The National Healthcare Safety Network (NHSN)

Forms and Documents

Document Name	Status
Form 57.106 57.106 Patient Safety Monthly Reporting Plan Form	Modified
Form 57.213 57.213 Healthcare Personnel Influenza Vaccination Monthly Summary Form	New
Form 57.139 57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF Form	New
Form 57.138 57.138 Laboratory-Identified MDRO or CDI Event for LTCF Form	New
Form 57.137 57.137 Patient Safety Component--Annual Facility Survey for LTCF Form	New
Form 57.304 57.304 Hemovigilance Adverse Reaction Form	Modified
Form 57.305 57.305 Hemovigilance Incident Form	Modified
Form 57.303 57.303 Hemovigilance Module Monthly Reporting Denominators Form	Modified
Form 57.302 57.302 Hemovigilance Module Blood Product Incident Reporting - Summary Data Form	Modified
Form 57.301 57.301 Hemovigilance Module Monthly Reporting Plan Form	Modified
Form 57.300 57.300 Hemovigilance Module Annual Survey Form	Modified
Form 57.75CC List of Blood Isolates Form	Removed
Form 57.200 57.200 Healthcare Personnel Safety Component Facility Survey Form	Modified
Form 57.208 57.208 Healthcare Worker Vaccination History Form	Modified
Form 57.204 57.204 Healthcare Worker Demographic Data Form	Modified
Form 57.206 57.206 Healthcare Worker Post-Exposure Prophylaxis Form	Modified
Form 57.205 57.205 Exposure to Blood and Body Fluids Form	Modified
Form 57.105 57.105 Group Contact Information Form	Modified
Form 57.75T Agreement to Participate and Consent Form	Removed
Form 57.140 57.140 High Risk Inpatient Influenza Vaccination Denominator Data Form - Method B Form	Modified
Form 57.103 57.103 Patient Safety Component Annual Facility Survey Form	Modified
Form 57.131 57.131 High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method B Form	Modified
Form 57.101 57.101 Facility Contact Information Form	Modified
Form 57.133 57.133 Patient Vaccination Form	Modified
Form 57.124 57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data Form	Modified
Form 57.130 57.130 High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method A Form	Modified
Form 57.123 57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Laboratory Data Form	Modified
Form 57.100 57.100 NHSN Registration Form Form	Modified
Form 57.121 57.121 Denominators for Procedure Form	Modified
Form 57.128 57.128 Laboratory Identified MDRO Event Form	Modified
Form 57.120 57.120 Surgical Site Infection (SSI) Form	Modified
Form 57.126 57.126 MDRO Infection Event Form	Modified
Form 57.119 57.119 Denominators for Outpatient Dialysis Form	Modified
Form 57.127 57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring Form	Modified
Form 57.118 57.118 Denominators for Intensive Care Unit (ICU) Other Locations (not NICU or SCA) Form	Modified
Form 57.207 57.207 Laboratory Testing Form	Modified
Form 57.117 57.117 Denominators for Specialty Care Area (SCA) Form	Modified
Form 57.125 57.125 Central Line Insertion Practices Adherence Monitoring Form Form	Modified
Form 57.116 57.116 Denominators for Neonatal Intensive Care Unit (NICU) Form	Modified
Form 57.212 57.212 Post-Season Survey on Influenza Vaccination Programs for Healthcare Personnel Form	Modified
Form 57.211 57.211 Preseason Survey on Influenza Vaccination Program for Healthcare Personnel Form	Modified
Form 57.114 57.114 Urinary Tract Infection (UTI) Form	Modified
Form 57.210 57.210 Healthcare Worker Influenza Antiviral Medication Administration Form	Modified
Form 57.111 57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram) Form	Modified
Form 57.209 57.209 Healthcare Worker Influenza Vaccination Form	Modified
Form 57.109 57.109 Dialysis Event Form	Modified
Form 57.75DD Manual Categorization of Positive Blood Cultures Form	Removed
Form 57.108 57.108 Primary Bloodstream Infection (BSI) Form	Modified
Form 57.104 57.104 Patient Safety Component --Outpatient Dialysis Center Practices Survey Form	Modified
Form 57.203 57.203 Healthcare Personnel Safety Reporting Plan Form	Modified
Form 57.202 57.202 Healthcare Worker Survey Form	Modified
0920-0666 NHSN_04 2011_SupSta PART B.doc Supporting Statement B	2011-04-29
AttE.3_ NHSN 308d Request for Ext and Amendment[1].docx Supplementary Document	2011-04-29
Att F IRB Approval.docx Supplementary Document	2011-04-29
G. Surveillance Methods Supporting Materials.zip Supplementary Document	2011-04-29
Att E.2_30d Memo.pdf Supplementary Document	2011-04-29
Att D.3_Revision of Estimated Annual Burden Hours[1].docx Supplementary Document	2011-04-29
Att D.2_Itemized IC Revisions and Justifications[1].docx Supplementary Document	2011-04-29
Att E.1_308d Approval.pdf Supplementary Document	2011-04-29
Att D.1_ Explanations and justifications for proposed revisions to OMB 0920-0666[1].docx Supplementary Document	2011-04-29
B. 60Day Federal Register Notice.pdf Supplementary Document	2011-04-29
2. 42 USC 242k.PDF Supplementary Document	2011-04-29
1. 42 USC 242b.PDF Supplementary Document	2011-04-29
3. 42 USC 242m.PDF Supplementary Document	2011-04-29
0920-0666 NHSN_04 2011 SupSta PART A.doc Supporting Statement A	2011-04-29

