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Notice

Agency Forms Undergoing Paperwork Reduction Act Review

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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 (404) 639-7570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

Proposed Project

National Healthcare Safety Network (NHSN) (OMB No. 0920-0666), exp. 12/31/2015—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 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. The NHSN consists of six components: Patient Safety, Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility (LTCF), Dialysis, and Outpatient Procedure.

The new Dialysis Component was developed in order to separate reporting of dialysis events from the Patient Safety Component. The new component will tailor the NHSN user interface for dialysis users to simplify their data entry and analyses processes as well as provide options for expanding the Dialysis Component in the future to include dialysis surveillance in settings other than outpatient facilities.

The new Outpatient Procedure Component was developed to gather data on the impact of infections and other outcomes related to outpatient procedures that are performed in settings such as Ambulatory Surgery Centers (ASCs), Hospital Outpatient Departments (HOPDs), and physicians' offices. Three event types will be monitored in this new component: Same Day Outcome Measures, Prophylactic Intravenous (IV) Antibiotic Timing, and Surgical Site Infections (SSI).

This revision submission includes two new NHSN components and their corresponding forms. The Dialysis Component consists of changes to three previously approved forms and the addition of four new forms. These new forms include component specific monthly reporting plan, prevention process measures monthly monitoring, patient influenza vaccination, and patient influenza vaccination denominator forms. The Outpatient Procedure Component consists of four new forms: Component specific annual survey, monthly reporting plan, event, and monthly denominators and summary forms.

Further, the breadth of organism susceptibility data required on all of the healthcare-associated infection (HAI) report forms (i.e., BSI, UTI, SSI, PNEU (VAP and VAE), DE, LTUTI, and MDRO Infection Surveillance) has been reduced for the purposes of streamlining, simplification, and removing undue burden where possible. Significant changes were made to the NHSN Biovigilance Component forms as a result of a subject matter expert and stakeholder working groups. This includes the removal of the monthly incident summary form. A brand new form was added (Form 57.600—State Health Department Validation Record) to collect aggregate validation results that will be gathered by state health departments when conducting facility-level validation of NHSN healthcare-associated infection (HAI) data within their jurisdictions using the CDC/NHSN Validation Guidance and Toolkits.

Additionally, minor revisions have been made to 32 other forms within the package to clarify and/or update surveillance definitions.

The previously approved NSHN package included 48 individual collection forms; the current revision request adds nine new forms and removes one form for a total of 56 forms. The reporting burden will increase by 542,122 hours, for a total of 4,104,776 hours.

