Full text
Department of Health and Human Services
OFFICE OF
INSPECTOR GENERAL
CERTAIN FOR-PROFIT NURSING
HOMES MAY NOT HAVE COMPLIED
WITH FEDERAL REQUIREMENTS
REGARDING THE INFECTION
PREVENTIONIST POSITION
Inquiries about this report may be addressed to the Office of Public Affairs at
Public.Affairs@oig.hhs.gov.
Amy J. Frontz
Deputy Inspector General
for Audit Services
August 2024
A-01-22-00001
Office of Inspector General
https://oig.hhs.gov
The mission of the Office of Inspector General (OIG) is to provide objective oversight to promote the
economy, efficiency, effectiveness, and integrity of the Department of Health and Human Services (HHS)
programs, as well as the health and welfare of the people they serve. Established by Public Law
No. 95-452, as amended, OIG carries out its mission through audits, investigations, and evaluations
conducted by the following operating components:
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. The audits examine the
performance of HHS programs, funding recipients, and contractors in carrying out their respective
responsibilities and provide independent assessments of HHS programs and operations to reduce waste,
abuse, and mismanagement.
Office of Evaluation and Inspections. OEI’s national evaluations provide HHS, Congress,
and the public with timely, useful, and reliable information on significant issues. To promote impact,
OEI reports also provide practical recommendations for improving program operations.
Office of Investigations. OI’s criminal, civil, and administrative investigations of fraud and
misconduct related to HHS programs and operations often lead to criminal convictions, administrative
sanctions, and civil monetary penalties. OI’s nationwide network of investigators collaborates with the
Department of Justice and other Federal, State, and local law enforcement authorities. OI works with
public health entities to minimize adverse patient impacts following enforcement operations. OI also
provides security and protection for the Secretary and other senior HHS officials.
Office of Counsel to the Inspector General. OCIG provides legal advice to OIG on HHS
programs and OIG’s internal operations. The law office also imposes exclusions and civil monetary
penalties, monitors Corporate Integrity Agreements, and represents HHS’s interests in False Claims Act
cases. In addition, OCIG publishes advisory opinions, compliance program guidance documents, fraud
alerts, and other resources regarding compliance considerations, 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.
August 2024 | A-01-22-00001
Certain For-Profit Nursing Homes May Not Have Complied With Federal
Requirements Regarding the Infection Preventionist Position
Why OIG Did This Audit
• More than 1.3 million people live in nursing homes nationwide. These individuals are susceptible to a
high number of health care-associated infections.
• Prior OIG audits found that nursing homes did not always comply with Federal regulations regarding
designating an infection preventionist (IP) who met Federal requirements for that position.
• This audit examined whether for-profit nursing homes nationwide complied with Federal requirements
pertaining to IPs.
What OIG Found
Not all for-profit nursing homes that we reviewed met Federal requirements. Seventy-six of the 100 for-profit
nursing homes in our sample complied with Federal requirements pertaining to IPs. However:
• 17 potentially did not comply with the requirement that the IP complete specialized infection
prevention and control training prior to assuming the role and
• 7 potentially did not comply with the requirement to designate an IP.
On the basis of our sample results, we estimated that 2,568 for-profit nursing homes nationwide
(approximately 1 in 4) may not have complied with Federal requirements pertaining to IPs during our audit
period. As a result, there may be increased health and safety risks for the residents and staff of these nursing
homes.
What OIG Recommends
We recommend that the Centers for Medicare & Medicaid Services:
1. instruct the State survey agencies to follow up with the 24 nursing homes that may not have complied
with Federal requirements to verify that they have taken corrective actions, and
2. share the results of this audit with the State survey agencies and encourage them to focus their
oversight on verifying that nursing homes designate an IP and that the IPs complete specialized
training prior to filling that position.
CMS concurred with both recommendations and indicated that it would implement them.
