[NCEZID] The National Healthcare Safety Network (NHSN)

ICR 202408-0920-016

OMB: 0920-0666

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Justification for No Material/Nonsubstantive Change
2024-08-26
Justification for No Material/Nonsubstantive Change
2024-02-28
Supplementary Document
2023-11-14
Supplementary Document
2023-11-14
Supplementary Document
2023-11-14
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2023-11-14
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2023-11-14
Supplementary Document
2023-11-14
Supplementary Document
2023-11-14
Supplementary Document
2023-11-14
Supplementary Document
2023-11-14
Supplementary Document
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Supplementary Document
2023-11-14
Supplementary Document
2023-11-14
Supplementary Document
2023-11-14
Supporting Statement B
2024-02-15
Supporting Statement A
2023-11-16
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ICR Details
0920-0666 202408-0920-016
Received in OIRA 202402-0920-011
HHS/CDC 0920-0666
[NCEZID] The National Healthcare Safety Network (NHSN)
No material or nonsubstantive change to a currently approved collection   No
Regular 08/26/2024
  Requested Previously Approved
12/31/2026 12/31/2026
5,271,122 5,267,622
2,434,332 2,433,165
0 0

The National Healthcare Safety Network (NHSN) is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and promote healthcare safety. Specifically, the data is used to determine the magnitude of various healthcare-associated adverse events and trends in the rates of these events among patients and healthcare workers with similar risks. The data will be used to detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing risks. This non-substantive change request is submitted in response to interruptions in the supply of Becton Dickinson (BD) BACTECTM blood culture media bottles because of recent supplier issues. The FDA and other entities recommend that facilities, laboratories, and health care providers consider conservation strategies to prioritize the use of blood culture media bottles, preserving the supply for patients at highest risk. A new form will be added to the NHSN portfolio to assess the impact of this supply shortage on individual facilities and how CDC NHSN bloodstream infection surveillance might be affected. Facilities enrolled in the NHSN Patient Safety Component will be asked questions regarding the impact of the Becton Dickinson (BD) BACTECTM blood culture media bottles for their facility. It will be collected electronically via NHSN. CDC requests addition of 1,167 burden hours.

US Code: 42 USC 242b Name of Law: Public Health Service Act
   US Code: 42 USC 242k Name of Law: Public Health Service Act
   US Code: 42 USC 242m(d) Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  88 FR 56827 08/21/2023
88 FR 78364 11/15/2023
Yes