IC Document Collections

IC ID	Document Title	Status
7134	57.106 Patient Safety Monthly Reporting Plan Form	Modified
197544	57.213 Healthcare Personnel Influenza Vaccination Monthly Summary Form	New
197543	57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF Form	New
197542	57.138 Laboratory-Identified MDRO or CDI Event for LTCF Form	New
197541	57.137 Patient Safety Component--Annual Facility Survey for LTCF Form	New
190365	57.304 Hemovigilance Adverse Reaction Form	Modified
190364	57.305 Hemovigilance Incident Form	Modified
190363	57.303 Hemovigilance Module Monthly Reporting Denominators Form	Modified
190362	57.302 Hemovigilance Module Blood Product Incident Reporting - Summary Data Form	Modified
190361	57.301 Hemovigilance Module Monthly Reporting Plan Form	Modified
190360	57.300 Hemovigilance Module Annual Survey Form	Modified
183583	List of Blood Isolates Form	Removed
183582	57.200 Healthcare Personnel Safety Component Facility Survey Form	Modified
183580	57.208 Healthcare Worker Vaccination History Form	Modified
183579	57.204 Healthcare Worker Demographic Data Form	Modified
183578	57.206 Healthcare Worker Post-Exposure Prophylaxis Form	Modified
183577	57.205 Exposure to Blood and Body Fluids Form	Modified
183576	57.105 Group Contact Information Form	Modified
183574	Agreement to Participate and Consent Form	Removed
183573	57.140 High Risk Inpatient Influenza Vaccination Denominator Data Form - Method B Form	Modified
183572	57.103 Patient Safety Component Annual Facility Survey Form	Modified
183571	57.131 High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method B Form	Modified
183570	57.101 Facility Contact Information Form	Modified
183569	57.133 Patient Vaccination Form	Modified
183568	57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data Form	Modified
183567	57.130 High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method A Form	Modified
183566	57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Laboratory Data Form	Modified
183565	57.100 NHSN Registration Form Form	Modified
183564	57.121 Denominators for Procedure Form	Modified
183563	57.128 Laboratory Identified MDRO Event Form	Modified
183562	57.120 Surgical Site Infection (SSI) Form	Modified
183561	57.126 MDRO Infection Event Form	Modified
183560	57.119 Denominators for Outpatient Dialysis Form	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) Form	Modified
183557	57.207 Laboratory Testing Form	Modified
183556	57.117 Denominators for Specialty Care Area (SCA) Form	Modified
183555	57.125 Central Line Insertion Practices Adherence Monitoring Form Form	Modified
183554	57.116 Denominators for Neonatal Intensive Care Unit (NICU) Form	Modified
183553	57.212 Post-Season Survey on Influenza Vaccination Programs for Healthcare Personnel Form	Modified
183552	57.211 Preseason Survey on Influenza Vaccination Program for Healthcare Personnel Form	Modified
183551	57.114 Urinary Tract Infection (UTI) Form	Modified
183550	57.210 Healthcare Worker Influenza Antiviral Medication Administration Form	Modified
183549	57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram) Form	Modified
183548	57.209 Healthcare Worker Influenza Vaccination Form	Modified
183547	57.109 Dialysis Event Form	Modified
183546	Manual Categorization of Positive Blood Cultures Form	Removed
183545	57.108 Primary Bloodstream Infection (BSI) Form	Modified
183544	57.104 Patient Safety Component --Outpatient Dialysis Center Practices Survey Form	Modified
183543	57.203 Healthcare Personnel Safety Reporting Plan Form	Modified
183542	57.202 Healthcare Worker Survey Form	Modified

