(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
Interpretive Guidelines: §416.43
The QAPI CfC requires an ASC to take a proactive, comprehensive and ongoing approach to improving the quality and safety of the surgical services it delivers. The QAPI CfC presumes that ASCs employ a systems approach to evaluating their systems and processes, identifying problems that have occurred or that potentially might result from the ASC's practices and getting to root causes of problems rather than just superficially addressing one problem at a time.
From a survey perspective, the focus of the QAPI condition is not on whether an ASC has any deficient practices, but rather on whether it has an effective, ongoing system in place for identifying problematic events, policies, or practices and taking actions to remedy them, and then following up on these remedial actions to determine if they were effective in improving performance and quality. QAPI programs work best in an environment that fixes problems rather than assigning blame.
For surveyors this can sometimes pose difficult challenges, because it requires a balancing act. ASCs are not relieved of their obligation to comply with all Medicare CfCs, and surveyors are obligated when they find evidence of violations of a CfC to cite accordingly. However, surveyors generally should avoid using the ASC's own QAPI program data and analyses as evidence of violations of other CfCs. For example, an ASC that identifies problems with infection control through its QAPI program and takes effective actions to reduce the potential for transmission of infection would be taking actions consistent with the QAPI CfC. Absent evidence independently collected by the surveyors of current noncompliance with the infection control CfC, it would not be appropriate for surveyors to use the infection control information in the hospital's QAPI program as evidence of violations of the infection control CfC. There can be egregious cases under investigation where it might be appropriate to use QAPI program information as evidence of a deficiency, but these cases should be the exception rather than the rule.
CMS does not prescribe a particular QAPI program; it provides each ASC with the flexibility to develop its own program. Each program must, however, satisfy the regulatory criteria:
When there is a team surveying the ASC, survey of the QAPI Condition should be coordinated by one surveyor.
(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
(1) The program must include, but not be limited to, an ongoing program that demonstrates measurable improvement in patient health outcomes, and improves patient safety by using quality indicators or performance measures associated with improved health outcomes and by the identification and reduction of medical errors.
(2) The ASC must measure, analyze, and track quality indicators, adverse patient events, infection control and other aspects of performance that includes care and services furnished in the ASC.
There are a variety of types of indicators that are currently in use for measuring and improving quality of healthcare. This is also a rapidly changing field, as interest and research in patient safety and healthcare quality measurement grows. As a result of a recommendation of a 1998 Presidential Advisory Commission, the National Quality Forum (NQF), a public-private not-for-profit membership organization, was created in 1999 to develop and implement a national strategy for healthcare quality measurement and reporting. Since then NQF has developed detailed recommendations for ways to promote and measure quality and patient safety, including in ASCs. The federal Agency for Healthcare Quality and Research (AHRQ) supports research assessing the effectiveness of care practices and procedures. A number of other organizations are also active in the field of healthcare quality improvement and patient safety. As a result, ASCs have many choices of indicators to use.
Indicators can be broken down into several types:
- Outcomes Indicators measure results of care; typical outcomes measures include risk-adjusted mortality rates, complication rates, healthcare-associated infection rates, length of stay, readmission rates, etc. In the ASC setting, outcomes measures might focus on things like complication rates, healthcare-associated infection rates, cases exceeding 24 hours, transfers to hospitals, wrong site surgeries, etc.
- Process of Care Indicators measure how often the standard of care was met for patients with a diagnosis related to that standard. For example, in the ASC setting, measures might focus on the administration and time of prophylactic antibiotics.
- Patient Perception Indicators measure a patient's experience of the care he/she received in the ASC. AHRQ sponsored development of one patient experience of care instrument, H-CAHPS, that CMS now uses in reporting on hospital quality. There may be similar patient survey instruments that could be used in the ASC setting.
