Gerry Blass (gerry@complyassistant.com) is President and CEO at ComplyAssistant in Iselin, New Jersey. Dana Penny (dpenny@jewishhome.org) is Chief Compliance Officer at The New Jewish Home in New York, NY.
In the wake of COVID-19, healthcare organizations have seen an uptick in spot or surprise audits by their state departments of health (DOHs) for emergency preparedness plans with a specific focus on pandemic response. Similar to other Centers for Medicare & Medicaid Services (CMS) mandates for emergency preparedness,[1] every response is local, and health departments must handle many different emergencies, including expected, unexpected, and unimaginable threats. Collaboration between DOHs and healthcare providers is crucial during these times. Hence, state and local health departments’ current urgency is to ensure their regional healthcare providers are fully prepared for spot or surprise audits.
Is your organization ready in case that occurs? In this article, we cover steps your organization can and should take today to prepare in the event of a spot audit by your state’s DOH, beginning with how to build and publish an official pandemic response plan.
Change management and pandemic response
Following guidance from the Centers for Disease Control and Prevention (CDC),[2] many state health departments now require providers to develop an official pandemic response plan and publish it on their websites. The posted plan must include provisions for staffing, infection control, and enhanced communications and should answer a variety of questions, such as:
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How will you enable communications between patients and their families?
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If medical staff are in quarantine due to exposure, do they have the means to telecommute to conduct patient care?
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What training and communications processes are in place for staff, patients, and families?
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What infection control steps were taken? How do you plan to limit staff interaction? How will you minimize contamination between units?
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How will you ensure providers have easy access to patient records?
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What is your process for staying updated with recommendations from state and local health departments?
U.S. Department of Health & Human Services is currently focused on evaluating emergency preparedness plan (EPP) programs[3] —how well organizations assessed what they needed to do during the pandemic, what processes they followed, and how they will implement EPP practices in case of future incidents. Is the program organized, up to date, and ready to be followed the next time around? Department auditors want to see lessons learned, mitigation measures, and related due diligence through complete, current documentation.
Preparation paid off at The New Jewish Home in New York City
When The New Jewish Home in Manhattan, New York, was tapped for a surprise DOH audit while conducting a mock audit, high ratings resulted from conscientious preparation using customized checklists based on CDC and CMS guidelines. The New Jewish Home structured infection control surveys in advance to ensure preparation to answer surveyors’ questions with evidence regarding policies, procedures, staff training, purchase and utilization of personal protective equipment (PPE), schedules for extra cleanings, and more. Self-assessment and mock audits were conducted continually to ensure readiness and quality control.
The most important preparation and compliance strategy is to ensure documentation is complete, up to date, and available in both paper and electronic formats. It should also be standardized based on official guidance and organized for efficient management—and more than one person should be familiar with the documentation.
A best practice is to designate point people in administration, security, and emergency preparedness who understand the documentation, know where it is located, and are credentialled to produce it.
During self-assessment and mock audits, it is critical to document every step, piece of evidence, process, and protocol. Having complete documentation makes an actual spot audit go much more smoothly and shows that your organization can demonstrate due diligence.
Using governance, risk, and compliance software to gather, organize, and store all documentation is another good rule of thumb. It ensures that the responses are consolidated, thorough, and standardized to what the auditors want to see.
Building the pandemic EPP team
A pandemic EPP must include communication, staffing, and training plans that specify responsibilities and expectations regarding care, self-protection, PPE, hygiene, and more.
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Hygiene: Provide training for all staff to meet hygiene requirements.
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PPE: Specify how to purchase, maintain, stockpile, and distribute. Establish strategies and justifications for reuse.
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Remote work: Create guidelines for communication among staff. Make sure remote staff follow Health Insurance Portability and Accountability Act guidelines and security.
Preparation for these emergencies is best guided by a multidisciplinary team that includes representatives from medical leadership, administrative leadership, human resources, nursing, materials management, pharmacy, environmental services, infection control, food and nutrition, communications, information technology (IT), security, compliance, and general counsel. In the case of a pandemic, it is essential to designate subgroups to address specific issues in their expertise areas.
For example, ensuring sufficient PPE is in storage at all times requires clinical, materials management, environmental services, and IT to make sure the inventory is available. Subgroups report to the entire team via checklists and monitoring tools. How much PPE is being distributed each day? Keeping lists up to date is essential.
The team looks at each potential hazard to ensure proper assessment and preparation. Two of the most critical factors are staff outages and leadership. If the director of nursing and the medical director are out, who is in charge? Does someone have the skills to step in? These issues require proactive planning and readiness, should they occur.
Four common compliance challenges to tackle proactively
There are four areas for compliance professionals to address when it comes to pandemic EPPs and associated spot audits.
Build a structured system to manage audits, assessments, incidence response, and subject matter contracts
Today, we find that even some large healthcare organizations still use spreadsheets with unstructured files, managed according to different compliance requirements and located in various departments. This makes it hard to efficiently and securely manage audits, assessments, incidence response, and subject-matter contracts. A structured system supports change management, risk management, and a smooth audit process. The ability to show evidence of due diligence in a well-organized way helps to avoid lengthy audits when DOH recognizes that your organization has everything in place.
Keep documentation up to date
Documentation must be up to date with the latest guidance for internal drills and emergency response across all types of emergency preparedness plans—pandemic, IT, hurricanes, and more. From an audit or survey perspective, credible documentation is the focal point. Documentation represents a living, breathing process as well as a paper document or electronic file. Some documentation may not have changed over time but must have periodic review dates.
Establish communication protocols
Create protocols for communication. In the case of The New Jewish Home, communication protocols were established with residents and their families, between residents and their families, and between facilities and families. Specify multiple channels as appropriate with staff assistance—video conferencing, smartphone, tablet. Make sure everyone has the tools they need.
Define accountability
One of the biggest pitfalls is lack of clarity and understanding about who is doing what. You can identify who is accountable or assigned to a specific task, but who is doing it? Preparing for an audit requires having processes in place and documenting the completion of those processes according to the latest guidance. Make sure you identify all players and verify their roles, responsibilities, and actions. Follow the compliance mantra: “Trust, but verify compliance.”
Sample checkpoints
It is critically important for hospital administrators, especially those in long-term care facilities, to maintain healthcare services during the ongoing COVID-19 pandemic. CDC[4] and CMS[5] have each released COVID-19 pandemic guidance checklists to assist in making sure healthcare organizations continue to provide the best quality of care for patients while preparing for surprise audits. Below are sample checkpoints from both lists:
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COVID-19 planning has been incorporated into disaster planning and exercises for the hospital.
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A multidisciplinary planning committee or team has been created to specifically address COVID-19 preparedness planning. List committee or team name.
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Staff are assigned responsibility for coordinating preparedness planning, including a COVID-19 response coordinator (with backup) and planning committee members. Insert name(s), title(s), and contact information.
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Are staff performing hand hygiene when indicated?
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If alcohol-based hand rub is available, is it readily accessible and preferentially used by staff for hand hygiene?
Takeaways
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Discover new ways to prepare your organization’s pandemic emergency preparedness plan and to efficiently maintain it on an ongoing basis.
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Find out how to use checklists from the Centers for Disease Control and Prevention, World Health Organization, U.S. Department of Health & Human Services, Centers for Medicare & Medicaid Services, and more to gather required data.
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Get a recommended structure for an organization’s emergency preparedness team.
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Review recommended processes to successfully pass an audit and demonstrate regulatory compliance.
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Define four common compliance challenges to tackle proactively.