Report (2020-03-26)

Full text

Department of Health and Human Services
OFFICE OF
INSPECTOR GENERAL

CERTAIN NURSING HOMES MAY NOT
HAVE COMPLIED WITH FEDERAL
REQUIREMENTS FOR INFECTION
PREVENTION AND CONTROL AND
EMERGENCY PREPAREDNESS

Christi A. Grimm
Inspector General

July 2022
A-01-20-00005

Inquiries about this report may be addressed to the Office of Public Affairs at
Public.Affairs@oig.hhs.gov.

Office of Inspector General
https://oig.hhs.gov

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to protect the integrity of the Department of Health and Human Services (HHS) programs, as well as the
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Notices

THIS REPORT IS AVAILABLE TO THE PUBLIC
at https://oig.hhs.gov

Section 8M of the Inspector General Act, 5 U.S.C. App., requires
that OIG post its publicly available reports on the OIG website.

OFFICE OF AUDIT SERVICES FINDINGS AND OPINIONS

The designation of financial or management practices as
questionable, a recommendation for the disallowance of costs
incurred or claimed, and any other conclusions and
recommendations in this report represent the findings and
opinions of OAS.  Authorized officials of the HHS operating
divisions will make final determination on these matters.

Report in Brief
Date: July 2022
Report No. A-01-20-00005
Certain Nursing Homes May Not Have Complied
With Federal Requirements for Infection Prevention
and Control and Emergency Preparedness

What OIG Found
Selected nursing homes may not have complied with Federal requirements
for infection prevention and control and emergency preparedness.
Specifically, 28 of the 39 nursing homes had possible deficiencies.  We found
48 instances at 25 nursing homes of possible noncompliance with infection
prevention and control requirements and 18 instances at 18 nursing homes of
possible noncompliance with emergency preparedness requirements related
to all-hazards risk assessments and strategies to address emerging infectious
diseases.  The nursing homes attributed the possible noncompliance to:
(1) nursing home inadequate internal controls, (2) nursing home inadequate
management oversight, (3) nursing home administrative and leadership
changes, (4) inadequate communication and training from the Centers for
Medicare & Medicaid Services (CMS), and (5) inconsistent and confusing
regulations.

What OIG Recommends and CMS Comments
We recommend that CMS: (1) instruct SSAs to follow up with the 28 nursing
homes that we have identified with potential infection prevention and control
and emergency preparedness deficiencies to ensure that they have taken
corrective actions; (2) issue updated phase 3 interpretive guidance as soon as
feasible; (3) provide training to SSAs on the updated phase 3 interpretive
guidance as soon as feasible; and (4) consider updating the regulation to make
clear that nursing homes must include emerging infectious diseases as a risk
on their facility- and community-based all-hazards risk assessments.
CMS concurred with our first three recommendations and described
corrective actions it had taken or planned to take, such as ensuring that SSAs
follow up with the nursing homes, issuing phase 3 interpretive guidance, and
providing training related to the phase 3 interpretive guidance.  CMS stated
that it had intended to release the phase 3 interpretive guidance during the
second quarter of 2020.  However, prior to issuing the guidance, the COVID-19
public health emergency (PHE) was declared, and CMS immediately redirected
resources to address patient safety needs related to the PHE.  Regarding our
fourth recommendation, CMS stated that it would consider this
recommendation in future rulemaking and that it has taken considerable steps
to make clear that nursing homes should include emerging infectious diseases
as an identified risk on their facility- and community-based all-hazards risk
assessments.
Why OIG Did This Audit
The Centers for Disease Control and
Prevention indicates that individuals
who are aged 65 and older or nursing
home residents are at a higher risk
for severe illness from COVID-19.  In
addition, 8 out of 10 COVID-19
deaths reported in the United States
in 2020 were adults aged 65 and
older.  COVID-19 is especially
dangerous for the more than
1.3 million residents who live in the
15,446 Medicare and Medicaid
certified nursing homes nationwide.

Our objective was to determine
whether selected nursing homes
complied with Federal requirements
for infection prevention and control
and emergency preparedness.

How OIG Did This Audit
We analyzed State survey agency
(SSA) data on Medicare.gov for the
most recent standard surveys and the
previous 12 months of complaint
reports.  We identified 6,830 nursing
homes that were cited for infection
prevention and control program
deficiencies, and Medicare.gov
indicated that 39 nursing homes had
not provided a plan of correction for
the deficiencies as of March 26, 2020.
We contacted the 39 nursing homes
and requested that they provide us
with infection prevention and control
and emergency preparedness
program documents that were in
effect from January 1, 2019, through
May 31, 2020.
The full report can be found at https://oig.hhs.gov/oas/reports/region1/12000005.asp.

Infection Prevention and Control and Emergency Preparedness of Nursing Homes (A-01-20-00005)

TABLE OF CONTENTS

INTRODUCTION ......................................................................................................................... 1

Why We Did This Audit ................................................................................................. 1

Objective ....................................................................................................................... 1

Background ................................................................................................................... 1
Medicare and Medicaid Coverage of Nursing Homes ...................................... 1
CMS Revised Emergency Preparedness and Infection Control
   Requirements ................................................................................................. 2
Requirements for Infection Prevention and Emergency Preparedness ........... 3
Responsibilities for Infection Prevention and Emergency Preparedness  ........ 4
Additional CMS Guidance ................................................................................. 4
COVID-19 Reporting Requirements for Nursing Homes ................................... 5

How We Conducted This Audit ................................................................................... 6

FINDINGS ................................................................................................................................... 7

Selected Nursing Homes May Not Have Complied With Infection Prevention and
   Control Requirements ................................................................................................ 8
Nursing Homes Did Not Designate Infection Preventionists Who Met Federal
   Requirements ................................................................................................. 8
Nursing Homes Did Not Conduct Quarterly Quality Assessment and
   Assurance Committee Meetings .................................................................... 9
Infection Preventionists Did Not Attend Quality Assessment and Assurance
   Committee Meetings ................................................................................... 10
Nursing Homes’ Reporting Policies Did Not Specify When and to Whom
   Incidents of Communicable Disease Should Be Reported ........................... 10
Nursing Homes Did Not Review Infection Prevention and Control Programs
   Annually ........................................................................................................ 11
One Nursing Home Did Not Demonstrate That It Conducted Infection
   Prevention and Control Training .................................................................. 11

Selected Nursing Homes May Not Have Complied With Emergency Preparedness
   Requirements ........................................................................................................... 12
All-Hazards Risk Assessments Did Not Include Emerging Infectious
   Diseases ........................................................................................................ 12
Emergency Plans Did Not Include Strategies To Address Emerging Infectious
   Diseases ........................................................................................................ 12

Causes of Possible Noncompliance With Federal Requirements ............................... 13

Infection Prevention and Control and Emergency Preparedness of Nursing Homes (A-01-20-00005)

Selected Nursing Homes May Have Increased the Risk of Infections to Residents
   and Staff ................................................................................................................... 13

RECOMMENDATIONS ............................................................................................................. 13

CMS COMMENTS AND OFFICE OF INSPECTOR GENERAL RESPONSE ..................................... 14

Introductory Comments  ............................................................................................. 14

CMS Comments ............................................................................................... 14

Office of Inspector General Response ............................................................ 14

Comments on Recommendations .............................................................................. 15

CMS Comments ............................................................................................... 15

Office of Inspector General Response ............................................................ 15

OTHER MATTERS ..................................................................................................................... 16

APPENDICES

A: Audit Scope and Methodology ............................................................................... 17

B: List of CMS Public Health Actions for Nursing Homes Concerning
   the COVID-19 Public Health Emergency .................................................................. 18

C: Areas of Infection Prevention and Control Possible Noncompliance .................... 22

D: Areas of Emergency Preparedness Possible Noncompliance ................................ 24

E: CMS Comments ....................................................................................................... 25

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INTRODUCTION

WHY WE DID THIS AUDIT

At the start of the pandemic, the Centers for Disease Control and Prevention (CDC) indicated
that individuals who are aged 65 and older or nursing home residents are at a higher risk for
severe illness from COVID-19.  In addition, 8 out of 10 COVID-19 deaths reported in the United
States in 2020 were adults aged 65 and older.1  COVID-19 is especially dangerous for the more
than 1.3 million residents who live in the 15,446 Medicare and Medicaid certified nursing
homes nationwide.

