Trial Magazine

Your office receives a call from someone who recently lost a loved one—a resident at a local nursing home—to COVID-19. You’ve obtained the relevant medical records, confirmed the cause of death, created a detailed medical timeline, and meticulously reviewed the records for holes or issues in the chart. But to prove negligence, you need to show the standard of care was breached—that the facility failed to provide care that reasonable and prudent nursing home personnel would provide when caring for the same or a similar resident in the same or similar circumstances.

To understand the standard of care required during the pandemic, it’s important to know the regulatory changes. In early February 2020, the Centers for Medicare and Medicaid Services (CMS) issued a memo advising that the nation’s nursing homes and other health care facilities take critical steps to prepare for COVID-19.¹ The Centers for Disease Control and Prevention (CDC) also provided guidance for nursing homes, including recommending that facilities assign individuals with training in infection control to manage their response, have a plan for visitor restrictions, and create a plan for testing residents and health care personnel.² And CMS has prioritized “immediate jeopardy” investigations over recertification surveys.³ CMS also has directed state agencies to continue to conduct complaint-related inspections of nursing homes and to conduct targeted infection control inspections.⁴

And CMS twice has amended applicable infection control regulations at 42 C.F.R. §483.80.⁵ Those regulations have long specified that a “facility must establish and maintain an infection prevention and control program designed to provide a safe, sanitary, and comfortable environment and to help prevent the development and transmission of communicable diseases and infections.”⁶ The program must include, at a minimum, “a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors,” and others providing services to nursing home residents under a contractual arrangement with the nursing home.⁷ The program also must be based on the nursing home’s facility assessment⁸ and comply with accepted national standards.⁹

In response to the COVID-19 outbreak, CMS added specific reporting requirements.¹⁰ Facilities now must report weekly information about “(i) suspected and confirmed COVID-19 infections among residents and staff, (ii) total deaths and COVID-19 deaths among residents and staff, (iii) personal protective equipment and hand hygiene supplies in the facility, (iv) ventilator capacity and supplies in the facility, (v) resident beds and census, (vi) access to COVID-19 testing . . . [and] staffing shortages.”¹¹ Facilities also must inform residents and their representatives and families by “5 p.m. the next calendar day following the occurrence of either a single confirmed infection of COVID-19 or three or more residents or staff with new-onset of respiratory symptoms occurring within 72 hours of each other.”¹²

CMS also added testing requirements for residents and staff—including those who provide services at the nursing home and volunteers—once there is a confirmed diagnosis of COVID-19 in the facility or identification of any person with symptoms consistent with COVID-19 or with known or suspected exposure to COVID-19.¹³ Routine testing based on county positivity rate also is required.¹⁴ For each instance of staff testing, facilities must document in the employees’ files that testing was completed and the results.¹⁵ In resident records, facilities must document that testing was offered, completed (as appropriate to the resident’s testing status), and the results of each test.¹⁶

These new requirements can form your requests for production. In addition to what you typically would seek in nursing home cases, ask for

• policies and procedures, especially infection prevention and control policies and procedures. This includes any amended policies since COVID-19 appeared in the United States and any information pertaining to the nursing home’s infection control programs. There should be newly adopted or revised policies and procedures in response to COVID-19 and CMS’s targeted plan.
• emails, letters, and other correspondence related to infection prevention and control, COVID-19, state agency inspections, budgets, and nursing personnel and resident safety.
• state agency surveys and complaint inspection reports, which should show any deficiencies (known as “F-Tags”), and the nursing home’s written response to those deficiencies.
• cost reports from the beginning of 2018 to the present. These also can be obtained via Freedom of Information Act (FOIA) requests to the state agency responsible for nursing home certification.
• nurse consultant reports, emails, and documents—whether external or internal. Larger nursing home corporations typically have nurse consultants on staff, normally organized by region (such as the Southeast).
• supply receipts, contracts, and invoices from outside vendors—especially those that supply masks, other PPE, COVID-19 tests, and other pandemic-related supplies.
• any monthly and quarterly audit reports showing the number of COVID-19 cases within the nursing home, as well as staffing, budgeting, and spending.
• all nursing personnel training records for internal in-service training and outside training provided by external nurse consultants.
• any documents pertaining to payroll protection program loan information and value-based COVID payments (federal relief funding for nursing facilities that show they can reduce COVID-19 infections and deaths).¹⁷ This information is important because it will be a full disclosure of the nursing home’s finances, which you can then use.
• the resident’s complete medical chart, in color, including the audit trail for the electronic medical record.

