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PATIENT SAFETY

A Novel Process for Introducing a New Intraoperative Program: A Multidisciplinary Paradigm for Mitigating Hazards and Improving Patient Safety

Jose M. Rodriguez-Paz, MD^*, Lynette J. Mark, MD^*, Kurt R. Herzer^*, James D. Michelson, MD, Kelly L. Grogan, MD^*, Joseph Herman, MD, MSc, David Hunt, RN, Linda Wardlow, RN, Elwood P. Armour, PhD, and Peter J. Pronovost, MD, PhD^*

From the *Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland; Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont; Departments of Radiation Oncology and Molecular Radiation Sciences, and Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Address correspondence and reprint requests to Jose M. Rodriguez-Paz, MD, Department of Anesthesiology and Critical Care Medicine, 600 North Wolfe St., Meyer 297 A, Baltimore, MD 21287. Address e-mail to jrodrig1{at}jhmi.edu.

Abstract

BACKGROUND: Since the Institute of Medicine’s report, To Err is Human, was published, numerous interventions have been designed and implemented to correct the defects that lead to medical errors and adverse events; however, most efforts were largely reactive. Safety, communication, team performance, and efficiency are areas of care that attract a great deal of attention, especially regarding the introduction of new technologies, techniques, and procedures. We describe a multidisciplinary process that was implemented at our hospital to identify and mitigate hazards before the introduction of a new technique: high-dose-rate intraoperative radiation therapy, (HDR-IORT).

METHODS: A multidisciplinary team of surgeons, anesthesiologists, radiation oncologists, physicists, nurses, hospital risk managers, and equipment specialists used a structured process that included in situ clinical simulation to uncover concerns among care providers and to prospectively identify and mitigate defects for patients who would undergo surgery using the HDR-IORT technique.

RESULTS: We identified and corrected 20 defects in the simulated patient care process before application to actual patients. Subsequently, eight patients underwent surgery using the HDR-IORT technique with no recurrence of simulation-identified or unanticipated defects.

CONCLUSION: Multiple benefits were derived from the use of this systematic process to introduce the HDR-IORT technique; namely, the safety and efficiency of care for this select patient population was optimized, and this process mitigated harmful or adverse events before the inclusion of actual patients. Further work is needed, but the process outlined in this paper can be universally applied to the introduction of any new technologies, treatments, or procedures.

Concern regarding patient safety has been growing since the Institute of Medicine (IOM) released its report, To Err is Human, publicizing the effects of medical errors on patient deaths in the United States.1 Since then, numerous efforts and interventions have been implemented to correct the defects that lead to medical errors.

Nevertheless, it is not clear whether we have improved the safety of care delivered to patients.2 The Joint Commission has identified the leading cause of sentinel events and errors in the United States to be errors in communication.3 Sentinel events may be amplified as health care institutions introduce new technologies, techniques, and procedures without first evaluating the patient care team’s comfort with the change, the team’s recognition of all of the potential problems, and the team members’ understanding of each of their roles in safely caring for patients.

In general, the health care community takes a reactive approach to safety, responding when events occur. Rarely are proactive steps taken to identify hazards and design systems to eliminate or mitigate those hazards. The purpose of this paper is to describe the creation and testing of a process led by the Department of Anesthesiology at Johns Hopkins Medical Institutions that allowed us to prospectively identify and mitigate hazards related to a new intraoperative procedure. This process included in situ simulation to identify hazards in a simulated clinical environment before exposing real patients to the new procedure.

METHODS

In October 2006, the Department of Radiation Oncology at the Johns Hopkins Hospital joined the Weinberg Perioperative Clinical Services Team (WPCST), a multidisciplinary team comprising anesthesiologists, nurses, safety officers, risk managers, equipment specialists, and other Operating Room (OR) personnel, to introduce a new technique to the institution: High-dose-rate intraoperative radiation therapy (HDR-IORT).