In order to minimize exposure to and transmission of COVID-19, it is critical that nursing homes
strictly adhere to Federal requirements for proper infection prevention and control practices.
However, the Centers for Medicare & Medicaid Services (CMS) reported, through State survey
agency (SSA) survey reports published on Medicare.gov, that nursing homes do not always
adhere to these requirements.  Specifically, according to these reports, 39 nursing homes in 10
States did not always comply with all infection prevention and control requirements, such as
following proper hand hygiene, and had not provided a plan of correction for the infection
prevention and control deficiencies as of March 26, 2020.  In March 2021, CMS officials said
that the nursing homes had satisfactorily addressed all deficiencies identified by these surveys.
Our audit focuses on these 39 nursing homes.

COVID-19 has created extraordinary challenges for the delivery of health care and human
services.  As the oversight agency for the Department of Health and Human Services (HHS), the
Office of Inspector General (OIG) oversees HHS’s COVID-19 response and recovery efforts.  This
audit is part of OIG’s COVID-19 response strategic plan.2

OBJECTIVE

Our objective was to determine whether the selected nursing homes complied with Federal
requirements for infection prevention and control and emergency preparedness.

BACKGROUND

Medicare and Medicaid Coverage of Nursing Homes

The Medicare and Medicaid programs cover care in nursing homes for eligible residents.
Sections 1819 and 1919 of the Social Security Act (the Act) establish requirements for CMS and

1 “COVID-19 Mortality Overview,” available online at https://www.cdc.gov/nchs/covid19/mortality-overview.htm.
(Accessed July 13, 2021.)

2 OIG’s COVID-19 response strategic plan and information about its oversight activities can be accessed at HHS-
OIG’s Oversight of COVID-19 Response and Recovery | HHS-OIG.

Infection Prevention and Control and Emergency Preparedness of Nursing Homes (A-01-20-00005)
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States to perform surveys of nursing homes to determine whether they meet Federal
participation requirements.3

CMS Revised Emergency Preparedness and Infection Control Requirements

After a review of guidance developed by several agencies—including the Food and Drug
Administration, CDC, and Health Resources and Services Administration—and a review of the
existing Medicare emergency preparedness requirements for providers and suppliers, CMS
found that the existing emergency preparedness regulatory requirements were not
comprehensive enough to address the complexities of emergencies.  As a result, CMS issued a
proposed rule in December 2013 that would establish national emergency preparedness
requirements for providers and suppliers that participate in Medicare and Medicaid to ensure
that they adequately plan for natural and man-made disasters.4  CMS acknowledged in the final
rule, issued in September 2016, that the United States faced several new and emerging
diseases, such as Middle East Respiratory Syndrome, Ebola, and Enterovirus D68.5

In the September 2016 national emergency preparedness final rule, CMS stated that finalizing
the rule was an important part of improving the national response to any infectious disease
threats and that if a nursing home does not have an emergency preparedness plan in place
prior to an emergency, it could encounter difficulties providing continuity of care for its
residents.6

In 2015, CMS issued another proposed rule that included revisions to infection prevention and
control requirements that nursing homes must meet to participate in the Medicare and
Medicaid programs.7  These revisions resulted from CMS’s comprehensive review of the then
current regulations to: (1) improve the quality of life, care, and services in long-term care
facilities and (2) optimize resident safety.  The proposed changes took a multifaceted approach
to reducing health care associated infections and unnecessary hospitalizations.  The final rule,
issued in October 2016, stated that infection prevention and control is a critical issue for
nursing home residents because of the high number of health care associated infections, the
residents’ increased susceptibility to infections, and the significant exposure to health care

3 For Medicare and Medicaid, these statutory participation and survey requirements are implemented at 42 CFR,
part 483, subpart B, and 42 CFR, part 488, subpart E, respectively.

4 78 Fed. Reg. 79082, 79084 (Dec. 27, 2013).

5 81 Fed. Reg. 63860, 63862 (Sept. 16, 2016).

6 81 Fed. Reg. 63862, 63863 (Sept. 16, 2016).

7 80 Fed. Reg. 42167 (July 16, 2015).

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associated infections residents face.8  The final rule phased in new infection prevention and
control regulations over a 3-year period.9

In the final rule, CMS required nursing homes to, among other things:

• have a broad effective infection prevention and control program (IPCP) that included a
system for preventing, identifying, reporting, investigating, and controlling infections
and communicable diseases for residents and staff (phase 1);

• provide their Quality Assurance and Performance Improvement (QAPI) plans to their
SSA not later than 1 year after the date the regulation is issued, at each annual
recertification survey, and upon request (phase 2); and

• have the individual(s) responsible for the nursing home’s IPCP complete specialized
training in infection prevention and control (phase 3).

The regulations in phase 1 had an implementation date of November 28, 2016, regulations in
phase 2 had an implementation date of November 28, 2017, and regulations in phase 3 had an
implementation date of November 28, 2019.  CMS informed SSAs on November 22, 2019, that
although the phase 3 requirements would be effective November 28, 2019, CMS would not
release interpretive guidance and training for these requirements until the second quarter of
calendar year 2020.10  The guidance was not issued during the second quarter of calendar year
2020.  CMS stated that the COVID-19 public health emergency (PHE) contributed to the delay in
issuing the phase 3 interpretive guidance.

Requirements for Infection Control and Emergency Preparedness

Nursing homes are required to operate and provide services in compliance with all Federal,
State, and local laws, regulations, and codes, as well as accepted professional standards and
principles (42 CFR § 483.70).  Federal regulations on infection control (42 CFR § 483.80) require
nursing homes to establish and maintain an IPCP designed to provide a safe, sanitary, and
comfortable environment and to help prevent the development and transmission of
communicable diseases and infections.  In addition, Federal regulations on emergency
preparedness (42 CFR § 483.73) include specific requirements for nursing homes’ emergency
preparedness plans, such as requirements that facilities complete a facility-based and
community-based all-hazards (including emerging infectious diseases) risk assessment and

8 81 Fed. Reg. 68688, 68808 (Oct. 4, 2016).

9 CMS chose to implement the requirements over a “phase-in” period to allow for appropriate clarification and
education for facilities, surveyors, and other stakeholders.

10 Nov. 22, 2019, memo from the Director of Quality, Safety & Oversight Group at CMS to the State Survey Agency
Directors (REF: QSO-20-03-NH).

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develop strategies to address the risks identified.11  CMS informed SSA directors in February
2019 that it was updating and adding emerging infectious diseases to the current definition of
all-hazards approach in Appendix Z of the State Operations Manual.

Responsibilities for Infection Prevention and Emergency Preparedness

The Act mandates the establishment of minimum health and safety standards that must be met
by providers participating in the Medicare and Medicaid programs.  CMS is responsible for
overseeing health care provider compliance with Medicare and Medicaid health and safety
standards.  CMS delegates a variety of tasks related to this oversight to the SSAs (the Act §
1864).  One of these tasks is to conduct investigations and fact-finding surveys to determine
whether health care providers, including nursing homes, comply with their applicable
conditions of participation (CoPs).  Standard surveys of nursing homes must occur no later than
15 months after the previous survey.12, 13  SSAs are also responsible for conducting a complaint
survey if a complaint alleging noncompliance with CoPs is substantiated.  Such a survey can
happen at any time, regardless of standard survey intervals.  SSAs cite nursing homes with
deficiencies when they do not meet the CoPs, including when they do not follow infection
prevention and control requirements.

Management and staff at a nursing home are ultimately responsible for ensuring the safety and
well-being of residents and staff and for complying with Federal, State, and local regulations.
They are responsible for ensuring that the nursing home develops, maintains, and implements
infection prevention and control and emergency preparedness programs.

Additional CMS Guidance

To keep COVID-19 out of nursing homes and to stop its spread, CMS issued many guidance
memoranda during the COVID-19 PHE.  These included, among other things, requiring nursing
homes to: (1) limit visits from family and friends to certain situations, such as end of life;
(2) cease group activities and communal dining; (3) screen residents and others (including staff,
vendors, and visitors) entering the nursing home for respiratory illness symptoms; and (4) test
residents and staff for COVID-19.  See Appendix B for a list of CMS memoranda issued during
the pandemic.

11 Emerging infectious diseases are those that have newly appeared in a population or have existed but are rapidly
increasing in incidence or geographic range.  “Emerging Infectious Diseases” is available online at
https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens.  (Accessed Jan. 20, 2022.)

