capacity should only takepart in research when research involving adults withcapacity cannot provide the same benefits.

ConsentFeatures

From Our Files




References

1 Under the Medicines for Human Use ClinicalTrials Regulations 2004 all trials must beauthorised by the Medicines and Health CareProducts Regulatory Agency and approved by aLocal Research Ethics Committee (regulated bythe United Kingdom Ethics CommitteeAuthority).

2. Support Care Cancer 2010 September 18 (9) –115#21.epub2010 March 4 - ‘Communication &Informed Consent in Phase 1 Trials. A review ofthe literature from January 2005 to July 2009’.

3 The European Journal of Cancer 2011 July:47(10): 1490 – 7.epub 2011 March 30.

4 ‘Unrealistic Optimism in Early Phase OncologyTrials’, Lynne A Jansen

5 Archives of Internal Medicine 2008’: 168 (12) –1294 -1299, Wendler et al

6 GMC Good practice in research 2010, para 15

November 2011 Volume 27 Issue 2 MDU Journal 1312 MDU Journal Volume 27 Issue 2 November 2011

This scenario raises an interesting andcomplex set of considerations. The doctor isrightly concerned that the patient should haverealistic expectations about any benefit shemight derive from the trial treatment, and alsothat her poor prognosis might so stronglyaffect her judgment as to call in to questionher ability to give consent to the newtreatment. This has led the doctor to wonderabout the validity of the whole process. Theseconcerns are supported by research relating toconsent in early phase clinical trials.

A review of the literature in 2010 noted thatexplaining potential participation in a phase 1trial in patients with cancer is a difficult taskand requires a doctor to be sure that thepatient has an accurate understanding of theircondition including admission of a probablelack of any therapeutic benefits from the trialdrugs and discussing fully any potentialunwanted side-effects, some of which may be unknown2.

As part of the process of seeking consentfrom participants in an early phase 1 trial,consideration should be given to theindividual patient’s reasons for participating ornot participating in such trials. ‘Optimism’ isconsidered a significant factor in many reviewsand can mean that achieving consent thatmight be considered properly informed fromthese patients can be difficult3.

In some studies, optimism is consideredethically benign. Others claim that unrealisticoptimism results from misunderstanding andcan be addressed by providing moreinformation. Other studies suggest that more

attention should be given to how patientsubjects apply information to themselves4.

In 2009 a study noted most respondentscontinued to participate in the hope ofbenefitting their own health and that themajority also recognised they werecontributing to help others and experiencedpride because of this5.

A number of studies have looked at factorsthat might affect patients’ decision-makingwhen taking part in early stage trials, wherethere is to be little or no therapeutic benefit tothemselves. Those identified included the areaof unrealistic optimism about the potentialbenefits from the trial treatment but also areal sense of altruism and wishing to take partto help others. This suggests that even thosewith a realistic understanding that they mightnot benefit themselves might still wish toparticipate in a clinical trial or research.

Therefore in this scenario the studies abovewould emphasise the importance of providingpatients with clear information about the trial,and its likely lack of therapeutic benefit andpotential side-effects, to ensure that consentis as fully informed as possible. In addition,GMC guidance6 requires the doctor to besatisfied that the benefits to participantsoutweigh the foreseeable risks, or that therisks are minimal where the research will onlypotentially benefit others more generally. Ifthe doctor believes that the patient hasessentially no chance of benefit from the trialtreatment, then their participation should onlybe considered if the risks are minimal.

Early phase trialsMy patient is a 34-year oldwoman suffering from anaggressive form of lymphoma.She has previously beeninvolved in a number of trialsrelating to specificchemotherapy treatments. Her prognosis is poor and shewishes to discuss thepossibility of becominginvolved in a further earlystage trial.

This trial is very unlikely tohave any therapeutic benefitto her and although she iskeen to become involved, I am concerned as to theoverall consent process in acase where the patient herselfis unlikely to receive anybenefit from the research.

Areas ofspecial

consideration

CONSENTCONSENT

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Consent






This scenario raises an interesting andcomplex set of considerations. The doctor isrightly concerned that the patient should haverealistic expectations about any benefit shemight derive from the trial treatment, and alsothat her poor prognosis might so stronglyaffect her judgment as to call in to questionher ability to give consent to the newtreatment. This has led the doctor to wonderabout the validity of the whole process. Theseconcerns are supported by research relating toconsent in early phase clinical trials.

A review of the literature in 2010 noted thatexplaining potential participation in a phase 1trial in patients with cancer is a difficult taskand requires a doctor to be sure that thepatient has an accurate understanding of theircondition including admission of a probablelack of any therapeutic benefits from the trialdrugs and discussing fully any potentialunwanted side-effects, some of which may be unknown2.

As part of the process of seeking consentfrom participants in an early phase 1 trial,consideration should be given to theindividual patient’s reasons for participating ornot participating in such trials. ‘Optimism’ isconsidered a significant factor in many reviewsand can mean that achieving consent thatmight be considered properly informed fromthese patients can be difficult3.

In some studies, optimism is consideredethically benign. Others claim that unrealisticoptimism results from misunderstanding andcan be addressed by providing moreinformation. Other studies suggest that more

attention should be given to how patientsubjects apply information to themselves4.

In 2009 a study noted most respondentscontinued to participate in the hope ofbenefitting their own health and that themajority also recognised they werecontributing to help others and experiencedpride because of this5.

A number of studies have looked at factorsthat might affect patients’ decision-makingwhen taking part in early stage trials, wherethere is to be little or no therapeutic benefit tothemselves. Those identified included the areaof unrealistic optimism about the potentialbenefits from the trial treatment but also areal sense of altruism and wishing to take partto help others. This suggests that even thosewith a realistic understanding that they mightnot benefit themselves might still wish toparticipate in a clinical trial or research.

Therefore in this scenario the studies abovewould emphasise the importance of providingpatients with clear information about the trial,and its likely lack of therapeutic benefit andpotential side-effects, to ensure that consentis as fully informed as possible. In addition,GMC guidance6 requires the doctor to besatisfied that the benefits to participantsoutweigh the foreseeable risks, or that therisks are minimal where the research will onlypotentially benefit others more generally. Ifthe doctor believes that the patient hasessentially no chance of benefit from the trialtreatment, then their participation should onlybe considered if the risks are minimal.

GMC guidance makes clear that youshould only undertake researchinvolving an adult who lacks capacity ifit is related to their incapacity ortreatment of the condition that causestheir incapacity, and that you shouldonly involve these patients in clinicaltrials of investigation into drugs ormedicinal products if the research isexpected to provide a benefit to themthat outweighs the risks.

In seeking to involve adults withoutcapacity in research you should:

• Consider the views of the peopleclose to the adult and take intoaccount any advance statement ordecision made when the patienthad capacity.

• Where there is no one apparentlyclose to the adult, section 32 of theMedical Capacity Act, requires youto take reasonable steps to identifyan unpaid carer or person interestedin the patient’s welfare who isprepared to be consulted about thepatient’s involvement in the research.If there is no such person, theresearcher must nominate someonewith no connection to the project.

• If the trial relates to investigationalmedicinal products, the Medicinesfor Human Use (Clinical Trials)Regulations 2004 require thatconsent is obtained from a legalrepresentative appointed under theMental Capacity Act 2005.Additionally, adults who lack

capacity should only participate intrials of such products where theresearch is expected to provide abenefit to them that outweighs therisk.

• Where the research does not involveclinical trial of investigationalmedicinal products, adults who lackcapacity may sometimes participateeven where the research is not likelyto provide a direct benefit to thembut will contribute to theunderstanding of their incapacity.This will, however, only beappropriate where the person willnot suffer harm or distress by takingpart and where the risks areminimal.

