The National Healthcare Safety Network (NHSN)

Forms and Documents

Document Name	Status
Form 57.213 57.213 Healthcare Personnel Influenza Vaccination Monthly Summary Form	Removed
Form 57.303 57.303 Hemovigilance Module Monthly Reporting Denominators Form	Modified
Form 57.301 57.301 Hemovigilance Module Monthly Reporting Plan Form	Modified
Form 57.208 57.208 Healthcare Worker Vaccination History Form	Removed
Form 57.205 57.205 Exposure to Blood and Body Fluids Form	Modified
Form 57.105 57.105 Group Contact Information Form	Modified
Form 57.101 57.101 Facility Contact Information Form	Modified
Form 57.127 57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring Form	Modified
Form 57.212 57.212 Post-Season Survey on Influenza Vaccination Programs for Healthcare Personnel Form	Removed
Form 57.210 57.210 Healthcare Worker Prophylaxis/Treatment - Influenza Form	Modified
Form 57.209 57.209 Healthcare Worker Influenza Vaccination Form	Removed
Form 57.202 57.202 Healthcare Worker Survey Form	Removed
091512 SupSta Part B (0666).docx Supporting Statement B	2012-10-15
Att E CMS Reporting Requirement Cover Page.docx Supplementary Document	2012-10-26
2. Itemized IC Revisions and Justifications.docx Supplementary Document	2012-10-26
2. NHSN - Report of End of Human Research Review 0.1253.docx Supplementary Document	2012-10-15
1. Explanations and justifications for proposed revisions to OMB 0920.docx Supplementary Document	2012-10-15
B. 60 Day Federal Registry Notice.pdf Supplementary Document	2012-10-15
3. 42 USC 242m.PDF Supplementary Document	2012-10-15
2. 42 USC 242k.PDF Supplementary Document	2012-10-15
1. 42 USC 242b.PDF Supplementary Document	2012-10-15
10. LTCF Prev Process Measures (IC#52).pdf Supplementary Document	2012-10-15
17. Ventilator-Associated Event (IC# 49).pdf Supplementary Document	2012-10-15
5_HPS_fluVacc.pdf Supplementary Document	2011-12-05
LTC MDRO CDI Protocol.docx Supplementary Document	2011-12-05
LTC TOI LAB ID EVENT.docx Supplementary Document	2011-12-05
LTC TOI Annual Facility Survey.docx Supplementary Document	2011-12-05
1-10-BV-Protocol.pdf Supplementary Document	2011-12-05
1-10-BV-Protocol.pdf Supplementary Document	2011-12-05
1-10-BV-Protocol.pdf Supplementary Document	2011-12-05
1-10-BV-Protocol.pdf Supplementary Document	2011-12-05
Appendix-G-BV-Protocol.pdf Supplementary Document	2011-12-05
Appendix-F-BV-Protocol.pdf Supplementary Document	2011-12-05
Appendix-E-BV-Protocol.pdf Supplementary Document	2011-12-05
Appendix-D-BV-Protocol.pdf Supplementary Document	2011-12-05
Appendix-C-BV-Protocol.pdf Supplementary Document	2011-12-05
Appendix-B-BV-Protocol.pdf Supplementary Document	2011-12-05
Appendix-A-BV-Protocol.pdf Supplementary Document	2011-12-05
1-10-BV-Protocol.pdf Supplementary Document	2011-12-05
1-10-BV-Protocol.pdf Supplementary Document	2011-12-05
