RQHR Surgical Site Infection Business Case Executive Summary In November of 2005 Regina Qu’Appelle Health Region, officially enrolled into the Canadian Safer Healthcare Now! (SHN) campaign. The SHN campaign was initiated to enlist Canadian healthcare organizations in implementing six targeted patient safety intervention: 1. Improve care for myocardial infarction 2. Prevent central line-associated infections 3. Prevent adverse drug events by implementing medication reconciliation 4. Prevent deaths by implementing rapid response teams 5. Prevent surgical site infections 6. Prevent ventilator-associated pneumonia The prevention of surgical site infections is an important and significant patient safety issue. Although the RQHR has many prevention practices that are supported by evidenced based research, it is recognized that there is a need to develop systematic process to reduce the rate of surgical site infections. The objective of the SSI program is to decrease the incidence of surgical site infections by consistently implementing a set of evidence based peri-operative care interventions known as the SSI care bundle to all surgical patients. The four components of the SSI care bundle are: 1. Optimal use of prophylactic antibiotics; 2. Appropriate hair removal; 3. Maintenance of post operative glucose control; and 4. Post Operative normothermia. This grouping of evidencebased practices when implemented together, have proven to dramatically reduce the incidence of surgical site infections. The scope of this project will be driven by the following project plan: Identification of a project team (including physicians, anaesthetists, nurses, pharmacists etc), team lead and project sponsor/champions Completion of gap analysis Development of a project charter, measures and goals Development of an action plan that includes a communication strategy and stakeholder assessment. Selection of a pilot project Initiation and evaluation of pilot project Development and implementation of project spread Resource Requirements for the Pilot Project The cost to implement this SSI program on a yearly basis (until project spread is complete – approximately two years) is estimated to be $xxxxx.xx based on the secondment of a 1.0 FTE Project Coordinator and minimal resource requirements for the Project Sponsor, Quality Improvement Consultant, Infection Control Consultant, Physician Champion and other team members. (Chart 1. pg8) Benefits to the Region Surgical site infections are the second most common type of adverse events occurring in hospitalized patients in the United States (Brennan. N Engl J Med. 1991;324:370-376). The costs associated with as SSI include longer hospital stays, increased readmission rates, outpatient and emergency visits, further surgery, prolonged antibiotic treatment, additional radiological procedures, laboratory tests, home health visits, and other services, drugs and SSI Business Case 1 March 8, 2007 professional fees all of which add to contribute stress on the healthcare system (Urban. Surg Infect. 2006:7:s19-s22). The literature also identifies significant cost related to surgical site infections. It is estimated to cost $400 US ($468.00 CAN) per case for a superficial SSI to more than $30,000 US ($35,100) per case for serious organ or space infections (Urban. Surg Infect. 2006:7:s19-s22) There was an average of xxx surgical site infections documented at the xxx and xxx hospitals in 2004/2005, xxx (xx%) resulting in superficial infections, xxx (xx%) classified as deep wound infections and xxx(x%) resulting in organ and space infections. Based on the above research and the RQHR 2004/2005 SSI rates, surgical site infections cost the region over xxxxxxxx dollars annually (xx cases @ $468 = xx, xxx plus xx cases @ $18,252* = $xxxxxxx plus xx cases @ $ 35,100= $ xxxxxxxx). *This figure is based on the midpoint between the above referenced most costly and least costly SSI’s. The IHI recommends aiming for a SSI reduction rate of fifty percent but cautions that results may not be realized for at least 18 months post bundle implementation. Taking this into consideration, staged reductions in SSI rates have been predicted following the implementation of this program to see a 25% SSI reduction in year one, 35% in year two and 50% in all subsequent years. The literature also states that one surgical site infection on average can extend a hospital stay by 12 days (Kirkland. Infect Control Hosp Epidemiol.1999;20(11):725-30). Based on this assumption, the impact on bed days in 2004/2005 related to surgical site infections was approximately xxxxx days (xxxxx cases x 12 days/case) This document presents the RQHR proposal to engage in the Safer HealthCare Now Surgical Site Infection (SSI) program. It will provide overview of the program including the RQHR current state, a risk/benefit analysis and the methodology of the program. Project sponsor(s): xxxxxxxxxxx, Executive Director of Speciality Care Services and