CLINICAL KIDNEY JOURNAL

Clinical Kidney Journal, 2016, vol. 9, no. 3, 335–342

doi: 10.1093/ckj/sfw019
Advance Access Publication Date: 14 April 2016
Original Article

ORIGINAL ARTICLE

Feasibility of a hemodialysis safety checklist for nurses

and patients: a quality improvement study
Alison Thomas1,*, Samuel A. Silver1,*, Andrea Rathe1, Pamela Robinson1,
Ron Wald1,2, Chaim M. Bell3,4 and Ziv Harel1,2
1
Division of Nephrology, St Michael’s Hospital, University of Toronto, Toronto, ON, Canada, 2Department of
Medicine and Keenan Research Center, Li Ka Shing Knowledge Institute of St Michael’s Hospital, University of
Toronto, Toronto, ON, Canada, 3Institute of Health Policy, Management, and Evaluation, University of Toronto,
Toronto, ON, Canada and 4Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto, ON,
Canada
Correspondence and offprint requests to: Ziv Harel; E-mail: [email protected]
*
These authors equally contributed to this work.

Abstract
Background: Patients with end-stage renal disease are at high risk for medical errors given their comorbidities, polypharmacy
and coordination of care with other hospital departments. We previously developed a hemodialysis safety checklist (Hemo
Pause) to be jointly completed by nurses and patients. Our objective was to determine the feasibility of using this checklist
during every hemodialysis session for 3 months.

Methods: We conducted a single-center, prospective time series study. A convenience sample of 14 nurses and 22 prevalent in-
center hemodialysis patients volunteered to participate. All participants were trained in the administration of the Hemo Pause
checklist. The primary outcome was completion of the Hemo Pause checklist, which was assessed at weekly intervals. We also
measured the acceptability of the Hemo Pause checklist using a local patient safety survey.

Results: There were 799 hemodialysis treatments pre-intervention (13 January–5 April 2014) and 757 post-intervention (5 May–
26 July 2014). The checklist was completed for 556 of the 757 (73%) treatments. Among the hemodialysis nurses, 93% (13/14)
agreed that the checklist was easy to use and 79% (11/14) agreed it should be expanded to other patients. Among the
hemodialysis patients, 73% (16/22) agreed that the checklist made them feel safer and should be expanded to other patients.

Conclusions: The Hemo Pause safety checklist was acceptable to both nurses and patients over 3 months. Our next step is to
spread this checklist locally and conduct a mixed methods study to determine mechanisms by which its use may improve
safety culture and reduce adverse events.

Key words: checklist, hemodialysis, patient safety, quality improvement

Received: November 16, 2015. Accepted: February 29, 2016

© The Author 2016. Published by Oxford University Press on behalf of ERA-EDTA.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/
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336 | A. Thomas et al.