HDR-IORT consists of a high-dose-rate brachytherapy technique that employs encapsulated Iridium-192 and is used in most large radiation oncology departments; however, its use in the intraoperative setting is uncommon. HDR-IORT offers the benefit of delivering controlled, high-dose radiation treatment directly to the tumor through an operative wound with minimal exposure to surrounding tissues.4,5 This form of intraoperative brachytherapy has been used successfully in the treatment of several types of tumor, including prostatic, intrathoracic (endobronchial, esophageal, etc.), gynecologic, pediatric, breast, rectal, head and neck tumors, mesotheliomas and soft tissue sarcomas.6,7 One of its limitations is that its safe delivery requires a special, shielded OR absent of personnel during the delivery of the radiation for as long as 60 min. Not all institutions have these OR facilities. In many, patients must be transported from the OR to the radiation therapy suite while fully anesthetized and with an open wound, thereby increasing the potential for adverse events. To address this issue, the technology to deliver HDR-IORT via a mobile device was developed in the late 1980s for use in ambulatory settings.8 In recent years, through the development of new applicators, this technique has moved into a shielded OR that can contain the radiation.9,10

The WPCST recognized that this new and unfamiliar therapy posed new and potentially unknown hazards to patients and clinicians, and that its use would require modifications to both the OR and the provision of care, as no member of the OR team could be physically present during the delivery of the treatment. We needed to create a process that would allow identification and mitigation of all foreseeable hazards before the use of HDR-IORT in real patients.

A multidisciplinary, systematic process was created to allow the development of a treatment protocol, the testing of the readiness of the team that would be performing the procedure, and the practice of its delivery in a safe manner to avoid any potential harm to future patients. All concerns and defects uncovered were recorded during debriefing sessions, as well as provider interventions, reaction times, outcomes during each simulated scenario, and all suggestions made by the team members to improve the process.

THE INTRAOPERATIVE BRACHYTHERAPY PROJECT: THE PROCESS

After discussion and reflection, we identified all stakeholders involved in the process and potential system defects, and we defined the safety and quality objectives to be achieved. The main problems identified were the lack of experience of OR personnel with this type of procedure, the associated risks for the patients and staff, the lack of available knowledge and protocols to guide the management of these cases and, most importantly, the staff’s readiness to safely assume the care of these patients (Table 1). The steps used in the process are detailed below.

Identify Existing Knowledge of Hazards and Defenses
The members of the Departments of Surgery and Radiation Oncology were asked to present their needs to the WPCST, describe the types of cases and patients who would receive the therapy, and identify what was needed from the Departments of Nursing, Surgery, and Anesthesiology to meet the requirements for safe delivery of brachytherapy.

Through extensive literature review and direct contact with other institutions to identify associated hazards and defenses that may have been implemented, we accumulated the limited existing knowledge on HDR-IORT. Nearly all of the information came from the radiation oncology literature, which mostly addressed technical aspects of the therapy and described short case series.11 Little information was available regarding multidisciplinary operational protocols for how to introduce HDR-IORT and integrating care in a safe way,8,9,12 and most institutions operated under a "trial and error" approach. As a result, we decided to develop and test a more systematic approach that could be applied for the introduction of this new therapy and, by extension, to any new treatments or therapies. All of the information was compiled and presented to the members of the team.

Anticipate What Can Go Wrong/Weaknesses
Using Gary Klein’s13 concept of premortem, identifying in advance why a project may fail, we developed the following steps:

Preparing
Through a series of briefing sessions, all members of the team were presented with the information pertinent to the project so that they could understand what was going to happen. This step was crucial for ensuring that everyone understood the HDR-IORT procedure and its implications for patient safety.

Imagining a FIASCO
After the initial briefing sessions, participants were asked to identify possible defects or problems within their specific domains and how they perceived the procedure could pose risks to patients. Several participants identified concerns, some of which were related to radiation safety, lack of specific protocols in the OR for managing radiation, emergency plans, and equipment (lack of anesthesia "slave" monitors, problems with the video systems already installed, the complexities of administering medications from a distance, etc.). Additional potential problems were identified concerning the lack of specific protocols and actions to take at each step of the procedure (e.g., when and how to abort the procedure, obtaining adequate patient consent).

Generating Reasons for Failure
Failure was defined as an unanticipated adverse event experienced by any patient undergoing HDR-IORT, and team members were asked to list possible reasons for failure. The advantage of this step was that it revealed varying views of the process and mental models. Reasons for failure included1 problems with equipment once the case was underway and lack of understanding of what was needed to ensure that the case would go smoothly,2 inadequate monitoring which would limit the ability of the anesthesiologist to recognize problems with the patient,3 length of time required for the OR to be radiation-free after the radiation procedure is aborted emergently,4 lack of knowledge regarding the anticipated length of treatment for each specific case, and5 problems with the patient that might occur during the treatment period and how to address them.

