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COVID-19 in Nursing Homes: CMS Needs to Continue to Strengthen Oversight (GAO-22-105133)

Summary

GAO-22-105133, a September 2022 report from the United States Government Accountability Office to congressional addressees, titled COVID-19 in Nursing Homes: CMS Needs to Continue to Strengthen Oversight of Infection Prevention and Control. GAO reports that seven of the eight key indicators of nursing home resident mental and physical health worsened at least slightly in 2020, compared to the years prior to the pandemic. It describes actions CMS and CDC took on infection prevention and control and areas where CMS could take additional actions. GAO makes three recommendations to CMS; HHS agreed with the first and neither agreed nor disagreed with the other two.

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“COVID-19 in Nursing Homes: CMS Needs to Continue to Strengthen Oversight (GAO-22-105133).” Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/22-105133-covid-19-in-nursing-homes-cms-needs-caa16f5749/, SHA-256 06b7ca1895411a01a45a5de6086ac8f31a244ec35152443788a0296dc1e1ccd4.

Full text

                 United States Government Accountability Office
                 Report to Congressional Addressees




                 COVID-19 IN
September 2022




                 NURSING HOMES

                 CMS Needs to
                 Continue to
                 Strengthen Oversight
                 of Infection Prevention
                 and Control




GAO-22-105133
                                            September 2022

                                            COVID-19 IN NURSING HOMES
                                            CMS Needs to Continue to Strengthen Oversight of
                                            Infection Prevention and Control
Highlights of GAO-22-105133, a report to
congressional addressees




Why GAO Did This Study                      What GAO Found
Implementing proper infection               The Centers for Medicare & Medicaid Services (CMS) is responsible for ensuring
prevention and control practices can        that nursing homes meet federal standards. CMS enters into agreements with
be critical for preventing the spread of    state survey agencies to conduct surveys and investigations of the state’s
infectious diseases. Infection              nursing homes. The Centers for Disease Control and Prevention (CDC) issues
prevention and control has been a           guidance, operates surveillance systems, and provides technical assistance to
long-standing concern in the nation’s       support infection prevention and control in nursing homes.
more than 15,000 nursing homes—one
that the COVID-19 pandemic has              GAO analysis of CMS data reported by nursing homes shows that seven of the
brought into sharper focus. Some            eight key indicators of nursing home resident mental and physical health
infection prevention and control            worsened at least slightly the first year of the pandemic (2020), compared to the
practices in nursing homes, such as         years prior to the pandemic. See the figure below for examples of two outcomes
social isolation, may negatively affect     we reviewed.
resident mental and physical health.
                                            Percentage of Residents Who Experienced Depression and Unexplained Weight Loss, by Year
The CARES Act directs GAO to
monitor the federal pandemic
response. GAO was also asked to
review federal oversight of nursing
homes in light of the pandemic. Among
other objectives, this report: (1)
describes what data reveal about any
changes in resident health before and
during the pandemic and (2) examines
infection prevention and control actions
CMS and CDC have taken in nursing
homes before and during the
pandemic.
GAO (1) reviewed CMS and CDC
documents, (2) analyzed CMS resident
health data from 2018 through 2021,         CMS and CDC took actions on infection prevention and control prior to and
and (3) interviewed CMS, CDC, state         during the COVID-19 pandemic. For example, prior to the pandemic, CMS
survey agency, and nursing home             required nursing homes to designate an infection preventionist on staff. This
officials in a non-generalizable sample     person is a trained employee responsible for the home’s infection prevention and
of eight states selected for variation in   control program and was crucial to nursing homes during the pandemic. CMS
factors such as geographic location.        also made changes in how nursing homes were surveyed during the pandemic.
                                            However, GAO found areas where CMS could take additional actions, including:
What GAO Recommends
                                            • Strengthening oversight of the infection preventionist role. GAO identified
GAO is making three
                                              ways CMS could strengthen oversight of the infection preventionist role, such
recommendations to CMS related to
                                              as by establishing minimum training standards. CMS could also collect
the role of the infection preventionist
and clarifying infection prevention and
                                              infection preventionist staffing data and use it to determine whether the current
control guidance. HHS agreed with our         infection preventionist staffing requirement is sufficient.
first recommendation, but neither           • Strengthening infection prevention and control guidance. GAO identified
agreed nor disagreed with our other           how CMS could strengthen this guidance by providing information to help
two recommendations.                          surveyors assess the scope and severity of infection prevention and control
View GAO-22-105133. For more information,
                                              deficiencies they identify. For example, CMS could add COVID-19-relevant
contact John Dicken at (202) 512-7114 or      examples for scope and severity classifications to its State Operations
dickenj@gao.gov.                              Manual—the key guidance state survey agencies use for conducting nursing
                                              home surveys.

                                                                                      United States Government Accountability Office
Contents


Letter                                                                                       1
               Background                                                                   6
               Some Indicators of Resident Mental and Physical Health
                  Worsened during the COVID-19 Pandemic                                    10
               Infection Prevention and Control Deficiencies Persisted in Nursing
                  Homes during the COVID-19 Pandemic                                       15
               CMS and CDC Took Actions to Strengthen Infection Prevention
                  and Control but Should Do More                                           21
               Conclusions                                                                 33
               Recommendations for Executive Action                                        33
               Agency Comments and Our Evaluation                                          34

Appendix I     Related GAO Products on COVID-19 in Nursing Homes                           38



Appendix II    Examples of Infection Prevention and Control Deficiencies Cited
               in Nursing Homes during the Pandemic                                        39



Appendix III   Types of Surveys and Investigations to Assess Whether
               Nursing Homes Are Meeting Federal Standards                                 40



Appendix IV    Number and Percentage of Surveyed Nursing Homes with Infection
               Prevention and Control (IPC) Deficiencies                                   44



Appendix V     Federal Nursing Home Infection Prevention and Control (IPC) Actions 45



Appendix VI    Comments from the Department of Health and Human Services                   49



Appendix VII   GAO Contact and Staff Acknowledgments                                       55




               Page i                              GAO-22-105133 Nursing Home Infection Control
Tables
          Table 1: Selected Federal Infection Prevention and Control (IPC)
                  Actions and Examples of Stakeholder-Reported
                  Perspectives on Advantages and Disadvantages                       26
          Table 2: Illustrative Examples of Narratives from Infection
                  Prevention and Control Deficiencies Cited in Nursing
                  Homes during the Pandemic                                          39
          Table 3: Number and Percentage of Surveyed Nursing Homes
                  with Infection Prevention and Control (IPC) Deficiencies,
                  by Calendar Year and Deficiency Code                               44
          Table 4: Nursing Home Infection Prevention and Control (IPC)
                  Actions Taken by the Centers for Medicare & Medicaid
                  Services (CMS) and the Centers for Disease Control and
                  Prevention (CDC)                                                   45

Figures
          Figure 1: Percentage of Long-Stay Nursing Home Residents Who
                   Experienced Selected Mental Health Indicators, by Year            11
          Figure 2: Percentage of Long-Stay Nursing Home Residents Who
                   Experienced Selected Physical Health Indicators, by Year          12
          Figure 3: Type of Survey or Investigation Used by State Survey
                   Agencies to Identify Infection Prevention and Control
                   Deficiencies, 2018 through 2021                                   17
          Figure 4: Types of Surveys and Investigations Used by State
                   Survey Agencies to Assess Whether Nursing Homes Are
                   Meeting Federal Standards, as of April 2022                       42




          Page ii                            GAO-22-105133 Nursing Home Infection Control
Abbreviations

CDC               Centers for Disease Control and Prevention
CMS               Centers for Medicare & Medicaid Services
HHS               Department of Health and Human Services
IPC               Infection Prevention and Control




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Page iii                                    GAO-22-105133 Nursing Home Infection Control
                       Letter




441 G St. N.W.
Washington, DC 20548




                       September 14, 2022

                       Congressional Addressees

                       Infection prevention and control (IPC) has been a long-standing concern
                       in the nation’s more than 15,000 Medicare- and Medicaid-certified nursing
                       homes—one the COVID-19 pandemic has brought into sharper focus. 1
                       Prior to the COVID-19 pandemic, infections were a leading cause of
                       death and hospitalization among nursing home residents, with estimates
                       of up to 380,000 residents dying each year. 2 Since that time, COVID-19
                       has emerged as a new and highly contagious respiratory disease that has
                       had devastating consequences for the nation’s more than one million
                       nursing home residents, including high rates of severe illness and death.
                       COVID-19 has also substantially affected the broader nursing home
                       industry, including nursing home staff. The initial unknown nature of the
                       virus that causes COVID-19 and the scope of the pandemic also created
                       unprecedented challenges for state and federal agencies that work to
                       ensure the quality of care delivered in nursing homes and to protect
                       public health. 3

                       In our previous reporting, we found that, in the years prior to the
                       pandemic, nursing homes had persistent and widespread challenges with
                       IPC. 4 For example, we found that implementing proper IPC practices,
                       such as isolating infected residents, can be critical for preventing the
                       spread of infectious diseases, including COVID-19—thus protecting both
                       resident and staff health and well-being. However, some IPC practices in


                       1According to the Centers for Disease Control and Prevention, IPC protects patients,
                       residents, healthcare personnel, and visitors by preventing healthcare-associated
                       infections and limiting the spread of pathogens through the implementation of evidence-
                       based interventions.
                       2Department of Health and Human Services, The National Action Plan to Prevent Health
                       Care-Associated Infections: Road Map to Elimination (Washington, D.C.: 2013).
                       3As GAO has previously reported, during the COVID-19 pandemic, nursing homes
                       experienced high staff cases and deaths and challenges related to staffing, personal
                       protective equipment, and testing. See, for example, GAO, COVID-19: Federal Efforts
                       Could Be Strengthened by Timely and Concerted Actions, GAO-20-701 (Washington,
                       D.C.: Sept. 21, 2020).
                       4GAO, Infection Control Deficiencies Were Widespread and Persistent in Nursing Homes
                       Prior to COVID-19 Pandemic, GAO-20-576R (Washington, D.C.: May 20, 2020).




                       Page 1                                     GAO-22-105133 Nursing Home Infection Control
nursing homes, such as social isolation, may negatively affect resident
mental and physical health. 5

The Department of Health and Human Services (HHS), primarily through
the Centers for Medicare & Medicaid Services (CMS) and the Centers for
Disease Control and Prevention (CDC), has led the response to the
COVID-19 pandemic in nursing homes. CMS is the federal oversight
agency responsible for ensuring that nursing homes meet federal quality
standards to be eligible to participate in the Medicare and Medicaid
programs. These standards require, for example, that nursing homes
establish and maintain an IPC program. To monitor compliance with
these standards, CMS enters into agreements with state survey agencies
in each state government and oversees the work the state survey
agencies do. CDC issues guidance with recommendations for preventing
and managing infectious diseases, operates infectious disease
surveillance systems, and provides technical assistance through
programs aimed at supporting and assessing IPC in nursing homes, and
tracking IPC data.

The CARES Act includes a provision directing us to monitor the federal
response to the COVID-19 pandemic. 6 Further, you also asked us to
examine federal oversight of IPC protocols and the adequacy of
emergency preparedness standards for emerging infectious diseases in
nursing homes, as well as CMS’s response to the pandemic. Since 2020,
we have examined the response to COVID-19 in nursing homes in
multiple studies. Some studies have been completed and released and
others are ongoing. (See app. I for a list of completed related reports.)

In this report, we: (1) describe what data reveal about any changes in
resident mental and physical health before and during the COVID-19
pandemic, (2) describe whether IPC challenges have persisted in nursing
homes during the pandemic, and (3) examine the IPC actions that CMS



5National Academies of Sciences, Engineering, and Medicine, Social Isolation and
Loneliness in Older Adults: Opportunities for the Health Care System (Washington, D.C.:
The National Academies Press, 2020).
6Pub. L. No. 116-136, § 19010(b), 134 Stat. 281, 580 (2020). Throughout the pandemic,
we regularly issued government-wide reports on the federal response to COVID-19. All
government-wide reports are available on GAO’s website at
https://www.gao.gov/coronavirus.




Page 2                                     GAO-22-105133 Nursing Home Infection Control
and CDC have taken related to nursing homes before and during the
pandemic.

To describe what data reveal about any changes in resident mental and
physical health before and during the COVID-19 pandemic, we analyzed
2018 through 2021 CMS Minimum Data Set resident assessment data. 7
We compared selected health indicators across calendar years for all
long-stay residents who had lived in the nursing home greater than 100
days. 8 We selected four mental and four physical health indicators to
analyze based on indicators highlighted in our review of relevant literature
and during conversations with knowledgeable stakeholders. 9 Then, using
each resident’s calendar year assessments, we determined the
percentage of residents experiencing each selected health indicator. 10 We
analyzed the data in the CMS Minimum Data Set as they were reported
by nursing homes to CMS. We did not otherwise independently verify the
accuracy of the information with these nursing homes. We assessed the
reliability of the dataset by checking for missing values and obvious
errors, reviewing relevant CMS documents, and reviewing other studies

72021 was the most recent calendar year available at the time of our analysis.

The CMS Minimum Data Set is reported by nursing homes, which are required to
complete resident assessments at regular intervals as part of federal requirements to
participate in the Medicare and Medicaid programs. Nursing homes are required to
conduct resident assessments at entry, quarterly, at discharge, and if there are any
significant changes or corrections. During standard surveys, surveyors can evaluate
whether a nursing home’s assessments meet federal standards for accuracy.
8The same resident may have lived in the home for multiple years and would therefore be
present in each calendar year. Most nursing homes provide both long-term residential and
short-term rehabilitative care.

According to CMS, the number of nursing home residents declined sharply during the
pandemic.
9For example, see M. Levere, P. Rowan, A. Wysocki, “The Adverse Effects of the COVID-
19 Pandemic on Nursing Home Resident Well-Being,” JAMDA, vol. 22, no. 5 (2021): 948-
954 and L. Fleisher et al., “Health Care Safety During the Pandemic and Beyond—
Building a System That Ensures Resilience,” The New England Journal of Medicine, vol.
386, no. 7 (2022): 609-611.
10The mental health indicators we selected and analyzed included whether, on any
assessment in a given calendar year, a resident had any symptoms of depression or took
anti-depressant, anti-psychotic, or anti-anxiety medications. The physical health indicators
we selected and analyzed included whether, on any assessment in a given calendar year,
a resident experienced at least one fall, unexplained weight loss, urinary incontinence
ranging from occasionally incontinent to always incontinent, or at least one or more stage
1 or higher unhealed pressure ulcers.