The regulation at §416.43(a) requires that an ASC's QAPI program must improve both patient health outcomes and patient safety in the ASC. In order to achieve these goals, the ASC's QAPI program must:
- 1. Be ongoing - i.e., the program is a continuing one, not just a one-time effort or occasional effort. Evidence that the ASC's program is ongoing would include, for example, collection by the ASC of quality data at regular intervals; analysis of the updated data at regular intervals; and updated records of actions taken to address quality problems identified in the analyses, as well as new data collection to determine if the corrective actions were effective.
- 2. Use quality indicators or performance measures associated with improved health outcomes in a surgical setting. The quality and safety indicators available differ in terms of the weight and type of evidence for their effectiveness in measuring quality. For some indicators there is compelling peer-reviewed research of an association with improved health outcomes. For others, typically process of care indicators, consensus among experts in the field suggests a strong association with improved quality of care. Indicators also differ in terms of how the data is collected, and how frequently the data should be collected.
For example, measures of how quickly an ASC produces error-free billing claims, while relevant to the ASC's financial performance and of interest to ASC governing bodies, have no direct relationship to the quality of care the ASC provides. On the other hand, a measure of the frequency with which the ASC administers antibiotic prophylaxis consistent with generally accepted standards of care would be related to improved health outcomes, i.e., prevention of surgical site infections. Likewise, an ASC could choose to collect data measuring its compliance with applicable National Quality Forum Safe Practices, or with applicable Centers for Disease Control and Prevention (CDC) infection control guidelines, or with guidelines issued by national professional societies, such as the American College of Surgeons, or with recommended practices developed by national accreditation organizations or other organizations specializing in healthcare quality improvement, such as the Institute for Healthcare Improvement. CMS does not prescribe a certain set of indicators/measures for ASCs to use, but ASCs must be able to demonstrate that the indicators they are tracking will enable them to improve outcomes for ASC patients.
The regulations at §416.43(c)(1) also require the ASC to set priorities in choosing its quality indicators/measures, because what is measured will determine where the ASC focuses its efforts to make changes that improve performance. For example, if the ASC does not track measures related to infection control, it will not be in a position to determine whether or not its infection control program is working well or poorly, and thus will not be in a position to improve it.
The ASC is required to focus on high risk, high volume, and problem-prone areas. It is required to consider, when selecting the measures/indicators that will shape its improvement activities in these areas, the following:
The incidence, i.e., the rate or frequency at which problems occur in the ASC related to area measured by the indicator. "Incidence" is a technical term used in epidemiology, referring to the frequency with which something, such as a disease, appears in a particular population or area. In disease epidemiology, the incidence is the number of newly diagnosed cases during a specific time period. Applying this concept in the ASC setting, as an example, the annual incidence of surgical site infections in an ASC would be the rate that results when dividing the number of such infections that occurred in a calendar year by the total number of surgical cases in the ASC during that same year. Likewise, the annual incidence of emergency transfers to a hospital would be the rate that results when dividing the number of such transfers by the total number of surgical cases during the same year;
The prevalence, i.e., how widespread something is in an ASC at a given point in time. "Prevalence" is also a technical term used in epidemiology, and is a statistical concept referring to the number of cases of a disease that are present in a particular population at a given time. In an ASC setting, for example, it would make little sense to employ measures related to prevalence of pressure ulcers among ASC patients, since the limited amount of time a patient typically spends in an ASC makes it unlikely that the ASC's care processes contributes to pressure ulcers. On the other hand a more appropriate measure might be periodic observation of the hand hygiene practices of all staff providing direct patient care, in order to assess the prevalence of good versus deficient practices; and
The severity of problems. For example, any single instance of a transfer of a patient to a hospital represents a serious adverse, unplanned outcome of the surgical procedure, and it would be appropriate for an ASC to track and evaluate all such cases, due to their severity, even if they are low volume incidents.
Once having identified the quality indicators it will use, the ASC must collect and analyze data on these indicators.
"An error is defined as the failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning)."
"An adverse event is an injury caused by medical management rather than the underlying condition of the patient."
"An adverse event attributable to error is a preventable adverse event."
