Report (2020-02-26)

Full text

Department of Health and Human Services
OFFICE OF
INSPECTOR GENERAL

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

Christi A. Grimm
Inspector General

September 2022
A-01-20-00004

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

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as amended, is
to protect the integrity of the Department of Health and Human Services (HHS) programs, as well as the
health and welfare of beneficiaries served by those programs.  This statutory mission is carried out
through a nationwide network of audits, investigations, and inspections conducted by the following
operating components:

Office of Audit Services

The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting audits with
its own audit resources or by overseeing audit work done by others.  Audits examine the performance of
HHS programs and/or its grantees and contractors in carrying out their respective responsibilities and are
intended to provide independent assessments of HHS programs and operations.  These audits help reduce
waste, abuse, and mismanagement and promote economy and efficiency throughout HHS.

Office of Evaluation and Inspections

The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide HHS, Congress,
and the public with timely, useful, and reliable information on significant issues.  These evaluations focus
on preventing fraud, waste, or abuse and promoting economy, efficiency, and effectiveness of
departmental programs.  To promote impact, OEI reports also present practical recommendations for
improving program operations.

Office of Investigations

The Office of Investigations (OI) conducts criminal, civil, and administrative investigations of fraud and
misconduct related to HHS programs, operations, and beneficiaries.  With investigators working in all 50
States and the District of Columbia, OI utilizes its resources by actively coordinating with the Department
of Justice and other Federal, State, and local law enforcement authorities.  The investigative efforts of OI
often lead to criminal convictions, administrative sanctions, and/or civil monetary penalties.

Office of Counsel to the Inspector General

The Office of Counsel to the Inspector General (OCIG) provides general legal services to OIG, rendering
advice and opinions on HHS programs and operations and providing all legal support for OIG’s internal
operations.  OCIG represents OIG in all civil and administrative fraud and abuse cases involving HHS
programs, including False Claims Act, program exclusion, and civil monetary penalty cases.  In
connection with these cases, OCIG also negotiates and monitors corporate integrity agreements.  OCIG
renders advisory opinions, issues compliance program guidance, publishes fraud alerts, and provides
other guidance to the health care industry concerning the anti-kickback statute and other OIG enforcement
authorities.

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.

,..
U.S. DEPARTMENT OF HEALTH & H UMAN SERVICES
\•,,,,
,,J -
OFFICE OF INSPECTOR GENERAL\:" 1
··:.,­
't.wJ!
Report in Brief
Date: September 2022
Report No. A-01-20-00004
Why OIG Did This Audit
At the start of the pandemic, the
Centers for Disease Control and
Prevention 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.
COVID-19 is especially dangerous for the
more than 1.3 million residents who live
in the 15,450 Medicare and Medicaid
certified nursing homes nationwide.
Our objective was to determine whether
selected Life Care Centers of America
(Life Care) 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
surveys. We identified that 6,622
nursing homes had been cited for
infection prevention and control
program deficiencies as of February 26,
2020, and Medicare.gov indicated that
24 nursing homes were part of the Life
Care nursing home chain. We contacted
Life Care’s corporate office regarding
the 24 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 2019 through May 2020.
Certain Life Care Nursing Homes May Not Have
Complied With Federal Requirements for Infection
Prevention and Control and Emergency
Preparedness
What OIG Found
Selected Life Care nursing homes may not have complied with Federal
requirements for infection prevention and control and emergency
preparedness.  Specifically, 23 of the 24 nursing homes selected had possible
deficiencies. Actual deficiencies can only be determined following a thorough
investigation by trained surveyors. At 22 nursing homes, we found 35
instances of possible noncompliance with infection prevention and control
requirements related to annual reviews of the Infection Prevention and
Control Program, training, designation of a qualified infection preventionist,
and Quality Assessment and Assurance Committee meetings. We also found
at 16 nursing homes 20 instances of possible noncompliance with emergency
preparedness requirements related to the annual review of emergency
preparedness plans and annual emergency preparedness risk assessments.
Life Care officials attributed the possible noncompliance to: (1) leadership
turnover, (2) staff turnover, (3) documentation issues (i.e., information was
not documented or documentation was either lost or misplaced), (4) staff
members who were unfamiliar with requirements (i.e., requirements
stipulating that there is no grace period for infection preventionists to
complete specialized training and that emergency preparedness plans needed
to be reviewed annually), (5) qualified personnel shortage, and (6) challenges
related to the COVID-19 public health emergency. We also believe that 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 control requirements, or clarification about the
essential components to be integrated in the nursing homes’ emergency
plans.
What OIG Recommends and CMS Comments
We recommend that CMS instruct SSAs to follow up with the 23 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 concurred with our recommendation and stated that it has contacted the
appropriate SSAs to ensure that the 23 nursing homes with possible infection
prevention and control and emergency preparedness deficiencies have taken
corrective actions in accordance with Federal requirements.
The full report can be found at https://oig.hhs.gov/oas/reports/region1/12000004.asp.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

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 Control and Emergency Preparedness ................. 4
Responsibilities for Infection Prevention and Emergency Preparedness ......... 4
Additional CMS Guidance ................................................................................. 5
COVID-19 Reporting Requirements for Nursing Homes ................................... 5
Life Care Centers of America ............................................................................ 6

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

FINDINGS ................................................................................................................................... 8

Selected Life Care Nursing Homes May Not Have Complied With Infection
   Prevention and Control Requirements ...................................................................... 9
Nursing Homes May Not Have Reviewed IPCPs Annually ................................ 9
Nursing Homes May Not Have Maintained an Effective Training Program
   for Infection Control ..................................................................................... 10
Nursing Homes May Not Have Designated an Infection Preventionist
   Who Met Federal Requirements .................................................................. 11
Nursing Homes May Not Have Conducted Quarterly Quality Assessment
   and Assurance Committee Meetings With All Key Members ...................... 13