Page 3                                       GAO-22-105133 Nursing Home Infection Control
that used these data and identified some limitations of our analysis. 11
Based on this review, we determined the data were sufficiently reliable for
the purposes of this reporting objective. We also conducted interviews
with officials from a non-generalizable sample of nine selected nursing
homes in eight selected states: Arkansas, California, Florida, Maryland,
Michigan, Montana, Rhode Island, and Washington. 12 These states were
selected based on three criteria: (1) geographic location; (2) number of
nursing home beds; and (3) number of nursing home residents and staff
with confirmed positive cases of COVID-19. 13 We then selected nursing
homes to obtain variation in factors such as bed count and profit or not-
for-profit status. We asked nursing home officials to describe resident
mental and physical health during the pandemic. Additionally, we
interviewed national associations, including the American Health Care
Association and National Consumer Voice for Quality Long-Term Care,
about these issues.

To describe whether IPC challenges have persisted in nursing homes
during the pandemic, we analyzed CMS data on nursing home
deficiencies cited by state surveyors in all 50 states and Washington,



11Some studies have found that the Minimum Data Set data reported by nursing homes
underreports anti-psychotic use and falls. Therefore, it is possible that our analysis also
underreports these health indicators. For examples, see HHS Office of Inspector General,
CMS Could Improve the Data It Uses to Monitor Antipsychotic Drugs in Nursing Homes,
OEI-07-19-00490 (Washington, D.C.: May 3, 2021) and J. Mintz et al., “Validation of the
Minimum Data Set Items on Falls and Injury in Two Long-Stay Facilities,” Journal of the
American Geriatrics Society, vol. 69, no. 4 (April 2021). Unless the rate of underreporting
changed during the pandemic, the analysis of change over time would still likely be
broadly valid.

In addition, as the pandemic progressed, it is possible that nursing homes had to delay
submitting their resident assessments if, for example, they were responding to a COVID-
19 outbreak. In March 2020, CMS waived the timeframe requirements for nursing homes
to complete and transmit resident assessments in order to allow nursing homes to focus
on infection control efforts. However, these timeframes were re-instated by CMS in April
2021. According to CMS, the majority of nursing homes were completing and transmitting
their assessments in a timely fashion. This is consistent with our analysis, where we
determined that less than 10 percent of nursing home quarterly assessments were
delayed in each year of our review. See Centers for Medicare & Medicaid Services,
Updates to Long-Term Care Emergency Regulatory Waivers Issued in Response to
COVID-19, QSO-21-17-NH (Baltimore, Md.: April 8, 2021).
12In Washington State, we interviewed officials from two nursing homes, while in the other
states, we interviewed officials from one home in each state.
13COVID-19 case rates were for the week ending May 16, 2021.




Page 4                                      GAO-22-105133 Nursing Home Infection Control
D.C., from 2018 through 2021. 14 Using these data, we analyzed the
deficiency codes used by state surveyors when a nursing home fails to
meet CMS’s requirements for IPC. We also used CMS’s Quality,
Certification, and Oversight Reports website to obtain high-level summary
data on the percentage of nursing homes with an overdue standard
survey. 15 We assessed the reliability of these datasets by checking for
missing values and obvious errors and reviewing relevant CMS
documents and determined the data were sufficiently reliable for the
purposes of this reporting objective. We also conducted interviews with
state survey agency officials and nursing home officials in the non-
generalizable sample of eight states described above. We asked
interviewees to describe the extent to which IPC challenges persisted in
nursing homes and how they have responded.

To examine the IPC actions that CMS and CDC have taken related to
nursing homes before and during the pandemic, we reviewed CMS and
CDC regulations and guidance. We also interviewed officials at CMS and
CDC and officials from state survey agencies and nine nursing homes in
the non-generalizable sample of eight states described above, as well as
officials from the national associations with knowledge of nursing home
issues previously noted. We determined that the control environment
component of internal control was significant to this objective, along with
the underlying principle that management should establish expectations
of competence for key roles. We also determined that the risk
assessment component of internal control was significant to this
objective, along with the underlying principle that management should
define objectives clearly to enable the identification of risks and define
risk tolerances. Finally, we determined that the information and
communication component of internal control was significant to this
objective, along with the underlying principle that management should
use quality information to achieve the entity’s objectives. We assessed
CMS’s oversight activities implemented leading up to and during the
COVID-19 pandemic in the context of these internal control principles, as
well as HHS statutory requirements, CMS regulatory requirements for

142021 was the most recent calendar year available at the time of our analysis.

In addition, we used the CMS Care Compare Inspection Date files, which were accessed
on March 28, 2022 from https://data.cms.gov/provider-data/dataset/svdt-c123.
15CMS’s Quality, Certification, and Oversight Reports system is a website that provides
summary-level data reports on nursing homes. This system is available at
https://qcor.cms.gov and was accessed on April 7, 2022.




Page 5                                      GAO-22-105133 Nursing Home Infection Control
                        nursing home participation in Medicare and Medicaid programs, and
                        CMS’s State Operations Manual, to determine whether these oversight
                        actions were clearly defined and understood to enable nursing homes
                        and state survey agencies to address the risk posed by COVID-19; and
                        whether the agency has access to quality information about whether its
                        oversight actions were achieving their stated objectives. 16

                        We conducted this performance audit from April 2021 to September 2022
                        in accordance with generally accepted government auditing standards.
                        Those standards require that we plan and perform the audit to obtain
                        sufficient, appropriate evidence to provide a reasonable basis for our
                        findings and conclusions based on our audit objectives. We believe that
                        the evidence obtained provides a reasonable basis for our findings and
                        conclusions based on our audit objectives.

                        Federal law requires nursing homes to keep residents safe from
Background              infectious diseases by establishing and maintaining an IPC program
                        designed to help prevent the development and transmission of
                        communicable diseases and infections. 17

Infections in Nursing   Even before COVID-19, nursing home residents were at a high risk for
Homes                   several different types of infections, including respiratory infections,
                        gastroenteritis, skin and soft tissue infections, and urinary tract infections.
                        Nursing home residents can be particularly susceptible to infections
                        because of their advanced age and higher risk of comorbidities. 18 Further,
                        nursing home residents are increasingly requiring more medically
                        complex care and are therefore more susceptible to infection. For
                        example, residents discharged from the hospital back to the nursing

                        16Federal law establishes minimum requirements nursing homes must meet to participate
                        in the Medicare and Medicaid programs, and designates the HHS Secretary as
                        responsible to ensure that requirements governing the provision of care in nursing homes,
                        and the enforcement of such requirements, are adequate to protect the health, safety,
                        welfare, and rights of residents and promote the effective and efficient use of public
                        moneys. 42 U.S.C. §§ 1395i-3(f)(1),1396r(f)(1); 42 C.F.R. §§ 483.1--483.95 (2021).
                        GAO, Standards for Internal Control in the Federal Government, GAO-14-704G
                        (Washington, D.C.: Sept. 10, 2014). Internal control is a process effected by an entity’s
                        oversight body, management, and other personnel that provides reasonable assurance
                        that the objectives of an entity will be achieved.
                        1742 U.S.C. §§ 1395i-3(d)(3)(A), 1396r(d)(3)(A); 42 C.F.R. § 483.80 (2021).

                        18Comorbidity refers to the presence of more than one distinct disease in a person at the
                        same time.




                        Page 6                                       GAO-22-105133 Nursing Home Infection Control
                       home can bring infections into the home. They may also require a high-
                       degree of clinical monitoring in order to identify and prevent infection and
                       to help prevent the spread of resistant pathogens between residents. In
                       addition, while nursing homes create important social opportunities for
                       residents through communal dining and recreational spaces, these
                       shared spaces can increase the transmission risk for infectious diseases,
                       especially viruses causing respiratory or gastrointestinal outbreaks.

                       The COVID-19 pandemic has led to high rates of infection and death in
                       nursing home residents and staff. Nursing home residents are at
                       increased risk because older adults and those with underlying health
                       conditions have a high mortality rate when infected with the virus,
                       according to CDC. 19 In addition, the congregate nature of nursing
                       homes—with staff caring for multiple residents and residents sharing
                       rooms and other communal spaces—can increase the risk that COVID-19
                       will enter the home and easily spread. 20 The introduction of COVID-19
                       vaccines in December 2020 resulted in a sharp decline in nursing home
                       cases and deaths through the first part of 2021; however, cases and
                       deaths began to increase again with the emergence of more highly
                       transmissible virus variants during the summer of 2021, coinciding with
                       the emergence of the Delta variant, and again in winter 2022, coinciding
                       with the emergence of the Omicron variant.

Federal Oversight of   Federal laws establish minimum requirements nursing homes must meet
Nursing Homes          to participate in the Medicare and Medicaid programs, including
                       standards for the quality of care. 21 Primarily through its State Operations
                       Manual, CMS establishes the responsibilities of state survey agencies in
                       ensuring that these federal quality standards for nursing homes are met,

                       19Centers for Disease Control and Prevention, COVID-19: People Who Live in a Nursing
                       Home or Long-Term Care Facility, accessed on May 7, 2022,
                       https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-in-nursing-ho
                       mes.html.
                       20According to CDC, COVID-19 is spread in three main ways: (1) breathing in small
                       droplets or particles exhaled by an infected person (2) having these small droplets and
                       particles land on the eyes, nose, or mouth, especially through a cough or a sneeze (3)
                       touching eyes, nose, or mouth with hands that have the virus on them. See Centers for
                       Disease Control and Prevention, How COVID-19 Spreads, accessed on April 16, 2022,
                       https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.
                       2142 U.S.C. §§ 1395i-3, 1396r; 42 C.F.R. §§ 483.1--483.95 (2021). Federal statutes and
                       their implementing regulations use the terms “skilled nursing facility” (Medicare) and
                       “nursing facility” (Medicaid). For the purposes of this report, we use the term nursing home
                       to refer to both skilled nursing facilities and nursing facilities.




                       Page 7                                      GAO-22-105133 Nursing Home Infection Control
such as that nursing homes establish and maintain an IPC program. 22 To
monitor compliance with these standards, CMS enters into agreements
with state survey agencies in each state to assess whether nursing
homes meet CMS’s standards. Prior to the pandemic, state surveyors
from the state survey agencies were responsible for assessing nursing
homes using (1) recurring comprehensive standard surveys, or (2) as-
needed investigations for complaints from the public and facility-reported
incidents.

•   Standard surveys. State survey agencies are required by federal law
    to perform unannounced, on-site standard surveys of every nursing
    home receiving Medicare or Medicaid payment at least every 15
    months, with a statewide average frequency of every 12 months. 23
    Standard surveys are important for protecting nursing home residents
    because they serve as a comprehensive assessment of the safety
    and quality of nursing home care across several areas including food
    and nutrition, resident rights, physician and nursing services, and the
    physical environment.
•   Investigations. In addition to performing standard surveys, state
    survey agencies are required by federal law to investigate all
    complaints of nursing home violations of requirements. 24 These fall
    into two categories: (1) complaints submitted by residents, family
    members, friends, physicians, and nursing home staff; and (2)
    “facility-reported incidents” that are self-reported by the nursing
    homes. These investigations offer the state survey agency a unique
    opportunity to identify and correct care problems, as they can provide
    a timely alert of acute issues that otherwise might not be addressed
    until a standard survey takes place.

If a surveyor from a state survey agency determines that a nursing home
violated a federal standard during a survey or investigation, the nursing

22At a minimum, nursing homes must (1) have a system to prevent, identify, report,
investigate, and control infections and communicable diseases for all residents, staff,
volunteers, visitors, and others providing services in the home; (2) have written standards,
policies, and procedures for their infection prevention and control program; (3) have
antibiotic use protocols and a system to monitor antibiotic use; and (4) have a system for
recording incidents identified under the home’s infection prevention and control program
and any corrective actions taken. 42 C.F.R. § 483.80(a)(1)-(4) (2021).
2342 U.S.C. §§ 1395i-3(g)(1)(A), (g)(2)(A)(iii), 1396r(g)(1)(A), (g)(2)(A)(iii); 42 C.F.R. §
488.308(a)-(b) (2021).
2442 U.S.C. §§ 1395i-3(g)(4), 1396r(g)(4); 42 C.F.R. § 488.332(a) (2021).




Page 8                                         GAO-22-105133 Nursing Home Infection Control
                 home is cited for the deficiency using a specific deficiency code (referred
                 to as an F-tag). Cited deficiencies are then classified into categories
                 according to scope (the number of residents potentially affected) and
                 severity (the potential for or occurrence of harm to residents). For most
                 cited deficiencies, nursing homes are required to submit a plan of
                 correction that addresses how the home plans to correct the
                 noncompliance and implement systemic change to ensure the deficient
                 practice would not recur. 25 In addition, when nursing homes are cited with
                 deficiencies, federal enforcement actions can be implemented to
                 encourage homes to make corrections. 26 In general, for deficiencies with
                 a higher scope and severity, CMS may implement the enforcement action
                 immediately. 27 For other deficiencies with a lower scope and severity, the
                 nursing home may be given an opportunity to correct the deficiencies,
                 which, if corrected before the scheduled effective date, can result in the
                 planned enforcement action not being implemented.

                 In 2016, CMS finalized a comprehensive update to its nursing home
                 standards. 28 The update included new requirements and aligned existing
                 requirements with current clinical practices. These standards covered a
                 variety of categories, such as quality of care and IPC.

Prior GAO Work   We have issued several reports examining COVID-19 in nursing homes,
                 part of our larger bodies of work on nursing home oversight and on the
                 federal response to the COVID-19 pandemic (see app. I.) For example, in
                 May 2020, we analyzed CMS deficiency data and found that most nursing

                 25The plan of correction serves as the nursing home’s allegation of compliance.
                 Depending on the severity of the deficiency cited, surveyors revisit the nursing home to
                 ensure that the home actually implemented its plan and corrected the deficiency.
                 26CMS does not require enforcement actions be implemented for all deficiencies.
                 Enforcement actions include, but are not limited to, directed in-service training, fines
                 known as civil money penalties, denial of payment, and termination from the Medicare and
                 Medicaid programs.
                 27The scope and severity of a deficiency is one of the factors that CMS may take into
                 account when implementing enforcement actions. CMS may also consider a nursing
                 home’s prior compliance history, desired corrective action and long-term compliance, and
                 the number and severity of all the nursing home’s deficiencies.
                 28Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care
                 Facilities, 81 Fed. Reg. 68,688 (Oct. 4, 2016). Phase 1 (effective November 28, 2016)
                 implemented most minor modifications to the existing nursing home regulations; phase 2
                 (effective November 28, 2017) implemented new regulations and re-structured CMS’s
                 deficiency code system; and phase 3 (effective November 28, 2019) implemented the
                 remaining requirements.