6_HPS_toi.pdf Supplementary Document	2011-12-05
5_HPS_fluVacc.pdf Supplementary Document	2011-12-05
6_HPS_toi.pdf Supplementary Document	2011-12-05
5_HPS_fluVacc.pdf Supplementary Document	2011-12-05
4_HPS_bbfExpos.pdf Supplementary Document	2011-12-05
11. LTCF Urinary Tract Infection (IC# 32).pdf Supplementary Document	2012-10-15
F1.13PSC_HRIIV.pdf Supplementary Document	2011-12-05
F1.13PSC_HRIIV.pdf Supplementary Document	2011-12-05
1. Antimicrobial Use and Resistance (IC# 25, 27).pdf Supplementary Document	2012-10-15
F1.13PSC_HRIIV.pdf Supplementary Document	2011-12-05
1. Antimicrobial Use and Resistance (IC# 25, 27).pdf Supplementary Document	2012-10-15
F1.17PSC_NosInfDef.pdf Supplementary Document	2011-12-05
F1.16PSC_KeyTerms.pdf Supplementary Document	2011-12-05
F1.15PSC_LocationsDescriptions.pdf Supplementary Document	2011-12-05
F1.2PSC_IdentifyingHAIs_NHSN.pdf Supplementary Document	2011-12-05
F1.1PSC_Overview.pdf Supplementary Document	2011-12-05
5. Denominators (IC# 13, 15, 17, 23).pdf Supplementary Document	2012-10-15
F1.12PSC_MDRO_CDAD.pdf Supplementary Document	2011-12-05
15. Surgical Site Infection (IC# 21).pdf Supplementary Document	2012-10-15
F1.12PSC_MDRO_CDAD.pdf Supplementary Document	2011-12-05
F1.14PSC_Form_Instructions.pdf Supplementary Document	2011-12-05
F1.12PSC_MDRO_CDAD.pdf Supplementary Document	2011-12-05
5. Denominators (IC# 13, 15, 17, 23).pdf Supplementary Document	2012-10-15
7. Healthcare Personnel Safety Component (IC#s 3, 9, 16, 34, 35, 36, 38).pdf Supplementary Document	2012-10-15
5. Denominators (IC# 13, 15, 17, 23).pdf Supplementary Document	2012-10-15
3. Central Line Insertion Practices (IC# 14).pdf Supplementary Document	2012-10-15
5. Denominators (IC# 13, 15, 17, 23).pdf Supplementary Document	2012-10-15
5_HPS_fluVacc.pdf Supplementary Document	2011-12-05
5_HPS_fluVacc.pdf Supplementary Document	2011-12-05
2. Catheter-Associated Urinary Tract Infection (IC# 10).pdf Supplementary Document	2012-10-15
7. Healthcare Personnel Safety Component (IC#s 3, 9, 16, 34, 35, 36, 38).pdf Supplementary Document	2012-10-15
13. Pneumonia (IC# 8).pdf Supplementary Document	2012-10-15
5_HPS_fluVacc.pdf Supplementary Document	2011-12-05
6. Dialysis (IC# 6, 19).pdf Supplementary Document	2012-10-15
4. Central Line-Associated Blood Stream Infection (IC# 5).pdf Supplementary Document	2012-10-15
7. Healthcare Personnel Safety Component (IC#s 3, 9, 16, 34, 35, 36, 38).pdf Supplementary Document	2012-10-15
8_HPS_cdcCodes.pdf Supplementary Document	2011-12-05
7_HPS_keyTerms.pdf Supplementary Document	2011-12-05
2_HPS_intro.pdf Supplementary Document	2011-12-05
6_HPS_toi.pdf Supplementary Document	2011-12-05
14. Reporting Plan (IC# 1).pdf Supplementary Document	2012-10-15
082712 SupSta Part A (0666).docx Supporting Statement A	2012-10-15

