[Federal Register Volume 77, Number 207 (Thursday, October 25, 2012)]
[Notices]
[Pages 65192-65194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26268]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-0666]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
(404) 639-7570 or send an email to [email protected]. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC 
20503 or by fax to (202) 395-5806. Written comments should be received 
within 30 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

[[Page 65193]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                      No. of        Avg. burden
         Form number and name              Type of respondents       Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
57.100: NHSN Registration Form........  Registered Nurse                   2,000               1            5/60
                                         (Infection
                                         Preventionist).
57.101: Facility Contact Information..  Registered Nurse                   2,000               1           10/60
                                         (Infection
                                         Preventionist).
57.103: Patient Safety Component--      Registered Nurse                   6,000               1           30/60
 Annual Hospital Survey.                 (Infection
                                         Preventionist).
57.104: Patient Safety Component--      Registered Nurse                   5,700               1             1.5
 Outpatient Dialysis Center Practices    (Infection
 Survey.                                 Preventionist).
57.105: Group Contact Information.....  Registered Nurse                   6,000               1            5/60
                                         (Infection
                                         Preventionist).
57.106: Patient Safety Monthly          Registered Nurse                  10,000              12           35/60
 Reporting Plan.                         (Infection
                                         Preventionist).
57.108: Primary Bloodstream Infection   Registered Nurse                   6,000              36           35/60
 (BSI).                                  (Infection
                                         Preventionist).
57.109: Dialysis Event................  Staff RN................           5,700              60           16/60
57.111: Pneumonia (PNEU)..............  Registered Nurse                   6,000              72           32/60
                                         (Infection
                                         Preventionist).
57.112: Ventilator-Associated Event...  Registered Nurse                   6,000             144           25/60
                                         (Infection
                                         Preventionist).
57.114: Urinary Tract Infection (UTI).  Infection Preventionist.           6,000              27           32/60
57.116: Denominators for Neonatal       Staff RN................           6,000               9               3
 Intensive Care Unit (NICU).
57.117: Denominators for Specialty      Staff RN................           6,000               9               5
 Care Area (SCA)/Oncology (ONC).
57.118: Denominators for Intensive      Staff RN................           6,000              18               5
 Care Unit (ICU)/Other locations (not
 NICU or SCA).
57.119: Denominator for Outpatient      Staff RN................           5,700              12            6/60
 Dialysis.
57.120: Surgical Site Infection (SSI).  Registered Nurse                   6,000              36           32/60
                                         (Infection
                                         Preventionist).
57.121: Denominator for Procedure.....  Staff RN................           6,000             540            5/60
57.123: Antimicrobial Use and           Laboratory Technician...           6,000              12            5/60
 Resistance (AUR)--Microbiology Data
 Electronic Upload Specification
 Tables.
57.124: Antimicrobial Use and           Pharmacy Technician.....           6,000              12            5/60
 Resistance (AUR)--Pharmacy Data
 Electronic Upload Specification
 Tables.
57.125: Central Line Insertion          Registered Nurse                   1,000             100            5/60
 Practices Adherence Monitoring.         (Infection
                                         Preventionist).
57.126: MDRO or CDI Infection Form....  Registered Nurse                   6,000              72           32/60
                                         (Infection
                                         Preventionist).
57.127: MDRO and CDI Prevention         Registered Nurse                   6,000              24           10/60
 Process and Outcome Measures Monthly    (Infection
 Monitoring.                             Preventionist).
57.128: Laboratory-identified MDRO or   Registered Nurse                   6,000             240           15/60
 CDI Event.                              (Infection
                                         Preventionist).
57.130: Vaccination Monthly Monitoring  Registered Nurse                   6,000               5              14
 Form--Summary Method.                   (Infection
                                         Preventionist).
57.131: Vaccination Monthly Monitoring  Registered Nurse                   2,000               5               2
 Form--Patient-Level Method.             (Infection
                                         Preventionist).
57.133: Patient Vaccination...........  Registered Nurse                   2,000             250           10/60
                                         (Infection
                                         Preventionist).
57.137: Long-Term Care Facility         Registered Nurse                     250               1           45/60
 Component--Annual Facility Survey.      (Infection
                                         Preventionist).
57.138: Laboratory-identified MDRO or   Registered Nurse                     250               8           15/60
 CDI Event for LTCF.                     (Infection
                                         Preventionist).

[[Page 65194]]

 
57.139: MDRO and CDI Prevention         Registered Nurse                     250              12            5/60
 Process Measures Monthly Monitoring     (Infection
 for LTCF.                               Preventionist).
57.140: Urinary Tract Infection (UTI)   Registered Nurse                     250               9           30/60
 for LTCF.                               (Infection
                                         Preventionist).
57.141: Monthly Reporting Plan for      Registered Nurse                     250              12            5/60
 LTCF.                                   (Infection
                                         Preventionist).
57.142: Denominators for LTCF           Registered Nurse                     250              12               3
 Locations.                              (Infection
                                         Preventionist).
57.143: Prevention Process Measures     Registered Nurse                     250              12            5/60
 Monthly Monitoring for LTCF.            (Infection
                                         Preventionist).
57.150: LTAC Annual Survey............  Registered Nurse                     400               1           30/60
                                         (Infection
                                         Preventionist).
57.151: Rehab Annual Survey...........  Registered Nurse                   1,000               1           25/60
                                         (Infection
                                         Preventionist).
57.200: Healthcare Personnel Safety     Occupational Health RN/              100               1               8
 Component Annual Facility Survey.       Specialist.
57.203: Healthcare Personnel Safety     Occupational Health RN/              100               9           10/60
 Monthly Reporting Plan.                 Specialist.
57.204: Healthcare Worker Demographic   Occupational Health RN/              100             200           20/60
 Data.                                   Specialist.
57.205: Exposure to Blood/Body Fluids.  Occupational Health RN/              100              50               1
                                         Specialist.
57.206: Healthcare Worker Prophylaxis/  Occupational Health RN/              100              30           15/60
 Treatment.                              Specialist.
57.207: Follow-Up Laboratory Testing..  Laboratory Technician...             100              50           15/60
57.210: Healthcare Worker Prophylaxis/  Occupational Health RN/              600              50           10/60
 Treatment--Influenza.                   Specialist.
57.300: Hemovigilance Module Annual     Medical/Clinical                     500               1               2
 Survey.                                 Laboratory Technologist.
57.301: Hemovigilance Module Monthly    Medical/Clinical                     500              12            2/60
 Reporting Plan.                         Laboratory Technologist.
57.302: Hemovigilance Module Monthly    Medical/Clinical                     500              12               2
 Incident Summary.                       Laboratory Technologist.
57.303: Hemovigilance Module Monthly    Medical/Clinical                     500              12           30/60
 Reporting Denominators.                 Laboratory Technologist.
57.304: Hemovigilance Adverse Reaction  Medical/Clinical                     500             120           10/60
                                         Laboratory Technologist.
57.305: Hemovigilance Incident........  Medical/Clinical                     500              72           10/60
                                         Laboratory Technologist.
----------------------------------------------------------------------------------------------------------------


    Dated: October 18, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2012-26268 Filed 10-24-12; 8:45 am]
BILLING CODE 4163-18-P