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Proposed Data Collections Submitted for Public Comment and Recommendations

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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 404-639-5960 and send comments to Daniel Holcomb, CDC Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 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. 05/31/2014—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 Start Printed Page 56459adverse events resulting from new and current medical therapies and changing risks. The NHSN previously consisted of four components: Patient Safety, Healthcare Personnel Safety, Biovigilance, and eSurveillance. In addition, a fifth component, Long Term Care Facilities (LTCF) is included in this revision. 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 will be used to more specifically and appropriately capture data from the residents of skilled nursing facilities. In order to facilitate this reporting, seven LTCF forms were created by using forms from the Patient Safety Component as a base, with modifications to specifically address the nuances of LTC residents.

This revision submission includes the remaining three LTCF Component forms needed to facilitate healthcare-associated infection (HAI) surveillance in this setting, for which no standardized reporting methodology or mechanism currently exists. The three submitted LTCF forms along with the four previously approved LTCF forms will complete the LTCF Component. 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). In addition, two new annual facility surveys will be added for Long-term Acute Care Hospitals (LTAC) and Rehabilitation Hospitals (REHAB). A CMS ruling states that these specific hospital types must begin reporting HAI surveillance. Therefore, in order to accurately capture data relevant to those specific facility types, separate annual facility surveys were created. Also within the Patient Safety Component, a new form will be added, Streamlined Ventilator-Associated Pneumonia, to provide a streamlined, objective definition via which NHSN users may detect and report cases of ventilator-associated pneumonia in adult patients only. Finally there are many updates, clarifications, and data collection revisions proposed in this submission.

The previously approved NSHN package included 48 individual collection forms; the current revision request includes six new forms for a total of 54 forms. The reporting burden will increase by 64,050 hours, for a total of 3,978,175 hours.

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. 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)6,00015/60500
57.101: Facility Contact InformationRegistered Nurse (Infection Preventionist)6,000110/601,000
57.103: Patient Safety Component—Annual Facility SurveyRegistered Nurse (Infection Preventionist)6,000130/603,000
57.104: Patient Safety Component—Outpatient Dialysis Center Practices SurveyRegistered Nurse (Infection Preventionist)5,500115,500
57.105: Group Contact InformationRegistered Nurse (Infection Preventionist)6,00015/60500
57.106: Patient Safety Monthly Reporting PlanRegistered Nurse (Infection Preventionist)6,000935/6031,500
57.108: Primary Bloodstream Infection (BSI)Registered Nurse (Infection Preventionist)6,0003633/60118,800
57.109: Dialysis EventStaff RN5,5007516/60110,000
57.111: Pneumonia (PNEU)Registered Nurse (Infection Preventionist)6,0007232/60230,400
57.112: Streamlined Ventilator-Associated PneumoniaRegistered Nurse (Infection Preventionist)6,00014425/60360,000
57.114: Urinary Tract Infection (UTI)Registered Nurse (Infection Preventionist)6,0002732/6086,400
57.116: Denominators for Neonatal Intensive Care Unit (NICU)Staff RN6,00093162,000
57.117: Denominators for Specialty Care Area (SCA)Staff RN6,00095270,000
57.118: Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)Staff RN6,000185540,000
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57.119: Denominator for Outpatient DialysisStaff RN5,500126/606,600
57.120: Surgical Site Infection (SSI)Registered Nurse (Infection Preventionist)6,0003632/60115,200
57.121: Denominator for ProcedureStaff RN6,0005408/60432,000
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: Patient Safety Component—Annual Facility Survey for LTCFRegistered Nurse (Infection Preventionist)250125/60104
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)25035/6063
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/Specialist6,0001848,000
57.202: Healthcare Worker SurveyOccupational Health RN/Specialist60010010/6010,000
57.203: Healthcare Personnel Safety Monthly Reporting PlanOccupational Health RN/Specialist600910/60900
57.204: Healthcare Worker Demographic DataOccupational Health RN/Specialist60020020/6040,000
57.205: Exposure to Blood/Body FluidsOccupational Health RN/Specialist60050130,000
57.206: Healthcare Worker Prophylaxis/TreatmentOccupational Health RN/Specialist6001015/601,500
57.207: Follow-Up Laboratory TestingLaboratory Technician60010015/6015,000
57.208: Healthcare Worker Vaccination HistoryOccupational Health RN/Specialist60030010/6030,000
57.209: Healthcare Worker Influenza VaccinationOccupational Health RN/Specialist60050010/6050,000
57.210: Healthcare Worker Prophylaxis/Treatment—InfluenzaOccupational Health RN/Specialist6005010/605,000
57.211: Pre-season Survey on Influenza Vaccination Programs for Healthcare PersonnelOccupational Health RN/Specialist600110/60100
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57.212: Post-season Survey on Influenza Vaccination Programs for Healthcare PersonnelOccupational Health RN/Specialist600110/60100
57.213: Healthcare Personnel Influenza Vaccination Monthly SummaryOccupational Health RN/Specialist6,0006272,000
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 Hours: 3,978,175

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Dated: September 6, 2011.

Daniel Holcomb,

Reports Clearance Officer, Centers for Disease Control and Prevention.

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[FR Doc. 2011-23302 Filed 9-12-11; 8:45 am]