[Federal Register Volume 85, Number 224 (Thursday, November 19, 2020)]
[Notices]
[Pages 73713-73716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25576]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-21-0666]


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 15, 2020 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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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) (OMB Control No. 0920-
0666, Exp. 12/31/2022)--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. 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 planned

[[Page 73714]]

Neonatal Component is expected to launch during the winter of 2020/
2021. 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. These 
infections are usually serious, causing a prolongation of hospital 
stay, increased cost, and risk of morbidity and mortality. 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. A new form has been introduced for field testing--
Respiratory Tract Infection (RTI)--not to be used by NHSN users, but as 
part of an EIP project with 4 EIP sites. Form title will be 
Denominators for Healthcare Associated Infections (HAIs): Respiratory 
Tract Infections. The purpose of this form is to allow testing prior to 
introducing a new module and forms to NHSN users. The CDC's 
Epidemiology Research & Innovations Branch (ERIB) team will use the 
form to perform field testing of variables to explore the utilization, 
applicability, and data collection burden associated with these 
variables. This process will inform areas of improvement prior to 
incorporating the new module, including protocol, forms, and 
instructions into NHSN. The estimated burden for this form is 20 
minutes, which is based on a similar denominator form. 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 April 2020, 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 ICR previously approved in December of 2019 for 5,352,360 
responses; 3,113,631 burden hours. The proposed changes in this new ICR 
include revisions to eight data collection forms and the addition of 
ten new forms for a total of 79 proposed data collection forms. In this 
Revision, CDC requests OMB approval for an estimated 1,321,443 annual 
burden hours.
    The ICR previously approved in December of 2019 for 5,352,360 
responses; 3,113,631 burden hours and $101,009,102 in annual cost, is 
due to expire on December 31, 2022. The reporting burden decreased by 
1,792,188 hours for a total estimated burden of 1,321,443 hours. The 
annual cost of reporting will increase by $1,642,524 for a total cost 
burden of $102,651,626. The proposed changes in this new ICR include 
revisions to eight data collection forms and the addition

[[Page 73715]]

of two new forms for a total of 79 proposed data collection forms. In 
this Revision, CDC requests OMB approval for an estimated 1,321,443 
annual burden hours.

                                        Estimated Annualized Burden Hours
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                                                                     Number of      Avg. burden
                 Form No. & name                     Number of     responses per   per response    Total burden
                                                    respondents     respondent      (min./hour)       (hours)
----------------------------------------------------------------------------------------------------------------
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           6,765               1           55/60           6,201
 Survey.........................................
57.105 Group Contact Information................           1,000               1            5/60              83
57.106 Patient Safety Monthly Reporting Plan....           7,821              12           15/60          23,463
57.108 Primary Bloodstream Infection (BSI)......           5,775               5           38/60          18,288
57.111 Pneumonia (PNEU).........................           1,800               2           30/60          18,288
57.112 Ventilator-Associated Event..............           5,463               8           28/60          20,395
57.113 Pediatric Ventilator-Associated Event                 334               1           30/60             167
 (PedVAE).......................................
57.114 Urinary Tract Infection (UTI)............           6,000               5           20/60          10,000
57.115 Custom Event.............................             600              91           35/60          31,850
57.116 Denominators for Neonatal Intensive Care            1,100              12            4/60             880
 Unit (NICU)....................................
57.117 Denominators for Specialty Care Area                  500              12            5/60             503
 (SCA)/Oncology (ONC)...........................
57.118 Denominators for Intensive Care Unit                5,500              60            5/60          27,665
 (ICU)/Other locations (not NICU or SCA)........
57.120 Surgical Site Infection (SSI)............           6,000               9           35/60          31,500
57.121 Denominator for Procedure................           6,000             602           10/60         602,000
57.122 HAI Progress Report State Health                       55               1           28/60              26
 Department Survey..............................
57.123 Antimicrobial Use and Resistance (AUR)-             2,500              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           3,960
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              79           20/60         126,400
57.129 Adult Sepsis.............................              50             250           25/60           5,208
57.135 Late Onset Sepsis/Meningitis Denominator              300              12            5/60             300
 Form: Data Table for monthly electronic upload.
57.136 Late Onset Sepsis/Meningitis Event Form:              300               4            5/60             100
 Data Table for Monthly Electronic Upload.......
57.137 Long-Term Care Facility Component--Annual           3,079               1            1/60              51
 Facility Survey................................
57.138 Laboratory-identified MDRO or CDI Event             1,998              24           12/60           9,590
 for LTCF.......................................
57.139 MDRO and CDI Prevention Process Measures            1,998              12           12/60           4,795
 Monthly Monitoring for LTCF....................
57.140 Urinary Tract Infection (UTI) for LTCF...             339              12           12/60             814
57.141 Monthly Reporting Plan for LTCF..........           2,011              12           12/60           4,826
57.142 Denominators for LTCF Locations..........             339              12          250/60             814
57.143 Prevention Process Measures Monthly                   130              12           12/60             312
 Monitoring for LTCF............................
57.150 LTAC Annual Survey.......................             620               1           10/60              10
57.151 Rehab Annual Survey......................           1,340               1           10/60             625
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...........................
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

[[Page 73716]]

 
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                7,200               1          127/60          15,240
 Survey.........................................
57.501 Dialysis Monthly Reporting Plan..........           7,200              12            5/60           7,200
57.502 Dialysis Event...........................           7,200              30           25/60          90,000
57.503 Denominator for Outpatient Dialysis......           7,200              30           10/60          14,400
57.504 Prevention Process Measures Monthly                 1,730              12           75/60          25,950
 Monitoring for Dialysis........................
57.505 Dialysis Patient Influenza Vaccination...             615              50           10/60           5,125
57.506 Dialysis Patient Influenza Vaccination                615               5           10/60             513
 Denominator....................................
57.507 Home Dialysis Center Practices Survey....             430               1           30/60             215
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-25576 Filed 11-18-20; 8:45 am]
BILLING CODE 4163-18-P