Establishing a new cardiac surgery service in an Australian university hospital: Pitfalls and lessons learned

Cardiovascular disease is the leading cause of death among Australians. Creating and delivering a world-class cardiac surgery service in a cost-effective way is the principle goal of health care organisations and managers. Establishing a new health care service is a unique opportunity and requires detailed planning and implementation. Managing change is pivotal to establishing a new patient-focused health care service, and should be coupled with effective communication and teamwork among all stakeholders. There are foreseen and unforeseen challenges associated with any project so sharing the lessons learned is an important way for others in a similar situation to avoid potential pitfalls.


Introduction
Cardiovascular disease is the principle cause of death across Australia and worldwide 1 . In Australia, cardiovascular disease affects more than three million people, with individuals living in regional and rural areas more likely to succumb to this disorder compared to those in metropolitan areas 2 . Creating an accredited cardiac surgery service in a regional area increases the equity of health care access and reflects the National Strategic Framework for Rural and Remote Health 3 . To date, cardiac surgery remains the best treatment for those patients with complex cardiovascular disease 4 .
Establishing a new cardiac surgery service across a large regional community is complex and requires detailed planning and organisation. The overall aim is to deliver a high quality, evidence-based cardiac surgery service in a cost-effective, safe and efficient manner 5 . Based on the literature and situated in the public hospital context, this article outlines the process of establishing a cardiac operating room (OR) in a new adult cardiac surgery service at the Gold Coast University Hospital (GCUH). Also outlined are the challenges and lessons learned during this process.
Cardiac surgery services are a highly specialised area of health care involving the diagnosis, management and treatment of patients with an extensive range of cardiac diseases such as severe coronary artery disease 3 . Following referral to these services, patients can receive a range of highly skilled interventions and treatments such as coronary bypass grafts or valve surgery 3 . Delivered by a specialised multi-disciplinary cardiac surgical team in the OR, the patient's continuity of care spans Peer-reviewed article across the perioperative and postoperative clinical areas. Broadly speaking, cardiac surgery services encompass a cardiac surgical ward, a coronary care unit (CCU), the intensive care unit (ICU) and the cardiac OR 6 . Considered the centre of cardiac surgery services, the cardiac OR is the focal point of all elective and emergency cardiac surgeries. The key clinical performance indicators of the cardiac OR team are measured in terms of complications and mortality rates, and determine the achievements of any cardiac surgery facility 7 .
The GCUH opened in 2013 and services the population across the Gold Coast district, which extends from south of Logan River to Tweed Heads on the Queensland (QLD)-New South Wales (NSW) border, and west to Beechmont and Tamborine Mountain. GCUH also accepts patients from northern NSW. Prior to the establishment of the new cardiac surgery service, patients from the Gold Coast region who required cardiac surgery were transferred to Brisbane hospitals, more than 70 kilometres away. More than 300 Gold Coast patients were travelling to Brisbane each year for cardiac surgery 8 . Due to the predicted population growth across the Gold Coast and northern NSW regions, coupled with the high number of tourists 9 , it was determined that the ability to provide cardiac surgery to 400 patients a year was required to meet the region's growing health care needs. Planning of the new cardiac surgery service at GCUH commenced in 2013, with the first cardiac surgery performed on 19 February 2014. Establishing a new health care service is a major undertaking so consulting the current evidence is an important first step.

Literature review
To set up a new clinical service, a number of well thought out steps and detailed planning are required; these include implementation of change management theories, access to adequate resources (specialised staff, economic resources and equipment), an appropriate timeline, adequate evaluation and identification of barriers and enablers. In addition, the new cardiac surgery service should be evidence-based and reflect current clinical standards and guidelines 10 . A review of the literature and current Australian and New Zealand Society of Cardiac and Thoracic Surgeons guidelines for establishing an adult cardiac surgery unit are presented 10 .
Cardiac surgery is a relatively new specialty that, with the advancement of technology, is rapidly evolving. For example, the first heart transplant was performed in 1967, only three years after the first effective coronary artery bypass grafting 11 . Since then, many changes have been implemented in cardiac surgery. Most importantly, the development of advanced cardiopulmonary life support improved the safety of heart surgery, offering surgeons the opportunity to perform complex surgical procedures on high-risk patients, with good patient outcomes reported 11 . The ongoing and extensive testing and improvements associated with cardiac surgery has improved cardiovascular mortality rates 12 . This demonstrates the fast rate of change in this clinical specialty so having a detailed understanding of the change management process in health care is a key to establishing a new cardiac surgery service.