xxxxxxxxxxxxxxxr, Executive Director Laboratory, Diagnostic Imaging, Nuclear Medicine Key Stakeholders: Infection Control, Speciality Care Services, Department of Anaesthesia, Department of Obstetrics and Genecology, OR Staff and Management, Department of Surgery, Department of Pharmacy, Quality Improvement and patient/families. Business case authors: S. Anderson, ……. SSI Business Case 2 March 8, 2007 I. Introduction A. Project objective and scope The objective of the SSI program is to decrease the incidence of surgical site infections by consistently implementing a set of evidence based peri-operative care interventions known as the SSI care bundle to all surgical patients that require both inpatient and outpatient care. Care bundles, in general, are groupings of evidenced based best practices with respect to a disease process that are known to improve care, however when these practices are applied together, they result in a substantially greater improvement to care than when applied individually. The science supporting each bundle component is sufficiently established to be considered the standard of care. The four components of the SSI care bundle are: 1. Optimal use of prophylactic antibiotics – antibiotics given within 60 minutes prior to surgical incision 2. Appropriate hair removal – no razor use, hair removal with clippers only 3. Maintenance of post operative glucose control*: for major cardiac surgical patients – blood glucose less than 11.1 mmol/L for forty-eight hours post-op. 4. Post Operative normothermia* for colorectal surgery patients - post anaesthetic care unit temperature above 36.0. *These components of care are supported by clinical trials and experimental evidence in the specified populations: they may prove valuable for other surgical patients as well. This grouping of evidence-based practices when implemented together, have proven to dramatically reduce the incidence of surgical site infections. The scope of this project will be driven by the following project plan: Identification of a project team (including physicians, anaesthetists, nurses, pharmacists etc), team lead and project sponsor/champions Completion of gap analysis Development of a project charter, measures and goals Development of an action plan that includes a communication strategy and stakeholder assessment. Selection of a pilot project Initiation and evaluation of pilot project including baseline data Development and implementation of project roll out The Quality Improvement Consultant will provide process improvement expertise and assistance to the project manager/coordinator throughout the project. B. Current RQHR Situation/Gap Analysis: Current practice in the OR, ICU and PACU to reduce the incidence of surgical site infection already parallel many of the components of the SSI care bundle described above. However without policy and continuous monitoring of the care bundle practices, there is no assurance that all the components of the SSI bundle are being systematically applied in the Region. SSI Business Case 3 March 8, 2007 1. Optimal use of prophylactic antibiotics Nursing staff and physicians strive to give prophylactic antibiotics one hour before the anticipated surgical incision time; however, this goal is difficult to achieve within our current pre-op process. Anecdotal feedback from staff and physicians is that the success rate to achieving ideal administration times is low. This was confirmed by a small chart audit of 22 randomly selected patients who had colorectal surgery between April 2005 and December 2006 in which only xx per cent of patients received prophylactic antibiotics within the optimal one hour period. 2. Appropriate hair removal Pre operative hair removal is primarily done outside the OR suite. Although clippers are primarily used for hair removal in both the pre-assessment clinic (PAC) and the day admission surgery (DAS) there may be some acute care areas that use razors for pre-op hair removal. All charts reviewed in the audit had pre-op care completed in the PAC/DAC. Clippers were used for all cases requiring hair removal. 3. Maintenance of post operative glucose control for major cardiac surgical patients All CABG procedures and patients receiving post-operative ICU care meet this requirement as per the Intensive Insulin Therapy Protocol. Other patients are regularly monitored if clinically indicated. Current practice does not dictate that blood glucose levels are monitored 48 hour post-operatively on all patients as recommended in the literature. This was evident in the chart audit. 