[Federal Register: July 26, 2007 (Volume 72, Number 143)]
[Notices]
[Page 41077-41079]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26jy07-53]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-07-0666]
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 Maryam I. Daneshvar, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an 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 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 Control No. 0920-
0666)--Revision--National Center for Preparedness, Detection, and
Control of Infectious Diseases (NCPDCID), 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.
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. This application to OMB
includes a significant increase in the number of burden hours to the
previously approved data collection. The increase is due to inclusion
of new forms and an increased number of respondents.
NHSN was first approved by OMB in 2005 and CDC proposes to revise
this data collection by adding new modules to the NHSN as well as
modifying currently approved forms. Four new forms are proposed: (1)
Healthcare Worker Influenza Vaccination form; (2) Healthcare Worker
Influenza Antiviral Medication Administration form; (3) Pre-season
survey on Influenza Vaccination Programs for Healthcare Workers; and
(4) Post-season Survey on Influenza Vaccination Programs for Healthcare
Workers. The purpose of these new forms is to help participating
healthcare institutions and CDC to: (1) Monitor influenza vaccination
coverage among healthcare personnel at individual facilities and to
provide aggregate coverage estimates for all participating facilities;
(2) monitor progress towards attaining the Healthy People 2010 goal of
60% vaccination coverage among healthcare personnel; (3) monitor
influenza vaccination coverage by ward/unit of the facility or
occupational group so that areas or groups with low vaccination rates
can be targeted for interventions; (4) monitor adverse reactions
related to receipt of the vaccine or receipt of antiviral medications;
and (5) assess the characteristics of influenza vaccination programs
pre- and post-influenza season to identify practices associated with
high immunization rates. The total estimated annual burden for these
forms is 13,800 hours.
CDC is proposing to add an additional form, Central Line Insertion
Practices Monitoring Form, to the Patient Safety Component Device
Associated Module. This new form will enable participating facilities
and CDC to (1) monitor central line insertion practices in individual
patient care units and facilities and provide aggregate data for all
participating facilities (facilities have the option of recording
inserter-specific adherence data); (2) link gaps in recommended
practice with the clinical outcome both in individual facilities and
for all participating facilities; (3) facilitate quality improvement by
identifying specific gaps in adherence to recommended prevention
practices, thereby helping to target intervention strategies for
reducing central line infection rates. The total estimated annual
burden for this form is 12,500 hours.
CDC proposes to add the Multi-Drug Resistant Organism (MDRO)
Prevention Process Monitoring Module to the Patient Safety Component.
This module consists of four forms: (1) MDRO Prevention Process
Monitoring Form; (2) MDRO Infection Event Form; (3) Laboratory-
identified MDRO Event Form; and (4) Laboratory-identified MDRO Event
Summary Form. The purpose of these forms is to: (1) Monitor processes
and practices in individual patient care units and facilities and to
provide aggregate adherence data for all participating facilities; (2)
link gaps in recommended practice with the clinical outcome (i.e., MDRO
infection) both in individual facilities and for all participating
facilities; (3) facilitate quality improvement by identifying specific
gaps in adherence to
[[Page 41078]]
recommended prevention practices, thereby helping to target
intervention strategies for reducing MDRO infection rates. The total
estimated annual burden for these forms is 244,500 hours.
The fourth new proposed collection to the NHSN is the High Risk
Inpatient Influenza Vaccination Module. This module consists of four
forms: (1) Influenza High Risk Inpatient Influenza Vaccine Summary
Form--Method A; (2) Influenza High Risk Inpatient Influenza Vaccine
Summary Form--Numerator Data Form Method B; (3) Influenza High Risk
Inpatient Influenza Vaccine Summary Form--Method B; and (4) Influenza
High Risk Inpatient Influenza Vaccine--Denominator Form Method B. The
purpose of these forms is to: (1) Monitor influenza vaccination
practices for high risk patients and provide aggregate data in regard
to the number of high risk patients receiving vaccination, those
already vaccinated, and those who decline due to medical
contraindications or other reasons; and (2) to identify reasons that
high risk patients are not receiving influenza vaccination. The total
estimated annual burden of these forms is 161,250 hours.
CDC is also proposing to open enrollment to any healthcare
facility; therefore this submission includes a registration form
(Registration Form) to collect necessary registration information. The
total estimated annual burden for this form is 125 hours.
A Long Term Acute Care Hospital (LTACH) survey form is included in
this submission. This survey will allow long term acute care hospitals
and CDC to collect information on LTACH characteristics, infection
control practices, and microbiology laboratory practices. This data
will provide CDC with more comprehensive information on all of the
types of facilities that utilize the NHSN. The total estimated annual
burden for this form is 38 hours.
