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Proposed Data Collections Submitted for Public Comment and Recommendations

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Information about this document as published in the Federal Register.

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In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-7570 and send comments to Kimberly S. Lane, CDC Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

National Healthcare Safety Network (NHSN) (OMB No. 0920-0666), exp. 01/31/2015—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 four components: Patient Safety, Healthcare Personnel Safety, Biovigilance, and Long-Term Care Facility (LTCF). In general, the data reported under the Patient Safety Component protocols are used to (1) determine the magnitude of the healthcare-associated adverse events under study, trends in the rates of events, in the distribution of pathogens, and in the adherence to prevention practices, and (2) to detect changes in the epidemiology of adverse events resulting from new medical therapies and changing patient risks. Additionally, reported data will be used to describe the epidemiology of antimicrobial use and resistance and to understand the relationship of antimicrobial therapy to this growing problem. Under the Healthcare Personnel Safety Component protocols, data on events, both positive and adverse, are used to determine (1) the magnitude of adverse events in healthcare personnel and (2) compliance with immunization and sharps injuries safety guidelines. Under the Biovigilance Component, data on adverse reactions and incidents associated with blood transfusions are used to provide national estimates of adverse reactions and incidents. The Long-Term Care Facility (LTCF) Component is used to more specifically and appropriately capture data from the residents of skilled nursing facilities. Surveillance methods and definitions for this component specifically address the nuances of LTCF residents.

This revision submission includes major revisions to the Patient Safety Component—Outpatient Dialysis Center Practices Survey (Form 57.104) in an effort to provide further clarification to those collecting the information. Additionally, some of the changes have been made to improve surveillance data available for the outpatient dialysis population. Due to the CMS End Stage Renal Disease (ESRD) Quality Improvement Program (QIP) reporting requirements, over 5,700 dialysis facilities have already enrolled or will enroll into NHSN to report data in 2012. Form 57.104 is completed by each facility upon enrollment into NHSN and then every January thereafter.

Furthermore, minor revisions have been made to 28 other forms within the package to clarify and/or update surveillance definitions. Six forms have been removed for the purposes of simplification from the Healthcare Personnel Safety Component of the package due to changes within NHSN reporting of healthcare personnel influenza vaccination. Old functionality of individual level vaccination reporting will be removed from NHSN. CMS Inpatient Quality Reporting (IQR) requirements designate that all acute care facilities will report healthcare personnel vaccination counts at the summary level for the 2012-2013 flu season.

The previously approved NSHN package included 54 individual collection forms; the current revision request removes six forms for a total of 48 forms. The reporting burden will decrease by 415,523 hours, for a total of 3,562,653 hours.

Healthcare institutions that participate in NHSN 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. 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.

