[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46490-46493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19902]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-0666]
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 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 May 11, 2018 to obtain comments
from the public and affected agencies. CDC received one comment 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 (0920-0666, Expiration Date 1/
31/2021)--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. Specifically,
resulting data estimates the magnitude of Healthcare Associated
Infections (HAI), monitor HAI trends, and facilitate inter-facility and
intra-facility comparisons with risk-adjusted data used for local
quality improvement activities. The data will be used to detect changes
in the epidemiology of adverse events resulting from new and current
medical therapies and changing risks. The NHSN currently consists of
six components: Patient Safety, Healthcare Personnel Safety,
Biovigilance, Long-Term Care Facility (LTCF), Outpatient Procedure
Component, and Dialysis.
Changes were made to 34 data collection facility surveys with this
revision 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 46491]]
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 34 forms
within the package to clarify and/or update surveillance definitions,
increase or decrease the number of reporting facilities, and add new
forms.
Finally, NHSN has achieved significant burden reduction with this
ICR due to a decrease in the number of respondents for the Specialty
Care Area (SCA) and Oncology (ONC) facilities reporting to NHSN. NHSN
re-evaluated these reporting facilities and determined that
approximately 2,000 SCA and ONC facilities are reporting to NHSN
compared to the estimated 6,000 that was estimated last year.
Additionally, NHSN streamlined many response options, which also
attributed to a reduction in the overall burden.
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
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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Healthcare facility................ 57.100 NHSN Registration 2,000 1 5/60
Form.
57.101 Facility Contact 2,000 1 10/60
Information.
57.103 Patient Safety 6,000 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 6,000 44 33/60
Infection (BSI).
57.111 Pneumonia (PNEU).... 1,800 72 30/60
57.112 Ventilator- 6,000 144 28/60
Associated Event.
57.113 Pediatric Ventilator- 100 120 30/60
Associated Event (PedVAE).
57.114 Urinary Tract 6,000 40 20/60
Infection (UTI).
57.115 Custom Event........ 600 91 35/60
57.116 Denominators for 6,000 12 4
Neonatal Intensive Care
Unit (NICU).
[[Page 46492]]
57.117 Denominators for 2,000 9 302/60
Specialty Care Area (SCA)/
Oncology (ONC).
57.118 Denominators for 6,000 60 302/60
Intensive Care Unit (ICU)/
Other locations (not NICU
or SCA).
57.120 Surgical Site 6,000 36 35/60
Infection (SSI).
57.121 Denominator for 6,000 540 10/60
Procedure.
57.122 HAI Progress Report 55 1 45/60
State Health Department
Survey.
57.123 Antimicrobial Use 1,000 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 100 100 25/60
Insertion Practices
Adherence Monitoring.
57.126 MDRO or CDI 6,000 72 30/60
Infection Form.
57.127 MDRO and CDI 6,000 24 15/60
Prevention Process and
Outcome Measures Monthly
Monitoring.
57.128 Laboratory- 6,000 240 20/60
identified MDRO or CDI
Event.
57.129 Adult Sepsis........ 50 250 25/60
57.137 Long-Term Care 2,600 1 2
Facility Component--Annual
Facility Survey.
57.138 Laboratory- 2,600 12 20/60
identified MDRO or CDI
Event for LTCF.
57.139 MDRO and CDI 2,600 12 20/60
Prevention Process
Measures Monthly
Monitoring for LTCF.
57.140 Urinary Tract 2,600 14 35/60
Infection (UTI) for LTCF.
57.141 Monthly Reporting 2,600 12 5/60
Plan for LTCF.
57.142 Denominators for 2,600 12 250/60
LTCF Locations.
57.143 Prevention Process 2,600 12 5/60
Measures Monthly
Monitoring for LTCF.
57.150 LTAC Annual Survey.. 400 1 70/60
57.151 Rehab Annual Survey. 1,000 1 70/60
57.200 Healthcare Personnel 50 1 8
Safety Component Annual
Facility Survey.
57.203 Healthcare Personnel 19,500 1 5/60
Safety Monthly Reporting
Plan.
57.204 Healthcare Worker 50 200 20/60
Demographic Data.
57.205 Exposure to Blood/ 50 50 1
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 200 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.
57.309 Hemovigilance 500 1 20/60
Adverse 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.
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.
[[Page 46493]]
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 5,000 1 10/60
Component--Annual Facility
Survey.
57.401 Outpatient Procedure 5,000 12 20/60
Component--Monthly
Reporting Plan.
57.402 Outpatient Procedure 1,200 25 40/60
Component Same Day Outcome
Measures.
57.403 Outpatient Procedure 1,200 12 40/60
Component--Monthly
Denominators for Same Day
Outcome Measures.
57.404 Outpatient Procedure 5,000 540 10/60
Component--SSI Denominator.
57.405 Outpatient Procedure 5,000 36 35/60
Component--Surgical Site
(SSI) Event.
57.500 Outpatient Dialysis 7,000 1 127/60
Center Practices Survey.
57.501 Dialysis Monthly 7,000 12 5/60
Reporting Plan.
57.502 Dialysis Event...... 7,000 60 25/60
57.503 Denominator for 7,000 12 10/60
Outpatient Dialysis.
57.504 Prevention Process 2,000 12 85/60
Measures Monthly
Monitoring for Dialysis.
57.505 Dialysis Patient 325 75 10/60
Influenza Vaccination.
57.506 Dialysis Patient 325 5 10/60
Influenza Vaccination
Denominator.
57.507 Home Dialysis Center 350 1 30/60
Practices Survey.
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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. 2018-19902 Filed 9-12-18; 8:45 am]
BILLING CODE 4163-18-P