Pennsylvania Patient Safety Advisory Beyond the Bundle: Reducing the Risk of Central Line-Associated Bloodstream Infections ABSTRACT As described by the Institute for Healthcare Improve- Central venous catheterization is one of the most ment (IHI), the central line bundle is a group of widely used invasive procedures, and it significantly evidence-based interventions for patients with increases the risk for infection. Sustained reduc- CVCs that individually improve care and, when tion of central line-associated bloodstream infection implemented together, result in substantially bet- (CLABSI) remains elusive in many institutions despite ter outcomes. The science supporting each bundle increased awareness of evidence-based preventive component has sufficiently established each to be strategies, publication of successful hospital CLABSI the standard of care. The five key components of the elimination programs, and elimination of reimburse- IHI central line bundle are as follows: hand hygiene, ment for the cost of treating CLABSIs. A March 2009 maximal sterile barriers, chlorhexidine skin antisepsis, Centers for Disease Control and Prevention report optimal catheter site selection (with subclavian vein estimates the cost of one CLABSI in 2007 U.S. dollars as the preferred site for nontunneled catheters), and to be $29,156, which totals $2.68 billion in excess daily review of line necessity with prompt removal of costs annually. A study by Klevens et al. found that of unnecessary lines.2 the 98,987 patient deaths caused by or associated with healthcare-associated infections in 2002, 31% The Association for Professionals in Infection Control of those cases were attributed to bloodstream infec- and Epidemiology (APIC) promotes a culture of zero tions. Pennsylvania hospitals answer questions in each tolerance for healthcare-associated infections (HAI) CLABSI report submitted to the National Healthcare and unsafe practices associated with them. APIC Safety Network indicating compliance with three Vision 2012, APIC's strategic plan, includes the expec- evidence-based practices including use of maximal tation that healthcare workers will consistently apply sterile barriers, chlorhexidine site preparation, and infection prevention and control measures and will documentation of review of daily necessity for con- have access to resources and administrative support.3 tinuation of the central line. The Pennsylvania Patient U.S. Department of Health and Human Services Sec- Safety Authority’s analysis of CLABSI event reports retary Kathleen Sebelius has also called on hospitals from July 2008 through March 2009 concludes that across America to commit to reducing CLABSIs in while Pennsylvania’s CLABSI and central line utilization ICUs by 75% over the next three years.4 rates are significantly better than the national average, hospitals were unable to document compliance with Sustained reduction of CLABSIs remains elusive evidence-based best practices for CLABSI prevention in many institutions despite increased awareness of in 38% of events reported. Hospitals with the lowest evidence-based preventive strategies, publication of CLABSI rates reported twice the use of all three prac- successful hospital CLABSI elimination programs, tices than hospitals with the highest rates of infection. and elimination of reimbursement for the cost of The key to achieving sustainable, actionable CLABSI treating CLABSIs. The key to achieving sustainable, reduction is to combine adaptive cultural changes with actionable CLABSI reduction is to combine adaptive evidence-based practices and a renewed focus from cultural changes with evidence-based practices and a hospital leaders and clinicians on a culture of safety. renewed focus from hospital leaders and clinicians. (Pa Patient Saf Advis 2010 Mar;7[Suppl 1]:1-9.) Background CLABSI is a serious complication of intravascular therapy used to deliver medication, blood, or nutri- tion. Central venous catheterization is a widely used Introduction invasive procedure and significantly increases the Central venous catheters (CVC) are vital in modern- risk for bloodstream infection.1 That risk increases day medical practice, particularly in the intensive for patients whose catheters are inserted during non- care unit (ICU); however, their use puts patients at sterile emergent situations and for patients who are risk for central line-associated bloodstream infec- discharged with lines in place for long-term intrave- tion (CLABSI) complications. These deadly and nous therapies. The use of central lines is becoming often preventable infections increase the risk of more common in non-ICU patients.5 morbidity and mortality and prolong hospital stays.1 Once in contact with a CVC, bacteria rapidly secrete Practical risk reduction strategies enable consistent an adhesive-like substance, causing the organisms to application of evidence-based recommendations for stick to the catheter sheath. The bacteria then pro- central line insertion and maintenance. Healthcare duce a protective biofilm. Antibiotics and white blood workers must be educated and engaged in a culture cells cannot penetrate the biofilm to kill the bacteria. of safety to achieve consistent application of these In a 2002 review of biofilm resistance to antimicro- recommendations. bial agents, Donlan et al. found that the age of the Vol. 7, Suppl. 