Unplanned delayed removal of ureteric stents

Introduction

The objective of this investigation was to explore the care of patients who have ureteric stents inserted following a diagnosis of a kidney or ureteric stone. A ureteric stent is a narrow tube that is inserted into the ureter (the tube that connects the kidney to the bladder) to help with urine drainage.

As an example, which is referred to as ‘the reference event’, the investigation reviewed the care of Linda, who suffered an episode of kidney stones which was treated successfully but required the insertion of a ureteric stent. The stent was left in situ (in position) for a longer period than intended and became encrusted – that is, minerals filtered from the bloodstream attached to and built up on the stent. This led to Linda needing a more extensive operation to remove the stent.

The findings and conclusions aim to prevent the future occurrence of unplanned delayed removal of stents and improve care for patients across the NHS.

The reference event

Linda, who was 77 and had a complex health history, went to her local district general hospital’s emergency department with severe pain in her flank. She was diagnosed with kidney stones. Once her immediate pain was brought under control, was referred to the urology team, which specialises in the treatment of conditions of the kidneys, bladder and urinary tract. She was referred for treatment in line with the National Institute for Health and Care Excellence guidance, commencing with extracorporeal shockwave lithotripsy (treatment which uses sound waves to break up kidney stones). This treatment proved unsuccessful and Linda was admitted to hospital for a procedure known as a ureteroscopic removal of stones (URS). This is a process by which the stones are broken up using a laser or a surgical tool. The ureteroscope is passed up the ureter via the urethra and bladder to allow the surgeon to see the stone. For some patients, including Linda, the insertion of a ureteric stent may be required if it is likely that stone fragments will need to be passed in the patient’s urine, or if the ureter becomes swollen as a result of the insertion of the ureteroscope.

Linda’s stent was inserted successfully and was left in situ pending a review planned for 12 weeks after the URS. At the review appointment, rather than planning to remove the stent, a further 12-week review period was agreed between the registrar and Linda. Following this, Linda began to suffer recurrent urinary tract infections and was treated by her GP.

Some months later, it was found that Linda’s stent had become encrusted. Her urological care was transferred to a larger hospital which had a specialist stone care service and her stent was eventually removed 20 months after insertion.

The national investigation

A senior urologist at a large teaching hospital trust referred Linda’s case to the Healthcare Safety Investigation Branch (HSIB) as a matter for potential investigation. Following initial information gathering and evaluation against the HSIB patient safety risk criteria, HSIB’s Chief Investigator authorised a national safety investigation.

The national investigation focused on: the logging and tracking of ureteric stents; patient communication strategies (both verbal and written) to ensure that patients are informed about their stent, expected side effects, and the importance of having it removed by an agreed date; and communication with GPs to ensure they are informed about stents and the potential for patients to present with signs of a urinary tract infection that could be caused by a stent.

Findings

• There is currently no national stent register being used across the NHS.
• Hospitals deploy a range of systems to track and log stent insertion. Some trusts also have systems to reconcile stent removal (that is, to log the removal of each patient’s stent against the record of its insertion).
• Paper-based stent logging/tracking appears to be effective in the absence of electronic systems.
• The combination of human oversight and effective stent logging/tracking systems may be beneficial in preventing delayed removal of stents. Systems should not rely solely on human oversight.
• Other medical specialties which use ureteric stents may not use the same stent logging/tracking systems as the urology team.
• Patients being discharged with stents in situ need clear and consistent communication, both verbally and in writing.
• Involving patients in their care has been shown to improve the quality and experience of care.
• The written advice available for patients with ureteric stents is inconsistent across the country.
• Poor communication may lead to loss of opportunity for patients to self-care and be aware of potential complications with their stents.
• Clear information given to patients with tethered stents (stents that can be removed by the patient) ensures compliance with their planned removal schedule.
• GPs and other clinical staff working in primary and urgent care services may not be aware of the side effects and complications associated with ureteric stents.
• Hospital discharge letters and other communications do not carry standardised information for healthcare professionals about ureteric stents.
• The Summary Care Record system (which makes an electronically collated version of patients’ healthcare records accessible to a range of clinical services) does not currently have a ‘flag’ or other method of identifying patients with ureteric stents.

HSIB makes the following safety recommendations

Note: HSIB developed these safety recommendations in collaboration with the Royal College of Surgeons of England and the British Association of Urological Surgeons (BAUS). It was agreed between all parties that BAUS would formally receive the recommendations.

HSIB makes the following safety observations

1.1 Anatomy and function of the kidneys, ureters and bladder

1.1.1 The main purpose of the kidneys, ureters and bladder, along with the urethra and external anatomy, is to remove waste products and excess water from the bloodstream. This function is essential to prevent toxins building up in the bloodstream and maintains the balance of nutrients required to achieve homeostasis (stable physiological state).

1.1.2 The kidneys are positioned high up at the back of the abdomen (figure 1). Their function is to filter waste products and remove excess fluid, as well as to balance other elements in the bloodstream.

Fig 1 Anatomical position of kidneys, ureters and bladder

1.1.3 The ureters are long tubes which connect the kidneys to the bladder. The waste and other elements filtered from the bloodstream form urine in the kidneys, which drains into the ureters. The ureters store the urine until a quantity has accumulated which creates the urge to urinate.

1.1.4 The bladder is a muscular sac which is located within the pelvic region. The bladder can hold a large amount of fluid (urine) and distends (swells) as it fills. The presence of urine and the distention of the bladder stimulates receptors which tells the brain that the bladder needs to be emptied. Emptying of the bladder is achieved through contraction of the muscles which pushes the urine down through the urethra and out of the body. The length of the urethra is different for men and women.

1.2 Ureteric stents

1.2.1 Stents are medical devices inserted into anatomical structures in the body, such as blood vessels or ducts (tubes which move fluids within or between organs or other structures) to help keep them open and improve or maintain flow. Stents are needed when the vessel or duct is partially or fully blocked, for example by kidney stones. The type of stent used depends on the body system and vessel/duct affected.

1.2.2 A common example of stent insertion is where a blood vessel in the heart is partially blocked, causing angina (chest pain), and a metal stent is inserted to keep the blood vessel open. These kinds of stents are designed to be left in position (in situ) for the rest of the patient’s life. Other kinds of stents, such as ureteric stents (figure 2), are made of various materials including polyurethane and are more commonly left in situ for short periods of time as they may become encrusted (see 1.2.7), become blocked, or otherwise degrade.

Fig 2 Example of ureteric stent

Image courtesy of © 2020 Boston Scientific Corporation or its affiliates.

1.2.3 The following is an extract from the British Association of Urological Surgeons patient advice leaflet which describes what ureteric stents are, their purpose, and how patients should manage their own care while stents are in situ.

‘A ureteric stent is a small, hollow tube which is put inside your ureter (the tube that drains urine from your kidney to your bladder). It is curled at both ends to keep the upper end fixed inside the kidney, and the lower end in place inside your bladder. Stents are put in for several reasons; the commonest are:

• blockage of the ureter – the tube draining urine from the kidney to the bladder can be blocked by stones, stone fragments, scarring, external compression or other factors
• before lithotripsy – to create some space around a stone so that it will respond better to shockwave treatment
• to allow the ureter to heal – either after injury to the ureter, major abdominal (tummy) surgery on the bladder or ureter, or after endoscopic surgery within the ureter itself

Stents are designed to allow people to lead as normal a life as possible. However, they do have side-effects so there is a balance between the risk of these and the advantages of relieving blockage.

Fortunately, most of the sideeffects are minor and can be tolerated without too much difficulty. In some people, they can be more severe. Most patients with a ureteric stent will be aware of its presence for a lot of the time.’ (British Association of Urological Surgeons, 2017)

1.2.4 Ureteric stents are inserted via the urethra and bladder using an instrument called a cystoscope, which helps the doctor see the opening of the ureters. A guidewire is inserted into the ureter and the stent is then introduced over the guidewire and advanced up into the kidney. The guidewire is withdrawn leaving the stent in place. The curled sections at either end of the stent keep the device in position. Ureteric stents can also be inserted through a surgical incision (percutaneously) via the kidney (antegrade [1]) by interventional radiologists (specialist doctors), especially in cases where retrograde [2] insertion via the bladder has been unsuccessful or is likely to be challenging.

