Investigation report: Surgical care of NHS patients in independent hospitals

Concerns about patient safety in any area of NHS-funded healthcare in England can be referred to us by any person, group or organisation. We review these concerns against our investigation criteria to decide whether to conduct a national investigation. National investigation reports are published on our website and include safety recommendations for specific organisations. These organisations are requested to respond to our safety recommendations within 90 days, and we publish their responses on our website.

We investigate incidents in NHS maternity services that meet criteria set out within one of the following national maternity healthcare programmes:

• Royal College of Obstetricians and Gynaecologists’ ‘Each Baby Counts’ report
• MBRRACE-UK ‘Saving Lives, Improving Mothers’ Care’ report.

Incidents are referred to us by the NHS trust where the incident took place, and, where an incident meets the criteria, our investigation replaces the trust’s own local investigation. Our investigation report is shared with the family and trust, and the trust is responsible for carrying out any safety recommendations made in the report.

In addition, we identify and examine recurring themes that arise from trust-level investigations in order to make safety recommendations to local and national organisations for system-level improvements in maternity services.

For full information on our national and maternity investigations please visit our website.

The purpose of this investigation is to help improve patient safety in relation to the care of patients who have NHS-funded surgery in an independent hospital. It uses a real patient safety incident, referred to as ‘the reference event’, to examine issues. The NHS is a public body for the delivery of healthcare. Healthcare is also delivered by other bodies, such as those in the independent (also known as private) sector, including on behalf of the NHS. In the early stages of the COVID-19 pandemic a national agreement was reached to secure support from the independent sector to deliver more care on behalf of the NHS, including certain types of surgery.

Rodney, a man aged 58 who had previously been in good health, was diagnosed with bowel cancer. Plans were made for him to have surgery to remove part of his bowel. He was listed for laparoscopic (keyhole) surgery in an NHS Hospital. Before the operation his fitness for surgery was assessed (known as a preoperative assessment). His body mass index (a measure of body fat based on height and weight) was 17kg/m2, meaning he was underweight.

Rodney’s initial surgery was cancelled and he was rebooked for surgery 5 days later at a nearby Independent Hospital. Local NHS cancer surgery had been transferred to the Independent Hospital because of new arrangements made in response to the COVID-19 pandemic.

On the day of his operation at the Independent Hospital, Rodney was asked to give his consent for open bowel surgery (rather than laparoscopic surgery). The change to open surgery was the result of guidance at the time around a potentially increased risk of COVID-19 transmission with laparoscopic surgery. The cancerous part of Rodney’s bowel was removed and the bowel joined back together.

Following surgery Rodney made a slow recovery. Overnight into day 8 after surgery his condition deteriorated rapidly. It was decided that urgent transfer to the local NHS Hospital was needed so that Rodney could receive intensive care, as this was not available at the Independent Hospital. He also required an urgent scan of his abdomen.

Rodney was transferred by ambulance and on arrival at the NHS Hospital was very unwell. A scan and subsequent surgery showed a leak in his bowel which led to sepsis and organ failure. Rodney succumbed to the infection and died later the same day. A post-mortem examination commented that Rodney had been in a frail physical state, meaning that his ability to cope with infection would have been poor.

HSIB received a referral describing an NHS-funded patient’s experience of inadequate surgical care in an independent hospital. In response HSIB undertook the investigation into the reference event, which was identified through the Strategic Executive Information System (a national database of patient safety incidents).

The reference event investigation identified safety risks that merited exploration at a national level, as there was the potential to learn lessons that could be applied across the healthcare system.

The national investigation aimed to:

• explore the factors that support and inhibit implementation of NHS-surgical services in independent hospitals in response to dynamic situations (such as COVID-19)
• examine the factors that support and inhibit the preoperative identification of clinical risk to NHS-funded surgery patients, and the optimisation of their physical condition before surgery, including a focus on frailty.

The national investigation involved:

• observational visits and interviews with staff at NHS and independent hospitals across England
• interviews with national and regional stakeholders including those involved in healthcare commissioning, regulation and research
• analysis using safety science methods to explore the factors that contributed to the safety risks
• engagement with national bodies in the development of safety recommendations.

NHS-funded surgery in independent hospitals

• The COVID-19 pandemic placed unprecedented demand on NHS and independent healthcare provision.
• The capability and capacity of independent hospitals for the provision of surgical care was seen to vary across the country.
• National and local NHS organisations had limited understanding of independent hospitals’ capabilities. This resulted in variation in how independent hospitals were used during COVID-19.
• With a move to integrated care systems (partnerships that co-ordinate healthcare services in a particular geographical area) there have been limited efforts to understand the capabilities of independent hospitals. This may undermine future relationships and understanding of how best to use resources at times of high demand.
• Some independent hospitals saw patients with increasingly complex conditions and undertook more complex operations during COVID-19. The increasing complexity was well managed where capability of the independent hospitals had been evaluated and addressed prior to implementation of new services.
• Where pathways between NHS and independent hospitals were effective, it was often found that relationships between the hospitals had been longstanding and direct.
• Other factors that created risks in NHS-funded surgical pathways between NHS and independent hospitals included: unclear roles and responsibilities; limited integration of information and communication systems; and variation in what surgery was deemed suitable for an independent hospital.

Preoperative assessment and optimisation

• There was variation in how preoperative assessments were undertaken across NHS and independent hospitals. This included what tests were ordered and risk assessments undertaken.
• The American Society of Anesthesiologists status classification system alone was used in some independent hospitals to decide on patients’ suitability for surgery and whether to escalate a patient’s case for discussion by a multidisciplinary team.
• Preoperative nutrition screening was inconsistent across NHS and independent hospitals. Examples were identified where it was not undertaken, or undertaken too late to allow any preoperative optimisation – that is, to make sure the patient was in the best possible nutritional state before their operation.
• Remote preoperative assessment became the norm during COVID-19, but created risks when staff were not able to see the patient. Lack of video call facilities and staff preference meant assessments were commonly done by telephone.
• There is no agreed clinical definition of frailty in patients under the age of 65, and no validated tools to assess people under 65 for frailty, either before surgery or in other fields of care.
• There is no consensus on the most impactful and best value model for care before, during and after surgery (perioperative care), with variation in care provision across the country.

1.1.1 The NHS is a public body for the delivery of healthcare to the UK population. Healthcare in the UK is also delivered by other bodies, such as those in the independent (also known as private) healthcare sector. Independent healthcare refers to the delivery of care outside of the NHS. The independent sector provides services purchased by private individuals, health insurers, local authorities and the NHS itself.

1.1.2 Providers of independent healthcare deliver a range of services including acute, primary, community and dental. The Independent Healthcare Providers Network (IHPN) acts as a representative body for the majority of these providers in the UK. The IHPN supports sharing of information and provides a voice for the independent sector.

1.1.3 The providers represented by the IHPN deliver healthcare services across 500 sites in the UK and employ over 85,000 staff (Independent Healthcare Providers Network, 2019a). In England the IHPN has 69 members (Independent Healthcare Providers Network, n.d.), many of which also deliver care on behalf of the NHS.

1.1.4 Like the NHS, independent healthcare is regulated by the Care Quality Commission (CQC) (Care Quality Commission, 2021). The CQC monitors and inspects independent healthcare services to ensure they meet expected standards of quality and safety. The CQC also provides performance ratings on the services it inspects. As of 1 September 2021, around 84% of independent non-specialist acute hospitals were rated as good or outstanding (Independent Healthcare Providers Network, 2021a).

1.1.5 This HSIB national investigation specifically considers independent hospitals in England where they deliver NHS-funded surgical care. Independent providers often have several independent hospitals across the country

1.2.1 For several years there has been co-working between independent healthcare and the NHS. In 2018, 4.8% of NHS-funded patients had elective (planned, non-emergency) care at independent healthcare sites (Private Healthcare Information Network, 2019). The IHPN described (based on NHS performance data) that, prior to COVID-19, over 500,000 NHS elective surgical procedures were carried out per year at independent healthcare sites, accounting for 21% of all NHS gastroenterology (conditions associated with the digestive tract) and orthopaedic (conditions relating to bones and muscles) patients (Independent Healthcare Providers Network, 2019a). The amount of NHS-funded care delivered across the independent sector varies from none to being the majority of the work at some hospitals.

1.2.2 The NHS Long Term Plan described a need to make use of independent healthcare capacity to provide NHS patients with a choice of where and how quickly they would like to receive their elective care (NHS, 2019). This has been supported by independent healthcare with an ambition of ‘working together to provide seamless patient care, rather than one organisation providing everything itself’ (Independent Healthcare Providers Network, 2019b).

1.2.3 Prior to COVID-19, independent healthcare for NHS-funded patients was contracted via one of two routes. Care was either directly commissioned by a clinical commissioning group or NHS England and NHS Improvement under the NHS Standard Contract, or sub-contracted by individual NHS healthcare organisations in collaboration with a local independent healthcare provider. Contracting arrangements changed as a result of COVID-19.

1.3.1 Since March 2020 independent healthcare has become increasingly involved in supporting the NHS’s response to COVID-19. On 24 March 2020 NHS England and NHS Improvement, brokered by the IHPN, ‘reached a national agreement with independent sector (IS) healthcare providers to secure all available inpatient capacity and resource in every area in England to form part of our response to COVID-19’ (NHS England and NHS Improvement, 2020a). The national agreement superseded local agreements and aimed to deliver services for NHS patients including urgent NHS elective cases and cancer care pathways. As a result regions were asked to set up coordination networks to develop local service plans.

1.3.2 On 14 August 2020 modifications were made to the national agreement between the NHS and independent healthcare to maintain access to independent hospital capacity while longer-term plans were being developed (NHS England and NHS Improvement, 2020b). Subsequently a contract was developed for January to March 2021 aimed at independent hospitals delivering volumes of activity with a minimum guaranteed payment. This agreement was also intended to support a return to local commissioning arrangements following COVID-19; not all independent providers were part of this contract.

1.3.3 In 2020 the IHPN ran its first ‘industry barometer’ exploring the impact of COVID-19 on the independent healthcare market (Independent Healthcare Providers Network, 2020). Ninety six per cent of respondents felt that COVID-19 had created challenges associated with the transmission of infection and how they ran their services. The increasing waiting lists for NHS elective care were also highlighted. There was also positive impact with anticipated growth in NHS-funded services in independent healthcare, improved relationships with the NHS, and the implementation of new technologies.