1—March 18, 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 1 Pennsylvania Patient Safety Advisory biofilm may affect its susceptibility to antibiotics and days for critical care areas and 1.1 for ward locations, that 10-day-old biofilm are significantly more resistant which is significantly better than the national averages than 2-day-old biofilm.6 of 2.0/1,000 central line days for critical care areas and 1.4 for ward locations (p < 0.01; z-test for two pro- Catheter flushing, infusion, and movement can cause portions). Additionally the Authority’s analysis shows detachment of clumps or fragments of the biofilm, that the central line utilization rates of 0.45 in critical which may contain thousands of bacterial cells. These care and 0.11 in ward locations in Pennsylvania are bacteria then float into the patient’s bloodstream significantly better than the national averages of 0.48 and lead to systemic infections, often with endotoxin in critical care and 0.16 in ward locations (p < 0.01; release. Usually, the only means of treatment requires z-test for two proportions).13 (See Table 1.) removal of the biofilm-encrusted device.7 Analysis of Pennsylvania NHSN CLABSI events Socioeconomic Burden found that compliance with the evidence-based best practices averaged 55.8% for the 1,916 CLABSI Bloodstream infections associated with an intra- reports. However, 38% of the CLABSI reports docu- vascular device are the most life-threatening type mented unknown compliance with these basic best of infection related to invasive medical devices.7 practices, and 4.4% of the remaining responses indi- CLABSIs require additional treatments that impose cated that the best practices were not used. The best significant economic consequences. The downstream practice questions were not answered in 1.5% of the effects of these infections include extended illness, reports. (See Table 2.) loss of wages, and the intangible costs related to a diminished quality of life. A March 2009 Centers for Excluding hospitals that did not know if the best prac- Disease Control and Prevention (CDC) report esti- tices were used, stated that they were not applicable, mates the cost of one CLABSI in 2007 U.S. dollars to or left the answer blank, the hospitals in the quartile be $29,156, which totals $2.68 billion in excess costs with the lowest CLABSI rates had significantly higher annually.8 A study by Klevens et al. found that 98,987 rates of compliance than hospitals in the quartile with patient deaths were caused by or associated with HAIs the highest CLABSI rates for the use of maximum in 2002, and 31% of those HAIs were attributed to sterile barriers (186/187 versus 482/503; p < 0.05, bloodstream infections.9 In an evidence-based practice chi-square test), chlorhexidine insertion protocols advisory study of reasonably preventable infections (193/196 versus 457/503; p < 0.001, chi-square test), using a 2002 estimate, Umscheid et al. calculated that and daily evaluation and documentation of central a reduction in the risk of septicemia with implemen- line necessity (186/201 versus 373/510; p < 0.001, tation of recommended infection control measures chi-square test). (See Table 2.) ranges from 18% to 82%, equaling 5,520 to 25,145 Of the 160 hospitals that reported CLABSIs, 14 preventable deaths a year.10 (35%) of the hospitals in the quartile with the low- est rates consistently used all three best practices, CLABSI Data Snapshot compared to 7 (17.5%) of the hospitals in the quartile with the highest rates (although the difference was The Health Care-Associated Infection Prevention not statistically significant). (See Table 3.) and Control Act, Act 52 of 2007, requires healthcare facilities in Pennsylvania to report HAI data to the Authority analysis of the hospital reports concludes Pennsylvania Department of Health, the Pennsylvania that the high performing hospitals had an average Health Care Cost Containment Council, and the CLABSI rate of 0.98/1,000 central line days and Pennsylvania Patient Safety Authority through CDC’s 18.5% of the statewide total of CLABSI. Low per- National Healthcare Safety Network (NHSN).11 The forming hospitals had an average CLABSI rate of NHSN CLABSI event reports were customized for 3.3/1,000 central line days and 45.6% of the total Pennsylvania hospitals to include reporting of compli- CLABSI. (See Tables 2 and 3.) ance with nationally recognized, evidence-based best This analysis highlights the finding that more consis- practices. Facilities answer questions in each CLABSI tent use of maximal sterile barriers and chlorhexidine report submitted to NHSN indicating compliance insertion protocols had a positive impact on Penn- with three evidence-based practices, including use of sylvania CLABSI rates. However, this analysis also maximal sterile barriers during insertion, chlorhexi- demonstrates that documentation of daily necessity dine site preparation, and documentation of review and methods of accurately measuring compliance of daily necessity for continuation of the central line. with best practices remains a struggle in some organi- These practices for central line insertion have been zations. Programs to target zero CLABSI need to be recommended since 2002 by CDC,1 IHI,2 and, more adopted to help avoid complacency and to give clini- recently, the Society for Healthcare Epidemiology of cians a tangible goal to strive toward. America (SHEA).12 In early 2010, the Pennsylvania Department of Health The Authority’s analysis of CLABSI events from released its report on HAIs in Pennsylvania hospitals, Pennsylvania hospitals (all unit types), as reported to for the second half of 2008, which includes CLABSI NHSN from July 2008 through March 2009, calcu- lated average CLABSI rates of 1.8/1,000 central line (continued on page 4) Page 2 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Vol. 7, Suppl. 