ICR Details

OMB Control No: 0920-0666	ICR Reference No: 201105-0920-001
Status: Historical Active	Previous ICR Reference No: 200908-0920-002
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: 05/12/2011
	Date Received in OIRA: 05/02/2011
Terms of Clearance: Approved consistent with the addition of Supporting Statement Part B.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2014	36 Months From Approved	09/30/2012
Responses	8,809,350	0	9,620,950
Time Burden (Hours)	3,914,125	0	5,172,244
Cost Burden (Dollars)	162,000	0	162,000

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Abstract: The NHSN is a knowledge system for accumulating, exchanging and integrating relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and healthcare personnel by promoting healthcare safety. Specifically, the data will be used to determine the magnitude of various healthcare-associated adverse events and trends in the rates of these events among patients and healthcare personnel with similar risks or exposures. This revision adds a Hemovigilance module to develop a national system for outcome surveillance that included recipients of blood and blood products, and deletes two forms no longer needed by the NHSN.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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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:
	75 FR 62833	10/13/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 12119	03/04/2011
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
57.210 Healthcare Worker Influenza Antiviral Medication Administration	57.210	Healthcare Worker Prophylaxis/Treatment Influenza
57.114 Urinary Tract Infection (UTI)	57.114	Urinary Tract Infection (UTI)
57.211 Preseason Survey on Influenza Vaccination Program for Healthcare Personnel	57.211	Pre-season Survey on Influenza Vaccination Programs 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
57.116 Denominators for Neonatal Intensive Care Unit (NICU)	57.116	Denominators for Neonatal Intensive Care Unit (NICU)
57.125 Central Line Insertion Practices Adherence Monitoring Form	57.125	Central Line Insertion Practices (CLIP) Adherence Monitoring
57.117 Denominators for Specialty Care Area (SCA)	57.117	Denominators for Specialty Care Area (SCA)
57.207 Laboratory Testing	57.207	Follow-up Laboratory Testing
57.118 Denominators for Intensive Care Unit (ICU) Other Locations (not NICU or SCA)	57.118	Denominator 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	57.119	Denominators or Outpatient Dialysis
57.126 MDRO Infection Event	57.126	MDRO or CDI Infection Event
57.120 Surgical Site Infection (SSI)	57.120	Surgical Site Infection (SSI)
57.128 Laboratory Identified MDRO Event	57.128	Laboratory-identified MDRO or CDI Event
57.121 Denominators for Procedure	57.121	Denominator for Procedure
57.100 NHSN Registration Form	57.100	NHSN Registration Form
57.123 Antimicrobial Use and Resistance (AUR) - Microbiology Laboratory Data	57.123	Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables
57.130 High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method A	57.130	Vaccinatin Monthly Monitoring Form -Summary Method
57.124 Antimicrobial Use and Resistence (AUR) - Pharmacy Data	57.124	Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specificaton Tables
57.133 Patient Vaccination	57.133	Patient Vaccination
57.106 Patient Safety Monthly Reporting Plan	57.106	Patient Safety Monthly Reporting Plan
57.202 Healthcare Worker Survey	57.202	HealthCare Worker Survey
