[Federal Register Volume 76, Number 177 (Tuesday, September 13, 2011)]
[Notices]
[Pages 56458-56461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23302]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-11-0666]


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 404-639-5960 
and send comments to Daniel Holcomb, CDC Reports Clearance Officer, 
1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 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. 
05/31/2014--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

[[Page 56459]]

adverse events resulting from new and current medical therapies and 
changing risks. The NHSN previously consisted of four components: 
Patient Safety, Healthcare Personnel Safety, Biovigilance, and 
eSurveillance. In addition, a fifth component, Long Term Care 
Facilities (LTCF) is included in this revision. 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 will be used to more 
specifically and appropriately capture data from the residents of 
skilled nursing facilities. In order to facilitate this reporting, 
seven LTCF forms were created by using forms from the Patient Safety 
Component as a base, with modifications to specifically address the 
nuances of LTC residents.
    This revision submission includes the remaining three LTCF 
Component forms needed to facilitate healthcare-associated infection 
(HAI) surveillance in this setting, for which no standardized reporting 
methodology or mechanism currently exists. The three submitted LTCF 
forms along with the four previously approved LTCF forms will complete 
the LTCF Component. 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). In addition, two new 
annual facility surveys will be added for Long-term Acute Care 
Hospitals (LTAC) and Rehabilitation Hospitals (REHAB). A CMS ruling 
states that these specific hospital types must begin reporting HAI 
surveillance. Therefore, in order to accurately capture data relevant 
to those specific facility types, separate annual facility surveys were 
created. Also within the Patient Safety Component, a new form will be 
added, Streamlined Ventilator-Associated Pneumonia, to provide a 
streamlined, objective definition via which NHSN users may detect and 
report cases of ventilator-associated pneumonia in adult patients only. 
Finally there are many updates, clarifications, and data collection 
revisions proposed in this submission.
    The previously approved NSHN package included 48 individual 
collection forms; the current revision request includes six new forms 
for a total of 54 forms. The reporting burden will increase by 64,050 
hours, for a total of 3,978,175 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of      Avg. burden
              Form number and name                         Type of respondents               Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
57.100: NHSN Registration Form.................  Registered Nurse (Infection                       6,000               1            5/60             500
                                                  Preventionist).
57.101: Facility Contact Information...........  Registered Nurse (Infection                       6,000               1           10/60           1,000
                                                  Preventionist).
57.103: Patient Safety Component--Annual         Registered Nurse (Infection                       6,000               1           30/60           3,000
 Facility Survey.                                 Preventionist).
57.104: Patient Safety Component--Outpatient     Registered Nurse (Infection                       5,500               1               1           5,500
 Dialysis Center Practices Survey.                Preventionist).
57.105: Group Contact Information..............  Registered Nurse (Infection                       6,000               1            5/60             500
                                                  Preventionist).
57.106: Patient Safety Monthly Reporting Plan..  Registered Nurse (Infection                       6,000               9           35/60          31,500
                                                  Preventionist).
57.108: Primary Bloodstream Infection (BSI)....  Registered Nurse (Infection                       6,000              36           33/60         118,800
                                                  Preventionist).
57.109: Dialysis Event.........................  Staff RN...............................           5,500              75           16/60         110,000
57.111: Pneumonia (PNEU).......................  Registered Nurse (Infection                       6,000              72           32/60         230,400
                                                  Preventionist).
57.112: Streamlined Ventilator-Associated        Registered Nurse (Infection                       6,000             144           25/60         360,000
 Pneumonia.                                       Preventionist).
57.114: Urinary Tract Infection (UTI)..........  Registered Nurse (Infection                       6,000              27           32/60          86,400
                                                  Preventionist).
57.116: Denominators for Neonatal Intensive      Staff RN...............................           6,000               9               3         162,000
 Care Unit (NICU).
57.117: Denominators for Specialty Care Area     Staff RN...............................           6,000               9               5         270,000
 (SCA).
57.118: Denominators for Intensive Care Unit     Staff RN...............................           6,000              18               5         540,000
 (ICU)/Other locations (not NICU or SCA).

[[Page 56460]]

