According to an article published by the Becker’s Hospital Review (Vaidva, Zimmerman, & Bean, 2018), the top 10 patient safety concerns for 2018 are:
Disparate EHRs (electronic health records)
Hand hygiene
Nurse-patient ratios
To prepare for this Discussion:
Review this week’s Learning Resources. Pay particular attention to the Learning Resources focused on policy in the healthcare setting to improve patient safety.
Find a peer-reviewed journal article (no more than 5 years old) in the Walden Library that focuses on policy in the healthcare setting and its impact on patient safety. NOTE: Do not just focus on medical errors. Instead, find an article that addresses the circumstances that led to an unsafe action (i.e., that compromised patient safety), which in turn led to the implementation of a policy in the healthcare workplace.
Review this week’s Learning Resources. Pay particular attention to the Learning Resources focused on policy in the healthcare setting to improve patient safety.Review Vaidya, Zimmerman, and Bean’s op 10 patient safety issues for 2018.”
Find a peer-reviewed journal article (no more than 5 years old) in the Walden Library that focuses on policy in the healthcare setting and its impact on patient safety. NOTE: Do not just focus on medical errors. Instead, find an article that addresses the circumstances that led to an unsafe action (i.e., that compromised patient safety), which in turn led to the implementation of a policy in the healthcare workplace.
ORIGINAL RESEARCH
Clinical Medicine 2022 Vol 22, No 5: 423–33
A content analysis of contributory factors reported in
serious incident investigation reports in hospital care
ABSTRACT
Authors: Mohammad F Peerally, A Sue Carr,B Justin Waring,C Graham MartinD and Mary Dixon-WoodsE
Background
Serious incident (SI) investigations aim to identify factors that
caused or could have caused serious patient harm. This study
aimed to use the Human Factors Analysis and Classification
System (HFACS) to characterise the contributory factors
identified in SI investigation reports.
Methods
We performed a content analysis of 126 investigation reports
from a multi-site NHS trust. We used a HFACS-based framework
that was modified through inductive analysis of the data.
Results
Using the modified HFACS framework, ‘unsafe actions’
were the most commonly identified hierarchical level of
contributory factors in investigation reports, which were
identified 282 times across 99 (79%) incidents. ‘Preconditions
to unsafe acts’ (identified 223 times in 91 (72%) incidents)
included miscommunication and environmental factors.
Supervisory factors were identified 73 times across 40 (31%)
incidents, and organisational factors 115 times across 59 (47%)
incidents. We identified ‘extra-organisational factors’ as a
new HFACS level, though it was infrequently described.
Conclusions
Analysis of SI investigation reports using a modified
HFACS framework allows important insights into what
investigators view as contributory factors. We found an
emphasis on human error but little engagement with why it
occurs. Better investigations will require independence and
professionalisation of investigators, human factors expertise,
and a systems approach.
KEYWORDS: patient safety, incident investigations, Human Factors
Analysis and Classification System, HFACS, adverse event
DOI: 10.7861/clinmed.2022-0042
Authors: Aassociate professor, University of Leicester, Leicester,
UK and consultant gastroenterologist, Kettering General Hospital,
Kettering, UK; Bconsultant nephrologist, University Hospitals of
Leicester NHS Trust, Leicester, UK and deputy medical director
General Medical Council, London, UK; Cprofessor of medical
sociology and healthcare organisation, University of Birmingham
School of Social Policy, Birmingham, UK; Ddirector of research, THIS
Institute, Cambridge, UK; Edirector and professor of healthcare
improvement studies, THIS Institute, Cambridge, UK
© Royal College of Physicians 2022. All rights reserved.
Introduction
Over 1.4 million patient safety incidents (defined as events that
cause or could cause harm to patients) are reported to NHS England
annually.1 More than 20,000 are classed as ‘serious’ according to
their level of harm or their potential to cause serious harm.2 Those
adverse events classed as ‘serious incidents’ (SIs) are required to be
notified to local commissioners of healthcare services and undergo
a structured investigation led by the healthcare organisation where
the incident occurred, with the aim of determining contributory
factors (see supplementary material S1).
