Agency Forms Undergoing Paperwork Reduction Act Review, 53441-53444 [2019-21753]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Notices
Centers for Disease Control and
Prevention
Disease Control and Prevention (CDC)
has submitted the information
collection request titled National
Healthcare Safety Network (NHSN) to
the Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on June 5, 2019 to obtain
comments from the public and affected
agencies. CDC received two comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
[30Day–19–0666]
Proposed Project
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
Reserve Bank indicated. The
applications will also be available for
inspection at the offices of the Board of
Governors. Interested persons may
express their views in writing on the
standards enumerated in the BHC Act
(12 U.S.C. 1842(c)).
Comments regarding each of these
applications must be received at the
Reserve Bank indicated or the offices of
the Board of Governors, Ann E.
Misback, Secretary of the Board, 20th
and Constitution Avenue NW,
Washington, DC 20551–0001, not later
than November 7, 2019.
A. Federal Reserve Bank of Atlanta
(Kathryn Haney, Assistant Vice
President) 1000 Peachtree Street NE,
Atlanta, Georgia 30309. Comments can
also be sent electronically to
Applications.Comments@atl.frb.org:
1. IFB Bancorp, Inc., Miami, Florida;
to become a bank holding company by
acquiring International Finance Bank,
also of Miami, Florida.
B. Federal Reserve Bank of
Philadelphia (William Spaniel, Senior
Vice President) 100 North 6th Street,
Philadelphia, Pennsylvania 19105–
1521. Comments can also be sent
electronically to
Comments.applications@phil.frb.org:
1. OceanFirst Financial Corp., Toms
River, New Jersey; to acquire Two River
Bancorp and thereby indirectly acquire
Two River Community Bank, both of
Tinton Falls, New Jersey.
2. OceanFirst Financial Corp., Toms
River, New Jersey; to acquire Country
Bank Holding Company and thereby
indirectly acquire Country Bank, both of
New York, New York.
Board of Governors of the Federal Reserve
System, October 2, 2019.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2019–21787 Filed 10–4–19; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
VerDate Sep<11>2014
18:29 Oct 04, 2019
Jkt 250001
National Healthcare Safety Network
(NHSN)—Revision—National Center for
Emerging and Zoonotic Infection
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
53441
Background and Brief Description
The Division of Healthcare Quality
Promotion (DHQP), National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC) collects
data from healthcare facilities in the
National Healthcare Safety Network
(NHSN) under OMB Control Number
0920–0666. During the early stages of its
development, NHSN began as a
voluntary surveillance system in 2005
managed by DHQP. NHSN provides
facilities, states, regions, and the nation
with data necessary to identify problem
areas, measure the progress of
prevention efforts, and ultimately
eliminate healthcare-associated
infections (HAIs) nationwide. NHSN
allows healthcare facilities to track
blood safety errors and various
healthcare-associated infection
prevention practice methods such as
healthcare personnel influenza vaccine
status and corresponding infection
control adherence rates.
NHSN currently has six components:
Patient Safety (PS), Healthcare
Personnel Safety (HPS), Biovigilance
(BV), Long-Term Care Facility (LTCF),
Outpatient Procedure (OPC), and the
Dialysis Component. NHSN’s new
Neonatal Component is expected to
launch during the summer of 2020. This
component will focus on premature
neonates and the healthcare-associated
events that occur as a result of their
prematurity. This component will be
released with one module, which
includes Late Onset-Sepsis and
Meningitis. Late-onset sepsis (LOS) and
Meningitis are common complications
of extreme prematurity. Studies have
indicated that 36% of extremely low
gestational age (22–28 weeks) infants
develop LOS and that 21% of very low
birth weight infants surviving beyond
three days of life will develop LOS.
Meningitis occurs in 23% of bacteremic
infants, but 38% of infants with a
pathogen isolated from the
cerebrospinal fluid may not have an
organism isolated from blood. These
infections are usually serious, causing a
prolongation of hospital stay, increased
cost, and risk of morbidity and
mortality.
Some cases of LOS can be prevented
through proper central line insertion
and maintenance practices. These are
addressed in the CDC’s Healthcare
Infection Control Practices Advisory
Committee (CDC/HICPAC) Guidelines
for the Prevention of Intravascular
Catheter-Related Infections, 2011.
