“To Err is Human” report and the patient safety literature

Chasing Zero Patient safety literature review

Patient Safety WHO

MPS Compass Oct 2011

Avoidable Harm to Patients BMJ 20010

The price of wishful thinking Iona Heath

oversimplified statistics drawing on Samual Johnson, Charles E Rosenberg, Alvan Feinstein and Sander Grenland



National Patient Safety Agency

National Reporting and Learning System

NPSA  Reports 2010/2011



Significant event reporting

Staff should report all types of incidents and near miss events through the Significant Event (Critical Incident)reporting system.The information is used in improving systems and processes within the service and reducing associated risks to people, premises, property and the organisations reputation.
The NHS locally is now reporting to external agencies from the significant event forms (lilac) that all staff complete.

The two key agencies are:
National Patient Safety Agency (NPSA) for all patient related events – notified of all events via an anonymous significant event report form which the Trust submits.
Security Management Service (SMS) for all physical assaults on staff – notified of events via the significant event form (in this case the form is not anonymous).


NPSA Emerging Patient Safety Issues

NPSA / National Reporting and Learning System

Barriers to Reporting
People can be reluctant to report events for several reasons:
Fear of reprisals; lack of trust.
Additional burden of work too busy.
Fear of exposure of weakness; lack of competence; suspension; litigation.
Loss of reputation; income or job.
Lack of action to stop things happening again.
CHOC Policy is to promote a fair blame culture and that only under specific circumstances would disciplinary action be considered following a reported event.

Reporting Concerns
All staff, both clinical and nonclinical, have a duty to report their concerns using whichever process or procedure they feel comfortable with. Concerns must be reported by:
Reporting on a significant event report form
Using the Whistleblowing Policy.
Clinical supervision.
Team meetings.
Management supervision.


Significant events
Common  Errors Prescribing error
Failure to action an abnormal result
Failure to diagnose
Failure to refer
Failure to deal with an emergency call
Breach in confidentiality
Common Causes Breakdown in communication
Information issues
Lack of important information ‘to hand’ during the consultation
Examples of potentially important missing data:
Comorbidities e.g. previous bronchospasm when considering beta blockers
Current drugs.
Previous drug side effects
Previous drug allergies
Current drugs re potential interactions
Patient Factors The doctor failed to check:
That they understood the reasons for treatment
They understood the dosing, timing, stop and start dates
They understood the safetynetting guidance
The possible side effects
Doctor Factors Poor communication skills
Lack of medical knowledge or skills
Unable to identify the limit of their competence
Simple mistakes due to; pressure of time, unnecessary interruptions, poor emotional housekeeping etc.
Systems Failure Lack of education and training
Lack of supervision
Poor identification of roles and responsibilities
Lack of detailed procedures, protocols etc
Lack of audit or SEA
Organisational Ethos
eg An incorrectly typed or addressed referral letter may mean a delay in diagnosis or treatment.
A poorly handled telephone call may result in a patient not seeking help when they need it.
A box, trolley or piece of equipment left unattended in an inappropriate place could result in someone falling over it.

Significant Event  Meetings
These are generally multidisciplinary but need not be so and need to be sensitively chaired. Notes should be taken but should not include patient identification. Each attendee should be encouraged to take along at least one significant event. The meeting can choose which to discuss first and anybody can have the right to veto if that area is considered too sensitive. The events are then discussed, first highlighting the aspects of high standard and then those standards that can be improved. A decision about the case needs to be reached. This could be: celebration of excellent care, no change, audit required, immediate change required or whatever
Report should describe the aspects which were of high standard and those which could be improved. Action plan.
The decision(s) taken need to be contained in the report.
The reasons for these decisions should be described together with any other lessons learned from the discussion.
Follow up of these decisions should be arranged and this may occur at the next significant event analysis meeting


