Proposed Data Collections Submitted for Public Comment and Recommendations
Federal Register, Volume 77 Issue 144 (Thursday, July 26, 2012)
Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)
Notices
Pages 43828-43831
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2012-17987
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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
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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
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Number of Avg. Burden
Form number and name Type of Number of responses per per response Total burden
respondents respondents respondent (in hours) (in hours)
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57.100: NHSN Registration Form Registered Nurse 2,000 1 5/60 167
(Infection
Preventionist).
57.101: Facility Contact Registered Nurse 2,000 1 10/60 333
Information. (Infection
Preventionist).
57.103: Patient Safety Registered Nurse 6,000 1 30/60 3,000
Component--Annual Hospital (Infection
Survey. Preventionist).
57.104: Patient Safety Registered Nurse 5,700 1 1.5 8,550
Component--Outpatient (Infection
Dialysis Center Practices Preventionist).
Survey.
57.105: Group Contact Registered Nurse 6,000 1 5/60 500
Information. (Infection
Preventionist).
57.106: Patient Safety Monthly Registered Nurse 10,000 12 35/60 70,000
Reporting Plan. (Infection
Preventionist).
57.108: Primary Bloodstream Registered Nurse 6,000 36 35/60 126,000
Infection (BSI). (Infection
Preventionist).
57.109: Dialysis Event........ Staff RN........ 5,700 60 16/60 91,200
57.111: Pneumonia (PNEU)...... Registered Nurse 6,000 72 32/60 230,400
(Infection
Preventionist).
57.112: Ventilator-Associated Registered Nurse 6,000 144 25/60 360,000
Event. (Infection
Preventionist).
57.114: Urinary Tract Infection 6,000 27 32/60 86,400
Infection (UTI). Preventionist.
57.116: Denominators for Staff RN........ 6,000 9 3 162,000
Neonatal Intensive Care Unit
(NICU).
57.117: Denominators for Staff RN........ 6,000 9 5 270,000
Specialty Care Area (SCA)/
Oncology (ONC).
57.118: Denominators for Staff RN........ 6,000 18 5 540,000
Intensive Care Unit (ICU)/
Other locations (not NICU or
SCA).
57.119: Denominator for Staff RN........ 5,700 12 6/60 6,840
Outpatient Dialysis.
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57.120: Surgical Site Registered Nurse 6,000 36 32/60 115,200
Infection (SSI). (Infection
Preventionist).
57.121: Denominator for Staff RN........ 6,000 540 5/60 270,000
Procedure.
57.123: Antimicrobial Use and Laboratory 6,000 12 5/60 6,000
Resistance (AUR)-Microbiology Technician.
Data Electronic Upload
Specification Tables.
57.124: Antimicrobial Use and Pharmacy 6,000 12 5/60 6,000
Resistance (AUR)-Pharmacy Technician.
Data Electronic Upload
Specification Tables.
57.125: Central Line Insertion Registered Nurse 1,000 100 5/60 8,333
Practices Adherence (Infection
Monitoring. Preventionist).
57.126: MDRO or CDI Infection Registered Nurse 6,000 72 32/60 230,400
Form. (Infection
Preventionist).
57.127: MDRO and CDI Registered Nurse 6,000 24 10/60 24,000
Prevention Process and (Infection
Outcome Measures Monthly Preventionist).
Monitoring.
57.128: Laboratory-identified Registered Nurse 6,000 240 15/60 360,000
MDRO or CDI Event. (Infection
Preventionist).
57.130: Vaccination Monthly Registered Nurse 6,000 5 14 420,000
Monitoring Form-Summary (Infection
Method. Preventionist).
57.131: Vaccination Monthly Registered Nurse 2,000 5 2 20,000
Monitoring Form-Patient-Level (Infection
Method. Preventionist).
57.133: Patient Vaccination... Registered Nurse 2,000 250 10/60 83,333
(Infection
Preventionist).
57.137: Long-Term Care Registered Nurse 250 1 45/60 188
Facility Component--Annual (Infection
Facility Survey. Preventionist).
57.138: Laboratory-identified Registered Nurse 250 8 15/60 500
MDRO or CDI Event for LTCF. (Infection
Preventionist).
57.139: MDRO and CDI Registered Nurse 250 12 5/60 250
Prevention Process Measures (Infection
Monthly Monitoring for LTCF. Preventionist).
57.140: Urinary Tract Registered Nurse 250 9 30/60 1,125
Infection (UTI) for LTCF. (Infection
Preventionist).
57.141: Monthly Reporting Plan Registered Nurse 250 12 5/60 250
for LTCF. (Infection
Preventionist).
57.142: Denominators for LTCF Registered Nurse 250 12 3 9,000
Locations. (Infection
Preventionist).
57.143: Prevention Process Registered Nurse 250 12 5/60 250
Measures Monthly Monitoring (Infection
for LTCF. Preventionist).
57.150: LTAC Annual Survey.... Registered Nurse 400 1 30/60 200
(Infection
Preventionist).
57.151: Rehab Annual Survey... Registered Nurse 1,000 1 25/60 417
(Infection
Preventionist).
57.200: Healthcare Personnel Occupational 100 1 8 800
Safety Component Annual Health RN/
Facility Survey. Specialist.
57.203: Healthcare Personnel Occupational 100 9 10/60 150
Safety Monthly Reporting Plan. Health RN/
Specialist.
57.204: Healthcare Worker Occupational 100 200 20/60 6,667
Demographic Data. Health RN/
Specialist.
57.205: Exposure to Blood/Body Occupational 100 50 1 5,000
Fluids. Health RN/
Specialist.
57.206: Healthcare Worker Occupational 100 30 15/60 750
Prophylaxis/Treatment. Health RN/
Specialist.
57.207: Follow-Up Laboratory Laboratory 100 50 15/60 1,250
Testing. Technician.
57.210: Healthcare Worker Occupational 600 50 10/60 5,000
Prophylaxis/Treatment- Health RN/
Influenza. Specialist.
57.300: Hemovigilance Module Medical/Clinical 500 1 2 1,000
Annual Survey. Laboratory
Technologist.
57.301: Hemovigilance Module Medical/Clinical 500 12 2/60 200
Monthly Reporting Plan. Laboratory
Technologist.
57.302: Hemovigilance Module Medical/Clinical 500 12 2 12,000
Monthly Incident Summary. Laboratory
Technologist.
57.303: Hemovigilance Module Medical/Clinical 500 12 30/60 3,000
Monthly Reporting Laboratory
Denominators. Technologist.
57.304: Hemovigilance Adverse Medical/Clinical 500 120 10/60 10,000
Reaction. Laboratory
Technologist.
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57.305: Hemovigilance Incident Medical/Clinical 500 72 10/60 6,000
Laboratory
Technologist.
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Total Est Annual Burden ................ .............. .............. .............. 3,562,653
Hours.
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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
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