Annals of Medicine and Surgery 77 (2022) 103520

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Annals of Medicine and Surgery

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Review

The comprehensive double loop activities for patient safety management

Tatsuya Fukami *, Yoshimasa Nagao
Department of Patient Safety, Nagoya University Hospital, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Aichi, Japan

A R T I C L E I N F O A B S T R A C T

Keywords: We practice patient safety as a model that links patient safety and quality improvement in healthcare. The most
Incident report important activity is the incident report. The loop on the left is during usual situation activity related to quality
Response to the critical situation improvement in healthcare. The loop on the right is during critical situations activity related to patient safety.
Quality improvement
What is important in these activities is the initial response to the critical situation, which is the first corner of the
Safety management
right loop. We practice emphasizing the initial response to the critical situation, creating the pattern, and taking
measures without omissions. Although many patient safety measures have been taken, it has become clear that
there is a shortage of doctors who can practice them. We have practiced that pattern and supported advanced
healthcare. We want you to explain the pattern and use it in practice.

As a global turning point for patient safety, the 1990s were signifi­ suggested improvements, the results of the suggested improvements, or
cant, and clarified patient safety managers’ comprehensive role in their effects in preventing serious medical accidents. Furthermore,
hospitals. Primarily, patient safety managers need to recognize the medical institutions’ prevention measures, descriptions, and data pro­
overall picture of patient safety, that is, safety in all and general medical vide them little information about the effects of the patient safety efforts.
services rather than just in their details; they should carefully analyze During normal times in Japan, this crucial aspect is missing in the pa­
what aspects are missing in their hospitals and which equipment, fa­ tient safety operations and is the reason the “P” (plan) of the PDCA cycle
cilities, and human resources need to be developed and deployed to fill often remains a vague qualitative target, without concrete quantitative
the existing gaps. In this study, we divided patient safety management numerical goals. Indeed, quantitative numerical goals are difficult to
into usual and critical situations, illustrated it as loops (see Fig. 1), and establish, not because of patient safety managers’ low capacity or
outlined present safety problems and efforts. inability but because, first, the occurrence of serious adverse events is
rare compared with the total hospital-wide services. For a hospital, no
1. Patient safety management during usual situations one wants to establish a positive number as an outcome of serious
adverse events (e.g., 1000-bed hospitals typically suffer zero to several
In normal times, patient safety management includes the following: fatal accidents a year). In addition, if an incident does not lead to a
integration and triage of near-miss and hospital-wide comprehensive serious adverse event, it might not lead to an incident report, which is
adverse event reports, analysis and extraction of these events’ root voluntary, either. Then, of course, the option to base outcomes on the
causes, meetings with multi-professional healthcare providers, reviews number of incidents is not very helpful to patient safety management. As
of rules and manuals, consideration of measures to prevent recurrences; incident reports have been historically avoided as an outcome, their
development of a contingency management plan, patient safety training numerical reliability is low according to hospitals’ populations. There­
and education, hospital-wide round monitoring, and quality improve­ fore, only some event groups, such as falls, whose occurrence is rela­
ment of all medical services. Plan–Do–Check–Act (PDCA) cycle, pro­ tively easy to grasp and whose absolute number is large, have been
moted by Deming [1]. as a learning and improvement characteristic, monitored as outcomes. Second, medical work processes are not stan­
provide a widely accepted structure for improving the quality of a dardized although the medical field has overcome similar issues using
healthcare system [2]. Every day, institutional patient safety managers problem-solving methods such as “process standardization, measuring
receive reports about several important issues and instruct the hospital the deviation from the standard, and initiation of countermeasures.” In
staff about the required measures for improvement. However, they are other words, one method is to establish a healthcare service procedure to
unable to determine the number of staff actually practicing the produce reliable results, formulate various staff compliance trainings,

* Corresponding author.
E-mail address: [email protected] (T. Fukami).