Seven step significant event analysis
 1 Identify and record significant events for analysis and highlight these at a suitable forum e.g. dedicated SEA or team meetings. Enable staff to routinely record significant events using a log book or a special proform
 2 Collect and collate as much factual information as possible for an event including written & electronic records, and the thoughts and opinions of those directly and indirectly involved in the event. This may include patients or relatives or health care professionals based outside the practice.
 3 Convene a meeting to discuss and analyse the event(s) with all relevant members of the team. The meeting should be conducted in an open, fair, honest and nonthreatening atmosphere. A note of the meeting should be taken and circulated.
Meetings should be held routinely, perhaps as part of monthly team meetings, when all events of interest can be highlighted, discussed, and analysed with all relevant people present and with the opportunity for others to offer their thoughts and suggestions. However, for some practices, the dynamic in this forum may not be conducive to analysing significant events, and it may be more productive to hold dedicated meetings.
The person you choose to facilitate a significant event meeting or to take responsibility for an event analysis again depends on practice dynamics and staff confidence. One suggestion is for the individual with the greatest knowledge of the event to assume this role if they are happy to do this. This may be straightforward for many experienced medical staff, but daunting for other members of the practice. The practice manager could facilitate the process initially, especially for administrative events, and then support and encourage other staff to take charge of future analyses. It may also be an idea for some purely clinical significant events to be discussed amongst the clinical staff only as these may not be of direct interest to the rest of the practice team.
 4 Undertake a structured analysis of the significant event. The focus of the meeting should be on establishing exactly what happened and why it happened, with the main emphasis being on learning from the event and changing behaviours, practices, or systems, where appropriate. If this is the case, the purpose of the analysis is to minimise or prevent the chances of the event recurring.
One method we suggest of analysing a significant event in a structured manner is by answering in-depth the following four questions:
What happened?
Gather all the facts relating to the significant event (including relevant dates, times, and people or organisations involved) from those directly and indirectly involved, so you can establish a clear and full picture of what happened. It is important to also consider what the impact or potential impact was for the patient, the team and/or others.
You should gather as much of this information as possible before the event is discussed at the meeting. But time and staff availability are factors here, and it’s not always immediately clear why an event happened, so you may need to tease this out at the meeting.
Why did it happen?
At the meeting, establish all of the main and underlying reasons why the event occurred. Consider, for instance, the professionalism of the team, the lack of a practice system or a failing in an existing system, lack of knowledge or the complexity associated with the event.What have you learnt?
Highlight any learning issues you and/or the practice experience. You should be able to demonstrate that reflection and learning have taken place on an individual or team basis. For example, it may be related to a training need or to personal learning issues concerned with therapeutics, disease management, or administrative procedures. It could also reflect a learning experience (good or bad) in dealing with patients, colleagues, or other organisations.What have you changed?
With many significant events, you will need to make a change to improve the provision of care or minimise the risk that a similar event will occur, or both. Consider, for instance, if an existing protocol needs to be updated or a new one developed, or if members of staff require additional training. If so, you need to ensure that affirmative action is to be taken rather than simply discussing what changes you would like to see implemented or documenting a wish list of actions that have no real prospect of being carried out. A member of staff should be designated to lead on the change and report back on progress at future meetings.
On some occasions it may not be possible to implement change. For example, the likelihood of the event happening again may be very small, or change may be out of your control. If so, clearly document why you have not taken action.
 5 Monitor progress of all actions that are agreed and implemented by the team. For example, if the head receptionist agrees to design and introduce a new protocol for taking telephone messages then progress on this new practice development should be reported back as an agenda item at a future meeting.
 6 Writeup the event analysis once change has been agreed and implemented. This provides documentary evidence that the event has been dealt with. It is good practice to attach any additional evidence (e.g. a copy of a letter or an amended protocol) to the report. The report should be writtenup by the individual who has the greatest knowledge of the event or who led on the event analysis.SEA Template
Date of event.
Date of meeting.
Lead investigator.
1. What happened?
2. Why did it happen?
3. What has been learned?
4. What has been changed?
 7 Seek educational feedback on the standard of the event analysis undertaken once it has been written-up. This is because research has repeatedly shown that around one third of event analyses are considered to be unsatisfactory, mainly because the team has failed to fully understand why the event happened or failed to take necessary or appropriate action to prevent recurrence

BMJ Learning Module

NHS Scotland SEA


Swiss Cheese Model

James Reason

Most significant events are multi-factorial rather than there being a single cause.

