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A patient intubated with Kimberly-Clark’s MicroCuff ET recevies treatment from a nurse using K-C’s Bal-Cath Device.

What is a bundle?

A bundle is a collection of best practices and processes identified by evidence-based science as necessary to provide optimum care for patients in certain circumstances involving particular risks to achieve the goal of improved outcome. It sounds more complicated than it is. This is where the K(eep) I(t) S(mart but) S(imple) Method comes in. Bundles are intentionally made simple, so as to make them easier to implement, which means they’re more likely to be implemented.

Matt Moore, senior marketing manager, venous access, Teleflex Medical, Reading, PA, observed: "The bundle components must be manageable, mentally and physically, so that the teams responsible for implementation buy into the process." Joyce Ryan, MSN, NP, medical science liaison–East Coast, Sage Products, Liverpool, NY, and Englewood, FL, added: "Bundling is beneficial to the healthcare worker (HCW) in that it offers a systematic, streamlined approach with all components included. This simplicity generates greater compliance and staff satisfaction. Even when clinicians know the best therapies, they may not always apply these therapies in the chaos of everyday practice. Simplicity is key."

Bundles generally have only four or five steps. Consistency in performing the steps in a bundle is paramount, because the approach is "all or nothing." If only three of four steps in a bundle are performed, the healthcare giver gets a failing grade. Every single step must be performed for every single patient every single time. Those who fail are held accountable. "The steps must all be completed to succeed," insisted Ryan. "The ‘all or none’ feature is the source of the bundle’s power." 

Checklists are an important part in ensuring that all steps are performed 100% of the time. "Missing one step can open the door for infection, giving new meaning to the expression about the ‘chain being only as strong as its weakest link’," said Judene Bartley, MS, MPH, CIC, clinical consultant, Premier Safety Institute, Charlotte, NC.

Bartley added: "A key element and critical success factor of bundles is the empowerment of each member of the team to have permission to ‘call out’ to colleagues when a step in the process is not being carried out according to protocol. The empowerment and mutual support is part of the safety culture and fosters a ‘non-blame’ atmosphere to identify the cause when a single infection does occur. The facility impact is a ‘win-win’ all around: improved outcome, morale among staff, reputation, reduced cost, liability, and satisfied customers."

Ryan believes that the pass-fail, all-or-nothing approach raises the bar for standards. "In his December 2004 IHI [Institute for Healthcare Improvement] National Forum plenary launching the 100,000 Lives Campaign," said Ryan, "Donald Berwick, IHI president and CEO, described the bundle as central to what he called a new scoring system for clinicians that would ‘up the stakes on reliability.’ Rather than scoring ourselves for successfully completing individual steps in a list of proven interventions for a group of patients, he said, what if we rate ourselves ‘on a pass-fail basis for the whole bundle of things? A patient gets a "yes" if we actually did everything we planned to do and a "no" if anything, even one thing, was left out.’ This bundled scoring system pushes us to raise the bar on healthcare performance. Consistency and compliance must be present."

Cardinal Health’s Presource Central Line Insertion Packs can help prevent central-line infections

Providing a little history, Gina Pugliese, vice-president, Premier Safety Institute, Charlotte, NC, explained that, until recently, the norm was to focus on implementing individual measures, one at a time, rather than a bundle. "It was not until the past few years that we took a close look at what percentage of the most important prevention practices for a particular type of infection was actually being practiced and found that it often was very low. So, the practice of ‘bundling’ was born and took off like wildfire. Evidence-based practices implemented as a group or bundle could indeed eliminate infections and has become a standard of practice for quality and safety."

"Healthcare-associated infection (HAI) bundles are developed from each of the Centers for Disease Control and Prevention (CDC) guideline recommendations for which evidence best demonstrates how to prevent a particular infection," said Bartley. "The most frequently used bundles are aligned with the four major HAIs: central line-associated bloodstream infections (CLA-BSI); ventilator-associated pneumonia (VAP); catheter-associated urinary tract infection (CA-UTI); and surgical-site infection (SSI)." [See sidebar.]

When your hospital is ready to get serious about bundles, where do you start? How do you know which bundles to implement first?