4. Post operative normothermia PACU monitors temperature and does not release patients to the OR if their temperature is below 35.5 degrees. Patient warming devices are used in the OR at the discretion of the anaesthesiologist and surgeon. Intra-operative temperatures are monitored if the surgical procedure is going to be lengthy. The chart audit indicated that only xx percent of patients maintained a temperature above optimal 36 degrees during the intra-op/post-op period as recommended to reduce the risk of surgical site infections. C. Literature Review: The Canadian Adverse Event study (May 2005) estimated that 7.5 per cent of patients admitted to acute care hospitals in Canada in the fiscal year 2000 experienced one or more adverse events, and that 36.9 per cent of those patients were judged to have highly preventable adverse events. The rate of adverse events in other countries ranges from 2.916.6 per cent. Surgical site infections are the second most common type of adverse events occurring in hospitalized patients in the United States (Brennan. N Engl J Med. 1991;324:370-376). Surgical site infections have been shown to increase mortality, readmission rate, length of stay, and cost for patients who incur them (Kirkland.Infect Control Hosp Epidemiol. 1999;20:725). While the US rate of surgical site infection averages between two and three percent for clean cases, an estimated 40 to 60 percent of these infections are preventable. A review of the medical literature, including Canadian based studies, show that the following care components, when reliable implemented together, drastically reduce the incidence of surgical site infection: appropriate use of antibiotics; appropriate hair removal; maintenance SSI Business Case 4 March 8, 2007 of post operative glucose control for major cardiac surgery; and post operative normothermia for colorectal surgery. (Safer HealthCare Now Getting Started Kit). Moreover, a medical record review of 34,133 charts performed under the auspices of the Centers for Medicare & Medicaid Services (CMS) in the US demonstrated that there is significant opportunity for improvement in surgical site prevention (Bratzler. Arch Surg. 2005;140:174182). D. Methodology The Safer Healthcare Now (SHN) Campaign has developed a Surgical Site Infection “Getting Started Kit” (2005. Cambridge, MA). The kit outlines specific methodology and metrics for implementation and sustaining the SSI bundle. To ensure project success, SHN recommends using the Institute for Health Care Improvement’s model for improvement, a simple tool for accelerating improvement that has been used successfully by hundreds of health care organizations. The model guides organizations through a step by step process to improve health outcomes. The model has three fundamental questions that guide improvement teams to: 1) Set clear aims 2) Establish measures that will tell if changes are leading to improvement, and 3) Identify changes that are likely to lead to improvement. The model uses action oriented Plan-Do-Study-Act (PDSA) cycles to conduct small-scale tests of change in real work settings. Once a “small test of change” has become successful the change is spread to other parts of the organization or to other organizations. Measurement is a critical component of the Safer Healthcare Now Campaign. The SSI project will start by establishing baseline intervention measures specific to the bundle components. These measures will be tracked throughout the implementation of the project to demonstrate improvement. The interventions measures specific to the SSI project are as follows: 1. % surgical patient with “on time prophylactic antibiotic administration Target: 95% antibiotic administration within 60 minutes prior to surgical incision 2. % surgical patients with appropriate prophylactic antibiotic discontinuation - within 24 hours after surgery end time. Target: 95% (for cardiothoracic surgery recent evidence suggests that antibiotics could be discontinued 48 hours after surgery) 3. % of surgical patients with appropriate hair removal Target: 95% no hair removal or clipping 4. % major cardiac surgical patients with controlled post operative serum glucose Target: 95% of glucose level of <11.1 mmol/L 5. % colorectal surgical patients with normothermia in post anaesthesia care unit Target: 95% of patients with Temperature between 36.0 –38.0 C. SSI Business Case 5 March 8, 2007 II. External Assessment A. The 100,000 Lives Campaign In 2004, the Institute for Healthcare Improvement (IHI) launched a 100,000 Lives Campaign, aimed at preventing 100,000 unnecessary hospital-related deaths. Their campaign included six initiatives: Improve care for myocardial infarction Prevent central line-associated infections Prevent adverse drug events by implementing medication reconciliation Prevent deaths by implementing rapid response teams Prevent surgical site infections Prevent ventilator-associated pneumonia B. The Safer Healthcare Now! Campaign The Canadian Patient Safety Institute (CPSI) has adopted the 100,000 Lives Campaign, creating a Canadian version known as the Safer Healthcare Now (SHN) Campaign. Reducing Surgical Site Infections is one of six key initiatives embedded in the campaign, to significantly improve patient safety in participating facilities. Currently 178 healthcare organizations in Canada have deployed 587 teams to work on SHN initiatives. There are 