Agency Forms Undergoing Paperwork Reduction Act Review

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Published

November 15, 2023

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Health and Human Services DepartmentCenters for Disease Control and Prevention

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<title>Federal Register, Volume 88 Issue 219 (Wednesday, November 15, 2023)</title>
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[Federal Register Volume 88, Number 219 (Wednesday, November 15, 2023)]
[Notices]
[Pages 78364-78367]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-25156]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-24-0666]

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 August 21, 2023 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. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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) (OMB Control No. 0920-
0666, Exp. 6/30/2026)--Revision--National Center for Emerging and
Zoonotic Infectious 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 HAI prevention practice methods such as
healthcare personnel influenza vaccine status and corresponding
infection control adherence rates.
Enrollment in NHSN has continuously increased, with over 37,000
actively reporting healthcare facilities across the U.S. Of the total
enrolled healthcare facilities, there are over 6,000 acute care
facilities; 8,400 dialysis facilities; 600 long-term acute care
facilities; 400 inpatient rehabilitation facilities; 800 inpatient
psychiatric facilities; nearly 20,000 long-term care facilities; and
6,000 ambulatory surgery facilities. NHSN currently has eight
components: Patient Safety (PS), Healthcare Personnel Safety (HPS),
Biovigilance (BV), Long-Term Care Facility (LTCF), Outpatient Procedure
(OPC), Dialysis Component, Neonatal Component, and Medication Safety
Component.
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 (LTCF), 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.

[[Page 78365]]

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).
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 Neonatal Component includes one module, Late-Onset Sepsis/
Meningitis (LOS/MEN). This module will track late-onset sepsis and
meningitis events in very low birthweight neonates housed in Level II/
III, Level III, and Level IV nursery locations.
The Medication Safety Component tracks medication safety and
adverse drug events (ADEs) that are among the most common causes of
iatrogenic harm in U.S. hospitals.
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's 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. The proposed
changes in this new ICR include revisions to 23 existing data
collection forms and nine new forms. In this Revision, CDC requests OMB
approval for an estimated annual burden 1,784,296 hours.

Estimated Annualized Burden Hours
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Number of Avg. burden
Form number and name Number of responses per per response
respondents respondent (min./hour 60)
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57.100 NHSN Registration Form................................... 2,000 1 5/60
57.101 Facility Contact Information............................. 2,000 1 10/60
57.103 Patient Safety Component--Annual Hospital Survey......... 5,311 1 135/60
57.104 NHSN Facility Administrator Change Request Form.......... 800 1 5/60
57.105 Group Contact Information................................ 1,000 1 5/60
57.106 Patient Safety Monthly Reporting Plan.................... 7,821 12 15/60
57.108 Primary Bloodstream Infection (BSI)...................... 5,775 5 39/60
57.111 Pneumonia (PNEU)......................................... 1,800 2 31/60
57.112 Ventilator-Associated Event.............................. 5463 8 29/60
57.113 Pediatric Ventilator-Associated Event (PedVAE)........... 334 1 31/60
57.114 Urinary Tract Infection (UTI)............................ 6000 5 21/60
57.115 Custom Event............................................. 600 91 36/60
57.116 Denominators for Neonatal Intensive Care Unit (NICU)..... 1,100 12 4/60
57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC) 500 12 5/60
57.118 Denominators for Intensive Care Unit (ICU)/Other 5500 60 5/60
locations (not NICU or SCA)....................................
57.120 Surgical Site Infection (SSI)............................ 3,800 12 36/60
57.121 Denominator for Procedure................................ 3,800 12 10/60
57.122 HAI Progress Report State Health Department Survey....... 55 1 28/60
57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data 5,500 12 5/60
Electronic Upload Specification Tables.........................
57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy Data 5,500 12 5/60
Electronic Upload Specification Tables.........................
57.125 Central Line Insertion Practices Adherence Monitoring.... 500 213 26/60
57.126 MDRO or CDI Infection Form............................... 720 11 31/60
57.127 MDRO and CDI Prevention Process and Outcome Measures 5,500 29 15/60
Monthly Monitoring.............................................
57.128 Laboratory-identified MDRO or CDI Event.................. 4800 79 21/60

[[Page 78366]]

