Queen Elizabeth Hospital Birmingham

The cardiac surgery service at the Queen Elizabeth Medical Centre provides cardiac surgery to adult patients either as an elective (planned) case or as an emergency. The service performs a number of specialist cardiac surgery procedures as well as conventional surgery. Patients are referred locally and nationally to the service. A cardiac transplant service is also provided.

The Care Quality Commission (CQC) received notification of potential concerns regarding patient outcomes following cardiac surgery at University Hospitals Birmingham NHS Foundation Trust. There were two separate sources of statistical analysis:

• We were notified in 26 August 2015 of an outlier alert for in-hospital mortality associated with coronary artery bypass graft (‘CABG (other)’) procedures, generated by the Dr Foster Unit at Imperial College London.
• We were notified on 11 September 2015, of an outlier alert for in-hospital survival rates following adult cardiac surgery, generated by the National Institute for Cardiovascular Outcomes Research (NICOR) in association with the Society for Cardiothoracic Surgery in Great Britain and Ireland (SCTS) (April 2011 to March 2014). The data was formally notified to the trust in August 2015 and published in September 2015. The trust was first alerted to concerns March 2015.

We requested information from the trust on the actions taken in response to the outlier alert on 4 September 2015 and requested information on trust’s audit outcomes for adult cardiac surgery. The trust responded to us on 14 September 2015 and identified ‘significant methodological issues’ with the outlier data and told us they had implemented a quality improvement programme. The trust challenged the statistical methodology that had been applied with Imperial College and NICOR. We received confirmation from Imperial College and NICOR on 15 October 2015 that the statistical analysis of the outlier data was accurate. The outlier data is risk adjusted and is therefore not contributed to by the complexity of surgery. We received further information of concern from Health Care Quality Improvement Partnership (HQIP) following a meeting with them in November 2015.

We carried out a short notice focused responsive inspection of cardiac surgery services on 22 and 21 December 2015. The inspection was announced to the trust on 14 December 2015. We inspected this service because of the serious concerns relating to cardiac surgery mortality, and a lack of specific information provided by the Trust in order to understand the significance of the concern or the immediate actions being taken.

We followed the pathway for patients and inspected the pre-operative assessment, operative care (in theatres), post-operative critical care and care on the cardiac ward. We did not inspect heart transplant surgery. We inspected cardiac surgery services, which is part of a surgical services core service. We have therefore not provided ratings for the service.

Our key findings were as follows:

• The cardiac surgery service had been identified as a significant mortality outlier when compared to similar services. The cardiac surgery service monitored patient outcomes, but the results of this monitoring were not used effectively to improve quality.

• The trust had only recently started a quality improvement programme (QIP), despite concerns being identified in 2013 during an internal review and consultants approaching the executive team in 2014 with concerns around patient mortality and morbidity. The trust was also informed about the NICOR mortality outlier in March 2015. The trust had failed to take effective action in response to these concerns. There had also been many concerns raised by staff with service, divisional and trust leads that had also not triggered effective action. Some staff we spoke with were not aware that the service had been identified as a significant outlier through a national audit and national outlier programme, nor that a QIP had been started by the trust.

• The cardiac surgery service had no vision or strategy and lacked clear clinical and operational leadership at service and divisional level. This resulted in a service that was fragmented and dysfunctional, with departments working in isolation rather than as a team. There were delays in decisions being made both clinically and organisationally which impacted on patient care. The service had not anticipated, and was not monitoring, the impact of taking an increasing number of complex patients for heart failure and transplant surgery which had decreased the volume of routine heart operations.

• There were significant concerns around the lack of governance processes to monitor quality, safety and risk. Patient outcome data was collected but was not shared or used effectively by the service to improve quality. There was insufficient attendance, and challenge about patient outcomes, at mortality and morbidity meetings and multidisciplinary team meetings. The service did not consistently take account of relevant national guidance and evidence based practice to ensure a standardised approach to patient care and treatment.

• The Five Steps to Safer Surgery were not always completed to minimise the risk of avoidable harm to patients. Surgical trainees were not always supervised by a consultant in theatres when it was appropriate to do so. There had been instances where it had been difficult to quickly locate a surgeon when a complication had arisen in theatre. Some operations took longer than expected and patients were on cardiopulmonary bypass for long periods and higher than expected use of blood products. Re-bleeding rates post-surgery were higher than expected, and proportion of patients having to return to theatre for re-exploration and further surgery was much higher than that nationally.

• Consultant cardiac surgeons did not consistently undertake ward rounds on the cardiac surgery ward, they were not always in theatre at appropriate times and they were failing to effectively communicate with nursing staff and intensivists in critical care.

• There was a high rate of cancellations for elective patients (planned surgery), with some patients’ surgery being cancelled on multiple occasions. Staff repeatedly raised concerns about cancellations and the impact on patients as well as the morale of staff. The majority of cancellations were due to a lack of critical care beds and staffing. However, institutional behaviours of surgeons including late starts to operations, extended length of operation times and waiting for confirmation of a bed in ITU often resulted in the cancellation of the second case. Actions to decrease the number of cancellations were not having sufficient impact. Weekly meetings took place to review cancellations but there had not been significant change or action by the trust despite the data being collected. Clinical staff had identified for areas for improvement, for example, a step down cardiac ward, but there we not clear plans to implement these changes.