104
IC Title Form No. Form Name
57.100 NHSN Registration Form CDC 57.100 NHSN Registration Form
57.101 Facility Contact Information CDC 57.101 Facility Contact Information
57.103 Patient Safety Component - Annual Hospital Survey 57.103 Patient Safety Component-Annual Hospital Survey
57.104 NHSN Administrator Change Request Form none Facility Administrator Change Request
57.105 Group Contact Information CDC 57.105 Group Contact Information
57.106 Patient Safety Monthly Reporting Plan 57.106 Patient Safety Monthly Reporting Plan
57.108 Primary Bloodstream Infection (BSI) 57.108 Primary Bloodstream Infection (BSI)
57.109 Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire 57.109 Becton Dickinson BACTECTM Blood Culture Media Bottles Shortage Impact Questionnaire
57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram) 57.111 Pneumonia (PNEU)
57.112 Ventilator-Associated Event (VAE) 57.112 Ventilator Associated Event (VAE)
57.113 Pediatric Ventilator-Associated Event (PedVAE) 57.113 Pediatric Ventilator-Associated Event (PedVAE)
57.114 Urinary Tract Infection (UTI) 57.114 Urinary Tract infection (UTI)
57.115 Custom Event CDC 57.115 Custom Event
57.116 Denominators for Neonatal Intensive Care Unit (NICU) CDC 57.116 PedVAE Optional Denominators Neonatal Intensive Care Unit (NICU)
57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC) CDC 57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC)
57.118 Denominators for Intensive Care Unit (ICU) Other Locations (Not NICU or SCA) CDC 57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)
57.120 Surgical Site Infection (SSI) CDC 57.120 Surgical Site Infection
57.121 Denominators for Procedure 57.121 Denominator for Procedure
57.122 HAI Progress Report State Health Department Survey CDC 55.122 State Health Department HAI Mandate and Validatyion Survey
57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Data Upload Tables 57.123 Antimicrobial Use and Resistance (AUR): Microbiology Laboratory Data Monthly Electronic Upload Specification Tables
57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data 57.124 Antimicrobial Use and Resistance (AUR): Pharmacy Data Monthly Electronic Upload Specification Tables
57.125 Central Line Insertion Practices Adherence Monitoring Form CDC 57.125, CDC 57.115 Central Line Insertion Practices Adherence Monitoring ,   Central Line Insertion Practices Adherence Monitoring (revised GISAB questions)
57.126 MDRO or CDI Infection Event CDC 57.126, 57.126 MDRO or CDI Infection Event ,   MDRO or CDI Infection Event (with revised GISAB questions)
57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring CDC 57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Reporting
57.128 Laboratory Identified or CDI MDRO Event CDC 57.128 Rev 7, v8.5, 57.128 Lab ID Event ,   Laboratory-identified MDRO or CDI Event (with revised GISAB questions)
57.129_Adult Sepsis_BLANK 57.129 Adult Sepsis_
57.130 - Patient Safety Component CSV Data Collection-Infection Preventionist CSV Data Collection-Infection Preventionist 57.130 Reporting Plan - Respiratory Pathogens Surveillance (RPS)
57.130 - Patient Safety Component FHIR Measure Respiratory Pathogens Surveillance (RPS) - IT Yearly Maintenance 57.130 Reporting Plan - Respiratory Pathogens Surveillance (RPS)
57.130 - Patient Safety Component FHIR Measure Respiratory Pathogens Surveillance (RPS)-Infection Preventionist 57.130 Reporting Plan - Respiratory Pathogens Surveillance (RPS)
57.130 Patient Safety Component FHIR Measure Respiratory Pathogens Surveillance (RPS) - IT Initial Set up 57.130 Reporting Plan - Respiratory Pathogens Surveillance (RPS)
57.132 - Patient Safety Component FHIR Measures-HOB, HT-CDI Modules-IT Initial Set up 57.132 Reporting Plan HOB and HTCDI
57.132 - Patient Safety Component FHIR Measures-HOB, HT-CDI Modules-IT Yearly Maintenance 57.132 Reporting Plan HOB and HTCDI
57.132 - Patient Safety Component FHIR Measures-HOB, HT-CDI Modules-Infection Preventionist 57.132 Reporting Plan HOB and HTCDI
57.133 - Patient Safety Component FHIR Measures-VTE Module- Infection Preventionist 57.133 Reporting Plan Venous Thromboembolism
57.133 - Patient Safety Component FHIR Measures-VTE Module-IT Initial Set up 57.133 Reporting Plan Venous Thromboembolism
57.133 - Patient Safety Component FHIR Measures-VTE Module-IT Yearly Maintenance 57.133 Reporting Plan Venous Thromboembolism
57.135 Late Onset Sepsis/Meningitis Denominator Form: Data Table (Monthly) 57.135 57.135 Late Onset Sepsis/ Meningitis Denominator Form: Data Table for monthly electronic upload
57.136 Long Term Care Facility Component - Respiratory Tract Infection 57.136 Long-Term Care Facility Component – Respiratory Tract Infection
57.137 Long Term care Facility Component--Annual Facility Survey CDC 57.137 Long-Term Care Facility Component -- Annual Facility Survey
57.138 Laboratory-Identified MDRO or CDI Event for LTCF CDC 57.138 Laboratory-identified MDRO or CDI Event for LTCF