1.3.4 At the time of writing, COVID-19 remains an ongoing challenge for healthcare. It has resulted in a significant waiting list for NHS elective surgery following reprioritisation of care during the peaks of the pandemic. Figures suggest that at the end of August 2021 there were almost 5.5 million patients on the planned hospital treatment waiting lists, with over 400,000 having been waiting more than a year. As a result, members of the public and the NHS have been looking towards the independent sector for further support.

1.4.1 Bowel cancer (cancer in a person’s colon or rectum) is one of the most common types of cancer in the UK. Treatment varies depending on the location of the cancer and whether it has spread to other areas, termed metastatic cancer. Where surgery is an option for treatment, the cancer will be removed along with part of the bowel where the cancer is located. For example, a high-anterior resection is an operation that removes the sigmoid colon and part of the rectum (see figure 1).

1.4.2 High-anterior resections, much like other bowel surgery, can be undertaken via open or laparoscopic surgery. Open surgery refers to the traditional type of surgery which is performed through an incision in the patient’s body; the incision can be large depending on the type of operation. Laparoscopic surgery is also referred to as keyhole surgery or minimally invasive surgery. In laparoscopic surgery, much smaller incisions are made and a camera is used to see inside the patient’s body.

1.4.3 There has been a move away from open surgery towards more laparoscopic surgical procedures as surgery has advanced. The benefits of laparoscopic over open surgery include:

• minimal wound size for healing
• less pain
• less handling of a patient’s organs, reducing complication such as ileus (slowing or stopping of normal bowel movement)
• reduced infection and impact on subsequent recovery
• shorter hospital stays
• quicker mobilisation (that is, the patient can move around more quickly after the operation) which reduces the risks of pressure ulcers, blood clots and physical decline affecting a patient’s abilities to undertake activities.

1.4.4 Evidence suggests that patients undergoing laparoscopic removal of parts of the bowel have lower risk of death and complications such as blood clots (Mamidanna et al, 2012; Cone et al, 2011)

COVID-19 and surgery

1.4.5 Early in the COVID-19 pandemic, concerns about transmission of the virus led to changes in the way operations were undertaken. General surgery guidance produced by a group of UK surgical royal colleges and associations (referred to in this report as intercollegiate guidance), was published in early 2020. It described concerns around the risk of viral transmission from laparoscopic surgery, meaning that it should only be used where benefits outweighed the risks (Intercollegiate guidance, 2020a). The guidance further described that surgeons should consider forming stomas (where the bowel is brought out through an opening in the abdomen) following bowel surgery, rather than reconnecting the bowel (anastomosis), as this may minimise the risk of complications and the need for intensive care.

1.4.6 The intercollegiate general surgery guidance was updated in May 2020. Surgical units started to re-establish laparoscopy where the risks of viral transmission could be minimised (Intercollegiate guidance, 2020b).

1.5.1 A patient who has surgery will pass through a series of phases. These include assessment before an operation, the operation itself, and recovery after the operation; these are referred to as the preoperative, intraoperative and postoperative phases respectively (see figure 2). Together these phases are referred to as perioperative care.

1.5.2 The Centre for Perioperative Care (CPOC) describes the importance of effective perioperative care and that it should be ‘integrated multidisciplinary care of patients from the moment surgery is contemplated through to full recovery’ (Centre for Perioperative Care, n.d.a)

Preoperative assessment

1.5.3 Preoperative assessment explores the individual risks to the patient of anaesthesia and surgery. The assessment process also aims to:

• ensure a patient is fully informed about the operation
• ensure the patient understands the risks and can therefore make an informed decision about whether to proceed
• identify any other medical illnesses and optimise (improve them) them as much as possible
• plan for discharge after surgery (Association of Anaesthetists of Great Britain and Ireland, 2010).

1.5.4 The National Institute for Health and Care Excellence (NICE) has published guidance for preoperative assessment. This includes guidance on perioperative care in adults (National Institute for Health and Care Excellence, 2020) and routine preoperative tests for elective surgery (National Institute for Health and Care Excellence, 2016). The guidance includes the need for preoperative assessment of risks to the patient, discussion of lifestyle modifications (such as smoking and alcohol consumption) and review of and optimisation of certain factors, such as nutrition. Preoperative requirements depend on the grade of surgery (see table 1) and the patient’s fitness for surgery.

1.5.5 A commonly used assessment of a patient’s fitness for surgery is the American Society of Anesthesiologists status classification system (see figure 3), referred to as ASA. It assesses the patient’s pre-anaesthesia medical condition. While it does not directly predict the risk to the patient of undergoing an operation, it can be helpful when considered with other factors (American Society of Anesthesiologists, 2020).

1.5.6 Nutritional preoperative screening assesses a patient’s nutritional state before an operation – for example whether they are underweight, overweight or malnourished – to help make a decision about the risk of surgery. It should be offered to patients having intermediate, major or complex surgery (National Institute for Health and Care Excellence, 2016). Nutritional screening should assess the patient’s body mass index and percentage unintentional weight loss. The Malnutrition Universal Screening Tool (MUST) (British Association for Parenteral and Enteral Nutrition, 2020) may be used for this (National Institute for Health and Care Excellence, 2020) and NICE provides a definition of malnutrition which includes a BMI of less than 18.5kg/m2 or unintentional weight loss greater than 10% in the last 3 to 6 months (National Institute for Health and Care Excellence, 2017). MUST supports decisions around what actions are needed for patients who are malnourished or at risk of malnourishment.

Postoperative care

1.5.7 Following an operation such as a high-anterior resection, complications may include ileus (slowing of the bowel), bleeding, infection, blood clots, and leakage of bowel contents at the point where the bowel has been joined back together (anastomotic leak). Anastomotic leaks commonly occur between 5 and 10 days following surgery and are associated with an increased risk of death (D’Souza et al, 2019).

1.5.8 In the postoperative phase, the location in which patients receive care will depend on their ‘level of care’ (see figure 4) This level relates to the amount of care a patient needs. Following major or complex surgery, or if a patient suffers complications, they may need to be cared for in a more intensive care setting, also referred to as critical care.

Figure 4 Levels of care available in hospitals (Intensive Care Society, 2019)

1.6.1 This investigation refers to the identification and management of frailty. Frailty is used as a descriptive term for people who are less likely to be able to cope with significant stress on their body and are therefore at increased risk of poor health outcomes, such as falls, disability, hospitalisation and death (National Institute for Health Research, 2020a). It is commonly associated with ageing.

1.6.2 Frailty can be described in different ways. It can be seen as three or more of: exhaustion, weight loss, weakness/loss of muscular strength, reduced walking speed and reduced energy/physical activity (Fried et al, 2001); or as an accumulation of symptoms, signs and disabilities (Mitnitski et al, 2001). The concept is now familiar across the NHS, but the majority of work to date has been focused on frailty in older people, with limited research into the concept in younger people. The National Institute for Health Research estimated that 1.2% of people aged 65 were frail, with 2.7% of over 65s at risk of becoming frail (pre-frailty) (National Institute for Health Research, 2020b).

1.6.3 In people undergoing surgery, evidence suggests that assessing frailty in older people is important to improve outcomes after operations (Fagard et al, 2016). Similarly, in cancer, more than half of older cancer patients are frail or at risk of becoming frail, and are at increased risk of surgical complications (Handforth et al, 2015)

2.1.1 Rodney was aged 58 and a self-employed accountant. His Wife described him as tall, thin and intelligent. He liked to play golf and travel, and had recently retired. He had no significant past medical history other than previously requiring surgery for bone fractures.

2.1.2 Rodney saw his GP on 4 February because he was experiencing loose stools, bloating and reduced appetite. Tests were organised and the results prompted a referral to the local NHS Hospital for suspected cancer. The referral was made on 18 February and described that Rodney smoked, had some restriction undertaking physical, strenuous activity and had no weight loss.

2.1.3 Rodney was booked for a colonoscopy (where the bowel and rectum are examined using a camera) at the NHS Hospital on 29 February. This was postponed as Rodney was on holiday. He therefore had the colonoscopy on 9 March. The colonoscopy identified a large cancer in his sigmoid colon (see figure 1) and a number of smaller cancers. Biopsies (samples of tissue for testing) were taken and a multidisciplinary team meeting was arranged to discuss a plan for Rodney’s care.

2.1.4 The bowel biopsy confirmed that Rodney had a sigmoid colon cancer. A computerised tomography (CT) scan showed that the cancer had not spread. A multidisciplinary team meeting on 16 March agreed that surgery could be curative (that is, it could cure the cancer).

2.1.5 Rodney saw a consultant colorectal surgeon in an NHS outpatient clinic on 20 March. At the appointment he was informed of the diagnosis of cancer and offered surgery. The plan was for a laparoscopic (keyhole) high-anterior resection (see 1.4.2) to be undertaken on 27 March. The risks of surgery were described to Rodney, including infection, bleeding, anastomotic leak (see 1.5.7), chest infection, blood clots and a small risk of death. The outpatient clinic notes recorded Rodney as being slim, a smoker and a social drinker.

2.2.1 Rodney attended an NHS preoperative assessment clinic on 25 March. At this assessment he saw a preoperative assessment nurse, consultant anaesthetist and enhanced recovery programme nurse. The assessment recorded him getting short of breath on exertion when climbing one flight of stairs. He had a body mass index (BMI) of 17kg/m2 indicating that he was underweight; no Malnutrition Universal Screening Tool (MUST) score was completed. The nurse classified him as status 2 under the American Society Click here for contents page 25 of Anesthesologists (ASA) classification system (see 1.5.5 and figure 3). A consultant anaesthetist classified Rodney as ASA status 1 and documented for his surgery to be undertaken at the NHS Hospital. Rodney was also seen by the enhanced recovery programme nurse (a programme to get patients back to normal life as quickly as possible following their operation) who explained the programme, provided an information sheet (which included information on preoperative fasting) and provided preoperative nutrition drinks. Rodney was also given dietary advice for the period before his operation including what foods he could and should not be eat.

2.2.2 Rodney had blood taken for preoperative assessment blood tests. The results were available on the same day and showed abnormalities including anaemia, low urea and creatinine (which can be caused by malnutrition), and abnormal liver tests with a low albumin (a marker of illness).

