Validating Digital Pathology: White Papers to be Unveiled at the Pathology Visions Conference

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Two important white papers examining the validation of digital pathology will be presented at the 2011 Pathology Visions Conference in San Diego, Oct. 30 – Nov. 2. The white papers will focus on two different settings for digital pathology systems: the healthcare environment and the regulated nonclinical environment. Sam V. Machotka and Adam Smith of Merck Research Laboratories will present the white paper entitled: "Validation of Digital Pathology Systems in the Regulated Nonclinical Environment." Amanda Lowe of Digital Pathology Consultants, LLC will present the white paper: "Validation of Digital Pathology in a Healthcare Environment."

Two important white papers examining the validation of digital pathology will be presented at the 2011 Pathology Visions Conference in San Diego, Oct. 30 – Nov. 2.

The white papers will focus on two different settings for digital pathology systems: the healthcare environment and the regulated nonclinical environment.

Digital Pathology Association (DPA) members will make the presentations during the DPA Town Hall Meeting on Tuesday, November 1.

“Laboratories using digital pathology in a regulated environment are required to validate their digital pathology system,” said Dirk Soenksen, President of the Digital Pathology Association and Chair of the Pathology Visions Program Committee. “The DPA’s white paper committees have done an excellent job defining best practices for how to validate digital pathology. We expect this year’s Town Hall meeting to be informative and relevant for anyone using or planning to use digital pathology.”    

Sam V. Machotka and Adam Smith of Merck Research Laboratories will present the white paper entitled: "Validation of Digital Pathology Systems in the Regulated Nonclinical Environment."

“Approaches to and results of validation of digital pathology systems for use in nonclinical regulated studies are not readily available for review,” said Richard Long of Charles River Laboratories, team lead for the nonclinical white paper. “Thus, the strengths and weakness of those efforts are essentially unknown outside of the organization in which they were performed. This paper attempts to fill some of that gap by providing a high-level validation approach with sufficient detail and references to allow an organization to understand the validation process, to establish a validation project, and/or to identify areas where additional expertise is needed.”

Additional purposes of this white paper include:

  • Discussing validation of a whole slide scanner as part of a digital pathology system from the point of setting up the whole slide scanner for scanning a glass slide through saving a whole slide image on a server.
  • Discussing the validation of specific digital pathology applications, such as the viewing of digital slides for diagnostic purposes and the use of image analysis tools.

Amanda Lowe of Digital Pathology Consultants, LLC will present the findings from the "Validation of Digital Pathology in a Healthcare Environment."

This white paper will look at why attempts at validation of digital pathology systems are limited due to a lack of understanding on how to efficiently conduct a validation and how to navigate regulations that could have an impact on laboratory accreditation and healthcare compliance.

Ms Lowe added, “Validation of the digital pathology system is necessary for clinical use to ensure laboratory compliance and accreditations, protect patient safety and confidentiality, assure the digital pathology data is accurate, and to maximize the value of a digital pathology system.”

This white paper will serve as a high-level overview of what should be considered in the validation process, while aligning with other resources available to the pathology community including CAP Checklists and the recently published CAP draft guidelines for validating whole slide imaging systems for diagnostic purposes in pathology.

To hear both white paper presentations, have the opportunity to earn CME credits, and learn from more than 40 distinguished speakers, register now for the 2011 Pathology Visions Conference in San Diego, Oct. 30 – Nov. 2. The conference is geared toward all types of healthcare professionals and service providers interested in learning about digital pathology solutions and deployment strategies.

The conference will also host cutting-edge industry workshops covering innovative topics in digital pathology, scientific poster sessions, roundtable discussions, the latest product solutions, and networking events.

About the DPA: The mission of the Digital Pathology Association is to facilitate education and awareness of digital pathology applications in healthcare and life sciences. Members will be encouraged to share best practices and promote the use of the technology among colleagues in order to demonstrate efficiencies, awareness, and its ultimate benefits to patient care.

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