57.139 MDRO and CDI Prevention Process Measures Monthly for LTCF CDC 57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF
57.140 Urinary Tract Infection (UTI) for LTCF 57.140 Urinary Tract Infection (UTI) for LTCF
57.141 Monthly Reporting Plan for LTCF CDC 57.141 Monthly Reporting Plan for LTCF
57.142 Denominators for LTCF Locations CDC 57.142 Denominators for LTCF
57.143 Prevention Process Measures Monthly Monitoring for LTCF CDC 57.143 Prevention Process Measures Monthly Monitoring
57.144 - Long Term Care Respiratory Tract Infections (RTI) Module 57.144 Long-Term Care RTI Module
57.145 - Long Term Care Antimicrobial Use (LTC-AU) Module CDA 57.145 LTC-AU Module
57.150 Patient Safety Component -- Annual Facility Survey for LTAC 57.150 Urinary Tract Infection (UTI) for LTCF
57.151 Patient Safety Component -- Annual Facility Survey for IRF 57.151 Patient Safety Component—Annual Facility Survey for IRF
57.200 Healthcare Personnel Safety Component Facility Survey CDC 57.200 Healthcare Personnel Safety - Annual Facility Survey
57.203 Healthcare Personnel Safety Reporting Plan CDC 57.203 Healthcare Personnel Safety Monthly Reporting Plan
57.204 Healthcare Worker Demographic Data CDC 57.204 Healthcare Worker Demographic Data
57.205 Exposure to Blood and Body Fluids CDC 57.205 Exposure to Blood/Body Fluids
57.206 Healthcare Worker Prophylaxis/Treatment CDC 57.206 Healthcare Worker Prophylaxis/Treatment
57.207 Follow-up Laboratory Testing CDC 57.207 Follow-up Laboratory Testing
57.210 Healthcare Worker Prophylaxis/Treatment - Influenza CDC 57.210 HCW Prophylaxis/Treatment-Influenza
57.300 Hemovigilance Module Annual Survey -- Acute Care Facility CDC 57.300, 57.300 Hemovigilance Module - Annual Survey ,   Hemovigilance Module Annual Survey (with revised GISAB questions)
57.301 Hemovigilance Module Monthly Reporting Plan 57.301 57.301_HV Monthly Reporting Plan_BLANK
57.303 Hemovigilance Module Monthly Reporting Denominators CDC 57.303 Hemovigilance Module Monthly Reporting Denominators
57.305 Hemovigilance Incident CDC 57.305 Hemovigilance Module Incident
57.306 Hemovigilance Module Annual Facility Survey - Non-acute Care Facility 57.306, CDC 57.306 Hemovigilance Module Annual Survey - Non-acute Care Facility ,   Hemovigilance Module Annual Facility Survey - Non-acute Care Facilities (with revised GISAB questions)
57.307 Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction 57.307, CDC 57.307 Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction ,   Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction (with revised GISAB questions)
57.308 Hemovigilance Adverse Reaction - Allergic Transfusion Reaction 57.308, CDC 57.308 Hemovigilance Adverse Reaction - Allergic Transfusion Reaction ,   Hemovigilance Module Adverse Reaction Allergic Transfusion Reaction (with revised GISAB questions)
57.309 Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction CDC 57.309, CDC 57.309 Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction ,   Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction (with revised GISAB questions)
57.310 Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction 57.310, CDC 57.310 Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction ,   Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction (with revised GISAB questions)
57.311 Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction CDC 57.311, CDC 57.311 Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction ,   57.311 Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction (with revised GISAB questions)
57.312 Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction 57.312, CDC 57.312 Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction ,   Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction (with modified GISAB questions)
57.313 Hemovigilance Adverse Reaction - Infection 57.313, CDC 57.313 Hemovigilance Adverse Reaction - Infection ,   Hemovigilance Adverse Reaction - Infection (with revised GISAB questions)
57.314 Hemovigilance Adverse Reaction - Post Transfusion Purpura 57.314, CDC 57.314 Hwemovilgilance Adverse Reaction - Post Transfusion Purpura ,   Hemovigilance Adverse Reaction - Post Transfusion Purpura (with revised GISAB questions)
57.315 Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea CDC 57.315, CDC 57.315 Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea ,   Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea (with revised GISAB questions)
57.316 Hemovigilance Adverse Reaction - Transfusion Associated Graft vs. Host Disease CDC 57.316, CDC 57.316 Hemovigilance Adverse Reaction - Transfusin Associated Graft vs. Host Disease ,   Hemovigilance Adverse Reaction - Transfusion Associated Graft vs. Host Disease (with revised GISAB questions)
57.317 Hemovigilance Adverse Reaction - Transfusion Associated Acute Lung Injury 57.317, CDC 57.317 Hemovigilance Adverse Reaction - Transfusion Related Acute Lung Injury ,   Hemovigilance Adverse Reaction - Transfusion Associated Acute Lung Injury (with revised GISAB questions)
