Safety Science 121 (2020) 529–541

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Safety Science
journal homepage: www.elsevier.com/locate/safety

Adaptive behavior of clinicians in response to an over-constrained patient T

safety policy on the administration of concentrated potassium chloride
solutions
Aoi Uema , Harumi Kitamura, Kazue Nakajima
⁎

Department of Clinical Quality Management, Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan1

ARTICLE INFO ABSTRACT

Keywords: In response to fatal accidents involving concentrated potassium chloride (KCl) solutions, the Japanese hospital
Complex adaptive system accreditation body released a safety policy in 2004 requiring the use of foolproof diluted KCl solutions
Resilient health care throughout hospitals. However, the policy caused difficulties in treating seriously ill patients in critical care
Patient safety policy settings who require concentrated KCl solutions promptly. Resilient health care (RHC) provides a theoretical
Concentrated potassium chloride solutions
perspective for understanding how work is achieved in complex healthcare systems. ‘Work-as-imagined’ (WAI),
Work-as-imagined
Work-as-done
as it should be done, and ‘work-as-done’ (WAD), as it actually takes place, are core concepts for understanding
performance adjustment among individuals. This study aimed to investigate WAD regarding the administration
of KCl solutions in the environment changed by WAI according to the authoritative policy.
In 2017, we sent questionnaires to 346 critical care physicians. Topics included types of KCl products
available in their units, administration methods, need for concentrated KCl solutions, hospital policies, and
physician opinions. The response rate was 30.3% (105/346). Thirty-five physicians (33.3%) used conventional
products out of compliance with the safety policy. Among 95 physicians using foolproof products, 69 (72.6%)
obtained concentrated solutions from the products in an unsafe manner. The gap between WAI and WAD ne-
cessitated performance adjustments by physicians that introduced a new risk of adverse events despite the use of
safer products.
The study demonstrated that RHC theory can be used to inform the development and improvement of patient
safety policies. Policy makers need to understand WAD when intervening in complex adaptive systems such as
health care.

1. Introduction similar appearance (Patient safety alert, 2001).

Potassium is an essential electrolyte for the human body. It is deeply
involved in heart rate regulation; hypokalemia (a low serum level of
potassium) induces lethal arrhythmias. In particular, patients with se-
vere heart failure are prone to hypokalemia due to low cardiac function
or the effects of diuretics (Alfonzo et al., 2006). Concentrated potassium
chloride (KCl) solutions, high-risk medications that are often used to
treat patients with low serum potassium levels, can be fatal if given
inappropriately. Since rapid injection of a concentrated KCl solution
causes a spike in serum potassium levels that can lead to cardiac arrest,
the speed of administration should be no greater than 20 mmol of po-
tassium/hour (Kim and Han, 2002). Several rapid injection events have
resulted from accidental administration of concentrated KCl solutions
instead of sodium chloride, heparin, and furosemide, which all have a
In response to the serious consequences associated with in-
appropriate rapid injection of these medications, safety recommenda-
tions have been issued in multiple countries. They include two main
recommendations (Joint Commission on Accreditation of Healthcare
Organizations, 1998; National Patient Safety Agency, 2002; Australian
Council for Safety and Quality in Healthcare Medication Safety
Taskforce, 2004). One was the removal of ampoules of concentrated
KCl solutions from storage in non-critical care areas and replacement of
these ampoules with commercially premixed solutions, in order to de-
crease the risk of accidental rapid injection of concentrated solutions.
The other recommendation involves restrictions on the storage of am-
poules in critical care units, along with strict procedures and staff
education, to ensure that seriously ill patients promptly receive con-
centrated KCl solutions appropriately when needed.

⁎
Corresponding author at: Department of Clinical Quality Management, Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan.
E-mail addresses: auema@hp-cqm.med.osaka-u.ac.jp (A. Uema), haruru@kid.med.osaka-u.ac.jp (H. Kitamura), kazuen@hp-cqm.med.osaka-u.ac.jp (K. Nakajima).
1
Present address.

