Surgical Site Infection Reduction by theSolutions for Patient Safety HospitalEngagement NetworkJoshua K. Schaffzin, MD, PhDa, Lory Harte, PharmD, CPHQb, Scott Marquette, MHSAc, Karen Zieker, MSd, Sharyl Wooton, MSd,Kathleen Walsh, MD, MScd, Jason G. Newland, MD, Medb
abstractOBJECTIVE: Surgical site infections (SSIs) negatively affect patients and the healthcare system. National standards for SSI prevention do not exist in pediatricsettings. We sought to reduce SSI-related harm by implementing a preventionbundle through the Solutions for Patient Safety (SPS) national hospitalengagement network.
METHODS: Our study period was January 2011 to December 2013. We formeda national workgroup of content and quality improvement experts. Wefocused on 3 procedure types at high risk for SSIs: cardiothoracic,neurosurgical shunt, and spinal fusion surgeries. We used the Model forImprovement methodology and the Centers for Disease Control andPrevention SSI definition. After literature review and consultation withexperts, we distributed a recommended bundle among network partners.Institutions were permitted to adopt all or part of the bundle and reportedlocal bundle adherence and SSI rates monthly. Our learning network usedwebinars, discussion boards, targeted leader messaging, and in-personlearning sessions.
RESULTS: Recommended bundle elements encompassed proper preoperativebathing, intraoperative skin antisepsis, and antibiotic delivery. Within6 months, the network achieved 96.7% reliability among institutionsreporting adherence data. A 21% reduction in SSI rate was reported acrossnetwork hospitals, from a mean baseline rate of 2.5 SSIs per 100 proceduresto a mean rate of 1.8 SSIs per 100 procedures. The reduced rate was sustainedfor 15 months.
CONCLUSIONS: Adoption of a SSI prevention bundle with concomitant reliabilitymeasurement reduced the network SSI rate. Linking reliability measurementto standardization at an institutional level may lead to safer care.
Surgical site infections (SSIs) arecommon, accounting for nearly one-thirdof all health care–associated infectionsamong hospitalized adults.1,2 Theseinfections increase patient morbidityand mortality and pose a high costburden to the US health care system.3–5
In 1 study, the national SSI rate inchildren was reported to be 1.8%.6
Procedures that have been associatedwith higher SSI rates in children include
cardiothoracic, neurosurgical ventricularshunt, and spinal fusion surgeries.Reported rates of infection have largeinstitutional variability: 2.3% to 5% forcardiothoracic,7–9 5.7% to 10.4% forneurosurgical ventricular shunt,10–12
and 4.4% to 10.2% for spinal fusionsurgeries.13–16 For this reason, these 3types of procedures are commonlymonitored for SSIs and targeted for SSIreduction.
aDivision of Hospital Medicine, and dChildren’s Hospitals’Solutions for Patient Safety National Network, James MAnderson Center for Healthcare Systems Excellence,Cincinnati Children’s Hospital Medical Center, Cincinnati,Ohio; bDepartment of Pediatrics, Children’s Mercy Hospital,Kansas City, Missouri; and cCS Mott Hospital Administration,University of Michigan Hospital and Health Systems, AnnArbor, Michigan
Drs Schaffzin and Newland, Ms Harte, Mr Marquette,and Ms Wooton designed and executedinterventions; Ms Harte, Mr Marquette, Ms Zieker,Ms Wooton, and Drs Walsh and Newland reviewedand interpreted data and contributed to initialdrafting and revision of the manuscript; Ms Ziekerdesigned and executed data analysis; Dr Schaffzindrafted the initial manuscript and subsequentrevisions; and all authors approved the finalmanuscript as submitted.
www.pediatrics.org/cgi/doi/10.1542/peds.2015-0580
DOI: 10.1542/peds.2015-0580
Accepted for publication Jun 8, 2015
Address correspondence to Joshua K. Schaffzin, MD,PhD, Division of Infectious Diseases, CincinnatiChildren’s Hospital Medical Center, 3333 Burnet AveMLC 7017, Cincinnati, OH 45229-3039. E-mail: [email protected]
FINANCIAL DISCLOSURE: The authors have indicatedthey have no financial relationships relevant to thisarticle to disclose.