Selected Nursing Homes May Not Have Complied With Emergency Preparedness
   Requirements ........................................................................................................... 14
Nursing Homes May Not Have Reviewed and Updated Emergency
   Preparedness Plans Annually ....................................................................... 14
Nursing Homes May Not Have Completed Annual Emergency
   Preparedness Risk Assessments ................................................................... 15

Causes of Possible Noncompliance With Federal Requirements ............................... 15

Selected Nursing Homes May Have Increased the Risk of Infections to Residents
   and Staff ................................................................................................................... 16

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

RECOMMENDATIONS ............................................................................................................. 16

CMS COMMENTS AND OFFICE OF INSPECTOR GENERAL RESPONSE ..................................... 16

OTHER MATTERS ..................................................................................................................... 17

APPENDICES

A: Audit Scope and Methodology ............................................................................... 19

B: List Of CMS Public Health Actions for Nursing Homes Concerning
   the COVID-19 Public Health Emergency .............................................................. 20

C: Number of Life Care Facilities by State as of March 2022 ...................................... 25

D: Areas of Infection Prevention and Control Possible Noncompliance at 22 of 24
   Nursing Homes .................................................................................................... 26

E: Areas of Emergency Preparedness Possible Noncompliance at 16 of 24
   Nursing Homes .................................................................................................... 27

F: CMS Comments ....................................................................................................... 28

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

1

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 15,450 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, results from survey reports published on the Centers for Medicare and Medicaid
Service’s (CMS’s) Nursing Home Care Compare website indicate that nursing homes are not
always in compliance with infection prevention and control requirements.  Specifically,
according to these reports, 24 Life Care Centers of America (Life Care) nursing homes in 11
States did not always comply with all infection prevention and control requirements, such as
following proper hand hygiene, as of February 26, 2020.  In March 2021, CMS officials said that
the nursing homes had satisfactorily addressed all of the deficiencies identified by these
surveys.  Our audit focuses on these 24 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 Life Care 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 Mar. 10, 2022.)

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 Life Care Centers of America Nursing Homes
(A-01-20-00004)

2

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, residents’ increased susceptibility to infections, and the significant exposure to

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).

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

3

health care-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 includes 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) plan to their SSA
no later than 1 year after the date the regulation is issued, at each annual recertification
survey, and upon request (phase 2);10 and

• have the individuals responsible for a 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, while
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 2020.11  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.12

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 QAPI plans are a data-driven and proactive approach to quality improvement.  All members of an organization,
including residents, are involved in continuously identifying opportunities for improvement.  Gaps in systems are
addressed through planned interventions with a goal of improving the overall quality of life and quality of care and
services delivered to nursing home residents.

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

12 Despite the delay, CMS communicated to nursing homes that they should not wait on the issuance of the
interpretive guidance to ensure that they are in compliance with new regulations.  (McKnights Long-Term Care
News, With Phase 3 guidance nearing, skilled nursing providers advised ‘don’t wait’ on infection preventionist,
other regs, Oct. 22, 2021.  (Accessed Aug. 26, 2022.))

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

4

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
develop strategies to address the risks identified.13  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.  CMS also updated
Appendix Z with guidance for “emergency preparedness.”14

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.  Standard surveys of nursing homes must occur no later
than 15 months after the previous survey.15, 16  SSAs cite nursing homes with deficiencies when
they do not meet the conditions of participation, including when they do not follow infection
prevention and control requirements.

Management and staff at a nursing home are responsible for ensuring the safety and well-being
of residents and staff and for complying with Federal, State, and local regulations.  They are

13 Emerging infectious diseases are those that have newly appeared in a population or have existed but are rapidly
increasing in incidence or geographic range.  “NIAID Emerging Infectious Diseases/Pathogens” is available online at
https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens.  (Accessed Mar. 10, 2022.)

14 Memo From the Director of Quality, Safety & Oversight Group at CMS to State Survey Agency Directors, Mar. 26,
2021 (REF: QSO-21-15-ALL).

15 The Act §§ 1819(g)(2)(A)(iii)(I) and 1919(g)(2)(A)(iii)(I) and 42 CFR § 488.308(a).

16 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).

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

5

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 stop its spread, CMS issued many guidance
memoranda during the COVID-19 PHE.  These included, among other things, requiring nursing
homes to: (1) prohibit visits from family and friends (except in 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.

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 (NHSN).
Nursing homes were required to report on a weekly basis beginning May 17, 2020.17  CMS
published on its website the information reported to NHSN by nursing homes.18

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 December 26,
2021, by 15,447 nursing homes.19, 20

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
942,849
900,190
1,843,039
141,514
2,230
143,744

17 85 Fed. Reg. 27627 (May 8, 2020).

18 COVID-19 Nursing Home Data - Centers for Medicare & Medicaid Services Data (cms.gov).  (Accessed Mar. 10,
2022.)

19 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 predated the effective date of the interim final rule; it was left to the
discretion of the nursing homes whether to report historical data.  As a result, these data could include figures
lower than actual figures for COVID-19 cases and COVID-19-related deaths if nursing homes chose not to report
the historical data.

20 We removed the COVID-19 cases and related deaths reported by the 24 nursing homes in our audit from these
numbers and reported them separately.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

6

Residents and staff at the 24 selected nursing homes were severely impacted by COVID-19.
Many of these residents and staff contracted COVID-19—and 293 of these individuals 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
December 26, 2021.