One commonly used approach for investigating adverse
events in high-risk industries (including healthcare) is root
cause analysis (RCA).1,3 RCA seeks to provide an analytical
framework for investigators to construct an understanding of
what happened and why, with the aim of identifying underlying
causes and informing future preventive actions.1 In the English
healthcare context, RCA investigations are usually undertaken
by in-house investigators who gather evidence from varying
sources (eg medical records, interviews and statements) and
establish a timeline of key facts. An analysis of factors that appear
to have contributed to the incident is then undertaken using
various RCA tools (eg fishbone diagrams or five whys).4,5 Finally,
recommendations are generated and an action plan formulated.6
Previous research on incident investigations has typically focused
on analyses of particular classes of incident (eg adverse drug
reactions or inpatient suicides) or of specific specialties (eg intensive
care).7–9 These studies have produced valuable learning about what
investigators identify as contributing factors for incidents in specific
areas. However, study at the organisational level (agnostic to class
of incident or specialty) has remained limited despite criticisms
that RCAs may fail to identify and address systemic issues within
organisations across multiple incidents.10,11
To understand what investigators report as factors contributing
to SIs at an organisational level, a structured framework is of
potential benefit. Though several options are available, an important
example of such a framework is the Human Factors Analysis and
Classification System (HFACS).6,12–15 HFACS builds on Reason’s Swiss
cheese model by providing taxonomies for active failures and latent
conditions, divided into four levels: unsafe actions, preconditions
for unsafe acts, unsafe supervision and organisational influences.16
Each level comprises several sub-levels corresponding to aspects of
human behaviour or properties of systems that may contribute to an
error.14 Originally developed for accident analysis in aviation, HFACS
demonstrates good analytic properties and has been modified for use
in healthcare.15,17–19 Isherwood et al are among those who propose
423
Mohammad F Peerally, Sue Carr, Justin Waring et al
that HFACS-based frameworks have particular value in healthcare,
facilitating the identification of system-based actions that can help
reduce the likelihood of future serious incidents.20
We conducted a structured analysis of investigation reports from
different specialties using a modified HFACS framework in a multisite English hospital trust to characterise the kinds of contributory
factors identified by investigators in these reports.
Methods
Setting
Stage 1: Open coding of SI investigation reports
Using an inductive approach, two researchers analysed a subsample of 60 SI investigation reports independently by reading
and re-reading them to familiarise themselves with the data
before performing open coding of contributory factors from the
SI investigation reports.22 In keeping with qualitative research
norms, they compared their coding to reach consensus.23 A third
researcher was available when consensus could not be reached or
where ambiguities remained.
Stage 2: Content analysis of contributory factors using a
HFACS framework
The study was located at a large teaching hospital trust with over
10,000 staff looking after over one million patients per year. It
followed the SI reporting process, investigation techniques and
reporting templates set out by the NHS SI framework policy.1
Data collection and sample
A search was carried out in July 2016 of the trust’s risk
management software (RLDatix (formerly Datix)) to identify
anonymised SI investigation reports presented to local
commissioners between 01 January 2013 and 31 December 2015.
The sample did not include investigations that were still ongoing.
It also excluded investigations into pressure ulcers and healthcareassociated infections (such as Methicillin-resistant Staphylococcus
aureus bacteraemia or Clostridioides difficile) as these events were
locally investigated using different processes. Each report included
in the sample covers an individual incident. Each was expected
to be prepared using the guidelines of the SI framework from
NHS England though, in practice, the formats varied somewhat.1
Typically, each SI investigation report included a background to
the incident, a chronology of key events in the care of the patient,
a breakdown of service and care delivery problems as identified by
investigators, the root causes, and the actions taken.1
We started by using a HFACS framework that was previously
developed in a healthcare context and used the open codes from
stage 1 to make some initial adjustments.15 This version of the
framework was modified iteratively following interaction with
successive SI investigation reports to produce a modified HFACS
framework (Fig 2 and supplementary material S2). All included
SI investigation reports were analysed using this modified HFACs
framework based on the principles of content analysis.24 Data
analysis was supported by NVivo (QSR International, Burlington,
USA). Simple descriptive statistics were generated to report the
frequencies of different types of incidents as reported in the SI
investigation reports, roles of members of the investigating teams,
departments and patient outcomes.
Research ethics
The study was deemed not to require ethical board approval
according to the decision tool from the NHS Health Research
Authority website (www.hra-decisiontools.org.uk/ethics) and
was registered with the trust’s audit and service evaluation team
(project 6545).
Data analysis
Results
Data analysis involved two stages, involving inductive and
deductive approaches (Fig 1), led by two researchers with expertise
in qualitative research and incident investigation.21 One researcher
had additional training on use of HFACS. No researcher had been
involved in any of the investigations studied.
We identified 126 investigation reports into SIs that met the
inclusion criteria for the period studied: 36 in 2013, 50 in 2014 and
40 in 2015. The incidents had been investigated by teams mostly
comprising representatives from the trust’s patient safety team
(115 (91%)), consultants (109 (87%)) and senior nurses (band 7 or
Open coding of 60 SI
invesgaon reports
(researcher 1)
HFACS framework
Applied to the whole data set
using content analysis
Fig 1. Data analysis process. HFACS = Human
Factors Analysis and Classification System; SI =
serious incidents.