2.2.3 The planned surgery on 27 March at the NHS Hospital was cancelled following a national decision to create capacity in NHS hospitals to respond to the anticipated demands of the COVID-19 pandemic (NHS England and NHS Improvement, 2020a). The NHS Hospital was therefore not able to deliver elective surgery. As a result, Rodney’s surgery was transferred to a nearby Independent Hospital to be undertaken on 1 April. The local Independent Hospital was a level 1 hospital (see figure 4) meaning that it could provide additional monitoring, but not intensive care.

2.2.4 Rodney had a further preoperative assessment on 31 March at the Independent Hospital. He was classified as ASA status 2. The assessment recorded his BMI as 20kg/m2 to 24.9kg/m2 with a Waterlow score (which estimates the risk of pressure sores) of 6 (low risk). No MUST score was completed. A consultant anaesthetist review found Rodney to be suitable for surgery and a bed was booked for him to receive increased monitoring for the first 24 hours after surgery.

2.2.5 Rodney was admitted to the Independent Hospital on 1 April for surgery. His consent was obtained on the day for an open high-anterior resection. The plan had been changed from laparoscopic to open surgery.

2.3.1 Rodney’s operation took place on 1 April. The surgical team included a consultant anaesthetist and two consultant surgeons, including the surgeon who saw Rodney in clinic on 20 March, who had practicing privileges (permission to work) at the Independent Hospital. Rodney was put under general anaesthetic for the operation and an epidural (injection of medicines Click here for contents page 26 into the back) was inserted for postoperative pain relief. The anaesthetist’s notes classified Rodney as ASA status 3, weight 58kg, height 180cm (representing a BMI of 17.9kg/m2), and a smoker. His preoperative blood results and their abnormalities were noted by the anaesthetist.

2.3.2 Rodney underwent an open (rather than laparoscopic) high-anterior resection. Reviews undertaken by the Hospitals involved described that this was ‘due to risk of inhalation/coronavirus’; there had also been recent national guidance on the risk from laparoscopic surgery (Intercollegiate guidance, 2020a). The cancer was successfully removed. During the surgery, difficulties were encountered with the surgical stapling gun used to make the join in the bowel (anastomosis), however, following formation of the join it was tested for leaks and found to be satisfactory. During the operation Rodney had poor urine output and received 3 litres of intravenous fluid (fluid delivered into a vein) as he was dehydrated. He had minimal blood loss.

2.4.1 Following surgery Rodney was transferred to a single-patient room on a ward. He received close monitoring by a nurse trained in extra monitoring for 24 hours in line with the Hospital’s policy.

2.4.2 During Rodney’s postoperative phase he was reviewed daily by the consultant (who saw him in clinic and operated on him), and regularly by the Hospital’s resident medical officers (RMOs). He had episodes of vomiting, low blood pressure, reduced urine output and periods where he was declining drinks and activity. He also developed an ileus (slowing of the bowel) for which he was given treatment.

2.4.3 On 8 April (7 days after the operation) Rodney became confused, had a low urine output, had low blood glucose and was found to have abnormalities in his blood tests consistent with infection. The RMO and consultant saw him and treated him with intravenous fluids, antibiotics and glucose. Rodney’s condition subsequently improved meaning transfer to the NHS Hospital was not required at that time.

2.4.4 In the early hours of 9 April (8 days after the operation) the RMO was asked to again see Rodney because he had low blood pressure, abdominal distension (bloating), and was unable to pass urine. The consultant was contacted and when he arrived found that Rodney was very unwell. Rodney required transfer to the local NHS Hospital for a CT scan to identify the reason for his deteriorating condition, and for more enhanced monitoring in an intensive (critical) care environment (level 2 or 3 care).

2.4.5 Rodney was transferred via ambulance and taken to the NHS Hospital’s emergency department (ED). During his time in ED he had a cardiac arrest (his heart stopped) from which he was resuscitated. A CT scan of his abdomen suggested a leak from his bowel and so the consultant decided that Rodney needed further surgery.

2.4.6 Surgery identified what appeared to be an intact anastomosis, but on testing, a small leak was noted. The anastomosis was therefore removed and a stoma created. After the operation, Rodney went to intensive (level 3) care where he required significant support for his breathing and blood pressure.

2.4.7 Despite treatment, Rodney’s condition continued to deteriorate and he developed multi-organ failure. He succumbed to the infection later the same day and died.

2.5.1 The NHS Trust reviewed the circumstances around Rodney’s death and identified that the risk of an anastomotic leak was probably increased because he had a poor level of health coming into surgery. It was also noted that usual surgical practice may have been affected by changes as a result of COVID-19; for example, open surgery was used instead of laparoscopic (Intercollegiate guidance, 2020a). The review did not identify any concerns about the location of the surgery.

2.5.2 The Provider that ran the Independent Hospital undertook an investigation into Rodney’s care. It also sought independent assessment of Rodney’s ASA status. That assessment described that ASA status 2 was appropriate, and may have changed on the day of surgery in light of the change from laparoscopic to open surgery.

2.5.3 A post-mortem examination identified Rodney’s bowel as the source of infection. Pre-existing liver problems (unknown prior to surgery) and a frail physical state were also identified, meaning that his ability to cope with infection would have been poor. His cause of death was determined to be multi-organ failure as a consequence of sepsis (infection) due to a complication of his recent surgery. The post-mortem report also described Rodney as ‘extremely frail’ and noted that it had taken him over 6 months to recover from previous surgery; this was not seen to be noted in his preoperative documentation.

3.1.1 HSIB received a referral from a member of the general public. They raised concerns that the level of surgical specialty care available in independent healthcare for NHS patients may not be adequate.

3.1.2 In response to the referral HSIB undertook a review of patient safety incidents that had been reported on two national systems – the Strategic Executive Information System and the National Reporting and Learning System. This review identified examples of harm to NHS-funded patients who had received surgical care in independent hospitals. These examples included the reference event used in this investigation.

3.1.3 As a result of the referral and HSIB review, an investigation of the reference event was launched.

3.2.1 The investigation of the reference event gave HSIB insight into NHS-funded surgical care in independent hospitals. This led to consideration of the need for HSIB to undertake a national investigation exploring the capability of independent hospitals to meet the surgical needs of NHS patients. A national investigation was launched because findings from the reference event investigation met the following criteria.

Outcome impact – what was, or is, the impact of the safety issue on people and services across the healthcare system?

• For patients who have had surgery a good outcome depends on whether any complications are recognised and treated. Any delay in recognising such complications can make management more difficult and can result in significant physical and psychological harm, and/or death. In the reference event Rodney developed sepsis following a complication of his surgery and died. Complications also increase lengths of stay in hospital and readmissions.
• For staff, harm may be psychological. HSIB has published a national learning report in this area: ‘Supporting staff following patient safety incidents’ (Healthcare Safety Investigation Branch, 2021).
• For organisations, there is a risk of reputational harm. There may also be financial harm if care is taken elsewhere or extra care is required.

Systemic risk – how widespread and how common a safety issue is this across the healthcare system?

• Complications of care are common and sometimes unavoidable. For example, patients undergoing anterior resections sometimes develop bleeding, infections, leaks from bowel joints and blood clots. Rarely this surgery can result in death.
• The processes that minimise patient harm from complications in independent healthcare are the selection of suitable patients for surgery and the ability to recognise and manage deterioration. HSIB has published a national investigation report in this area: ‘Recognising and responding to critically unwell patients’ (Healthcare Safety Investigation Branch, 2019).
• More NHS patients than ever before are being cared for in independent healthcare settings. There has been a general increase during recent years and a significant increase due to COVID-19. Most independent hospitals do not have the full range of facilities that NHS hospitals have.

Learning potential – what is the potential for an HSIB investigation to lead to positive changes and improvements to patient safety across the healthcare system?

• The reference event and developments for independent healthcare supporting the NHS in light of COVID-19 suggest that this investigation has learning potential. The investigation offers the opportunity to explore how independent healthcare services can be supported to deliver safe and effective care to NHS-funded patients.
• This is the first time HSIB has investigated NHS-funded care within independent healthcare. This novel area of investigation, and the complexities as a result of COVID-19, make this investigation relevant.

Investigative approach

3.3.1 An HSIB investigation does not apportion blame to any individual or organisation involved in investigations. The healthcare system is considered in its entirety to identify the factors that have contributed to events under investigation.

3.3.2 To help understand the healthcare system, the investigation used the Systems Engineering Initiative for Patient Safety (Holden et al, 2013; Carayon et al, 2006). SEIPS is a framework for understanding structures, processes and outcomes and the relationships between them. SEIPS is explained in more detail in appendix 9.1. Investigation team

3.3.3 The HSIB investigation team was multidisciplinary and included individuals with experience in:

• NHS clinical care
• NHS regulatory and complaints management
• patient safety, transport safety and quality improvement
• systems safety and human factors.

Interviews

3.4.1 The reference event investigation interviewed Rodney’s Wife to seek her experiences of the events affecting her husband. The investigation visited the Independent Hospital where Rodney had surgery and interviewed staff who cared for him and who were involved in planning and implementing services. Interviewees included:

• the consultant surgeon and anaesthetist
• resident medical officers
• inpatient nursing staff
• directors and governance staff.

3.4.2 The investigation also interviewed the Surgical Division Lead Consultant at the nearby NHS Hospital where Rodney’s preoperative assessment took place and where he was treated after surgery when his condition deteriorated.

Evidence gathering

3.4.3 Multiple sources of evidence were gathered and reviewed for the reference event investigation. These included:

• Rodney’s independent and NHS clinical records
• relevant local and national policy, processes, guidance and contracts • observation in the Independent Hospital
• relevant academic literature.

3.4.4 Findings were presented to the NHS Hospital, Independent Hospital and Independent Provider where the reference event occurred. This allowed sharing of learning and corroboration of findings.

3.5.1 The following objectives were defined for the national investigation due to their system-wide learning potential:

• to explore the factors that support and inhibit implementation of NHS surgical services in independent hospitals in response to dynamic situations (such as COVID-19)
• to examine the factors that support and inhibit the preoperative identification of clinical risk to NHS-funded surgery patients, and the optimisation of their physical condition before surgery, including a focus on frailty.

3.5.2 The reference event investigation identified several other safety risks that were out of scope of the national investigation. Those risks have been presented to HSIB’s Intelligence Unit to support future identification of risks for national investigation. The risks included: monitoring of vital signs (for example heart rate) and management of the balance of fluids in a patient’s body; handover of critical information; informed consent for surgery; and timely transfer of patients to specialist care.

