Bundle Implementation

The development of the sepsis bundles required careful thought and attention to those aspects of care that are essential to the proper management of severely septic patients and those with septic shock. The purpose of creating change bundles is to articulate a clear framework of levers for change. Following the severe sepsis bundles will eliminate the piecemeal or inappropriate application of standards for sepsis care. However, simply posting the bundles is unlikely to produce any change. Taking the bundles and creating a customized clinical protocol that fits the logistical and cultural needs of your institution is essential.   

Teams should use the bundles to create customized protocols and pathways that will function well within their institutions. However, all of the elements in the bundles must be incorporated into the protocols. The protocols should mirror the bundles but allow flexibility to accommodate the specific needs of a local hospital. The severe sepsis bundles (and thereby the hospital’s protocol) form the basis for the measurements the team will conduct. If all the elements of the bundles are not incorporated into your customized protocol, then performance on the measures will suffer.  

A strong protocol will accomplish all of the items listed in the severe sepsis bundles. If the protocol designer pays careful attention to the details in the bundles, the protocol will score well on the severe sepsis quality indicators. Hospitals will want to publicize their efforts with regard to improving sepsis care and make the protocol an integral part of their rollout strategy. Launching an educational imitative regarding the effort is imperative. 

Plan-Do-Study-Act Worksheet 

Project Charter

Prototype Testing Roadmap ​​

 

 Protocol Development

 
Entering the severe sepsis bundles on the chart as if they were orders would result in many questions. Therefore, a protocol is necessary to implement the bundles. A customized protocol will not only adapt execution of the bundles to your hospital’s practice environment, but it will also reduce errors in the delivery of care and begin the key process of standardizing sepsis care at your institution. The two most important ways to eliminate errors in care are to:  
  • Reduce the number of steps involved in any process 
  • Adopt standardized routines    

 
The probability of making an error increases proportionately as the number of steps in a process increases:  
  • With a 25-step process there is a 5% probability of making an error 
  • With a 50-step process there is a 39% probability of making an error 
  • With 100 steps the probability climbs to 63%  
  
The development of the bundles has pared the SSC guidelines down to as few instructions as possible. Standardization accounts for the next most substantial improvement in quality after evaluative steps. Standardization involves the use of the following at the local level tailored to individual practice environments:  
  • Protocols
  • Guidelines 
  • Care processes (pathways) 
  • Equipment 
  • Procedures  
  
The purpose of developing protocols is to build a collaborative environment and bring about change in the local culture. Hospitals that transform their care from chaotic practice environments characterized by individual preferences to one that operates in harmony under routine conditions also transform the staff’s attitude regarding quality of care. By organizing many levels of the organization around a single package of care, the creativity and problem-solving abilities within an institution are unleashed. In contrast, protocols that are simply mapped onto a hospital’s care pattern rarely succeed and rarely result in anyone’s taking ownership of them in the institution. Follow these steps to standardize care and create lasting changes in the practice environment:
  • Assemble the experts, the front-line clinicians from multiple disciplines who will be affected by the protocol.  This includes physicians and nurses in the critical care units, floors, and emergency department, pharmacists, respiratory therapists, laboratory supervisors, quality personnel, etc. Reaching out to a diverse set of experts allows you to identify problems with the new standard through the eyes of different disciplines.
  • Using the severe sepsis bundles and knowledge of your environment, design a protocol that is likely to be acceptable to current practitioners. (If you restrict your protocol to one ICU, only consider the practitioners of that ICU.)
  • Distribute the first draft of your protocol to all who have a stake in its performance. 
  • Use the feedback from practitioners and staff to improve the protocol and obtain consensus through iterative cycles.
  • Test the new protocol in the clinical environment and use iterative cycles to improve the logic until it becomes functional.
  • Once the protocol is ready for general use, assign a “process owner” to serve as a contact person for suggestions and concerns that need to be addressed in revising the protocol.

 
 

 Testing

 
The following are keys to successful implementation of protocols or care standards: 
  • When possible, base the protocol on firm evidence from the scientific literature.
  • Design the protocol using a multidisciplinary team. 
  • Involve all stakeholders, using an information-feedback process to facilitate everyone's trust, confidence, and buy in. 
  • Test the protocol in the clinical environment using small Plan-Do-Study-Act (PDSA) cycles, modifying it as needed to make it unambiguous, safe, and acceptable to practitioners. 
  • Measure the protocol's impact on work processes and outcomes and feed back the information to the users. 
  • Test the protocol vigorously, using multiple small tests to reduce safety and compliance problems to a minimum before full implementation. 