                 Page 9                                      GAO-22-105133 Nursing Home Infection Control
                      homes were cited for IPC deficiencies, such as failure to use proper hand
                      hygiene, in the years prior to the COVID-19 pandemic. 29 In addition,
                      during the COVID-19 pandemic, most nursing homes had multiple
                      outbreaks and weeks of sustained COVID-19 transmission from May
                      2020 through January 2021. 30 In response to the CARES Act, we have
                      examined the federal response to COVID-19 in nursing homes in multiple
                      reports, where we reported on nursing home-related actions HHS had
                      taken in response to the pandemic, as well as challenges nursing homes
                      faced responding to COVID-19.

                      Our analysis of CMS data shows that seven of the eight key indicators of
Some Indicators of    nursing home resident mental and physical health that we reviewed
Resident Mental and   worsened at least slightly in 2020, the first year of the pandemic,
                      compared to the years prior to the pandemic. 31 Six of these key indicators
Physical Health       continued to be worse in the second year of the pandemic than in the
Worsened during the   years prior to the pandemic. 32 For example, the percentage of residents
COVID-19 Pandemic     who experienced depression was 58.7 percent in 2018, 63.9 percent in
                      2020, and 61.5 percent in 2021. Similarly, the percentage of residents
                      who experienced unexplained weight loss was 14.8 percent in 2018, 19.3
                      percent in 2020, and 17.4 percent in 2021. (See figures 1 and 2.)




                      29See GAO-20-576R.

                      30GAO, COVID-19 in Nursing Homes: Most Homes Had Multiple Outbreaks and Weeks of
                      Sustained Transmission from May 2020 through January 2021, GAO-21-367
                      (Washington, D.C.: May 19, 2021).
                      31During the COVID-19 pandemic, there have been concerns about mental health in the
                      general population. For example, in January 2021, four in 10 U.S. adults reported
                      symptoms of anxiety or depressive disorder, up from one in 10 in 2019. See N. Panchal,
                      R. Kamal, C. Cox, and R. Garfield, The Implications of COVID-19 for Mental Health and
                      Substance Abuse (San Francisco, Calif.: Henry J. Kaiser Family Foundation, 2021).
                      32We observed a large decrease (44 percent) in the number of long-stay nursing home
                      residents between 2018 and 2021 (from about 1.9 million to 1.0 million). CMS officials
                      indicated that they also observed a sharp decline in the number of nursing home residents
                      during the pandemic. It is likely that more residents left nursing homes or passed away
                      during the pandemic, either due to COVID-19 or other factors, compared to prior years. It
                      is unclear whether the residents who remained in nursing homes during the pandemic in
                      2020 and 2021 had different health issues than residents who lived in nursing homes prior
                      to the pandemic.




                      Page 10                                    GAO-22-105133 Nursing Home Infection Control
Figure 1: Percentage of Long-Stay Nursing Home Residents Who Experienced
Selected Mental Health Indicators, by Year




Notes: Long-stay residents are those living in a nursing home for greater than 100 days. The data in
the Minimum Data Set are self-reported to CMS by nursing homes. “Experienced depression”
indicates whether a resident had any symptoms of depression on any assessment in a given calendar
year. “Took anti-depressant medications,” “took anti-psychotic medications,” and “took anti-anxiety
medications” indicates if, on any assessment in a given calendar year, a resident took anti-
depressant, anti-psychotic, or anti-anxiety medications in the prior 7 days before the assessment or, if
less than 7 days, since admission.




Page 11                                           GAO-22-105133 Nursing Home Infection Control
Figure 2: Percentage of Long-Stay Nursing Home Residents Who Experienced
Selected Physical Health Indicators, by Year




Notes: Long-stay residents are those living in a nursing home for greater than 100 days. The data in
the Minimum Data Set are self-reported to CMS by nursing homes. “Experienced at least one fall”
indicates if, on any assessment in a given calendar year, a resident experienced at least one fall
since the prior assessment or since admission, whichever was more recent. “Experienced
unexplained weight loss” indicates if, on any assessment in a given calendar year, a resident
experienced weight loss of 5 percent or more in the last month or 10 percent or more in the last six
months. “Experienced incontinence” indicates if, on any assessment in a given calendar year, a
resident experienced urinary incontinence ranging from occasionally incontinent to always
incontinent. “Experienced at least one pressure ulcer” indicates if, on any assessment in a given
calendar year, a resident had at least one or more stage 1 or higher unhealed pressure ulcers.




Page 12                                          GAO-22-105133 Nursing Home Infection Control
The results of our data analysis were supported by our interviews with
nursing home officials in selected states, who told us they observed
worsening resident mental and physical health during the COVID-19
pandemic. Specifically, for resident mental health, officials from some
nursing homes we interviewed told us they observed more residents who
experienced depression, as well as more residents who took anti-
psychotic medication. Nursing home officials and national organizations
we interviewed attributed this in part to the isolation residents felt from the
limitations CMS placed on visitation or group activities in nursing homes
during the pandemic to limit the transmission of COVID-19. CMS initially
restricted visitation and suspended group activities in March 2020. After
the initial restrictions, CMS made changes to its guidance multiple times
during the pandemic to allow for more visitation and group activities, while
identifying some situations where limitations would be appropriate to help
prevent COVID-19 infections. In November 2021, all visitation limitations
were fully lifted. 33 According to CDC, these restrictions were intended to
help limit transmission of COVID-19 early in the pandemic, when nursing
homes faced multiple complex challenges, including: understanding a
novel virus, inability to test to detect asymptomatic infected individuals,
variable personal protective equipment supply access, staffing shortages
that made controlled visitation more difficult, increasing cases across the
country with few effective treatments available, and no vaccine
availability.

Nursing home officials in our selected states also told us that they
observed worsening resident physical health during the COVID-19
pandemic. Officials from some of the nursing homes we interviewed told
us they observed more residents who experienced weight loss and falls
when visitation and group activities were limited. One factor contributing
to unintended weight loss by residents may have been that, prior to the
pandemic, visitors assisted some residents with eating. Officials from one
nursing home said that these residents did not eat as well when being fed
by a busy staff member rather than an attentive visitor and thus lost
33These restrictions began in March 2020, were changed in September 2020, March
2021, and April 2021, and were fully lifted for all residents in November 2021. See Centers
for Medicare & Medicaid Services, Guidance for Infection Control and Prevention of
COVID-19 in Nursing Homes, QSO-20-14-NH (Baltimore, Md.: March 13, 2020) and
Centers for Medicare & Medicaid Services, Nursing Home Visitation – COVID-19, QSO-
20-39-NH (Baltimore, Md.: Sept. 17, 2020), revised March 10, 2021, April 27, 2021, and
November 12, 2021. CMS also released question and answer documents to help enable
visitation and frequently asked question documents on visitation, such as this example
published March 10, 2022:
https://www.cms.gov/files/document/nursing-home-visitation-faq-1223.pdf accessed June
8, 2022.




Page 13                                     GAO-22-105133 Nursing Home Infection Control
weight. Officials from another nursing home said that residents were at a
higher risk for falls for various reasons including, for example, they were
alone in their rooms and would try to move independently without staff
assistance or with inadequate staff assistance. According to CMS, some
nursing homes may have been overly restrictive on visitation in a manner
that was inconsistent with CMS guidance. CMS noted that the agency
requires nursing homes to implement care plans for each resident to
attain or maintain the resident’s highest practicable physical, mental, and
psychosocial well-being.

In November 2021, CMS updated its guidance to allow visitation and
group activities with no restrictions, noting that the agency recognized
that physical separation from family had taken a physical and emotional
toll on residents. 34 Officials from some of the nursing homes we
interviewed described seeing a visible improvement in residents once
visitation and group activities were allowed again. For example, officials
from one selected nursing home said that depression decreased and
residents began eating better.

There may be other factors that have contributed to worsening resident
mental and physical health during the pandemic. For example, in April
2022, CMS cited significant concerns with the quality of resident care
identified by surveyors, such as weight loss, depression, and pressure
ulcers as a key rationale for its plans to end certain emergency blanket
waivers issued during the pandemic, such as waived training
requirements for certified nurse aides. 35 In addition, according to one
study we reviewed, changes in nursing home resident well-being could be
the result of a variety of causes, including the direct effects of being sick
with COVID-19, fears associated with contracting the virus, grief from
losing friends and loved ones, changes in care practices, such as the




34See Centers for Medicare & Medicaid Services, QSO-20-39-NH (November 12, 2021
revision).
35CMS noted that by waiving these training requirements, certified nurse aides may not
have received the necessary training to, for example, help identify and prevent weight loss
in residents. As a result, CMS stated that the agency is concerned about how residents’
health and safety has been impacted by the regulations that have been waived. See
Centers for Medicare & Medicaid Services, Update to COVID-19 Emergency Declaration
Blanket Waivers for Specific Providers, QSO-22-15-NH (Baltimore, Md.: April 7, 2022).




Page 14                                     GAO-22-105133 Nursing Home Infection Control
                            declines in the provision of therapy, and other policies put in place to limit
                            the spread of the virus. 36

                            The percentage of nursing homes cited for infection prevention and
Infection Prevention        control deficiencies during the COVID-19 pandemic was generally
and Control                 consistent with the years prior. Nursing homes received IPC deficiencies
                            during the COVID-19 pandemic in 2020 and 2021 for failing to follow
Deficiencies                basic practices, such as proper handwashing, but also for failing to follow
Persisted in Nursing        COVID-19-specific practices. Officials from the state survey agencies we
                            interviewed said the most persistent IPC challenges in nursing homes
Homes during the            during the pandemic were often attributed to staffing challenges. Despite
COVID-19 Pandemic           these challenges, stakeholders we interviewed said that nursing homes
                            had gained valuable knowledge about IPC during the pandemic.

The Percentage of           Our analysis of CMS data shows that the percentage of nursing homes
Nursing Homes Cited for     cited for infection prevention and control deficiencies in 2020 and 2021
                            was generally consistent with the years prior. 37 Specifically, about 44
Infection Prevention and
                            percent of nursing homes were cited for at least one IPC deficiency in
Control Deficiencies        2020, which decreased to about 37 percent in 2021. Prior to the
during the Pandemic Was     pandemic, in 2018 and 2019, about 43 percent of nursing homes were
Generally Consistent with   cited for at least one IPC deficiency. We also previously reported that, in
Prior Years                 each year from 2013 through 2017, the percent of all nursing homes
                            inspected by state surveyors with an IPC deficiency ranged from 39 to 41
                            percent. 38

                            According to most of the state survey agency officials we interviewed and
                            our review of IPC deficiency narratives written by state surveyors, nursing
                            homes received IPC deficiencies during the pandemic for failing to follow
                            basic IPC practices, such as proper handwashing and personal protective
                            equipment usage, but some state survey officials noted that nursing
                            homes also received IPC deficiencies for failing to follow COVID-19-
                            specific practices such as failing to quarantine and isolate COVID-19
                            positive residents. (See app. II for illustrative examples of IPC
                            deficiencies.) When examining the severity of the deficiencies cited, we

                            36See M. Levere, P. Rowan, A. Wysocki, “The Adverse Effects of the COVID-19
                            Pandemic on Nursing Home Resident Well-Being,” JAMDA, vol. 22, no. 5 (2021): 948-
                            954.
                            37For this analysis, we analyzed the deficiency code F-880 for nursing homes that were
                            cited for not meeting federal standards for establishing and maintaining an IPC program.
                            38See GAO-20-576R.




                            Page 15                                     GAO-22-105133 Nursing Home Infection Control
found that in 2018 and 2019, only 1 percent of IPC deficiencies were
classified at a high severity where the surveyor determined that residents
were harmed or in immediate jeopardy of being harmed. 39 However,
during the pandemic in 2020 and 2021, this increased to about 8 and 4
percent, respectively.

CMS put greater emphasis on IPC when it temporarily suspended
standard surveys and introduced focused infection control surveys
beginning in March 2020. (See app. III for more information on the
focused infection control survey and the next finding for how it fits in with
other actions CMS took during the pandemic.) While the enhanced
scrutiny of IPC through CMS’s focused infection control survey does not
appear to have resulted in a greater percentage of nursing homes being
cited by surveyors for IPC deficiencies during the pandemic compared to
prior years, the focused infection control surveys were the key source of
IPC deficiencies in 2020. 40 Specifically, our analysis of the CMS data
showed that, prior to the pandemic, the vast majority of IPC deficiencies
were identified during standard surveys (about 84 percent in 2018 and



39This is consistent with our prior reporting, where we found that, in each year from 2013
through 2017, nearly all IPC deficiencies (about 99 percent in each year) were classified
by surveyors as not severe, meaning the surveyor determined that residents were not
harmed. See GAO-20-576R.
IPC deficiencies were also categorized by scope—whether the incident was an isolated
occurrence, a part of a pattern of behavior, or a widespread behavior. In 2018 and 2019,
about 50 percent of IPC deficiencies cited were categorized as isolated, about 30 percent
categorized as a pattern, and about 14 percent categorized as widespread. In 2020 and
2021, about 35 percent of IPC deficiencies cited were categorized as isolated, about 40
percent were categorized as pattern, and about 20 percent were categorized as
widespread. Percentages do not add to 100 due to rounding.
40In January 2021 and again in November 2021, CMS gave state survey agencies more
capacity to conduct additional standard surveys by changing the criteria for how often a
focused infection control survey must be conducted, after a year of state survey agencies
mainly conducting the more frequent focused infection control surveys. See Centers for
Medicare & Medicaid Services, COVID-19 Survey Activities, CARES Act Funding,
Enhanced Enforcement for Infection Control Deficiencies, and Quality Improvement
Activities in Nursing Homes, QSO-20-31-ALL (Baltimore, Md.: June 1, 2020) (revised
January 4, 2021) and Centers for Medicare & Medicaid Services, Changes to COVID-19
Survey Activities and Increased Oversight in Nursing Homes, QSO-22-02-ALL (Baltimore,
Md.: Nov. 12, 2021). Nursing homes could be inspected multiple times in a calendar year
with a focused infection control survey, depending on the number of outbreaks. On
average, nursing homes had four focused infection control surveys in 2020 and three in
2021. In each year from 2018 through 2021, nursing homes had, on average, two
complaint or facility-reported incident investigations and one standard survey.




