2015-03805. 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 [phone] or send an email to [e-mail]. 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 [phone]. 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 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

Type of respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (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 Preventionist or Informatics Director (for example, privacy officer or risk management specialist)	Interview Guide	30	1
Clinic Director	Interview Guide	30	1
Other as referred by Clinic Director (for example, patient records manager)	Interview Guide	30	1

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.