1.2.5 Ureteric stents may be used as part of the treatment of renal calculi, commonly known as kidney stones (see 1.3). In this context, ureteric stents are not intended to be left in situ indefinitely and must always be removed (or replaced regularly, depending on the condition being treated). The timescale for removal will vary depending on the patient’s circumstances. For example, following an uncomplicated ureteroscopic removal of stones (see 1.3.6) (Tsiotras et al., 2018) the ureter may become inflamed for a few days and a stent is inserted to ensure that the swelling does not impede the flow of urine. Some patients may experience more serious trauma to their ureter, requiring a stent for several weeks while the tissue heals.

1.2.6 Ureteric stents may have tethers which enable the patient to remove their own stent, rather than having to go back into hospital for removal by a urologist. Tethered stents usually stay in for less than a week. Nontethered stents are used where the stent needs to stay in for a longer period.

1.2.7 In patients who suffer from kidney stones, the main complication of ureteric stents is encrustation (although encrustation can occur in patients without a history of stones). This is where the stone material (which varies in its mineral composition) becomes attached to the stent, which can lead to the stent becoming blocked. Encrusted stents may need to be removed using more invasive surgical procedures.

1.3 Kidney/ureteric stones

1.3.1 Kidney stones are made up of chemicals which build up in the body and are filtered by the kidney, where they can accumulate and form a stone or stones. Stones can vary in size and may remain in the kidney or move into the ureter.

1.3.2 Where a stone causes a blockage in the ureter and/or kidney, this can cause very severe pain. This pain is known as renal colic.

1.3.3 Men are more prone to experiencing kidney stones. Dehydration, dietary habits and certain medicines are also known to increase the likelihood of the formation of stones in some patients.

1.3.4 Most stones are formed from calcium or uric acid, or from material that accumulates following a urine infection (known as struvite). Stones can vary in size, ranging from a few millimetres to 1 or 2 centimetres or greater. Smaller stones may pass naturally (that is, leave the body during urination). In the case of larger ones, medical procedures may be required to remove or break them up.

1.3.5 Patients with certain health conditions, such as Crohn’s disease, are at increased risk of forming kidney stones.

1.3.6 Kidney stones that do not pass spontaneously and are causing pain or blockages can be treated in four main ways:

• Conservatively – managing pain and using medicines to help expel the stone.
• Extracorporeal shockwave lithotripsy – this involves directing shockwaves at the location of the stone in order to break it into fragments which can be passed naturally. It is undertaken in a hospital outpatient setting.
• Ureteroscopic removal of stone (URS) – a ureteroscope (device to look inside the ureters) is inserted via the urethra and bladder. The stone can then be broken up using an instrument or a laser. Commonly, a stent is inserted as part of this procedure.
• Percutaneous nephrolithotomy (PCNL) – this is an invasive procedure which is done under general anaesthetic. A small ‘keyhole’ incision is made into the patient’s side by their affected kidney, and the stone is removed surgically from the kidney. A tube (nephrostomy) may be left in place through the incision to help the kidney drain, or a stent may be placed.

Fig 3 Example of a single-use disposable ureteroscope

Image courtesy of © 2020 Boston Scientific Corporation or its affiliates.

1.4 Urinary tract infection

1.4.1 Urinary tract infections (UTIs) are very common. They are usually mild in nature and go away on their own, although some patients may require antibiotics to treat the infection (National Institute for Health and Care Excellence, 2018).

1.4.2 The urinary tract includes the urethra, bladder, ureters and kidneys. UTIs most commonly affect the lower part of the urinary tract (bladder and urethra). Where the kidneys are affected, this is known as pyelonephritis and may lead to more serious signs and symptoms and require stronger antibiotics.

1.4.3 Women are more at risk of developing a UTI. There are several reasons for this, the main one being the anatomical differences between men and women and the shorter length of the female urethra, which means bacteria can travel to the bladder more easily.

1.4.4 The signs and symptoms of a UTI may include:

• an increased urge to urinate
• a burning sensation when urinating
• passing frequent, small amounts of urine
• cloudy urine
• urine with a strong or unpleasant smell.

1.4.5 UTIs can be caused by different types of bacteria, and the appropriate type of antibiotic is needed to treat the individual infection. The healthcare professional treating the UTI may treat it empirically (that is, on the basis of a patient’s signs and symptoms rather than scientific tests) using antibiotics which are known to be sensitive to the most common bacteria. If the infection persists, a urine sample may be taken and tested in a hospital laboratory to identify the type of bacteria causing the UTI. This then allows an antibiotic to be prescribed that targets the particular bacteria type.

1.4.6 Patients with indwelling devices (devices that sit inside the body) such as urinary catheters and ureteric stents may experience similar symptoms to those of a UTI due to the presence of the foreign material irritating the bladder. These patients may also be more likely to develop a UTI, due to aggregation of bacteria on the device within the urinary tract. The considerable overlap in symptoms makes it difficult to diagnose the cause of symptoms in patients with an indwelling urinary tract device, and often the patient will be diagnosed as having a UTI without the device being considered as the possible cause of symptoms.

Linda is 77 years old and has a long and complex health history which includes Crohn’s disease, gallstones, osteoporosis, arthritis, an episode of skin cancer, and a hiatus hernia. She also has a visual impairment, which has worsened over recent years.

2.1 In April 2017, Linda experienced a sudden onset of flank pain (pain in the side of her upper abdomen) which was so severe she could not come down the stairs to alert her partner. She banged on the floor of the bedroom to summon her partner and when he came to her aid, she asked him to take her to hospital. They opted to use their own car to get to hospital, rather than calling 999 for an ambulance.

2.2 On arrival at their local hospital, Linda was seen by a doctor who suspected that Linda was suffering with kidney stones. Her immediate pain was managed, and she underwent diagnostic examinations, including blood tests and X-rays, to confirm the suspected diagnosis.

2.3 Within a few hours of arriving at the emergency department, a diagnosis of kidney stones was made clinically. This was subsequently confirmed with the presence of stones being visible on X-rays. Linda’s clinical condition and pain had improved following the administration of painkillers and she was discharged from the emergency department. She was referred to the urology team at the same hospital and subsequently received a letter inviting her to the urology outpatient clinic.

2.4 On 3 August 2017, Linda was seen in the urology clinic at the local hospital. She underwent further assessment by a urologist and a plan of care was developed. It was agreed to commence extracorporeal shockwave lithotripsy (ESWL) (see 1.3.6). The urologist completed a ’TCI form’ (TCI means ‘to come in [to hospital]’) in order to begin the process for Linda to be invited for treatment in due course.

2.5 Two days prior to the appointment on 3 August 2017, Linda spontaneously passed two kidney stones (that is, the stones came out when she urinated). Linda collected the stones and took them with her to the clinic appointment where they were identified as most likely being kidney stones.

2.6 A letter to Linda’s GP from the urology department dated 13 September 2017, following her attendance in the outpatient clinic, confirmed that Linda had passed two stones from her left ureter. The letter also stated that she had been referred for a CT scan [3] and to undergo ESWL. The letter confirmed that Linda still had a large stone in her right ureter.

2.7 On 16 September 2017, Linda attended the local hospital to undergo her first ESWL treatment. Prior to an ESWL, the clinician leading the treatment undertakes imaging to locate the stones and direct the shockwaves accurately. In Linda’s case, the clinician could not see the stones and the ESWL did not go ahead. A plan was documented which included sending Linda for a ‘CTKUB’ (a CT scan of the kidneys ureters and bladder) and to attend a follow-up outpatient appointment in four weeks’ time.

2.8 On 23 September 2017, Linda received a letter from the hospital inviting her to attend the urology outpatient clinic on 17 October 2017. The plan documented in her notes was to repeat the CTKUB and review again in four weeks’ time. Appointments were arranged for the outpatient attendance and CTKUB.

2.9 Following this attendance, Linda received a further letter asking her to attend the urology outpatient clinic on 14 November 2017. At this appointment she was seen by a different consultant urologist than at previous appointments. It was decided that Linda should be admitted, and she was asked to come back to the hospital’s emergency department the next day.

2.10 On 15 November 2017 Linda attended the emergency department as requested and was admitted to hospital at 12:25 hours by the urology team.

2.11 The following day, Linda underwent a procedure called ureteroscopic removal of stone (URS) (see 1.3.6). Following the removal of the stone from her right ureter, a ‘double J’ ureteric stent was inserted.