https://doi.org/10.1016/j.amsu.2022.103520
Received 24 January 2022; Received in revised form 10 March 2022; Accepted 26 March 2022
Available online 1 April 2022
2049-0801/© 2022 The Authors. Published by Elsevier Ltd on behalf of IJS Publishing Group Ltd. This is an open access article under the CC BY license
(http://creativecommons.org/licenses/by/4.0/).
T. Fukami and Y. Nagao Annals of Medicine and Surgery 77 (2022) 103520

and monitor the compliance rate and outcome process variations. react after the events, which then threaten to recur. Thus, patient safety
Although such measurement is indirect, it can be applied to patient managers must recognize the danger of a negative spiral. During normal
safety [3]. To our disappointment, myriad tasks are yet to be stan­ situations, they must always pay attention to the following: quality
dardized, and hence, measuring compliance rates and variability is control, instructions of the procedures of the multi-professional
impossible even when researchers and practitioners desire to do so. In healthcare providers are checked in mutual co-operation, compliance
other words, from incident reports, safety management should identify with procedure rates, and measurement of available result variations.
hospital issues and establish stable medical service procedures for task Reconsidering the institution’s patient safety system from the perspec­
categories because to reveal the latest achievement rates, safety man­ tive of required equipment, facilities, and human resources is crucial in a
agers must begin with baseline measurements. In addition, a certain proper PDCA cycle, as is mutual support through partnerships.
period’s variation should be evaluated by a controlled extent plan. For
example, “increasing the implementation rate of the full name check to 2. Patient safety management during critical situations
prevent patient misidentification accidents” is not an appropriate
objective; the original plan states the following: In the procedure for When a serious issue occurs, medical institutions must quickly
preventing patient misidentification defined by the rules of a hospital, construct an emergency management system in an organized manner.
60% of nurses and 40% of doctors currently perform collation between During a crisis, operations to ensure patient safety include the following:
full name information from the patient and full name information in cross-organizational treatment co-operation for patient recovery
hand by medical staff; within one year, these percentages must rise to confirmed in each department; open disclosure to the patient; co-
90% for nurses and 70% for doctors. If any intervention plan is ambig­ operation among the pathology and radiology departments to investi­
uous, its effectiveness will remain unclear. In addition, if the interven­ gate a cause of death, if necessary; determining the necessity of notifying
tion results remain unknown, the staff will be tired of the excessive rules the medical accident investigation center and the police; medical acci­
required one after another and eventually fail to adhere to them. dent investigation and report preparation; explanation of findings to
Contributing incident reports aimed at improvement will thus be patients; and publication of findings to society. Even during the normal
disappointing, and the staff’s reporting behavior will eventually fade. times, patient safety management operations and personnel play an
Furthermore, delayed reports will make it difficult to identify organi­ important role, but the hospital director has the pivotal role in making
zational issues, and in the event of an emergency (described in the next important decisions about responses to unusual situations. Indeed,
section), initiating an immediate response will be impossible. When initial response failure to a patient’s serious safety issue sometimes
serious adverse events occur within a vicious cycle, the staff will always threatens hospital closure. As serious accidents do not happen

Fig. 1. Loops of patient safety activities

Thick black lines represent daily operation of patient safety. In usual situations with the Plan–Do–Check–Act cycle, patient safety operations are illustrated in the
right loop, and in critical situations, in the left loop.

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T. Fukami and Y. Nagao Annals of Medicine and Surgery 77 (2022) 103520