104 SHN teams across the country implementing the SSI initiative. C. CCHSA Required Organization Practices The Canadian Council on Health Services Accreditation (CCHSA) has recently released Patient Safety Goals and Required Organizational Practices (ROPs) which organizations are now responsible for implementing. One of the Infection Control ROP’s requires organizations to monitor infection rates and share this information throughout the organization (Canadian Council on Health Services Accreditation; Patient Safety Goals and Required Organizational Practices (ROPs): www.cchsa.ca). CCHSA is also in the process of piloting additional ROP’s one of which specifically focuses on surgical site infections which is anticipated to become a new requirement for 2008 accreditation. D. Other Healthcare Organizations Capitol Health in Edmonton initiated the SSI program in one of their 13 hospitals in January of 2006. After the initial phase of team and charter development, baseline data collection and staff education (approximately three months), the bundle was implemented on all colorectal surgical patients. It took 2 months for the bundle components to be introduced into the various care units and approximately six months to become fully imbedded into practice. This SSI team is presently starting to spread the initiative to orthopaedic and gynaecological surgeries. Capitol Health has resourced this project with a full-time SSI Coordinator who has just started her second year of work (this individual is an OR nurse who is presently on “light duty” work) as well as an Infection Control Specialist (0.20 FTE) and a Quality Care Consultant (0.20 FTE). Shelley Johannsson, Quality Care Coordinator for Capitol Health, states that “the success of SSI Business Case 6 March 8, 2007 this project depends heavily on participation of the physician population. The primary focus has been education of physicians.” Prince Albert Parkland Health Region (PAPHR) SSI team is testing a series of changes to improve SSI rates, among them are: using standard orders that specify when antibiotics are to be given, in what dosage, and when they are to be stopped; changing drug supplies in operating rooms to include only standard doses and drugs; ensuring consistent use of warming units for patients undergoing colorectal surgery; and maintaining standard room temperatures in OR theatres. PAPHR is implementing the SSI bundle on hip and colorectal surgeries of which they perform 316 per month. According to the Quality of Care Coordinator, “the biggest challenge to this project is inadequate resourcing of the project lead.” The Calgary Health Region has collaborated to reduce the risk of SSI by obtaining more the 90% compliance with on-time prophylactic antibiotics, and appropriate hair removal as close to incision time as possible among patients undergoing surgery. Hamilton Health Sciences determined surgical site infections to be a priority patent safety initiative in 2005, since that time interventions have resulted in 100% of patients arriving in PACU with temperature of 36 degrees, 71 % of patients receiving antibiotics with 15-60 minutes of incision and 100% of patients receiving correct antibiotics. III. Internal Assessment: A. Implications and Risk for RQHR: Tracking and monitoring surgical site infections in any health care organization is a very complex multifaceted process that involves manual data entry of reported cases and manual manipulation of the data to meaningful reports. ………………………………………………….. …………………………………………………. With this in mind, this proposed SSI program is thought to be one component of a larger region wide revised surgical site infection surveillance program. Implementation of any new process will likely be met with initial barriers. A Pan-Canadian Survey of healthcare organization teams implementing improvement projects identified these five barriers and challenges: Lack of time/resources for data collection - 86.2% Lack of staff engagement - 41.5% Lack of internal QI knowledge and technical skill to submit measurement forms - 30.8% Other (e.g. insufficient population base, ongoing resource challenges) - 29.8% Insufficient senior management/clinical leadership support - 21.2% It is anticipated that implementation of the RQHR SSI project will also meet the same challenges identified in the Pan-Canadian Survey. Adequate allocation of resources is considered to be vital to the success and sustainability of this project. Assigning a dedicated project coordinator and securing enthusiastic dedicated team members will be important to meeting the demands of the project plan. Communicating with and obtaining support from key opinion leaders (surgeon, anaesthetists’ managers etc) as well as finding effective tools to engage front line staff is also considered a priority. SSI Business Case 7 March 8, 2007 Other barriers identified that impact the successful implementation of the SSI bundle components are: delays or rescheduling of OR