Table 2: COVID-19 Cases and COVID-19-Related Deaths at 24 Nursing Homes*

Confirmed and Suspected
COVID-19 Cases
COVID-19-Related Deaths
Residents
Staff
Total
Residents
Staff
Total
1,994
1,479
3,473
291
2
293
* These numbers include case and death counts reported directly to OIG by the 24 nursing homes through
May 31, 2020, and case and death counts reported to CDC and CMS from June 1, 2020, through December 26,
2021.  Life Care was unable to provide OIG with suspected COVID-19 cases.  Therefore, the data reported
directly to OIG by the 24 nursing homes through May 31, 2020, only includes confirmed COVID-19 cases.

Life Care Centers of America

Life Care is the country’s largest privately held nursing home company with annual revenue of
approximately $3 billion, according to an estimate by Forbes.21  Life Care’s headquarters is in
Cleveland, Tennessee, and it operates or manages more than 200 skilled nursing, rehabilitation,
Alzheimer’s, and senior living campuses in 28 states.22

At the beginning of the COVID-19 pandemic, news articles indicated two Life Care nursing
homes potentially did not comply with regulations pertaining to reporting respiratory infections
to appropriate health authorities.23

HOW WE CONDUCTED THIS AUDIT

As of February 26, 2020, there were 15,450 Medicare and Medicaid certified nursing homes in
the United States.  We analyzed SSA survey data on Medicare.gov for the most recent standard
surveys and the previous 12 months of complaint surveys.24  Based on that analysis, we

21 Forbes.com, Life Care Centers of America.  (Accessed Mar. 10, 2022.)

22 See Appendix C for the number of Life Care facilities by State.

23 The Washington Post, Washington nursing home with deadly coronavirus cluster failed to flag illnesses, federal
inspectors find, Mar. 23, 2020.  (Accessed Mar. 10, 2022.)  CBS Boston, Littleton Assisted Living Facility Considered
‘Hot Spot’ for Coronavirus, Apr. 2, 2020.  (Accessed Mar. 10, 2022.)

24 A complaint survey is conducted based on a substantial allegation of noncompliance.  A substantial allegation of
noncompliance is a complaint that would, if noncompliance is found to be present, adversely affect the health and

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

7

determined that 6,622 nursing homes (approximately 43 percent) had been cited for IPCP
deficiencies related to: (1) not providing and implementing an infection prevention and control
program (5,977 nursing homes), (2) not developing and implementing policies and procedures
for flu and pneumonia vaccinations (232 nursing homes), or (3) both (413 nursing homes).
Medicare.gov indicated that 24 of the 6,622 nursing homes were part of the Life Care nursing
home chain.  The deficiencies included:

• staff members did not wear appropriate personal protective equipment (PPE) while in
the rooms of residents who were in isolation,

• staff and residents used improper hand hygiene,

• a nursing home failed to vaccinate eligible residents with the pneumococcal vaccines as
indicated by the facility’s policy and current CDC guidelines, and

• a staff member failed to ensure that the glucometer used to test blood glucose levels
was properly cleansed between testing for two residents.

We contacted Life Care’s corporate office regarding the 24 nursing homes and requested that
officials 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 infection preventionist positions,
quality assessment and assurance committees (QAACs), 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 emergency preparedness.  CMS officials informed us that actual
deficiencies are to be cited onsite following a thorough investigation by trained Federal, State,
and contractual surveyors to determine compliance with the Federal requirements for
participation (i.e., 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.

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.

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).

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

8

FINDINGS

Selected Life Care nursing homes may not have complied with Federal requirements for
infection prevention and control and emergency preparedness.25  Specifically, 23 of the 24
nursing homes had possible deficiencies, and 20 of these nursing homes had more than 1
possible deficiency.26  At 22 nursing homes, we found 35 instances of possible noncompliance
with infection prevention and control requirements related to:

• the nursing homes’ annual reviews of their IPCPs,
• training,
• designations of a qualified infection preventionist, and
• QAAC meetings.

We also found at 16 nursing homes 20 instances of possible noncompliance with emergency
preparedness requirements related to the annual review of emergency preparedness plans and
annual emergency preparedness risk assessments.

Life Care officials attributed the areas of possible noncompliance we identified to:
(1) leadership turnover, (2) staff turnover, (3) documentation issues (i.e., information was not
documented or documentation was either lost or misplaced), (4) staff members who were
unfamiliar with requirements (i.e., requirements stipulating that there is no grace period for
infection preventionists to complete specialized training and that emergency preparedness
plans needed to be reviewed annually), (5) qualified personnel shortage, and (6) challenges
related to the COVID-19 PHE.  Life Care officials also said that they have taken actions to correct
all possible identified deficiencies.27

In addition, we believe that 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

25 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., 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.

26 Of the 23 nursing homes with possible deficiencies, 15 had infection prevention and control and emergency
preparedness deficiencies, 7 had only infection prevention and control deficiencies, and 1 had only emergency
preparedness deficiencies.

27 Life Care officials informed us that the corrective actions apply to all nursing homes that are part of the Life Care
chain, not just the 24 nursing homes identified in this audit.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

9

new, phase 3 infection control requirements, or clarification about the essential components to
be integrated in the nursing homes’ emergency plans.28

As a result of the possible deficiencies we identified, 23 of the 24 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 LIFE CARE NURSING HOMES MAY NOT HAVE COMPLIED WITH INFECTION
PREVENTION AND CONTROL REQUIREMENTS

We found that 22 of the 24 nursing homes covered by our audit had at least 1 possible
deficiency related to infection prevention and control, and 10 of the 22 nursing homes had
more than 1 possible deficiency, totaling 35 possible deficiencies.  Appendix D summarizes the
areas of possible infection prevention and control noncompliance.  These possible deficiencies
were related to: (1) annual reviews of the IPCPs, (2) training, (3) designations of an infection
preventionist who met Federal regulations, and (4) QAAC meetings.