• There was no monitoring of risk for patients whose surgery had been cancelled or those who were on the waiting list for longer than they should be. Waiting lists were not shared across surgeons via ‘pooling’, which resulted in some patients waiting longer than the 18 week target. Cardiologists at the trust were increasingly referring patients to other local hospitals for surgery where there were the shorter wait times, fewer cancellations, and good patient outcomes. This was leading to the service operating at a low volume with associated risks

• Staff described a bullying and blame culture in theatres and critical care. Staff found it difficult to raise concerns or challenge poor performance and behaviours. Staff did not always report incidents; where these were discussed the blame culture prevented an open discussion to encourage learning and improvements to patient safety.

• There were issues regarding low staffing numbers and the insufficiency of training for staff to undertake their role. There were vacancies in theatres that resulted in operations being cancelled or staff working additional shifts. Nursing staff in critical care were concerned that they had not received specific training to look after cardiac patients or in the specialist equipment they required. Medical staff in critical care were not all cardiac trained and at night there were difficulties accessing the on-call surgeon or the consultant anaesthetist. There had been a number of near misses and unexpected patient deaths in critical care.

• Consultant staff in particular felt demoralised about their service. Staff had become disengaged and morale was low. Staff were not confident that the QIP would address all the concerns they had about the service and ensure the safe care and treatment of cardiac surgery patients.

• Patient feedback was very positive. Staff treated patients with dignity and respect. Patients described the excellent quality care they received from staff.

• Patients told us they had been involved in making decisions about their care. Staff took the time to speak with them and treated them holistically, rather than just focusing on their medical needs.

• Staff working in the cardiac surgery service were positive about this inspection. They wanted to improve the quality of their service and saw the inspection is as an opportunity to ensure this happened.

There were areas of poor practice where the trust needs to make improvements.

We told the trust to immediately:

• Commission, and undertake, an external review of cardiac surgery to identity the key actions that are necessary in response to the concerns identified.

• Provide information to CQC on patient outcomes to provide assurance around safety and quality pending the outcome of the external review and to take steps to ensure patient safety.

The trust must ensure:

• Patient outcomes, based on SCTS data set, are regularly reviewed and monitored and action is taken in response to any patient safety concerns both at individual and service level.

• There is a positive reporting culture for reporting incidents across the whole service with learning as the key objective

• The impact of cancellations and patients waiting is monitored and actions taken to minimise the risk to patients arising from long waits and multiple cancelled operations.

• The Five Steps to Safer Surgery checklist is implemented appropriately and regular observational audit takes place to ensure this is happening.

• Staffing levels in theatres and critical care are reviewed to meet national guidance and ensure rotas clearly identify staff roles.

• Consultant surgeons are always available to provide supervision and immediate support whenever trainee cardiac surgeons operate to meet national guidance.

• Sufficient surgical and medical staff are available and have the appropriate skills, knowledge and expertise to care for patients on the ward and in critical care

• Medical staffing rotas (including on-call) mean staff are appropriately available and also not on-call for two departments at the same time.

• All staff complete safeguarding children and vulnerable adults training in line with trust targets.

• The storage room in theatres are appropriately maintained so all equipment and supplies can be accessed. Review the appropriateness of all items stored in this room to ensure staff and patient safety.

• Medicines are stored and managed safely.

• Standardised care pathways are further developed in surgery and developed in critical care and these take account of national guidance.

• There are best practice based standard operating procedures and protocols for all areas within cardiac surgery services and these are reviewed routinely and kept in date.

• All discussions with patients about their care are documented in the patients’ medical record.

• There is regular attendance at MDT meetings by relevant staff.

• Patients are nil by mouth for the minimum time necessary pre operatively.

• Nursing staff on critical care have the appropriate competence and skills to provide the required care and treatment to cardiac surgery patients, including the safe use of equipment.

• There are effective operational improvement plans to improve patient flow.

• Cardiac surgery theatre use and productivity improves to meet the demands of the service and to minimise the risk to patients from long referral to treatment times (RTT).

• Cancellations of elective cardiac surgery for non-clinical reasons are significantly reduced.

• Patient on waiting list are prioritised appropriately and they receive treatment within national waiting times.

• There is effective multidisciplinary working in the cardiac surgery service.

• A clear strategy and vision agreed by all across cardiac surgery services.

• The pace of change within cardiac surgery services is significantly and demonstrably increased to ensure patient safety.

• Appropriate clinical and operational leadership arrangements are in place to support improvement across the cardiac surgery service.

• Robust governance processes to monitor quality and to identify, assess and manager risk.This includes an effective clinical audit programme and national benchmarking. Keys areas of concern are reportedly on regularly and action taken promptly.

• Action is taken to address issues of bullying of staff, promote staff welfare and manage poor performance appropriately.

• Action is taken to identify and take action on the reasons why staff are leaving the service and to develop retention plans.

• Staff concerns across the service are listened to and responded to in a timely manner.

• Patient consent is obtained appropriately at all times, including when their personal confidential information is displayed in public areas.

Action the hospital SHOULD take to improve

The trust should:

• Develop more effective ways to actively involve patients and their families or carers in the development of the service.

We informed the trust of our serious concerns immediately after the inspection and told them to take immediate action. We instructed the trust to undertake an external review and to supply us with weekly reports on patient outcome and activity data. We are monitoring the service and patient care with our specialist advisors.

Professor Sir Mike Richards

Chief Inspector of Hospitals