Catastrophic events can arise from a series of sequential errors or failings in checks or safety mechanisms causing or permitting a sequential chain of event to disaster.

As much as illustrating how untoward incidents arise, the model also illustrates why they might not happen as often as they could do.

but see also why this model can be harmful to health


MPS risk management and communication skills

Harvard Medical Practice Study
Florida Obstetricians Study
70 % of risk of being sued relates to communication.
Fixed risk factors include:
male sex
age over 40,
overseas graduate
high risk speciality.
Non fixed risk factors include
unacknowledged delay
apathetic Dr

The patient wont remember much of what you said bit they will remember how you were and if were ok with them they will cut you some slack particularly but not exclusively if you have had a good prior experience with the patient and so some goodwill in the bank.

Risky behaviours: (Beckmann)
Desertion attending physician becomes unavailable
Devaluing patients or relatives views
Dysfunctional information delivery includes giving no information!
Not understanding patient/relatives perspective.
ie failure to use ICE2

Sources: MPS Risk Management GP Update Effective Consultation


WHO surgical checklist



Discussing adverse outcome MPS ASSIST model


Risk analysis matrix

Risk Matrix Wikipaediahttp://hacking-medschool.com/hse-risk-assessment


Being open





NHS Special Authority – Internal Affairs for Medics with performance related concerns


Internal Link Poorly Performing Doctors



Medicines and Healthcare products Regulatory Agency

Department of Health Agency responsible for medicines and medical devices efficacy and safety

MHRA Yellow Card Reporting System


Health and Safety

Healh & Safety Made Simple HSE

Essentials of health and safety at work Download Fourth edition

An introduction to Health and Safety

Health and Safety Law Poster

5 Steps to Risk Assessment

All businesses with > 5 employees are legally required to assess and control health and safety risks and to carry out a risk assessment
Health and Safety Executive inspectors may visit premises either unannounced or by prior arrangement to ensure that they comply with their legal duties and to advise on improving arrangements
Control of pollution inspections are carried out by the Environmental Department of the local authority and the Fire Brigade Service also carry out inspections.

GPs will need to clarify the limits of their responsibilities.For those who own their premises and are the sole user, the position is straightforward. Those who use premises owned or managed by someone else, such as a health authority, will need to clarify, by the terms of their contract, who is responsible for which health and safety matters. GPs using temporary premises, such as village halls for clinics, will need to liaise with the owners to assess the suitability of the premises for this use, and may wish to check that they are covered by public liability insurance.

Risks relate to: People, procedures (clinical) and the working environment

Minimum Requirements
1 Written safety policy A statement of intent, available to all, expressing commitment to the protection of staff, patients and others on the premises. The practical expression of this intention is the implementation plan based on the risk assessment.
2 Health and safety law poster or leaflet Display the official poster setting out the law or issue employees with the corresponding leaflet.
3 Consultation with employees
4 Display Current Employers’ liability insurance

Employer is required to notify the Health and Safety Executive of accidents on the premises that are fatal, serious or result in a person being unable to perform their normal work for more than three days. Violent incidents and reportable work-related diseases also have to be reported.
A record must be kept of any reportable injury, disease or dangerous occurrence. This can be in any form, such as computer records or file copies of report forms.

First aid arrangements
There should be someone appointed to take charge in an emergency, a first aid box, and a notice telling staff who the trained first aider or appointed person is and where the first aid box is kept. It is also important to establish procedures for sudden collapse of patients and to train staff to identify people who show signs of imminent collapse.