Nursing Homes May Not Have Reviewed 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 nursing homes up to date on
current infection prevention and control best practices.29

Of the 24 nursing homes we reviewed, 17 had possible deficiencies related to conducting annual
reviews of their IPCPs.30  Specifically, we found that 17 nursing homes may not have complied
with the Federal requirement to review the IPCP at least annually because they did not provide
documentation, such as a signed and dated annual review and approval document.

As a result of our audit, Life Care officials said that they have taken multiple corrective actions to
ensure that each Life Care nursing home conducts an annual review of their IPCPs.  Life Care
officials stated that they established a corporate calendar for annual reviews of their IPCP and
implemented a system to alert their nursing homes when an IPCP needs to be reviewed.  Life
Care officials stated that they created an online portal that serves as a centralized repository of
facility documents that can be reviewed at the regional, divisional, and corporate levels.  Each

28 CMS made training materials related to the new interpretive guidance available to the SSAs on June 28, 2022.
On June 29, 2022, CMS informed OIG that they issued the phase 3 interpretive guidance.

29 80 Fed. Reg. 42216 (July 16, 2015).

30 Among the 17 nursing homes, there were a total of 17 possible deficiencies related to the annual review of their
IPCPs.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

10

nursing home is required to submit documents related to their IPCP plan to the portal.  Life Care
officials also stated that they are conducting monthly training webinars for staff regarding IPCPs.
Finally, Life Care officials said that Life Care’s compliance department conducts monthly calls
with each division vice president to discuss the status of IPCP plans at their facilities.31

Nursing Homes May Not Have Maintained an Effective Training Program for Infection Control

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.32  A nursing home must include, as
part of its infection prevention and control program, mandatory training that includes the
written standards, policies, and procedures for the program.

Of the 24 nursing homes that we reviewed, 8 had possible deficiencies related to infection
control training.33  We determined that each of 24 nursing homes developed and implemented a
training program for new and existing staff.  However, eight nursing homes may not have
complied with the requirement to maintain an effective training program for staff because these
nursing homes possibly did not ensure that their staff took their required infection control
training classes.

Life Care said that a total of 147 employees at 8 of the 24 nursing homes we reviewed tested
positive for COVID-19 during our audit period.  For these 147 employees, we reviewed the
portion of Life Care’s training program related specifically to infection control.  The eight nursing
homes determined the amount and types of training necessary and assigned the specific training
classes to its staff.  These nursing homes assigned the 147 employees to a total of 1,271
mandatory classes specifically related to infection control.  All of these classes were assigned
during our 17-month audit period.  Although all of the 1,271 classes were mandatory, Life Care
did not provide evidence, such as training certificates or sign-in sheets, to indicate that
employees completed 851 (67 percent) of the classes.  Of the 147 employees, Life Care provided
evidence that only 23 (16 percent) of the employees completed all classes.  However, 68
(46 percent) of the remaining employees possibly did not complete any classes and 56

31 Life Care officials said that the corrective actions they took for each possible deficiency noted in this report
applied to all Life Care nursing homes in each of the 28 States in which they operate.

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

33 Among the eight nursing homes, there were a total of eight possible deficiencies related to infection prevention
and control training.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

11

(38 percent) of the remaining employees completed some classes.34  Because Life Care could not
provide evidence that a high number of employees completed their mandatory infection
prevention and control related trainings, the eight nursing homes possibly did not comply with
the Federal requirement to maintain an effective training program.35

As a result of our audit, Life Care officials said that Life Care has taken multiple corrective actions
to ensure that Life Care nursing homes maintain an infection control training program.  The
compliance department now sends out course completion reports to other departments as part
of an enhanced focus on education.  The nursing homes are encouraged to discuss mandatory
training in staff meetings and QAAC meetings.  Executive directors, in coordination with the
regional and divisional team, are encouraged to evaluate the logistics and availability of learning
stations to enhance compliance with training opportunities.36  Life Care officials also said that
they are consulting with their information technology department to explore options, such as
training dashboards, that would allow each facility to monitor its training completion status.
Finally, Life Care officials said that the compliance department conducts monthly calls with each
division vice president to discuss the course completion percentage for mandatory training.

Nursing Homes May Not Have Designated an Infection Preventionist Who Met Federal
Requirements

A nursing home must designate one or more individuals as the infection preventionist(s)
responsible for the nursing home’s IPCP.  An infection preventionist 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.37  In addition, CMS

34 Further analysis identified that the 124 employees did not complete 62 percent of their assigned trainings in
2019 and did not complete 71 percent of their assigned trainings in 2020.  (Sixty-eight employees did not complete
any class and 56 employees completed some classes in 2020).  Life Care did not provide evidence, such as training
certificates or sign-in sheets, for 62 percent of the assigned trainings in 2019 and 71 percent of the assigned
trainings in 2020.

35 We are not suggesting that these employees contracted COVID-19 as a result of the possibility that they did not
complete all mandatory training classes.

36 Many of Life Care’s staff members do not work on a computer as part of their duties and must use one that is
designated for training.  Therefore, Life Care set up designated computer kiosks (i.e., learning stations) for staff to
complete required training.

37 81 Fed. Reg. 68810 (Oct. 4, 2016).

