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Carson-Stevens A, Hibbert P, Williams H, et al. Characterising the nature of primary care patient safety incident reports in the England and Wales National Reporting and Learning System: a mixed-methods agenda-setting study for general practice. Southampton (UK): NIHR Journals Library; 2016 Sep. (Health Services and Delivery Research, No. 4.27.)

Cover of Characterising the nature of primary care patient safety incident reports in the England and Wales National Reporting and Learning System: a mixed-methods agenda-setting study for general practice

Characterising the nature of primary care patient safety incident reports in the England and Wales National Reporting and Learning System: a mixed-methods agenda-setting study for general practice.

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Chapter 5Serious harms and death in general practice

In this chapter, we provide a summary of all reports describing serious harm and deaths in incident reports received from general practice.

Overview

Of the total 13,699 incident reports, 996 incidents resulted in moderate or severe harm to, or death of, a patient. Moderate and severe harms, using the WHO ICPS definitions,63 were considered to be permanent loss of function, conditions necessitating hospital admission or disability. We called these serious harms.

An overview of level of harm outcome by incident category is provided in Table 7.

TABLE 7

TABLE 7

Summary of incident reports describing serious harm or death

Priority contributory themes

Fewer than half of the 996 reports (n = 431, 43%) contained descriptions of contributory factors. Combined with insights generated by thematic analysis, the four main contributory themes underpinning serious harm- and death-related incidents were:

  1. communication errors in the referral and discharge of patients
  2. physician decision-making
  3. delays in cancer diagnosis associated with unfamiliar symptom presentation and/or inadequate administration
  4. delayed management or mismanagement following failures to recognise signs of clinical (medical, surgical and mental health) deterioration.

Table 8 highlights the proportion of serious harms and death outcomes by each theme.

TABLE 8

TABLE 8

Summary of incident reports describing serious harm or death outcomes by priority contributory theme

Factors contributing to incidents describing serious harm and death

In this section, we provide a summary of the contributory factors identified in all serious harm and death reports.

Patient-related factors were the most frequently reported (n = 215) contributors to incidents resulting in serious harm and death. These included patient characteristics, such as patient pathophysiology (n = 51) or frailty (n = 21). For example, one patient without a care package following discharge from hospital, and with poor eyesight, self-administered the wrong dose of insulin. Rare presentations, such as for an atypical cancer presentation, or a rare disease such as bladder cancer in a young child, may have made diagnosis more challenging in 43 incidents. Service-related contributory factors were also frequently described (n = 190). The out-of-hours primary care services (n = 48) were often implicated; for example, some incidents were attributed to the failure of HCPs to share information. In one case, the out-of-hours service failed to pass on urgent blood test results to the patient’s GP and thereby delayed further assessment. Forty-one incidents were attributed to inadequate protocols; for example, inadequate protocols regarding the handling of referrals by mental health teams resulted in some cases delays in assessment, and led to deterioration in the patient’s mental health or death by suicide. Working conditions, such as staff being too busy to spend sufficient time assessing a patient, were described in 17 reports. Staff-related factors were described in 108 reports and included failure to follow protocols (n = 38), such as those for warfarin dosing, and staff members having an inadequate skill set or knowledge to assess acutely unwell patients, resulting in missed emergency diagnoses (n = 36).

Examination of priority themes

In this section, we will define each priority theme by considering the role of identified contributory factors, and, when relevant, the events leading up to the incident, and other contextual issues identified by thematic analysis.

Communication errors in the referral and discharge of patients

Errors in the processes involved in transferring patient information compromised the continuity of care between primary and secondary care. The most frequently reported error, mentioned in 47 reports, was the failure of referral to take place as intended. These resulted in delays in management for 18 patients and in the death of 10 patients. For example:

Discharge home with pressure sore on sacrum and × 2 heels from [community hospital]. Unable to mobilise and/or eat and drink – district nurse was not informed.

Errors relating to referrals not being made were sometimes preceded by another incident, including poor discharge planning, for example failure to refer to community practitioners such as district nurses for wound reviews (n = 10), missed diagnoses (n = 7) or failure to transfer patient information (n = 5), such as failure to send patients’ discharge summaries to their GP.