Page 16                                     GAO-22-105133 Nursing Home Infection Control
2019). 41 In contrast, in 2020, which encompasses the period when
standard surveys were temporarily suspended, the majority of IPC
deficiencies were identified during focused infection control surveys—60
percent in 2020, which decreased to 31 percent in 2021. Further, as the
percentage of IPC deficiencies identified during standard surveys
dropped during the pandemic, the percentage of IPC deficiencies
identified during complaint or facility-reported incident inspections
increased from about 16 percent in 2018 and 2019, to 26 percent in 2020
and 29 percent in 2021. (See fig. 3.)

Figure 3: Type of Survey or Investigation Used by State Survey Agencies to Identify
Infection Prevention and Control Deficiencies, 2018 through 2021




Notes: For 352 of the 34,522 IPC deficiencies cited from 2018 through 2021 (about 1 percent), we
were unable to determine from CMS’s data whether the deficiency was identified during a standard
survey, complaint or facility-reported incident investigation, or focused infection control survey. We
excluded these deficiencies from our percentages.




41For 352 of the 34,522 IPC deficiencies cited from 2018 through 2021 (about 1 percent),
we were unable to determine from CMS’s data whether the deficiency was identified
during a standard survey, complaint or facility-reported incident investigation, or focused
infection control survey. We excluded these deficiencies from our percentages.




Page 17                                            GAO-22-105133 Nursing Home Infection Control
CMS’s suspension of standard surveys and shift to prioritizing the new
focused infection control survey in 2020 was a factor contributing to
standard survey backlogs in some states due to the growing number of
nursing homes exceeding the federal standard of 15 months without a
standard survey. 42 According to CMS data, as of April 2022, about 40
percent of nursing homes went at least 16 months without receiving a
standard survey. 43 Our review of CMS data found that about 95 percent of
nursing homes had a standard survey conducted in each of the 2 years
we examined prior to the pandemic. During the pandemic, only 28
percent of nursing homes had a standard survey in 2020 while nearly all
homes had at least one focused infection control survey, resulting in half
as many total deficiencies as prior to the pandemic. In 2021, about 57
percent of nursing homes had a standard survey, and about 80 percent of
nursing homes had at least one focused infection control survey, but the
resulting number of total deficiencies cited by surveyors was still about
one-quarter less than pre-pandemic levels. 44 This may be because the
standard survey provides a comprehensive assessment across multiple
areas of a nursing home’s safety and quality of care, while the focused
infection control survey is more narrowly scoped to assess a nursing
home’s IPC practices in light of COVID-19.

Our analysis of CMS data shows that a smaller percentage of nursing
homes were cited for eight other IPC deficiency codes during the time

42According to CMS, some state survey agencies had staffing issues during the pandemic
that hindered their ability to conduct standard surveys, including staff reassignments and
retirements, which also contributed to the backlog. For example, CMS officials said that
many states had to pull their surveyors, most of whom were nurses, from their survey
roles and deploy them to provide direct care to community residents or to fill other clinical
roles in response to the pandemic. Also, many state survey agencies saw an increase in
complaint allegations that needed to be investigated, which took resources away from
conducting standard surveys.
43This is a decrease from May 2021, when the HHS Office of Inspector General reported
that 71 percent of nursing homes had gone at least 16 months without receiving a
standard survey. See HHS Office of Inspector General, States’ Backlogs of Standard
Surveys of Nursing Homes Grew Substantially During the COVID-19 Pandemic, OEI-01-
20-00431 (Washington, D.C.: July 27, 2021). One factor contributing to this decrease
could be the steps CMS announced in November 2021 to assist state survey agencies in
addressing the backlog of standard surveys, such as by revising the criteria for conducting
a focused infection control survey and guidance for resuming standard surveys. See
Centers for Medicare & Medicaid Services, QSO-22-02-ALL (Nov. 12, 2021).
44The percentage of nursing homes with a complaint or facility-reported incident
investigation was about 53 percent in 2018, about 56 percent in 2019, about 45 percent in
2020, and about 52 percent in 2021.




Page 18                                      GAO-22-105133 Nursing Home Infection Control
                           period examined. 45 Specifically, four of these eight IPC deficiency codes
                           were established by CMS during the pandemic. 46 For example, a
                           deficiency code for not meeting federal standards for informing residents,
                           representatives, and families of COVID-19 cases in a nursing home went
                           into effect in May 2020 and, in 2020 and 2021, less than 3 percent of
                           nursing homes inspected by surveyors were cited for this deficiency code.
                           The remaining four IPC deficiency codes were established by CMS in the
                           years prior to the pandemic. For example, the antibiotic stewardship
                           program deficiency code went into effect in November 2017 and, from
                           2018 through 2021, 5 percent or less of the nursing homes inspected by
                           surveyors were cited for this deficiency code. (See app. IV for additional
                           data on deficiencies cited.)

Selected State Officials   Officials from seven of the eight state survey agencies we spoke to said
Attributed Persistent      that persistent IPC challenges faced by nursing homes during the
                           pandemic, were rooted in staffing challenges, including staffing shortages
Infection Prevention and   and high rates of staff turnover. 47 According to CMS officials, the reasons
Control Challenges to      for staffing shortages can be complex and unclear, ranging from an
Staffing Shortages and     inadequate recruitment pool to management decisions. Officials we
High Turnover              interviewed from four state survey agencies said that, if a nursing home
                           does not have enough staff, it could be challenging for staff to adhere to
                           proper IPC practices, such as taking the time to properly put on and
                           remove personal protective equipment or wash their hands between
                           caring for multiple residents. Officials from one state survey agency we
                           interviewed said that staffing shortages have occurred in nursing homes
                           throughout the pandemic because, for example, employees are out sick.
                           In addition, officials from four nursing homes we interviewed said that
                           they have sought to adhere to CDC guidance recommending a dedicated
                           space in the home, if possible, for residents with confirmed COVID-19


                           45These eight other deficiency codes are F-881 for the antibiotic stewardship program, F-
                           882 for the infection preventionist role, F-883 for influenza and pneumococcal
                           immunization, F-945 for infection control training, F-884 for reporting to the National
                           Healthcare Safety Network, F-885 for reporting to residents, representatives, and family,
                           F-886 for COVID-19 testing for residents and staff, and F-887 for COVID-19
                           immunizations.
                           46See 42 C.F.R. § 483.80(d)(3), (g), (h) (2021).

                           47Even before the COVID-19 pandemic, nursing homes have historically struggled with
                           staffing shortages and high rates of staff turnover. For more, see National Academies of
                           Sciences, Engineering, and Medicine, The National Imperative to Improve Nursing Home
                           Quality: Honoring Our Commitment to Nursing Home Residents, Families, and Staff
                           (Washington, D.C.: The National Academies Press, 2022).




                           Page 19                                      GAO-22-105133 Nursing Home Infection Control
infections, which has resulted in additional staffing needs. 48 Officials from
seven of the nine nursing homes we spoke with said they have
experienced a staffing shortage during the pandemic.

Officials from five of the state survey agencies we spoke with noted that
there had been a lot of staff turnover during the pandemic, which made it
difficult for a home to ensure that new or temporary staff are trained on
IPC. (In response to the pandemic, CMS gave nursing homes more
flexibility in hiring temporary employees to work as nurse aides by
suspending certain training and certification requirements. 49) According to
officials from one state survey agency, some of these temporary
employees had never worked in a nursing home before. Officials from
some nursing homes we interviewed also reported using temporary staff
from nurse staffing agencies. Officials we interviewed from three state
survey agencies said that while nursing homes typically do in-service
training for their own permanent staff, they may not have had the time or
resources to provide the same training to temporary staff during the
pandemic, including staff from nurse staffing agencies. Officials from
seven nursing homes we interviewed noted that this was compounded by
the challenges of keeping staff trained on guidance, which officials said
was constantly changing due to the changing circumstances of the
pandemic.




48CDC guidance specifies that staff should be assigned to work only in this unit when it is
in use and that at a minimum, staff in the COVID-19 unit should include the primary
nursing assistants and nurses assigned to care for these residents. Accessed on
November 8, 2021, https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html.
49Specifically, from March 2020 through June 2022, CMS waived the requirement that a
nursing home not employ anyone for more than 4 months unless they meet certain
training and certification requirements to address potential staffing shortages in nursing
homes due to the COVID-19 pandemic. See Centers for Medicare & Medicaid Services,
COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, (Baltimore,
Md.: March 13, 2020) and Centers for Medicare & Medicaid Services, QSO-22-15-NH
(April 7, 2022).




Page 20                                      GAO-22-105133 Nursing Home Infection Control
Despite Challenges,         Nursing home officials we interviewed from our selected states said that
Nursing Home Officials      nursing homes gained valuable knowledge about IPC practices during the
                            COVID-19 pandemic. For example, nursing home officials said their
from Selected States
                            understanding of the significance and additional application of basic IPC
Reported Gaining            practices—such as the importance of proper handwashing and the proper
Knowledge about Infection   use of personal protective equipment—was enhanced. Officials from one
Prevention and Control      nursing home said that, prior to the pandemic, the home would conduct
Practices during the        an annual IPC “boot camp” training but the pandemic taught them that
                            those IPC skills were easy to forget when they were not constantly put
Pandemic                    into practice. An official from another nursing home said that the IPC
                            lessons that staff learned during the COVID-19 pandemic were applicable
                            to preventing the spread of other types of infections.

                            Nursing home officials we interviewed also described learning new
                            COVID-19 specific practices, such as how to conduct on-site testing, set
                            up quarantine and isolation units, and screen visitors and staff. Officials
                            from one nursing home described developing a process for swabbing and
                            testing nearly 150 staff members for COVID-19 twice a week. Officials
                            from another nursing home said they learned how to work with the design
                            of their building to locate adequate quarantine and isolation spaces.
                            Officials from two other nursing homes described IPC practices they
                            implemented during the pandemic that they hoped to continue going
                            forward. For example, officials from one nursing home said that when the
                            pandemic ends they plan to continue the visitor and staff symptom
                            screening they put in place for COVID-19 to prevent the spread of
                            infections.


CMS and CDC Took
Actions to Strengthen
Infection Prevention
and Control but
Should Do More
CMS and CDC Took            Our review of agency documentation and interviews with agency officials
Numerous Actions on         show that CMS and CDC took numerous actions to improve infection
                            prevention and control both prior to and during the pandemic. For
Infection Prevention and
                            example, prior to the pandemic, CMS required nursing homes to
Control                     designate an infection preventionist on staff and, during the pandemic,
                            CMS and CDC provided infection prevention resources to nursing homes.
                            (See app. V for a full list of IPC actions identified by CMS and CDC.)



                            Page 21                             GAO-22-105133 Nursing Home Infection Control
The infection preventionist role                         Examples of actions CMS and CDC took prior to the COVID-19 pandemic
The infection preventionist is a nursing home            include the following:
employee with training in infection prevention
and control who is responsible for the home’s
program for preventing, identifying, reporting,
                                                         •   Required designated infection preventionist. CMS updated IPC
investigating, and controlling infections and                requirements to include the requirement that nursing homes designate
communicable diseases. Beginning                             at least one infection preventionist to oversee the facility’s IPC
November 2019, the Centers for Medicare &
Medicaid Services (CMS) required all nursing                 program, effective beginning November 2019.
homes to designate one or more infection
preventionists who has completed specialized             •   Developed infection preventionist training. To support the infection
training in infection prevention and control and             preventionist requirement, CMS, in consultation with CDC, developed
who works at the nursing home at least part-                 a free online infection preventionist training program that was
time. Some of the responsibilities of the
infection preventionist may include contact                  available to nursing homes as of March 2019. 50 The specialized
tracing during an infectious disease outbreak,               training provided content covering a range of IPC topics to prepare
reporting surveillance data, and educating
staff on proper adherence to infection                       infection preventionists for their role.
prevention and control practices.
Source: GAO summary of CMS and the Centers for Disease
                                                         •   Conducted IPC pilot program and released Infection Control
Control and Prevention documents. | GAO-22-105133            Worksheet tool. To help assess and prevent infections in nursing
                                                             homes, CMS, in consultation with CDC, conducted a 3-year IPC pilot
                                                             project from fiscal year 2016 through 2018, which used a worksheet
                                                             tool, developed with CDC and expert input, to identify gaps in nursing
                                                             home IPC practices and guide assistance to address those gaps. 51
                                                             CMS released the worksheet as an IPC self-assessment tool to
                                                             nursing homes in November 2019. 52

                                                         Examples of key actions CMS and CDC took during the pandemic include
                                                         the following:

                                                         •   Initiated focused infection control surveys. In March 2020, CMS
                                                             made key changes in how it oversees nursing homes by requiring
                                                             state survey agencies to conduct a new survey type known as the
                                                             focused infection control survey that assessed IPC-related
                                                             requirements specific to COVID-19, such as adherence to visitor


                                                         50See Centers for Medicare & Medicaid Services, Specialized Infection Prevention and
                                                         Control Training for Nursing Home Staff in the Long-Term Care Setting is Now Available,
                                                         QSO-19-10-NH (Baltimore, Md.: March 11, 2019).
                                                         51See Centers for Medicare & Medicaid Services, Infection Control Pilot Project, S&C-16-
                                                         05-ALL (Baltimore, Md.: Dec. 23, 2015).
                                                         52For the pilot, the new survey tool was used for educational purposes rather than to
                                                         assess compliance with existing IPC requirements. After the surveyors assessed the
                                                         participating nursing homes’ IPC practices, the nursing homes were provided with
                                                         technical assistance based on the survey’s results. See Centers for Medicare & Medicaid
                                                         Services, S&C-16-05-ALL (Dec. 23, 2015).




