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conduct of the surgical procedure, must be familiar with the ASC’s strategies for avoiding wrong patient, wrong site, wrong side, wrong procedure, wrong implant, and adverse surgical events. All staff involved in the preparation and administration of injectable medications should be aware of standard safe injection practices designed to avoid the transmission of infectious disease. Staff should be encouraged to ask questions when they observe a practice, or receive an order, etc. that they believe might compromise patient safety or quality of care in the ASC. Prospective ASC’s Applying for Initial Certification in Medicare A facility seeking initial certification as an ASC may not have been in operation long enough to demonstrate extensive data collection or the identification of opportunities for improvement based on the monitoring data. However, it must be able to show that it has an active data collection and analysis infrastructure in place as well as to indicate when it expects to have sufficient data to begin analysis and what procedures it has put in place to consider the results of QAPI program analyses. Ask the ASC who is responsible for the data col-lection and analysis, and what their qualifications are? In particular, ask the ASC how it determines the causes of adverse events – does the ASC stop with the immediate cause (staff error, equipment failure, etc.) or does it probe to discover the under-lying root causes of the adverse events? If ASC staff handle these duties, do they have education or training that equips them to conduct analyses of the data? Ask the ASC to provide examples of instances where it used QAPI data to identify opportunities for improving processes for providing care. Ask how it evaluated whether the improvements were effective a (2) The ASC must document the projects that are being conducted. The documentation, at a mini-mum, must include the reason(s) for implement-ing the project, and a description of the project’s results. Every ASC must undertake one or more specific quality improvement projects each year. Larger ASCs with multiple ORs or procedure rooms, multiple types of surgical procedures offered, or high volume of cases are expected to undertake more or more complex projects. Furthermore, a highly complex improvement project might be of such scope that it could reasonably be the only project an ASC undertakes in a given year. CMS does not specify particular projects that each ASC must undertake, but instead expects the projects to be based on the types of services the ASC furnishes, as well as other aspects of the ASC’s operations. The requirement for annual projects does not mean that an ASC may not undertake a complex project that is expected to require more than 1 year in order to be completed. The ASC must keep records on its performance improvement projects. Each project must, at a minimum, include an explanation of why the project was undertaken. The explanation must indicate what data collected in the ASC or based on recommendations of nationally recognized organizations leads the ASC to believe that the project’s activities will actually result in improvements in patient health outcomes and safety in the ASC. For projects that are still underway, the ASC must be able to explain what activities the project entails, and how the impact of the project is being monitored. Unless the project has just begun, the ASC must be able to provide evidence that it is collecting data that will enable it to assess the project’s effectiveness. For projects that are completed, the ASC must be able to show documentation that explains what the results of the project were, and what actions, if any, the ASC took in response to those results. Ask the ASC to show you documentation for performance improvement projects currently under-way, as well as those completed in the prior year. If a large, complex, or high volume ASC has only one project underway, is the scope of that project such that it is likely to have a significant impact on the ASC’s quality of care or patient safety? Does the ASC’s documentation indicate the ratio-nale for undertaking each project? Does the ASC have data indicating it had a problem in the area targeted for improvement, or could the ASC point to recommendations from a nationally recognized expert organization suggesting the activities? Does the documentation for the completed project(s) include the project’s results? If a project was unsuccessful, ask the ASC what actions it took as a result of that information. If the project was changes as needed; Is designed to establish clearly the governing body’s expectations that patient safety is a priority, not only by the tracking of all adverse events, but also by the program’s processes for analyzing and making changes in ASC operations to prevent future such events; and Has sufficient resources, i.e., the ASC’s governing body must allocate sufficient and qualified staff (including consultants), staff time, information systems and training to support the program. Given the great variety in size and complexity among ASCs, the extent of resources required will vary as well. However, the resources dedicated to the QAPI program must be commensurate with the ASC’s overall scope and complexity. The ASC must also be able to identify in detail the resources that it dedicates to the QAPI program. An ongoing, successful QAPI program requires the support and direction of the ASC’s leadership. This regulation makes clear CMS’ expectations that the ASC’s governing body must assume responsibility for all aspects of the design and implementation of every phase of the QAPI program. The governing body must assure that the ASC’s QAPI program:• Is defined, in writing, for example in the minutes of a meeting where the governing body established the program; Opioids play an important role in pain management—both in acute and chronic settings. Pre-scribing opioids safely is a laudable goal for healthcare providers, especially considering that 60 percent of Americans over age 65 seek relief from persistent pain. However, the dramatic increase in opioid use over the past few decades has resulted in an opioid-related epidemic of addiction and death. There has also been substantial misuse of opioids obtained by diversion—Poor outcomes related to opioids are a common cause of medical malpractice claims. The Doctors Company reviewed 1,770 claims that closed between 2007 and 2015 in which patient harm involved medication factors. In 272 of these claims (15 percent), the medications were narcotic analgesics. In the context of the current epidemic of opioid-related deaths occurring predominantly among outpatients (OPs), this analysis focused on claims arising in that setting, rather than on claims arisi g in an inpatient (IP) setting.11. Be aware of risk factors for opioid use in managing postoperative pain, particularly for respiratory depression in patients with diagnosed or suspected OSA, morbid obesity, COPD, heart disease, sedating drugs already in use, or those who use tobacco, are over 65 years old, have surgery with general anesthesia lasting more than six hours’ duration, or have surgery performed on airway, upper abdominal, or thoracic regions. In summary, it is possible to prescribe opioids responsibly and safely for patients with chronic pain who do not obtain sufficient relief and reasonable function with nonopioid treatment. However, to do so, it is necessary to have adequate knowledge of the pharmacology of opioids, risk factors, and side effects. Safe opioid prescribing requires thorough patient evaluation, attention to detail, and familiarity with guidelines and regulations. With a written medical record, it is important to create a suspense file or follow-up list for all ordered laboratory tests, imaging studies, diagnostic