Purpose of the law
To establish and define standards of acceptable (e.g. respect for autonomy)
To maintain standards and punish ‘offences’
To protect the vulnerable (e.g. certain ‘consent’ cases must come before a court)
Above all – to achieve the resolution of disputes
Types of the law
Criminal law Civil law (e.g. Contract & Tort) Public law (e.g. Judicial Review (JR))
Sources of law
Statute
Common law/ case law
Statute - source of law
Abortion Act 1967 Human Tissue Act 2004 Human Fertilisation & Embryology Act 1990 Human Rights Act 1998 Mental Capacity Act (MCA) 2005
Common Law/ Case Law
Judge – made law based on a system of Precedent
Judgements made by higher courts (i.e. Supreme Court & Court of Appeal) have to be followed by lower Courts and in future cases
Regulation and professional guidances
EU Directive – European Working tine Directive; consumer protection
GMC – licensing of doctors
Regulatory bodies – HSE, PHSO, Human Tissue Authority, HFEA
What must a pt establish to make a negligence claim
- That they were owed a duty of care
- That the duty of care was ‘breached’
- That they have sustained an injury (loss)
- Injury was ‘caused’ by that breach of duty (causation)
Must be within limitation period
Breach of duty
‘Failing to act in accordance w/ the standards of reasonably competent medical men acting in the relevant field at the relevant time’
Example of something that is not ethical but lawful
Under old Human Tissue Act (1961) patients agreed to retention of ‘tissue’ - but didn’t realise this could involve whole organs
Example of something that is not lawful but ethical
Mercy killings
Advance decisions - MCA
Refusal of life saving treatment:
18+ and mentally competent
Must be in writing
Be signed and witnessed
Must be clear what treatment is being refused & under what circumstances
State clearly that the decision applies, even if life is at risk
Where does the duty of confidentiality come from
Legal - HRA 1998, DPA 2008
Professional codes of conduct
Terms of employment
Tech problems causing confidentiality issues
Misdirected emails where 2 people have similar names
Email forwarding
Info lost, left somewhere or stolen e.g. unencrypted memory sticks, ward/team handover notes
Casual convo problems causing confidentiality issues
Many improper disclosures are unintentional
Patients in the public eye
Social media problems causing confidentiality issues
GMC Doctors’ Use of Social Media (2013)
Facebook/ Twitter
Peer Group Forums
Consequences of a breach of confidentiality
Serious persistent failure to follow GMC guidance puts your registration at risk
Criminal prosecution
Dismissal
Embarrassment and bad publicity for employer
Financial penalty for your employer
Who are entitled rot same duty of confidence as adults
Young people aged 16-17
Sliding scale of competence
Younger you are, harder to demonstrate you have ability to make decisions for yourself; perverse – right to consent treatment but not deny
What rights does a child have if they are Gilick competent
Rights of the child to have confidential advice and treatment more important than any rights of the patient
What are child <16 owed if they are not Gilick competent
A duty of confidentiality, which may not arise in practice due to inability of giving consent
Adults who lack capacity
Owed a duty of confidentiality
However, s4(7) MCA 2005 states that people who are in involved in their care should be consulted about their wishes and any relevant values and beliefs
Discussions must be limited and disclosures in the best interest of pt
Confidentiality and deceased pt
Generally considered that duty of confidentiality survives death
Circumstances in which relevant info has to be disclosed e.g. to assist coroner or when required by law
Cases where you can breach confidentiality
- Consent of patient (implied or expressed)
- In the patient’s best interests
- Required by Law (statue and judge-ordered)
- For the protection of patients and others – ‘public interest’
Breach confidentiality - consent
Pt must understand what Is to be disclosed and why
Disclosure kept to a minimum
Implied consent - confidentiality
Can disclose info to other members of the healthcare team and family unless pt has explicitly said not to
Breaching confidentiality in the best interest of the pt
Emergency situations e.g in A&E
