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Improving Surgical Standards: Using IndustrialPractices and Technology to Improve Surgical PracticeMark L. Manwaring, MD,* and Conor P. Delaney, MD, PhD†

The sophistication of health and surgical care quality improvement strategies is limited.This is particularly true when compared with initiatives in manufacturing and other majorindustries. Over the last several decades, industry improvements in efficiency, reliability,and production quality using methods, such as Six Sigma and Lean, may offer insight on thenext steps in quality improvement in colorectal surgical care. Other tools, such as surgeon-specific registries, integrated databases, enhanced recovery pathways, and standardiza-tion of surgery, when coupled with these process improvement schemes, have greatpotential for improved safety, efficiency, and outcomes in patient care. The authors discussthese strategies and how they relate to surgical care quality improvement.

Semin Colon Rectal Surg 23:184-187 © 2012 Elsevier Inc. All rights reserved.

Although technology, pharmacologic advances, biochem-istry, and engineering have brought great advances to

urgery, there remain significant gaps in the ability of ourealth system to consistently deliver high-quality care. Un-

ike other scientific areas of study, clinical data are subject toonfounding variables that cannot be perfectly quantified—he basis for the importance of randomized controlled trialsn isolating cause/effect relationships. Because quality initia-ives have gained momentum,1 critics have highlighted the

paucity of quality data that exist to support specific perfor-mance measures as markers of quality, and thereby questionwhich metrics should even be assessed. The high innate com-plication rate associated with colorectal surgery highlightsthe need to identify metrics within our specialty and collectdata to scientifically advance quality improvement.

In previous work, the authors have used consensus amongexperts to formulate an initial set of quality-oriented datapoints as a starting point for development of surgeon-specificregistry data points.2 Examples include data points commonto all cases (eg, comorbidity, body mass index) as well as datapoints for specific procedures (eg, anastomotic leak for co-lectomy, use of neoadjuvant therapy for rectal cancer sur-gery, and Parks classification for anal fistula). However, it isunknown whether variability in these items will correlatewith quality. Although not currently used for this purpose,

*Department of Surgery, East Carolina University, Greenville NC.†Division of Colorectal Surgery, University Hospital Case Medical Center,

Cleveland, OH.Address reprint requests to: Mark L.Manwaring, MD, Department of Sur-

gery, East Carolina University, 600 Moye Boulevard, Greenville NC,

27834. E-mail: manwaringm@ecu.edu

184 1043-1489/$-see front matter © 2012 Elsevier Inc. All rights reserved.http://dx.doi.org/10.1053/j.scrs.2012.07.009

the development and rapid adoption of the American Collegeof Surgeons (ACS) case-log system may provide an opportu-nity to prospectively collect quality data for those surgeonsnot affiliated with larger organizations that collect qualitydata, such as through the National Surgical Quality Improve-ment Program (NSQIP). In whatever manner data is gath-ered, it will require analysis to answer these questions. Thecorporate world and industry have developed several toolsthat will help formulate a system of analysis to translate thesedata into processes and systems of care.

Lessons FromIndustry: Six Sigma and LeanIn the mid-1980s, Motorola pioneered Six Sigma (SS) as amethod of process improvement. This involved rigorous as-sessment and statistical analysis followed by targeted processredesign to optimize reliability, with the goal that errorshould occur in 3.4 per million events or less (error free to 6standard deviations, hence the term). SS was initially devel-oped to be applied to manufacturing and production lineswith little variability, which allowed industry to reach suchhigh levels of conformity and excellence. The approach wasfurther popularized by General Electric in the 1990s, and thistype of data driven process analysis and targeted manipula-tion has since been modified and applied to nearly everymajor industry.

SS uses a 5-step methodology that involves design, mea-surement, analysis, improvement, and control. Central to SSis rigorous statistical analysis to determine relationships be-

tween data to identify the source of variance within a process.

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Improving surgical standards 185

Along with many other more complex tools, this is doneusing process control—a tool that allows logical analysis oftrends. Control charts are created to describe performance ofa specific process over time.3 Pertinent data are then collectedand analyzed to “determine whether the performance of aprocess is stable and predictable or whether there is variationin the performance that makes the process unstable and un-predictable.” Although rarely described in surgical care im-provement publications,4 this can be represented graphicallyo help one interpret raw performance and trend data. Iden-ification of inconsistent or unpredictable processes allowsargeted creation of an alternate process that eliminates thesenconsistencies. Using the final improvement/control steps,ach change incrementally improves the capacity for consis-ent error-free operation.

