The National Healthcare Safety Network (NHSN)

Forms and Documents

Document Name	Status
Form CDC 57.106 57.106_ Patient Safety Monthly Reporting Plan Form	Modified
Form 57.138 57.138 Laboratory-identified MDRO or CDI Event for LTCF Form	New
Form CDC 57.213 57.213_Healthcare Personnel Influenza Vaccination Monthly Summary Form	New
Form CDC 57.139 57.139_MDRO or CDI Prevention Process Measures Monthly Monitoring for LTCF Form	New
Form CDC 57.137 57.137_Patient Safety Component --Annual Facility Survey for LTCF Form	New
Form CDC 57.304 57.304_Hemovigilance Adverse Reaction Form	Modified
Form CDC 57.305 57.305_Hemovigilance Module Adverse Reaction Form	Modified
Form CDC 57.303 57.303_Hemovigilance Module Monthly Reporting Denominators Form	Modified
Form CDC 57.302 57.302_Hemovigilance Module Blood Product Incident Reporting - Summary Data Form	Modified
Form CDC 57.301 57.301_Hemovigilance Module Monthly Reporting Plan Form	Modified
Form CDC 57.300 57.300_Hemovigilance Module Annual Survey Form	Modified
Form 57.75CC List of Blood Isolates Form	Removed
Form CDC 57.200 57.200_Healthcare Personnel Safety Component Facility Survey Form	Modified
Form CDC 57.208 57.208_Healthcare Worker Vaccination History Form	Modified
Form CDC 57.204 57.204_Healthcare Worker Demographic Data Form	Modified
Form CDC 57.206 57.206_Healthcare Worker Post-Exposure Prophylaxis Form	Modified
Form CDC 57.205 57.205_Exposure to Blood and Body Fluids Form	Modified
Form CDC 57.105 57.105_Group Contact Information Form	Modified
Form 57.75T Agreement to Participate and Consent Form	Removed
Form CDC 57.140 57.140 Urinary Tract Infection (UTI) for LTCF Form	Modified
Form CDC 57.103 57.103_Patient Safety Component Annual Facility Survey Form	Modified
Form CDC 57.131 57.131_High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method B Form	Modified
Form CDC 57.101 57.101_Facility Contact Information Form	Modified
Form CDC 57.133 57.133_Patient Vaccination Form	Modified
Form CDC 57.124 57.124_Antimicrobial Use and Resistence (AUR) - Pharmacy Data Form	Modified
Form CDC 57.130 57.130_Vaccination Monthly Monitoring Form - Summary Method Form	Modified
Form CDC 57.123 57.123_Antimicrobial Use and Resistance (AUR) - Microbiology Laboratory Data Form	Modified
Form CDC 57.100 57.100_NHSN Registration Form Form	Modified
Form CDC 57.121 57.121_Denominators for Procedure Form	Modified
Form CDC 57.128 57.128_Laboratory Identified MDRO Event Form	Modified
Form CDC 57.120 57.120_Surgical Site Infection (SSI) Form	Modified
Form CDC 57.126 57.126_MDRO or CDI Infection Event Form	Modified
Form CDC 57.119 57.119_Denominators for Outpatient Dialysis Form	Modified
Form CDC 57.127 57.127_Multi-drug Resistant Organism (MDRO) Prevention Process and Outcome Measures Monthly Monitoring Form Form	Modified
Form CDC 57.118 57.118_Denominators for Intensive Care Unit (ICU) Other Locations (not NICU or SCA) Form	Modified
Form CDC 57.207 57.207_Follow-up Laboratory Testing Form	Modified
Form CDC 57.117 57.117_Denominators for Specialty Care Area (SCA) Form	Modified
Form CDC 57.125 57.125_Central Line Insertion Practices Adherence Monitoring Form Form	Modified
Form CDC 57.116 57.116_Denominators for Neonatal Intensive Care Unit (NICU) Form	Modified
Form CDC 57.212 57.212_Post-Season Survey on Influenza Vaccination Programs for Healthcare Personnel Form	Modified
Form CDC 57.211 57.211_Preseason Survey on Influenza Vaccination Program for Healthcare Personnel Form	Modified
Form CDC 57.114 57.114_Urinary Tract Infection (UTI) Form	Modified
Form CDC 57.210 57.210_Healthcare Worker Influenza Antiviral Medication Administration Form	Modified
Form CDC 57.111 57.111_Pneumonia (PNEU) Form	Modified
Form CDC Form 57.209 57.209_Healthcare Worker Influenza Vaccination Form	Modified
Form CDC 57.109 57.109_Dialysis Event Form	Modified
Form 57.75DD Manual Categorization of Positive Blood Cultures Form	Removed
Form CDC 57.108 57.108_Primary Bloodstream Infection (BSI) Form	Modified
Form CDC 57.104 57.104_Patient Safety Component-- Outpatient Dialysis Center Practice Survey Form	Modified
Form CDC 57.203 57.203_Healthcare Personnel Safety Reporting Plan Form	Modified
Form CDC 57.202 57.202_Healthcare Worker Survey Form	Modified
G. Surveillance Methods Supporting Materials.zip Supplementary Document	2011-03-07
2. NHSN - Report of End of Human Research Review 0.1253.docx Supplementary Document	2011-03-07
3. NHSN 308d Request for Extension and Amendment.docx Supplementary Document	2011-03-07
2. NHSN 308d approval memo 2010.pdf Supplementary Document	2011-03-07
1. NHSN 308d approval 2010.pdf Supplementary Document	2011-03-07
4. Revision of Estimated Annual Cost Burden.docx Supplementary Document	2011-03-07
3. Revision of Estimated Annual Burden Hours.docx Supplementary Document	2011-03-07
2. Itemized IC Revisions and Justifications.docx Supplementary Document	2011-03-07
1. Explanations and justifications for proposed revisions to OMB 0920-0666.docx Supplementary Document	2011-03-07
3. 42 USC 242m.PDF Supplementary Document	2011-03-07
1. 42 USC 242b.PDF Supplementary Document	2011-03-07
B. 60 Day Federal Register Notice.pdf Supplementary Document	2011-03-07
2. 42 USC 242k.PDF Supplementary Document	2011-03-07
0920-0666 Revision SupSta A.0411 OMBv.1.doc Supporting Statement A	2011-04-01