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

12

collaborated with CDC to develop a free, online training course on infection prevention and
control for nursing home staff.  Topics of the training course ranged from hand washing to
infection preventionist responsibilities and included the facility infection preventionist program
overview.38

Of the 24 nursing homes we reviewed, 5 had possible deficiencies related to designating an
infection preventionist who met Federal requirements.39  Specifically, we found that three
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, and two nursing homes may not have complied with the Federal
requirement to designate at least one individual as an infection preventionist during a portion of
the time from November 28, 2019, through May 31, 2020.40, 41

As a result of our audit, Life Care officials said that they have taken multiple corrective actions to
ensure that Life Care nursing homes designate an infection preventionist who meets Federal
requirements.  Life Care officials stated they appointed a corporate director to track the
appointment of all infection preventionists across the company to ensure that those positions
are filled promptly and that backup infection preventionists are in place.  In addition, the
corporate director ensures that infection preventionists and their backups provide proof of
specialized training completion.  Life Care officials also stated that the corporate director each
month conducts a 6-hour orientation for all new infection preventionists.  All infection
preventionists must attend at least one orientation and may repeat the orientation as many
times as desired.  Finally, Life Care officials said they created a new “IP Corner” on the
company’s intranet that provides educational resources and guidance and allows infection
preventionists to post questions.

38 CMS and CDC offer a specialized online class called Nursing Home Infection Preventionist Training, available at
https://www.cdc.gov/longtermcare/training.htmlv .  (Accessed Mar. 10, 2022.)  However, nursing home staff have
the option to complete specialized infection prevention and control training offered by other sources.

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

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

41 We did not receive supporting documentation, such as a certificate of completion of specialized infection
prevention and control training, for the three nursing homes to support that the infection preventionists
completed their specialized training by Nov. 28, 2019.  We did not receive supporting documentation for the two
nursing homes to support that they had designated an infection preventionist who met Federal requirements.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

13

Nursing Homes May Not Have Conducted Quarterly Quality Assessment and Assurance
Committee Meetings With All Key Members

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)).42  A QAAC must consist of a minimum of: (1) the director of nursing services;
(2) the medical director or a designee; (3) at least three other members of the facility’s staff, at
least one of whom must be the administrator, owner, a board member, or another individual in
a leadership role; and (4) the infection preventionist (42 CFR § 483.75(g)(1).43

Effective QAPI programs are critical to improving the quality of life, care, and services delivered
in facilities, according to CMS.44  Section 6102 of the Affordable Care Act required the
establishment and implementation of a QAPI program for nursing homes.  Therefore, CMS has
required that nursing homes develop, implement, and maintain an effective, comprehensive,
and data-driven QAPI program that focuses on systems of care, outcomes, and services for
residents and staff.  A QAAC reports to the governing body regarding its activities,45 including
implementation of the QAPI program, and the governing body has the ultimate responsibility to
ensure that the QAPI program is defined, implemented, and maintained.46

Of the 24 nursing homes we reviewed, 5 had possible deficiencies related to conducting QAAC
meetings at least quarterly with all key members.47  Specifically, we found that two nursing
homes may not have complied with the Federal requirements to conduct a QAAC meeting with
the medical director or their designee at least quarterly, and three nursing homes may not have
complied with the Federal requirement to conduct a QAAC meeting with the infection
preventionist at least quarterly.48

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

43 81 Fed. Reg. 68688 (Oct. 4, 2016).

44 81 Fed. Reg. 68804 (Oct. 4, 2016).

45 The facility must have a governing body, or designated persons functioning as a governing body, that is legally
responsible for establishing and implementing policies regarding 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)).

46 42 CFR § 483.75(f) and 80 Fed. Reg. 42212–42214 (July 16, 2015).

47 Among the five nursing homes, there were a total of five possible deficiencies related to conducting QAAC
meetings at least quarterly with all key members.

48 We did not receive supporting documentation, such as QAAC meeting notes or sign-in sheets, to show evidence
that the key members attended QAAC meetings at least quarterly.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

14

As a result of our audit, Life Care officials said that they have taken multiple corrective actions to
ensure that Life Care nursing homes conduct QAAC meetings at least quarterly with all key
members.  Life Care requires that each nursing home submit the documents related to their
QAAC Program to an online portal.  Life Care officials also stated that their Compliance
Department conducts monthly calls with each division vice president to discuss the status of
their facilities’ QAAC Programs.  Finally, Life Care officials said that they conducted additional
QAAC training for executive directors and directors of nursing.

SELECTED NURSING HOMES MAY NOT HAVE COMPLIED WITH EMERGENCY PREPAREDNESS
REQUIREMENTS

We found that 16 of the 24 nursing homes had at least 1 possible deficiency related to
emergency preparedness.  Four of the 16 nursing homes had more than 1 possible deficiency,
for a total of 20 possible deficiencies.  Appendix E summarizes the areas of possible emergency
preparedness noncompliance.  These possible deficiencies related to annual review of the
emergency preparedness plans and annual emergency preparedness risk assessments.

Nursing Homes May Not Have Reviewed and Updated Emergency Preparedness
Plans Annually

Nursing homes must develop and maintain an emergency preparedness plan that must be
reviewed and updated at least annually (42 CFR § 483.73(a)).

Of the 24 nursing homes that we reviewed, 8 had possible deficiencies related to reviewing or
updating their emergency preparedness plans.49  Specifically, we found that seven nursing
homes may not have complied with the Federal requirement to review their emergency
preparedness plan at least annually because they did not provide documentation, such as a
signed and dated annual review document.50  One nursing home may not have complied with
the Federal requirement to update its emergency preparedness plan at least annually; this
nursing home had not made any updates to its emergency preparedness plan since 2016,
including any updates in response to COVID-19.51

As a result of our audit, Life Care officials said that they have taken multiple corrective actions to
ensure that Life Care nursing homes review and update their emergency preparedness plans.