1—March 18, 2010 Pennsylvania Patient Safety Advisory Table 1. Comparison of National and Pennsylvania Central Line-Associated Bloodstream Infection Rates* NATIONAL HEALTHCARE SAFETY NETWORK PENNSYLVANIA, (NHSN), 2006 THROUGH 2008†,1 JULY 2008 THROUGH MARCH 2009‡ Central Central No. of Central CLABSI Line Patient No. of Central CLABSI Line Patient Days CLABSI Line Days Rate§ Utilization€ Days CLABSI Line Days Rate§ Utilization€ Critical Care Units Burn 126,826 390 70,932 5.5 0.56 8,546 17 4,301 4.0 0.50 Medical 1,699,768 2,097 911,476 2.3 0.54 104,777 90 57,174 1.6 0.55 Medical cardiac 1,096,749 876 436,409 2.0 0.40 81,743 43 27,417 1.6 0.34 Medical/surgical 5,073,058 4,053 244,1719 1.7 0.48 330,898 250 149,840 1.7 0.45 Neonatal intensive 1,893,787 870 349,263 2.5 0.18 190,060 120 45,196 2.7 0.24 care unit level II and III Neurologic 100,840 61 45,153 1.4 0.45 14,308 10 6,915 1.4 0.48 Neurosurgical 362,881 396 160,879 2.5 0.44 29,283 20 13,694 1.5 0.47 Pediatric 95,130 195 58,626 3.3 0.62 14,696 28 6,982 4.0 0.48 cardiothoracic Pediatric medical 43,797 23 17,321 1.3 0.40 1,587 1 525 1.9 0.33 Pediatric medical/ 655,402 929 314,306 3.0 0.48 23,511 50 13,997 3.6 0.60 surgical Respiratory 29,520 29 17,223 1.7 0.58 6,380 11 3,462 3.2 0.54 Surgical 1,230,430 1,683 729,989 2.3 0.59 54,123 57 36,301 1.6 0.67 Surgical 893,084 879 632,769 1.4 0.71 76,362 54 50,541 1.1 0.66 cardiothoracic Trauma 354,494 814 224,864 3.6 0.63 38,366 41 25,927 1.6 0.68 Totals 20,428,592 19,445 9,764,124 2.0 0.48 974,640 792 442,272 1.8 0.45 Inpatient Wards Adult step down 793,149 299 141,374 2.1 0.18 438,472 80 61,657 1.3 0.14 Behavioral health/ 83,545 0 1,803 0.0 0.02 519,564 0 1,604 0.0 0.00 psychiatric Genitourinary 57,237 22 16,902 1.3 0.30 15,861 1 3,071 0.3 0.19 Gerontology 18,567 4 2,674 1.5 0.14 9,530 3 1,326 2.3 0.14 Gynecology 60,466 6 5,694 1.1 0.09 17,735 1 1,857 0.5 0.10 Labor and delivery/ 25,892 0 810 0.0 0.03 112,335 0 357 0.0 0.00 recovery Medical 1,408,507 422 278,221 1.5 0.20 766,481 157 140,819 1.1 0.18 Medical/surgical 3,839,045 733 618,196 1.2 0.16 2,211,320 327 280,162 1.2 0.13 Neurologic 69,343 8 10,723 0.7 0.15 25,384 2 2,560 0.8 0.10 Neurosurgical 83,780 12 13,866 0.9 0.17 41,521 3 6,488 0.5 0.16 Nursery I & II 9,197 2 1,516 1.3 0.16 123,390 1 335 3.0 0.00 Orthopedic 343,273 32 40,425 0.8 0.12 199,385 9 15,920 0.6 0.08 Pediatric medical 59,826 18 10,232 1.8 0.17 48,499 17 8,170 2.1 0.17 Pediatric medical/ 165,571 102 32,581 3.1 0.20 89,891 20 9,129 2.2 0.10 surgical Postpartum 67,780 0 943 0.0 0.01 189,550 0 579 0.0 0.00 Rehabilitation 570,671 39 47,052 0.8 0.08 470,420 21 31,779 0.7 0.07 Surgical 664,399 189 132,336 1.4 0.20 361,418 49 62,548 0.8 0.17 Vascular surgery 50,079 13 11,345 1.1 0.23 14,627 0 2,055 0.0 0.14 Totals 8,370,327 1,901 1,366,693 1.4 0.16 5,655,383 691 630,416 1.1 0.11 Long-Term 63,417 6 6,030 1.0 0.10 5,022 1 795 1.3 0.16 Care Units * The Pennsylvania care locations included in rate calculation were limited to those locations also published in the NHSN data summary. † NHSN data summary for 2006 through 2008. ‡ Authority analysis of Pennsylvania CLABSI reports to NHSN from July 2008 through March 2009. § CLABSI rate: number of CLABSIs / number of line days x 1,000. € Device utilization rate: number of line days / number patient days. Note 1. Edwards JR, Peterson KD, Andrus ML. National Healthcare Safety Network (NHSN) report, data summary for 2006 through 2008. Am J Infect Control 2009 Dec;37(10):783-805. Vol. 7, Suppl. 1—March 18, 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 3 Pennsylvania Patient Safety Advisory Table 2. Pennsylvania Patient Safety Authority Analysis of CLABSI Prevention Best Practice Compliance, by Event* CENTRAL LINE-ASSOCIATED BLOODSTREAM NOT USE NOT NO INFECTION [CLABSI] BEST PRACTICES USED USED UNKNOWN APPLICABLE ANSWER Statewide (N = 1,916; CLABSI Rate 1.46 / 1,000 Central Venous Catheter [CVC] Days) Maximal sterile barriers used during line insertion 1,098 26 761 2 29 Chlorhexidine skin asepsis used during line 1,068 59 746 14 29 insertion Line necessity evaluated daily and documented 1,044 167 677 1 27 Lowest Quartile Rates (n = 354 CLABSI; CLABSI Rate 0.98 / 1,000 CVC Days) Maximal sterile barriers used during line insertion 186 1 157 0 10 Chlorhexidine skin asepsis used during line 193 3 144 4 10 insertion Line necessity evaluated daily and documented 186 15 143 0 10 Highest Quartile Rates (n = 874 CLABSI; CLABSI Rate 3.3 / 1,000 CVC Days) Maximal sterile barriers used during line insertion 482 21 365 0 8 Chlorhexidine skin asepsis used during line 457 46 364 1 8 insertion Line necessity evaluated daily and documented 373 137 358 0 8 * Authority analysis of Pennsylvania CLABSI reports to the National Healthcare Safety Network from July 2008 through March 2009. (continued from page 2) System factors. These include barriers to clear process task responsibility, availability of resources and sup- outcomes. See the box “2008 Report: Healthcare- plies, appropriate use of supplies, and use of decision Associated Infections in Pennsylvania Hospitals.” aids such as checklists and standing orders. System barriers also include how the unit’s physical structure Barriers to Progress affects compliance, as well