[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Pages 43828-43831]
From the Federal Register Online via the Government Publishing 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 
[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 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

[[Page 43829]]

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
----------------------------------------------------------------------------------------------------------------
                                                                     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)
----------------------------------------------------------------------------------------------------------------
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.

[[Page 43830]]

 
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.

[[Page 43831]]

 
57.305: Hemovigilance Incident  Medical/Clinical             500              72           10/60           6,000
                                 Laboratory
                                 Technologist.
                               ---------------------------------------------------------------------------------
    Total Est Annual Burden     ................  ..............  ..............  ..............       3,562,653
     Hours.
----------------------------------------------------------------------------------------------------------------


    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