Finally, CDC also proposes to make minor edits and modifications to
currently approved forms.
CDC is also adding an increased number of participating healthcare
institutions from a wide spectrum of settings. Part of this increase in
burden hours is due to the passage of legislation in many states
requiring mandatory reporting of healthcare-associated infections. Some
states plan to use or are using NHSN as their data collection system to
meet this mandate.
Participating institutions must have a computer capable of
supporting an Internet service provider (ISP) and access to an ISP. The
only other cost to respondents is their time to complete the
appropriate forms.
Estimate of Annualized Burden Hours
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Average Average
Number of number of burden per Total burden
Form respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Facility Contact Information.................... 1,500 1 10/60 250
Patient Safety Component Hospital Survey........ 1,500 1 30/60 750
Agreement to Participate and Consent............ 1,500 1 15/60 375
Group Contact Information....................... 1,500 1 5/60 125
Patient Safety Monthly Reporting Plan........... 1,500 9 35/60 7,875
Healthcare Personnel Safety Reporting Plan...... 150 9 10/60 225
Primary Bloodstream Infection (BSI)............. 1,500 36 30/60 27,000
Pneumonia (PNEU)--also includes Any Patient 1,500 72 30/60 54,000
Pneumonia Flow Diagram and Infant and Children
Pneumonia Flow Diagram.........................
Urinary Tract Infection (UTI)................... 1,500 27 30/60 20,250
Surgical Site Infection (SSI)................... 1,500 27 30/60 20,250
Dialysis (DI)................................... 80 90 15/60 1,800
Antimicrobial Use and Resistance (AUR)-- 1,500 45 3 202,500
Microbiology Laboratory Data...................
Antimicrobial Use and Resistance--Pharmacy Data. 1,500 36 2 108,000
Denominators for Intensive Care Unit (ICU)/Other 1,500 18 5 135,000
locations (Not NICU or SCA)....................
Denominators for Specialty Care Area (SCA)...... 1,500 9 5 67,500
Denominators for Neonatal Intensive Care Unit 1,500 9 4 54,000
(NICU).........................................
Denominator for Procedure....................... 1,500 540 8/60 108,000
Denominator for Outpatient Dialysis............. 80 9 5/60 60
Patient Safety Component--Outpatient Dialysis 80 1 1 80
Center Practices Survey........................
List of Blood Isolates.......................... 1,500 1 1 1,500
Manual Categorization of Positive Blood Cultures 1,500 1 1 1,500
Exposures to Blood/Body Fluids.................. 150 50 1 7,500
Healthcare Personnel Post-exposure Prophylaxis.. 150 10 15/60 375
Healthcare Personnel Demographic Data........... 150 200 20/60 10,000
Healthcare Personnel Vaccination History........ 150 300 10/60 7,500
Annual Facility Survey.......................... 150 1 8 1,200
Implementation of Engineering Controls.......... 150 1 30/60 75
Healthcare Worker Survey........................ 150 100 10/60 2,500
Healthcare Personnel Influenza Vaccination Form. 150 500 10/60 12,500
Healthcare Personnel Influenza Antiviral 150 50 10/60 1,250
Medication Administration Form.................
Pre-season Survey on Influenza Vaccination 150 1 10/60 25
Programs for Healthcare Workers................
Post-Season Survey on Influenza Vaccination 150 1 10/60 25
Programs for Healthcare Workers................
Central Line Insertion Practices Adherence 1,500 100 5/60 12,500
Monitoring Form (CLIP).........................
Laboratory Testing.............................. 150 100 15/60 3,750
MDRO Prevention Process and Outcome Measures 1,500 24 10/60 6,000
Monthly Monitoring Form........................
MDRO Infection Event Form....................... 1,500 72 30/60 54,000
Laboratory Identified MDRO Event Form (LIME).... 1,500 240 30/60 180,000
Registration Form............................... 1,500 1 5/60 125
[[Page 41079]]
High Risk Inpatient Influenza Vaccine--Summary 1,500 5 16 120,000
Form Method A..................................
High Risk Inpatient Influenza Vaccine-Numerator 500 250 10/60 20,833
Data Form Method B.............................
High Risk Inpatient Influenza Vaccine--Summary 500 5 4 10,000
Form Method B..................................
High Risk Inpatient Influenza Vaccine-- 500 250 5/60 10,417
Denominator Data Form Method B.................
Laboratory Identified MDRO Event--Summary Form.. 1,500 3 1 4,500
Long-term Acute Care Hospital Survey............ 75 1 30/60 38
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Total....................................... .............. .............. .............. 1,276,153
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Dated: July 19, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E7-14432 Filed 7-25-07; 8:45 am]
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