OIG.HHS.GOV
TABLE OF CONTENTS
INTRODUCTION............................................................................................................................. 1
Some Nursing Homes May Not Have Complied With the Infection Preventionist
Some Nursing Homes May Not Have Complied With the Requirement to Designate an
As Many as One in Four Nursing Homes Nationwide May Not Have Complied With IP
APPENDICES
Why We Did This Audit...................................................................................................... 1
Objective ........................................................................................................................... 1
Background ....................................................................................................................... 1
Medicare and Medicaid Coverage of Nursing Homes............................................ 1
Requirements for Infection Prevention and Control ............................................. 2
Responsibilities for Infection Prevention and Control ........................................... 2
How We Conducted This Audit.......................................................................................... 3
FINDINGS ...................................................................................................................................... 4
Training Requirements ................................................................................................... 5
Infection Preventionist ................................................................................................... 6
Why Nursing Homes May Not Have Complied With IP Requirements .............................. 6
Requirements ................................................................................................................. 7
RECOMMENDATIONS.................................................................................................................... 7
CMS COMMENTS .......................................................................................................................... 7
A: Audit Scope and Methodology......................................................................................8
B: Statistical Sampling Methodology...............................................................................10
C: Sample Results and Estimates.....................................................................................11
D: Areas of Infection Preventionist Possible Noncompliance At 24 Nursing Homes ....... 12
E: CMS Comments...........................................................................................................13
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
INTRODUCTION
WHY WE DID THIS AUDIT
More than 1.3 million people reside in the approximately 15,000 Medicare and Medicaid
certified nursing homes nationwide. Approximately two-thirds of those nursing homes are for-
profit nursing homes, and the remaining one-third of nursing homes is comprised of nonprofit
and Government-owned nursing homes. In October 2016, the Centers for Medicare &
Medicaid Services (CMS) issued a final rule that stated infection prevention and control is a
critical issue for nursing homes because of the high number of health care associated
infections, the residents’ increased susceptibility to infections, and the significant exposure to
health care associated infections residents face.
To minimize exposure to and transmission of
infections and contagious diseases, it is critical that nursing homes strictly adhere to Federal
requirements for proper infection prevention and control practices. Prior Office of Inspector
General (OIG) audits found that nursing homes did not always comply with infection prevention
and control (IPC) Federal regulations regarding designating an infection preventionist (IP) who
met Federal requirements for that position.
1
2
OBJECTIVE
Our objective was to determine whether for-profit nursing homes nationwide complied with
Federal requirements pertaining to IPs.3
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
States to perform surveys of nursing homes to determine whether they meet Federal
participation requirements.4
1 81 Fed. Reg. 68688, 68808 (Oct. 4, 2016).
2 Certain Life Care Nursing Homes May Not Have Complied With Federal Requirements for Infection Prevention and
Control and Emergency Preparedness (A-01-20-00004), issued Sept. 15, 2022, and Certain Nursing Homes May Not
Have Complied With Federal Requirements for Infection Prevention and Control and Emergency Preparedness
(A-01-20-00005), issued July 26, 2022..
3 We have begun an audit of the IP position at nonprofit and Government-owned nursing homes and will issue a
report of those audit results.
4 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.
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
1
Requirements for Infection Prevention and Control
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). CMS implemented new regulations in 2016 requiring that nursing
homes establish and maintain an infection prevention and control program (IPCP) designed to
provide a safe, sanitary, and comfortable environment. The IPCP must include:
• a system for preventing, identifying, reporting, investigating, and controlling infections
and communicable diseases for residents and staff (including volunteers, visitors, and
other individuals providing services under a contractual arrangement);
• written standards, policies, and procedures for the program that must include: (1) a
system of surveillance designed to identify possible communicable diseases or infections
before they can spread to other persons in the nursing home, (2) when and to whom
possible incidents of communicable diseases or infections should be reported,
(3) standard and transmission-based precautions to be followed to prevent the spread
of infections, (4) when and how isolation should be used for a resident, (5) the
circumstances under which the facility must prohibit employees with a communicable
disease or infected skin lesions from direct contact with residents or their food, and
(6) the hand hygiene procedures to be followed by staff involved in direct resident
contact;
• an antibiotic stewardship program that includes a system to monitor antibiotic use; and
• a system for recording incidents identified under the IPCP and the corrective actions
taken by the nursing home (42 CFR § 483.80(a)(1-4)).
Under these regulations, nursing homes are required to designate at least one individual as the
IP who is responsible for the facility’s IPCP. Per the regulations, the IP(s) must: (1) have primary
professional training in nursing, medical technology, microbiology, epidemiology, or other
related field; (2) be qualified by education, training, experience, or certification; (3) work at
least part-time at the facility; and (4) have completed specialized training in infection
prevention and control (42 CFR § 483.80(b)(1-4)).
Responsibilities for Infection Prevention and Control
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 established these
standards and incorporated them in the Title 42 of the Code of Federal Regulations. 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 State survey
agencies (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
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
2
with their applicable conditions of participation (CoPs). Standard surveys of nursing homes
must occur no later than 15 months after the previous survey.5, 6 SSAs are also responsible for
conducting a complaint survey if a review of the complaint allegation concludes that
noncompliance with CoPs may have occurred. 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
an IPCP.
