The American Journal of Surgery xxx (xxxx) xxx

Contents lists available at ScienceDirect

The American Journal of Surgery

journal homepage: www.americanjournalofsurgery.com

Statistical Process Control (SPC) to drive improvement in length of

stay after colorectal surgery
Deborah S. Keller*, Thais Reif de Paula, Guanying Yu, Haiqing Zhang, Ahmed Al-Mazrou,
Ravi P. Kiran
Division of Colorectal Surgery, Columbia University Medical Center, New York, NY, USA

a r t i c l e i n f o a b s t r a c t

Article history: Background: Novel quality improvement(QI) methods are needed to optimize healthcare costs and value.
Received 4 August 2019 Our goal was to determine if Statistical Process Control(SPC), an industrial QI tool, could transform length
Received in revised form of stay(LOS) into a process measure, identify outliers, and their impact on surgical outcomes.
19 August 2019
Methods: SPC was performed on an institutional colorectal resection database 1/1/13-5/1/2018 to
Accepted 28 August 2019
identify outliers and compare outcome variables across outliers and non-outliers. Control charts
Poster Presentation, The Society of Alimen- analyzed the process performance of LOS over time. Control limits were set at ± 1 standard deviation(SD)
tary and Gastrointestinal Endoscopic Sur- from the mean. Measures were stable within these limits.
geons Annual Conference, April 1e4, 2019. Results: LOS was stable, with consistent annual rates and variation of outliers. Outliers had identifiable
Baltimore, MD causes of variation that were significantly different from non-outliers(p < 0.05). The variation resulted in
more complications, readmissions, and reoperations in outliers(p < 0.05).
Keywords: Conclusions: SPC can be applied to LOS, a stable process measure with decreasing variability over time,
Colorectal surgery and easy outlier identification. Identifying outliers can facilitate targeted quality improvement.
Quality improvement
© 2019 Elsevier Inc. All rights reserved.
Healthcare outcomes
Length of stay
Statistical process control (SPC)

Summary Product, and is projected to grow 5.5% annually. Hospital inpatient

Statistical process control, an industrial tool for quality
improvement work, can be easily applied to colorectal surgery,
transforming a common outcome measure, like length of stay, into
a process measure to easily identify and address variation.
Introduction
In the United States, healthcare spending continues to grow at
an unsustainable rate. In 2017, healthcare spending grew 3.9%,
reaching $3.5 trillion or $10,739 per person. Spending on health-
care currently accounts for 17.9% of the nation's Gross Domestic
* Corresponding author. Surgery Division of Colon and Rectal Surgery, Depart-
ment of Surgery, NewYork-Presbyterian, Columbia University Medical Center, 161
Fort Washington Avenue, 8th Floor Herbert Irving Pavilion, New York, NY, 10032,
USA.
E-mail addresses: debby_keller@hotmail.com (D.S. Keller), thaisreif@gmail.com
(T. Reif de Paula), gy2263@cumc.columbia.edu (G. Yu), haiqingzhang81@gmail.
com (H. Zhang), almazrou@live.co.uk (A. Al-Mazrou), rpk2118@cumc.columbia.
edu (R.P. Kiran).
care constitutes a major portion of this expenditures, costing the
health system at least $377.5 billion per year.1 In today's value-
based care environment, there are major efforts ongoing for hos-
pitals to reduce this spending while maintaining quality.2 In sur-
gery, a frequent metric for gauging the success of inpatient cost
containment efforts has become postoperative hospital length of
stay (LOS).3 While an easily retrievable outcome variable, LOS can
be a simply measured surrogate for efficiency and clinical perfor-
mance.4 The performance of LOS is directly linked to common
outcome measures, such as complications and cost control.5,6 LOS
has also been found to be related to patient satisfaction and the risk
factors that affect outcomes.7,8 Thus, studies have applied LOS as a
measure to benchmark quality and facilitate quality improvement.
Consequently, LOS may be more effective as an institutional process
measure, which investigates and addresses potential factors to
improve LOS, rather than an outcome measure that reports a value.9
A novel method of applying LOS as a process measure is with
Statistical Process Control (SPC). SPC started as an industry meth-
odology, where it was widely used for controlling quality during
processes, such as car manufacturing in Japan. SPC distinguishes
itself from other process improvement tools, in that it uses active

https://doi.org/10.1016/j.amjsurg.2019.08.029
0002-9610/© 2019 Elsevier Inc. All rights reserved.

