[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Pages 26110-26113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11650]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-19-0666; Docket No. CDC-2019-0040]
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 is a public health surveillance system that
collects, analyzes, reports, and makes available data for monitoring,
measuring, and responding to healthcare associated infections (HAIs),
antimicrobial use and resistance, blood transfusion safety events, and
the extent to which healthcare facilities adhere to infection
prevention practices and antimicrobial stewardship.
DATES: Written comments must be received on or before August 5, 2019.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
by any of the following methods:
Federal eRulemaking Portal: Regulation.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-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov. Please note: Submit all comments through the
Federal eRulemaking portal (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 Jeffery M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 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; and
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.
5. Assess information collection costs.
Proposed Project
National Healthcare Safety Network (NHSN)--Revision--National
Center for
[[Page 26111]]
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 3
days of life will develop LOS.\1\ 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. 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 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
[[Page 26112]]
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)),
(Attachment A).
The ICR previously approved in November of 2018 included revisions
to 34 data collection forms and the addition of one new Patient Safety
form for a total of 73 proposed data collection forms. The proposed
revisions to the information collection tools in NHSN include 38
changes to previously approved data collection tools. Incorporating all
proposed revisions, the estimated burden for reporting reflects a
decrease in hours by 2,472,007 hours for a total annual burden of
3,031,463 hours. Subsequently, the estimated cost burden reflects a
decrease of $86,726,153 for a total annual cost of $110,756,566.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Form No. and name respondents responses per response (hours)
respondent (min./hour)
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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 5,175 1 75/60 6,469
Survey.........................................
57.105 Group Contact Information................ 1,000 1 5/60 83
57.106 Patient Safety Monthly Reporting Plan.... 6,000 12 15/60 18,000
57.108 Primary Bloodstream Infection (BSI)...... 5,775 5 38/60 18,288
57.111 Pneumonia (PNEU)......................... 1,800 30 30/60 27,000
57.112 Ventilator-Associated Event.............. 5,500 5 28/60 12,833
57.113 Pediatric Ventilator-Associated Event 334 120 30/60 20,040
(PedVAE).......................................
57.114 Urinary Tract Infection (UTI)............ 5,500 5 20/60 9,167
57.115 Custom Event............................. 600 91 35/60 31,850
57.116 Denominators for Neonatal Intensive Care 220 12 249/60 10,956
Unit (NICU)....................................
57.117 Denominators for Specialty Care Area 165 12 302/60 9,966
(SCA)/Oncology (ONC)...........................
57.118 Denominators for Intensive Care Unit 5,500 60 302/60 1,661,000
(ICU)/Other locations (not NICU or SCA)........
57.120 Surgical Site Infection (SSI)............ 4,500 11 35/60 28,875
57.121 Denominator for Procedure................ 4,500 680 10/60 510,000
57.122 HAI Progress Report State Health 55 1 45/60 41
Department Survey..............................
57.123 Antimicrobial Use and Resistance (AUR)- 1,500 12 5/60 1,500
Microbiology Data Electronic Upload
Specification Tables...........................
57.124 Antimicrobial Use and Resistance (AUR)- 2,000 12 5/60 2,000
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 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 87 20/60 139,200
57.129 Adult Sepsis............................. 50 250 25/60 5,208
57.137 Long-Term Care Facility Component--Annual 2,220 1 120/60 4,440
Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event 2,150 24 15/60 12,900
for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures 2,200 12 20/60 8,800
Monthly Monitoring for LTCF....................
57.140 Urinary Tract Infection (UTI) for LTCF... 400 12 30/60 2,400
57.141 Monthly Reporting Plan for LTCF.......... 2,220 12 5/60 2,220
57.142 Denominators for LTCF Locations.......... 2,220 12 250/60 111,000
57.143 Prevention Process Measures Monthly 375 12 5/60 375
Monitoring for LTCF............................
57.150 LTAC Annual Survey....................... 500 1 70/60 583
57.151 Rehab Annual Survey...................... 1,200 1 70/60 1,400
57.200 Healthcare Personnel Safety Component 50 1 480/60 400
Annual Facility Survey.........................
57.203 Healthcare Personnel Safety Monthly .............. 1 5/60 ..............
Reporting Plan.................................
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 1/60 100
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...........................
[[Page 26113]]
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..
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 700 1 10/60 117
Facility Survey................................
57.401 Outpatient Procedure Component--Monthly 700 12 15/60 2,100
Reporting Plan.................................
57.402 Outpatient Procedure Component Same Day 200 1 40/60 133
Outcome Measures...............................
57.403 Outpatient Procedure Component--Monthly 200 400 40/60 53,333
Denominators for Same Day Outcome Measures.....
57.404 Outpatient Procedure Component--SSI 700 100 40/60 46,667
Denominator....................................
57.405 Outpatient Procedure Component--Surgical 700 5 40/60 2,333
Site (SSI) Event...............................
57.500 Outpatient Dialysis Center Practices 7,100 1 127/60 15,028
Survey.........................................
57.501 Dialysis Monthly Reporting Plan.......... 7,100 12 5/60 7,100
57.502 Dialysis Event........................... 7,100 30 25/60 88,750
57.503 Denominator for Outpatient Dialysis...... 7,100 12 10/60 14,200
57.504 Prevention Process Measures Monthly 1,760 12 75/60 26,400
Monitoring for Dialysis........................
57.505 Dialysis Patient Influenza Vaccination... 860 60 10/60 8,600
57.506 Dialysis Patient Influenza Vaccination 860 1 5/60 72
Denominator....................................
57.507 Home Dialysis Center Practices Survey.... 430 1 30/60 215
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Total Estimated Annual Burden (Hours)....... .............. .............. .............. 3,031,463
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-11650 Filed 6-4-19; 8:45 am]
BILLING CODE 4163-18-P