57.129 Adult Sepsis............................................. 50 250 25/60
57.135 Late Onset Sepsis/Meningitis Denominator Form: Late Onset 300 6 5/60
Sepsis/Meningitis Denominator Form: Data Table for monthly
electronic upload..............................................
57.136 Late Onset Sepsis/Meningitis Event Form: Data Table for 300 6 5/60
Monthly Electronic Upload......................................
57.137 Long-Term Care Facility Component--Annual Facility Survey 17,700 1 120/60
57.138 Laboratory-identified MDRO or CDI Event for LTCF......... 1,086 24 20/60
57.139 MDRO and CDI Prevention Process Measures Monthly 1,019 12 20/60
Monitoring for LTCF............................................
57.140 Urinary Tract Infection (UTI) for LTCF................... 339 36 35/60
57.141 Monthly Reporting Plan for LTCF.......................... 1,099 12 15/60
57.142 Denominators for LTCF Locations.......................... 714 12 35/60
57.143 Prevention Process Measures Monthly Monitoring for LTCF.. 357 12 5/60
57.149 Weekly Healthcare Personnel Influenza Vaccination 125 52 60/60
Cumulative Summary for Long-Term Care Facilities...............
57.150 LTAC Annual Survey....................................... 392 1 89/60
57.151 Rehab Annual Survey...................................... 1,160 1 89/60
57.200 Healthcare Personnel Safety Component Annual Facility 50 1 480/60
Survey.........................................................
57.204 Healthcare Worker Demographic Data....................... 50 200 20/60
57.205 Exposure to Blood/Body Fluids............................ 50 50 60/60
57.206 Healthcare Worker Prophylaxis/Treatment.................. 50 30 15/60
57.207 Follow-Up Laboratory Testing............................. 50 50 15/60
57.210 Healthcare Worker Prophylaxis/Treatment-Influenza........ 50 50 10/60
57.211 Weekly Healthcare Personnel Influenza Vaccination 125 52 60/60
Cumulative Summary for Non-Long-Term Care Facilities...........
57.214 Annual Healthcare Personnel Influenza Vaccination Summary 5,000 1 120/60
57.218 Weekly Resident Influenza Vaccination Cumulative Summary 2,500 52 60/60
for Long-Term Care Facilities..................................
57.300 Hemovigilance Module Annual Survey....................... 500 1 86/60
57.301 Hemovigilance Module Monthly Reporting Plan.............. 500 12 60/60
57.303 Hemovigilance Module Monthly Reporting Denominators...... 500 12 77/60
57.305 Hemovigilance Incident................................... 500 10 10/60
57.306 Hemovigilance Module Annual Survey--Non-acute care 500 1 36/60
facility.......................................................
57.307 Hemovigilance Adverse Reaction--Acute Hemolytic 500 4 21/60
Transfusion Reaction...........................................
57.308 Hemovigilance Adverse Reaction--Allergic Transfusion 500 4 21/60
Reaction.......................................................
57.309 Hemovigilance Adverse Reaction--Delayed Hemolytic 500 1 21/60
Transfusion Reaction...........................................
57.310 Hemovigilance Adverse Reaction--Delayed Serologic 500 2 21/60
Transfusion Reaction...........................................
57.311 Hemovigilance Adverse Reaction--Febrile Non-hemolytic 500 4 21/60
Transfusion Reaction...........................................
57.312 Hemovigilance Adverse Reaction--Hypotensive Transfusion 500 1 21/60
Reaction.......................................................
57.313 Hemovigilance Adverse Reaction--Infection................ 500 1 21/60
57.314 Hemovigilance Adverse Reaction--Post Transfusion Purpura. 500 1 21/60
57.315 Hemovigilance Adverse Reaction--Transfusion Associated 500 1 20/60
Dyspnea........................................................
57.316 Hemovigilance Adverse Reaction--Transfusion Associated 500 1 21/60
Graft vs. Host Disease.........................................
57.317 Hemovigilance Adverse Reaction--Transfusion Related Acute 500 1 21/60
Lung Injury....................................................
57.318 Hemovigilance Adverse Reaction--Transfusion Associated 500 2 21/60
Circulatory Overload...........................................
57.319 Hemovigilance Adverse Reaction--Unknown Transfusion 500 1 21/60
Reaction.......................................................
57.320 Hemovigilance Adverse Reaction--Other Transfusion 500 1 21/60
Reaction.......................................................
57.400 Outpatient Procedure Component--Annual Facility Survey... 350 1 10/60
57.401 Outpatient Procedure Component--Monthly Reporting Plan... 350 12 15/60
57.402 Outpatient Procedure Component Same Day Outcome Measures. 50 1 40/60
57.403 Outpatient Procedure Component--Monthly Denominators for 50 400 40/60
Same Day Outcome Measures......................................
57.404 Outpatient Procedure Component--SSI Denominator.......... 300 100 10/60
57.405 Outpatient Procedure Component--Surgical Site (SSI) Event 300 36 35/60
57.408 Monthly Survey Patient Days & Nurse Staffing............. 2500 12 60/60
57.500 Outpatient Dialysis Center Practices Survey.............. 7400 1 12/60
57.501 Dialysis Monthly Reporting Plan.......................... 7400 12 5/60
57.502 Dialysis Event........................................... 7400 12 15/60
57.503 Denominator for Outpatient Dialysis...................... 7400 24 10/60
57.504 Prevention Process Measures Monthly Monitoring for 1730 12 75/60
Dialysis.......................................................
57.505 Dialysis Patient Influenza Vaccination................... 615 50 10/60
57.506 Dialysis Patient Influenza Vaccination Denominator....... 615 5 10/60
57.507 Home Dialysis Center Practices Survey.................... 450 1 36/60
57.130 New Form--Patient Safety Component FHIR Measure 5,500 1 1620/60
Respiratory Pathogens Surveillance (RPS)-IT Initial Set up.....
57.130 New Form--Patient Safety Component FHIR Measure 5,500 1 1200/60
Respiratory Pathogens Surveillance (RPS)-IT Yearly Maintenance.
57.130 New Form--Patient Safety Component FHIR Measure 5,500 1 6/60
Respiratory Pathogens Surveillance (RPS)-Infection
Preventionist..................................................
57.130 New Form--Patient Safety Component CSV Data Collection- 5500 365 2/60
Infection Preventionist CSV Data Collection-Infection
Preventionist..................................................
57.132 New Form--Patient Safety Component FHIR Measures-HOB, HT- 5500 1 1620/60
CDI Modules-IT Initial Set up..................................