2.12 Linda was kept in hospital overnight following her URS and was discharged home on 17 November 2017 with her ureteric stent in situ in her right ureter. Linda was told that she would need a renogram (a specialised imaging procedure which assesses the function of the kidneys) and that an appointment would be made for her.

2.13 Linda was asked to attend the nuclear medicine department at the local hospital on 29 November 2017 to undergo a renogram with diuretic (medicine that increase urine production).

2.14 Scans such as ultrasound scans and CT scans mainly show the structure of the urinary tract and whether there are anatomical abnormalities and/or obstructions. The advantage of a nuclear medicine scan, sometimes called a MAG3 renogram in reference to the nuclear material used, is that it can show how well the kidneys are working (processing urine) as well as providing structural information.

2.15 Just over a week later, the hospital wrote to Linda’s GP to inform them of the findings of the renogram. The results revealed that her renal function on the right side was 30%. Normally each kidney would be expected to contribute approximately 50% to the overall kidney function, so a contribution of 30% from the right side, and therefore 70% from the left, indicated that the right kidney was not working as well as it should have been.

2.16 Linda attended a further outpatient clinic appointment on 6 December 2017, where the results of the renogram were discussed with her. It was not until 28 December 2017 that the hospital wrote to Linda’s GP to confirm that Linda had ‘stone fragmentation’ in her right kidney. A ureteric stent had been inserted, and it was documented that the plan was for the stent to stay in for now, pending a further renogram in three months’ time.

2.17 During the same time period, Linda went to her GP (on 18 December 2017) complaining of having noticed blood in her urine for the last seven days. The GP sent Linda to her local emergency department where she was assessed and discharged on the same day. It was documented that she would be followed up at her next scheduled urology outpatient clinic appointment (planned for March, as documented at her clinic appointment on 6 December 2017).

2.18 On 15 February 2018, Linda received a letter inviting her to attend the nuclear medicine department on 12 March 2018, as agreed at the previous appointment in December 2017.

2.19 Between January and November 2018, Linda experienced recurrent dysuria (pain on passing urine). Each time this occurred she contacted her GP. The following episodes were recorded in the summary of care in her GP notes:

• Attended GP practice on 18 January 2018 with urinary symptoms and diagnosed with a UTI. She was prescribed nitrofurantoin, an oral (by mouth) antibiotic used as first-line treatment for a UTI (British National Formulary, 2020a).
• On 5 February 2018, Linda’s partner dropped off a urine sample due to their concern regarding a possible further UTI. The GP tested the urine using a urinalysis dipstick [4]. The test supported a clinical diagnosis of a UTI, and so a further course of antibiotics was prescribed.
• Linda attended her GP practice on 20 July 2018 describing dysuria but stated that she was ‘otherwise systemically well’. A further course of antibiotics was prescribed.
• Ten days later, on 30 July 2018, Linda attended her GP practice with further urinary symptoms. Her GP suspected that these were due to an ongoing UTI which had not responded to the initial antibiotic (nitrofurantoin). The GP collected a sample of mid-stream urine [5] (MSU) which was sent for microbiological testing. In the meantime, an alternative antibiotic was prescribed called ofloxacin (British National Formulary, 2020b).
• On 10 September 2018, Linda attended her GP practice with further urinary symptoms and was diagnosed with a UTI, and a further course of nitrofurantoin was prescribed.
• Linda attended her GP practice on 22 October 2018 to deliver a urine sample, which she had been asked to collect by her GP due to further dysuria. The sample was sent to the hospital laboratory for microbiology testing. Linda reported feeling well and was happy to wait for the results of the MSU test to come back before commencing further treatment.
• The results of the urine testing were sent to the GP on 25 October 2018. The test was positive for bacteria associated with a UTI and the GP prescribed a course of antibiotics. The GP notified Linda of this and asked her to collect the antibiotics from a local chemist to which the prescription had been sent.
• On 7 November 2018, Linda attended her GP again with urinary symptoms and a UTI was diagnosed. The GP prescribed antibiotics and sent a further MSU sample for testing.

2.20 In addition to receiving treatment for her recurrent UTIs, Linda continued to receive care for her other chronic conditions. In July 2018, her consultant gastroenterologist at the tertiary (specialist) centre treating her Crohn’s disease noted that Linda was ‘waiting for appointment at [name of local hospital] to discuss her ureteric stent and whether [it] needs to be removed’.

2.21 Linda attended a urology clinic appointment on 29 August 2018. At this appointment she expressed her wish to have her care transferred from the local hospital to the hospital where she was receiving her other specialist medical care. This was reflected in a letter from the Urology team to her GP dated 18 September 2018. The letter also stated that a KUB (kidneys, ureters and bladder) X-ray had been arranged, and an admission form had been submitted for the removal of the stent using the ‘flexible cystoscopy’ technique [6] ‘if the x-ray KUB is normal’. However, a date for the stent removal procedure was not set at this point.

2.22 Following the letter sent on 18 September 2018, the urology department at the hospital where Linda’s other specialist care was being provided arranged for her urological care to be transferred. This took place over several weeks.

2.23 After a subsequent haematology outpatient appointment which took place at the hospital to which Linda’s urological care was being transferred, the consultant haematologist wrote to Linda with a summary of the clinic attendance. The letter also summarised their conversation regarding moving her urological care from the local hospital to the specialist centre in order to help co-ordinate her care.

2.24 Linda attended a further, planned, gastroenterology outpatient clinic in November 2018. Following the appointment, the gastroenterologist wrote to Linda’s GP with the following concerns regarding her stents:

‘Unfortunately, she has not had the most smooth care for her urological problems at [name of local hospital] and I am now quite concerned that the delays in her care may be quite a risk to ongoing health.

She had a ureteric stent put in [in] November 2017 for a stone and hydronephrosis [7].

She has been waiting for very many months for any kind of follow-up and to remove the stent. During this period, she has had nine courses of antibiotics for UTIs’.

2.25 On 21 December 2018, Linda attended her GP practice with urinary symptoms and was diagnosed with a UTI. The GP prescribed nitrofurantoin and collected an MSU sample for analysis.

2.26 Linda received a letter dated 28 November 2018 inviting her to attend a urology outpatient appointment at the local hospital on 10 January 2019 to see the urology consultant. On 23 December 2018, the local hospital received a letter from the hospital which was taking over her care confirming the completion of her transfer of care. As a result, Linda cancelled the appointment on 10 January 2019. This also triggered the cancellation of the procedure to remove her stent, which had been requested via the TCI form that was submitted in August 2018. At this point, Linda’s urological care ended at the local hospital.

2.27 In early 2019, Linda received an appointment to attend a preoperative assessment clinic at the hospital which had taken over her care. This was in preparation for the planned operation to remove her stent. The pre-operative clinic appointment went ahead, but the procedure did not go ahead on the original date planned as Linda was unable to attend.

2.28 Linda attended her GP practice on 1 April 2019 with urinary symptoms. Her GP sent a urine sample for analysis and agreed to delay prescribing any antibiotics until the results were available. On 10 April 2019, the urine test results were returned and showed the same bacteria associated with a UTI. Linda’s GP prescribed a course of antibiotics on 12 April 2019.

2.29 Linda suffered a further episode of urinary symptoms and saw her GP on 10 May 2019. She was given a further course of antibiotics.

2.30 Linda subsequently attended a second pre-operative assessment clinic prior to being admitted for the removal of the stent. The operation went ahead on 23 July 2019 and the stent was successfully removed. Linda made a good recovery from the operation and was discharged home. A member of the investigation team spoke with Linda a few weeks after the operation and she reported that she was feeling better.

2.31 See Appendix A for a tabular summary of Linda’s care at the local hospital.

3.1 Notification of the reference event

3.1.1 The issue of unplanned retention of ureteric stents was referred to Healthcare Investigation Branch (HSIB) by a senior urologist at a large teaching trust. Two example cases highlighted that ureteric stents had been inserted and not removed in a timely way, leading to the stent becoming encrusted. Stents can normally be removed easily, either by the patient or a healthcare professional if the stent is ‘tethered’, or by a medical professional in a hospital clinic by passing a small telescope into the bladder and using some grasping forceps, with the patient under local anaesthetic. However, encrusted stents can cause the patient harm and may have to be removed by a urologist under a general anaesthetic using more extensive surgical techniques.

