In the United States, hospital-acquired infection is one of the 10 leading causes of death.1 According to Sievert et al,2 the data reported by hospitals to the National Healthcare Safety Network (NHSN) for 2009 to 2010 revealed that surgical site infections (SSI) make up about 23% of hospital-acquired infections. In 2001, it was estimated that 290,000 SSIs occur per year, resulting in approximately 8000 deaths.3,4 NHSN reported that between 2006 and 2008 the incidence rate for knee and hip replacements ranged from 0.58% to 1.6% and 0.67% to 2.4%, respectively.5 It has been estimated that 31,000 to 35,000 orthopaedic SSIs occurred in the United States from 2006 to 2008.6 In addition to increased risks of morbidity and mortality, SSIs place a significant economic burden on both patients and hospitals due to extensive treatment and prolonged length of stay.7 At an excess of $11,874 to $34,670 (2007 consumer price index for inpatient hospital services) per infection, the cost of SSIs ranges from $3.45 to $10.07 billion per year in direct medical expenses.8 When the infection involves a prosthetic joint, expenses can exceed $90,000 per case.9 In our own institution, the charges for treating an infected total joint or spinal fusion procedure is about $109,000, with some complex multidrug–resistant organism cases costing significantly more.
Locating accurate data on national standards or benchmarks for SSI rates is challenging. Data variation are due to differences in definition for SSI, incomplete risk adjustment for patient comorbidities, and lack of consistent data sources. In developed countries, the incidence rate for SSIs is estimated between 1% and 2%. Recent data from the Center for Disease Control/National Hospital Safety Network estimates SSI rates of 1.9%.10 Over an 8-year period (2003 to 2011), the SSI rate for NHSN-reported procedures at our institution was approximately 1.2% for all surgical procedures. In the recent years, New England Baptist Hospital in Boston has reported SSI rates for these procedures of ≤0.5%.
In May of 2011, the St. Luke’s Health System of Boise, Idaho implemented a committee for SSI reduction. Project Zero was organized around the orthopaedic and neurosurgical departments to focus on total joints and spine procedures, including scoliosis. Several initial goals were established for the Project Zero team:
- Create a multidisciplinary approach to include surgeons, infectious disease/infection control staff, administration, OR and inpatient nursing staff, Central Instrument Processing, anesthesia, Environmental Services staff, and engineering (heating, ventilation, air conditioning—HVAC), etc.
- Create a culture focused upon patient safety and infection prevention.
- Reduce operating room variation where appropriate.
- Reduce the orthopedic and neurosurgical SSI rate by 50% over the first 18 months.
- Improve communication with surgeons and hospital staff about SSI rates and proposed changes to reduce SSI.
Outside Data Sources
The group investigated several resources to determine the best foundations upon which to base recommendations to lower SSIs. Several resources were selected:
- Published literature with level 1 or level 2 prospective study designs as primary resources, and the use of lower level studies when higher level research was not available.
- Practices and recommendations from top performing institutions in North America and Europe.
- Recommendations from organizations, including the Association of periOperative Room Nurses, American Academy of Orthopedic Surgeons, Center for Disease Control, Infectious Disease Society or North American, and Association of Professionals in Infection Control.
- Clean room practices/technology such as sterile techniques, tissue handling, and air quality practices at an allograft harvest facility (Allosource, Centennial, CO), and computer chip manufacturing facility (Micron Industries, Boise, ID).
