[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37265-37268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16028]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-15-0666; Docket No. CDC-2015-0048]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing efforts to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies to take this opportunity to comment on proposed and/or
continuing information collections, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on the National
Healthcare Safety Network (NHSN). NHSN is a
[[Page 37266]]
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.
DATES: Written comments must be received on or before August 31, 2015.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0048 by any of the following methods:
Federal eRulemaking Portal: Regulation.gov. Follow the
instructions for submitting comments.
Mail: Leroy A. Richardson, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE., MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to Regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to Regulations.gov.
Please note: All public comment should be submitted through the
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact the Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
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; (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; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services
to provide information. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; to develop, acquire,
install and utilize technology and systems for the purpose of
collecting, validating and verifying information, processing and
maintaining information, and disclosing and providing information; to
train personnel and to be able to respond to a collection of
information, to search data sources, to complete and review the
collection of information; and to transmit or otherwise disclose the
information.
Proposed Project
National Healthcare Safety Network (NHSN)--Revision--National
Center for Emerging and Zoonotic Infection 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 currently consists of five components: Patient Safety,
Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility
(LTCF), and Dialysis. The Outpatient Procedure Component is on track to
be released in NHSN in 2016/2017. The development of this component has
been previously delayed to obtain additional user feedback and support
from outside partners.
Changes were made to seven facility surveys. Based on user feedback
and internal reviews of the annual facility surveys it was determined
that questions and response options be amended, removed, or added to
fit the evolving uses of the annual facility surveys. The surveys are
being increasingly used to help intelligently interpret the other data
elements reported into NHSN. Currently the surveys are used to
appropriately risk adjust the numerator and denominator data entered
into NHSN while also guiding decisions on future division priorities
for prevention.
Additionally, minor revisions have been made to 27 forms within the
package to clarify and/or update surveillance definitions. Two forms
are being removed as those forms will no longer be added to the NHSN
system. The previously approved NHSN package included 54 individual
collection forms; the current revision request removes two forms for a
total of 52 forms. The reporting burden will increase by 583,825 hours,
for a total of 4,861,542 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Registered Nurse (Infection NHSN 2,000 1 5/60 167
Preventionist). Registration
Form.
Registered Nurse (Infection Facility Contact 2,000 1 10/60 333
Preventionist). Information.
Registered Nurse (Infection Patient Safety 5,000 1 50/60 4,167
Preventionist). Component--Annu
al Hospital
Survey.
[[Page 37267]]
Registered Nurse (Infection Group Contact 1,000 1 5/60 83
Preventionist). Information.
Registered Nurse (Infection Patient Safety 6,000 12 15/60 18,000
Preventionist). Monthly
Reporting Plan.
Registered Nurse (Infection Primary 6,000 44 30/60 132,000
Preventionist). Bloodstream
Infection (BSI).
Registered Nurse (Infection Pneumonia (PNEU) 6,000 72 30/60 216,000
Preventionist).
Registered Nurse (Infection Ventilator- 6,000 144 25/60 360,000
Preventionist). Associated
Event.
Registered Nurse (Infection Urinary Tract 6,000 40 20/60 80,000
Preventionist). Infection (UTI).
Staff RN...................... Denominators for 6,000 9 3 162,000
Neonatal
Intensive Care
Unit (NICU).
Staff RN...................... Denominators for 6,000 9 5 270,000
Specialty Care
Area (SCA)/
Oncology (ONC).
Staff RN...................... Denominators for 6,000 60 5 1,800,000
Intensive Care
Unit (ICU)/
Other locations
(not NICU or
SCA).
Registered Nurse (Infection Surgical Site 6,000 36 35/60 126,000
Preventionist). Infection (SSI).
Staff RN...................... Denominator for 6,000 540 5/60 270,000
Procedure.
Laboratory Technician......... Antimicrobial 6,000 12 5/60 6,000
Use and
Resistance
(AUR)-
Microbiology
Data Electronic
Upload
Specification
Tables.
Pharmacy Technician........... Antimicrobial 6,000 12 5/60 6,000
Use and
Resistance
(AUR)-Pharmacy
Data Electronic
Upload
Specification
Tables.
Registered Nurse (Infection Central Line 1,000 100 25/60 41,667
Preventionist). Insertion
Practices
Adherence
Monitoring.
Registered Nurse (Infection MDRO or CDI 6,000 72 30/60 216,000
Preventionist). Infection Form.
