This report is based on the investigation done by the Healthcare commission in Maidstone and Tunbridge Wells NHS Trust. This trust had an outbreak of Clostridium difficile infection during April 2004 to September 2006 which resulted in 345 deaths where the patients had C. difficile infection following an admission to the trust. During the initial outbreak of the infection, board of members did not show concern for it which resulted in 150 cases in October to December 2005. After slight reduction in the number of cases in January 2006, it rose again in March 2006, and declared as an outbreak. The main reasons for an outbreak was mainly lack of hygiene in the Trust, insufficient nursing staff, inappropriate medication to the patients, and the partially unsuccessful policies made by the trust against the infection. The healthcare commission then reviewed 50 cases randomly from the people who died out of the infection. They reviewed these cases on several aspects like general management of C. difficile infection, timeliness of treatment, prescription of antibiotics, management of fluid balance and nutritional status, assessment and management of complications, and resuscitation status. After thorough investigation and interviewing staff and patients, reviewers listed out the problems of the trust and prepared a recommendation list. It included the diagnosis of the disease on time, adequate provision of the quality services of care to the patients by the doctors and nursing staff, maintenance of the proper hygiene, following the policy for prescribing antibiotics, keeping escalation areas available for the emergency, proper care in handing patients from one ward to another, handling the complications along with the normal diarrhea and infection, taking more care in filling up the death certificates in respect of this condition.
Healthcare commission performs investigation whenever there is serious failing of allegations which concerns about patient's safety. After proper investigation, healthcare commission provides solution to improve the quality of care and also building and restoring the patient's confidence in healthcare. They also ensure that the case provided is safe through out the NHS.
Maidstone and Tunbridge Well NHS Trust was formed in the April 2000 by merging of Mid Kent Healthcare NHS Trust and Sussex Weald NHS Trust, serving 500,000 with around 5,000 staff in different roles and specialities. This Trust has three hospitals with 850-900 beds at time of outbreak Of C. difficile infection.
Maidstone and Tunbridge Wells NHS Trust was an example of poorly performing organisation due to outbreak of C. difficile in the hospital, resulting into considerable deaths due to the infection and ineffective measures for prevention and treatment of this infection associated diseases. The Trust was facing high rate of infection from past several years but it went unnoticed. By 2005, number of patients with the infection doubled but even then it was not properly been taken care of. Due to this liberal behaviour of the trust, 150 patients were affected and a number of them died. This brought major concern which resulted in decrease in number of cases. But, it rose again in 2006 and by April 2006, 258 new cases were reported. A total of 500 cases were being reported since October 2005, with around 60 died with the infection being the major cause of the death.
During the outbreak, 345 patients died and had a C. difficile diagnosis following an admission between April 2004 and September 2006. Although, It was difficult to predict the reason for these deaths because patients with this infection often have other potentially fatal diseases. 155 patients who had the diagnosis were discharged alive. The trust was not aware of the true figures of the cases before April 2006 which disabled them from taking any actions. The local surveillance of the trust's system was also not effective. It went worse after senior infection control nurse left the job who was handling the case till that time. The first significant outbreak was missed and board was informed of confirmation for virulent strain of C. difficile in January, 2006. No review for this account was done. The outbreak was declared on 11 April 2006 which could have been declared much before than that. Kent and Sussex Hospital reported higher number of admission compared to Maidstone Hospital.
Health Commission conducted an investigation during Oct. 2006 to April 2007. They studied around 50 cases that admitted into the hospital with C. difficile infection and died. They interviewed 200 people including patients, relatives, past and present staff members of the trust and other organisations. They examined over 100 documents related to policies, records of meetings and audits. They also performed random and unannounced visits to wards. This investigation was mainly for assessing the quality of care provided for the patients and to establish the adequacy of the identification, prevention and control of disease during the outbreak and subsequently.
Healthcare commission was agreed for an investigation because of the following reasons:-
- There was no recognition of the disease between October-December 2005, which might have resulted into the disease to reach at its peak by mid 2006.