Introduction Declaration of Helsinki, was approved by the Research Ethics

Board of St Michael’s Hospital, and all nurses and patients gave
Hemodialysis is a complex and invasive procedure that affords
written informed consent. This quality improvement initiative
risk to vulnerable patients. It has been estimated that 2–4% of
was also approved by the Division of Nephrology and Diabetes
end-stage renal disease (ESRD) patient deaths may be attributed
Comprehensive Care Program at St Michael’s Hospital in Toronto,
to a hemodialysis-related complication [1]. A survey carried out
ON, Canada.
in 2006 that elicited opinions from patients and health care pro-
viders about safety concerns in the hemodialysis unit reported
that ∼50% of the patients fear that an error will be made during Hemo Pause intervention
their hemodialysis treatment [2]. Moreover, hemodialysis nurses
The Hemo Pause checklist is meant to be used at three different
have reported a lack of compliance with established hemodialy-
intervals: (i) before the patient arrives (‘sign in’), (ii) prior to can-
sis policies and procedures and a feeling of ‘always needing to
nulation and hemodialysis initiation (‘time out’) and (iii) after
rush’ to get patients in and out for hemodialysis treatment as on-
hemodialysis completion (‘sign out’). The specific checklist ele-
going barriers to patient safety [3].
ments are outlined in Figure 1. A key element of the checklist is
Dialysis unit staff (nurses, nephrologists, technicians) have
the ‘time out’ section, whereby nurses engage in a conversation
called for action to improve the delivery of hemodialysis care
with the patient and the patient has an opportunity to ask
and reduce risk. Several nephrology leaders have provided re-
questions about their treatment plan and correct any errors or
commendations for strategies that should be considered to
omissions. All participants received training on the proper
achieve these goals [4, 5]. Improving the patient safety culture
administration of the Hemo Pause checklist prior to its imple-
in the hemodialysis unit is one such strategy [6, 7]. Studies
mentation. Nurses and patients were also encouraged to offer
have demonstrated that incorporating a culture of trust, trans-
suggestions throughout the implementation period to improve
parency and discipline is associated with sustainable improve-
the performance of the Hemo Pause checklist, consistent with
ments in patient safety [8]. The use of checklists in surgical and
quality improvement methodology.
intensive care settings is one patient safety strategy that may im-
prove safety culture by promoting communication, teamwork
and consistency of care through standardization of protocols Outcomes
and procedures [9].
The primary outcome was completion of the Hemo Pause check-
Checklists may represent a solution to improving the safety
list, which was assessed at weekly intervals. A random sample of
culture in the hemodialysis unit. Indeed, checklists have been pi-
20 encounters between nurses and patients while using the
loted in two European hemodialysis units, which demonstrated
Hemo Pause checklist were also observed to document the dur-
an improvement in safety culture and quality of care [10, 11]. Des-
ation and quality of the interaction (i.e. participants were using
pite the improvements, the aforementioned checklists focused
the Hemo Pause checklist as intended, and not haphazardly
primarily on nurse–physician communication and the patient
checking off items).
experience. Neither checklist was designed to be used collabora-
We assessed the effect of the Hemo Pause checklist on patient
tively between nurses and patients, which is an important aspect
safety and the patient experience using a local patient safety sur-
of the hemodialysis procedure.
vey adapted from the Renal Physicians’ Association survey [2].
Accordingly, to increase patient involvement and empower-
This was conducted before and after implementation of the
ment in hemodialysis, we recently developed a hemodialysis
Hemo Pause checklist. A 5-point Likert scale from strongly
safety checklist (Hemo Pause) using a structured panel process
agree [5] to strongly disagree [1] was used to score the patient
and principles of human factors engineering [12]. In brief,
safety survey.
the Hemo Pause checklist was designed by a multidisciplinary
We also collected data on pre-specified quality of care items
team of physicians, nurses and administrators using an iterative
and adverse events to guide outcome selection for future studies.
process that consisted of literature reviews, surveys and an in-
These included pre-/post-hemodialysis weights missed, pre-/
person consensus meeting. This method is a proven technique
post-hemodialysis blood pressure missed, incorrect hemodialy-
for developing quality and patient safety measures in health
sis prescription, missed hemodialysis sessions, missed medica-
care [13–18]. In the next phase, we now describe the results from
tion administration, missed physician orders, more than two
a small-scale pilot quality improvement program to determine
cannulation attempts, needle dislodgements, access infections
the feasibility of using the Hemo Pause checklist during every
and interventions, blood transfusions, systolic blood pressure
hemodialysis session for 3 months before widescale adoption
<90 mmHg during hemodialysis treatment, falls, hospitaliza-
to the entire hemodialysis unit.
tions and death.

