[Federal Register Volume 77, Number 207 (Thursday, October 25, 2012)]
[Notices]
[Pages 65192-65194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26268]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-13-0666]
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
(404) 639-7570 or send an email to [email protected]. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC
20503 or by fax to (202) 395-5806. Written comments should be received
within 30 days of this notice.
Proposed Project
National Healthcare Safety Network (NHSN) (OMB No. 0920-0666), exp.
01/31/2015--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 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 Long-Term Care Facility (LTCF). 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 is used to more
specifically and appropriately capture data from the residents of
skilled nursing facilities. Surveillance methods and definitions for
this component specifically address the nuances of LTCF residents.
This revision submission includes major revisions to the Patient
Safety Component--Outpatient Dialysis Center Practices Survey (Form
57.104) in an effort to provide further clarification to those
collecting the information. Additionally, some of the changes have been
made to improve surveillance data available for the outpatient dialysis
population. Due to the CMS End Stage Renal Disease (ESRD) Quality
Improvement Program (QIP) reporting
[[Page 65193]]
requirements, over 5,700 dialysis facilities have already enrolled or
will enroll into NHSN to report data in 2012. Form 57.104 is completed
by each facility upon enrollment into NHSN and then every January
thereafter.
Furthermore, minor revisions have been made to 28 other forms
within the package to clarify and/or update surveillance definitions.
Six forms have been removed for the purposes of simplification from the
Healthcare Personnel Safety Component of the package due to changes
within NHSN reporting of healthcare personnel influenza vaccination.
Old functionality of individual level vaccination reporting will be
removed from NHSN. CMS Inpatient Quality Reporting (IQR) requirements
designate that all acute care facilities will report healthcare
personnel vaccination counts at the summary level for the 2012-2013 flu
season.
The previously approved NSHN package included 54 individual
collection forms; the current revision request removes six forms for a
total of 48 forms. The reporting burden will decrease by 415,523 hours,
for a total of 3,562,653 hours.
Healthcare institutions that participate in NHSN 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
----------------------------------------------------------------------------------------------------------------
No. of Avg. burden
Form number and name Type of respondents Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
57.100: NHSN Registration Form........ Registered Nurse 2,000 1 5/60
(Infection
Preventionist).
57.101: Facility Contact Information.. Registered Nurse 2,000 1 10/60
(Infection
Preventionist).
57.103: Patient Safety Component-- Registered Nurse 6,000 1 30/60
Annual Hospital Survey. (Infection
Preventionist).
57.104: Patient Safety Component-- Registered Nurse 5,700 1 1.5
Outpatient Dialysis Center Practices (Infection
Survey. Preventionist).
57.105: Group Contact Information..... Registered Nurse 6,000 1 5/60
(Infection
Preventionist).
57.106: Patient Safety Monthly Registered Nurse 10,000 12 35/60
Reporting Plan. (Infection
Preventionist).
57.108: Primary Bloodstream Infection Registered Nurse 6,000 36 35/60
(BSI). (Infection
Preventionist).
57.109: Dialysis Event................ Staff RN................ 5,700 60 16/60
57.111: Pneumonia (PNEU).............. Registered Nurse 6,000 72 32/60
(Infection
Preventionist).
57.112: Ventilator-Associated Event... Registered Nurse 6,000 144 25/60
(Infection
Preventionist).
57.114: Urinary Tract Infection (UTI). Infection Preventionist. 6,000 27 32/60
57.116: Denominators for Neonatal Staff RN................ 6,000 9 3
Intensive Care Unit (NICU).
57.117: Denominators for Specialty Staff RN................ 6,000 9 5
Care Area (SCA)/Oncology (ONC).
57.118: Denominators for Intensive Staff RN................ 6,000 18 5
Care Unit (ICU)/Other locations (not
NICU or SCA).
57.119: Denominator for Outpatient Staff RN................ 5,700 12 6/60
Dialysis.
57.120: Surgical Site Infection (SSI). Registered Nurse 6,000 36 32/60
(Infection
Preventionist).
57.121: Denominator for Procedure..... Staff RN................ 6,000 540 5/60
57.123: Antimicrobial Use and Laboratory Technician... 6,000 12 5/60
Resistance (AUR)--Microbiology Data
Electronic Upload Specification
Tables.