IC Document Collections

IC ID	Document Title	Status
7134	57.106_ Patient Safety Monthly Reporting Plan Form	Modified
197371	57.138 Laboratory-identified MDRO or CDI Event for LTCF Form	New
197320	57.213_Healthcare Personnel Influenza Vaccination Monthly Summary Form	New
197319	57.139_MDRO or CDI Prevention Process Measures Monthly Monitoring for LTCF Form	New
197318	57.137_Patient Safety Component --Annual Facility Survey for LTCF Form	New
190365	57.304_Hemovigilance Adverse Reaction Form	Modified
190364	57.305_Hemovigilance Module Adverse Reaction 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 Urinary Tract Infection (UTI) for LTCF 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_Vaccination Monthly Monitoring Form - Summary Method 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 or CDI Infection Event Form	Modified
183560	57.119_Denominators for Outpatient Dialysis Form	Modified
183559	57.127_Multi-drug Resistant Organism (MDRO) Prevention Process and Outcome Measures Monthly Monitoring Form Form	Modified
183558	57.118_Denominators for Intensive Care Unit (ICU) Other Locations (not NICU or SCA) Form	Modified
183557	57.207_Follow-up 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 (PNEU) 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 Practice 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: 201104-0920-012
Status: Historical Inactive	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: Improperly submitted and continue	Conclusion Date: 04/28/2011
	Date Received in OIRA: 04/14/2011
Terms of Clearance: This collection requires a Part B.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	36 Months From Approved	09/30/2012
Responses	9,620,950	0	9,620,950
Time Burden (Hours)	5,172,244	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? No