Only disclose relevant info
Breaching confidentiality - law statute
Public Health (Control of Disease) Act 1984 NHS counter Fraud Investigations GMC – investigation of a doctor’s fitness to practice
Breaching confidentiality in public interest
To prevent and support detection, investigation and punishment of serious crime
And/or prevent abuse or serious harm to others
Public good outweighs confidentiality obligations
Extent of disclosure in the public interest
Proportionate and limited to the relevant details
Each decision must be on its own merits
Wherever possible disclosure should be discussed w/ the individual concerned and consent sought
Record should be kept to show the circumstances in which the decision to disclose was made
Healthcare professionals should not see their role as police informants
Police and public interest discussion
Serious crime and national security e.g. murder, rape, treason, kidnapping or serious harm to the surety of the state or to public order, crimes involving substantial financial gain
Theft, fraud or damage to property where loss and damage is not substantial doesn’t warrant breach in confidence
Caldicott principles
Staff who have access to personal info should handle them as defined by the Caldicott principles
Responsibility of Caldicott Guardians
Safeguarding and governing the uses of patient information within the Trust and acting as the ‘conscience’ of the Trust
Right of rectification
Data subjects have the right to correct data if it is inaccurate or incomplete
Do clinical opinions count as inaccurate data
Even if it turns out not to have been correct, can allow a patient to add a note to records indicating that they disagree
Right of erasure
Allows an individual to request removal or deletion of personal data where the example the data is no longer necessary for the purpose it was collected
Doesn’t apply to healthy records
What constitutes a battery
Performing the wrong operation
Ignoring a spp prohibition against treatment
Ignoring a withdrawal of consent e.g. continuing to ventilate a patient
Performing unnecessary treatment e.g. procedures that aren’t clinically indicated
What constitutes valid consent according to DOH
- Patient must have capacity to consent to intervention
- Patient must be appropriately informed
- Must be given voluntarily – no under any undue influence
Key principles of MCA
PLUMB
Presumption of capacity Least restrictive Unwise decisions Maximise capacity Best interests
Presumption of capacity - MCA
Most people can make some decisions
Least restrictive - MCA
Consider all the ways to promote rights and freedom
Unwise decisions - MCA
Remember unwise is not the same as unable
Best interests - MCA
If an individual lacks capacity, any decision made/ actions taken must be made in their best interest (in a wider sense)
Stages of determining capacity
Stage 1 – is the patient suffering from an impairment of, or a disturbance in the functioning of, the mind or brain?
Stage 2 – does the disturbance/ impairment make a person unable to make decision for himself, at the time. Use a functional test
Functional test - capacity
a. To understand the info relevant to the decision
b. To retain that info; or
c. To use or weigh that info as part of the process of making the decision; or
d. To communicate his decision (whether by talking, using sign language or any other means)
Mental capacity and mental illness
A patient can still have mental capacity even where they have a mental disorder e.g. schizophrenia: Re C (Refusal of Treatment) [1994] – had gangrene and thought he was doctor so refused treatment
Temporary factors that can erode capacity
Shock, pain or drugs
Re MB [1997] – Needle phobia render a patient temporarily incapable of making a decision, needed C-section but was too afraid so doctors did it anyways and won case
What should we do for pts who lack capacity
Section 1(5) MCA - If the patient lacks capacity to make a decision, clinicians must act in their ‘best interests’
Section 4 MCA
For patients who don’t have capacity
- Encourage patient participation and find out their views by speaking to next of kin
- Identify all the relevant circumstances e.g. religion
- Avoid discrimination/ assumptions
- Assess whether the patient will regain capacity
- Does the decision concern life sustaining treatment?