 
57.119: Denominator for Outpatient Dialysis....  Staff RN...............................           5,500              12            6/60           6,600
57.120: Surgical Site Infection (SSI)..........  Registered Nurse (Infection                       6,000              36           32/60         115,200
                                                  Preventionist).
57.121: Denominator for Procedure..............  Staff RN...............................           6,000             540            8/60         432,000
57.123: Antimicrobial Use and Resistance (AUR)-- Laboratory Technician..................           6,000              12            5/60           6,000
 Microbiology Data Electronic Upload
 Specification Tables.
57.124: Antimicrobial Use and Resistance (AUR)-- Pharmacy Technician....................           6,000              12            5/60           6,000
 Pharmacy Data Electronic Upload Specification
 Tables.
57.125: Central Line Insertion Practices         Registered Nurse (Infection                       1,000             100            5/60           8,333
 Adherence Monitoring.                            Preventionist).
57.126: MDRO or CDI Infection Form.............  Registered Nurse (Infection                       6,000              72           32/60         230,400
                                                  Preventionist).
57.127: MDRO and CDI Prevention Process and      Registered Nurse (Infection                       6,000              24           10/60          24,000
 Outcome Measures Monthly Monitoring.             Preventionist).
57.128: Laboratory-identified MDRO or CDI Event  Registered Nurse (Infection                       6,000             240           15/60         360,000
                                                  Preventionist).
57.130: Vaccination Monthly Monitoring Form--    Registered Nurse (Infection                       6,000               5              14         420,000
 Summary Method.                                  Preventionist).
57.131: Vaccination Monthly Monitoring Form--    Registered Nurse (Infection                       2,000               5               2          20,000
 Patient-Level Method.                            Preventionist).
57.133: Patient Vaccination....................  Registered Nurse (Infection                       2,000             250           10/60          83,333
                                                  Preventionist).
57.137: Patient Safety Component--Annual         Registered Nurse (Infection                         250               1           25/60             104
 Facility Survey for LTCF.                        Preventionist).
57.138: Laboratory-identified MDRO or CDI Event  Registered Nurse (Infection                         250               8           15/60             500
 for LTCF.                                        Preventionist).
57.139: MDRO and CDI Prevention Process          Registered Nurse (Infection                         250               3            5/60              63
 Measures Monthly Monitoring for LTCF.            Preventionist).
57.140: Urinary Tract Infection (UTI) for LTCF.  Registered Nurse (Infection                         250               9           30/60           1,125
                                                  Preventionist).
57.141: Monthly Reporting Plan for LTCF........  Registered Nurse (Infection                         250              12            5/60             250
                                                  Preventionist).
57.142: Denominators for LTCF Locations........  Registered Nurse (Infection                         250              12               3           9,000
                                                  Preventionist).
57.143: Prevention Process Measures Monthly      Registered Nurse (Infection                         250              12            5/60             250
 Monitoring for LTCF.                             Preventionist).
57.150: LTAC Annual Survey.....................  Registered Nurse (Infection                         400               1           30/60             200
                                                  Preventionist).
57.151: Rehab Annual Survey....................  Registered Nurse (Infection                       1,000               1           25/60             417
                                                  Preventionist).
57.200: Healthcare Personnel Safety Component    Occupational Health RN/Specialist......           6,000               1               8          48,000
 Annual Facility Survey.
57.202: Healthcare Worker Survey...............  Occupational Health RN/Specialist......             600             100           10/60          10,000
57.203: Healthcare Personnel Safety Monthly      Occupational Health RN/Specialist......             600               9           10/60             900
 Reporting Plan.
57.204: Healthcare Worker Demographic Data.....  Occupational Health RN/Specialist......             600             200           20/60          40,000
57.205: Exposure to Blood/Body Fluids..........  Occupational Health RN/Specialist......             600              50               1          30,000
57.206: Healthcare Worker Prophylaxis/Treatment  Occupational Health RN/Specialist......             600              10           15/60           1,500
57.207: Follow-Up Laboratory Testing...........  Laboratory Technician..................             600             100           15/60          15,000
57.208: Healthcare Worker Vaccination History..  Occupational Health RN/Specialist......             600             300           10/60          30,000
57.209: Healthcare Worker Influenza Vaccination  Occupational Health RN/Specialist......             600             500           10/60          50,000
57.210: Healthcare Worker Prophylaxis/           Occupational Health RN/Specialist......             600              50           10/60           5,000
 Treatment--Influenza.
57.211: Pre-season Survey on Influenza           Occupational Health RN/Specialist......             600               1           10/60             100
 Vaccination Programs for Healthcare Personnel.

[[Page 56461]]

 
57.212: Post-season Survey on Influenza          Occupational Health RN/Specialist......             600               1           10/60             100
 Vaccination Programs for Healthcare Personnel.
57.213: Healthcare Personnel Influenza           Occupational Health RN/Specialist......           6,000               6               2          72,000
 Vaccination Monthly Summary.
57.300: Hemovigilance Module Annual Survey.....  Medical/Clinical Laboratory                         500               1               2           1,000
                                                  Technologist.
57.301: Hemovigilance Module Monthly Reporting   Medical/Clinical Laboratory                         500              12            2/60             200
 Plan.                                            Technologist.
57.302: Hemovigilance Module Monthly Incident    Medical/Clinical Laboratory                         500              12               2          12,000
 Summary.                                         Technologist.
57.303: Hemovigilance Module Monthly Reporting   Medical/Clinical Laboratory                         500              12           30/60           3,000
 Denominators.                                    Technologist.
57.304: Hemovigilance Adverse Reaction.........  Medical/Clinical Laboratory                         500             120           10/60          10,000
                                                  Technologist.
57.305: Hemovigilance Incident.................  Medical/Clinical Laboratory                         500              72           10/60           6,000
                                                  Technologist.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Total Est Annual Burden Hours: 3,978,175

    Dated: September 6, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-23302 Filed 9-12-11; 8:45 am]
BILLING CODE 4163-18-P