as adequacy of staffing and policies, administrative support, performance moni- Gurses et al. report that interventions to overcome toring, and feedback. barriers are often implemented without an investiga- tion into the actual reasons for failure to standardize Data derived from the barrier identification process care processes.14 Translating evidence into practice can then be summarized and prioritized, and an requires a systematic approach to identify, prioritize, action plan can be developed for each targeted bar- and remove barriers. Gurses’ program to eliminate rier. Practical tools to enable clinicians and leadership barriers to compliance recommends assembly of a to identify and analyze and address barriers in the team of frontline workers and quality improvement care setting can be found in the October 2009 Joint staff to collect data and identify barriers. This can Commission Journal on Quality and Patient Safety.14 be accomplished by observing staff during central CLABSI Risk Reduction Strategies line insertion and maintenance processes, simulat- ing the process while attempting to comply with the Infection Control—Leadership and Accountability protocols, and interviewing healthcare workers about The Joint Commission National Patient Safety Goals issues with process compliance. Contributing factors (NPSGs) outline specific elements of performance that prevent consistent and appropriate application of for implementation of evidence-based practices to evidence-based practices include the following: prevent CLABSI. By April 2009, hospital leadership was required to assign responsibility for oversight and Provider factors. These include knowledge of the ele- coordination of the implementation of all the ele- ments of the guideline, attitude toward the guideline, ments of NPSG.07.0401 and to ensure that a work perceived compliance with the guideline, current plan is in place with assigned accountabilities and practice habits, and the influence of unit culture timeline for full implementation by January 1, 2010.15 on compliance. The Comprehensive Unit-Based Safety Program Guideline factors. These include applicability of the (CUSP) developed by the Johns Hopkins Quality and guideline to the patients on the unit, ease of compli- Safety Research Group describes the senior execu- ance, and strength of scientific evidence. tive’s role as a partnership to bridge the gap between Page 4 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Vol. 7, Suppl. 1—March 18, 2010 Pennsylvania Patient Safety Advisory Table 3. Pennsylvania Patient Safety Authority Analysis of CLABSI Prevention Best Practice Compliance, By Hospital* HIGH LOW STATEWIDE PERFORMERS PERFORMERS Number of hospitals reporting central line- 160 40 40 associated bloodstream infections (CLABSI) Compliance with all three best practices 32 14 7 Percentage of compliance 20% 35% 17.5% CLABSI rate / 1,000 line days 1.46 0.98 3.30 * Authority analysis of Pennsylvania CLABSI reports to the National Healthcare Safety Network from July 2008 through March 2009. senior management and frontline providers by can be empowered to enforce the use of an insertion conducting safety rounds. The executive meets with checklist to assure all processes related to central providers on the unit while discussing safety issues line placement are executed for each line insertion. and helps remove barriers to implementing improve- Leadership support can be provided in the form of ment efforts. The executive’s role is also to stimulate a written protocol that also identifies which hos- further discussions about safety, help prioritize safety pital leader can be called to the scene if needed to concerns, suggest solutions to these concerns, and enforce protocols. Letters sent to medical and nursing help set goals for the unit. Executives may not be staff—signed by the ICU medical director, infectious aware that system defects exist in their hospital, and disease physician, and the hospital chief executive tremendous knowledge can be gained from observing officer—have been used to communicate leadership’s and understanding the challenges faced each day on commitment to CLABSI prevention. Standardization the front lines.16 (For more information, see the box of protocols and communication flow is essential for “Comprehensive Unit-Based Safety Program.”) successful programs.17 SHEA Practice Recommendations summarize and Education and Training prioritize CVC evidence-based practices, including As of January 1, 2010, the Joint Commission requires the role of leadership and medical staff, and advise that hospitals must implement CVC policies aligned accountability at all levels of hospital staff. Leader- with CDC and evidence-based standards and have ship should support an adequately staffed infection an educational plan for healthcare workers, patients, prevention and control program, provide resources and families. Healthcare workers involved in inser- for education ensuring that all healthcare workers are tion care and maintenance must be educated about trained and competent to perform job responsibili- CLABSI prevention on hire, annually, or when added ties, and hold personnel accountable for their actions. to job responsibilities.15 SHEA strategies additionally Hospital leaders can also empower nurses, physi- recommend ensuring that clinicians who insert CVCs cians, and other healthcare workers trained in CVC undergo a credentialing process as well as periodic insertion protocols to stop