frequently, most hospital directors and patient safety personnel should are to ensure the following: patient safety, accurate fact-finding, open
recognize their unfamiliarity with handling a crisis. When facing the disclosure, verification of cause analysis, and recurrence prevention.
challenge of inconvenient facts, they often hesitate and then attempt to The usual and the unusual or critical are linked like loops. Hence, the
respond as optimistically as possible. This is largely congruent with hospital director and the chief safety officer should be conscious of
“story generation” as a cognitive heuristic employed when attempting to linked activities, have consistent attitudes, and make fair and objective
understand a confusing situation. Hospital directors and chief patient decisions in both crises and normal situations. Overall, healthcare
safety officers must monitor the entire organization for story generation quality improvement must be continuous, and seamless efforts toward
and make fair and objective situational decisions. In the short term, such patient safety should continue apace.
decisions might be stressful for the hospital staff, partly out of fear of
lacking objectivity and fairness. However, as not acting objectively and 3. Loops of patient safety activities
fairly might lead to a more serious situation for both the organization
and the employee, it must be avoided. Hospital directors and chief pa­ We described the comprehensive double loop activities for patient
tient safety officers must not lose sight of the mid-to long-term per­ safety managements. The loop described as patient safety management
spectives; they need to remember that fair behavior, independent of during critical situations on right side and patient safety management
immediate interests, is the only way to protect the organizations, staff, during usual situations on left side and is represented as a continuous
and patients. In addition, they certainly need to pay attention to whether infinity (∞) shape (Fig. 1). Either way, the starting point is activation of
every hospital department reports serious issues responsibly. Medical an in-hospital report. Especially, activation of reports from doctors.
doctors’ reporting of incidents reflects organizational transparency and Significance of medical doctors’ incident reports for organizational
drives toward improvement in healthcare quality and safety. In addi­ transparency and as a driving force for patient safety. 4 We have placed
tion, hospital-wide reporting of near-miss events is also significant the starting point for this double loop figure here as point zero. We
because these events are precursors of adverse events. After identifying created a cyclical model in which these activities are properly carried
various clinical departments’ high-risk areas, the next step should be to out, the importance of reporting is understood, and it returns to acti­
analyze the root cause of incidents, especially those reported by doctors, vation of in-hospital reporting.
and intervene appropriately to improve healthcare quality [4]. This The contents of usual situations on left side:
aspect should contribute directly to safer care and overall enforcement
of the hospital’s patient safety culture, particularly because reports from (1) Accumulation of in-hospital incident/accident information. Pa­
doctors are overwhelmingly more severe than those from other occu­ tient safety incident reporting is mandatory for all staff.
pations; this means that hospitals cannot accurately ascertain adverse (2) Daily report checks and classification. Triage. Follow-up or quick
events unless doctors submit their reports. As chief safety officers, they response. Triage at various in-hospital meetings.
want, as much as possible, to clear adverse events and respond to (3) Review and analysis at various in-hospital meetings. Search and
particularly serious adverse events by reporting the best about the consideration of improvement plan. Morbidity and mortality
hospital. However, as many medical institutions have indicated, physi­ conferences. Objectives of the improvement plan, including
