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\begin{document}

\title{Development and Formative Evaluation of an Innovative, National
Near-miss Reporting System for Curative Healthcare Institutions in Sri
Lanka}



\author[1]{Paula  Bowman}%
\author[2]{Reece Hinchcliff}%
\author[3]{Munasinghage Priyanwada Jayalath}%
\author[1]{Dilantha Dharmagunawardene}%
\author[4]{Samath Dhamminda Dharmaratne}%
\affil[1]{Queensland University of Technology School of Public Health and Social Work}%
\affil[2]{Griffith University School of Applied Psychology Mount Gravatt Campus}%
\affil[3]{Government of Sri Lanka Ministry of Health Sri Lanka}%
\affil[4]{University of Peradeniya Faculty of Medicine}%


\vspace{-1em}



  
  \date{May 24, 2024}


\begingroup
\let\center\flushleft
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\selectlanguage{english}
\begin{abstract}
Background: Near-misses are errors that have the potential to cause an
adverse event but fail to do so because of chance or because they are
intercepted. By 2021, Sri Lanka had only established systems for
maternal and blood transfusion services. Methods: A new, holistic
near-miss reporting system was developed and piloted at a large tertiary
hospital in 2022 to guide subsequent nationwide implementation. During
the pre-interventional phase, national-level consultative meetings
(n=20), key informant interviews (n=10) and focus groups (n=22) were
convened with purposively selected representatives of professional
colleges, academia, medical administrators, and senior staff of the
participating hospital to identify existing methods of reporting
near-misses. A near-miss reporting format and guidelines were designed
with input from national-level consultative meetings. Training on the
new system for medical and nursing officers, periodic reminders to
staff, and dissemination of preventive measures for patient safety
incidents were implemented as interventions. A pre-post evaluation was
conducted to identify the effect of the new system, and stakeholders'
views on potential for nationwide implementation. Results: Eight
near-misses were reported three months following implementation,
compared to none prior to implementation. Study participants expressed
satisfaction with the new system's user-friendliness, clarity,
non-punitiveness, voluntary nature, and confidentiality protection. The
system was perceived to be suitable for national implementation
following refinements. Conclusions: This evidence-based near-miss
reporting system, combined with the complementary activities implemented
in the pilot setting, should now be introduced into additional hospitals
before national implementation to further enhance its design, support
from stakeholders, and quality and safety impact.%
\end{abstract}%



\sloppy


\textbf{Title:}

Development and Formative Evaluation of an Innovative, National
Near-miss Reporting System for Curative Healthcare Institutions in Sri
Lanka

\textbf{Running Title:}

Pilot of a near miss reporting system for Sri Lankan hospitals

\textbf{Full names of the authors and full contact details of the
corresponding author:}

Munasinghage Priyanwada Jayalath Dilantha Dharmagunawardene Samath
Dhamminda Dharmaratne Paula Bowman (Corresponding Author) Email -
paula.bowman@qut.edu.au Reece Hinchcliff

\textbf{Author's institutional affiliations}

Munasinghage Priyanwada Jayalath Post Graduate Trainee in Medical
Administration, Ministry of Health, Sri Lanka Dilantha Dharmagunawardene
Consultant in Medical Administration, Ministry of Health, Sri
Lanka11Current Affiliation -- School of Public Health and Social Work,
Queensland University of Technology, Australia Samath Dhamminda
Dharmaratne Director, Post Graduate Institute of Medical Sciences of
Peradeniya, Sri Lanka Paula Bowman (Corresponding Author) Lecturer,
School of Public Health and Social Work, Faculty of Health, Queensland
University of Technology Reece Hinchcliff Professor, Academic Lead, and
Programme Director in Health Services Management, School of Applied
Psychology, Griffith University, Australia

\textbf{Acknowledgments}

Authors would like to acknowledge partial funding for the research
project provided from the Sri Lanka Medical Association through a
research grant. The sincere gratitude is also conveyed to the
Directorate of Healthcare Quality and Safety, Ministry of Health, Sri
Lanka, the participants of the National level Consultative meetings and
the research participants of DGH Avissawella.