CapacityA 73-year old patient suffers from dementia and lacks capacity togive consent to being involved in research. I wish to seek hisinvolvement in research in relation to medication which may slow theprogression of the dementia from which he is suffering.

Research involvingchildrenI would like to recruit a 14-year old patient who suffersfrom asthma to a trial whichinvolves a series of blood tests overa three month period. The patienthas given consent – is it reasonablefor me to proceed?

While it is recognised that researchinvolving children and young people canbenefit all children, the GMC is clear thatchildren or young people should only beinvolved in trials when research in adultscannot provide the same benefits.

Research can relate to therapies thatbenefit children or young people generallyas long as it does not go against their bestinterests or involves minimal or low risk ofharm. The potential therapeutic benefits of

the research should outweigh anyforeseeable risks, which themselves shouldbe kept as low as possible.

When conducting research involvingchildren who are not able to consent it isessential to obtain the authority of aparent. GMC guidance states that consentshould be obtained from both parents, ifpossible, particularly where the researchinvolves more than low or minimal risk ofharm. You should consider involving theparents, depending on the nature of theresearch, even when a child or youngperson is able to consent for themselves

In this case, the member was satisfied thatthe patient was competent to give consentand the trial was also discussed with theboy’s parents with his consent.

Doctors should be familiar with the guidanceon involving children and young people inresearch, such as the guidelines for the EthicalConduct of Medical Research.

CONSENTCONSENT

ConsentFeatures

From Our Files




The role of children and youngpeople in making decisions abouttheir treatment has evolved

considerably over time. The Family LawReform Act 1969 created a presumptionthat a young person over the age of 16could give their own consent to medicaltreatment. The recognition that childrenunder the age of 16 could, if sufficientlymature, give consent to treatment camethrough the very well known case ofGillick v West Norfolk and Wisbech AreaHealth Authority¹. Although this caserelated to the provision of contraceptivetreatment in the under 16s, the principlesset out in the judgment have been widelyapplied to consent to all forms of medicaltreatment in children.

The GMC recognises that children who arecompetent to do so may consent to their owntreatment². It also advises that children andyoung people should be involved as much aspossible in decisions about their care, evenwhen they are not able to make decisions forthemselves. Whether the child has capacity tomake the decision will be a central questionfor all doctors providing treatment to children.

An assessment of capacity is not simplyrelated to age. It is about the patient beingable to understand what the procedure is,why it is being carried out and the risksinvolved. This will very much depend on thematurity of the individual child, and theparticular procedure. A younger child may beable to consent to a relatively minorprocedure without too much difficulty but itwould be expected that he or she would needto be older and have a higher level ofmaturity to consent to a more complicatedprocedure.

Communication is important and needs to beon a level that the child understands.Members of the multidisciplinary team can beinvaluable in helping a child make a decisionas they can take time to explore a child’sanxieties and fears and try to allay these. Theycan help present information in an easy tounderstand way. It may not be appropriate topresent all the information at one time andthe child should be allowed enough time,perhaps over several appointments, to thinkabout the procedure and ask any questions.

While the law recognises the right of acompetent minor to consent to treatment, theposition with regard to refusal of treatmentthat is considered to be in their best interestsis more complex. Neither the Family LawReform Act nor the Gillick case removed theability of a person with parental responsibilityto give authority for medical treatment of aminor. However, overriding the refusal of acompetent young person requires very careful


consideration. MDU members are encouraged to contact theadvisory helpline in these cases as they can be particularlychallenging. It is advisable to consult with other seniorcolleagues and also the Child Protection Lead. Most cases maywell be resolved with careful explanation and discussion, butsome may require legal advice or a court decision.

When a child lacks capacity to consent, it is necessary to seekauthority from those with parental responsibility for the child. Ifthis is the child’s natural parents, authority can be given byeither parent, not necessarily both. It would certainly be goodpractice to involve both parents in any discussions and if there isany dispute between the parents in relation to their authority itis advisable to try and resolve this.

Difficult situations can arise when parents refuse consent for atreatment in a child who does not have capacity and you thinkthe treatment is in the child’s best interests. Ultimately it may befor the courts to make a decision as to what are the child’s bestinterests.

Of course, if a child requires urgent life-saving treatment thenyou may proceed without consent to provide such treatment asis immediately necessary in the best interests of the child.

Children –a special caseObtaining consent totreat a child posesparticular challenges, asDr Ruth Gibson explains.

CONSENTCONSENT

News


Consent





The role of children and youngpeople in making decisions abouttheir treatment has evolved

considerably over time. The Family LawReform Act 1969 created a presumptionthat a young person over the age of 16could give their own consent to medicaltreatment. The recognition that childrenunder the age of 16 could, if sufficientlymature, give consent to treatment camethrough the very well known case ofGillick v West Norfolk and Wisbech AreaHealth Authority¹. Although this caserelated to the provision of contraceptivetreatment in the under 16s, the principlesset out in the judgment have been widelyapplied to consent to all forms of medicaltreatment in children.

The GMC recognises that children who arecompetent to do so may consent to their owntreatment². It also advises that children andyoung people should be involved as much aspossible in decisions about their care, evenwhen they are not able to make decisions forthemselves. Whether the child has capacity tomake the decision will be a central questionfor all doctors providing treatment to children.

An assessment of capacity is not simplyrelated to age. It is about the patient beingable to understand what the procedure is,why it is being carried out and the risksinvolved. This will very much depend on thematurity of the individual child, and theparticular procedure. A younger child may beable to consent to a relatively minorprocedure without too much difficulty but itwould be expected that he or she would needto be older and have a higher level ofmaturity to consent to a more complicatedprocedure.

Communication is important and needs to beon a level that the child understands.Members of the multidisciplinary team can beinvaluable in helping a child make a decisionas they can take time to explore a child’sanxieties and fears and try to allay these. Theycan help present information in an easy tounderstand way. It may not be appropriate topresent all the information at one time andthe child should be allowed enough time,perhaps over several appointments, to thinkabout the procedure and ask any questions.

While the law recognises the right of acompetent minor to consent to treatment, theposition with regard to refusal of treatmentthat is considered to be in their best interestsis more complex. Neither the Family LawReform Act nor the Gillick case removed theability of a person with parental responsibilityto give authority for medical treatment of aminor. However, overriding the refusal of acompetent young person requires very careful


consideration. MDU members are encouraged to contact theadvisory helpline in these cases as they can be particularlychallenging. It is advisable to consult with other seniorcolleagues and also the Child Protection Lead. Most cases maywell be resolved with careful explanation and discussion, butsome may require legal advice or a court decision.

When a child lacks capacity to consent, it is necessary to seekauthority from those with parental responsibility for the child. Ifthis is the child’s natural parents, authority can be given byeither parent, not necessarily both. It would certainly be goodpractice to involve both parents in any discussions and if there isany dispute between the parents in relation to their authority itis advisable to try and resolve this.

Difficult situations can arise when parents refuse consent for atreatment in a child who does not have capacity and you thinkthe treatment is in the child’s best interests. Ultimately it may befor the courts to make a decision as to what are the child’s bestinterests.

Of course, if a child requires urgent life-saving treatment thenyou may proceed without consent to provide such treatment asis immediately necessary in the best interests of the child.

Parental responsibility

Mothers automatically haveparental responsibility, as dofathers if they are married tothe mother either at the timeof birth or subsequently.There are differing means bywhich unmarried fathers canobtain parental responsibilityand MDU members areadvised to contact us forspecific advice in thesesituations. Parents do notlose parental responsibility ifthey divorce.

The scene

A consultant treating a 15-year old patient with autoimmunehepatitis was concerned that she was developing liver failureand would soon need a transplant. When he raised thispossibility, she vehemently refused, saying she would neverconsider a transplant as she had followed the blog of a girl ofher own age who had died following protracted complicationof a transplant.

