Maintaining continuous compliance with multiple regulatory requirements can be challenging for even the most seasoned hospital teams. We are frequently asked for current survey trends and effective strategies to prevent regulatory issues. In this article, top CMS deficiencies are shared, as noted on the CMS Quality, Certification, and Oversight Reports (QCOR) website.
Safety and quality are primary goals of healthcare. Survey deficiencies typically point to concerning safety and quality issues. Serious survey outcomes such as condition-level and immediate jeopardy findings result in resurveys and can be resource consumption-intensive, costly, and discouraging to your organization. Is your hospital at risk for a top CMS deficiency?
Top Deficiencies from November 2022 with Prevention Strategies
The CMS State Operations Manual Appendix A addresses hospital regulations for organizations such as medical-surgical and psychiatric healthcare settings. Appendix A includes Interpretive Guidelines that direct the surveyor’s evaluation of compliance with the regulations and is an excellent guide for understanding the full expectation of the regulation. The following regulations were the top areas with cited deficiencies in the past six months:
A-0115 Condition of Participation: Patient’s Rights
As a Condition of Participation (CoP), this regulation covers many distinct aspects of patient rights, such as grievances, informed consent, and privacy. For this period, CMS deficiencies included failure to investigate a serious incident, lack of monitoring of a suicidal patient, issues with protecting patients from self-harming behaviors, and deficiency in continuous cardiac monitoring. During onsite visits, we have observed breaks in protocols – especially with patient observation and consistent checking of emergency equipment such as Automatic External Defibrillators (AED) that were undetected for significant periods of time. Sometimes frequent and commonly checked areas like code carts become overlooked due to the repetitive nature of checking or insufficient orientation of new staff. However, these lapses in practices can easily lead to patient harm, as well as adverse survey outcomes. It is essential to consider complacency as a root cause of breaks in practices and gaps in repetitive checking.
Key prevention strategies include:
- Focus on processes and systems. If one incident occurs, assume there is a system issue until proven otherwise and not simply human error causes. Trace processes like monitoring patients on 1:1 observation to proactively detect problems. Use Failure Mode and Effects Analysis to identify how a vulnerable process step can be safeguarded against failure.
- Conduct leadership rounds for oversight. Check the AED log. When was the last time the AED was unplugged and tested? Does the code cart contain expired AED pads? Are they appropriate for the age of the population served? Are staff sufficiently oriented to job duties upon hire or transfer?
- Investigate incidents thoroughly and urgently. To prevent recurrence, empower supervisors to act immediately as needed, especially during off-hours. Use Root Cause Analysis to uncover the true causes of incidents so that issues are truly corrected.
- Ensure regular checks are in place and performed without failure or missed steps. Check that staff know how to perform the checks properly.
- Conduct mock surveys to place external eyes on your processes routinely. External eyes bring a fresh perspective and offer best practices for challenging issues.
A-0144 Patient Rights: Care in a Safe Setting
Under the Patient’s Rights Condition of Participation, this tag refers to the overall safety of care within the environment of care. In the past six months, A-0144 deficiencies have been cited at an Immediate Jeopardy level. Findings included issues with identifying patients at risk for suicide, mitigating environmental safety risks, and managing aggressive behaviors. Workplace violence can also be cited under this tag as a focus area.
Key prevention strategies for this tag include:
- Carefully review the suicide risk assessment (SRA) process. Is your organization’s suicide risk assessment evidence-based and used fully as designed? Conducting random tracers on the SRA process is essential, given the high-risk nature of this assessment.
- Does your organization use any aggressive/violent behavior assessments? Given the expectation of providing care in a safe setting, assessing aggressive behavior proactively upon admission and during hospitalization can help identify and mitigate potential risks for harm to patients and staff.
- Ligature Risk Assessments conducted annually at minimum, along with changes in the environment, such as physical renovations, are instrumental in identifying potential harm. Be sure to include mitigation strategies, staff training on the strategies, and oversight monitoring as an overall plan. Can staff speak to the mitigation strategies if asked by a surveyor? Ensure that staff understand why certain procedures must be followed and the associated outcome risks when not performed according to procedures.