\textbf{Funding or sources of support}

Partial funding from a research grant of Sri Lanka Medical Association

\textbf{Conflict of interest statement for all authors}

None declared

\textbf{Abstract and Key Words}

Background: Near-misses are errors that have the potential to cause an
adverse event but fail to do so because of chance or because they are
intercepted. By 2021, Sri Lanka had only established systems for
maternal and blood transfusion services.

Methods: A new, holistic near-miss reporting system was developed and
piloted at a large tertiary hospital in 2022 to guide subsequent
nationwide implementation. During the pre-interventional phase,
national-level consultative meetings (n=20), key informant interviews
(n=10) and focus groups (n=22) were convened with purposively selected
representatives of professional colleges, academia, medical
administrators, and senior staff of the participating hospital to
identify existing methods of reporting near-misses. A near-miss
reporting format and guidelines were designed with input from
national-level consultative meetings. Training on the new system for
medical and nursing officers, periodic reminders to staff, and
dissemination of preventive measures for patient safety incidents were
implemented as interventions. A pre-post evaluation was conducted to
identify the effect of the new system, and stakeholders' views on
potential for nationwide implementation.

Results: Eight near-misses were reported three months following
implementation, compared to none prior to implementation. Study
participants expressed satisfaction with the new system's
user-friendliness, clarity, non-punitiveness, voluntary nature, and
confidentiality protection. The system was perceived to be suitable for
national implementation following refinements.

Conclusions: This evidence-based near-miss reporting system, combined
with the complementary activities implemented in the pilot setting,
should now be introduced into additional hospitals before national
implementation to further enhance its design, support from stakeholders,
and quality and safety impact.

\textbf{Highlights}

\begin{itemize}
\tightlist
\item
  Evidence-based
\item
  Intervention
\item
  Near-miss reporting system
\item
  Guidance for LMICs
\end{itemize}

\textbf{Key Words}

Quality Improvement, Patient Safety, Healthcare Near-misses, Near-miss
Reporting Systems, Intervention Study, Low- and Middle-Income Countries

\textbf{Ethics Approval}

Ethical clearance was obtained from Post Graduate Institute of Medicine,
University of Colombo (ERC/PGIM/2021/222)



\textbf{Main Text}

\textbf{Introduction}

The World Health Organization (WHO) defines a near-miss as an error that
has the potential to cause an adverse event (patient harm) but fails to
do so due to chance or because it is intercepted (1). There is a
relationship between adverse events and near-misses because, according
to Heinrich's Law, ``for every adverse event, there are 30 minor
injuries and 300 near-misses'' (2). Near-misses are considered red flags
for future adverse events, offering an opportunity to analyse and
address causal factors (3).

Most high-income and several middle-income countries have implemented
national-level near-miss reporting systems that routinely collect
relevant data from hospitals (4). However, recent research identified
few countries in the South and Southeast Asian regions with these
systems in place (5). Sri Lanka does not have a comprehensive, holistic
national-level near-miss reporting system other than for the specific
issues of maternal near-misses (managed by the Family Health Bureau
(FHB) and near-misses related to blood transfusion (managed by the
National Blood Transfusion Services (NBTS) (6). Limited research has
been conducted regarding near-misses in Sri Lanka, confined solely to
maternal near-misses (7).

This interventional study, supported by the Sri Lankan Ministry of
Health, had the following objectives: 1) explore gaps in the current
issue-specific near-miss reporting systems; 2) use this information to
develop a more comprehensive, holistic, and effective system; and 3)
encourage healthcare professionals to report near-misses and take
actions to prevent their recurrence in the future. The overarching aim
was to strengthen the structures and processes used for reporting
near-misses in Sri Lanka and, in doing so, advance the national quality
and safety agenda.

\textbf{Methodology}

This study was conducted in three phases: pre-interventional,
interventional, and post-interventional. Several qualitative research
methods were used during the pre-and post-interventional phases. Ethical
clearance was obtained from the Ethics Review Committee, Post Graduate
Institute of Medicine, University of Colombo. Permission to carry out
the project was obtained from the Ministry of Health, Deputy Director
General -- Medical Services I, Director- Directorate of Healthcare
Quality \& Safety (DHQS), Director- FHB, Director -NBTS, Provincial
Director of Health Services -- Western Province, Regional Director of
Health Services -- Colombo and the Head of the Institution of DGH
Avissawella.