The doctor was aware that a competent young person couldconsent to treatment but had been advised by a colleague thatshe ‘could not refuse until she was 18’.

The consultant felt the patient needed the surgery but thatforcing her to undergo treatment which required her ongoingengagement would be counterproductive. He was alsoconcerned that, while his patient appeared intellectuallymature, she placed so much emphasis on the contents of theblog that she would not entertain other view points. He rangthe MDU advisory helpline for assistance.

The advice

The MDU adviser agreed that this was a complex situation andrequired sensitive management. Although the law is ofteninterpreted as meaning that a person under 18 can consent tobut not refuse treatment, the adviser explained that the refusalof a competent minor should not be overridden lightly.

Taking notice of the experience detailed in the blog may not initself lead to concerns about the patient’s capacity, but may doso if its prominence seemed to have overwhelmed the patient’sability to weigh the relevant factors appropriately. It mighttherefore be appropriate first to seek a view from a colleagueor another specialist, such as a child psychiatrist, to assess hercapacity and to explore whether other interventions might behelpful. The adviser also encouraged the member to follow hisusual practice in helping the patient understand what atransplant would involve.

If the patient continued to refuse treatment that was thoughtto be in her best interests, it might become necessary to applyto a court for a declaration as to the lawfulness or otherwise ofproceeding in the face of her refusal. The trust would need tobe involved at an early stage in any application to the court.The adviser agreed, however, that taking this adversarialapproach might not achieve the best outcome as the patientwould still need to engage positively with treatment.

A few weeks later the member called to report that his patienthad met with members of the multidisciplinary team, and alsowith other transplant patients who shared their experienceswith her. He was confident that she was thinking about mattersin a more balanced way and hoped she would soon look morepositively on a transplant.

References

1

1 Gillick v West Norfolk and Wisbech Area Health Authority [1985] All ER 402 (HL)

2 GMC 0-18 years: guidance for doctors

CONSENTCONSENT

ConsentFeatures

From Our Files




s the use of telemedicinegrows, what

are the medico-legalimplications? By Susan Field.

In August 2011, theDepartment of Health (DH)invited the public and clinicians

to propose ideas for innovativemobile health apps or nominatetheir favourite existing ones¹.Nearly 500 apps were submitted,reflecting a growing interest intelemedicine, driven by theproliferation of portable devicessuch as smartphones and tabletcomputers.

Last year the think tank 2020Health claimed² that the NHScould save up to £1billion byusing technology to remotelymonitor patients with long-term conditions such asdiabetes, heart disease andlung disease. More recently, theNHS Confederationcomplained³ that: ‘For too longthe development of digitalhealth tools has been stifled byassumptions about whatpatients want.’ There is also agrowing number of examplesof telemedicine in action, suchas the first remoteneuropsychology clinic byvideolink between the WesternIsles and Glasgow, announcedthis year�.

Supporters of telemedicineargue it often represents anattractive alternative totraditional face-to-faceconsultations and it seems likelythat the technology will beembraced within the NHS.However, it’s also important to

address the medico-legalimplications and the extent ofyour MDU indemnity forremote consultations. The MDUadvises doctors to consider thefollowing points beforeagreeing to providetelemedicine services.

Patient safety

The inability to conduct aphysical examination will makesome conditions unsuitable forremote diagnosis and doctorsare advised to invite patientsfor a face-to-face consultationif they think it is clinicallynecessary.

At the time of writing(September 2011) the GMCwas reviewing its prescribingguidance but the most recentversion5 includes a section onremote prescribing. It saysdoctors must:

• ensure that they are able toestablish the patient’smedical history andconcurrent or recent use ofother medications,including non-prescriptionmedicines

• carry out an adequateassessment of the patient'scondition and its likelycause

• ensure there is sufficientjustification to prescribe themedicines/treatmentproposed.

The GMC states that wheredoctors cannot satisfy theconditions set out, they ‘shouldnot use remote means toprescribe medicine for apatient’. Even when the criteriaare satisfied, if you are notproviding continuing care forthe patient or if you are

deputising for someonewho is, and you do nothave access to thepatient’s medical records,you must comply with the stringentrequirements for follow-up and monitoring, asset out in GMCguidance.

Confidentiality anddata protection

Doctors have an ethical duty toprotect the confidentiality ofpatient information, as well as a legal duty under the DataProtection Act 1998 to ensurepersonal data is held securelyand protected fromunauthorised or unlawfulprocessing.

In the case of telemedicine, thismeans satisfying yourself thatrobust security measures are inplace, such as data encryption,and you may wish to takeappropriate professional advice.

Consent

You must be satisfied thatthe patient understands thelimitations of an onlineconsultation including thelimits of a safe clinicalassessment and onlinesecurity, and is happy tocontinue.

Indemnity

Negligence claims whicharise from work undertakenby hospital doctors as partof their NHS contract,including NHS telemedicineservices, are likely to bepicked up by NHS indemnity.


FEATUREFEATURE

Medical records are not justessential in ensuring thecontinuity of care of patients.

They are often required for legal purposesand can be hugely important indefending a complaint or a clinicalnegligence claim because they provide asnapshot of the doctor’s clinical judgmentat the time of the examination.

However, there are occasions when adoctor may be prompted to review apatient’s medical records for reasonsother than clinical care – perhaps

following receipt of asolicitor’s letter, or arequest to provide amedical report forlitigation, or for aninquest.

What if, when readingthrough the notes, thedoctor realises that thewritten record does notprovide a fulsomeaccount of theconsultation? Perhapsthe thought crosses hismind that a simpleaddition to the recordswill help clarify mattersand save time and

trouble in the long term.

It may be tempting, but doctors must notamend or alter the records in order to passthe entry off as contemporaneous with theoriginal consultation. To do so is dishonestand will incur the wrath of the GMC.

It is also important to recognise thatmaking amendments to medical recordscould attract criminal liability. In certaincircumstances such amendments couldbe considered to be a forgery offence, afraud offence, or if incorrect records areknowingly relied on in court, this couldamount to perjury or even an attempt topervert the course of justice.

Date your amendment

If any alterations are to be made tomedical records, the date on which theamendment was made should be clearlyadded, together with the name of thedoctor and the reason for theamendment.

Doctors should bear in mind that audittrails can be conducted for computer

records, which reflect each and everyentry in the records together with thedate and time at which they were madeand the name of the person who madethe entries.

GMC guidance states that doctors must‘make records at the same time as theevents (you) are recording or as soon aspossible afterwards’¹. Further, doctors arerequired to be honest and trustworthywhen writing reports, completing orsigning forms, reports and otherdocuments², and must to do their best ‘to make sure that any documents (you)write or sign are not false or misleading’³.

A failure to clearly mark that anamendment is retrospective will not onlydiminish the credibility of the doctor inquestion, but is an act which in itself ismore th an capable of leading to a referralto a GMC Fitness to Practise (FTP) panel.

The GMC will consider each case on itsown merits, but given that honesty andprobity are at the core of the medicalprofession�, any actions which may beviewed as misleading or dishonest aretreated very seriously.

While it may have an impact as tosanction, the actual content of theadditions or amendments are in partirrelevant. Ironically, the original record isoften sufficient to provide that snapshotof clinical judgment during the crucialwindow under investigation.

The addition of the date and a reason forthe alteration could be the differencebetween a simple clarification and aGMC referral.

This is, of course, an extreme example ofhow a relatively minor act can escalate.However, it is possible to managedevelopments with the correct support,advice and guidance. Members who haveconcerns about a particular situation areadvised to contact the MDU at theearliest opportunity, before consideringmaking any additions or alterations tonotes.