 
 

 PDSA

 
The Model for Improvement is a simple yet powerful tool for accelerating improvement. 

 
This model has been used by hundreds of health care organizations in many countries to improve many different health care processes, resulting in improved outcomes. Using the key elements of the model, especially testing changes on a small scale with Plan-Do-Study-Act (PDSA) cycles, has helped organizations improve care. 
 
Example: Implement a process to ensure the early detection of severe sepsis.

 
Cycle 1: Set up a measuring system to collect data and use it in a retrospective chart review to establish how well we identify early patients with severe sepsis and septic shock within a 2-hour period. 

 
Cycle 2: Develop a screening tool for the triage nurse and/or admitting clerk to use to identify potential severe sepsis and septic shock patients. Get buy-in from emergency room physicians. 

 
Cycle 3: Have the emergency department admissions clerk and/or triage nurse prospectively flag potential severe sepsis and septic shock patients and measure any improvement in identifying these patients. Modify the screening tool as needed and retest. 

 
Cycle 4: Establish a system to collect the physical and laboratory data automatically by protocol that is agreed upon by physicians, nurses, laboratory technicians, and unit clerks. 

 
Cycle 5: Test the protocol on the next sepsis patient. Document problems. Modify the protocol as needed to eliminate ambiguity, work process objections, and non-protocol compliance. 

 
Cycle 6: Test the protocol on two or three more patients and measure the times until the information is available to make the diagnosis of severe sepsis or septic shock. 

 
Cycle 7: Modify the screening and information gathering processes until the time to identification is less than 2 hours from emergency department admission. 
 
 

 Enhancing Reliability

 
How will you know that your changes as intended are being faithfully implemented on the wards? Where are the bottlenecks? What steps can be taken to make the new clinical processes you have implemented function more reliably?  To learn more about spread, view the SSC webcasts​ on spread topics.

 
The Model for Improvement will be used in concert with Enhancing Reliability, an active approach to clinical process improvement that embeds steps to prevent, identify, and mitigate failures directly into the process itself. Reliability is a scientific method that evaluates, calculates, and improves the overall reliability of a complex system. It is a goal of consistently producing appropriate outcomes and preventing adverse events. The Enhancing Reliability methodology has three levels, as described below. 

 
1. Stabilization (Prevention):

 
It is impossible to sustain improvement of a chaotic process. In general, any process that fails 1 time in 10 (functions less than 90 percent of the time as intended) is chaotic and unreliable. Efforts to stabilize the system prevent failures. 
The first step in stabilizing a process is the establishment of a standardized approach. Therefore, a standardized protocol customized to your institution will be necessary to implement the sepsis bundle. 
Next, measure the baseline reliability of the clinical processes you have created in your protocol. These are process measures. Each process being measured can be improved individually. 

 
In the event that standardization is already in place but a particular process is functioning at less than 90 percent reliability, more work is necessary to stabilize that process. Some examples include building decision aids and reminders into the system and making the desired action the default strategy rather than an option. 

 
2. Redundancy (Identification):

 
Once a process functions reliably 90 percent of the time or better, it is reasonable to pursue improvement in the next PDSA cycle toward the next threshold of reliability - 1 failure per every 100 opportunities, or 99 percent reliability. Redundancy of procedures helps to achieve this goal by identifying more instances when the process should be applied. 
No effort to pursue this level of improvement in the course of a PDSA cycle should be undertaken for an unstable process. This is so because redundant efforts are, by definition, resource intensive. Implementing a redundant procedure in an unstable system is wasteful. 
Effective redundancy steps function independently of the normal mechanism that triggers use of the clinical process. For example, the laboratory may have a procedure to contact physicians directly for routine labs that suggest acidosis, such as very low bicarbonate levels, which may indicate sepsis. A successful redundancy step may bring the number of missed cases below 10 percent and advance the process toward a 1 percent failure rate. 

 
3. Failure Modes Analysis (Mitigation):

 
Once sufficient recovery of cases can be established to approach better than 90 percent reliability, further steps involve identifying the causes of failure and mitigating their effect. 
Specific impediments to the functioning of reliable processes will be identified in the course of implementation. These represent failure modes that need to be eliminated or in some other way circumvented in subsequent PDSA cycles. 
The particular impediment detected will drive your team to create a new level of customization to prevent further failures and to achieve increasingly reliable processes.