Risk Factors: Patient, Environment, Procedure
Risk of obtaining an SSI is multifactorial, and may be related to patient medical comorbidities, operating room practices, and type of procedure. In a systematic review that looked at risk factors associated with infection rates after spinal surgery, Schuster and colleagues reported patient factors such as age, obesity, diabetes, and a high American Society of Anesthesiology score significantly increase a patient’s risk of developing an SSI. Other factors include smoking, diabetes, high postoperative glucose levels, and malnutrition.11 Nasal colonization with Staphylococcus aureus will also increase the patient’s risk of developing an SSI.12
Procedural factors such as increased blood loss, drainage, operating room (OR) time,13 use of implants, and inadequate skin preparation are shown to be associated with increasing a patient’s risk of developing an SSI. Regular communication with surgeons about the department’s performance and individual surgeon performance are critical steps for addressing SSI. The medical staff involvement with this process is essential, and providing reliable data to the surgeons is important to engage them in quality improvement. Regular meetings to discuss SSIs, complications, and other areas of variation in surgical practice now occur within surgical specialty groups.
Environmental aspects that include maintaining sterile equipment, clean air management, monitoring staff traffic in and out of rooms, as practiced by top performing institutions and allograft harvest facilities, have been associated with lower infection rates.14,15 According to Mangram and colleagues, the air in an OR may contain dust, lint, skin cells, or respiratory droplets laden with microbes. Furthermore, the number of microbes in the air is directly proportional to the number of people in the operating room.15,16 Maintaining adequate airflow and minimizing foot traffic may help reduce the risk for SSI. Association of Professionals in Infection Control’s Guide for the Elimination of Orthopedic Surgical Site Infections states that uninterrupted airflow is vital in preventing settled particles, which can become disturbed with air turbulence thus increasing the risk for wound contamination.17 Environmental factors require significant attention, including the sterile practices of the individual staff, OR staffing patterns, and preoperative planning for procedures and associated instruments.
After identifying the major risk factors associated with developing an SSI, the committee recommended changes. To address the patient risk factors, a preoperative clinic staffed by primary care providers was implemented. This allows the surgeon and medical staff to ensure that their patients are in the best possible health before going into surgery. A screening and decolonizing program for methicillin resistant staph aureus/methicilin sensitive staph aureus was introduced. Although there is an associated cost with the preoperative clinic and staph screening, Urban18 suggests that it may be more financially sound to treat high-risk patients before surgery than to treat SSIs. The preoperative clinic has created care pathways for patients with medical comordities that increase SSI risk including diabetes, nasal colonization with methicilin sensitive staph aureus/methicillin resistant staph aureus, obesity, poor dentition, malnutrition, and those using immunosuppressive medications.
Protocols for management of environmental and procedural factors were also recommended. Designated OR surgical uniforms, hand hygiene, surgical instrument sterilization processes, skin preparation processes, postoperative wound care, OR traffic, and room cleaning processes have been standardized and monitored. These changes were paired with educational programs for OR personnel and surgeons. Regular communication about protocol/practice changes was conveyed through educational displays and posters in staff lounges, department meetings, and email communication.
Improved communication between surgeons, OR scheduling staff, and the OR crews was also an area of focus. These groups concentrated upon improving case schedule protocols, to ensure all equipment was ready 12 to 24 hours before the procedure. Case preference cards, which contain items normally used during the surgery, were reviewed and revised to ensure that the right items were available during the case. This reduces the number of times OR staff would need to leave the OR suite to obtain an item necessary for the procedure. Preventing delays for the first surgical case and reducing turnover times, increases OR performance and surgeon satisfaction.
Reduction in variation can also have a positive impact on team performance. Before this project, wound dressing/care protocols for the inpatient nursing staff showed remarkable variation. Early on, the nursing staff had to manage 14 different dressing/drain change protocols on the orthopaedic floor. At the end of the review, these 14 protocols were refined to 2, contributed to improved nursing compliance and performance. Standard surgical site preparation protocols were implemented throughout the OR.
Over the first 18 months after Project Zero began, there were <19 SSIs than expected, based upon historical infection rates and case volume. The goal to reduce the infection rate by half was met by the end of 2012, lowering the rate from 1.2% to 0.54%. These rates have shown some variation throughout 2013 and 2014, but the orthopaedic SSI rates have remained close to or <0.5 for the last 18 months.