                                                         Page 22                                    GAO-22-105133 Nursing Home Infection Control
    screening and personal protective equipment protocols. 53 (See app.
    III.)
•   Restricted visitation and group activities. In March 2020, to limit
    the transmission of COVID-19, CMS temporarily restricted visitation
    from all visitors and non-essential health care personnel, except for
    certain compassionate care situations and suspended group
    activities. 54 In November 2021, CMS lifted these restrictions. 55
•   Developed IPC-specific training and technical assistance. CMS
    and CDC developed training and technical assistance resources to
    help nursing homes implement IPC practices. For example, in May
    2020, CMS released a toolkit of COVID-19 best practices. 56 In June
    2020, CMS deployed a network of quality improvement organizations
    to provide technical assistance to approximately 3,000 low performing
    nursing homes with a history of infection control challenges. 57
    Beginning in July 2020, CDC deployed “strike teams” of infection
    prevention and public health professionals to nursing homes facing




53CMS continued to require state survey agencies to conduct high-priority complaint
investigations, such as those conducted in response to alleged abuse or neglect. See
Centers for Medicare & Medicaid Services, Prioritization of Survey Activities, QSO-20-20-
ALL (Baltimore, Md.: March 20, 2020).
54These restrictions included ombudsmen, which are advocates for nursing home
residents. These restrictions were later clarified to allow certain conditions for visitation,
such as to allow residents access to long-term care ombudsmen. See Centers for
Medicare & Medicaid Services, QSO-20-14-NH (Mar. 13, 2020 revision) and Centers for
Medicare & Medicaid Services, Nursing Home Five Star Quality Rating System Updates,
Nursing Home Staff Counts, Frequently Asked Questions, and Access to Ombudsman,
QSO-20-28-NH (Baltimore, Md.: April 24, 2020 and Jul. 9, 2020 revision). After the initial
restrictions, CMS made changes to its visitation guidance multiple times during the
pandemic to allow increased visitation and group activities. See Centers for Medicare &
Medicaid Services QSO-20-39-NH (Sept. 17, 2020), revised March 10, 2021 and April 27,
2021.
55See Centers for Medicare & Medicaid Services, QSO-20-39-NH (Nov. 12, 2021
revision).
56See Centers for Medicare & Medicaid Services, CMS Issues Nursing Homes Best
Practices Toolkit to Combat COVID-19, May 13, 2020, accessed April 18, 2022,
https://www.cms.gov/newsroom/press-releases/cms-issues-nursing-homes-best-
practices-toolkit-combat-covid-19.
57See Centers for Medicare & Medicaid Services, QSO-20-31-ALL (June 1, 2020).




Page 23                                       GAO-22-105133 Nursing Home Infection Control
    challenges with infection control. 58 In August 2020, CMS released
    online IPC training courses developed in consultation with CDC.
•   Mandated COVID-19 surveillance reporting. In May 2020, CMS
    required nursing homes to report data at least weekly through CDC’s
    National Healthcare Safety Network on COVID-19 cases and deaths
    among residents and staff, personal protective equipment supplies,
    access to testing, and staff shortages, among other things. 59
•   Increased IPC enforcement actions. In June 2020, CMS increased
    financial and other penalties, such as requiring directed plans of
    correction, for nursing home noncompliance with IPC requirements
    and made enforcement actions more significant for nursing homes
    with a history of past infection control deficiencies. 60




58The strike teams identified challenges related to staffing, personal protective equipment
supplies, COVID-19 testing, and infection prevention and control measure implementation.
See L. Anderson et al., “Protecting Nursing Home Residents from COVID-19: Federal
Strike Team Findings and Lessons Learned,” New England Journal of Medicine Catalyst
(June 28, 2021).
5985 Fed. Reg. 27,550, 27,627 (May 8, 2020) (codified at 42 C.F.R. § 483.80(g)). Until
December 31, 2024, the new requirement provides for these data to be reported at the
federal level through CDC’s National Healthcare Safety Network and to be updated and
publicly reported. Prior to this reporting requirement, state and local health departments
may have required nursing homes to report certain COVID-19 related information to them
as part of their infectious disease surveillance programs. See 42 C.F.R. § 483.80(a)(2)(ii)
(2021). In May 2021, CMS also required nursing homes to report COVID-19 vaccine and
therapeutics treatment information to the CDC’s National Healthcare Safety Network.
Medicare and Medicaid Programs; COVID–19 Vaccine Requirements for Long-Term Care
Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities
Residents, Clients, and Staff, 86 Fed. Reg. 26,306, 26,336 (May 13, 2021) (codified at 42
C.F.R. § 483.80(g)(1)(viii)-(ix)).
60As part of these efforts, CMS encouraged state survey agencies to develop and issue to
noncompliant nursing homes directed plans of correction, as their enforcement action, in
which state survey agencies specify actions a nursing home must take to address
infection control deficiencies, such as obtaining further IPC training or hiring an IPC
consultant. See Centers for Medicare & Medicaid Services, QSO-20-31-ALL (June 1,
2020).
On February 28, 2022, the White House announced that it would lead further efforts to
improve quality and safety in nursing homes through enforcement actions. For example, it
announced a commitment to hold poorly performing nursing homes accountable for
improper and unsafe care by expanding financial penalties and other sanctions and
including more nursing homes in an enhanced oversight program targeting the poorest
performers.




Page 24                                     GAO-22-105133 Nursing Home Infection Control
Stakeholders Reported    Nursing home and state survey agency officials reported to us what they
Advantages and           believed were advantages and disadvantages for selected IPC actions
                         taken before and during the pandemic. For example, state survey agency
Disadvantages of CMS
                         and nursing home officials told us that CMS’s requirement to designate
and CDC Infection        an infection preventionist was crucial to nursing homes during the
Prevention and Control   COVID-19 pandemic. See table 1.
Actions




                         Page 25                           GAO-22-105133 Nursing Home Infection Control
Table 1: Selected Federal Infection Prevention and Control (IPC) Actions and Examples of Stakeholder-Reported Perspectives
on Advantages and Disadvantages

Action                    Description                     Advantages                              Disadvantages
Required designated       The Centers for Medicare &      •   Critical role in nursing homes      •   Requirement needs
infection preventionist   Medicaid Services (CMS)             during the pandemic (eight of           strengthening to ensure
                          updated IPC requirements to         nine nursing homes and five of          sufficient infection preventionist
                          include the designation of          eight state survey agencies)            staffing levels (two of nine
                          infection preventionists.                                                   nursing homes and three of
                                                                                                      eight state survey agencies)
                                                                                                  •   Difficult to hire or retain infection
                                                                                                      prevention professionals in order
                                                                                                      to comply (one of nine nursing
                                                                                                      homes and two of eight state
                                                                                                      survey agencies)
Developed infection       CMS, in consultation with the   •   Training is helpful,                •   Training is time intensive (one of
preventionist training    Centers for Disease Control         comprehensive (six of nine              nine nursing homes and two of
                          and Prevention (CDC),               nursing homes and three of              eight state survey agencies)
                          developed infection                 eight state survey agencies)        •   Training curriculum is limited,
                          preventionist training in                                                   other training opportunities
                          preparation for the infection                                               needed (one of nine nursing
                          preventionist requirement.                                                  homes and four of eight state
                                                                                                      survey agencies)
Conducted IPC pilot       CMS, in consultation with     Generally, the information we gathered from stakeholders indicated limited
program and released      CDC, conducted a pilot from awareness of the worksheet as a tool to help nursing homes.
Infection Control         fiscal year 2016 through 2018
Worksheet                 to help prevent the spread of
                          infections in nursing homes.
                          CMS released the Infection
                          Control Worksheet for nursing
                          homes.
Initiated focused         CMS developed the focused •      Helps improve IPC practices        •    Punitive rather than helpful
infection control surveys infection control survey to      (seven of nine nursing homes            approach (five of nine nursing
                          assess IPC-related               and four of eight state survey          homes and one of eight state
                          requirements specific to         agencies)                               survey agencies)
                          COVID-19.                                                           •    Frequent and distracting from
                                                                                                   resident care (four of nine
                                                                                                   nursing homes and five of eight
                                                                                                   state survey agencies)
                                                                                              •    Guidance unclear (three of nine
                                                                                                   nursing homes and eight of eight
                                                                                                   state survey agencies)
                                                                                              •    Contributed to state survey
                                                                                                   agencies’ backlogs of standard
                                                                                                   surveys (six of eight state survey
                                                                                                   agencies)
Restricted visitation and CMS temporarily restricted      •   Necessary to keep residents and     •   Isolated residents and resulted
suspended group           nursing home visitation and         staff safe (three of nine nursing       in some mental or physical
activities                suspended group activities.         homes and four of eight state           declines in health (six of nine
                                                              survey agencies)                        nursing homes and five of eight
                                                                                                      state survey agencies)




                                            Page 26                                     GAO-22-105133 Nursing Home Infection Control
 Action                                Description                                   Advantages                          Disadvantages
 Developed IPC-specific                CMS and CDC developed                         •  Helps improve IPC practices (six •   Content basic or not timely and
 training and technical                training and technical                           of nine nursing homes and six of     accessible (three of nine nursing
 assistance                            assistance resources to help                     eight state survey agencies)         homes and six of eight state
                                       nursing homes implement                                                               survey agencies)
                                       IPC practices.
 Mandated COVID-19                     CMS required nursing homes                    •     Useful for directing resources     •   Weekly reporting burden (five of
 surveillance reporting                to report to CDC weekly                             and policy improvements (one of        nine nursing homes and four of
                                       surveillance data, such as                          nine nursing homes and four of         eight state survey agencies)
                                       COVID-19 cases and deaths.                          eight state survey agencies)       •   Lack of clear training and
                                                                                                                                  instructions (three of nine
                                                                                                                                  nursing homes)
 Increased IPC                         CMS increased financial and                   •     Incentivizes improvements (five    •   Overly punitive during a
 enforcement actions                   other penalties for nursing                         of eight state survey agencies)        pandemic (four of nine nursing
                                       home noncompliance with                       •     Provides more effective options,       homes and five of eight state
                                       IPC requirements.                                   such as directed plans of              survey agencies)
                                                                                           correction, for system change
                                                                                           (four of eight state survey
                                                                                           agencies)
Source: GAO interviews with selected state survey agency and nursing home officials in eight states. | GAO-22-105133




CMS Has Opportunities to                                          In our review of CMS IPC oversight, we identified areas where CMS could
Strengthen Infection                                              take more actions to strengthen oversight of IPC in nursing homes.
                                                                  Specifically, we found that CMS could take steps to strengthen both the
Prevention and Control
                                                                  role of the infection preventionist in nursing homes and IPC guidance.
Oversight
Strengthen Oversight of the                                       As previously described, most nursing home and state survey agency
Infection Preventionist Role                                      officials we interviewed indicated that CMS’s requirement that nursing
                                                                  homes have an infection preventionist was critical to helping nursing
                                                                  homes address IPC challenges during the pandemic. Some of these
                                                                  officials, representing two very distinct perspectives, suggested CMS take
                                                                  actions to clarify and strengthen requirements for the role. We identified
                                                                  two ways that CMS could strengthen its oversight of the infection
                                                                  preventionist role: (1) establish minimum training standards and (2)
                                                                  collect and use infection preventionist staffing data to assess the
                                                                  sufficiency of the current staffing requirement.

                                                                  Establish minimum infection preventionist training standards. We
                                                                  found that training for nursing home infection preventionists is
                                                                  inconsistent because CMS has not specified the minimum training that
                                                                  infection preventionists need to receive so that they can be effective
                                                                  performing their role in nursing homes.

                                                                  As part of its 2016 regulatory update of nursing home requirements, CMS
                                                                  began requiring nursing homes to designate an infection preventionist by


                                                                  Page 27                                              GAO-22-105133 Nursing Home Infection Control
November 28, 2019, and required infection preventionists to have
completed “specialized training in IPC.” However, the requirement lacks
specificity about what, at a minimum, the specialized training should
comprise. According to CMS, the agency does not set minimum training
requirements for other types of nursing home personnel and expects
nursing homes to provide the amount of training needed to ensure staff
have the skills to do their jobs. 61 One state survey agency official told us
that nursing homes are using a variety of training programs that are not
equally rigorous to meet the CMS requirement, each with different
curricula and covering different topics. Therefore, the official saw a need
for standardizing infection preventionist training programs. 62 Further,
survey results from a 2018 study found that only 39 percent of nursing
homes surveyed reported that their infection preventionists had
completed specialized training in IPC. 63 Additionally, CMS, CDC, and
state survey agency officials from some of our selected states identified
noticeable gaps in the skills of nursing home infection preventionists
during the pandemic, with CMS and CDC officials noting that some
infection preventionists were unable to develop strategies for addressing
common IPC practice errors, such as with hand hygiene. According to
CMS and CDC officials, there are numerous trainings available for
infection preventionists, including a comprehensive training program
developed by CMS, in consultation with CDC, in March of 2019.



61CMS said that the agency requires nurse aides to complete 75 hours of training,
because this minimum initial training standard is established in statute. See 42 U.S.C. §§
1395i-3(f)(2)(A)(i)(II), 1396r(f)(2)(A)(i)(II).
62Further, CDC officials said that historically there have been limited training courses
available for a nursing home infection preventionist to obtain nursing-home specific IPC
knowledge because many of the available training programs were not initially designed for
nursing home settings. CDC officials also noted that since 2016, when the infection
preventionist requirement was published, multiple courses have been developed and that
these courses may be variable in terms of training time and topics since they were not
developed in response to required specifications.
In addition, studies have found a lack of training among the personnel responsible for
infection prevention and control in nursing homes. See National Academies of Sciences,
Engineering, and Medicine, The National Imperative to Improve Nursing Home Quality:
Honoring Our Commitment to Nursing Home Residents, Families, and Staff (Washington,
D.C.: The National Academies Press, 2022).
63P. Stone et al., “Nursing Home Infection Control Program Characteristics, CMS
Citations, and Implementation of Antibiotic Stewardship Policies: A National Study,”
INQUIRY: The Journal of Health Care Organization, Provision, and Financing, vol. 55
(2018) 1-7.




Page 28                                     GAO-22-105133 Nursing Home Infection Control
Establishing minimum training requirements would be consistent with
federal standards for internal control that call for management to set clear
expectations of competence for key roles, such as the role of the infection
preventionist. 64 CMS planned to issue additional guidance to clarify the
role of the infection preventionist, which could include more information
about the minimum training infection preventionists need, but CMS
officials told us that the agency has delayed issuance multiple times due
to the COVID-19 pandemic. In June 2022, CMS released an advance
copy of guidance, which clarifies the role of the infection preventionist but
does not clarify infection preventionists’ minimum training requirements,
such as how many hours of training infection preventionists must
complete. 65 Until CMS establishes minimum training standards for
infection preventionists, nursing homes may not know which training
programs are adequate and required for preparing their infection
preventionists, and the skills of infection preventionists may not be
adequate to allow them to effectively perform their role.

Collect and use infection preventionist staffing data. We found that
CMS does not collect staffing data on infection preventionists in its
staffing data system as it does for other positions. As a result, the agency
lacks information it could use to assess whether CMS’s minimum staffing
standard for a part-time infection preventionist is sufficient to address
infection risks to both residents and staff in all nursing homes.

Some nursing home and state survey agency officials from our selected
states told us that many part-time infection preventionists do not have
sufficient time to conduct the IPC tasks that could limit the risk of
infections. Specifically, we heard from some of the nursing homes and
state survey agency officials that having only a part-time infection
preventionist was not sufficient for some homes. Infection preventionists
we interviewed from five of nine nursing homes in our review were staff
members who shared other significant and demanding roles, such as
serving as the Director of Nursing, and, as a result, some were hampered
in their ability to carry out all of their infection prevention responsibilities.
For example, one nursing home infection preventionist said that, because
she also serves as the facility’s assistant director of nursing, often her
infection preventionist role is a “second thought assignment.”