However, almost one-third of LOS
events in a quality-improvement study
were not related to central-lines.
E:\FR\FM\07OCN1.SGM
07OCN1
53442
Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Notices
Prevention strategies for the non-central
line-related infection events have yet to
be fully defined, but include adherence
to hand-hygiene, parent and visitor
education, and optimum nursery design
features. Other areas that likely
influence the development of LOS
include early enteral nutritional support
and skin care practices. The data for this
module will be electronically submitted,
and manual data entry will not be
available. This will allow more hospital
personnel to be available to care for
patients and will reduce annual burden
across healthcare facilities.
Additionally, LOS data will be utilized
for prevention initiatives.
Data reported under the Patient Safety
Component are used to determine the
magnitude of the healthcare-associated
adverse events and trends in the rates of
the events, in the distribution of
pathogens, and in the adherence to
prevention practices. Data will help
detect changes in the epidemiology of
adverse events resulting from new
medical therapies and changing patient
risks. Additionally, reported data is
being used to describe the epidemiology
of antimicrobial use and resistance and
to better understand the relationship of
antimicrobial therapy to this rising
problem. Under the Healthcare
Personnel Safety Component, protocols
and data on events—both positive and
adverse—are used to determine (1) the
magnitude of adverse events in
healthcare personnel, and (2)
compliance with immunization and
sharps injuries safety guidelines. Under
the Biovigilance Component, data on
adverse reactions and incidents
associated with blood transfusions are
reported and analyzed to provide
national estimates of adverse reactions
and incidents. Under the Long-Term
Care Facility Component, data is
captured from skilled nursing facilities.
Reporting methods under the LTCF
component have been created by using
forms from the PS Component as a
model with modifications to specifically
address the specific characteristics of
LTCF residents and the unique data
needs of these facilities reporting into
NHSN. The Dialysis Component offers a
simplified user interface for dialysis
users to streamline their data entry and
analyses processes as well as provide
options for expanding in the future to
include dialysis surveillance in settings
other than outpatient facilities. The
Outpatient Procedure Component (OPC)
gathers data on the impact of infections
and outcomes related to operative
procedures performed in Ambulatory
Surgery Centers (ASCs). The OPC is
used to monitor two event types: Same
Day Outcome Measures and Surgical
Site Infections (SSIs).
NHSN has increasingly served as the
operating system for HAI reporting
compliance through legislation
established by the states. As of March
2019, 36 states, the District of Columbia
and the City of Philadelphia,
Pennsylvania have opted to use NHSN
as their primary system for mandated
reporting. Reporting compliance is
completed by healthcare facilities in
their respective jurisdictions, with
emphasis on those states and
municipalities acquiring varying
consequences for failure to use NHSN.
Additionally, healthcare facilities in five
U.S. territories (Puerto Rico, American
Samoa, the U.S. Virgin Islands, Guam,
and the Northern Mariana Islands) are
voluntarily reporting to NHSN.
Additional territories are projected to
follow with similar use of NHSN for
reporting purposes.
NHSN’s data is used to aid in the
tracking of HAIs and guide infection
prevention activities/practices that
protect patients. The Centers for
Medicare and Medicaid Services (CMS)
and other payers use these data to
determine incentives for performance at
healthcare facilities across the US and
surrounding territories, and members of
the public may use some protected data
to inform their selection among
available providers. Each of these
parties is dependent on the
completeness and accuracy of the data.
CDC and CMS work closely and are
fully committed to ensuring complete
and accurate reporting, which are
critical for protecting patients and
guiding national, state, and local
prevention priorities.