The changes recommended by Project Zero were met with resistance from some groups. Over the past 3 years, the Project Zero team has learned several lessons regarding the process and struggle of implementing change. The first of these is to encourage input from staff in the OR including nursing, surgical technicians, surgeons, etc. The staff has valuable ideas and first-hand knowledge of how the process works and may be improved. Including personnel in these discussions helps to minimize the “us” against “them” mentality and gives them an appropriate level of “ownership” in performance-improvement initiatives.
Communication with all OR staff is important, including regular updates to the staff about the mission, goals, research, successes, and failures of the project. Doing so keeps the employees up to date and can help lessen resistance to change. This opposition is best addressed by regular and frequent communication with all the staff involved, including surgeons, nurses, administrative staff, etc. Providing good information on complications, SSI rates, medical comorbidities, etc., is essential for the medical/surgical staff that will be making decisions about improving medical care.
Another lesson learned was the critical importance of physician leadership, both medical and surgical. Involvement of internal medicine, including inpatient and outpatient medical staff, along with input from the Infectious Disease medical staff is crucial. Surgeons are the leaders in the OR; having them on board with the change process greatly influences the rest of the OR staff. Regular discussion with key members of the medical staff, including surgical department chairman and other surgical leaders, is vital for gaining buy-in from entire surgical departments. Personal surgeon-to-surgeon communication with key surgical leaders is paramount. Engaging these individuals in a dialog, and asking for their input and recommendations is crucial to success. Physicians will challenge some of the proposed changes; in many cases, these challenges will improve the protocols and increase the likelihood of success.
Input from the public health, infection control, and epidemiology staff of the hospital is also fundamental. These staff and departments provide comprehensive, up-to-date data on SSI rates, infection profiles, antibiotic resistance, and other pertinent issues. Their ability to provide data on a timely manner is critical to success. Having access to these data will also allow individual meetings with groups of surgeons, to work on reducing SSI. In our own group, we have individual-approached surgeon groups for spine/scoliosis, total joint, fractures, colon/bowel, breast, etc. These individual meetings, which include specific reports on department and individual SSI, can be very valuable in engaging the surgeons in leading the necessary changes.
Regular communication with nursing staff, both in the OR and the inpatient floors, is another important measure. The nursing staff is very engaged in performance and quality-improvement initiatives; their enthusiasm and support are superb.
Transformation takes time; recognizing the importance of patience and flexibility are important lessons for those leading this change. Obstacles may stall the process and resistance is inevitable. A willingness to work around problems and remain patient with both staff and institution is important for success.
Looking forward, Project Zero has plans to continue implementing necessary changes to help reach the overall goal of zero infections. As previously stated, clean air management has been associated with lowering the risk of SSIs. Allosource, an allograft facility in Denver known for its thorough sterile techniques and quality control, is an inspiration to Project Zero with regards to air quality and sterile practices in the OR. The allograft company’s approach to clean air is similar to that of a computer company, where even the tiniest of airborne particles can destroy computer chip–manufacturing processes. Knowing this, the team collaborated with Boise State University and Micron Industries to establish steps that will help lower the particulate count in the ORs and further increase St. Luke’s air quality control.
Increasingly, our group is working to identify high-risk patient categories before surgery, and mitigate these risks when possible. A current area of focus is diabetes, as both nationally and locally, these patients remain some of the highest at risk for SSIs and other complications. Our goal is to develop a diabetes program that educates patients, improves health preoperatively, manages glucose optimally in the postoperative period, and reduces risk of SSI and other complications.
Future OR designs and remodeling projects will also consider architectural changes that can have an impact on the OR SSI reduction performance. This may include the development of “ultraclean” OR regions that care for high-risk SSI patients or procedures.
There will be many challenges going forward. Antibiotic resistance emergence will continue to threaten our progress. Obesity remains a significant risk factor for SSI, and addressing this problem will be challenging. Project Zero plans to continue learning from top performing institutions and push toward better clean room standards, persistently chasing the overall goal of zero infections.
