[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10094-10095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03805]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-15FY]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: 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
State Health Department Access to Electronic Health Record Data
from Healthcare Facilities during a Healthcare-Associated Infection
Outbreak: A Retrospective Assessment--New--National Center for Emerging
and Zoonotic Infections Diseases (NCEZID), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Two years ago, contaminated steroid injections caused the largest
fungal meningitis outbreak in the United States, affecting 20 states
and resulting in 751 infections and 64 deaths. The subsequent
healthcare-associated infection (HAI) outbreak response required
significant collaboration between healthcare providers and facilities
and public health departments (HDs). Following the outbreak response,
HDs reported that various challenges with access to patient health
information in electronic health records (EHRs) hindered the efficient
and rapid identification of potential fungal meningitis cases in
healthcare facilities. The fungal meningitis outbreak experience
highlights the need to better understand the landscape of granting and
using access to EHRs for outbreak investigations.
The Division of Healthcare Quality Promotion (a component of
NCEZID), the Office for State, Tribal, Local and Territorial Support,
and the Office of Public Health Scientific Services at the Centers for
Disease Control and Prevention (CDC) are partnering with Association of
State and Territorial Health Officials and The Keystone Center to
evaluate the challenges surrounding HDs access to EHRs in healthcare
facilities' during an HAI outbreak investigation. The evaluation seeks
to compile information across states from experts in the public and
private sector to assess experiences, identify issues, and seek
recommendations for improving HDs access to EHRs during future
outbreaks.
In addition to a study report, the insights from healthcare
facility staff will be used to build a toolkit to help state HDs
understand the perspectives and needs of the healthcare facilities
related to EHR access. The toolkit will provide perceived barriers,
recommendations to overcome those barriers, best practices that support
EHR access, and practical tools such as templates, memorandums of
understanding (MOUs), and policies. The toolkit will be distributed to
HDs, healthcare facilities, and other stakeholders to support awareness
and
[[Page 10095]]
strengthen relationships between public health and clinical care.
These activities will facilitate the quick and efficient
identification of cases in future outbreaks and protect the health and
safety of patients. This request corresponds with an initial ongoing
data collection (Phase I), State Health Department Access to Electronic
Health Record Data during an Outbreak: A Retrospective Assessment,
which involves interviews with four types of Health Department staff:
Healthcare-associated infection coordinator, epidemiologist, legal
counsel, and informatics director (OMB Number 0920-0879, approved on
04/24/2014). Phase I data analysis is ongoing.
For Phase II of this study, we will be requesting participation
from hospital and clinic staff in their official capacities across the
same 15 states included in the Phase I request. The states chosen for
Phase I and Phase II data collections are: Florida, Indiana, Kansas,
Maryland, Michigan, Minnesota, New Hampshire, New Jersey, New York,
North Carolina, Ohio, Oregon, Tennessee, Texas, and Virginia. Data will
be collected from 150 hospital and clinic staff in their official
capacities using one 30-minute telephone interview per person and
limiting interviews to two hospitals and two clinics per state.
Hospital participants include: Infection preventionists, informatics
directors, and others as referred. Clinic participants include: Clinic
directors and others as referred.
The focus of this OMB request is to conduct interviews with 150
healthcare facilities' staff, hospitals and clinics, in their official
capacity who has been asked by HDs to provide access to their EHRs
during an HAI outbreak investigation. In hospitals, the evaluation team
will be conducting interviews with staff members serving in one of
three roles: Infection preventionist, informatics director, and other
as referred (e.g. privacy officer, risk management, etc.). In clinics,
the evaluation team will be conducting interviews with the clinic
director, and other as referred (e.g. patient records manager, etc.)
The maximum estimates for burden hours are derived from interview
guide pilot testing and data collection with HDs during Phase I data
collection, in which interviews took 27 minutes. The total annual
burden is 90 hours.
The data to be collected do not involve questions of a personal or
sensitive nature and should have no impact on the individual's privacy.
There are no costs to the respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
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HD Epidemiologist..................... Interview Guide......... 15 1 60/60
Infection Preventionist............... Interview Guide......... 30 1 30/60
Informatics Director.................. Interview Guide......... 30 1
Other as referred by Infection Interview Guide......... 30 1
Preventionist or Informatics Director
(for example, privacy officer or risk
management specialist).
Clinic Director....................... Interview Guide......... 30 1
Other as referred by Clinic Director Interview Guide......... 30 1
(for example, patient records
manager).
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-03805 Filed 2-24-15; 8:45 am]
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