https://doi.org/10.1016/j.ssci.2019.09.023
Received 31 December 2018; Received in revised form 10 September 2019; Accepted 20 September 2019
Available online 09 October 2019
0925-7535/ © 2019 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license
(http://creativecommons.org/licenses/BY-NC-ND/4.0/).
A. Uema, et al.
In Japan, safety recommendations for concentrated KCl solutions
are more aggressive than those in other countries. The Japan Council
for Quality Health Care (JCQHC), a third-party hospital accreditation
body founded in 1995 (Japan Council for Quality Health Care, 2019) ,
has certified over 2000 hospitals to date. On June 1, 2004, in reaction
to a fatal incident in the intensive care unit of an accredited hospital (A
Medication Adverse Event in Chiba, 2004), the JCQHC Certified Hos-
pital Patient Safety Promotion Council released a recommendation for
total removal of ampoule-type KCl products (20 mmol and 40 mmol of
potassium/20 mL) from all areas of the hospital other than the phar-
macy department (Japan Council for Quality Health Care, 2004). In-
stead, the use of ‘foolproof’ syringe-type products prefilled with con-
centrated KCl solutions (20 mmol of potassium/20 mL) was
recommended. In the science of human factors, the use of constraints is
an established design principle. A constraint involves restrictions and
compulsions to avoid a given action (Norman, 1988). The prefilled
syringe-type concentrated KCl products are in line with this principle.
These products are designed so that they are not directly connectable to
three-way stopcocks in intravenous lines. They can only be connected
to fluid infusion bags or bottles to achieve diluted potassium con-
centrations of 40 mmol/L or less. In the same year, the Ministry of
Health, Labour and Welfare of Japan issued a follow-up alert to endorse
the recommendation (Ministry of Health, Labour and Welfare, 2004). In
addition, current pharmaceutical references for any type of con-
centrated KCl solution state that the solution should be diluted to a
potassium concentration of 40 mmol/L or less, although previous re-
ferences only specified a maximum administration speed of 20 mmol of
potassium/hour.
This authoritative safety policy raised concerns among critical care
physicians in Japan (Certified Hospital Patient Safety Promotion
Council, 2004, 2007). One challenge was the physicians’ potential in-
ability to administer concentrated solutions to avoid volume overload
because prefilled syringe-type products need to be substantially diluted.
Another challenge was the potential failure to promptly administer
concentrated solutions to patients with fatal arrhythmia because the
solutions now need to be prepared in the pharmacy department. Ev-
eryday clinical work in critical care units requires lower volumes of
concentrated KCl solutions and prompt administration, but safety
policy requires the use of dilute KCl solutions, which are associated
with potential volume overload. Due to these medical needs, some
hospitals did not immediately follow the recommendation. According
to JCQHC’s survey of 1258 accredited hospitals conducted 2 years after
the release of the safety policy, 793 of 930 hospitals that responded
recognized JCQHC’s policy but 432 (46%) used ampoule-type con-
centrated KCl products. Of the hospitals using ampoule-type products,
44% stocked them in their departments or units (Certified Hospital
Patient Safety Promotion Council, 2007). Japanese critical care physi-
cians discussed on a mailing list how they provided concentrated KCl
solutions after JCQHC’s recommendation. One method was to stock
ampoule-type products in critical care units. Another was to transfer
concentrated KCl solutions from prefilled syringes into other empty
syringes by sticking the needle of an empty syringe into the prefilled
syringe (Japanese Society of Education for Physicians and Trainees in
Intensive Care, 2017).
Our interviews with cardiologists, cardiac surgeons, intensivists,
and nurses in a university hospital in 2015 revealed that when hypo-
kalemia leads to fatal arrhythmia in patients, delivery of concentrated
KCl solutions from the pharmacy department was not realistic because
it would take a long time and require a ward staff member to pick them
up from the pharmacy department after business hours. Stocking and
using concentrated KCl solutions in intensive care units, operating
rooms, and hemodialysis units are necessary. Without ampoule-type
products, physicians and nurses were compelled to draw concentrated
KCl solutions from prefilled syringes into other empty syringes in order
to provide highly concentrated KCl solutions through central venous
lines using syringe pumps. Additional interviews with patient safety
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Safety Science 121 (2020) 529–541
officers and managers of four other university hospitals revealed the
same practices in their hospitals (Nakajima et al., 2018).
Ten years after the recommendation, unsafe practices involving
prefilled syringe-type products surfaced. The JCQHC Adverse Event
Prevention Division, which runs the national adverse event reporting
system, issued a patient safety report about a case involving an un-
endorsed method of preparing medications using a prefilled syringe-
type KCl product in 2015. In the emergency department, a nurse drew
concentrated KCl solution from a prefilled syringe product into an
empty syringe. Subsequently, a resident physician injected the un-
diluted solution rapidly through a peripheral venous line (Japan
Council for Quality Health Care, 2015). The incident happened because