3.2 Decision to investigate

3.2.1 Following a preliminary investigation, HSIB’s Chief Investigator authorised a national investigation based on the following patient safety risk criteria:

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

• Ureteric stents which are unintentionally left in situ for an extended period can cause significant ill health, require additional costly surgery, and may even cause permanent kidney damage and/or lead to the removal of the kidney(s).

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

• A Getting It Right First Time (GIRFT) [8] report on urology services (2018) has highlighted significant variation in clinical practice across the 140 hospital trusts that provide urology services.
• Ureteric stents are used within medical specialties outside of urology, such as interventional radiology and transplant surgery, with potential for limited support from and liaison with urology.
• Hospitals may or may not use a stent register, have an electronic patient record system or rely on manual/paper-based medical records. This means that there is systemic variability across the NHS in terms of how stents are recorded, and how retention of stents is alerted to clinicians.

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

There is potential for an HSIB investigation to:

• identify learning opportunities which will ensure that: - patients understand the purpose of their stent and the consequence of delayed removal - GPs understand that patients have a stent inserted, and how long it is intended that the stent will remain in place • seek to understand how ureteric stents are tracked and look for ways to make this more consistent across the NHS.

3.3 Scope of the investigation

3.3.1 To identify the safety factors, safety issues and local risk controls, the investigation reviewed the patient’s clinical records and interviewed frontline staff and managers at the hospital trust where the reference event occurred.

3.3.2 After preliminary investigation, it was agreed that the national investigation would explore:

• the strategies for ensuring effective communication with patients and their GPs regarding a patient’s stent
• the use of stent registries to track the insertion and removal of stents.

3.4 Method

3.4.1 Investigative approach

HSIB uses a standard process in all its investigations:

• Gather all relevant evidence.
• Establish the factual circumstances leading up to the reference event.
• Analyse the evidence.
• Identify the most significant safety factors and safety issues contributing to the safety risk being investigated:
  • a safety factor ‘is an event or condition that increases safety risk’ (Australian Transport Safety Bureau, 2011).
  • a safety issue is a safety factor that ‘is a characteristic of an organisation or a system, rather than a characteristic of a specific individual, or… environment at a specific point in time. Safety issues will usually refer to problems with…risk controls’ (Australian Transport Safety Bureau, 2011)
• Identify which safety factors are contributory to the reference event.
• Identify which safety issues are likely to contribute to future, similar events nationally. This informs the wider investigation (see section 5).
• Develop safety recommendations and safety observations to reduce identified safety risks.

3.5 Demographics and urological services of healthcare organisations

Reference event trust

The trust in the reference event was a medium sized district general hospital trust which operated across two main inpatient sites. It served a population of around 750,000. The hospital admitted approximately 100,000 patients per year, half of which were non-elective (that is, they were emergency admissions). The Trust had a team of seven consultant urological surgeons who provided an on-call service for emergency urology patients. One of these consultants led on stone care in the Trust, along with a locum consultant. The Trust used the stent register provided by the British Association of Urological Surgeons.

Organisations visited as part of the national investigation

The investigation visited three trusts that provided urological care for stone patients. The trusts were selected to provide the opportunity to see relevant care and practice in hospitals of different types, size and catchments.

• The first hospital trust visited was similar in size to the trust in the reference event but dealt with a higher number of patients from its locality with kidney stones. It had established a dedicated stone service overseen by two surgeons who specialised in stone care. It operated a locally designed, built and deployed electronic stent register which was overseen by a team of healthcare assistants within the urology advanced nurse practitioner team.
• The second trust operated over a larger geographic area to the one in the reference event and operated a dedicated stone service. This trust did not have an electronic stent register but used a hybrid paper-based and Excel spreadsheet-based system to track stent insertion and removal. Receipt of stent documents, updating of spreadsheets and admission of patients into hospital for stent removal was managed by a medical secretary.
• The final trust visited was a large city-centre hospital which ran a fully dedicated stone service which, while operated within the urology directorate, was in many ways a standalone service. Its stone unit had a dedicated walk-in clinic, consulting rooms, operating theatre and lithotripter (the equipment used in extracorporeal shockwave lithotripsy). Patients with stents were given information about their stent and encouraged to come straight back to the hospital in the event of any issues. The trust did not have an electronic stent register, but a clerical officer role was dedicated to the case management of patients with stents.

3.6 Evidence gathering and verification of findings

The investigation used the following methods to gather evidence and verify findings:

• review of Linda’s clinical records and of hospital policies, procedures and practice relating to the care, management and transfer of patients’ care between trusts
• interviews with Linda and her partner
• interviews with staff at the trust where the reference event occurred
• liaison with a subject matter advisor in urology
• in-person and telephone interviews with representatives from relevant national organisations and subject matter advisors [9]
• review of published guidance and literature relevant to the safety risk
• review of the GIRFT report on urological care (2018).

3.7 Analysis

The investigation used two models, STEP and AcciMap, to examine the safety factors influencing the care given in the reference event, and the issues that arose which led to the ureteric stent being in situ for an extended period.

A Sequential Timed Event Plotting (STEP) diagram (Hendrick and Benner, 1987) was used to analyse the reference event. STEP shows the task process, the tasks performed and the interaction between patients and elements of the system (for example, documentation, equipment and IT systems) over time. This method is particularly useful for analysis and representing distributed teamwork or collaborative activity.

The AcciMap model (Svedung and Rasmussen, 2002) was also used to analyse the reference event information and support the direction of the national investigation. AcciMap is an incident analysis method that identifies factors within the system that influenced the occurrence of an incident. The analysis focuses on identifying relationships between the different levels of the system (figure 4), which include government policy and budgeting; regulatory bodies and associations; local area management; physical processes and actor activities (what staff, people, organisations, systems did); and equipment and surroundings (Stanton et al., 2013).

AcciMap is useful for visually representing contributory factors across the entire organisational system and their interrelationships. It removes the apportioning of blame to individuals and promotes the development of ways of preventing incidents which consider multiple factors (systemic countermeasures) (Salmon et al., 2011).

Fig 4 The AcciMap Method (Svedung and Rasmussen, 2002)

This investigation originated from the following potential safety risk:

’If a ureteric stent is left in for a long time it can become more difficult to remove, leading to a longer hospital stay, extended recovery time, and is associated with increased morbidity. It can affect a patient’s long-term kidney function and can lead to iatrogenic loss of a kidney (loss of an organ due to a medical intervention or lack of it). If bilateral, loss of both kidneys can occur necessitating dialysis or transplant.’

(Bultitude et al., 2003)

’It has been suggested, by the referrer, who is a consultant urologist, that the use of ‘holding interventions’ in the NHS can lead to patients not being prioritised, resulting in significant waiting time for definitive surgery. There are also other candidate contributory factors such as the continuity of care between providers and the lack of a registry.’

(taken from HSIB referral)

4.1 Urology services at the reference event hospital trust

4.1.1 The hospital offered a range of services including inpatient and outpatient general urology, such as urgent, emergency and follow-up care to patients with a range of urological conditions, including kidney stones. The Trust told the investigation that it did not operate a fully dedicated sub-specialist stone service, as described by in the Getting It Right First Time (GIRFT) report (2018). Instead it provided stone care within the general urology team, which included two consultants (one of whom was a locum) who focused on the care of patients with kidney or ureteric stones.

4.1.2 The Trust had no formally designated lead for its stone care service and did not employ any urology clinical nurse specialists. A previous inspection by GIRFT recommended developments for the stone service and noted good quality stone care and a high number of admissions of patients with stones.

4.1.3 The GIRFT report suggested that for a hospital to provide a sub-specialist stone service, a population of between 750,000 and 1.5 million is needed. This may require hospitals and trusts to form ‘urology area networks (UANs)’ to achieve the suggested number of patients (Getting It Right First Time, 2018). The hospital trust in the reference event had a resident population of 750,000 and ran urology services on both of its two sites.

4.1.4 The Trust had a team of seven consultant urologists (of which two led on stone care) who oversaw the care of patients with a range of urological diseases. These included patients with cancers (such as prostate and bladder cancer), bladder and continence problems, and kidney/ureteric stones. The consultants were supported by junior doctors, including specialist trainees (doctors who are working towards becoming a consultant) and middle grade associate specialists [10].

4.1.5 The urology consultants operated a “consultant of the week” system which meant that patients admitted to the urology team came under the care of that consultant. However, that consultant may not provide the patients’ ongoing care. This may mean that patients could have their operations carried out, and/or be seen in follow-up outpatient clinics, by different consultants.