References

1 Good Medical Practice, paragraph 3(f)

2 Ibid. paragraph 63



A small actwith BIGconsequences

They may be made withthe best intentions, but afew tweaks to medicalrecords here and therecan land you before theGMC. Grace Burns andJohn Kingston, MDUsolicitors, explain.

News


Consent





s the use of telemedicinegrows, what

are the medico-legalimplications? By Susan Field.

In August 2011, theDepartment of Health (DH)invited the public and clinicians

to propose ideas for innovativemobile health apps or nominatetheir favourite existing ones¹.Nearly 500 apps were submitted,reflecting a growing interest intelemedicine, driven by theproliferation of portable devicessuch as smartphones and tabletcomputers.

Last year the think tank 2020Health claimed² that the NHScould save up to £1billion byusing technology to remotelymonitor patients with long-term conditions such asdiabetes, heart disease andlung disease. More recently, theNHS Confederationcomplained³ that: ‘For too longthe development of digitalhealth tools has been stifled byassumptions about whatpatients want.’ There is also agrowing number of examplesof telemedicine in action, suchas the first remoteneuropsychology clinic byvideolink between the WesternIsles and Glasgow, announcedthis year�.

Supporters of telemedicineargue it often represents anattractive alternative totraditional face-to-faceconsultations and it seems likelythat the technology will beembraced within the NHS.However, it’s also important to

address the medico-legalimplications and the extent ofyour MDU indemnity forremote consultations. The MDUadvises doctors to consider thefollowing points beforeagreeing to providetelemedicine services.

Patient safety

The inability to conduct aphysical examination will makesome conditions unsuitable forremote diagnosis and doctorsare advised to invite patientsfor a face-to-face consultationif they think it is clinicallynecessary.

At the time of writing(September 2011) the GMCwas reviewing its prescribingguidance but the most recentversion5 includes a section onremote prescribing. It saysdoctors must:

• ensure that they are able toestablish the patient’smedical history andconcurrent or recent use ofother medications,including non-prescriptionmedicines

• carry out an adequateassessment of the patient'scondition and its likelycause

• ensure there is sufficientjustification to prescribe themedicines/treatmentproposed.

The GMC states that wheredoctors cannot satisfy theconditions set out, they ‘shouldnot use remote means toprescribe medicine for apatient’. Even when the criteriaare satisfied, if you are notproviding continuing care forthe patient or if you are

deputising for someonewho is, and you do nothave access to thepatient’s medical records,you must comply with the stringentrequirements for follow-up and monitoring, asset out in GMCguidance.

Confidentiality anddata protection

Doctors have an ethical duty toprotect the confidentiality ofpatient information, as well as a legal duty under the DataProtection Act 1998 to ensurepersonal data is held securelyand protected fromunauthorised or unlawfulprocessing.

In the case of telemedicine, thismeans satisfying yourself thatrobust security measures are inplace, such as data encryption,and you may wish to takeappropriate professional advice.

Consent

You must be satisfied thatthe patient understands thelimitations of an onlineconsultation including thelimits of a safe clinicalassessment and onlinesecurity, and is happy tocontinue.

Indemnity

Negligence claims whicharise from work undertakenby hospital doctors as partof their NHS contract,including NHS telemedicineservices, are likely to bepicked up by NHS indemnity.


FEATUREFEATURE

References

1 Is there an app for that?, DH, August 22, 2011http://www.dh.gov.uk/health/2011/08/is-there-an-app-for-that/

2 Healthcare without Walls: Delivering telehealthat scale, 2020Health, 24 November 2010http://www.2020health.org/2020health/research/telehealth.html

3 Remote control: The patient-practitionerrelationship in a digital age, NHSConfederation, 25 January 2011http://www.nhsconfed.org/Publications/reports/Pages/Remote-control.aspx

4 New telehealth service launched for WesternIsles patients, NHS24, 4 March 2011

5 Good practice in prescribing medicines -guidance for doctors, GMC, September 2008

Medical records are not justessential in ensuring thecontinuity of care of patients.

They are often required for legal purposesand can be hugely important indefending a complaint or a clinicalnegligence claim because they provide asnapshot of the doctor’s clinical judgmentat the time of the examination.

However, there are occasions when adoctor may be prompted to review apatient’s medical records for reasonsother than clinical care – perhaps

following receipt of asolicitor’s letter, or arequest to provide amedical report forlitigation, or for aninquest.

What if, when readingthrough the notes, thedoctor realises that thewritten record does notprovide a fulsomeaccount of theconsultation? Perhapsthe thought crosses hismind that a simpleaddition to the recordswill help clarify mattersand save time and

trouble in the long term.

It may be tempting, but doctors must notamend or alter the records in order to passthe entry off as contemporaneous with theoriginal consultation. To do so is dishonestand will incur the wrath of the GMC.

It is also important to recognise thatmaking amendments to medical recordscould attract criminal liability. In certaincircumstances such amendments couldbe considered to be a forgery offence, afraud offence, or if incorrect records areknowingly relied on in court, this couldamount to perjury or even an attempt topervert the course of justice.

Date your amendment

If any alterations are to be made tomedical records, the date on which theamendment was made should be clearlyadded, together with the name of thedoctor and the reason for theamendment.

Doctors should bear in mind that audittrails can be conducted for computer

records, which reflect each and everyentry in the records together with thedate and time at which they were madeand the name of the person who madethe entries.

GMC guidance states that doctors must‘make records at the same time as theevents (you) are recording or as soon aspossible afterwards’¹. Further, doctors arerequired to be honest and trustworthywhen writing reports, completing orsigning forms, reports and otherdocuments², and must to do their best ‘to make sure that any documents (you)write or sign are not false or misleading’³.

A failure to clearly mark that anamendment is retrospective will not onlydiminish the credibility of the doctor inquestion, but is an act which in itself ismore th an capable of leading to a referralto a GMC Fitness to Practise (FTP) panel.

The GMC will consider each case on itsown merits, but given that honesty andprobity are at the core of the medicalprofession�, any actions which may beviewed as misleading or dishonest aretreated very seriously.

While it may have an impact as tosanction, the actual content of theadditions or amendments are in partirrelevant. Ironically, the original record isoften sufficient to provide that snapshotof clinical judgment during the crucialwindow under investigation.

The addition of the date and a reason forthe alteration could be the differencebetween a simple clarification and aGMC referral.

This is, of course, an extreme example ofhow a relatively minor act can escalate.However, it is possible to managedevelopments with the correct support,advice and guidance. Members who haveconcerns about a particular situation areadvised to contact the MDU at theearliest opportunity, before consideringmaking any additions or alterations tonotes.

References

1 Good Medical Practice, paragraph 3(f)




Consultation

MDU members undertakingtelemedicine consultations notcovered by NHS indemnity (oranother employer’s indemnityscheme) should discuss theirindemnity requirements with theMDU membership department.

Where indemnity is agreed, memberswill be covered under the terms oftheir MDU professional indemnitypolicy of insurance for negligenceclaims arising from consultations onlywhere both doctor and patient arelocated in the UK.

FeaturesFrom

Our Files




CLAIMS ANALYSISCLAIMS ANALYSIS


The changing

surgeryfaceofplastic

Perceptions ofbodily perfectionhave changed

dramatically in the lastdecade, fuelled by thecult of celebrity, mediasaturation, the internetand social networking.So, too, have patientexpectations. Patientselecting to havecorrective surgery, aswell as those for whomthe surgery is atherapeutic necessity,may now expect theoutcome to be perfect,not just better. If thingsgo wrong or they areunhappy with the result,statistics show that theyare increasingly likely tobring a claim forcompensation.

James Armstrong, headof underwriting at theMDU, examines thetrends in types of claimnotified to the MDU.