Please cite this article as: Keller DS et al., Statistical Process Control (SPC) to drive improvement in length of stay after colorectal surgery, The
American Journal of Surgery, https://doi.org/10.1016/j.amjsurg.2019.08.029
2 D.S. Keller et al. / The American Journal of Surgery xxx (xxxx) xxx

inspection to detect and prevent problems and waste, leading to (central line), define the predictable normal variation in LOS (an
cost efficiency. SPC can identify common sources of variation, upper line for the upper control limit and a lower line for the lower
which are an expected part of a process, from unexpected (special) control limit), and then used as a basis for determination of outliers,
sources of variation, and eliminate them so that the process is for the points falling outside of the controlled field. The preset
stable, with little variation from the expected result. SPC also upper and lower control limits were set at ± 1 standard deviation
monitors the ongoing production process, using graphical control (SD) from the mean.
charts, to present performance on a process, with the aim to detect Control charts were used to display the data graphically and
and reduce variation in the outcome, improving quality.10 Unstable analyze the process performance of LOS over time. From the control
and unexpected processes can be stabilized, making it possible for chart, the process of LOS would be defined as stable or unstable. A
process improvement measures to be successfully initiated. After stable process produces predictable results consistently, while
years of using SPC in industry, the tool is being applied to health processes that are “out of control” would have large variation in
care for surgical quality improvement, including reducing surgical their SD from the mean. Each year, the control limits were re-
site infections, unplanned reoperations, and streamlining cardiac calculated to determine the stability of the process. A change in
surgical care.11e15 SPC could help identify the specific institutional the average or center line and/or reduced variation would
practices that lead to outliers and unexpected outcomes. demonstrate success or failure of a process change. LOS outliers,
Our hypothesis was that LOS can be evaluated as a process known as variation, would be indicative of an unstable or unex-
measure, and graphed to determine if the process is unstable and if pected process, with the number of outliers directly related to the
so why, to facilitate process improvement. Our goal was to deter- degree of unstability. A stable process has less than 25% of the
mine if SPC can be applied to LOS to identify outliers, patterns for measures outside of the control limits or ± 1 SD from the mean LOS.
outliers, and their impact on quality outcome measures in colo- If the LOS process was unstable, the outliers/points lying outside
rectal surgery. the upper control limit (UCL) and lower control limit (LCL) were
known as special cause variation. Special causes can be individually
Material and methods investigated, and changes proposed to eliminate them and move
towards a statistically controlled process. If the variation stems
After Institutional Review Board approval (#AAAS0165), a re- from expected causes, the process has common cause variation.
view of a prospective divisional database at a single urban tertiary With only common caluse variation and acceptable variation
referral center was performed to identify elective colorectal around the mean, the process is in statistical control. Of note, in
resectional procedures done between 1/1/13 and January 5, 2018. 2013, there was a major staff change in the division, with imple-
Cases were included if performed by a surgeon in the Division of mentation of a divisional database to track outcomes. There were
Colorectal Surgery, using an abdominal approach, the patients were no major process changes or quality improvement projects during