CMS collects some HAI data and
healthcare personnel influenza
vaccination summary data, which is
done on a voluntary basis as part of its
Fee-for-Service Medicare quality
reporting programs, while others may
report data required by a federal
mandate. Facilities that fail to report
quality measure data are subject to
partial payment reduction in the
applicable Medicare Fee-for-Service
payment system. CMS links their
quality reporting to payment for
Medicare-eligible acute care hospitals,
inpatient rehabilitation facilities, longterm acute care facilities, oncology
hospitals, inpatient psychiatric
facilities, dialysis facilities, and
ambulatory surgery centers. Facilities
report HAI data and healthcare
personnel influenza vaccination
summary data to CMS via NHSN as part
of CMS’s quality reporting programs to
receive full payment. Still, many
healthcare facilities, even in states
without HAI reporting legislation,
submit limited HAI data to NHSN
voluntarily.
NHSN’s data collection updates
continue to support the incentive
programs managed by CMS. For
example, survey questions support
requirements for CMS’ quality reporting
programs. Additionally, CDC has
collaborated with CMS on a voluntary
National Nursing Home Quality
Collaborative, which focuses on
recruiting nursing homes to report HAI
data to NHSN and to retain their
continued participation. This project
has resulted in a significant increase in
long-term care facilities reporting to
NHSN. The collection of information is
authorized by the Public Health Service
Act (42 U.S.C. 242b, 242k, and 242m
(d)).
The proposed changes in this new ICR
include revisions made to 40 NHSN
data collection tools for a total of 76
data collection tools included in this
ICR. The reporting burden decreased by
2,363,508 hours for a total estimated
burden of 3,033,930 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondent type
Form No. & name
Healthcare Practitioner ...........
57.100 NHSN Registration Form ...........................................
57.101 Facility Contact Information .....................................
57.103 Patient Safety Component—Annual Hospital Survey.
57.105 Group Contact Information ......................................
57.106 Patient Safety Monthly Reporting Plan ...................
57.108 Primary Bloodstream Infection (BSI) .......................
VerDate Sep<11>2014
18:29 Oct 04, 2019
Jkt 250001
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
E:\FR\FM\07OCN1.SGM
Number of
responses
per
respondent
Average
burden per
response
(hours)
2,000
2,000
5,175
1
1
1
5/60
10/60
75/60
1,000
6,000
5,775
1
12
5
5/60
15/60
38/60
07OCN1
53443
Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Respondent type
Number of
respondents
Form No. & name
57.111 Pneumonia (PNEU) .................................................
57.112 Ventilator-Associated Event .....................................
57.113 Pediatric Ventilator-Associated Event (PedVAE) ....
57.114 Urinary Tract Infection (UTI) ....................................
57.115 Custom Event ..........................................................
57.116 Denominators for Neonatal Intensive Care Unit
(NICU).
57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC).
57.118 Denominators for Intensive Care Unit (ICU)/Other
locations (not NICU or SCA).
57.120 Surgical Site Infection (SSI) ....................................
57.121 Denominator for Procedure .....................................
57.122 HAI Progress Report State Health Department Survey.
57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables.
57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables.
57.125 Central Line Insertion Practices Adherence Monitoring.
57.126 MDRO or CDI Infection Form ..................................
57.127 MDRO and CDI Prevention Process and Outcome
Measures Monthly Monitoring.
57.128 Laboratory-identified MDRO or CDI Event ..............
57.129 Adult Sepsis .............................................................
57.137 Long-Term Care Facility Component—Annual Facility Survey.
57.138 Laboratory-identified MDRO or CDI Event for LTCF
57.139 MDRO and CDI Prevention Process Measures
Monthly Monitoring for LTCF.
57.140 Urinary Tract Infection (UTI) for LTCF ....................
57.141 Monthly Reporting Plan for LTCF ............................
57.142 Denominators for LTCF Locations ..........................
57.143 Prevention Process Measures Monthly Monitoring
for LTCF.
57.150 LTAC Annual Survey ...............................................
57.151 Rehab Annual Survey ..............................................
57.200 Healthcare Personnel Safety Component Annual
Facility Survey.
57.203 Healthcare Personnel Safety Monthly Reporting
Plan.
57.204 Healthcare Worker Demographic Data ...................
57.205 Exposure to Blood/Body Fluids ...............................
57.206 Healthcare Worker Prophylaxis/Treatment ..............
57.207 Follow-Up Laboratory Testing .................................
57.210 Healthcare Worker Prophylaxis/Treatment-Influenza.
57.300 Hemovigilance Module Annual Survey ....................
57.301 Hemovigilance Module Monthly Reporting Plan .....
57.303 Hemovigilance Module Monthly Reporting Denominators.
57.305 Hemovigilance Incident ............................................
57.306 Hemovigilance Module Annual Survey—Non-acute
care facility.
