2010-5843. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Laboratory Medicine Best Practices Project (LMBP)—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) (proposed), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC is seeking approval from the Office of Management and Budget (OMB) to collect information from healthcare organizations in order to conduct a systemic review of laboratory practice effectiveness. The purpose of information collection is to include completed unpublished quality improvement studies/assessments carried out by healthcare organizations (laboratories, hospitals, clinics) in systematic reviews of practice effectiveness. CDC has been sponsoring the Laboratory Medicine Best Practices (LMBP) initiative to develop new systematic evidence reviews methods for making evidence-based recommendations in laboratory medicine. This initiative supports the CDC's mission of improving laboratory practices.

The focus of the Initiative is on pre- and post-analytic laboratory medicine practices that are effective at improving health care quality. While evidence-based approaches for decisionmaking have become standard in healthcare, this has been limited in laboratory medicine. No single-evidence-based model for recommending practices in laboratory medicine exists, although the number of laboratories operating in the United States and the volume of laboratory tests available certainly warrant such a model.

The Laboratory Medicine Best Practices Initiative began in October 2006, when Division of Laboratory Systems (DLS) convened the Laboratory Medicine Best Practices Workgroup (Workgroup), a multidisciplinary panel of experts in several fields including laboratory medicine, clinical medicine, health services research, and health care performance measurement. The Workgroup has been supported by staff at CDC and the Battelle Memorial Institute under contract to CDC.

To date, the Laboratory Medicine Best Practices (LMBP) project work has been completed over three phases. During Phase 1 (October 2006-September 2007) of the project, CDC staff developed systematic review methods for conducting paper reviews related to the effectiveness of laboratory medicine practices. Results of a review of practices that reduce patient specimen identification indicated that an insufficient quality and number of published studies were available for completing systematic evidence reviews of laboratory medicine practice effectiveness for multiple practices. These results were considered likely to be generalizable to most potential review topics of interest. A finding from Phase 1 work was that laboratories would be unlikely to publish quality improvement projects or studies demonstrating practice effectiveness in the peer reviewed literature, but that they routinely conducted quality improvement projects and had relevant data for completion of evidence reviews. Phase 2 (September 2007-November 2008) and Phase 3 (December 2008-September 2009), involved further development of methods to obtain and critically appraise published and unpublished data. A pilot test of a standardized data collection form with less than nine potential laboratory respondents supported the Phase 1 finding that data from completed laboratory medicine quality improvement projects could supplement published evidence in systematic reviews. The objective for successive LMBP evidence reviews of practice effectiveness is to supplement the published evidence with unpublished evidence to fill in gaps in the literature.

Healthcare organizations and facilities (laboratories, hospitals, clinics) will have the opportunity to voluntarily enroll in an LMBP network and submit readily available unpublished studies; quality improvement projects, evaluations, assessments, and other analyses relying on unlinked, anonymous data using the LMBP Submission Form. LMBP Network participants will also be able to submit unpublished studies/data for evidence reviews on an annual basis using this form. There will be no charge to respondents for their participation, other than their time. The total estimated annualized burden hours for this information collection request are 138 hours.

Estimated Annualized Burden Hours

Respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Healthcare Organizations	150	1	55/60

Date: March 11, 2010.

Maryam I. Daneschvar,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.