NORTHFIELD, Ill.--(BUSINESS WIRE)-- The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020.CAP inspectors use the checklists, with approximately 3,000 requirements, during inspections to ensure laboratories comply with the Centers for Medicare and Medicaid Services (CMS) regulations and achieve accreditation. 2 0 obj They are the leading source of disparities between the findings of the programs inspectors and inspection audits done by the Centers for Medicare and Medicaid Services. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. Northfield, ILPublished on October 24, 2022, the College of American Pathologists' (CAP) Laboratory Accreditation Program checklists introduces enhancements with the new 2022 edition to clarify and simplify the inspection process for both laboratories and inspectors. As the worlds largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. Work is underway to improve the user experience (Nakhleh RE, et al. 4 0 obj 1. For more information, visityourpathologist.orgto watch pathologists at work and see the stories of the patients who trust them with their care. Were closing the loop on quality management wherever we can, Dr. Sarewitz says. Highlights of the checklist enhancements include: April 2013The paperless office may be just around the corner, and virtual reality may lie ahead too. Participants of the CAP accreditation programs may download the checklists from the CAP website (cap.org) by logging into e-LAB Solutions Suite. For immunohistochemistry, this unhurried disclosure has meant evolving ideas of whether these tests must indeed be validated and, if so, then how, exactly. The pandemic is providing a perfect example of that in the laboratory world, but with added twists, at least for now. Arrow Right. Read more. Personnel is a hot topic for the College, says CAP Checklists Committee chair William W. West, MD. 2017;141[9]:11531154). Read theCAP Annual Report. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. Orders must include your area code and telephone number. Current CAP Guidelines Mismatch Repair and Microsatellite Instability Testing for Immune Checkpoint Inhibitor Therapy Diagnostic Testing for Diffuse Gliomas Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies Validating Whole Slide Imaging for Diagnostic Purposes in Pathology - Update Laboratory Workup of Lymphoma in Adults As the worlds largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. All Common Checklist . Just today I canceled the third hemoglobin electrophoresis test order on a patient. The new requirement follows the addition in 2019 of GEN.20310 Investigation of Non-conforming Events, which Dr. Goodman calls a significant movement toward the introduction of ISO concepts to the CAP checklists. By being able to bring that to managements attention they are able to help safeguard both patients and the lab. All rights reserved. As a 501(c)(6) membership organization, the CAP is the only entity representing pathologists with unrestricted advocacy capability and a political action committee, PathPAC. June 2020Best practices for HIV primary diagnostic testing and rapid detection of Mycobacterium tuberculosis complex are clarified and codified in new checklist requirements in the 2020 Laboratory Accreditation Program checklist edition published June 4. Thank you for getting in touch with us, well get back to you as soon as possible. Program Benefits. College of American Pathologists (CAP). October 2013For anyone worried about the new CAP reporting templates for cancer biomarkers, Patrick L. Fitzgibbons, MD, has an important message: Dont panic. Were not adding anything. It requires that any such concerns be included in laboratory QM records. Powered by Madgex Job Board Software, https://www.businesswire.com/news/home/20200604005016/en/, http://www.businesswire.com/news/home/20200604005016/en. Do you have a question related to pathology and laboratory medicine practice? This protocol is a collaborative effort, based on input from past and present members of the CAP Cytopathology Committee and prepared in conjunction with the CAP Pathology Electronic Reporting Committee. September 2020Strong quality management, patient safety, and conformity with regulations are at the heart of the new and revised requirements in the 2020 CAP accreditation program transfusion medicine checklist, released in June. Sales Tax This all helps to close gaps in quality management, Dr. Rutledge says. z\G832. Thats how Stephen J. Sarewitz, MD, vice chair of the CAP Checklists Committee, characterizes the changes to the quality management requirements in the 2020 laboratory general checklist, released in June. !JQ)"OAJOYD=d4NbA endobj As the worlds largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. Updated to reflect review of all references 9.0 . Our inspectors, who are trained, practicing laboratory professionals, understand laboratory operations and challenges, and through the accreditation program we are able to provide expert guidance to peers.. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. The Checklists used f or inspection b y the College of Amer ican Pathologists' Accreditation Prog rams have Laboratories have seen lower gynecologic volumes and an increase in both nongynecologic fine-needle aspiration biopsy and touch imprint samples. Visit cap.org to register. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. There are other tests that are done redundantly, excessively, and are noncontributory to good patient care. These are nothing new, says Dr. Fitzgibbons, a pathologist at St. Jude Medical Center, Fullerton, Calif., and chair of the CAP Cancer Biomarker Reporting Committee. <>>> Learn more about the webinar and register. Infused with best practices, our checklists are updated annually to help laboratories stay current with rapidly evolving advances in laboratory medicine, technology, and regulatory compliance. "With the checklists, we strive to provide laboratories a clear roadmap to operate a high-quality laboratory, especially critical in times like these, and secure accreditation, said Richard Scanlan, MD, FCAP, chair, CAP Council on Accreditation, which oversees the accreditation program and Checklists Committee. Now a change to the CAP Laboratory Accreditation Programs checklists will clarify expectations for directors who are in charge of more than one laboratory. Some items have been removed from your Media Cart because they are no longer available or expired. 7445 ROSE for patient care has proven value. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. In 2020 checklist, a gentle push to next quality level, Do you have a question related to pathology and laboratory medicine practice? Read the CAP Annual Report. July 2018Take the new ASCO/CAP guideline for HER2 testing. August 2017There was no trip to the spa. <>/Metadata 2347 0 R/ViewerPreferences 2348 0 R>> September 2016For the CAP Laboratory Accreditation Program, inspection checklist requirements covering personnel are a perennial concern. %PDF-1.5 Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. Recaptcha secret parameter is missing or invalid! 4 0 obj You must complete additional steps or remove assets to resume downloading. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. Just ask Cubs fans who watched their team leap from a 101-loss season in 2012 to a 103-win season in 2016 and a World Series title as the cherry on top. The assigned checklist is based on the specific The requirement also specifies that it applies to clinical, rather than business/financial issues. Less severe non-conforming events require investigation but not a full root cause analysis, Dr. Sarewitz says. GEN.20316 QM Indicators of Quality says a QM program must include monitoring key indicators of quality in the preanalytic, analytic, and postanalytic testing phases by regularly comparing performance against targets defined by the laboratory. They shouldnt be considered a significant burden.. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. Sample adequacy allows for a single visit and avoids having to make multiple attempts to provide material sufficient for all required testing, including flow cytometry, microbiology, cell block preparation for immunohistochemical and histochemical staining, and molecular testing. At the start of the project, I think everyone going into it realized it was going to be a time-consuming, long process. August 2018Testing turnaround times can affect whether non-small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated. Or ask Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup of acute leukemia. non-conforming events) and for quality indicators that do not meet defined targets, as well as for evaluating the effectiveness of the actions taken. While there is no conceptual change to the requirement, Dr. Goodman says, the revision now specifies that the laboratory director should determine the number of monitored indicators. A s the 2020 laboratory general checklist now drills deeper into quality management, it incorporates more terminology found in ISO. As related to COVID-19, the CAP enhanced, for example, Laboratory General safety requirements for viral exposure due to airborne transmission and Microbiology specimen collection and processing. PSS is designed specifically for the measurement of ctDNA, and panels are developed for particular clinical intended uses where high sensitivity detection may provide unique insights and improve outcomes. The note calls for a written policy that describes the overall program, in sufficient detail to describe the objectives and essential elements of the program. Written in easy-to-understand language, they remove the guesswork from compliance which can be especially helpful for laboratories facing staffing challenges. The guideline will help facilitate pathologys increasing use of not only digital pathology but also artificial intelligence, says Marilyn Bui, MD, PhD, chair of the CAP expert panel for QIA of HER2 IHC. Non-Small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor indicated... Guesswork from compliance which can be especially helpful for laboratories facing staffing challenges but a... A time-consuming, long process language, they remove the guesswork from which... Cap accreditation programs may download the checklists from the CAP is a accreditation! Clarify expectations for directors who are in charge of more than one laboratory order on a patient terminology! To help safeguard both patients and the largest of its kind, utilizes of. 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cap laboratory general checklist 2020 pdf