safer products were being used in an unsafe manner, which was the
workaround invented as an adjustment to the work environment when
the use of ampoule-type concentrated KCl products was restricted.
Resilient health care (RHC) is defined as the ability of the health
care system to adjust its functioning prior to, during, or following
changes and disturbances so that it can sustain performance under any
condition (Hollnagel et al., 2013). Gaps often exist between ‘work-as-
imagined’ (WAI), as it should be done, and ‘work-as-done’ (WAD), as it
actually takes place, because the work environment is changing over
time and resources are limited (Hollnagel et al., 2015; Hollnagel,
2014a). RHC theory provides a perspective for understanding how
WAD is achieved under various conditions, rather than imposing WAI
to improve patient safety (Hollnagel et al., 2018).
Everyday clinical work in critical care units requires ampoule-type
concentrated KCl solutions for lower volume and prompt administra-
tion, although the safety policy requires the use of diluted KCl solutions,
which is associated with potential volume overload or lengthy pre-
paration time in the pharmacy department. This study aimed to illu-
minate how health care professionals coped with the gap between ac-
tual clinical practices (WAD) and the safety policy (WAI) in regards to
administration of concentrated KCl solutions in critical care settings. In
addition, we analyzed risks emerging from the gap between WAD and
WAI, with the goal of exploring policy implications for patient safety in
the complex adaptive system of health care.
2. Methods
To gather data about actual clinical practices (WAD) related to the
administration of concentrated KCl solutions to patients requiring cri-
tical care, we conducted a questionnaire survey of physicians working
in Japanese critical care settings by mail. To evaluate WAD, we chose to
administer the questionnaire by mail because it was not realistic to
make observations of actual practices at a large number of hospitals.
Critical care physicians were surveyed directly to capture physicians’
behaviors and thoughts accurately because other health care profes-
sionals might have different attitudes about the JCQHC recommenda-
tions. In our earlier study, in fact, hospitals were often sensitive to
following the authoritative policy and had adopted prefilled syringe-
type KCl products, whereas critical care physicians expressed concerns
about the policy due to clinical reasons (Nakajima et al., 2018). Nurses
working in critical care units were not included as study subjects. In
Japanese critical care units, physicians usually give nurses orders on
medicines, methods of administration, and administration routes.
Nurses do not have the authority to adjust these orders on their own.
Critical care physicians know how concentrated KCl solutions are pre-
pared because regulations required them to provide specific instruc-
tions including product name and medication volume when adminis-
tering concentrated KCl solutions.
Questionnaire topics included: (1) types of concentrated KCl pro-
ducts available in critical care units; (2) methods for preparing con-
centrated KCl solutions for administration; (3) use of more highly
concentrated potassium solutions and reasons for use; (4) hospital po-
licies on concentrated KCl solutions; and (5) physicians’ opinions about
the instructions in pharmaceutical references, the current authoritative
A. Uema, et al.
safety policy, and potential solutions for current issues regarding con-
centrated KCl solutions.
The questionnaire was originally designed by two physicians, a
nurse, and a pharmacist with experience in specialized clinical practice
as well as patient safety and quality improvement at a university hos-
pital. The questions were consistent with current clinical practices re-
garding storage, preparation, and administration of concentrated KCl
solutions. Questions in related categories were grouped and divided
into modules (Polit and Hungler, 1999). After drafting a provisional
plan, we consulted with several researchers specializing in patient
safety or human factors. We revised the questions based on their
feedback. In addition, we asked two physicians not involved in the
questionnaire development process, one intensive care specialist and
one patient safety specialist, to perform preliminary tests on whether
the questions were clinically reasonable and easy to understand and
answer.
To gather information from physicians responsible for treating adult
or pediatric patients at risk for hypokalemia nationwide, we selected
110 hospitals certified as training centers by the Japanese Board of
Cardiovascular Surgery and the Japanese Society of Pediatric
Cardiology. These hospitals had 110 departments of cardiovascular
surgery and 98 departments of cardiology. We also selected 138 hos-
pitals certified as training institutions by the Japanese Society of
Pediatric Cardiology, which had 138 departments of pediatrics. In
August–September 2017, the questionnaires were sent to 346 depart-
ment directors in these hospitals, who were asked to assign one phy-
sician who treats seriously ill patients requiring concentrated KCl so-
lutions to answer the questionnaire. The study subjects were 346
physicians, which consisted of 110 cardiovascular surgeons, 98 cardi-
ologists, and 138 pediatricians. To promote psychological comfort of
respondents in answering questions about actual practices, detailed
demographic data about respondents and their institutions were not
collected.