FUNDING: This improvement work was supported inpart by the Centers for Medicare and MedicaidServices (grant HHSM-500-2012-0026C).
POTENTIAL CONFLICT OF INTEREST: Dr Newlandreceives funding from Pfizer/Joint Commission fora grant to study antimicrobial stewardship, serveson an advisory board for RPS Diagnostics, and wasa 1-time advisor to Cubist; the other authors haveindicated they have no potential conflicts of interestto disclose.
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In 2011, a national hospitalengagement network (HEN),Solutions for Patient Safety (SPS), wasestablished to eliminate harm inhospitalized children.17 One goal ofthe HEN was to eliminate SSIs amongcardiothoracic, neurosurgicalventricular shunt, and spinal fusionsurgeries. Previous work amonga collaborative network of 8children’s hospitals in Ohiodemonstrated an increase in thenumber of months in which no SSIoccurred when a common preventionbundle was adopted.18 We describethe formation of a national pediatricSSI prevention network and itsimpact on reducing SSI rates amonghigh-risk surgeries.
METHODS
Setting
Children’s Hospitals SPS is a nationalnetwork of children’s hospitalsworking together to eliminate seriousharm among children hospitalized inthe United States.17 At the time of thestudy, January 2011 throughDecember 2013, the networkcomprised 33 children’s hospitalsnationwide. SPS was initiated as partof the federal Partnership forPatients initiative, a nationwidepublic-private collaboration toimprove the quality, safety, andaffordability of health care for allAmericans.19 SPS is the only HENfocused on pediatric patient safetyand prevention of common hospital-acquired conditions.
Planning the Intervention
A network leadership team of subjectmatter and quality improvementexperts was recruited. The Model forImprovement was used, includingroot cause and failure mode analysisand key driver identification.20
Analyses of process and outcome datawere used to design interventions.Interventions were tested througha series of plan/do/study/actcycles.20 The key driver diagram wasupdated periodically to incorporate
learning from observations, feedback,and testing and to guide future work.This work was determined not tobe human subjects research andtherefore was exempt frominstitutional review.
Operational Definitions
A detailed operational definitiondocument was generated and sharedwith all network hospitals (seeSupplemental Information). Anincluded procedure was defined asa spinal fusion, neurosurgicalventricular shunt, or cardiothoracicsurgery in which the chest was fullyclosed in the operating room, inconcert with National Health SafetyNetwork (NHSN) definitions at thetime.21,22 Procedures during whichthe patient had an active infection,growing construct adjustments, andrefusion procedures were excluded.For neurosurgical ventricular shunts,facilities were given 2 options forreporting. The preferred method wasdividing shunt procedures into 3separate groups: primary shunts,secondary shunts, and revisionshunts (Supplemental Appendix A).The second option was reporting allneurosurgical ventricular shuntprocedures as 1 according to NHSNdefinitions.22
An SSI was defined according todefinitions published by the Centersfor Disease Control and Preventionand NHSN.21,22 Changes made to thenational definition in January 2013,which shortened the postoperativesurveillance period for certainsurgical procedures, wereincorporated into the network’soutcome definition.22 The incidenceof SSI was measured as events per100 included procedures.
Based on published evidence andteam consensus, 6 elements believedto reduce the risk of SSIs wereincluded in a recommended bundlefor all participating hospitals(Table 1). The bundle was distributedto all network hospitals. Hospitalswere given the option to implement
all or a set of individual bundlecomponents. Hospitals were expectedto measure the reliability of thebundle elements implemented.Reliability was measured as thenumber of audited opportunities permonth in which all components of thelocally implemented bundle werecompleted divided by the numberof audited opportunities multipliedby 100.
Improvement Activities
Bundle implementation began inJanuary 2012. The network SMART(specific, measurable, attainable,relevant, and time-based) aim was toreduce the mean network SSI ratefrom 2.5 to 1.5 SSIs per 100procedures by December 31, 2013.This goal was determined byconsensus among network partnersthat a 40% rate reduction wouldbe considered a significantimprovement. Achievement of thisaim would rely on the following keydrivers: reliable implementation ofSSI prevention bundle, focus on3 key surgical procedure types(cardiothoracic, neurosurgicalventricular shunt, and spinal fusionsurgeries), transparency of data todrive continual learning andimprovements, and effective use ofhigh-reliability methods (Fig 1).
