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). ddB .2c"7Da KhY. x]Ys7~weA pdWbh0_%qj!$*y_ExO".n? 4 0 obj In 2020 checklist, a gentle push to next quality level, Do you have a question related to pathology and laboratory medicine practice? Research News and Expert Quotes for your Next Story, Source Newsroom: The Checklists used f or inspection b y the College of Amer ican Pathologists' Accreditation Prog rams have <> PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. About the College of American Pathologists. "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. And now its taking place with imaging mass spectrometry. 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. Highlights of the checklist enhancements include: The aim of others is to improve the preanalytic quality of specimens used for all types of testing. 1 0 obj The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). 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? Highest quality files will be downloaded for all the assets. Some items have been removed from your Media Cart because they are no longer available or expired. Possibly the action taken is applied to a problem you thought was present, though all the while it was another problem that was present and causing problems. 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. Are we serving our customerspatients, clinicians, hospitals, and othersin the best way possible?, Its not a leap for anyone. 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. 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. What if patients call the number and no one records their complaints? %PDF-1.7 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. 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. non-conforming events) and for quality indicators that do not meet defined targets, as well as for evaluating the effectiveness of the actions taken. Archives of Pathology & Laboratory Medicine, Clinical Laboratory Improvement Amendments. <>/Metadata 2347 0 R/ViewerPreferences 2348 0 R>> College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 06.04.2020. . 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20200604005016/en/, Joe Schramm Visit cap.org to register. 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. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. 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 August 2020For quality management in the laboratory, its not enough to have checks and balances. 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. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. 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. Include a copy of institutional purchase . You must enable cookies in your browser to use the Media Cart feature. 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. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). Management or email cdm@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. August 2017Quantum theory is often interpreted to mean an object can be in two places simultaneously. 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). GEN.20208 QM Patient Care/Client Services says the QM program must include a process to identify and evaluate non-conforming events. While the aim of the changes was to simplify and clarify, Dr. Rutledge says, Were getting away from the idea that there can be just a written document that sits there and fulfills the requirement. 7.0 September, 2017 1. 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. 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 discussion recently culminated in a new CAP guideline for laboratories. 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. May 2015Quality control is second nature and part of the air that laboratories breathe. z\G832. The list of requirements, which was a new section in the molecular pathology checklist, focused on constitutive (germline) testing and oncology testing. <> For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. About the College of American Pathologists. Considering a document control system to manage your laboratorys policies, procedures, and documents? And its open and accessible to all. June 2021As COVID-19 restrictions halted traditional laboratory inspections, virtual and blended inspections became the stand-ins, and early adopters say theres much to like and hold on to post-pandemic. We dont want any fear of whistleblower blowback in labs. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612.12 792.12] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> 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. 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. Phone: 800-323-4040, ext. Read the CAP Annual Report. There are other tests that are done redundantly, excessively, and are noncontributory to good patient care. Its been fantastic, he says. 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. 2022 Issues, ARTICLES, Cytopathology, May 2022. endobj Labs need to have a complaint/non-conforming event resolution system. <>>> Its not enough just to have taken an action; it has to have made a difference. There are several reasons why it could happen, he says. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. endobj 2020 Issues, ARTICLES, COVID-19, November 2020. 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. 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. But for the time being, when it comes to demonstrating that personnel have the required educational qualification to perform nonwaived point-of-care testing, the Centers for Medicare and Medicaid Services and the CAP have a message for laboratory directors: Primary documents are king. Your staff will save time in their inspection preparation and ongoing compliance efforts because they will only see the requirements that apply to your unique laboratory. 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. Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. Now, with the release of the new checklist edition this month, NGS laboratories will find the NGS section in their customized checklists leaner, more relevant, and easier to read. Dr. Rutledge says the addition of the requirement in 2019 pushed labs to look at how the whole system is doing and determine if it is a living system. If so, and if it is likely to be of interest to others in laboratories, send it to CAP TODAYs Q&A column (srice@cap.org) or complete our online form. Recaptcha secret parameter is missing or invalid! 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. 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. August 2020For quality management in the laboratory, its not enough to have checks and balances. 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. Sentinel events require a root cause analysis to determine the cause and prevent recurrence. Read theCAP Annual Report. <> The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines. Highlights of the checklist enhancements include: These new features will be available for use starting with the 2022 Checklist edition. Business/financial/contractual issues are certainly important, but they are not within the purview of the CAP program, Dr. Sarewitz says. March 2018Among the many never-ending chores that humans undertakepaying bills, filing taxes, flossingwriting medical guidelines can seem like an especially perpetual task. ROSE for patient care has proven value. At the start of the project, I think everyone going into it realized it was going to be a time-consuming, long process. Less severe non-conforming events require investigation but not a full root cause analysis, Dr. Sarewitz says. 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