Materials and methods Statistical analysis

We expressed continuous variables as mean [standard deviation
Study design
(SD)] or median [interquartile range (IQR)] as appropriate and cat-
We conducted a single-center, prospective time series study at egorical variables as a percentage. We used statistical process
St Michael’s Hospital in Toronto, ON, Canada. The pre-intervention control (SPC) charts to analyze checklist completion [19]. The
period was from 13 January to 5 April 2014 and the post-interven- SPC charts combine chronological analysis with tests of statistic-
tion period was from 5 May to 26 July 2014. During the interven- al significance, which allow them to evaluate the effectiveness
tion period, the Hemo Pause checklist was used during every and sustainability of a process over time. This approach is par-
hemodialysis session. A convenience sample of 14 nurses (out ticularly useful for quality improvement interventions [20].
of 60) and 22 prevalent in-center hemodialysis patients (out of Control limits were plotted 3 SDs from the mean; this is typical
72) volunteered to participate. The study was limited to Eng- for SPC charts since almost all data will fall within ±3 SDs
lish-speaking nurses and patients. The study adhered to the of the mean if the underlying process is in statistical control
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Hemodialysis safety checklist for nurses and patients | 337

Fig. 1. Hemodialysis safety checklist (Hemo Pause). CVC, central venous catheter.

[19, 20]. We compared variables using Student’s t-test, the Mantel– Table 1. Baseline characteristics of the Hemo Pause patients
Haenszel χ2 test or Fisher’s exact test, as appropriate. We considered
Hemo Pause
a two-sided P-value <0.05 as statistically significant.
Characteristic cohort (n = 22)

Mean age, years (SD) 59 (11)

Results Male, n (%) 15 (68)
Mean duration on dialysis, years (SD) 6.9 (5.9)
There were 799 hemodialysis treatments pre-intervention and
Mean number of medications (SD) 13.6 (4.1)
757 post-intervention. Table 1 describes the characteristics of
Number of dialysis days per week,
the patients enrolled in the study.
median (IQR) 3.0 (2.3)
During the 3-month implementation period, the Hemo Pause
Dialysis access, n (%)
checklist was completed for 556 of 757 (73%) possible hemodialy-
Fistula 13 (59)
sis treatments. The most common reasons for non-completion of
Graft 3 (14)
the checklist were a shortage of nursing staff trained in the use of Central venous catheter 6 (27)
the checklist during the summer vacation months and patient Comorbidities, n (%)
admission to the hospital. Of the 20/757 (3%) observed encoun- Diabetes 9 (41)
ters, all were conducted with sufficient quality and in <5 min. Hypertension 20 (91)
Figure 2 demonstrates usage of the Hemo Pause checklist through- Coronary artery disease 9 (41)
out the implementation period. Congestive heart failure 1 (5)
There were no significant differences between the pre-inter- Chronic obstructive pulmonary disease 2 (9)
vention and post-intervention scores on the patient safety sur- Peripheral vascular disease 2 (9)
veys (Figure 3). Among hemodialysis nurses, 93% (13/14) agreed Cerebrovascular disease 1 (5)
that the Hemo Pause checklist was easy to use, 79% (11/14) agreed Cancer 0 (0)
it should be expanded to other patients and 93% (13/14) would
want the Hemo Pause checklist used during their hemodialysis
sessions if they developed ESRD. Among hemodialysis patients, pre-dialysis weights, pre-dialysis blood pressure and intradialy-
73% (16/22) agreed that the Hemo Pause checklist made them tic hypotension were statistically significant, but the effect
feel safer and 73% (16/22) agreed it should be expanded to other sizes were small and the direction of the changes inconsistent
patients. Of the 200 total survey questions asked to nurses and (both in favor of and in opposition to the Hemo Pause checklist).
patients, negative comments occurred on 4% (7/200) of survey The most common quality of care problems were (i) missed blood
responses. pressure before hemodialysis [385/757 (51%)], (ii) missed blood
Table 2 compares the safety parameters collected during the pressure after hemodialysis [276/757 (36%)] and (iii) missed weight
pre-intervention and post-intervention periods. The changes in measurements after hemodialysis [27/757 (4%)].
CLINICAL KIDNEY JOURNAL
338 | A. Thomas et al.

Fig. 2. The percentage of the Hemo Pause checklists in the patient chart completed on a weekly basis. Upper and lower control limits (UCL and LCL) are plotted at ±3 SDs
from the mean. A shortage of nurses trained in administration of the Hemo Pause checklist started the second week of July.

