[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 
<a href="/cdn-cgi/l/email-protection#543b3936143730377a333b22"><span class="__cf_email__" data-cfemail="1c73717e5c7f787f327b736a">[email protected]</span></a>.
    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
----------------------------------------------------------------------------------------------------------------
                                                                                    Burden per     Total annual
     Form number and name          Respondents       Number of     Responses per   response  (in    burden  (in
                                                    respondents     respondent        hours)          hours)
----------------------------------------------------------------------------------------------------------------
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).

[[Page 62834]]

 
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.
                               ---------------------------------------------------------------------------------
    Total Est Annual Burden     ................  ..............  ..............  ..............       3,914,125
     Hours.
----------------------------------------------------------------------------------------------------------------


    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]
BILLING CODE 4163-18-P


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