[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46490-46493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19902]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-18-0666]


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 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 May 11, 2018 to obtain comments 
from the public and affected agencies. CDC received one comment 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 (0920-0666, Expiration Date 1/
31/2021)--Revision--National Center for Emerging and Zoonotic 
Infectious Diseases (NCEZID), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    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. Specifically, 
resulting data estimates the magnitude of Healthcare Associated 
Infections (HAI), monitor HAI trends, and facilitate inter-facility and 
intra-facility comparisons with risk-adjusted data used for local 
quality improvement activities. The data will be used to detect changes 
in the epidemiology of adverse events resulting from new and current 
medical therapies and changing risks. The NHSN currently consists of 
six components: Patient Safety, Healthcare Personnel Safety, 
Biovigilance, Long-Term Care Facility (LTCF), Outpatient Procedure 
Component, and Dialysis.
    Changes were made to 34 data collection facility surveys with this 
revision ICR. CDC revised three annual facility surveys for the Patient 
Safety component for Hospitals, Long-Term Acute Care Facilities, and 
Inpatient Rehabilitation Facilities. CDC's revisions clarify the 
reporting requirements for the data collected on fungal testing, 
facility locations, and laboratory testing locations. Additionally, 
corresponding response

[[Page 46491]]

options for these questions have been revised to include updated 
testing methods used by facilities to capture current HAI specific data 
specification requirements for NHSN. New required questions have been 
added to all Patient Safety component surveys. The new questions are 
designed to provide data on surveillance processes, policies, and 
standards that are used by reporting facilities to ensure that when an 
event is detected, the facility has the appropriate mechanism to 
conduct complete reporting. The Hospital Annual Survey added new 
required questions to provide data about neonatal antimicrobial 
stewardship practices because the focus of stewardship efforts in 
neonatology differ from the focus in adult and pediatric practice. 
Questions were removed and replaced on all three Patient Safety surveys 
to align better with the Core Elements of Hospital Antibiotic 
Stewardship Programs specified by CDC. The Core Elements defined by CDC 
are part of broad-based efforts by CDC and its healthcare and public 
health partners to combat the threat of antibiotic-resistant bacteria. 
The new Antibiotic Stewardship Program questions will provide 
additional data about operational features of the programs that 
hospitals have implemented, which in turn will enable CDC and its 
healthcare and public health partners to target their efforts to help 
invigorate and extend antibiotic stewardship.
    CDC is introducing a new optional survey form that is designed to 
be completed by state and local health departments that participate in 
HAI surveillance and prevention activities. This new form will provide 
data on legal and regulatory requirements that are pertinent to HAI 
reporting. CDC plans to include data the health department survey in 
its annual National and State Healthcare-Associated Infection Progress 
Report. The report helps identify the progress in HAI surveillance and 
prevention at the state and national levels. Data about the extent to 
which state health departments have validated HAI data that healthcare 
facilities in their jurisdiction report to NHSN and the extent of state 
and local health department HAI reporting requirements are important 
data for users of CDC's HAI Progress Report to consider when they are 
reviewing and interpreting data in the report.
    NHSN now includes a ventilator-associated event available for NICU 
locations, which requires additional denominator reporting, in which 
CDC has provided an option to accommodate facilities that are reporting 
requested data by updating the corresponding surveys. The Pediatric 
Ventilator-Associated Event (PedVAE) was removed from the survey 
because a single algorithm is used to detect PedVAE events.
    NHSN has made updates to the Antimicrobial Use and Resistance (AUR) 
data collection tools for the purposes of monitoring additional 
microorganisms and their antimicrobial susceptibility profiles. Use of 
these updates in AUR surveillance will provide important additional 
data for clinical and public health responses to mounting antibiotic 
resistance problems.
    The Long-term Care Facility Component (LTCF) will be updating three 
forms, two of which will include an update for facilities to document 
the ``CDI treatment start'' variable. Early CDI reporting data from 
nursing homes has shown exceptionally low event rates for many 
reporting facilities (e.g., zero events for six or more months). Since 
current CDI event detection is based on presence of a positive 
laboratory specimen, variability in the use of diagnostic testing as 
part of CDI management will have direct impact on the estimate of CDI 
burden in a facility (e.g., empiric treatment for CDI without 
confirmatory testing may result in the appearance of low disease 
burden). In order to determine whether low CDI event rates might be due 
to empiric CDI treatment practices, a new process measure will be 
incorporated into the monthly summary data on CDI for LTCFs. This 
measure, called ``CDI treatment starts,'' will allow providers to 
capture the number of residents started on antibiotic treatment for CDI 
that month based on clinical decisions (i.e., even those without a 
positive CDI test). This process measure should provide data on 
clinically-treated CDI in order to inform our understanding of CDI 
management practices and serve as a proxy for CDI burden in nursing 
homes.
    Overall, minor revisions have been made to a total of 34 forms 
within the package to clarify and/or update surveillance definitions, 
increase or decrease the number of reporting facilities, and add new 
forms.
    Finally, NHSN has achieved significant burden reduction with this 
ICR due to a decrease in the number of respondents for the Specialty 
Care Area (SCA) and Oncology (ONC) facilities reporting to NHSN. NHSN 
re-evaluated these reporting facilities and determined that 
approximately 2,000 SCA and ONC facilities are reporting to NHSN 
compared to the estimated 6,000 that was estimated last year. 
Additionally, NHSN streamlined many response options, which also 
attributed to a reduction in the overall burden.
    The previously approved NHSN package included 72 individual 
collection forms; the current revision request includes a total of 73 
forms. The reporting burden will decrease by 109,745 hours, for a total 
of 5,393,725 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Healthcare facility................  57.100 NHSN Registration              2,000               1            5/60
                                      Form.
                                     57.101 Facility Contact               2,000               1           10/60
                                      Information.
                                     57.103 Patient Safety                 6,000               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            6,000              44           33/60
                                      Infection (BSI).
                                     57.111 Pneumonia (PNEU)....           1,800              72           30/60
                                     57.112 Ventilator-                    6,000             144           28/60
                                      Associated Event.
                                     57.113 Pediatric Ventilator-            100             120           30/60
                                      Associated Event (PedVAE).
                                     57.114 Urinary Tract                  6,000              40           20/60
                                      Infection (UTI).
                                     57.115 Custom Event........             600              91           35/60
                                     57.116 Denominators for               6,000              12               4
                                      Neonatal Intensive Care
                                      Unit (NICU).