HOW WE CONDUCTED THIS AUDIT
As of July 2022, there were 15,178 Medicare- and Medicaid-certified nursing homes
nationwide, of which 10,702 were for-profit nursing homes (located in the 50 States, the
District of Columbia, Guam, and Puerto Rico).7 We selected a simple random sample of 100 for-
profit nursing homes from the 10,702 for-profit nursing homes to determine whether they
complied with Federal regulations pertaining to IPs during the audit period July 1, 2021,
through June 30, 2022.8, 9 The nursing homes were in 31 States; the blue dots on the map in
Figure 1, on the next page, show the locations of the selected nursing homes. For each of the
sampled items, we contacted the nursing homes and requested nursing home officials provide
information identifying the IP(s) during the audit period, the IP(s) qualifications for the position,
the nursing home’s IP job description, and policies and procedures regarding IPC coverage
when the IP is unavailable. We also requested information regarding changes in nursing home
administrators and ownership. We reviewed the documentation to determine whether the
nursing homes complied with Federal regulations pertaining to IPs.
5 The Act §§ 1819(g)(2)(A)(iii)(l), 1919(g)(2)(A)(iii)(I) and 42 CFR § 488.308.
6 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 requirements of participation (42 CFR § 488.301).
7 Data.cms.gov: Nursing homes including rehab services datasets. Available online at:
https://data.cms.gov/provider-data/search?theme=Nursing%20homes%20including%20rehab%20services.
Accessed on Aug. 4, 2022.
8 Two of the selected nursing homes closed operations after we selected our sample. Therefore, we were unable
to contact them to request documentation to determine compliance with Federal requirements. As a result, we
considered these two sample items non-errors.
9 One of the selected nursing homes was incorrectly identified as a for-profit nursing home instead of a nonprofit
nursing home on the Medicare.gov website. Since this nursing home should not have been in our sampling frame,
we did not determine compliance with Federal requirements for this sample item. As a result, we considered this
sample item a non-error.
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
3
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 describes our audit scope and methodology, Appendix B describes our statistical
sampling methodology, and Appendix C contains our sample results and estimates.
Figure 1: The Locations of the 100 Sampled Nursing Homes
FINDINGS
Of the 100 for-profit nursing homes in our nationwide sample, 76 complied with Federal
requirements pertaining to IPs; however, 24 may not have complied with certain
requirements.10 Specifically:
10 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 follow-up review at the selected nursing homes to determine whether a deficiency exists for each
condition identified in this report.
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
4
• 17 nursing homes potentially did not comply with the requirement that the IPs
complete specialized IPC training prior to assuming their role, and
• 7 nursing homes potentially did not comply with the requirement to designate an IP.
Nursing home officials attributed the potential noncompliance to: (1) difficulties hiring and
retaining experienced and qualified IPs; (2) significant changes in IPs, administrators, or
ownership; (3) challenges completing specialized training in a timely manner due to pandemic
work demands and changing regulatory requirements; and (4) struggles accessing available
statewide in-person or online training.
On the basis of our sample results, we estimated that 2,568 for-profit nursing homes
nationwide (approximately 1 in 4 for-profit nursing homes) may not have complied with Federal
requirements pertaining to IPs during our audit period. As a result, there may be increased
health and safety risks for the residents and staff of these nursing homes.
Appendix D summarizes the types of potential noncompliance that we identified at each
nursing home.
SOME NURSING HOMES MAY NOT HAVE COMPLIED WITH THE INFECTION PREVENTIONIST
TRAINING REQUIREMENTS
The individual that a nursing home designates as its IP must meet the following Federal
requirements: (1) have primary professional training in nursing, medical technology,
microbiology, epidemiology, or other related field; (2) be qualified by education, training,
experience, or certification; (3) work at least part time at the facility; and (4) have completed
specialized training in infection prevention and control (42 CFR § 483.80(b)(1-4)).
The nursing homes in our sample complied with the first three requirements. However, the IPs
at 17 of the nursing homes did not complete specialized IPC training prior to assuming their role
as the designated IP.
For the nursing homes that complied with this requirement, Federal and State agencies
provided approximately 77 percent of the specialized training classes. Private entities provided
the remaining training classes. See Figure 2 on the next page for the breakout of the different
training sources.
