[Federal Register: November 21, 2007 (Volume 72, Number 224)]
[Notices]
[Page 65578-65580]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21no07-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-07-0666]
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
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
National Healthcare Safety Network (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
[[Page 65579]]
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.
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.
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 recommended prevention practices, thereby helping
to target intervention strategies for reducing MDRO infection rates.
The fourth new proposed collection to the NHSN is the High Risk
Inpatient Influenza Vaccination Module. This module consists of five
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; (4) Influenza High
Risk Inpatient Influenza Vaccine--Denominator Form Method B; and (5)
High Risk Inpatient Influenza Vaccination Standing Orders Form. The
last form is an optional form that may be used in NHSN, but is not
required as part of the High Risk Patient Influenza Vaccination module.
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.
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.
Finally, CDC also proposes to make minor edits and modifications to
currently approved forms. The NHSN is currently approved for 65,817
hours for these 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 are or 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.
The National Healthcare Safety Network is currently approved for
65,817 burden hours. This revision is seeking an increase of 1,212,498
burden hours The total estimated annualized burden hours are 1,278,315.
Estimate of Annualized Burden Hours
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Average no. of Average burden
Form No. of responses per per response (in
respondents respondent hours)
----------------------------------------------------------------------------------------------------------------
A. Patient Safety Monthly Reporting Plan............... 1,500 9 35/60
AA. Healthcare Worker Survey........................... 150 100 10/60
B. Healthcare Personnel Safety Reporting Plan.......... 150 9 10/60
BB. Dialysis Survey.................................... 80 1 1
CC. List of Blood Isolates\+\.......................... 1,500 1 1
D. Primary Bloodstream Infection (BSI)\**\............. 1,500 36 30/60
DD. Manual Categorization of Positive Blood Cultures\+\ 1,500 1 1
E. Dialysis Event...................................... 80 200 15/60
FF. Healthcare Worker Influenza Vaccination............ 150 500 10/60
G. Pneumonia (PNEU) (Includes decision algorithms:..... 1,500 72 30/60
Ga. Any Patient--Pneumonia Flow Diagram
Gb. Infant and Children--Pneumonia Flow Diagram)
GG. Healthcare Worker Influenza Antiviral Medication 150 50 10/60
Administration........................................
H. Urinary Tract Infection (UTI)....................... 1,500 27 30/60
HH. Preseason Survey on Influenza Vaccination Programs 150 1 10/60
for Healthcare Personnel..............................
II. Postseason Survey on Influenza Vaccination Programs 150 1 10/60
for Healthcare Personnel..............................
J. Denominators for Neonatal Intensive Care Units 1,500 9 4
(NICU)................................................
JJ. Central Line Insertion Practices Adherence 1,500 100 5/60
Monitoring Form.......................................
K. Denominators for Specialty Care Area (SCA).......... 1,500 9 5
KK. Laboratory Testing................................. 150 100 15/60
L. Denominators for Intensive Care Units (ICU)/Other 1,500 18 5
locations (not NICU or SCA)...........................
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LL. Multi-drug Resistant Organism (MDRO) Prevention 1,500 24 10/60
Process and Outcome Measures Monthly Monitoring Form..
M. Denominator for Outpatient Dialysis................. 80 9 5/60
MM. MDRO Infection Form................................ 1,500 72 30/60
N. Surgical Site Infection (SSI)....................... 1,500 27 30/60
NN. Laboratory-identified MDRO Event................... 1,500 240 30/60
O. Denominator for procedure........................... 1,500 540 8/60
OO. NHSN Registration Form............................. 1,500 1 5/60
P. Antimicrobial Use and Resistance (AUR)--Microbiology 1,500 45 3
Laboratory Data\**\...................................
PP. High Risk Inpatient Influenza Vaccination Monthly 1,500 5 16
Monitoring Form--Method A.............................
Q. Antimicrobial Use and Resistance (AUR)--Pharmacy 1,500 36 2
Data\**\..............................................
QQ. High Risk Inpatient Influenza Vaccination Numerator 500 250 10/60
Data Form--Method B...................................
R. Facility Contact Information........................ 1,500 1 10/60
RR. High Risk Inpatient Influenza Vaccination Monthly 500 5 4
Monitoring Form--Method B.............................
S. Patient Safety Component Annual Facility Survey..... 1,500 1 30/60
SS. High Risk Inpatient Influenza Vaccination 500 250 5/60
Denominator Data Form--Method B.......................
T. Agreement to Participate and Consent................ 1,500 1 15/60
TT. Laboratory-identified MDRO Event Summary Form...... 1,500 3 1
U. Group Contact Information........................... 1,500 1 5/60
V. Exposure to Blood/Body Fluids....................... 150 50 1
W. Healthcare Worker Post-exposure Prophylaxis......... 150 10 15/60
X. Healthcare Worker Demographic Data.................. 150 200 20/60
Y. Healthcare Worker Vaccination History............... 150 300 10/60
Z. Implementation of Engineering (safety device) 150 1 30/60
Controls for Sharps Injury Prevention.................
Za. Healthcare Personnel Safety Component Facility 150 1 8
Survey................................................
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\**\ Burden will be eliminated when reporting these data once an NHSN institution implements electronic data
capture.
\+\ Burden during validation phase only, then eliminated.
Dated: November 14, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E7-22731 Filed 11-20-07; 8:45 am]
BILLING CODE 4163-18-P