12 Social Security Act §§ 1819(g)(2)(A)(iii)(I) and 1919(g)(2)(A)(iii)(I) and 42 CFR § 488.308(a).

13 A standard survey is a periodic, resident-centered inspection that gathers information about the quality of
service furnished in a facility to determine compliance with the requirements of participation (42 CFR § 488.301).

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COVID-19 Reporting Requirements for Nursing Homes

CMS issued an interim final rule on May 8, 2020, that required nursing homes to report, among
other things, the number of confirmed and suspected COVID-19 cases and COVID-19-related
deaths among residents and staff to CDC’s National Healthcare Safety Network on a weekly
basis beginning on May 17, 2020.  CMS published on its website the information it received
from nursing homes.

Table 1 contains the total number of residents and staff with confirmed and suspected
COVID-19 cases and COVID-19-related deaths reported to CDC and CMS through October 17,
2021, by 15,425 nursing homes.14, 15

Table 1: COVID-19 Cases and COVID-19-Related Deaths

Confirmed and Suspected COVID-19 Cases
COVID-19-Related Deaths
Residents
Staff
Total
Residents
Staff
Total
906,409
855,145
1,761,554
138,305
2,140
140,445

Residents and staff at the 39 selected nursing homes were severely impacted by COVID-19.
Many of these residents and staff contracted COVID-19—and 360 died.  Table 2 includes the
number of residents and staff with confirmed and suspected COVID-19 cases and
COVID-19-related deaths reported to OIG by the selected nursing homes through October 17,
2021.

Table 2: COVID-19 Cases and COVID-19-Related Deaths at 39 Nursing Homes*

Confirmed and Suspected
COVID-19 Cases
COVID-19-Related Deaths
Residents
Staff
Total
Residents
Staff
Total
2,039
1,471
3,510
357
3
360
* These numbers include case and death counts reported directly to OIG by the 39 nursing homes through
March 31, 2021, and case and death counts reported to CDC and CMS from April 1, 2021, through October 17,
2021.

14 Nursing homes were required to begin reporting these data as of May 17, 2020.  However, there was no
requirement for them to report data that predate the effective date of the interim final rule; it was left to the
discretion of the nursing homes whether to report the historical data.  As a result, these data could be lower than
the actual COVID-19 cases and COVID-19-related deaths if nursing homes chose to not report the historical data.

15 We removed the COVID-19 cases and related deaths reported by the 39 nursing homes in our audit from these
numbers and reported them separately.

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HOW WE CONDUCTED THIS AUDIT

As of March 26, 2020, there were 15,446 Medicare and Medicaid certified nursing homes.  We
analyzed SSA survey data on Medicare.gov for the most recent standard surveys and the
previous 12 months of complaint surveys.16  Based on that analysis, we determined that 6,830
nursing homes (approximately 44 percent) had been cited for IPCP deficiencies related to:
(1) not providing and implementing an infection prevention and control program (6,169 nursing
homes), (2) not developing and implementing policies and procedures for flu and pneumonia
vaccinations (243 nursing homes), or (3) both (418 nursing homes).  Medicare.gov indicated
that 39 of the 6,830 nursing homes had not provided a plan of correction for the infection
prevention and control deficiencies to the SSAs as of March 26, 2020.  The deficiencies
included:

• failure of surveillance program to identify and prevent the spread of possible
communicable diseases or infections,

• improper hand hygiene among staff and residents,

• failure to disinfect shared equipment between uses, and

• improper care and storage of a resident’s nebulizer mask and tubing that was attached
to the nebulizer machine.

We contacted the 39 nursing homes and requested that they provide us with documentation
related to infection prevention and control and emergency preparedness program policies and
procedures that were in effect from January 1, 2019, through May 31, 2020.  This
documentation included, but was not limited to, the nursing homes’ IPCP policies and
procedures, information regarding the infection preventionist position, quality assessment and
assurance committees (QAAC), training, all-hazards risk assessments, and emergency
preparedness policies and procedures.  We reviewed these documents to determine whether
the nursing homes complied with Federal requirements for infection prevention and control
and infection-control-related emergency preparedness.  CMS officials informed us that actual
deficiencies are cited onsite following a thorough investigation by trained Federal, State, and
contractual surveyors to determine compliance with the Federal requirements for participation
(i.e., the minimum health and safety standards).  Therefore, we defer to trained surveyors who
may conduct a followup review at the selected nursing homes to determine whether a
deficiency exists for each condition identified in this report.

16 A complaint survey is conducted based on a substantial allegation of noncompliance.  A substantial allegation of
noncompliance is a complaint that would, if found to be present, adversely affect the health and safety of
residents and raises doubts as to a provider’s compliance with any Medicare condition of participation, condition
for coverage, condition for certification, or requirements (42 CFR § 488.1).

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We conducted this performance audit 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.
Appendix A contains the details of our audit scope and methodology.

FINDINGS

Selected nursing homes may not have complied with Federal requirements for infection
prevention and control and emergency preparedness.17  Specifically, 28 of the 39 nursing
homes had possible deficiencies,18 and 18 of these nursing homes had more than 1 possible
deficiency.  We found 48 instances at 25 nursing homes of possible noncompliance with
infection prevention and control requirements related to:

• the designation of a qualified infection preventionist,

• the occurrence of QAAC meetings,

• infection preventionist attendance at QAAC meetings,

• policies and procedures regarding reporting possible incidents of communicable
diseases and infections,

• the nursing homes’ annual reviews of their IPCPs, and

• training.

We also found 18 instances at 18 nursing homes of possible noncompliance with emergency
preparedness requirements related to all-hazards risk assessments and strategies to address
emerging infectious diseases.

Nursing home officials attributed the areas of possible noncompliance we identified to:
(1) inadequate internal controls, (2) inadequate management oversight, (3) administrative and
leadership changes, (4) inadequate CMS communication and training, and (5) inconsistent and

17 CMS officials informed us that actual deficiencies are cited onsite following a thorough investigation by trained
Federal, State, and contractual surveyors to determine compliance with the Federal requirements for participation
(i.e., the minimum health and safety standards).  Therefore, we will defer to the trained surveyors who may
conduct a followup review at the selected nursing homes to determine whether a deficiency exists for each
condition identified in this report.

18 Of the 28 nursing homes with possible deficiencies, 15 had infection prevention and control and emergency
preparedness deficiencies; 10 had only infection prevention and control deficiencies; and 3 had only emergency
preparedness deficiencies.

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confusing regulations.  In addition, we believe many of the conditions noted in our report
occurred because CMS did not provide nursing homes with communication and training related
to complying with the new phase 3 infection requirements or clarification about the essential
components to be integrated in the nursing homes’ emergency plans.

As a result of the possible deficiencies, 28 of the 39 nursing homes we audited may have
increased the risk of health and safety issues, including emerging infectious disease threats, for
their residents and staff.

SELECTED NURSING HOMES MAY NOT HAVE COMPLIED WITH INFECTION PREVENTION AND
CONTROL REQUIREMENTS

We found that 25 of the 39 nursing homes had at least 1 possible deficiency related to infection
prevention and control, and 14 of the 25 nursing homes had more than 1 possible deficiency
totaling 48 possible deficiencies.  Appendix C summarizes the areas of possible infection
prevention and control noncompliance.  These possible deficiencies were related to: (1) the
designation of an infection preventionist who met Federal regulations, (2) conducting QAAC
meetings at least quarterly, (3) infection preventionist attendance at the QAAC meetings,
(4) policies and procedures regarding reporting possible incidents of communicable diseases
and infections, (5) annual review of the IPCP, and (6) training.

Nursing Homes Did Not Designate an Infection Preventionist Who Met Federal Requirements

A nursing home must designate one or more individuals as the infection preventionist who is
responsible for the nursing home’s IPCP.  This person must, among other things, have completed
specialized training in infection prevention and control (42 CFR § 483.80(b)).

In the final rule dated October 4, 2016, CMS discussed the importance of nursing homes having a
designated individual responsible for a nursing home’s infection prevention and control
program.  CMS said that nursing homes should ensure coverage whenever the designated
infection preventionist is unavailable.  Therefore, CMS allows nursing homes the flexibility to
designate more than one individual to be responsible for the IPCP.19

In addition, CMS collaborated with the CDC to develop a free online training course on infection
prevention and control for nursing home staff.20

19 81 Fed. Reg. 68810 (Oct. 4, 2016).