3.5.3 The investigation did not focus on deterioration of patients in independent hospitals. This decision was made because the reference event investigation’s findings related to suitability selection of patients which ultimately led to Rodney being in the Independent Hospital when his condition deteriorated. HSIB recognises the national safety risks associated with deteriorating patients and has published an investigation report on deterioration: ‘Recognising and responding to critically unwell patients’ (Healthcare Safety Investigation Branch, 2019).

Evidence gathering

3.5.4 To achieve its objectives, the investigation engaged with various independent providers and hospitals, and national stakeholders. Table 2 provides an overview of the stakeholders. Further evidence was gathered from academic, professional and policy publications

Analysis

3.5.5 The investigation interviewed stakeholders using a semi-structured approach. Notes were taken and specific interviews were audio recorded with consent.

3.5.6 The analysis considered the objectives and explored them further through interviews with stakeholders and review of the research literature. This supported identification of learning and associated recommendations. These were shared with those engaged with during the reference investigation and subsequent national investigation. This has allowed further corroboration, challenge and adjustment where necessary.

4.1.1 On 24 March 2020 NHS England and NHS Improvement secured all independent hospital inpatient capacity and resource in England to support the response to COVID-19 (NHS England and NHS Improvement 2020a). This included for provision of urgent NHS elective surgery including cancer surgery. In response, geographical regions were notified to put in place local arrangements. This is why Rodney’s surgery was transferred to the Independent Hospital on 1 April.

4.1.2 The investigation heard views that local planning and movement of more NHS-funded surgical care to the Independent Hospital did not consider all the resources that may have been required for NHS-funded patients with more complex needs. The factors that contributed to this are described below. National agreement and situation

4.1.3 The national COVID-19 situation was the key contributor to the need to undertake local service changes at the time of Rodney’s surgery. Growing numbers of COVID-19 cases placed pressure on the NHS and there were increasing concerns about the impact the disease could have on patient outcomes following surgery (for example, COVIDSurg Collaborative, 2020). The local NHS Hospital was also facing specific challenges as a result of COVID-19.

4.1.4 These factors necessitated the rapid movement of surgery to the Independent Hospital from the NHS Hospital. The situation at the time meant that for anything other than emergency surgery for life-threatening conditions, surgery would likely have been unavailable if the Independent Hospital had not been used.

4.1.5 The NHS and Independent Hospitals told the investigation that the national agreement in support of implementing local arrangements did not detail how services should be implemented; rather it “told” them to do it. This led to the Hospitals implementing services in a way that they thought best, but sometimes with limited consideration of some areas of risk, such as staff capability and experience.

Local leadership and planning

4.1.6 The investigation met with the local NHS and Independent Hospital leadership and was told about their role in planning and implementation of services. At the beginning of the COVID-19 pandemic the leadership was focused on continuing certain surgeries that the NHS Hospital was unable to do. The focus was on addressing the surgical need; there was more limited consideration that the Independent Hospital may have previously found patients to be unsuitable for their facility because of capability and resource.

4.1.7 The Independent Hospital was able to provide enhanced monitoring, but not intensive care. While patients having anterior resection operations would not necessarily need intensive care after surgery, NHS hospitals have that resource as a backup. The investigation was told by the NHS and Independent Hospital staff that the local NHS Hospital was perceived to be a safer place for complex surgery because of the other resources available.

4.1.8 The investigation recognised that it had been necessary to move surgery to the Independent Hospital rapidly. Rodney was one of the first patients to have an operation at the Independent Hospital under the COVID-19 agreement. The investigation was told that at the time there was limited access to specialist input such as specialist anaesthetic and surgical doctors (other than the operating surgeon and anaesthetist), and bowel and enhanced recovery nurse specialists. The investigation was later told by the Independent Provider that some of these services may have been in place at the time of Rodney’s operation, but staff did not describe any involvement in his specific care.

Clarity of responsibilities between the Hospitals

4.1.9 A good relationship was described between individuals at the Independent Hospital and the NHS Hospital. The investigation was told that these relationships provided clarity on responsibilities at an organisational level, but less so on a frontline level. Independent Hospital staff were therefore not clear of their responsibilities when delivering care to NHS patients for newly implemented services.

4.1.10 The investigation was informed by the Independent Provider that Rodney’s care at the Independent Hospital was delivered under the national COVID-19 agreement and therefore the Independent Hospital had clinical responsibility for his care at its location. The agreement required hospitals to work together to devise integrated governance processes and systems.

Staffing resource and skill mix at the Independent Hospital

4.1.11 The staff at the Independent Hospital were described as trained for the types of care they usually provide. The Independent Hospital had undertaken major surgery previously, including bowel surgery. The investigation was told that an open anterior resection was a less familiar procedure.

4.1.12 The investigation was told about staff training and competency requirements at the Independent Hospital. Staff described limited consideration of the skillmix of staff when implementing new surgical services. Some staff, depending on experience, were less familiar with the typical complications seen in the NHS such as those after an anterior resection.

4.1.13 Local staff also described limited input from NHS staff at the time of Rodney’s surgery, other than from the consultant surgeon. The investigation was subsequently told that, at the time of Rodney’s surgery, there was input available from NHS specialist nurses, such as enhanced recovery, at the independent hospital. However, the investigation has been unable to ascertain whether any input was provided to Rodney and staff did not recall any support or additional training in relation to Rodney’s care.

4.1.14 The medical staffing model in most independent hospitals in England relies on resident medical officers (RMOs) who provide support 24 hours a day, 7 days a week. RMOs vary in their experience, and some may have had limited training or experience beyond a few years of clinical practice. The investigation was told that the reference event Independent Hospital’s RMOs had various levels of experience and could be left “vulnerable” when caring for patients with complex needs, particularly at night without intensive care support. At the Independent Hospital, the RMOs were supported by the consultant surgeon who had operated on Rodney. The investigation was also told that a consultant anaesthetist who anaesthetises a patient is clinically responsible for the patient for a period after an operation that would not normally exceed 24 to 48 hours.

Integrated patient records between the Hospitals

4.1.15 The investigation was told about the limited integration of electronic patient records between the NHS and Independent Hospitals. Preoperative staff had to rely on paper notes sent over from the NHS Hospital. These were not always complete. Rodney’s notes had limited preoperative assessment details and incomplete risk assessments. Infrastructure challenges meant it was not possible to fully integrate patient record systems.

Shared purpose

4.1.16 The staff at the Independent Hospital described their motivation to support the NHS in the face of COVID-19. They told the investigation that all decisions were made with the best of intentions in difficult circumstances. Staff reflected that the unprecedented situation may have increased leaders’ tolerance of risk across health services with a focus on supporting the NHS.

4.2.1 The investigation was told by staff who cared for Rodney that he was thin and looked older than his age. Rodney’s Wife described him as “very frail” and she felt he was too weak for surgery. The post-mortem noted that Rodney had a frail physical state, pre-existing liver issues and had made slow progress recovering from previous injuries. These factors would have increased his risk of complications from surgery and his ability to respond to them.

4.2.2 Neither the NHS Hospital nor Independent Hospital preoperative assessments flagged up Rodney’s poor physical health or significant weight loss. Rodney’s Wife described that her husband had lost a significant amount of weight between the original referral and the day of the operation.

4.2.3 Those interviewed described Rodney’s death as a “shock” as they thought he was fit and healthy for his age. Rodney’s preoperative assessments did not prompt consideration as to whether surgery was appropriate and where it should take place. The factors that contributed to the limited consideration of Rodney’s suitability for surgery and location are described below.

Local practice for suitability selection of patients

4.2.4 The Independent Provider of the reference event Hospital had a policy that described suitable patients for their level 1 hospitals and stated that any concerns about suitability must be escalated. Rodney met the criteria for escalation because of factors including low body mass index (BMI) and abnormal liver blood tests. For any of these criteria, the investigation was told that the expected process was for the consultant anaesthetist and surgeon to assess the patient’s fitness and the hospital clinical lead to make the decision about whether the patient is suitable for surgery.

4.2.5 At the time of Rodney’s preoperative assessment at the Independent Hospital the investigation found that the process to escalate to the clinical lead for concerns around suitability was not followed. The investigation was told of concerns that individual surgeons and anaesthetists, who may have been less familiar with local capabilities, influenced decisions. This was in part due to local leadership factors at the time of the incident that were out of scope of the investigation.

Task of preoperative assessment

4.2.6 The Independent Provider’s preoperative assessment policy described that where a patient is referred to one of their independent hospitals following a preoperative assessment within the NHS, it is reasonable to accept the NHS assessment. The investigation was told about the varying quality of NHS assessments, which may have missing information, or limited information that did not meet the requirements of the Independent Provider/Hospital. The independent requirements were described to be more comprehensive than NHS requirements because independent hospitals often had limited access to intensive care support. Where information was limited a preoperative assessment would be repeated by the Independent Hospital.

4.2.7 The investigation reviewed Rodney’s preoperative assessments and noted inconsistencies:

• The NHS recorded his BMI as 17kg/m2 and Malnutrition Universal Screening Tool (MUST) and Waterlow scores were not completed. The Independent Hospital assessment included a Waterlow score, but the MUST score was not completed. It also recorded his BMI as 20kg/m2 to 24.9kg/m2; the investigation calculated his BMI to be 17.9kg/m2 on the day of surgery. The assessments did not identify that Rodney had lost a significant amount of weight prior to his operation or acknowledge his low BMI, both of which would have classed him as being at high risk of malnutrition.
• Rodney was classified as ASA status 1 (in the consultant anaesthetist’s assessment), 2 (in the NHS and Independent Hospital perioperative nurses’ assessment) and 3 (by the consultant anaesthetist on day of surgery). The investigation heard differing opinions about Rodney’s true ASA status from staff involved and not involved with his care. These varied between ASA status 2 and 3, but were higher when the various factors such as weight loss, BMI and previous recovery history were known and considered
• Rodney’s smoking and alcohol history was recorded differently at each assessment.
• It was not clear when Rodney’s blood results were reviewed and whether these informed consideration of suitability or ASA status until the day of surgery. The results showed Rodney to be less fit than previously thought.