Fig. 3. Patient safety survey results. The top panel represents nurse responses and the bottom panel patient responses. A 5-point Likert scale from strongly agree (5) to
strongly disagree (1) was used to score the surveys.

Discussion involved in this pilot study agreed that the Hemo Pause checklist
In our pilot quality improvement study, we found that the Hemo was easy to use and should be expanded to other patients.
Pause checklist was completed for 556 of the 757 (73%) treat- The results of our study are in keeping with the results of two
ments over 3 months. The majority of nurses and patients other hemodialysis checklist feasibility studies [10, 11]. The
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Hemodialysis safety checklist for nurses and patients | 339

Table 2. Quality of care and adverse events before and after the Hemo Pause implementation

Pre-checklist Post-checklist
P-value
N % N %

Hemodialysis treatments 799 757

Pre-weights missed 1 0 12 2 0.01
Post-weights missed 18 2 27 4 0.13
Pre-blood pressures missed 452 57 385 51 0.03
Post-blood pressures missed 320 40 276 36 0.16
Incorrect hemodialysis prescription 16 2 13 2 0.71
Missed hemodialysis session 24 3 24 3 0.88
Missed medication administration 8 1 14 2 0.19
Missed physician orders 8 1 5 1 0.58
More than two cannulation attempts 0 0 0 0 N/A
Needle dislodgements 0 0 0 0 N/A
Access infections 0 0 0 0 N/A
Access interventions 2 0 2 0 1.00
Blood transfusions 8 1 2 0 0.11
Falls 0 0 0 0 N/A
Systolic blood pressure <90 mmHg during hemodialysis 5 1 22 3 0.01
Hospitalizations 3 0 1 0 0.62
Deaths 0 0 0 0 N/A

checklists by Marcelli et al. [10] and Galland et al. [11] were found session progresses, whereas the checklist by Marcelli et al. [10]
to be feasible and acceptable for use among their study partici- was completed automatically from device monitors and elec-
pants. The acceptance of our checklist by nursing staff and pa- tronic records rather than being physically checked by a person.
tients may be related to the common features it shares with the This difference may be important, since it is the act of completing
aforementioned checklists, with 70–80% of the items similar the checklist that affects behavior, not using the checklist as a
across all three checklists. Specifically, all three checklists incorp- means of data collection or assurance [22, 23].
orate three phases of safety checks: pre-session, session initi- Feasibility testing is an important part of any quality improve-
ation and post-session. Common checklist items at each time ment effort since it allows for a change to be incrementally
point include the following: accepted by staff and patients and modified by end users on a
small scale before widespread dissemination [24]. There are a
• Pre-session: confirmation of patient identity and a review of number of observations noted in our study that relate to the
patient-reported problems and the dialysis access (including feasibility of the Hemo Pause checklist and have implications
infection prevention and cannulation plan) regarding its future modification and implementation. First,
• Session initiation: a review of the dialysate prescription, treat- checklist completion declined at the same time as a nurse short-
ment plan (including blood pressure, target weight, treatment age during the summer vacation period. This observation sug-
time and possible complications) and dialysis access difficul- gests that all dialysis unit staff should be trained in checklist
ties (including needle size and cannulation attempts) administration since it is spread throughout the unit. Second,
• Post-session: a review of vital signs, blood loss and dialysis ac- nurse and patient perceptions of safety climate and engagement
cess complications, target weight and treatment time. did not improve at the end of the study. This result may have
been due to these items being rated highly prior to the checklist,
These checklist similarities provide face validity for the items in- which did not leave much room for scores to increase. These
cluded on all three checklists. Therefore, these elements should positive safety ratings may have been due to the highly selected
be strongly considered for inclusion on current and future hemo- convenience sample of nurses and patients who participated in
dialysis safety checklists. the study. Additional considerations are that a more sensitive
However, our checklist differs from those of Marcelli et al. and and validated patient safety measurement tool may be needed
Galland et al. in its intended purpose and format. The checklist by or improvements in safety culture require a series of interven-
Marcelli et al. focused on the patient experience and allowed tions rather than a single intervention. Published strategies to
nurses to complete hemodialysis sessions independently with strengthen safety culture include structured educational pro-
minimal physician input required due to the reorganization of grams, leadership walk rounds and team training [25, 26]. Com-
dialysis services, while the checklist by Galland et al. focused prehensive Unit-Based Safety Programs (CUSPs) combine all of
on communication between nurses and physicians. In contrast, these elements along with specific strategies to promote best
our checklist focused on communication between nurses and pa- practices, and they have shown promise in two systematic re-
tients. These differences emphasize the importance of local con- views on safety culture promotion methods [25, 26]. Recent opin-
text in quality improvement [21]. Indeed, although checklists ion leaders also suggest that team training is a prerequisite for
may have common elements and can be adapted between dialy- checklist effectiveness [27]. These interventions were not used
sis units, each dialysis unit must tailor the checklist to their own along with the Hemo Pause checklist and may explain why the
environment, work processes and needs. Another important dif- unit safety culture did not improve despite highly motivated
ference is the format of the checklist. The Hemo Pause checklist nurses and patients. Third, the checklist did not affect the rate
was designed to be completed manually as the hemodialysis of quality of care deficiencies or adverse events. Several items
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340 | A. Thomas et al.

