[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]


=======================================================================
-----------------------------------------------------------------------

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)
----------------------------------------------------------------------------------------------------------------
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