[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Notices]
[Pages 47075-47076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19240]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-12-12PZ]


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 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to Kimberly S. Lane, at 1600 Clifton Road, MS D74, 
Atlanta, GA 30333 or send an email to [email protected].
    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 or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Proficiency Testing in U.S. Clinical Laboratories: Perception, 
Practices and Potential for Expanded Utility--NEW--the Office of 
Surveillance, Epidemiology and Laboratory Services (OSELS), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The primary focus of this project is to conduct a systematic 
analysis in order to understand which types of laboratories would be 
likely to follow Proficiency Testing (PT) Good Laboratory Practices 
(GLPs). The Association of Public Health Laboratories (APHL) and CDC 
(Centers for Disease Control and Prevention) hope to learn more about 
which laboratories are not following Clinical Laboratory Amendments of 
1988 (CLIA) PT guidelines and the reasons why. Our survey population 
frame is 20,500 Certificate of Compliance laboratories and 16,800 
Certificate of Accreditation laboratories. All of these laboratories 
are required to perform PT in accordance with the CLIA. Many of these 
labs also use their PT results internally for laboratory quality 
improvement (PT GLPs).
    In addition, Centers for Medicaid and Medicare Services (CMS) and 
CDC are currently collaborating to revise the CLIA regulations to 
update the list of non-microbiological tests (analytes) for which PT is 
required, and to update the requirements for microbiology PT. Both of 
these changes are expected to have some impact on clinical and public 
health laboratories, but CDC has very little data to estimate the 
impact. This information is needed to complete the regulatory impact 
analysis. The Department of Health and Human Services knows very little 
about which analytes are tested in the affected laboratories other than 
those for which PT is required by CLIA regulations. This survey will 
ask laboratories whether they offer testing for candidate analytes, and 
how the regulatory changes would impact their costs and PT practices in 
their laboratory. Similarly for microbiology laboratories, CMS and CDC 
are considering whether to remove the levels of service model for PT 
enrollment. Therefore the survey will ask a sample of microbiology 
laboratories how this and other potential changes would impact their 
costs, PT practices, and perceived risk of failing PT.
    The goal of this project is to complete a needs assessment to 
identify the populations that would benefit from receiving information 
on PT GLPs. Since laboratories already pay for these

[[Page 47076]]

PT materials, information provided to further use PT for quality 
improvement purposes has the potential to further improve laboratory 
quality at no additional cost to U.S. clinical laboratories.
    The first phase of this project was conducted by Association of 
Public Health Laboratories (APHL) through focus group research in 2011. 
The focus groups explored how clinical and public health laboratories 
perceived commercial PT programs, and explored the ways in which the 
laboratories used PT (GLPs) to assure and improve the quality of 
testing in their own laboratories. This second phase of the project 
will be administration of a survey to help identify laboratories that 
would benefit from learning additional uses for PT and providing 
information on how to disseminate them to laboratories in a strategic 
and targeted way.
    The goal is to achieve an 80% response rate (29,840 out of 37,300 
labs). APHL and CDC will strive to ensure a high response rate by 
promoting the survey through advertisements in laboratory trade 
publications, at professional meetings, and possibly through programs 
and laboratory accreditation organizations.
    The cohort of laboratories will be all laboratories listed in the 
Centers for Medicare and Medicaid (CMS) Online Survey, Certification 
and Reporting (OSCAR) database. The OSCAR database contains demographic 
information and practice characteristics for all laboratories included 
in the database.
    The survey will be administered through a web-based survey system, 
specifically Survey Monkey. APHL will send each laboratory a postmarked 
letter explaining the survey and providing them with a link to log in 
to the survey with a unique identifier on their address label. Two 
weeks afterwards, APHL will follow-up with a postcard reminder which 
will also include that unique identifier on the address label.
    Approximately 37,300 clinical laboratories will be targeted and 
solicited to take the on-line survey. Each laboratory is permitted to 
submit only one completed survey. Preliminary pilot testing indicates 
completion of the on-line survey will take approximately 15 minutes. 
Assuming a 80% response rate, there would be 29,840 respondents.
    There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response  (in     (in hrs)
                                                                    respondent         hrs)
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Laboratorians.................  Laboratory                29,840               1           20/60           9,947
                                 Practices.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           9,947
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    Dated: July 31, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Directors, Centers for 
Disease Control and Prevention.
[FR Doc. 2012-19240 Filed 8-6-12; 8:45 am]
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