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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 (404) 639-7090. Send written comments to CDC, Desk Officer; Human Resources and Housing Branch, New Executive Office Building, Room 10235; Washington, DC 20503. Written comments should be received within 30 days of this notice.

Proposed Project

National Survey of Hospital Coagulation Laboratories—New—Public Health Practice Program Office (PHPPO), Centers for Disease Control and Prevention (CDC). As part of the continuing effort to support public health objectives of treatment, disease prevention and surveillance programs, the Centers for Disease Control and Prevention (CDC), Public Health Practice Program Office (PHPPO), seeks to collect information on coagulation testing practices among U.S. hospital laboratories. The purpose of this project is to define the state of testing practices in a random sample of 800 U.S. hospital laboratories for selected coagulation analytes by conducting a questionnaire survey of these laboratories. The objectives of this survey are to collect data to assess the variability of selected analytical and non-analytical variables, such as normal ranges, used for selected coagulation tests. There has not been a systematic and nationally based survey of coagulation testing practices among U.S. hospital laboratories. Such a surveillance is needed due to the impact that coagulation testing practices can have on the diagnosis and management of coagulation disorders.

There is ample evidence of variability in coagulation testing practices based on published literature corresponding to experiences of individual institutions that deal with analytical (e.g., impact of instrument and kit reagents on laboratory results) as well as pre-analytical (such as specimen treatment) and post-analytical (such as results presentation) issues. However, there has not been a systematic survey of national hospital laboratories that has documented the nature and extent of such variability for selected coagulation tests. Preliminary observations document substantial inter-institutional variability in coagulation testing practices, with likely effect on patient outcome.

This study will explore current practices for one or more selected coagulation tests to document the extent and nature of variability in the testing processes. It is anticipated that information from this study will be used for several purposes. First, results from this project may be used in a future study in order to surmise the potential impact of various testing practices on patient outcomes. A second anticipated use of this study's results is to implement targeted laboratory improvement efforts. Finally, this study may form the basis for a future study to assess the extent and nature of problems in diagnosis and treatment of patients caused by inaccurate laboratory results. Because hypo-and hypercoagulability disorders are prevalent in the U.S. and they are defined to a great extent by laboratory tests, a well designed laboratory practice survey is expected to be of great public health significance for the nation.

CDC plans to sample 800 laboratories that perform selected coagulation tests. The time required to complete a survey will be approximately 0.5 hours. We anticipate that, of the respondents, approximately 80 will be Coagulation Laboratory Directors (physicians) and approximately 720 will be Coagulation Laboratory Supervisors. The total estimated annualized burden is 425 hours.