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Top Compliance Challenges for Ambulatory Care Organizations in 2021

12/20/2021

By Hermann McKenzie, MBA, CHSP, director of engineering, Standards Interpretation Group; Elizabeth Even, MSN, RN, CEN, Associate Director, Clinical Standards Interpretation Group; and Tiffany Wiksten, MSN, RN-CIC, Associate Director, Standards Interpretation

It’s interesting for our ambulatory care team to review the most frequently cited standards every year and offer our accredited organizations advice on avoiding common pitfalls.

In 2021, the most challenging ambulatory care standards fell in the realm of:

  • environment of care (EC)
  • infection control (IC)
  • human resources (HR)

We’ve gathered subject matter experts in each of these areas to offer insight on how to avoid common findings.

Environment of Care
EC 02.03.05 – The elements of performance (EPs) around this standard focus on a building’s systems and equipment that provide detection, notification and extinguishment of fire conditions. Included in this standard are the devices that signal the fire alarm system to activate and notify first responders to a fire emergency.

Most of these devices (e.g., pull stations, fire and smoke detectors) are typically not maintained by in-house staff. Consequently, the inspection, testing and maintenance (ITM) tasks are contracted. When this is the case, organizations must ensure they set up maintenance intervals that align with National Fire Protection Association (NFPA) code requirements, be it quarterly, semi-annually or annually.  

If contractors are used, they need to provide service for the entire complement of devices and provide detailed reports to the organization on each item that has successfully passed its test. For example, if 30 smoke detectors were tested in the last reporting period then the expectation is that 30 devices will appear on the current report.

One test usually handled by staff is the monthly inspection of fire extinguishers. It’s important to document this activity to ensure there is a reconciliation for all extinguishers on the inventory. 

EC 02.05.07 – This standard focuses on ITM activities related to electrical infrastructure support systems, specifically:

  • emergency lights
  • generators
  • supplemental electrical power systems

The critical nature of these systems is directly tied to the delivery of patient care. A failure could result in serious injury or the inability to safely evacuate a space during an emergency. The first step to make sure an organization is compliant is to properly inventory these systems to keep current with maintenance intervals. Whether these tasks are performed by in-house staff or a contractor, the responsible party must have a working knowledge of the EPs and the intent of the code requirements.

As with all ITM activities, documentation of these tasks must be current, accurate and made available to Joint Commission staff when requested on survey. Many ambulatory and office-based surgery sites are led by a clinical staff member, so it is important to develop a relationship with someone who can offer general guidance on EC accountabilities. 

Infection Control
IC.02.01.01 – This standard, requiring organizations to implement IC activities, is commonly cited for failure to implement IC activities or required evidence-based guidance such as Standard Precautions. This standard may also be cited if organizations fail to follow:

  • state or federal regulations
  • manufacturer’s instructions for use (MIFU) and/or processes
  • organizational policies or procedures

Following the Infection Prevention & Control Hierarchy will help ensure that the activities your organization implements are compliant with regulations, Centers for Medicare and Medicaid Services (CMS) Conditions for Coverage (CfCs) where applicable, and MIFU. Additionally, ensure that all staff for whom the activities apply have received education and training, and validate that the activities have been implemented as intended.

IC 02.02.01 – This standard helps organizations reduce the risk of infections associated with medical equipment, devices and supplies. It is most commonly cited for failure to ensure that reusable medical devices are reprocessed as per intended use and MIFU, and for failure to store medical equipment, devices and supplies in a manner to protect them from contamination.

Ensure compliance when reprocessing reusable medical devices, including but not limited to:

  • ultrasound probes
  • instruments used for surgery and/or procedures
  • other reusable patient care equipment

Following the MIFU for any devices, instruments, products, accessories or equipment used ensures they are being cleaned and disinfected or sterilized as per intended use. Failure to perform the minimum level of reprocessing based on intended use or follow the manufacturers validated instructions can lead to improperly disinfected or sterilized items.

Today, many organizations are faced with reprocessing complex instruments and devices. It is important to ensure that only manufacturer approved products are used and that all steps of the MIFU are followed for all items undergoing reprocessing, including equipment and accessories.

This list of applicable equipment and accessories is extensive:

  • sterilization pouches or trays
  • sterilizers
  • reprocessors
  • biologic indicators
  • high-level disinfectant solution

Prior to release of the items for patient care, validate that the critical parameters for the disinfection and/or sterilization such as process time, temperature, pressure and cycle completion have been met. 

Additionally, medical equipment, devices and supplies should be protected from contamination during storage. This applies to the cleanliness of the area in which items are directly stored (e.g., drawers or shelves). If clean and dirty items are managed in the same room or area, there needs to be a workflow or process in place to provide clear separation of clean and dirty items. Staff who are responsible for accessing clean medical equipment, devices and supplies need to do so in a manner to prevent contamination.

Human Resources
This area has returned a top cited compliance issue after a hiatus over the last few years.

HR.02.01.03 – This standard is again a challenge for many of our accredited organizations. It requires organizations to grant initial, renewed or revised clinical privileges to individuals who are permitted by law and the organization to practice independently.

The decision on who an organization brings in to care for its patients is arguably the most important decision an organization makes. There are many opportunities surrounding the credentialing and privileging process that are identified during survey due to the fact that care is delivered by:

  • traditional staff
  • contracted employees
  • telehealth providers  

Organizations that have expanded their provider hiring process may be following Joint Commission requirements, but not their own policies as described under EP 1 which states, “The organization follows a process, approved by its leaders, to grant initial, renewed, or revised privileges and to deny privileges.” 

One tip often shared with organizations is that whenever there is a change in how they bring in providers, they should also evaluate the process approved by leadership to evaluate if changes need to be made to ensure both accreditation and organizational requirements are met. Many organizations are under the false impression that because the providers they hire are employed elsewhere they do not have to credential and privilege them at their organization. However, this is not the case. While Joint Commission accredited and CMS-deemed organizations can share certain information, the hiring organization is responsible to ensure that all EPs under HR.02.01.03 are completed for each provider.

The second most common issue falls into the maintenance of provider files, including issues related to licensure verification prior to the expiration date and renewal of privileges prior to when the current privileges expire. Many organizations employ reminder files and may elect to maintain all providers on the same or rolling calendar date for renewals to stay on top of the process. This would be an organizational decision and the organization will be surveyed to the process approved by leadership.  

We hope this post helps you avoid some of the problems that have impacted other ambulatory care organizations. If you have further questions, please do not hesitate to contact your account executive or the Standards Interpretation Group.

Herman McKenzie is currently the director, Department of Engineering in the Standards Interpretation Group at The Joint Commission. Mr. McKenzie has more than 25 years of health care experience having held managerial and director level roles in clinical engineering, plant operations and facilities services throughout the Chicagoland area. He was part of the team that opened the first new hospital in Illinois in over 25 years. 

Elizabeth Even, MSN, RN, CEN, is associate director, Clinical Standards Interpretation Group, for The Joint Commission. She is also on staff in the emergency department at Northwestern Memorial Hospital. Prior to this position she managed the emergency department at Northwestern Memorial Hospital and was a clinical educator at Northwestern University Feinberg School of Medicine.  She also has experience in home health and working as a nurse at Wrigley Field in Chicago.

Tiffany Wiksten, MSN, RN-CIC, is Associate Director, Standards Interpretation Department.