Change management theories to guide implementation
Change within any organisation is challenging for staff and the organisation 13 ; however, with mutual support and co-operation the strategic goals can be achieved 14 . Allen 13 p. 58 stated that 'change is a challenge that most organisations experience' and the capability of change, adjustment and progress is the benefit of this process 15 . The implementation of change needs to be effective to guarantee positive outcomes for patients and health care staff 16 . It should involve developing efficient implementation strategies, which include every stakeholder, and be well coordinated and flexible enough to anticipate and respond to any issues that may disrupt the change process 16 . Two major organisational change theories were used to guide the establishment of the new cardiac OR at GCUH. These were Lewin's theory (1951) which identifies three stages of change process, and Lippitt's theory (1958) which presents seven phases of the change management process 14 .
Kurt Lewin was a pioneer in change theories 14 and, in 1951, outlined three stages during the change process: 1. unfreezing, which involves assessing the current situation and planning for the upcoming change 14 2. changing or moving, which involves the implementation of the proposed changes 3. refreezing, which encompasses the evaluation and consolidation of the changes 17 .
Lewin's theory is considered the most effective for the change and implementation process and has been widely used in health care change processes, nursing research, professional nursing practice, nursing education and management 18  The phases in Lippitt's theory are comparable to the components of the nursing process -assessment, planning, implementation and evaluation -making the theory easy to follow and providing a comprehensive implementation plan specific to health care settings 14 . The four steps of the nursing process and Lippitt's theory are fundamentally connected. For example, the assessment phase in the nursing process is similar to the first three phases of Lippitt's theory (identifying, evaluating and considering) 14 . Planning in the nursing process corresponds to Lippitt's fourth and fifth phases (selecting and indicating) 14 . Lippitt's sixth phase (sustaining) is similar to implementation in the nursing process, while phase seven (concluding) mirrors evaluation 14 .
An essential difference between the two theories is that Lippitt focuses more on the change agent, provides more time to implement change and involves frequent assessment of the changing process; thus increasing the confidence of health care staff management and confirming the selection of this theory in health care change management 17 . Alternatively, Lewin's three-stage theory is more suited to moderate changes, implemented in constant circumstances 13 . A comparison between the two theories and the nursing process is presented in Table 1.

Human and material resources
Cardiac surgery is a resourceintensive and costly component of a hospital budget that needs specialised staff and equipment 10,19 .
A clear vision and ongoing financial support, underpinned by sound decision-making processes are needed to make the unit feasible in the long term and meet budgetary constraints 7 . The cardiac OR is complex 20 -patient care is provided by a recognised and specially qualified interdisciplinary clinical team 6,10 . Human resources are pivotal to the delivery of cardiac surgery services, with the team comprising cardiac surgeons, perioperative nurses, anaesthetists and clinical perfusionists 5 . Cardiac team members need highly specialised skills 20 and the ability to manage highly technical equipment 5 .
According to current ANZSCTS guidelines 10 , a new cardiac service should be situated in a tertiary hospital 5, 10 with the necessary staff and facilities to support safe patient care before and after cardiac surgery 6 . Importantly, this new service should also have an established referring relationship with a reputable cardiac surgical unit that has been accredited for at least three years 5,10 .
Reflecting current guidelines, a cardiac surgery service requires the following facilities, including the cardiac OR 5, 10 : • at least one operating room dedicated to cardiac surgery • an ICU with adequate equipment for patient care after cardiac surgery • a cardiac catheterisation and angiography laboratory (It is highly recommended that a hybrid suite is available or the possibility to upgrade exists.) • a distinct cardiac surgical ward, with dedicated patient monitoring systems and telemetry, to treat patients pre-and post-operatively • a high dependency or step-down unit well equipped to be able to care for high risk cardiac and thoracic patients • a radiology department that provides portable X-rays, image intensifier services, CT scans and cardiac MRIs • an echocardiography unit, with echo apparatus with transoesophageal echocardiogram (TOE) and 3-D capability, for every cardiac theatre and a transportable machine available for patients in ICU or other units • a well-resourced blood bank; pharmacy, pathology and haematological facilities; and a microbiology and biochemistry test centre.
These facilities should be located close to and with direct access from the cardiac OR, guaranteeing ease of communication and patient transfer without functional impediments in patient care 7,10 .
In addition, the hospital should have allied health services, including physiotherapists, dietitians, rehabilitation and occupational therapists, to aid in the patient's post-operative recovery and reduce complications 21 . At the same time, the patient's continuity of care is supported by access to other services 22 , such as an infectious disease service, infection control policies, a respiratory unit, pacemaker installation facilities, nuclear medicine 5, 10 and patient counselling and education services. During the immediate post-operative period, an on-call cardiopulmonary resuscitation team should be available to respond to any postoperative emergency.
Furthermore, the development and implementation of new health care service processes, policies and procedures are fundamental to the delivery of quality and safe patient care. It is very important to develop an appropriate and agreed timeline for planning and implementing these processes, thus providing staff with an element of certainty 7,13 . Regular review of established timelines is also necessary so that responsive changes can be made and the project outcomes met 13 .