- Duty to consult others
Material risk
Would a reasonable person in the patients position attach significance to it, or the DR knows that a patient would attach sig. to it
Considerations for material risk
Effect on that patient
The importance to the patient of the benefits/ desire to have treatment Alt. treatments available Risks associated w/ alt. treatment
Choosing reasonable alternatives to suggested treatment
Must know about procedure
Must be accepted practice
Must be an appropriate option, not a possible option
Not a variant of current treatment
Consent - undue influence
Consent must be given voluntarily and freely, without pressure or undue influence - DOH Re T (Adult: Refusal of medical treatment) [1992] – refusal of blood transfusion, undue influence from mother who was a Jehovah witness. Suffered haemorrhage and died
Standard consent forms
Form 1 – adults or children w/ mental capacity
Form 2 – parental consent to treatment/ investigation of a child or YP
Form 3 – procedure spp consent form
Form 4 – adults who lack mental capacity
Negligence
Any act or omission which falls short of the standard to be expected
Part of civil law
Examples of clinical negligence
Delayed diagnosis or misdiagnosis
Incorrect treatment
Surgical mistakes
Prescribing inappropriate medication
Causation - negligence claims
The claimant must show the breach of duty caused (or materially contributed to) the harm or injury
The burden of establishing that the breach caused harm rests w/ the claimant
What does a Dr need to successfully defend a negligence claim
Call evidence that shows:
A reasonable body of doctors
Skilled in that particular speciality
Would’ve done just the same as the defendant doctor did
With the exception of consent cases the Bolam test is applied to all aspects of the doctor/ patient rship
What should happen if a Dr goes against guidelines
Clear documentation of the reasoning behind the decision should be made
How can you discharge your duty of care
Seek advice the assistance from more senior colleagues
Make a note of advice in the medical records: date, time, who spoke to and the agreed plan
The responsibility then falls on the more senior colleague
The ‘but for’ test
To establish causation the claimant must answer “but for the Defendant’s negligence would the harm have occurred to the claimant in any event?”
Balance of probabilities is also used
Examples of causation - negligence
Histopathology - Cancer metastasis, reduced life expectancy.
A&E - non-union led to fixation surgery, decreased ROM
Good Samaritan Act
When a doctor, who is not on duty, helps in emergency situation
A doctor has no legal obligation to treat someone who is not his patient
Vicarious liability
In respect of the acts and omissions of all their staff committed in the course of their employment
If the healthcare professional negligently performs his duty of care to the patient the NHS is liable
NHS indemnity
NHS indemnity introduced in 1990
All NHS hosp indemnified their own staff against legal liability
When did all NHS trusts get covered under the CNST
Since 31 March 1995, all NHS Trusts have been covered under the Clinical Negligence Scheme for Trusts (CNST)
Unforgettable medical scandals in the UK
Western Sussex Hosp – listeria outbreak Drug -resistant superbugs Whorlton hall abuse Stafford Hosp scandal (Mid Staffs) Bristol Royal Infirmary heart scandals Alder Hey Hosp organ scandal Infected blood scandal
Whorlton Hall abuse
Patients w/ learning disabilities and autism
BRI scandal
170 children died due to hosp keeping hearts; Kennedy Enquiry
Alder Hey Hosp organ scandal
Retained organs and foetuses; Redfern Enquiry
Infected blood scandal
Haemophilia patients given blood infected w/ HIV and Hep B/C
Donaldson Report
Prof Liam Donaldson, Chief Medical Officer
At least 105,000 organs retained at hosp and med schools across England
Adequate and free consent was rarely obtained
Following the organ retention scandal
Retained Organs Commission (ROC) established in April 2001 until 31 March 2004
Legislation: Human Tissue Act 2004 and Coroners Amendments Rules 2005
Litigation - Claimants BRI as a group shared £3.6 million and had legal costs paid of £1.7 million. Memorial plaque erected at Alder Hey.
