Proposed Data Collection Submitted for Public Comment and Recommendations, 37265-37268 [2015-16028]
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37265
Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
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
Prevent Hepatitis Transmission Among
Persons Who Inject Drugs—New—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease
Control and Prevention (CDC)
Background and Brief Description
Hepatitis C virus (HCV) infection is
the most common chronic blood borne
infection in the United States;
approximately 3 million persons are
chronically infected. Identifying and
reaching persons at risk for HCV
infection is critical to prevent
transmission and treat and cure if
infected. CDC monitors the national
incidence of acute hepatitis C through
passive surveillance of acute,
symptomatic cases of laboratory
confirmed hepatitis C cases. Since 2006,
surveillance data have shown a trend
toward reemergence of HCV infection
mainly among young persons who inject
drugs (PWID) in nonurban counties. Of
the cases reported in 2013 with
information on risk factors 62%
indicated injection drug use as the
primarily through drug treatment
programs and syringe exchange
programs, as well as persons referred to
these sites as a result of referral from
other programs and respondent driven
sampling. Those who consent to
participate will be administered an
eligibility interview questionnaire by
trained field staff. If found eligible, the
participant will take an intervieweradministered survey that includes
information on initiation of drug use,
injection practices, HCV and HIV
infection status, access to prevention
and medical care, desire to receive and
barriers to receiving HCV treatment, and
missed opportunities for hepatitis
prevention. Participants will receive
counselling regarding adherence to
medical and/or drug treatment services
and prevention services. Participants
will be interviewed for a maximum of
5 times within any 12-month interval
during the course of the study: Consent
and interview at enrollment/baseline for
an estimated 60 minutes, and 30-minute
follow-up interviews every 3 months
thereafter. Participants who are
recruited early in the study have more
follow-up interviews than those who are
recruited in the later part of the study
during the 3-year project. However,
recruitment will be spread over 2 years
and on average, the duration of followup is estimated to be one year.
Participation in interviews and
responses to all study questions are
totally voluntary and there is no cost to
respondents other than their time. The
maximum burden is 3,375 hours.
primary risk for acute hepatitis C. The
prevention of HCV infection among
PWIDs requires an integrated approach
including harm reduction interventions,
substance abuse treatment, prevention
of other blood borne infections, and care
and treatment of HCV infection.
The purpose of the proposed study is
to address the high prevalence of HCV
infection by developing and
implementing an integrated approach
for detection, prevention, care and
treatment of infection among persons
aged 18–30 years who reside in nonurban counties. Awardees will develop
and implement a comprehensive
strategy to enroll young non-urban
PWID, collect epidemiological
information, test for HCV infection and
provide linkage to primary care services,
prevention interventions, and treatment
for substance abuse and HCV infection.
In addition to providing HCV testing,
participants will be offered testing for
the presence of co-infections with
hepatitis B virus (HBV) and HIV. Rates
of HCV infection or re-infection will be
evaluated through follow-up blood tests.
Furthermore, adherence to prevention
services and retention in care will be
assessed through follow up interviews.
The project will recruit an estimated
total of 1,500 young PWIDs to enroll
1,000. The participants will be recruited
from settings where young PWIDs
obtain access to care and treatment
services. Recruitment will be direct and
in-person by partnering with local harm
reduction sites. Recruiters will enroll
subjects across recruitment sites
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hrs.)
Total burden
(in hrs.)
Type of respondents
Form name
Young PWIDs ...................................
Eligible young PWIDs .......................
Eligible young PWIDs .......................
Screener ...........................................
Initial Survey .....................................
Follow-up survey ..............................
1500
1000
1000
1
1
4
15/60
60/60
30/60
375
1000
2000
Total ...........................................
...........................................................
........................
........................
........................
3375
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–16027 Filed 6–29–15; 8:45 am]
[60Day–15–0666; Docket No. CDC–2015–
0048]
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
AGENCY:
VerDate Sep<11>2014
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ACTION:
Notice with comment period.
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
SUMMARY:
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Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
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.
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: omb@cdc.gov.
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
FOR FURTHER INFORMATION CONTACT:
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.
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
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
VerDate Sep<11>2014
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
(Infection
NHSN Registration Form .................