Evaluation
Ongoing evaluation is an integral component of change management. Although frequently viewed as an important final stage, it should include enquiries about the achievements and sustainability of the change and the completion or need for additional action 13 . This should be followed by quality reflection that will confirm the project outcomes 23 . Evaluation can sometimes result in the revisiting of earlier stages in the change management process, and the implementation of new actions 13 . These actions should be viewed as a normal part of the change process, not as an indication of failure 13 .
The implementation of change can face numerous obstructions to achieving the desired outcomes; however, a cautious selection and use of a change management process theory can prevent many obstacles from impeding the chance of success 14   For a successful implementation of the new cardiac OR, a significant continuing commitment of time and determination from the entire team is essential to ensure a culture of quality development by observing and matching the standards of care delivered 26 . At the same time, this will improve perioperative competencies, work arrangement and ability to manage change 15 . Achieving the identified objectives of establishing a new health care service is invariably challenged by different barriers.

Barriers and enablers to setting up a new cardiac operating room
An effective implementation of a new health care service includes the management of inevitable barriers that can stall the process 13 . Having an efficient plan, understanding the change management theories and recognising the possible barriers to the process are ways to ensure success 17 . The barriers identified through the process of establishing the new cardiac surgery service at GCUH are related to human resources, structural and financial factors.

Human resources barriers
Human resources, together with physical resources and consumables, are the main requirements needed for a health care system to deliver high quality care so effective management of human resources is important 27 . Four specialised disciplines make up the cardiac surgical team, which is led by the surgeon who works in synchronicity with the anaesthetist, scrub/scout and anaesthetic nurses and the perfusionist. The role of each team member is clearly defined and effective teamwork, characterised by continuous synchronisation of responsibilities, contributes to maintaining safe surgical practice. With scrupulous observation and meticulous attention to detail team members monitor the progress of the surgery and anticipate the next step or any potential adverse event 28 .
Patient outcomes from cardiac surgery can be compromised by a lack of appropriately skilled multidisciplinary staff. This challenge is compounded by the global shortage of specialised medical and nursing staff 7 . Evidence suggests nursing staff who specialise in cardiac surgery can result in reduced rates of adverse events 29 . The difficulty of recruiting specialised cardiac surgical nurses was acknowledged as a major challenge by GCUH from the outset because of the shortage of these highly trained nurses in the Gold Coast region. The first step to overcoming this barrier to an effective OR was identifying capable nursing staff already working in the OR at GCUH and seconding them to established cardiac surgery services for extensive training. The other strategy was to actively recruit experienced cardiac surgical nurses from across Australia. Both strategies required time and money to implement and organisational support was an important factor. To increase sustainability and staff retention, ongoing targeted education and in-service sessions were established along with set-up exercises and mock trials.
When the first cardiac surgery was performed at the GCUH, the cardiac OR had only three experienced cardiac instrument/ circulating registered nurses and four anaesthetic registered nurses. These numbers were insufficient to maintain the service or meet the needs of the service's proposed elective and emergency activity. Clearly, a proactive approach to expansion and succession planning was required to increase the number of suitably experienced staff. One strategy to address this in the short term was to train experienced perioperative nurses from other specialties, such as vascular or general surgery, who expressed an interest in joining the cardiac team.

