cap laboratory general checklist 2020 pdfcap laboratory general checklist 2020 pdf

Within weeks, several other cases emerged. April 2019With the release in January of a new guideline for quantitative image analysis of HER2 immunohistochemistry for breast cancer, the CAP believes it is filling a gap and blazing a trail for the profession. August 2020For quality management in the laboratory, its not enough to have checks and balances. endobj Contact us at 800-323-4040 or accred@cap.org. Since the first groundbreaking joint guideline appeared 11 years ago, the authors have made a habit of addressing cases that flummox pathologists, medical oncologists, and patients. 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. The Checklists used f or inspection b y the College of Amer ican Pathologists' Accreditation Prog rams have August 2018The CAP and the Centers for Medicare and Medicaid Services reached an understanding earlier this year on how adequacy assessments and rapid on-site evaluations in cytology can be accounted for without causing undue impact on workload limits. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. CAP Checklists Used to Inspect COVID-19 Test Activities Use this document to determine which checklist(s) can be used to inspect COVID-19 related testing. 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. 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 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. 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. 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. 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. Setting the bar higher was important because thats the culture here, he says. What are the CAP Checklists? Updated to reflect August 21, 2017 CAP Checklist edition changes 8.0 September, 2018 : 1. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. All services provided by Mayo Clinic Laboratories that involve joint efforts will be done in a manner which enables our clients to comply with HIPAA and the College of American Pathologists (CAP) Laboratory General Checklist (CAP GEN. 41303). Employees must feel there is no barrier, Dr. Sarewitz says. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. Modifications to the Laboratory General checklist for waived-only laboratories to right-size the content in a customized checklist for laboratories performing only waived testing. They are available in different checklist types and formatting options, . July 2018Take the new ASCO/CAP guideline for HER2 testing. Personnel is a hot topic for the College, says CAP Checklists Committee chair William W. West, MD. Less severe non-conforming events require investigation but not a full root cause analysis, Dr. Sarewitz says. Check to see which vendors participate in the CAPs Checklist Distribution Program. Visit cap.org to register. College of American Pathologists (CAP). Well forward it to experts for a reply. June 2021For the June 2021 release of updates for the CAP cancer protocols and the corresponding electronic cancer checklists used by electronic health record vendors, pTX and pNX will no longer be selectable options for use by pathologists when assigning pathologic staging based on definitive surgical resection (pTNM). 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. 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. November 2020Its been well understood since the Ten Commandments that rules that appear simple in theory can be fiendishly complex or even impossible to execute. March 2014Like Gypsy Rose Lee, tests and their true nature reveal themselves bit by bit. 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. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> March 2018Among the many never-ending chores that humans undertakepaying bills, filing taxes, flossingwriting medical guidelines can seem like an especially perpetual task. For more information, visityourpathologist.orgto watch pathologists at work and see the stories of the patients who trust them with their care. stream The 2017 edition of the checklists, released this month, has eliminated the specific requirements for laboratory directors who are not on site full time and has clarified responsibilities for all directors, on site or remote. Its not enough just to have taken an action; it has to have made a difference. z\G832. About the College of American Pathologists. Detailed standards developed based on broad principles defined in the CAP Standards for Laboratory Accreditation -21 different checklists with about 2,900 requirements Tool for laboratories to prepare for inspection Roadmap guide for inspectors to perform an inspection Customizable based on tests and activities 3 0 obj Updated to reflect review of all references 9.0 . In the 2020 edition, the CAP made additions and changes to checklists including Laboratory General, Microbiology, Immunology, Chemistry, Point of Care, Transfusion Medicine, and Reproductive Medicine. 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. Written in easy-to-understand language, they remove the guesswork from compliance which can be especially helpful for laboratories facing staffing challenges. Subsequent CAP changes, if applicable, are not reflected in this eAlert. Some items have been removed from your Media Cart because they are no longer available or expired. For more information on the ones we use and how to delete or block them please read our policy. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. 4 0 obj Perhaps there is another action that is better. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. % Laboratories can register now for our checklist update webinar, 2022 CAP Accreditation Checklist Updates: Changes that Matter, scheduled for Wednesday, October 19, 2022. September 2018Ten years ago, Richard J. Zarbo, MD, was feeling pretty proud of his laboratory. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. NORTHFIELD, Ill.--(BUSINESS WIRE)--The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. You must complete additional steps or remove assets to resume downloading. The inclusion of the activities of andrology and endocrine August 2018One new requirement and several modified requirements in the CAP transfusion medicine checklist are part of the new edition of CAP accreditation program checklists released this month. 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. About the College of American Pathologists. Annually, the CAP reviews all checklists to maintain program stringency and the highest standards of patient care while reflecting advancements in medicine, technology, and laboratory management. October 2018Laboratory personnel safety is at the center of two new requirements and a revised requirement in the latest edition of the CAP accreditation program checklists, released in August. 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, CAP lab accreditation/checklists/protocols/guidelines, Quality assurance/quality control/quality improvement. Addition of deficiencies cited on previous inspections (including the requirement number, inspection date, and inspector comments) in the inspector version of the checklists. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. For immunohistochemistry, this unhurried disclosure has meant evolving ideas of whether these tests must indeed be validated and, if so, then how, exactly. Read more. Everybody wants to do this, Dr. Rutledge continues. It also introduced recently a Quality Cross Check program that makes it possible for labs performing nucleic acid amplification testing for SARS-CoV-2 to monitor performance across multiple instruments, in compliance with the CMS directive prohibiting proficiency testing on multiple instruments. 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. By bit remove assets to resume downloading a customized checklist for waived-only to... 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