1. de Lissovoy G, Fraeman K, Hutchins V, et al.. Surgical site infection
: incidence and impact on hospital utilization and treatment costs. Am J Infect Control.. 2009;37:387–397.
2. Sievert DM, Ricks P, Edwards JR, et al.. Antimicrobial-resistant pathogens associated with healthcare-associated infections: summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2009-2010. Infect Control Hosp Epidemiol.. 2013;34:1–14.
3. Klevens RM, Edwards JR, Richards CL Jr, et al.. Estimating health care-associated infections and deaths in US hospitals, 2002. Public Health Rep.. 2007;122:160–166.
4. Evans RP. Surgical site infection
prevention and control: an emerging paradigm. J Bone Joint Surg Am.. 2009;91(suppl 6):2–9.
5. Edwards JR, Peterson KD, Mu Y, et al.. National Healthcare Safety Network (NHSN) report: data summary for 2006 through 2008, issued December 2009. Am J Infect Control.. 2009;37:783–805.
6. Greene LR. Guide to the elimination of orthopedic surgery surgical site infections: an executive summary of the Association for Professionals in Infection
Control and Epidemiology elimination guide. Am J Infect Control.. 2012;40:384–386.
7. Whitehouse JD, Friedman ND, Kirkland KB, et al.. The impact of surgical-site infections following orthopedic surgery at a community hospital and a university hospital: adverse quality
of life, excess length of stay, and extra cost. Infect Control Hosp Epidemiol.. 2002;23:183–189.
8. Centers for Disease Control and Prevention. The direct medical costs of healthcare-associated infections in US hospitals and the benefits of prevention. Healthcare-associated Infections. The burden. 2009. Available at: http://www.cdc.gov/hai/pdfs/hai/scott_costpaper.pdf
. Accessed September 2, 2014.
9. Kurtz SM, Lau E, Watson H, et al.. Economic burden of periprosthetic joint infection
in the United States. J Arthroplasty.. 2012;27:61–65. e1.
10. Mu Y, Edwards JR, Horan TC, et al.. Improving risk-adjusted measures of surgical site infection
for the national healthcare safety network. Infect Control Hosp Epidemiol.. 2011;32:970–986.
11. Schuster JM, Rechtine G, Norvell DC, et al.. The influence of perioperative risk factors and therapeutic interventions on infection
rates after spine surgery: a systematic review. Spine.. 2010;35:S125–S137.
12. Kim DH, Spencer M, Davidson SM, et al.. Institutional prescreening for detection and eradication of methicillin-resistant Staphylococcus aureus
in patients undergoing elective orthopaedic surgery. J Bone Joint Surg Am.. 2010;92:1820–1826.
13. Ercole FF, Franco LM, Macieira TG, et al.. Risk of surgical site infection
in patients undergoing orthopedic surgery. Rev Lat Am Enfermagem.. 2011;19:1362–1368.
14. Anderson DJ, Kaye KS, Classen D, et al.. Strategies to prevent surgical site infections in acute care hospitals. Infect Control Hosp Epidemiol.. 2008;29(suppl 1):S51–S61.
15. Mangram AJ, Horan TC, Pearson ML, et al.. Guideline for prevention of surgical site infection
, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection
Control Practices Advisory Committee. Am J Infect Control.. 1999;27:97–132. quiz 3-4; discussion 96.
16. Ayliffe GA. Role of the environment of the operating suite in surgical wound infection
. Rev Infect Dis.. 1991;13(suppl 10):S800–S804.
17. Church N, Bjerke N. Surgical Services., 3rd edition. Washington, DC: APIC; 2009.
18. Urban JA. Cost analysis of surgical site infections. Surg Infect (Larchmt).. 2006;7(suppl 1):S19–S22.