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

IC Title	Form No.	Form Name
57.114_Urinary Tract Infection (UTI)	CDC 57.114	Urinary Tract Infection (UTI)
57.211_Preseason Survey on Influenza Vaccination Program for Healthcare Personnel	CDC 57.211	Pre-season Survey on Influenza Vaccination Programs for Healthcare Personnel
57.212_Post-Season Survey on Influenza Vaccination Programs for Healthcare Personnel	CDC 57.212	Post-season Survey on Influenza Vaccination Programs for Healthcare Personnel
57.116_Denominators for Neonatal Intensive Care Unit (NICU)	CDC 57.116	Denominators for Neonatal Intensive Care Unit (NICU)
57.125_Central Line Insertion Practices Adherence Monitoring Form	CDC 57.125	Central Line Insertion Practices Adherence Monitoring
57.117_Denominators for Specialty Care Area (SCA)	CDC 57.117	Denominators for Specialty Care Area (SCA)
57.207_Follow-up Laboratory Testing	CDC 57.207	Follow-up Laboratory Testing
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)
57.127_Multi-drug Resistant Organism (MDRO) Prevention Process and Outcome Measures Monthly Monitoring Form	CDC 57.127	MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring
57.119_Denominators for Outpatient Dialysis	CDC 57.119	Denominators for Outpatient Dialysis
57.126_MDRO or CDI Infection Event	CDC 57.126	MDRO or CDI Infection Event
57.120_Surgical Site Infection (SSI)	CDC 57.120	Surgical Site Infection (SSI)
57.128_Laboratory Identified MDRO Event	CDC 57.128	Laboratory-identified MDRO or CDI Event
57.121_Denominators for Procedure	CDC 57.121	Denominator for Procedure
57.100_NHSN Registration Form	CDC 57.100	NHSN Registration Form
57.123_Antimicrobial Use and Resistance (AUR) - Microbiology Laboratory Data	CDC 57.123	Antimicrobial Use and Resistance (AUR): Microbiology Laboratory Data Monthly Electronic Upload Specification Tables
57.124_Antimicrobial Use and Resistence (AUR) - Pharmacy Data	CDC 57.124	Antimicrobial Use and Resistance (AUR): Pharmacy Data Monthly Electronic Upload Specification Tables
57.302_Hemovigilance Module Blood Product Incident Reporting - Summary Data	CDC 57.302	Hemovigilance Module Monthly Incident Summary
57.130_Vaccination Monthly Monitoring Form - Summary Method	CDC 57.130	Vaccination Monthly Monitoring Form-- Summary Method
57.133_Patient Vaccination	CDC 57.133	Patient Vaccination
57.101_Facility Contact Information	CDC 57.101	Facility Contact Information
57.131_High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method B	CDC 57.131	Vaccination Monthly Monitoring Form-- Patient-Level Method
57.103_Patient Safety Component Annual Facility Survey	CDC 57.103	Patient Safety Component --Annual Facility Survey
57.140 Urinary Tract Infection (UTI) for LTCF	CDC 57.140	Urinary Tract Infection (UTI) for LTCF
57.105_Group Contact Information	CDC 57.105	Group Contact Information
57.205_Exposure to Blood and Body Fluids	CDC 57.205	Exposure to Blood/Body Fluids
57.206_Healthcare Worker Post-Exposure Prophylaxis	CDC 57.206	Healthcare Worker Prophylaxis/Treatment
57.204_Healthcare Worker Demographic Data	CDC 57.204	Healthcare Worker Demographic Data
57.208_Healthcare Worker Vaccination History	CDC 57.208	Healthcare Worker Vaccination History
57.200_Healthcare Personnel Safety Component Facility Survey	CDC 57.200	Healthcare Personnel Safety Component Annual Facility Survey
57.300_Hemovigilance Module Annual Survey	CDC 57.300	Hemovigilance Module Annual Facility Survey
57.301_Hemovigilance Module Monthly Reporting Plan	CDC 57.301	Hemovigilance Module Monthly Reporting Plan
57.106_ Patient Safety Monthly Reporting Plan	CDC 57.106	Patient Safety Monthly Reporting Plan
57.202_Healthcare Worker Survey	CDC 57.202	Healthcare Worker Survey
57.203_Healthcare Personnel Safety Reporting Plan	CDC 57.203	Healthcare Personnel Safety Monthly Reporting Plan
57.104_Patient Safety Component-- Outpatient Dialysis Center Practice Survey	CDC 57.104	Patient Safety Component--Outpatient Dialysis Center Practices Survey
57.108_Primary Bloodstream Infection (BSI)	CDC 57.108	Primary Bloodstream Infection (BSI)
Agreement to Participate and Consent	57.75T	Agreement to Participate and Consent
List of Blood Isolates	57.75CC	List of Blood Isolates
57.305_Hemovigilance Module Adverse Reaction	CDC 57.305	Hemovigilance Module Incident
57.304_Hemovigilance Adverse Reaction	CDC 57.304	Hemovigilance Module Adverse Reaction
57.137_Patient Safety Component --Annual Facility Survey for LTCF	CDC 57.137	Patient Safety Component --Annual Facility Survey for LTCF
57.109_Dialysis Event	CDC 57.109	Dialysis Event
57.209_Healthcare Worker Influenza Vaccination	CDC Form 57.209	Healthcare Worker Influenza Vaccination
57.111_Pneumonia (PNEU)	CDC 57.111	Pneumonia (PNEU)
57.210_Healthcare Worker Influenza Antiviral Medication Administration	CDC 57.210	Healthcare Worker Prophylaxis/Treatment
57.303_Hemovigilance Module Monthly Reporting Denominators	CDC 57.303	hemovigilance Module Monthly Reporting Denominators
57.139_MDRO or CDI Prevention Process Measures Monthly Monitoring for LTCF	CDC 57.139	MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF
57.213_Healthcare Personnel Influenza Vaccination Monthly Summary	CDC 57.213	Healthcare Personnel Influenza Vaccination Monthly Summary
Manual Categorization of Positive Blood Cultures	57.75DD	Manual Categorization of Positive Cultures
57.138 Laboratory-identified MDRO or CDI Event for LTCF	57.138	57.138_LabIDEvent_ LTCF_BLANK

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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:

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

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 04/14/2011

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