Select Committee on Health Written Evidence


Memorandum by the Association of Anaesthetists of Great Britain and Ireland (AAGBI) (PS 63)

PATIENT SAFETY

SUMMARY

1.   What the risks to patient safety are and to what extent they are avoidable, including:

  "It is not you that I don't trust, it is your species" All human beings will continue to make errors, so we must study and manage them. Reduction of harm to patients, not just the elimination of error, must be the primary focus.

  Human factors are reported in 75% of aircraft incidents, and will be similar in patient safety incidents.

  A feature of errors in medicine as distinct from errors in most other situations is that the patients involved often have coexisting medical diseases which add extra hidden opportunities for harm to arise.

  Clinical practice can never be risk-free. Processes should be designed to reduce patient harm.

  The public should be given more credit for commonsense and information provided for them.

2.   What the current effectiveness is of bodies in ensuring patient safety:

  NPSA are working with anaesthetists to pilot new specialty specific incident reports for anaesthesia.

  Evidence from the ISTC programme shows that safety is not their first priority.

  The process in "Safety First" for investigating incidents needs further development.

  Each trust should have a patient safety budget to spend on new initiatives each year.

  Funding for Standards work should be included in future Patient Safety spending plans.

  The MHRA has been very effective with the safety and design of anaesthetic apparatus.

  NHS PASA should use its purchasing power along with the NPSA "Purchasing for safety" policy.

  NCEPOD recommendations have produced significant advances in patient safety.

  AAGBI recommendations for minimal monitoring standards resulted in all NHS patients having continuous monitoring during anaesthesia. Such recommendations have clinical "buy in" to achieve widespread implementation.

  The Royal College Hospital Visiting Programme played an important role in Patient Safety and should be reinstated.

  The NHSLA does not cover all NHS patients having operations in the independent sector. It is suggested in the new Health Bill currently in process but the detailed wording needs to guarantee it.

  NHS Study Leave budget should be ring fenced, inflation linked and not diverted to cover deficits as in 06-07.

3.   What should the NHS do next regarding patient safety?

  Consider lead clinicians for Patient Safety in Trusts and patient representatives on clinical governance committees

  Audit/clinical governance meetings held with similar groups from neighbouring hospitals are extremely valuable.

  In connection with The World Health Organisation (WHO) World Alliance for Patient Safety Global Challenge " Safe Surgery Saves Lives" the NHS should routinely collect the required data.

INTRODUCTION

  1.  The AAGBI is the senior body representing anaesthetists with 10,000 members including most of the anaesthetists in the UK, the largest group in the hospital medical workforce (16%). The organisation has been interested in Patient Safety since its foundation in 1932, formally constituted a Safety committee in 1976 and has initiated many safety developments in the specialty.

What the risks to patient safety are and to what extent they are avoidable

  2.  The level of the risk has been estimated nationally in several western countries. In the UK studies give the percentage adverse event rate per hospital admission of around 10%. It is thought that about half of these adverse events can be avoided.

Role of human error and poor clinical judgement

  3.   "to err is human" ( Alexander Pope) and it has been said "It is not you that I don't trust, it is your species" All human beings will continue to make errors, so we must study them, and manage them to reduce the harm they do to patients and their lower their number. Reduction of harm to patients, not just the elimination of error (as there will always be some, it can never be completely prevented) must be the primary focus.

  4.  Human factors (HF) are reported in about 75% of aircraft incidents, and it is likely to be similar in medical patient safety incidents. (HF) are features that make us different from logical, completely predictable machines and aspects that affect our personal performance. Airline pilot Martin Bromiley's wife Elaine died following a failed intubation in 2005 and as a result Martin Bromiley set up a Clinical Human Factors Group (CHFG) of experts to promote HF Training to all healthcare staff. A video presentation on the tragic incident "Just a Routine Operation" can be seen on http://chfg.co.uk/resources.htm

  5.  HF training has improved air safety and Martin Bromiley is someone the committee may wish to speak to, the CHFG group details are on http://chfg.co.uk/index.htm

  6.  The extent of the role of poor clinical judgement is also not known but one of the distinguishing features of errors in medicine as distinct from errors in most other situations, which usually have fixed variables, is that the patients involved often have coexisting medical diseases which can add extra hidden opportunities for harm to arise. Clinical judgment can be poor in making the wrong decision about the primary diagnosis out of lack of knowledge or turn out to be poor from its result on the coexisting disease.