Actual Hazards
have staff or patients been injured as a result of healthcare procedures or using equipment? is there a risk of violence or injury in the practice environment? have there been injuries from patient lifting or violence?
patients – who are more liable than staff to injure themselves as they are in unfamiliar surroundings. Ensure that hot surfaces on equipment are not readily accessible, for instance, and that temporary floor coverings put down in wet weather do not pose a tripping or slipping hazard. children and others who may perform mistaken, mischievous or wilful acts which can involve risks from sharps, medications or electricity. Ensure that sharps boxes and medications are kept out of reach.

Waste disposal , clinical procedures
any equipment with uncertain electrical safety is still needed; it is necessary to keep a corrosive substance used for particular treatments in the consulting room;

safe procedures – for example, segregation and containment, together with clear instructions and labelling, effectively reduce risk in the disposal of sharps and clinical waste; how to avoid violence and on the effects of stressors at work; the handling of foreseeable incidents – the actions required after a needlestick injury or the spillage of blood or mercury, for instance, need to be defined in advance, and any equipment or protective clothing to prevent contamination made available.

Stress and mental wellbeing
There has been considerable concern about workrelated stress among general practitioners, as workloads can be high and unpredictable, and patients’ expectations and the demands on the health service are increasing. Practice staff may also be adversely affected by work
Recognise the existence of workrelated stress, and accept the need to identify its symptoms and resolve its causes.

Personal safety and protection against violence
Adults and children may accidentally or willfully cause damage to themselves or others while on the practice premises. Some patients and their relatives, as well as other members of the public, may pose a risk to GPs and staff in the practice premises or during home visits. Working alone increases certain types of risk to staff and requires separate assessment.

Are the public areas of the premises ‘child proofed’ with facilities for caring for children during their parents’ consultations? Are the areas for visitors designed to minimise risks of violence and harm – with welllit entrances, pleasant ambience in waiting areas, information for patients on waiting times, wide counters (or screens in exceptional circumstances) to separate reception staff, panic buttons in reception, and adequate response arrangements for consulting rooms? Are cash and medications (including those in doctors’ bags) inaccessible? Is there a notice to this effect?

Are GPs and staff trained to recognise and handle threatening behaviour by avoiding confrontation or anger, diffusing aggression in others, and summoning help, including the police, if necessary? Are violent incidents or those involving aggressive behaviour recorded so that staff can be briefed and made aware of likely troublemakers? Is working alone essential? Are those working alone fit and trained in practice safety arrangements? In the case of clinical work, is attendance by appointment only? Is entry controlled, while emergency exits remain available? Are other parts of the premises closed and alarmed? Are there emergency contact arrangements for summoning assistance?

Are the schedules for home visits recorded, with contact arrangements made (using mobile phones, for example)? Is visiting in pairs an option where problems are anticipated? Is it feasible to cover out-of-hours visits using a cooperative, with drivers remaining present during the visit and in contact with base?
Combating violence in general practice. General Medical Services Committee. BMA

Staff health
rubella and hepatitis B? Are they aware of their responsibility to report any suspected infectious condition which may put others at risk?

Poor manual handling (during clinical activities and in the course of handling objects such as stock) may result in acute injuries and chronic problems, especially low back pain.

Healthcare risks
Clinical procedures
Risk management during clinical procedures is primarily directed to the outcome for the patient, but risks to clinical/professional staff should also be considered in relation to existing and new procedures

Assessing the situation
Is there a risk of infection during clinical procedures?
Is this exacerbated by a risk of needle-stick or sharps injury?
Is there a risk of spillage of body fluids?
Are there any associated risks with current or proposed practice procedures, such as sterilisation (the use of glutaraldehyde) or latex allergy from gloves?
Are there any associated risks with current or proposed substances used, such as caustics, liquid nitrogen, glutaraldehyde (as a respiratory sensitiser) and anaesthetic gases (procedures for scavenging and ventilation should be in place)?
Are staff protection issues considered when making decisions on new practice services such as minor surgery or physiotherapy?

Preventing dermatitis at work: advice for employers and employees.