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Breast (37%)

Facelift (14%)

Blepharoplasty (11%)

Rhinoplasty (10%)

Abdominoplasty (8%)

Liposuction

Isolagen

Laser treatment

Dermal fillers & injectables

Otoplasty

Chemical peel

Hair transplant

Calf/thigh/buttock implant

Penoplasty

Types of procedureAnalysis of the types of plasticsurgical procedure thatcommonly give rise to claimsdemonstrates that 80% of allclaims arise from five branchesof surgery – namely, breastsurgery (reconstruction,augmentation and reduction), facelift,blepharoplasty, rhinoplasty and abdominoplasty (fig. 2)

Perceptions ofbodily perfectionhave changed

dramatically in the lastdecade, fuelled by thecult of celebrity, mediasaturation, the internetand social networking.So, too, have patientexpectations. Patientselecting to havecorrective surgery, aswell as those for whomthe surgery is atherapeutic necessity,may now expect theoutcome to be perfect,not just better. If thingsgo wrong or they areunhappy with the result,statistics show that theyare increasingly likely tobring a claim forcompensation.

James Armstrong, headof underwriting at theMDU, examines thetrends in types of claimnotified to the MDU.

Some 38,274 cosmetic surgeryprocedures were carried out bysurgeons in their independentpractice in the UK in 2009¹, up from22,000 in 2005 (itself a 35% increaseon the year before). With such a hugerise in both number of proceduresand patient expectations of a perfectoutcome, it is hardly surprising thatclaims for compensation notified tothe MDU have also gone up.

Although the majority of patientstreated by MDU members enjoyexcellent outcomes, there willundoubtedly be patients who sufferan adverse incident or who aredissatisfied with their outcome. Insome cases a dissatisfied patient maypursue a complaint or claim.

An analysis of claims notified by ourplastic surgeon members for bothplastic and cosmetic procedures over

a recent five year period demonstratesa significant increase in the number ofnotifications (fig.1) during this time.

It is interesting to note that the rate ofsettlement in plastic surgical claims issomewhat higher than in otherspecialties. Excluding those claimsthat remain active, 45.2% of claimswere settled over the period ofanalysis. This exceeds by some marginthe average settlement rate of allMDU claims which is generally around30%.

The level of compensation paid in asettled claim reflects the cost ofrestoring the claimant to the positionthey would have been in had thenegligence not occurred. The bulk ofthe damages usually relate to painand suffering and loss of incomerather than future care costs.

Year 1 Year 2 Year 3 Year 4 Year 5Year 1 Year 2 Year 3 Year 4 Year 5Year 1 Year 2 Year 3 Year 4 Year 5Year 1 Year 2 Year 3 Year 4 Year 5Year 1 Year 2 Year 3 Year 4 Year 5

Fig. 1

Fig. 2

From Our Files


The consent questionOf the claims notified during this period, 20%related, at least in part, to allegationsconcerning the consent process. Of the claimsthat have been settled so far, that proportionincreases to more than a quarter at 28%.

In many of the ‘consent’ claims the patientsuffered an adverse incident, ranging fromhaematoma to necrotising fasciitis to strokeand claimed they would not have agreed tothe procedure had they been made aware ofthe risks before surgery. One such example isof a claimant who alleged that the surgeonhad failed to obtain fully informed consentand a full medical history before carrying out afacelift. The patient suffered a post-operativestroke. The claim was eventually settled forover £500,000.

In other cases the surgery resulted in scarringor asymmetry, or simply produced a result thatdid not meet the patient’s expectations, andagain the patient claimed they would not haveagreed to the procedure had they known ofthe risks.

In several cases, the claim was settledfollowing expert opinion that indicated thepatient should have undergone psychologicalassessment prior to surgery – for example, inthe case of patients requesting a second orthird breast augmentation procedure.

A robust consent procedure represents animportant stage of the preparation for alltypes of surgical procedure but it is perhapsparticularly crucial in the field of aestheticsurgery, where patients seeking physical

‘perfection’ may have high, even unrealistic,expectations. In many cases aestheticprocedures are performed on healthy patientsand so adverse outcomes are perhaps less welltolerated than in cases where surgery iscarried out to treat organic pathology.

Other types of medico-legalassistanceDoctors seek help from the MDU in manycircumstances other than claims for clinicalnegligence, including GMC investigations,complaints, coroner’s inquiries, disciplinaryinvestigation, criminal investigation, handlingthe media and advisory assistance.

GMC investigationsPatients seeking to hold their doctor toaccount are increasingly turning to the fitnessto practise procedures of the General MedicalCouncil. The annual number of enquiries tothe GMC about doctors’ fitness to practiseincreased by 30% between 2004 and 2009.

The GMC investigatory process can be slowand expensive and the MDU advisory and legalteams support members throughout therigours of a GMC investigation. In manyinstances, no impairment is found, but thecase will invariably have a lasting effect on thedoctor concerned.

Over the period of analysis the MDU assistedmore than 50 members working in plasticsurgery with GMC investigations, with costs insome cases approaching £200,000.



We recommend that surgeons working in the field of plastic surgeryconsider the following MDU consent checklist and compare it withtheir own practice.

• Employ a two-stage consent procedure, the first at the time ofconsultation and the second just before surgery.

• Provide written information about the risks and benefits of eachprocedure that you offer.

• Ensure the patient’s GP knows that the patient is planning toundergo cosmetic surgery and seek a full medical history.

• Seek each patient’s consent yourself.

• Warn patients about the risk of all major adverse outcomes and allcommonly occurring minor adverse outcomes.

• Consider what risks a reasonable person might need or want toknow.

• Consider what risks this particular patient might need or want toknow.

• Never gloss over risks or encourage or coax a patient into agreeingto a procedure.

• Ensure the patient has understood the risks you have explained.

• Ensure an effective translator is present if the patient doesn’t speakyour language.

• Document your discussions in as much detail as possible.

• Consider the need for psychological assessment prior to surgery.

• Ensure any advertising literature you publish does not createunrealistic expectations.

Medical records are a vital component of good medical care. The lackof a comprehensive, contemporaneous clinical record may also hampersuccessful defence of a claim. so ensure the records include:

• a full medical history

• any clinical examination made pre-operatively

• the specific counselling given for each clinical procedure, includingany cautions, problems or complaints

• all telephone conversations and clinical advice concerning thepatient's care

• good quality pre- and post-operative photographs, including thedate and time.

Also ensure that additions to the clinical record are signed and datedand do not obscure the original note.

Consent

Record-keeping

Manage

References

1 BAAPS Statistics 2010

2 GMC 2009 Annual statistics: Fitness topractise, http://www.gmc-uk.org/2009_Annual_Statistics.pdf_33097340.pdf.

3 The clinical negligence insurance policyprovided to members of the MDU is co-underwritten by SCOR UK Company Limitedand by International Insurance Company ofHannover Limited.

If you receive notification of a complaint tothe GMC, please contact the MDU as soon aspossible.

ComplaintsA significant number of claims notified startlife as a simple complaint. In our experience,sensitive and constructive complaint handlingcan be effective in reducing or removing therisk of a subsequent claim for negligence.

It is interesting to note that a relativelycommon cause for complaints made againstplastic surgeons was unrelated to surgicaloutcomes, but concerned the publication ofpatient images, allegedly without consent. It isoften very difficult to truly anonymise aphotograph, particularly where facial featuresare included, or the patient has distinctivemoles, birthmarks or tattoos. For this reason itis seldom, if ever, advisable to publish aphotographic image of a patient withoutexplicit consent in relation both to the materialthat will be used and how it will be used.

Disciplinary investigationsThe MDU assisted a number of plastic surgeonmembers in relation to disciplinaryproceedings brought by an employer, both inthe NHS and in the private sector.