57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion Reaction.
57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction.
57.30 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction.
57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction.
57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction.
57.312 Hemovigilance Adverse Reaction—Hypotensive
Transfusion Reaction.
57.313 Hemovigilance Adverse Reaction—Infection ..........
VerDate Sep<11>2014
18:29 Oct 04, 2019
Jkt 250001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Number of
responses
per
respondent
Average
burden per
response
(hours)
1,800
5,500
334
5,500
600
220
30
5
120
5
91
12
30/60
28/60
30/60
20/60
35/60
249/60
165
12
302/60
5,500
60
302/60
4,500
4,500
55
11
680
1
35/60
10/60
45/60
1,500
12
5/60
2,000
12
5/60
500
213
25/60
720
5,500
12
29
30/60
15/60
4,800
50
2,220
87
250
1
20/60
25/60
120/60
2,150
2,200
24
12
15/60
20/60
400
2,220
2,220
375
12
12
12
12
30/60
5/60
250/60
5/60
500
1,200
50
1
1
1
70/60
70/60
480/60
........................
1
5/60
50
50
50
50
50
200
50
30
50
50
20/60
60/60
15/60
15/60
10/60
500
500
500
1
12
12
85/60
1/60
70/60
500
500
10
1
10/60
35/60
500
4
20/60
500
4
20/60
500
1
20/60
500
2
20/60
500
4
20/60
500
1
20/60
500
1
20/60
E:\FR\FM\07OCN1.SGM
07OCN1
53444
Federal Register / Vol. 84, No. 194 / Monday, October 7, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Respondent type
Number of
respondents
Form No. & name
57.314 Hemovigilance Adverse Reaction—Post Transfusion Purpura.
57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea.
57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft vs. Host Disease.
57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute Lung Injury.
57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload.
57.319 Hemovigilance
Adverse
Reaction—Unknown
Transfusion Reaction.
57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction.
57.400 Outpatient Procedure Component—Annual Facility
Survey.
57.401 Outpatient Procedure Component—Monthly Reporting Plan.
57.402 Outpatient Procedure Component Same Day Outcome Measures.
57.403 Outpatient Procedure Component—Monthly Denominators for Same Day Outcome Measures.
57.404 Outpatient Procedure Component—SSI Denominator.
57.405 Outpatient Procedure Component—Surgical Site
(SSI) Event.
57.500 Outpatient Dialysis Center Practices Survey ..........
57.501 Dialysis Monthly Reporting Plan ..............................
57.502 Dialysis Event ..........................................................
57.503 Denominator for Outpatient Dialysis ........................
57.504 Prevention Process Measures Monthly Monitoring
for Dialysis.
57.505 Dialysis Patient Influenza Vaccination .....................
57.506 Dialysis Patient Influenza Vaccination Denominator
57.507 Home Dialysis Center Practices Survey .................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–21753 Filed 10–4–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–4186–N]
Medicare Program; Medicare Appeals;
Adjustment to the Amount in
Controversy Threshold Amounts for
Calendar Year 2020
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
This notice announces the
annual adjustment in the amount in
controversy (AIC) threshold amounts for
Administrative Law Judge (ALJ)
hearings and judicial review under the
SUMMARY:
VerDate Sep<11>2014
18:29 Oct 04, 2019
Jkt 250001
Medicare appeals process. The
adjustment to the AIC threshold
amounts will be effective for requests
for ALJ hearings and judicial review
filed on or after January 1, 2020. The
calendar year 2020 AIC threshold
amounts are $170 for ALJ hearings and
$1,670 for judicial review.
DATES: This annual adjustment takes
effect on January 1, 2020.