The study was conducted from February 2022 to December 2022 in the
District General Hospital (DGH) -- Avissawella, the only District
General Hospital in Colombo district- the capital of Sri Lanka. The
hospital comprises all major specialties, theatre, and ICU facilities,
and almost all sub-specialties that a District General Hospital should
have (8). Considering the service availability, practical feasibility,
and administrative support for implementation, the research team
selected the site mentioned above to pilot the project.

\textbf{Pre-intervention Phase}

The two existing, topic-specific near-miss reporting systems and adverse
event/incident reporting systems were critically analysed during the
pre-intervention phase. Consultative meetings, key informant interviews
(KIIs), and focus group discussions (FGDs) were conducted by the
principal investigator (PI) using semi-structured guides until
theoretical saturation was achieved (9). Study tools were validated
through input from officials from DHQS, and pre-testing was undertaken
with FHB and NBTS staff. These guides were designed to extract
information from purposively selected participants about their
perceptions and opinions about near-misses, near-miss reporting, key
barriers, and recommendations for developing and implementing a national
reporting system.

An initial consultative meeting was held with a purposively selected
sample of 20 representatives from prominent professional colleges and
academic centres, e.g. Sri Lanka College of Surgeons, Sri Lanka College
of Obstetricians and Gynaecologists, Sri Lanka College of
Anaesthesiologists, Sri Lanka College of Physicians, Sri Lanka College
of Paediatricians, University of Colombo, etc.

These representatives, who were specialist medical officers in several
specialties, were from different hospitals in different geographical
areas in the country. Since they were experienced senior specialists,
they possessed a clear understanding and knowledge about the near-misses
that occur in their units.

KIIs were held with the present and two previous Directors of the DHQS,
the National Programme Manager of the Maternal Morbidity/Mortality
Surveillance Programme of the FHB, the Head of the Hemovigilance Unit --
NBTS, and three purposively selected heads of the institutions and two
Special Grade Nursing Officers (SGNO) (equivalent Chief Nursing
Officers) of DGH Avissawella. FGDs were held with eight Consultants
(Group 1) and 14 Nursing Sisters and Unit in-charge Nursing Officers
(Group 2) of DGH Avissawella.

\textbf{Intervention}

A process map, then Strengths, Weaknesses, Opportunities, and Threats
(SWOT) analysis, was completed to identify bottlenecks in reporting
systems and pragmatic methods available to strengthen current systems.
The outcomes of these analyses are presented in Figure 1. Based on the
gaps identified in the pre-intervention phase, the following
interventions were agreed upon by the project team:

\begin{itemize}
\tightlist
\item
  refinement of existing process and systems for near-miss reporting.
\item
  development of guidelines to facilitate near-miss reporting; and
\item
  the design of a user-friendly near-miss reporting format.
\end{itemize}

\textbf{Figure 1 SWOT Analysis of the Existing Near-miss Reporting
Systems and Adverse Event / Incident Reporting System in Sri Lanka}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image1/image1}

\end{center}
\end{figure}

The results, in combination with key findings elicited through a
desktop, non-systematic scan of the peer-reviewed literature, were used
to design a draft near-miss reporting form and guidelines, which were
reviewed and finalized with input at the second and the third
national-level consultative meetings. These were held with the
participation of the Director - DHQS, representatives from purposively
selected professional colleges and academia (as mentioned above), and
purposively selected hospital administrators who are well experienced in
health care management in different levels of hospitals in different
areas in the country.

Conduct of training programmes

Training programs were conducted for medical and nursing officers to
improve their knowledge and alleviate negative perceptions about
near-misses and near-miss reporting processes. During these programs,
the newly designed near-miss reporting form and guidelines were
introduced to the medical officers and nursing officers of the hospital.

