Simione™ Healthcare Consultants

CLIMB THE LADDER OF SUCCESS WITH CoPs: Quality Assessment/Performance Improvement & Infection Prevention/Control

Part 3 of a 6-Part Series

This is the third of six updates in a series from Simione on the NEW Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (CoPs) for Home Health. These regulations are scheduled to take effect July 13, 2017.  Two of the most significant changes in the new CoPs include new requirements for Quality Assessment and Performance Improvement (QAPI) and Infection Prevention and Control:

  • QAPI (484.56): CMS requires a data-driven, agency-wide quality assessment and performance improvement program that continually evaluates and improves agency care for all patients.
    • These new QAPI provisions replace the former CoPs at 484.16 Group of Professional Personnel and 484.52 Evaluation of an Agency’s Program.
  • Infection Control (484.70): The new infection prevention and control requirement focuses on the use of infection control practices and patient/caregiver education and teaching.

Even though home health providers may have some of the elements of a QAPI program or Infection Control program due to existing state-specific, federal regulations and accreditation standards, these new CoPs require a much more robust, data-driven program and oversight.  Home health agencies must take steps now to ensure compliance with these important requirements by the implementation date. Some of the key requirements include the fol


Home health agencies must develop, evaluate, and maintain an effective, ongoing, agency-wide, data driven QAPI program. The home health agency’s governing body must ensure the QAPI program includes the following:


  • Reflects the complexity of its organization and services, involves all agency services (including those provided under contract or arrangement);
  • Focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and readmissions, and
  • Takes actions that address the agency’s performance across the spectrum of care, including the prevention and reduction of medical errors.


The home health agency must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS surveyors. The standards under this CoP include the following:


Program Scope

CMS summarizes in the comments that this first standard, requiring that a home health agency’s QAPI program must include, but not be limited to, the use of objective measures to demonstrate improved performance. 


Program Data

The program must use quality indicator data, including measures derived from OASIS (where applicable) and other relevant data, and track performance to ensure that improvement is sustained over time.


Program Activities

The home health agency must set priorities for performance improvement, consider the prevalence and severity of identified problems, and give priority to improvement activities that affect clinical outcomes.


Performance Improvement Projects

The fourth standard requires the home health agency to conduct performance improvement projects that reflect the scope, complexity and past performance of the agency’s services and operations, and document these projects.

  • It is important to note that home health agencies have until January 13, 2018 to conduct PI projects. CMS has added a phase-in to allow agencies necessary time to establish their QAPI Programs and collect data prior to implementing performance improvement projects. All other QAPI requirements take effect July 13, 2017.


Executive Responsibilities

The home health agency’s governing body is responsible for ensuring that: 

  • An ongoing program for QI and patient safety is defined, implemented and maintained;
  • The agency-wide QAPI efforts address priorities for improving quality of care and patient safety, and that all improvement actions are evaluated for effectiveness;
  • Clear expectations for patient safety are established, implemented and maintained; and
  • Any findings of fraud or waste are appropriately addressed.

Home health agencies need to develop policies governing the approach to the development, implementation, maintenance and evaluation of the QAPI program.  Flexibility is provided in the regulations to ensure that each agency’s program is individualized and reflects the scope of its services. CMS believes this will provide a performance expectation that agencies will set their own QAPI plan and goals, using the information to continuously strive to improve their performance over time. Home health agencies must develop a comprehensive, ongoing, data driven, agency-wide QAPI program. Simione Healthcare Consultants recommends the following strategies for success with these QAPI requirements:


  • Conduct a home health agency-wide assessment to identify QAPI program priorities and include all departments and services, including those under contract. 
  • Conduct a data inventory to identify where QAPI program data may be collected. Agencies are reminded to focus not only on the publicly reported outcomes when identifying opportunities for performance improvement, but also make all reasonable efforts to collect, analyze and use data from a wide variety of sources to develop and analyze performance improvement projects (PIPs).
  • Establish a QAPI Plan (based on the agency-wide assessment) that targets areas for improvement. This plan must be individualized to reflect the home health agency’s high-risk, high-volume, problem prone areas, and must include routine monitoring such as infection control, adverse events, occurrence reports and patient/family complaints.  Additionally, the plan must reflect other operational monitoring to identify opportunities for improvement (such as personnel files audits, physician order tracking, scheduling issues, etc.). Agency-wide involvement and commitment to the QAPI program are essential.
  • Use a consistent process for implementation, documentation and communication of PIPs.   Examples include, but are not limited to, Plan-Do-Study-Act (PDSA) or Lean/Six Sigma principles and processes.
  • Designate in writing the person or persons responsible for oversight of the QAPI program. Agencies will need to evaluate staffing and responsibilities to ensure that the individual(s) appointed to oversee the QAPI program have sufficient time and resources to ensure all program requirements have been met.
  • Determine the process to ensure evidence of governing body involvement in the development/approval of the QAPI plan, including approval of frequency and detail of data collection. The agency may use a QI committee or PIP teams to develop and implement its QAPI priorities, but ultimately there must be a direct connection for approval by the governing body.
  • Implement a contract oversight program as part of the agency’s QAPI program. 



