[Federal Register Volume 72, Number 224 (Wednesday, November 21, 2007)]
[Notices]
[Pages 65578-65580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22731]


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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 [email protected]. 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
----------------------------------------------------------------------------------------------------------------
                                                                             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)...........................

[[Page 65580]]

 
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................................................
----------------------------------------------------------------------------------------------------------------
\**\ 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