[Federal Register Volume 89, Number 79 (Tuesday, April 23, 2024)]
[Notices]
[Pages 30367-30370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08597]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-24-0666; Docket No. CDC-2024-0030]
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.
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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 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.
DATES: CDC must receive written comments on or before June 24, 2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0030 by either of the following methods:
Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (www.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 Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 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;
[[Page 30368]]
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; and
5. Assess information collection costs.
Proposed Project
National Healthcare Safety Network (NHSN) (OMB Control No. 0920-
0666, Exp. 12/31/2026)--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. 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 eight components:
Patient Safety (PS), Healthcare Personnel Safety (HPS), Biovigilance
(BV), Long-Term Care Facility (LTCF), Outpatient Procedure (OPC),
Dialysis, Neonatal, 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, 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 Respiratory Tract
Infection Form (RTI)--will not to be used by NHSN users, but as part of
an EIP project with four EIP sites. The Form is titled Denominators for
Healthcare Associated Infections (HAIs): Respiratory Tract Infections.
The purpose of this form is to allow testing prior to introducing a new
module and forms to NHSN users. The CDC's Epidemiology Research &
Innovations Branch (ERIB) team will use the form to perform field
testing of variables to explore the utilization, applicability, and
data collection burden associated with these variables. This process
will inform areas of improvement prior to incorporating the new module,
including protocol, forms, and instructions into NHSN. The Dialysis
Component offers a simplified user interface for dialysis users to
streamline their data entry and analysis 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). The Neonatal Component
focuses on premature neonates and the healthcare associated events that
occur because of their prematurity. This component currently has one
module, which includes Late Onset-Sepsis and Meningitis. The Medication
Safety Component tracks medication safety and adverse drug events 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 July 2023, 37 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 U.S. 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
[[Page 30369]]
National Nursing Home Quality Collaborative, which focuses on
recruiting nursing homes to report HAI data to NHSN and to retain their
continued participation.
The ICR was previously approved in March 2024 for 2,433,165 burden
hours. The proposed changes in this new ICR include revisions to 80
existing data collection forms and three new forms. In this Revision,
CDC requests OMB approval for an estimated annual burden 3,635,534
hours.
Estimated Annualized Burden Hours
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Number of Avg. burden
Form number & name Number of responses per per response Total burden
respondents respondent (min./hour 60) (hours)
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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--Annual Hospital 5,400 1 137/60 12,330
Survey.........................................
57.104 NHSN Facility Administrator Change 800 1 5/60 67
Request Form...................................
57.105 Group Contact Information................ 1,000 1 5/60 83
57.106 Patient Safety Monthly Reporting Plan.... 7,821 12 15/60 23,463
57.108 Primary Bloodstream Infection (BSI)...... 6,000 12 30/60 36,000
57.111 Pneumonia (PNEU)......................... 1,800 2 29/60 1,740
57.112 Ventilator-Associated Event (VAE)........ 5,463 8 28/60 20,395
57.113 Pediatric Ventilator-Associated Event 334 1 31/60 173
(PedVAE).......................................
57.114 Urinary Tract Infection (UTI)............ 6,000 12 20/60 24,000
57.115 Custom Event............................. 600 91 35/60 31,850
57.116 Denominators for Neonatal Intensive Care 1,100 12 240/60 52,800
Unit (NICU)....................................
57.117 Denominators for Specialty Care Area 500 12 300/60 30,000
(SCA)/Oncology (ONC)...........................
57.118 Denominators for Intensive Care Unit 5,500 60 300/60 1,650,000
(ICU)/Other locations (not NICU or SCA)........
57.120 Surgical Site Infection (SSI)............ 3,800 12 11/60 8,360
57.121 Denominator for Procedure................ 3,800 12 11/60 8,360
57.122 HAI Progress Report State Health 55 1 50/60 46
Department Survey..............................
57.123 Antimicrobial Use and Resistance (AUR)-- 5,500 12 5/60 5,500
Microbiology Data Electronic Upload
Specification Tables...........................
57.124 Antimicrobial Use and Resistance (AUR)-- 5,500 12 5/60 5,500
Pharmacy Data Electronic Upload Specification
Tables.........................................
