[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Pages 37224-37226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-14752]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-13-0666]


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 or 
send comments to Kimberly S. Lane, 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. 
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 17 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 542,123 hours, for a total of 4,104,776 hours.

[[Page 37225]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents        Form number and     Number of     responses per   per response    Total burden
                                      name          respondents     respondent       (in hrs.)       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Registered Nurse (Infection     57.100: NHSN               2,000               1            5/60             167
 Preventionist).                 Registration
                                 Form.
Registered Nurse (Infection     57.101: Facility           2,000               1           10/60             333
 Preventionist).                 Contact
                                 Information.
Registered Nurse (Infection     57.103: Patient            6,000               1           30/60           3,000
 Preventionist).                 Safety
                                 Component--Annu
                                 al Hospital
                                 Survey.
Registered Nurse (Infection     57.105: Group              6,000               1            5/60             500
 Preventionist).                 Contact
                                 Information.
Registered Nurse (Infection     57.106: Patient            6,000              12           35/60          42,000
 Preventionist).                 Safety Monthly
                                 Reporting Plan.
Registered Nurse (Infection     57.108: Primary            6,000              36           32/60         115,200
 Preventionist).                 Bloodstream
                                 Infection (BSI).
Registered Nurse (Infection     57.111:                    6,000              72           29/60         208,800
 Preventionist).                 Pneumonia
                                 (PNEU).
Registered Nurse (Infection     57.112:                    6,000             144           22/60         316,800
 Preventionist).                 Ventilator-
                                 Associated
                                 Event.
Infection Preventionist.......  57.114: Urinary            6,000              27           29/60          78,300
                                 Tract Infection
                                 (UTI).
Staff RN......................  57.116:                    6,000               9               3         162,000
                                 Denominators
                                 for Neonatal
                                 Intensive Care
                                 Unit (NICU).
Staff RN......................  57.117:                    6,000               9               5         270,000
                                 Denominators
                                 for Specialty
                                 Care Area (SCA)/
                                 Oncology (ONC).
Staff RN......................  57.118:                    6,000              54               5       1,620,000
                                 Denominators
                                 for Intensive
                                 Care Unit (ICU)/
                                 Other locations
                                 (not NICU or
                                 SCA).
Registered Nurse (Infection     57.120: Surgical           6,000              36           29/60         104,400
 Preventionist).                 Site Infection
                                 (SSI).
Staff RN......................  57.121:                    6,000             540            5/60         270,000
                                 Denominator for
                                 Procedure.
Laboratory Technician.........  57.123:                    6,000              12            5/60           6,000
                                 Antimicrobial
                                 Use and
                                 Resistance
                                 (AUR)-
                                 Microbiology
                                 Data Electronic
                                 Upload
                                 Specification
                                 Tables.
Pharmacy Technician...........  57.124:                    6,000              12            5/60           6,000
                                 Antimicrobial
                                 Use and
                                 Resistance
                                 (AUR)-Pharmacy
                                 Data Electronic
                                 Upload
                                 Specification
                                 Tables.
Registered Nurse (Infection     57.125: Central            1,000             100            5/60           8,333
 Preventionist).                 Line Insertion
                                 Practices
                                 Adherence
                                 Monitoring.
Registered Nurse (Infection     57.126: MDRO or            6,000              72           29/60         208,800
 Preventionist).                 CDI Infection
                                 Form.
Registered Nurse (Infection     57.127: MDRO and           6,000              24           12/60          28,800
 Preventionist).                 CDI Prevention
                                 Process and
                                 Outcome
                                 Measures
                                 Monthly
                                 Monitoring.
Registered Nurse (Infection     57.128:                    6,000             240           15/60         360,000
 Preventionist).                 Laboratory-
                                 identified MDRO
                                 or CDI Event.
Registered Nurse (Infection     57.130:                      100               5              14           7,000
 Preventionist).                 Vaccination
                                 Monthly
                                 Monitoring Form-
                                 Summary Method.
Registered Nurse (Infection     57.131:                      100               5               2           1,000
 Preventionist).                 Vaccination
                                 Monthly
                                 Monitoring Form-
                                 Patient-Level
                                 Method.
Registered Nurse (Infection     57.133: Patient              100             250           10/60           4,167
 Preventionist).                 Vaccination.
Registered Nurse (Infection     57.137: Long-                250               1           45/60             188
 Preventionist).                 Term Care
                                 Facility
                                 Component--Annu
                                 al Facility
                                 Survey.
Registered Nurse (Infection     57.138:                      250               8           15/60             500
 Preventionist).                 Laboratory-
                                 identified MDRO
                                 or CDI Event
                                 for LTCF.
Registered Nurse (Infection     57.139: MDRO and             250              12            5/60             250
 Preventionist).                 CDI Prevention
                                 Process
                                 Measures
                                 Monthly
                                 Monitoring for
                                 LTCF.
Registered Nurse (Infection     57.140: Urinary              250               9           27/60           1,013
 Preventionist).                 Tract Infection
                                 (UTI) for LTCF.
Registered Nurse (Infection     57.141: Monthly              250              12            5/60             250
 Preventionist).                 Reporting Plan
                                 for LTCF.
Registered Nurse (Infection     57.142:                      250              12               3           9,000
 Preventionist).                 Denominators
                                 for LTCF
                                 Locations.
Registered Nurse (Infection     57.143:                      250              12            5/60             250
 Preventionist).                 Prevention
                                 Process
                                 Measures
                                 Monthly
                                 Monitoring for
                                 LTCF.
Registered Nurse (Infection     57.150: LTAC                 400               1           30/60             200
 Preventionist).                 Annual Survey.
Registered Nurse (Infection     57.151: Rehab              1,000               1           25/60             417
 Preventionist).                 Annual Survey.
Occupational Health RN/         57.200:                       50               1               8             400
 Specialist.                     Healthcare
                                 Personnel
                                 Safety
                                 Component
                                 Annual Facility
                                 Survey.

