Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506 (c) (2) (A) of the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) is providing an opportunity for public comment on proposed data collection projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call the CDC/ATSDR Reports Clearance Officer at (404) 639-7090.

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; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques for other forms of information technology. Send comments to CDC/ATSDR Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 30333. Written comments should be received within 60 days of this notice.

1. Proposed Projects

National Survey of Laboratory Practices for Selected Coagulation Tests in Hospital Laboratories—New—As part of the continuing effort to support public health objectives of treatment, disease prevention and surveillance programs, the Public Health Practice Program Office (PHPPO), Division of Laboratory Systems 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 up to 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.

We plan to sample up to 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 burden hours to complete the survey is estimated to be 400. Based on hourly wage estimates, the cost to respondents could be approximately $9,000. Because we expect the Laboratory Directors and Supervisors to complete the survey during their usual working hours. We anticipate that there will be no actual cost to the respondents.