Using these definitions, if an ASC performing orthopedic procedures operates on the right shoulder of a patient with a left shoulder rotator cuff injury requiring surgery, then the ASC has committed an error. The patient suffered an adverse event - i.e., the harm to the patient of undergoing surgery on the wrong shoulder, and presumably having to undergo yet another surgery on the correct shoulder. Because the ASC's error resulted in the adverse event, it is a preventable adverse event that could and should have been avoided.
Not every adverse event is the result of an error. For example, the standard of practice might call for use of a particular medication when certain indications are present. A patient might have an allergy to that medication that is unknown to the patient and the patient's physicians. The patient develops an allergic reaction to the medication, requiring further medical intervention to counteract the reaction. Due to the unknown nature of the patient's allergy, there was no error, even though there was an injury resulting from medical management. On the other hand, if the allergy had been documented in the patient's medical record and the medication had been administered anyway, this would constitute an error.
Not every error results in an adverse event; for example, an ASC with two operating rooms might mix up the records of two ASC patients scheduled to have the same orthopedic procedure, e.g., foot surgery, on the same date, but on the opposite feet. This is an error. But the ASC employs a time-out procedure to verify the identity of the patients and site of the surgery and recognizes the error before surgery begins. The error did not result in an adverse event, but it was a near miss.
ASCs must track all patient adverse events, in order to determine through subsequent analysis whether they were the result of errors that should have been preventable, to reduce the likelihood of such events in the future. ASCs are also expected to identify errors that result in near misses, since such errors have the potential to cause future adverse events.
ASCs seeking initial enrollment in the Medicare program are unlikely to have collected extensive data for their QAPI program indicators, since they likely have been in operation for a relatively brief period of time. Nevertheless, these initial applicants must have a QAPI program in place, and must be able to describe how the program functions, including which indicators/measures are being tracked, at what intervals, and how the information will be used by the ASC to improve quality and safety.
The following information is based on the National Quality Forum's (NQF) consensus standards for ASCs, and is provided only as an illustration of several types of measures an ASC might choose to include in its QAPI program. An ASC is free to use different measures, so long as the measures it chooses meets the regulatory criteria. ASCs are also expected to develop additional measures related to infection control, for example to enable it to comply with the requirement at §416.51(b)(2) for its infection control program to be integrated into its QAPI program, and at §416.44(a)(3) to have a program to identify healthcare associated infections and report diseases as required under State law. Depending on the individual characteristics of the ASC, including problems it had experienced in the past, it may be necessary to track other additional indicators as well.
More information on these and other NQF ASC measures is available on the National Quality Forum site: http://www.qualityforum.org/Projects/a-b/Ambulatory_Care,_Standardizing_(2004)/Ambulatory_Care_Performance_Measures_Overview.aspx
- Patient Burn - Percentage of ASC admissions experiencing a burn prior to discharge. Approximately 100 surgical fires occur each year nationally, in all surgical settings, with about 20 resulting in serious injuries to patients.
- Prophylactic Intravenous Antibiotic Timing - Percentage of ASC patients who received appropriate antibiotics ordered for surgical site infection prophylaxis on time.
- Hospital Transfer/Admission - Percentage of ASC admissions requiring a hospital transfer or hospital admission prior to being discharged from the ASC.
- Patient Fall - Percentage of ASC admissions experiencing a fall in the ASC.
- Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant - Percentage of ASC admissions experiencing a wrong site, wrong side, wrong patient, wrong procedure, or wrong implant.
1P. 28, ToErr is Human, Institute of Medicine, November, 1999.
(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
(2) Performance improvement activities must track adverse patient events, examine their causes, implement improvements, and ensure that improvements are sustained over time.
(3) The ASC must implement preventive strategies throughout the facility targeting adverse patient events and ensure that all staff are familiar with these strategies.
Active Data Collection
The ASC must not only have identified a number of indicators or measures of quality and patient safety, but it must actively collect data related to those measures at the intervals called for by its QAPI program. Staff responsible for collection of the data should be trained in appropriate techniques to collect and maintain the data.