the insertion procedure assessment of knowledge and adherence to preventive if a break in aseptic technique is observed. Direct practices.12 IHI mentors suggest the development of healthcare providers and ancillary staff must consis- an educational program, including elements such tently apply appropriate infection prevention practices as an easily accessible paper or electronic education including hand hygiene protocols, standard and program with pre- and post-tests. Education and certi- isolation precautions, equipment and environmental fications should be based on evidence-based literature cleaning and disinfection practices, aseptic technique, for CVC insertion and maintenance. Consider and CVC insertion and maintenance evidence- development of a competency checklist for staff in all based practices. The facility infection preventionist areas where lines are inserted.17 Lessons learned from is responsible for active surveillance and analysis of analysis of CLABSI events should be disseminated to CLABSI events, integration of evidence-based prac- all stakeholders in the process. tices into the infection prevention program, and event CVC Insertion Protocols reporting to hospital leaders and staff.12 CLABSIs associated with CVCs that occur within the The IHI introduced the CLABSI prevention toolkit first 10 days of insertion are most often correlated and the bundle concept in 2005. The IHI Web site with extraluminal biofilm formation. The current pre- also has a detailed mentor section full of practical vention bundle focuses primarily on the prevention tips to help other hospitals achieve the same success. of extraluminal colonization, as the skin surrounding IHI leadership strategy examples include selection the insertion site is the primary source of bacteria of a physician champion who acts as liaison to the colonizing the external catheter surface. The initial medical staff and designation of unit-based nurs- colonization occurs with attachment of bacteria to ing leaders who can maintain unit awareness of the catheter tip and the external catheter surface with CLABSI prevention practices and outcomes. Nurses passage through the skin during insertion and can Vol. 7, Suppl. 1—March 18, 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 5 Pennsylvania Patient Safety Advisory catheter checklist, and a standard protocol for inser- 2008 Report: Healthcare-Associated tion. Hand hygiene must be performed prior to Infections in Pennsylvania Hospitals catheter insertion or manipulation, and femoral More than 13,000 healthcare-associated infec- CVCs should not be inserted in adult patients unless tions (HAI) were reported by Pennsylvania other sites are unavailable. A chlorhexidine-based hospitals for a rate of 2.84 HAIs per 1,000 days antiseptic must be used as insertion skin prep in of hospitalization in the last six months of 2008, patients older than two months of age.15 according to initial data released in January 2010 by the Department of Health.1 The report includes IHI strategies for implementation of these practice HAIs for each hospital, with an emphasis on uri- elements include posting hand hygiene reminder nary tract infections associated with the use of a signs at the entrances and exits to the patient rooms. catheter and bloodstream infections associated Another strategy is to initiate a campaign using post- with the use of a central line. These infections are ers of celebrated hospital doctors and employees to among the more common HAIs and were selected address such topics as using proper hand hygiene, to measure trends over time and for hospital-to- recognizing optimal site contraindications on the hospital comparisons. catheter checklist, and allowing skin antiseptic solu- When compared to other areas of the nation, tion time to dry up to two minutes before puncturing the overall rates of these infections were lower in the site.17 Pennsylvania than elsewhere. The three most com- monly reported HAIs in Pennsylvania were urinary The Catheter Insertion Checklist tract infections, surgical site infections, and intesti- Development and implementation of a catheter nal infections. insertion checklist ensures and documents compli- In February 2008, all hospitals began electroni- ance with aseptic technique. A nurse, physician, or cally reporting HAIs using the National Healthcare other trained healthcare worker should observe the Safety Network. The Department of Health process and fill in the checklist.12 The checklist can reported the data as required by Act 52, part be packaged with the kit or cart and is an appropri- of the Governor’s Prescription for Pennsylvania, ate tool to analyze compliance with process measures. which calls for monitoring the occurrence of HAIs in all Pennsylvania hospitals and long-term care The Authority’s review of several existing checklists facilities, for implementing scientifically dem- concluded that the following elements be considered onstrated interventions to reduce HAIs, and for when designing a facility-specific insertion checklist: limiting reimbursement for costs associated with the occurrence of HAIs. The goal is to control and Data field columns—lists items completed or eventually eliminate HAIs in healthcare institutions done with reminder, and rationale for deviation in the Commonwealth of Pennsylvania. from procedure. To read the full report, visit http://www.health. Before insertion section—includes information state.pa.us. regarding site assessment, bundle elements com- Note pleted, and full body drape in place. 