cap laboratory general checklist 2020 pdfcap laboratory general checklist 2020 pdf

Setting the bar higher was important because thats the culture here, he says. About the College of American Pathologists. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). But those things dont always accomplish the goal of effective change, he says. Or ask Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup of acute leukemia. September 2017Like an old friend with a new facelift, or a high-mileage car with a thorough tune-up, the 2017 edition of the CAP transfusion medicine checklist has undergone a significant number of small changesnone of which is startling in itself, but all of which combine to produce a fresh and streamlined effect. Archives of Pathology & Laboratory Medicine, View Vendors List forCAPs Checklist Distribution Program, Browser and Operating System Requirements, Notes, references, and practical examples to further clarify requirements and facilitate compliance, Citations to additional resources for further explanation, Built-in references for easy access to specific regulations, Evidence of compliance with integrated best practices. Look for icon, Cytopathology in focus: Protocol for reporting cervicovaginal cytology specimens, For inspectors, a new and better training course, Cytopathology in focus: Know the accreditation requirements for telecytology, Cytopathology in focus: Statistical reportingbenefits beyond the numbers, MMR, MSI testing guideline nears finish line, Latest checklist takes quality management to next level, AST and safety at core of microbiology checklist changes, A preanalytics push in accreditation checklists, Virtual, blended inspections a sign of the times, pTX and pNX should not be used in tumor staging, From manual to staging systemAJCCs new path, Checklist, CLIA line up on COVID reporting, At POC and in lab, 2 new checks on SARS-CoV-2 testing, Whats new in latest transfusion medicine checklist, In 2020 checklist, a gentle push to next quality level, New checklist hones labs verification and validation requirements, HIV, TB requirements in latest accreditation checklist edition, ER/PgR guideline hones approach to ER-low positives, Reporting, other changes in requirements for histocompatibility labs, For accredited biobanks, a path to CLIA equivalence, New requirements for molecular micro waived testing, Quantitative image analysis: In guideline, preliminary rules for pathologys third revolution, New requirements for use and storage of liquid nitrogen, dry ice, New accreditation program checklist section: Imaging mass spec scores its own quality standards, For autopsy service, new requirements in AP checklist plus nine new requirements for forensic autopsies, We wanted to be the best we could possibly be: CAP ISO 15189-accredited labs on the difference it makes, Transfusion medicine checklist: Record and other requirements updated in new release, Cytology workload limits: For adequacy assessments, its time, not slides, Molecular lung cancer testing: from guideline to practice, Small groups, big answers in HER2 testing, Clearing the air for electronic cancer checklists, Lung guideline goals: more tests, treatment, New sections added to AP, cytopathology checklists, PD-L1 guideline panels hustle to keep pace with drug advances, NGS checklist takes in infectious disease testing, New requirement, updates in transfusion checklist, A slimmer molecular micro section among changes to checklists, Laboratory director duties clarified in 2017 checklist, Acute leukemia workups, from top to bottom, Laboratory accreditation program 2016 checklists: Less legwork, more clarity seen in personnel changes, New tests, technologies at center of 2016 CAP checklist revamp, In situ hybridization: more harmony across checklists, Carbapenem resistance: advice from the frontline, QC for accreditation: CMS validation inspections, Checklist changes put out fire (drills), for starters, No ifs, ands, or buts on IHC assay validation, No worries with new cancer biomarker templates, For prenatal NGS labs, new accreditation requirements. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). 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. For more information on the ones we use and how to delete or block them please read our policy. 4 0 obj This all helps to close gaps in quality management, Dr. Rutledge says. A CAP team made up of members of the Checklists, Personalized Health Care, and Cytopathology committees collaborated to incorporate into the checklists the evidence-based recommendations set forth in a 2019 article on preanalytics and precision pathology. 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. All rights reserved. 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. %PDF-1.5 They include test order accuracy, test turnaround time, critical result reporting, and blood culture contamination, among others. New to the list of suggested indicators is laboratory test utilization, an indicator Dr. Goodman says he focuses on at his hospital. April, 2020 . It was presented via webinar to the CAP House of Delegates on March 31. May 2014Gerald Hoeltge, MD, chair of the CAP Checklists Committee, is pretty sure he knows exactly the way many laboratories will react to a particular change in the latest edition of the Laboratory Accreditation Program checklists, which launch this month. Within weeks, several other cases emerged. Are we serving our customerspatients, clinicians, hospitals, and othersin the best way possible?, Its not a leap for anyone. Now, a newly published CAP guideline should help physicians figure out the right fit in multiple settings. About the College of American Pathologists. 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 . 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 CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. Employees must feel there is no barrier, Dr. Sarewitz says. 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.. 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.. October 2019The requirement revisions in the new edition of the Biorepository Accreditation Program checklist, published last month, are aimed at accommodating a growing overlap between clinical diagnostic activity and biomedical research. Personnel is also high on the list of questions asked of Laboratory Accreditation Program staff. Behind that effort is the undeniable: Structured discrete data, using a controlled vocabulary, can be captured, stored, and reviewed much more readily than data in other formats, says Mary Edgerton, MD, PhD, vice chair of the CAPs Pathology Electronic Reporting (PERT) Committee and associate professor of pathology, University of Texas MD Anderson Cancer Center. 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. 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. 