FOR FURTHER INFORMATION CONTACT: Liz
Hosna (Katherine.Hosna@cms.hhs.gov),
(410) 786–4993.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1869(b)(1)(E) of the Social
Security Act (the Act), as amended by
section 521 of the Medicare, Medicaid,
and SCHIP Benefits Improvement and
Protection Act of 2000 (BIPA),
established the amount in controversy
(AIC) threshold amounts for
Administrative Law Judge (ALJ)
hearings and judicial review at $100 and
$1,000, respectively, for Medicare Part
A and Part B appeals. Section 940 of the
Medicare Prescription Drug,
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Number of
responses
per
respondent
Average
burden per
response
(hours)
500
1
20/60
500
1
20/60
500
1
20/60
500
1
20/60
500
2
20/60
500
1
20/60
500
1
20/60
700
1
10/60
700
12
15/60
200
1
40/60
200
400
40/60
700
100
40/60
700
5
40/60
7,100
7,100
7,100
7,100
1,760
1
12
30
12
12
127/60
5/60
25/60
10/60
75/60
860
860
430
60
1
1
10/60
5/60
30/60
Improvement, and Modernization Act of
2003 (MMA), amended section
1869(b)(1)(E) of the Act to require the
AIC threshold amounts for ALJ hearings
and judicial review to be adjusted
annually. Beginning in January 2005,
the AIC threshold amounts are to be
adjusted by the percentage increase in
the medical care component of the
consumer price index (CPI) for all urban
consumers (U.S. city average) for July
2003 to July of the year preceding the
year involved and rounded to the
nearest multiple of $10. Section
940(b)(2) of the MMA provided
conforming amendments to apply the
AIC adjustment requirement to
Medicare Part C/Medicare Advantage
(MA) appeals and certain health
maintenance organization and
competitive health plan appeals. Health
care prepayment plans are also subject
to MA appeals rules, including the AIC
adjustment requirement. Section 101 of
the MMA provides for the application of
the AIC adjustment requirement to
Medicare Part D appeals.
E:\FR\FM\07OCN1.SGM
07OCN1
]]>Agencies
[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Notices]
[Pages 53441-53444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21753]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-0666]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled National Healthcare Safety Network (NHSN) to
the Office of Management and Budget (OMB) for review and approval. CDC
previously published a ``Proposed Data Collection Submitted for Public
Comment and Recommendations'' notice on June 5, 2019 to obtain comments
from the public and affected agencies. CDC received two comments
related to the previous notice. This notice serves to allow an
additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
National Healthcare Safety Network (NHSN)--Revision--National
Center for Emerging and Zoonotic Infection Diseases (NCEZID), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
The Division of Healthcare Quality Promotion (DHQP), National
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention (CDC) collects data from healthcare
facilities in the National Healthcare Safety Network (NHSN) under OMB
Control Number 0920-0666. During the early stages of its development,
NHSN began as a voluntary surveillance system in 2005 managed by DHQP.
NHSN provides facilities, states, regions, and the nation with data
necessary to identify problem areas, measure the progress of prevention
efforts, and ultimately eliminate healthcare-associated infections
(HAIs) nationwide. NHSN allows healthcare facilities to track blood
safety errors and various healthcare-associated infection prevention
practice methods such as healthcare personnel influenza vaccine status
and corresponding infection control adherence rates.
NHSN currently has six components: Patient Safety (PS), Healthcare
Personnel Safety (HPS), Biovigilance (BV), Long-Term Care Facility
(LTCF), Outpatient Procedure (OPC), and the Dialysis Component. NHSN's
new Neonatal Component is expected to launch during the summer of 2020.
This component will focus on premature neonates and the healthcare-
associated events that occur as a result of their prematurity. This
component will be released with one module, which includes Late Onset-
Sepsis and Meningitis. Late-onset sepsis (LOS) and Meningitis are
common complications of extreme prematurity. Studies have indicated
that 36% of extremely low gestational age (22-28 weeks) infants develop
LOS and that 21% of very low birth weight infants surviving beyond
three days of life will develop LOS. Meningitis occurs in 23% of
bacteremic infants, but 38% of infants with a pathogen isolated from
the cerebrospinal fluid may not have an organism isolated from blood.
These infections are usually serious, causing a prolongation of
hospital stay, increased cost, and risk of morbidity and mortality.