1. Pennsylvania Department of Health. 2008 During procedure section—include documentation REPORT Healthcare-associated infections (HAI) in Pennsylvania hospitals [online]. 2010 Jan 13 of maintenance of sterile field, maximal sterile bar- [cited 2010 Jan 14]. Available from the Internet: riers and drape change if contaminated. http://www.health.state.pa.us. After procedure section—document the following actions: site cleansed with antiseptic agent; sterile gauze or transparent dressing applied; placement verified; facility-specific practices applied, such as therefore be prevented through effective hand hygiene, a securement device, a chlorhexidine impregnated use of maximal sterile barriers and appropriate skin sponge or dressing, or lot number of the catheter. disinfection. The CDC draft Guideline for the Preven- tion of Intravascular Catheter-Related Infections, posted in Physician competence requirement statement— the November 3, 2009, Federal Register, updates and include a statement noting requirement that expands evidence-based recommendations from the physicians or intravenous team inserters must be 2002 Guideline for the Prevention of Intravascular Catheter- credentialed to place CVC lines or the number Related Infections.1 The guideline recommends the use of acceptable attempts prior to calling in another of chlorhexidine skin disinfectant due to its persis- clinician. tence and effectiveness in decreasing colonization of Procedure note—integrate physician documenta- the catheter in the presence of serum and skin flora tion into the checklist by including site selection, at the catheter insertion site, citing that the combina- insertion status, type of anesthesia, insertion site, tion of chlorhexidine with alcohol increases the kill the number of lumens, reason for line, type of line, rate and drying time.18 and the number of attempts to pass the needle. As of January 1, 2010, the Joint Commission requires Signatures section—document names of inserting hospitals to use a standardized supply kit or cart, clinician, supervising clinician, and nurse. Page 6 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Vol. 7, Suppl. 1—March 18, 2010 Pennsylvania Patient Safety Advisory Care and Maintenance Catheters that are in place for longer than 10 days are Comprehensive Unit-Based Safety almost always associated with intraluminal biofilm. The Program internal and external surfaces of catheter hubs are the Johns Hopkins’ Comprehensive Unit-Based Safety immediate portal of entry to the intraluminal surface Program (CUSP) for prevention of central line- of the catheter. Microbial biofilm on the intraluminal associated bloodstream infections (CLABSI) was surface originate from microorganisms transported designed to improve safety culture and learn from through contaminated injection ports, needleless mistakes by integrating safety practices into the connectors, stopcocks, and catheter hubs, overwhelm- daily work of a unit or clinical area.1 Pennsylvania ing the immune system and leading to bloodstream hospitals are among a select group participating in a two-year collaborative to stop bloodstream infection. Hub colonization is a significant cause of infections through the use of CUSP . CLABSI due to frequent opening and manipulation, contaminated healthcare workers hands, poor hand General CUSP interventions are as follows: hygiene, improper glove use during tubing or connec- ■ Evaluate safety culture using the Agency for tor changes, and the presence of blood or solutions Healthcare Research and Quality (AHRQ) in the hub. Unless the hub is adequately disinfected, Hospital Survey on Patient Safety Culture. microorganisms can gain entry into the intraluminal ■ Educate staff on the science of safety to flow system through any contaminated portal or con- develop a unit-level safety culture. nector site. Once inside, contact with any internal ■ Identify defects in care using the collective surface component of the administration system (e.g., wisdom of frontline workers. extension tubing, needleless connectors, hub, catheter ■ Commit to executive partnership. surface) results in biofilm attachment. The infection ■ Learn from one defect and implement one source is usually colonization (biofilm) of the skin tract from the insertion site to the vein.18 As of January 1, culture improvement tool per month. 2010, the Joint Commission requires hospitals to use ■ Remeasure culture annually, and submit data a standard protocol to disinfect hub and catheter ports to AHRQ’s benchmarking database. before access.15 The five CUSP interventions specific to CLABSI are as follows: Examples of clinical approaches to disinfecting cath- eter hubs, needless connectors, and injection ports are 1. Educate staff on evidence-based practices to to scrub the port before every access with 70% alcohol reduce CLABSI. or an alcohol/chlorhexidine preparation to reduce 2. Implement a checklist to ensure compliance intraluminal contamination, as well as change gauze with these practices. dressings every two days and transparent dressings at least every seven days. Dressings should be changed 3. Empower nurses to ensure compliance with the checklist. more frequently if soiled, loose, or damp. Administra- tion sets and add-on devices are replaced “no more 4. Provide feedback on infection rates including frequently than at 72 hours” but should be changed at the unit level. every 24 hours if used for blood