Changes to structures and processes

An internal circular signed by the Director about the near-miss
reporting process was distributed among the units by the Nursing Officer
(NO) -- Quality Management Unit (QMU) with a folder containing the
near-miss reporting forms and the national guideline. The in-charge
nursing officers were instructed to keep the folder accessible to any
health care worker (HCW). Details of the intervention were shared in the
social media groups of HCWs and conveyed by the head of the institution
during consultant meetings and unit in-charge meetings. A near-miss
reporting form box was established in front of the QMU to drop the
completed forms confidentially. Fortnightly reminders about near-miss
reporting were shared in staff social media groups, and periodic
feedback was provided at consultant meetings and in-charge meetings to
improve reporting.

\textbf{Post-intervention Phase}

Separately designed KII and FGD guides were used to assess the
effectiveness of the package of interventions. The designing and
pre-testing of semi-structured guides followed the same process as the
pre-intervention phase. During the post-intervention phase, feedback
about the new reporting system was elicited from the head of the
institution, consultants, SGNOs, sisters in charge, and in-charge
nursing officers.

The data from consultative meetings, KIIs, and FGDs were recorded with
the consent of participants and then transcribed. Thematic analysis was
executed according to a pre-defined framework framed upon the KII and
FGD guides. Coding was completed using a Thematic Analysis approach (10,
11). Analysis was led by the first author, with ongoing input from the
broader research team. Quotes were captured and presented below to
exemplify the main themes identified.

\textbf{Results}

The results are provided separately for the pre-and post-intervention
phases.

\textbf{Results of the pre-interventional phase}

Thematic Analysis of Consultative Meetings

Several key issues were identified as the major bottlenecks in the
current systems, including inadequate HCW knowledge about near-misses
and adverse events/incidents; negative perceptions of HCWs about
near-misses, adverse events/incidents, and reporting processes; poor
user-friendliness of the existing near-miss reporting systems; and a
lack of a well-established mechanism to incorporate preventive measures
as best practices to be implemented across all healthcare institutions.
The major gaps identified were that the existing near-miss reporting
systems in Sri Lanka covered only maternal near-misses or those related
to blood transfusions and that the current reporting forms were not
user-friendly.

Thematic Analysis of KIIs and FGDs

Results of the KIIs held at the national and institutional levels during
the pre-intervention phase are illustrated in Figure 2. The results of
the FGDs of the pre-intervention phase are illustrated in Figure 3.

\par\null

\textbf{Figure 2 Thematic Analysis of KIIs (Pre interventional phase)}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image2/image2}

\end{center}
\end{figure}



\textbf{Figure 3 Thematic Analysis of FGDs (Pre interventional phase)}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image3/image3}

\end{center}
\end{figure}

Reasons for under-reporting and strategies to improve reporting .

Reasons for underreporting were highlighted at the initial
national-level consultative meeting and the pre-interventional phase
KIIs and FGDs. Exemplifying quotes are presented below.

\emph{``Although we have a designated Directorate for Healthcare Quality
and Safety, policies and guidelines, the HCWs' negative attitudes of
HCWs contribute a lot to the reporting of near-misses. They think, ``Why
should we report?'' and ``Reporting will highlight our mistakes.'' If we
want to improve reporting, we should include the importance of
near-misses and reporting of those in the undergraduate and postgraduate
curricular of HCWs,' and they should be given a good orientation about
these at the time of recruitment.'' (DHQS- A)``At {[}an{]} institutional
level, lack of staff (designated medical officers for hospital QMUs),
and frequent transfers of trained staff are significant barriers to
reporting, because to maintain a successful reporting system, there
should be a designated person who can monitor, analyse and provide
feedback on the reports. In addition, HCWs' ignorance and negative
attitudes are also barriers.'' (DGH Avissawella- B).}

\textbf{Results of the post -interventional phase.}

Results of the KIIs and the FGDs during the post-interventional phase
are illustrated in Figure 4 and Figure 5, respectively.