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
5
•
•
Figure 2: Specialized Training Sources
71%
6%
23%
Federal Sources
State Sources
Private Entities
SOME NURSING HOMES MAY NOT HAVE COMPLIED WITH THE REQUIREMENT TO DESIGNATE
AN INFECTION PREVENTIONIST
Nursing homes must designate one or more individuals as the infection preventionist (IP) who is
responsible for its IPCP (42 CFR § 483.80(b)).
In its October 2016 final rule, CMS discussed the importance of nursing homes having a
designated individual responsible for its IPCP. CMS stated that nursing homes should ensure
coverage whenever the designated IP is unavailable. Therefore, CMS allows nursing homes the
flexibility to designate more than one individual to be responsible for the IPCP.11
We found that most nursing homes in our sample complied with designating an IP responsible
for their IPCP during the audit period. However, seven nursing homes did not have an
individual designated as the IP at some point during the audit period. One of the seven nursing
homes did not have an IP at any time during the audit period, and six of the nursing homes had
an IP for part of the audit period but not the entire period. The amount of time that five of
these six nursing homes were without a designated IP ranged from 30 to 311 days. The sixth
nursing home stated that it had an IP for part of the audit period but not the entire audit
period; however, this nursing home did not provide us with enough information to determine
what periods of time it was without an IP.
WHY NURSING HOMES MAY NOT HAVE COMPLIED WITH IP REQUIREMENTS
Officials from the 24 nursing homes provided various reasons why their IP did not complete
specialized training prior to assuming their new role or they did not designate an IP.
Specifically, the officials noted that the nursing homes:
11 81 Fed. Reg. 68810 (Oct. 4, 2016).
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
6
• encountered difficulties hiring and retaining experienced and qualified IPs;
• incurred significant changes in IPs, administrators, or ownership;
• experienced challenges completing specialized training in a timely manner due to
pandemic work demands and changing regulatory requirements; and
• struggled accessing available statewide in-person or online training.
AS MANY AS ONE IN FOUR NURSING HOMES NATIONWIDE MAY NOT HAVE COMPLIED WITH
IP REQUIREMENTS
On the basis of our sample results, we estimated that 2,568 for-profit nursing homes
nationwide (approximately 1 in 4 for-profit nursing homes) may not have complied with Federal
requirements for IPs to have completed specialized training prior to designation or to designate
an IP.12 As a result, there may be increased health and safety risks for the residents and staff of
these nursing homes.
RECOMMENDATIONS
We recommend that the Centers for Medicare & Medicaid Services:
• instruct the SSAs to follow up with the 24 nursing homes that may not have complied
with Federal requirements to verify that they have taken corrective actions13 and
• share the results of this audit with the SSAs and encourage them to focus their oversight
on verifying that nursing homes designate an IP and that the IPs complete specialized
training prior to filling that position.
CMS COMMENTS
In written comments on our draft report, CMS concurred with our recommendations and
indicated that it would implement them. CMS also provided technical comments, which we
addressed as appropriate. CMS’s comments, excluding the technical comments, are included as
Appendix E.
12 CMS and CDC collaborated to develop and offer a specialized online class called “Nursing Home Infection
Preventionist Training Course.” Available online at https://www.train.org/cdctrain/training_plan/3814. (Accessed
July 24, 2024.)
13 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.
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
7
APPENDIX A: AUDIT SCOPE AND METHODOLOGY
SCOPE
As of July 2022, there were 10,702 Medicare- and Medicaid-certified for-profit nursing homes
in operation during the audit period with valid 6-digit Federal provider numbers.14 We selected
100 of these nursing homes for review.
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’ policies and procedures related to
the IP.
We performed our audit from October 2022 through June 2024.
METHODOLOGY
To accomplish our objective, we:
• reviewed applicable Federal requirements,
• corresponded with CMS program officials to gain an understanding of the infection
preventionist requirements,
• obtained a list of all Medicare- and Medicaid-certified for-profit nursing homes,
• selected a simple random sample of 100 for-profit nursing homes,
• contacted selected nursing homes and requested documentation related to the IP,
• reviewed documentation from nursing homes to determine whether they complied with
Federal regulations pertaining to the IP,
• estimated the number of nursing homes that potentially did not comply with Federal
regulations pertaining to IPs, and
• discussed the results of our audit with CMS officials.
See Appendix B for our statistical sampling methodology and Appendix C for our sample results
and estimates.
14 To determine if a nursing home was in operation during the audit period, we used the CMS Quality, Certification
& Oversight Reports website, https://qcor.cms.gov/main.jsp. Accessed on Jan. 31, 2023.
