[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73288-73292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28031]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-0666]
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 September 27, 2021 to obtain
comments from the public and affected agencies. CDC received four non-
substantive comments 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.
[[Page 73289]]
Comments and recommendations for the proposed information collection
should be sent within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. 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. 12/31/2023)--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 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. Additionally, 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 Component, and the Neonatal Component. NHSN has increasingly
served as the operating system for HAI reporting compliance through
legislation established by the states. As of April 2020, 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. Members of the
public may also 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.
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.
NHSN was previously approved in December of 2020 for 5,943,401
responses; 1,321,991 burden hours, and is due to expire on December 31,
2023. The proposed changes in this new ICR include revisions to ten
data collection forms. There are a total of 86 proposed data collection
forms, but no new forms are being added at this time. The total
estimated burden requested in this Revision is for 1,584,651 hours.
Estimated Annual Burden
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Average
Number of Number of burden per
Respondent type Form number & name respondents responses per response
respondent (hour)
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U.S. Healthcare Facilities/NHSN 57.100 NHSN Registration 2,000 1 5/60
Participants. Form.
57.101 Facility Contact 2,000 1 10/60
Information.
57.103 Patient Safety 6,765 1 90/60
Component--Annual
Hospital Survey.
57.104 Facility 800 1 5/60
Administrator Change
Request Form.
57.105 Group Contact 1,000 1 5/60
Information.
57.106 Patient Safety 7,821 12 15/60
Monthly Reporting Plan.
57.108 Primary 5,775 5 38/60
Bloodstream Infection
(BSI).
57.111 Pneumonia (PNEU). 1,800 2 30/60
57.112 Ventilator- 5,463 8 28/60
Associated Event.
57.113 Pediatric 334 1 30/60
Ventilator-Associated
Event (PedVAE).
[[Page 73290]]
57.114 Urinary Tract 6,000 5 20/60
Infection (UTI).
57.115 Custom Event..... 600 91 35/60
57.116 Denominators for 1,100 12 4/60
Neonatal Intensive Care
Unit (NICU).
57.117 Denominators for 500 12 5/60
Specialty Care Area
(SCA)/Oncology (ONC).
57.118 Denominators for 5,500 60 5/60
Intensive Care Unit
(ICU)/Other locations
(not NICU or SCA).
57.120 Surgical Site 6,000 9 35/60
Infection (SSI).
57.121 Denominator for 6,000 602 10/60
Procedure.
57.122 HAI Progress 55 1 28/60
Report State Health
Department Survey.
57.123 Antimicrobial Use 2,500 12 5/60
and Resistance (AUR)-
Microbiology Data
Electronic Upload
Specification Tables.
57.124 Antimicrobial Use 2,500 12 5/60
and Resistance (AUR)-
Pharmacy Data
Electronic Upload
Specification Tables.
57.125 Central Line 500 213 25/60
Insertion Practices
Adherence Monitoring.
57.126 MDRO or CDI 720 11 30/60
Infection Form.
57.127 MDRO and CDI 5,500 29 15/60
Prevention Process and
Outcome Measures
Monthly Monitoring.
57.128 Laboratory- 4,800 79 20/60
identified MDRO or CDI
Event.
57.129 Adult Sepsis..... 50 250 25/60
57.135 Late Onset Sepsis/ 300 6 5/60
Meningitis Denominator
Form: Data Table for
monthly electronic
upload.
57.136 Late Onset Sepsis/ 300 6 5/60
Meningitis Event Form:
Data Table for Monthly
Electronic Upload.
57.137 Long-Term Care 17,700 1 120/60
Facility Component--
Annual Facility Survey.
57.138 Laboratory- 1,998 24 20/60
identified MDRO or CDI
Event for LTCF.
57.139 MDRO and CDI 1,998 12 20/60
Prevention Process
Measures Monthly
Monitoring for LTCF.
57.140 Urinary Tract 339 36 35/60
Infection (UTI) for
LTCF.
57.141 Monthly Reporting 2,011 12 5/60
Plan for LTCF.
57.142 Denominators for 339 12 35/60
LTCF Locations.
57.143 Prevention 130 12 5/60
Process Measures
Monthly Monitoring for
LTCF.
57.150 LTAC Annual 620 1 82/60
Survey.
57.151 Rehab Annual 1,340 1 82/60
Survey.
57.200 Healthcare 50 1 480/60
Personnel Safety
Component Annual
Facility Survey.
57.204 Healthcare Worker 50 200 20/60
Demographic Data.
57.205 Exposure to Blood/ 50 50 60/60
Body Fluids.
57.206 Healthcare Worker 50 30 15/60
Prophylaxis/Treatment.
57.207 Follow-Up 50 50 15/60
Laboratory Testing.
57.210 Healthcare Worker 50 50 10/60
Prophylaxis/Treatment-
Influenza.
57.300 Hemovigilance 500 1 85/60
Module Annual Survey.
57.301 Hemovigilance 500 12 60/60
Module Monthly
Reporting Plan.
57.303 Hemovigilance 500 12 70/60
Module Monthly
Reporting Denominators.
57.305 Hemovigilance 500 10 10/60
Incident.
57.306 Hemovigilance 500 1 35/60
Module 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.
[[Page 73291]]
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.
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 700 1 10/60
Procedure Component--
Annual Facility Survey.
57.401 Outpatient 700 12 15/60
Procedure Component--
Monthly Reporting Plan.
57.402 Outpatient 200 1 40/60
Procedure Component
Same Day Outcome
Measures.
57.403 Outpatient 200 400 40/60
Procedure Component--
Monthly Denominators
for Same Day Outcome
Measures.
57.404 Outpatient 700 100 40/60
Procedure Component--
SSI Denominator.
57.405 Outpatient 700 5 40/60
Procedure Component--
Surgical Site (SSI)
Event.
57.500 Outpatient 7,200 1 12/60
Dialysis Center
Practices Survey.
57.501 Dialysis Monthly 7,200 12 5/60
Reporting Plan.
57.502 Dialysis Event... 7,200 30 25/60
57.503 Denominator for 7,200 30 10/60
Outpatient Dialysis.
57.504 Prevention 1,730 12 75/60
Process Measures
Monthly Monitoring for
Dialysis.
57.505 Dialysis Patient 615 50 10/60
Influenza Vaccination.
57.506 Dialysis Patient 615 5 10/60
Influenza Vaccination
Denominator.
57.507 Home Dialysis 430 1 30/60
Center Practices Survey.
Weekly Healthcare 125 52 60/60
Personnel Influenza
Vaccination Cumulative
Summary for Non-Long-
Term Care Facilities.
Weekly Healthcare 1,200 52 60/60
Personnel Influenza
Vaccination Cumulative
Summary for Long-Term
Care Facilities.
Weekly Resident 2,500 52 60/60
Influenza Vaccination
Cumulative Summary for
Long-Term Care
Facilities.
Annual Healthcare 5,000 1 120/60
Personnel Influenza
Vaccination Summary.
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[[Page 73292]]
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-28031 Filed 12-23-21; 8:45 am]
BILLING CODE 4163-18-P