The response form was returned by 108 physicians. For the analysis,
105 were valid; the remaining three were excluded due to very limited
information. The overall response rate for the questionnaire was 30.3%
(105/346); by specialty, the response rate was 30.8% (64/208) for
cardiovascular surgeons and cardiologists and 29.7% (41/138) for pe-
diatricians.
We used Microsoft Excel 2016 for analysis, which included de-
scriptive statistics and cross-sectional analysis with excluding missing
data. Narrative comments were evaluated qualitatively. All data were
aggregated and used for analysis because the topic of the study was not
patient characteristics (adult or pediatric) or physician specialty (car-
diovascular surgery, cardiology, or pediatrics) but patients’ clinical
conditions requiring a very limited volume load when adjusting serum
potassium levels.
The study was approved by the Institutional Review Board of Osaka
University Hospital (approval number: 17146).
3. Results
Most respondents stated that they were not following the JCQHC
policy. Instead, they had adapted their behavior to work around the
removal of ampoule-type concentrated KCl solutions. Furthermore, the
current procedures for preparing concentrated KCl solutions are not
necessarily adaptive but have become normal practice over time as
foolproof-type products are being treated as containers of concentrated
KCl solutions as alternatives to ampoule-type products.
3.1. Product types and preparation methods for concentrated KCl solutions
in critical care units
Fig. 1 shows the types of concentrated KCl products available in
Japan. Among 105 physicians, 35 (33.3%) responded that ampoule-
type products were available in their critical care units. Thirteen
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Safety Science 121 (2020) 529–541
reported that these products were regularly stocked in their units. On
the other hand, 95 physicians (90.5%) answered that prefilled or kit-
type products were available in their critical care units; of those, 65
responded that they were regularly stocked in their units. There were
59 physicians (56.2%) who could use only prefilled or kit-type pro-
ducts, 26 (24.8%) who could use both ampoule-type and prefilled or
kit-type products, and 6 (5.7%) who could use only ampoule-type
products.
Table 1 shows methods for preparing potassium solutions by pro-
duct type. For both ampoule-type and prefilled or kit-type products, the
most common method for diluting concentrated KCl solutions was to
inject them into infusion bags (diluted-in-bag or bottle product). The
second most common was to dilute with a saline ampoule into another
syringe (diluted-in-syringe product). The third most common was to
draw them into another syringe without dilution (not-diluted-in-syringe
product). The least common was to drain some solution from the in-
fusion bag before mixing with a concentrated KCl solution (modified
diluted-in-bag or bottle product). Seven physicians reported diluting
concentrated KCl solutions by putting them into a chamber in the in-
fusion route and diluting them with part of the contents of an infusion
bag.
Among the 95 physicians using prefilled or kit-type products, 36
(37.9%) used the diluted-in-syringe preparation method and 33
(34.7%) used the not-diluted-in-syringe preparation method. When
using these methods, KCl could not be administered to the patient un-
less the concentrated KCl solution was transferred from the prefilled or
kit-type product into another syringe.
3.2. Methods for transferring concentrated KCl solutions from prefilled or
kit-type products into other syringes
Among 95 physicians using prefilled or kit-type products, 69
(72.6%) transferred concentrated KCl solutions from prefilled or kit-
type products into other empty syringes. Even if ampoule-type products
were also available, 17 of these physicians transferred concentrated KCl
solutions from prefilled or kit-type products into other syringes.
Fig. 2 shows the methods used to transfer concentrated KCl solu-
tions from prefilled syringes into other syringes. Among 69 physicians
who transferred concentrated KCl solutions from prefilled syringes into
empty syringes, 67 (97.1%) collected the concentrated KCl solution by
inserting an injection needle into the tip of a prefilled syringe. Three
collected the solution by drawing from the plunger side of a prefilled
syringe. One poured the solution from the prefilled syringe into another
sterile container and drew up the solution with an empty syringe. Three
physicians used two methods. One physician aspirated the solution
from a kit-type product with an empty syringe; this method is not
shown in the figure.
3.3. Use of more highly concentrated potassium solutions and reasons for
doing so
Table 2 shows the use of more highly concentrated potassium so-
lutions and the major reasons for using potassium solutions with con-
centrations higher than the recommended concentration in pharma-
ceutical references (≤40 mmol/L). There were two major reasons for
this behavior: urgent correction of serum potassium levels to prevent
fatal arrhythmia and restriction of fluid volume to be administered due
to heart failure or lower body weight in children. Among all physicians,
61 (58.1%) used more highly concentrated potassium solutions for one
of these reasons, whereas 41 (39.0%) did not. Three physicians re-
sponded that they might use more highly concentrated potassium so-
lutions for reasons other than fluid volume restriction or urgent cor-
rection, but they did not specify those reasons.
A. Uema, et al. Safety Science 121 (2020) 529–541

