Proposed Data Collections Submitted for Public Comment and Recommendations
Federal RegisterOct 13, 2010
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-10-0666]
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. Alternatively, to obtain a copy of the data collection plans and instrument, call 404-639-5960 and send comments to Carol E. Walker, Acting CDC Reports Clearance Officer, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30333; comments may also be sent by e-mail to
omb@cdc.gov.
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 will have a 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 clarify 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 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. 3/31/2012)—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 to 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 eSurveillance. 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 the 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.
This revision submission includes an amended Assurance of Confidentiality, which required an update of the Assurance of Confidentiality language on all forms included in the NHSN surveillance system. 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). The Patient Safety (PS) Component is being expanded to include long-term care facilities to facilitate HAI surveillance in this setting, for which no standardized reporting methodology or mechanism currently exists. Four new forms are proposed for this purpose. A new form is proposed to be added to the Healthcare Personnel Safety (HPS) Component to facilitate summary reporting of influenza vaccination in healthcare workers, which is anticipated to be required by CMS in the near future. In addition to this new form, the scope of the HPS Annual Facility Survey is being expanded to include all acute care facilities that would enroll if CMS does implement this requirement. The NHSN Antimicrobial Use and Resistance module is transitioning from manual web entry to electronic data upload only, which results in a significant decrease to the reporting burden for this package. Eight forms that are no longer necessary are being removed from this information data request. Finally, there are many updates, clarifications, and data collection revisions proposed in this submission.
The previously approved NHSN package included 54 individual data collection forms; the current revision request includes five new forms and the removal of eight forms from the package. If all proposed revisions are approved, the reporting burden will decrease by 1,258,119 hours, for a total estimated burden of 3,914,125 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
Form number and name
Respondents
Number of
respondents
Responses per
respondent
Burden per
response
(in hours)
Total annual burden
(in hours)
57.100: NHSN Registration Form
Registered Nurse (Infection Preventionist)
6,000
1
5/60
500
57.101: Facility Contact Information
Registered Nurse (Infection Preventionist)
6,000
1
10/60
1,000
57.103: Patient Safety Component—Annual Facility Survey
Registered Nurse (Infection Preventionist)
6,000
1
40/60
4,000
57.104: Patient Safety Component—Outpatient Dialysis Center Practices Survey
Registered Nurse (Infection Preventionist)
5,500
1
1
5,500
57.105: Group Contact Information
Registered Nurse (Infection Preventionist)
6,000
1
5/60
500
57.106: Patient Safety Monthly Reporting Plan
Registered Nurse (Infection Preventionist)
6,000
9
35/60
31,500
57.108: Primary Bloodstream Infection (BSI)
Registered Nurse (Infection Preventionist)
6,000
36
32/60
115,200
57.109: Dialysis Event
Staff RN
500
75
15/60
9,375
57.114: Urinary Tract Infection (UTI)
Registered Nurse (Infection Preventionist)
6,000
27
32/60
86,400
57.116: Denominators for Neonatal Intensive Care Unit (NICU)
Staff RN
6,000
9
4
216,000
57.117: Denominators for Specialty Care Area (SCA)
Staff RN
6,000
9
5
270,000
57.118: Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)
Staff RN
6,000
18
5
540,000
57.119: Denominator for Outpatient Dialysis
Staff RN
500
12
5/60
500
57.120: Surgical Site Infection (SSI)
Registered Nurse (Infection Preventionist)
6,000
27
32/60
86,400
57.121: Denominator for Procedure
Staff RN
6,000
540
10/60
540,000
57.124: Paper form obsolete. See Electronic Data Upload Specification Tables
Pharmacy Technician
6,000
12
5/60
6,000
57.125: Central Line Insertion Practices Adherence Monitoring
Registered Nurse (Infection Preventionist)
6,000
100
5/60
50,000
57.126: MDRO or CDI Infection Form
Registered Nurse (Infection Preventionist)
6,000
72
32/60
230,400
57.127: MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring
Registered Nurse (Infection Preventionist)
6,000
24
10/60
24,000
57.128: Laboratory-identified MDRO or CDI Event
Registered Nurse (Infection Preventionist)
6,000
240
25/60
600,000
57.130: Denominators for Summary Vaccination Method
Registered Nurse (Infection Preventionist)
6,000
5
14
420,000
57.133: Patient Vaccination
Registered Nurse (Infection Preventionist)
2,000
250
10/60
83,333
57.137: Patient Safety Component—Annual Facility Survey for LTCF
Registered Nurse (Infection Preventionist)
250
1
25/60
104
57.138: Laboratory-identified MDRO or CDI Event for LTCF
Registered Nurse (Infection Preventionist)
250
8
30/60
1,000
57.139: MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF
Registered Nurse (Infection Preventionist)
250
3
7/60
88
57.140: Urinary Tract Infection (UTI) for LTCF
Registered Nurse (Infection Preventionist)
250
9
30/60
1,125
57.202: Healthcare Worker Survey
Occupational Health RN/Specialist
600
100
10/60
10,000
57.203: Healthcare Personnel Safety Monthly Reporting Plan
Occupational Health RN/Specialist
600
9
10/60
900
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
57.210: Healthcare Worker Prophylaxis/Treatment—Influenza
Occupational Health RN/Specialist
600
50
10/60
5,000
57.211: Pre-season Survey on Influenza Vaccination Programs for Healthcare Personnel
Occupational Health RN/Specialist
600
1
10/60
100
57.212: Post-season Survey on Influenza Vaccination Programs for Healthcare Personnel
Occupational Health RN/Specialist
600
1
10/60
100
57.213: Healthcare Personnel Influenza Vaccination Monthly Summary
Occupational Health RN/Specialist
6,000
6
2
72,000
57.300: Hemovigilance Module Annual Survey
Medical/Clinical Laboratory Technologist
500
1
2
1,000
57.301: Hemovigilance Module Monthly Reporting Plan
Medical/Clinical Laboratory Technologist
500
12
2/60
200
57.303: Hemovigilance Module Monthly Reporting Denominators
Medical/Clinical Laboratory Technologist
500
12
30/60
3,000
57.304: Hemovigilance Adverse Reaction
Medical/Clinical Laboratory Technologist
500
120
10/60
10,000
57.305: Hemovigilance Incident
Medical/Clinical Laboratory Technologist
500
72
10/60
6,000
Total Est Annual Burden Hours
3,914,125
Dated: October 5, 2010.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-25695 Filed 10-12-10; 8:45 am]
BILLING CODE 4163-18-P
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