Impact off medical scandals
Patient safety – a high priority Goal is harm-free patient care Openness/ Transparency/ Accountability Protecting whistleblowers GMC – Revalidation every 5 years Duty of Candour Changes to Coroner rules
GMC revalidation
Licensed doctors have to revalidate, every 5 years, by having regular appraisals that are based on GMC core guidance – Good Medical Practice (2013)
Whistleblowing
Employee speaks out about wrongdoings in the healthcare setting in the public interest
Legal framework protecting whistleblowers
Employment Rights Act, 1996
Public Interest Disclosure Act, 1998
Equality Act 2010
The Enterprise and Regulatory Reform Act, 2013
Candour
“The volunteering of all relevant information to persons who have or may have been harmed by the provision of services, whether or not the information has been requested and whether or not a complaint or a report about that provision has been made.”
When was contractual Duty of Candour put in place
2013
When did Duty of Candour become statutory
2014
Notifiable pt safety incidents
Any incidents which does or could cause death; severe; moderate or prolonged psychological harm
Examples of moderate harm
Unexplained return to surgery
Unplanned readmission
Extra time in hospital
Cancelling treatment
Examples of severe harm
Permanent lessening of bodily sensory, motor or intellectual function e.g. removal or wrong limb/ organ
What is classified as prolonged harm
For at least 28 days
Notifiable pt safety incidents
Any incidents which does or could cause death; severe; moderate or prolonged psychological harm
Examples of moderate harm
Unexplained return to surgery
Unplanned readmission
Extra time in hospital
Cancelling treatment
Examples of severe harm
Permanent lessening of bodily sensory, motor or intellectual function e.g. removal or wrong limb/ organ
What is classified as prolonged harm
For at least 28 days
Live birth
A foetus, whatever its gestational age, exits maternal body and subsequently shows any signs of life (voluntary movement
Miscarriage
Spontaneous loss of a pregnancy before 24 weeks gestation
Legal status of foetus
Foetus does not acquire any legal rights until it can survive independently from its mother
Congenital Disability (Civil Disability) ACT 1976
Gives rights to a child born handicapped to sue in negligence in limited circumstances – mother exempted
HRA 1998 - Article 2
Everyone’s right to life shall be protected by law (does not apply to foetus – Vo v France)
HRA 1998 - Article 3
Prohibition of torture (prolonging life)
HRA 1998 - Article 8
Right to private & family life
HRA 1998 - Article 12
Men and women of marriageable age have the right to marry and found a family
Time period to register a birth
42 days
Registering a birth when parents are married
At time of conception or birth, either the mother or father can register the birth on their own
Registering a birth if parents are unmarried
Details of both will be on certificate if they sign birth register together, a statutory declaration of percentage is prepared or a court order indicating parental responsibility is taken. Fathers’ details do not have to be included
Registering a birth - married same sex couples
Either can register if the child born by donor insemination or fertility treatment
Regisyerig a birth - same sex couples (unmarried)
Must get a parental order – cannot get this until 6 weeks after birth
Therefore, birthmother must register
What is parental responsibility
Defined in the Children Act 1989 “all the rights, duties, powers, responsibilities and authorities which by law a parent of a child has in relation to the child and his property”
How can an unmarried father obtain parental responsibility
Marrying the mother
Having his name registered
Making a parental responsibility agreement with the mother
Obtaining a parental responsibility order fork the court
Obtaining a residence order from the court
Becoming the child’s guardian on the mother’s death
When do adoptive parents get parental responsibility
On adoption
How do step parents obtain PR
By obtaining a parental responsibility order form the court
Do foster parents have PR
No, it either remains with the parents or is shared between the parents and local Authority
Do sperm donors have PR
If donation through HFEA licensed clinic, not the legal parent of child (no financial obligation, no rights, not on birth certificate)
If unlicensed clinic, will be legal father of the child
Do egg donors have PR
If you give birth, you are the legal mother, even with a donated egg
Surrogacy Arrangement Act 1985
“Surrogate mother” – a woman who carries a child in pursuance of an arrangement:
a. Made before she began to carry the child and
b. Made with a view to any child carried in pursuance of being handed over to, and [PR being met} by another person(s)
