Patient Safety Framework for Mitigating Risk in Interventional Radiology RECOMMENDATIONS OF THE INTERVENTIONAL RADIOLOGY TASK FORCE Created: 2017 TABLE OF CONTENTS Executive Summary ........................................................................... 1 Introduction ..................................................................................... 3 Definitions .......................................................................................4 1. Introduction of New/Rare Procedures/Technologies ........................ 5 2. Pre-assessment & Clinical Decision-making ................................. 6 3. Staffing ....................................................................................... 9 4. Communications & Hand-Offs ................................................... 10 5. Production Issues ........................................................................12 6. Institutional & Executive Leadership Issues ..................................13 7. Emerging Issue: Hybrid Rooms .................................................... 15 Appendix: Interventional Radiology WHO Safety Checklist .................... 16 ABOUT THIS DOCUMENT The recommendations for Patient Safety Framework for Mitigating Risk in Interventional Radiology were developed under the auspices of the Academic Medical Center Patient Safety Organization (AMC PSO) Interventional Radiology Task Force. These consensus recommendations are for informational purposes only and should not be construed or relied upon as a standard of care. The AMC PSO recommends institutions review these guidelines and accept, modify or reject these recommendations based on their own resources and patient populations. Additionally, institutions should continue to review and modify these recommendations as the field continues to evolve. ©2017 Academic Medical Center Patient Safety Organization (AMC PSO), a component patient safety organization within The Risk Management Foundation of the Harvard Medical Institutions Incorporated AMC PSO | INTERVENTIONAL RADIOLOGY EXECUTIVE SUMMARY A 65-year-old male was admitted for treatment of lymphoma. On hospital day 5, the patient developed an acute change in mental status that worsened over the day; he was unable to tolerate a lumbar puncture at the bedside. In Interventional Radiology (IR), the patient required incremental doses of Ativan for the management of his altered mental status and acute agitation. The incremental doses of medication were obtained from the inpatient unit, but administered by the IR nurse. The patient arrested and expired during the procedure. In an effort to proactively address emerging risks The Task Force began with a review of the latest literature, associated with changes in healthcare delivery, the scientific evidence, guidance documents and opinion Academic Medical Center Patient Safety Organization statements from relevant sources. Further insights were (AMC PSO) convened the Interventional Radiology Task gathered from AMC PSO member subject matter experts Force to arrive at a set of literature-supported, consensus- from Interventional Radiology, Anesthesiology, Nursing, based patient safety guidelines for considerations for medical trainees, risk management, and patient safety. Interventional Radiology procedures. What follows is a document that reflects the aim, mission With advancements in technology and minimally invasive and consensus opinion of the Task Force. It offers approaches to interventional procedures, procedural guidance for patient safety experts in their efforts to areas such as interventional radiology suites, cardiac provide the safest possible care to patients. catheterization labs and endoscopy units effectively function as satellite operating rooms. Opportunities exist to align and standardize practice to reflect this evolution. © 2017 AMC PSO 1 AMC PSO | INTERVENTIONAL RADIOLOGY INTRODUCTION Procedural areas are high volume, diverse, fast-paced units that are rapidly growing due to advances in technology and the increased demand for outpatient and non-surgical treatments. Common ambulatory procedural areas include occurring outside of an operating room. Claims ranged endoscopy suites, cardiac catheterization laboratories, substantially in severity from death and serious injury pain management clinics, radiology suites, as well as to more minor events, such as intravenous infiltration. clinic-based procedural areas found in dermatology, Lack of communication was identified as a major theme rheumatology, and orthopedic clinics. Traditionally, in this analysis. On detailed review, some events were these areas are administered and managed by individual preventable. A lack of consistent safety practices in diverse departments with no central coordination and limited areas responsible for invasive procedures was also noted. multidisciplinary oversight in the hospital, making a The increase in patient risk in procedural areas stems from review of unanticipated events, shared learning, and multiple issues, including increases in patient-related implementation of improvement or corrective action factors/patient acuity, staff training and education, remote extremely challenging. The lack of centralized governance settings, production pressure and emphasis on efficiency. for procedural areas thus creates a serious problem There is an increase in ‘low risk’ procedures being when attempting to create standardized protocols and performed on high-risk patients. In addition, unlike most training opportunities aimed at reducing risk. The lack surgeons and anesthesiologists in operating rooms, staff of centralization also reinforces the misconception that in procedural areas are less likely to have had significant procedures in non-operating room locations must be less team-based safety training. Also, many procedural risky, and do not need the same strict safety protocols physicians are highly specialized and routinely perform and oversight as the operating rooms. Studies have high-risk procedures, but may have limited experience or demonstrated the heightened risk of an adverse event expertise in ‘crisis’ management or utilizing team resources occurring in remote procedure areas. in the event of a serious or life-threatening event. In busy The 2013 CRICO benchmarking report (Malpractice ambulatory procedural areas, procedures may be inherently Risks of Routine Medical Procedures) provided a detailed lower risk, but the volume can be staggering, adding to the account of malpractice litigation related to procedures complexity of delivering safe care. © 2017 AMC PSO 3 AMC PSO | INTERVENTIONAL RADIOLOGY DEFINITIONS Hybrid Room A multipurpose procedural suite jointly accessed by both IR and surgical teams and specifically designed for use as both an OR and interventional procedure room. Warm Handoff A verbal exchange of patient care information between two members of the health care team that occurs during transitions of care, allowing for synopsis and verbal confirmation by the receiver. © 2017 AMC PSO 4 AMC PSO | INTERVENTIONAL RADIOLOGY 1 Introduction of New/Rare Procedures/Technologies CONSIDERATIONS RECOMMENDATIONS • A lack of systems to introduce new and evolving Evaluate the effectiveness of organizational procedures or technologies to the organization and to structures to provide oversight of new procedures and key stakeholders can increase risk. technologies (or variations of established procedures) and to facilitate multidisciplinary input, education and • Anesthesiologists and key care team members may review as they are introduced. (i.e., opportunities may be unfamiliar with the risks associated with new or exist for expanded education and communication). established procedures. Potential approaches include: • Missed opportunities may exist to adequately assess { Charter a multidisciplinary committee to oversee associated monitoring, sedation, training and oversight the introduction of new/adapted procedures/ requirements. technologies. • There are risks associated with the increased morbidity and complexity of patients. { Review credentialing and privileging processes. Credentialing should be guided by patient safety and quality improvement principles in this area. { Define what is considered a “new” procedure vs. a “variation” of an established procedure. • Consider the creation of an expedited process for variations on a similar procedure. • Consider the creation of a pathway for urgent procedures that require expedited approval (include how to address orientation of staff). © 2017 AMC PSO 5 AMC PSO | INTERVENTIONAL RADIOLOGY 2 Pre-assessment & Clinical Decision-making CONSIDERATIONS RECOMMENDATIONS • Who requests the procedure? { Establish a multidisciplinary process for IR, Anesthesiology and Intensive Care Unit (ICU) - Is the procedure appropriate for the patient and leadership to develop standards for sedation and/or condition? anesthesia planning and monitoring in IR. - Is there clarity on what the procedure involves? { Collaborate with Nursing, Anesthesiology and ICU - Are the comorbidities and stability of the patient leadership to develop a standard approach to the considered? support of a patient’s sedation and/or anesthesia - Has the urgency of the procedure been assessed? and related monitoring needs by ensuring the - Does the patient or health care proxy understand the availability of appropriately trained providers. risks, benefits, and nature of the procedure, including • Empower team members. alternative treatments? • Use escalation protocols to activate