The National Healthcare Safety Network (NHSN)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 57.75A A_PSPlan.ppt	Form	Modified	Available
Form 57.304 Hemovigilance Adverse Reaction	Form	New	Available
Form 57.305 Hemovigilance Incident	Form	New	Available
Form 57.303 Hemovigilance Module Monthly Reporting Denominators	Form	New	Available
Form 57.302 Hemovigilance Module Blood Product Incident Reporting - Summary Data	Form	New	Available
Form 57.301 Hemovigilance Module Monthly Reporting Plan	Form	New	Available
Form 57.300 Hemovigilance Module Annual Facility Survey	Form	New	Available
Form 57.75CC List of Blood Isolates	Form	Modified	Available
Form 57.75Za Healthcare Personnel Safety Component Facility Survey	Form	Modified	Available
Form 57.75Z Implementation of Engineering (safety devices) Controls for Sharps Injury Prevention	Form	Removed	Available
Form 57.75Y Healthcare Worker Vaccination History	Form	Modified	Repair queued
Form 57.75X Healthcare Worker Demographic Data	Form	Modified	Available
Form 57.75W Healthcare Worker Post-Exposure Prophylaxis	Form	Modified	Available
Form 57.75V Exposure to Blood and Body Fluids	Form	Modified	Available
Form 57.75U Group Contact Information	Form	Modified	Available
Form 57.75TT Laboratory-identified MDRO Event Summary Form	Form	Removed	Repair queued
Form 57.75T Agreement to Participate and Consent	Form	Modified	Available
Form 57.75SS High Risk Inpatient Influenza Vaccination Denominator Data Form - Method B	Form	Modified	Available
Form 57.75S Patient Safety Component Annual Facility Survey	Form	Modified	Available
Form 57.75RR High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method B	Form	Modified	Available
Form 57.75R Facility Contact Information	Form	Modified	Available
Form 57.75QQ High Risk Inpatient Influenza Vaccination Numerator Data Form - Method B	Form	Modified	Repair queued
Form 57.75Q Antimicrobia Use and Resistence (AUR) - Pharmacy Data	Form	Modified	Available
Form 57.75PP High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method A	Form	Modified	Available
Form 57.75P Antimicrobial Use and Resistance (AUR) - Microbiology Laboratory Data	Form	Modified	Available
Form 57.75OO NHSN Registration Form	Form	Modified	Available
Form 57.75O Denominators for Procedure	Form	Modified	Available
Form 57.75NN Laboratory Identified MDRO Event	Form	Modified	Available
Form 57.75N Surgical Site Infection (SSI)	Form	Modified	Available
Form 57.75MM MDRO Infection Event	Form	Modified	Available
Form 57.75M Denominators for Outpatient Dialysis	Form	Modified	Available
Form 57.75LL Multi-drug Resistant Organism (MDRO) Prevention Process and Outcome Measures Monthly Monitoring Form	Form	Modified	Available
Form 57.75L Denominators for Intensive Care Unit (ICU) Other Locations (not NICU or SCA)	Form	Modified	Available
Form 57.75KK Laboratory Testing	Form	Modified	Available
Form 57.75K Denominators for Specialty Care Area (SCA)	Form	Modified	Available
Form 57.75JJ Central Line Insertion Practices Adherence Monitoring Form	Form	Modified	Repair queued
Form 57.75J Demonination for Neonatal Intensive Care Unit (NICU)	Form	Modified	Available
Form 57.75II Post-Season Survey on Influenza Vaccination Programs for Healthcare Personnel	Form	Modified	Available
Form 57.75HH Preseason Survey on Influenza Vaccination Programs for Healthcare Personnel	Form	Modified	Available
Form 57.75H Urinary Tract Infection (UTI)	Form	Modified	Available
