PPS Patient Safety, Clinical Risk and Errors

Question 1

Medical errors vs adverse events

Answer 1

Medical errors: do something you shouldnt do or not doing something you should have when treating a patient

-near misses (errors that do not result in adverse events)

Adverse events: unwanted outcome

-non-preventable adverse events

these intersect: preventable adverse events (errors that result in adverse events)

Question 2

What are the 3 basic error types?

Answer 2

1. Slips/lapses- good plan poor execution SKILL/TECHNIQUE PROBLEM
2. Mistakes- bad plan executed well KNOWLEDGE PROBLEM
3. Violations- deliberate deviation from what’s accepted ATTITUDE/BEHAVIOUR PROBLEM

Question 3

What are the 2 categories of error?

Answer 3

PERSONAL
Identifies individuals at fault
Allows blame, retraining
Mirrors legal process

SYSTEMIC
Acknowledges human fallibility
Identifies promoting factors
Builds systemic safety

Question 4

Swiss cheese model (James Reason)

Answer 4

From medical error to patient harm there are multiple layers- training, policies, teamworking, automation, supervision and auditing. All of these can together prevent the error from causing patient harm, but they all have potential holes in them. (eg, not everyone attends the training, not enough team members etc)

Question 5

Yin Yang model

Answer 5

Two sides- reducing medical error and preventing patient harm from occurring due to medical error

Systems and culture- how is the system aiding or not aiding this, and what is the culture like?

System reflects culture

Question 6

How has the view of medical errors changed over time?

Answer 6

Ignorance -> denial -> personal -> systemic

Question 7

What are switch points?

Answer 7

Where you are making a decision to do something different- a point where things can go either way for the patient

Question 8

The 10 deadly errors

Answer 8

Sloth
Fixation- stuck on an idea or plan even when we get info that challenges that
Communication
Team working
Playing the odds- we expect common diseases more than rare
Bravado
Ignorance- don't know what's needed
Mis-triage- do things in wrong order
Lack of skill
System error

Question 9

Reporting to affect system design

Answer 9

Datix incident -> identify underlying mindsets, behaviours, processes -> what is the opposite to this? -> route to new position

Question 10

Best solution for medical error

Answer 10

Systemic improvement (eg, clinical governance, reporting to agencies) as errors usually systemic problems and rarely ‘one offs’

Question 11

How can patients have recourse if an error occurs?

Answer 11

NHS Complaints Procedure

General Medical Council General Medical Council

The Law

Question 12

If the complaints procedure ends in dissatisfaction, what is the final option for patients?

Answer 12

Parliamentary and Health Service Ombudsman

Question 13

GMC fitness to practice panel:

If they conclude that the doctor’s fitness to practice is impaired the following sanctions are available:

Answer 13

to take no action

to accept undertakings offered by the doctor provided the panel is satisfied that such undertakings protect patients and the wider public interest

to place conditions on the doctor’s registration

to suspend the doctor’s registration

to erase the doctor’s name from the Medical Register, so that they can no longer practise.

Question 14

Duty of candour GMC

Answer 14

Every healthcare professional must be open and honest with patients when something that goes wrong with their treatment or care causes, or has the potential to cause, harm or distress. This means that healthcare professionals must:

1. tell the patient (or, where appropriate, the patient’s advocate, carer or family) when something has gone wrong
2. apologise to the patient (or, where appropriate, the patient’s advocate, carer or family)
3. offer an appropriate remedy or support to put matters right (if possible)
4. explain fully to the patient (or, where appropriate, the patient’s advocate, carer or family) the short and long term effects of what has happened.

ALSO be open and honest with their colleagues, employers and relevant organisations, and take part in reviews and investigations when requested. They must also be open and honest with their regulators, raising concerns where appropriate. They must support and encourage each other to be open and honest, and not stop someone from raising concerns.