20 CMS and CDC offer a specialized online class called “Infection Prevention and Control Training for Nursing Home
Staff in the Long-Term Care Setting” at https://www.cdc.gov/longtermcare/training.html.  (Accessed July 13,
2021.)  However, nursing home staff have the option to complete specialized infection prevention and control
training from other sources.

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Of the 39 nursing homes that we reviewed, 12 had possible deficiencies related to designating
an infection preventionist who met Federal requirements.21  Specifically, we found that six
nursing homes may not have complied with the Federal requirement to ensure that the
designated infection preventionist completed specialized training by the implementation date of
the Federal requirement.  We also found that six nursing homes were unable to provide
documentation, such as a certificate of completion of specialized infection prevention and
control training, to support that the designated infection preventionist had met the Federal
requirement of completing specialized training.22, 23

Nursing Homes Did Not Conduct Quarterly Quality Assessment and Assurance
Committee Meetings

A nursing home’s QAAC must meet at least quarterly and as needed to coordinate and evaluate
activities under the quality assurance and performance improvement program (42 CFR
§ 483.75(g)(2)(i)).24

Effective QAPI programs are critical to improving the quality of life, care, and services delivered
in facilities, according to CMS.25  Section 6102 of the Affordable Care Act required the
establishment and implementation of a QAPI program for nursing homes.  Therefore, CMS has
required nursing homes to develop, implement, and maintain an effective, comprehensive, data-
driven QAPI program that focuses on systems of care, outcomes, and services for residents and
staff.  The QAAC reports to the governing body regarding its activities,26 including
implementation of the QAPI program, and the governing body has ultimate responsibility to
ensure that the QAPI program is defined, implemented, and maintained.27

21 Among the 12 nursing homes, there were a total of 12 deficiencies related to designating an infection
preventionist who met Federal requirements.

22 CMS required nursing homes to designate an infection preventionist who met Federal requirements by Nov. 28,
2019.

23 Of the six nursing homes that were unable to provide documentation that they designated an infection
preventionist who met Federal requirements, three nursing homes were unable to provide documentation that
they had designated an infection preventionist, and three nursing homes had designated an infection preventionist
but were unable to provide documentation that the infection preventionist had completed specialized training.

24 CMS required at least quarterly meetings of the QAAC with phase 3 of implementation, Nov. 28, 2019.

25 81 Fed. Reg. 68804 (Oct. 4, 2016).

26The facility must have a governing body, or designated persons functioning as a governing body, that is legally
responsible for establishing and implementing policies regarding the management and operation of the facility (42
CFR § 483.70(d)(1)).  The governing body is responsible and accountable for the QAPI program (42 CFR § 483.75(f)).

27 42 CFR § 483.75(f) and 80 Fed. Reg. 42212—42214 (July 16, 2015).

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Of the 39 nursing homes we reviewed, 7 had possible deficiencies related to conducting QAAC
meetings at least quarterly.28  Specifically, we found that one nursing home may not have
complied with the Federal requirements to conduct a QAAC meeting at least quarterly, and six
nursing homes did not provide documentation, such as agendas or sign-in sheets, to support
that they had complied with the Federal requirement.29

Infection Preventionists Did Not Attend Quality Assessment and Assurance
Committee Meetings

Infection preventionists must be members of nursing homes’ QAAC to ensure that they are
active participants in nursing homes’ QAPI plan (42 CFR §§ 483.75(g)(1)(iv) and 483.80(c)).
Infection preventionists coordination with the QAAC and with QAPI activities is important to the
success of the infection control and prevention program.30

Of the 39 nursing homes that we reviewed, 13 had possible deficiencies related to infection
preventionists’ participation in the QAAC meetings.31  Specifically, we found that four nursing
homes may not have complied with the Federal requirement to ensure that designated infection
preventionists attended QAAC meetings, and nine nursing homes did not provide
documentation, such as meeting sign-in sheets, to support that they had complied with the
Federal requirement.

Nursing Homes’ Reporting Policies Did Not Specify When and to Whom Incidents of
Communicable Diseases Should Be Reported

Nursing homes must have written standards, policies, and procedures for the program, which
must include an explanation of when and to whom possible incidents of communicable disease
or infections should be reported (42 CFR § 483.80).  Nursing homes must know how to
recognize and contain infectious disease outbreaks and take appropriate steps to contain an
outbreak.32

28 Among the seven nursing homes, there were a total of seven deficiencies related to at least quarterly QAAC
meetings.

29 One nursing home was closed; therefore, we did not get any documentation for meetings from that nursing
home.  The other five nursing homes provided documentation of meetings; however, the documentation did not
support that meetings were held at least quarterly.  For example, one nursing home provided documentation for
meetings held every 4 months, and another nursing home provided documentation for meetings held in August
2019 and March 2020.

30 80 Fed. Reg. 42214 (July 16, 2015).

31 Among the 13 nursing homes, there were a total of 13 deficiencies related to infection preventionist attendance
at QAAC meetings.

32 State Operations Manual, Appendix PP – Guidance to Surveyors for Long Term Care Facilities (Rev. 173, Nov. 22,
2017, p. 684—685).

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Of the 39 nursing homes that we reviewed, 9 had possible deficiencies related to their
reporting policies and procedures.33  Specifically, these nursing homes may not have complied
with the Federal requirement to specify in their written standards, policies, and procedures for
the program when and to whom possible incidents of communicable diseases or infections
should be reported.

Nursing Homes Did Not Review IPCPs Annually

Nursing homes must conduct annual reviews of their IPCPs and update their programs, as
necessary (42 CFR § 483.80(f)).  CMS stated that an annual update of nursing home IPCPs is
important to ensure the effectiveness of the IPCP in order to keep the nursing homes up to date
on current infection prevention and control best practices.34

Of the 39 nursing homes that we reviewed, 6 had possible deficiencies related to the annual
review of their IPCPs.35  Specifically, we found that one nursing home may not have complied
with the Federal requirement to review its IPCP at least annually, and five nursing homes did not
provide documentation, such as dated policies and procedures or signed and dated manual
annual review and approval documents, to support that they complied with the Federal
requirement that the IPCP had been reviewed at least annually.

One Nursing Home Did Not Demonstrate That It Conducted Infection Prevention and
Control Training

A nursing home must develop, implement, and maintain an effective training program for all
new and existing staff; individuals providing services under a contractual arrangement; and
volunteers, consistent with their expected roles (42 CFR § 483.95).  A nursing home must
determine the amount and types of training necessary based on a facility assessment.  Training
topics must include, but are not limited to, infection control.36  A nursing home must include, as
part of its infection prevention and control programs, mandatory training that includes the
written standards, policies, and procedures for the program.

Of the 39 nursing homes that we reviewed, 1 had a possible deficiency related to infection
prevention and control training.37  Specifically, this nursing home did not provide any
documentation, such as in-service training sign-in sheets, to support that it complied with the

33 Among the nine nursing homes, there were a total of nine deficiencies related to policies regarding when and to
whom possible incidents of communicable diseases should be reported.

34 80 Fed. Reg. 42216 (July 16, 2015).

35 Among the six nursing homes, there were a total of six deficiencies related to the annual review of the IPCP.

36 This requirement had an implementation date of Nov. 28, 2019.

37 For this nursing home, there was one deficiency related to infection prevention and control training.

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Federal requirement to conduct infection prevention and control training.

SELECTED NURSING HOMES MAY NOT HAVE COMPLIED WITH EMERGENCY PREPAREDNESS
REQUIREMENTS

We found that 18 of the 39 nursing homes each had 1 possible deficiency related to emergency
preparedness.  Appendix D summarizes the areas of emergency preparedness possible
noncompliance.  These possible deficiencies related to completing a facility-based and
community-based risk assessment and strategies to address emerging infectious diseases.

All-Hazards Risk Assessment Did Not Include Emerging Infectious Diseases

Nursing homes must develop and maintain an emergency preparedness plan that must be
reviewed and updated at least annually.  The plan must be based on a facility- and community-
based risk assessments, using an “all-hazards approach” (42 CFR §483.73(a)(1)).  In February
2019, CMS updated Appendix Z of the State Operations Manual to include emerging infectious
diseases to the definition of an all-hazards approach.38

Of the 39 nursing homes that we reviewed, 10 had possible deficiencies related to all-hazards
risk assessments.39  Specifically, we found that one nursing home may not have complied with
the Federal requirement to complete facility- and community-based risk assessment, and nine
nursing homes did not include emerging infectious diseases on their all-hazards risk
assessments.40

Emergency Plans Did Not Include Strategies To Address Emerging Infectious Diseases

Nursing homes’ emergency preparedness plans must include strategies for addressing
emergency events identified by the risk assessment (42 CFR §483.73(a)(2)).