Structural barriers
A new cardiac surgery service requires organised space for the proposed activities and storage areas for equipment. According to ANZSCTS guidelines 10 , the cardiac ICU and the cardiac surgical ward should be in close proximity to the cardiac The new cardiac OR was to be part of GCUH's cardiac service level 6 that provides complete surgical cardiac care, including composite multisystem life support to critically ill patients.
The service was proposed to be a networked adult cardiac service to provide a comprehensive range of cardiac care services with certain exclusions such as transplantation and paediatric cardiac surgery and to achieve about 400 cases per annum 9 .
The service would include onsite access to balloon pump insertion and management, onsite access to cardiac intensive care for pre-and post-operative care and an interventional cardiac service9.
The service should include a perioperative cardiac service level 6 along with all other services at the same level, including: • cardiac medicine • CCU • cardiac diagnostics and intervention • cardiac rehabilitation unit • cardiac ICU • cardiac anaesthetics • pathology and pharmacy.

Phase 2:
Evaluating the drive for and ability to change The incentive for change was the desire for a new cardiac OR that would provide high quality surgical care to cardiac patients. Key deliverables related to this were identified as: • patient-centred model of care and service ramp-up plan • equipment and instrumentation • consumables and consignment stock • support service prepared • service evaluation plan • emergency response.
Indicators of the ability to make the change included: • a service agreement with private sector • a workforce plan including staff recruitment and education • policies, procedures and protocols • a communication plan.

Phase 3:
Considering the change agent's drive and resources Consideration of financial and human resources included: • a budget and activity plan • benchmarking with the established cardiac services and local private providers • a stakeholder and staffing profile of cardiac operating room teams -surgeons, nurses, anaesthetic doctors, anaesthetic nurses and medical perfusionists • the nursing team: nursing staff responsible for direct patient care are registered nurses, with enrolled nurses, student nurses and assistants in nursing with the support and supervision of registered nurses • at least one registered nurse competent in providing advanced life support rostered on at all times • qualifications of nursing team: all nursing staff with or working towards relevant competencies and education programs in cardiac perioperative nursing • two categories of nursing staff -cardiac scrub/scout nurses and cardiac anaesthetic nurses.

Phase 4:
Selecting a clear change objective The objective was to implement cardiac surgery in a safe and timely manner through: • a patient-centred model of care with a focus on quality • confirming stability of care across the service providers • meeting activity targets (GCHHS service agreement 2013) • utilising available funds in the most efficient way possible to deliver high quality care.

Phase 5:
Indicating suitable roles for the agents involved According to ANZSCTS guidelines 10 the new cardiac operating room is dedicated exclusively to cardiac surgery and has: • a large OR fully equipped to perform cardiac surgery • an additional anaesthetic or induction room • a perfusion store room and set up room • consumables, consignment stock room and proper sterile instruments store room.
There will be a dedicated cardiac OR leading team with specified roles and responsibilities of: • surgical lead • nursing lead • anaesthetic lead • perfusion lead.
Required supporting services include: • cardiac ICU • cardiac surgical ward • perioperative services • sterilisation department • logistic and supply department • pharmacy, pathology and blood bank.
Communication with and assistance and support from the established cardiac surgery service are necessary to provide emergency sustainability. Planning for and implementation of this include: • full equipment, consumables and instruments set up OR, or at least on the same floor, to guarantee a timely and safe transfer of patients pre-and post-operatively.
The current design at GCUH has the OR on level two of the building and the ICU and cardiac wards on level four. As cardiac surgery patients are highly dependent and sometimes very unstable, transferring them between two floors was a challenge for the team. Faced with this barrier, the goal was to identify strategies that would ensure safe transfer of patients. One strategy was to have a well-equipped transport trolley attached to the patient bed during transfer, improving the management of any adverse events during transfer. The anesthetic teams transferring patients were also given an emergency keycard for the lifts to avoid any delays. During set-up, comprehensive trials and simulations were carried out to familiarise the team with the new environment and equipment, thus ensuring timely and safe patient transfer. All possible events were discussed and emergency protocols were established. Since the first cardiac surgery case in 2014, the team has performed over 1100 cardiac surgeries with no patient safety incidents associated with patient transfer having been reported.
In addition to spacial design, the hospital infrastructure needs to be carefully planned, especially because the cardiac OR and all the other perioperative departments need to function interdependently to ensure smooth transitions in patient care 7 . As Mehta and Bhatia 7 state, all cardiac ORs should have a minimum of two mobile pendants with additional gas flow meters for the cardiopulmonary bypass machine and anaesthetic equipment.
The cardiac OR at GCUH has three mobile pendants, and only two have the additional gas flow meters and connections required for the bypass and anaesthetic machines. The position of the three pendants and the layout of the OR with five-door access jeopardises the sterility of the surgical set-up. Different set-ups and arrangements were tested to find the best position for the OR equipment to preserve a sterile surgical setup. To comply with infection control standards, a surgical sterile set-up must be undertaken in an isolated area with minimum traffic 30 . The solution implemented by the team was for the sterile surgical set-up to be conducted on the right side of the operating table and moved into the required position on the left side as soon as the patient was prepped and draped. This is an example of how the cardiac instrument/circulating nurses developed 'workarounds' to manage these types of structural barriers without any compromise to patient care.
Finally, a lack of storage space for cardiac surgery equipment, instrumentation and consumables that meets Australian standards presented another structural barrier to an effective OR. The Australian standards 10 recommend that all equipment and instrumentation be in close proximity of the cardiac OR for easy access in an emergency. The space allocated for cardiac surgery consumables and instrument storage was limited in the department at GCUH. The team worked around the spatial limitations and arranged the stock in different ways in an effort to find the most appropriate solution. The small room for The new cardiac OR will be supported to meet the objective of providing cardiac surgery in a safe and timely manner through: • following policies and procedures • implementing and improving emergency response (a 24-hour on-call cardiac surgery team) • improving quality of care • briefing and debriefing team meetings • demonstrating processes for the formal audits and review of cardiac OR activity, quality and safety meetings, mortality and morbidity meetings • operational team meetings and communication.

