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 Start Printed Page 35869requests, call the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail to email@example.com. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395-6974. Written comments should be received within 30 days of this notice.
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.
|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|
|Start Printed Page 35870|
|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|
|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|
|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 Adverse Reaction||500||120||10/60|
Dated: July 13, 2009.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-17263 Filed 7-20-09; 8:45 am]
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