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
8
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 Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
9
APPENDIX B: STATISTICAL SAMPLING METHODOLOGY
SAMPLING FRAME
The sampling frame included 10,702 active for-profit nursing homes that have valid 6-digit
Federal provider numbers.15, 16
SAMPLE UNIT
The sample unit was a for-profit nursing home.
SAMPLE DESIGN AND SAMPLE SIZE
We selected a simple random sample of 100 for-profit nursing homes.
SOURCE OF RANDOM NUMBERS
We generated the random numbers using the OIG, Office of Audit Services (OAS), statistical
software.
METHOD FOR SELECTING SAMPLE UNITS
We sorted the items in the sampling frame by the Federal provider number in ascending order
and consecutively numbered the items. After generating 100 random numbers, we selected
the corresponding frame items for review.
ESTIMATION METHODOLOGY
We used the OIG/OAS, statistical software to estimate the number of for-profit nursing homes
in the sampling frame that potentially did not comply with Federal regulations regarding IPs.
Using this software, we calculated the point estimate and a two-sided 90-percent confidence
interval (Appendix C).
15 We determined whether a nursing home was still active using the Quality, Certification & Oversight Reports
website, https://qcor.cms.gov/main.jsp.
16 The Federal provider numbers of less than 1 percent of the for-profit nursing homes in the provider data catalog
were in scientific notation.
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
10
I
I
I
I
APPENDIX C: SAMPLE RESULTS AND ESTIMATES
Nursing Homes Potentially Not In Compliance With
Federal Regulations Regarding Infection Preventionist
Sampling Frame Sample Size Number of Errors
10,702
100
24
Estimated Number of Nursing Homes in the Sampling Frame
that were Potentially Not In Compliance
(Limits Calculated for a 90-Percent Confidence Interval)
Point estimate 2,568
Lower limit
1,837
Upper limit
3,427
Estimated Percentage of Nursing Homes in the Sampling Frame
that were Potentially Not In Compliance
(Limits Calculated for a 90-Percent Confidence Interval)
Point estimate 24.00%
Lower limit
17.17%
Upper limit
32.02%
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
11
APPENDIX D: AREAS OF INFECTION PREVENTIONIST
POSSIBLE NONCOMPLIANCE AT 24 NURSING HOMES
Sample
Item
Did Not
Designate
An IP For At
Least Some
Of The
Audit Period
IP Did Not
Complete
Specialized
Training Prior
To Designation
Total
4
-
1
1
6
-
1
1
11
1
-
1
12
-
1
1
20
-
1
1
22
-
1
1
33
1
-
1
35
1
-
1
36
1
-
1
43
-
1
1
44
-
1
1
47
-
1
1
59
-
1
1
60
1
-
1
66
-
1
1
75
1
-
1
76
-
1
1
77
-
1
1
78
-
1
1
79
-
1
1
83
-
1
1
84
-
1
1
86
1
-
1
89
-
1
1
Total
7
17
24
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
12
( ~t
4E.
DEPARTMENT OF HEALTH & HUMAN SERVICES
"'1, :;j
<¥j"' ltvd:,a
Centers for Medicare & Medicaid Services
Administrator
Washington, DC 20201
DATE:
July 23, 2024
TO:
FROM:
Amy J. Frontz
Deputy Inspector General
Chiquita Brooks-LaSure
Administrator
APPENDIX E: CMS COMMENTS
SUBJECT:
Office of Inspector General Draft Report: Review of Nursing Facility Compliance
with Federal Regulations Pertaining to Infection Preventionist (A-01-22-00001)
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. Additionally, CMS continues to implement the Biden-Harris Administration’s efforts to
ensure pandemic and emergency preparedness in nursing homes, including strengthening
infection prevention and control practices.
In 2016, CMS took pivotal actions by issuing the “Medicare and Medicaid Programs: Reform of
Requirements for Long-Term Care Facilities” Final Rule.1 This rule was the impetus for the
requirement that nursing homes develop, implement, and maintain a quality assurance and
performance improvement (QAPI) program (§483.75), an infection prevention and control
program that includes an antibiotic stewardship program (ASP) (§483.80), and designation of at
least one infection preventionist (IP) (§483.80) to ensure the QAPI program’s effectiveness.
These regulations were implemented in three phases. The first phase was implemented in
November 2016, phase two in November 2017, and phase three in November 2019.
