Proposed Data Collection Submitted for Public Comment and Recommendations, 22074-22077 [2018-10094]
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22074
Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
EDN data entry staff at state and local health
departments.
The EDN Tuberculosis Follow-up Worksheet
for Newly-Arrived Persons With Overseas
Tuberculosis Classifications.
Jeffrey Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–10064 Filed 5–10–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–0666; Docket No. CDC–2018–
0042]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled National Healthcare Safety
Network (NHSN). NHSN is a public
health surveillance system that collects,
analyzes, reports, and makes available
data for monitoring, measuring, and
responding to healthcare associated
infections (HAIs), antimicrobial use and
resistance, blood transfusion safety
events, and the extent to which
healthcare facilities adhere to infection
prevention practices and antimicrobial
stewardship.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
CDC must receive written
comments on or before July 10, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0042 by any of the following methods:
DATES:
VerDate Sep<11>2014
19:21 May 10, 2018
Jkt 244001
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy A.
Richardson, Information Collection
Review Office, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS–D74, Atlanta, Georgia
30329; phone: 404–639–7570; Email:
omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. 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;
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
550
48
Average
burden per
response
(in hours)
30/60
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. 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 submissions
of responses.
5. Assess information collection costs.
Proposed Project
National Healthcare Safety Network
(NHSN)—Revision—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
NHSN is a public health surveillance
system that collects, analyzes, reports,
and makes available data for
monitoring, measuring, and responding
to healthcare associated infections
(HAIs), antimicrobial use and resistance,
blood transfusion safety events, and the
extent to which healthcare facilities
adhere to infection prevention practices
and antimicrobial stewardship. The data
collected will be used to inform and
detect changes in the epidemiology of
adverse events resulting from new and
current medical therapies and changing
risks. NHSN is comprised of six
components: Patient Safety, Healthcare
Personnel Safety, Biovigilance, LongTerm Care Facility, Outpatient
Procedure, and Dialysis.
Changes were made to 33 data
collection facility surveys with this new
ICR. CDC revised three annual facility
surveys for the Patient Safety
component for Hospitals, Long-Term
Acute Care Facilities, and Inpatient
Rehabilitation Facilities. CDC’s
revisions clarify the reporting
requirements for the data collected on
fungal testing, facility locations, and
laboratory testing locations.
Additionally, corresponding response
E:\FR\FM\11MYN1.SGM
11MYN1
22075
Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices
options for these questions have been
revised to include updated testing
methods used by facilities to capture
current HAI specific data specification
requirements for NHSN. New required
questions have been added to all Patient
Safety component surveys. The new
questions are designed to provide data
on surveillance processes, policies, and
standards that are used by reporting
facilities to ensure that when an event
is detected, the facility has the
appropriate mechanism to conduct
complete reporting. The Hospital
Annual Survey added new required
questions to provide data about neonatal
antimicrobial stewardship practices
because the focus of stewardship efforts
in neonatology differ from the focus in
adult and pediatric practice. Questions
were removed and replaced on all three
Patient Safety surveys to align better
with the Core Elements of Hospital
Antibiotic Stewardship Programs
specified by CDC. The Core Elements
defined by CDC are part of broad-based
efforts by CDC and its healthcare and
public health partners to combat the
threat of antibiotic-resistant bacteria.
The new Antibiotic Stewardship
Program questions will provide
additional data about operational
features of the programs that hospitals
have implemented, which in turn will
enable CDC and its healthcare and
public health partners to target their
efforts to help invigorate and extend
antibiotic stewardship.
CDC is introducing a new optional
survey form that is designed to be
completed by state and local health
departments that participate in HAI
surveillance and prevention activities.
This new form will provide data on
legal and regulatory requirements that
‘‘CDI treatment start’’ variable. Early CDI
reporting data from nursing homes has
shown exceptionally low event rates for
many reporting facilities (e.g., zero
events for six or more months). Since
current CDI event detection is based on
presence of a positive laboratory
specimen, variability in the use of
diagnostic testing as part of CDI
management will have direct impact on
the estimate of CDI burden in a facility
(e.g., empiric treatment for CDI without
confirmatory testing may result in the
appearance of low disease burden). In
order to determine whether low CDI
event rates might be due to empiric CDI
treatment practices, a new process
measure will be incorporated into the
monthly summary data on CDI for
LTCFs. This measure, called ‘‘CDI
treatment starts,’’ will allow providers
to capture the number of residents
started on antibiotic treatment for CDI
that month based on clinical decisions
(i.e., even those without a positive CDI
test). This process measure should
provide data on clinically-treated CDI in
order to inform our understanding of
CDI management practices and serve as
a proxy for CDI burden in nursing
homes.