greater than 18 years of age, a resection was performed during the the study period. The main outcome measure was the feasibility of
case, the colorectal procedure was the primary procedure for the applying SPC to LOS as a process measure in elective colorectal
episode of care, and complete electronic medical records were surgery. The secondary outcomes were the degree of control in the
available for the patient's inpatient surgical episode. The specific LOS process, the ability to detect and define causes of variation, and
colorectal resection cases included are seen in Appendix 1. Patients reduce variation if present.
were excluded if the procedures were urgent or emergent, per-
formed via an anorectal or endoscopic approach, if a combined Results
procedure with another visceral resection was performed, and if no
resection was performed during the procedure (eg. lysis of adhe- 1218 consecutive patients were identified during the study
sions or diagnostic laparoscopy). period, 1097 patients met inclusion criteria and analyzed. The
Preoperative demographic, intraoperative procedural, labora- overall mean LOS was 6.6 days (SD 4.4), giving an upper control
tory, and short-term post-operative variables (within 30 days post limit of 11 days and a lower control limit of 2 days. In 2013, there
procedure), from an institutional database, were evaluated. Factors was a major staff change in the division, with implementation of
that were not inputs were re-evaluated as outputs that could the divisional database to track outcomes. There were no major
impact LOS outlier status. The data fields included age, gender, body process changes or quality improvement projects during the study
mass index (BMI), comorbidities (ASA class, Charlson Comorbidity period. By year, the mean LOS and the variability around the mean
Index, and all elements of the ACS risk calculator), prior procedures LOS declined from the 2013 initiation to 2014; after that point, the
performed, baseline and postoperative laboratory studies, diag- means and standard deviation stabilized (Table 1). Recalculation of
nosis, procedure performed, operative approach, intraoperative the confidence limits each year graphically showed a LOS as a
procedural details, use of bowel prep, drains, transfusion, surgeon, relatively stable process (Fig. 1).
wound class, LOS, discharge disposition, postoperative complica-
tions, readmission, reintubation, reoperation, and mortality. The Table 1
surgeon that performed the procedure was the provider in charge The length of stay (days) Process measure over time.
of the postoperative care. The data were stratified by calendar year 2013 2014 2015 2016 2017 2018
for comparison of the patient and procedural means and variation.
Cases Included (n) 60 166 206 223 254 188
Univariate analysis was performed to identify the outliers, and Minimum 2 2 2 2 1 1
compare the demographic, operative, and outcome variables across 25% Percentile 4 4 4 3 3 3
outliers and non-outliers. Means (with standard deviation) or Median 6 5 5 5 4 4
medians (with ranges) for normally and non-normally distributed 75% Percentile 9 8 8 7 6 7
Maximum 88 28 75 58 44 60
continuous variables, and frequency (with percent) for categorical
Mean 10.67 6.71 6.18 6.32 5.82 6.22
variables, were used as appropriate for description. Mann-Whitney Std. Deviation 14.63 5.81 6.55 6.04 5.79 6.66
U test, Fisher's exast test, or chi-squared tests were used to compare Lower Confidence Limit 0 1.90 0 1 1 0
outcomes across groups, as appropriate. All tests of significance Upper Confidence Limit 25.3 11.51 14.73 12.36 11.31 12.89
were two-tailed, with P < 0.050 indicating statistical significance. Negative values for the lower confidence limit were considered as 0.
Statistical Process Control charts were used to display the mean LOS Values between 0 and 1 for the lower confidence limit were rounded up to 1 day.