49 Among the eight nursing homes, there were a total of eight possible deficiencies related to reviewing or
updating their emergency preparedness plans.

50 To comply with this Federal requirement, Life Care officials stated that the individual nursing homes prepare an
“Annual Review Sheet” and management officials, such as an executive director, sign and date the document after
they have reviewed the annual plan in its entirety.

51 Of the remaining 23 nursing homes we reviewed, 19 nursing homes updated their emergency preparedness
plans in response to COVID-19.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

15

Life Care officials stated that they established a corporate calendar for annual reviews of their
emergency preparedness plan and implemented a system to alert their nursing homes when the
emergency preparedness plan needs to be reviewed.  Life Care now requires each nursing home
to submit a signed and dated annual review sheet to the portal.  In addition, Life Care officials
stated that they provided emergency preparedness plan training to divisional and regional staff
and to applicable facility leaders.  Life Care officials also said that the compliance department
conducts monthly calls with each division vice president to discuss the status of the emergency
preparedness plan at their facilities.

Nursing Homes May Not Have Completed Annual Emergency Preparedness Risk Assessments

Nursing homes’ emergency preparedness plans must be based on and include a documented,
facility-based and community-based risk assessment, utilizing an “all-hazards approach” (42 CFR
§ 483.73(a)(1)).

Of the 24 nursing homes we reviewed, 12 had possible deficiencies related to all-hazards risk
assessments.52  Specifically, we found that these 12 nursing homes may not have complied with
the Federal requirement to document an annual facility-based and community-based risk
assessment that uses an all-hazards approach.

As a result of our audit, Life Care officials said that they have taken multiple corrective actions to
ensure that Life Care nursing homes complete their all-hazards risk assessments.  Life Care
officials stated that the nursing homes are required to submit their risk assessment documents
to the portal.  In addition, Life Care’s compliance department conducts monthly calls with each
division vice president to discuss the status of the emergency preparedness documents at their
nursing homes.

CAUSES OF POSSIBLE NONCOMPLIANCE WITH FEDERAL REQUIREMENTS

Life Care officials provided the following reasons for possibly not complying with Federal
requirements for infection prevention and control and emergency preparedness:

• leadership turnover,

• staff turnover,

• documentation issues (i.e., either information was not documented or the
documentation was lost or misplaced),

52 Among the 12 nursing homes, there were a total of 12 possible deficiencies related to all-hazards risk
assessments.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

16

• staff members were unfamiliar with requirements (i.e., requirements stipulating that
there is no grace period for infection preventionists to complete specialized training and
that emergency preparedness plans needed to be reviewed annually),

• qualified personnel shortage, and

• challenges related to the COVID-19 PHE.

We believe that 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 control requirements, or clarification about the essential components to be
integrated in the nursing homes’ emergency plans.

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

As a result of 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 instruct SSAs to follow up
with the 23 nursing homes that we have identified with possible infection prevention and
control and emergency preparedness deficiencies to verify that they have taken corrective
actions.53

CMS COMMENTS AND OFFICE OF INSPECTOR GENERAL RESPONSE

In written comments on our draft report, CMS concurred with our recommendation and
described actions that it has taken to address our recommendation.  Specifically, CMS stated
that it has contacted the appropriate SSAs to ensure that the 23 nursing homes with possible
infection prevention and control and emergency preparedness deficiencies have taken
corrective actions in accordance with Federal requirements.  CMS also provided technical
comments on our draft report, which we addressed as appropriate.  CMS’s comments,
excluding the technical comments, appear as Appendix F.

We commend CMS for the action it has taken to ensure the safety and quality of care for
residents of our Nation’s nursing homes.  We also included in Appendix B a list of many of the
actions that CMS took in response to the PHE.

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

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

17

OTHER MATTERS

Federal regulations state that nursing facilities must establish an infection prevention and
control program that must include, at a minimum, written standards, policies, and procedures
for the program.  These standards, policies, and procedures must address “[w]hen and to
whom possible incidents of communicable disease or infections should be reported” (42 CFR
§ 483.80(a)(2)(ii)).

We identified seven nursing homes (located in five States) that identified resident cases of
COVID-19 during our audit period.54  Among these seven, we determined that four nursing
homes (located in four States) reported cases of COVID-19 in accordance with their State
reporting requirements.  However, for the remaining three nursing homes—all located in
Massachusetts—we were unable to determine whether the nursing homes reported COVID-19
cases in accordance with the State’s reporting requirements.55

Life Care officials said that the three nursing homes in Massachusetts were in daily contact with
officials from their local boards of health to discuss COVID-19 cases in the nursing homes.
Although Life Care provided us with written statements from two of the three local boards of
health confirming this statement, Life Care did not maintain any records of these discussions to
support that the cases of COVID-19 were reported in accordance with the State reporting
requirements.  Life Care officials said that the three nursing homes did not keep
contemporaneous records involving any conversations with the local boards of health regarding
COVID-19 cases.

Furthermore, we attempted on numerous occasions to directly contact officials at the
Massachusetts Department of Public Health and local boards of health (via telephone and
email) for independent, third-party verification regarding reported COVID-19 cases for each
nursing home.  But the officials were unresponsive to our requests.