Infection Prevention and Control

Home health agencies must maintain and document an infection prevention and control program with the goal of prevention and control of infections and communicable diseases. It is important to note that all aspects of the Infection Prevention and Control CoP are current standards of practice – from teaching patients and caregivers about proper prevention practices and monitoring infection disease occurrences within a HHA’s population to cooperating with other providers and federal/state/local regulatory agencies during disease outbreaks. This CoP contains specific standards related to Prevention, Control and Education that include the following:



The agency must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases.

  • Agencies are already required to meet federal regulations such as OSHA blood borne pathogens standard, CDC requirements, and state-specific and accreditation requirements (if applicable).



The agency must maintain a coordinated agency-wide program for surveillance, identification, prevention control and investigation of infectious and communicable diseases that is an integral part of the agency’s QAPI program.

  • The infection control program must include a method for identifying infectious and communicable disease problems, and plan for appropriate actions that are expected to result in improvement and disease prevention.



The agency must provide infection control education to staff (including contractors), patient and caregivers.

Simione recommends the following strategies and activities to implement a comprehensive Infection Prevention and Control program: 


  • Review current policies, reporting processes and protocols to determine areas needing further development in meeting these new requirements.
  • Utilize evidence-based practice and existing regulations as a resource for development of the infection control program. Federal and state agencies such as the Centers for Disease Control and Prevention and state departments of health, as well as accreditation organizations and national professional organizations such as the American Association for Professionals in Infection Control (APIC) have all developed infection prevention and control standards of practice, which can be used by home health agencies in creation of their programs.
    • Note that CMS expects a home health agency to be able to identify the source of the standards it selects, and to explain why those standards were chosen for incorporation in the infection prevention and control program.
  • Review client and caregiver education materials to ensure that they reflect current standards and that they are consistent with the scope of the agency’s infection prevention and control program. The education, both in content and format, must meet the needs of the individual patient and caregivers based on their specific needs. This includes consideration of learning format (i.e.  written, verbal, demonstration) and in a language the patients/caregivers can understand.
  • Implement infection prevention and control documentation processes in a manner that suits the workflow of the agency, and successfully demonstrate upon survey that this requirement was met.
  • Incorporate infection prevention and control monitoring into the agency’s QAPI Program, including the development of PIPs as needed to address areas in need of improvement. The key to ensuring successful implementation of an infection control program is observation.
    • Supervisory home visits are needed to observe practices such as proper handwashing, clean technique, wound care and bag technique.
    • Clinical record audits are important for identification of patients who have experienced infections and determination of whether there was appropriate staff follow-up and intervention.
    • Staff monitoring of infections is also important, especially in determining the possibility of cross-contamination between patients and staff.


Home health agencies will need to evaluate operations as a whole to determine the most efficient structure and processes necessary to meet all of the new CoPs, including these new QAPI and infection prevention and control requirements.  To assist in this effort, Simione is available to conduct QAPI and infection prevention and control program assessments and provide recommendations for implementation of a comprehensive program, while demonstrating efficiency and effectiveness. Our expert consultants can assist with a CoPs readiness assessment, policy development, staff education and identification of resources and tools to streamline your program and optimize outcomes.

Contact us at 844-215-8820 or


About Simione Healthcare Consultants
Founded in 1966, Simione Healthcare Consultants embodies a diverse group of business talent across the U.S. to provide accessible, cost-effective business solutions for the home health and hospice organizations. Key areas of expertise include operations, compliance and risk, finance, sales and marketing, cost reporting, information technology, and mergers and acquisitions.  Simione supports performance improvement across the healthcare continuum, engaging agencies, hospitals, health networks for more effective delivery of home health and hospice care. More than 1,500 organizations use Simione’s experts and tools to improve quality, reduce costs, and minimize risk to drive business performance. 

Share This