Of the 39 nursing homes that we reviewed, 8 had possible deficiencies related to their
emergency plans.41  Specifically, we found that 8 of the 29 nursing homes that completed a risk
assessment and included emerging infectious diseases as a risk on their risk assessments may
not have complied with the Federal requirement to include strategies in their emergency plans

38 84 Fed. Reg. 51732, 51755 (Sept. 30, 2019) and Feb. 19, 2019, memo from the Director of Quality, Safety &
Oversight Group at CMS to the State Survey Agency Directors (REF: QSO19-06-ALL).

39 Among the 10 nursing homes, there were a total of 10 deficiencies related to all-hazards risk assessments.

40 During the exit conference, CMS officials said that they would expect an SSA to cite a nursing home for a
deficiency if the nursing home did not include emerging infectious diseases on its all-hazards risk assessment.  CMS
added that it cannot state that the SSAs must (emphasis added) cite a deficiency because the regulations do not
state that the risk assessment must (emphasis added) include emerging infectious diseases.

41 Among the eight nursing homes, there were a total of eight deficiencies related to emerging infectious disease
strategies.

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to address emerging infectious diseases.

CAUSES OF POSSIBLE NONCOMPLIANCE WITH FEDERAL REQUIREMENTS

Officials from the 28 nursing homes provided the following reasons for potentially not
complying with Federal requirements for infection prevention and control and
infection-control-related emergency preparedness:

• nursing home internal controls were inadequate,

• nursing home management oversight was lacking,

• nursing home administrative and leadership positions experienced changes,

• inadequate CMS communication and training, and

• inconsistent and confusing regulations.42

We also believe that the lack of interpretive guidance could have contributed to the number of
infection prevention and control possible deficiencies.

SELECTED NURSING HOMES MAY HAVE INCREASED THE RISK OF INFECTIONS TO RESIDENTS
AND STAFF

As a result of the potential infection prevention and control and emergency preparedness
deficiencies, selected nursing homes may have an increased risk for health and safety issues,
including emerging infectious disease threats for residents and staff.

RECOMMENDATIONS

We recommend that the Centers for Medicare & Medicaid Services:

42 Title 42 CFR § 483.73(a)(1) states that nursing homes must (emphasis added) develop an emergency plan that is
based on a facility-based and community-based risk assessment utilizing an all-hazards approach, including missing
residents.  A February 2019 memo from CMS to SSA directors informed them that it was updating Appendix Z of
the State Operations Manual to reflect changes to add emerging infectious diseases to the current definition of
all-hazards approach.  The February 2020 revision of Appendix Z of the State Operations Manual states that
planning for using an all-hazards approach should (emphasis added) also include emerging infectious disease
threats.

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• instruct SSAs to follow up with the 28 nursing homes that we have identified with
possible infection prevention and control and emergency preparedness deficiencies to
verify that they have taken corrective actions,43
• issue the updated phase 3 interpretive guidance as soon as feasible,44

• provide training to SSAs on the updated, phase 3 interpretive guidance as soon as
feasible,45 and

• consider updating the regulation to make clear that nursing homes must include
emerging infectious diseases as a risk on their facility- and community-based all-hazards
risk assessments.

CMS COMMENTS AND OFFICE OF INSPECTOR GENERAL RESPONSE

In written comments on our draft report, CMS concurred with our first three recommendations.
Regarding our fourth recommendation, CMS stated that it would consider this recommendation
in future rulemaking.  Summaries of CMS’s comments and our responses are provided below.

CMS also provided technical comments on our draft report, which we addressed as
appropriate.  CMS’s comments, excluding the technical comments, appear as Appendix E.

INTRODUCTORY COMMENTS

CMS Comments

In its introductory comments on this report, CMS stated that it takes seriously its role in
improving the safety and quality of care in the Nation’s nursing homes and that it is leading the
Biden-Harris Administration’s new efforts to increase accountability for nursing homes.  The
Administration has laid out 21 initiatives spread across 5 key, strategic goals.  One goal is to
ensure pandemic and emergency preparedness in nursing homes and carry forward lessons
learned during COVID-19.  These initiatives were developed with extensive input from
advocates, industry experts, nursing home workers, and nursing home residents and their loved
ones.  CMS said it is considering a wide range of methods to accomplish this important work.

CMS further stated that since the beginning of COVID-19 it has taken numerous actions to
further strengthen infection prevention and control in nursing homes.  CMS also stated that
focused infection control surveys had been conducted at more than 99 percent of nursing

43 SSAs should prioritize followup activities: (1) based upon the level of risk to beneficiaries and (2) in accordance
with CMS policies for triaging nursing home complaints and incidents.

44 CMS provided comments to the OIG draft report on May 18, 2022.  On June 29, 2022, CMS informed OIG that
they issued the phase 3 interpretive guidance.

45 CMS made training materials related to the new interpretive guidance available to the SSAs on June 28, 2022.

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homes as of July 2020 and that it now requires that SSAs conduct annual, focused infection
control surveys at 20 percent of nursing homes.

CMS added that it uses data submitted by nursing homes to improve oversight and inform the
public.  This data includes things such as COVID-19 testing, cases, and mortality for residents
and staff; nursing home staff and resident COVID-19 vaccination; and weekend nurse staffing
levels.

Office of Inspector General Response

We commend CMS for the action it has and plans to take in order to ensure the safety and
quality of care for residents of our Nation’s nursing homes.  We included examples in the report
of actions that CMS took such as: (1) limiting visits to certain situations, such as end of life,
(2) ceasing group activities and communal dining, (3) screening residents and others entering
the nursing home for respiratory illness symptoms, and (4) testing residents and staff for
COVID-19.  We also included in Appendix B a list of many of the actions that CMS took in
response to the PHE.

COMMENTS ON RECOMMENDATIONS

CMS Comments

CMS concurred with our first three recommendations and described actions that it has taken or
plans to take to address our recommendations.  CMS stated that it will: (1) ensure that SSAs
follow up with the 28 nursing homes to verify that they have taken corrective actions, (2) issue
the phase 3 interpretive guidance, and (3) provide training as soon as feasible.  CMS stated that
it had intended to release the phase 3 interpretive guidance during the second quarter of 2020.
However, prior to issuing the guidance, the COVID-19 PHE was declared, and CMS immediately
redirected resources to address patient safety needs related to the PHE.  Regarding our fourth
recommendation, CMS stated that it would consider this recommendation in future
rulemaking.  CMS further stated that it has taken considerable steps to make clear that nursing
homes should include emerging infectious diseases as an identified risk on their facility- and
community-based, all-hazards risk assessments.

Office of Inspector General Response

Regarding our fourth recommendation, OIG believes that the regulation should be
strengthened to require the inclusion of emerging infectious diseases as an identified risk on
their facility- and community-based all-hazards risk assessments.  Although CMS addresses the
inclusion of emerging infectious diseases as a risk in its State Operations Manual, Appendix Z,
“Emergency Preparedness for All Provider and Certified Supplier Types Interpretive Guidance,”
the manual states that planning for using an all-hazards approach should also include emerging
infectious disease (EID) threats.  The word “should” could be inferred by nursing homes to
mean that the inclusion of emerging infectious diseases is not a requirement but rather a

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recommendation.

OTHER MATTERS

Nursing homes typically struggle with staffing shortages and turnover, which only became
worse during the COVID-19 PHE.  For example, one of the nursing homes in our audit had
shortages that led it to require staff who received positive COVID-19 tests while at work to
complete their shifts.46  When asked about the rationale for this, nursing home officials stated
that the extreme staffing shortage made it necessary in order to ensure the safety of the
residents.  They also stated that all employees donned full PPE for their entire shifts.
Additionally, 34 of the 39 nursing homes that we reviewed reported to OIG that between
January 1, 2019, and April 30, 2021, they had average monthly staff turnover rates ranging from
a low of 1 percent to a high of 20 percent.47  One nursing home reported a 154 percent staff
turnover during 2020.  Nursing homes also often had turnover in ownership and key senior
management positions.  Nursing homes reported to us:

• 4 changes in ownership (4 nursing homes reported changes in ownership 1 time each
from January 1, 2019, through April 30, 2021),

• 49 changes in administrators (24 nursing homes reported changes in administrators
between 1 and 5 times from January 1, 2019, through April 30, 2021), and

• 56 changes in the infection preventionist position (21 nursing homes reported changes
in the position between 1 and 6 times from January 1, 2019, through April 30, 2021).

