This story was written by Carla Daley Shehata, RN, BSN, vice president of operations for Regent Surgical Health.
With the implementation of the Center for Medicare and Medicaid Services 2009 Conditions for Coverage, numerous new standards were mandated for ASCs to follow in order to maintain compliance. In recent surveys, the surveyors have seemed to focus on five key areas.
These five areas are: Governing Body and Management (416.41), Quality Assessment and Performance Improvement (416.43), Environment (416.44),Infection Control (416.51), and the Safe Surgical Checklist (mandated by CMS as of January 2012). Even though we will be focusing on these five areas, it is important to remember that ASCs must follow all standards within the Conditions for Coverage in order to be compliant with CMS.
1. Governing body responsibility. CMS has mandated that the governing body retains the ultimate responsibility for the overall operations of the ASC. It's important that the governing body understand exactly what this means and provide sufficient evidence this is happening within the facility. The surveyor will generally use two methods to ensure the ASC is following these standards: auditing board meeting minutes and looking at facility policies. The regulation particularly stresses the responsibility of the governing body for the following:
• Accountability for the quality assessment and performance improvement program
• The quality of the ASC's healthcare services
• The safety of the ASC's environment
• Development and maintenance of the disaster preparedness plan
2. Ongoing quality assessment and performance improvement. Quality assessment and performance improvement must be proven to be ongoing and data driven. CMS does not mandate how the QAPI program is established; it gives the ASC the flexibility to design its own program. In order to satisfy the regulatory conditions, the program must be proven to be ongoing, in that it is continuing and not a "one-time" effort. The surveyor will look to see whether the QAPI program collects quality data at regular intervals to be analyzed and updated frequently, as well as whether necessary corrective action(s) is(are) taken and proven to be effective.
The program must also be data-driven, in that it must identify in a methodical manner what and how data will be collected. Standard 416.43(c) states that the PI program activities must focus on high-risk, high-volume, and problem-prone areas.
3. Environment. Providing a safe, functional and sanitary environment is another issue that CMS is focusing on. In order to ensure that the ASC is compliant, the surveyor will look at infection prevention and control, fire safety, emergency equipment and emergency personnel. There have been many surveyors trained specifically in life safety, and they use their training to ensure that the facility is compliant in providing a safe physical environment.
4. Infection control. Infection control has become even more crucial to the ASC industry since the implementation of the standards in the 2009 Conditions for Coverage. Within the topic of infection control, CMS will be inspecting to ensure the ASC has an infection control program that minimizes infections and communicable diseases and maintains a sanitary environment. CMS will also be checking to ensure that there a designated qualified professional with infection control training leading the facility's infection control program.
5. Safe surgical checklist. In January of this year, CMS mandated that the ASC create and implement the use of a Safe Surgical Checklist. CMS has not been authoritarian in how this is accomplished and currently uses the World Health Organization checklist as an example.
The issues mentioned in this article will not change anytime in the near future, but CMS' focus on these five areas will increase, starting with the advent of required quality reporting in October 2012.
Learn more about Regent Surgical Health.
With the implementation of the Center for Medicare and Medicaid Services 2009 Conditions for Coverage, numerous new standards were mandated for ASCs to follow in order to maintain compliance. In recent surveys, the surveyors have seemed to focus on five key areas.
These five areas are: Governing Body and Management (416.41), Quality Assessment and Performance Improvement (416.43), Environment (416.44),Infection Control (416.51), and the Safe Surgical Checklist (mandated by CMS as of January 2012). Even though we will be focusing on these five areas, it is important to remember that ASCs must follow all standards within the Conditions for Coverage in order to be compliant with CMS.
1. Governing body responsibility. CMS has mandated that the governing body retains the ultimate responsibility for the overall operations of the ASC. It's important that the governing body understand exactly what this means and provide sufficient evidence this is happening within the facility. The surveyor will generally use two methods to ensure the ASC is following these standards: auditing board meeting minutes and looking at facility policies. The regulation particularly stresses the responsibility of the governing body for the following:
• Accountability for the quality assessment and performance improvement program
• The quality of the ASC's healthcare services
• The safety of the ASC's environment
• Development and maintenance of the disaster preparedness plan
2. Ongoing quality assessment and performance improvement. Quality assessment and performance improvement must be proven to be ongoing and data driven. CMS does not mandate how the QAPI program is established; it gives the ASC the flexibility to design its own program. In order to satisfy the regulatory conditions, the program must be proven to be ongoing, in that it is continuing and not a "one-time" effort. The surveyor will look to see whether the QAPI program collects quality data at regular intervals to be analyzed and updated frequently, as well as whether necessary corrective action(s) is(are) taken and proven to be effective.
The program must also be data-driven, in that it must identify in a methodical manner what and how data will be collected. Standard 416.43(c) states that the PI program activities must focus on high-risk, high-volume, and problem-prone areas.
3. Environment. Providing a safe, functional and sanitary environment is another issue that CMS is focusing on. In order to ensure that the ASC is compliant, the surveyor will look at infection prevention and control, fire safety, emergency equipment and emergency personnel. There have been many surveyors trained specifically in life safety, and they use their training to ensure that the facility is compliant in providing a safe physical environment.
4. Infection control. Infection control has become even more crucial to the ASC industry since the implementation of the standards in the 2009 Conditions for Coverage. Within the topic of infection control, CMS will be inspecting to ensure the ASC has an infection control program that minimizes infections and communicable diseases and maintains a sanitary environment. CMS will also be checking to ensure that there a designated qualified professional with infection control training leading the facility's infection control program.
5. Safe surgical checklist. In January of this year, CMS mandated that the ASC create and implement the use of a Safe Surgical Checklist. CMS has not been authoritarian in how this is accomplished and currently uses the World Health Organization checklist as an example.
The issues mentioned in this article will not change anytime in the near future, but CMS' focus on these five areas will increase, starting with the advent of required quality reporting in October 2012.
Learn more about Regent Surgical Health.