Because NHS trusts are required to observestrict clinical governance procedures it is notuncommon for managers to take immediateaction against a doctor when concerns areraised, even where those concerns are foundsubsequently to be unsubstantiated. Theexclusion of a doctor from the workplacepending an investigation, or the placement ofrestrictions on their practice, are considered‘neutral’ acts; however, their effect can beanything but neutral for the doctor concerned.

Please contact the MDU immediately if you arefacing a disciplinary investigation.

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From Our Files









Unexpected scarring

A 43-year old man underwent a face lift andblepharoplasty but was unhappy with the results.He made a claim against his surgeon alleging thathe was not warned that scars might be visibleafter the facelift, and that he had been left withan unusual scar near his mouth. Investigationshowed this to have been the result of a burnfrom a diathermy instrument used during theoperation to seal blood vessels. It had accidentallytouched the patient’s face. The claim was settledfor £25,000.

Breathing problem

A patient complained to his surgeon that he hadsuffered breathing problems since undergoingrhinoplasty. He also felt that, in spite of hisrequest to make his nose smaller, the surgeonhad not done so. It took two further operationsto achieve the nose the patient desired, and tocorrect his breathing problem. Fortunately, thedoctor had kept careful notes of the pre-operative discussion and was able to show thathe had counselled the patient about the aestheticeffect that could be achieved. The MDU wastherefore able to defend the surgeon successfullyagainst the first allegation. However, the claimwas settled for £10,000 in recognition of thepatient’s breathing problem.

Wrong size implants

A young woman had breast implant surgery asshe felt she was too flat-chested. Some monthslater, she brought a claim against the cosmeticsurgeon, alleging that the implants were toosmall and her breasts were now of unequal size.From the notes, it was apparent that the surgeonhad been reluctant to proceed with the operationbecause the patient was so young. He hadwarned her of the possibility of damage to thedeveloping breast. However, it was clear that thewoman had been given the wrong size implantsand the claim was settled on that basis.

We recommend that surgeons working in the field of plastic surgeryconsider the following MDU consent checklist and compare it withtheir own practice.

• Employ a two-stage consent procedure, the first at the time ofconsultation and the second just before surgery.

• Provide written information about the risks and benefits of eachprocedure that you offer.

• Ensure the patient’s GP knows that the patient is planning toundergo cosmetic surgery and seek a full medical history.

• Seek each patient’s consent yourself.

• Warn patients about the risk of all major adverse outcomes and allcommonly occurring minor adverse outcomes.

• Consider what risks a reasonable person might need or want toknow.

• Consider what risks this particular patient might need or want toknow.

• Never gloss over risks or encourage or coax a patient into agreeingto a procedure.

• Ensure the patient has understood the risks you have explained.

• Ensure an effective translator is present if the patient doesn’t speakyour language.

• Document your discussions in as much detail as possible.

• Consider the need for psychological assessment prior to surgery.

• Ensure any advertising literature you publish does not createunrealistic expectations.

Medical records are a vital component of good medical care. The lackof a comprehensive, contemporaneous clinical record may also hampersuccessful defence of a claim. so ensure the records include:

• a full medical history

• any clinical examination made pre-operatively

• the specific counselling given for each clinical procedure, includingany cautions, problems or complaints

• all telephone conversations and clinical advice concerning thepatient's care

• good quality pre- and post-operative photographs, including thedate and time.

Also ensure that additions to the clinical record are signed and datedand do not obscure the original note.

Consent

Record-keeping

Manage the riskIf you receive notification of a complaint tothe GMC, please contact the MDU as soon aspossible.

ComplaintsA significant number of claims notified startlife as a simple complaint. In our experience,sensitive and constructive complaint handlingcan be effective in reducing or removing therisk of a subsequent claim for negligence.

It is interesting to note that a relativelycommon cause for complaints made againstplastic surgeons was unrelated to surgicaloutcomes, but concerned the publication ofpatient images, allegedly without consent. It isoften very difficult to truly anonymise aphotograph, particularly where facial featuresare included, or the patient has distinctivemoles, birthmarks or tattoos. For this reason itis seldom, if ever, advisable to publish aphotographic image of a patient withoutexplicit consent in relation both to the materialthat will be used and how it will be used.

Disciplinary investigationsThe MDU assisted a number of plastic surgeonmembers in relation to disciplinaryproceedings brought by an employer, both inthe NHS and in the private sector.

Because NHS trusts are required to observestrict clinical governance procedures it is notuncommon for managers to take immediateaction against a doctor when concerns areraised, even where those concerns are foundsubsequently to be unsubstantiated. Theexclusion of a doctor from the workplacepending an investigation, or the placement ofrestrictions on their practice, are considered‘neutral’ acts; however, their effect can beanything but neutral for the doctor concerned.

Please contact the MDU immediately if you arefacing a disciplinary investigation.

From Our Files


In this case there were also suggestions of a‘system error’ when it emerged that severaldoctors, including a GP and a radiologist,reportedly referred to the lesion beingon the wrong side, highlighting theneed for all doctors to be carefulwhen describing the site ofpathology.

That a doctor could perform such a majorprocedure as a nephrectomy on the wrongside and remove a healthy organ instead of adiseased one stretches the credulity of thepublic. Yet incidents of this sort occur in eventhe most well-run hospitals. With waiting listinitiatives and generic operating lists becomingmore common, the risk of wrong site surgerymay well be greater than before since thesurgeon may not have assessed the patient inclinic. Indeed a recent study from the USA hassuggested that the incidence has almostdoubled since 2004¹.

Simple stepsThere have been a number of steps taken overthe years to try to avoid this problem. Forexample the World Health Organisationpromoted the use of a surgical checklist. Thiswas supported by a multi-professional groupincluding the relevant Royal Colleges and theNational Patient Safety Agency who adapted itfor use in the UK in 2009. Part of the ‘timeout’ section of this checklist requires bothsurgeon and anaesthetist to confirm the siteof the planned procedure. All NHS hospitalsshould now have implemented this.

In the UK, wrong site surgery is classed by theNational Patient Safety Agency (NPSA) as aserious, largely preventable patient safetyincident that should not occur if suitablemeasures are in place. The National Reportingand Learning Service had 57 reports of wrongsite surgery in 2009/10 and this made upmore than half of the reported preventableincidents that year².

A recent analysis of claims made to the MDUsince January 2000 revealed 63 cases of wrongsite procedures, an average of 5 per year. In ouranalysis orthopaedic cases were by far the mostcommon, accounting for 26 (41%) of cases.

Risk managementadviceBased on our experience in assisting memberswith claims, the MDU suggests the followingrisk management steps:

• When referring to side, site or anatomicallocation on consent forms and operatinglists, write in full and avoid usingabbreviations.

• To avoid ambiguity about the digits on thehand, describe fingers as: thumb, index,middle, ring and little. Toes should bereferred to as: hallux, second, third, fourthand fifth.

• Check the patient's referral letter againstthe clinical record, consent form and theoperation list to ensure they are inagreement.

• Confirm the patient’s surgery details at allstages of the patient's route to theatre: onadmission, when leaving the ward enroute to theatre, on entering the theatresuite, in the anaesthetic room, and so on.

• A member of the surgical team shouldmark the correct surgical site on the wardor in the day case area. This person shouldbe in theatre as the procedure is carriedout.

• The process of marking the siteshould, if possible, involve thepatient and/or if appropriate familymembers or significant others.

• Ask the patient to verballystate (rather than simplyconfirm) their full name,date of birth and theanatomical location of theintended procedure. Theoperating surgeonshould see the patientbefore theadministration ofanaesthesia andensure all clinicaldocumentation(referral letter, sourceof referral, a signedconsent form andsupporting images orfilms) is available.

• When marking an operation site, use aspecified, clear, unambiguous, indeliblemethod. A water-based marker pen maywash off or transfer to another limb.

