View Information Collection Request (ICR) Package
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View ICR - OIRA Conclusion
OMB Control No:
0920-0666
ICR Reference No:
202408-0920-016
Status:
Historical Inactive
Previous ICR Reference No:
202402-0920-011
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-0666
Title:
[NCEZID] The National Healthcare Safety Network (NHSN)
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Improperly submitted and continue
Conclusion Date:
09/06/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/26/2024
Terms of Clearance:
Changes are not appropriate for a non-substantive change. Recommend submission as a revision or alternative format.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2026
12/31/2026
12/31/2026
Responses
5,267,622
0
5,267,622
Time Burden (Hours)
2,433,165
0
2,433,165
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
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
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
88 FR 56827
08/21/2023
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 78364
11/15/2023
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
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
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
At request of FDA Non-Substantive Change seeks to add new data collection form and addition of 1,167 burden hours.
Annual Cost to Federal Government:
$49,992,135
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
Yes
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Yes
Agency Contact:
Jeffrey Zirger 404 639-7118 wtj5@cdc.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
08/26/2024
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