[Federal Register Volume 65, Number 246 (Thursday, December 21, 2000)]
[Notices]
[Pages 80435-80436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32547]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30DAY-11-01]


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 (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.

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                                                                     Number of     Responses per    Average No.
                           Respondent                               respondents     respondent     hrs/tesponse
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Laboratory Director.............................................              80               1           30/60
Laboratory Supervisor...........................................             720               1           30/60

[[Page 80436]]

 
Director Follow-up..............................................             300               1            5/60
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    Dated: December 15, 2000.
Nancy Cheal,
Acting Director for Policy, Planning, and Evaluation, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 00-32547 Filed 12-20-00; 8:45 am]
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