Registered Nurse (Infection MDRO and CDI 6,000 24 15/60 36,000
Preventionist). Prevention
Process and
Outcome
Measures
Monthly
Monitoring.
Registered Nurse (Infection Laboratory- 6,000 240 30/60 720,000
Preventionist). identified MDRO
or CDI Event.
Registered Nurse (Infection Long-Term Care 250 1 1 250
Preventionist). Facility
Component--Annu
al Facility
Survey.
Registered Nurse (Infection Laboratory- 250 8 15/60 500
Preventionist). identified MDRO
or CDI Event
for LTCF.
Registered Nurse (Infection MDRO and CDI 250 12 5/60 250
Preventionist). Prevention
Process
Measures
Monthly
Monitoring for
LTCF.
Registered Nurse (Infection Urinary Tract 250 9 30/60 1,125
Preventionist). Infection (UTI)
for LTCF.
Registered Nurse (Infection Monthly 250 12 5/60 250
Preventionist). Reporting Plan
for LTCF.
Registered Nurse (Infection Denominators for 250 12 3.25 9,750
Preventionist). LTCF Locations.
Registered Nurse (Infection Prevention 250 12 5/60 250
Preventionist). Process
Measures
Monthly
Monitoring for
LTCF.
Registered Nurse (Infection LTAC Annual 400 1 50/60 333
Preventionist). Survey.
Registered Nurse (Infection Rehab Annual 1,000 1 50/60 833
Preventionist). Survey.
Occupational Health RN/ Healthcare 50 1 8 400
Specialist. Personnel
Safety
Component
Annual Facility
Survey.
Occupational Health RN/ Healthcare 17,000 1 5/60 1,417
Specialist. Personnel
Safety Monthly
Reporting Plan.
Occupational Health RN/ Healthcare 50 200 20/60 3,333
Specialist. Worker
Demographic
Data.
Occupational Health RN/ Exposure to 50 50 1 2,500
Specialist. Blood/Body
Fluids.
Occupational Health RN/ Healthcare 50 30 15/60 375
Specialist. Worker
Prophylaxis/
Treatment.
Laboratory Technician......... Follow-Up 50 50 15/60 625
Laboratory
Testing.
Occupational Health RN/ Healthcare 50 50 10/60 417
Specialist. Worker
Prophylaxis/
Treatment-
Influenza.
[[Page 37268]]
Medical/Clinical Laboratory Hemovigilance 500 1 2 1,000
Technologist. Module Annual
Survey.
Medical/Clinical Laboratory Hemovigilance 500 12 1/60 100
Technologist. Module Monthly
Reporting Plan.
Medical/Clinical Laboratory Hemovigilance 500 12 1 6,000
Technologist. Module Monthly
Reporting
Denominators.
Medical/Clinical Laboratory Hemovigilance 500 48 15/60 6,000
Technologist. Adverse
Reaction.
Medical/Clinical Laboratory Hemovigilance 500 10 10/60 833
Technologist. Incident.
Staff RN...................... Patient Safety 5,000 1 5/60 417
Component--Annu
al Facility
Survey for
Ambulatory
Surgery Center
(ASC).
Staff RN...................... Outpatient 5,000 12 15/60 15,000
Procedure
Component--Mont
hly Reporting
Plan.
Staff RN...................... Outpatient 5,000 25 40/60 83,333
Procedure
Component Event.
Staff RN...................... Outpatient 5,000 12 40/60 40,000
Procedure
Component--Mont
hly
Denominators
and Summary.
Registered Nurse (Infection Outpatient 6,500 1 2.0 13,000
Preventionist). Dialysis Center
Practices
Survey.
Staff RN...................... Dialysis Monthly 6,500 12 5/60 6,500
Reporting Plan.
Staff RN...................... Dialysis Event.. 6,500 60 25/60 162,500
Staff RN...................... Denominators for 6,500 12 10/60 13,000
Dialysis Event
Surveillance.
Staff RN...................... Prevention 1,500 12 1.25 22,500
Process
Measures
Monthly
Monitoring for
Dialysis.
Staff RN...................... Dialysis Patient 325 75 10/60 4,063
Influenza
Vaccination.
Staff RN...................... Dialysis Patient 325 5 10/60 271
Influenza
Vaccination
Denominator.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 4,861,542
----------------------------------------------------------------------------------------------------------------
Maryam I. Daneshvar,
Deputy Director, Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2015-16028 Filed 6-29-15; 8:45 am]
BILLING CODE 4163-18-P