[Federal Register Volume 75, Number 197 (Wednesday, October 13, 2010)]
[Notices]
[Pages 62832-62834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25695]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-10-0666]
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.
Alternatively, to obtain a copy of the data collection plans and
instrument, call 404-639-5960 and send comments to Carol E. Walker,
Acting CDC Reports Clearance Officer, 1600 Clifton Road NE., MS-D74,
Atlanta, Georgia 30333; comments may also be sent by e-mail to
[email protected].
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 will have a 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 clarify 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 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.
3/31/2012)--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 to 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 eSurveillance. 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 the 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
[[Page 62833]]
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.
This revision submission includes an amended Assurance of
Confidentiality, which required an update of the Assurance of
Confidentiality language on all forms included in the NHSN surveillance
system. 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). The Patient Safety (PS) Component is being
expanded to include long-term care facilities to facilitate HAI
surveillance in this setting, for which no standardized reporting
methodology or mechanism currently exists. Four new forms are proposed
for this purpose. A new form is proposed to be added to the Healthcare
Personnel Safety (HPS) Component to facilitate summary reporting of
influenza vaccination in healthcare workers, which is anticipated to be
required by CMS in the near future. In addition to this new form, the
scope of the HPS Annual Facility Survey is being expanded to include
all acute care facilities that would enroll if CMS does implement this
requirement. The NHSN Antimicrobial Use and Resistance module is
transitioning from manual web entry to electronic data upload only,
which results in a significant decrease to the reporting burden for
this package. Eight forms that are no longer necessary are being
removed from this information data request. Finally, there are many
updates, clarifications, and data collection revisions proposed in this
submission.
The previously approved NHSN package included 54 individual data
collection forms; the current revision request includes five new forms
and the removal of eight forms from the package. If all proposed
revisions are approved, the reporting burden will decrease by 1,258,119
hours, for a total estimated burden of 3,914,125 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
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Burden per Total annual
Form number and name Respondents Number of Responses per response (in burden (in
respondents respondent hours) hours)
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57.100: NHSN Registration Form Registered Nurse 6,000 1 5/60 500
(Infection
Preventionist).
57.101: Facility Contact Registered Nurse 6,000 1 10/60 1,000
Information. (Infection
Preventionist).
57.103: Patient Safety Registered Nurse 6,000 1 40/60 4,000
Component--Annual Facility (Infection
Survey. Preventionist).
57.104: Patient Safety Registered Nurse 5,500 1 1 5,500
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 6,000 9 35/60 31,500
Reporting Plan. (Infection
Preventionist).
57.108: Primary Bloodstream Registered Nurse 6,000 36 32/60 115,200
Infection (BSI). (Infection
Preventionist).
57.109: Dialysis Event........ Staff RN........ 500 75 15/60 9,375
57.114: Urinary Tract Registered Nurse 6,000 27 32/60 86,400
Infection (UTI). (Infection
Preventionist).
57.116: Denominators for Staff RN........ 6,000 9 4 216,000
Neonatal Intensive Care Unit
(NICU).
57.117: Denominators for Staff RN........ 6,000 9 5 270,000
Specialty Care Area (SCA).
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........ 500 12 5/60 500
Outpatient Dialysis.
57.120: Surgical Site Registered Nurse 6,000 27 32/60 86,400
Infection (SSI). (Infection
Preventionist).
57.121: Denominator for Staff RN........ 6,000 540 10/60 540,000
Procedure.
57.124: Paper form obsolete. Pharmacy 6,000 12 5/60 6,000
See Electronic Data Upload Technician.
Specification Tables.
57.125: Central Line Insertion Registered Nurse 6,000 100 5/60 50,000
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 25/60 600,000
MDRO or CDI Event. (Infection
Preventionist).
57.130: Denominators for Registered Nurse 6,000 5 14 420,000
Summary Vaccination Method. (Infection
Preventionist).
57.133: Patient Vaccination... Registered Nurse 2,000 250 10/60 83,333
(Infection
Preventionist).
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57.137: Patient Safety Registered Nurse 250 1 25/60 104
Component--Annual Facility (Infection
Survey for LTCF. Preventionist).
57.138: Laboratory-identified Registered Nurse 250 8 30/60 1,000
MDRO or CDI Event for LTCF. (Infection
Preventionist).
57.139: MDRO and CDI Registered Nurse 250 3 7/60 88
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).
57.202: Healthcare Worker Occupational 600 100 10/60 10,000
Survey. Health RN/
Specialist.
57.203: Healthcare Personnel Occupational 600 9 10/60 900
Safety Monthly Reporting Plan. Health RN/
Specialist.
57.204: Healthcare Worker Occupational 600 200 20/60 40,000
Demographic Data. Health RN/
Specialist.
57.205: Exposure to Blood/Body Occupational 600 50 1 30,000
Fluids. Health RN/
Specialist.
57.206: Healthcare Worker Occupational 600 10 15/60 1,500
Prophylaxis/Treatment. Health RN/
Specialist.
57.207: Follow-Up Laboratory Laboratory 600 100 15/60 15,000
Testing. Technician.
57.208: Healthcare Worker Occupational 600 300 10/60 30,000
Vaccination History. Health RN/
Specialist.
57.210: Healthcare Worker Occupational 600 50 10/60 5,000
Prophylaxis/Treatment-- Health RN/
Influenza. Specialist.
57.211: Pre-season Survey on Occupational 600 1 10/60 100
Influenza Vaccination Health RN/
Programs for Healthcare Specialist.
Personnel.
57.212: Post-season Survey on Occupational 600 1 10/60 100
Influenza Vaccination Health RN/
Programs for Healthcare Specialist.
Personnel.
57.213: Healthcare Personnel Occupational 6,000 6 2 72,000
Influenza Vaccination Monthly Health RN/
Summary. 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.
57.303: 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.
57.305: Hemovigilance Incident Medical/Clinical 500 72 10/60 6,000
Laboratory
Technologist.
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Total Est Annual Burden ................ .............. .............. .............. 3,914,125
Hours.
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Dated: October 5, 2010.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2010-25695 Filed 10-12-10; 8:45 am]
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