Consolidating the Lists
All of the concerns were recorded and discussed in the debriefing of each session. They were also reviewed at the beginning of each subsequent session to ensure that they were addressed; where necessary, changes or preparations were made to mitigate or avoid possible defects.

Simulate the Process
Simulation is a tool widely used in other industries (aviation, the military, etc.), and since the late 1980s, it has been incorporated into health care.14–23 Simulators allow practicing procedures without exposing patients to risk. In situ simulation brings simulation to the actual environment in which the delivery of care occurs, using the same front-line caregivers and resources that will be used in real-life events and potentially permitting evaluation and modification of structures, team interactions, and processes.23–27

In our project, we used a high-fidelity mannequin simulator (SimMan, Laerdal, NY) in the actual OR where HDR-IORT would be delivered to real patients.

The simulation was run according to the following plan:

• The environment in which the HDR-IORT cases were going to occur was replicated, and members of the team were aided in understanding all steps of the process, their roles, and what should be expected, allowing the capture of latent failures embedded in the system.
  
• Potential hazards identified in the premortem phase that related both to radiation problems and potential patient adverse events were used to create scenarios with different levels of complexity for subsequent sessions. During the debriefing session every member of the team added further hazards or potential hazards discovered during the simulated session, and these scenarios and the changes implemented after unveiling hazards were incorporated in subsequent simulated sessions. Every finding, suggested correction, and potential change for improving the process was annotated and incorporated into the process. One safety nurse from the team (DH) recorded all events and potential defects in the patient care process and verified that all introduced changes to the system worked as planned.
  
• SimMan acted as a standard 70-kg man with stable hemodynamics under full general endotracheal anesthesia and with standard American Society of Anesthesiologists monitors undergoing exploratory laparotomy for HDR-IORT for bladder cancer. Simulation started with the patient already fully anesthetized and the surgical field already exposed immediately before all personnel left the OR to begin applying the radiation. Up to that point, the case had been uneventful and the patient stable.
  

After verifying with the manufacturer (Laerdal) and with the radiation safety experts at our institution that it would not damage the mannequin, we decided to use real radiation on the simulator. Doing so added an important element of realism and allowed us to assess the real effects of the radiation on personnel involved with patient care, so that we could establish safer practices, both for the patients and the health care providers. The entire process was monitored by our radiation safety experts. Team members were allowed to perform their regular functions based on their real-life roles.

Two simulated sessions of 4 h each were scheduled attended by all stakeholders who would participate in real life during these cases: nurses, anesthesiologists, surgeons, radiation oncologists, and radiation safety specialists. In each session, three full scenarios were played out: in the first, during the administration of HDR-IORT with every member of the team outside of the OR, the simulated patient had an episode of bradycardia; in the second, the patient suffered a bronchospastic event with desaturation and hemodynamic instability during the application of radiation; in the third, the patient suffered a ventricular tachycardic arrest during the application of radiation therapy. In all cases, members of the WPCST recorded all interventions, reaction times, and outcomes of the interventions. Other recorded outcomes were remote monitor and video setup, radiation safety, equipment performance, and emergency plans.

Two weeks later the process was repeated as a validity check. We began with a briefing session during which all of the defects/hazards, suggestions and all implemented improvements were presented. We then repeated the process to answer the question, "Have the identified hazards been mitigated?" Three new simulated cases with added complexity (hypotension, tachyarrhythmia, cardiac arrest) were run. Again, during debriefing one team member recorded all new potential defects/hazards identified by the patient care team that had not been detected during the first session.

Summarize Hazards/Defects (Debriefing the Process)
After the simulated scenarios, the entire team participated in a debriefing session in which they analyzed their experiences, expressed concerns over safety issues, identified more possible defects and hazards, and proposed solutions. A list of all of the defects was created during the initial session and action items for improving specific areas were assigned to the appropriate parties.

Twenty potential defects inpatient care were identified and corrected. Six defects were related to radiation safety for both the patient and the clinical staff, four defects were associated with nonradiation safety for the patient (anesthesia-related), six defects concerned teamwork and communication, and four defects related to equipment and supplies (Table 2).