57.203 Healthcare Personnel Safety Reporting Plan	57.203	Healthcare Personnel Safety Reporting Plan
57.104 Patient Safety Component --Outpatient Dialysis Center Practices Survey	57.104	Patient Safety Component--Outpatient Dialysis Center Practices Survey
57.108 Primary Bloodstream Infection (BSI)	57.108	primary Bloodstream Infection (BSI)
57.109 Dialysis Event	57.109	Dialysis Event
57.209 Healthcare Worker Influenza Vaccination	57.209	Healthcare Worker Influenza Vaccinatuion
57.111 Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram)	57.111	Pneumonia (PNEU)
57.101 Facility Contact Information	57.101	Facility Contact Information
57.131 High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method B	57.131	Vaccination Monthkly Monitoring Form-Patient-Level Method
57.103 Patient Safety Component Annual Facility Survey	57.103	Patient Safety Component -- Annual Facility Survey
57.140 High Risk Inpatient Influenza Vaccination Denominator Data Form - Method B	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 Post-Exposure Prophylaxis	57.206	Healthcare Worker Prophylaxis/Treatment
57.204 Healthcare Worker Demographic Data	57.204	Healthcare Worker Demographic Data
57.208 Healthcare Worker Vaccination History	57.208	Healthcare Worker Vaccination History
57.200 Healthcare Personnel Safety Component Facility Survey	57.200	Healthcare Personnel Safety Component Annual Facility Survey
57.300 Hemovigilance Module Annual Survey	57.300	Hemovigilance Module Annual Survey
57.301 Hemovigilance Module Monthly Reporting Plan	57.301	Hemovigilance Module Monthly Reporting Plan
57.302 Hemovigilance Module Blood Product Incident Reporting - Summary Data	57.302	Hemovigilance Module Monthly Incident Summary
57.303 Hemovigilance Module Monthly Reporting Denominators	57.303	Hemovigilance Module Monthly Reporting Denominators
57.305 Hemovigilance Incident	57.305	Hemovigilance Incident
Agreement to Participate and Consent	57.75T	Agreement to Participate and Consent
57.304 Hemovigilance Adverse Reaction	57.304	Hemovigilance Adverse Reaction
57.137 Patient Safety Component--Annual Facility Survey for LTCF	57.137	Patient Safety Component--Annual Facility Survey for LTCF
57.138 Laboratory-Identified MDRO or CDI Event for LTCF	57.138	Laboratory-Identified MDRO or CDI Event for LTCF
57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF	57.139	MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF
57.213 Healthcare Personnel Influenza Vaccination Monthly Summary	57.213	Healthcare Personnel Influenza Vaccination Monthly Summary
Manual Categorization of Positive Blood Cultures	57.75DD	Manual Categorization of Positive Cultures
List of Blood Isolates	57.75CC	List of Blood Isolates

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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	8,809,350	9,620,950	0	-811,600	0	0
Annual Time Burden (Hours)	3,914,125	5,172,244	0	-1,258,119	0	0
Annual Cost Burden (Dollars)	162,000	162,000	0	0	0	0

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: Yes

Burden Reduction Due to: Changing Forms

Short Statement: Modifications to existing forms and the deletion of several forms result in a decrease of 811,600 responses and a decrease of 1,258,119 annual burden hours.

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Annual Cost to Federal Government: $7,451,954

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: 05/02/2011

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