4.2.8 The Independent Provider’s policy for level 1 hospitals described that an ASA status 3 requires discussion around suitability with the hospital clinical lead. The investigation was told that generally a “good” ASA status 3 patient would be suitable for the reference event Independent Hospital and that local practice was that it was generally up to the anaesthetist to decide. Rodney was not escalated to the clinical lead for suitability consideration. The investigation also heard other opinions that an ASA status 3 should prompt consideration of level 2 care.

Preoperative preparation and optimisation

4.2.9 At his preoperative assessment Rodney received dietary advice and information about the colorectal enhanced recovery programme from the NHS Hospital. Rodney’s Wife showed the investigation the dietary advice and described that strictly following it had resulted in her husband losing more weight prior to his operation. She felt the advice was focused on preparing overweight patients for surgery, and did not account for her husband’s individual circumstances. This finding was shared with the NHS Hospital which will review the information it gives to patients.

4.2.10 The enhanced recovery programme was part of the NHS Hospital’s processes and the information for patients included fasting prior to surgery, avoiding complications from surgery, and postoperative care. The investigation was told that, while the expectations of the programme could be delivered at the Independent Hospital, it is unlikely there was an established focus for newer types of surgery, such as what Rodney underwent. The investigation did not hear about any enhanced recovery processes at the Independent Hospital from staff, but was subsequently informed that enhanced recovery had been in place prior to COVID-19 and the NHS Hospital supported the Independent Hospital via an enhanced recovery lead nurse.

4.2.11 Both the NHS and Independent Hospital preoperative assessments occurred a short time before Rodney’s planned surgery dates. This potentially limited opportunities to identify and optimise his physical state prior to surgery. Rodney did receive preoperative nutritional drinks and his Wife confirmed that he took these. He was not able to have a full course of drinks because of the rapidity with which his operation was undertaken.

Staff assessment of frailty

4.2.12 The investigation was repeatedly told by staff that Rodney was thin and frail looking. His appearance, in combination with other information such as recent weight loss, nutritional intake, abnormal blood tests and slow recovery from a previous operation, suggested that he was frail. The investigation found no clear practice that reviewed Rodney’s past medical history in depth, or collated all the available information to make a holistic assessment.

4.2.13 Frailty is often associated with ageing (National Institute for Health and Care Excellence, 2015) and the investigation was told by staff that it would not be commonly considered in a patient such as Rodney who was under 65. On the day of surgery

4.2.14 On the morning of his operation Rodney was reviewed by the consultant surgeon and consultant anaesthetist, who noted the various assessments and blood results. The operative approach had been changed from laparoscopic to open and the consultant anaesthetist classified Rodney’s ASA status as higher at 3.

4.2.15 The investigation was told that the final patient review prior to surgery was an opportunity to identify any new risks and make a final decision about whether to proceed. The choice was whether to proceed with Rodney’s surgery knowing now that his case was more complex, or cancelling the surgery. Due to the national and local context at the time, if the surgery was cancelled it was unlikely that Rodney would be able to have his surgery elsewhere, with a risk that his cancer would remain untreated.

4.2.16 The investigation was also told about factors that may influence the decision to go ahead with surgery on the day or not. These included sometimes not wanting to cancel operations once a patient had arrived to minimise distress to the patient and because everything was already prepared. The investigation also noted that the national COVID-19 situation may have influenced the opinions of staff

4.3.1 Rodney’s Wife told the investigation that neither she nor her husband were aware of the change to open surgery until the day of his operation. She felt that he could have “dealt with keyhole surgery, but not open surgery.” The investigation was told of concerns that Rodney had limited opportunity to make an informed choice about his treatment.

4.3.2 The change in operative approach was reviewed by the NHS Hospital and noted that practice may have been impacted by COVID-19. The publication of intercollegiate general surgery guidance at the time led to Rodney undergoing open rather than laparoscopic surgery because of a potential risk of viral transmission when undertaking laparoscopic surgery (Intercollegiate guidance, 2020a). The guidance also recommended stoma formation rather than anastomosis (see 1.4.4) to minimise the risk of complications and need for intensive care which was at risk of being overwhelmed. Rodney received an anastomosis.

4.3.3 The investigation was told that the guidance was seen as a directive and that individual units and surgeons did not have a choice. The consultant surgeon described that their preference was to do a laparoscopy, but that they followed the guidance. It is unclear why Rodney had an anastomosis rather than stoma, but the investigation heard that there was limited clarity on what the right course of action was at the time.

Consent

4.3.4 Rodney was asked to give formal consent on the day of surgery. This was the point at which he became aware of the change from laparoscopic to open surgery. His Wife was not sure why the change had occurred until the intercollegiate guidance (2020a) was shared with her by the investigation.

4.3.5 Rodney was one of the first NHS-funded patients to have cancer surgery at the Independent Hospital under the new agreement. There was a rapid transfer of services following the national agreement being published, resulting in a need to adapt to the changing situation. The investigation recognises that these changes limited the opportunity for Rodney to consider his options. The investigation was told that the alternative to open surgery was no surgery, but it is unclear how much shared decision making took place.

4.3.6 The investigation has not explored the process of consent further. However, the subject of consent for invasive procedures is an often-raised patient safety risk, including in the independent inquiry into surgeon Ian Paterson in 2017 (James, 2020)

4.4.1 Rodney had complications following his operation and was subsequently transferred to the NHS Hospital. The processes for recognising when a patient is deteriorating and their subsequent management were explored by the investigation. No specific issues were identified that were thought to have directly contributed to Rodney’s death. Interviews identified further contextual factors which are described below.

Increasing complexity of patient needs

4.4.2 The investigation was told that the increase in NHS-funded patients at the Independent Hospital had resulted in increased lengths of stay when compared to the NHS for the same cohort of patients. The increase also led to a rise in surgical complications. This was contributed to by patients having other medical conditions, such as cancer, and more complex surgical procedures. Previously the focus of the Independent Hospital had been on well patients having surgery on hips, knees and eyes. The Independent Hospital had previously undertaken some types of bowel surgery.

Independent Hospital preparation for increasing complexity

4.4.3 As described under section 4.1, clinical staff at the Independent Hospital had varying levels of clinical experience. The investigation was told that cancer surgery and its associated complications were new to staff. Early in the COVID-19 pandemic there was limited on-site support from NHS staff. There had also been limited development of staff knowledge and skills to recognise and manage less familiar complications at the Independent Hospital.

4.4.4 The investigation was also told about limitations in available resources at the Independent Hospital, particularly out of hours. These included rapid imaging and reporting, specialist intensive care support or advice, and dietetic and bowel specialist support. Since the reference event several of these limitations have been addressed.

Processes for transfer of patients to the NHS Hospital

4.4.5 The investigation was told about the challenges and barriers associated with transferring a patient to the NHS Hospital from the Independent Hospital. Service agreements were in place for transfer of unwell patients from the Independent Hospital to the NHS Hospital. The decision to transfer a patient was described as a multidisciplinary decision, led by the consultant in charge of the patient’s care.

4.4.6 Staff at the Independent Hospital described limited guidance on when a patient should be transferred. There were various opinions about the criteria for transfer and evidence that staff had generated their own ‘rules of thumb’ for when a transfer was appropriate. The Independent Provider told the investigation that it had considered transfer criteria, but had found it difficult to define these.

4.4.7 The investigation was also told that, at the time of the Rodney’s operation, the Independent Hospital was designated a COVID-free site. Staff described this as a potential influence on decisions to transfer patients to the NHS Hospital, because this would risk infecting the patient. The investigation did not find this a factor in the decision to transfer Rodney.

5.1.1 To explore the implementation of collaborative services between NHS and independent hospitals, the investigation considered the organisation of surgical pathways between them.

5.1.2 The investigation found common challenges relating to the development of pathways between NHS and independent hospitals. Relevant to this investigation were surgical patients who started a pathway in the NHS and were then transferred to an independent hospital. These pathways included outpatient appointments, screening for suitability, preoperative assessment, transfer of patient records, physical transfer of patients, intraoperative and postoperative care.

5.1.3 The following sections describe the investigation’s findings surrounding development of pathways of care between the NHS and independent hospitals. Specific findings relating to preoperative assessment pathways are described in section 6

5.2.1 The investigation saw how independent hospitals worked with NHS hospitals to deliver NHS-funded care. These services evolved over time and particularly in response to COVID-19. This section describes the service changes in relation to COVID-19, with examples (see figure 6).

Before COVID-19

5.2.2 Independent hospitals have had a longstanding role delivering NHS-funded care. The volume of NHS-funded work has varied, ranging from none to 99% of an independent hospital’s work. Where surgical care has been delivered, this has often included specialties such as ophthalmology (eyes) and urology (urinary tract). Other specialties have been available at independent hospitals with intensive care capability, such as heart, lung and spinal surgery.

5.2.3 Before the COVID-19 pandemic, surgery for NHS-funded patients in independent hospitals was directly commissioned by a clinical commissioning group (CCG) or NHS England and NHS Improvement under the NHS Standard Contract, or sub-contracted by an individual NHS trust dependent on local need.

5.2.4 The investigation was told that NHS-funded elective surgery in the independent sector aims for “best value” by balancing the time and skill required for a particular procedure against the cost to the NHS. This has meant a focus on short operations for patients who are normally fit and well, or who have mild health conditions. Risk and complexity has therefore been low, with some exceptions in independent hospitals with intensive care facilities.

5.2.5 The investigation saw the differences in independent hospital infrastructure and capabilities across England. This was exemplified by two independent hospitals within the same provider:

• Hospital 1: multiple inpatient and outpatient specialties and facilities with the ability to take acute admissions, deliver highly specialised care and deliver extensive intensive care support including outreach teams.
• Hospital 2: small hospital with limited specialties, predominantly for day-case surgery and with five overnight rooms for short inpatient stays.

Early stage of the pandemic

5.2.6 In March 2020, as England faced escalating COVID-19 infections, rapid discussions were held between the NHS and independent providers, brokered by the Independent Healthcare Providers Network (IHPN). These resulted in the national agreement for certain independent providers with hospital bed capacity to provide 100% of that capacity to local NHS hospitals (NHS England and NHS Improvement, 2020a).

5.2.7 The investigation was told about the service changes that resulted from the national agreement. These included where NHS hospitals transferred their services to independent hospitals by using the NHS hospital’s Care Quality Commission (CQC) registration to provide services on behalf of the NHS hospital; or where NHS hospitals and independent hospitals agreed to share which hospital took on responsibility for a patient’s care (as in the reference event).

