# Proposed Data Collections Submitted for Public Comment and Recommendations > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2012-17987 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** July 26, 2012 - **Citation:** 77 FR 43828 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-12-0666] Proposed Data Collections Submitted for Public Comment and Recommendations 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 omb@cdc.gov. 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 name Type of respondents Number of respondents Number of responses per respondent Avg. Burden per response (in hours) Total burden (in hours) 57.100: NHSN Registration Form Registered Nurse (Infection Preventionist) 2,000 1 5/60 167 57.101: Facility Contact Information Registered Nurse (Infection Preventionist) 2,000 1 10/60 333 57.103: Patient Safety Component—Annual Hospital Survey Registered Nurse (Infection Preventionist) 6,000 1 30/60 3,000 57.104: Patient Safety Component—Outpatient Dialysis Center Practices Survey Registered Nurse (Infection Preventionist) 5,700 1 1.5 8,550 57.105: Group Contact Information Registered Nurse (Infection Preventionist) 6,000 1 5/60 500 57.106: Patient Safety Monthly Reporting Plan Registered Nurse (Infection Preventionist) 10,000 12 35/60 70,000 57.108: Primary Bloodstream Infection (BSI) Registered Nurse (Infection Preventionist) 6,000 36 35/60 126,000 57.109: Dialysis Event Staff RN 5,700 60 16/60 91,200 57.111: Pneumonia (PNEU) Registered Nurse (Infection Preventionist) 6,000 72 32/60 230,400 57.112: Ventilator-Associated Event Registered Nurse (Infection Preventionist) 6,000 144 25/60 360,000 57.114: Urinary Tract Infection (UTI) Infection Preventionist 6,000 27 32/60 86,400 57.116: Denominators for Neonatal Intensive Care Unit (NICU) Staff RN 6,000 9 3 162,000 57.117: Denominators for Specialty Care Area (SCA)/Oncology (ONC) Staff RN 6,000 9 5 270,000 57.118: Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA) Staff RN 6,000 18 5 540,000 57.119: Denominator for Outpatient Dialysis Staff RN 5,700 12 6/60 6,840 57.120: Surgical Site Infection (SSI) Registered Nurse (Infection Preventionist) 6,000 36 32/60 115,200 57.121: Denominator for Procedure Staff RN 6,000 540 5/60 270,000 57.123: Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables Laboratory Technician 6,000 12 5/60 6,000 57.124: Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables Pharmacy Technician 6,000 12 5/60 6,000 57.125: Central Line Insertion Practices Adherence Monitoring Registered Nurse (Infection Preventionist) 1,000 100 5/60 8,333 57.126: MDRO or CDI Infection Form Registered Nurse (Infection Preventionist) 6,000 72 32/60 230,400 57.127: MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring Registered Nurse (Infection Preventionist) 6,000 24 10/60 24,000 57.128: Laboratory-identified MDRO or CDI Event Registered Nurse (Infection Preventionist) 6,000 240 15/60 360,000 57.130: Vaccination Monthly Monitoring Form-Summary Method Registered Nurse (Infection Preventionist) 6,000 5 14 420,000 57.131: Vaccination Monthly Monitoring Form-Patient-Level Method Registered Nurse (Infection Preventionist) 2,000 5 2 20,000 57.133: Patient Vaccination Registered Nurse (Infection Preventionist) 2,000 250 10/60 83,333 57.137: Long-Term Care Facility Component—Annual Facility Survey Registered Nurse (Infection Preventionist) 250 1 45/60 188 57.138: Laboratory-identified MDRO or CDI Event for LTCF Registered Nurse (Infection Preventionist) 250 8 15/60 500 57.139: MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF Registered Nurse (Infection Preventionist) 250 12 5/60 250 57.140: Urinary Tract Infection (UTI) for LTCF Registered Nurse (Infection Preventionist) 250 9 30/60 1,125 57.141: Monthly Reporting Plan for LTCF Registered Nurse (Infection Preventionist) 250 12 5/60 250 57.142: Denominators for LTCF Locations Registered Nurse (Infection Preventionist) 250 12 3 9,000 57.143: Prevention Process Measures Monthly Monitoring for LTCF Registered Nurse (Infection Preventionist) 250 12 5/60 250 57.150: LTAC Annual Survey Registered Nurse (Infection Preventionist) 400 1 30/60 200 57.151: Rehab Annual Survey Registered Nurse (Infection Preventionist) 1,000 1 25/60 417 57.200: Healthcare Personnel Safety Component Annual Facility Survey Occupational Health RN/Specialist 100 1 8 800 57.203: Healthcare Personnel Safety Monthly Reporting Plan Occupational Health RN/Specialist 100 9 10/60 150 57.204: Healthcare Worker Demographic Data Occupational Health RN/Specialist 100 200 20/60 6,667 57.205: Exposure to Blood/Body Fluids Occupational Health RN/Specialist 100 50 1 5,000 57.206: Healthcare Worker Prophylaxis/Treatment Occupational Health RN/Specialist 100 30 15/60 750 57.207: Follow-Up Laboratory Testing Laboratory Technician 100 50 15/60 1,250 57.210: Healthcare Worker Prophylaxis/Treatment-Influenza Occupational Health RN/Specialist 600 50 10/60 5,000 57.300: Hemovigilance Module Annual Survey Medical/Clinical Laboratory Technologist 500 1 2 1,000 57.301: Hemovigilance Module Monthly Reporting Plan Medical/Clinical Laboratory Technologist 500 12 2/60 200 57.302: Hemovigilance Module Monthly Incident Summary Medical/Clinical Laboratory Technologist 500 12 2 12,000 57.303: Hemovigilance Module Monthly Reporting Denominators Medical/Clinical Laboratory Technologist 500 12 30/60 3,000 57.304: Hemovigilance Adverse Reaction Medical/Clinical Laboratory Technologist 500 120 10/60 10,000 57.305: Hemovigilance Incident Medical/Clinical Laboratory Technologist 500 72 10/60 6,000 Total Est Annual Burden Hours 3,562,653 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] BILLING CODE 4163-18-P --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2012-17987. Public record. Not legal advice.