57.125 Central Line Insertion Practices 500 213 26/60 46,150
Adherence Monitoring...........................
57.126 MDRO or CDI Infection Form............... 720 12 30/60 4,320
57.127 MDRO and CDI Prevention Process and 5,500 29 15/60 39,875
Outcome Measures Monthly Monitoring............
57.128 Laboratory-identified MDRO or CDI Event.. 4,800 12 20/60 19,200
57.129 Adult Sepsis............................. 50 12 25/60 250
57.132 Patient Safety Component Digital Measure 5,500 1 1,620/60 148,500
Reporting Plan (HOB, HT-CDI, VTE, Adult Sepsis,
RPS, NVAP)--IT Initial Set up..................
57.132 Patient Safety Component Digital Measure 5,500 1 1,200/60 110,000
Reporting Plan (HOB, HT-CDI, VTE, Adult Sepsis,
RPS, NVAP)--IT Yearly Maintenance..............
57.132 Patient Safety Component Digital Measure 5,500 4 10/60 3,667
Reporting Plan (HOB, HT-CDI, VTE, Adult Sepsis,
RPS, NVAP)--Infection Preventionist............
57.132 Patient Safety Digital Reporting Plan 5,500 365 2/60 66,917
(RPS CSV)......................................
57.137 Long-Term Care Facility Component--Annual 6,270 1 128/60 13,376
Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event 286 24 20/60 2,288
for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures 738 12 10/60 1,476
Monthly Monitoring for LTCF....................
57.140 Urinary Tract Infection (UTI) for LTCF... 373 24 35/60 5,222
57.141 Monthly Reporting Plan for LTCF.......... 546 12 5/60 546
57.142 Denominators for LTCF Locations.......... 724 12 35/60 5,068
57.143 Prevention Process Measures Monthly 434 12 5/60 434
Monitoring for LTCF............................
57.144 Resident Respiratory Pathogens Even Form. 16,500 24 25/60 165,000
57.145 Long Term Care Antimicrobial Use (LTC-AU) 16,500 12 5/60 16,500
Module CDA.....................................
57.150 LTAC Annual Survey....................... 395 1 102/60 672
57.151 Rehab Annual Survey...................... 395 1 102/60 672
57.204 Healthcare Worker Demographic Data....... 50 200 20/60 3,333
57.211 Weekly Healthcare Personnel Influenza 8,000 8 60/60 64,000
Vaccination Cumulative Summary for Non-Long-
Term Care Facilities...........................
57.214 Annual Healthcare Personnel Influenza 22,000 1 120/60 44,000
Vaccination Summary............................
57.215 Seasonal Survey on Influenza Vaccination 15,426 1 45/60 11,570
Programs for Healthcare Personnel..............
57.300 Hemovigilance Module Annual Survey....... 63 1 85/60 89
57.301 Hemovigilance Module Monthly Reporting 108 12 1/60 22
Plan...........................................
57.302 Hemovigilance Module Monthly Incident 9 12 30/60 54
Summary........................................
57.303 Hemovigilance Module Monthly Reporting 102 12 70/60 1,428
Denominators...................................
57.305 Hemovigilance Incident................... 13 77 10/60 167
57.306 Hemovigilance Module Annual Survey--Non- 20 1 35/60 12
acute care facility............................
57.307 Hemovigilance Adverse Reaction--Acute 8 2 20/60 5
Hemolytic Transfusion Reaction.................
57.308 Hemovigilance Adverse Reaction--Allergic 50 11 20/60 183
Transfusion Reaction...........................
[[Page 30370]]
57.309 Hemovigilance Adverse Reaction--Delayed 9 2 20/60 6
Hemolytic Transfusion Reaction.................
57.310 Hemovigilance Adverse Reaction--Delayed 19 5 20/60 32
Serologic Transfusion Reaction.................
57.311 Hemovigilance Adverse Reaction--Febrile 85 13 20/60 368
Non-hemolytic Transfusion Reaction.............
57.312 Hemovigilance Adverse Reaction-- 23 3 20/60 23
Hypotensive Transfusion Reaction...............
57.313 Hemovigilance Adverse Reaction--Infection 2 2 20/60 1
57.314 Hemovigilance Adverse Reaction--Post 1 1 20/60 0.33
Transfusion Purpura............................
