The College of American Pathologists (CAP) accreditation checklists contain the CAP accreditation program requirements, developed on more than 50 years of insight and pathology expertise. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. May 2018Length, cost, variability in vendor support, and lack of consistency have cast a cloud for pathologist users over the CAPs cancer protocols and the electronic version of those protocols, the electronic cancer checklists. Labs need to have a complaint/non-conforming event resolution system. Chemistry, Healthcare, Immunology, Coronavirus, social media distr - auto for marked clients, Laboratory Medicine, Pathology and Laboratory Medicine, pathologists, Medical Laboratory, COVID-19, 265 Turkey Sag Trail, Suite 102, #110, Palmyra VA 22963, View all Meeting, Grants & Events Channels, Register for reporter access to contact details, social media distr - auto for marked clients. <>/Metadata 2347 0 R/ViewerPreferences 2348 0 R>> !l8FXl'ir^f[3z2}==:$wD>1pq]l }$j4YG 2022 Issues, ARTICLES, September 2022, September Issue. The previous guidelines turned out to be tough acts to followa bit like following Sean Connery in the role of James Bondeven as the new one benefits from new data. The following is a complete list of the CAP accreditation checklists: CHECKLISTS SUBDISCIPLINES DESCRIPTION OF CONTENTS All Common N/A Proficiency testing August 2017There was no trip to the spa. It also clarifies language from the 2013 guideline that had sent some labs astray, and it addresses the use of multiple alternative chromosome 17 probe assays. April 2020The CAP and the American Society of Clinical Oncology released two years ago a focused update of their clinical practice guideline for HER2 testing for breast cancer, following an update in 2013. They shouldnt be considered a significant burden.. Its one thing to have a procedure on paper and a few written records. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. 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. Newswise Northfield, ILThe College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. <> 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. August 2016Maybe laboratory accreditation checklists arent the first reading you reach for when you want to unwind. http://www.businesswire.com/news/home/20200604005016/en, 1985 - 2023 BioSpace.com. If so, and if it is likely to be of interest to others in laboratories, send it to CAP TODAYs Q&A column (, SeraCare releases FFPE solid tumor CNV reference material, ARUP chooses Gestalts PathFlow for digital pathology, Maine Molecular QC releases SpotFire RSP controls, FDA clears Leica Biosystems MMR antibody panel, Sarstedt launches NFT urine collection system, Chemistry and Immunoassay Analyzers for POC and Low-Volume Labs, Chemistry and Immunoassay Analyzers for Mid- and High-Volume Labs, Coagulation Analyzers POC, Self-Monitoring, Laboratory Automation Systems and Workcells, Checklists now made to fit for next-gen sequencing labs, Need a written policy or procedure? 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 . To provide you with a more responsive and personalized service, this site uses cookies. 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. April 2021In the continuum of cancer care, diagnostic specialties such as ours play critical roles. For immunohistochemistry, this unhurried disclosure has meant evolving ideas of whether these tests must indeed be validated and, if so, then how, exactly. Written has been removed and it now says a lab must have a QM program. 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. You must complete additional steps or remove assets to resume downloading. Research News and Expert Quotes for your Next Story, Source Newsroom: endobj stream PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. Subsequent CAP changes, if applicable, are not reflected in this eAlert. The agreement, communicated to state survey agency directors in a March 16 CMS memorandum, is reflected in the updated CAP accreditation program cytopathology checklist released this month. Powered by Madgex Job Board Software, https://www.businesswire.com/news/home/20200604005016/en/, http://www.businesswire.com/news/home/20200604005016/en. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. 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. "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. September 2013With the 2013 edition of theLaboratory Accreditation Program checklist, the College moves to a new level in its effort to ensure the highest-quality practices in clinical laboratories use of next-generation DNA sequencing. 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.. Well forward it to experts for a reply. p9-m M=*Zm. 2022 Issues, ARTICLES, August 2022, Cytopathology. In transfusion medicine, the changes this year center on computer crossmatches, record retention, forward/reverse typing, and ABO group and Rh(D) type verification. ddB .2c"7Da KhY. endobj 2020 CAP Accreditation Checklist Updates: Changes That Matter Harris Goodman MD, FCAP Stephen Sarewitz, MD, FCAP DECEMBER 16, 2020 Opinions expressed in this presentation are those of the speaker and do not express the views or opinions of Cardinal Health The assigned checklist is based on the specific 3 0 obj Addition of deficiencies cited on previous inspections (including the requirement number, inspection date, and inspector comments) in the inspector version of the checklists. Learn more about the webinar and register. For accreditation under CLIA, its not enough to know personnel are qualified because of their certificate or license; you have to prove it with copies of their transcripts and diplomas. As a deemed status organization, validation surveys are performed annually through the Centers for Medicare and Medicaid Services and the feedback obtained provides direction for education. Significant progress has been made in laboratory quality over time, thanks to people, instrumentation, and processes, says Joe C. Rutledge, MD, member of the CAP 15189 Committee and professor of laboratory medicine, University of Washington. 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. At disease progression on an EGFR TKI, integrating circulating tumor DNA and tissue-based testing may lessen some of the limitations of each form of testing. <> November 2021In the latest edition of the laboratory general checklist, released in September, the requirements of the CAP Accreditation Programs have been edited to be more aligned with CAP 15189 (ISO 15189) accreditation requirements. The CAP expects to release its 2022 CAP checklist edition in October. The widespread use of the CAP cancer protocols has improved cancer reporting by standardizing format and terminology while also incorporating the concept of human factors engineering and standards for developing high-quality clinical practice guidelines. Written in easy-to-understand language, they remove the guesswork from compliance which can be especially helpful for laboratories facing staffing challenges. 2020 Issues, ARTICLES, COVID-19, November 2020. Send completed order form to 847-832-8168, ATTN: Customer Data . The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. 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. And now its taking place with imaging mass spectrometry. order or credit card information. May 2022The number of minimally invasive fine-needle aspirations requiring rapid on-site evaluation (ROSE) in the cytopathology laboratory has increased over the past decade. GEN.20325 Employee and Patient Quality Communication folds communication into the QM program, with a process that makes it possible for employees and patients to share with management their concerns about quality and safety. October 2021By Jan. 1, 2024, laboratories must use current breakpoints to interpret antimicrobial minimum inhibitory concentration and disk diffusion test results, according to a new requirement in the latest edition of the CAP Accreditation Programs microbiology checklist, released Sept. 22. November 2020The CAP released in September its proficiency testing program for SARS-CoV-2 antigen testing, with the first shipment to laboratories set for Nov. 30. Its been fantastic, he says. In work led by the CAP Council on Accreditation, the checklists are examined anew and revised yearly, where needed. GEN.20326 Assessment of the QM Program Implementation is a revised requirement that existed previously as GEN.16902 QM Program Implementation. GEN.20326 says that in any lab that has been CAP accredited for more than 12 months, the QM program must be implemented as designed and assessed at least annually for effectiveness. Now, in 2018, they have clarified the diagnostic approach to in situ hybridization groups two, three, and four, rare cases that nonetheless cause an outsized share of headaches and worries. 3 0 obj Use of enhanced NOTE customization for laboratories performing next generation sequencing (NGS) to limit the NGS NOTE content to the testing applications on the laboratorys activity menu. % endobj It was an important step for in vivo microscopy. 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. Email: MEDIA@CAP.ORG. Orders must include your area code and telephone number. 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. It is a test you only need once. 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