A-0385 Condition of Participation: Nursing Services
Like A-0115, A-0385 is a Condition of Participation that addresses many aspects. CMS expects nursing services to be well-organized, appropriately staffed, and incorporated into the hospital’s Quality Assurance and Performance Improvement program. The latest findings indicate an accumulative effect of process breakdowns and system issues, such as a lack of awareness and management of condition changes. Multiple safety issues were found during the survey process. Simply put, it was not just one issue cited but rather an aggregation of safety issues and processes that were not followed. Cited deficiencies include gaps in reporting critical lab results, lack of accountability in reporting incidents, problems with verbal orders, and patient monitoring lapses. The inadequacy of staffing was also cited.
A systems approach is critical to prevent occurrences and the degree of process breakdowns.
To support nursing services, key strategies include:
- Trace specific processes such as the reporting of critical lab results. Follow how gaps in reporting can lead to serious delays in emergency treatment, especially for patients with complex needs. Involve nursing staff by asking, “How should the process go according to policy and procedure? What if this happens (vital signs become unstable, for example) – what should happen next, and what are the potential barriers to these actions occurring? Who would you notify first? Engage staff in a supportive manner and collaborate on system changes and builds to create processes that minimize the risk of harm and error. Encourage and recognize critical thinking skills.
- Conduct leadership rounds for oversight and on-the-spot training opportunities. Create flowcharts and checklists of high-risk processes to facilitate the evaluation of these processes by leaders and staff. Find issues that are minor and easier to address. Keep an eye out for anomalies that could indicate a systems issue. Follow up with a tracer to evaluate.
- During staffing challenges, assume issues could easily exist and that processes/systems may become stressed, leading to increased risk of errors. As staffing levels are addressed, look out for excessive distractions/stressors and breaks in communication that can negatively affect the delivery of patient care.
A-0145 Patient Rights: Free from Abuse/Harassment
In this tag, CMS states, “The intent of this requirement is to prohibit all forms of abuse, neglect (as a form of abuse) and harassment whether from staff, other patients, or visitors. The hospital must ensure that patients are free from all forms of abuse, neglect, or harassment . . . must have mechanisms in place to ensure patients are free of all forms of abuse, neglect, or harassment.” For this period, findings were noted for lack of background checks, issues in reporting suspected abuse or neglect, substantiated cases of abuse, and insufficient protection of vulnerable patient populations.
CMS suggests seven components for effective abuse, neglect, and harassment protection.
In assessing your organization’s plan, check for the following components:
- Prevent incidents with adequate staffing, especially on off-hours when ancillary and other support staff tend to be fewer. As is well known, staffing is more than numbers. Experience, training, and various staff disciplines also affect the adequacy of staffing.
- Screen employees to detect any background issues. Double-check HR processes that all employees are screened upon hire and routinely per policy without fail. We routinely see gaps in onboarding new employees and annual checks due to a lack of double-checks.
- Identify potential issues through proactive measures. Does your organization use assessments to determine the risk of aggressive behaviors? Proactive assessments can make a significant difference in enacting a solid plan to manage impulsive behaviors.
- Train staff on all aspects of abuse, neglect, and harassment and use drills to gauge training effectiveness in how the team would manage an allegation. Do new employees know what to do if an allegation is reported on off-shifts and holidays?
- Protect patients immediately by taking swift action whenever an allegation of abuse, neglect, or harassment occurs. Allow a thorough investigative process to determine if the allegation is substantiated while protecting against potential additional incidents.
- Investigate thoroughly, objectively, and timely and keep leadership well-informed.
- Report/Respond to any incident per local, State, or Federal requirements with timely reporting and documented actions taken as needed.
Regulatory and accreditation requirements are essential components of a safety and quality plan. With reliable checks, thorough investigations of compliance, and proactive reviews, organizations can prevent harm to patients and staff while gleaning the benefits of a robust regulatory plan. Keep your finger on the pulse of regulatory trends to assess potential issues that can be easily mitigated for consistent quality and safety of care.
CMS State Operations Manual Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals (Rev. 200, 02-21-20)