Form 57.75GG Healthcare Worker Influenza Antiviral Medication Administration	Form	Modified	Available
Form 57.75G, 57.75Ga, 5 Pneumonia (includes Any Patient Pneumonia Flow Diagram and Infant and Children Pneumonia Flow Diagram)	Form and Instruction	Modified	Available
Form 57.75FF Healthcare Worker Influenza Vaccination	Form	Modified	Available
Form 57.75E Dialysis Event	Form	Modified	Available
Form 57.75DD Manual Categorization of Positive Cultures	Form	Modified	Available
Form 57.75D Primary Bloodstream Infection (BSI)	Form	Modified	Available
Form 57.75BB Dialysis Survey	Form	Modified	Available
Form 57.75B Healthcare Personnel Safety Reporting Plan	Form	Modified	Available
Form 57.75AA Healthcare Worker Survey	Form	Modified	Available
Attachment 5_Biovigilance Task Force.doc	Supplementary Document	Uploaded 2009-07-20	Available
Attachment 4_ACBSA.pdf	Supplementary Document	Uploaded 2009-07-20	Available
Attachment 3_2007 National Blood Collection and Utilization Survey Report.pdf	Supplementary Document	Uploaded 2009-07-20	Available
Attachment 2_Patient Safety Act of 2005.pdf	Supplementary Document	Uploaded 2009-07-20	Available
Attachment 1_42 USC 241.pdf	Supplementary Document	Uploaded 2009-07-20	Available
0920-0666 Supporting Statement 07_06_09.doc	Supporting Statement A	Uploaded 2009-07-20	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
7134	Patient Safety Monthly Reporting Plan	Form	Modified	A_PSPlan.ppt
190365	Hemovigilance Adverse Reaction	Form	New	Hemovigilance Adverse Reaction
190364	Hemovigilance Incident	Form	New	Hemovigilance Incident
190363	Hemovigilance Module Monthly Reporting Denominators	Form	New	Hemovigilance Module Monthly Reporting Denominators
190362	Hemovigilance Module Blood Product Incident Reporting - Summary Data	Form	New	Hemovigilance Module Blood Product Incident Reporting - Summary Data
190361	Hemovigilance Module Monthly Reporting Plan	Form	New	Hemovigilance Module Monthly Reporting Plan
190360	Hemovigilance Module Annual Survey	Form	New	Hemovigilance Module Annual Facility Survey
183583	List of Blood Isolates	Form	Modified	List of Blood Isolates
183582	Healthcare Personnel Safety Component Facility Survey	Form	Modified	Healthcare Personnel Safety Component Facility Survey
183581	Implementation of Engineering (safety devices) Controls for Sharps Injury Prevention	Form	Removed	Implementation of Engineering (safety devices) Controls for Sharps Injury Prevention
183580	Healthcare Worker Vaccination History	Form	Modified	Healthcare Worker Vaccination History
183579	Healthcare Worker Demographic Data	Form	Modified	Healthcare Worker Demographic Data
183578	Healthcare Worker Post-Exposure Prophylaxis	Form	Modified	Healthcare Worker Post-Exposure Prophylaxis
183577	Exposure to Blood and Body Fluids	Form	Modified	Exposure to Blood and Body Fluids
183576	Group Contact Information	Form	Modified	Group Contact Information
183575	Laboratory-identified MDRO Event Summary Form	Form	Removed	Laboratory-identified MDRO Event Summary Form
183574	Agreement to Participate and Consent	Form	Modified	Agreement to Participate and Consent
183573	High Risk Inpatient Influenza Vaccination Denominator Data Form - Method B	Form	Modified	High Risk Inpatient Influenza Vaccination Denominator Data Form - Method B
183572	Patient Safety Component Annual Facility Survey	Form	Modified	Patient Safety Component Annual Facility Survey