- There was no consistent data available with the trust for number of cases and mortality rate due to infection.
- There were issues related to the cleanliness and adequacy of the staff.
- Maidstone trust had suffered from the outbreak of C. difficile infection in the past and no progress has been identified in relation to identification and reducing the rate.
- The HPA and Healthcare commission undertook a survey in all the acute NHS trust in 2005. It comes in the light that 40% of the trust didn't arrange for the isolation for the patients and 38% did not have restriction on the prescription of the broad spectrum antibiotics. So, it was ensure in December 2005 to all the trusts that antibiotics prescription should follow the current guidelines on best practice and should be then monitored.
To assess the quality of the care, healthcare commission listed out 50 patients records out of 274 deaths during April 2004 to June 2006. They assess the quality and management of the care in these patients by looking on to the aspects like general management of C. difficile infection, timeliness of the treatment, prescription of antibiotics, management of fluid balance, management of nutritional status, assessment and management of complications of disease, and the resuscitation.
Management Problems within the Trust
A number of management problems in Maidstone and Tunbridge Well NHS Trust resulted in the outbreak of C. difficile infection. There was no isolation for the infected patients. There were no proper revisits by the doctors in wards. Medicines were not changed even if they were ineffective. Nursing care provided to the patients was not adequate. Beds and Bathrooms were not properly cleaned. Complications of the infection like dehydration, poor nutrition and serious cases of colitis were not properly monitored. There were complaints by the relatives due to the non satisfaction with the treatment and services.
The strategic reasons for the outbreak of the C. difficile are as follows:-
- The director himself doesn't know the understanding at the outbreak of the infection.
- The director failed to show the capability for the surveillance and feedback as given by the other trusts.
- There was a poor management for the infection control team.
- There was no strategic planning or implementation done for the project as well as they were unsure about the candidature for the leadership position for the project.
- There was difference in the opinion of the microbiologists presenting a lack in consistency of the approach.
- Policies made for the infection control was on the local computer network but it was also out of date which was neither available to all the staff. The key strategies for the policies were also missing.
- Mandatory trainings for updating the infection control methods were also attended by only 51% staff during September 2005- October 2006.
- Survey done for the infection control has also illustrated strange results:-
- 30% of the staff was satisfied with the trust's promotion in relation to the importance of the hand washing against 77% of the typical score for the acute trusts.
- The trust scored 33% in promoting the hand washing among patients and their relatives in comparison to 59% score for the typical acute trusts.
- 38% staff agreed to the statement of "infection control applied to me and my role", against 79% of the typical acute trusts.
There had been considerable difference in the structure and responsibilities of the governance and management of risk which questions the accountability of the trust. The handling of untoward incidents was poor, they also provide very little evidence of adequate investigation along with very few reports.
The major problem highlighted such as insufficient and inexperienced staff, poor care of patients, poor handover of patients between the wards and escalation wards were made unseen by the board, at level both at whole board or risk sub committee levels. There was absence of any systematic mechanism to implementing any action required or to share the lessons. Altogether, the system made to bring down the factual situation in front of the board and board members which unfortunately didn't work properly leaving the board unanswerable in front of the investigation team.A new governance structure was formed in January 2007 with involvement of senior clinical staff in making the decision and taking responsibilities.
Chris Cornforth (2003) describes about the changes in governance in the NHS. The board selects the candidates on the basis of their understanding of health issues and their local knowledge. There is also a need of strong board to ensure the balance of power between the different stakeholder groups, as well as effective management and performance.
Response of the Trust and Board Managers
The sole aim of the trust and board members was patient's safety. Despite of all the efforts, trust lags in achieving success in areas like bed occupancy and movement of patients, etc. Due to lack of organisational stability and lot of structural changes and continuous replacement of senior mangers, it leads to an improperly handled organisation. The style of management was particularly been described as 'Reactive' with frequent changes in the process. Instability in the experienced staff demands for more training and results in more chances of mistakes as it happened in MTW trust.
