[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
                                                 ---------------------------------------------------------------
    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]
BILLING CODE 4163-18-P