[[Page 46492]]

 
                                     57.117 Denominators for               2,000               9          302/60
                                      Specialty Care Area (SCA)/
                                      Oncology (ONC).
                                     57.118 Denominators for               6,000              60          302/60
                                      Intensive Care Unit (ICU)/
                                      Other locations (not NICU
                                      or SCA).
                                     57.120 Surgical Site                  6,000              36           35/60
                                      Infection (SSI).
                                     57.121 Denominator for                6,000             540           10/60
                                      Procedure.
                                     57.122 HAI Progress Report               55               1           45/60
                                      State Health Department
                                      Survey.
                                     57.123 Antimicrobial Use              1,000              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                     100             100           25/60
                                      Insertion Practices
                                      Adherence Monitoring.
                                     57.126 MDRO or CDI                    6,000              72           30/60
                                      Infection Form.
                                     57.127 MDRO and CDI                   6,000              24           15/60
                                      Prevention Process and
                                      Outcome Measures Monthly
                                      Monitoring.
                                     57.128 Laboratory-                    6,000             240           20/60
                                      identified MDRO or CDI
                                      Event.
                                     57.129 Adult Sepsis........              50             250           25/60
                                     57.137 Long-Term Care                 2,600               1               2
                                      Facility Component--Annual
                                      Facility Survey.
                                     57.138 Laboratory-                    2,600              12           20/60
                                      identified MDRO or CDI
                                      Event for LTCF.
                                     57.139 MDRO and CDI                   2,600              12           20/60
                                      Prevention Process
                                      Measures Monthly
                                      Monitoring for LTCF.
                                     57.140 Urinary Tract                  2,600              14           35/60
                                      Infection (UTI) for LTCF.
                                     57.141 Monthly Reporting              2,600              12            5/60
                                      Plan for LTCF.
                                     57.142 Denominators for               2,600              12          250/60
                                      LTCF Locations.
                                     57.143 Prevention Process             2,600              12            5/60
                                      Measures Monthly
                                      Monitoring for LTCF.
                                     57.150 LTAC Annual Survey..             400               1           70/60
                                     57.151 Rehab Annual Survey.           1,000               1           70/60
                                     57.200 Healthcare Personnel              50               1               8
                                      Safety Component Annual
                                      Facility Survey.
                                     57.203 Healthcare Personnel          19,500               1            5/60
                                      Safety Monthly Reporting
                                      Plan.
                                     57.204 Healthcare Worker                 50             200           20/60
                                      Demographic Data.
                                     57.205 Exposure to Blood/                50              50               1
                                      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             200               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.
                                     57.309 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.

[[Page 46493]]

 
                                     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           5,000               1           10/60
                                      Component--Annual Facility
                                      Survey.
                                     57.401 Outpatient Procedure           5,000              12           20/60
                                      Component--Monthly
                                      Reporting Plan.
                                     57.402 Outpatient Procedure           1,200              25           40/60
                                      Component Same Day Outcome
                                      Measures.
                                     57.403 Outpatient Procedure           1,200              12           40/60
                                      Component--Monthly
                                      Denominators for Same Day
                                      Outcome Measures.
                                     57.404 Outpatient Procedure           5,000             540           10/60
                                      Component--SSI Denominator.
                                     57.405 Outpatient Procedure           5,000              36           35/60
                                      Component--Surgical Site
                                      (SSI) Event.
                                     57.500 Outpatient Dialysis            7,000               1          127/60
                                      Center Practices Survey.
                                     57.501 Dialysis Monthly               7,000              12            5/60
                                      Reporting Plan.
                                     57.502 Dialysis Event......           7,000              60           25/60
                                     57.503 Denominator for                7,000              12           10/60
                                      Outpatient Dialysis.
                                     57.504 Prevention Process             2,000              12           85/60
                                      Measures Monthly
                                      Monitoring for Dialysis.
                                     57.505 Dialysis Patient                 325              75           10/60
                                      Influenza Vaccination.
                                     57.506 Dialysis Patient                 325               5           10/60
                                      Influenza Vaccination
                                      Denominator.
                                     57.507 Home Dialysis Center             350               1           30/60
                                      Practices Survey.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-19902 Filed 9-12-18; 8:45 am]
 BILLING CODE 4163-18-P