[Federal Register Volume 79, Number 231 (Tuesday, December 2, 2014)]
[Notices]
[Pages 71429-71430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28236]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-15-15FY]
Proposed Data Collections Submitted for Public Comment and
Recommendations
The Centers for Disease Control and Prevention (CDC), as part of
its continuing effort to reduce public burden, 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. To request more information on the
below proposed project or to obtain a copy of the information
collection plan and instruments, call 404-639-7570 or send comments to
Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or
send an email to [email protected].
Comments submitted in response to this notice will be summarized
and/or included in the request for Office of Management and Budget
(OMB) approval. 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. Written comments should be received within 60
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, 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
[[Page 71430]]
stakeholders to support awareness and 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,
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 Control Number 0920-0879, approved on 04/24/2014). We anticipate
that the Phase I data analysis will be completed in late 2014.
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
capacities who have 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 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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Average
Number of Number of burden per Total burden
Type of respondent respondents responses per response (in hours
respondent hours)
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Infection Preventionist......................... 30 1 .............. 15
Informatics Director............................ 30 1 .............. 15
Other as Referred............................... 30 1 30/60 15
Clinic Director................................. 30 .............. .............. 15
Other as referred by Clinic Director............ 30 1 .............. 15
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Totals...................................... 150 1 .............. 75
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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. 2014-28236 Filed 12-1-14; 8:45 am]
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