424
+
Open coding of 60 SI
invesgaon reports
(researcher 2)
Stage 1
Collecvely agree a set of codes
of contributory factors
Modified HFACS
framework
Iterave modificaon of the HFACS
framework when applied to the data set
126 SI
invesgaon
reports
Stage 2
Characterisaon of contributory factors
based on the modified HFACS framework
© Royal College of Physicians 2022. All rights reserved.
HFACS analysis of contributory factors to SIs
Extra-organisaonal
factors
Organisaonal
factors
Opera onal
processes
Resource
management
Organisa onal
culture
Supervisory
factors
Inadequate
oversight
Inadequate
planning
Failure to
address a known
problem
Supervisory
viola ons
Precondions for
unsafe acts
Environmental
factors
Communica on
factors
Team dynamics
Staff wellbeing and
preparedness for
work
Pa ent factors
Unsafe acons
Errors
Viola ons
Decision-based
errors
Rou ne
viola ons
Ac on-based
errors
Excep onal
viola ons
Fig 2. Modified Human Factors Analysis
and Classification System.
Perceptual
errors
above; 85 (67%)). Human factors specialists were involved in three
(2%) investigations.
Characteristics of the incidents investigated
The two most frequently occurring incident types were ‘inpatient
falls’ (15 (12%)) and ‘delayed or missed diagnosis of other (noncancer) condition’ (15 (12%); Table 1). Emergency medicine (18%),
and obstetrics and gynaecology (15%) were the two specialties
most commonly involved based on the SI investigation reports
(Table 2). Table 3 shows the patient outcomes from the SIs, with
‘death’ the most frequent outcome (37 (29%)). Twenty-seven
(21%) cases resulted in no harm.
Content analysis of contributory factors using the
modified HFACS framework
The final framework produced by our inductive and deductive
analysis (modified HFACS; Fig 2) comprised five levels: extraorganisational factors, organisational factors, supervisory factors,
preconditions for unsafe acts and unsafe actions. Each level was
further divided into numerous sub-levels of contributory factors
(supplementary material S2).
© Royal College of Physicians 2022. All rights reserved.
Table 1. Ten most common types of serious
incidents from investigation reports generated
between 2013 and 2015
Type of serious incidents
n (%)
Fall
15 (12)
Delayed/missed diagnosis of non-cancer condition
15 (12)
Unexpected death
14 (11)
≥10 drug error
12 (10)
Failure to recognise deteriorating patient
12 (10)
Delayed/missed diagnosis of cancer
9 (7)
Delay in following up patient / patient not followed
up
8 (6)
Capacity issues (eg beds)
6 (5)
Wrong implants/devices
5 (4)
Inappropriate treatment
4 (3)
Using this framework, we identified 701 contributory factors
(median per incident 4 (interquartile range 2–7)) across the 126
425
Mohammad F Peerally, Sue Carr, Justin Waring et al
Table 2. Five most common specialties involved in
the serious incident investigation reports reviewed
between 2013 and 2015
Specialty
n (%)
Emergency medicine
23 (18)
Obstetrics and gynaecology
19 (15)
Radiology
11 (9)
Paediatrics and neonates
11 (9)
Ophthalmology
7 (6)
SI reports. Table 4 provides a breakdown of frequencies and
percentages of the five different levels of contributory factors and
their respective sub-levels, accompanied with illustrative excerpts
from the SI investigation reports. We provide descriptions of each
level in supplementary material S2.
Unsafe actions
The most commonly identified level of contributory factor in the
reports was ‘unsafe actions’, comprising errors and violations. We
identified that ‘unsafe actions’ were reported 282 times across 99
(79%) incidents.
We identified that errors (defined by Diller et al as mistakes,
unintentional slips and lapses (action-based errors and perceptual
errors) or conscious actions that proceed as intended but were
inappropriate for the situation (decision-based errors)) were
reported 162 times across 79 (63%) incidents.15
Decision-based errors in the reports related to inadequate clinical
decision-making (eg due to poor judgement and cognitive biases;
Table 4, extract 1), though deeper insights into the rationale for
poor decision-making were rarely provided by investigations.
Action-based errors (unintentional slips and lapses made during
the execution of seemingly familiar tasks) were reported to have
occurred despite controls in place to mitigate risk, such as checklists
and guidelines (Table 4, extract 2). Perceptual errors, such as
important clinical information being missed or misinterpreted by
staff, were rarely identified in investigation reports. When described,
Table 3. Degree of harm to patients in serious
incident investigation reports reviewed that had
occurred between 2013 and 2015
Effect on patient
n (%)
Death
37 (29)
Damage to organs
35 (28)
None
27 (21)
Delay in diagnosis/treatment
20 (16)
Psychological
2 (2)
Unknown
2 (2)
Risk of future complications
1 (1)
Transient physiological compromise
1 (1)
Decreased functionality
1 (1)
426
they were found in medication prescribing and administration, and
interpretation of radiological imaging (Table 4, extract 3).