Question 15

3 sources for duty of candour

Answer 15

Ethics
Professional guidance
Law

Question 16

Contractual duty of candour

Answer 16

NHS organisations whose services are commissioned under a post-April 2013 standard NHS contract, with the exception of primary care services, have a contractual duty of candour

Question 17

Statutory duty of candour

Answer 17

The new statutory duty of candour was introduced for NHS bodies in England (e.g. trusts, foundation trusts and special health authorities) and all other care providers registered with CQC.

Question 18

Notifiable Patient Safety Incident (NPSI)

Answer 18

As soon as is reasonably practicable after a Notifiable Patient Safety Incident (NPSI) occurs, the organisation must tell the patient (or their representative) about it in person.

A NPSI has a specific statutory meaning: it applies to incidents where a patient suffered (or could have suffered) unintended harm that results in death, severe or moderate harm, or prolonged psychological harm.

Question 19

If someone takes action against a doctor, what are the legal options?

Answer 19

1. A criminal action [rare]:
   e. g. Gross negligence manslaughter [v. rare]
2. A civil action:
   The patient could sue for damages using:
   -tort of negligence (NHS or private patient)
   -breach of contract (private patients only)

Question 20

In order to prove negligence in a civil suit the plaintiff must prove what three things?

Answer 20

1. The doctor had a duty of care
2. The duty of care was breached
3. The breach of the duty of care caused harm

Question 21

Basics in duty of care

Answer 21

Doctors have a duty of care towards anyone with whom they have a doctor-patient relationship

It is easy to establish that a doctor had a duty of care to establish that a doctor had a duty of care

NHS trusts have a duty of care to provide a comprehensive service to their service users and can be sued if such care is not forthcoming

The NHS also has vicarious liability for the errors that doctors employed by the NHS make

Question 22

Duty of care grey areas

Answer 22

No Good Samaritan law in UK

Good Samaritan laws offer legal protection to people who give reasonable assistance to those who are, or whom they believe to be injured, ill, in peril, or otherwise incapacitated.[1] The protection is intended to reduce bystanders’ hesitation to assist, for fear of being sued or prosecuted for unintentional injury or wrongful death.

GMC requires doctors to help if they are able (and it is safe)

If you do not help then you can be found negligent:
“If a person holds himself out as a possessing special skill & knowledge…he owes a duty to the patient” R v Bateman (1925)

Question 23

How to know if there was a breach of duty of care?

Answer 23

In order to know whether the duty of care was breached, we need to know what the duty of care amounts to:

This means that we need to know what the expected standard of care is.

According to Bolam a doctor is not guilty of negligence “if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”
Bolam v Friern Barnet Hospital Management [1957] 2 All ER 118

According to Bolitho a doctor is not guilty of negligence if his actions have a “logical basis”
Bolitho v City of Hackney Health Authority [1996] 7 Med LR 1

Question 24

Bolitho test

Answer 24

The Bolitho test ensures that, although medical experts will still play a vital role in determining the standard of care, judges are now much more willing to scrutinise the rationale behind doctors decisions.

Question 25

Causation

Answer 25

Injuries/deaths often caused by number of factors

Sometimes it is easy to establish causation

However, proving – on the balance of probabilities – that the doctor’s negligent action was the cause (or a substantial cause) is very difficult (CIVIL LEGAL ACTION)

The basic test of causation is the “but for” test:
“but for the defendant’s negligence, would the patients have suffered an injury?”

Sometimes it is easy to establish causation e.g. if a surgeon removes the wrong kidney!

Question 26

Causation (omission)

Answer 26

There is a particular problem surrounding the idea of causation where the “cause” is an omission

Generally the law would not regard an omission as a cause

However…If I see a man drowning and fail to save him, I cannot be said to have caused his death.

And the law does seek to ensure that health care professionals who allow harm to befall their patients due to a failure to act can be found liable

This leads to the problems of counterfactuals and educated guesses (aka: outright speculation)

Question 27

Damages

Answer 27

If negligence is proven then the “outcome” for a civil case of negligence is “damages”

Damages may be awarded for both physical and mental/emotional harm as well as for loss of earnings and higher costs (e.g. if there is now a disability)

Note: damages might be reduced by concept of “contributory negligence” where courts might say patient may have contributed not just doctor

Question 28

Prescriptions

Answer 28

If you sign a prescription (even on the advice of another) YOU are legally responsible.