Marvella Thomas, RN, MSN, clinician manager, Presource Products and Services, Cardinal Health, Dublin, OH, offered this advice: "When determining which bundles would make the most impact on a given facility’s ability to reduce rates of infection, hospitals can start by measuring infections and then performing root-cause analyses to determine which procedures have the highest likelihood of causing infections."

The connection between surveillance and use of bundles was highlighted by Bartley. "To prioritize activities," explained Bartley, "hospital leadership and clinical experts need to assess their program priorities that are supported by the facility’s HAI surveillance data. Also, federal and state requirements need to be considered. Nearly 20 states have requirements for reporting HAI rates, with most requiring CLA-BSI rates. Centers for Medicare and Medicaid Service (CMS)’s Surgical Care Improvement Project (SCIP) includes a number of measures related to the prevention of SSI. CMS’s inpatient reimbursement has been reduced for certain HAIs, such as mediastinitis, CLA-BSI, and CA-UTI. The strategy to prevent these infections for patient safety, improved outcome, and regulatory compliance is to implement bundles to prevent these infections."

Ryan, Sage Products, also suggested allowing the data to guide where efforts need to be placed: "Compliance and outcomes must be tracked, and periodic reports should be provided, so that all staff members are aware of the progress. If the trend is going in the wrong direction, corrective action needs to be implemented. If the outcome is positive, then celebration is appropriate. A mindset of ‘we’re all in this together’ will go a long way in any healthcare facility."

A new publication from the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America was strongly recommended by Ryan: "Although IHI is recognized for pioneering the bundling concept, most facilities are encouraged to follow "The Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals" [Infect Control Hosp Epidemiol 2008 Oct;29 Suppl 1:S12-21]. It has the most up-to-date bundle recommendations for specific infections. These healthcare associations have advanced the prevention of HAIs as a national imperative. The Compendium offers specific strategies and recommendations towards this goal." [To view/download the compendium, go to http://www.shea-online.org/about/compendium.cfm. At the same web address, the new "Patient Guides," which explains to patients the care they will receive, including care outlined in bundles, also can be viewed or downloaded.]

Robyn Whalen, marketing director of North American medical devices, Kimberly-Clark Health Care, Roswell, GA, noted: "We’ve seen facilities have the most success with lowering infection rates by augmenting their use of bundles with other best practices outlined by professional organizations such as CDC, SHEA, American Association of Critical-Care Nurses, and others. At Kimberly-Clark, we’ve organized our products and services by platform tied to these best practices to complement the efforts of our customers. Our sales process, in-servicing, and educational programs are designed to support the implementation of clinical best practices, whether they are in support of VAP prevention or SSI prevention."

Arrow maximal barrier kit, Teleflex Medical

Advantages of bundling

The advantages of bundling are manifold for the patient, the HCW, and the healthcare facility. Ryan, Sage Products, outlined a few advantages: "Bundling can enhance convenience, compliance, costs savings, and, most importantly, clinical outcomes. Potential advantages for the patient include less morbidity and mortality. The advantage for the HCW is a simplified care path, resulting in better compliance to the intervention and control over the outcomes. Advantages to the facility include cost avoidance, as they attempt to eliminate ‘never events’, which include several HAIs. CMS guidelines will no longer reimburse for these occurrences. A better scorecard for the institution is also desirable, as HAI rates are reported and become available for public viewing. Cost avoidance is recognized through decreased length of patient stay and fewer costs from treating complications. Effective bundling also decreases the cost associated with patient dissatisfaction, as well as negative public perception. The most significant benefit however, is the appropriate patient outcome."

Moore, Teleflex Medical, agreed: "Patients benefit from the impact of focused improvements from engaged staff. The staff benefits from the empowerment and satisfaction from seeing improvement as a result of their care. The facility benefits from the well-documented reduction in unreimbursed costs, as well as a bump in patient and employee satisfaction and public reputation."

Another advantage is that supplies needed for the task at hand are more readily accessible, having been assembled prior to need. Bartley explained: "Digging deeper into the elements of a bundle such as CLA-BSI, or steps in SCIP processes, will show that successful implementation of bundles involves standardization of processes and supplies. For example, in the Michigan Keystone collaborative, the CLA-BSI’s checklist for catheter insertion led to the development of standardized packs or kits with right-sized drapes, specific skin prep antiseptic (chlorhexidine), etc., so there would be no time lapse in locating materials when time is critical. The time element is crucial for the patient’s outcome. The ease of locating supplies reduces frustration for the worker, and the overall efficiency of the process saves time and costs for the facility."