Please cite this article as: Keller DS et al., Statistical Process Control (SPC) to drive improvement in length of stay after colorectal surgery, The
American Journal of Surgery, https://doi.org/10.1016/j.amjsurg.2019.08.029
 D.S. Keller et al. / The American Journal of Surgery xxx (xxxx) xxx 3

While the process of LOS was relatively stable, there were LOS Table 2
outliers present, 115 in total. The mean outlier LOS was 21.4 (SD Length of stay outliers (n) by year.

12.6). At the time of initiation in 2013, 25% of patients were outliers. Year Outliers Total Cases Percentage (%)
The rate of outliers stabilized to 7e8% and the spread around the 2013 15 60 25.00
mean became consistent between 2016 and 2018, likely signifiying 2014 19 166 11.45
the shift from special cause variation to common cause variation 2015 28 206 13.59
(Table 2 and Fig. 2). The outliers were compared to non-outliers, in 2016 17 223 7.62
2017 20 254 7.87
order to identify the variables associated with LOS outliers. Outliers
2018 16 188 8.51
had comparable age, gender, BMI, albumin, primary diagnosis, and
procedure performed to non-outliers (Table 3). Outliers did have
significantly greater co-morbidities (p < 0.001), rates of neo-
process measure in an institutional dataset, where the process was
adjuvant chemoradiation (p ¼ 0.012), and higher rates of previous
graphically stable, with decreasing variability over time, and easy
abdominal surgery (p ¼ 0.002). The LOS outliers also had signifi-
identification of outliers. The causes of outliers were also identified,
cantly lower use of preoperative oral and mechanical bowel prep-
with higher rates of overall complications, readmissions, reopera-
aration than non-outliers (79.1% vs. 83.9%, respectively; p ¼ 0.018).
tions, and post-discharge nursing facilities in the outliers group.
During the intraoperative period, LOS outliers had significantly
Prior studies have supported the concept that SPC can be suc-
greater blood loss and rates of transfusion, complications, and
cessfully applied for quality improvement in surgery. SPC has been
drains placed (p < 0.001). Outliers had fewer anastomoses per-
shown to identify and improve adherence to process indicators in
formed than non-outliers (79.1% vs. 93.3%, respectively, p < 0.001).
liver transplantation, facilitate real-time performance monitoring
Postoperatively, LOS outliers had significantly higher rates of
allowing early detection and intervention in altered performance in
overall complications, readmissions, unplanned reoperations, and
cardiac surgery and interventional cardiology, reduce surgeon
use of post-discharge nursing facilities than non-outliers (all
waiting time between cases in colon surgery, and develop a risk-
p < 0.001) (Table 3).
adjustment model for unplanned return to theatre outcomes
following colorectal surgery.12,17,18,18e20 Here, we successfully
Discussion applied SPC to show the LOS process over time stabilized after the
initial process change of new leadership and division faculty in
Healthcare quality is measured from structure, process, and 2013, with stable upper and lower control limits over the time
outcome measures.9 With the demand for the highest-quality care period evaluated.
coupled with pressure to reduce costs, reliable methods of Previous reports also suggest that industrial tools such as SPC
measuring process improvement in industry are being applied to could reliably, easily and effectively identify variations in process
healthcare.11,16 Statistical process control aims to determine control that occur on surgical services.20 Our study supports this
whether a process being evaluated is stable, to detect when vari- finding. The outliers had consistent patterns from the preoperative
ation occurs, and help determine the cause of the variation.16 and intnraoperative periods-greater co-morbidities, higher rates of
Length of stay, a common outcome masure, could be applied as a neoadjuvant chemoradiation, higher rates of previous abdominal
process measure in the SPC framework for quality improvement. surgery, lower compliance with the bowel preparation, greater
We sought to determine if SPC can be applied to LOS to identify blood loss and rates of transfusion, higher rates of intraoperative
outliers, patterns for outliers, and their impact on quality outcome complications, and drains placed during surgery, and lower rates of
measures in colorectal surgery. We found LOS can be applied as a

Fig. 1. Control chart for length of stay.

Please cite this article as: Keller DS et al., Statistical Process Control (SPC) to drive improvement in length of stay after colorectal surgery, The
American Journal of Surgery, https://doi.org/10.1016/j.amjsurg.2019.08.029
4 D.S. Keller et al. / The American Journal of Surgery xxx (xxxx) xxx

these stable processes and patterns of variation around the mean

Fig. 2. Variability in length of stay outliers.
anastomoses performed than non-outliers. Our results are in
agreement with an earlier work, that showed the feasibility of
initiating SPC to identify LOS outliers within laparoscopic and open
colorectal surgery cohorts, for both emergent and elective cases,
and the worse outcomes of outliers, in higher postoperative
complication rates, higher readmission rates.15 These measures
may be markers for more higher risk patients and more complex
procedures, which would have inherently worse outcome mea-
sures of costs, complication rates, and length of stay.21 Recognizing
over time is imperative at the institutional level, as this defines the
patient population and procedural case mix, allowing institutional
outcome metric goals to be planned.
With institution's identity and expected outcomes known,
process and quality improvement measures can be best under-
taken. With LOS as a stable process, a division-wide Enhanced
Recovery Protocol (ERP) was implemented into practice. The factors
found associated with outlier status in this work were prospec-
tively considered in the ERP. Patients with higher comorbidities,
reoperative cases and those who had neoadjuvant chemoradiation
were referred for preoperative nutrition and conditioning. The
preoperative oral and mechanical bowel preparation was stan-
dardized with patient and provider education to reach over 95%
compliance. Disposition planning pathways with Wound Ostomy
Continence Nursing, social work, and physical therapy were placed
at the time of admission for planned stoma cases, those with higher
comorbidities, intraoperative complications, and/or drains. Defined
quarterly time frames reassessed the process measure after inita-
tion, and control charts successfully graphically displayed the
changes in the mean LOS to 4.5 days, variation around the mean to
2.4, new control limits of 6.9 and 2.1, and a reduction in outliers to
5.47% (n ¼ 17). A further work will describe changes in the outcome
measures, such as surgical site infections, catheter associated

Table 3
Comparison of demographic variables and outcomes for outliers and non-outliers.