5.2.8 In practice the investigation found several ways in which independent hospitals were used for the NHS. These included:

• transfer of equipment (for example, ventilators) and staff from independent hospital to local NHS and Nightingale hospitals
• conversion of independent hospital sites to COVID-19 sites for medical and/or hospice care for COVID-19 patients
• allocation of independent hospital sites as COVID-19-free sites for various types of medical and surgical inpatient and outpatient care.

5.2.9 In some areas the investigation found ‘hub models.’ These grouped NHS and independent hospitals together with a single surgical pathway. This model allowed streamlining of referrals from multiple sources.

5.2.10 Staff at some independent hospitals described a noticeable increase in patients with complex health problems. The complexity related to patients having co-existing health conditions and more advanced disease, such as cancer, because of the wait for surgery and limited access to services in the NHS. The increased complexity was described to have manifested locally in longer lengths of stay, increased surgical complications, more transfers of patients to NHS hospitals for specialist care, and distress and anxiety for staff.

Later in the pandemic

5.2.11 As 2020 progressed the national agreement moved to focus on delivery of activity rather than capacity. Some independent hospitals were able to recommence private patient work, but with the caveat that the NHS could take back capacity if required. Some independent hospitals completely withdrew from the national agreement.

5.2.12 In practice the investigation saw how services evolved in independent hospitals. Examples included:

• independent hospitals having their equipment and staff returned to allow resumption of elective surgery for both NHS-funded and private patients
• broadening of the types of elective surgery delivered at an independent hospital, in agreement with the NHS, focusing on more urgent cases such as cancer.

5.2.13 The investigation was told about local discussions between independent and NHS hospitals when planning for new surgical services. In some cases these services did not materialise following recognition that some independent hospitals did not have the required resources or capabilities. Examples also included where more complex surgery was implemented, but only following extensive consideration of the risk and its mitigation, for example, with onsite junior (non consultant) doctor and anaesthetic support from the NHS.

At the time of writing and the future

5.2.14 At the time of writing, COVID-19 continues to impact on the healthcare system. Nationally the priority has become restoration of elective and cancer care (NHS England and NHS Improvement, 2021a) with recognition of the need to ‘maximise available physical and workforce capacity across each system (including via the Independent Sector)’.

5.2.15 The IHPN told the investigation that the independent sector had performed over 3.2 million procedures, including over 160,000 cancer and cardiac procedures, during the pandemic. However, under current contracting arrangements, NHS activity within the independent sector was lower than pre-pandemic levels.

5.2.16 The national agreement ceased on 31 March 2021. However, with the ongoing challenges associated with COVID-19 and increasing NHS waiting lists, arrangements were made to secure services from independent sector providers to meet local demand for elective care and to address waiting lists. The Increasing Capacity Framework (NHS England, 2020) provided commissioners and trusts with a route to contract and sub-contract acute elective services to independent sector providers. The investigation was told that not all hospitals had entered the Increasing Capacity Framework, instead choosing to maintain direct relationships with local organisations as they felt it best for patients and maintained effective local NHS and independent hospital relationships.

5.2.17 The investigation was told that NHS and independent hospitals wished to continue their established relationships and the benefits these were bringing. COVID-19 resulted in NHS and independent hospitals having to work together more closely. Several hospitals described the formation of collaborative relationships for the benefit of patients in local communities. This resulted in greater understanding of the independent sector by the NHS, a more integrated system, and the upskilling of staff in some independent hospitals.

5.2.18 The investigation was also told of future challenges and that COVID-19 may have increased the tolerance of risk across healthcare. It was described that the need to rapidly mobilise services meant a reduction in bureaucracy, but also in the level of scrutiny of services; this has been seen by other HSIB investigations, for example ‘COVID-19 transmission in hospitals: management of the risk – a prospective safety investigation’ (Healthcare Safety Investigation Branch, 2020). In the long term the investigation was also told that independent hospitals have been unable to plan. The majority of independent hospitals visited were found to have capacity issues, with local managers describing the need for investment to allow continued support of NHS-funded work.

5.3.1 The investigation explored how the national agreement of March 2020 (NHS England and NHS Improvement, 2020a) was interpreted by several NHS and independent hospital collaborations.

5.3.2 The investigation engaged with the authors of the national agreement and the IHPN. The intent of the agreement was for local areas to decide how best to use their available resources to meet local needs. This acknowledged the differences in resources across the country. The investigation was also told of the expectation that the NHS would remain responsible for delivery of care and provide staff and equipment where needed for independent hospitals; independent hospitals would provide the facilities.

5.3.3 In practice, the investigation did not see the above expectation consistently applied. There was significant variation in how independent hospitals were used and which organisation was primarily responsible for the care of patients (see section 5.2). The investigation was told that, particularly early in the pandemic, there were challenges in agreeing who was responsible for regulated activities. Factors that contributed to this included complexity of the healthcare system, autonomy of local systems, different bodies working at different paces, and the rapidly escalating COVID-19 issue. As a result there was a period of transition before absolute clarity was available.

5.3.4 The investigation was told by hospital leaders of their difficulties when interpreting the national agreement for local application. This resulted in variation in how independent hospitals were used. Some stakeholders told the investigation that they felt some were underused, while others were thought to be inappropriately used. For example, some independent hospitals that were capable of delivering high-volume elective surgery had equipment removed, were redirected to other activities, or closed.

5.3.5 The investigation was told that some NHS hospitals were directed to use independent hospitals as they wished. This led to conflict between those NHS and independent hospitals, particularly where relationships had not already been established. Many independent hospitals had already been providing services and capacity for the NHS prior to COVID-19.

5.3.6 As the pandemic progressed, the national agreements evolved to allow more flexibility. The investigation was told that hospitals would have welcomed the opportunity to see how others had implemented services, but there was limited information on good practice and successes.

5.3.7 The investigation found that in some parts of the country, prior to COVID-19, the NHS and independent sector worked separately from each other. COVID-19 created a healthcare system where the functions of the independent and NHS hospitals became more integrated. The findings of this investigation may help to identify where improvements can be made to support future collaboration.

Integrated care systems

5.3.8 The use of independent hospitals during COVID-19 demonstrated how the capability and capacity of those hospitals could be used as part of an integrated system when responding to future challenges. The investigation was told that this required transparency from independent providers on their hospitals’ capabilities to allow a clear understanding. The transparency of data from the independent sector has been challenged previously (Private Healthcare Information Network, n.d.).

5.3.9 A focus of the NHS Long Term Plan was for all parts England to have an integrated care system (ICS) (NHS, 2019). ICSs are partnerships across a geographical area with the remit to co-ordinate services to improve health in that area and reduce inequality. Legislation for ICSs is currently progressing (UK Parliament, 2021) and NHS England and NHS Improvement has published documents setting out how ICSs should work (NHS England and NHS Improvement, 2021b; 2020c). These describe the intention for local autonomy and that independent providers should be engaged (NHS England and NHS Improvement, 2021b).

5.3.10 The investigation noted concerns about the role of the independent sector in ICSs raised during a national consultation (NHS England and NHS Improvement, 2021c) and which have been repeated since in news articles. The consultation described concerns about private companies sitting on ICS boards and directing decisions for their own benefit.

5.3.11 The investigation engaged with independent and NHS hospital leads about their involvement in local ICS planning discussions. Some ICSs were yet to fully form, but the investigation found that where they had been formed, there had been limited engagement with local independent hospitals and their providers. ICSs may therefore have limited awareness of the capabilities of the independent hospitals in their areas.

5.3.12 The investigation engaged with three ICSs and confirmed the variation in engagement with local independent hospitals. Where there had been engagement, this had often been via a subcontracting NHS hospital rather than directly. The investigation was told that some independent hospitals had not wanted to engage with ICSs/CCGs during COVID-19, with a perception that those hospitals did not want or feel able to provide support.

5.3.13 In August 2021 the IHPN published a research paper considering effective working between the NHS and independent sector to support recovery post COVID-19 (Independent Healthcare Providers Network, 2021b). The IHPN described the need to explore and understand what good partnerships look like, and is seeking to work with ICSs to take this forward. The paper also sets out the IHPN’s reflections on practical steps to help ICSs engage with the independent sector.

5.3.14 The investigation engaged with NHS England and NHS Improvement to discuss how ICSs may ensure they appreciate the capability and capacity of their local independent hospitals. It was agreed that where there is a good understanding this assists in safe and effective management of demand.

5.4.1 The investigation was able to explore the barriers and facilitators to the setting up of pathways between NHS and independent hospitals during COVID-19. Appendix 9.3 provides a summary of the findings that underpinned safe and effective collaboration, barriers and how they were overcome.

5.4.2 Where collaborations were found to be effective, they had often formed between closely located hospitals and where there had been pre-existing, direct relationships. In one case, for example, the NHS and independent hospitals were located across the road from one another and the NHS directly subcontracted services from the independent hospital.

5.4.3 Other facilitators to developing pathways included longstanding relationships, transparency and understanding of independent hospitals’ capabilities by the NHS, shared decision making, regular communication between the hospitals, and collaboration at frontline and management levels.

5.4.4 The investigation found four recurrent challenges during engagement with NHS and independent hospitals. These are described in the following sections. Responsible staff and organisations

5.4.5 The investigation was told by hospital leaders and clinical staff that it was often not clear which hospital (NHS or independent) and which staff were responsible for which parts of a patient’s clinical care along a pathway. Similar to the reference event investigation, some staff were unsure of whose policies/guidance should be followed. Examples included infection control and deteriorating patient policies when patients were treated in an independent hospital but under the responsibility of the NHS.

5.4.6 In those collaborations where relationships had been longstanding, responsibilities were found to be clearer, with defined procedures and a shared understanding between the hospitals. Where relationships had been newly formed during COVID-19, the planning phase was short and the investigation was told of “ad-hoc” identification of responsibilities – for example, consultant anaesthetists staying overnight in an independent hospital following complex surgery because it “seemed the right thing to do”.

5.4.7 The investigation found variation in the availability of clear and detailed documentation defining the responsibilities of NHS and independent hospitals and staff for NHS-funded patients on surgical pathways. This sometimes made it difficult for staff to deliver safe care.

