Skip to Content

Notice

Proposed Data Collections Submitted for Public Comment and Recommendations

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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 omb@cdc.gov.

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 Start Printed Page 71430stakeholders 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

Type of respondentNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)Total burden hours
Infection Preventionist30115
Informatics Director30115
Other as Referred30130/6015
Clinic Director3015
Other as referred by Clinic Director30115
Totals150175
Start Signature

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.

End Signature End Preamble

[FR Doc. 2014-28236 Filed 12-1-14; 8:45 am]

BILLING CODE 4163-18-P