In many instances, the reason why a nursing home was unable to provide documentation to
support that it had complied with Federal regulations appeared to be related to turnover.  For
example, one nursing home was unable to provide documentation that infection prevention
and control training had taken place because ownership was new and the new owner did not
have access to the prior owner’s computer system that maintained training records.  In other
instances, the administrators who responded to our audit were not employed by the nursing
homes during our audit period or were not the administrators throughout the entire audit
period; therefore, they were unable to answer certain questions, such as whether the nursing
home had designated an infection preventionist at the start of the requirement’s
implementation date.

46 CDC guidance allowed for COVID-19 positive staff to continue working during periods of staff shortages
https://www.cdc.gov/coronavirus/2019-ncov/hcp/mitigating-staff-shortages.html.  (Accessed Mar. 1, 2022.)

47 Of the five remaining nursing homes, two nursing homes closed during our fieldwork, one nursing home had an
ownership change during fieldwork and did not have turnover information from the previous owner, one nursing
home stated that it did not track staff turnover, and one nursing home did not respond to our request.

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APPENDIX A: AUDIT SCOPE AND METHODOLOGY

SCOPE

As of March 26, 2020, there were 15,446 Medicare and Medicaid certified nursing homes.
SSA data on the Medicare.gov website indicated that 6,830 (approximately 44 percent) of
these 15,446 nursing homes had been cited for infection control deficiencies.  After further
analysis of the data, we found that these deficiencies had been corrected in all but 39 (less
than 1 percent) nursing homes that did not have a plan in place to correct the deficiencies as
of March 26, 2020.  We contacted the 39 nursing homes and requested documentation to
determine whether they complied with Federal regulations from January 1, 2019, through
May 31, 2020.

We did not assess CMS’s or the nursing homes’ overall internal control structures.  Rather, we
limited our review of internal controls to the nursing homes’ infection prevention and control
policies and procedures and infection-control-related emergency preparedness policies and
procedures.

We performed our audit from June 2020 through March 2022.

METHODOLOGY

To accomplish our objective, we:

• reviewed applicable Federal and State requirements;

• corresponded with CMS program officials to gain an understanding of the infection
prevention and control and emergency preparedness requirements;

• contacted the 39 nursing homes and requested documentation related to their infection
prevention and control and emergency preparedness plans;

• reviewed documentation from nursing homes to determine whether they have
programs for infection prevention and control and emergency preparedness in
accordance with Federal requirements; and

• discussed the results of the audit with CMS officials.

We conducted this performance audit 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.

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APPENDIX B: LIST OF CMS PUBLIC HEALTH ACTIONS FOR NURSING HOMES
 CONCERNING THE COVID-19 PUBLIC HEALTH EMERGENCY

Date
Title
February
6, 2020
CMS Prepares Nation’s Healthcare Facilities for Coronavirus Threat

https://www.cms.gov/newsroom/press-releases/cms-prepares-nations-
healthcare-facilities-coronavirus-threat
March 4,
2020
CMS Announces Actions to Address Spread of Coronavirus

https://www.cms.gov/newsroom/press-releases/cms-announces-actions-
address-spread-coronavirus
March 10,
2020
COVID-19 Response News Alert: CMS Issues Key Protective Mask Guidance for
Healthcare Workers

https://www.cms.gov/newsroom/press-releases/covid-19-response-news-alert-
cms-issues-key-protective-mask-guidance-healthcare-workers
March 13,
2020
Guidance for Infection Control and Prevention of Coronavirus Disease 2019
(COVID-19) in Nursing Homes (revised March 10, 2021)

https://www.cms.gov/files/document/qso-20-14-nh-revised.pdf
March 20,
2020
Prioritization of Survey Activities (updated March 10, 2021)

https://www.cms.gov/files/document/qso-20-20-allpdf.pdf
April 2,
2020
Trump Administration Issues Key Recommendations to Nursing Homes, State and
Local Governments

https://www.cms.gov/newsroom/press-releases/trump-administration-issues-
key-recommendations-nursing-homes-state-and-local-governments
April 19,
2020
Trump Administration Announces New Nursing Homes COVID-19 Transparency
Effort

https://www.cms.gov/newsroom/press-releases/trump-administration-
announces-new-nursing-homes-covid-19-transparency-effort
April 30,
2020
CMS Announces Independent Commission to Address Safety and Quality in
Nursing Homes

https://www.cms.gov/newsroom/press-releases/cms-announces-independent-
commission-address-safety-and-quality-nursing-homes

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May 6,
2020
Interim Final Rule Updating Requirements for Notification of
Confirmed and Suspected COVID-19 Cases Among Residents and Staff in Nursing
Homes

https://www.cms.gov/files/document/qso-20-29-nh.pdf
May 2020
Toolkit on State Actions to Mitigate COVID-19 Prevalence in Nursing Homes
(version 26, issued March 2022)

https://www.cms.gov/files/document/covid-toolkit-states-mitigate-covid-19-
nursing-homes.pdf
May 14,
2020
Trump Administration Announces Call for Nominations for Nursing Home
Commission

https://www.cms.gov/newsroom/press-releases/trump-administration-
announces-call-nominations-nursing-home-commission
May 18,
2020
Trump Administration Issues Guidance to Ensure States Have a Plan in Place to
Safely Reopen Nursing Homes

https://www.cms.gov/newsroom/press-releases/trump-administration-issues-
guidance-ensure-states-have-plan-place-safely-reopen-nursing-homes
June 1,
2020
COVID-19 Survey Activities, CARES Act Funding, Enhanced Enforcement for
Infection Control Deficiencies, and Quality Improvement Activities in Nursing
Homes (revised January 4, 2021)

https://www.cms.gov/files/document/qso-20-31-all-revised.pdf

CMS also issued a letter to governors:

https://www.cms.gov/files/document/6120-letter-governors.pdf
June 19,
2020
CMS Announces Membership of Independent Coronavirus Commission on Safety
and Quality in Nursing Homes

https://www.cms.gov/newsroom/press-releases/cms-announces-membership-
independent-coronavirus-commission-safety-and-quality-nursing-homes
June 23,
2020
CMS released revised guidance for nursing home visitation during the COVID-19
Public Health Emergency (revised March 10, 2021)

https://www.cms.gov/files/document/covid-visitation-nursing-home-
residents.pdf

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June 25,
2020
CMS Ends Emergency Blanket Waiver for the Nursing Home Staffing Data
Submission Requirement

https://www.cms.gov/newsroom/press-releases/cms-ends-emergency-blanket-
waiver-nursing-home-staffing-data-submission-requirement
July 10,
2020
CMS Directs Additional Resources to Nursing Homes in COVID-19 Hotspot Areas

https://www.cms.gov/newsroom/press-releases/cms-directs-additional-
resources-nursing-homes-covid-19-hotspot-areas
July 14,
2020
Trump Administration Announces Initiative for More and Faster COVID-19
Testing in Nursing Homes

https:/www.hhs.gov/about/news/2020/07/14/trump-administration-
announces-initiative-more-faster-covid-19-testing-nursing-homes.html
July 22,
2020
Trump Administration Announces New Resources to Protect Nursing Home
Residents Against COVID-19

https://www.cms.gov/newsroom/press-releases/trump-administration-
announces-new-resources-protect-nursing-home-residents-against-covid-19
August
17, 2020
CMS Announces Resumption of Routine Inspections of All Provider and Suppliers,
Issues Updated Enforcement Guidance to States, and Posts Toolkit to Assist
Nursing Homes

https://www.cms.gov/newsroom/press-releases/cms-announces-resumption-
routine-inspections-all-provider-and-suppliers-issues-updated-enforcement
August
24, 2020
CMS Issues Informational Bulletin on Medicaid Reimbursement Strategies to
Prevent Spread of COVID-19 in Nursing Facilities

https://www.cms.gov/newsroom/press-releases/cms-issues-informational-
bulletin-medicaid-reimbursement-strategies-prevent-spread-covid-19-nursing
August
25, 2020
Trump Administration Launches National Training Program to Strengthen
Nursing Home Infection Control Practices

https://www.cms.gov/newsroom/press-releases/trump-administration-
launches-national-training-program-strengthen-nursing-home-infection-control
August
25, 2020
Trump Administration Strengthens COVID-19 Surveillance with New Reporting
and Testing Requirements for Nursing Homes, Other Providers

https://www.cms.gov/newsroom/press-releases/trump-administration-
strengthens-covid-19-surveillance-new-reporting-and-testing-requirements