57.124: Antimicrobial Use and Pharmacy Technician..... 6,000 12 5/60
Resistance (AUR)--Pharmacy Data
Electronic Upload Specification
Tables.
57.125: Central Line Insertion Registered Nurse 1,000 100 5/60
Practices Adherence Monitoring. (Infection
Preventionist).
57.126: MDRO or CDI Infection Form.... Registered Nurse 6,000 72 32/60
(Infection
Preventionist).
57.127: MDRO and CDI Prevention Registered Nurse 6,000 24 10/60
Process and Outcome Measures Monthly (Infection
Monitoring. Preventionist).
57.128: Laboratory-identified MDRO or Registered Nurse 6,000 240 15/60
CDI Event. (Infection
Preventionist).
57.130: Vaccination Monthly Monitoring Registered Nurse 6,000 5 14
Form--Summary Method. (Infection
Preventionist).
57.131: Vaccination Monthly Monitoring Registered Nurse 2,000 5 2
Form--Patient-Level Method. (Infection
Preventionist).
57.133: Patient Vaccination........... Registered Nurse 2,000 250 10/60
(Infection
Preventionist).
57.137: Long-Term Care Facility Registered Nurse 250 1 45/60
Component--Annual Facility Survey. (Infection
Preventionist).
57.138: Laboratory-identified MDRO or Registered Nurse 250 8 15/60
CDI Event for LTCF. (Infection
Preventionist).
[[Page 65194]]
57.139: MDRO and CDI Prevention Registered Nurse 250 12 5/60
Process Measures Monthly Monitoring (Infection
for LTCF. Preventionist).
57.140: Urinary Tract Infection (UTI) Registered Nurse 250 9 30/60
for LTCF. (Infection
Preventionist).
57.141: Monthly Reporting Plan for Registered Nurse 250 12 5/60
LTCF. (Infection
Preventionist).
57.142: Denominators for LTCF Registered Nurse 250 12 3
Locations. (Infection
Preventionist).
57.143: Prevention Process Measures Registered Nurse 250 12 5/60
Monthly Monitoring for LTCF. (Infection
Preventionist).
57.150: LTAC Annual Survey............ Registered Nurse 400 1 30/60
(Infection
Preventionist).
57.151: Rehab Annual Survey........... Registered Nurse 1,000 1 25/60
(Infection
Preventionist).
57.200: Healthcare Personnel Safety Occupational Health RN/ 100 1 8
Component Annual Facility Survey. Specialist.
57.203: Healthcare Personnel Safety Occupational Health RN/ 100 9 10/60
Monthly Reporting Plan. Specialist.
57.204: Healthcare Worker Demographic Occupational Health RN/ 100 200 20/60
Data. Specialist.
57.205: Exposure to Blood/Body Fluids. Occupational Health RN/ 100 50 1
Specialist.
57.206: Healthcare Worker Prophylaxis/ Occupational Health RN/ 100 30 15/60
Treatment. Specialist.
57.207: Follow-Up Laboratory Testing.. Laboratory Technician... 100 50 15/60
57.210: Healthcare Worker Prophylaxis/ Occupational Health RN/ 600 50 10/60
Treatment--Influenza. Specialist.
57.300: Hemovigilance Module Annual Medical/Clinical 500 1 2
Survey. Laboratory Technologist.
57.301: Hemovigilance Module Monthly Medical/Clinical 500 12 2/60
Reporting Plan. Laboratory Technologist.
57.302: Hemovigilance Module Monthly Medical/Clinical 500 12 2
Incident Summary. Laboratory Technologist.
57.303: Hemovigilance Module Monthly Medical/Clinical 500 12 30/60
Reporting Denominators. Laboratory Technologist.
57.304: Hemovigilance Adverse Reaction Medical/Clinical 500 120 10/60
Laboratory Technologist.
57.305: Hemovigilance Incident........ Medical/Clinical 500 72 10/60
Laboratory Technologist.
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Dated: October 18, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate
Director for Science (OADS), Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2012-26268 Filed 10-24-12; 8:45 am]
BILLING CODE 4163-18-P