Estimated Annualized Burden Hours

Type of respondentsForm No. and nameNumber of respondentsNumber of responses per respondentAverage burden per response (in hrs.)
Registered Nurse (Infection Preventionist)57.100: NHSN Registration Form2,00015/60
Registered Nurse (Infection Preventionist)57.101: Facility Contact Information2,000110/60
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Registered Nurse (Infection Preventionist)57.103: Patient Safety Component—Annual Hospital Survey6,000130/60
Registered Nurse (Infection Preventionist)57.105: Group Contact Information6,00015/60
Registered Nurse (Infection Preventionist)57.106: Patient Safety Monthly Reporting Plan6,0001235/60
Registered Nurse (Infection Preventionist)57.108: Primary Bloodstream Infection (BSI)6,0003632/60
Registered Nurse (Infection Preventionist)57.111: Pneumonia (PNEU)6,0007229/60
Registered Nurse (Infection Preventionist)57.112: Ventilator-Associated Event6,00014422/60
Infection Preventionist57.114: Urinary Tract Infection (UTI)6,0002729/60
Staff RN57.116: Denominators for Neonatal Intensive Care Unit (NICU)6,00093
Staff RN57.117: Denominators for Specialty Care Area (SCA)/Oncology (ONC)6,00095
Staff RN57.118: Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)6,000545
Registered Nurse (Infection Preventionist)57.120: Surgical Site Infection (SSI)6,0003629/60
Staff RN57.121: Denominator for Procedure6,0005405/60
Laboratory Technician57.123: Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables6,000125/60
Pharmacy Technician57.124: Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables6,000125/60
Registered Nurse (Infection Preventionist)57.125: Central Line Insertion Practices Adherence Monitoring1,0001005/60
Registered Nurse (Infection Preventionist)57.126: MDRO or CDI Infection Form6,0007229/60
Registered Nurse (Infection Preventionist)57.127: MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring6,0002412/60
Registered Nurse (Infection Preventionist)57.128: Laboratory-identified MDRO or CDI Event6,00024015/60
Registered Nurse (Infection Preventionist)57.130: Vaccination Monthly Monitoring Form-Summary Method100514
Registered Nurse (Infection Preventionist)57.131: Vaccination Monthly Monitoring Form-Patient-Level Method10052
Registered Nurse (Infection Preventionist)57.133: Patient Vaccination10025010/60
Registered Nurse (Infection Preventionist)57.137: Long-Term Care Facility Component—Annual Facility Survey250145/60
Registered Nurse (Infection Preventionist)57.138: Laboratory-identified MDRO or CDI Event for LTCF250815/60
Registered Nurse (Infection Preventionist)57.139: MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF250125/60
Registered Nurse (Infection Preventionist)57.140: Urinary Tract Infection (UTI) for LTCF250927/60
Registered Nurse (Infection Preventionist)57.141: Monthly Reporting Plan for LTCF250125/60
Registered Nurse (Infection Preventionist)57.142: Denominators for LTCF Locations250123
Registered Nurse (Infection Preventionist)57.143: Prevention Process Measures Monthly Monitoring for LTCF250125/60
Registered Nurse (Infection Preventionist)57.150: LTAC Annual Survey400130/60
Registered Nurse (Infection Preventionist)57.151: Rehab Annual Survey1,000125/60
Occupational Health RN/Specialist57.200: Healthcare Personnel Safety Component Annual Facility Survey5018
Occupational Health RN/Specialist57.203: Healthcare Personnel Safety Monthly Reporting Plan50910/60
Occupational Health RN/Specialist57.204: Healthcare Worker Demographic Data5020020/60
Occupational Health RN/Specialist57.205: Exposure to Blood/Body Fluids50501
Occupational Health RN/Specialist57.206: Healthcare Worker Prophylaxis/Treatment503015/60
Laboratory Technician57.207: Follow-Up Laboratory Testing505015/60
Occupational Health RN/Specialist57.210: Healthcare Worker Prophylaxis/Treatment-Influenza505010/60
Medical/Clinical Laboratory Technologist57.300: Hemovigilance Module Annual Survey50012
Medical/Clinical Laboratory Technologist57.301: Hemovigilance Module Monthly Reporting Plan500121/60
Medical/Clinical Laboratory Technologist57.303: Hemovigilance Module Monthly Reporting Denominators500121
Medical/Clinical Laboratory Technologist57.304: Hemovigilance Adverse Reaction5004815/60
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Medical/Clinical Laboratory Technologist57.305: Hemovigilance Incident5001210/60
Staff RN57.400: Outpatient Procedure Component—Annual Facility Survey5,00015/60
Staff RN57.401: Outpatient Procedure Component—Monthly Reporting Plan5,0001215/60
Staff RN57.402: Outpatient Procedure Component Event5,0002540/60
Staff RN57.403: Outpatient Procedure Component—Monthly Denominators and Summary5,0001240/60
Registered Nurse (Infection Preventionist)57.500: Outpatient Dialysis Center Practices Survey6,00011.75
Staff RN57.501: Dialysis Monthly Reporting Plan6,000125/60
Staff RN57.502: Dialysis Event6,0006013/60
Staff RN57.503: Denominator for Outpatient Dialysis6,000126/60
Staff RN57.504: Prevention Process Measures Monthly Monitoring for Dialysis6001230/60
Staff RN57.505: Dialysis Patient Influenza Vaccination2507510/60
Staff RN57.506: Dialysis Patient Influenza Vaccination Denominator250510/60
Epidemiologist57.600: State Health Department Validation Record1525015/60
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Kimberly S. Lane,

Deputy Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.

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[FR Doc. 2013-20609 Filed 8-22-13; 8:45 am]

BILLING CODE 4163-18-P