Routine violations in the reports characteristically involved poor
documentation practices (Table 4, extract 4) and non-compliance
with written policies and guidelines. Exceptional violations (failures
to perform critical job activities) included delays in responding to
emergencies or acting upon results (Table 4, extract 5).15 Investigation
reports did not probe into the rationales for either type of violation.
Preconditions for unsafe acts
We identified ‘preconditions for unsafe acts’ reported 223
times across 91 (72%) incidents, comprising five sub-levels:
environmental factors, communication factors, patient factors,
factors relating to staff wellbeing and issues with team dynamics.
We deemed environmental factors to be physical, technological
and cultural (based on local context) in nature. Physical
environmental factors included those relating to the settings
within which patient care was delivered, eg high levels of activity
in clinical areas leading to overstretched resources (Table 4,
extract 6). Technological factors concerned issues with the design
and usability of IT systems and equipment, lack of inter-operability
between software solutions (Table 4, extract 7) and poorly
designed hardware, including some hazards that had already been
identified nationally (Table 4, extract 8). Local cultural factors
included the normalisation of potentially unsafe practices, such as
workarounds when completing checklists (Table 4 extract 9).
We identified communication factors as contributory factors
in the incident investigation reports at all organisational levels
(micro-level (between members of the same team such as at shift
handovers), meso-level (between departments) and macro-level
(between organisations)). Poor communication was reported to
result in lack of shared mental models of evolving clinical situations
(Table 4, extract 10). When investigators did probe the rationales
for communication failures, a recurring finding was lack of training
among staff members on how to use clinical and administrative
systems in place. Such training deficiencies were identified in relation
to some widely used tools in healthcare, such as the World Health
Organization (WHO) surgical safety checklist (Table 4, extract 11).
Supervisory factors
‘Supervisory factors’ in the reports comprised those decisions and
actions made by staff in positions of authority at a departmental
level that adversely affected performance in the organisation and
delivery of healthcare.14,15 Of the five broad levels of contributory
factors, supervisory factors were reported least frequently
(73 instances across 40 (31%) incidents). We deemed unsafe
supervision to be due to inappropriate planning, poor oversight,
failures to address known problems and supervisory violations
(Table 4, extracts 16 to 19). The most frequently identified
‘supervisory factor’ was inappropriate planning, present in 19%
of incidents. These instances led to patient-facing staff being
overloaded with work and created unbalanced teams, ultimately
leading to hazard-prone situations, sometimes despite prior
warnings from patient-facing staff (Table 4, extract 16).
Organisational factors
‘Organisational factors’, which we identified in reports 115 times
across 59 (47%) incidents, included actions and decisions made
© Royal College of Physicians 2022. All rights reserved.
HFACS analysis of contributory factors to SIs
Table 4. Frequencies of different levels of the modified Human Factors Analysis and Classification System
framework and corresponding textual extracts
Modified HFACS level
Incidents, n (%)
References across all
incidents, n (%)a
Illustrative quotes
Unsafe actions
99 (79)
282 (40)
Errors
79 (63)
162 (23)
Decision-based
62 (49)
117 (17)
Extract 1: Poor choice and timeliness of antibiotic
prescription; E-39:
Mrs X was still on a course of oral co-amoxiclav … but
in breach of the requirement for [intravenous (IV)]
antibiotics as set out in the sepsis pathway, IV antibiotics
were not commenced until [2 days later] when IV
co-amoxiclav was prescribed (the Sepsis Six pathway
recommends consideration of meropenem if severe sepsis
is suspected).
Action-based
26 (21)
36 (5)
Extract 2: Insertion of the wrong lens during cataract
surgery; E-52:
In line with the intraocular lens protocol, the ophthalmic
fellow circled their lens choice (lens A on the biometry
form). The lens [that] the ophthalmic fellow should have
circled, lens D, was in the box directly adjacent to lens A.
Perceptual
8 (6)
9 (1)
Extract 3: Wrong insulin dose; E-18:
The patient was administered an evening dose of insulin
by nurse B who had checked the medication with an
agency nurse. It was recorded … that 64 units had been
given. Both nurses … misread the prescription, reading
6U as 64 … they did not recognise that an error had
occurred … In other words what the nurse thought they
saw, wasn’t what was actually written because their mind
constructed a different pattern with data.