• The operating surgeon must be satisfied ofthe intended site, side or level of surgerybefore the patient is draped. If the patientis draped by another member of thetheatre team, they should audibly confirmwith the operating surgeon – referring tothe side, site or level.

• Ensure marks are clearly visible to theoperating surgeon after theatre drapes areput on.

• Call a 'time out' before the procedurestarts, so that the patient details,procedure, site and, if applicable, implantscan be re-checked against the records. Ifconcerns are expressed, the procedureshould not be started until the issues areresolved.

• If you think something iswrong, say so.

All doctors potentially havea part to play in preventing

these rare but serious errors intreatment. By paying careful attention

to how the site of any pathology isdescribed and ensuring that patient

checking procedures and protocols arefollowed consistently, the incidence of wrongsite surgery will be minimised, thus avoidingthe devastating consequences to patients ofthis type of preventable mistake.

References

1 The pain of wrong site surgery, Washington Post 20 June 2011

2 NPSA Never Event Annual Report 2009/10


FEATUREFEATURE

Wrong site,

Issues of patientsafety demandurgent action,especially whenthey involvesurgery to thewrong part ofbody. Sally Old,MDU medico-legal adviser,offers advice onhow to avoid thistype of error.

wrong sidewrong side

In 2006 a surgeon mistakenly removeda patient’s healthy kidney instead of thecancerous one. Thankfully the patientsurvived but the surgeon involved wassuspended from work for two years andlater faced a GMC Fitness to Practisehearing. The GMC found that the errorhad been misconduct on the part of thesurgeon but he was allowed to remainregistered after he presented evidencethat he had an otherwise good recordand had successfully retrained.

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In this case there were also suggestions of a‘system error’ when it emerged that severaldoctors, including a GP and a radiologist,reportedly referred to the lesion beingon the wrong side, highlighting theneed for all doctors to be carefulwhen describing the site ofpathology.

That a doctor could perform such a majorprocedure as a nephrectomy on the wrongside and remove a healthy organ instead of adiseased one stretches the credulity of thepublic. Yet incidents of this sort occur in eventhe most well-run hospitals. With waiting listinitiatives and generic operating lists becomingmore common, the risk of wrong site surgerymay well be greater than before since thesurgeon may not have assessed the patient inclinic. Indeed a recent study from the USA hassuggested that the incidence has almostdoubled since 2004¹.

Simple stepsThere have been a number of steps taken overthe years to try to avoid this problem. Forexample the World Health Organisationpromoted the use of a surgical checklist. Thiswas supported by a multi-professional groupincluding the relevant Royal Colleges and theNational Patient Safety Agency who adapted itfor use in the UK in 2009. Part of the ‘timeout’ section of this checklist requires bothsurgeon and anaesthetist to confirm the siteof the planned procedure. All NHS hospitalsshould now have implemented this.

In the UK, wrong site surgery is classed by theNational Patient Safety Agency (NPSA) as aserious, largely preventable patient safetyincident that should not occur if suitablemeasures are in place. The National Reportingand Learning Service had 57 reports of wrongsite surgery in 2009/10 and this made upmore than half of the reported preventableincidents that year².

A recent analysis of claims made to the MDUsince January 2000 revealed 63 cases of wrongsite procedures, an average of 5 per year. In ouranalysis orthopaedic cases were by far the mostcommon, accounting for 26 (41%) of cases.

Risk managementadviceBased on our experience in assisting memberswith claims, the MDU suggests the followingrisk management steps:

• When referring to side, site or anatomicallocation on consent forms and operatinglists, write in full and avoid usingabbreviations.

• To avoid ambiguity about the digits on thehand, describe fingers as: thumb, index,middle, ring and little. Toes should bereferred to as: hallux, second, third, fourthand fifth.

• Check the patient's referral letter againstthe clinical record, consent form and theoperation list to ensure they are inagreement.

• Confirm the patient’s surgery details at allstages of the patient's route to theatre: onadmission, when leaving the ward enroute to theatre, on entering the theatresuite, in the anaesthetic room, and so on.

• A member of the surgical team shouldmark the correct surgical site on the wardor in the day case area. This person shouldbe in theatre as the procedure is carriedout.

• The process of marking the siteshould, if possible, involve thepatient and/or if appropriate familymembers or significant others.

• Ask the patient to verballystate (rather than simplyconfirm) their full name,date of birth and theanatomical location of theintended procedure. Theoperating surgeonshould see the patientbefore theadministration ofanaesthesia andensure all clinicaldocumentation(referral letter, sourceof referral, a signedconsent form andsupporting images orfilms) is available.

• When marking an operation site, use aspecified, clear, unambiguous, indeliblemethod. A water-based marker pen maywash off or transfer to another limb.

• The operating surgeon must be satisfied ofthe intended site, side or level of surgerybefore the patient is draped. If the patientis draped by another member of thetheatre team, they should audibly confirmwith the operating surgeon – referring tothe side, site or level.

• Ensure marks are clearly visible to theoperating surgeon after theatre drapes areput on.

• Call a 'time out' before the procedurestarts, so that the patient details,procedure, site and, if applicable, implantscan be re-checked against the records. Ifconcerns are expressed, the procedureshould not be started until the issues areresolved.

• If you think something iswrong, say so.

All doctors potentially havea part to play in preventing

these rare but serious errors intreatment. By paying careful attention

to how the site of any pathology isdescribed and ensuring that patient

checking procedures and protocols arefollowed consistently, the incidence of wrongsite surgery will be minimised, thus avoidingthe devastating consequences to patients ofthis type of preventable mistake.

References

1 The pain of wrong site surgery, Washington Post 20 June 2011

2 NPSA Never Event Annual Report 2009/10


FEATUREFEATURE

wrong sidewrong side

FeaturesFrom

Our Files




ADVICE LINE DILEMMAS

Assisting a criminal offence

The scene

A consultant in palliative carereceived a request for medical recordsfrom a patient with multiple sclerosis.The patient had previously expressedher wish to arrange an assistedsuicide and had approached her GPfor a medical report and insertion ofa cannula. The GP had refused tocomply with her request. Theconsultant was in no doubt as to thepatient’s motivation for requestingher records and rang the MDU adviceline to find out what therepercussions might be if he compliedand the patient later committedsuicide.

The advice

The MDU adviser confirmed the consultant’s beliefthat if he knowingly assists a patient incommitting suicide, he would be committing acriminal offence.

A doctor could face a criminal investigation ifalleged to have assisted a patient with the act,even if the assistance is in the form of advice tothe patient. Even if criminal proceedings do notfollow, the GMC may still decide to investigatethe doctor’s fitness to practise. The member wastherefore advised not to engage in discussionabout this matter with the patient.

Section 2(1) of the Suicide Act 1961 states: ‘Aperson who aids, abets, counsels or procures thesuicide of another, or an attempt by another tocommit suicide, shall be liable on conviction onindictment to imprisonment for a term notexceeding 14 years.’

ADVICE LINE DILEMMAS

Although the Director of Public Prosecutionshas decided in the past that it would not bein the public interest to prosecute those whohave assisted, for example, patientstravelling to Switzerland to commit suicide,the decisions have been case-specific and donot change the legal position for doctorscaring for a patient.

It should also be noted that while healthcareprofessionals must follow an advancedecision if it is valid and applies to theparticular circumstances when a competent

patient wishes to refuse treatment, this isnot the same thing as taking active steps tokill a patient. Although the Mental CapacityAct 2005 provides for patients to make awritten statement requesting certaintreatment or expressing a preference, suchstatements will certainly not legally requiredoctors to take active steps to bring about apatient’s death and indeed Section 62 of theAct specifically states that nothing in the Actis to be taken to affect the law relating tomurder, manslaughter or assisted suicide.