How far clinical practice can be risk-free; the definition of "avoidable" risk; whether the "precautionary principle" can be applied to healthcare

  7.  Professor James Reason has said end users often inherit the errors of others earlier in the chain. The reports on the Intrathecal Vincristine incidents from both Nottingham and Great Ormond Street Children's Hospital and show that the risks were being taken at almost every step of the pathway. A lot of these are avoidable with careful analysis of the whole system and an organisational culture in place which is prepared to act and fund the appropriate measures. Currently systems in the NHS are only subject that this type of analysis once an incident has occurred and ideally all systems identified as high-risk should be subject this process on a regular basis whether or not they have failed recently. Learning from other parts of the NHS should help, as implied in "An Organisation with a memory" but this does still not happen. Enabling departments in neighbouring trusts to meet together on a regional basis on their monthly audit days would be one way of spreading information. This could easily be enabled at no cost by just synchronising the audit dates within a region at the beginning of the year. There are isolated areas of this type of good practice in the NHS eg the Northwest Regional cardiac surgical audit where the four regional cardiac surgery units of meet and discuss their combined data on a six monthly basis.

  8.  Clinical practice can never be risk-free because it is a human activity and because of the various patient variables that may be unknown, as mentioned above. The healthcare processes however should be designed to reduce harm to the patient whatever happens, so that whenever a risk becomes a reality and threatens the patient the safety nets are in place to reduce the effect and ameliorate any resulting harm to the patient.

The role of public perceptions of risk in determining NHS policy

  9.  The public should be given more credit for commonsense and information provided for them to understand potential risks. The recent NHS policy recommendations for clothing seemed to be driven by perceived public perceptions rather than what evidence exists at the moment. Indeed one of the main bullet points on page 3 said there was no evidence that clothing had any influence on these matters! Such documents also affect healthcare staff's "buy in" to such documents and future credibility. Medical staff in particular are used to reading and assessing papers published in medical journals which have been peer-reviewed and written from a quantum higher-level when they are having to make accountable decisions.

What the current effectiveness is of bodies in ensuring patient safety:

  10.  Local and regional NHS bodies are not generally effective in ensuring patient safety.

  11.  We are not aware of any Boards of NHS bodies that have established a safety culture. Whenever a new service initiative is proposed the first document draft usually puts patient safety at the top. However as the iterations take place and the potential cost becomes apparent patient safety slips down the list and is rarely considered in the final analysis. Sir Liam Donaldson's suggestion that safety should be first and continue to remain so has still to be implemented.

Systems for incident reporting, risk management and safety improvement

  12.  Systems for incident reporting had been well developed in Australia. Their "Anaesthetic incident monitoring system" (AIMS) system produces regular reports and seems to be effective in influencing practice there and wider afield including the UK. The National patient safety agency (NPSA) initial reporting system is cumbersome to use and very difficult to analyse. It has been extremely difficult to extract meaningful data about anaesthetic incidents from the NPSA system and now the Royal College, Association of Anaesthetists and the NPSA are now working together to pilot then introduce a newly designed specialty specific section for anaesthesia. So far the pilot project is going well and starting to identify trends.

  13.  Risk managers appointed in trusts often do not, or cannot, take action to address the root cause of incidents. More training in root cause analysis or similar methods is needed for both clinical and non-clinical managers.

The impact of the changing public-private mixing in provision.

  14.  The private sector has necessarily different objectives to public bodies particularly the requirement to provide a financial return to their investors. Evidence from the independence sector treatment centre (ISTC) programme shows that safety is not the first priority in their employment of staff, clinical governance, provision of equipment, and culture. This was all anticipated but the necessary structures to supervise and enforce the required standards in ISTCs were not put in place. A long established lesson in business is that outsourcing companies primarily work for themselves, not their paymaster. This is an example of the NHS half taking on a superficially attractive idea from business without fully thinking it through and addressing the potential downsides from the outset. The NHS money expended here could have funded a lot of Patient Safety initiatives.