Violations
59 (47)
120 (17)
Routine
46 (37)
79 (11)
Extract 4: Poor record keeping; E-12:
The standard of record keeping [while] Ms Y was on ward
N and prior to the caesarean section was poor, with the
majority of documentation within the maternal notes
being retrospective.
Exceptional
30 (24)
41 (6)
Extract 5: Delay in reviewing test results; C-39:
Preconditions for
unsafe acts
91 (72)
223 (32)
Environmental factors
56 (44)
92 (13)
There was a 12-hour delay in reviewing the x-ray.
© Royal College of Physicians 2022. All rights reserved.
Extract 6: Overstretched emergency department (ED);
D-06:
The capacity situation on both sites was full within the
assessment areas. The flow throughout the organisation
was poor hence patients were waiting within the ED.
The requirement for monitored beds was extremely
high hence the option was considered for patient to be
accommodated at site M.
Extract 7: Non-compatible software; D-05:
The investigation team identified the difficulty of
obtaining the [magnetic resonance imaging] images from
another hospital due to non-compatible IT systems.
427
Mohammad F Peerally, Sue Carr, Justin Waring et al
Table 4. Frequencies of different levels of the modified Human Factors Analysis and Classification System
framework and corresponding textual extracts (Continued)
Extract 8: Compatibility of epidural and intravenous
connections; D-33:
On the day of the incident, the nurse reported being
distracted by multiple conflicting priorities and therefore
was rushing to complete the request. This led to a human
error of the nurse connecting the lines incorrectly …
Epidural connections are compatible with IV connectors.
Extract 9: Locally accepted workarounds; E-05:
The [surgeon] was not directly involved in the theatre
checklist [World Health Organization] process for this
patient, as he was scrubbing for procedure in an adjacent
area. This was not challenged by the nursing team as it
had been standard practice within the service.
Communication factors
49 (39)
80 (11)
Extract 10: Lack of shared mental model; E-12:
Delays in the tasks allocated to midwives resulted
in knock-on delays in Ms Z’s transfer and lack of
communication at handover meant the urgency for
continued [fetal] heart monitoring and a medical review
was not appreciated.
Extract 11: Lack of training to use communication tools;
E-40:
However, although the [electronic system] is uploaded
onto all of the … computers in [the admission unit], the
staff had not been instructed on the use of [it].
Patient factors
27 (21)
33 (5)
Extract 12: Complexity and rarity of medical conditions;
E-08:
The patient had an atypical presentation of [condition A].
Therefore, the respiratory physician felt that a diagnosis
of [condition B] was much more likely. [Condition A] is
extremely rare and so was not considered … It is thought
that colleagues of similar experience would probably have
taken the same actions.
Staff wellbeing and
preparedness for work
8 (6)
10 (1)
Extract 13: Work-related stress; D-47:
The ED was experiencing very high inflow during the
evening … Additionally, a [member of staff] had been
unexpectedly brought into the department in cardiac
arrest … which inevitably adversely impacted on the
psychological wellbeing of the ED staff in the department.
Failure to maintain proficiency; E-37:
All clinical staff are required to complete [mental capacity
assessment] e-learning training. This is essential to job
role training and is linked to performance objectives at
appraisal … not all the ward team have completed this
training.
Team dynamics
6 (5)
8 (1)
Extract 15: Poor team working; D-29:
When [the patient] had severe bleeding … the
investigation team considered [that] there was a lack of
team working when assessing and managing the wound
problems. Surgeon F was initially trying to deal with
the problem when surgeon G arrived and proceeded to
attempt to control the bleeding. The patient transferred
to theatre, but it is reported that surgeon F appeared to
prefer to seek advice from outside the trust rather than
from experienced colleagues within [the trust].
428
© Royal College of Physicians 2022. All rights reserved.
HFACS analysis of contributory factors to SIs
Table 4. Frequencies of different levels of the modified Human Factors Analysis and Classification System
framework and corresponding textual extracts (Continued)
Supervisory factors
40 (31)
73 (10)
Inappropriate planning
24 (19)
36 (5)
Extract 16: Poor planning leading to over-stretched
patient-facing staff; D-33:
Nurse Q was supporting two other members of staff.
The baby being cared for by the nurse who was being
supervised by nurse Q, was ventilated … and required a
lot of additional interventions from nurse Q. At the time
of being allocated to support the nurse in supernumerary
period and the nurse who was undergoing additional
training, nurse Q challenged the decision making but the
shift leader felt the allocation was appropriate.
