A practical framework for patient care teams to prospectively identify and mitigate clinical hazards.

BACKGROUND: One of the greatest challenges facing both practitioners and risk managers is the identification of previously unknown clinical hazards and defects. With the rapid proliferation of new health care services, unknown hazards may propagate as new therapies are integrated into the existing health care system. The main goal of risk analysis is to make these hazards visible by proactively searching and probing the system. Yet, a comprehensive approach by which to safely integrate new therapies into the existing clinical environment has yet to be clearly articulated. Patient care teams can use the proposed framework when introducing new therapies. A PRACTICAL FRAMEWORK: The framework includes a background investigation and literature search; an in situ simulation (in the actual clinical setting used for patients); a Failure Mode and Effects Analysis to determine the severity, probability, and risk of the potential hazards; and a multidisciplinary protocol and safety checklist to standardize practice and ensure provider accountability. CASE EXAMPLES: Application of this framework to three operative scenarios--intraoperative radiation therapy (IORT), hyperthermic intraperitoneal chemotherapy (HIPEC), and an interventional pulmonology program--demonstrates its flexibility. Its use prospectively identified and mitigated 20 IORT, 5 HIPEC, and 18 interventional pulmonology hazards/defects. Subsequent patient cases were largely uneventful. All cases and patient safety reporting systems are monitored to identify any new defects in an effort to continuously improve patient care. CONCLUSION: The use of a comprehensive framework to identify and mitigate hazards in an on-site simulated environment promotes safer care for target patient populations; results in familiarity with procedures, amelioration of staff concerns, and standardization of practice; and facilitates teamwork and communication.

A novel process for introducing a new intraoperative program: a multidisciplinary paradigm for mitigating hazards and improving patient safety.

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.

Prevention of catheter-related bloodstream infections.

CRBSIs are expensive, prevalent, and often fatal complications. In the past few years, several preventive interventions have been applied with excellent results toward decreasing CRBSIs. Studies show that most CRBSIs are preventable; therefore, health care organizations should strive to substantially reduce if not eliminate them. In addition to being a measure of quality of care, reducing infections will soon be a bottom-line issue, given that the Centers for Medicare and Medicaid Services announced its decision to cease paying hospitals from October 2008 for some care necessitated by "preventable complications", including CRBSIs. Therefore, health care facilities that do not make the necessary adjustments to improve the quality of their patient care and avoid harm may be economically penalized. This article reviews the available evidence on and possible barriers to the widespread use of preventive strategies. The health care community has struggled to build a culture that can eliminate the barriers obstructing high-quality care. These new approaches must facilitate collaboration among caregivers. During the past few years, much effort has been dedicated to researching causes for inadequate patient care and executing interventions to improve processes of care; only now are projects beginning to focus on evaluating whether patients are safer. This article discusses the prevention of CRBSIs and shows that substantial reductions in the rate of these infections are possible. It is no longer acceptable for health care organizations to have the goal of being at the CDC mean for rate of infections; they should strive to substantially reduce or even eliminate them. Patients deserve no less.