Design System to Defend Against Hazards: Creation of a Multidisciplinary Safety Checklist and Protocol
The detection of several defects during this project prompted members of the team to create a tool that would allow any caregiver, when caring for actual patients, to be able to defend against the defects unveiled during this process and minimize risks. All team members contributed to the creation of a multidisciplinary safety checklist to facilitate the safe delivery of HDR-IORT by any caregiver, even those unfamiliar with the procedure. This safety checklist served as an independent redundancy step to be used before every case, and its use sought to ensure that all safety standards established by the above-described process were met. The checklist included items related to radiation safety, knowledge of procedures and protocols, nursing (e.g., equipment readiness) and anesthesia issues and it could be used for performance improvement on subsequent cases. Additionally, the checklist captured accountability by requiring that all members of the care team had responsibilities for ensuring that these quality/safety checks were met.

The final version of this protocol/checklist (Fig. 1) was tested in the final simulated session, approved by all members of the team, and placed in effect as the protocol for clinical use in real patients receiving HDR-IORT.

View larger version (33K): [in this window] [in a new window]   Figure 1. Multidisciplinary safety checklist and protocol. Example of a multidisciplinary safety checklist to facilitate the safe delivery of high-dose-rate intraoperative radiation therapy by any caregiver, even those unfamiliar with the procedure.

EFFICACY/EFFECTIVENESS OF THIS APPROACH

Since the development and testing of the process, HDR-IORT has been applied to eight real patients: three had prostate cancer, two underwent pelvic exenteration for gynecologic tumors, two underwent therapy for radial sarcoma (orthopedic surgery), and one underwent treatment for bladder cancer. The mean age was 60 yr (sd, 19). The mean duration of these procedures was 636 min (sd, 317), and the mean time of radiation exposure was 34 min (sd, 24). The longest radiation exposure was 79 min in 1 of the patients with pelvic gynecologic tumors. All patients received general endotracheal anesthesia and inhaled anesthesia during the application of the radiation therapy. Radiation application was not aborted in any of these cases because of unplanned events or complications. No adverse events were recorded by the investigators (L.M. and L.W.) or the actual anesthesia providers during the procedure or during the immediate postoperative time. All checklists were completed during the cases and all practitioners found them very useful. Only two cases were performed by anesthesiologists who were involved in the development and testing of the process.

DISCUSSION

Patient safety has become an integral part of the delivery of healthcare. Despite the publicity and concerns raised after the IOM report,1 it is not clear if our patients are safer now than they were when the report was published.2,28 The literature contains multiple recent examples of outcomes being improved through reactive changes in healthcare practices: prevention of catheter-related bloodstream infections, prevention of wrong-side surgery, introduction of medication reconciliation tools, etc.29–34

Relatively little work has been published concerning how to achieve safer practices by implementing processes that proactively mitigate risks to our patients. One such program is an initiative for proactive risk analysis by the Department of Veteran Affairs, which uses Failure Mode and Effects Analysis (FMEA).35 The FMEA is a proactive error-prevention system designed to identify problems in systems before any adverse events occur.36,37 This methodology has been used for reducing errors in medication administration,38–40 blood transfusion,41 and clinical laboratories.42 However, the application of FMEA in health care delivery is limited.

The IOM report also prompted the Senate Committee on Appropriations to direct the Agency for Healthcare Research and Quality (AHRQ) to lead the national effort to combat medical errors and improve patient safety. One AHRQ initiative has been to identify risks, hazards, and causes of patient injury associated with the delivery of health care. In particular, the introduction of technologies and processes into clinical care also introduces the possibility of new threats and unintended consequences. AHRQ is also interested in identifying and evaluating effective patient safety practices that eliminate or mitigate the effects of medical errors and system-related risks.