183571	High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method B	Form	Modified	High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method B
183570	Facility Contact Information	Form	Modified	Facility Contact Information
183569	High Risk Inpatient Influenza Vaccination Numerator Data Form - Method B	Form	Modified	High Risk Inpatient Influenza Vaccination Numerator Data Form - Method B
183568	Antimicrobial Use and Resistence (AUR) - Pharmacy Data	Form	Modified	Antimicrobia Use and Resistence (AUR) - Pharmacy Data
183567	High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method A	Form	Modified	High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method A
183566	Antimicrobial Use and Resistance (AUR) - Microbiology Laboratory Data	Form	Modified	Antimicrobial Use and Resistance (AUR) - Microbiology Laboratory Data
183565	NHSN Registration Form	Form	Modified	NHSN Registration Form
183564	Denominators for Procedure	Form	Modified	Denominators for Procedure
183563	Laboratory Identified MDRO Event	Form	Modified	Laboratory Identified MDRO Event
183562	Surgical Site Infection (SSI)	Form	Modified	Surgical Site Infection (SSI)
183561	MDRO Infection Event	Form	Modified	MDRO Infection Event
183560	Denominators for Outpatient Dialysis	Form	Modified	Denominators for Outpatient Dialysis
183559	Multi-drug Resistant Organism (MDRO) Prevention Process and Outcome Measures Monthly Monitoring Form	Form	Modified	Multi-drug Resistant Organism (MDRO) Prevention Process and Outcome Measures Monthly Monitoring Form
183558	Denominators for Intensive Care Unit (ICU) Other Locations (not NICU or SCA)	Form	Modified	Denominators for Intensive Care Unit (ICU) Other Locations (not NICU or SCA)
183557	Laboratory Testing	Form	Modified	Laboratory Testing
183556	Denominators for Specialty Care Area (SCA)	Form	Modified	Denominators for Specialty Care Area (SCA)
183555	Central Line Insertion Practices Adherence Monitoring Form	Form	Modified	Central Line Insertion Practices Adherence Monitoring Form
183554	Denominators for Neonatal Intensive Care Unit (NICU)	Form	Modified	Demonination for Neonatal Intensive Care Unit (NICU)
183553	Post-Season Survey on Influenza Vaccination Programs for Healthcare Personnel	Form	Modified	Post-Season Survey on Influenza Vaccination Programs for Healthcare Personnel
183552	Preseason Survey on Influenza Vaccination Program for Healthcare Personnel	Form	Modified	Preseason Survey on Influenza Vaccination Programs for Healthcare Personnel
183551	Urinary Tract Infection (UTI)	Form	Modified	Urinary Tract Infection (UTI)
183550	Healthcare Worker Influenza Antiviral Medication Administration	Form	Modified	Healthcare Worker Influenza Antiviral Medication Administration
183549	Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram)	Form and Instruction	Modified	Pneumonia (includes Any Patient Pneumonia Flow Diagram and Infant and Children Pneumonia Flow Diagram)
183548	Healthcare Worker Influenza Vaccination	Form	Modified	Healthcare Worker Influenza Vaccination
183547	Dialysis Event	Form	Modified	Dialysis Event
183546	Manual Categorization of Positive Blood Cultures	Form	Modified	Manual Categorization of Positive Cultures
183545	Primary Bloodstream Infection (BSI)	Form	Modified	Primary Bloodstream Infection (BSI)
183544	Dialysis Survey	Form	Modified	Dialysis Survey
183543	Healthcare Personnel Safety Reporting Plan	Form	Modified	Healthcare Personnel Safety Reporting Plan
183542	Healthcare Worker Survey	Form	Modified	Healthcare Worker Survey

