[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
                                                 ---------------------------------------------------------------
    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