cians are still reluctant to report accidents. If safety managers believe the morbidity and mortality conferences, are to identify adverse
reporting of serious accidents is weak, hospital administration should outcomes associated with medical accidents, modify behavior
consider activating physicians’ reporting behavior or tasking the patient and judgment based on previous experiences, and prevent repe­
safety department to introduce a required screening and reporting sys­ tition of errors leading to complications.
tem for accidental cases of death. In a crisis, one of the most important (4) Extraction of the problem. Visualization and standardization of
tasks is co-ordination of treatment in medical accident cases. For the operation process. Digitalization of variation from standard
example, if a drug overdose occurs, that fact should be immediately operation. Creating an improvement goal and its plan. Planning
reported to the safety management department, and experts from mul­ process for quality improvement.
tiple departments should gather to measure the drug’s blood concen­ (5) Implementation of the plan’s improvement activities. In-hospital
tration, administer an antagonist, remove the drug by plasma exchange, training and information. Practicing the quality improvement
and pool all resources to co-ordinate life-saving treatment. Many patient process.
deaths result from medical accidents caused by delays, missing reports, (6) Measurement of the effect and outcome. Checking the quality
or lack of appropriate initial responses. Certainly, co-ordination of improvement process.
treatment requires resilience and flexible responses. The hospital di­ (7) Assessment. Feedback. Occurrence of a new problem. Enacting
rector must assist the safety management department by ensuring that the quality improvement process again.
on-site reporting and co-ordination is conducted. “Open disclosure” is a (8) Facilitatory incident monitoring. Standardization and improve­
further requirement, that is, open discussion with the patient, their ment reporting culture.
families, their caregivers, and other support persons about incidents that
result in harm to a patient receiving healthcare. In other words, open The contents of usual critical situations on right side:
disclosure expresses apology and compassion for the patient having
received irregular healthcare. Hospital staff should promptly explain the (9) Clinical determination of the case. Consultation and treatment
facts currently grasped about the situation and examine ways in which co-ordination for recovery to the original state. On-site protective
undiscovered facts could be grasped. However, the timing of disclosure instruction. Cross-organizational treatment co-operation for pa­
can be crucial. Immediate disclosure after an accident might cause tient recovery.
cognitive discrepancy between the patient and hospital staff, leading to (10) Meetings for sharing cases. Checking the informed consent con­
a critical gap in communication. The hospital management board should tent and ethical procedures. Confirmation of proper informed
monitor whether open disclosure is appropriately conducted. Deciding consent.
whether to apply the Japanese medical accident investigation system is (11) Open disclosure. Explanation to the patient and sharing facts and
also an important decision that the hospital director has to make [5]. To background. Acceptance of autopsy/autopsy imaging. Each de­
avoid ad hoc responses, supporting the organization with ingenuity can partment’s confirmation of facts. In case of death, explain the
maintain the objectivity and transparency of the decision-making pro­ necessity of autopsy and autopsy imaging for the cause-of-death
cess and clarify the basis for decisions. The hospital director and the investigation to the bereaved family.
chief safety officer need a mutually supportive partnership in normal (12) When the case is determined a serious medical accident, report to
situations and strong leadership in crises. The most important actions a medical accident investigation support center and public