64GAO-14-704G.

65See Centers for Medicare & Medicaid Services, Revised Long-Term Care Surveyor
Guidance, QSO-22-19-NH (Baltimore, Md.: June 29, 2022).




Page 29                                 GAO-22-105133 Nursing Home Infection Control
When discussing the requirement that nursing homes must have at least
one part-time infection preventionist on staff, CMS officials told us the
requirement was designed to allow nursing homes flexibility to determine
the amount of time needed for an infection preventionist to effectively
oversee the facility’s IPC program. In June 2022, CMS released an
advance copy of guidance, which notes that, while the CMS requirement
is to have an infection preventionist at least part-time, nursing homes are
responsible for an effective IPC program and should ensure the role of
the infection preventionist is tailored to meet the nursing home’s needs. 66
However, nursing home and state survey agency officials from four states
in our review told us that nursing homes do not always dedicate funding
to hire infection preventionists beyond the minimum required, regardless
of the need. Finally, the CMS Coronavirus Commission for Safety and
Quality in Nursing Homes’ report from September 2020, highlighted
findings that part-time infection preventionists often cannot adequately
respond to the demands of the COVID-19 pandemic and recommended
that CMS determine whether or under what circumstances nursing homes
should have more than one part-time preventionist. 67

To the extent that CMS’s current infection preventionist requirement may
be inadequate for some nursing homes, it poses a potential risk to CMS’s
goal of ensuring quality care for nursing home residents. Addressing risk
is consistent with federal standards for internal control that call for
management to identify, analyze, and respond to risks by estimating their
effect on achieving a defined objective. 68 CMS could begin to assess this
risk with data on preventionist staffing levels across the nursing homes it
oversees. It could require nursing homes to submit staffing data on
infection preventionists through its Payroll Based Journal System, as it
does with other staffing positions, which would result in the agency having
comprehensive data on the number of hours infection preventionists are




66See Centers for Medicare & Medicaid Services, QSO-22-19-NH (June 29, 2022).

67Specifically, the commission recommended that CMS establish an evidence-based
standard for an infection preventionist educator full-time equivalent to bed ratio, among a
number of other recommended steps CMS could take to strengthen the role of infection
preventionists in nursing homes. See MITRE, Coronavirus Commission on Safety and
Quality in Nursing Homes, Commission Final Report (McLean, Va.: The MITRE
Corporation, 2020). This report was written for CMS under a government contract.
68GAO-14-704G.




Page 30                                      GAO-22-105133 Nursing Home Infection Control
                         paid to work each day. 69 CMS could then use these staffing data to
                         examine what level of infection preventionist staffing is needed based on
                         nursing home size and the complexity of resident care needs. The agency
                         could also use the data to compare the relationship, if any, between IPC
                         deficiencies and infection preventionist staffing levels. CMS does not
                         currently collect the infection preventionist staffing data in this way
                         because the infection preventionist role was created after the Payroll
                         Based Journal System was rolled out in 2015.

                         Collecting and utilizing quality information to inform agency decisions is
                         consistent with federal standards for internal control to use quality
                         information to achieve objectives. 70 Having comprehensive data on
                         infection preventionist staffing levels across nursing homes would allow
                         the agency to begin assessing whether the standard is sufficient for
                         protecting nursing home residents and staff or whether it needs to be
                         modified.

Strengthen Infection     As previously described, some nursing home and state survey agency
Prevention and Control   officials from our selected states indicated that the guidance issued by
Guidance                 CMS for some IPC oversight actions was unclear and, in some situations,
                         resulted in concerns about the enforcement actions taken against nursing
                         homes. We identified how CMS could strengthen its guidance around IPC
                         oversight actions by providing additional guidance to help nursing homes
                         and state survey agencies to assess IPC practices.

                         We found that CMS’s State Operations Manual—the key guidance state
                         survey agencies use for conducting nursing home surveys—does not
                         contain important IPC-related guidance. Specifically, as of May 2022, the
                         State Operations Manual does not have examples that surveyors can use
                         to assess the scope and severity of deficiencies applicable to COVID-19-
                         related IPC requirements. For example, the scope and severity examples
                         for the IPC deficiency code (F-880) did not include examples related to
                         the use of personal protective equipment, cohorting (or grouping)

                         69The Payroll Based Journal System was developed in 2015 in response to the Patient
                         Protection and Affordable Care Act, which required CMS to establish a national system to
                         collect and report payroll data on nurse staffing hours. Pub. L. No. 111-148, §§ 6103,
                         6106, 124 Stat. 119, 704 (2010) (codified at 42 U.S.C. §§ 1320-7j(g), 1395i-3(i)(1)(A)(i)),
                         1396r(i)(1)(A)(i)). The system allows the agency to collect staffing data on a regular and
                         more frequent basis than previously, when the data were reported by the homes during
                         surveys, and the system allows the data to be auditable to ensure accuracy.
                         70GAO-14-704G.




                         Page 31                                     GAO-22-105133 Nursing Home Infection Control
residents and staff to limit opportunities for transmission, and
quarantining, that may be more applicable to stopping the spread of
outbreaks from COVID-19 and other respiratory diseases spread by
droplets and aerosols (e.g., influenza). 71 According to CMS, routine
updates to the State Operations Manual have not been made during the
pandemic due to the temporary nature of certain guidance and the need
for issuing more frequent, immediate updates, which CMS released
through memoranda. In June 2022, while this report was with the agency
for review and comment, CMS released an advance copy of the State
Operations Manual to provide additional guidance to state surveyors for
IPC-related deficiencies, including additional scope and severity
classification examples, but these examples were not specific to COVID-
19 or other types of respiratory diseases. Without COVID-19-relevant
examples for scope and severity classification, some state survey
agencies told us they are sometimes uncertain about how to inspect
nursing homes for adherence to COVID-19 specific requirements, which
officials say can lead to surveyors applying these requirements
inconsistently.

Clarifying its guidance for surveyors would be consistent with CMS’s
State Operations Manual, which states that CMS is responsible for
“conveying operational instructions and official interpretations of policy.” 72
It would also be consistent with federal standards for internal control that
indicate management should communicate the necessary quality
information to achieve its objectives. 73 By providing examples of scope
and severity determinations for IPC related issues in the State Operations
Manual, CMS can help ensure that state survey agencies are better able



71While Appendix PP of the State Operations Manual provides examples of non-
compliance with precautions around topics such as bloodborne infections, gastrointestinal
illness, and the handling of soiled linens during scabies or head lice outbreaks, the manual
does not contain examples of scope and severity categorization for deficiencies related to
masking, cohorting and quarantining, or other precautions that may be more applicable to
COVID-19 or other respiratory diseases such as influenza transmission. See Centers for
Medicare & Medicaid Services, State Operations Manual, Appendix PP—Guidance to
Surveyors for Long Term Care Facilities (Baltimore, Md.: November 22, 2017). In June
2022, CMS released an advance copy of Appendix PP that will go into effect on October
24, 2022. See Centers for Medicare & Medicaid Services, QSO-22-19-NH (June 29,
2022).
72Centers for Medicare & Medicaid Services, State Operations Manual, Chapter 1—
Program Background and Responsibilities (Baltimore, Md.: October 3, 2014).
73GAO-14-704G.




Page 32                                     GAO-22-105133 Nursing Home Infection Control
                      to understand and uphold the requirements for managing COVID-19 and
                      other infectious diseases.

                      The COVID-19 pandemic has not only led to high rates of severe illness
Conclusions           and death in the nation’s nursing homes, but it also contributed to
                      worsened mental and physical health among residents and highlighted
                      persistent problems with infection prevention and control. While CMS and
                      CDC have taken important actions to try to improve nursing home
                      infection prevention and control both prior to and during the COVID-19
                      pandemic, there is more CMS should do. First, CMS should do more to
                      strengthen oversight of the role of the infection preventionist, a position
                      whose creation was reported to be critical for helping nursing homes
                      during the pandemic. Specifically, until CMS sets minimum training
                      standards for infection preventionists, nursing homes will not know which
                      training programs are adequate for preparing their infection
                      preventionists, and the skills of infection preventionists may not be
                      adequate to allow them to effectively perform their role. Similarly, until
                      CMS collects and uses infection preventionist staffing data, the agency
                      will lack information critical to understanding whether infection
                      preventionists are dedicating enough time to IPC to meet the risks of
                      infectious disease in nursing homes. Finally, CMS should clarify its IPC
                      guidance to nursing homes and state survey agencies. Specifically, until
                      CMS clarifies guidance on the scope and severity examples for IPC
                      deficiencies specific to COVID-19 and other respiratory diseases, state
                      survey agencies will continue to face uncertainty about how to inspect
                      nursing homes for adherence to IPC requirements.

                      We are making the following three recommendations to the Administrator
Recommendations for   of CMS to:
Executive Action
                      1) Establish minimum infection preventionist training standards.
                      (Recommendation 1)

                      2) Collect infection preventionist staffing data and use these data to
                      determine whether the current infection preventionist staffing requirement
                      is sufficient. (Recommendation 2)

                      3) Provide additional guidance in the State Operations Manual on making
                      scope and severity determinations for IPC-related deficiencies.
                      (Recommendation 3)




                      Page 33                             GAO-22-105133 Nursing Home Infection Control
                     We provided a draft of this report to HHS for review and comment. In its
Agency Comments      written comments, printed in appendix VI, HHS agreed with the first of our
and Our Evaluation   three recommendations, but did not state whether the department agreed
                     or disagreed with our other two recommendations.

                     Specifically, HHS concurred with our first recommendation and noted that
                     CMS will consider this recommendation when proposing new
                     requirements through the rulemaking process.

                     Regarding our second recommendation, while HHS did not specifically
                     state whether it agreed or disagreed, the department said that CMS will
                     consider this recommendation when proposing new requirements through
                     the rulemaking process. Further, HHS said that CMS will evaluate the
                     feasibility of collecting infection preventionist staffing data and take
                     appropriate actions based on this evaluation.

                     Regarding our third recommendation, HHS did not state whether it agreed
                     or disagreed, but the department noted that it believes that CMS
                     addressed this recommendation prior to GAO’s report publication and
                     therefore requested that GAO remove this recommendation. In June
                     2022, while a draft of this report was with HHS for review and comment,
                     CMS released an advance copy of revised guidance, including revisions
                     to sections of the State Operations Manual relevant to this
                     recommendation. CMS stated that the agency believes this revised
                     guidance addresses this recommendation. In response, we updated our
                     report to reflect this revised guidance. We acknowledge that the revisions,
                     scheduled to go into effect in October 2022 provide needed additional
                     guidance on determining the scope and severity of IPC-related
                     deficiencies. However, none of the revised scope and severity examples
                     relate to stopping the spread of outbreaks from COVID-19 or other
                     respiratory diseases spread by droplets and aerosols (e.g., influenza), as
                     we describe in our report. For example, as we note in our report, none of
                     the examples in the prior guidance or the revised guidance relate to the
                     use of personal protective equipment, cohorting residents and staff, or
                     quarantining residents to limit opportunities for transmission. While we
                     recognize that CMS has taken some important steps toward addressing
                     the clarity of the scope and severity examples in the recent update, we
                     maintain the importance of having examples related to COVID-19 or
                     respiratory diseases more generally in this guidance. In addition, HHS
                     also provided technical comments, which we incorporated as appropriate.




                     Page 34                             GAO-22-105133 Nursing Home Infection Control
We are sending copies of this report to the appropriate congressional
committees, the Secretary of HHS, and other interested parties. In
addition, the report is available at no charge on the GAO website at
http://www.gao.gov.

If you or your staff have any questions about this report, please contact
me at (202) 512-7114 or at dickenj@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. GAO staff who made key contributions to this
report are listed in Appendix VII.




John E. Dicken
Director, Health Care




Page 35                             GAO-22-105133 Nursing Home Infection Control
List of Addressees

The Honorable Patrick Leahy
Chairman
The Honorable Richard Shelby
Vice Chairman
Committee on Appropriations
United States Senate

The Honorable Ron Wyden
Chairman
The Honorable Mike Crapo
Ranking Member
Committee on Finance
United States Senate

The Honorable Patty Murray
Chair
The Honorable Richard Burr
Ranking Member
Committee on Health, Education, Labor, and Pensions
United States Senate

The Honorable Gary C. Peters
Chairman
The Honorable Rob Portman
Ranking Member
Committee on Homeland Security and Governmental Affairs
United States Senate

The Honorable Rosa L. DeLauro
Chair
The Honorable Kay Granger
Ranking Member
Committee on Appropriations
House of Representatives




Page 36                          GAO-22-105133 Nursing Home Infection Control
The Honorable Frank Pallone, Jr.
Chairman
The Honorable Cathy McMorris Rodgers
Republican Leader
Committee on Energy and Commerce
House of Representatives

The Honorable Bennie G. Thompson
Chairman
The Honorable John Katko
Ranking Member
Committee on Homeland Security
House of Representatives

The Honorable Carolyn B. Maloney
Chairwoman
The Honorable James Comer
Ranking Member
Committee on Oversight and Reform
House of Representatives

The Honorable Richard E. Neal
Chairman
The Honorable Kevin Brady
Republican Leader
Committee on Ways and Means
House of Representatives

The Honorable Michael F. Bennet
United States Senate




Page 37                           GAO-22-105133 Nursing Home Infection Control
Appendix I: Related GAO Products on
             Appendix I: Related GAO Products on COVID-
             19 in Nursing Homes


COVID-19 in Nursing Homes

             Health Care Capsule: Improving Nursing Home Quality and Information.
             GAO-22-105422. Washington, D.C.: January 14, 2022.

             COVID-19: Continued Attention Needed to Enhance Federal
             Preparedness, Response, Service Delivery, and Program Integrity.
             (Nursing Homes Enclosure). GAO-21-551. Washington, D.C.: July 19,
             2021.

             COVID-19: Most Homes Had Multiple Outbreaks and Weeks of Sustained
             Transmission from May 2020 through January 2021. GAO-21-367.
             Washington, D.C.: May 19, 2021.

             COVID-19: Sustained Federal Action is Crucial as Pandemic Enters its
             Second Year. (Nursing Homes Enclosure). GAO-21-387. Washington,
             D.C.: March 31, 2021.