IC Document Collections

IC ID	Document Title	Status
7134	57.106 Patient Safety Monthly Reporting Plan Other-WORD	Modified
200382	57.151 Patient Safety Component -- Annual Facility Survey for IRF Other-WORD	Modified
200381	57.150 Patient Safety Component -- Annual Facility Survey for LTAC Other-WORD	Modified
200380	57.143 Prevention Process Measures Monthly Monitoring for LTCF Other-WORD	Modified
200379	57.142 Denominators for LTCF Locations Other-WORD	Modified
200378	57.141 Monthly Reporting Plan for LTCF Other-WORD	Modified
200377	57.112 Ventilator-Associated Event (VAE) Other-WORD	Modified
197544	57.213 Healthcare Personnel Influenza Vaccination Monthly Summary Form	Removed
197543	57.139 MDRO and CDI Monthly Monitoring for LTCF Other-WORD	Modified
197542	57.138 Laboratory-Identified MDRO or CDI Event for LTCF Other-WORD	Modified
197541	57.137 Long Term care Facility Component--Annual Facility Survey Other-WORD	Modified
190365	57.304 Hemovigilance Module Adverse Reaction Other-WORD	Modified
190364	57.305 Hemovigilance Module Incident Other-WORD	Modified
190363	57.303 Hemovigilance Module Monthly Reporting Denominators Form	Modified
190362	57.302 Hemovigilance Module Monthly Incident Summary Other-WORD	Modified
190361	57.301 Hemovigilance Module Monthly Reporting Plan Form	Modified
190360	57.300 Hemovigilance Module Annual Facility Survey Other-WORD	Modified
183582	57.200 Healthcare Personnel Safety Component Facility Survey Other-WORD	Modified
183580	57.208 Healthcare Worker Vaccination History Form	Removed
183579	57.204 Healthcare Worker Demographic Data Other-WORD	Modified
183578	57.206 Healthcare Worker Prophylaxis/Treatment Other-WORD	Modified
183577	57.205 Exposure to Blood and Body Fluids Form	Modified
183576	57.105 Group Contact Information Form	Modified
183573	57.140 Urinary Tract Infection (UTI) for LTCF Other-WORD	Modified
183572	57.103 Patient Safety Component - Annual Hospital Survey Other-WORD	Modified
183571	57.131 Vaccination Monthly Monitoring Form - Patient-Level Method Other-WORD	Modified
183570	57.101 Facility Contact Information Form	Modified
183569	57.133 Patient Vaccination Other-WORD	Modified
183568	57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data Other-WORD	Modified
183567	57.130 Vaccination Monthly Monitoring Form - Summary Method Other-WORD	Modified
183566	57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Laboratory Data Other-WORD	Modified
183565	57.100 NHSN Registration Form Other-WORD	Modified
183564	57.121 Denominators for Procedure Other-WORD	Modified
183563	57.128 Laboratory Identified or CDI MDRO Event Other-WORD	Modified
183562	57.120 Surgical Site Infection (SSI) Other-WORD	Modified
183561	57.126 MDRO or CDI Infection Event Other-WORD	Modified
183560	57.119 Denominators for Outpatient Dialysis Other-WORD	Modified
183559	57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring Form	Modified
183558	57.118 Denominators for Intensive Care Unit (ICU) Other Locations (Not NICU or SCA) Other-WORD	Modified
183557	57.207 Follow-up Laboratory Testing Other-WORD	Modified
183556	57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC) Other-WORD	Modified
183555	57.125 Central Line Insertion Practices Adherence Monitoring Form Other-WORD	Modified
183554	57.116 Denominators for Neonatal Intensive Care Unit (NICU) Other-WORD	Modified
183553	57.212 Post-Season Survey on Influenza Vaccination Programs for Healthcare Personnel Form	Removed
183552	57.211 Preseason Survey on Influenza Vaccination Program for Healthcare Personnel Other-WORD	Removed
183551	57.114 Urinary Tract Infection (UTI) Other-WORD	Modified
183550	57.210 Healthcare Worker Prophylaxis/Treatment - Influenza Form	Modified
183549	57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram) Other-WORD	Modified
183548	57.209 Healthcare Worker Influenza Vaccination Form	Removed
183547	57.109 Dialysis Event Other-WORD	Modified
183545	57.108 Primary Bloodstream Infection (BSI) Other-WORD	Modified
183544	57.104 Patient Safety Component --Outpatient Dialysis Center Practices Survey Other-WORD	Modified
183543	57.203 Healthcare Personnel Safety Reporting Plan Other-WORD	Modified
183542	57.202 Healthcare Worker Survey Form	Removed

ICR Details

OMB Control No: 0920-0666	ICR Reference No: 201211-0920-005
Status: Historical Active	Previous ICR Reference No: 201112-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: The National Healthcare Safety Network (NHSN)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/21/2012
	Date Received in OIRA: 11/01/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2015	36 Months From Approved	01/31/2015
Responses	4,905,350	0	9,672,750
Time Burden (Hours)	3,562,653	0	3,978,175
Cost Burden (Dollars)	20,165,365	0	162,000

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Abstract: 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. 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; and to detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing risks.