Overall, minor revisions have been
made to a total of 33 forms within the
package to clarify and/or update
surveillance definitions, increase or
decrease the number of reporting
facilities, and add new forms.
The previously approved NHSN
package included 72 individual
collection forms; the current revision
request includes a total of 73 forms. The
reporting burden will decrease by
109,745 hours, for a total of 5,393,725
hours.
are pertinent to HAI reporting. CDC
plans to include data the health
department survey in its annual
National and State HealthcareAssociated Infection Progress Report.
The report helps identify the progress in
HAI surveillance and prevention at the
state and national levels. Data about the
extent to which state health
departments have validated HAI data
that healthcare facilities in their
jurisdiction report to NHSN and the
extent of state and local health
department HAI reporting requirements
are important data for users of CDC’s
HAI Progress Report to consider when
they are reviewing and interpreting data
in the report.
NHSN now includes a ventilatorassociated event available for NICU
locations, which requires additional
denominator reporting, in which CDC
has provided an option to accommodate
facilities that are reporting requested
data by updating the corresponding
surveys. The Pediatric VentilatorAssociated Event (PedVAE) was
removed from the survey because a
single algorithm is used to detect
PedVAE events.
NHSN has made updates to the
Antimicrobial Use and Resistance
(AUR) data collection tools for the
purposes of monitoring additional
microorganisms and their antimicrobial
susceptibility profiles. Use of these
updates in AUR surveillance will
provide important additional data for
clinical and public health responses to
mounting antibiotic resistance
problems.
The Long-term Care Facility
Component (LTCF) will be updating
three forms, two of which will include
an update for facilities to document the
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Healthcare facility ...........
sradovich on DSK3GMQ082PROD with NOTICES
Type of respondents
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) ...
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).
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Frm 00079
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
2,000
2,000
6,000
1
1
1
5/60
10/60
1.17
167
333
7,500
1,000
6,000
6,000
1,800
6,000
100
1
12
44
72
144
120
5/60
15/60
33/60
30/60
28/60
30/60
83
18,000
145,200
64,800
403,200
6,000
6,000
600
6,000
40
91
12
20/60
35/60
4
80,000
31,850
288,000
2,000
9
5.03
90,600
E:\FR\FM\11MYN1.SGM
11MYN1
22076
Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
sradovich on DSK3GMQ082PROD with NOTICES
Type of respondents
Number of
respondents
Form name
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.
57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction.
57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction.
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Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
6,000
60
5.03
1,812,000
6,000
6,000
55
36
540
1
35/60
10/60
45/60
126,000
540,000
41
1,000
12
5/60
1,000
2,000
12
5/60
2,000
100
100
25/60
4,167
6,000
6,000
72
24
30/60
15/60
216,000
36,000
6,000
240
20/60
480,000
50
2,600
250
1
25/60
2
5,208
5,200
2,600
12
20/60
10,400
2,600
12
20/60
10,400
2,600
14
35/60
18,200
2,600
2,600
2,600
12
12
12
5/60
4.17
5/60
2,600
130,000
2,600
400
1,000
50
1
1
1
1.17
1.17
8
467
1,167
400
19,500
1
5/60
1,625
50
200
20/60
3,333
50
50
50
30
1
15/60
2,500
375
50
50
50
50
15/60
10/60
625
417
500
1
1.42
708
500
12
1/60
100
500
12
1.17
7,000
500
200
10
1
10/60
35/60
833
117
500
4
20/60
667
500
4
20/60
667
500
1
20/60
167
500
2
20/60
333
E:\FR\FM\11MYN1.SGM
11MYN1
22077
Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents
Number of
respondents
Form name
57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion
Reaction.
57.312 Hemovigilance Adverse Reaction—Hypotensive Transfusion Reaction.
57.313 Hemovigilance Adverse Reaction—Infection.
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.
sradovich on DSK3GMQ082PROD with NOTICES
Total .................
.............................................................................
Average
burden per
response
(in hours)
Number of
responses per
respondent
500
4
20/60
667
500
1
20/60
167
500
1
20/60
167
500
1
20/60
167
500
1
20/60
167
500
1
20/60
167
500
1
20/60
167
500
2
20/60
333
500
1
20/60
167
500
1
20/60
167
5,000
1
10/60
417
5,000
12
20/60
15,000
1,200
25
40/60
20,000
1,200
12
40/60
9,600
5,000
540
10/60
450,000
5,000
36
35/60
105,000
7,000
1
2.12
14,817
7,000
7,000
7,000
12
60
12
5/60
25/60
10/60
7,000
175,000
14,000
2,000
12
1.42
17,000
325
75
10/60
4,063
325
5
10/60
271
350
1
30/60
175
........................