5.5.1 The investigation engaged with the Care Quality Commission (CQC) to explore its framework for inspection of independent healthcare services and the pathways that exist between NHS and independent hospitals (Care Quality Commission, 2018). The CQC will also have a future role in the regulation of ICSs when they become statutory bodies.

5.5.2 The CQC inspects registered providers and locations of care. Inspections therefore focus on a location rather than pathway. Its key lines of enquiry (the questions that form the framework for its inspections) do include components of pathways between NHS and independent hospitals, such as transfer protocols, but do not inspect pathways from end to end. The regulatory system came under scrutiny in the Paterson Inquiry, which identified the need for greater regulator collaboration to serve patient safety as the top priority (James, 2020).

5.5.3 The investigation found potential opportunities for improving safety assurance of existing pathways between NHS and independent hospitals, focusing on surgical pathways for NHS-funded patients.

6.1.1 The investigation found variation in the implementation of pathways for preoperative assessment of NHS patients who were to undergo surgery in an independent hospital. In practice the investigation saw three pathway models:

• The NHS undertakes all preoperative assessments and the independent hospital undertakes the surgery.
• The NHS undertakes a preoperative assessment and the independent hospital repeats a preoperative assessment (as happened in the reference event).
• The independent hospital undertakes all preoperative assessments and then proceeds with the surgery.

6.1.2 The investigation was told that in many locations, the NHS had maintained responsibility for preoperative assessment of its patients. However, at these locations the investigation found that the independent hospitals invariably repeated a preoperative assessment because of:

• their independent requirements for a more in-depth assessment than in the NHS
• limited trust in the accuracy of NHS assessments because they were being undertaken by staff who were not familiar with the capabilities of the independent hospital.

Regarding depth of assessment, independent hospital policies often asked for more assessments to be undertaken. This was heard to be because of the need to ensure appropriate patients were selected for surgery based on a hospital’s capabilities and that the risk of the operation to each individual patient was understood.

6.1.3 The investigation found differences in risk tolerance between the NHS and independent hospital preoperative assessments. The NHS was able to tolerate a wider range of risk, potentially because of the availability of on-site capabilities, such as intensive care, that could be used if there were complications. The independent hospitals’ risk tolerances were more proportionate to the capabilities of their hospitals.

6.1.4 The investigation was also told that COVID-19 had resulted in preoperative assessments often only occurring days before an operation. For example, a preoperative assessment for a patient scheduled for surgery on Monday may take place on the Friday before. This meant that the first time a patient may be seen in person with all their test results may be the morning of surgery. There was therefore limited time for any optimisation (improving) of the patient’s medical state to minimise the risk from undergoing surgery. The investigation heard from those working in perioperative care that the timing of assessments is critical to allow adequate opportunity for any further investigations or interventions.

6.2.1 The requirements for preoperative assessment are supported by NICE guidelines. The guidelines set out recommendations on the tests to be undertaken before different types of surgery and the ASA status of the patient (National Institute for Health and Care Excellence, 2016), and specific assessments such as reducing blood clot risk and nutritional assessment (National Institute for Health and Care Excellence, 2020). In June 2021, an intercollegiate group published new guidance to support the standardised management of patients on surgical waiting lists as they continue to increase, with a focus on preoperative assessment and optimisation (Intercollegiate guidance, 2021).

6.2.2 The investigation was told that preoperative assessment may sometimes be seen as a ‘tick-box exercise’ rather than an attempt to gather information and optimise patients. In practice across the NHS and independent hospitals, the investigation found variation in the way preoperative assessments were conducted. This included the method by which the assessment occurred, the tests undertaken, and the risk assessments completed. All independent hospitals engaged with had preoperative assessment policies, but these varied across providers and also between some hospitals run by the same provider.

6.2.3 The investigation focused on specific aspects of the preoperative assessment process that were identified as safety risks in the reference event investigation; these were also repeatedly raised by the NHS and independent hospital staff who were interviewed.

Individualised risk assessment and optimisation

6.2.4 Preoperative assessment includes assessment of the risk of the anaesthetic and operation, and complications. The investigation observed and was told how individualised risk assessment in the preoperative setting was undertaken across NHS and independent hospitals. In relation to the reference event, of particular interest was assessment of fitness for surgery and nutrition screening.

Assessing fitness for surgery

6.2.5 The use of ASA is recommended by NICE as a ‘simple scale describing fitness to undergo an anaesthetic’ (National Institute for Health and Care Excellence, 2016). In practice the investigation found ASA was widely used and noted that its validity and association with outcomes had been previously demonstrated (Mayhew et al, 2019). However, the investigation also found that ASA was highly subjective and variably applied. This was demonstrated in the reference event where Rodney was variously classified between ASA status 1 and 3.

6.2.6 Nurses and surgeons told the investigation that ASA was important for anaesthetists to assess risk and to help decide whether a patient was fit for an anaesthetic. In the independent hospitals, ASA was also part of the considerations as to whether a patient was suitable for that hospital. Nurses described caution when classifying ASA status, and often gave patients higher scores compared to those given by anaesthetists. ASA status 1 and 4 patients were described as easy to define, but ASA status 2 and 3 were felt to be ambiguous. The investigation was told that ASA status 2 and 3 are important because this is the threshold for decisions about what preoperative tests should be undertaken (National Institute for Health and Care Excellence, 2016), when a multidisciplinary team discussion about a patient’s suitability for surgery is undertaken, and when suitability for surgery in a particular independent hospital may be questioned.

6.2.7 The investigation reviewed the independent providers’ preoperative assessment policies. In hospitals without intensive care facilities, surgery was found to be reserved for ASA status 1 and 2 patients, and these patients did not require a multidisciplinary decision as to whether surgery was appropriate at the particular hospital. The investigation was told that those hospitals may also operate on ASA status 3 patients, but only following a multidisciplinary team discussion.

6.2.8 The investigation found that the subjectivity of ASA made it difficult to score, and meant a patient deemed suitable for surgery by one assessor (scored as an ASA status 1 or 2), may be escalated by another. In the reference event, only on the day of his surgery was it determined that Rodney had an ASA status of 3; this may have been influenced by availability of other test results.

6.2.9 The investigation was told by clinicians across the NHS and independent hospitals that ASA alone should not be used to make decisions about the suitability of patients for surgery; this is reflected in the research literature (Mayhew et al, 2019). However, in practice the investigation found that this was not always the case. This was demonstrated in the reference event where Rodney’s case was not escalated for discussion because he was classified as ASA status 2, despite other factors that would have warranted discussion according to the Provider’s policy.

6.2.10 The intercollegiate preoperative guidance (Intercollegiate guidance, 2021) describes the importance of individualised risk assessments for all patients undergoing surgical intervention. A risk model with an estimate of how likely a patient is to survive surgery rather than a simple score is recommended. The guidance suggests using the Surgical Outcome Risk Tool (SORT) (Protopapa et al, 2014) to provide a predicted risk of the patient dying within 30 days which can be used to make decisions about suitability for surgery and intensive care. Reviewing the facts known about the reference event in light of SORT and the intercollegiate guidance, Rodney’s predicted risk of death may have informed different decisions about his care.

6.2.11 The intercollegiate guidance (2021) offers an opportunity for organisations to review their processes to improve individualised risk assessment. The guidance also offers wider benefit through enhancing assessment of preoperative risk and implementation of early patient optimisation. The investigation noted that the intercollegiate guidance does not make reference to the independent sector, but the authors told the investigation that it can be applied across all healthcare sectors.

Functional assessment

6.2.12 Aligned with the assessment of fitness for surgery is the use of functional assessment. This refers to assessment of a patient’s ability to undertake daily activities which provides insights into their physical fitness. Reduced physical fitness is associated with an increased risk of postoperative complications, longer recovery times and poorer health outcomes (Centre for Perioperative Care, 2020a).

6.2.13 In the reference event Rodney was asked to climb stairs to give an indication of his functional capacity; it was noted that he was breathless after one flight. Research suggests that simple measures such as climbing stairs are limited in their ability to effectively assess functional capacity (Wijeysundera, 2019).

6.2.14 The intercollegiate guidance (2021) recommends that all patients being considered for surgical intervention are screened for functional capacity using a validated tool. The guidance suggests various tools, such as the Duke Activity Status Index (DASI). Where patients have reduced ability to undertake activities, formal assessment is needed and cardiopulmonary exercise testing (CPET) is recommended. The investigation found no other documented assessment of Rodney’s physical fitness.

6.2.15 The investigation was told about CPET as a test to indicate a patient’s capacity for exercise and helps estimate the risk to the patient of anaesthesia and surgery. CPET is seen as a “gold standard” by clinicians and national guidance (Intercollegiate guidance, 2021). The investigation found that CPET is not equally available across the NHS leading to variation in the quality of functional assessment. In some organisations where CPET is available, the investigation was told that all patients undergoing colorectal resection (removal of part of the bowel) would undergo a CPET.

Preoperative nutrition screening

6.2.16 The investigation found the Malnutrition Universal Screening Tool (MUST) score to be commonly used in NHS and independent hospitals to undertake preoperative nutrition screening. MUST is one example of a nutrition screening tool and NICE recommends that it is undertaken for all patients who are due to have intermediate, or major or complex surgery (National Institute for Health and Care Excellence, 2017).

6.2.17 The investigation explored the recognition of the importance of nutrition screening and the use of MUST. Medical staff told the investigation that MUST is something that they rarely used and is “more of a nursing tool”. Nursing staff told the investigation that they would always complete a MUST score, but that the opportunity to refer a patient to a dietician for intervention was sometimes limited. In the reference event Rodney did not have a MUST score before his operation. Since the reference event the Independent Provider has been undertaking a programme to support completion of MUST.

6.2.18 The investigation also found that nutrition screening was often undertaken only a few days before a patient’s surgery, on the day of surgery, or immediately following surgery. The COVID-19 situation was found to have some influence on this, with shorter times between assessment and surgery, and a move to remote assessment. However, the investigation was also told that at some independent hospitals screening on the day of surgery or post surgery was usual practice. The timing of nutrition screening limited the opportunity for improvements in nutrition prior to an operation.

6.2.19 Undernutrition before an operation is detrimental to patient outcomes and a review by the European Society for Clinical Nutrition and Metabolism led to its recommendation that ‘Patients with severe nutritional risk shall receive nutritional therapy prior to major surgery … even if operations including those for cancer have to be delayed. A period of 7-14 days may be appropriate’ (Weimann et al, 2017). In the reference event, even though there was no formal MUST, Rodney was given fortified drinks by the NHS prior to surgery, but only 2 days before his first planned NHS surgery date.