Inadequate oversight
16 (13)
26 (4)
Extract 17: Poor supervision of junior staff; E-35:
During the night, [specialist registrar] C contacted
consultant D on five occasions with concerns
regarding Mrs K, her pain, the fall in her haemoglobin,
the development of [disseminated intravascular
coagulopathy] and the activation of the major
haemorrhage protocol, and yet consultant D did not
come into the hospital until 09.00 hours when Mrs K was
already in theatre.
Failure to address a
known problem
6 (5)
6 (1)
Extract 18: Unaddressed hazards: C-32:
Prior to this incident, another patient had attempted
to harm themselves by hanging in the same toilet, this
attempt was unsuccessful, and patient came to no harm,
but the incident was a missed opportunity to recognise
the risks posed by that environment.
Supervisory violations
5 (4)
5 (1)
Extract 19: Significant deviation from accepted practice;
E-14:
The [head of service] had reviewed and approved the
locum consultant’s [curriculum vitae] … however, [they]
had not met and discussed the locum consultant’s
competency or experience in person since he had
commenced employment in the trust. This was
considered … a serious service delivery failure.
Organisational factors
59 (47)
115 (16)
Operational process
41 (33)
56 (8)
© Royal College of Physicians 2022. All rights reserved.
Extract 20: Confusing guidelines; E-49:
There was a general awareness of the [referral to
treatment] policy but the policy was described ‘too
difficult to follow’ and did not give clear guidance on
the management of the planned waiting list … To some
extent, the difficulties between colleagues appeared
to be generated by ‘system’ problems within the team
including that of staff having unclear standards and not
having defined responsibilities … complicated technical
guidance as well as lack of general support.
Extract 21: Patients falling through the net; E-01:
The current system relies on active engagement from the
patient to make contact via the telephone and there is no
evidence that the patient did this in order to book the test
… At the time of the incident there were no procedures
in place to follow up patients that do not make contact
with the administrative team and once removed from the
waiting list there is no further contact with the patient
unless they contact the team or are re-referred in.
429
Mohammad F Peerally, Sue Carr, Justin Waring et al
Table 4. Frequencies of different levels of the modified Human Factors Analysis and Classification System
framework and corresponding textual extracts (Continued)
Resource management
38 (30)
53 (8)
Extract 22: Inadequate staffing; E-02:
Due to changes of clinicians and reduced number
of clinicians within department P, the patient was
being seen by different doctors at some outpatient
attendances. This resulted in lack of continuity of care
and probably lack of ownership of this patient’s care.
Organisational culture
5 (4)
6 (1)
Extract 23: Hierarchical practices; E-39:
The [specialist nurse on duty that day] did not consider
making the referral [to the vascular team] herself. It
is now known that it was at that time acceptable for
direct referrals to be made via the on call vascular
administration registrar by nurses when required, but this
did not happen … historically, referrals [in trust H] are
only made by doctors.
Extra-organisational
factors
7 (6)
8 (1)
Extract 24: National shortage of staff with specific skills; E-44:
Due to the national shortage of radiologists, the department
uses locum staff. There are known difficulties in recruiting
into vacancies. This is due to the specialisation of
radiologists and recruiting into those specialties. There are
currently three vacancies [being advertised that] have not
been filled as there has been only one applicant to one of
the specialist posts.
a
Each reference denotes an occasion where a contributory factor in the incident investigation report was identified. HFACS = Human Factors Analysis and Classification System.
at the blunt end of the organisation that negatively impacted on
patient safety. These factors affected operational choices made
in individual departments and impacted on staff performance at
the sharp end.14,15 We further distinguished them into three sublevels, pertaining to issues with operational processes, resource
management and organisational culture.
Poor operational processes included instances where decisions
and rules (or lack thereof) from senior management ultimately
undermined how the organisation functioned, frustrating its ability
to deliver on goals for direct patient care. Examples included the
absence or impracticality of guidelines and standard operating
procedures, generating confusion among staff (Table 4, extract
20). Some organisational rules and practices had been in operation
for some time, despite their apparent lack of effectiveness and,
occasionally, deficient logic (Table 4, extract 21).
Issues relating to resource management consisted of
inappropriate handling of organisational assets, leading to unsafe
working conditions. A recurring issue was inadequate staffing
leading to poor continuity of care, reduced supervision of junior
staff and high caseloads (Table 4, extract 22).
As shown in Table 4, we rarely identified factors in the reports
relating to organisational culture (ie shared ways of thinking,
feeling and behaving across different departments in the trust).
When organisation culture factors were reported, they included
practices perpetuating hierarchical barriers that had remained
unquestioned (Table 4, extract 23).