reached statistical significance, but these likely represent false- other checklist studies [27]. Our checklist was designed using a
positive results due to the number of hypothesis-generating structured panel process, which is a proven technique for devel-
tests performed, the small effect sizes and the inconsistent rela- oping quality and patient safety measures in health care. We also
tionship both in favor of and against the checklist. Moreover, the involved human factors engineers to address safety problems
short duration of the follow-up period makes it unlikely that a that the checklist could introduce as a result of interactions be-
change in organizational safety culture would occur at such a tween people, technology and work environments [30]. Even
rapid pace to cause a change in quality of care and adverse though the hard copy format added time to the nurses’ workload,
events. Lastly, Table 2 should be interpreted with caution be- we believe that this step may have helped integrate the checklist
cause this study was not powered to detect an effect on hard clin- into normal hemodialysis workflow. Some integration chal-
ical outcomes, and we also found it challenging to measure so lenges still remain with our checklist, given a completion rate
many processes simultaneously that may have resulted in meas- of <100%. Our greatest challenges going forward are to further
urement and ascertainment bias. For example, it is very unlikely minimize duplication of work and ensure that the checklist pro-
that no patient required more than two cannulation attempts vides an immediate advantage to staff to compensate for their
over the complete 6-month study period, which suggests a prob- upfront time commitment. It is not enough to develop a fast
lem with the ascertainment of this outcome. Instead, we re- and simple checklist since staff must also feel that the checklist
inforce that these quality of care data are intended to guide makes their work easier and helps patients for it to become usual
future studies so that we can focus on the common quality of care. This combination has been achieved with some surgical
care problems in our hemodialysis unit. and intensive care unit checklists [9, 31], which suggests similar
Even though this study did not include a formal qualitative checklist integration may be possible with hemodialysis.
component, several comments by nurses and patients warrant Our study also has several limitations. First, the checklist test-
mention. Nurses noted that work duplication was a significant ing period was only 3 months and therefore it is possible that the
barrier to checklist implementation and preferred the study to observed checklist completion rate may not be sustainable. This
have been organized according to dialysis shift rather than self- drop-off was encountered by Marcelli et al. [10], where checklist
selection. In this way, nurses working on the same dialysis usage was compromised by the opening of a new dialysis shift.
shift would have more flexibility to change care processes in Second, the generalizability of our findings is limited by the
order to integrate the checklist into usual workflow and minim- single-center design involving a small number of self-selected
ize duplication of work. Several nurses commented that the nurses and patients. While these latter two limitations can be ad-
checklist being spread across so many different dialysis shifts dressed by studying the Hemo Pause checklist for additional time
limited its effectiveness, which is consistent with observations and in different clinical settings, the purpose of this study was to
that there can be wide variations in safety culture within a single demonstrate feasibility rather than sustainability and spread.
institution [28]. Patients noted that their initial reluctance to par- Moreover, as hemodialysis is a fairly stereotyped process, many
ticipate in safety initiatives was not substantiated at the end of of the components of our checklist could be incorporated into fu-
the study. Their concerns centered on how their feedback ture hemodialysis checklists. Third, Table 2 should be interpreted
would be perceived by nurses, as well as treatment delays from with caution since the objective was to inform outcome selection
the new process. At the end of the study, the patients appreciated for future studies. We suspect some measurement and ascertain-
the opportunity to work collaboratively with nurses on a shared ment bias given the number of outcomes that were recorded in