The infrastructure of Kent and Sussex hospital made the control of infection difficult. There were no side rooms and very few had en suite facilities. There was insufficient sluice space and storages. There was very less space between the beds. There was only one hand basin for 12 beds at Kent and Sussex some of which were hard to reach because of their position in the ward. Some bedpan macerators and bedpan washers were not working properly, increasing a risk of contamination. The hospital also faced problems due to mixed sex bays and wards which hospital didn't seems to be of concerned much.
Most of the buildings of Kent and Sussex hospitals were old and in a poor state of repair. Wards and stores were not clean enough. Bedpans were although regularly cleaned but contamination can be seen on the edges of it with traces of faeces on them. Beds were so closely placed to clean the in between areas and to prevent contamination between the adjoining beds. Privacy of the patients was compromised. There was significant shortage of the nursing staff in the wards to fulfil the tasks to keep them clean. The bed occupancy was considerably more than 90%, resulting in leaving the nurses with very less time to clean up the beds between the patient's movements.
Due to over flooding of the patients in the hospital, escalation areas were opened to fulfil the demands. These areas were not taken care of, properly which made the situation worse. Hygiene measures were not proper in these areas. No permanent funding was given for improvement of the escalator areas. These all factors had resulted in the increase in the spread of the infection. Before shifting the patients to the isolation, they were being treated in the general wards only, exposing other patients to the infection.
Cleaning of the hospital and disposal of the wastes was also an issue. In January 2006 Maidstone Hospital was only cleaned between 7.30am and midday, although domestic staff removed rubbish and checked toilets after this time. The trust had also introduced cleaning at night in Maidstone Hospital in April 2006 and in Kent and Sussex Hospital in September 2006. Patients and relatives reported poor standards of cleaning before and during the outbreak. An audit by the trust in September 2006 found that 98% of commodes were soiled. During our visits in the spring of 2007 the cleaning of commodes was still unsatisfactory on several wards. Many clean utility or treatment rooms were used as kitchens, posing an infection hazard. Linen was stored on open shelves on some wards.
Waterson (2009) described the reasons for outbreak using a system approach. Acc. to this approach, targets placed to the trust boards and management levels are very hard to achieve and led them to make poor decisions, and in some cases increase bed occupancy at the expense of the risk of an infection outbreak. Acc. to a research by Bean and Hood (2006), show that the impact of satisfying targets has not been analysed in terms of how it influences other related services like quality of care. Poor communication, confusion of responsibilities and accountabilities between and among the various regulatory bodies delayed the time in which they could react to the outbreaks.
The link between management, human resource management and work performance outcomes has been investigated in detail and the contribution of senior managers to the failure to prevent and deal with the outbreaks (wood and wall, 2002). Wood and wall also shows the link between HRM and employees to improve decision making among employees and increase productivity. West et al (2002) conducted a survey of the relationship between HRM practices and lower in hospital mortality.
According to the diagram, understaffing and the general lack of resources resulted in the outbreak. Hugonnet et al (2004) examined the direct relationship between the decrease in number of nursing staff and the hospital based infection. Many individuals at ward levels were aware of the conditions but could not do anything to improve the situation.
Clinical Roles and lacunae
Due to lack of effective system of surveillance for C. difficile, there was non identification of first outbreak in 2005. During second outbreak in April 2006, patients were cared for on a number of wards until an isolation wards were established in October 2006. the clinical management for the treatment of C. difficile infected patients were fell short of at least one of the basic care. Due to broad spectrum regimen to the patients with different diseases, patient who might have feel to recover completely, contracted C. difficile and died. Delay in announcing the outbreak was one of the major causes for the delay in the action and the mortality rate. 90 patients died due to C. difficile infection during October 2005- November 2006.
Antibiotic regimen was not properly assessed in the cases of C. difficile infection and 21 patients were the cause of the concern. . There was no reviewing of the letter from Chief medical Officer for the antibiotic policy in December 2005 which resulted in inappropriate prescribing in 42% of the cases reviewed. The Health Protection unit (HPU) has to insist on the review and effective implementation of the antibiotic policy.