Phase 7:
Concluding the liaison with those assisting Service agreements with the established cardiac surgery unit and private sector can be concluded with establishment of: • independent activity of the cardiac OR and 24/7 coverage of emergency • planned activity and budget • developed patient pathways.
sterile consumables was arranged and rearranged many times, with different shelving configurations, until the arrangement that allowed easiest access was found. Colourcoded labels were used for the consumables to assist with fast and correct identification. The consumable stock was separated from the consignment stock to simplify the reordering process and all cardiopulmonary bypass supplies were stored in close proximity to the OR. Finally, a scout nurse trolley was set up in the OR and stocked with extra supplies ensuring a quick and safe scouting process during surgery. Implementing this strategy to overcome this barrier was achieved through planning and persistence.

Financial barriers
Cardiac surgery is a rapidly growing specialty that uses more expensive technology than many other surgical specialties 19 . According to ANZSCTS guidelines 10  Another way to decrease costs was to reduce the time patients spent in the ICU after surgery. It is acknowledged that a lengthy ICU admission increases the cost of the service 33 and can produce bed-block and have negative impacts on cardiac surgery activity 34 . As the cardiac surgery at GCUH had been allocated only two beds in the ICU, maintaining a continuous flow of the daily surgeries can be achieved by ensuring timely patient transfer to the step-down unit. ICU stay is a significant part of the hospital journey for cardiac surgery patients and the length of ICU stay after cardiac surgery is subjected to different clinical and non-clinical factors and may vary between one and seven days 34 . The implementation process encountered various barriers because of the complexity of the specialty. However, the team identified solutions to overcome these barriers, and have now learnt some valuable and transferrable lessons during the implementation process.

Pitfalls and lessons learned
The cardiac OR is a complex environment where highly trained professionals work collaboratively using complex equipment to treat patients with severe cardiac disease and major co-morbidities. Wahr et al. 35 p. 1139 stated that these dedicated professionals are 'human and will make errors' and that avoidable mistakes can occur as a result of poor teamwork and communication rather than technical ability, preparation or knowledge. It is essential to build a cohesive team with effective communication skills underpinned by effective team training, shared knowledge, and conflict resolution 35 . These strategies reduce the potential for errors and improve the quality and safety of patient care 36 . The ability to build a cohesive team through a change management process requires good leadership.
Change management necessitates effective communication and connections. Establishing these and developing the ability to deal with the change while guiding staff through it is a significant leadership skill 37 . Building the cardiac OR team at GCUH was a process spanning about three years, with difficulties in the recruiting process. We came to realise that the best solution was to train existing staff eager to join the cardiac team. From an organisational and management perspective, it is vital to recognise the existing resources and explore how they could be used successfully to implement change 13 . It is important to identify the requirements for establishing a new cardiac OR but it is also crucial to acknowledge the resources that are already present in the health care facility 13 .
Involving all key stakeholders in the implementation process is valuable because it allows for different professional perspectives to be gleaned and implemented. Having stakeholders involved from the beginning would help with identifying possible obstacles and implementing suitable approaches to improve the change process 17 . Establishing a new cardiac unit, and especially a suitable focused care and acceptance of change led to establishing a successful service that offers high quality care.