Extra-organisational factors
We identified a limited number of factors from the SI investigation
reports that lay beyond the remit of the trust (eight references
across seven (6%) incidents). This level was not previously
430
described in the HFACS framework used by Diller et al.15 Though
rarely explored by investigators, we identified examples of ‘extraorganisational factors’, including system-wide lack of resources
(such as a lack of particular skills and limitations of national
guidance; Table 4, extract 24).
Discussion
Our analysis, using a modified HFACS framework, characterised
the contributory factors identified in 126 SI investigation reports
over a 3-year period in an NHS trust. The findings should not be
understood as providing an objective account of the true causes
of incidents or their relative frequencies. Instead, the distinctive
achievement of this analysis is to offer significant insight into
what investigators see as contributory factors to incidents that
they describe in investigation reports. Our findings raise questions
about why investigation teams identify certain contributory
factors more than others, about the absences or silences in
the reports as well as what is made prominent, and about the
potential biases that may influence investigators’ analysis. As
Nicolini reminds us, cultural and organisational priorities are likely
to colour the analytic lens that investigators apply.10
Notably, our analysis shows that there is an emphasis in
investigation reports on problems occurring at the sharp end of
care relating to, for example, clinical decision-making but little
engagement with why they might occur. This may suggest an
undue preoccupation with active errors and individual, rather than
systemic, causes of incidents. Similarly, we identified reported
instances of routine violations (such as poor documentation
practices and non-compliance with written policies) in more than a
third of SI investigation reports. However, the rationales for these
violations and instances of normalisation of deviance (such as
© Royal College of Physicians 2022. All rights reserved.
HFACS analysis of contributory factors to SIs
the influence of managerial decisions) were rarely explored in the
investigation reports. Issues with supervision and organisational
culture were identified much more rarely (making up 10% and
1% of all contributory factors, respectively) mirroring findings
from other studies.15,18 Focusing on the more easily visible slips,
lapses, mistakes and violations neglects the systemic origins of
behaviours at the blunt end of care, may promote a blame culture
and thwart learning.15,25
Another important emphasis in the reports was on
environmental factors (identified in 44% of all SI investigation
reports), such as poorly designed clinical spaces and technological
problems. At the same time, silence largely prevails regarding the
‘extra-organisational factors’ (such as procurement practices or
national standards) that might be implicated. In fact, previous
iterations of the HFACS framework applied to healthcare data
did not include a distinct level of contributory factors beyond
the remit of organisations.15,18,19 Identification of such factors is
of crucial importance in appropriate allocation of responsibility
across the system and, in particular, avoiding assigning individual
organisations the responsibility of solving such issues when they
may not possess the power and resources to do so successfully.26
Implications for practice and policy
These findings have important implications for practice and
policy. First, this study adds to the body of evidence for the
utility of HFACS as a tool to provide insights into the levels
of contributory factors identified from healthcare incident
investigations.15,18,19 HFACS complements other frameworks,
such as the Yorkshire contributory factors framework and the
London protocol, offering an additional level of granularity and
specificity.6,12 HFACS-based analysis may have a valuable role
in sensitising investigators in understanding how factors at the
blunt end of care influence those at the sharp end. A particular
advantage demonstrated by our study is that HFACS analyses
can be conducted at multiple levels (within specific specialties or
organisations, and across a whole healthcare system) to prioritise
targets for interventions.
We suggest that more attention should be paid in SI
investigations to understanding how the physical, technological
and cultural environment contributes to unsafe actions. This
may mean more routinely involving human factors specialists in
healthcare investigations. The limited availability of such expertise
(one qualified human factors specialist for every 300,000 staff
in the NHS in contrast to a ratio of one in 100 in the National
Air Traffic Service) highlights the scale of work ahead.27 More
broadly, these findings suggest that a move from individualisation
of contributory factors to a more system-level understanding of
causes of incidents is likely to be of benefit.
Linked to this, our findings indicate that investigations need
to focus more on identifying ‘organisational’ and ‘supervisory’
factors, as well as those at the ‘extra-organisational’ level; a
domain missing from previous HFACS frameworks. Many of
those factors may not be easily addressed within departments
and local healthcare organisations, and may require referral to
national professional, regulatory or improvement bodies. We
suggest that systems theory has much to offer to understand the
interdependency of contributory factors arising across the whole
healthcare ecology. Systems theory suggests that safety can
only be appreciated when all the interactions between different
components of a system are studied together.28 Examples of
© Royal College of Physicians 2022. All rights reserved.