1 0 obj The list of requirements, which was a new section in the molecular pathology checklist, focused on constitutive (germline) testing and oncology testing. Highlights of the checklist enhancements include: The milestone: development and adoption of a set of specialized checklist requirements for laboratories that want CAP accreditation. 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. Email: MEDIA@CAP.ORG. Addition of deficiencies cited on previous inspections (including the requirement number, inspection date, and inspector comments) in the inspector version of the checklists. It brings a little more rigor into the system.. 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. Phone: 800-323-4040, ext. 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. September 2018Ten years ago, Richard J. Zarbo, MD, was feeling pretty proud of his laboratory. It may be that you chose the wrong action or the action was never implemented. 4 0 obj 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. August 2016Maybe laboratory accreditation checklists arent the first reading you reach for when you want to unwind. 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. Its been fantastic, he says. October 2019Histocompatibility laboratories that provide services for cellular therapy transplant patients have one more inspection option to consider, thanks to a new edition of the CAPs histocompatibility checklist released in September. CAP checklists are available in Word, Excel, or PDF format. April 2021In the continuum of cancer care, diagnostic specialties such as ours play critical roles. 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. Were not adding anything. August 2017Quantum theory is often interpreted to mean an object can be in two places simultaneously. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. 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). 1. October 2022As the diagnostic uses for next-generation sequencing have grown, so too has the length of the NGS section of the CAP molecular pathology accreditation program checklist. In many cases, in fact, HPV testing is just what treating clinicians and patients need. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. 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. 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 endobj September 2021Taking steps to protect the integrity of specimens is at the heart of new and revised requirements in this years edition of the accreditation program checklists, set for release Sept. 22. 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. Definition of Terms in the All Common and Laboratory General Checklists. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. Standardizing terminology has been an area of interest to the CAP project team (composed of members of the Checklists, CAP 15189, and Quality Practices committees) charged with working to improve technical . The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. endobj Joe Schramm Recaptcha secret parameter is missing or invalid! About the College of American Pathologists. 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. Newswise Northfield, ILThe College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. endobj 7445 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 CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. http://www.businesswire.com/news/home/20200604005016/en, 1985 - 2023 BioSpace.com. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. Thats a key to closing the loop when dealing with problems in the laboratory. Evidence of compliance requires records of actions taken and of the effectiveness evaluation. S 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. Why are we making this change? PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. 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. It is something that should have been done without the requirement, but this makes it crystal clear it must be done, he says. They are available in different checklist types and formatting options, . Updated to reflect August 21, 2017 CAP Checklist edition changes 8.0 September, 2018 : 1. 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. Include a copy of institutional purchase . 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. What are the CAP Checklists? Labs need to have a complaint/non-conforming event resolution system. "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. Read the CAP Annual Report. 2022 Issues, ARTICLES, September 2022, September Issue. 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. Updated to reflect review of all references 9.0 . Contact us at 800-323-4040 or accred@cap.org. Additional explanation of these enhancements will be provided with the checklist release. But for an intriguing window into laboratory medicine and how its changing, you might take a look at the revisions in the 2016 edition of the Laboratory Accreditation Program checklists, released in August. 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. August 2020For quality management in the laboratory, its not enough to have checks and balances. Subsequent CAP changes, if applicable, are not reflected in this eAlert. Harris S. Goodman, MD, Checklists Committee chair and clinical laboratory director, Alameda Health System Highland Hospital, Oakland., Calif., says GEN.20318 underscores that there is no point in taking actions that do not accomplish anything. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. 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. Tag Archives: CAP lab accreditation/checklists/protocols/guidelines, CAP lab accreditation/checklists/protocols/guidelines, Do you have a question related to pathology and laboratory medicine practice? And now its taking place with imaging mass spectrometry. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. ddB .2c"7Da KhY. CAP Laboratory Accreditation helps laboratories: Maintain accuracy of test results and ensure accurate patient diagnosis. 2022 Issues, ARTICLES, August 2022, Cytopathology. August 2016As the use of in situ hybridization (ISH) expands, laboratories employing this form of testing increasingly rely on the CAP Laboratory Accreditation Program checklist for guidance. In fact, HPV testing is just what treating clinicians and patients need way possible? its! He says the CAPs program is based on rigorous accreditation standards that are translated into checklist! Laboratory 's overall management and operation them as a guide to assess laboratory. A key to closing the loop when dealing with problems in the laboratory 's overall management and operation of! Is also high on the ones we use and how to delete or block them please read our.. 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