ICR Details

OMB Control No: 0920-0666	ICR Reference No: 200908-0920-002
Status: Historical Active	Previous ICR Reference No: 200901-0920-009
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: 09/15/2009
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/19/2009
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	36 Months From Approved	03/31/2011
Responses	9,620,950	0	9,511,550
Time Burden (Hours)	5,172,244	0	5,144,844
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:
	72 FR 41077	07/26/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 35868	07/21/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 47

table that charts list of burden

IC Title	Form No.	Form Name
Agreement to Participate and Consent	57.75T	Agreement to Participate and Consent
Antimicrobial Use and Resistance (AUR) - Microbiology Laboratory Data	57.75P	Antimicrobial Use and Resistance (AUR) - Microbiology Laboratory Data
Antimicrobial Use and Resistence (AUR) - Pharmacy Data	57.75Q	Antimicrobia Use and Resistence (AUR) - Pharmacy Data
Central Line Insertion Practices Adherence Monitoring Form	57.75JJ	Central Line Insertion Practices Adherence Monitoring Form
Denominators for Intensive Care Unit (ICU) Other Locations (not NICU or SCA)	57.75L	Denominators for Intensive Care Unit (ICU) Other Locations (not NICU or SCA)
Denominators for Neonatal Intensive Care Unit (NICU)	57.75J	Demonination for Neonatal Intensive Care Unit (NICU)
Denominators for Outpatient Dialysis	57.75M	Denominators for Outpatient Dialysis
Denominators for Procedure	57.75O	Denominators for Procedure
Denominators for Specialty Care Area (SCA)	57.75K	Denominators for Specialty Care Area (SCA)
Dialysis Event	57.75E	Dialysis Event
Dialysis Survey	57.75BB	Dialysis Survey
Exposure to Blood and Body Fluids	57.75V	Exposure to Blood and Body Fluids
Facility Contact Information	57.75R	Facility Contact Information
Group Contact Information	57.75U	Group Contact Information
Healthcare Personnel Safety Component Facility Survey	57.75Za	Healthcare Personnel Safety Component Facility Survey
Healthcare Personnel Safety Reporting Plan	57.75B	Healthcare Personnel Safety Reporting Plan
Healthcare Worker Demographic Data	57.75X	Healthcare Worker Demographic Data
Healthcare Worker Influenza Antiviral Medication Administration	57.75GG	Healthcare Worker Influenza Antiviral Medication Administration
Healthcare Worker Influenza Vaccination	57.75FF	Healthcare Worker Influenza Vaccination
Healthcare Worker Post-Exposure Prophylaxis	57.75W	Healthcare Worker Post-Exposure Prophylaxis
Healthcare Worker Survey	57.75AA	Healthcare Worker Survey
Healthcare Worker Vaccination History	57.75Y	Healthcare Worker Vaccination History
Hemovigilance Adverse Reaction	57.304	Hemovigilance Adverse Reaction
Hemovigilance Incident	57.305	Hemovigilance Incident
Hemovigilance Module Annual Survey	57.300	Hemovigilance Module Annual Facility Survey
Hemovigilance Module Blood Product Incident Reporting - Summary Data	57.302	Hemovigilance Module Blood Product Incident Reporting - Summary Data
Hemovigilance Module Monthly Reporting Denominators	57.303	Hemovigilance Module Monthly Reporting Denominators
Hemovigilance Module Monthly Reporting Plan	57.301	Hemovigilance Module Monthly Reporting Plan
High Risk Inpatient Influenza Vaccination Denominator Data Form - Method B	57.75SS	High Risk Inpatient Influenza Vaccination Denominator Data Form - Method B
High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method A	57.75PP	High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method A
High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method B	57.75RR	High Risk Inpatient Influenza Vaccination Monthly Monitoring Form - Method B
High Risk Inpatient Influenza Vaccination Numerator Data Form - Method B	57.75QQ	High Risk Inpatient Influenza Vaccination Numerator Data Form - Method B
Implementation of Engineering (safety devices) Controls for Sharps Injury Prevention	57.75Z	Implementation of Engineering (safety devices) Controls for Sharps Injury Prevention
Laboratory Identified MDRO Event	57.75NN	Laboratory Identified MDRO Event
Laboratory Testing	57.75KK	Laboratory Testing
Laboratory-identified MDRO Event Summary Form	57.75TT	Laboratory-identified MDRO Event Summary Form
List of Blood Isolates	57.75CC	List of Blood Isolates
MDRO Infection Event	57.75MM	MDRO Infection Event
Manual Categorization of Positive Blood Cultures	57.75DD	Manual Categorization of Positive Cultures
Multi-drug Resistant Organism (MDRO) Prevention Process and Outcome Measures Monthly Monitoring Form	57.75LL	Multi-drug Resistant Organism (MDRO) Prevention Process and Outcome Measures Monthly Monitoring Form
NHSN Registration Form	57.75OO	NHSN Registration Form
Patient Safety Component Annual Facility Survey	57.75S	Patient Safety Component Annual Facility Survey
Patient Safety Monthly Reporting Plan	57.75A	A_PSPlan.ppt
Pneumonia (includes Any Patient Pneumonia flow Diagram and Infant and Children Pneumonia Flow Diagram)	57.75G, 57.75Ga, 57.75Gb	Pneumonia (includes Any Patient Pneumonia Flow Diagram and Infant and Children Pneumonia Flow Diagram)
Post-Season Survey on Influenza Vaccination Programs for Healthcare Personnel	57.75II	Post-Season Survey on Influenza Vaccination Programs for Healthcare Personnel
Preseason Survey on Influenza Vaccination Program for Healthcare Personnel	57.75HH	Preseason Survey on Influenza Vaccination Programs for Healthcare Personnel
Primary Bloodstream Infection (BSI)	57.75D	Primary Bloodstream Infection (BSI)
Surgical Site Infection (SSI)	57.75N	Surgical Site Infection (SSI)
Urinary Tract Infection (UTI)	57.75H	Urinary Tract Infection (UTI)

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ICR Summary of Burden

table that charts list 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	9,620,950	9,511,550	0	109,400	0	0
Annual Time Burden (Hours)	5,172,244	5,144,844	0	27,400	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: Miscellaneous Actions

Short Statement: The additional Hemovigilance module was added in response to an HHS Advisory Committee recommendation and increases the annual burden by 32,200 hours; the deletion of two forms reduces the annual burden by 4,800 hours for a net increase of 27,400 hours. There is no change to the number of respondents.

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Annual Cost to Federal Government: $2,093,612

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 08/19/2009

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