Fig. 1. Types of concentrated KCl products available in Japan.

Table 1
Frequency of using various combinations of KCl concentrate solutions and the most commonly used concentration.

3.4. Protocols for administering concentrated KCl solutions
For treatment of hypokalemia with concentrated KCl solutions, 12
physicians (11.4%) reported that their hospitals established hospital-
wide protocols governing dilution, total amount, administration speed,
and administration route, whereas 38 (36.2%) responded that their
hospital established ward-based protocols. No standardized procedures
had been developed in the hospitals where 48 respondents (45.7%)
worked. Among 69 physicians who transferred concentrated KCl solu-
tions from prefilled or kit-type products into other syringes, 54 (78.3%)

532
A. Uema, et al.
Method(1). Collection of concentrated potassium Method(2). Collection by removing concentrated
solution by inserting an injection needle into the tip potassium solution from the plunger side of a
of a prefilled potassium preparation prefilled potassium preparation
n= 67 (97.1%)
Fig. 2. Methods used to transfer prefilled injection solutions to another syringe for treatment (n = 69, multiple choices).
Table 2
Situations to use more highly concentrations of potassium solutions (n = 105).
For restriction of fluid Used
volumes to be Not used
administrated No response
Total
responded that they were given permission by the hospital. Among
these physicians, 17 (31.5%) answered that the procedures were clearly
described in their hospital safety manuals.
3.5. Physicians’ opinions on pharmaceutical references, safety policies, and
better safety measures
Comments from 59 of 72 responding physicians (81.9%) mentioned
that the pharmaceutical references about administering concentrations
of 40 mmol/L or less should be followed when KCl solutions are ad-
ministered via a peripheral vein to prevent vascular pain or necrosis.
However, they stated that the use of concentrated solutions was indis-
pensable for treating seriously ill patients with hypokalemia, and that
this practice was safe and effective when administered through a cen-
tral vein. Nine (12.5%) stated that the rule about administering con-
centrations of 40 mmol/L or less should be applied in all cases, re-
gardless of the route of administration.
Regarding the JCQHC safety policy, 38 (56.7%) of 67 respondents
agreed with the recommendation or believed that it would not lead to
problems in clinical practice, although 25(65.8%) of them stated that
they prepared KCl solutions by drawing from prefilled or kit-type pro-
ducts into other syringes. By contrast, 23 (34.3%) disagreed with the
recommendation, arguing that it was problematic and needed revision.
This latter group based their position on several major beliefs: ampoule-
type products should be placed in specific locations such as critical care
units, operating rooms, and dialysis units; safety measures should not
sacrifice patient benefit from treatment; drawing solutions from pre-
filled syringe-type products into other syringes as an alternative for
ampoule-type products is inadequate to prevent accidental rapid in-
jections; and preparing concentrated solutions in pharmacy depart-
ments require clinicians to pick them up or wait a long time for de-
livery, which is also associated with potential risks.
Several alternative solutions were proposed. These included the
development of syringe pumps for exclusive use with concentrated KCl
solutions as a preventive mechanism against accidental rapid injection;
establishment of evidence for administration of concentrated KCl
Safety Science 121 (2020) 529–541
Method(3). Collection by transferring drug solutions
to another sterile container
n= 3 (4.3%) n=1 (1.4%)
n (%)
For urgent corrections of serum potassium levels Total
Used Not used No response
37 (35.2) 13 (12.4) 3 (2.9) 53
6 (5.7) 41 (39.0) 0 (0.0) 47
2 (1.9) 0 (0.0) 3 (2.9) 5
45 54 6 105 (100.0)
solutions through research; revision of pharmaceutical references; and a
nationwide protocol for administrating concentrated KCl solutions.
4. Discussion
4.1. Major patterns of adaptive behavior in response to an authoritative
policy
This study revealed several major patterns of responses among cri-
tical care physicians to external safety pressures demanding total re-
moval of ampoule-type concentrated KCl solutions. One pattern was
stocking and using ampoule-type products in critical care units, which
is contrary to JCQHC recommendations. The typical adaptive behavior
for medication preparation was to draw a concentrated KCl solution
from a prefilled syringe-type product into an empty syringe by sticking