2,000
1
5/60
167
(Infection
Facility Contact Information .............
2,000
1
10/60
333
(Infection
Patient Safety Component—Annual
Hospital Survey.
5,000
1
50/60
4,167
17:34 Jun 29, 2015
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37267
Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
Form name
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Staff RN ............................................
Group Contact Information ...............
1,000
1
5/60
83
Patient Safety Monthly Reporting
Plan.
Primary Bloodstream Infection (BSI)
6,000
12
15/60
18,000
6,000
44
30/60
132,000
Pneumonia (PNEU) ..........................
6,000
72
30/60
216,000
Ventilator-Associated Event .............
6,000
144
25/60
360,000
Urinary Tract Infection (UTI) ............
6,000
40
20/60
80,000
Denominators for Neonatal Intensive
Care Unit (NICU).
Denominators for Specialty Care
Area (SCA)/Oncology (ONC).
Denominators for Intensive Care
Unit (ICU)/Other locations (not
NICU or SCA).
Surgical Site Infection (SSI) .............
6,000
9
3
162,000
6,000
9
5
270,000
6,000
60
5
1,800,000
6,000
36
35/60
126,000
Denominator for Procedure ..............
Antimicrobial Use and Resistance
(AUR)-Microbiology Data Electronic Upload Specification Tables.
Antimicrobial Use and Resistance
(AUR)-Pharmacy Data Electronic
Upload Specification Tables.
Central Line Insertion Practices Adherence Monitoring.
MDRO or CDI Infection Form ..........
6,000
6,000
540
12
5/60
5/60
270,000
6,000
6,000
12
5/60
6,000
1,000
100
25/60
41,667
6,000
72
30/60
216,000
MDRO and CDI Prevention Process
and Outcome Measures Monthly
Monitoring.
Laboratory-identified MDRO or CDI
Event.
Long-Term Care Facility Component—Annual Facility Survey.
Laboratory-identified MDRO or CDI
Event for LTCF.
MDRO and CDI Prevention Process
Measures Monthly Monitoring for
LTCF.
Urinary Tract Infection (UTI) for
LTCF.
Monthly Reporting Plan for LTCF ....
6,000
24
15/60
36,000
6,000
240
30/60
720,000
250
1
1
250
250
8
15/60
500
250
12
5/60
250
250
9
30/60
1,125
250
12
5/60
250
Denominators for LTCF Locations ...
250
12
3.25
9,750
Prevention
Process
Measures
Monthly Monitoring for LTCF.
LTAC Annual Survey .......................
250
12
5/60
250
400
1
50/60
333
Rehab Annual Survey ......................
1,000
1
50/60
833
Healthcare Personnel Safety Component Annual Facility Survey.
Healthcare Personnel Safety Monthly Reporting Plan.
Healthcare Worker Demographic
Data.
Exposure to Blood/Body Fluids ........
Healthcare Worker Prophylaxis/
Treatment.
Follow-Up Laboratory Testing ..........
Healthcare Worker Prophylaxis/
Treatment-Influenza.
50
1
8
400
17,000
1
5/60
1,417
50
200
20/60
3,333
50
50
50
30
1
15/60
2,500
375
50
50
50
50
15/60
10/60
625
417
Staff RN ............................................
Staff RN ............................................
Registered
Nurse
(Infection
Preventionist).
Staff RN ............................................
Laboratory Technician ......................
Pharmacy Technician .......................
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
(Infection
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
(Infection
(Infection
(Infection
(Infection
(Infection
(Infection
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
Laboratory Technician ......................
Occupational Health RN/Specialist ...
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37268
Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Type of respondents
Form name
Medical/Clinical Laboratory Technologist.
Medical/Clinical Laboratory Technologist.
Medical/Clinical Laboratory Technologist.
Medical/Clinical Laboratory Technologist.
Medical/Clinical Laboratory Technologist.
Staff RN ............................................
Hemovigilance Module Annual Survey.
Hemovigilance Module Monthly Reporting Plan.
Hemovigilance Module Monthly Reporting Denominators.
Hemovigilance Adverse Reaction ....
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Registered
Nurse
(Infection
Preventionist).
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Total ...........................................