Participating institutions createdlocal improvement teams withinstitution senior leadership supportto facilitate implementation of SSIprevention measures. Institutionswere asked to review the bundleelements to select which bestsuited their context for immediateimplementation. Institutions were notasked to report which componentsthey chose but were expected tomeasure and report the reliability ofcompletion of the components theychose to implement. For example, ifan institution chose to implement 3of the 6 recommended components,it would report the proportion ofincluded patients for whom all 3components were completed.
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We encouraged all institutions to usehigh-reliability methods, includingregular reporting of process andoutcomes measures with seniorleaders, daily huddles for processfailure review, systematic analysis ofinfections as they occurred, andpromotion of a safety culture.23,24
Quality improvement science andapplication webinars were deliveredmonthly to network participants. Thewebinar curriculum followed the
Model for Improvement20 andincluded use of hospital case studiesto demonstrate methodology.
Network Dissemination Methods
SPS developed a learning network,based on the Institute for HealthcareImprovement Breakthrough Seriesmethodology,25 among memberhospitals to improve several hospital-acquired conditions, including SSIs.SPS conducted regularly scheduledwebinars and an annual in-personlearning session. Webinars reviewed
the current process and outcome dataand discussed successes and barrierswith the bundle. The All Teach, AllLearn philosophy of open sharing ofsuccesses, failures, and lessonslearned was discussed in allwebinars. An SPS Sharepoint site wasestablished for posting of relevantmaterials, as well as a discussionboard where network members couldpost comments and questions.Network leaders were responsible forresponding to questions and wereavailable for informal coachingsessions for institutions as needed.
Data Collection and Analysis
Data on process and outcomes werecollected locally and submitted ona monthly basis to SPS using a web-based form. Data submissions weredue within 2 months, on the 10th ofthe month (eg, January data were dueMarch 10). SSIs were countedaccording to the month when theprocedure took place; hospitals couldupdate the numbers of SSIs as theywere identified. Network-levelprocess control charts weremaintained to track the bundlereliability (U-charts) and outcomemeasures (P-charts). Data wereanalyzed by using statistical processcontrol methods. Initial centerlinevalues were calculated by using thefirst 12 months of measurement(January through December 2011).Special cause, a pattern ofperformance that was not part of theexisting system as a result of a changein the system, was defined as either$8 consecutive points above orbelow the mean or any single pointoutside of the upper or lower controllimits.26
RESULTS
Demographics of Hospital Network
The 33 HEN hospitals were located in20 states and the District of Columbia.Regionally, 15% were located in theNortheast, 15% in the Southeast, 45%in the Midwest, 9% in the Southwest,and 15% in the Northwest. The
TABLE 1 Recommended Bundles
Phase and Bundle Element Recommended Approach Reference
PreoperativeBath Night before or morning of surgery
($2 mo old, chlorhexidinegluconate; ,2 mo old, soap andwater and regular shampoo for hair)
47, 48
Morning of surgery (chlorhexidinegluconate wipe for $2 mo oldbefore procedure)
IntraoperativeNo razor No razors for hair removal: clipper or
other nontraumatic method49
Appropriate skin antisepsis Chlorhexidine gluconate or providoneiodine (follow product guidelines forproper age group)
Vancomycin and fluoroquinolones 0–120min before incision
Appropriate antibiotic redosing Cefazolin and clindamycin ,4 h fromprevious intraoperative dose
31
Vancomycin every 6 hOther antibiotic redosing evaluated locally
PostoperativeTime to first postoperative
antibiotic doseFirst dose delivered at appropriate intervalbased on last intraoperative dose
Expert consensus
FIGURE 1Key drivers.
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average number of licensed beds was317 (range 72 to 595).