or lipids.1 IHI rec- 5. Implement monthly team meetings to assess ommends daily review of CVC necessity to prevent progress. unnecessary delays in removing lines that remain in place simply because they provide reliable access but A sample CLABSI toolkit, including daily goals sheet, insertion and maintenance checklists, and a are clearly no longer needed for care of the patient.2 cost calculator, is available online from the Johns This review can be included as part of multidisci- Hopkins Quality and Safety Research Group at plinary rounds. Daily goal sheets are useful to assess http://safercare.net. appropriateness of lines and compliance with bundle Note elements. Use of documentation prompts for record- ing the date and time of line placement, as well as care 1. Johns Hopkins Quality and Safety Research Group. On the CUSP: stop BSI. Comprehensive and maintenance activities, will aid in monitoring Unit-Based Safety Program (CUSP) toolkit [online]. process compliance. Care reminders available to staff 2008 Nov [cited 2009 Oct 30]. Available from on pocket and IV pump cards or signs prompt staff Internet: http://safercare.s3.amazonaws.com/ to complete clinical activities. Documentation can be support_media/docs/cusp/CUSP_Toolkit.doc. simplified with checkboxes and electronic hard stops.17 Special Approaches Special approaches are recommended for use in patients older than two months of age include areas with unacceptably high CLABSI rates despite bathing ICU patients daily with a chlorhexidine the implementation of prevention strategies.12 These preparation or using antimicrobial or antiseptic approaches are also recommended for patients with impregnated CVCs, dressings impregnated with heightened risk for severe complications, limited chlorhexidine, or antimicrobial lumen locks. A venous access, or a history of recurrent CLABSI. povidine-iodine preparation should be used in chil- Examples of special approaches appropriate for dren younger than two months of age, as the safety or Vol. 7, Suppl. 1—March 18, 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 7 Pennsylvania Patient Safety Advisory cfm?sample=1). This survey may provide further Additional Resources Available insight into issues surrounding CVC processes and The Pennsylvania Patient Safety Authority has a barriers. (See “Comprehensive Unit-Based Safety collection of educational tools for reducing the Program.”) risk of central line-associated bloodstream infec- tions, available at http://patientsafetyauthority. Conclusion org/EducationalTools/PatientSafetyTools/clabsi/ CLABSI will continue to pose a serious threat Pages/home.aspx. Its resources include this arti- unless prevention strategies are implemented and cle, educational video modules, and tools such as solutions to address the pathogenic mechanism a central line checklist. associated with vascular access devices are discovered The Authority gratefully acknowledges contribution and implemented.18 Effective strategies to prevent or of sample tools from Evangelical Community Hos- control biofilm on medical devices must take into pital and Roxborough Memorial Hospital. consideration the unique and tenacious nature of biofilm. Current intervention strategies are designed to prevent initial device colonization, minimize efficacy of chlorhexidine in this age group is an unre- microbial cell attachment to the device, penetrate the solved issue, according to CDC guidelines.1,19 biofilm matrix, kill the associated cells, or remove the device from the patient. Healthcare providers must Process and Outcome Measures adopt established best practices to reduce the risk of Establishment of a method to measure compliance CLABSI and associated morbidity and mortality to with CVC insertion and care processes is essential reduce healthcare costs. Hospitals can accelerate the to identify strategies for improvement. The Author- process by participating in collaborative efforts and ity’s analysis of CLABSI events from Pennsylvania networking with hospitals that have been successful hospitals (all unit types), as reported to NHSN from in reducing infection rates such as IHI mentors.17 July 2008 to March 2009, revealed a high percentage The key to successful CLABSI reduction is to com- of Pennsylvania hospitals reporting that compliance bine strategies from the available guidelines with the with best practices in patients with CLABSI was adaptive cultural changes necessary to achieve action- not known. able sustainable results. Renewed focus from hospital leadership, physicians, and nurses is essential to The Joint Commission requires hospitals to conduct promote a culture of zero tolerance for CLABSI and periodic risk assessments, measure CLABSI rates, unsafe practices. monitor compliance with best practices, evaluate effectiveness of prevention efforts, provide rate data Notes and outcome measures to key stakeholders, evaluate 1. O’Grady NP, Alexander M, Dellinger EP, et al. Guide- all CVCs routinely, and remove nonessential cath- lines for the prevention of intravascular catheter-related eters.15 Performance measures derived from published infections. MMWR Recomm Rep 2002 Aug 9;51 guidelines include measuring the percentage of (RR-10)1:29. compliance with the CVC insertion process as docu- 2. Institute for Healthcare Improvement. Getting started mented on an insertion checklist, daily assessment of kit: prevent central line infections how-to guide. 