systems approaches used when investigating causes of incidents
include Leveson’s safety control structure, Rasmussen’s AcciMap
and hierarchical risk management.28,29
We also suggest that local investigators in NHS organisations
should be independent of the department where the adverse
events occurred. Such independence may allow investigators to
question more ‘thorny’ issues (such as organisational culture and
poor supervision) creating a more factual representation of ‘workas-done’ in organisations, especially when things go wrong.30 A
previous qualitative study of railway investigators highlights the
value of independent investigators, empowering them to give a
critical view of operations and provide recommendations without
undue influence from organisation management.31
Lastly, we propose that SI investigations should be conducted by
professionals whose expertise lie primarily in safety investigation
and who also maintain a working knowledge of healthcare
systems.32 This is in contrast to the current reality in healthcare
where most investigators are healthcare workers with expertise
in clinical and nursing domains with a secondary interest, and
perhaps limited expertise, in safety. In England, the conduct of
national safety investigations through the Healthcare Safety
Investigation Branch (staffed with experts in different safety
sciences), the creation of a national patient safety curriculum
and the appointment of patient safety specialists in individual
healthcare organisations with the role of overseeing safety related
work are steps in the right direction.33,34 To improve individual
healthcare organisations’ capacity and capability in investigating
incidents robustly, we propose that local healthcare safety
investigators need to have dedicated time in their job plans to
conduct robust investigations and be supported to develop the
skills required to do so.
Limitations
This study has some limitations. First, the results of the study
may not represent a complete overview of all the contributory
factors to SIs, as we applied a HFACS-based framework
retrospectively to SI investigation reports that had themselves
been produced using RCA findings of investigators. Next, our
sample was limited to a single organisation between 2013
and 2015. Nevertheless, the commonality in results with other
studies using HFACS-based frameworks suggests that the wider
reproducibility of similar findings.15,18,19 Only 20% of the included
SI investigation reports were from incidents involving no harm,
highlighting a potential under-representation of near misses.
Inclusion of more near misses in reports might have allowed a
more transparent discussion of contributory factors. Relatedly,
new guidance on patient safety investigations in England has
been published since we conducted this analysis, prioritising the
conduct of investigations based on the level of risk as opposed to
the level of harm to patients.35
Conclusion
This content analysis of 126 SI investigation reports over a 3-year
period from different specialties in a multi-site organisation using
a modified HFACS framework provides important insights into
the nature of contributory factors identified in reports, but also
indicates that ‘extra-organisational factors’ should be included
as a distinct level in the HFACS framework. There are indications
from our analysis of excessive focus on individual behaviours
431
Mohammad F Peerally, Sue Carr, Justin Waring et al
and actions, to the neglect of systemic and organisational
contributions to serious incidents. To improve the strength of SI
investigations, we suggest the need for increased independence
and professionalisation of investigators, wider involvement of
human factors specialists and the use of systems theory during
the conduct of investigations.
Summary box
What is known?
Previous qualitative analyses of incident investigations have
looked at particular types of incidents and within specific
specialties.
Research looking at identifying influences on incidents across
different types of incidents and specialties is scarce, despite
concerns regarding the strength of current methods (such as root
cause analysis) used to investigate incidents.
What is the question?
Using the principles of content analysis, what are the
contributory factors to serious incidents in healthcare, based on
a modified Human Factors Analysis and Classification System
(HFACS) framework?
What was found?
The most commonly identified level of contributory factors found
from a content analysis of serious incident investigation reports,
based on a HFACS framework, were at the sharp end of care,
focusing on individual behaviours and actions, to the neglect of
systemic and organisational contributions to serious incidents.
Through inductive analysis, we identified ‘extra-organisational
factors’ as a new level to the modified HFACS framework, though
it was rarely detected by serious incident investigators.
What is the implication for practice now?
HFACS is a useful tool that provides deeper insights into
commonly identified contributory factors to incidents and
important factors missing from serious incident investigations.
Increased attention needs to be paid during the conduct of
serious incident investigations to the role of environmental,
organisational and extra-organisational factors on incidents.
More robust investigations will require independence and
professionalisation of investigators, increased involvement of
human factors experts and wider use of systems theory
Supplementary material
Additional supplementary material may be found in the online
version of this article at www.rcpjournals.org/clinmedicine:
S1 – Definition of serious incidents.
S2 – HFACS levels and modifications.
Funding
This study was funded by The Health Foundation’s Improvement
Science Fellowship. Mary Dixon-Woods and Graham Martin’s
contributions were funded by The Health Foundation’s grant to
THIS Institute (grant number RG88620). Mary Dixon-Woods is
a National Institute for Health and Care Research (NIHR) senior
investigator (NF-SI-0617-10026).
432
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Address for correspondence: Dr Mohammad F Peerally,
SAPPHIRE, Department of Health Sciences, George Davies
Centre, University of Leicester, 15 Lancaster Road, Leicester
LE1 7HA, UK.
Email: mfp6@le.ac.uk
Twitter: @FarhadPeerally2
433
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