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August 26,
2020
CMS posts guidance for implementing new testing requirements in nursing
homes and labs

https://www.cms.gov/newsroom/press-releases/cms-posts-guidance-
implementing-new-testing-requirements-nursing-homes-and-labs
September
16, 2020
Independent Nursing Home COVID-19 Commission Findings Validate
Unprecedented Federal Response

https://www.cms.gov/newsroom/press-releases/independent-nursing-
home-covid-19-commission-findings-validate-unprecedented-federal-
response
September
17, 2020
CMS Announces New Guidance for Safe Visitation in Nursing Homes During
COVID-19 Public Health Emergency

https://www.cms.gov/newsroom/press-releases/cms-announces-new-
guidance-safe-visitation-nursing-homes-during-covid-19-public-health-
emergency
September
29, 2020
CMS Updates COVID-19 Testing Methodology for Nursing Homes

https://www.cms.gov/newsroom/press-releases/cms-updates-covid-19-
testing-methodology-nursing-homes

November
17, 2020
CMS Releases Nursing Home COVID-19 Training Data with Urgent Call to
Action

https://www.cms.gov/newsroom/press-releases/cms-releases-nursing-
home-covid-19-training-data-urgent-call-action

November
18, 2020
CMS Urging Nursing Homes to Follow Established COVID Guidelines This
Holiday Season

https://www.cms.gov/newsroom/press-releases/cms-urging-nursing-homes-
follow-established-covid-guidelines-holiday-season
August 18,
2021
Biden-Harris Administration Takes Additional Action to Protect America’s
Nursing Home Residents from COVID-19

https://www.cms.gov/newsroom/press-releases/biden-harris-
administration-takes-additional-action-protect-americas-nursing-home-
residents-covid-19

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APPENDIX C: AREAS OF INFECTION PREVENTION
AND CONTROL POSSIBLE NONCOMPLIANCE
AT 25 NURSING HOMES

Nursing
Home
Did Not Designate
an Infection
Preventionist Who
Met Federal
Requirements
Did Not
Conduct
Quarterly
QAAC
Meetings
IP Did Not
Attend QAAC
Meetings
P&P Did Not Include
When and to Whom
Incidents of
Communicable
Diseases Should Be
Reported
Failed to
Review IPCP
Annually
Did Not
Support That
They
Conducted
IPCP Training
Total
2
1
-
-
1
-
-
2
3
1
-
-
-
-
-
1
4
-
-
-
1
-
-
1
5
-
-
1
-
-
-
1
6
1
-
-
1
-
-
2
7
1
-
-
1
1
-
3
8
1
-
1
-
-
-
2
9
-
-
-
1
-
-
1
10
1
1
1
1
1
-
5
11
-
-
1
1
-
-
2
13
1
-
-
-
-
-
1
15
-
-
1
1
1
-
3
16
-
-
-
-
1
-
1
18
1
1
1
-
-
-
3
19
-
-
1
-
-
-
1
20
-
1
1
-
-
-
2
23
-
1
1
-
1
-
3
26
-
1
1
-
-
-
2
27
-
1
1
1
-
-
3
28
1
-
-
-
-
-
1
30
1
-
-
-
-
-
1

Infection Prevention and Control and Emergency Preparedness of Nursing Homes (A-01-20-00005)
23
Nursing
Home
Did Not Designate
an Infection
Preventionist Who
Met Federal
Requirements
Did Not
Conduct
Quarterly
QAAC
Meetings
IP Did Not
Attend QAAC
Meetings
P&P Did Not Include
When and to Whom
Incidents of
Communicable
Diseases Should Be
Reported
Failed to
Review IPCP
Annually
Did Not
Support That
They
Conducted
IPCP Training
Total
31
-
-
-
-
-
1
1
32
1
-
1
-
-
-
2
33
1
1
1
-
-
-
3
37
-
-
-
-
1
-
1
Totals
12
7
13
9
6
1
48

Infection Prevention and Control and Emergency Preparedness of Nursing Homes (A-01-20-00005)
24
APPENDIX D: AREAS OF EMERGENCY
PREPAREDNESS POSSIBLE NONCOMPLIANCE
AT 18 NURSING HOMES

Nursing
Home
Did Not Complete an
All-Hazards Risk
Assessment
All-Hazards Risk
Assessment Did Not
Include EID
EID Strategies Not
Included in Emergency
Plans
Total
3
-
1
-
1
8
-
-
1
1
10
-
1
-
1
11
-
-
1
1
15
-
-
1
1
16
-
1
-
1
17
-
-
1
1
18
-
-
1
1
20
-
-
1
1
23
-
-
1
1
26
1
-
-
1
27
-
1
-
1
28
-
1
-
1
32
-
1
-
1
33
-
1
-
1
35
-
1
-
1
37
-
1
-
1
39
-
-
1
1
Totals
1
9
8
18

DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
Administrator
Washington, DC 20201
APPENDIX E: CMS COMMENTS
DATE:
May 18, 2022
TO:
Gregory Demske
Acting Principal Deputy Inspector General
FROM:
Chiquita Brooks-LaSure
Administrator
SUBJECT:
Office of Inspector General (OIG) Draft Report: Certain Nursing Homes May Not
Have Complied With Federal Requirements for Infection Prevention and Control
and Emergency Preparedness, A-01-20-00005
The Centers for Medicare & Medicaid Services (CMS) appreciates the opportunity to review and
comment on the Office of Inspector General’s (OIG) draft report.
CMS takes seriously its role in improving the safety and quality of care in our nation’s nursing
homes, as such, CMS is leading the Biden-Harris Administration’s new efforts to increase
accountability for nursing homes. The Administration has laid out 21 initiatives spread across
five key strategic goals, including a goal to ensure pandemic and emergency preparedness in
nursing homes and carry forward lessons learned during the COVID-19 public health
emergency. These initiatives were developed with extensive input from advocates, industry
experts, nursing home workers, and most importantly, residents and their loved ones. CMS is
considering a wide range of methods to accomplish this important work.
Nursing homes receiving Medicare or Medicaid payments are already required to comply with
CMS quality and safety standards, including those relating to infection prevention and control
and emergency preparedness. CMS shares responsibility of nursing home oversight with State
Survey Agencies (SSAs) who conduct onsite surveys to assess compliance with the Federal
requirements and investigate facility complaints. SSAs serve as the front-line responders to
address health and safety concerns raised by residents, their families, and facility staff.
Accordingly, when an SSA identifies an issue of non-compliance, the nursing home is cited for a
deficiency and is required to correct the issue(s) and demonstrate substantial compliance with all
Federal requirements.
Long before the COVID-19 pandemic began, CMS had acted to strengthen emergency
preparedness and infection control practices in nursing homes. CMS took pivotal actions in the
2016 final rule, Emergency Preparedness Requirements for Medicare and Medicaid Participating
Providers and Suppliers (81 FR 63860). This rule outlined updates to emergency preparedness
requirements for all facilities. The rule’s updates highlighted the need for nursing homes to guide
emergency preparedness and response within the framework of our national response to COVID­
19 and any infectious disease threats. The requirements encouraged providers and suppliers to
coordinate their preparedness efforts within their own communities and states as well as across
state lines, as necessary, to achieve their goals. The rule also required facilities to perform a risk
assessment that uses an all-hazards approach. It further laid out that an all-hazards approach was
one that “….focuses on capacities and capabilities that are critical to preparedness for a full
Infection Prevention and Control and Emergency Preparedness of Nursing Homes (A-01-20-00005)
25