Life Care officials said they have taken corrective action to ensure that their nursing homes have
written standards, policies, and procedures for when and to whom possible incidents of
communicable disease or infections should be reported.  Life Care officials stated they made
significant enhancements to the nursing homes’ reporting controls and processes related to
reportable diseases and conditions in 2021.  Life Care officials stated that they developed and
implemented State-specific policies that include instructions on what possible incidents of
communicable disease or infections need to be reported, when they need to be reported, and

54 The five States are Florida, Idaho, Indiana, Massachusetts, and Ohio.

55 Massachusetts required both suspected and confirmed cases of respiratory infections thought to be due to any
novel coronavirus to be reported immediately by telephone to the individual nursing home’s local board of health.
If local board of health officials were unavailable, nursing homes were required to contact the Massachusetts
Department of Public Health.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

18

to whom.  Each policy has links to applicable State criteria and applicable State or local
contacts, and the policies are periodically updated as necessary based on any changes
implemented by the States.  Life Care officials stated that these enhancements apply to all
nursing homes in each of the 28 States in which Life Care operates.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

19

APPENDIX A: AUDIT SCOPE AND METHODOLOGY

SCOPE

As of February 26, 2020, there were 15,450 Medicare and Medicaid certified nursing homes.
SSA data on the Medicare.gov website indicated that 6,622 (approximately 43 percent) of
these 15,450 nursing homes had been cited for infection control deficiencies.  After further
analysis of the data, we found that these deficiencies had occurred at 24 different nursing
homes that were part of the Life Care nursing home chain.  We contacted Life Care’s
corporate office regarding the 24 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 or the nursing homes’ overall internal control structures.  Rather, we
limited our review of internal controls to the selected Life Care nursing homes’ infection
prevention and control policies and procedures and emergency preparedness policies and
procedures.

We performed our audit from June 2020 through June 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 Life Care’s corporate office regarding the 24 nursing homes and requested
documentation related to their infection prevention and control and emergency
preparedness plans;

• reviewed documentation provided by Life Care to determine whether it has programs
for infection prevention and control and emergency preparedness in accordance with
Federal requirements; and

• discussed the results of the audit with Life Care officials and 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.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

20

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

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

21

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

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

22

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

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

23

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
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

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

24

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

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

25

APPENDIX C: NUMBER OF LIFE CARE FACILITIES BY STATE AS OF MARCH 2022

State
Number of Life Care Facilities
Arizona
10
California
10
Colorado
22
Florida
21
Georgia
3
Hawaii
4
Idaho
8
Indiana
15
Kansas
7
Kentucky
3
Massachusetts
15
Michigan
3
Missouri
10
Nebraska
2
Nevada
3
New Mexico
1
North Carolina
2
Ohio
4
Oregon
3
Pennsylvania
1
Rhode Island
2
South Carolina
3
Tennessee
29
Texas
8
Utah
2
Virginia
1
Washington
15
Wyoming
3
Total
210

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

26

APPENDIX D: AREAS OF INFECTION PREVENTION AND CONTROL POSSIBLE
NONCOMPLIANCE AT 22 OF 24 NURSING HOMES

Nursing
Home
Failed to Review
IPCP Annually
Employees Not Adequately Trained
in Infection Prevention and Control
Did Not Designate an IP Who
Met Federal Requirements
Did Not Conduct Quarterly QAAC
Meetings With All Key Members
Total
1
-
1
1
1
3
2
1
-
-
-
1
3
1
-
-
1
2
4
-
-
-
-
0
5
1
-
-
-
1
6
1
-
-
-
1
7
-
-
-
-
0
8
1
-
1
-
2
9
1
-
1
-
2
10
1
-
-
-
1
11
-
1
-
-
1
12
1
-
-
-
1
13
1
1
1
1
4
14
1
-
-
1
2
15
1
-
-
1
2
16
1
1
-
-
2
17
1
-
1
-
2
18
1
-
-
-
1
19
1
-
-
-
1
20
-
1
-
-
1
21
1
-
-
-
1
22
-
1
-
-
1
23
1
1
-
-
2
24
-
1
-
-
1
Totals
17
8
5
5
35

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

27

APPENDIX E: AREAS OF EMERGENCY PREPAREDNESS POSSIBLE
NONCOMPLIANCE AT 16 OF 24 NURSING HOMES

Nursing
Home
Failed to Review EP Plan
Annually
Failed to Complete EP Risk Assessment
Annually
Total
1
-
-
0
2
-
-
0
3
-
-
0
4
-
-
0
5
1
1
2
6
1
-
1
7
1
1
2
8
-
-
0
9
1
-
1
10
1
-
1
11
-
-
0
12
1
1
2
13
1
-
1
14
-
1
1
15
1
1
2
16
-
1
1
17
-
1
1
18
-
1
1
19
-
-
0
20
-
1
1
21
-
1
1
22
-
1
1
23
-
-
0
24
-
1
1
Totals
8
12
20

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

28

APPENDIX F: CMS COMMENTS
DATE:

August 18, 2022
TO:
Gregory Demske

Acting Principal Deputy Inspector General

FROM:
Chiquita Brooks-LaSure

Administrator

SUBJECT:
Office of Inspector General Draft Report: Certain Life Care Nursing Homes May
Not Have Complied with Federal Requirements for Infection Prevention and
Control and Emergency Preparedness, A-01-20-00004

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, and 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.1,2 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 required to comply with CMS
quality and safety standards, including those relating to infection prevention and control and
emergency preparedness. CMS shares management 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.