6.2.20 Recent research has highlighted challenges with the current provision of nutritional screening and intervention in the UK (Matthews et al, 2021). This described that around 50% of patients identified as being at nutritional risk were referred to a dietician, with around 23% of hospitals having structured pathways for managing malnourished patients. It also described that staff lacked confidence dealing with malnutrition perioperatively, there was a lack of organisational support, and patients were seen too close to surgery for optimisation. The investigation identified similar issues.

6.2.21 The intercollegiate preoperative guidance (Intercollegiate guidance, 2021) includes a focus on nutritional assessment and optimisation. Preoperative malnutrition is described as a significant risk factor for postoperative harm. Optimisation of preoperative nutritional issues has been shown to improve patient outcomes (Intercollegiate guidance, 2021). The guidance again recommends that all patients should be screened early for risk of malnutrition, and that patients found to be at risk have further assessments.

6.2.22 The investigation found that practice around nutrition screening and optimisation does not align with best practice. Of specific note was the timing of nutrition screening in some independent hospitals, which precluded preoperative optimisation of patients’ nutrition.

Telephone and video preoperative assessment

6.2.23 During the pandemic the use of remote preoperative assessment became commonplace for the majority of surgery patients. The investigation found remote assessment often took place by telephone, with face-to-face contact via video. The investigation was told about the risks of telephone assessment because it reduced opportunities for visual assessment of the patient. As a result certain risk assessments which required in-person measurements, such as a patient’s height and weight, could not be completed.

6.2.24 The investigation found examples of patients who had a telephone preoperative assessment and were then found to be unsuitable for surgery on the day of their operation. The investigation was told that this had resulted in difficult decisions about whether to cancel the surgery or continue despite the risk. Staff at several NHS and independent hospitals described that it can be difficult to cancel a patient’s surgery on the day.

6.2.25 The investigation observed several preoperative assessments being undertaken, face to face and by telephone. Use of the telephone was found to remove visual cues, create communication difficulties, and led to limited information from families. It was also found that, while some hospitals had the ability to undertake preoperative assessments by video, staff were reluctant to do so because of individual preference and difficulties with the technology.

6.2.26 The investigation was also told about the benefits of remote (telephone or video) preoperative assessment. These included efficiency, reduced appointment cancellations, infection prevention, and patient satisfaction. Those working in preoperative assessment told the investigation that video assessment did have a role for suitable patients.

Improving preoperative assessment

6.2.27 The investigation described the above findings to the Centre for Perioperative Care and NHS England and NHS Improvement’s National Clinical Director for Perioperative Care. The safety risks identified were acknowledged and it was found that many of the risks could be mitigated through implementation of recent intercollegiate guidance for ‘Preoperative Assessment and Optimisation for Adult Surgery’ (Intercollegiate guidance, 2021).

6.2.28 With respect to remote preoperative assessment, the investigation was told that these should be conducted via video to allow the staff member to see the patient. If video is unavailable, the assessment should be face to face. This echoes the intercollegiate guidance which acknowledges the future role for remote preoperative assessment, but that it must be used for locally defined groups of patients where the risks and benefits have been considered (Intercollegiate guidance, 2021).

6.3.1 During its exploration of preoperative assessment processes, the investigation identified several examples of perioperative care programmes across the country. The programme leads were approached for information. The investigation was told of the need for a holistic approach to preparing and managing patients before, during and after surgery. This is done by connecting the preoperative assessment and optimisation with intraoperative and postoperative care. An example of a perioperative programme is presented below.

Defining and identifying frailty

6.4.1 The investigation found that preoperative assessment for frailty was not routinely undertaken in the NHS and independent hospitals. Where it was undertaken, the investigation was told that in the reference event it may not have identified Rodney as frail.

6.4.2 Frailty is a recognised priority for the NHS, particularly in people aged over 65 (NHS, 2019; NHS Specialised Clinical Frailty Network, n.d.). In the surgical population, assessing for and managing frailty in over 65s is important to improve postoperative outcomes (Fagard et al, 2016). Patients over 65 with cancer are often frail, or have a high risk of frailty (Handforth et al, 2015).

6.4.3 The investigation was told about several frailty assessment tools used across healthcare (Faller et al, 2019). Where a frailty assessment was found to be undertaken before surgery, this was invariably in patients over 65 using the Clinical Frailty Scale (CFS), as recommended (Intercollegiate guidance, 2021).

6.4.4 The CFS was validated for those aged over 65 and considers a patient’s medical conditions, their activities of daily living and physical activities to make a judgement on their level of frailty (NHS Specialised Clinical Frailty Network, n.d.). The scale includes eight categories from very fit to very severely frail, and a further category for those terminally ill who are not otherwise evidently frail.

6.4.5 The investigation engaged with policy and research leads to explore frailty in people who are aged under 65 and in the preoperative setting. The investigation was told that there had been little research into the concept of frailty in those under 65, in or outside of the preoperative setting. How frailty is defined and its impact on patients under 65 is unknown (Spiers et al, 2021). For this reason, with regard to the reference event, it is not known whether Rodney was truly frail.

6.4.6 Shortly before the publication of this report, the Centre for Perioperative Care published a guideline with the British Geriatrics Society for perioperative care for people living with frailty undergoing elective and emergency surgery (Centre for Perioperative Care and British Geriatric Society, 2021).

Future research

6.4.7 The investigation found gaps in research and evidence around the definition, identification and management of frailty in patients under the age of 65. During COVID-19 there have been attempts to explore these gaps, but more evidence was found to be needed (National Institute for Health Research, 2020c).

6.4.8 Following a rapid review of the measurement of frailty in younger people (Spiers et al, 2021), the National Institute for Health Research put out a call for further research into the condition (National Institute for Health Research, 2021b). The investigation was told that findings from that research will potentially inform national policy around frailty in younger people and provide an evidence base for future work. This may include preoperative management of frailty in younger patients.

NHS-funded surgery in independent hospitals

• The COVID-19 pandemic placed unprecedented demand on NHS and independent healthcare provision.
• The capability and capacity of independent hospitals for the provision of surgical care was seen to vary across the country.
• National and local NHS organisations had limited understanding of independent hospitals’ capabilities. This resulted in variation in how independent hospitals were used during COVID-19.
• With a move to integrated care systems (partnerships that co-ordinate healthcare services in a particular geographical area) there have been limited efforts to understand the capabilities of independent hospitals. This may undermine future relationships and understanding of how best to use resources at times of high demand.
• Some independent hospitals saw patients with increasingly complex conditions and undertook more complex operations during COVID-19. The increasing complexity was well managed where capability of the independent hospitals had been evaluated and addressed prior to implementation of new services.
• Where pathways between NHS and independent hospitals were effective, it was often found that relationships between the hospitals had been longstanding and direct.
• Other factors that created risks in NHS-funded surgical pathways between NHS and independent hospitals included: unclear roles and responsibilities; limited integration of information and communication systems; and variation in what surgery was deemed suitable for an independent hospital.

Preoperative assessment and optimisation

• There was variation in how preoperative assessments were undertaken across NHS and independent hospitals. This included what tests were ordered and risk assessments undertaken.
• The American Society of Anesthesiologists status classification system alone was used in some independent hospitals to decide on patients’ suitability for surgery and whether to escalate a patient’s case for discussion by a multidisciplinary team.
• Preoperative nutrition screening was inconsistent across NHS and independent hospitals. Examples were identified where it was not undertaken, or undertaken too late to allow any preoperative optimisation – that is, to make sure the patient was in the best possible nutritional state before their operation.
• Remote preoperative assessment became the norm during COVID-19, but created risks when staff were not able to see the patient. Lack of video call facilities and staff preference meant assessments were commonly done by telephone.
• There is no agreed clinical definition of frailty in patients under the age of 65, and no validated tools to assess people under 65 for frailty, either before surgery or in other fields of care.
• There is no consensus on the most impactful and best value model for care before, during and after surgery (perioperative care), with variation in care provision across the country.

Safety observation O/2021/130:

In support of safety recommendation R/2021/155 it may be beneficial if independent providers of acute hospital services provided transparent and up-to-date information about the capability and capacity of their hospitals to integrated care systems to inform local decisions about healthcare provision.

Safety observation O/2021/131:

It may be beneficial if collaborating NHS and independent hospitals had clearly defined, accessible and usable procedures clarifying the roles, responsibilities and accountabilities of both hospitals when delivering NHS-funded surgical care in an independent hospital. These should be transparent to staff delivering and patients receiving care.

Safety observation O/2021/132:

It may be beneficial if NHS and independent sector organisations delivering NHS-funded surgical interventions reviewed their procedures and practice in light of the published 2021 guidance for ‘Preoperative Assessment and Optimisation for Adult Surgery’. Such a review should take into account:

• Individualised risk assessment using objective measures to support decisions about patient suitability for surgery and escalation for multidisciplinary review.
• Early nutritional screening to identify at-risk patients for expert assessment and optimisation.
• Risks and benefits of virtual preoperative assessment with defined local criteria for its suitability.

SEIPS is a systems engineering approach with human factors principles embedded within it (figure 7). SEIPS describes how components of the work system produce work processes which result in different outcomes. Work system factors are described below (Holden et al, 2013; Carayon et al, 2006):

• person(s): the people working in the particular system and the patient
• tasks: undertaken by the persons which may vary in complexity or variety
• tools and technology: used to undertake the tasks which may vary in usability and functionality
• internal environment: the physical space around the persons, for example layout, noise and temperature
• organisation: conditions external to the persons to support the organisation of, for example, resources and activity
• external environment: factors outside of the healthcare institution that might include policy, societal or economic factors.

Processes can be physical, cognitive, or behavioural and lead to outcomes for the patients, professionals or healthcare institutions. The interactions between the various components of the work system lead to different outcomes, both positive and negative. The framework includes feedback loops which represent the adjustments systems make over time.

Figure 8 provides an example of the investigation‘s analysis using SEIPS. In this example the work system factors contributing to local planning of the resources for increased surgical risk are considered. The associated outcome was that all resources and requirements were potentially not in place at the Independent Hospital at the time of Rodney‘s surgery.