[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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
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]
BILLING CODE 4163-18-P