Proposed Data Collection Submitted for Public Comment and Recommendations

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Published

August 21, 2023

Issuing agencies

Health and Human Services DepartmentCenters for Disease Control and Prevention

Abstract

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 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.

Full Text

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<title>Federal Register, Volume 88 Issue 160 (Monday, August 21, 2023)</title>
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[Federal Register Volume 88, Number 160 (Monday, August 21, 2023)]
[Notices]
[Pages 56827-56830]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17924]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-23-0666; Docket No. CDC-2023-0068]

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 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 October 20, 2023.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0068 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://ww.regulations.gov">ww.regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#cfa0a2ad8facabace1a8a0b9"><span class="__cf_email__" data-cfemail="345b5956745750571a535b42">[email&#160;protected]</span></a>.

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;
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. 6/30/2026)--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

[[Page 56828]]

Diseases (NCEZID), Centers for Disease Control and Prevention (CDC)
collects data from healthcare facilities in the National Healthcare
Safety Network (NHSN) (OMB Control No. 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
seven components: Patient Safety (PS), Healthcare Personnel Safety
(HPS), Biovigilance (BV), Long-Term Care Facility (LTCF), Outpatient
Procedure (OPC), Dialysis, and Neonatal Component.
Data reported under the PS 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 HPS 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 BV
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 LTCF 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 as a result of their prematurity. This component currently has
one module, which includes Late Onset-Sepsis and Meningitis. 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 National Nursing Home Quality Collaborative, which
focuses on recruiting nursing homes to report HAI data to NHSN and to
retain their continued participation.
The NHSN data collection was previously approved in June of 2023
for 6,209,922 responses and 1,693,215 annual burden hours. The proposed
changes in this Revision include modifications to 15 existing data
collection forms and one new form. CDC requests OMB approval for an
estimated annual burden 1,524,039 hours. There is no cost to
respondents other than their time to participate.

[[Page 56829]]

Estimated Annualized Burden Hours
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Number of Average burden
Form number & name Number of responses per per response Total burden
respondents respondent (min./hour) (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 5,311 1 135/60 11,950
Survey.........................................
57.104 Facility Administrator Change Request 800 1 5/60 67
Form...........................................
57.105 Group Contact Information................ 1,000 1 5/60 83
57.106 Patient Safety Monthly Reporting Plan.... 6,387 12 15/60 19,161
57.108 Primary Bloodstream Infection (BSI)...... 5,775 5 38/60 18,288
57.111 Pneumonia (PNEU)......................... 1,800 2 30/60 1800
57.112 Ventilator-Associated Event.............. 5,463 8 28/60 20,395
57.113 Pediatric Ventilator-Associated Event 334 1 30/60 167
(PedVAE).......................................
57.114 Urinary Tract Infection (UTI)............ 6,000 5 20/60 10,000
57.115 Custom Event............................. 600 91 35/60 31,850
57.116 Denominators for Neonatal Intensive Care 1,100 12 4/60 880
Unit (NICU)....................................
57.117 Denominators for Specialty Care Area 500 12 5/60 500
(SCA)/Oncology (ONC)...........................
57.118 Denominators for Intensive Care Unit 5,500 60 5/60 27,500
(ICU)/Other locations (not NICU or SCA)........
57.120 Surgical Site Infection (SSI)............ 6,000 9 35/60 31,500
57.121 Denominator for Procedure................ 6,000 602 10/60 602,000
57.122 HAI Progress Report State Health 55 1 28/60 26
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 25/60 44,375
Adherence Monitoring...........................
57.126 MDRO or CDI Infection Form............... 720 11 30/60 3,960
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 79 20/60 126,400
57.129 Adult Sepsis............................. 50 250 25/60 5,208
57.135 Late Onset Sepsis/Meningitis Denominator 300 6 5/60 150
Form: Data Table for monthly electronic upload.
57.136 Late Onset Sepsis/Meningitis Event Form: 300 6 5/60 150
Data Table for Monthly Electronic Upload.......
57.137 Long-Term Care Facility Component--Annual 17,700 1 122/60 35,990
Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event 1,086 24 20/60 8,688
for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures 1,019 12 20/60 4,076
Monthly Monitoring for LTCF....................
57.140 Urinary Tract Infection (UTI) for LTCF... 339 36 35/60 7,119
57.141 Monthly Reporting Plan for LTCF.......... 1,099 12 15/60 3,297
57.142 Denominators for LTCF Locations.......... 714 12 35/60 4,998
57.143 Prevention Process Measures Monthly 357 12 5/60 357
Monitoring for LTCF............................
57.150 LTAC Annual Survey....................... 392 1 89/60 581
57.151 Rehab Annual Survey...................... 1,160 1 89/60 1,721
57.200 Healthcare Personnel Safety Component 50 1 480/60 400
Annual Facility Survey.........................
57.204 Healthcare Worker Demographic Data....... 50 200 20/60 3,333
57.205 Exposure to Blood/Body Fluids............ 50 50 60/60 2,500
57.206 Healthcare Worker Prophylaxis/Treatment.. 50 30 15/60 375
57.207 Follow-Up Laboratory Testing............. 50 50 15/60 625
57.210 Healthcare Worker Prophylaxis/Treatment- 50 50 10/60 417
Influenza......................................
57.300 Hemovigilance Module Annual Survey....... 500 1 85/60 708
57.301 Hemovigilance Module Monthly Reporting 500 12 60/60 6,000
Plan...........................................
57.303 Hemovigilance Module Monthly Reporting 500 12 70/60 7,000
Denominators...................................
57.305 Hemovigilance Incident................... 500 10 10/60 833
57.306 Hemovigilance Module Annual Survey--Non- 500 1 35/60 292
acute care facility............................
57.307 Hemovigilance Adverse Reaction--Acute 500 4 20/60 667
Hemolytic Transfusion Reaction.................
57.308 Hemovigilance Adverse Reaction--Allergic 500 4 20/60 667
Transfusion Reaction...........................
57.309 Hemovigilance Adverse Reaction--Delayed 500 1 20/60 167
Hemolytic Transfusion Reaction.................
57.310 Hemovigilance Adverse Reaction--Delayed 500 2 20/60 333
Serologic Transfusion Reaction.................
57.311 Hemovigilance Adverse Reaction--Febrile 500 4 20/60 667
Non-hemolytic Transfusion Reaction.............
57.312 Hemovigilance Adverse Reaction-- 500 1 20/60 167
Hypotensive Transfusion Reaction...............
57.313 Hemovigilance Adverse Reaction--Infection 500 1 20/60 167
57.314 Hemovigilance Adverse Reaction--Post 500 1 20/60 167
Transfusion Purpura............................
57.315 Hemovigilance Adverse Reaction-- 500 1 20/60 167
Transfusion Associated Dyspnea.................
57.316 Hemovigilance Adverse Reaction-- 500 1 20/60 167
Transfusion Associated Graft vs. Host Disease..

