The COVID Challenge: Part Two

In the first part of our series, we examined the current landscape of COVID-19 cases and vaccinations, particularly among nursing home residents.  Senior care facilities have faced a barrage of directives, orders, rules, memorandums, and constantly changing guidance on every aspect of facility operations.  In this installment, we assess the challenge of collecting, storing, and organizing this guidance in a format that can be used by facilities to protect their patients/residents, staff, and business.

Industry Response and Strategy Development


Many parties play a role in the best defense of COVID-related cases.  Counsel has developed initial defense strategies, including seeking immunity under the PREP Act.   Healthcare organizations have the key role of collecting and maintaining all documentation regarding their actions during to the pandemic, including changes in policies and procedures in response to evolving state and federal guidance.


In a recent presentation to an industry group, Excelas asked attendees how their healthcare organizations have collected, organized, and archived COVID-19 guidance.  Most respondents indicated they are using spreadsheets and/or document images on a shared drive, while one admitted they are using a paper binder.  It was noted that this effort was disjointed at times, with new guidance often overwriting previous directives.


Demonstrating a facility’s compliance with all external regulations and guidelines is critical, but cumbersome.  Excelas’ objective was to support the entire industry by developing an archive of all guidance published by various agencies and overlay that with a healthcare organization’s response to those guidelines.  The result is a database, the C-19 Comprehensive Integrated Timeline Tool (CITT), which provides the supportive documentation necessary to create reports demonstrating that a facility and/or entire healthcare organization was taking action to assure compliance with the standards at any given time throughout the pandemic.

COVID Challenge 2

The CITT allows for efficient layering of data from these various sources and highlights a facility’s actions as related to published guidelines and standards.  Images of source documents are imbedded in the CITT for ease of reference.  Data is gathered from multiple sources, and updated as necessary, to build the demonstrative timeline.  These sources include, but are not limited to:

State and Federal Guidance


Long-term care facilities have been subject to changing COVID-19 guidance from federal agencies, including:


  • Centers for Medicare and Medicaid Services (CMS)

    • Emergency Preparedness Rules
    • Health System Expansion Guidance
    • Telehealth Recommendations
    • Waivers (acting in good faith; not subjected to sanctions for non-compliance)
    • Infection Control & Prevention Updates
    • Transportation Guidelines
    • Testing Requirements
    • Mask Guidance, Visitation Recommendations
    • Elective Surgery Recommendations
    • Reporting Requirements
    • Background Check Regulatory Requirements
    • Reopening Guidelines
    • Prioritization of Survey Activities
    • Pricing Transparency Requirements


  • Centers for Disease Control and Prevention (CDC)

    • Guidance for Monitoring Exposed or COVID-19 Positive Patients
    • Preparedness Checklists for Transport & Arrival of Patients
    • Guidance for Collecting, Handling, & Testing Clinical Specimens, Lab Biosafety Guidelines
    • Clinical Guidance for COVID-19 Outbreak
    • Risk Assessment; Cleaning, Disinfecting, & Decontamination Protocols
    • Higher Risk for Severe Illness with Comorbid Conditions
    • Infection Prevention & Control Recommendations
    • Updates to How the Virus is Spread
    • Clinical Screening Recommendations, Symptoms Updates, Isolation/Quarantine Precautions, Visitor Screening Guidance
    • Reporting Requirements
    • Postmortem Guidance, Guidance for Certifying Deaths
    • Return to Work Criteria
    • Optimization of PPE, PPE Guidance, PPE Burn Rate Calculator
    • Evaluation and Testing Recommendations
    • Recommendation on Vaccines (Storage/Temperature logs, Standing Orders, Preparation and Administration Summaries)
    • Mass Gathering/Social Distancing Recommendations
    • Initiating Case Investigation and Contact Tracing Activities


  • Food and Drug Administration (FDA)

    • Emergency Use Authorizations for Drugs to Treat, PPE, Decontamination Kits, Sterilization Systems, Testing Kits, Vaccine
    • Recommendation for Medical Gowns, Gloves, Respirators/Vents, Hand Sanitizers
    • Enforcement Policies for Sterilizers, Disinfectants, Air Purifiers, Thermometers, Face Shields, Surgical Masks
    • Conservation Strategies for PPE
    • Fact Sheet for Healthcare Providers for Medications Approved for Treatment
    • Storage Recommendations for Vaccines
    • Drug Shortage Responses


  • Health and Human Services (HHS)

    • Declaration of Public Health Emergency
    • PREP Act & CARES Act Clarifications
    • Authorizing Licensed Professionals to Perform Duties Not Normally Done
    • Hoarding Prevention Measures, Optimizing PPE
    • Guidance for Certifying Deaths
    • Laboratory Data Reporting Guidance
    • Uninsured Program
    • Operation Warp Speed-Accelerating Therapeutic Development/Vaccine Plan

Each state has issued executive orders and legislation relating to COVID-19 protections and immunities for the long-term care sector.  Many of these have changed since early 2020, the beginning of the public health emergency.  Seyfarth Shaw provides a survey of these state liability protections as they have been introduced over the course of the pandemic.


Local health departments have also issued mandates regarding:

  • Reporting Requirements
  • Return to Work Criteria
  • Face Coverings, Mass Gatherings, and Travel Recommendations
  • Isolation/Quarantine Recommendations
  • License Renewal Requirements for Healthcare Personnel


In collaboration with our clients, Excelas built this framework to allow you to quickly assess COVID-19 cases in this shifting legal and regulatory landscape.  Part Three of this series will focus on medical record documentation best practices and the use of a medical chronology in conjunction with published guidelines.  Contact us today for a demonstration of our C-19 Comprehensive Integrated Timeline Tool.

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