Premature or incomplete discharge planning was described in a further 31 reports. In 27 cases this resulted in the patient being readmitted to hospital; two patients died. One report described a frail elderly gentleman who could not cope without additional support at home following discharge and, as a result of self-neglect, developed cellulitis from leg wounds. He was eventually readmitted to hospital but later died. Of the 21 incidents in which patient age was reported, nearly three-quarters (n = 15) of patients were aged ≥ 66 years.

A further 22 incidents involved errors in the transfer of patient information between different health-care settings, with 10 resulting in the patient’s admission to hospital. These included incomplete discharge summaries (n = 5), failure to send discharge summaries (n = 5) and delay in sending discharge summaries (n = 4). In four cases, the patient’s GP failed to action recommendations included in the discharge summary. For example:

Patient attended GP appointment with a new resident GP. Enquired about the referral to urology department at acute hospital that should have been made by the long-term locum GP 3 months previous. On investigation, it was found unsent in the records.

Few contributory factors were reported in relation to incidents involving poor communication between health-care providers. Of note, poor continuity of care between health-care providers was only explicitly reported as a potential contributory factor in five cases.

Physician decision-making

In total, 96 incidents were identified as resulting from physician decision-making: 24 reports described errors in the clinical treatment decision process, 50 reports described errors in prescribing medications and 22 recorded errors in monitoring dose-dependent medications. For example:

Patient discharged from [hospital] on [date]; no warfarin dose or INR results sent to GP. INR checked and information added to INRstar (or did not enter dose was changed in hospital). Patient given 2 mg daily (subsequently found dose in hospital was 0.5 mg). Patient suffered GI [gastrointestinal] bleed and died on [date].

Over half (n = 56, 58%) of the reports were preceded by another incident. The interface between physicians, existing paper-based and/or computer-based systems and patients was the apparent underlying issue in a number of these incidents. Errors in the transfer of patient information between health-care settings were recorded in 17 reports, and errors in the process of recording, storing and accessing patient documentation in a further seven reports. Inadequate communication with patients was described in eight reports. For example, one report detailed a district nurse missing the opportunity to check the immunisation status of a patient; the patient did not receive the required pneumococcal vaccine and subsequently developed pneumococcal sepsis. In another example, the GP failed to act on discharge advice:

Practice notified that patient was being discharged following 10-day admission for treatment of iatrogenic hypercalcaemia caused by a high dose of alfacalcidol. GP did not change dose of alfacalcidiol as stated in letter.

At least one contributory factor was identified in over half (n = 54, 56%) of physician-related medication errors. Twelve reports described how patient behaviour or actions contributed to the development of incidents, for example non-compliance with instructions from the patient’s physician in some cases resulted in adverse drug events and recurrence of the patient’s illness.

A further 15 incidents were due, at least in part, to staff members failing to follow protocols or having an inadequate skill set or knowledge. For example, one GP prescribed 10 times the recommended dose of trimethoprim for an 8-week-old baby. Service-related factors included poor continuity of care between different HCPs (n = 8); for example, one patient received the wrong doses of insulin as a result of the lack of communication between the discharging medical team and the district nurses. Four incidents arose, at least in part, because the patient received care from an out-of-hours service. For example, one patient was prescribed a large quantity of amitriptyline by an out-of-hours GP despite a history of overdose, and was found dead 2 days later. This highlights the lack of background clinical information available to out-of-hours service doctors when making clinical decisions. Of particular note, 17 adverse events followed an error in the process of monitoring medications, of which 14 involved staff failing to follow protocol or having an inadequate skill set or knowledge. This included one case in which a patient’s INR was not monitored despite the patient being prescribed anti-tuberculosis medications known to interact with warfarin. The patient subsequently developed a pontine cerebrovascular event and was found to have an INR of 10. Another staff-related factor was mistakes in prescribing medications (n = 8), such as confusing drugs with similar names or appearances. For example:

A locum GP diagnosed tonsillitis and prescribed [p]enicillamine instead of [p]enicillin. The patient was unaware of the mistake and took the tablets as prescribed. He sought further medical advice as symptoms were not improving.