             COVID-19 in Nursing Homes: HHS Has Taken Steps in Response to
             Pandemic, but Several GAO Recommendations Have Not Been
             Implemented. GAO-21-402T. Washington, D.C.: March 17, 2021.

             COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity,
             and Other Challenges Require Focused Federal Attention. (Nursing
             Homes Enclosure). GAO-21-265. Washington, D.C.: January 28, 2021.

             COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal
             Response. (Nursing Homes Enclosure). GAO-21-191. Washington, D.C.:
             November 30, 2020.

             COVID-19: Federal Efforts Could Be Strengthened by Timely and
             Concerted Actions. (Nursing Homes Enclosure). GAO-20-701.
             Washington, D.C.: September 21, 2020.

             COVID-19: Opportunities to Improve Federal Response and Recovery
             Efforts. (Nursing Homes Enclosure). GAO-20-625. Washington, D.C.:
             June 25, 2020.

             Infection Control Deficiencies Were Widespread and Persistent in Nursing
             Homes Prior to COVID-19 Pandemic. GAO-20-576R. Washington, D.C.:
             May 20, 2020.




             Page 38                                      GAO-22-105133 Nursing Home Infection Control
Appendix II: Examples of Infection                              Appendix II: Examples of Infection Prevention
                                                                and Control Deficiencies Cited in Nursing


Prevention and Control Deficiencies Cited in
                                                                Homes during the Pandemic




Nursing Homes during the Pandemic
                                                                Infection prevention and control (IPC) practices can be critical to
                                                                preventing the spread of infectious diseases, including those specific to
                                                                COVID-19. We reviewed examples of IPC deficiency narratives written by
                                                                state surveyors to illustrate IPC deficiencies from different time points
                                                                during the pandemic.

Table 2: Illustrative Examples of Narratives from Infection Prevention and Control Deficiencies Cited in Nursing Homes during
the Pandemic

 Narrative details                                                                                                                                   Month and year
                                                                                                                                                     survey was
                                                                                                                                                     conducted
 State surveyors observed that high-touch surfaces were not being disinfected and that disinfecting supplies                                         July 2020
 were not readily available for staff use. In addition, surveyors observed certified nursing assistants and a
 nurse in a nursing home not properly wearing personal protective equipment. Specifically, they observed
 these staff failing to change or properly wear personal protective equipment between residents with known or
 suspected COVID-19, such as two certified nursing assistants who did not change their gowns after providing
 care to a resident on droplet precautions. Two staff members indicated to surveyors that they had not been
 given any guidance on how long to wear personal protective equipment and when to change it.
 State surveyors observed staff members in a nursing home having direct contact with residents across both                                           Sept. 2020
 the COVID-19 negative and positive units. The surveyors also learned that the nursing home had not
 previously quarantined any residents after a known exposure to a COVID-19 positive roommate. In addition,
 surveyors learned that the infection preventionist continued to work in the facility and have direct contact with
 multiple residents in her role as a charge nurse after testing positive for COVID-19. She was immediately sent
 home after testing positive, but then she was directed to return to work the next day by the administration and
 continued to work her schedule. Further, surveyors observed challenges with personal protective equipment.
 They observed a certified nursing assistant provide personal care and assistance to several residents on the
 COVID-19 positive unit wearing a jumpsuit, instead of a gown, that she did not change between residents.
 She told the surveyors that she had been provided with the jumpsuit by the home and had been wearing it for
 several days. She did not remove the jumpsuit prior to leaving the nursing home at the end of her shift and
 would instead remove it on her porch and leave it there until her next shift. Then, she would clean it with
 disinfecting spray before putting it back on and returning to the home for her shift.
 State surveyors observed newly admitted residents were not being quarantined from other residents at a        Feb. 2021
 nursing home because, according to the Director of Nursing, there were challenges with space at the home. In
 addition, staff failed to properly use full personal protective equipment. The surveyors observed a certified
 nursing assistant coming out of a resident’s room with her facemask around her chin and wearing eyeglasses
 with no face shield or goggles.
 State surveyors observed certified nursing assistants in a nursing home assisting residents without performing April 2021
 any hand hygiene between residents. One certified nursing assistant was observed assisting a resident with
 adjusting a wheelchair and a bed side table. Then, she removed the resident’s slice of bread from its wrapping
 with her bare hands and spread butter on the bread without performing any hand hygiene. Another certified
 nursing assistant did not perform hand hygiene when passing out lunch trays and setting up tray tables
 between residents. The certified nursing assistant said that she knew she should wash her hands between
 residents but she was trying to pass out the trays faster.
Source: GAO analysis of Form-2567 deficiency narrative reports from the Centers for Medicare & Medicaid Services (CMS). | GAO-22-105133




                                                                Page 39                                                        GAO-22-105133 Nursing Home Infection Control
Appendix III: Types of Surveys and
              Appendix III: Types of Surveys and
              Investigations to Assess Whether Nursing


Investigations to Assess Whether Nursing
              Homes Are Meeting Federal Standards




Homes Are Meeting Federal Standards
              As previously described, the Centers for Medicare & Medicaid Services
              (CMS) monitors nursing home compliance with federal standards
              primarily through the comprehensive standard surveys and as-needed
              investigations state survey agencies conduct. Beginning in March 2020,
              CMS required state survey agencies to conduct focused infection control
              surveys, a new type of survey developed by CMS and the Centers for
              Disease Control and Prevention (CDC) in response to the pandemic with
              a narrower scope than a standard survey. Focused infection control
              surveys assess federal standards for nursing home infection prevention
              and control that could contribute to the transmission of COVID-19, such
              as standards for personal protective equipment, testing, and isolating
              positive cases. CMS also suspended standard surveys and low priority
              investigations to limit surveyor time on site and focus state survey agency
              resources on limiting the spread of COVID-19. 1 Initially, state survey
              agencies conducted the focused infection control surveys in nursing
              homes specifically identified by HHS, and, beginning in June 2020, state
              survey agencies were required to conduct the focused infection control
              surveys any time a nursing home experienced a new COVID-19
              outbreak. 2 Beginning in August 2020, CMS indicated state survey
              agencies should resume standard surveys as soon as they have the
              resources to conduct the surveys but also required them to continue
              conducting focused infection control surveys. 3 In January 2021 and again
              in November 2021, CMS changed the requirement for when a focused

              1Under section 1135 of the Social Security Act, the Secretary of the Department of Health
              and Human Services (HHS) may temporarily waive or modify certain federal health care
              requirements, including those relating to standard surveys of nursing homes, when both a
              public health emergency and a disaster or emergency have been declared. 42 U.S.C. §
              1320b-5. This authority was triggered on March 13, 2020, when the President declared
              the COVID-19 outbreak to be a national emergency under the National Emergencies Act
              and a nationwide emergency under section 501(b) of the Robert T. Stafford Disaster
              Relief and Emergency Assistance Act. The Secretary of HHS had previously declared
              COVID-19 a public health emergency on January 31, 2020, retroactive to January 27,
              2020. See Centers for Medicare & Medicaid Services, QSO-20-20-ALL (March 20, 2020).
              2CMS also required state survey agencies to conduct focused infection control surveys in
              all the nursing homes in their states by July 31, 2020 and in 20 percent of nursing homes
              in their states starting in fiscal year 2021. CMS also authorized states to expand certain
              survey activities, including standard surveys and high-priority complaint surveys, at the
              state’s discretion. See Centers for Medicare & Medicaid Services, QSO-20-31-ALL (June
              1, 2020) and Centers for Medicare & Medicaid Services, QSO-20-20-ALL (March 20,
              2020).
              3See Centers for Medicare & Medicaid Services, Enforcement Cases Held During the
              Prioritization Period and Revised Survey Prioritization, QSO-20-35-ALL (Baltimore, Md.:
              August 17, 2020).




              Page 40                                     GAO-22-105133 Nursing Home Infection Control
Appendix III: Types of Surveys and
Investigations to Assess Whether Nursing
Homes Are Meeting Federal Standards




infection control survey must be conducted. Specifically, in November
2021, CMS required state survey agencies to perform focused infection
control surveys for 20 percent of nursing homes in their state annually,
prioritizing those facilities that report new COVID-19 cases and low
vaccination rates, in addition to continuing to conduct standard surveys
and investigations. 4 See figure 4 for a description of the types of surveys
and investigations used to assess whether nursing homes are meeting
federal standards as of April 2022.




4On November 30, 2020, elements of the focused infection control survey were
incorporated into the standard survey process, in addition to maintaining the focused
infection control survey as a stand-alone tool. See Centers for Medicare & Medicaid
Services, QSO-20-31-ALL (January 4, 2021 revision). Also see Centers for Medicare &
Medicaid Services, QSO-22-02-ALL (Nov. 12, 2021).




Page 41                                    GAO-22-105133 Nursing Home Infection Control
                                       Appendix III: Types of Surveys and
                                       Investigations to Assess Whether Nursing
                                       Homes Are Meeting Federal Standards




Figure 4: Types of Surveys and Investigations Used by State Survey Agencies to Assess Whether Nursing Homes Are
Meeting Federal Standards, as of April 2022




                                       Page 42                                    GAO-22-105133 Nursing Home Infection Control
Appendix III: Types of Surveys and
Investigations to Assess Whether Nursing
Homes Are Meeting Federal Standards




a
 Initially, state survey agencies conducted the focused infection control surveys in nursing homes
specifically identified by the Department of Health and Human Services, and beginning in June 2020,
state survey agencies were required to conduct the focused infection control surveys any time a
nursing home experienced a new COVID-19 outbreak. Beginning in August 2020, CMS indicated
state survey agencies should resume standard surveys as soon as they have the resources to
conduct the surveys but also required them to continue conducting focused infection control surveys.
In January 2021 and again in November 2021, CMS changed the requirement for when a focused
infection control survey must be conducted. Specifically, in November 2021, CMS required state
survey agencies to perform focused infection control surveys for 20 percent of nursing homes in their
state annually, prioritizing those facilities that report new COVID-19 cases and low vaccination rates,
in addition to continuing to conduct standard surveys and investigations.




Page 43                                           GAO-22-105133 Nursing Home Infection Control
Appendix IV: Number and Percentage of                          Appendix IV: Number and Percentage of
                                                               Surveyed Nursing Homes with Infection


Surveyed Nursing Homes with Infection
                                                               Prevention and Control (IPC) Deficiencies




Prevention and Control (IPC) Deficiencies
Table 3: Number and Percentage of Surveyed Nursing Homes with Infection Prevention and Control (IPC) Deficiencies, by
Calendar Year and Deficiency Code

                                                                                                 2018              2019                      2020                2021
 Deficiency codes that went into effect prior to the pandemic
 F-880: IPC programa                                                                6,316 (43.3%)        6,283 (42.5%)             6,810 (44.2%)       5,265 (37.3%)
 F-881: Antibiotic stewardship programb                                                    698 (4.8)             739 (5)                 195 (1.3)           307 (2.2)
 F-882: Infection preventionist rolec                                                              n/a               n/a                 138 (0.9)           240 (1.7)
 F-883: Influenza and pneumococcal immunizationd                                           564 (3.9)           643 (4.4)                 269 (1.7)           597 (4.2)
 F-945: Infection control traininge                                                                n/a               n/a                        n/a                n/a
 Deficiency codes that went into effect during the pandemic
 F-884: Reporting to the National Healthcare Safety                                                n/a               n/a             1,811 (11.8)        4,702 (33.3)
 Networkf
 F-885: Reporting to residents, representatives, and                                               n/a               n/a                 335 (2.2)           274 (1.9)
 familiesg
 F-886: COVID-19 testing for residents and staffh                                                  n/a               n/a                 424 (2.8)           576 (4.1)
 F-887: COVID-19 immunizationsi                                                                    n/a               n/a                        n/a          158 (1.1)
 Total surveyed nursing homes                                                                   14,591           14,773                    15,406              14,128
Source: GAO analysis of Centers for Medicare & Medicaid Services’ (CMS) data. | GAO-22-105133
                                                               a
                                                                F-880 is the deficiency code for not meeting federal standards for establishing and maintaining an
                                                               IPC program. This code went into effect as part of CMS’s restructuring of its deficiency codes on
                                                               November 28, 2017, replacing a prior deficiency code that had been in effect for several years.
                                                               b
                                                                F-881 is the deficiency code for not meeting federal standards for establishing an effective antibiotic
                                                               stewardship program. This deficiency code went into effect on November 28, 2017.
                                                               c
                                                                 F-882 is the deficiency code for not meeting federal standards for designating an infection
                                                               preventionist. This deficiency code went into effect on November 28, 2019. State survey agencies
                                                               began surveying nursing homes on it beginning August 26, 2020.
                                                               d
                                                                F-883 is the deficiency code for not meeting federal standards for influenza and pneumococcal
                                                               immunizations. This deficiency code went into effect as part of CMS’s restructuring of its deficiency
                                                               codes on November 28, 2017, replacing a prior deficiency code that had been in effect for several
                                                               years.
                                                               e
                                                                F-945 is the deficiency code for not meeting federal standards for infection control training. This
                                                               deficiency code went into effect on November 28, 2019, but, at the time of our review, CMS had not
                                                               yet directed state survey agencies to begin surveying homes on it. In June 2022, CMS announced
                                                               that state survey agencies should begin surveying homes on this deficiency code beginning October
                                                               2022.
                                                               f
                                                                F-884 is a COVID-19-specific deficiency code for not meeting federal standards for weekly COVID-19
                                                               reporting to the National Healthcare Safety Network. This deficiency code went into effect on May 6,
                                                               2020. Review for F-884 is conducted off-site by federal surveyors, who automatically cite nursing
                                                               homes for not submitting timely and complete data of all reporting elements.
                                                               g
                                                                F-885 is a COVID-19-specific deficiency code for not meeting federal standards for reporting COVID-
                                                               19 cases to residents, representatives, and family. This deficiency code went into effect on May 6,
                                                               2020.
                                                               h
                                                                F-886 is a COVID-19-specific deficiency code for not meeting federal standards for COVID-19
                                                               testing for residents and staff. This deficiency code went into effect on August 26, 2020.
                                                               i
                                                                F-887 is a COVID-19 specific deficiency code for not meeting federal standards for COVID-19
                                                               immunizations. This deficiency code went into effect on May 11, 2021.