2
1,000
500
12
1/60
100
500
12
1
6,000
500
48
15/60
6,000
Hemovigilance Incident ....................
500
10
10/60
833
Patient Safety Component—Annual
Facility Survey for Ambulatory
Surgery Center (ASC).
Outpatient Procedure Component—
Monthly Reporting Plan.
Outpatient Procedure Component
Event.
Outpatient Procedure Component—
Monthly Denominators and Summary.
Outpatient Dialysis Center Practices
Survey.
Dialysis Monthly Reporting Plan ......
Dialysis Event ...................................
Denominators for Dialysis Event
Surveillance.
Prevention
Process
Measures
Monthly Monitoring for Dialysis.
Dialysis Patient Influenza Vaccination.
Dialysis Patient Influenza Vaccination Denominator.
5,000
1
5/60
417
5,000
12
15/60
15,000
5,000
25
40/60
83,333
5,000
12
40/60
40,000
6,500
1
2.0
13,000
6,500
6,500
6,500
12
60
12
5/60
25/60
10/60
6,500
162,500
13,000
1,500
12
1.25
22,500
325
75
10/60
4,063
325
5
10/60
271
...........................................................
........................
........................
........................
4,861,542
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Centers for Medicare and Medicaid
Services
Notice of Hearing: Reconsideration of
Disapproval Texas Medicaid State Plan
Amendment (SPA) 14–25
Centers for Medicare and
Medicaid Services (CMS), HHS.
ACTION: Notice of Hearing:
Reconsideration of Disapproval.
AGENCY:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Total burden
(in hours)
1
[FR Doc. 2015–16028 Filed 6–29–15; 8:45 am]
This notice announces an
administrative hearing to be held on
August 6, 2015, at the Department of
Health and Human Services, Centers for
Medicare and Medicaid Services,
Division of Medicaid & Children’s
SUMMARY:
17:34 Jun 29, 2015
Average
burden per
response
(in hours)
500
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.
VerDate Sep<11>2014
Number of
responses per
respondent
Jkt 235001
Health, Dallas Regional Office, 1301
Young Street, Room 714, Dallas, TX
75202, to reconsider CMS’ decision to
disapprove Texas’ Medicaid SPA 14–25.
Closing Date: Requests to participate
in the hearing as a party must be
received by the presiding officer by July
15, 2015.
FOR FURTHER INFORMATION CONTACT:
Benjamin R. Cohen, Presiding Officer,
CMS, 2520 Lord Baltimore Drive, Suite
L, Baltimore, Maryland 21244;
Telephone: (410) 786–3169.
SUPPLEMENTARY INFORMATION: This
notice announces an administrative
hearing to reconsider CMS’ decision to
disapprove Texas’ Medicaid SPA 14–25,
which was submitted to the Centers for
Medicare and Medicaid Services (CMS)
on August 26, 2014 and disapproved on
April 7, 2015. In part, this SPA
requested CMS approval to revise the
methodology for calculating the
hospital-specific limit for the
Disproportionate Share Hospital (DSH)
program. Specifically, SPA 14–25
proposed to exclude from the
calculation, the portion of a Medicare
payment for an individual who is
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
dually-eligible for Medicare and
Medicaid that exceeds the Medicaid
allowable cost for the service provided
to the recipient. This exclusion would
permit the state to make Medicaid DSH
payments that are above and beyond
hospitals’ reported uncompensated
costs of providing services to Medicaid
and uninsured individuals.
The issue to be considered at the
hearing is:
• Whether Texas SPA 14–25 is
inconsistent with Medicaid DSH
requirements of sections 1902(a)(13)(A)(iv)
and 1923 of the Social Security Act (Act)
because it would provide for payment to
disproportionate share hospitals of amounts
that exceed the hospital’s uncompensated
costs which cannot be considered consistent
with DSH requirements pursuant to the
hospital-specific limit under section
1923(g)(1) of the Act.
Section 1116 of the Act and federal
regulations at 42 CFR part 430, establish
Department procedures that provide an
administrative hearing for
reconsideration of a disapproval of a
state plan or plan amendment. CMS is
required to publish a copy of the notice
E:\FR\FM\30JNN1.SGM
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]]>Agencies
[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: omb@cdc.gov.
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