the needle of the empty syringe into the prefilled one. Such behavior
was endorsed even by the hospital in many cases.
Findings from this study showed that JCQHC’s recommendations
correspond to WAI and physicians’ adaptive behavior correspond to
WAD. There was a gap between WAI and WAD for the administration of
KCl solutions in critical care units. According to a more detailed clas-
sification, (Shorrock, 2019) this can be interpreted as ‘work-as-pre-
scribed’ and ‘work-as-disclosed,’ although the idea is essentially the
same for expressing variations and features of human work.
Diversion of concentrated KCl from prefilled syringe-type products,
which occurred during an adverse event in the past, was being im-
plemented in Japanese hospitals. Such unintended use of foolproof
products was developed to prepare KCl solutions at higher concentra-
tions (e.g., 500 or 1000 mmol/L) when ampoule-type products were not
available.
This study identified clinically rational reasons for administering
KCl solutions of higher concentrations from syringes and the need to
stock them in critical care units despite the authoritative re-
commendations stated in pharmaceutical references and the JCQHC
alert. Patients with low cardiac or renal function are not able to tolerate
volume overload. For example, giving a patient 20 mmol of potassium
533
A. Uema, et al.
in 1 hour while abiding by the recommendation would require 500 mL
of diluted solution with a potassium concentration of 40 mmol/L, which
might induce congestive heart failure. Fluid volumes for medication
administration should also be limited in pediatric patients. In addition,
it is easier to finely adjust loading doses of potassium when clinicians
use syringes rather than bottles or bags containing many components.
In the current hospital environment, which lacks a system for im-
mediate preparation and delivery of concentrated KCl solutions, the
necessity for urgent correction of potassium levels in seriously ill pa-
tients requires the stocking of concentrated KCl solutions, whether
ampoule-type or prefilled or kit-type, in critical care units.
4.2. Potential risks of an over-constrained safety policy
According to RHC theory, performance adjustment at the sharp end
is recognized as a factor that can make everyday clinical work suc-
cessful (Hollnagel, 2013). Typical types of performance adjustments
include avoiding future problems, maintaining or creating good
working conditions, and compensating for something that is missing
(Hollnagel, 2014b). Stocking ampoule-type KCl products in critical care
units against the JCQHC safety policy is an example of an adjustment to
avoid a delayed response to a potentially fatal arrhythmia and to pro-
vide the clinically appropriate treatment for hypokalemia. Drawing
concentrated KCl solutions from prefilled syringes compensated for the
lack of ampoule-type products.
It should be recognized that adjustment poses a risk of adverse
outcomes at the same time. Once a concentrated solution of KCl is
drawn from a prefilled or kit-type product into another syringe, it can
be connected to three-way stopcocks. Therefore, accidental rapid in-
jection of a concentrated solution could occur due to clinicians’ lack of
knowledge of the dose of potassium or confusion with other medica-
tions in similar syringes. Given the potential risks of adjustment at the
sharp end, such adjustments, in other words, variability, need to be
dampened.
Even worse, when such a procedure becomes routine, syringes de-
signed to be foolproof are no longer safer, because they are treated as
containers of concentrated KCl solutions, just like ampoules. The only
difference between these two types of products is their shape, but
clinicians may perceive that ampoules are better because regulators
have deemed them to be safer. This study found that in critical care
units with both ampoule and prefilled or kit-type products, KCl solu-
tions with higher concentrations were being prepared from prefilled or
kit-type products in an unintended manner, not from ampoule-type
products. This practice may indicate that the current behavior of
drawing from prefilled products is not necessarily adaptive but has
become just normal practice in the more than 10 years since the im-
plementation of the JCQHC policy.
In the most recent alert released after the 2015 incident, the JCQHC
Adverse Event Prevention Division introduced a hospital-wide ban on
the drawing of concentrated KCl solutions from prefilled syringes as a
reactive safety measure adopted by the hospital where the incident
occurred (Japan Council for Quality Health Care, 2015). If this policy is
implemented nationwide, another surprising procedure would develop