57.318 Hemovigilance Adverse Reaction - Transfusion Associated Circulatory Overload CDC 57.318 Hemovigilance Adverse Reaction - Transfusion Associated Circulatory Overload
57.319 Hemovigilance Adverse Reaction - Unknown Transfusion Reaction CDC 57.319, CDC 57.319 Hemovigilance Adverse Reaction - Unknown Transfusion Reaction ,   Hemovigilance Adverse Reaction - Unknown Transfusion Reaction (with modified GISAB questions)
57.320 Hemovigilance Adverse Reaction - Other Transfusion Reaction 57.320, CDC 57.320 Hemovigilance Adverse Reaction - Other Transfusion Reaction ,   Hemovigilance Adverse Reaction - Other Transfusion Reaction (with revised GISAB questions)
57.400 Outpatient Procedure - Annual Facility Survey CDC 57.400 Outpatient Procedure Component - Annual Facility Survey
57.401 Outpatient Procedure - Monthly Reporting Plan CDC 57.401 Outpatient Procedure Component - Monthly Reporting Plan
57.402 Outpatient Procedure Component Event CDC 57.402 Outpatient Procedure - Component Event
57.403 Outpatient Procedure Component - Monthly Denominators and Summary CDC 57.403 Outpatient Procedure - Monthly Denominators and Summary
57.404 Outpatient Procedure Component - SSI Denominators 57.404 Outpatient Procedure Component - SSI Denominators
57.405 Outpatient Procedure Component - Surgical Site Infection (SSI) Event CDC 57.405 Outpatient Procedure Component - SSI Denominators
57.500 Outpatient Dialysis Center Practices Survey 57.500 Home Dialysis Center Practices Survey
57.501 Dialysis Monthly Reporting Plan CDC 57.501 NHSN Registration Form
57.502 Dialysis Event CDC 57.502 Dialysis Event
57.503 Denominators for Outpatient Dialysis CDC 57.503 Demominators for Dialysis Event Surveillance
57.504 Prevention Process Measures Monthly Monitoring for Dialysis CDC 57.504 Prevention Process Measures Monthly Monitoring for Dialysis
57.505 Dialysis Patient Influenza Vaccination CDC 57.505 Dialysis Patient Influenza Vaccination
57.506 Dialysis Patient Influenza Vaccination Denominator CDC 57.506 Dialysis Patient Influenza Vaccination Denominator
57.507 Home Dialysis Center Practices Survey 57.507, 57.507 57.507 Home Dialysis Center Practices Survey ,   57.507_dialhomesurv_2020_final
57.600 - Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-IT Initial Set up 57.600 Reporting Plan LOSMEN
57.600 - Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-IT Yearly Maintenance 57.600 Reporting Plan LOSMEN
57.600 - Neonatal Component FHIR Measure-Late Onset Sepsis Meningitis (LOSMEN) Module-Infection Preventionist 57.600 Reporting Plan LOSMEN
57.600 - Neonatal Component Late Onset Sepsis Meningitis (LOSMEN) Module CDA Data Collection-Infection Preventionist 57.600 Reporting Plan LOSMEN
57.700 - Medication Safety Component FHIR Measure-Glycemic Control Module Hypoglycemia-IT Initial Set up 57.700 Reporting Plan Glycemic Control Module Hypoglycemia
57.700 - Medication Safety Component FHIR Measure-Glycemic Control Module Hypoglycemia-IT Yearly Maintenance 57.700 Reporting Plan Glycemic Control Module Hypoglycemia
57.700 - Medication Safety Component FHIR Measure-Glycemic Control Module Hypoglycemia-Infection Preventionist 57.700 Reporting Plan Glycemic Control Module Hypoglycemia
57.701 - Glycemic Control Module-HYPO Annual Survey 57.701 Glycemic Control module Hypo-Annual Hospital Survey
Annual Healthcare Personnel Influenza Vaccination Summary 0920-0666 Annual Healthcare Personnel Influenza Vaccination Summary
Billing Code Data: 837I Upload
Hemovigilance Module Monthly Incident Summary CDC 57.302 Hemovigilance Module Monthly Incident Summary
Monthly Survey Patient Days & Nurse Staffing None, NA Monthly Survey Patient Days & Nurse Staffing ,   Monthly Survey Patient Days & Nurse Staffing
Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Long-Term Care Facilities 0920-0666 Weekly HCP Influenza Vaccination Cumulative Summary for Long-Term Care Facilities
Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Non-Long-Term Care Facilities 0920-0666 Weekly HCP Influenza Vaccination Cumulative Summary Non-Long-Term Care Facilities
Weekly Resident Influenza Vaccination Cumulative Summary for Long-Term Care Facilities 0920-0666 Weekly Resident Influenza Vaccination Cumulative Summary for Long-Term Care Facilities

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 5,271,122 5,267,622 0 3,500 0 0
Annual Time Burden (Hours) 2,434,332 2,433,165 0 1,167 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
At request of FDA Non-Substantive Change seeks to add new data collection form and addition of 1,167 burden hours.

$49,992,135
Yes Part B of Supporting Statement
    Yes
    Yes
No
No
No
Yes
Jeffrey Zirger 404 639-7118 [email protected]

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
08/26/2024


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