Standard Outliers p-value

n 982 115
Mean Age (SD) 61.43 (15.39) 64.26 (16.65) 0.095
Mean BMI (SD) 27.03 (5.73) 27.05 (6.88) 0.803
Gender (n, % Male) 457 (46.538%) 62 (53.913%) 0.140
Mean ASA Class 2.393 (0.568) 2.826 (0.596) <0.001
Steroid Use (n, %) 50 (5.092%) 11 (9.565%) 0.054
Neoadjuvant Radiation Therapy (n, %) 62 (6.314%) 15 (13.043%) 0.012
Mean Albumin (SD, g/dL) 3.742 (0.475) 3.515 (0.746) 0.246
Prior abdominal surgery (n, %) 510 (31.568%) 44 (38.261%) 0.006
Primary Diagnosis (n, %) 0.156
Colorectal Cancer 534 (54.398%) 69 (60.000%)
Diverticulitis 217 (22.098%) 19 (16.522%)
IBD 133 (13.544%) 14 (12.174%)
Other 87 (8.859%) 10 (8.696%)
Constipation/Fecal Incontinence 11 (1.120%) 3 (2.609%)
Compliance with Oral and Mechanical Bowel Prep (n %) 824 (83.910%) 86 (79.130%) 0.018
Procedure Performed (n, %) 0.062
Right Hemicolectomy/Ileocolic 343 (34.929%) 33 (28.696%)
Low Anterior Resection 236 (24.033%) 23 (20.000%)
Sigmoid Colectomy 191 (19.450%) 19 (16.522%)
Left Hemicolectomy 58 (5.906%) 9 (7.826%)
Total/Subtotal Colectomy 51 (5.193%) 11 (9.565%)
Proctectomy with J/K Pouch 44 (4.481%) 3 (2.609%)
Abdominoperineal Resection/Exenteration 28 (2.851%) 5 (4.348%)
Transverse Colectomy 16 (1.629%) 6 (5.217%)
Hartmann's Procedure 15 (1.527%) 7 (6.807%)
Median Wound Class (Range) 22e4 22e4 0.494
Intraoperative Transfusion (n, %) 45 (4.582%) 24 (20.870%) <0.001
Mean Blood Loss (SD, mL) 136 (194) 312 (514) <0.001
Drain Left (n, %) 119 (12.118%) 26 (22.609%) <0.001
Anastomoses Performed (n, %) 916 (93.279%) 91 (79.130%) <0.001
Intraoperative Complication (n, %) 32 (<1.000%) 27 (23.478%) <0.001
Mean LOS (Days, SD) 4.83 (2.169) 21.426 (12.850) <0.001
Postoperative Complication (n, %) 171 (17.413%) 94 (81.739%) <0.001
Readmission (n, %) 103 (10.489%) 30 (26.087%) <0.001
Unplanned Reoperation (n, %)* 34 (3.462%) 24 (20.870%) <0.001
Discharge Disposition (n, %) <0.001
Home 931 (94.806%) 87 (75.652%)
Skilled Nursing/Rehab Facility 38 (3.870%) 24 (20.870%)
Death 5 (<1.000%) 3 (2.609%)

BMI: body mass index.

*Reoperation-defined as an unplanned surgery related to the index surgical procedure within 30 days of the index procedure.