Are surrogacy agreements legally enforceable
No, even if a contract has been signed and expenses of the surrogate has been paid
Surrogacy and PR
The surrogate is legal mother unless or until parenthood is transferred to the intended parents (either by parental order or adoption)
Husband of surrogate also has PR
Surrogate has the legal right to keep the child, even if it is not genetically related to her
Applying for a parental order
You must be genetically related to a child to apply for a parental order =, i.e., the egg/sperm donor, and in a relationship where you and your partner are either married/ civil partners/ living as partners
You and your partner must also:
- Have the child living with you
- Reside permanently in either the UK, Channel Islands, or isle of Man
When must a parental order application be made
When the child is under 6 months
Adoption following surrogacy
If neither you or your partner are related to the child, or you’re single, adoption is the only way you can became the child’s legal parent
Subject to Adoptions Act 1976
Brainstem death
The irreversible cessation of the integrative function of the brainstem equates with death. and allows the medical practitioner to dx death
Purpose of medical certfcation of death
Enables the family to register the death
Provides an explanation of how/ why pt. died
Informs research into health effects of exposure to a wide range of risk factors
Who should certify a death
Statutory duty of Dr who attended in the last illness to complete
In a team of Drs – lead Consultant has the ultimate responsibility for this
If you cannot fulfil the above, must refer the death to HM Coroner
What does it mean to attend to a pt - death certificate
Dr who cared for pt. during illness that led to death
Must be familiar with PMH, ix and treatment
Seen the pt. in last 14 days, seen the body after death
Role of Medical Examiner
All deaths will be subject to either a ME scrutiny or a Coroner’s ix
Agree proposed cause of death and accuracy of MCCD with Dr
Discuss COD with NOK and establish if they have any q’s or concerns with care before death
Inform local morality arrangements
What to avoid when writing cause of death
Avoid ‘old age’ alone
Never use ‘natural causes’ alone
Avoid terminal events, mode of dying and other vague terms i.e., terms that do not identify disease e.g., cardiovascular event
Two ways to have a post-mortem
Coroner orders it to try and determine cod or
Agreed upon by the hosp and the family to gain fuller understanding of the deceased’s illness or cod and/or to enhance future medical care
What needs to be observed during a post-mortem
HTA 2004 and Code of Practice in either case
Coroner’s post-mortem
Doesn’t require consent of family
Must be done by a suitable practitioner – as soon as reasonably possible
Must comply with HTA 2004 standards
The Coroner must release the body for burial/cremation as soon as practicable usually with 28 days
If PM confirms natural cod; coroner doesn’t need to hold inquest
Laws on burial
No law that a body has to be buried in an authorised place e.g., graveyard
Not illegal to bury a body in your back garden as long as you obtain consent from the local authority; keep a burial register and it is not going to poison water supply
The cremation (England and Wales) Regulations 2008
The cremation (England and Wales) Regulations 2008
Cremation 4 – usually dr who has seen deceased in last illness
Cremation 5 – confirmatory certificate – nor mainly being done by the Medical Examiner. Speak to Crem 4 drs
Medical referee at crematoria
Notifications of death regulations 2019
In force 1 October 2019
Now a duty to report certain categories of deaths to the Coroner
Must inform Coroner as soon as reasonably practicable
May need to inform police if death through to be suspicious
What is an unnatural death
Need a suspicion of foul play or other wrongdoing e.g., incl medical treatment for non-fatal conditions which leads to death or respiratory disease (asbestosis) because of employment
Violent death involves an injury of some sort e.g. deliberate killing, accident e.g., cut, fall or RTA, struck by lightening
Purpose of Coroner’s inquest
Identify who the decreased was
How, when and where the deceased came by his/her death
Is a fact-finding hearing
Inquest hearing
Public heating, media can be present
Relatives can attend, ask q’s, be legally represented
Trust’s solicitor or barrister will be there if staff requested to provide written statement/ give oral evidence
What determination must a coroner reach during an inquest
Name of deceased The. Medical cause of death How, when and where the D’cd came by their death The conclusion (verdict) Registration particulars
Possible outcomes of an inquest (verdict)
Natural causes – incl fatal medical condns
Accident/ misadventure
Industrial disease of ..