Some cases of LOS can be prevented through proper central line
insertion and maintenance practices. These are addressed in the CDC's
Healthcare Infection Control Practices Advisory Committee (CDC/HICPAC)
Guidelines for the Prevention of Intravascular Catheter-Related
Infections, 2011. However, almost one-third of LOS events in a quality-
improvement study were not related to central-lines.
[[Page 53442]]
Prevention strategies for the non-central line-related infection events
have yet to be fully defined, but include adherence to hand-hygiene,
parent and visitor education, and optimum nursery design features.
Other areas that likely influence the development of LOS include early
enteral nutritional support and skin care practices. The data for this
module will be electronically submitted, and manual data entry will not
be available. This will allow more hospital personnel to be available
to care for patients and will reduce annual burden across healthcare
facilities. Additionally, LOS data will be utilized for prevention
initiatives.
Data reported under the Patient Safety Component are used to
determine the magnitude of the healthcare-associated adverse events and
trends in the rates of the events, in the distribution of pathogens,
and in the adherence to prevention practices. Data will help detect
changes in the epidemiology of adverse events resulting from new
medical therapies and changing patient risks. Additionally, reported
data is being used to describe the epidemiology of antimicrobial use
and resistance and to better understand the relationship of
antimicrobial therapy to this rising problem. Under the Healthcare
Personnel Safety Component, protocols and data on events--both positive
and adverse--are used to determine (1) the magnitude of adverse events
in healthcare personnel, and (2) compliance with immunization and
sharps injuries safety guidelines. Under the Biovigilance Component,
data on adverse reactions and incidents associated with blood
transfusions are reported and analyzed to provide national estimates of
adverse reactions and incidents. Under the Long-Term Care Facility
Component, data is captured from skilled nursing facilities. Reporting
methods under the LTCF component have been created by using forms from
the PS Component as a model with modifications to specifically address
the specific characteristics of LTCF residents and the unique data
needs of these facilities reporting into NHSN. The Dialysis Component
offers a simplified user interface for dialysis users to streamline
their data entry and analyses processes as well as provide options for
expanding in the future to include dialysis surveillance in settings
other than outpatient facilities. The Outpatient Procedure Component
(OPC) gathers data on the impact of infections and outcomes related to
operative procedures performed in Ambulatory Surgery Centers (ASCs).
The OPC is used to monitor two event types: Same Day Outcome Measures
and Surgical Site Infections (SSIs).
NHSN has increasingly served as the operating system for HAI
reporting compliance through legislation established by the states. As
of March 2019, 36 states, the District of Columbia and the City of
Philadelphia, Pennsylvania have opted to use NHSN as their primary
system for mandated reporting. Reporting compliance is completed by
healthcare facilities in their respective jurisdictions, with emphasis
on those states and municipalities acquiring varying consequences for
failure to use NHSN. Additionally, healthcare facilities in five U.S.
territories (Puerto Rico, American Samoa, the U.S. Virgin Islands,
Guam, and the Northern Mariana Islands) are voluntarily reporting to
NHSN. Additional territories are projected to follow with similar use
of NHSN for reporting purposes.
NHSN's data is used to aid in the tracking of HAIs and guide
infection prevention activities/practices that protect patients. The
Centers for Medicare and Medicaid Services (CMS) and other payers use
these data to determine incentives for performance at healthcare
facilities across the US and surrounding territories, and members of
the public may use some protected data to inform their selection among
available providers. Each of these parties is dependent on the
completeness and accuracy of the data. CDC and CMS work closely and are
fully committed to ensuring complete and accurate reporting, which are
critical for protecting patients and guiding national, state, and local
prevention priorities.
CMS collects some HAI data and healthcare personnel influenza
vaccination summary data, which is done on a voluntary basis as part of
its Fee-for-Service Medicare quality reporting programs, while others
may report data required by a federal mandate. Facilities that fail to
report quality measure data are subject to partial payment reduction in
the applicable Medicare Fee-for-Service payment system. CMS links their
quality reporting to payment for Medicare-eligible acute care
hospitals, inpatient rehabilitation facilities, long-term acute care
facilities, oncology hospitals, inpatient psychiatric facilities,
dialysis facilities, and ambulatory surgery centers. Facilities report
HAI data and healthcare personnel influenza vaccination summary data to
CMS via NHSN as part of CMS's quality reporting programs to receive
full payment. Still, many healthcare facilities, even in states without
HAI reporting legislation, submit limited HAI data to NHSN voluntarily.