2008 continued need for the CVC, avoidance of femoral [cited 2009 Oct 30]. Available from Internet: http:// vein insertions, and observed cleaning of catheter www.ihi.org/IHI/Programs/Campaign/ hubs and injection ports before access. These numera- CentralLineInfection.htm. tors are divided by the total number of patients with 3. Association for Professionals in Infection Control a CVC in the unit population being assessed times and Epidemiology. Targeting zero healthcare associ- 1,000 line days. Outcomes are measured by dividing ated infections [position statement online]. 2008 the number of CLABSIs by the number of catheter July 18 [cited 2009 Oct 30]. Available from Internet: days times 1,000 to express the measure in a rate.12 http://www.apic.org/AM/CM/ContentDisplay. cfm?ContentFileID=11707. IHI mentors suggest strategies such as starting 4. U.S. Department of Health and Human Services. Sec- with one unit-specific pilot project; developing a retary Sebelius releases inaugural health care “success facility-specific, standardized maintenance bundle; story” report [press release online]. 2009 July 13 [cited conducting bundle compliance reviews at several 2009 Oct 30]. Available from Internet: http://www.hhs. levels (e.g., infection prevention, administration); and gov/news/press/2009pres/07/20090713a.html. issuing a certificate of appreciation for improvement. 5. Mermel LA. Prevention of intravascular catheter-related Another strategy to consider involves developing a infections. Ann Intern Med 2000 Mar 7;132(5):391-402. method to share outcomes with the hospital peer 6. Donlan RM, Costerton JW. Biofilms: survival mecha- review committee, the medical executive committee, nism of clinically relevant microorganisms. Clin Microbiol the medical education program, nurse managers, Rev 2002 Apr;15(2):167-93. and the governing board.17 The hospital can mea- 7. Ryder MA. Catheter-related infections: it’s all about sure its culture of safety using a survey developed biofilm [online]. Top Adv Nurs 2005 Aug 18 [cited 2009 by the Agency for Healthcare Research and Quality Oct 30]. Available from Internet: http://www.medscape. (https://www.patientsafetygroup.org/survey/index. com/viewarticle/508109. Page 8 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Vol. 7, Suppl. 1—March 18, 2010 Pennsylvania Patient Safety Advisory 8. Scott RD. The direct medical costs of healthcare- with evidence-based practices. Jt Comm J Qual Patient Saf associated infections in U.S. hospitals and the benefits 2009 Oct;35(10):526-32. of prevention [online]. 2009 Mar [cited 2009 Oct 30]. Available from Internet: http://www.cdc.gov/ncidod/ 15. The Joint Commission. National Patient Safety Goals dhqp/pdf/Scott_CostPaper.pdf. [2008 Goal 7:07.04.01 online]. [cited 2009 Oct 30]. Avail- able from Internet: http://www.jointcommission.org/NR/ 9. Klevens RM, Edwards JR, Richards CL Jr, et al. Esti- rdonlyres/868C9e07-037f-433d-8858-0d5faa4322f2/0/ mating health care-associated infections and deaths revisedchapter_HAP-NPSG_20090924.pdf. in U.S. hospitals, 2002. Public Health Rep 2007 Mar- Apr;122(2):160-6. 16. Johns Hopkins Quality and Safety Research Group. 10. Umscheid CA, Mitchell MD, Agarwal R, et al. Mortality On the CUSP: stop BSI. Comprehensive Unit-Based from reasonably-preventable hospital-acquired infec- Safety Program (CUSP) toolkit [online]. 2008 Nov [cited tions [advisory online]. [cited 2009 Oct 30]. Available 2009 Oct 30]. Available from Internet: http://safercare. from Internet: http://www.shea-online.org/Assets/ s3.amazonaws.com/support_media/docs/cusp/ files/0408_Penn_Study.pdf. CUSP_Toolkit.doc. 11. Medical Care Availability and Reduction of Error 17. Institute for Healthcare Improvement. Mentor hospital (MCARE) Act. 40 P.S. § 1303.401, et. seq. (2007). registry: central line infection [online]. [cited 2009 Oct 30]. Available from Internet: http://www.ihi.org/IHI/ 12. Marschall J, Mermel LA, Classen D, et al. Strategies to programs/campaign/mentor_registry_cli.htm. prevent central line-associated bloodstream infections in acute care hospitals. Infect Control Hosp Epidemiol 2008 18. Ryder M. Improve CRBSI prevention: target intralumi- Oct;29 Suppl 1:S22-30. nal risks [online]. Exec Health 2009 Jul [cited 2009 13. Edwards JR, Peterson KD, Andrus ML. National Oct 30]. Available from Internet: http://www. Healthcare Safety Network (NHSN) report, data sum- executivehm.com/article/Improve-CRBSI- mary for 2006 through 2008. Am J Infect Control 2007 Prevention-Target-Intraluminal-Risks. Dec;37(10):783-805. 19. Mermel L. New technologies to prevent intravascular 14. Gurses AP, Murphy DJ, Martinez EA, et al. A practical catheter-related bloodstream infections. Emerg Infect Dis tool to identify and eliminate barriers to compliance 2001 Mar-Apr;7(2):197-9. Vol. 7, Suppl. 1—March 18, 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 9 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 7, Suppl. 1—March 18, 2010. The Advisory is a publication of the Pennsylvania Patient Safety Author- ity, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2010 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to https://www.papsrs.state.pa.us/ Workflow/MailingListAddition.aspx. To see other articles or issues of the Advisory, visit our Web site at http://www.patientsafetyauthority.org. Click on “Patient Safety Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s Web An Independent Agency of the Commonwealth of Pennsylvania site at http://www.patientsafetyauthority.org. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.