2011-30832. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an email to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

National Healthcare Safety Network (NHSN) (OMB No. 0920-0666 exp. 3/31/2012)—Revision—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

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 to 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. Healthcare institutions that participate in NHSN voluntarily report their data to CDC using a web browser based technology for data entry and data management. Data are collected by trained surveillance personnel using written standardized protocols. 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 revision submission includes an amended Assurance of Confidentiality, which required an update of the Assurance of Confidentiality language on all forms included in the NHSN surveillance system. The scope of NHSN dialysis surveillance is being expanded to include all outpatient dialysis centers so that the existing Dialysis Annual Survey can be used to facilitate prevention objectives set forth in the HHS HAI tier 2 Action Plan and to assess national practices in all Medicare-certified dialysis centers if CMS re-establishes this survey method (as expected). The Patient Safety (PS) Component is being expanded to include long term care facilities to facilitate HAI surveillance in this setting, for which no standardized reporting methodology or mechanism currently exists. Four new forms are proposed for this purpose. A new form is proposed to be added to the Healthcare Personnel Safety (HPS) Component to facilitate summary reporting of influenza vaccination in healthcare workers, which is anticipated to be required by CMS in the near future. In addition to this new form, the scope of the HPS Annual Facility Survey is being expanded to include all acute care facilities that would enroll if CMS does implement this requirement. The NHSN Antimicrobial Use and Resistance module is transitioning from manual web entry to electronic data upload only, which results in a significant decrease to the reporting burden for this package. Finally, there are many updates, clarifications, and data collection revisions proposed in this submission.

CDC is requesting to delete four currently approved forms that are no longer needed by the NHSN and add five new forms

The previously-approved NHSN package included 47 individual data collection forms. If all proposed revisions are approved, the reporting burden will decrease by 1,258,119 hours, for a total estimated burden of 3,914,125 hours and 48 total data collection tools.

Participating institutions must have a computer capable of supporting an Internet service provider (ISP) and access to an ISP. There is no cost to respondents other than their time. The total estimated annual burden hours are 3,914,125.

Estimate of Annualized Burden Hours

Respondents	Form name	Number of respondents	Responses per respondent	Burden per response (hours)
Infection Preventionist	NHSN Registration Form	6,000	1	5/60
	Facility Contact Information	6,000	1	10/60
	Patient Safety Component—Annual Facility Survey	6,000	1	40/60
	Patient Safety Component—Outpatient Dialysis Center Practices Survey	5,500	1	1
	Group Contact Information	6,000	1	5/60
	Patient Safety Monthly Reporting Plan	6,000	9	35/60
	Primary Bloodstream Infection (BSI)	6,000	36	32/60
	Dialysis Event	500	75	15/60
	Pneumonia (PNEU)	6,000	72	32/60
	Urinary Tract Infection (UTI)	6,000	27	32/60
Staff RN	Denominators for Neonatal Intensive Care Unit (NICU)	6,000	9	4
Denominators for Specialty Care Area (SCA)	6,000	9	5
	Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)	6,000	18	5
Staff RN	Denominator for Outpatient Dialysis	500	12	5/60
Infection Preventionist	Surgical Site Infection (SSI)	6,000	27	32/60
Staff RN	Denominator for Procedure	6,000	540	10/60
Laboratory Technician	Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables	6,000	12	5/60
Pharmacy Technician	Antimicrobial Use and Resistance (AUR)—Pharmacy Data Electronic Upload Specification Tables	6,000	12	5/60
Infection Preventionist	Central Line Insertion Practices Adherence Monitoring	6,000	100	5/60
	MDRO or CDI Infection Form	6,000	72	32/60
	MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	6,000	24	10/60
	Laboratory-identified MDRO or CDI Event	6,000	240	25/60
	Vaccination Monthly Monitoring Form-Summary Method	6,000	5	14
	Vaccination Monthly Monitoring Form-Patient-Level Method	2,000	5	2
	Patient Vaccination	2,000	250	10/60
	Patient Safety Component—Annual Facility Survey for LTCF	250	1	25/60
	Laboratory-identified MDRO or CDI Event for LTCF	250	8	30/60
	MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF	250	3	7/60
	Urinary Tract Infection (UTI) for LTCF	250	9	30/60
Occ Health RN	Healthcare Personnel Safety Component Annual Facility Survey	6,000	1	8
	Healthcare Worker Survey	600	100	10/60
	Healthcare Personnel Safety Monthly Reporting Plan	600	9	10/60
	Healthcare Worker Demographic Data	600	200	20/60
	Exposure to Blood/Body Fluids	600	50	1
	Healthcare Worker Prophylaxis/Treatment	600	10	15/60
Laboratory Technician	Follow-Up Laboratory Testing	600	100	15/60
Occ Health RN	Healthcare Worker Vaccination History	600	300	10/60
Occ Health RN	Healthcare Worker Influenza Vaccination	600	500	10/60
	Healthcare Worker Prophylaxis/Treatment-Influenza	600	50	10/60
	Pre-season Survey on Influenza Vaccination Programs for Healthcare Personnel	600	1	10/60
	Post-season Survey on Influenza Vaccination Programs for Healthcare Personnel	600	1	10/60
	Healthcare Personnel Influenza Vaccination Monthly Summary	6,000	6	2
Clinical Laboratory Technologist	Hemovigilance Module Annual Survey	500	1	2
	Hemovigilance Module Monthly Reporting Plan	500	12	2/60
	Hemovigilance Module Monthly Incident Summary	500	12	2
	Hemovigilance Module Monthly Reporting Denominators	500	12	30/60
	Hemovigilance Adverse Reaction	500	120	10/60
	Hemovigilance Incident	500	72	10/60

Dated: November 22, 2011

Daniel Holcomb,

Reports Clearance Officer, Centers for Disease Control and Prevention.