1 The White House, FACT SHEET: Protecting Seniors by Improving Safety and Quality of Care in the Nation's
Nursing Homes, February 28, 2022.
2 CMS Strategic Plan, August 2022.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

29

Even before the COVID-19 pandemic, CMS had acted to strengthen emergency preparedness
and infection prevention and control practices in nursing homes. CMS took pivotal actions
toward this goal in the 2016 final rule Emergency Preparedness Requirements for Medicare and
Medicaid Participating Providers and Suppliers.3 This rule outlined updates to emergency
preparedness requirements for all facilities. The updates from this final rule highlighted the need
for nursing homes to guide emergency preparedness and response4 using the same framework
used in 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 spectrum of emergencies or disasters.”4 In addition, CMS
also outlined specific reform requirements for long-term care facilities in the final rule, Medicare
and Medicaid Programs: Reform of Requirements for Long-Term Care Facilities, which was the
impetus for the requirement that nursing homes develop an infection prevention and control
program that includes an antibiotic stewardship program.5

In February 2019, CMS directed facilities to add emerging infectious diseases to their definition
of all-hazard emergency preparedness, and provided appropriate guidance in Appendix Z of the
State Operations Manual.6 ,7 Since the beginning of the COVID-19 public health emergency in
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. Through the
Quality Improvement Organizations (QIO) CMS also sent federal strike teams comprised of
representatives from Centers for Disease Control and Prevention (CDC), CMS, and the Office of
the Assistant Secretary for Health to help facilities address COVID-19 challenges related to
staffing, personal protective equipment supplies, COVID-19 testing, and infection prevention
and control measure implementation. More recently, in June 2022, CMS released the Phase 3
infection control guidance through the memorandum on revised long-term care guidance for
surveyors.8 In this memo CMS outlines updates made to the State Operations Manual, including
to Appendix PP, to, among other things, provide additional guidance for infection prevention and

3 Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid
Participating Providers and Suppliers, 81 Fed. Reg. 63860, 63862 (Sept. 16, 2016).
4 Fed. Reg. 63862.
5 Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68688
(Oct. 4, 2016).
6 QSO-19-06-All Emergency Preparedness - Updates to Appendix Z of the State Operations Manual
7 State Operations Manual, Appendix Z - Emergency Preparedness for All Provider and Certified Supplier Types
Interpretive Guidance
8 QSO-22-19-NH Revised Long-Term Care Surveyor Guidance: Revisions to Surveyor Guidance for Phases 2 & 3,
Arbitration Agreement Requirements, Investigating Complaints & Facility Reported Incidents, and the Psychosocial
Outcome Severity Guide.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

30

control related deficiencies.9 Further, CDC and CMS developed specialized infection
preventionist training to include topics such as transmission-based precautions and antibiotic
stewardship programs.10 CMS has held regular calls with stakeholders, nursing home
associations, and SSAs to keep them up to date on the latest information to respond to
COVID19, and to clarify expectations.

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 CDC and the Assistant Secretary for Preparedness and Response
(now the Administration for Strategy Preparedness and Response, ASPR). This tool was
informed in part by CMS’s experiences on the ground at a Life Care Center nursing home in
Kirkland, Washington – the epicenter of the COVID-19 outbreak in that state in early 2020.11
This tool was shared with providers who were encouraged by CMS to use it to self-assess their
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 onset of the COVID-19 public
health emergency warranted a more targeted approach for assessing a nursing homes’
compliance with infection prevention and control requirements, in November 2021, CMS
released a memorandum, Changes to COVID-19 Survey Activities and Increased Oversight in
Nursing Homes, to help SSAs focus their efforts on identifying concerns for all aspects of quality
of care, quality of life, and ensuring health and safety.12 CMS now requires SSAs to perform
annual focused infection control surveys at 20 percent of nursing homes.13 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-19.14 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- and Medicaid-certified nursing homes report COVID-19 testing,
case, and mortality data for residents and staff to the CDC’s National Healthcare Safety
Network.15 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

9 State Operations Manual, Appendix PP - Guidance to Surveyors for LTC Facilities .
10 CDC Train, Nursing Home Infection Preventionist Training Course.
11 CMS Announces Findings at Kirkland Nursing Homes and New Targeted Plan for Healthcare Facility Inspections
in light of COVID-19.
12 QSO-22-02-All: Changes to COVID-19 Survey Activities and Increased Oversight in Nursing Homes.
13 QSO-22-02-All.
14 QSO-21-08-NLTC: COVID-19 Focused Infection Control Survey Tool for Acute and Continuing Care Providers
and Suppliers.
15 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 Life Care Centers of America Nursing Homes
(A-01-20-00004)

31

booster shot data to the website.16 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.17

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 emergency 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 QIO
program, CMS assists these targeted 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’s responses are below.

OIG Recommendation
Instruct SSAs to follow up with the 23 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 has already contacted the appropriate SSAs to
ensure that the 23 nursing homes OIG identified with possible infection prevention and control
and emergency preparedness deficiencies have taken corrective actions as appropriate, in line

16 CMS Makes Nursing Home COVID-19 Booster Vaccination Online Increasing Transparency, CMS News Alert,
Feb. 09, 2022.
17 QSO-22-08-NH: Nursing Home Staff Turnover and Weekend Staffing Levels.

Infection Prevention and Control and Emergency Preparedness of Life Care Centers of America Nursing Homes
(A-01-20-00004)

32

with federal requirements. It is important to note 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 all the federal requirements.

File and source

File

A-01-20-00004-certain-life-care-nursing-homes-may-not-have-complied-with-federal-requirements.pdf

Size

895,321 bytes

SHA-256

9fe31f1e99898690bd9af357b271a8fdcb06e699f8332498a64aaa05042a0d11

Our copy

A-01-20-00004-certain-life-care-nursing-homes-may-not-have-complied-with-federal-requirements.pdf

Original

oig.hhs.gov