National Policy

  15.  The objectives set out in "Safety First", which is a good document, are appropriate. The process for investigating incidents was unclear and more progress needs to be made on this.

Whether past spending on patient safety has been sufficient and cost-effective and what future spending should be.

  16.  We are not aware of figures on past spending on patient safety; however the feeling is that it has been insufficient and patient safety initiatives have repeatedly failed through lack of funding at trust level and above, for example:

  17.  10 years ago reports in Australia showed that if a single patient use breathing filter were not used there was a risk of transmitting hepatitis between patients on a surgical list. One trust presented the business case for single use filters to their chief executive. He said that the anaesthetic department should find the additional funding from savings in their own budget. This was not possible so it did not take place. Later a patient with tuberculosis potentially infected a whole list of patients. All patients were recalled, counselled and tested and one patient later sued the trust for the distress caused whilst they waited six weeks for what turned out to be a negative test result. None of the patients had become infected. Single patient use breathing filters later became the national standard.

  18.  Each trust should have a patient safety budget to spend on new initiatives each year which often only require pump priming. They should have to account for what they have spent it on in the trust annual report.

  19.  In parallel with our Safety Committee the AAGBI holds a Standards Committee. Every anaesthetist who sits on a British or International Standards Committee for anaesthetic related equipment attends and this is the only forum where they can meet to discuss common issues. In this way independent clinicians can feed into the standards groups which draw up the standards equipment manufacturers must follow in future making sure they fit for NHS and Patient Safety requirements. A recurring problem however for these 12 individuals is obtaining the travel expenses to attend BS and ISO standards meetings. This money was held and distributed centrally but in the 1990s it was "devolved" down to trust level and as a consequence individual trusts do not understand this or the highly specialized activity that these doctors do often in their own spare time. Reverting to the previously successful arrangement where expenses (not a large sum) could be allocated centrally seems the only reliable solution. This activity is very cost effective for the clinical input and influence it provides and the AAGBI would ask that it be included in future Patient Safety spending plans.

National targets

  20.  National targets should be used sparingly. The AAGBI have produce over 50 documents nicknamed "glossies" which give detailed guidelines and recommendations for providing a safe service. These are freely available on the website www.aagbi.org. Audit standards for local comparison are also available in the Royal College of Anaesthetists audit recipe book "Raising the standard".

National Patient Safety Agency (NPSA)

  21.  The NPSA has become more effective recently, issuing guidance notes etc. It misses some opportunities to be more effective by not being more robust when appropriate. Its recent recommendations on design of drug packaging recommend printing the drug name on the five sides of the box, why not all six! Then whichever way the box is randomly placed in a cupboard the name can be read.

The Medicines and Healthcare Regulatory Agency (MHRA)

  22.  The MHRA has been very effective with safety and design of anaesthetic apparatus. They investigate incidents promptly and issue Hazard notices when required which get down to the front line and are discussed. They have a track record of competence, dealing sensibly with industry and an organisation that the committee may like to contact.

The NHS Purchasing and supply agency (PASA)

  23.  The NPSA has recommended a "Purchasing for safety" policy for the NHS: whenever a choice has to be made between two pieces of equipment or pharmaceutical products the safest one should always be purchased. The NHS rarely uses its purchasing power as it could and should. PASA is now setting up product councils involving clinicians and this may help. It could also invite tenders or produce for itself difficult to source items or "orphan" drugs eg. the old but still essential vasoconstrictor drug "Metaraminol" is now produced by the Devon Healthcare Trust for the whole NHS.

The National Confidential Enquiry into Patient Outcome and Death and (NCEPOD)

  24.  NCEPOD is an independent body originally set up by the AAGBI and the Association of Surgeons. It has gained the confidence of the profession through its confidential processes and periodic reports. As a result of its recommendations patient safety has seen significant advances. Each NHS trust now has a dedicated emergency theatre and out of hours about operating has largely been reduced to only essential life and limb saving procedures.

