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Laboratory Management


ASM together with CAP and CLSI are coordinating preparation of materials to help you address the CMS requirement for implementation of IQCP (Individualized Quality Control Plan) by January 1, 2016. Click on the links below to learn more about IQCP. You may find the “CLIA Brochures #12 and #13” on the CMS Webpage particularly useful as they have concise information about the program.

Templates and examples of IQCP for various tests in clinical microbiology will be posted as they are developed. We will send messages through DivC and Clinmicronet listserves to inform you of the additional postings.

CMS Webpage Describing IQCP

Letter Informing Laboratories about the IQCP option that contains significant detail about the program

Letter Informing Laboratories of the Removal of References to the Clinical Laboratory Standards Institute (CLSI) and to CLSI Documents from CLIA Survey Interpretive Guidelines (10/31/14)

CLIA Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (1/9/15)

Last Updated on Thursday, 19 February 2015 12:18

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Personnel Competency

Here are samples of competency assessments that can be used and modified at your institution...

Last Updated on Friday, 22 August 2014 10:30

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FDA Updates

New FDA Updates!

Last Updated on Friday, 20 March 2015 12:08

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Emerging Markets: The Public Health Lab Perspective

Dr. Yun F. Wang, M.D., Ph.D., discusses what resource-limited facilities can learn from health labs, the challenges faced by labs in emerging markets, best practices and technology recommendations in "Emerging Markets: The Public Health Lab Perspective" with GoMolecular.com.


Last Updated on Tuesday, 07 May 2013 09:52

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Starting a Molecular Lab

Download the WHO's guidelines for assisting clinical and laboratory personnel in developing countries to establish a PCR diagnostic facility here.

Last Updated on Wednesday, 02 July 2014 15:10

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Lean Lab in Action

In the Medical Laboratory Observer's Management Q & A, Joseph Campos, Ph.D. seeks to answer the following question: Can eliminating institutionalized inefficiencies in the lab result in better TATs and enhanced lab performance?

Last Updated on Wednesday, 02 January 2013 08:19

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Quality Assurance Monitoring

 Cumitech 3B: Quality Systems in the Clinical Microbiology Laboratory
Provides up-to-date information on quality systems and procedures in the clinical microbiology laboratory.
Anderson, N. L., M. A. Noble, A. S. Weissfeld, and R. J. Zabransky. 2005. Cumitech 3B,Quality Systems in the Clinical Microbiology Laboratory. Coordinating ed., D. L. Sewell. ASM Press, Washington, D.C.
Provides clinical microbiologists with strategies to define, detect, describe, categorize, and prevent CML-associated errors. 
Amsterdam, D., J. Barenfanger, J. Campos, N. Cornish, J. A. Daly, P. Della-Latta, L. D. Gray, G. S. Hall, H. Holmes, and R. L. Sautter. 2004. Cumitech 41, Detection and Prevention of Clinical Microbiology Laboratory-Associated Errors. Coordinating ed., James W. Snyder. ASM Press, Washington, D.C.
memonly-sm For Members

Last Updated on Wednesday, 18 June 2014 09:31

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CLIA Waived Tests

A list of tests granted waived status under CLIA sorted by CPT codes, test name, manufacturer, and use.

Last Updated on Friday, 09 September 2011 15:22

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CLIA Complexity Database - Searchable

CLIA Complexity Database
This FDA tool allows users to search the CLIA complexity database by entering any combination of fields. Users can also use the analyte drop down box to select a specific Analyte or search by test system name/manufacturer.

Last Updated on Friday, 09 September 2011 15:22

Hits: 29859

Good Lab Practices for Waived Sites

Good Laboratory Practices for Waived Testing Sites
Printed in Morbidity and Mortality Weekly Report, November 11, 2005, this article describes the survey findings from testing sites holding a certificate of waiver under the Clinical Laboratory Improvement Amendments of 1988 and recommendations for promoting quality testing.

Last Updated on Friday, 09 September 2011 15:30

Hits: 17931

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