Lean is a process management philosophy that developedut of Toyota Production System from the 1950s. It identifieshe customer’s needs and then eliminates steps or so-calledonvalue activities to gradually eliminate wasted steps in arocess. The method often uses value stream mapping,hich is done to depict processes and use organized inter-

hanges with participants, allowing identification of areas formprovement, so that new methods with increased efficiencyre solicited and adapted.

Application of these methods of process development gen-rally results in significant improvements to efficiency andeliability in industry, often with huge quality control andnancial benefits. Although the 99.9997% error-free opera-ion in health care is not attainable, and perhaps particularlyo in colorectal surgery, there is vast room for improvement.ean and SS with embedded process control are valuableools that have enabled industry to make tremendous im-rovement in quality and efficiency. Surgical quality endeav-rs should also harness these techniques.

ChallengesThe current health care delivery system is immensely com-plex. Unlike manufacturing or production, clinical surgicalpractice has patient, social, economical, regional, educa-tional, environmental, ethical, personal, legal, and other in-fluences that ultimately all play a role in the process of careand, to some degree, patient outcomes. Although completecontrol over all these confounders is impossible, the extent towhich they are quantified and can be analyzed will mirror thedegree to which progressive-directed system evolution to op-timal performance can be attained.

There are large variations in clinical outcomes in colorectalsurgery. The causes that impact these outcomes can be vari-ably controlled by the surgeon (Table 1). For example, fac-tors such as patient comorbidities are largely out the controlof the surgeon. Equipment and the team available to lookafter the patients are more under the surgeon’s control. Thesurgeon will have most impact on the perioperative care planand the quality of the surgical procedure. Any quality im-provement models established within an institution will,however, carry a “shelf-life.” Where potential variables and

sources of confounding, such as a patient-specific comorbid-

ity, may herald a deficiency in a process, with the ever-chang-ing practice of evidence-based medicine, these variables maynot be as reliable to direct reform with time. Although estab-lishment of these process control tools intends to aid strin-gent monitoring of health care outcomes, institutions mustalso be alert to the need to modify the model for continuedsuitability.

We have outlined some industry approaches to decreasingvariability and improving reliability. Although not all vari-ability in outcome can be attributable to controllable factors,the first step in decreasing variability in outcomes is to gatherdata on variation in care, and begin targeted reforms.

Surgeon-SpecificRegistries and Other DatabasesA number of databases are now available to compare out-comes between hospitals and surgeons, such as NSQIP orPremier Perspectives. Several groups have published out-comes using these sources, and have provided valuable in-sight into standardized outcomes for large numbers of hos-pitals.5-7 For various reasons, what each of these systems lacks the ability to have granular data for each surgeon, in aisk-adjusted and real-time manner.

Surgeon-specific data registries are a source of powerfuleal-world data relevant to quality improvement. This type ofegistry is a source of data for a majority of clinical researchublished by many authors’ at large institutions. Cost andvailability of these tools have limited their usage to largeenters in the past. However, with web-based system avail-bility, such as the ACS case-log system, this type of registrys becoming increasingly available to the individual surgeon.lthough at the present time, data in these specialty case logsre not available for research, this type of data has tremen-ous potential, particularly as collection of data becomesore seamless with the electronic health record.Efforts have been made to tailor the ACS case-log system

or use by colon and rectal surgeons incorporating clinicallyelevant data points2 so that eventual analysis can be per-

Table 1 Surgeon Control Over Causes of Variability in PatientOutcomes

No ControlPractice profile/Case mixPatient factorsNational culture

Some ControlOperating facilityEquipment availabilityTeamwork

ResidentsNursesAncillary staff

Most ControlPerioperative care planSurgical quality and technique

formed—whether by the individual surgeon for personal

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186 M.L. Manwaring and C.P. Delaney

quality improvement audits or by specialty boards for thepurpose of identifying areas of wide variability or substan-dard outcomes. Such analysis can make it possible to spreadeducational programs to those who have the most potentialbenefit. For example, enhanced recovery protocols can bedisseminated to those with high length of stay variability; andbest practice guidelines for avoidance of SSI can be deliveredin a targeted manner when SSI rates are elevated. Because ofthe digital nature of these systems with built in analysis,real-time data for surgeons to review are now a reality.