The Association of Anaesthetists of Great Britain and Ireland (AAGBI)

  25.  In 2007 the AAGBI 75th anniversary strap line was "75 years advancing patient safety". The Safety committee was formally founded in 1976 and remains the national forum for patient safety connected with anaesthesia having representatives from the RCA, MHRA, NPSA, and MDOs. The AAGBI has produced over 50 patient safety guidelines. In 1986 the AAGBI recommendations for minimal monitoring standards resulted in all NHS patients having continuous pulse oximetry, blood pressure, ECG and end tidal carbon dioxide monitoring used on them during anaesthesia. This was achieved over the following 5 years and verified by the Royal College of Anaesthetists (RCA) Hospital Visiting Programme. This demonstrated one of the values of these RCA visits and they should be reinstated

  26.  In 2004 the AAGBI recommended the use of syringe labels for intravenous drugs in the international colour codes. A national audit in 2005 showed over 95% of NHS hospitals using them. Such patient safety recommendations by the AAGBI as a professional body have credibility and clinical "buy in" to achieve widespread implementation quickly at low cost.

NHS litigation authority (NHSLA)

  27.  This could be used to provide more information about patient safety if it was able to analyse its database and publish closed claims reports. Currently its database was not designed for this purpose but could be changed in future.

  28.  Currently the NHSLA does not cover all NHS patients having operations in the independent sector. The AAGBI, BMA, surgical and patient organisations agree that it should. It is in the new Health Bill currently in process but the detailed wording needs to guarantee it.

Education for health professionals

  29.  Patient safety is now a topic in this. NHS Study Leave funding budgets should be ring fenced; inflation linked and not be removed to cover deficits elsewhere in the NHS as occurred in 2006-07.

What should the NHS do next regarding patient safety?

Whether the measures taken to improve patient safety are supported by adequate evidence regarding their clinical effectiveness and cost effectiveness

  30.  The medical profession is rightly concerned and trained from an early stage to always seek out the necessary evidence of clinical effectiveness. Some observers think that the medical profession almost unique in this respect but in serious questions of patient safety some common sense action should be taken pending the arrival, if ever, of such evidence. This is particularly applicable to rarely occurring hazards eg the safe administration of Vincristine. Making Vincristine only available in 50 ml minibags would significantly decrease the chances of it ever being given intrathecally. Local anaesthetic toxicity is another example. In 2007 the AAGBI recommended the use of Intralipid 20% during resuscitation based on rats experiments in 1998. There are now several articles in the world literature reporting that lives have been saved after overdoses using this technique.

How to determine best practice and ensure it is spread throughout the whole of the NHS

  31.  Setting up pilot projects to try new practice and then reporting the findings in the usual way still works. MHRA and NPSA notices must be brief and not overused to overload clinicians get ignored. Having a lead clinician for Patient Safety in appropriate areas that can sift the plethora of information and direct it may help.

How to ensure that learning is implemented

  32.  Regular audits are a way and every trust / specialty could be asked to do one or two specific audits every year. Also audit/ clinical governance meetings held with similar groups form neighbouring hospitals are extremely valuable.

What should be measured and assessed and what data should be published.

  33.  Any data published should be of good quality and validated. The information published in connection with cardiac surgery in the United Kingdom is appropriate and may be extended to other specialties. National safety audits proposed earlier could be made public when they are topical for that particular year.

  34.  In connection with The World Health Organisation (WHO) World Alliance for Patient Safety Global Challenge " Safe Surgery Saves Lives" the NHS should routinely collect the required data. to add NHS data to the WHO database and make meaningful comparisons internationally

What incentive should there be to improve patient safety.

  35.  The medical profession does not require great incentives to improve patient safety but there is obviously some inhibition taking place in the management structure. It may be that any savings could be returned to the appropriate units after implementing safety changes.

How patients and the public can be involved in ensuring that services are safe.

  36.  Some trusts have patient representatives on their clinical governance committees and this experience should be extended. Patient information could be developed to explain that some processes such as having to wait untreated and then being treated in a published order are actually safety measures and defences against them being harmed. Being asked six times by different members of staff and which leg they wish to have removed is not necessarily an incompetent system just a safety process of multiple checking.

  37.  We would ask the Health Committee to take this evidence into account in their inquiry into Patient Safety which we continue to see as a priority for healthcare worldwide.

September 2008






 
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