4.1.6 Linda was admitted under the consultant of the week and subsequently treated by a different consultant. She also attended an outpatient appointment on one occasion and was seen by the urology registrar [11] working for a third consultant. The investigation was told by staff at the hospital that being admitted and treated by multiple/different consultants was common practice and reflects the nature of the “acute take” (the way emergency patients are admitted). This situation may have affected the continuity of Linda’s care and could have influenced the duration that her stent was left in situ.

4.1.7 Summary

• The hospital had a general urology service and did not provide a sub-specialist stone service.
• The hospital had two consultant urologists who led on stone care.
• The Trust’s population was cared for across two sites, both of which provide urology services. The population was at the lower limit necessary to support a sub-specialist stone service.
• Patients with urological emergencies requiring admission or referral were assigned to the general urology consultant of the week.
• Linda was admitted, treated and followed up under different consultant urology teams.

4.2 Initial stone care, stent insertion and removal

4.2.1 Linda was seen in the emergency department and was given an initial diagnosis of kidney stones. She was treated with painkillers and referred to the urology team and discharged home pending an appointment for follow-up care. It was common for patients whose pain can be managed to not be admitted onto a ward in these circumstances.

4.2.2 Linda did not undergo any urological procedures as a result of the initial presentation to the emergency department. She did not have a ureteric stent inserted as a ‘temporising measure [12]’ at this stage and followed a typical pathway of treatment. This commenced with a referral for extracorporeal shockwave lithotripsy (ESWL) (see 1.3.6) to try to break up the stones. ESWL is not an invasive procedure and was indicated as the first-line treatment in the published clinical guidance (National Institute for Health and Care Excellence, 2019a). Linda attended for ESWL but did not receive the treatment as her stones could not be seen when imaging was carried out and therefore no target could be identified for the lithotripter shockwaves. Following this, Linda was booked into a urology consultant outpatient clinic for review.

4.2.3 Linda re-attended the emergency department with a further episode of pain, having passed fragments of kidney stones believed to be from her left kidney. Subsequently, Linda attended a follow-up outpatient appointment and was admitted to hospital the next day for further treatment to remove the stone in her right kidney/ureter.

4.2.4 Linda underwent a procedure to remove the kidney stone known as ureteroscopic removal of stones (URS) (see 1.3.6). At the end of the procedure, a double J ureteric stent was inserted in her right ureter to help ensure the kidney continued to drain urine and to allow for stone fragments to pass freely. The use of ureteric stents after a URS is indicated in guidance (National Institute for Health and Care Excellence, 2019a) and is a commonly used intervention. The stent allows the ureter to heal, as it can become swollen as a result of the ureteroscopy.

4.2.5 Ureteric stents are not intended to be left in situ indefinitely. The length of time that stents remain in situ is based on a clinical decision which considers the type of patient being treated and the severity of their condition.

4.2.6 Ureteric stents are manufactured with or without ‘tethers’ attached. Tethers are strings attached to the end of the stent and are left outside of the patient. The tethers allow the stent to be removed by the patient or, in some circumstances, a nurse. Tethered stents are used when the stent is intended to be in situ for shorter durations, commonly three to seven days, as suggested in published healthcare literature, and may be removed by the patient (Doersch et al., 2018). Prior to the insertion of Linda’s stent, the tethers were removed as the plan was for the stent to be in situ for around 12 weeks (as documented in the operation notes). The investigation was told by a urologist at the hospital that they rarely, if ever, offered a self-removal option to their stone patients and so tethers were usually removed from the stent prior to insertion to prevent accidental self-removal and to improve comfort for the patient.

4.2.7 Non-tethered stents cannot be removed by the patient and require removal using a cystoscope in hospital. A cystoscope is a device inserted into the bladder via the urethra in order to view the stent and grab it for removal. The decision to remove the tethers and the rationale for the duration of planned stent retention were not documented in Linda’s notes. During follow-up outpatient clinic appointments, the presence of the stent was noted and consideration regarding stent removal was documented.

4.2.8 The surgeon performing the URS and stent insertion filled out a ‘TCI form’ following the procedure in order to instigate follow-up. TCI stands for ‘to come in [to hospital]’ and the form is sent to the hospital’s admissions team to organise the requested procedure and admission date. The operation notes state that Linda would need to have a renogram (see 2.13) 6 weeks after the procedure. It was stated that the stent would remain in situ until her next outpatient review, 6 to 8 weeks after the renogram (12 to 14 weeks in total).

4.2.9 The Trust used the stent register provided by the British Association of Urological Surgeons (BAUS). This is a computer-based system which allows the insertion of a stent to be logged and prompts clinicians when the stent should be removed. In Linda’s case, the surgical notes do not state that the stent was recorded on the stent register and the investigation could not be provided with a copy of the entry.

4.2.10 The investigation was told by a consultant urologist that the BAUS register was going to cease operating. He also stated that the BAUS register generated lots of email traffic, including alerts regarding other consultants’ patients. The investigation spoke with representatives from BAUS, who said that the BAUS stent register was being discontinued for the following reasons:

• “Poor uptake,
• Concerns relating to General Data Protection Regulation and holding patient identifiable data,
• Ongoing costs to BAUS of maintaining a number of registers.”

4.2.11 The stent insertion was recorded in Linda’s surgical record and the sticker which is included in the stent packaging was affixed to her medical notes. Medical devices such as ureteric stents are supplied with a sticker which carries information such as the manufacturer’s name and serial number.

4.2.12 Following her operation, Linda was kept in hospital overnight before being discharged home. Linda could not recall if she was given an information leaflet or verbal advice about her ureteric stent – for example why it was inserted, what to expect in terms of discomfort, the risks associated with it, and the likely timescale for removal.

4.2.13 The investigation was unable to establish whether the Trust produced its own stent patient information leaflet.

4.2.14 Linda had her stent removed many months later. As her stent had become encrusted (see 1.2.7) this involved a general anaesthetic and extensive surgery (ureteroscopy), rather than the simple removal of the stent with a flexible cystoscope under local anaesthetic. The more extensive nature of this procedure was required due to encrustation associated with the extended length of time for which the stent was in situ.

4.2.15 Summary

• The patient received the appropriate care for her stone (referral for ESWL and then URS) according to the National Institute for Health and Care Excellence guidelines (2019a).
• The stent may not have been logged/tracked using a stent register (see section 5).
• There was a plan at the time of the URS and stent insertion to undertake imaging and ask Linda to attend an outpatient appointment to review the stent removal 12 weeks later.
• There was no evidence that information was provided to Linda about the stent, either verbally or in writing, prior to her discharge. Linda was unaware of the potential side effects and/or complications of delayed stent removal (see section 5).

4.3 Follow-up outpatient care at Linda’s local hospital

4.3.1 To achieve the intended timescales for follow-up, Linda was invited to an outpatient clinic to be seen by a different consultant team in the same trust. The urology registrar who saw Linda appears to have repeated the management plan documented at her previous clinic attendance (that is, to undertake imaging and review in 12 weeks). The notes do not reflect the total accumulated time period that the stent had been in situ for.

4.3.2 The notes do not record any clear rationale for keeping the stent in situ after the first planned review. The potential risks associated with the extended duration of the stent being in situ, such as encrustation, were not documented.

4.3.3 Linda experienced an interruption in her urological outpatient care between March and August 2018. The notes stated that Linda should have attended a follow-up appointment following her renogram on 12 March 2018. There is no evidence that this appointment was booked. This situation, and the fact that Linda saw multiple consultants and registrars on previous occasions, may have impacted on the medical teams’ awareness of the accumulated time the stent had been in situ. The issue of missed outpatient appointments affecting pathways of care has been highlighted in a previous HSIB investigation report, ‘Lack of timely monitoring of patients with glaucoma’ (Healthcare Safety Investigation Branch, 2020). It is also the subject of an ongoing HSIB investigation into outpatient appointments intended but not booked after inpatient stays (Healthcare Safety Investigation Branch, 2019a).

4.3.4 While reflecting that the stent had been in situ for some time, the medical notes did not record the ongoing cumulative time which had passed. The TCI form completed in August 2018 does however state ‘long duration stent’ and the request for an appointment was marked as urgent. The Trust did not have an effective system in place to prompt clinicians about extended stent durations.