Broad spectrum antibiotics were advised in most of the cases without proper evaluation of the condition of the patient and where a simple antibiotic would have sufficed. Additive antibiotics were prescribed rather than substitutive even for the simple infection. In 7 out of 25 patients, Metronidazole drug was continued even after no response after seven days or recurrence of the infection. Patients who were unable to take drugs orally were not considered for an alternative mode (Intravenous or Intramuscular).
Loss of fluid and electrolyte due to this disease can also lead to complications. 18 out of 50 cases were not regularly assessed for the fluid levels either through clinical tests or filling of the charts regularly. Although inadequate fluid management does not always affect outcome, 3 cases were reported for severe kidney deterioration in association with the infection. The demand for nutrition also increases due to loss and improper oral diet. 17 cases were the cause for concern for reviewers in this respect. 10 out these 17 patients were having diarrhoea from more than seven days out of which, 8 were referred to the dietician. This infection if not controlled will lead to several complications out of which, Pseudo membranous colitis is the most severe one. 15 out of 50 patients were not investigated for this complication in spite of having prominent signs indicating Pseudo membranous colitis. There was evidence for the false negative death certification of C. difficile. 4 out of 20 cases where C. difficile was mentioned, there was a high probability that this organism was the main cause for the death.
While assessing the records, it was found that only one third of the patients were reviewed by the doctors after the disease was diagnosed. In about five of the cases, they didn't even mention about the C. difficile despite of the symptoms like diarrhoea and abdominal problems. There was no proper monitoring for the infection and the complications. Stools charts were maintained in only less than 15% of the cases which were also not properly maintained through which it cannot be diagnosed whether the condition of the patient is improving or heading towards severe colitis. The records reveals that out of 50 cases, a microbiologist was involved in 17 (34%) cases, an infection control nurse in four (8%) cases, and the intensive care outreach team in six (12%) cases. In 22 cases, none of these supervising authorities was involved in the care of the patient. Out of these 22 cases, 6 cases were considered definitely or probably died due to C. difficile infection.
In case of diagnosis and start of the treatment, 30 patients had been tested for C. difficile within 2 days of developing symptoms, where as 17 patients were tested after three or more days. 3 patients were started on antibiotics on the basis of clinical suspicion or a previous positive result without new testing. 35 patients were started on antibiotic treatment within two days of a positive result, five patients three or more days after the positive result and 10 were not started on antibiotics, either because the diagnosis came too late, or for reasons not clear from the notes. In 12 cases, treatment was not started even after 1 week of diagnosis and appearance of symptoms. 3 patients had had diarrhea for over two weeks before being treated.
Inadequate Nursing Care
Patients and relatives who contacted seem to be dissatisfied with the standards of general nursing care of the trust. Either the number of the staff was not sufficient or the attitude of some nurses was not appreciable towards the patients or their relatives. They also complained about the information given to them for C. difficile was not satisfactory. They were unaware of the symptoms and complications of the disease and the fact that it can also leads to death. The trust was rated as worst 20% of all the trusts in the national hospital survey by patients, on the basis of overall standard of care.
The outbreak of the infection shows that the trust had no effective system for surveillance of C. difficile. As a consequence, 150 people were involved in the 2005 outbreak. The trust went through the difficult mergers, was having preoccupied finances, and had a demanding agenda for reconfiguration and PFI all of which consumed much of the time and efforts to look onto the matter like infection control (Goodwin). The clinical management of the majority of the patients the healthcare commission reviewed, fell short of an acceptable standard of care in at least one or the another aspect. Since there was no strategies been made to combat even after the first outbreak, second outbreak took place in April 2006 and it took four months to establish an isolation award which resulted in spread of infection already to a larger group of patients. Due to the poor management of the infection control team, standards of cleanliness and infection control was inadequate. The inappropriate medication of broad-spectrum antibiotics to the recovering people made them prone to the infection and as a result, some patients died. Many examples of contaminated equipments show the unacceptable standards of hygiene being maintained by the trust.