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T. Fukami and Y. Nagao Annals of Medicine and Surgery 77 (2022) 103520

institution. If not, go to No. 3. Determining the necessity of technology but still requires washing hands correctly and knowing how
notifying the medical accident investigation center and the po­ to be an effective team member.3 Many features of patient safety pro­
lice, thereby demonstrating organizational transparency. If the grams do not involve financial resources but rather individuals’
case does not fall under the medical accident investigation sys­ commitment to practice safely. All persons involved in medical care
tem, it is allocated for review and analysis at various in-hospital need to be conscious of safety and act accordingly. Patient safety man­
meetings. Search and consideration of the improvement plan. agers require determination, belief, and leadership.
(13) Co-operation with pathologist/radiologist. Search for the cause of In this way, we have learned and think that expanding the wearable
death. molds nationwide will contribute to the improvement of patient safety,
(14) Investigation of the cause of death (autopsy/autopsy imaging). and welfare research on the training of doctors who have expertise in
Search for the cause of death. patient safety and the measurement of risk at patient institutions. We are
(15) Joint clinicopathological conference. Search for the cause of working as a labor research institute. The “CQSO Project for Chief
death. Quality Safety Officers” is being developed at Nagoya University to train
(16) Investigation of the medical accident (confirmation of facts and doctors who specialize in patient safety. With the support of the Japa­
finding/investigating/analyzing the cause of death and its nese Ministry of Education, Culture, Sports, Science, and Technology for
occurrence). Identify a new basic idea of investigation in medical 5 years from 2014. It was held as ASUISHI project. From 2019, the
accidents, which is to clarify the cause of the accident and link the project was supported by the Ministry of Health, Labor, and Welfare.
findings for prevention of recurring accidents. Renewal points are Training leader doctors specializing in patient safety
(17) Writing and submitting the report. Summarize the cause of the and introducing Toyota’s quality control method to patient care Develop
accident and suggest how findings can prevent recurring students’ problem-solving skills. Those are the two major pillars.
accidents.
(18) Presenting and sharing preventive measures against recurrence. Availability of data and materials
Share the point of issue for healthcare providers.
(19) Explanation to the patient and society. Responsibility as a part of All data generated or analyzed during this study are included in this
social infrastructure. published article.
(20) Responding to a lawsuit. Conference for reconciliation with the
patient and the bereaved family. Competing interests
(21) Appropriate accident response. Growth of organizational safety
culture through accumulation of appropriate responses. The authors declare that they have no competing interests.
(22) Understanding the incident report’s importance. Finally, both in
usual and critical times, incident reports are important for orga­ Ethical approval
nizational transparency and driving forces for patient safety.
In order to keep the ethical soundness of the research, an ethical
4. Conclusion approval letter was obtained from the Institutional Review Board (IRB)
of Nagoya University Hospital. Comprehensive consent was also secured
Advanced healthcare is actually on the dangerous foundation of before data collection. (No. 2018–0283).
basic patient safety and infection control. Trust was piled up, in one big
accident will be destroyed. Many efforts have been made to patient Sources of funding for your research
safety, but the current situation is that the pattern is weak and the results
are not clear. We work on and practice patient safety as a model that This work was supported by JSPS KAKENHI, Grant Number
links patient safety and improves the quality of patient care. By creating 201620007B for YN and Terumo Life Science Foundation (Kanagawa,
a loop diagram, the overall picture of patient safety work (usual and Japan) for TF.
critical situation) was grasped. The loop diagram was considered to be
an important and useful tool for evaluating the patient safety system. Author contribution
What is important in this type is the initial response to an emergency,
which is the first corner of the light loop. It is patient safety that we TF and YN interpreted the data, drafted the manuscript, and revised
practice to emphasize the initial response to an emergency, create a the manuscript for important intellectual content. TF drafted the
mold that does not shake, and take measures without omissions. manuscript and revised the manuscript for important intellectual con­
Although the concept of patient safety has grown and spread rapidly tent. YN contributed to the acquisition of data, conducted data cleaning,
worldwide, it still seems merely added onto existing medical systems. and interpreted the data. YN also conceived and designed this study,
We thus need to shift our paradigm to patient safety-centered health­ interpreted the data, and revised the manuscript for important intel­
care, in which clinical governance is a fundamental concept. The United lectual content. T.F. wrote the main manuscript text and Y.N. prepared
Kingdom’s National Health Service (NHS) defines clinical governance as the figure. All authors reviewed the manuscript. All author have
a framework through which NHS organizations are accountable for approved the final manuscript.
continually improving their service quality and safeguarding high
standards of care by creating an environment in which excellent clinical Registration of research studies
care flourishes [6,7]. In other words, the NHS has systematically
approached the maintenance and improvement of patient-care quality. Name of the registry:
Finally, frequent medical accidents might be related to medical progress Nagoya University Hospital
because medical advances have created complex processes and team Unique Identifying number or registration ID:
healthcare, requiring control of potentially large numbers of human and 2018–0283
communication errors [8]. Medical care will be an acquired social value Hyperlink to your specific registration (must be publicly accessible
that is provided safely, and uncontrolled medical error can also some­ and will be checked):
times be a dangerous weapon to the patient. Thus, all medical care and https://www.med.nagoya-u.ac.jp/medical_J/ethics/
practice demands the concept of patient safety. The WHO Patient Safety
Curriculum Guide describes patient safety in both developed and
developing countries as a broad subject: it can incorporate the latest

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T. Fukami and Y. Nagao Annals of Medicine and Surgery 77 (2022) 103520

Consent Fumimasa Kitano. We appreciate Edanz Group (https://en-author-se

rvices.edanzgroup.com/ac) for editing a draft of this manuscript.
We confirmed the consent.
References
Guarantor
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amatsu, Tomomi Umemura, Masakazu Uemura, Mayumi Ichikawa and