4.3.5 The investigation was told that the length of time that a stent is left in situ is based on a clinical decision by the urology team. The Trust did not have local guidance for urology doctors to inform the length of time that stents should be left in situ, and this is considered as normal. A subject matter advisor told the investigation that it is not practical to develop guidance to inform stent duration as each patient’s stone care, and the health of their ureters, will vary. This supports the need to use senior clinical judgement for the management of these patients’ treatment, and a clear statement from the beginning about the intended duration of the stent staying in, which can be referred to at every appointment.

4.3.6 Summary

• The status of Linda’s stent was considered at each outpatient appointment. On two occasions, the duration of her planned stent retention was extended pending imaging.
• There was an interruption in Linda’s urological care between March and August 2018 and there is no evidence that a planned follow-up appointment was booked.
• Decisions about how long a stent should remain in place are based on senior clinical judgement and it is not practical for local trusts to develop guidance informing the maximum duration of planned stent retention.
• The Trust did not have an effective system to prompt clinicians about the length of time patients’ have had a stent in situ.

4.4 The patient’s contact with GPs and other healthcare services

4.4.1 In the period following her URS and stent insertion, Linda maintained contact with all the other specialist services she was seeing prior to experiencing her kidney stone. This included gastroenterology, rheumatology, haematology and ophthalmology. On several occasions, Linda’s stent status was noted by other speciality doctors following outpatient attendance at their clinics.

4.4.2 Linda also had regular contact with her GP, mainly for routine blood tests relating to her treatment under the rheumatology team.

4.4.3 Following her kidney stone treatment, Linda also saw her GP for recurrent urinary tract symptoms (dysuria [13]) and was diagnosed with urinary tract infections (UTIs) (see 1.4). The investigation was told by a subject matter advisor that dysuria is a common symptom associated with having a stent in situ. Linda’s GP initially followed common practice guidance to treat the presumed UTIs empirically with first-line antibiotics.

4.4.4 After initial treatment, Linda’s GP followed the usual guidance for managing a UTI and asked Linda for a urine sample which would be sent for laboratory testing. Urine samples can be analysed to establish the exact type of bacteria causing the infection, which allows for targeted use of an antibiotic that the bacteria are most sensitive to. Over the period of Linda’s recurrent presentations to her GP with apparent UTIs, at least two urine samples were collected for analysis.

4.4.5 The results of the urine samples identified bacteria commonly associated with simple lower urinary tract infections. Therefore, the GP was not concerned that Linda’s signs and symptoms could be due to another problem, such as her stent.

4.4.6 A subject matter advisor told the investigation that bacteria of varying types can colonise ureteric stents but the presence of the stent itself may cause the same signs and symptoms as a simple lower urinary tract infections. Dysuria arising from stent insertion may not respond to antibiotic therapy in the same way a UTI would. The investigation was told that the treatment for dysuria in a patient with a stent in situ is to remove the stent, if clinically appropriate to do so.

4.4.7 Linda’s GP told the investigation that they were unaware of specific complications for patients with stents in situ, such as dysuria and the potential for stents to mimic a simple lower UTI. The GP remarked that patients such as Linda who are having ongoing urological follow-up under a specialist team in secondary care (hospital) usually have an outpatient appointment booked in the near future. It is not seen as necessary for GPs to seek routine advice from a urologist regarding an uncomplicated UTI and the view of GPs is that they “do not need to do much as follow-up is automatic from the urology team”.

4.4.8 Furthermore, the GP stated that discharge letters from hospital urology teams do not carry information on patients’ stent status, removal dates, or advice for GPs should patients present to primary care with dysuria after stent insertion. The GP also stated that a “percentage of letters don’t reach us [GPs]”.

4.4.9 Summary

• Linda began suffering dysuria in the months following her discharge from hospital after her URS and stent insertion.
• GPs may be unaware of the potential for stents to cause dysuria and mimic a UTI (see section 5).

4.5 Transfer of Linda’s care to the specialist centre

4.5.1 Following concerns raised by other speciality teams, it was suggested to Linda that it may be beneficial to centralise all her care in one hospital trust.

4.5.2 The transfer of Linda’s care was initiated on 6 August 2018 when her gastroenterologist formally wrote to Linda’s GP following an outpatient appointment a few days previously. The gastroenterologist was concerned that the recurrent UTIs and repeated use of antibiotics may be causing Linda’s Crohn’s disease to flare up. Linda gave her consent for the transfer of care process to commence.

4.5.3 On 23 December 2018, a stone consultant at the hospital where Linda’s care was to be transferred to wrote to her gastroenterologist saying that he would like to see Linda and would make the arrangements to transfer her care.

4.5.4 Prior to agreeing to the transfer of care, Linda’s local hospital had commenced planning to remove her stent. A TCI form had been completed on 29 August 2018 which started the process, undertaken by the Trust’s clerical team, of booking Linda onto a urology theatre list. The planning process was curtailed upon completion of her transfer of care.

4.5.5 Linda was not made aware of the plans to admit her at this point (November 2018) and the admission process was cancelled once the transfer of care had been completed. Had this admission gone ahead, Linda may have had her stent removed several months sooner. There is no evidence however that this would have altered her outcome.

4.5.6 Summary

• Linda expressed her wish to have all her specialist care centralised at a single hospital.
• Her recurrent UTIs were potentially impacting on her Crohn’s disease due to repeated courses of antibiotics.
• The process of transferring care led to the cancellation of the stent removal procedure requested in August 2018 and the removal procedure was booked at the hospital to which Linda’s care was transferred.

4.6 Patient outcome

4.6.1 Linda had her ureteric stent removed 20 months after it had been inserted. In that time, her kidney function had been assessed and found to be reduced on the same side as the URS and stent insertion. While the patient reported feeling very unwell during this period, there is no evidence to suggest that the prolonged period of stent insertion caused the reduction in kidney function.

4.6.2 The investigation met with Linda several weeks before the operation to remove her stent, and again after. Linda told the investigation that she felt much better after the removal of her stent and was continuing to receive urological care. She was also continuing to receive specialist care for her other conditions and care from her local GP practice.

This section sets out the investigation’s findings in relation to the identified safety issues affecting patients who have ureteric stents inserted.

5.1. Stent logging, tracking and removal

5.1.1 Nationally, there is no stent register provided by a single organisation which is used universally by all healthcare providers who insert ureteric stents. Stent logging and tracking may be undertaken at trust level using locally derived systems or by using the stent register provided by the British Association of Urological Surgeons (BAUS).

5.1.2 Registers which record the placement of medical devices are common and include specific registers for items such as hip prostheses and breast implants. This enables tracking of patients for follow-up based on a specific type or batch of a particular type of implant, should an issue arise.

5.1.3 Implanted items such as hip prostheses and breast implants are not usually intended for removal. In registers for prostheses/implants, the function of logging/registering an implant or prosthesis against an individual patient is the same as in a stent register. However, implant/prosthesis systems do not provide for an end date to be recorded or for information about removal to be reconciled (that is, for patients’ stent removal to be recorded against stent insertion), and registers are not actively monitored.

5.1.4 While BAUS provided a stent register, the investigation was told that it was being withdrawn due to poor uptake, concerns regarding information governance and its compliance with the General Data Protection Regulation (Information Commissioner’s Office, 2018), and the cost to BAUS of maintaining this as one of several registers. The BAUS stent register was reported as being functional but created lots of email alerts. The system was not designed to separate patients being cared for by different consultant urologists. This meant that individual consultant urologists received multiple emails from the register almost every day, most of which did not relate to their patients or actions they needed to take.

5.1.5 The investigation observed the stent tracking systems in five trusts in England (two relating to the reference event and three during observation visits). The following provides a summary of each system (randomly ordered to avoid identifying the trust in the reference event):

• Trust 1: Used a paper-based system overseen by medical secretaries who transfer information from paper to individual Excel spreadsheets for each urology consultant.
• Trust 2: Used the BAUS stent register. Alerts are sent to all urology consultants.
• Trust 3: Used the BAUS register until recently.
• Trust 4: Used a locally designed and deployed electronic stent register (built on a ‘form-builder’ [14] software platform). System overseen by dedicated healthcare assistants within an advanced nurse practitioner team. (see appendix E for example of data entry screen)
• Trust 5: Used a paper-based system overseen by a dedicated clerical assistant.