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From Our Files








ADVICE LINE DILEMMASADVICE LINE DILEMMAS

A minor without capacity

The scene

A consultant gynaecologist treating a 17-year oldpatient for menorrhagia rang the MDU advice linequestioning how he should approach the issue ofconsent. The patient had Down’s syndrome and asno treatment had so far proved successful, he hadsuggested the next step should be to try animplanted contraceptive device. Her parents wereentirely supportive of this.

The member wanted to check the legal and ethicalrequirements for consent in a 17-year old withoutcapacity to consent herself. The consultant wasconcerned that an application to the courts mightbe required.

The advice

The MDU adviser talked through the case with the member andoutlined the legal framework for treatment of 16 and 17 year olds,which differs across the UK. At 16 a young person is presumed tohave capacity unless this is shown not to be the case. In England,Wales and Northern Ireland, parents or someone with parentalresponsibility may authorise treatment which is in the young person’sbest interests if the young person is aged 16 or 17 and does nothave capacity.

In England, after the patient’s 18th birthday the Mental Capacity Actapplies and decisions must be made by the doctor in the patient’sbest interests, although the doctor must take into account the viewsof those close to the patient. There are various other considerations;for example the doctor is required to consider which option is leastrestrictive of the patient’s future choices. In this case the proposal ofa reversible implanted device would be preferable to hysterectomy.

The need to apply to the courts for a decision usually only ariseswhere there is disagreement which cannot be resolved betweenthose caring for the patient.

Parents may consent on behalf ofchildren who lack capacity even whenthey are 16 or 17 in England, Wales andNorthern Ireland. From age 18, unlessthere is someone with lasting power ofattorney for health and welfare or adeputy appointed by the Court ofProtection, any decision abouttreatment in a patient who lackscapacity must be made by the doctor inthe patient’s best interests.

In Scotland a person is considered tobe an adult from age 16 and therelevant legislation is the Adults withIncapacity (Scotland) Act 2000. Parentsmay not consent on behalf of their childafter the child’s 16th birthday. Decisionsmust be made by the doctor, theintervention must be necessary andmust benefit the patient. The Act setsout the principles which must befollowed when making a decision on

behalf of an adult with incapacity. Theperson’s ability to contribute to thedecision must be maximised, and theirpast views and the views of their carersshould be taken into account.

In Northern Ireland there is noprimary legislation on capacity.Decisions about medical treatment mustbe made in accordance with commonlaw which requires that decisions aremade in a patient’s best interests.

The member was pleased to know the process which he must followeither before or after the patient’s 18th birthday, and that anapplication to the courts would not be necessary. The memberunderstood that in this case the parents were seeking to beappointed deputy by the court of protection so that they might makedecisions on behalf of their daughter once she reached 18, buttreatment need not be delayed while these arrangements were made.

Although the Director of Public Prosecutionshas decided in the past that it would not bein the public interest to prosecute those whohave assisted, for example, patientstravelling to Switzerland to commit suicide,the decisions have been case-specific and donot change the legal position for doctorscaring for a patient.

It should also be noted that while healthcareprofessionals must follow an advancedecision if it is valid and applies to theparticular circumstances when a competent

patient wishes to refuse treatment, this isnot the same thing as taking active steps tokill a patient. Although the Mental CapacityAct 2005 provides for patients to make awritten statement requesting certaintreatment or expressing a preference, suchstatements will certainly not legally requiredoctors to take active steps to bring about apatient’s death and indeed Section 62 of theAct specifically states that nothing in the Actis to be taken to affect the law relating tomurder, manslaughter or assisted suicide.

From Our Files


A FINELY BALANCED

DECISIONA businessman in his mid-60s wasreferred to our member, anexperienced colorectal surgeon, withpain associated with bowelsymptoms. The surgeon booked himfor a colonoscopy but the patientcancelled as he was travelling abroadon business. It was four months beforethe procedure took place, when thepatient underwent a gastroscopy andcolonoscopy which revealed a large rectalpolyp. The polyp was biopsied and found notto be malignant.

However, the colonoscopy could not be completed because thepatient experienced pain during the procedure. It was thoughtthat the rectal polyp may have been a potential cause of thesymptoms.

The surgeon advised the patient to undergo a transanalendoscopic microsurgery resection (TEM) and scheduled in thesurgery. At the last minute, just a day before surgery was due totake place, the patient once again cancelled as he was travelling.It was another six months before the surgery took place, at whichtime a large non-malignant polyp was removed. A colonoscopysix months after the TEM showed ‘no sign of sinister pathology’.

The patient’s abdominal symptoms apparently continued and, 11months later, while on business in Australia, he sought treatment.He was found to have a malignant tumour measuring 8x4x2.5cmin the proximal transverse colon. He underwent a hemicolectomyfollowed by chemotherapy.

He later brought a claim against the MDU member for allegeddelayed diagnosis of cancer, alleging that if the tumour had beendetected earlier it would have been removed and chemotherapywould not have been required. He also alleged that the surgeonhad failed to carry out a complete evaluation of the colon at theoriginal colonoscopy and that he had not used reasonable skilland care in carrying out the final colonoscopy.

On the surgeon’s behalf, the MDU denied negligence, assertingthat he had acted with reasonable skill and care in each of theinvestigative procedures.

Furthermore, the MDU asserted that the claimant suffered fromhyperplastic/metaplastic polyposis and had developed a microsatellite instability cancer (MSI) in the right colon. Therefore, theMDU argued that at the time of the final colonoscopy, there was


CASE HISTORY

probably a ‘diminutive flat or sessile serrated polyp/early cancer’,which was not capable of detection.

The case went to the county court, where the judge consideredcarefully the reports of the claimant’s and the defendant’s expertwitnesses. Both agreed that it would not be negligent to miss atumour of less than two centimetres at colonoscopy, but that it wouldbe negligent to miss a tumour larger than two centimetres. However,the experts’ arguments centred around the size of the tumour at thesurgeon’s final examination of the claimant, about which theydisagreed.

The judge thought their arguments very finely balanced and that itwas equally possible that the tumour was more, or less, than twocentimetres at the time of the relevant colonoscopy. But because bothexperts agreed that the tumour was of a type that develops veryquickly, it was possible that a tumour of less than two centimetrescould have reached the dimensions of the one which was removed ayear later. She therefore believed that the claimant had not establishedon the balance of probabilities that the defendant was negligent – iethat it was probable (not just possible) that the tumour was biggerthan two centimetres at the relevant time.

On the basis that the claimant did not prove the defendant’snegligence on the balance of probabilities, the judge dismissed theclaim.

Tamsin ThomasMDU solicitor

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probably a ‘diminutive flat or sessile serrated polyp/early cancer’,which was not capable of detection.

The case went to the county court, where the judge consideredcarefully the reports of the claimant’s and the defendant’s expertwitnesses. Both agreed that it would not be negligent to miss atumour of less than two centimetres at colonoscopy, but that it wouldbe negligent to miss a tumour larger than two centimetres. However,the experts’ arguments centred around the size of the tumour at thesurgeon’s final examination of the claimant, about which theydisagreed.

The judge thought their arguments very finely balanced and that itwas equally possible that the tumour was more, or less, than twocentimetres at the time of the relevant colonoscopy. But because bothexperts agreed that the tumour was of a type that develops veryquickly, it was possible that a tumour of less than two centimetrescould have reached the dimensions of the one which was removed ayear later. She therefore believed that the claimant had not establishedon the balance of probabilities that the defendant was negligent – iethat it was probable (not just possible) that the tumour was biggerthan two centimetres at the relevant time.

On the basis that the claimant did not prove the defendant’snegligence on the balance of probabilities, the judge dismissed theclaim.

Tamsin ThomasMDU solicitor

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