Bundle Adherence and SSI Rates
Of the 30 hospitals reporting baselineSSI rates, approximately one-third (8to 10 hospitals per month) submitteddata from January to December 2011.These data were used to calculatemean baseline reliability, which was89.9%. The number of hospitalssubmitting reliability data increasedsteadily, with close to 90% ofhospitals submitting reliability databy June 2013. Within 6 months, meanadherence increased to 93.7%, thenreverted to a sustained rate of 91.4%(Fig 2).
The baseline network SSI rate for all3 procedure types combined was 2.5per 100 procedures. Within 10months of network formation, the SSIrate decreased to 1.8 per 100procedures and was sustained for 15months (Fig 3). During the same timeperiod, rate reduction after bundleimplementation was also seen amongcardiothoracic surgeries (1.7 to 1.3per 100 procedures) andneurosurgical ventricular shuntprocedures (3.2 to 2.3 per 100procedures). For spinal fusionsurgeries, a reduction in rate (3.7 to2.1 per 100 procedures) wasobserved, although the shift beganbefore network formation (data notshown). Among individual hospitals,12 (36%) of the 33 had a significantreduction (measured by a centerlineshift) in SSI rates. Additionally, 27(90%) of the 30 facilities reportingbaseline data demonstrateda significant reduction in SSI rates inat least 1 of the 3 procedure typesfollowed.
DISCUSSION
The collaborative SPS HENsuccessfully reduced the SSI rateof cardiothoracic, neurosurgicalventricular shunt, and spinal fusionsurgeries by 21%. This study is thefirst in pediatrics to demonstrate ona national scale that increasing
reliability of part or all ofa recommended SSI preventionbundle for high-risk surgeries canresult in significant improvement.
Our choice of recommended bundlecomponents was driven by high-quality, rigorous evidence. Becausesuch evidence is limited forprevention of pediatric SSIs in theincluded high-risk surgeries,27–29 therelevant pediatric literature was usedalong with adult literature. SurgicalCare Improvement Project measureswere evaluated because theyrepresent a national standard andhave been shown to reduce SSI ratesamong adult surgical patients.30 Wewere careful to choose only thosemeasures we believed would be mostappropriate for pediatric populations.Specifically, we chose to not includeproper choice of intraoperativeantibiotic, despite its inclusion inadult guidance.31 This decision wasin part due to a lack at the time ofcomprehensive national guidancefor antibiotic choice in pediatricpopulations. The most recentguidelines do include pediatricrecommendations based on expertopinion.32
The network operational definitionsfor surgical procedures and SSIs werealigned with national standards forconsistency across network hospitals.During the study period, the NHSNsurveillance definition for SSIchanged, shortening the surveillanceperiod for tracked procedures from365 to 90 days after the procedure.22
This change would be expected toreduce SSI rates, and therefore toaffect our outcome measure. Whenwe applied the new definition to datacollected before the change, 3% of thereduction observed was due to thedefinition change (data not shown).The remainder of change, 21%, ishow much we reduced the networkSSI rate.
An important aspect of theimprovement observed was thewillingness of a diverse group ofhospitals to work as a collaborative.
This strategy has been beneficial inimproving other health care–acquiredconditions, including centralline–associated bloodstreaminfections and ventilator-associatedpneumonia.33–35 As in similar cases,this allowed us to learn both asinstitutions and as a network. TheModel for Improvement served as anexcellent basis to enhance or initiatequality improvement work amongnetwork partners and ultimately tochange outcomes. Network learning,rather than intense individualinstitutional training, seems to havebeen sufficient to enable groups toimplement and measure successfully.
Institutional context is believed toaffect organizational and practicechange.36,37 In our study, the SPSnetwork partners representeda heterogeneous group of children’shospitals with respect to geography,catchment area population, size, andquality improvement experience atthe onset of our project. Furthermore,we permitted heterogeneity in theinterventions implemented amonginstitutions. Despite this heterogeneity,success was achieved at a networklevel in process reliability andoutcome, and 27 of 30 hospitalsreported a significant rate improvementin at least 1 area measured. Ourproject was based on the beliefthat standardization of processeswith high reliability leads to safercare.38,39 It is possible that thestandardized approach playeda significant role in the outcomeimprovement, perhaps to an extentequal to or greater than the bundlecomponents themselves.
