Independent review of the circumstances surrounding four serious adverse incidents that occurred in the Oncology Day Beds Unit, Bristol Royal Hospital for Children on Wednesday, 3 January 2007

This report or a redacted version of it should be made available to all members of staff via the Trust Document Management System so that they can learn from these PSI’s.

The Trust should make this report available on its website so that all those who have an interest in patient safety worldwide can learn from these four PSI’s.

The Trust should ensure that all Divisions are aware of the drug Alerts and Risk Assessment Tools produced by the National Patient Safety Agency and that they are employed to their full advantage to increase patient safety.

The Trust should seek to modify the data structure and taxonomy used by the PSI database so that more detailed data can be captured and analysed so as to improve the potential numbers of lessons that could be drawn from such events.

The Trust should ensure that the lessons learned from each PSI are inculcated into the practice and procedures of all relevant departments. This could be accomplished by maintaining a list of all such lessons and periodically auditing departments against them.

The Trust should undertake a review of all the different concentrations of heparin used and minimise the number of different types purchased to as few as reasonably practicable. (See NPSA Alerts 18 and 20)

High concentration heparin should not be stored in patient treatment areas, apart from Operating Theatres, but prescribed by a doctor, collected from the Pharmacy and immediately administered to the patient or patients. Any remaining stock of high concentration heparin should be immediately returned to the Pharmacy.

The Trust should appoint an appropriately medically qualified member of staff to make recommendations to the ‘Medicines Steering Group’ as to the circumstance where ‘heparin flushes’ might safely be changed to saline.

Only controlled drugs must be stored in a CDC and only authorised persons should have access to it.

When any non-controlled drug is found in a CDC it must be reported to the identified Lead for Clinical Governance of that Division.

Any person found accessing a CDC who is not authorised must be reported to the identified Lead for Clinical Governance of that Division.

Where there is a requirement for non-controlled drugs or other items to be stored securely a lockable cupboard should be purchased for that purpose.

The Trust should develop a monitoring system for explicitly recording when members of staff have read new policies, amendments to existing polices and communications that a policy has been discontinued.

The Trust should make it a requirement of employment that all staff explicitly record when they have read new policies, amendments to existing polices or acknowledge that a policy has been discontinued.

The Trust should redesign their policy communications system so that new policies have a summary sheet of no more than two pages highlighting the crucial issues in the policy. Changes to existing policies should state what the changes are and where in the policy they are located. Where a review of a policy has been carried out but no changes have been made this should be clearly stated in the communication. The estimated time to read the full policy document should be recorded on the first page of the summary.

The makers of Trust wide policies on clinical issues should before submitting their policy or policy amendments for ratification ensure that the whole document is read by senior colleagues of all the medical specialities concerned who have not been involved in its production.

All members of staff should be periodically reminded that Trust wide policies can be found on the Document Management System.

All members of staff should be reminded periodically that it is a provision of their contact of employment that they must comply with the Trust Policies and Procedures and that ignorance of them is no excuse.

Trust policy documents should not emphasis any particular segment of the text as being of particular importance as some readers may only read the emphasised sections and not the complete document.

Anaesthetists managing the Wednesday ODB Treatment Room Theatre List who have not had a rest break since commencing work should delay the start time of the list in order to have one.

Where an anaesthetist has had a rest break but arrives late on ODB the start time of the list should be delayed so that all the necessary pre-operative procedures can be undertaken without undue haste.

A list of all the medicines stored within a CDC or secure cabinet containing hazardous drugs should be displayed on the inside of the cupboards door.

When patients are not to be anaesthetised in Theatres all the drugs to be administered intravenously should be prepared by the Pharmacy and collected by the ODP or anaesthetist. If for operational reasons that should not prove to be possible the drugs should be package by Pharmacy and delivered to where the anaesthesia is to be provided with strict instructions that only the ODP or anaesthetist may open the package. (See NPSA Alert 20)

In order to prevent a systemic failure when several patients are to receive exactly the same drugs as part of their anaesthesia they should not be drawn up as batch. (See NPSA Alert 20)

Subject to a satisfactory risk assessment once the contents of an ampoule have been drawn up into a syringe the ampoule should be placed on the anaesthetics tray for that patient and not discarded. This is so, in as far as reasonably practicable, there is a physical record of what drugs the patient has had administered intravenously and hence can be checked at any time. Ampoules should only be discarded once the operation is over and the anaesthetist is confident that the patient is recovering satisfactorily from the anaesthesia.

The Trust should draw up an explicit appropriately configured verbal double-checking safety protocol for the preparation, drawing up and intravenous administration of drugs. (See NPSA Alert 20)

All members of Trust staff should, subject to their clinical judgement, carry out the verbal double-checking safety protocol drawn up by the Trust when preparing drugs for the administration of intravenous drugs to patients and at the point of administration. (See NPSA Alert 20)

Where a verbal double-checking safety protocol is not undertaken, because in the clinical judgement of the healthcare professional administering the drug it would be unsafe to do so, then the reason must be documented in the appropriate medical record. Such exceptions must be reported to the identified Lead for Clinical Governance of that Division.