[[Page 37226]]

 
Occupational Health RN/         57.203:                       50               9           10/60              75
 Specialist.                     Healthcare
                                 Personnel
                                 Safety Monthly
                                 Reporting Plan.
Occupational Health RN/         57.204:                       50             200           20/60           3,333
 Specialist.                     Healthcare
                                 Worker
                                 Demographic
                                 Data.
Occupational Health RN/         57.205: Exposure              50              50               1           2,500
 Specialist.                     to Blood/Body
                                 Fluids.
Occupational Health RN/         57.206:                       50              30           15/60             375
 Specialist.                     Healthcare
                                 Worker
                                 Prophylaxis/
                                 Treatment.
Laboratory Technician.........  57.207: Follow-               50              50           15/60             625
                                 Up Laboratory
                                 Testing.
Occupational Health RN/         57.210:                       50              50           10/60             417
 Specialist.                     Healthcare
                                 Worker
                                 Prophylaxis/
                                 Treatment-
                                 Influenza.
Medical/Clinical Laboratory     57.300:                      500               1               2           1,000
 Technologist.                   Hemovigilance
                                 Module Annual
                                 Survey.
Medical/Clinical Laboratory     57.301:                      500              12            1/60             100
 Technologist.                   Hemovigilance
                                 Module Monthly
                                 Reporting Plan.
Medical/Clinical Laboratory     57.303:                      500              12               1           6,000
 Technologist.                   Hemovigilance
                                 Module Monthly
                                 Reporting
                                 Denominators.
Medical/Clinical Laboratory     57.304:                      500              48           15/60           6,000
 Technologist.                   Hemovigilance
                                 Adverse
                                 Reaction.
Medical/Clinical Laboratory     57.305:                      500              12           10/60           1,000
 Technologist.                   Hemovigilance
                                 Incident.
Staff RN......................  57.400:                    5,000               1            5/60             417
                                 Outpatient
                                 Procedure
                                 Component--Annu
                                 al Facility
                                 Survey.
Staff RN......................  57.401:                    5,000              12           15/60          15,000
                                 Outpatient
                                 Procedure
                                 Component--Mont
                                 hly Reporting
                                 Plan.
Staff RN......................  57.402:                    5,000              25           40/60          83,333
                                 Outpatient
                                 Procedure
                                 Component Event.
Staff RN......................  57.403:                    5,000              12           40/60          40,000
                                 Outpatient
                                 Procedure
                                 Component--Mont
                                 hly
                                 Denominators
                                 and Summary.
Registered Nurse (Infection     57.500:                    6,000               1            1.75          10,500
 Preventionist).                 Outpatient
                                 Dialysis Center
                                 Practices
                                 Survey.
Staff RN......................  57.501: Dialysis           6,000              12            5/60           6,000
                                 Monthly
                                 Reporting Plan.
Staff RN......................  57.502: Dialysis           6,000              60           13/60          78,000
                                 Event.
Staff RN......................  57.503:                    6,000              12            6/60           7,200
                                 Denominator for
                                 Outpatient
                                 Dialysis.
Staff RN......................  57.504:                      600              12           30/60           3,600
                                 Prevention
                                 Process
                                 Measures
                                 Monthly
                                 Monitoring for
                                 Dialysis.
Staff RN......................  57.505: Dialysis             250              75           10/60           3,125
                                 Patient
                                 Influenza
                                 Vaccination.
Staff RN......................  57.506: Dialysis             250               5           10/60             208
                                 Patient
                                 Influenza
                                 Vaccination
                                 Denominator.
Epidemiologist................  57.600: State                152              50           15/60           1,900
                                 Health
                                 Department
                                 Validation
                                 Record.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............       4,104,776
----------------------------------------------------------------------------------------------------------------


Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate 
Director for Science, Office of the Director.
[FR Doc. 2013-14752 Filed 6-19-13; 8:45 am]
BILLING CODE 4163-18-P