57.315 Hemovigilance Adverse Reaction-- 18 3 20/60 18
Transfusion Associated Dyspnea.................
57.316 Hemovigilance Adverse Reaction-- 1 1 20/60 0.33
Transfusion Associated Graft vs. Host Disease..
57.317 Hemovigilance Adverse Reaction-- 1 1 20/60 0.33
Transfusion Related Acute Lung Injury..........
57.318 Hemovigilance Adverse Reaction-- 40 4 21/60 56
Transfusion Associated Circulatory Overload....
57.319 Hemovigilance Adverse Reaction--Unknown 15 3 20/60 15
Transfusion Reaction...........................
57.320 Hemovigilance Adverse Reaction--Other 39 3 20/60 39
Transfusion Reaction...........................
57.400 Outpatient Procedure Component -- Annual 350 1 10/60 58
Ambulatory Surgery Center Survey...............
57.401 Outpatient Procedure Component--Monthly 350 12 10/60 700
Reporting Plan.................................
57.402 Outpatient Procedure Component Same Day 50 1 40/60 33
Outcome Measures...............................
57.403 Outpatient Procedure Component-- 50 400 20/60 6,667
Denominators for Same Day Outcome Measures.....
57.404 Outpatient Procedure Component--SSI 300 100 20/60 10,000
Denominator....................................
57.405 Outpatient Procedure Component--Surgical 300 36 40/60 7,200
Site (SSI) Event...............................
57.408 Monthly Survey Patient Days & Nurse 2,500 12 300/60 150,000
Staffing.......................................
57.500 Outpatient Dialysis Center Practices 6,900 1 150/60 17,250
Survey.........................................
57.501 Dialysis Monthly Reporting Plan.......... 7,400 12 5/60 7,400
57.502 Dialysis Event........................... 7,400 30 50/60 185,000
57.503 Denominator for Outpatient Dialysis...... 7,400 12 10/60 14,800
57.504 Prevention Process Measures Monthly 1,730 12 60/60 20,760
Monitoring for Dialysis........................
57.507 Home Dialysis Center Practices Survey.... 550 1 65/60 596
57.600 Neonatal Component FHIR Measure--Late 5,500 1 1620/60 148,500
Onset Sepsis Meningitis (LOSMEN) Module--IT
Initial Set up.................................
57.600 Neonatal Component FHIR Measure--Late 5,500 1 1,200/60 110,000
Onset Sepsis Meningitis (LOSMEN) Module--IT
Yearly Maintenance.............................
57.600 Neonatal Component FHIR Measure--Late 5,500 6 6/60 3,300
Onset Sepsis Meningitis (LOSMEN) Module--
Infection Preventionist........................
57.600 Neonatal Component Late Onset Sepsis 5,500 12 2/60 2,200
Meningitis (LOSMEN) Module CDA Data Collection--
Infection Preventionist........................
57.601 Late Onset Sepsis/Meningitis Denominator 300 6 5/60 150
Form: Late Onset Sepsis/Meningitis Denominator
Form: Data Table for monthly electronic upload.
57.602 Late Onset Sepsis/Meningitis Event Form: 300 6 6/60 180
Data Table for Monthly Electronic Upload.......
57.700 Medication Safety--Digital Measure 5,500 1 1,620/60 148,500
Reporting Plan (HYPO, HAKI, ORAE)--IT Initial
Set up.........................................
57.700 Medication Safety--Digital Measure 5,500 1 1,200/60 110,000
Reporting Plan (HYPO, HAKI, ORAE)--IT Yearly
Maintenance....................................
57.700 Medication Safety--Digital Measure 5,500 4 10/60 3,667
Reporting Plan (HYPO, HAKI, ORAE)--Infection
Preventionist..................................
57.701 Glycemic Control Module--HYPO Annual 10 1 120/60 20
Survey.........................................
Billing Code Data: 837I Upload.................. 5,500 4 5/60 1,833
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Total....................................... .............. .............. .............. 3,635,534
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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. 2024-08597 Filed 4-22-24; 8:45 am]
BILLING CODE 4163-18-P