times, unreported surgical site infections, availability of prophylactic antibiotics for emergent OR cases done outside regular pharmacy hours and timely reporting of culture and sensitivity tests that identifies appropriate antibiotic treatment. B. Chart 1 Resource Requirements Pilot project - year one Project Coordinator* Monthly hourly meetings with Sponsor, QI, Team Lead and Physician Champion Roll out - year two Project Coordinator* Monthly hourly meetings with Sponsor, QI, Team Lead and Physician Champion Estimated cost 25 hrs/wk x 52 weeks x $xx/hr Meetings @ $xx/hr x 3 people x 12 months Meetings @ $xx/hr* x 6 months Total Estimated cost 18 hrs/wk x 52 weeks x $xx/hr Meetings @ $xx/hr x 3 people x 12 months Meetings @ $xx/hr* x 6 months Total Totals $xx,xxx $x,xxx $x,xxx $xx,xxxx Totals $xx,xxx $x,xxx $x,xxx $xx,xxx *Project Coordinator would: o Organizes and guide project from start to finish o Be responsible training and mentoring nurses and physicians o Responsible for developing educational and communication materials related to the project o Report to project sponsor and team leaders o Conduct and coordinate monthly audits C. Benefits to the Region The Safer Healthcare Now SSI project is a well researched and widely implemented program with measurable successes in many jurisdictions. The benefits of implementing this program are clearly patient specific and relate to the reduction morbidity and mortality. Patients who develop surgical site infections use significantly more resources than those without an SSI. The costs associated with as SSI include longer hospital stays, increased readmission rates, outpatient and emergency visits, further surgery, prolonged antibiotic treatment, additional radiological procedures, laboratory tests, home health visits, and other services, drugs and professional fees all of which add to contribute stress on the healthcare system (Urban. Surg Infect. 2006:7:s19-s22). SSI Business Case 8 March 8, 2007 The literature also identifies significant cost related to surgical site infections. It is estimated to cost $400 US ($468.00 CAN) per case for a superficial SSI to more than $30,000 US ($35,100) per case for serious organ or space infections (Urban. Surg Infect. 2006:7:s19-s22). The Center of Disease Control and Prevention (CDC) estimates that one surgical site infection, such as staphylococcus aureus, on average can extend a hospital stay by 12 days (Kirkland. Infect Control Hosp Epidemiol. 1999;20(11):725-30). Furthermore, post-discharge infections can account for approximately 25% of SSI rates, at an estimated cost of $3,382 per case (Heunger. AJIC. 33(8):455-562). Post discharge surveillance is out side the scope of this project but has been identified as part of a larger comprehensive surveillance program that the region hopes to address. There was an average of xxsurgical site infections documented at the xxxxx and xxxxx hospitals in 2004/2005, xx (xx%) resulting in superficial infections, xx (xx%) classified as deep wound infections and xx (x%) resulting in organ and space infections. Based on the above research and RQHR 2004/2005 average rates, surgical site infections cost the region over $xxxxxxx annually (xxxcases @ $468 = $ xx,xxx plus xx cases @ $18,252* = $ xxxxxxxx plus xx cases @ $ 35,100= $xxxxxxx. *This figure is based on the midpoint between the above referenced most costly and least costly SSI’s. The literature also states that one surgical site infection on average can extend a hospital stay by 12 days. Based on this assumption, the impact on bed days in 2004/2005 related to surgical site infections was approximately xxxxxx days (xxxxcases x 12 days/case) The IHI recommends aiming for a SSI reduction rate of fifty percent but cautions that results may not be realized for at least 18 months post bundle implementation. Taking this into consideration, staged reductions in SSI rates have been predicted to see a 25% SSI reduction in year one, 35% in year two and 50% in all subsequent years. SSI Business Case 9 March 8, 2007 D. Chart 2 Summary of Cost/Benefits Year One Pilot Project costs – year one Savings in year one (25% SSI reduction rate) Annual Cost Saving -year one $ xx,xxx $ xxx,xxx $ xxx,xxx Year Two Roll out costs – year two Savings in year two (35% SSI reduction rate) Cost Saving year two $ xx,xxx $ xxx,xxx $ xxx,xxx E. Chart 3 Next Steps and Timelines Timelines for the project plan are as follows: RQHR Surgical Site Infection Project Time Line 2007 - 2008 J F M A M J J A S O N D J F M A M J Identification of a Senior Leader Project Sponsor Identification of a core pilot project team Completion of business case and collection of base line data Presentation of Business Case to SMT Presentation of Business Case to MAC Develop project charter (aim, objectives, measures, goals) Develop an action plan that includes a communication/education strategy Implement Pilot Project Evaluate results and spread improved region process SSI Business Case 10 March 8, 2007