Cost and inventory reduction is yet another point in favor of bundling. Thomas, Cardinal Health, added: "Bundling reduces the opportunity for contamination of the surgical field; reduces procedure set up time, which can be extremely important in emergency situations; assists in identifying procedure costs; reduces inventory and handling/processing time involved in inventory management; and can increase case pick accuracy." A bonus, pointed out Thomas, is that clinician time is freed "to focus on patient care, improve productivity, and reduce overall healthcare costs while helping to improve patient safety."

Q•Care Oral Cleansing and Suctioning Systems from Sage Products

Anecdotal evidence

Encouraging stories abound where the bundle has been used successfully as an avenue to reduce HAI in facilities. A few are reported below.

Ryan told Healthcare Purchasing News about a couple of examples in Sage Products’ experience. "There have been many instances in which an institution has implemented bundling into their treatment regime and found significant improvement in outcomes. Children’s Healthcare of Atlanta instituted both ventilator and comprehensive oral-care bundling in its neonatal intensive care unit (ICU) to address VAP. A 69% decrease in VAP rates was noted, along with significant costs savings. Overlake Hospital, a 337-bed hospital in Washington, noted a steady increase in their VAP rates. In 2004, the hospital leadership participated in the IHI 100K Lives campaign. A comprehensive oral-care regimen was instituted. The hospital subsequently reduced its VAP incidents by 81% and estimates an overall savings of $1.4 million in cost avoidance from December 2004 to December 2005."

Pugliese offered examples from Premier’s experience: "Unprecedented reductions in rates of CLA-BSI and VAP, for example, have been reported by hospitals participating in local, regional, state, and national bundling initiatives. Many examples of reduced rates and length of stay are documented on Premier’s Safety Institute web site www.premierinc.com/quality-safety/tools-services/safety/topics/bundling/.

Bartley, Premier, also noted that "a number of organizations have led successful collaboratives with groups of hospitals that have shared their success in using bundles, reporting dramatic reductions in HAI rates, including IHI, a regional initiative led by the New Jersey Hospital Association (NJHA), and Michigan Health and Hospital Association’s Keystone Center for Patient Safety and Quality."

"The final results of an 18-month study involving 103 ICUs were published in the New England Journal of Medicine in December 2006, reporting that 103 Michigan ICUs reduced catheter-related BSI to zero at 3 months. Up to 66% sustained the zero rates during the 18-month study period."

The NJHA ICU collaborative, an initiative of the NJHA Quality Institute, also reported successes due to bundling. Bartley said, "Twenty-four hospitals and health systems encompassing more than 30 facilities were involved in the initial phase of the project, which uses a collaborative model to report data, reinvent processes, and share best practices in ICU care. It is based on a successful model used in IHI’s 100,000 Lives Campaign. As reported in June 2005, results based on data reports from all participating hospitals show that the rate of VAP decreased from 5.12 in June 2004 to 3.29 in January 2005; the rate of catheter-related BSI fell from 7.2 in June 2004 to 4.82 in January 2005; the average ICU length of stay declined from 4.28 days in June 2004 to 3.59 days in January 2005."

Billings Clinic in Billings, MT, is working with national healthcare alliance VHA Inc. to learn how to manage patient catheter use to prevent CL-BSI incidence, and has implemented an aggressive patient safety program and practices. As a result, the hospital reported zero CL-BSIs in 2007 and as of the date of publication had only one case in 2008. The facility established physician champions – intensivist and infectious disease; developed a training simulation lab to re-orient current staff and teach new staff about infection control and risk; developed one universal definition for a CL-BSI; ensured that all physicians and clinicians followed the same insertion procedures throughout the hospital; made sure that all blood cultures are drawn from two different sites and do not culture catheter tips; implemented procedure carts for every unit containing all necessary line insertion materials and designated one staff person to be responsible for all cart items being stocked/valid; required full protective equipment (cap, gown, mask, gloves) to be worn by all staff person doing the insertion; and implemented use of Biopatch, which was believed to be key to success.