NHSN's data collection updates continue to support the incentive
programs managed by CMS. For example, survey questions support
requirements for CMS' quality reporting programs. Additionally, CDC has
collaborated with CMS on a voluntary National Nursing Home Quality
Collaborative, which focuses on recruiting nursing homes to report HAI
data to NHSN and to retain their continued participation. This project
has resulted in a significant increase in long-term care facilities
reporting to NHSN. The collection of information is authorized by the
Public Health Service Act (42 U.S.C. 242b, 242k, and 242m (d)).
The proposed changes in this new ICR include revisions made to 40
NHSN data collection tools for a total of 76 data collection tools
included in this ICR. The reporting burden decreased by 2,363,508 hours
for a total estimated burden of 3,033,930 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Respondent type Form No. & name respondents responses per response
respondent (hours)
----------------------------------------------------------------------------------------------------------------
Healthcare Practitioner............ 57.100 NHSN Registration 2,000 1 5/60
Form.
57.101 Facility Contact 2,000 1 10/60
Information.
57.103 Patient Safety 5,175 1 75/60
Component--Annual Hospital
Survey.
57.105 Group Contact 1,000 1 5/60
Information.
57.106 Patient Safety 6,000 12 15/60
Monthly Reporting Plan.
57.108 Primary Bloodstream 5,775 5 38/60
Infection (BSI).
[[Page 53443]]
57.111 Pneumonia (PNEU).... 1,800 30 30/60
57.112 Ventilator- 5,500 5 28/60
Associated Event.
57.113 Pediatric Ventilator- 334 120 30/60
Associated Event (PedVAE).
57.114 Urinary Tract 5,500 5 20/60
Infection (UTI).
57.115 Custom Event........ 600 91 35/60
57.116 Denominators for 220 12 249/60
Neonatal Intensive Care
Unit (NICU).
57.117 Denominators for 165 12 302/60
Specialty Care Area (SCA)/
Oncology (ONC).
57.118 Denominators for 5,500 60 302/60
Intensive Care Unit (ICU)/
Other locations (not NICU
or SCA).
57.120 Surgical Site 4,500 11 35/60
Infection (SSI).
57.121 Denominator for 4,500 680 10/60
Procedure.
57.122 HAI Progress Report 55 1 45/60
State Health Department
Survey.
57.123 Antimicrobial Use 1,500 12 5/60
and Resistance (AUR)-
Microbiology Data
Electronic Upload
Specification Tables.
57.124 Antimicrobial Use 2,000 12 5/60
and Resistance (AUR)-
Pharmacy Data Electronic
Upload Specification
Tables.
57.125 Central Line 500 213 25/60
Insertion Practices
Adherence Monitoring.
57.126 MDRO or CDI 720 12 30/60
Infection Form.
57.127 MDRO and CDI 5,500 29 15/60
Prevention Process and
Outcome Measures Monthly
Monitoring.
57.128 Laboratory- 4,800 87 20/60
identified MDRO or CDI
Event.
57.129 Adult Sepsis........ 50 250 25/60
57.137 Long-Term Care 2,220 1 120/60
Facility Component--Annual
Facility Survey.
57.138 Laboratory- 2,150 24 15/60
identified MDRO or CDI
Event for LTCF.
57.139 MDRO and CDI 2,200 12 20/60
Prevention Process
Measures Monthly
Monitoring for LTCF.
57.140 Urinary Tract 400 12 30/60
Infection (UTI) for LTCF.
57.141 Monthly Reporting 2,220 12 5/60
Plan for LTCF.
57.142 Denominators for 2,220 12 250/60
LTCF Locations.
57.143 Prevention Process 375 12 5/60
Measures Monthly
Monitoring for LTCF.