We describe a new process that allowed us to prospectively identify and mitigate hazards related to the introduction of a new surgical procedure. The purpose of this process was twofold1: develop a process that would allow us to safely introduce an unfamiliar procedure (HDR-IORT), and2 develop a generalizable conceptual framework for identifying potential patient risks that could be implemented in multiple clinical areas, both prospectively (to introduce new techniques/procedures) and retrospectively (to address existing defective systems). This process is novel because it does not capture systems errors in clinical practices; rather, it identifies potential errors in a proposed new clinical practice and, as a result, a process was designed entirely from a simulated scenario. By conducting in situ simulation in the same location where actual care takes place, using the same resources and involving actual health-care team members and existing processes, we believe that we provided as near-real an experience as possible. Although the level of situational awareness was not formally captured, during the debriefing sessions we assessed the vigilance of physiologic derangements and the perceptions and reactions of the team members to potential risks/threats during the simulated activity. Although not strictly necessary for a process such as the one that we describe, simulation adds realism to facilitate testing the system. The AHRQ stated that "simulation can complement other organizational change methods to facilitate adoption and implementation of new technologies or best practices."43 In some clinical environments, simulation may be essential for detecting hazards that otherwise might not be found simply by theorizing about the treatment delivery process. In some instances, the concerns revealed in the premortem may be distinct from the actual clinical hazards identified when simulating the process. For example, in our case, the concerns that resulted from the premortem were very general, and thus difficult to act on. However, the defects and hazards identified by simulating the process were specific and allowed for very concrete interventions (e.g., the best way to monitor the patient and orient the cameras, the most effective way to administer medications, and how to create a specific protocol to test for the presence of radiation in the OR). We also found that simulating the process became an important mechanism for testing and implementing changes to the system and actively engaging the team in designing a safe care delivery process.

We realized that the lessons learned during a process are richer and useful only if a tool is created that allows its consistent application. Checklists are used extensively to create independent redundancies for key steps in any process, and their use in aviation has been associated with the reduction of human error and improvement of outcomes. There have been checklists in health care for a few years (e.g., American Society of Anesthesiologists Recommendations for Preanesthesia Checkout Procedures). Recently, interest has increased in understanding the relationship between the implementation of checklists and risk management and patient safety.44–50 At our institution, checklists have been successfully applied in clinical practice to improve quality of care and outcomes.51,52

LIMITATIONS

Our process is novel, however it has several potential limitations. Simulation is a costly tool that requires resources, equipment, and trained personnel to run the scenarios (approximately 12 h, or approximately 170 man hours, were devoted by our team members to create and test the process). Moreover, using simulation as an in situ training process requires blocking of actual OR time that could be used to provide care for real patients, and using real care providers (nurses, physicians, etc.) represents an additional cost. We have not conducted a cost analysis for this project. However, the face validity and the potential savings in terms of injury avoidance for the patient and shorter hospital stays are worthy of consideration for further study.

Another possible limitation of this work is the potential lack of support by the institutions to allow the development and testing of such efforts. Moreover, the establishment of a multidisciplinary process requires the convergence of multiple departments with completely different agendas. This alone is one of the major challenges faced in the world of patient safety. In our case, the leadership of the hospital and the departments involved in the project were very active in developing safety efforts. We presented this project to our institutional leadership and provided them with regular progress updates. It is clear that a crucial aspect in succeeding with such projects is that they be multidisciplinary efforts that involve all possible stakeholders, as well as senior executives.53

Another limitation relates to the generalizability of this process. The entire project was developed with the objective of making the process as generalizable as possible so that it could be used in other domains, as long as the same principles were applied. We are currently testing this process in other perioperative and clinical care areas (such as interventional pulmonology).

CONCLUSION

The methodology presented in this paper for introducing a new procedure has been successful in achieving the goal of minimizing patient risk by decreasing the percentage of defects per hazard. We developed a process that allowed us to identify and address hazards and change the system before exposing patients to the potential risks. This model may be applied to any old or new process that involves team interaction and for which training and preparation may decrease defects and improve patient safety. The structured process proactively identified hazards and tested the care system before patient exposure. Such a multidisciplinary, systematic, and proactive approach is rare in health care. This approach and the replication of the environment and the conditions in which processes occur, via in situ simulation, greatly facilitates proactive risk management inpatient care. Moreover, standardization of practice, detection of defects, and correction of defects before patient exposure results in familiarity and comfort of the team members with a new and totally unfamiliar technique and produces a cultural change with great potential to affect outcomes. This improves teamwork and communication among various specialties, with the overarching goal of improving patient safety.

Footnotes

Accepted for publication August 27, 2008.

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