5.1.6 Ureteric stents are inserted by urologists and clinicians in other specialties such as interventional radiologists and transplant surgeons. In trusts where a stent logging/tracking system was used, it was commonly reported that there was not universal adoption by all specialties. This means that other specialties may not follow the same stent logging/tracking systems as urology departments.

5.1.7 The investigation observed that only one of the five stent logging/ tracking systems had a specific requirement to reconcile the removal of stents. Reconciliation of stent removal allows auditing to be undertaken and patients who are approaching their stent removal date can be booked in for the removal procedure.

5.1.8 The investigation heard that there is a risk that patients with stents may not be followed-up or be “lost”. There was a difference among hospital staff who worked on the stone care pathway regarding how they described or defined “losing patients [from the system]” and failing to reconcile the removal of stents. Failure to follow up patients (commonly described as losing patients, or loss to follow-up) may not be detected, leading to unplanned delayed removal of stents. Where stent removal is reconciled and recorded, the process is typically organised in parallel with other outpatient booking processes and provides a second layer of protection from the risk of harm from delayed removal of stents.

5.1.9 It was reported to the investigation that failure to reconcile stent removal does not mean that the patient has not had their stent removed. For example, patients may be treated while on holiday and return to their local trust for stent removal. The system deployed in one trust visited required confirmation from the patient’s local trust of stent removal in these circumstances.

5.1.10 There is currently no provision to flag patients with stents on the NHS Summary Care Record system [15]. Patients who present to urgent care services with conditions that may be attributable to a ureteric stent may not be identified if this information is not shared during history taking.

5.1.11 The investigation observed that stent logging/tracking systems may be overseen by a variety of staff. Usually, these staff were either clerical, healthcare support workers, or qualified staff (such as nurses, specialist nurses or junior doctors). While the types of stent logging/tracking systems were either electronic or paper-based, and the type of staff overseeing them also varied, the investigation saw no evidence that one system performed better at tracking patients and the removal of their stents than the others. However, there is a risk associated with the lack of standardisation between the various systems’ design and use, and the variation of approach between trusts and specialties, both locally and nationally.

5.1.12 The investigation was told by the urology subject matter advisor that there is currently no national standard for the logging, tracking and reconciliation of removal of ureteric stents.

5.1.13 The investigation spoke to a healthcare assistant who worked within a specialist nursing team. Their role had two main elements: supervised clinical duties such as supporting urology clinics and overseeing the ureteric stent register. There were two full-time healthcare assistants undertaking the role. The healthcare assistant reported that their oversight of the stent register allowed them to proactively manage the list of patients needing stent removal by the various methods (for example, as a day-case procedure, or nurse-led stent removal using a cystoscope). They also said that the combination of an electronic system overseen by a dedicated operator was essential and that in their view “you could not have one without the other”. This trust reported almost no unreconciled ‘loss’ of patients. Nearly all losses were attributed to non-UK patients returning to their country of origin after initial treatment.

5.1.14 The other paper-based systems that the investigation observed relied on clerical staff transferring information about stent insertion into a spreadsheet. The investigation noted that paper-based systems created duplication of work and created the risk of data loss due to the information being stored physically in multiple locations. Transferring information manually also creates a risk of transcription error.

5.1.15 Paper-based systems, while potentially no less effective at preventing delayed removal of stents than electronic systems, appeared significantly more complex. One medical secretary told the investigation that she had prepared a six-page handover document regarding their stent logging system for colleagues to refer to when she went on leave or was off sick. The document explained the system used and, while comprehensive, was by its very nature hard to follow and presented opportunity for the system to fail when being overseen by an inexperienced operator.

5.1.16 The investigation reviewed examples of other areas in healthcare where patients are tracked using systems overseen by human operators. In the document ‘Delivering cancer waiting times: a good practice guide’ (NHS Interim Management and Support, 2015) the importance of having specified staff tracking patients is highlighted. The guide states that: ‘It is good practice for organisations to have in place staff, systems and processes to ‘pull’ cancer patients along their diagnosis and treatment pathways.’ The document goes on to state that: ‘Responsibility for daily tracking varies considerably amongst NHS organisations and may cover one post of an MDT [multidisciplinary team] Coordinator or may be part of several related roles…’ Reliable tracking systems require the combination of people and effective systems and processes to minimise the risk of delays in care pathways due to failure to monitor patients’ progress.

5.1.17 Irrespective of the type of system used, patient communication appeared uncoupled from the stent logging and tracking processes in all the trusts where observations took place (see section 5.2). Stent tracking was separate from patient discharge, which is the point at which patients would usually receive information about their ongoing health and care. As a result, one aspect of healthcare system resilience – being able to work alongside well-informed patients – may be lost. For example, patients may not be aware that their stent is being tracked and that they should expect to be contacted about its removal by a specific date, and what to do if this does not happen.

5.1.18 One hospital visited by the investigation appeared to use tethered stents more frequently than other trusts. Tethered stents, which can be removed by the patient, were used when the stent was to remain in situ for a short period of time, such as three to five days. These stents were recorded using a different logging and tracking system. The main difference from the same trust’s system for non-tethered stents was that the patient’s details were entered into a “stent diary” which had a “stent removal form” inserted on the date of removal. Patients who were being discharged with tethered stents were given a verbal briefing and an advice leaflet about their stent (see section 5.2). Patients were asked to telephone the stone unit on the day of the stent self-removal to confirm removal. This information was then reconciled in the stent diary.

5.1.19 In the reference event, Linda’s stent status was reviewed during routine outpatient appointments which occurred every three months. In other trusts visited by the investigation, the review of patients’ overarching stone care appeared to be uncoupled from the management of their stents. This was particularly true where patients had tethered stents inserted for self-removal.

5.1.20 Summary

There is currently no national stent register being used across the NHS.

• Hospitals deploy a range of systems to track and log stent insertion. Some trusts also have systems to reconcile stent removal.
• While more complex and requiring additional steps, paper-based stent logging/tracking appears to be effective in the absence of electronic systems.
• The combination of human oversight and effective stent logging/tracking systems may be beneficial in preventing delayed removal of stents. Systems should not rely solely on the human element.
• Within a trust, other medical specialties which insert ureteric stents may not use the same stent logging/tracking systems as the urology team.

HSIB makes the following safety recommendation

5.3 Communication with primary care services and information for clinical staff

5.3.1 A well-established communication system exists between secondary and primary care services (for example, between hospitals and GP practices) relating to patients undergoing hospitalbased specialist care – both as inpatients and outpatients. After each episode of secondary care, a discharge summary is sent to the patient’s GP, usually in the form of a letter. While well established, the timeliness, quality and effectiveness of such communication is not evaluated or subject to continuous improvement activity.

5.3.2 Discharge summaries update GPs about the care undertaken and should outline any actions the GP needs to take relating to the patient’s ongoing care (for example, changes to routine prescriptions). GPs may review these letters routinely, prior to or during appointments with patients. A previous investigation by HSIB identified issues where pertinent information was not included in discharge letters/summaries, and made safety observations highlighting the importance of the standards for patient records, including discharge summaries, published by the Academy of Medical Royal Colleges (Healthcare Safety Investigation Branch, 2019b).

5.3.3 The letters sent to the patient’s GP in the reference event, and other examples seen or discussed during observation visits and discussed with the subject matter advisor for general practice, do not provide advice to GPs about ureteric stents. A subject matter advisor stated that useful information for GPs may include the planned stent removal date and common side effects (such as dysuria).

5.3.4 The layout of discharge letters is not standardised and information about a patient’s stent can vary (in terms of detail and where information appears in the letter) or may be omitted. Specifically, discharge letters often do not include information for GPs regarding how stents can cause and/or mimic the signs and symptoms of an UTI. This means that GPs may treat patients with stents presenting with urinary symptoms as an uncomplicated UTI without considering the stent as the cause of a patient’s signs and symptoms.

5.3.5 A subject matter advisor (a GP in primary and urgent care) suggested that patients who meet the criteria for recurrent UTIs (that is, they have had 2 or more UTIs in the last 6 months or 3 or more UTIs in the last 12 months (Bonkat et al., 2017)) will usually be managed in the way Linda was in the reference event. Clinical guidance for the treatment of UTIs in women promotes treating acute infections using empirical antibiotic therapy, followed by laboratory analysis of a urine sample leading to targeted antibiotics for any specific bacteria identified, should the initial course not resolve the infection (National Institute for Health and Care Excellence, 2019b).