\par\null

\textbf{Figure 4 Thematic Analysis of KIIs (Post interventional phase)}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image4/image4}

\end{center}
\end{figure}

\textbf{Figure 5 Thematic Analysis of FGDs (Post interventional phase)}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/image5/image5}

\end{center}
\end{figure}

A total of eight near-misses were reported during the intervention
period of three months. Three near-misses were radiology or
laboratory-related, and two were related to the patient monitoring
process of detecting circulatory problems on time and preventing patient
harm. The details are depicted in Table 1. No adverse events/incidents
were reported during the same three months.

\textbf{Table 1: Summary of Near-Misses Reported at DGH Avissawella from
01.07.2022 to 30.09.2022}\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
\begin{minipage}[b]{0.22\columnwidth}\raggedright\strut
\textbf{Category}\strut
\end{minipage} & \begin{minipage}[b]{0.22\columnwidth}\raggedright\strut
\textbf{Type}\strut
\end{minipage} & \begin{minipage}[b]{0.22\columnwidth}\raggedright\strut
\textbf{Category number}\strut
\end{minipage} & \begin{minipage}[b]{0.22\columnwidth}\raggedright\strut
\textbf{Frequency}\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Drug administering process\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Detecting a wrong dosage before administering/Detecting a wrong drug
infusion rate set before administering\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
DA3\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
01\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
Radiology/ Laboratory\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
Detecting delayed/missed important/critical radiological or laboratory
investigation\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
RL3\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
03\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Patient monitoring process\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Detecting circulatory problems on time and preventing patient harm\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
PM1\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
02\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Detecting airway problems on time and preventing patient harm\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
PM2\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
01\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Other\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
A critical patient missed ECG monitoring for a brief period.\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
01\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{Total}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\textbf{08}\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

The training programs held for medical officers and nursing officers
might have helped to improve knowledge of near-misses and the importance
of reporting near-misses, as well as alleviated negative perceptions.
Nevertheless, during the post-interventional FGDs, the following views
and suggestions were brought forward.

\emph{``The new near-miss reporting system has not won the trust of the
employees yet. It does not motivate the employees to report near-misses.
Therefore, we suggest holding intermittent training programs,
establishing a mechanism to provide feedback, and gradually building
trust among employees.'' (DGH Avissawella-C)``We believe that once the
employees get used to the system and understand the true value of
reporting, the habit of reporting may be absorbed into the
organizational culture.'' (DGH Avissawella-C)}

\textbf{Discussion}

The importance of national near-miss reporting systems is universally
accepted. This pilot study provides an evidence-based foundation for
implementing the first comprehensive national system in Sri Lanka.

Although this study was implemented at DGH Avissawella only, the
intention is for it to be gradually expanded to other healthcare
institutions to enable ongoing evaluations and refinement before
national implementation. Both the initial pilot and intended future
rollout have been assisted through multi-stakeholder support, including
from the national focal point on patient safety and quality (DHQS).

The main interventions carried out in this study were identified through
a scan of the international literature and a comprehensive analysis of
existing process problems in Sri Lanka, including the need to design a
user-friendly near-miss reporting form and guidelines. Since inadequate
knowledge of near-misses and negative perceptions about reporting were
identified as bottlenecks to implementing the key interventions, these
were addressed through training programs. The initial pilot findings
have emphasized that the new reporting system is user-friendly,
non-punitive, voluntary, and confidential.

Feedback from system users was generally positive, but some users
mentioned that filling out the form was time-consuming, feedback was
insufficient, inadequate actions were taken on reports, the system was
less motivational, and the trust of all employees had not yet fully
gained\textbf{.} At the initial stage, considerable time may have been
required to fill out the form as it was unfamiliar. Once HCWs become
more used to filling out the forms during their routine work, the time
required for reporting may be reduced, facilitating staff engagement and
effective implementation.

Participants of national consultative meetings, KIIs, and FGDs mentioned
that the system should be voluntary to gain the employees' trust without
resistance. Accordingly, the new Sri Lankan system is voluntary, in
contrast to (for example) the Swedish and Danish systems (1). In
Finland's reporting system, the analysis and dissemination of results
are only completed at the local hospital level (12). In contrast, the
proposed Sri Lankan system will undertake analysis and dissemination of
results both at the national and local hospital levels. This approach is
more similar to the system used in Japan, where, in addition to the
national-level reporting system, healthcare providers use their own
reporting and learning systems at the local hospital level (13).

