[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Notices]
[Pages 52533-52535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20609]


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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. 
12/31/2015--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 six components: Patient Safety, Healthcare 
Personnel Safety, Biovigilance, Long-Term Care Facility (LTCF), 
Dialysis, and Outpatient Procedure.
    The new Dialysis Component was developed in order to separate 
reporting of dialysis events from the Patient Safety Component. The new 
component will tailor the NHSN user interface for dialysis users to 
simplify their data entry and analyses processes as well as provide 
options for expanding the Dialysis Component in the future to include 
dialysis surveillance in settings other than outpatient facilities.
    The new Outpatient Procedure Component was developed to gather data 
on the impact of infections and other outcomes related to outpatient 
procedures that are performed in settings such as Ambulatory Surgery 
Centers (ASCs), Hospital Outpatient Departments (HOPDs), and 
physicians' offices. Three event types will be monitored in this new 
component: Same Day Outcome Measures, Prophylactic Intravenous (IV) 
Antibiotic Timing, and Surgical Site Infections (SSI).
    This revision submission includes two new NHSN components and their 
corresponding forms. The Dialysis Component consists of changes to 
three previously approved forms and the addition of four new forms. 
These new forms include component specific monthly reporting plan, 
prevention process measures monthly monitoring, patient influenza 
vaccination, and patient influenza vaccination denominator forms. The 
Outpatient Procedure Component consists of four new forms: Component 
specific annual survey, monthly reporting plan, event, and monthly 
denominators and summary forms.
    Further, the breadth of organism susceptibility data required on 
all of the healthcare-associated infection (HAI) report forms (i.e., 
BSI, UTI, SSI, PNEU (VAP and VAE), DE, LTUTI, and MDRO Infection 
Surveillance) has been reduced for the purposes of streamlining, 
simplification, and removing undue burden where possible. Significant 
changes were made to the NHSN Biovigilance Component forms as a result 
of a subject matter expert and stakeholder working groups. This 
includes the removal of the monthly incident summary form. A brand new 
form was added (Form 57.600--State Health Department Validation Record) 
to collect aggregate validation results that will be gathered by state 
health departments when conducting facility-level validation of NHSN 
healthcare-associated infection (HAI) data within their jurisdictions 
using the CDC/NHSN Validation Guidance and Toolkits.
    Additionally, minor revisions have been made to 32 other forms 
within the package to clarify and/or update surveillance definitions.
    The previously approved NSHN package included 48 individual 
collection forms; the current revision request adds nine new forms and 
removes one form for a total of 56 forms. The reporting burden will 
increase by 542,122 hours, for a total of 4,104,776 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents               Form No. and name        Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Registered Nurse (Infection             57.100: NHSN                       2,000               1         5/60
 Preventionist).                         Registration Form.
Registered Nurse (Infection             57.101: Facility Contact           2,000               1        10/60
 Preventionist).                         Information.

[[Page 52534]]