Once you have this key background information, schedule depositions with a focus on infection prevention and control, establishing notice of the risks, and proving that the standard of care was breached. Infections, including urinary tract infections, antibiotic-resistant staphylococcal infections, and pneumonia, made up a significant percent of deaths within nursing homes even before COVID-19.¹⁸ Infection prevention and control should be an inherent part of a facility’s training program. Protocols, including those related to infection prevention, should all be in writing, documented through in-service training, and supported by policies and procedures.

Most, if not all, nursing homes will admit that their policies and procedures align with the standard of care. Consequently, not following their own policies and procedures is, in fact, evidence of a breach of the standard of care. Review the infection prevention and control policies and procedures line by line with the director of nursing and the administrator, while focusing on your client’s care or lack thereof. Compare its infection prevention and control program before the pandemic to its current program and assess whether the facility timely adjusted policies to new CMS requirements. Also assess whether it trained staff and ensured compliance with new policies.

Even during such uncertain times, following protocols to protect staff and residents and meeting the standard of care are paramount, so understanding new CMS requirements is crucial.

Stefan B. Feidler is an attorney at Anastopoulo Law Firm in Charleston, S.C., and can be reached at Stefan@akimlawfirm.com.

Notes

1. U.S. Dep’t of Health & Human Servs., Ctrs. for Medicare & Medicaid Servs., Information for Healthcare Facilities Concerning 2019 Novel Coronavirus Illness (2019-nCoV), Feb. 6, 2020, https://www.cms.gov/files/document/qso-20-09-all.pdf.
2. Ctrs. for Disease Control & Prevention, Preparing for COVID-19 in Nursing Homes, Nov. 20, 2020, https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html.
3. U.S. Dep’t of Health & Human Servs., Ctrs. for Medicare & Medicaid Servs., CMS Announces Findings at Kirkland Nursing Home and New Targeted Plan for Healthcare Facility Inspections in Light of COVID-19, Mar. 23, 2020, https://tinyurl.com/tau8926.
4. Id.
5. Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program, 85 FR 27,627 (May 8, 2020); Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency, 85 Fed. Reg. 54,820 (Sept. 2, 2020). See also U.S. Dep’t of Health & Human Servs., Ctrs. for Medicare & Medicaid Servs., Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency Related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID–19 Focused Survey Tool, Aug. 26, 2020, https://www.cms.gov/files/document/qso-20-38-nh.pdf.
6. 42 C.F.R. §483.80 (2020).
7. 42 C.F.R. §483.80(a)(1).
8. For more on facility assessment requirements, see 42 C.F.R. §483.70(e).
9. 42 C.F.R. §483.80(a)(1).
10. 42 C.F.R. §483.80(g)–(h).
11. 42 C.F.R. §483.80(g)(1)(i)–(viii); 42 C.F.R. §483.80(g)(2).
12. 42 C.F.R. §483.80(g)(3).
13. 42 C.F.R. §483.80(h)(1)(i)–(iii); see also U.S. Dep’t for Health & Human Servs., supra note 5.
14. 42 C.F.R. §483.80(h)(1)(iv); see also U.S. Dep’t for Health & Human Servs., supra note 5.
15. 42 C.F.R. §483(h)(3)(i).
16. 42 C.F.R. §483.80(h)(3)(ii). A resident’s testing status is dependent on whether the resident agreed to be tested for COVID-19.
17. The federal government has set aside $2 billion in value-based COVID-19 payments as relief funding for nursing facilities that show they can reduce COVID-19 infections and deaths. Before receiving this relief, the nursing home must pass a pair of “gateway qualifications”: a rate of COVID-19 infections lower than that of the surrounding county and a COVID-19 death rate that “falls below a nationally established performance threshold for mortality among nursing home residents infected with COVID.” Then the nursing home will be evaluated by the Department of Health and Human Services under formulas intended to quantify how well the nursing home both stopped the spread of COVID-19 and prevented those who contracted the virus from dying. For more, see “Allocation for Skilled Nursing Facilities and Nursing Homes” at U.S. Dep’t of Health & Human Servs., CARES Act Provider Relief Fund: General Information, Targeted Distributions, https://tinyurl.com/y72tbwgn; see also Alex Spanko, HHS Releases Final Details of $2 Billion in Value-Based COVID Payments for Nursing Homes, Skilled Nursing News, Sept. 18, 2020, https://tinyurl.com/y4hgchk2.
18. Ana Montoya & Lona Mody, Common Infections in Nursing Homes: A Review of Current Issues and Challenges, 7 Aging Health 889 (Dec. 2011).