[[Page 56830]]

57.317 Hemovigilance Adverse Reaction-- 500 1 20/60 167
Transfusion Related Acute Lung Injury..........
57.318 Hemovigilance Adverse Reaction-- 500 2 20/60 333
Transfusion Associated Circulatory Overload....
57.319 Hemovigilance Adverse Reaction--Unknown 500 1 20/60 167
Transfusion Reaction...........................
57.320 Hemovigilance Adverse Reaction--Other 500 1 20/60 167
Transfusion Reaction...........................
57.400 Outpatient Procedure Component--Annual 350 1 10/60 117
Facility Survey................................
57.401 Outpatient Procedure Component--Monthly 350 12 15/60 1,050
Reporting Plan.................................
57.402 Outpatient Procedure Component Same Day 50 1 40/60 33
Outcome Measures...............................
57.403 Outpatient Procedure Component--Monthly 50 400 40/60 13,333
Denominators for Same Day Outcome Measures.....
57.404 Outpatient Procedure Component--SSI 300 100 10/60 5,000
Denominator....................................
57.405 Outpatient Procedure Component--Surgical 300 36 35/60 6,300
Site (SSI) Event...............................
57.500 Outpatient Dialysis Center Practices 7,400 1 125/60 15,417
Survey.........................................
57.501 Dialysis Monthly Reporting Plan.......... 7,400 12 5/60 7,400
57.502 Dialysis Event........................... 7,400 30 27/60 99,900
57.503 Denominator for Outpatient Dialysis...... 7,400 24 10/60 29,600
57.504 Prevention Process Measures Monthly 1,730 12 75/60 25,950
Monitoring for Dialysis........................
57.505 Dialysis Patient Influenza Vaccination... 615 50 10/60 5,125
57.506 Dialysis Patient Influenza Vaccination 615 5 10/60 3075
Denominator....................................
57.507 Home Dialysis Center Practices Survey.... 450 1 36/60 270
Weekly Healthcare Personnel Influenza 125 52 60/60 6,500
Vaccination Cumulative Summary for Non-Long-
Term Care Facilities...........................
Weekly Healthcare Personnel Influenza 1,200 52 60/60 62,400
Vaccination Cumulative Summary for Long-Term
Care Facilities................................
Weekly Resident Influenza Vaccination Cumulative 2,500 52 60/60 130,000
Summary for Long-Term Care Facilities..........
Annual Healthcare Personnel Influenza 5,000 1 120/60 10,000
Vaccination Summary............................
Healthcare-facility onset, antibiotic-treated 7,821 1 10/60 1,304
Clostridioides difficile (C. difficile)
Infection (HT-CDI) Event Module Annual
Reporting Plan.................................
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Total Estimated Annual Burden Hours......... .............. .............. .............. 1,524,039
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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. 2023-17924 Filed 8-18-23; 8:45 am]
BILLING CODE 4163-18-P

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