When the COVID-19 public health emergency was declared in early 2020, CMS took several
actions to strengthen infection prevention and control practices within nursing homes. CMS
began by issuing guidance to nursing homes to reiterate the importance of longstanding infection
control guidelines and the use of personal protective equipment. CMS continued to provide
updated guidance as new information was learned. CMS also partnered with the Centers for
Disease Control and Prevention (CDC) to support surveillance and collection of COVID-19 data,
which were used to strengthen surveillance locally and nationally, monitor trends in infection
rates, and help local, state, and federal authorities get help to nursing homes faster. In an effort to
1 Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 81 Fed. Reg. 68688,
Nov. 28, 2016.
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
13
allow CMS and the states to focus on infection prevention and control and slowing the spread of
COVID-19, CMS instructed the State Survey Agencies (SSAs) to conduct onsite surveys to
assess compliance with federal requirements and investigate facility complaints, with a
streamlined review tool to conduct focused infection control surveys. CMS has since integrated
the focused infection control survey into the standard survey process, which is typically done on
behalf of CMS by the SSAs.
In June 2022, CMS announced the release of new survey guidance to support implementing all
phases of the Reform of Requirements for LTC facilities.2 In the updated guidance, CMS
clarified that the amount of time required to fulfill the IP role must be at least part-time and
should also be determined by the facility assessment, conducted according to §483.71, to
determine the resources a facility needs for its infection prevention and control program (IPCP),
and ensure that those resources are provided for the IPCP. Similarly, the IP must participate in
the nursing homes’ Quality Assessment and Assurance (QAA) Committee and report on the
IPCP and incidents such as healthcare-associated infections and communicable diseases.
Additionally, ASP is a team effort with nursing homes’ staff, such as physicians, nursing staff,
leadership, etc. CMS clarified that the IP is responsible for ensuring that the program meets the
requirements. The IP should also review and approve infection prevention and control training
topics and content and ensure facility staff are trained on IPCPs.3
Further, the IP must have primary professional training in nursing, medical technology,
microbiology, epidemiology, or other related fields of training, such as physicians, pharmacists,
and physician assistants.4 CMS states that the IP must be qualified by education, training,
experience, or certification. The IP must have the knowledge to perform the role. The IP should
remain current with infection prevention and control issues and be aware of national
organizations’ guidelines and those from national, state, and local public health authorities (e.g.,
emerging pathogens). The facility should ensure the individual(s) selected as the IP has the
background and ability to fully carry out the requirements of the IP based on the needs of the
resident population, such as interpreting clinical and laboratory data. Examples of experience in
infection prevention and control may include but are not limited to identifying infectious disease
processes, surveillance and epidemiological investigation, and preventing and controlling the
transmission of infectious agents.5
The regulations intend to ensure that each nursing home develops and implements an ongoing,
facility-wide system for infection prevention, identification, reporting, investigating, and control
of infection and communicable diseases of residents, staff, and visitors and review and update
the program plans annually and as necessary.6 As of October 24, 2022, SSAs have been using the
guidance to survey for compliance or non-compliance with all requirements from the 2016 Final
Rule from all three phases.7
2 CMS QSO-22-19-NH, Revised Long-Term Care Surveyor Guidance, June 29, 2022
3 State Operations Manual, Appendix PP - Guidance to Surveyors for Long Term Care Facilities, February 2023
4 Id.
5 Id.
6 Id.
7 CMS QSO-22-19-NH, Revised Long-Term Care Surveyor Guidance, June 29, 2022
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
14
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 the SSAs to follow up with the 24 nursing homes that may not have complied with
federal requirements to verify they have taken corrective actions.
CMS Response
CMS concurs with this recommendation. It is important to note that OIG’s audit period was June
1, 2021, through June 30, 2022, and during that time, CMS was not surveying nursing homes for
compliance with designating an IP because CMS had not yet released the expected State
Operations Manual surveyor guidance phase two and three updates. However, CMS is now
surveying for all requirements and will instruct the SSAs, as appropriate, to follow up with the
24 nursing homes to determine if they meet all federal requirements.
OIG Recommendation
Share the results of this audit with the SSAs and encourage them to focus their oversight on
verifying that nursing homes designate an IP and that the IPs complete specialized training prior
to filling that position.
CMS Response
CMS concurs with this recommendation. CMS will share the findings of this audit with the
SSAs. CMS notes that specialized infection prevention and control training is a federal
requirement for the IP, and the survey process includes a full review of the IP’s qualifications.
However, CMS will remind the SSAs of the importance of IPs completing specialized training
before filling that position.
Infection Preventionist Position at For-Profit Nursing Homes (A-01-22-00001)
15