[Federal Register Volume 65, Number 77 (Thursday, April 20, 2000)]
[Notices]
[Pages 21199-21200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9886]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control And Prevention

[60 Day-00-33]


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.

                                      Estimates of Annualized Burden Hours
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                                                                                          Average
                    Type of respondents                        Number of   Frequency of   time per   Annual hour
                                                              respondents    response     response     burden
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Laboratory Director........................................            80             1      30/60            40
Laboratory Supervisor......................................           720             1      30/60           360
                                                            ----------------------------------------------------
Totals.....................................................           800  ............  .........           400
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[[Page 21200]]

    Dated: April 13, 2000.
Nancy Cheal,
Acting Associate Director for Policy, Planning, and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 00-9886 Filed 4-19-00; 8:45 am]
BILLING CODE 4163-18-P