when clinicians need to administer highly concentrated KCl solutions to
seriously ill patients with hypokalemia in hospitals with only prefilled
syringe-type KCl products.
4.3. Implications of patient safety approaches in complex adaptive systems
Based on RHC theory, which provides a perspective for under-
standing how work is achieved in complex adaptive systems, the study
revealed a gap between WAI and WAD and that health care practi-
tioners adjusted their performance to adapt to the environment. A real
challenge is how this information can be implemented in policy making
at the national level.
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Safety Science 121 (2020) 529–541
The study findings suggested several strategies for reconciling WAI
at the blunt end and WAD at the sharp end (Hollnagel, 2015b;
Hollnagel, 2017a). First, context-rich data related to everyday clinical
work should be gathered through multiple sources including observa-
tions, interviews, and various data depositories. The collected in-
formation should be analyzed quantitatively or qualitatively and the
results should be interpreted by multiple stakeholders (Hollnagel,
2015a). Second, all stakeholders should recognize that health care is
complex adaptive systems that by nature require multiple evaluations
of what is happening. Third, strengthening formal and informal com-
munication is needed to implement lessons learned from WAD in policy
making at the national level (Braithwaite, 2018). Changes in systems as
reactions to emerging problems should be implemented carefully be-
cause their effect on system behavior over time and space can yield
surprising results (Hollnagel, 2015b). Finally, human factors design
principles should be carefully applied to make it easier to do everyday
clinical work appropriately (World Health Organization, 2011). The
JCQHC safety policy, which was intended to restrict access to high-risk
medications, seemed like a typical option in a human factors approach.
The use of constraints such as restrictions to facilitate safer procedures
can be effective when such a safety measure can control or dampen
performance variability. However, a one-size-fits-all approach should
be carefully examined because it might cause performance variability
when it does not match the clinical context. In general wards, the
JCQHC policy should be followed thoroughly; however, in critical care
units, it is necessary to resume stocking ampoule-type KCl products
after developing appropriate medication management methods and
educating clinical staff, as in safety policies that other countries have
adopted. The human factors approach should take WAD, not WAI, into
consideration (Hollnagel, 2017b).
There are some limitations to our study. First, participants consisted
of only physicians; nurses were not included. Second, the setting was
limited to critical care units in training institutions for specific medical
specialties. Third, conflicts among different departments (e.g., phar-
macy department, patient safety department, and patient units or
wards) in the same hospital were not identified. It would be more in-
formative to get the perspective of all user groups on everyday clinical
work related to the authoritative safety policy.
In conclusion, this study demonstrated that RHC theory can be used
to inform the development and improvement of health care safety po-
licies. Policy makers need to understand WAD when intervening in
complex adaptive systems such as health care.
Research grant
This study was funded by a 2014–2017 Grant-in-Aid for Scientific
Research (B) 26293157: practical application of resilience engineering
theory in patient safety and improvement (Research director: Kazue
Nakajima, MD, PhD).
Acknowledgments
The authors gratefully thank Drs. Kyota Nakamura, Masato Minami,
Ayumi Tokunaga, Takanori Ayabe, Koji Tanaka and Shin Nakajima, and
Professors Shigeru Haga, Akinori Komatsubara, Akio Gofuku, Kenji
Harada, Shigeatsu Hashimoto and Yuji Fujino for their suggestions for
developing the questionnaire; Mr. Noriyasu Kinoshita for his profes-
sional input on medications as a hospital pharmacist; and Drs. Akitomo
Yonei and Makiko Takizawa for the preliminary assessment of the
questionnaire.
Declaration of Competing Interest
The authors declare no conflicts of interest associated with this
manuscript.
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Appendix A

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Appendix B. Supplementary material
Supplementary data to this article can be found online at https://doi.org/10.1016/j.ssci.2019.09.023.
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