........................
........................
5,393,725
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–10094 Filed 5–10–18; 8:45 am]
BILLING CODE 4163–18–P
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Jkt 244001
PO 00000
Frm 00081
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Total burden
(in hours)
Sfmt 9990
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]]>Agencies
[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22074-22077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10094]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-18-0666; Docket No. CDC-2018-0042]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled National Healthcare Safety
Network (NHSN). NHSN is a public health surveillance system that
collects, analyzes, reports, and makes available data for monitoring,
measuring, and responding to healthcare associated infections (HAIs),
antimicrobial use and resistance, blood transfusion safety events, and
the extent to which healthcare facilities adhere to infection
prevention practices and antimicrobial stewardship.
DATES: CDC must receive written comments on or before July 10, 2018.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0042 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Leroy A. Richardson, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
[email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. 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
submissions of responses.
5. Assess information collection costs.
Proposed Project
National Healthcare Safety Network (NHSN)--Revision--National
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
NHSN is a public health surveillance system that collects,
analyzes, reports, and makes available data for monitoring, measuring,
and responding to healthcare associated infections (HAIs),
antimicrobial use and resistance, blood transfusion safety events, and
the extent to which healthcare facilities adhere to infection
prevention practices and antimicrobial stewardship. The data collected
will be used to inform and detect changes in the epidemiology of
adverse events resulting from new and current medical therapies and
changing risks. NHSN is comprised of six components: Patient Safety,
Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility,
Outpatient Procedure, and Dialysis.
Changes were made to 33 data collection facility surveys with this
new ICR. CDC revised three annual facility surveys for the Patient
Safety component for Hospitals, Long-Term Acute Care Facilities, and
Inpatient Rehabilitation Facilities. CDC's revisions clarify the
reporting requirements for the data collected on fungal testing,
facility locations, and laboratory testing locations. Additionally,
corresponding response
[[Page 22075]]
options for these questions have been revised to include updated
testing methods used by facilities to capture current HAI specific data
specification requirements for NHSN. New required questions have been
added to all Patient Safety component surveys. The new questions are
designed to provide data on surveillance processes, policies, and
standards that are used by reporting facilities to ensure that when an
event is detected, the facility has the appropriate mechanism to
conduct complete reporting. The Hospital Annual Survey added new
required questions to provide data about neonatal antimicrobial
stewardship practices because the focus of stewardship efforts in
neonatology differ from the focus in adult and pediatric practice.
Questions were removed and replaced on all three Patient Safety surveys
to align better with the Core Elements of Hospital Antibiotic
Stewardship Programs specified by CDC. The Core Elements defined by CDC
are part of broad-based efforts by CDC and its healthcare and public
health partners to combat the threat of antibiotic-resistant bacteria.
The new Antibiotic Stewardship Program questions will provide
additional data about operational features of the programs that
hospitals have implemented, which in turn will enable CDC and its
healthcare and public health partners to target their efforts to help
invigorate and extend antibiotic stewardship.
CDC is introducing a new optional survey form that is designed to
be completed by state and local health departments that participate in
HAI surveillance and prevention activities. This new form will provide
data on legal and regulatory requirements that are pertinent to HAI
reporting. CDC plans to include data the health department survey in
its annual National and State Healthcare-Associated Infection Progress
Report. The report helps identify the progress in HAI surveillance and
prevention at the state and national levels. Data about the extent to
which state health departments have validated HAI data that healthcare
facilities in their jurisdiction report to NHSN and the extent of state
and local health department HAI reporting requirements are important
data for users of CDC's HAI Progress Report to consider when they are
reviewing and interpreting data in the report.
NHSN now includes a ventilator-associated event available for NICU
locations, which requires additional denominator reporting, in which
CDC has provided an option to accommodate facilities that are reporting
requested data by updating the corresponding surveys. The Pediatric
Ventilator-Associated Event (PedVAE) was removed from the survey
because a single algorithm is used to detect PedVAE events.
NHSN has made updates to the Antimicrobial Use and Resistance (AUR)
data collection tools for the purposes of monitoring additional
microorganisms and their antimicrobial susceptibility profiles. Use of
these updates in AUR surveillance will provide important additional
data for clinical and public health responses to mounting antibiotic
resistance problems.