                                                               Page 44                                            GAO-22-105133 Nursing Home Infection Control
Appendix V: Federal Nursing Home Infection    Appendix V: Federal Nursing Home Infection
                                              Prevention and Control (IPC) Actions


Prevention and Control (IPC) Actions

Table 4: Nursing Home Infection Prevention and Control (IPC) Actions Taken by the Centers for Medicare & Medicaid Services
(CMS) and the Centers for Disease Control and Prevention (CDC)

Date               Action
Actions prior to the pandemic
2009               CDC helped develop the National Action Plan to Prevent Healthcare-Associated Infections: Roadmap to
                   Elimination, a plan intended to coordinate and maximize the efficiency of healthcare-associated infection prevention
                   efforts across the federal government.a
                   CDC began working with state-based Healthcare-Associated Infection programs, which are able to provide on-the-
                   ground IPC assessments and technical assistance in nursing homes and other health care facilities.
2012               CDC created a module in the National Healthcare Safety Network for national infection surveillance that allowed
                   nursing homes to voluntarily report infections, such as C. difficile.b
                   CDC conducted the National Survey of Long-Term Care Providers to collect information from nursing homes on
                   IPC practices, as well as the immunization status of and infection burden among nursing home residents.
                   CMS begins to publicly report influenza and pneumococcal vaccination of nursing home residents and other IPC
                   quality measures, such as urinary tract infections among residents.
2015               CDC developed and released the Core Elements of Antibiotic Stewardship for Nursing Homes which outlines steps
                   nursing homes and other long-term care facilities could take to improve antibiotic prescribing practices and reduce
                   their inappropriate use.
2016               CDC developed and released an IPC assessment tool to assist health departments and facilities assess infection
                   control programs and practices in nursing homes and other long-term care facilities.c
                   CMS published a final rule revising requirements for nursing homes’ broader IPC program with varying
                   implementation dates. The requirements implemented in 2016 included that nursing homes must have a system for
                   preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for residents
                   and staff.d
2017               CMS required nursing homes to develop an antibiotic stewardship program to combat the growing concern of multi-
                   drug resistant organisms.e
2019               CMS and CDC collaborated on the development of a free on-line infection preventionist training course.f
                   CMS and CDC released the Nursing Home Infection Control Worksheet, a nursing home self-assessment tool
                   developed through a 3-year pilot program across 40 participating nursing homes.
                   CMS required nursing homes to designate an infection preventionist who works at least part-time at the facility.
                   CMS updated surveyor interpretive guidance to clarify that a facility’s emergency preparedness planning should
                   include “emerging infectious diseases.”
Actions during the pandemic
Feb. 14, 2020      CMS created and released the “Head to Toe Toolkit,” offering educational materials and interventions for bedside
                   staff to prevent common infections.
Starting on Feb.   CDC conducted about 100 COVID-19 outbreak investigations in nursing homes and other long-term care facilities
27, 2020           in collaboration with local and state health departments.g
Mar. 1, 2020       CDC issued guidance to assist nursing homes’ response to COVID-19.h
                   CMS initiated blanket waivers to grant nursing homes flexibilities, such as waiving certain training and certification
                   requirements for certified nurse aides.
Mar. 4, 2020       CMS prioritized certain survey activities, such as surveys responding to allegations of abuse and neglect.
Mar. 13, 2020      CMS restricted all visitors and non-essential health care personnel from entering nursing homes, with exceptions
                   made for compassionate care situations, such as end-of-life situations. Surveyors were also granted access.
                   Cancelled communal dining and group activities.




                                              Page 45                                      GAO-22-105133 Nursing Home Infection Control
                                            Appendix V: Federal Nursing Home Infection
                                            Prevention and Control (IPC) Actions




Date             Action
Mar. 20, 2020    CMS temporarily suspended all standard surveys and suspended some other types of survey work.
                 CMS released a targeted IPC survey tool—the focused infection control survey—and instructed states to use this
                 survey in place of the standard survey process.
                 CMS suspended most enforcement actions for facilities not in substantial compliance, until revisit surveys could be
                 resumed.
May 6, 2020      CMS created new deficiency codes, known as F-tags (F-884 and F-885) associated with required reporting of
                 cases and deaths to CDC through the National Healthcare Safety Network and to residents, their representatives,
                 and their families.
June 1, 2020     CMS initiated a performance-based funding requirement tying CARES Act supplemental grants for state survey
                 agencies to the completion of focused infection control surveys.
                 CMS increased penalties for noncompliance with IPC, making the penalties more significant for those nursing
                 homes with a history of past IPC deficiencies or that caused actual harm to residents or immediate jeopardy.
                 CMS announced the deployment of Quality Improvement Organizations to provide technical assistance to
                 approximately 3,000 low-performing nursing homes that had a history of IPC challenges.
June 4, 2020     CMS announced it will post survey results that were conducted on or after March 4, 2020 on Nursing Home
                 Compare.
June 23 through CMS convened the Coronavirus Commission for Safety and Quality in Nursing Homes, a committee of experts
Aug. 19, 2020   tasked to identify lessons learned from the early days of the pandemic and develop recommendations for future
                actions to improve IPC measures in nursing homes.i
July 18, 2020    The Department of Health and Human Services (HHS), including CDC and CMS staff, began sending strike teams
                 to nursing homes to assist with responding to COVID-19 outbreaks.
Aug. 17, 2020    CMS authorized the resumption of standard surveys.
Aug. 25, 2020    CMS released a national nursing home training program for frontline staff and management.
Aug. 26, 2020    CMS set civil monetary penalties for failure to report COVID-related data to the National Healthcare Safety
                 Network, associated with any F-884 citation.
Aug. 26, 2020    CMS created a new F-tag (F-886) associated with required COVID-19 testing of nursing homes staff and residents
                 and proper documentation of testing data.
                 CMS updated the focused infection control survey tool to assess compliance with new COVID-19 testing
                 requirements, as well as prior updates in guidance.
                 CMS temporarily updated the focused infection control survey tool to assess compliance with the requirement to
                 designate an infection preventionist.
Sept. 17, 2020   CMS changed restrictions on nursing home visitation to allow limited indoor visits while still adhering to social
                 distancing precautions.j
Oct. 29, 2020    CDC launched the Project Firstline Healthcare Infection Control Training Collaborative, a coalition of health care,
                 public health, and academic partners who developed interactive infection control trainings for all health care
                 workers, including nursing home staff.
Nov. 30, 2020    CMS integrated elements of the focused infection control survey tool into the standard survey IPC pathway for all
                 standard surveys beginning after November 30, 2020, in addition to maintaining the focused infection control survey
                 as a stand-alone tool.
Dec. 4, 2020     CMS announced the agency will resume calculating nursing home health inspection and quality measure ratings on
                 January 27, 2021.
Dec. 21, 2020    CDC launched the federal Pharmacy Partnership for Long-term Care program to bring COVID-19 vaccine clinics to
                 residents and staff members in nursing homes across the country.
Jan. 4, 2021     CMS revised the criteria requiring states to conduct focused infection control surveys.




                                            Page 46                                      GAO-22-105133 Nursing Home Infection Control
                                                            Appendix V: Federal Nursing Home Infection
                                                            Prevention and Control (IPC) Actions




Date                     Action
Mar. 10, 2021            CMS further changed some visitation restrictions by allowing visitation even when a nursing home had COVID-19
                         positive residents and permitting physical contact between visitors and residents when a resident is vaccinated.
May 11, 2021             CMS published an interim final rule that established requirements regarding offering COVID-19 vaccines to
                         residents and staff and established an accompanying new F-tag (F-887). CMS also began requiring the reporting of
                         vaccination data to CDC.k
Oct. 1, 2021             CDC, in partnership with CMS, provided funding for state-based strike teams to provide surge capacity, address
                         staffing shortages, and strengthen IPC activities in nursing homes.l
Nov. 12, 2021            CMS announced steps to assist state survey agencies in addressing the backlog of complaint and standard
                         surveys. These steps included revising the criteria for conducting a focused infection control survey so that a survey
                         is not required in response to COVID-19 outbreaks and providing guidance for resuming standard surveys.
Nov. 12, 2021            CMS began allowing nursing home visitation for all residents at all times.
Dec. 28, 2021            CMS began issuing guidance requiring health care staff vaccination. Additional guidance was released in January
                         2022.
April 7, 2022            CMS announced plans to phase in an end to certain emergency declaration blanket waivers for nursing homes,
                         such as the waiver allowing nursing homes to employ nurse aides that have not completed a full course of training,
                         which would end on June 6, 2022.m
Source: GAO summary of CMS and CDC identified actions. | GAO-22-105133
                                                            a
                                                             In 2013, the Department of Health and Human Services released an update to the National Action
                                                            Plan that included a chapter on healthcare-associated infection prevention across the long-term care
                                                            spectrum, including in nursing homes. Department of Health and Human Services, The National
                                                            Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination (Washington,
                                                            D.C.: 2013).
                                                            b
                                                             Between 2016 and 2018, CDC, CMS, and a network of health care quality improvement
                                                            organizations enrolled 2,000 nursing homes in the National Healthcare Safety Network to report and
                                                            track C. difficile bacterial infections in order to support antibiotic stewardship and infection prevention
                                                            practices. C. difficile is a bacterium that causes severe diarrhea and inflammation of the colon and
                                                            infections result in disproportionately higher rates of hospitalization and death in individuals over the
                                                            age of 65. During the pandemic, CDC expanded the National Health Care Safety Network to allow for
                                                            reporting of COVID-19 cases and deaths from nursing homes, as well as other COVID-19 related
                                                            data such as nursing home access to testing, personal protective supplies, and staff and resident
                                                            vaccinations.
                                                            c
                                                             The IPC assessment for nursing homes–known as the Infection Control Assessment and Response
                                                            tool–was later adapted and used by health departments and other partners to perform remote video-
                                                            assisted or onsite assessment of COVID-19-specific IPC practices and guide quality improvement
                                                            activities in nursing homes.
                                                            d
                                                             Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed.
                                                            Reg. 68,688 (Oct. 4, 2016).
                                                            e
                                                             CDC also implemented initiatives to address antibiotic-resistant infections and to promote antibiotic
                                                            stewardship efforts in nursing homes to align with CDC’s activities to address antibiotic resistance as
                                                            outlined in the U.S. National Action Plan for Combating Antibiotic-Resistant Bacteria, which was
                                                            issued in 2015. See The White House, U.S. National Action Plan for Combating Antibiotic-Resistant
                                                            Bacteria (Washington, D.C.: March 2015).
                                                            f
                                                                CMS also created a nursing home antibiotic stewardship program training.
                                                            g
                                                             CDC has provided further outbreak investigation and support services. For example, according to
                                                            CDC officials, the CDC funded Healthcare-Associated Infection and Antimicrobial Resistance
                                                            Prevention Programs that assisted with over 21,000 COVID-19 outbreak investigations in nursing
                                                            homes. CDC staff along with state and local health departments also conducted thousands of
                                                            Infection Control Assessment and Response assessments (both in-person and by telephone) in long-
                                                            term care facilities, including nursing homes.
                                                            h
                                                             Specifically, on March 1, 2020, CDC issued Responding to COVID-19 in Nursing Homes and
                                                            Performing Facility-wide SARS-CoV-2 Testing in Nursing Homes, as a supplemental addition to




                                                            Page 47                                             GAO-22-105133 Nursing Home Infection Control
Appendix V: Federal Nursing Home Infection
Prevention and Control (IPC) Actions




CDC’s overall IPC guidance, initially released January 28, 2020. The nursing home-specific guidance
was updated multiple times during the pandemic. In addition, on March 17, 2020, CDC began a
series of clinician outreach and communication activity calls on COVID-19 in nursing homes and
other long-term care facilities. See Centers for Disease Control and Prevention, Interim Infection
Prevention and Control Recommendations to Prevent SARS-CoV-2 Spread in Nursing Homes,
accessed on November 8, 2021,
https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html. This online guidance was
merged with Centers for Disease Control and Prevention, Responding to COVID-19 in Nursing
Homes and Centers for Disease Control and Prevention, Performing Facility-wide SARS-CoV-2
Testing in Nursing Homes, as of March 29, 2021.
The Commission’s final report was issued in September 2020. MITRE, Coronavirus Commission on
i

Safety and Quality in Nursing Homes, Commission Final Report (McLean, Va.: The MITRE
Corporation, 2020). This report was written for CMS under a government contract.
j
    CMS also changed restrictions on communal activities and dining.
k
 Medicare and Medicaid Programs; COVID-19 Vaccine Requirements for Long-Term Care Facilities
and Intermediate Care Facilities for Individuals with Intellectual Disabilities Residents, Clients, and
Staff, 86 Fed. Reg. 26,306, 26,336 (May 13, 2021).
The purpose of the funding is to assist nursing homes during their response to COVID-19 infections,
l

and to build and maintain the infection prevention infrastructure necessary to support resident, visitor,
and facility healthcare personnel safety. According to CDC officials, funding to health departments to
conduct these activities has been distributed and CDC continues to provide technical expertise and
assistance to the recipients.
m
  CMS had previously waived the requirement that nursing homes may not employ anyone for longer
than four months unless they met the training and certification requirements under section 483.35(d)
of title 42 of the Code of Federal Regulations.




Page 48                                            GAO-22-105133 Nursing Home Infection Control
Appendix VI: Comments from the
                   Appendix VI: Comments from the Department
                   of Health and Human Services


Department of Health and Human Services




         Page 49                                               GAO-22-105133 Nursing Home Infection Control
          Appendix VI: Comments from the Department
          of Health and Human Services




Page 50                                               GAO-22-105133 Nursing Home Infection Control
          Appendix VI: Comments from the Department
          of Health and Human Services




Page 51                                               GAO-22-105133 Nursing Home Infection Control
          Appendix VI: Comments from the Department
          of Health and Human Services




Page 52                                               GAO-22-105133 Nursing Home Infection Control
          Appendix VI: Comments from the Department
          of Health and Human Services




Page 53                                               GAO-22-105133 Nursing Home Infection Control
          Appendix VI: Comments from the Department
          of Health and Human Services




Page 54                                               GAO-22-105133 Nursing Home Infection Control
Appendix VII: GAO Contact and Staff
                  Appendix VII: GAO Contact and Staff
                  Acknowledgments


Acknowledgments

                  John E. Dicken, (202) 512-7114 or dickenj@gao.gov
GAO Contact
                  In addition to the contact named above, Karin Wallestad (Assistant
Staff             Director), Sarah-Lynn McGrath (Analyst-in-Charge), Elise Pressma,
Acknowledgments   Kathryn Richter, Elaina Stephenson, and Julianne Flowers. Also
                  contributing were Isabella Guyott, Laurie Pachter, and Jennifer Whitworth.




(105133)
                  Page 55                               GAO-22-105133 Nursing Home Infection Control
                         The Government Accountability Office, the audit, evaluation, and investigative
GAO’s Mission            arm of Congress, exists to support Congress in meeting its constitutional
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