 
Registered Nurse (Infection             57.103: Patient Safety             6,000               1        30/60
 Preventionist).                         Component--Annual
                                         Hospital Survey.
Registered Nurse (Infection             57.105: Group Contact              6,000               1         5/60
 Preventionist).                         Information.
Registered Nurse (Infection             57.106: Patient Safety             6,000              12        35/60
 Preventionist).                         Monthly Reporting Plan.
Registered Nurse (Infection             57.108: Primary                    6,000              36        32/60
 Preventionist).                         Bloodstream Infection
                                         (BSI).
Registered Nurse (Infection             57.111: Pneumonia (PNEU)           6,000              72        29/60
 Preventionist).
Registered Nurse (Infection             57.112: Ventilator-                6,000             144        22/60
 Preventionist).                         Associated Event.
Infection Preventionist...............  57.114: Urinary Tract              6,000              27        29/60
                                         Infection (UTI).
Staff RN..............................  57.116: Denominators for           6,000               9            3
                                         Neonatal Intensive Care
                                         Unit (NICU).
Staff RN..............................  57.117: Denominators for           6,000               9            5
                                         Specialty Care Area
                                         (SCA)/Oncology (ONC).
Staff RN..............................  57.118: Denominators for           6,000              54            5
                                         Intensive Care Unit
                                         (ICU)/Other locations
                                         (not NICU or SCA).
Registered Nurse (Infection             57.120: Surgical Site              6,000              36        29/60
 Preventionist).                         Infection (SSI).
Staff RN..............................  57.121: Denominator for            6,000             540         5/60
                                         Procedure.
Laboratory Technician.................  57.123: Antimicrobial              6,000              12         5/60
                                         Use and Resistance
                                         (AUR)-Microbiology Data
                                         Electronic Upload
                                         Specification Tables.
Pharmacy Technician...................  57.124: Antimicrobial              6,000              12         5/60
                                         Use and Resistance
                                         (AUR)-Pharmacy Data
                                         Electronic Upload
                                         Specification Tables.
Registered Nurse (Infection             57.125: Central Line               1,000             100         5/60
 Preventionist).                         Insertion Practices
                                         Adherence Monitoring.
Registered Nurse (Infection             57.126: MDRO or CDI                6,000              72        29/60
 Preventionist).                         Infection Form.
Registered Nurse (Infection             57.127: MDRO and CDI               6,000              24        12/60
 Preventionist).                         Prevention Process and
                                         Outcome Measures
                                         Monthly Monitoring.
Registered Nurse (Infection             57.128: Laboratory-                6,000             240        15/60
 Preventionist).                         identified MDRO or CDI
                                         Event.
Registered Nurse (Infection             57.130: Vaccination                  100               5           14
 Preventionist).                         Monthly Monitoring Form-
                                         Summary Method.
Registered Nurse (Infection             57.131: Vaccination                  100               5            2
 Preventionist).                         Monthly Monitoring Form-
                                         Patient-Level Method.
Registered Nurse (Infection             57.133: Patient                      100             250        10/60
 Preventionist).                         Vaccination.
Registered Nurse (Infection             57.137: Long-Term Care               250               1        45/60
 Preventionist).                         Facility Component--
                                         Annual Facility Survey.
Registered Nurse (Infection             57.138: Laboratory-                  250               8        15/60
 Preventionist).                         identified MDRO or CDI
                                         Event for LTCF.
Registered Nurse (Infection             57.139: MDRO and CDI                 250              12         5/60
 Preventionist).                         Prevention Process
                                         Measures Monthly
                                         Monitoring for LTCF.
Registered Nurse (Infection             57.140: Urinary Tract                250               9        27/60
 Preventionist).                         Infection (UTI) for
                                         LTCF.
Registered Nurse (Infection             57.141: Monthly                      250              12         5/60
 Preventionist).                         Reporting Plan for LTCF.
Registered Nurse (Infection             57.142: Denominators for             250              12            3
 Preventionist).                         LTCF Locations.
Registered Nurse (Infection             57.143: Prevention                   250              12         5/60
 Preventionist).                         Process Measures
                                         Monthly Monitoring for
                                         LTCF.
Registered Nurse (Infection             57.150: LTAC Annual                  400               1        30/60
 Preventionist).                         Survey.
Registered Nurse (Infection             57.151: Rehab Annual               1,000               1        25/60
 Preventionist).                         Survey.
Occupational Health RN/Specialist.....  57.200: Healthcare                    50               1            8
                                         Personnel Safety
                                         Component Annual
                                         Facility Survey.
Occupational Health RN/Specialist.....  57.203: Healthcare                    50               9        10/60
                                         Personnel Safety
                                         Monthly Reporting Plan.
Occupational Health RN/Specialist.....  57.204: Healthcare                    50             200        20/60
                                         Worker Demographic Data.
Occupational Health RN/Specialist.....  57.205: Exposure to                   50              50            1
                                         Blood/Body Fluids.
Occupational Health RN/Specialist.....  57.206: Healthcare                    50              30        15/60
                                         Worker Prophylaxis/
                                         Treatment.
Laboratory Technician.................  57.207: Follow-Up                     50              50        15/60
                                         Laboratory Testing.
Occupational Health RN/Specialist.....  57.210: Healthcare                    50              50        10/60
                                         Worker Prophylaxis/
                                         Treatment-Influenza.
Medical/Clinical Laboratory             57.300: Hemovigilance                500               1            2
 Technologist.                           Module Annual Survey.
Medical/Clinical Laboratory             57.301: Hemovigilance                500              12         1/60
 Technologist.                           Module Monthly
                                         Reporting Plan.
Medical/Clinical Laboratory             57.303: Hemovigilance                500              12            1
 Technologist.                           Module Monthly
                                         Reporting Denominators.
Medical/Clinical Laboratory             57.304: Hemovigilance                500              48        15/60
 Technologist.                           Adverse Reaction.

[[Page 52535]]

 
Medical/Clinical Laboratory             57.305: Hemovigilance                500              12        10/60
 Technologist.                           Incident.
Staff RN..............................  57.400: Outpatient                 5,000               1         5/60
                                         Procedure Component--
                                         Annual Facility Survey.
Staff RN..............................  57.401: Outpatient                 5,000              12        15/60
                                         Procedure Component--
                                         Monthly Reporting Plan.
Staff RN..............................  57.402: Outpatient                 5,000              25        40/60
                                         Procedure Component
                                         Event.
Staff RN..............................  57.403: Outpatient                 5,000              12        40/60
                                         Procedure Component--
                                         Monthly Denominators
                                         and Summary.
Registered Nurse (Infection             57.500: Outpatient                 6,000               1            1.75
 Preventionist).                         Dialysis Center
                                         Practices Survey.
Staff RN..............................  57.501: Dialysis Monthly           6,000              12         5/60
                                         Reporting Plan.
Staff RN..............................  57.502: Dialysis Event..           6,000              60        13/60
Staff RN..............................  57.503: Denominator for            6,000              12         6/60
                                         Outpatient Dialysis.
Staff RN..............................  57.504: Prevention                   600              12        30/60
                                         Process Measures
                                         Monthly Monitoring for
                                         Dialysis.
Staff RN..............................  57.505: Dialysis Patient             250              75        10/60
                                         Influenza Vaccination.
Staff RN..............................  57.506: Dialysis Patient             250               5        10/60
                                         Influenza Vaccination
                                         Denominator.
Epidemiologist........................  57.600: State Health                 152              50        15/60
                                         Department Validation
                                         Record.
----------------------------------------------------------------------------------------------------------------


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. 2013-20609 Filed 8-22-13; 8:45 am]
BILLING CODE 4163-18-P