A written record should be made in the appropriate medical record by the person who prepared the medicine for intravenously administration and the person who witnessed it. A similar record should be kept with regard to the physical administration of the medicine. The recording of the names in both cases should be in uppercase letters and with their signature in near proximity.

In the case of anaesthetists the ‘Anaesthetic Record’ should be redesigned to incorporate an area where the person who prepared the medicine for intravenously administration and the person who took part in the protocol can record their names. A similar record should be kept with regard to the physical administration of the medicine. The recording of the names in both cases should be in uppercase letters and with their signature in near proximity.

Operating Department Practitioners and nurses should be trained to assist anaesthetists with verbal double-checking safety protocols for the preparation, drawing up and administration of intravenous drugs.

Out of hours telephone enquires to Ward 34 BRCH regarding patients who are being treated on ODB should be recorded in writing along with the action taken and the information forwarded to ODB as soon as possible.

BRCH senior management should ensure that when they issue a direction that a drug should no longer be readily available in Theatres or any other location that all members of staff receive written notification of the decision.

The Pharmacy should be informed of any decision to remove drugs from patient treatment areas so they can ensure that the medicine concerned is not released for use unless it is prescribed for immediate use.

As soon as possible, but within 24 hours, all the healthcare professionals present at a serious PSI must submit a written statement of their involvement to the identified Lead for Clinical Governance within that Division.

The Trust should provide all Divisions with a protocol that explicitly maps out the structural and functional relationships between them and the Trust Risk Management Team in the event of a serious PSI.

In the first instance all information regarding a PSI must be channelled through the identified Lead for Clinical Governance of the Division concerned. This is so that a determination can be made as to whether or not the Medical Director and the Trusts Risk Management Team need to be alerted.

The Trust should explore the possibility of using the developments that have been made in anaesthetic technology as a means to improving patient safety.

Where a member of staff wilfully disregards an appropriately qualified colleagues warning that she or he is putting a patient’s safety at significant risk then an internal Review should be undertaken to determine if the Trust’s ‘Code of Expectation of Staff’ has been violated.

The Editorial Boards of ‘The British Journal of Anaesthesia’ (The Royal College of Anaesthetists) and ‘Anaesthesia’ (The Association of Anaesthetist in Great Britain and Ireland) should encourage the submission of papers on intravenous drug errors during anaesthesia that contain denominator data so that the frequency rates per 1000 drug administrations can be calculated.

The Association of Anaesthetist in Great Britain and Ireland and The Royal College of Anaesthetists should strongly recommend to their members that all errors which physically occur are reported to the appropriate ‘Adverse Incident Reporting System’ (AIRS).

The Association of Anaesthetist in Great Britain and Ireland and The Royal College of Anaesthetists should consider whether the failure of a Member to report an error he or she has committed to the appropriate AIRS is a breach of professional good practice and therefore a matter for disciplinary action.

The Association of Anaesthetist in Great Britain and Ireland and The Royal College of Anaesthetists should strongly urge to their members to adopt the recommendations made in this report with respect to the use of verbal double-checking safety protocols in anaesthesia.

The Department of Health should direct the National Institute for Health Research, Research Centres for Patient Safety and Service Quality to undertake or commission research into the individual, group, organisational and cultural factors that can lead to patient safety incidents.

The Department of Health should direct the National Institute for Health Research, Research Centres for Patient Safety and Service Quality to undertake or commission research into the risks and safety benefits surrounding the use of appropriately configured explicit verbal double-checking safety protocols.

The Department of Health should direct The Medicines and Healthcare products Regulatory Agency, as a matter of urgency, to work with the national regulators of medicines worldwide to ensure that the manufacturers of pharmaceutical products are not permitted to produce look-alike drug packaging and labelling.

The Department of Health should direct the National Institute for Clinical Excellence, as a matter of urgency, to undertake a cost and safety benefit analysis of the 0.9% saline and heparin flush methods used to maintain the patency of peripheral, central venous and arterial indwelling catheters so that authoritative guidance can be provided to the whole of the NHS as to their relative efficacy.

Subject to European Union regulations on medicines, the Department of Health should direct The Medicines and Healthcare products Regulatory Agency, to issue an instruction to all pharmaceutical manufacturers that the NHS specification for ampoule labeling must not be used on any of their products by the end of 2007 otherwise the products license will be withdrawn on the grounds of patient safety.

The Department of Health should consider providing the necessary funds to The Association of Anaesthetist in Great Britain and Ireland and The Royal College of Anaesthetists for the provision of a joint Patient Safety Incident Reporting System.

The National Patient Safety Agency should seek to modify or change the data structure and taxonomy utilised by the National Reporting and Learning System so that more specific details than those recorded at present regarding the circumstances surrounding a PSI can be captured and analysed. Thus reflecting the findings of the Department of Health’s monograph ‘Safety First A report for patients, clinician and healthcare managers’.

The NHS Litigation Authority should seek to modify or change the taxonomy and data structure utilised by its Claims Management System so that more specific details than those recorded at present regarding the circumstances surrounding a PSI can be captured and analysed.