We established our goal SSI rate of1.5 per 100 procedures based ongroup consensus seeking a 40%improvement from our baseline rateof 2.5 per 100 procedures. A nationalbenchmark for pediatric SSI ratesdoes not currently exist, andpublished rates are predominantlyfrom single centers and mayoverestimate rates on a nationalscale.7–16 Although we did not
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achieve our goal rate, we did achievea ∼21% improvement in overall SSIrate across the network (Fig 3). The
establishment of clear goals isbelieved to be an important factor in
quality improvement efforts,20 whichmay have influenced our efforts as
a network. In practice, many partnersfaced data-related challenges
that caused delays in SSI ratedetermination and prevented timely
SSI rate feedback to systemparticipants. We instead focused onachieving high reliability with ourprocesses, for which timely feedbackwas easily available. We used our ratechart as a long-term indicator ofsystem change, in which movementtoward our goal, if not beyond thegoal, was considered a success.
High reliability is believed to beessential for a process to affect an
outcome.38,40 The reliability of oursystem remained moderatethroughout the study period.Therefore, it is unclear whether theincrease in reliability observed duringthe study influenced the SSI ratedirectly. Specifically, system reliabilityimproved by 1.5% (89.9% to 91.4%)and remained less than the .95%reliability standard established forother bundles.41,42 However,improvement in SSI rates may not bedirectly linked to bundle reliability.SSI prevention does not fit theoriginal bundle model developed forcatheter-associated infection orventilator-associated pneumonia,mainly owing to a lack of a definedteam in 1 geographic location.Additionally, a recently published SSIprevention bundle for colorectalsurgery demonstrated significantimprovement despite notdemonstrating high reliability.43
Furthermore, significantimprovement in outcomes has beenreported with lower reliability ratesthan observed in our study, as lowas 51% in 1 instance.44–46 Thus, it islikely that other factors contributedto the reduction in SSI rate, such assystem learning and the developmentof a culture of safety, to which all SPSnetwork partners commit.17,40
Interpretation of our findings issubject to limitations common toquality improvement methodology.Specifically, facilities selected whichbundle components to implement, sointerventions are likely not the sameamong all hospitals. Therefore, wecannot determine which bundlecomponents most affected the SSIrate, nor can we determine to whatdegree, if any, adherence to a portionof the components influenced theoutcome. Future studies are necessaryto understand the interaction ofpractice standardization, adherenceto bundle components, and thespecific bundle components thatresult in the lowest SSI rates.Additionally, the change in SSI ratescould have been due to a seculartrend. Identification of special cause
FIGURE 2P-chart depicting network bundle reliability. Baseline centerline was 89.9%. n, number of hospitalssubmitting data.
FIGURE 3U-chart depicting network SSI rate. Baseline centerline was 2.5 SSIs per 100 procedures. n, numberof hospitals submitting data.
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as well as sustainment of the lowerSSI rate suggests it is indeed a resultof our improvement work. Finally,our study was not designed to assessthe effect on reliability and outcomeof team composition, attendance atnetwork sessions, or implementationstrategy. Further study of theseeffects could inform future large-scalemulticenter quality transformationefforts.
CONCLUSIONS
Using quality improvement methods tostandardize care reduced SSI ratesamong high-risk pediatric surgeries.Despite the likely heterogeneity in actualinterventions implemented across thenetwork, we successfully reduced harmto patients and cost to the health caresystem. Future study is necessary toevaluate the effect of individual bundleelements on SSI prevention.
ACKNOWLEDGMENTS
We thank Kathy Ball for hercollaboration in the early part of thisproject, Dr Lloyd Provost forstatistical guidance, and Drs SteveMuething and Anne Lyren for theirleadership and guidance. We alsothank all of the network facility staffwhose diligence and dedicationensured the success of this project.
ABBREVIATIONS
HEN: hospital engagementnetwork
NHSN: National Healthcare SafetyNetwork
SPS: Solutions for Patient SafetySSI: surgical site infection
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DOI: 10.1542/peds.2015-0580 originally published online October 5, 2015; 2015;136;e1353Pediatrics
Kathleen Walsh and Jason G. NewlandJoshua K. Schaffzin, Lory Harte, Scott Marquette, Karen Zieker, Sharyl Wooton,
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