Delays in cancer diagnosis associated with unfamiliar symptom presentation and/or inadequate administration

Communication process errors commonly underpin missed and delayed cancer diagnoses. Missed or delayed cancer diagnosis accounted for 9% (n = 93) of reports describing serious patient harm or death. In 25 cases, these were preceded by an incident involving investigative processes, such as an error in reporting of diagnostic imaging results. In 16 cases, communication process errors were preceded by a referral error. For example, an elderly patient with an identified lung opacification on a chest radiograph was given a routine rather than an urgent referral. By the time adenocarcinoma was diagnosed, the cancer had metastasised and the patient developed carcinomatosis. Another 59 reports recorded a delay in the assessment or management of a cancer diagnosis, and 18 of those described the death of a patient. For example:

Patient attended surgery with symptoms of irritable bowel syndrome. Given prescription, over next few months came back for telephone advice. Told had colitis and given further medication. Patient was not given a PR [per rectal] examination at any visit. Referred to endoscopy 7 months later and found to have bowel tumour. Patient undergoing chemotherapy at the time of report.

In over half of incidents involving a delay in cancer diagnosis, the patient’s age was recorded (n = 24, 62%), and missed cancer diagnoses were reported for a broad range of age groups. Symptoms of a rare presentation was the most common contributory factor for a delayed cancer diagnosis. Other factors included non-disclosure of symptoms (n = 9) and visiting different HCPs for the same symptoms (n = 6). For example:

Patient’s mother contacted the Patient Advice and Liaison Service, stating that her adult daughter died. For 6 months prior to her daughter’s death, the GP had been treating her for migraine, anxiety, depression and panic attacks. In addition, she had been losing her eyesight but the GP had insisted that she see an optician who had referred her back to the GP, stating that something else was amiss. The patient had been told that the GP was in touch with the optician. After the patient died, two brain tumours were discovered.

Failures to recognise signs of clinical deterioration

Missed or delayed diagnosis of an acute clinical condition (n = 61) frequently resulted from errors during telephone triage (n = 28), of which seven involved out-of-hours services. For example:

Call passed from NHS Direct to out-of-hours service with a ‘less urgent’ priority. 10-week-old baby with central cyanosis, increased respiratory rate, and ‘noisy’ breathing.

Acute clinical conditions were missed in 23 reports, and a further 10 reports described the delayed diagnosis of an emergency condition, such as bowel perforation, which resulted in a delayed hospital admission and the death of a patient. Another example includes:

2-month-old baby taken to A&E [accident and emergency] as Sudden Unexpected Death of Infancy having died at home. Baby had been seen by GP on previous evening with temperature of 38 Celsius; diagnosed with possible chest infection and prescribed amoxicillin. NICE guidance states that fever ≥ 38 Celsius in child less than 3 months is a red flag and a child should be admitted to hospital. Preliminary results from post-mortem suggest that infection is likely cause of death.

Involvement of out-of-hours services was described in 10 of these incidents. For example:

Patient seen on home visit. Advised had been seen with symptoms strongly suggestive of an acute stroke at home by out-of-hours service at approximately 2015 hours yesterday evening and told to contact her GP the next morning. Policy is that patient suspected of suffering an acute stroke should be admitted as a 999 to hospital for appropriate diagnosis and treatment.

In eight cases, the HCP did not appreciate the severity of illness, leading to delays in escalating concerns and co-ordinating urgent transport to hospital. Of the 36 reports that described emergency transport delays, 10 stated that the delay was preceded by failures in triaging patients or in the assessment of acutely unwell patients. In addition, four incidents were preceded by inadequate verbal communication between HCPs.

Errors in the process of identifying patients at risk of deterioration as a result of mental health problems were largely fatal, with 27 out of 29 incidents resulting in the death of a patient. The majority of these involved the patient taking an overdose of medication. Patient behaviour, such as not attending a planned review with their GP, contributed to these incidents in five cases.

Copyright © Queen’s Printer and Controller of HMSO 2016. This work was produced by Carson-Stevens et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK385181

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