E9-17263. 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 e-mail 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)—Revision—National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), 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. The data will be used to detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing 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. This revision submission to OMB is a request to add a Hemovigilance module to the NHSN. This module is a response to a recommendation from HHS' Advisory Committee on Blood Safety and Availability (ACBSA) to develop a national system for outcome surveillance that includes recipients of blood and blood products. The module consists of 6 additional forms: (1) The Hemovigilance Module Annual Survey (1,000 annualized burden hours); (2) the Hemovigilance Module Monthly Reporting Plan (200 annualized burden hours); (3) Hemovigilance Module Blood Produce Incident Reporting—Summary Data (12,000 annualized burden hours); (4) Hemovigilance Module Monthly Reporting Denominators (3,000 annualized burden hours); (5) Hemovigilance Incident form (6,000 annualized burden hours); and (6) Hemovigilance Adverse Reaction form (10,000 annualized burden hours). The Hemovigilance Module totals an estimated 32,200 annualized burden hours

Also in this submission, CDC is also requesting to delete two forms currently approved by OMB: Implementation of Engineering Controls (currently approved for 300 burden hours) and the Laboratory Identified Multi-drug Resistant Organism (MDRO) Event Summary Form (currently approved for 4,500 burden hours). These forms are no longer needed by the NHSN. These deletions total 4,800 burden hours.

NHSN was first approved by OMB in 2005 and a revision request was approved by OMB in 2008. The 2008 revision request included modifications to approved forms, new modules, and an increase in the number of respondents. Later in 2008, CDC requested and received OMB approval to increase the number of respondents for the NHSN to 6,000 healthcare facilities. This change was a result of an increasing number of State legislatures requiring reporting of healthcare-acquired infections by healthcare facilities using the NHSN.

Participating institutions must have a computer capable of supporting an Internet service provider (ISP) and access to an ISP. The only other cost to respondents is their time to complete the appropriate forms.

OMB No. 0920-0666: National Healthcare Safety Network (NHSN) is currently approved for 5,144,844 annualized burden hours. This request includes a net increase of 27,400 burden hours (deletion of 2 forms: −4,800 burden hours; new Hemovigilance Module: +32,200 burden hours), bringing the total estimated annualized burden hours for the entire information collection request to 5,172,244 hours. There are no additional respondents for this request as they are already part of the respondent population.

Estimate of Annualized Burden Hours

Respondents	Form	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Infection Control Practitioner	Facility Contact Information	6,000	1	10/60
	Patient Safety Component Hospital Survey	6,000	1	30/60
	Agreement to Participate and Consent	6,000	1	15/60
	Group Contact Information	6,000	1	5/60
	Patient Safety Monthly Reporting Plan	6,000	9	35/60
	Healthcare Personnel Safety Reporting Plan	600	9	10/60
	Primary Bloodstream Infection (BSI)	6,000	36	30/60
	Pneumonia (PNEU)—also includes Any Patient Pneumonia Flow Diagram and Infant and Children Pneumonia Flow Diagram	6,000	72	30/60
	Urinary Tract Infection (UTI)	6,000	27	30/60
	Surgical Site Infection (SSI)	6,000	27	30/60
.	Dialysis Event (DI)	225	200	15/60
	Antimicrobial Use and Resistance (AUR)—Microbiology Laboratory Data	6,000	45	3
	Antimicrobial Use and Resistance—Pharmacy Data	6,000	36	2
	Denominators for Intensive Care Unit (ICU)/Other locations (Not NICU or SCA)	6,000	18	5
	Denominators for Specialty Care Area (SCA)	6,000	9	5
	Denominators for Neonatal Intensive Care Unit (NICU)	6,000	9	4
	Denominator for Procedure	6,000	540	8/60
	Denominator for Outpatient Dialysis	225	9	5/60
	Dialysis Survey	225	1	1
	List of Blood Isolates	6,000	1	1
	Manual Categorization of Positive Blood Cultures	6,000	1	1
	Exposures to Blood/Body Fluids	600	50	1
	Healthcare Personnel Post-exposure Prophylaxis	600	10	15/60
	Healthcare Personnel Demographic Data	600	200	20/60
	Healthcare Personnel Vaccination History	600	300	10/60
	Annual Facility Survey	600	1	8
	Healthcare Worker Survey	600	100	10/60
	Healthcare Personnel Influenza Vaccination Form	600	500	10/60
	Healthcare Personnel Influenza Antiviral Medication Administration Form	600	50	10/60
	Pre-season Survey on Influenza Vaccination Programs for Healthcare Workers	600	1	10/60
	Post-Season Survey on Influenza Vaccination Programs for Healthcare Workers	600	1	10/60
	Central Line Insertion Practices Adherence Monitoring Form (CLIP)	6,000	100	10/60
	Laboratory Testing	600	100	15/60
	MDRO Prevention Process and Outcome Measures Monthly Monitoring Form	6,000	24	10/60
	MDRO or CDAD Infection Event Form	6,000	72	30/60
	Laboratory Identified MDRO or CDAD Event Form (LabID)	6,000	240	30/60
	Registration Form	6,000	1	5/60
	High Risk Inpatient Influenza Vaccine—Summary Form Method A	6,000	5	16
	High Risk Inpatient Influenza Vaccine—Numerator Data Form Method B	2,000	250	10/60
	High Risk Inpatient Influenza Vaccine—Summary Form Method B	2,000	5	4
	High Risk Inpatient Influenza Vaccine—Denominator Data Form Method B	2,000	250	5/60
	Hemovigilance Module Annual Survey	500	1	2
	Hemovigilance Module Monthly Reporting Plan	500	12	2/60
	Hemovigilance Module Blood Product Incident Reporting—Summary Data	500	12	2
	Hemovigilance Module Monthly Reporting Denominators	500	12	30/60
	Hemovigilance Incident	500	72	10/60
	Hemovigilance Adverse Reaction	500	120	10/60

Dated: July 13, 2009.

Marilyn S. Radke,

Reports Clearance Officer, Centers for Disease Control and Prevention.