Says Dr. Evans, “If there’s a CLIA certificate for the lab where the slides are generated, and there’s a separate certificate for the site where the images are interpreted, then the site doing the interpretation is technically considered a referral laboratory.”
Of the four-point definition of remote assessment, he says, “We went to great lengths to try to make this as practical and understandable as possible.”
Inspectors will look for three things: a sampling of digital pathology policies and procedures, a sampling of reports generated from reviews of images/slides and data files performed by digital pathology, and records of digital pathology system validation and verification.
In the same section of the checklist, GEN.50057 requires that the individual reviewing cases have a method to ensure correct patient identification for slides/images and data files submitted for review. “The team envisioned the possibility that there could be situations where laboratory information systems are not integrated with image management systems, creating a risk for a patient-image mismatch with catastrophic consequences,” Dr. Evans says.
Laboratories are required to have a process—manual or automated—to ensure patient record matching across digital pathology systems. Says Dr. Roush: “If you have positive patient identification through a digital platform, certainly use that. If you do not, or if you’re in a downtime situation, you have to have alternative methods for positive patient identification.”
Laboratories will have to provide evidence, Dr. Evans says, that they have a validated system or process to ensure correct patient identification between reports, the information in reports that is used to inform patient care, and the images used to generate that information. “It is imperative we make sure everything matches,” he says.
GEN.50630 requires the laboratory to validate or verify digital pathology systems used for clinical diagnostic purposes by performing its own studies, including approval for implementation by the lab director (or a designee who meets CAP director qualifications) for systems involving resolution-dependent analysis.
“There are already plenty of checklist requirements for validating any additional instrumentation you have on site,” notes Dr. Roush, vice chair of the Department of Pathology, Methodist Health System, Dallas-Fort Worth, Tex. But if there is instrumentation that will be used at a remote site, that too needs to be validated and shown to be working equivalently, whether for glass slides or digital images. “And there are some things related to comparison and quality management solutions you would want to consider as well. All are under medical director discretion in terms of how robust that should be or what measures should be taken.”
To verify a whole slide imaging platform for primary diagnosis, Dr. Evans says, the laboratory must ensure that with its own material, its own pathologists, and its own workflows, the approved claims of the manufacturer can be satisfied before the lab goes live in using it for patient care. “It’s just a basic safety and quality step,” he notes.
GEN.52860 requires digital pathology services to be included in the laboratory’s quality management system, and it provides examples of what the laboratory might monitor. They include, among others, the frequency of deferral of digital frozen section and rapid onsite cytologic diagnoses (ROSE), scan/fail rates, reconciliation of discordant frozen sections and final diagnoses, and criteria for determining diagnostically acceptable image quality.
“Those are things that may not relate to every digital platform,” Dr. Roush says, “but depending on the digital image analysis you are doing, some of the examples could be targeted for your specific area. They’re ideas that may spawn even other or better ideas that you could use to enforce quality monitoring of these platforms.”
The inspectors, too, will have the list of examples. Says Dr. Evans: “They can say, ‘If you’re using whole slide images for frozen sections, can you provide your scan/fail rate? Can you show me your document describing parameters to assess image quality? What is your risk mitigation protocol?’”
For all of these digital pathology and remote data assessment requirements, he says, the aim of the project team and Checklists Committee was to provide laboratories with the information they need for safe operation and inspectors with what they should look for. “The overarching principle is that the technology should be implemented in such a way as to ensure safety and quality for all stakeholders, especially the patients we serve. And that every laboratory is on the same page in terms of standardizing the way the technology is rolled out and used.”