Four-fold duty

• correct patient name and drug name
• no comparative or absolute contraindications
• correct dose and directions are given
• provision for appropriate monitoring/follow up

Question 29

Limitation period

Answer 29

Action alleging negligence to be brought within three years of claimant discovering damage

Courts have the discretion to extend limitation period

In case of neonates and children the limitation period does not start until patient reaches maturity (i.e. 18) – i.e. actions can be brought until the child is 21.

Question 30

Lack of expertise

Answer 30

Lack of expertise IS taken into account when determining negligence.

Doctors do not have to be experts in all things medical. Thus a rheumatologist does not have to have the skills of a cardiac surgeon.

However, doctors have a duty to refer to someone who does have the relevant expertise.

Question 31

Inexperience

Answer 31

Lack of experience is NOT taken into account when determining negligence in legal settings.

This may seem harsh. However, this is the law.

If doctors are not competent to proceed they should seek senior advice and assistance. Do NOT “go it alone”. Seek advice/help.

cf Learner (or new) drivers

Question 32

Guidelines

Answer 32

Doctors have less discretion because of national & local guidelines

Guidelines are issued by a number of different bodies including: DOH, NICE, RCGP, GMC, BMA

By definition, guidelines are guidelines, not rules. However, if you depart from a guideline, you must be prepared to justify the departure.

This is potentially a major problem in litigation terms because the guidelines are rapidly increasing in number/size and most doctors are unfamiliar with them:
E.g. the NICE guidelines on dementia is… 392 pages long.

Question 33

Note keeping

Answer 33

The importance of keeping good notes and records cannot be overestimated

Notes and records are often very poor

Your notes will be your (and the courts) main guide to the events that transpired

How much will you will remember of patients you saw years ago?

Question 34

The law often does not achieve justice for either claimant or defendant- why?

Answer 34

Process is costly, slow & alienating for both parties

Many doctors become demoralized (72%) & clinically depressed (38%)

70% of claimants are unhappy with the claims process (even if they win)

Cases decided on technical points of law (e.g. causation and direction) rather than substantive merits.

1 million adverse events per year, yet only ~5,000 claims are made against the NHS per annum

Question 35

Defensive medicine

Answer 35

Defensive medicine is…

“the practice of performing tests as a safeguard against possible malpractice liability rather than to ensure the health of patients”

Defensive medicine is also…

• rarely a sustainable explanation for action
• makes litigation more likely (unnecessary investigations/treatment)
• very expensive
• violates the trust that patients have in doctors

Question 36

NHS Redress Act 2006

Answer 36

British solution: NHS Redress Act 2006

This gives patients an alternative to litigation and does not involve the court system

Deals with claims of less than £20,000

Aim is to move away from the blame culture, to reduce costs and to “preventing harm”, “reducing risks” and “learning from mistakes”.

Question 37

Other solutions to litigation crisis

Answer 37

Kiwi solution: No fault scheme

Compensation is paid to people who suffer harm following medical treatment REGARDLES of whether the harm was caused by negligence

Question 38

How is probability of legal action is increased?

Answer 38

The probability of legal action is increased:

1. by a failure to provide explanation or apology
2. poor communication
3. poor rapport between patient & doctor

apology is NOT a legal admission of guilt/ liability

GMC : doctors have a duty to apologise & to offer an accurate explanation when events do not go as planned

Question 39

How to know if there was a breach of duty of care?

Answer 39

In order to know whether the duty of care was breached, we need to know what the duty of care amounts to:

This means that we need to know what the expected standard of care is.

According to Bolam a doctor is not guilty of negligence “if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”
Bolam v Friern Barnet Hospital Management [1957] 2 All ER 118

According to Bolitho a doctor is not guilty of negligence if his actions have a “logical basis”
Bolitho v City of Hackney Health Authority [1996] 7 Med LR 1