Once having collected the data, the ASC must analyze it to monitor ASC performance, i.e., to determine what the data suggests about the ASC's quality of care and the effectiveness and safety of its services. Analysis must take place at regular intervals, in order to avoid too much time elapsing before the ASC is able to detect problem areas. In the case of data related to adverse events, the ASC must use the data to analyze the cause(s) of the adverse events. Data collection and analysis must be conducted by personnel with appropriate qualifications to collect and interpret quantitative data. CMS does not expect ASCs to engage in sophisticated statistical modeling of data, but calculation of incidence rates should be within the skill set of individual(s) conducting the analysis. On the other hand, CMS does expect ASCs to conduct thorough analyses that focus on systemic issues. For example, if the ASC's adverse event tracking system identifies a medication error that resulted in serious injury to a patient, the ASC would not be taking the type of systems approach mandated under the QAPI regulations if it states that the event was caused by the staff member who administered the medication incorrectly, and that its method for improving performance was to fire that staff member. An acceptable analysis would look at the root causes that facilitated the error by the staff member: Were medications stored in a manner that increased the possibility of error? Were the physician's orders clearly written? Was the staff member appropriately trained? Is there any evidence of similar errors made by other staff members, including errors that did not result in adverse events? There are probably additional issues that should be investigated in order to fully understand the causes of the adverse event. Once there is a thorough analysis of these causes, the ASC would then be in a better position to identify improvement strategies that are appropriately designed to address the underlying causes.
The ASC may choose to use contractors for technical aspects of the QAPI program, including analysis of data, but the ASC is also expected to actively involve ASC staff in the program and the ASC's leadership retains the responsibility for the ongoing management of the program, even when a contractor is used.
Analysis of the monitoring data must be used to identify areas where there is room for improvement in the ASC's performance, as well as follow-up actions taken to improve performance. A good monitoring system, even in a good ASC surgical program, is likely to always find some areas of performance that are weaker than others. These identified areas of weakness present opportunities for the ASC to make changes in its systems, policies or procedures that result in improved patient care.
Implement Improvements/Preventive Strategies
Once the ASC's analysis of its data has identified opportunities for improvement, the ASC must develop specific changes in its policies, procedures, equipment, etc., as applicable, to accomplish improvements in the identified areas of weakness. In particular, an ASC must implement preventive strategies designed to reduce the likelihood of adverse events throughout the ASC. For example, if an ASC has three operating or procedure rooms, and it has an adverse event in a case in one of these rooms that is attributable in part to a confusing storage of emergency medications, the ASC should review the set up in each of the rooms to ensure that the same problem does not occur elsewhere.
The ASC must also have a method to ensure that the improvements it makes are sustained over time. For example, if an ASC's QAPI program identifies problems with hand hygiene in ASC staff providing care to patients, the ASC must be able to demonstrate that whatever solution it adopted to address this problem continues to work over time. Generally this means that the ASC must collect data on indicators that measure staff hand hygiene on an ongoing basis.
The ASC is required to make all staff aware of the strategies it has adopted for prevention of adverse events. For example, all staff who are involved in the preparation of a patient for the surgical procedure, as well as in the 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.
(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
(1) The number and scope of distinct improvement projects conducted annually must reflect the scope and complexity of the ASC's services and operations.
(2) The ASC must document the projects that are being conducted. The documentation, at a minimum, must include the reason(s) for implementing 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.
(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
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 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;
- Is actually implemented, with written evidence of this implementation, as well as evidence of knowledge of the program by the ASC's staff;
- Is implemented on an ongoing basis;
- Employs quality and patient safety indicators that reflect appropriate prioritization, as required by §416.43(c);
- Describes in detail the indicator data to be collected, how it will be collected, how frequently it will be collected;
- Uses the data collected and analyzed to improve the ASC's performance;
- Evaluates changes designed to improve the ASC's performance to determine whether they are effective, and takes appropriate actions to make further 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.