Very little research has been conducted on the wider behavioral, social, and organisational factors that may also determine infection control outbreaks (Griffiths et al, 2008). Lessons need to be reinforced about appropriate antibiotic prescribing, the need for effective isolation as opposed to ineffective cohorting, the importance of scrupulous cleanliness and hygiene, and the need to provide a high standard of care of patients with C. difficile. More attention needs to be paid to the accuracy of completing death certification in respect of this condition.
There should be a considerable change in the committee structures for the management of risk. The board should review the leadership of the trust and ensure to be able to discharge its responsibilities to an acceptable standard. SHA (Strategic Health Authority) in a position of performance manager must conduct these reviews appropriately. The risk register and assurance framework needs to be improved. The trust must review the requirement of the staff and recruit the new staff accordingly. There was a need of new nurses in medical and surgical staff as there was no recruitment since 2003/2004. The trust's board must give more priority to the infection control and the different factors which are affecting the ability to control the infection like environment, cleaning, movement of patients, and the level of bed occupancy. There was need for the board to establish a relationship between the care of patients with the staffing levels. Infection control teams must be monitored properly for its functioning and surveillance. There must be considerable change for the responsibilities and structure relating to governance. The structure needs to be simple and must ensure that serious operational problems and risk to patient's safety are identified and assessed along with taking the effective actions. Clinical directors must attend the governance and risk committee and should provide leadership and monitoring of the directorates.
There was a need for a new hospital in the trust, funded by the PFI with the major reconfiguration of services. The trust needs to prioritize PFI, finance, access targets, and reconfiguration of services and control of infection equally. The role of chief executive has to be redefined by the board members. He has to look onto each matter and provide complete and accurate information to the board. The senior managers have to be in a stable state because high turnover causes problem in dealing with the problems. The trust has to improve onto the behavior with the colleagues and co-managers. They need to create positive feeling for their co-workers. The trust should include consultants in making decisions and strategies. The information provided to the board, public and healthcare commission must be accurate and complete so that they can work effectively to handle the situation.
The medical and nursing staff must adhere to the standards for patient care and ensure the quality care in respect to reviewing the patient conditions by the doctors, taking care of cleaning by the nursing staff, prescription of proper and narrow spectrum antibiotics and considering the complications of the infection. Commissioners of care must ensure that acute trusts have appropriate guidelines for the prevention and management of this infection, including the care of patients who acquire this infection.
Current situation of the Maidstone and Tunbridge Wells NHS Trust
Nowadays, Trust is working from four hospitals: Maidstone Hospital, Kent & Sussex Hospital, Pembury Hospital and Preston Hall (Aylesford, near Maidstone). Trust also provides cancer services at Kent and Canterbury hospital at Canterbury. The problem for infection control is no longer exists now and they are among the lowest rates in the country. They are now looking onto progress in areas like reducing waiting times and improving efficiency
The main objectives for the trust board and the staff in controlling C. difficile infection during 2008-09 were:
- Submission of the weekly infection control report to the board and senior staff.
- The Chief Executive and directors of the Trust including the Director of Infection Prevention and Control addresses all members of staff on hand hygiene, infection control and the Saving Lives program.
- All staff has to be bare below the elbow to prevent cross infection by the clothes.
- Number of sinks is increased to increase concern for hand washing.
- Regular check up in the wards to ensure proper hand hygiene.
- Regular monitoring of cleaning standards in all areas.
- Rapid identification of the infectious diarrhea by the staff.
- Detailed screening before admitting any patient in accordance with the Department of Health guidelines.
- Improving the infrastructure by buying four Hydrogen Peroxide dry fogging machines for decontamination of the clinical areas.
- Appointing an additional consultant microbiologist to supervise the infection control team. (Annual Report, MTW trust, 2008-09)