The new Sri Lankan processes result in verbal feedback being provided
during consultant and in-charge meetings. During the pilot, the
discussion of two near-miss cases, including feedback and information
about preventive measures taken, was conducted only with the staff
involved, and other staff were unaware of the actions taken. In the
reporting system of Switzerland (CIRRNET), feedback is provided through
Quick-Alerts, published in specialist journals and the Patient Safety
Foundation website (12). Furthermore, in a study in Western North
Carolina, regular reminders and feedback were used to improve reporting
(14). In 2017, Japanese researchers identified that enhanced feedback
for reporters promoted voluntary in-hospital reporting (4). Aligning
with best practice principles arising from this published research, the
new Sri Lankan system involves a streamlined mechanism to provide
feedback to healthcare professionals and use a periodic reminder system
via social media groups to improve reporting.

Two studies from the United States have shown that the provision of
incentives for staff for reporting led to more successful reporting at
the initial stage of implementation (14, 15), but the continuation of
reporting in an established system was not dependent on incentives (15).
However, this approach has been criticized because these incentives may
not be available in more resource-constrained settings (16). In
addition, it was postulated that incentives may lead to biases, create
issues in the quality of reporting, and become impossible to remove
without threatening the system's sustainability and viability (16). For
this reason, quality and safety stakeholders in other countries have
developed successful near-miss reporting systems that are not dependent
on the provision of monetary incentives to motivate behaviour change
(17). Due to the above reasons, the financial constraints present within
the Sri Lankan health system, and the desire to create a sustainable,
long-term system, our pilot study did not use financial incentives to
facilitate implementation.

Under-reporting of near-misses was a major bottleneck identified in
implementing a successful near-miss reporting system during this study,
which is similar to experiences in other settings (18). The literature
suggests that providing training and education about near-misses and the
importance of reporting near-misses, as well as ensuring the
confidentiality of reporters and a blame-free culture, are important
considerations in developing a near-miss system (19), and these
principles informed the design and implementation of the new Sri Lankan
system.

We found that HCWs' inadequate knowledge and negative perceptions had
adversely affected the pre-existing level of reporting. For this reason,
before implementing the new system, HCWs were given training on
near-misses and the importance of reporting near-misses to reframe their
perceptions more positively. However, it was found that more than
training alone was needed to fundamentally improve the reporting
behaviour of the participants. The project team postulates that once the
habit of reporting is incorporated into organizational culture and when
the new system has built trust among all employees, reporting behaviour
is expected to improve over time. This illustrates the importance of
viewing the development of the new system as just one element of the
overall quality and safety agenda rather than as a standalone panacea
capable of `solving' all existing problems.

A more extended implementation period will be required for the new
reporting system to produce the level of detailed near-miss data
required to reach reliable conclusions about how similar or different
Sri Lankan near-misses are to other countries. The project team is
actively working towards this objective, using these pilot results as
the foundation for this ongoing body of work.

\textbf{Limitations}

This reporting system was implemented in a single setting, and the
findings cannot be generalized to other hospitals at this stage. The
reporting was expected only from two categories of staff: medical
officers and nursing officers. Therefore, at this stage of the
implementation process, we cannot predict the level of compliance of
other staff categories to the new reporting system. These limitations
will be addressed through the broader trial of the reporting system in
additional hospitals over the next year.

\textbf{Conclusion}

Although there are two current issue-specific near-miss reporting
systems in curative healthcare institutions in Sri Lanka, there needs to
be an inclusive near-miss reporting system covering all major
specialties. The level of reporting of the existing systems is also
unsatisfactory. This study provides a foundational evidentiary basis
upon which the pilot can now be extended to other institutions, with the
intention of the system being further refined before national
implementation. This systematic, gradual approach will maximise the
uptake and effectiveness of the new national system. A similar process
is advocated for other countries in the region that do not currently
have a near-miss reporting system. Quality and safety stakeholders from
the region are encouraged to contact the project team to discuss
opportunities for ongoing regional learning and collaboration.



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