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. 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. 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. 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. 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. endobj These requirements were implicit in the prior edition of the checklist, Dr. Sarewitz says. It is something that should have been done without the requirement, but this makes it crystal clear it must be done, he says. 4 0 obj 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. 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. order or credit card information. Work is underway to improve the user experience (Nakhleh RE, et al. Some items have been removed from your Media Cart because they are no longer available or expired. March 2018Among the many never-ending chores that humans undertakepaying bills, filing taxes, flossingwriting medical guidelines can seem like an especially perpetual task. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. CAP requirements commonly exceed the standards, bolstering patient care and safety. Joe Schramm 1 0 obj 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. Include a copy of institutional purchase . As system chairman of pathology and laboratory medicine at Detroit-based Henry Ford Health System, over the previous few years hed seen his team rigorously implement Lean practices, practices that had paid off in greater safety and efficiency. 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. You must enable cookies in your browser to use the Media Cart feature. 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. Program Benefits. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. 4 0 obj 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. endobj And its open and accessible to all. "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. x]Ys7~weA pdWbh0_%qj!$*y_ExO".n? These detailed checklists include: Notes, references, and practical examples to further clarify requirements and facilitate compliance Infused with best practices, our checklists are updated annually to help laboratories stay current with rapidly evolving advances in laboratory medicine, technology, and regulatory compliance. August 2016As the use of in situ hybridization (ISH) expands, laboratories employing this form of testing increasingly rely on the CAP Laboratory Accreditation Program checklist for guidance. % Annually, the CAP reviews all checklists to maintain program stringency and the highest standards of patient care while reflecting advancements in medicine, technology, and laboratory management. xZn8}TiNE4]"@>x1]%Q7ZB E5au,nv?-n~X-vy^ow]?Hq9G7Onv%A7tEo?^!WB(,3aXDL3h&1ch]|~#ld8Hk8Tn ''psn(00AR -?-+PPtyPa(SPp158g Sc3USSvCMO i@p310jxKh1]N8.x'SkdxEN0~mS]lC2Dp, (*yyk$rAEF~]>.t}uZB@I7 y.V4YrOPl*aT:tgD!zgEF#.8{ Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). July 2020If a manufacturer assists a laboratory in setting up a new FDA-approved or -cleared test, the lab must make sure that the personnel who will perform the test participate in the verification or validation study. 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. Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. 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. 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. Developed with input from more than 500 pathologists and laboratory experts, our 21 discipline-specific accreditation checklists provide a clear roadmap for not only achieving accreditation but also for running a high-quality laboratory. May 2022Users of the CAPs redesigned laboratory inspector training course, introduced last December, should find it to be more fun, less chore, and tailored to what they need to know, say those who developed the new course. Thank you for getting in touch with us, well get back to you as soon as possible. But I dont think anyone realized how long, says Dr. Arber, professor and chair of pathology, University of Chicago, and the CAP co-chair for the guideline group. 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. 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. xKO@F Its been fantastic, he says. The inclusion of the activities of andrology and endocrine If you need a different quality of the file please download the asset individually. Good Housekeeping: What Does the End of COVID Emergency Declarations Really Mean? 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. Read more. Licenses and Certificates. The CAP expects to release its 2022 CAP checklist edition in October. This change is coming after extensive discussions with the American Joint Committee on Cancer (AJCC) and with its unanimous endorsement. 7445 November 2017A new flow cytometry section in the anatomic pathology checklist and a section on immunochemistry in the cytopathology checklist are among the many changes found in the latest edition of the CAP Laboratory Accreditation Program checklists, released in August. Arrow Right. p9-m M=*Zm. Unfortunately, quantum theory doesnt apply to laboratory directors, at least not on a scheduling level. endobj Something like sedately stepping onto a moving sidewalk. Communication Date: August 1, 2022NOTE: The information below was current at the time of communication. Less severe non-conforming events require investigation but not a full root cause analysis, Dr. Sarewitz says. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. 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. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. 2017;141[9]:11531154). September 2018Ten years ago, Richard J. Zarbo, MD, was feeling pretty proud of his laboratory. Many of the new and revised requirements, which are in seven checklists, are aimed at improving the quality of tissue and blood specimens that may undergo molecular testing for patients with cancer. The Checklists used f or inspection b y the College of Amer ican Pathologists' Accreditation Prog rams have 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. Archives of Pathology & Laboratory Medicine, 2022 CAP Accreditation Checklist Updates: Changes that Matter, Browser and Operating System Requirements, 2022 Checklist Updates: New Enhancements Coming This Fall. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. For more information on the ones we use and how to delete or block them please read our policy. But now we can take it to the next level by embracing what other industries have doneadopt a quality management system that is robust and livingand continually ask the questions, Are we effective with our improvements and with our corrections? 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. September 2018Quality management, communication, and consent are among the issues addressed in new and revised requirements in the autopsy pathology section of the latest edition of the CAP accreditation program anatomic pathology checklist. Learn more about the webinar and register. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. At the start of the project, I think everyone going into it realized it was going to be a time-consuming, long process. 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. 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. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. 2022 Issues, ARTICLES, September 2022, September Issue. Visit cap.org to register. College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750. 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. August 2022The protocol for the reporting of cervicovaginal cytology, the first in a series of CAP cytopathology protocols, became available for use in a synoptic format on June 22. 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 checks and balances have to work to improve quality. 3 0 obj Highlights of the checklist enhancements include: Internet Explorer presents a security risk. 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 Arch Pathol Lab Med. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). Well forward it to experts for a reply. 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. <>>> One of the changes is GEN.20318 Corrective and Preventive Action, a new requirement that says a labs quality management program must include processes for recording corrective and preventive actions taken for errors and incidents (i.e. 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. The assigned checklist is based on the specific Read More AST and safety at core of microbiology checklist changes 2021 Issues, ARTICLES, October 2021 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. endobj The CAP expects to release its 2022 CAP checklist edition in October. The software solutions in our Accreditation Checklist Distribution program have been evaluated by the CAP to ensure functionality to manage ongoing accreditation compliance using . That is one reason members from three CAP committees started meeting to revise the ISH checklist, says CAP Surgical Pathology Committee member Aleodor Andea, MD, MBA. Subsequent CAP changes, if applicable, are not reflected in this eAlert. Email: MEDIA@CAP.ORG, View this news release online at: Email: MEDIA@CAP.ORG. It was an important step for in vivo microscopy. 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). And employees must have a way of bringing observations and suggestions forward. Evidence of compliance calls for records of employee and patient complaints with appropriate follow-up. Were not adding anything. Everybody wants to do this, Dr. Rutledge continues. !l8FXl'ir^f[3z2}==:$wD>1pq]l }$j4YG 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. 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 . For the purposes of clarity, this requirement was added and includes ISO concepts, the point being that not only does a laboratory have to record corrective and preventive actions taken for non-conforming events and quality indicators that do not meet targets, but the lab also must evaluate how effective its corrective and preventive actions are. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. NORTHFIELD, Ill.The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. 1 0 obj Perhaps there is another action that is better. Do you have a question related to pathology and laboratory medicine practice? It was presented via webinar to the CAP House of Delegates on March 31. CAP checklists are available in Word, Excel, or PDF format. Written has been removed and it now says a lab must have a QM program. It also introduced the term non-conforming event, which is an ISO term for an error or problem that results from a laboratory procedure or process not having gone as it should have. This all helps to close gaps in quality management, Dr. Rutledge says. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. If the question and answer are published in the column, the only name published will be that of the person who answered the question. %PDF-1.5 Laboratories can register now for our checklist update webinar, 2022 CAP Accreditation Checklist Updates: Changes that Matter, scheduled for Wednesday, October 19, 2022. 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. Read the CAP Annual Report. April 2021In the continuum of cancer care, diagnostic specialties such as ours play critical roles. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. Setting the bar higher was important because thats the culture here, he says. On the other hand, not every head and neck case requires it. The specific checklist used is automatically assigned when a laboratory updates its activity menu in Organization Profile on cap.org. In 2020 checklist, a gentle push to next quality level, Do you have a question related to pathology and laboratory medicine practice? 2 0 obj 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. Send completed order form to 847-832-8168, ATTN: Customer Data . All rights reserved. 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. Please accept marketing cookies to share content. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. 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. The requirement also specifies that it applies to clinical, rather than business/financial issues. 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. Archives of Pathology & Laboratory Medicine, Clinical Laboratory Improvement Amendments. 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. endobj 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. Check to see which vendors participate in the CAPs Checklist Distribution Program. <> 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. 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. 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. 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