Are there arrangements for clearing up mercury spills if you have mercury sphygmomanometers? (Information is available from the health authority or community pharmacist.)

Medications and other harmful substances

As most medications are now packaged, the scope for occupational exposure in general practice is limited, but other risks should be addressed.

In dispensing practices, are dispensers trained in health and safety aspects of formulation?

Taking steps
Medications, as well as other hazardous substances, including biological agents, are regulated by the Control of Substances Hazardous to Health Regulations (COSHH) 1994. As part of their compliance with COSHH, employers must:
identify and assess the risks to employees and others from all hazardous substances, inlcuding biological agents. Advice on the risks and precautions to be taken will be detailed on manufacturers’ data sheets and product labels. A written record of the assessments should be kept;

adequately control those risks;
provide suitable and sufficient information, instruction and training for employees about the risks they may encounter. This should include training in what action to take if there is significant accidental exposure;
provide appropriate health surveillance and immunisation;
review the assessment as and when necessary.

Control of Substances Hazardous to Health Regulations 1994
COSHH: the new brief guide for employers. INDG 136

Clinical waste
Arrangements for the disposal of clinical waste, including sharps and body fluids , should comply with health and safety regulations and the requirements of the Environmental Protection Act 1990.

Environmental Protection Act 1990, section 34: duty of care for waste disposal

Safe disposal of clinical waste (1998). Health and Safety Executive. £4.50. ISBN 0 7176 0447 0*

Code of practice for safe use and disposal of sharps (1990). BMA
RCN guidance on the prevention of sharps injuries

The working environment and risk

You must assume that fire will occur and have measures in place which will minimise its effects on life and property.
Fire safety is covered by the requirements of the Fire Precautions Act 1971 and the Fire Precautions (Workplace) Regulations 1997, and is regulated separately from other aspects of health and safety.

Electricity poses the threat of electrocution and is a source of fires. Electrical appliances may also cause injury (from trailing leads) and burns.
Electricity at Work Regulations 1989
Electrical safety and you. INDG 231(free)*

Maintaining portable electrical equipment in offices and other low risk environments. INDG 160(L) (free)*

Building design
Adequate lighting, including in passages and storage areas, is needed. Floor surfaces must be level, secure and slip resistant. Slips, trips and falls are common causes of injury in buildings, especially among members of the public. Swing doors must have vision panels. When making major changes to a building you should consider the flow of patients and restrict their access to those areas which they need to enter, ensuring as far as possible that such areas can be viewed by reception staff.

Workstations, screens and keyboards
Poor workstation design can be a cause of musculoskeletal and perceptual problems leading to poor performance, distress and illness. If keyboard and screen use is a significant part of a person’s daily work there is a legal requirement to assess the workstation and ensure that it meets defined standards (Health and Safety (Display Screen Equipment) Regulations 1992). The person working at a screen is entitled to regular breaks from work, to eye and eyesight tests, and to the provision of spectacles – at the employer’s expense – if they are needed for the work. The working environment should provide adequate space and be ergonomically designed, taking into account the siting of facilities such as printers and drinking water.

VDUs: an easy guide to the regulations (1994). HSE Books. £5.00, ISBN 0 7176 0735 6

Poor housekeeping is an important cause of staff injuries and contributes to low standards of work. Ensure that there is adequate and secure storage space to avoid items collecting on floors and in corridors. Also avoid high storage for regularly used items. Ensure that cabinets are fixed to avoid toppling and that drawers are not left open. Toys in waiting areas and elsewhere can be a boon, but they are a cause of falls and need care if they are to remain safe and hygienic. A member of staff should be responsible for their safety, tidiness and upkeep

Health and safety at work: guidance for general practitioners (1995), R. Moore and S. Moore. Practice Organisation Series 1. RCGP Publications Unit. ISBN 0 85084 205 0

Diagnostic errors

Diagnostic errors  NPC Jul 2011

Diagnostic Errors — The Next Frontier for Patient Safety JAMA 2009

Learning from clinical claims in primary care MPS Sep 2011





Decision support


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