Featuring the top questions asked during OneLab’s popular 2023 webinar, with answers from Penny Keller, BS MB(ASCP), Centers for Medicare and Medicaid Services.

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Protocol for labeling secondary laboratory containers.

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Continual improvement means making things better to benefit both the customer and the laboratory.

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The cost of quality is more than a management tool. It’s a mindset that should be adopted at every operational level of a laboratory. The implications and cost associated with poor quality, or no quality, create ripple effects well beyond the walls of your laboratory.

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Clinical and public health laboratories have a responsibility to ensure all specimen and testing activities are of the highest quality. Quality in the laboratory is a continual process and best accomplished using a systematic, managed approach.

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Investing in a QMS will help your laboratory efficiently manage organizational assets, quantify the value, and impact a QMS brings, and identify opportunities to continuously improve your laboratory’s mission.

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Reference Document for the 12 Quality System Essentials (QSE), that describe the foundational elements of laboratory Quality Management Systems (QMS). 

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This document contains the qualifications required for a clinical consultant in a laboratory performing high complexity testing.

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This document contains the qualifications required for a cytology general supervisor in a laboratory performing high complexity testing.

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This document contains the qualifications required for a cytotechnologist in a laboratory performing high complexity testing.

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This document contains the qualifications required for a general supervisor in a laboratory performing high complexity testing.

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This document contains the qualifications required for a laboratory director in a laboratory performing high complexity testing.

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This document contains the qualifications required for a technical supervisor in a laboratory performing high complexity testing. Cytology technical supervisor qualifications are also included in the cytology section.

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This document contains the qualifications required for testing personnel in a laboratory performing high complexity testing.

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eLearning course to equip learners with foundational information about CLIA.

 

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Instructions and list of supplies (with images) for examining specimens for yeast.

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This job aid covers essential topics for correctly delegating responsibilities to CLIA laboratory personnel and for identifying responsibilities a laboratory director must retain.

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This flowchart outlines the qualifications necessary for a clinical consultant to comply with CLIA regulations related to moderate complexity testing as specified in 42 CFR 493.1417.

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This flowchart outlines the qualifications necessary for a laboratory director to manage and direct laboratory personnel and the performance of moderate complexity tests as specified by CLIA regulations in 42 CFR 493.1405.

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This flowchart details the qualifications required for a technical consultant to ensure compliance with CLIA regulations for moderate complexity testing as specified in 42 CFR 493.1411.

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This flowchart describes the qualifications required for testing personnel to perform moderate complexity testing as specified by CLIA regulations in 42 CFR 493.1423.

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Regulatory requirements, resources including forms and examples, and images of common microscopic findings for the nine specific microscopic examinations that may be performed under a Certificate of PPM Procedures.

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Instructions and list of supplies (with images) describing the process of making a smear preparation.

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eLearning course to prepare physicians, midlevel providers, and dentists to meet requirements for PPM procedures under a CLIA certificate. 

 

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