Estimate of Annualized Burden Hours

Form number and nameType of respondentsNumber of respondentsNumber of responses per respondentAvg. Burden per response (in hours)Total burden (in hours)
57.100: NHSN Registration FormRegistered Nurse (Infection Preventionist)2,00015/60167
57.101: Facility Contact InformationRegistered Nurse (Infection Preventionist)2,000110/60333
57.103: Patient Safety Component—Annual Hospital SurveyRegistered Nurse (Infection Preventionist)6,000130/603,000
57.104: Patient Safety Component—Outpatient Dialysis Center Practices SurveyRegistered Nurse (Infection Preventionist)5,70011.58,550
57.105: Group Contact InformationRegistered Nurse (Infection Preventionist)6,00015/60500
57.106: Patient Safety Monthly Reporting PlanRegistered Nurse (Infection Preventionist)10,0001235/6070,000
57.108: Primary Bloodstream Infection (BSI)Registered Nurse (Infection Preventionist)6,0003635/60126,000
57.109: Dialysis EventStaff RN5,7006016/6091,200
57.111: Pneumonia (PNEU)Registered Nurse (Infection Preventionist)6,0007232/60230,400
57.112: Ventilator-Associated EventRegistered Nurse (Infection Preventionist)6,00014425/60360,000
57.114: Urinary Tract Infection (UTI)Infection Preventionist6,0002732/6086,400
57.116: Denominators for Neonatal Intensive Care Unit (NICU)Staff RN6,00093162,000
57.117: Denominators for Specialty Care Area (SCA)/Oncology (ONC)Staff RN6,00095270,000
57.118: Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)Staff RN6,000185540,000
57.119: Denominator for Outpatient DialysisStaff RN5,700126/606,840
57.120: Surgical Site Infection (SSI)Registered Nurse (Infection Preventionist)6,0003632/60115,200
57.121: Denominator for ProcedureStaff RN6,0005405/60270,000
57.123: Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification TablesLaboratory Technician6,000125/606,000
57.124: Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification TablesPharmacy Technician6,000125/606,000
57.125: Central Line Insertion Practices Adherence MonitoringRegistered Nurse (Infection Preventionist)1,0001005/608,333
57.126: MDRO or CDI Infection FormRegistered Nurse (Infection Preventionist)6,0007232/60230,400
57.127: MDRO and CDI Prevention Process and Outcome Measures Monthly MonitoringRegistered Nurse (Infection Preventionist)6,0002410/6024,000
57.128: Laboratory-identified MDRO or CDI EventRegistered Nurse (Infection Preventionist)6,00024015/60360,000
57.130: Vaccination Monthly Monitoring Form-Summary MethodRegistered Nurse (Infection Preventionist)6,000514420,000
57.131: Vaccination Monthly Monitoring Form-Patient-Level MethodRegistered Nurse (Infection Preventionist)2,0005220,000
57.133: Patient VaccinationRegistered Nurse (Infection Preventionist)2,00025010/6083,333
57.137: Long-Term Care Facility Component—Annual Facility SurveyRegistered Nurse (Infection Preventionist)250145/60188
57.138: Laboratory-identified MDRO or CDI Event for LTCFRegistered Nurse (Infection Preventionist)250815/60500
57.139: MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCFRegistered Nurse (Infection Preventionist)250125/60250
57.140: Urinary Tract Infection (UTI) for LTCFRegistered Nurse (Infection Preventionist)250930/601,125
57.141: Monthly Reporting Plan for LTCFRegistered Nurse (Infection Preventionist)250125/60250
57.142: Denominators for LTCF LocationsRegistered Nurse (Infection Preventionist)2501239,000
57.143: Prevention Process Measures Monthly Monitoring for LTCFRegistered Nurse (Infection Preventionist)250125/60250
57.150: LTAC Annual SurveyRegistered Nurse (Infection Preventionist)400130/60200
57.151: Rehab Annual SurveyRegistered Nurse (Infection Preventionist)1,000125/60417
57.200: Healthcare Personnel Safety Component Annual Facility SurveyOccupational Health RN/Specialist10018800
57.203: Healthcare Personnel Safety Monthly Reporting PlanOccupational Health RN/Specialist100910/60150
57.204: Healthcare Worker Demographic DataOccupational Health RN/Specialist10020020/606,667
57.205: Exposure to Blood/Body FluidsOccupational Health RN/Specialist1005015,000
57.206: Healthcare Worker Prophylaxis/TreatmentOccupational Health RN/Specialist1003015/60750
57.207: Follow-Up Laboratory TestingLaboratory Technician1005015/601,250
57.210: Healthcare Worker Prophylaxis/Treatment-InfluenzaOccupational Health RN/Specialist6005010/605,000
57.300: Hemovigilance Module Annual SurveyMedical/Clinical Laboratory Technologist500121,000
57.301: Hemovigilance Module Monthly Reporting PlanMedical/Clinical Laboratory Technologist500122/60200
57.302: Hemovigilance Module Monthly Incident SummaryMedical/Clinical Laboratory Technologist50012212,000
57.303: Hemovigilance Module Monthly Reporting DenominatorsMedical/Clinical Laboratory Technologist5001230/603,000
57.304: Hemovigilance Adverse ReactionMedical/Clinical Laboratory Technologist50012010/6010,000
57.305: Hemovigilance IncidentMedical/Clinical Laboratory Technologist5007210/606,000
Total Est Annual Burden Hours3,562,653

Dated: July 3, 2012.

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.

[FR Doc. 2012-17987 Filed 7-25-12; 8:45 am]