The Long-term Care Facility Component (LTCF) will be updating three
forms, two of which will include an update for facilities to document
the ``CDI treatment start'' variable. Early CDI reporting data from
nursing homes has shown exceptionally low event rates for many
reporting facilities (e.g., zero events for six or more months). Since
current CDI event detection is based on presence of a positive
laboratory specimen, variability in the use of diagnostic testing as
part of CDI management will have direct impact on the estimate of CDI
burden in a facility (e.g., empiric treatment for CDI without
confirmatory testing may result in the appearance of low disease
burden). In order to determine whether low CDI event rates might be due
to empiric CDI treatment practices, a new process measure will be
incorporated into the monthly summary data on CDI for LTCFs. This
measure, called ``CDI treatment starts,'' will allow providers to
capture the number of residents started on antibiotic treatment for CDI
that month based on clinical decisions (i.e., even those without a
positive CDI test). This process measure should provide data on
clinically-treated CDI in order to inform our understanding of CDI
management practices and serve as a proxy for CDI burden in nursing
homes.
Overall, minor revisions have been made to a total of 33 forms
within the package to clarify and/or update surveillance definitions,
increase or decrease the number of reporting facilities, and add new
forms.
The previously approved NHSN package included 72 individual
collection forms; the current revision request includes a total of 73
forms. The reporting burden will decrease by 109,745 hours, for a total
of 5,393,725 hours.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Healthcare facility............................. 57.100 NHSN Registration Form......... 2,000 1 5/60 167
57.101 Facility Contact Information... 2,000 1 10/60 333
57.103 Patient Safety Component-- 6,000 1 1.17 7,500
Annual Hospital Survey.
57.105 Group Contact Information...... 1,000 1 5/60 83
57.106 Patient Safety Monthly 6,000 12 15/60 18,000
Reporting Plan.
57.108 Primary Bloodstream Infection 6,000 44 33/60 145,200
(BSI).
57.111 Pneumonia (PNEU)............... 1,800 72 30/60 64,800
57.112 Ventilator-Associated Event.... 6,000 144 28/60 403,200
57.113 Pediatric Ventilator-Associated 100 120 30/60 6,000
Event (PedVAE).
57.114 Urinary Tract Infection (UTI).. 6,000 40 20/60 80,000
57.115 Custom Event................... 600 91 35/60 31,850
57.116 Denominators for Neonatal 6,000 12 4 288,000
Intensive Care Unit (NICU).
57.117 Denominators for Specialty Care 2,000 9 5.03 90,600
Area (SCA)/Oncology (ONC).
[[Page 22076]]
57.118 Denominators for Intensive Care 6,000 60 5.03 1,812,000
Unit (ICU)/Other locations (not NICU
or SCA).
57.120 Surgical Site Infection (SSI).. 6,000 36 35/60 126,000
57.121 Denominator for Procedure...... 6,000 540 10/60 540,000
57.122 HAI Progress Report State 55 1 45/60 41
Health Department Survey.
57.123 Antimicrobial Use and 1,000 12 5/60 1,000
Resistance (AUR)-Microbiology Data
Electronic Upload Specification
Tables.
57.124 Antimicrobial Use and 2,000 12 5/60 2,000
Resistance (AUR)-Pharmacy Data
Electronic Upload Specification
Tables.
57.125 Central Line Insertion 100 100 25/60 4,167
Practices Adherence Monitoring.
57.126 MDRO or CDI Infection Form..... 6,000 72 30/60 216,000
57.127 MDRO and CDI Prevention Process 6,000 24 15/60 36,000
and Outcome Measures Monthly
Monitoring.
57.128 Laboratory-identified MDRO or 6,000 240 20/60 480,000
CDI Event.
57.129 Adult Sepsis................... 50 250 25/60 5,208
57.137 Long-Term Care Facility 2,600 1 2 5,200
Component--Annual.
Facility Survey:
57.138 Laboratory-identified MDRO 2,600 12 20/60 10,400
or CDI Event for LTCF.
57.139 MDRO and CDI Prevention 2,600 12 20/60 10,400
Process Measures Monthly
Monitoring for LTCF.
57.140 Urinary Tract Infection 2,600 14 35/60 18,200
(UTI) for LTCF.
57.141 Monthly Reporting Plan for 2,600 12 5/60 2,600
LTCF.
57.142 Denominators for LTCF 2,600 12 4.17 130,000
Locations.
57.143 Prevention Process Measures 2,600 12 5/60 2,600
Monthly Monitoring for LTCF.