5.3.6 It is possible that for patients such as Linda who have a stent in situ and are experiencing urinary symptoms:

• the stent alone is the cause of their symptoms, likely due to local irritation of the bladder
• they have underlying asymptomatic bacteriuria (bacteria in the urine which do not lead to symptoms associated with UTIs) with potentially unrelated dysuria/ urinary symptoms caused by the ureteric stent, or
• they have a complicated urinary tract infection, possibly arising from colonisation of the stent with bacteria which cause urinary symptoms.

Clinicians such as GPs and other first-contact practitioners may seek to make clinical decisions based on a reasonable diagnosis of UTI based on the presence of patient-reported symptoms of dysuria and clinical signs. A clinical diagnosis backed up with microbiological results showing bacteria (particularly bacteria commonly associated with UTIs such as E. coli and Pseudomonas) may cause an understandable confirmation bias (a tendency to use information in a way that supports an existing view), especially if the ureteric stent has not been considered.

5.3.7 The lack of awareness among clinicians in primary care and in urgent care services of the potential complications experienced by patients with indwelling ureteric stents may lead to patients re-presenting with unresolved urinary symptoms and the repeated, potentially unnecessary prescribing of antimicrobials. The European Association of Urology states that: ‘Patients with indwelling or suprapubic catheters [urinary catheter inserted through the abdominal wall] and nephrostomy tubes invariably become carriers of ABU [asymptomatic bacteriuria], with antibiotic treatment showing no benefit. This is also applicable for patients with ABU and indwelling ureteral stents.’ (Bonkat et al., 2017)

5.3.8 The GP in the reference event stated that patients with ureteric stents are uncommon in the practice population of a GP. In the patient population of a typical sized GP practice it is likely that fewer than 10 patients have stents at any one time. In the UK, there are around 2,000 patients per GP.

5.3.9 Guidance by the National Institute for Health and Care Excellence (NICE) (2019b) for UTIs in women does not include the consideration of in situ ureteric stents as a potential cause of urinary symptoms. GPs will seek to address the infection as it presents clinically and will treat it empirically according to the NICE guidance. A urology subject matter advisor suggested that for most patients with a ureteric stent in situ, in the presence of a diagnosis of UTI (and particularly, recurrent UTIs), the best course of action is to expedite follow-up with a view to removing or changing the stent if clinically appropriate.

5.3.10 There may be opportunities to promote consideration of stent complications as differential diagnoses (comparing diseases and/or causes of symptoms) via engagement with the Royal College of General Practitioners or the authors of the relevant NICE guidelines. This could support GPs and other health professionals working in primary and urgent care services who may not be aware of issues unique to patients with ureteric stents.

5.3.11 Patients with ureteric stents in situ may also present to urgent care services, either over the telephone via NHS 111, or in person at an urgent treatment centre or equivalent. Urgent care services increasingly use the digital Summary Care Record system (SCR) system which holds information about patients’ health history, allergies, prescribing history, hospital attendance, and other key details about their health background.

5.3.12 The SCR system will include the diagnosis of kidney/ureteric stones within a patient’s health history, but the presence of a stent may not be included. The SCR system may in the future have the capability to flag patients with specific conditions, and consideration should be given to including ureteric stents as a condition which could benefit from being flagged.

5.3.13 Summary

• GPs and other clinical staff working in primary and urgent care services may not be aware of the side effects and complications associated with ureteric stents.
• Hospital discharge letters and other communications do not carry standardised information for healthcare professionals about ureteric stents.
• The SCR system does not currently have a flag or other method of identifying patients with ureteric stents.

HSIB makes the following safety recommendation

HSIB makes the following safety observations

Summary of HSIB findings

The investigation identified:

• There is currently no national stent register being used across the NHS.
• Hospitals deploy a range of systems to track and log stent insertion. Some trusts also have systems to reconcile stent removal.
• Paper-based stent logging/ tracking appears to be effective in the absence of electronic systems.
• The combination of human oversight and effective stent logging/tracking systems may be beneficial in preventing delayed removal of stents. Systems should not rely solely on human element.
• Other medical specialties which insert ureteric stents may not use the same stent logging/tracking systems as the urology team.
• Patients being discharged with stents in situ need clear and consistent communication, both verbally and in writing.
• Involving patients in their care has been shown to improve the quality and experience of care.
• The written advice available for patients with ureteric stents is inconsistent across the country.
• Poor communication may lead to loss of opportunity for patients to self-care and be aware of potential complications with their stents.
• Clear information given to patients with tethered stents ensures compliance with their planned removal schedule.
• GPs and other clinical staff working in primary and urgent care services may not be aware of the side-effects and complications associated with ureteric stents.
• Hospital discharge letters and other communication does not carry standardised information for healthcare professionals about ureteric stents.
• The Summary Care Record system does not currently have a flag or other method of identifying patients with ureteric stents.

HSIB makes the following safety recommendations

Note: HSIB developed these safety recommendations in collaboration with the Royal College of Surgeons of England and the British Association of Urological Surgeons (BAUS). It was agreed between all parties that BAUS would formally receive the recommendations.

HSIB makes the following safety observations

Appendix A

Timeline of attendances at the local hospital

Appendix B

Examples of patient information leaflets Leaflet 1

Leaflet 2 Page 1 of 2

Leaflet 2 Page 2 of 2

Appendix C

Patient information leaflet published by the British Association of Urological Surgeons Leaflet 3

Page 1 of 5

Leaflet 3 Page 2 of 5

Leaflet 3 Page 3 of 5

Leaflet 3 Page 4 of 5

Leaflet 3 Page 5 of 5

Appendix D

Example of stent card which may be given to patients

Appendix E

Example of data entry screen of locally developed stent logging system

[1] Antegrade means in the normal direction of flow. Inserting a stent via the kidney means the stent enters the ureter in the same direction as urine flowing towards the bladder.

[2] Retrograde means in the opposite direction to normal flow. In the case of ureteric stent insertion, this means inserting via the bladder and therefore in the opposite direction that urine flows from the bladder.

[3] CT stands for computerised tomography. This is an imaging procedure which uses X-rays to create cross-sectional images of the body and its structures in ‘slices’.

[4] Urinalysis is used to identify changes in the urine which are suggestive of an infection (or other clinical condition). Urinalysis may be undertaken as a simple point-of-care dipstick test, which can also be done electronically.

[5] The term mid-stream urine (MSU) relates to the urine that is collected for testing in a microbiology laboratory. Mid-stream urine is less likely to be contaminated with bacteria from hands or the skin around the urethra.

[6] Flexible cystoscopy is a procedure to examine the urethra, bladder and ureters using a flexible scope through which the visual examination takes place. [

7] Hydronephrosis is where one or both kidneys become distended/ swollen as the result of a build-up of urine inside them. This may be caused by kidney stones, infections and other diseases. (NHS, 2018).

[8] Getting It Right First Time (GIRFT) is a national programme designed to improve medical care within the NHS by reducing unwarranted variations. By tackling variations in the way services are delivered across the NHS, and by sharing best practice between trusts, GIRFT identifies changes that will help improve care and patient outcomes, as well as delivering efficiencies such as the reduction of unnecessary procedures and cost savings.

[9] Subject matter advisors included, for example, senior leads from the Royal College of Surgeons, British Association of Urological Surgeons, Royal College of Nursing, and NHS England and NHS Improvement.

[10] Associate specialists are senior doctors below consultant grade who are not in training to become a consultant.

[11] A middle grade doctor is a qualified doctor working at registrar level. They may be undergoing speciality training, be practicing as a clinical fellow, or be employed in a staff grade post (grade below consultant).

[12] Temporising measures (in the context of using stents) means the use of a ureteric stent to aid urine flow prior to the commencement of treatment (such as extracorporeal shockwave lithotripsy or ureteroscopy).

[13] Form-building systems are computer programmes which allow users to create online forms within their organisations. In a hospital trust setting, these systems are installed within a secure environment and connect to patient databases and allow clinical staff to enter information into forms which can be used for a variety of purposes to improve efficiency and reduce the use of paper.

[14] Summary Care Records (SCR) are an electronically collated version of a patient’s healthcare record which is accessible to a range of clinical services. Summary care records allow clinicians who do not usually provide the patient’s care to obtain accurate information about the patient’s health history, the medicines they take, and any allergies they have. Patients consent to having a summary care record and give consent each time the records are accessed (except in emergencies, when access can be obtained without verbal consent).

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