purpose. They felt their input was valued and important, which this feasibility study. Finally, there is no high-quality evidence
outweighed any small disruptions to treatment duration. These to prove that the Hemo Pause checklist improves patient safety
comments from nurses and patients suggest some concerns culture, the patient experience or patient outcomes.
and strategies to consider when involving nurse and patient sta- We are currently addressing these questions in the next phase
keholders in patient safety and quality improvement activities. of our quality improvement program. First, the Hemo Pause
Our findings have several implications. First, they provide checklist will be expanded locally at St Michael’s Hospital. We
support that a hemodialysis safety checklist is a feasible patient will randomize different hemodialysis shifts to the Hemo Pause
safety tool that can be integrated into every hemodialysis ses- checklist or usual care for 3 months. The primary outcome will
sion. The exact design of the checklist should be modified to be safety culture and patient experience, as measured by vali-
the policies and practices of the local hemodialysis unit and its dated Agency for Healthcare Research and Quality tools [32, 33].
patient safety objectives, keeping in mind that hemodialysis is Secondary outcomes will include intradialytic hypotension, ac-
a fairly stereotyped process such that the core features of our cess infections, hospital admissions and death. We will also in-
checklist should be considered in the design of other hemodialy- clude a formal qualitative interview component to try and
sis checklists. Second, our findings highlight the importance of identify the mechanisms by which the Hemo Pause checklist
patient safety to nursing staff and patients, as both groups agreed may improve patient safety and reduce adverse events. If the sur-
that this initiative improved patient safety and should be ex- vey and qualitative data support the Hemo Pause checklist, we
panded to other patients. This result supports local, provincial would then engage other hemodialysis units to conduct a cluster
and national health care mandates to improve patient safety randomized controlled trial that is adequately powered for the
and may serve as the initial impetus to consider a policy to use composite outcome of intradialytic hypotension, access infec-
checklists in the hemodialysis unit as a measure to promote tions, hospital admissions and death.
best practices and organizational safety culture. In Canada, gov-
ernments have already started to incorporate checklists and their
compliance as a quality metric in other medical disciplines [29].
The strengths of our study include its practical quality im-
Conclusion
provement approach, which incorporated real-time feedback In summary, our study shows that the Hemo Pause safety check-
from nurses and patients to improve the checklist. We also per- list was acceptable to both nurses and patients when integrated
formed a small random audit of checklist encounters to docu- into usual care over a 3-month period. Further research is needed
ment the quality of the interaction, which is often omitted in to determine the role of checklists in hemodialysis and their
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Hemodialysis safety checklist for nurses and patients | 341

impact on safety culture, the patient experience and clinical 10. Marcelli D, Matos A, Sousa F et al. Implementation of a quality
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study design; A.T., A.R. and P.R. participated in data acquisition; 12. Silver SA, Thomas A, Rathe A et al. Development of a hemo-
S.S., A.T., A.R., P.R., Z.H. and C.B. carried out data analysis/inter- dialysis safety checklist using a structured panel process. Can
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H. and C.B were involved in supervision or mentorship. Each au- 13. Guttmann A, Razzaq A, Lindsay P et al. Development of mea-
thor contributed important intellectual content during manu- sures of the quality of emergency department care for children
script drafting or revision and accepts accountability for the using a structured panel process. Pediatrics 2006; 118: 114–123
overall work by ensuring that questions pertaining to the accur- 14. Kroger E, Tourigny A, Morin D et al. Selecting process quality
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