57.150 LTAC Annual Survey.. 500 1 70/60
57.151 Rehab Annual Survey. 1,200 1 70/60
57.200 Healthcare Personnel 50 1 480/60
Safety Component Annual
Facility Survey.
57.203 Healthcare Personnel .............. 1 5/60
Safety Monthly Reporting
Plan.
57.204 Healthcare Worker 50 200 20/60
Demographic Data.
57.205 Exposure to Blood/ 50 50 60/60
Body Fluids.
57.206 Healthcare Worker 50 30 15/60
Prophylaxis/Treatment.
57.207 Follow-Up Laboratory 50 50 15/60
Testing.
57.210 Healthcare Worker 50 50 10/60
Prophylaxis/Treatment-
Influenza.
57.300 Hemovigilance Module 500 1 85/60
Annual Survey.
57.301 Hemovigilance Module 500 12 1/60
Monthly Reporting Plan.
57.303 Hemovigilance Module 500 12 70/60
Monthly Reporting
Denominators.
57.305 Hemovigilance 500 10 10/60
Incident.
57.306 Hemovigilance Module 500 1 35/60
Annual Survey--Non-acute
care facility.
57.307 Hemovigilance 500 4 20/60
Adverse Reaction--Acute
Hemolytic Transfusion
Reaction.
57.308 Hemovigilance 500 4 20/60
Adverse Reaction--Allergic
Transfusion Reaction.
57.30 Hemovigilance Adverse 500 1 20/60
Reaction--Delayed
Hemolytic Transfusion
Reaction.
57.310 Hemovigilance 500 2 20/60
Adverse Reaction--Delayed
Serologic Transfusion
Reaction.
57.311 Hemovigilance 500 4 20/60
Adverse Reaction--Febrile
Non-hemolytic Transfusion
Reaction.
57.312 Hemovigilance 500 1 20/60
Adverse Reaction--
Hypotensive Transfusion
Reaction.
57.313 Hemovigilance 500 1 20/60
Adverse Reaction--
Infection.
[[Page 53444]]
57.314 Hemovigilance 500 1 20/60
Adverse Reaction--Post
Transfusion Purpura.
57.315 Hemovigilance 500 1 20/60
Adverse Reaction--
Transfusion Associated
Dyspnea.
57.316 Hemovigilance 500 1 20/60
Adverse Reaction--
Transfusion Associated
Graft vs. Host Disease.
57.317 Hemovigilance 500 1 20/60
Adverse Reaction--
Transfusion Related Acute
Lung Injury.
57.318 Hemovigilance 500 2 20/60
Adverse Reaction--
Transfusion Associated
Circulatory Overload.
57.319 Hemovigilance 500 1 20/60
Adverse Reaction--Unknown
Transfusion Reaction.
57.320 Hemovigilance 500 1 20/60
Adverse Reaction--Other
Transfusion Reaction.
57.400 Outpatient Procedure 700 1 10/60
Component--Annual Facility
Survey.
57.401 Outpatient Procedure 700 12 15/60
Component--Monthly
Reporting Plan.
57.402 Outpatient Procedure 200 1 40/60
Component Same Day Outcome
Measures.
57.403 Outpatient Procedure 200 400 40/60
Component--Monthly
Denominators for Same Day
Outcome Measures.
57.404 Outpatient Procedure 700 100 40/60
Component--SSI Denominator.
57.405 Outpatient Procedure 700 5 40/60
Component--Surgical Site
(SSI) Event.
57.500 Outpatient Dialysis 7,100 1 127/60
Center Practices Survey.
57.501 Dialysis Monthly 7,100 12 5/60
Reporting Plan.
57.502 Dialysis Event...... 7,100 30 25/60
57.503 Denominator for 7,100 12 10/60
Outpatient Dialysis.
57.504 Prevention Process 1,760 12 75/60
Measures Monthly
Monitoring for Dialysis.
57.505 Dialysis Patient 860 60 10/60
Influenza Vaccination.
57.506 Dialysis Patient 860 1 5/60
Influenza Vaccination
Denominator.
57.507 Home Dialysis Center 430 1 30/60
Practices Survey.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-21753 Filed 10-4-19; 8:45 am]
BILLING CODE 4163-18-P