spectrum of emergencies or disasters.”1 In addition, CMS also outlined specific reform
requirements for long-term care facilities in the 2016 final rule, Medicare and Medicaid
Programs: Reform of Requirements for Long-Term Care Facilities (81 FR 68688), which was the
impetus for the requirement that nursing homes develop an infection prevention and control
2
program that includes an antibiotic stewardship program.
Since the COVID-19 public health emergency declaration in early 2020, CMS has taken a
number of actions to further strengthen infection prevention and control within nursing homes.
CMS began by issuing guidance to nursing homes encouraging them to take appropriate action to
address potential and confirmed COVID-19 cases and mitigate transmission. CMS reiterated the
importance of longstanding infection control guidelines, and guidelines on screening processes
and the use of personal protective equipment (PPE).
In an effort to focus on controlling the spread of COVID-19, CMS provided SSAs with a
streamlined review tool to conduct focused infection control surveys of providers identified
through collaboration with the Centers for Disease Control and Prevention (CDC) and the
Assistant Secretary for Preparedness and Response (ASPR). This tool was shared with providers
who were encouraged by the agency to use it to self-assess their own ability to prevent the spread
of COVID-19. By July 2020, over 99 percent of nursing homes had a focused infection control
survey conducted onsite. As the public health emergency continued, the focused infection control
survey was revised to incorporate new infection control requirements to address the spread of
COVID-19. While the COVID-19 public health emergency warranted a more targeted approach
for assessing a nursing homes’ compliance with infection prevention and control requirements,
CMS recently released guidance to help SSAs focus their efforts on identifying concerns for all
aspects of quality of care, quality of life, and ensuring health and safety. CMS now requires
SSAs to perform annual focused infection control surveys at 20 percent of nursing homes.3 CMS
also published a toolkit comprised of recommendations and best practices from a variety of
frontline health care providers, state governors’ COVID-19 task forces, associations, and other
experts that is intended to serve as a catalogue of resources dedicated to addressing the specific
challenges facing nursing homes as they combat COVID-19.4 CMS continues to review and
revise guidance as appropriate.
In addition to the survey process used to verify compliance with Federal requirements, CMS uses
data submitted by nursing homes to improve oversight and inform the public. CMS implemented
a requirement that Medicare-certified nursing homes report COVID-19 testing, case, and
5
mortality data for residents and staff to the CDC’s National Healthcare Safety Network.
Thereafter, in September of 2021, CMS began posting nursing home staff and resident COVID­
19 vaccination data in a user-friendly format on its Nursing Home Care Compare website.
Subsequently, in February 2022, CMS began posting staff and resident booster shot data to the
1 Medicare and Medicaid Programs; Emergency Preparedness Requirements, 81 Fed. Reg. 63860, 63862 (Sept. 16,
2016).
2 Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68688
(Nov. 28, 2016).
3 QSO-22-02-All: Changes to COVID-19 Survey Activities and Increased Oversight in Nursing Homes
4 QSO-21-08-NLTC: COVID-19 Focused Infection Control Survey Tool for Acute and Continuing Care Providers
and Suppliers
5 QSO-20-26-NH Upcoming Requirements for Notification of Confirmed COVID-19 (or COVID-19 Persons under
Investigation) Among Residents and Staff in Nursing Homes
Infection Prevention and Control and Emergency Preparedness of Nursing Homes (A-01-20-00005)
26

website.6 To further enhance the information available to consumers, residents, and families and
to help support their healthcare decisions and incentivize quality improvement among nursing
homes, CMS began posting weekend nurse staffing levels as well as nursing home staff turnover
data.7
These data are also used in the coordinated effort between CMS and CDC to provide detailed
information to state and local health departments and nursing homes to inform infection
prevention and control policies and strategies across the country to further support nursing home
residents. These data are also used by CMS when it is considering adjusting or introducing new
policies. They have informed CMS’s national policies as to when to implement, revise, or
terminate waivers, and they have allowed CMS to target specific nursing homes for assistance
with infection control or vaccine uptake. Specifically, through the work of the Quality
Improvement Organization (QIO) program, CMS assists nursing homes in strengthening
infection control practices to reduce and prevent transmission of COVID-19.
The QIOs provide educational activities, including frontline training of nursing home staff and
management on infection prevention practices to reduce the spread of infection and manage
outbreaks effectively, as well as providing individualized training resources based on the nursing
homes’ specific needs through toolkits, resource materials, guides, webinars, and clinician office
hours to provide expert consultation on the particular challenges nursing homes face. CMS
collects best practices and lessons learned from each of the QIOs and coordinates the sharing of
that information across QIOs nationally for rapid deployment. Additionally, CMS partners with
Federal agencies such as the CDC and ASPR, who are the national leaders in disease prevention
and control and public health emergency response to ensure coordination of services and
alignment of guidance for nursing homes.
CMS thanks OIG for its efforts on this important issue and looks forward to working with OIG
on this and other issues in the future. OIG’s recommendations and CMS’ responses are below.
OIG Recommendation
Instruct SSAs to follow up with the 28 nursing homes that we have identified with possible
infection prevention and control and emergency preparedness deficiencies to verify that they
have taken corrective actions.
CMS Response
CMS concurs with OIG’s recommendation. CMS will ensure that the appropriate SSAs follow
up with the 28 nursing homes OIG identified with possible infection prevention and control and
emergency preparedness deficiencies to verify that they have taken corrective actions as needed,
in line with Federal requirements. It is important to note, however, that when an SSA cites a
nursing home with an infection control deficiency, as with any cited deficiency, the nursing
home is required to correct the issue and come back into compliance with the Federal
requirements. OIG found that less than one percent of nursing homes had not corrected their
potential deficiencies at the time of OIG’s review.
OIG Recommendation
6 CMS Makes Nursing Home COVID-19 Booster Vaccination Online Increasing Transparency, CMS News Alert,
Feb. 09, 2022
7 QSO-22-0-08-NH: Nursing Home Staff Turnover and Weekend Staffing Levels
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27

Issue the updated phase three interpretive guidance as soon as feasible.
CMS Response
CMS concurs with the OIG’s recommendation. In November of 2019, CMS expressed its
intention to release the phase III guidance.8 However, before CMS could implement the
guidance, the COVID-19 public health emergency was declared. CMS immediately moved to
redirect resources to address immediate needs relating to resident safety. Despite the surveyor
guidance not being issued, the requirements were all in effect by November 28, 2019 and
facilities were expected to comply with the requirements. CMS continues to prioritize the health
and safety of residents, and will release phase three interpretive guidance when feasible.
OIG Recommendation
Provide training to SSAs on the updated phase three interpretative guidance as soon as feasible.
CMS Response
CMS concurs with the OIG’s recommendation. In November of 2019, CMS expressed its
intention to release phase III guidance along with information on training and implementation of
related changes to the Long-Term Care Survey Process.9 CMS continues to prioritize the health
and safety of residents and will release phase III interpretive guidance and provide training as
soon as feasible.
OIG Recommendation
Consider updating the regulation to make clear that nursing homes must include emerging
infectious diseases as a risk on their facility- and community-based all-hazards risk assessments.
CMS Response
CMS will consider this recommendation in future rulemaking. CMS has taken considerable steps,
as laid out below, to make clear that nursing homes should include emerging infectious diseases as
an identified risk on their facility- and community-based all-hazards risk assessments. The
Emergency Preparedness Final Rule (81 Fed. Reg. 63860, Sept. 16, 2016) requires facilities to
perform a risk assessment that uses an all-hazards approach. It further defines an all-hazards
approach as one that “…focuses on capacities and capabilities that are critical to preparedness for a
full spectrum of emergencies or disasters.”
CMS determined it was critical for facilities to include planning for infectious diseases within their
emergency preparedness program, and specified “emerging infectious diseases” in the definition of
“all-hazards” in the interpretive guidance in the State Operations Manual. In light of the COVID-19
pandemic, CMS further updated the emergency preparedness guidance to further expand
information on best practices, lessons learned, and planning considerations for emerging infectious
disease outbreaks. Specifically, the update noted, “… as emerging infectious disease outbreaks may
affect any facility in any location across the country, a comprehensive emergency preparedness
program should include emerging infectious diseases and pandemics during a public health
emergency. As part of the comprehensive emergency preparedness program, emerging infectious
disease planning should encompass how facilities will plan, coordinate and respond to localized and
widespread pandemic, similar to what is occurring with the COVID-19 public health emergency.”10
8 QSO-20-03-NH Updates and Initiatives to Ensure Safety and Quality in Nursing Homes.
9 QSO-20-03-NH Updates and Initiatives to Ensure Safety and Quality in Nursing Homes.
10 QSO-21-15-All: Updated Guidance for Emergency Preparedness - Appendix Z of the SOM
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