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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: US Code: 42 USC 242k Name of Law: Public Health Service Ac t

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 43828	07/26/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 65191	10/25/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 48

IC Title	Form No.	Form Name
57.106 Patient Safety Monthly Reporting Plan
57.203 Healthcare Personnel Safety Reporting Plan
57.104 Patient Safety Component --Outpatient Dialysis Center Practices Survey
57.131 Vaccination Monthly Monitoring Form - Patient-Level Method
57.103 Patient Safety Component - Annual Hospital Survey
57.108 Primary Bloodstream Infection (BSI)
57.109 Dialysis Event
57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram)
57.210 Healthcare Worker Prophylaxis/Treatment - Influenza	57.210	Healthcare Worker Prophylaxis/Treatment Influenza
57.114 Urinary Tract Infection (UTI)
57.116 Denominators for Neonatal Intensive Care Unit (NICU)
57.125 Central Line Insertion Practices Adherence Monitoring Form
57.117 Denominators for Specialty Care Area (SCA)/Onocology (ONC)
57.207 Follow-up Laboratory Testing
57.118 Denominators for Intensive Care Unit (ICU) Other Locations (Not NICU or SCA)
57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	57.127	MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring
57.119 Denominators for Outpatient Dialysis
57.126 MDRO or CDI Infection Event
57.120 Surgical Site Infection (SSI)
57.128 Laboratory Identified or CDI MDRO Event
57.121 Denominators for Procedure
57.100 NHSN Registration Form
57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Laboratory Data
57.130 Vaccination Monthly Monitoring Form - Summary Method
57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data
57.133 Patient Vaccination
57.101 Facility Contact Information	57.101	Facility Contact Information
57.140 Urinary Tract Infection (UTI) for LTCF
57.105 Group Contact Information	57.105	Group Contact Information
57.205 Exposure to Blood and Body Fluids	57.205	Exposure to Blood/Body Fluids
57.206 Healthcare Worker Prophylaxis/Treatment
57.204 Healthcare Worker Demographic Data
57.200 Healthcare Personnel Safety Component Facility Survey
57.300 Hemovigilance Module Annual Facility Survey
57.301 Hemovigilance Module Monthly Reporting Plan	57.301	Hemovigilance Module Monthly Reporting Plan
57.302 Hemovigilance Module Monthly Incident Summary
57.303 Hemovigilance Module Monthly Reporting Denominators	57.303	Hemovigilance Module Monthly Reporting Denominators
57.305 Hemovigilance Module Incident
57.304 Hemovigilance Module Adverse Reaction
57.137 Long Term care Facility Component--Annual Facility Survey
57.138 Laboratory-Identified MDRO or CDI Event for LTCF
57.139 MDRO and CDI Monthly Monitoring for LTCF
57.112 Ventilator-Associated Event (VAE)
57.141 Monthly Reporting Plan for LTCF
57.142 Denominators for LTCF Locations
57.143 Prevention Process Measures Monthly Monitoring for LTCF
57.150 Patient Safety Component -- Annual Facility Survey for LTAC
57.151 Patient Safety Component -- Annual Facility Survey for IRF
57.202 Healthcare Worker Survey	57.202	HealthCare Worker Survey
57.209 Healthcare Worker Influenza Vaccination	57.209	Healthcare Worker Influenza Vaccinatuion
57.211 Preseason Survey on Influenza Vaccination Program for Healthcare Personnel
57.212 Post-Season Survey on Influenza Vaccination Programs for Healthcare Personnel	57.212	Post-season Survey on Influenza Vaccination Programs for Health Personnel
57.208 Healthcare Worker Vaccination History	57.208	Healthcare Worker Vaccination History
57.213 Healthcare Personnel Influenza Vaccination Monthly Summary	57.213	Healthcare Personnel Influenza Vaccination Monthly Summary

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ICR Summary of Burden

	Total Approved	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	4,905,350	9,672,750	0	-4,190,200	-577,200	0
Annual Time Burden (Hours)	3,562,653	3,978,175	0	-253,322	-162,200	0
Annual Cost Burden (Dollars)	20,165,365	162,000	0	20,003,365	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: There are multiple updates and revisions to 29 of the currently approved forms based on user feedback, changes in surveillance definitions; and Centers of Medicare and Medicaid Services (CMS) reporting requirements. A total of six forms will be removed from the package as they will be no longer used within NHSH resulting in the decrease in burden since last submission.

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Annual Cost to Federal Government: $11,337,860

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

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? Uncollected

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Common Form ICR:  No

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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: 11/01/2012

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