Dependence on drugs/ issue of drugs
Killed himself
Killed unlawfully
Open verdict insufficient evidence – case left open
Neglect
Narrative verdicts – brief description of factual events
Can only be challenged by judicial review
Adverse findings of an inquest - neglect
Gross failure to provide basic care
Does not look at clinical judgement
Must be over a period of time
Adverse findings of an inquest - Regulation 28 report
Repost on action to prevent future deaths
Coroner now has a duty to issue a report to public authorities’ circumstances which pose a risk of future deaths
A copy of the report is sent to the Chief Coroner who publishes them
Donoghue v Stevenson
Mrs D had a ginger beer in a café and the bottle was found to have a decomposing snail inside
Developed gastroenteritis and brought a claim against manufacture
No ‘contractual’ relationship bust she successfully argued a claim in the tort of negligence as manufacturer owed the consumers a duty of care
The cost of making mistakes
The annual cost of harm arising from clinical actives during 2019/20 covered by the Clinical Negligence Scheme for Trusts was £8.3 billion, reducing from £8.8 billion for 2018/2019” - NHSR
The standard of proof required in a negligence claim
Balance of probabilities” – more likely than not e.g., 51%
Hatcher v Black [1954]
Pt suffered s/e from an operation on their throat and sued the surgeon
Bolam Test
A mentally ill pt. was given ECT during which P suffered a fractured pelvis and other injuries. Risk could’ve been reduced if relaxant drugs was given but medical professionals were divided on the matter
Bolitho
The Bolam test was reviewed and confirmed by the House of Lords in Bolitho
The views of the expert must be honestly and sincerely held
The Courts, not the medical profession, are the final arbiters of the standard of care in clinical negligence claims
Bolam is still good law, but Dr must still be able to show that this opinion has a logical basis
What is the Standard of Care that has to be attained
Not that of the highest skilled practitioner but that of the ordinary competent practitioner in that field
Standards are those which were adopted at the time of the negligence, not at the time of the trial.
Wilsher v Essex AHA [1986]
The argument that a junior doctor did their best in view of their inexperience, was rejected.
The law requires all medical staff to meet the standard of competence
What happens if negligence is proved
Compensation known as “damages” is awarded
No special rules applied to damages awarded in clinical negligence cases
Aim of damages
To put the claimant in the same position as they would’ve been if there was no negligence
How many times are damages awarded
Once
Provisional damages
Provides the pt. with the option to return to court to seek a further sum of compensation if they deteriorate significantly after orig claim is settled
What prevents just anyone from seeking damages
Costs – Loser pays winner’s costs
What are general damages awarded for
“Pain, suffering and loss of amenity”
Based on JSB guidelines and case law
What are special damages
Quantifiable losses e.g., past, and future loss of earning, cost of nursing care, aids, and equipment and other out of pocket expenses
Good Samaritan Acts - contractual duty
“You must offer help if emergencies arise in clinical setting or in the community, taking account of your own safety, your competence and the availability of ither options for care” – Good Medical Practice – para 26
What should be considered when offering help - GSA
Your safety
Your competence
The availability of other options
Social Action, Responsibility and Heroism Act 2015
You should:
Make a detailed record of the incident and your involvement
Obtain consent from the pt.
Explain your actions and treatment to the patient
CNST
Run by NHS Resolution (NSHR)
Created a pooling arrangement to meet liabilities arising out of pt. claims
“Premiums” for individual Trusts are worked out, depending on the type of Trust, specialities offered, scale of operations and standards achieved