Please cite this article as: Keller DS et al., Statistical Process Control (SPC) to drive improvement in length of stay after colorectal surgery, The
American Journal of Surgery, https://doi.org/10.1016/j.amjsurg.2019.08.029
 D.S. Keller et al. / The American Journal of Surgery xxx (xxxx) xxx
urinary tract injections, opioid use, and readmissions with the new
process implemented that helped proactively prevent variabililty
and unexpected outcomes.
The ability to successfully measure a process change with SPC
was previously shown with the addition of a transverse abdomi-
nus plane block and acetaminophen on a stable system, where a
significantly reduced LOS and reduced spread of outliers around
the mean LOS.14 SPC using risk-adjusted cumulative summation
scores has also been used to graphically demonstrate risk
adjustment and visualize variations in surgical mortality after
colorectal surgery.22
There are important clinical implications from this work. We
show the use of data can drive change. The novel and simple
properties of SPC to show the outcomes from a process can enable a
practice changes. Finding new and effective ways to improve out-
comes is necessary, with consumers, credentialing agencies, the
American Board of Surgery, the Joint Commission, and payers in
both the public and private sectors driving the need to systemati-
cally track, report, and improve the quality of surgical care.23 The
SPC charts informative, real-time visual representation of ongoing
surgical performance, and can provide a more intuitive presenta-
tion of the process of care to health care providers and admin-
istrators.22We also found consistent patterns for LOS outliers, with
the implication that the current “one-size fits all approach” may not
be the best fit for these complex patients and procedures; with the
common causes of the outliers identified, prospective process
changes can be customized to consider the needs and risks of the
outliers, to help improve their outcomes. In our study, patient and
surgical complexity were associated with outlier status for LOS as
expected. While these factors may not be controllable, outliers
were also associated with the omission of combined bowel prep-
aration consisting of mechanical bowel preparation and oral anti-
biotics prior to colorectal resection, thus identifying an opportunity
to combat LOS outlier status. While combined preparation has been
in use for all patients since 2013, the significance of its impact on
outcomes was cemented following a recent study that confirmed
that it improves several outcomes and reduces LOS after colorectal
resection.24 A more regimental approach in its use throughout the
period of the study may have potentially reduced variation in LOS
and improved outcomes. This finding further underlines the ben-
efits of SPC process to identify outliers and evaluate factors asso-
ciated with the outliers.
We recognize limitations in this work. We are introducing an
industrial practice, which may seem foreign to health care, but
there is an evidence base to support use,12,14,15,17,18,18e20,22 and
the success of other more involved industrial practices, such six
sigma and lean methodologies.25 Our study design used a retro-
spective review of a single center, where there are risks of
inherent bias, coding errors, and the lack of genenralizability. The
single center design was necessary for us to define our baseline
and variation trends for our institution's LOS process. With the
sample size, we assumed coding errors would not have an impact.
To reduce bias, there is a need to conduct controlled studies over
time with a larger sample size across multiple institutions. The
univariate analysis performed on outlier variables has several
covariates, which were not controlled for inn this initial feasibility
of the SPC tool on LOS. With these results, further works include a
multivariate analysis to help define the role of these variables and
their independent impact on LOS. Despite any limitations, this
work adds value showing the feasibility of using a simply obtained
outcome measure as a process measure to identify instability,
trends, and causes of outliers. Further work will entail continual
reassessment of these measures after adding quality improve-
ment initiatives in order to further understand the power of this
tool.
Please cite this article as: Keller DS et al., Statistical Process Control (SPC) to drive improvement in length of stay after colorectal surgery, The
American Journal of Surgery, https://doi.org/10.1016/j.amjsurg.2019.08.029
5
Conclusions
With the need to improve surgical quality, SPC can be a valuable
to monitor performance. SPC shifts the quality improvement
paradigm from problem description to care improvement, using
graphical outputs that are easy to obtain and understand. We found
SPC can be applied at the institutional level using LOS as a process
measure rather than an outcome measure, and the practices that
led to variations and unexpected outcomes were recognized. With
this information, process improvement measures that address our
patterns and outliers can be incorporated, and ongoing reporting to
measure their impact on LOS, LOS variances, patient outcomes, and
healthcare efficiency implemented. Further studies are underway
to show the impact of the SPC initiatve on the LOS process measure,
outcomes, and resource utilization.
Disclaimers
None.
Funding
This research did not receive any specific grant from funding
agencies in the public, commercial, or not-for-profit sectors.
Acknowledgement
The authors recognize Ms. Samantha K Nemeth, MS MPH for her
assistance with statistical analysis.
Appendix 1. Specific Colorectal Resection Cases Included in
the Analysis
ICD-9 procedure codes
Open 45.71, 45.72, 45.73, 45.74, 45.75, 45.76, 45.79, 45.82, 45.83
Laparoscopic: 17.31, 17.32, 17.33, 17.34, 17.35, 17.36, 17.39, 45.81
CPT/HCPCS Codes for colectomy
Open 44140, 44141, 44143, 44144, 44145, 44146, 44150, 44151,
44155, 44156, 44157, 44158, 44160, 45113, 45121
Laparoscopic 44204, 44205, 44206, 44207, 44208, 44210, 44211, 44212
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