The authors believe that the current barriers to using case-log systems as registries for research purposes are not insur-mountable. Foremost challenges include security and de-identification issues to maintain compliance with currenthealth information security standards. Other challenges liewith data collection, entry, completeness, risk adjustment,and reliability. Although each issue listed is complex, solu-tions to each of these barriers can be developed with activeparticipation of colon and rectal surgeons in the developmentof these systems and quality standards. A related system inthe National Trauma Data Bank has been established that hasconquered many of these barriers. Surgeons familiar with thissystem have recognized the need for a similar system to mon-itor outcomes and facilitate study of other surgical patients.8

System Outcomes ClinicalResearch AdministrativeEfficiency Software (SOCRATES)Programs, such as NSQIP, Premier Perspectives, and the Uni-versity Hospitals Consortium, have been brought from theVeteran’s Administration Medical Center system into privateand academic health care systems to sample surgical out-comes and provide hospitals with benchmarks that can beachieved, as well as informing them where they rank in theoverall results.9 Unfortunately, systems, such as NSQIP, are

ased on sampling a percentage of cases performed eacheek and do not track all cases or all providers. Therefore,any cases are not tracked in any way.Hospitals use a variety of software programs for profes-

ional billing, administration (such as operating room sched-ling), and technical charge assessment that by definitionracks every case. Each of these systems is coded in a differentay, making comparisons between databases and data sets

hallenging. For instance, many billing systems code by cur-ent procedural terminology, whereas administrative systemsode by international classification of diseases or diagnosis-elated group codes, and operating room scheduling systemsay code by free text. In 2006, our institution defined a need

or reporting technology, which could integrate disparateospital administrative information systems.To facilitate this process, we initially proposed and devel-

ped the General Surgical Outcomes Quality Improvementatabase—subsequently renamed SOCRATES—novel soft-are, which tracks all surgical, medical, and radiological en-

ounters occurring at University Hospitals Case Medical

enter, Cleveland, OH. Having completed software develop-

ent and validation, and integrated feedback from a numberf user groups in administration and different medical andurgical departments, SOCRATES has evolved and been inse at University Hospitals Case Medical Center for 5 years.his code has now been upgraded and functions as a dataarehouse, which cleans and sorts data and performs sophis-

icated reporting, integrating administrative data from a va-iety of sources in near real-time fashion. Reports can berovided for specific physicians, departments or groups, andny grouping of codes in a risk-adjusted manner. We believehat if hospitals merged their complex existing data such thathey could be altered into a collection of simple readableeports, objective cost and care decisions could be made,mproving understanding both qualitatively and quantita-ively.

Enhanced Recovery Pathwaysand Standardized SurgeryThe mechanisms to achieve these improved outcomes, whichcan be measured with technology, such as SOCRATES, in-clude standardization of the perioperative care process andstandardization of the surgery itself. Enhanced recoverypathways (ERP) are an effective means of improving the qual-ity and efficiency of surgical care.10 ERP encompass a system-atic and evidence-based appraisal of all interventions per-formed in an episode of care. They have been associated witha reduction in length of hospital stay, readmission, and reop-eration, together with decreased mortality and morbidity,improved pain control, better cost containment, and im-proved patient satisfaction.11 Although ERP have the poten-tial to make an important contribution to distressed healthcare systems, they are used in less than one-third of surgicalpractices in both the United States and United Kingdom.Furthermore, physicians are frequently given no informationon how their outcomes differ from those of their peers, andtherefore, they lack the appropriate tools or insight to changetheir processes of care. This becomes even more important ashospitals struggle to maintain a profitable status, or breakeven, because health care reimbursement is reduced.

Standardization of the operative procedure is also becom-ing easier. In the days of open surgery, surgeons qualifiedfrom a residency program and often never observed anotherperson operate until their retirement. With the advent oflaparoscopy, surgeons have the opportunity to see othersperform operations in a manner never experienced before.Indeed, knowing the popularity of video sessions at meet-ings, this is something in which surgeons appear to haveparticular interest.

Laparoscopy has provided a means of standardizing surgi-cal technique, and many groups have published their meth-odology for certain types of cases. We have also done this forlaparoscopic colorectal surgery.12-14 This, in combinationwith simulation15 and tissue-based resident training,16 hasallowed us to achieve efficient operative times and short

length of hospital stay.9,17

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Improving surgical standards 187

ConclusionsIncreasing public awareness of medical errors since the Insti-tute of Medicine’s report in 200118 has prompted structuredssessment and intervention to be applied to health care atany different levels. In an effort to minimize error and

mprove reliability in surgery, industrial process control haseen used or evaluated in processes, such as antibiotic pro-hylaxis, perioperative glycemic control and chest tube air

eak assessment in cardiac surgery, operating room effi-iency, positioning of hip prostheses, and others. However,n review of this limited implementation, one quickly recog-izes the vast areas where clinical care is unmonitored and

ack of data precludes this type of rigorous evaluation. Asurgeons, we have the responsibility to make these next stepsn the perpetual journey toward optimal surgical care. Stan-ardization of care practices and using new software pro-rams to facilitate monitoring of outcomes and reporting ofata should help us in this journey.

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