[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Notices]
[Pages 53441-53444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21753]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-0666]
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 June 5, 2019 to obtain comments
from the public and affected agencies. CDC received two 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 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 (NHSN)--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. 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 healthcare-associated infection prevention
practice methods such as healthcare personnel influenza vaccine status
and corresponding infection control adherence rates.
NHSN currently has six components: Patient Safety (PS), Healthcare
Personnel Safety (HPS), Biovigilance (BV), Long-Term Care Facility
(LTCF), Outpatient Procedure (OPC), and the Dialysis Component. NHSN's
new Neonatal Component is expected to launch during the summer of 2020.
This component will focus on premature neonates and the healthcare-
associated events that occur as a result of their prematurity. This
component will be released with one module, which includes Late Onset-
Sepsis and Meningitis. Late-onset sepsis (LOS) and Meningitis are
common complications of extreme prematurity. Studies have indicated
that 36% of extremely low gestational age (22-28 weeks) infants develop
LOS and that 21% of very low birth weight infants surviving beyond
three days of life will develop LOS. Meningitis occurs in 23% of
bacteremic infants, but 38% of infants with a pathogen isolated from
the cerebrospinal fluid may not have an organism isolated from blood.
These infections are usually serious, causing a prolongation of
hospital stay, increased cost, and risk of morbidity and mortality.
Some cases of LOS can be prevented through proper central line
insertion and maintenance practices. These are addressed in the CDC's
Healthcare Infection Control Practices Advisory Committee (CDC/HICPAC)
Guidelines for the Prevention of Intravascular Catheter-Related
Infections, 2011. However, almost one-third of LOS events in a quality-
improvement study were not related to central-lines.
[[Page 53442]]
Prevention strategies for the non-central line-related infection events
have yet to be fully defined, but include adherence to hand-hygiene,
parent and visitor education, and optimum nursery design features.
Other areas that likely influence the development of LOS include early
enteral nutritional support and skin care practices. The data for this
module will be electronically submitted, and manual data entry will not
be available. This will allow more hospital personnel to be available
to care for patients and will reduce annual burden across healthcare
facilities. Additionally, LOS data will be utilized for prevention
initiatives.
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 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 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).
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' 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. This project
has resulted in a significant increase in long-term care facilities
reporting to NHSN. The collection of information is authorized by the
Public Health Service Act (42 U.S.C. 242b, 242k, and 242m (d)).
The proposed changes in this new ICR include revisions made to 40
NHSN data collection tools for a total of 76 data collection tools
included in this ICR. The reporting burden decreased by 2,363,508 hours
for a total estimated burden of 3,033,930 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Respondent type Form No. & name respondents responses per response
respondent (hours)
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Healthcare Practitioner............ 57.100 NHSN Registration 2,000 1 5/60
Form.
57.101 Facility Contact 2,000 1 10/60
Information.
57.103 Patient Safety 5,175 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 5,775 5 38/60
Infection (BSI).
[[Page 53443]]
57.111 Pneumonia (PNEU).... 1,800 30 30/60
57.112 Ventilator- 5,500 5 28/60
Associated Event.
57.113 Pediatric Ventilator- 334 120 30/60
Associated Event (PedVAE).
57.114 Urinary Tract 5,500 5 20/60
Infection (UTI).
57.115 Custom Event........ 600 91 35/60
57.116 Denominators for 220 12 249/60
Neonatal Intensive Care
Unit (NICU).
57.117 Denominators for 165 12 302/60
Specialty Care Area (SCA)/
Oncology (ONC).
57.118 Denominators for 5,500 60 302/60
Intensive Care Unit (ICU)/
Other locations (not NICU
or SCA).
57.120 Surgical Site 4,500 11 35/60
Infection (SSI).
57.121 Denominator for 4,500 680 10/60
Procedure.
57.122 HAI Progress Report 55 1 45/60
State Health Department
Survey.
57.123 Antimicrobial Use 1,500 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 500 213 25/60
Insertion Practices
Adherence Monitoring.
57.126 MDRO or CDI 720 12 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 87 20/60
identified MDRO or CDI
Event.
57.129 Adult Sepsis........ 50 250 25/60
57.137 Long-Term Care 2,220 1 120/60
Facility Component--Annual
Facility Survey.
57.138 Laboratory- 2,150 24 15/60
identified MDRO or CDI
Event for LTCF.
57.139 MDRO and CDI 2,200 12 20/60
Prevention Process
Measures Monthly
Monitoring for LTCF.
57.140 Urinary Tract 400 12 30/60
Infection (UTI) for LTCF.
57.141 Monthly Reporting 2,220 12 5/60
Plan for LTCF.
57.142 Denominators for 2,220 12 250/60
LTCF Locations.
57.143 Prevention Process 375 12 5/60
Measures Monthly
Monitoring for LTCF.
57.150 LTAC Annual Survey.. 500 1 70/60
57.151 Rehab Annual Survey. 1,200 1 70/60
57.200 Healthcare Personnel 50 1 480/60
Safety Component Annual
Facility Survey.
57.203 Healthcare Personnel .............. 1 5/60
Safety Monthly Reporting
Plan.
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 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 500 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.
57.30 Hemovigilance Adverse 500 1 20/60
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.
[[Page 53444]]
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 Procedure 700 1 10/60
Component--Annual Facility
Survey.
57.401 Outpatient Procedure 700 12 15/60
Component--Monthly
Reporting Plan.
57.402 Outpatient Procedure 200 1 40/60
Component Same Day Outcome
Measures.
57.403 Outpatient Procedure 200 400 40/60
Component--Monthly
Denominators for Same Day
Outcome Measures.
57.404 Outpatient Procedure 700 100 40/60
Component--SSI Denominator.
57.405 Outpatient Procedure 700 5 40/60
Component--Surgical Site
(SSI) Event.
57.500 Outpatient Dialysis 7,100 1 127/60
Center Practices Survey.
57.501 Dialysis Monthly 7,100 12 5/60
Reporting Plan.
57.502 Dialysis Event...... 7,100 30 25/60
57.503 Denominator for 7,100 12 10/60
Outpatient Dialysis.
57.504 Prevention Process 1,760 12 75/60
Measures Monthly
Monitoring for Dialysis.
57.505 Dialysis Patient 860 60 10/60
Influenza Vaccination.
57.506 Dialysis Patient 860 1 5/60
Influenza Vaccination
Denominator.
57.507 Home Dialysis Center 430 1 30/60
Practices Survey.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-21753 Filed 10-4-19; 8:45 am]
BILLING CODE 4163-18-P