[[Page 78367]]

57.132 New Form--Patient Safety Component FHIR Measures-HOB, HT- 5500 1 1200/60
CDI Modules-IT Yearly Maintenance..............................
57.132 New Form--Patient Safety Component FHIR Measures-HOB, HT- 5500 6 6/60
CDI Modules-Infection Preventionist............................
57.133 New Form--Patient Safety Component FHIR Measures-VTE 5500 1 1620/60
Module-IT Initial Set up.......................................
57.133 New Form--Patient Safety Component FHIR Measures-VTE 5500 1 1200/60
Module-IT Yearly Maintenance...................................
57.133 New Form--Patient Safety Component FHIR Measures-VTE 5500 6 6/60
Module- Infection Preventionist................................
57.600 New Form--Neonatal Component FHIR Measure-Late Onset 5500 1 1620/60
Sepsis Meningitis (LOSMEN) Module-IT Initial Set up............
57.600 New Form--Neonatal Component FHIR Measure-Late Onset 5500 1 1200/60
Sepsis Meningitis (LOSMEN) Module-IT Yearly Maintenance........
57.600 New Form--Neonatal Component FHIR Measure-Late Onset 5500 6 6/60
Sepsis Meningitis (LOSMEN) Module-Infection Preventionist......
57.600 New Form--Neonatal Component Late Onset Sepsis Meningitis 5500 12 2/60
(LOSMEN) Module CDA Data Collection-Infection Preventionist....
57.700 New Form--Medication Safety Component FHIR Measure- 5500 1 1620/60
Glycemic Control Module Hypoglycemia-IT Initial Set up.........
57.700 New Form--Medication Safety Component FHIR Measure- 5500 1 1200/60
Glycemic Control Module Hypoglycemia-IT Yearly Maintenance.....
57.700 New Form--Medication Safety Component FHIR Measure- 5500 6 6/60
Glycemic Control Module Hypoglycemia-Infection Preventionist...
57.701 New Form--Glycemic Control Module-HYPO Annual Survey..... 10 1 120/60
57.144 New Form--Long Term Care Respiratory Tract Infections 16,500 24 25/60
(RTI) Module...................................................
57.145 New Form--Long Term Care Antimicrobial Use (LTC-AU) 16,500 12 5/60
Module CDA.....................................................
New Form--Billing Code Data: 837I Upload........................ 5500 4 5/60
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2023-25156 Filed 11-14-23; 8:45 am]
BILLING CODE 4163-18-P

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