57.150 LTAC Annual Survey.......... 400 1 1.17 467
57.151 Rehab Annual Survey......... 1,000 1 1.17 1,167
57.200 Healthcare Personnel Safety 50 1 8 400
Component Annual Facility Survey.
57.203 Healthcare Personnel Safety 19,500 1 5/60 1,625
Monthly Reporting Plan.
57.204 Healthcare Worker 50 200 20/60 3,333
Demographic Data.
57.205 Exposure to Blood/Body 50 50 1 2,500
Fluids.
57.206 Healthcare Worker 50 30 15/60 375
Prophylaxis/Treatment.
57.207 Follow-Up Laboratory Testing 50 50 15/60 625
57.210 Healthcare Worker 50 50 10/60 417
Prophylaxis/Treatment-Influenza.
57.300 Hemovigilance Module Annual 500 1 1.42 708
Survey.
57.301 Hemovigilance Module Monthly 500 12 1/60 100
Reporting Plan.
57.303 Hemovigilance Module Monthly 500 12 1.17 7,000
Reporting Denominators.
57.305 Hemovigilance Incident...... 500 10 10/60 833
57.306 Hemovigilance Module Annual 200 1 35/60 117
Survey--Non-acute care facility.
57.307 Hemovigilance Adverse 500 4 20/60 667
Reaction--Acute Hemolytic
Transfusion Reaction.
57.308 Hemovigilance Adverse 500 4 20/60 667
Reaction--Allergic Transfusion
Reaction.
57.309 Hemovigilance Adverse 500 1 20/60 167
Reaction--Delayed Hemolytic
Transfusion Reaction.
57.310 Hemovigilance Adverse 500 2 20/60 333
Reaction--Delayed Serologic
Transfusion Reaction.
[[Page 22077]]
57.311 Hemovigilance Adverse 500 4 20/60 667
Reaction--Febrile Non-hemolytic
Transfusion Reaction.
57.312 Hemovigilance Adverse 500 1 20/60 167
Reaction--Hypotensive Transfusion
Reaction.
57.313 Hemovigilance Adverse 500 1 20/60 167
Reaction--Infection.
57.314 Hemovigilance Adverse 500 1 20/60 167
Reaction--Post Transfusion Purpura.
57.315 Hemovigilance Adverse 500 1 20/60 167
Reaction--Transfusion Associated
Dyspnea.
57.316 Hemovigilance Adverse 500 1 20/60 167
Reaction--Transfusion Associated
Graft vs. Host Disease.
57.317 Hemovigilance Adverse 500 1 20/60 167
Reaction--Transfusion Related
Acute Lung Injury.
57.318 Hemovigilance Adverse 500 2 20/60 333
Reaction--Transfusion Associated
Circulatory Overload.
57.319 Hemovigilance Adverse 500 1 20/60 167
Reaction--Unknown Transfusion
Reaction.
57.320 Hemovigilance Adverse 500 1 20/60 167
Reaction--Other Transfusion
Reaction.
57.400 Outpatient Procedure 5,000 1 10/60 417
Component--Annual Facility Survey.
57.401 Outpatient Procedure 5,000 12 20/60 15,000
Component--Monthly Reporting Plan.
57.402 Outpatient Procedure 1,200 25 40/60 20,000
Component Same Day Outcome
Measures.
57.403 Outpatient Procedure 1,200 12 40/60 9,600
Component--Monthly Denominators
for Same Day Outcome Measures.
57.404 Outpatient Procedure 5,000 540 10/60 450,000
Component--SSI Denominator.
57.405 Outpatient Procedure 5,000 36 35/60 105,000
Component--Surgical Site (SSI)
Event.
57.500 Outpatient Dialysis Center 7,000 1 2.12 14,817
Practices Survey.
57.501 Dialysis Monthly Reporting 7,000 12 5/60 7,000
Plan.
57.502 Dialysis Event.............. 7,000 60 25/60 175,000
57.503 Denominator for Outpatient 7,000 12 10/60 14,000
Dialysis.
57.504 Prevention Process Measures 2,000 12 1.42 17,000
Monthly Monitoring for Dialysis.
57.505 Dialysis Patient Influenza 325 75 10/60 4,063
Vaccination.
57.506 Dialysis Patient Influenza 325 5 10/60 271
Vaccination Denominator.
57.507 Home Dialysis Center 350 1 30/60 175
Practices Survey.
---------------
Total................................... ...................................... .............. .............. .............. 5,393,725
--------------------------------------------------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of
Scientific Integrity, Office of the Associate Director for Science,
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-10094 Filed 5-10-18; 8:45 am]
BILLING CODE 4163-18-P
