Laboratories can register now for our checklist update webinar, 2022 CAP Accreditation Checklist Updates: Changes that Matter, scheduled for Wednesday, October 19, 2022. On the other hand, not every head and neck case requires it. Highlights of the checklist enhancements include: The assigned checklist is based on the specific Internet Explorer presents a security risk. 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. To provide you with a more responsive and personalized service, this site uses cookies. It is something that should have been done without the requirement, but this makes it crystal clear it must be done, he says. 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. The specific checklist used is automatically assigned when a laboratory updates its activity menu in Organization Profile on cap.org. April, 2020 . The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. April 2021In the continuum of cancer care, diagnostic specialties such as ours play critical roles. Thank you for getting in touch with us, well get back to you as soon as possible. August 2020For quality management in the laboratory, its not enough to have checks and balances. stream 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 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. The software solutions in our Accreditation Checklist Distribution program have been evaluated by the CAP to ensure functionality to manage ongoing accreditation compliance using . These requirements were implicit in the prior edition of the checklist, Dr. Sarewitz says. 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. 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. 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. ROSE for patient care has proven value. But some sections of the 2017 edition of the CAP Laboratory Accreditation Program checklist are looking trimmed and toned compared with last years checklists. 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. Something like sedately stepping onto a moving sidewalk. In many cases, in fact, HPV testing is just what treating clinicians and patients need. Written in easy-to-understand language, they remove the guesswork from compliance which can be especially helpful for laboratories facing staffing challenges. 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. 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. A s the 2020 laboratory general checklist now drills deeper into quality management, it incorporates more terminology found in ISO. Learn more about the webinar and register. View source version on businesswire.com: https://www.businesswire.com/news/home/20200604005016/en/, Joe Schramm 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.. 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. It may be that you chose the wrong action or the action was never implemented. August 2020For quality management in the laboratory, its not enough to have checks and balances. Orders must include your area code and telephone number. Phone: 800-323-4040, ext. Its not enough just to have taken an action; it has to have made a difference. 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. 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. Within weeks, several other cases emerged. And its open and accessible to all. 1 0 obj The key question at that point was quotidian: Have new data emerged to warrant changing the original recommendations? endobj To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. Check to see which vendors participate in the CAPs Checklist Distribution 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. In 2020 checklist, a gentle push to next quality level, Do you have a question related to pathology and laboratory medicine practice? The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. 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. College of American Pathologists Created in 1993 to meet the needs of reproductive laboratories with: o. These detailed checklists include: Notes, references, and practical examples to further clarify requirements and facilitate compliance View Vendors List forCAPs Checklist Distribution Program CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. To uncover and understand all the possibilities, you must evaluate the effectiveness of your actions.. ddB .2c"7Da KhY. Well forward it to experts for a reply. 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. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. We touch virtually all aspects of cancer care through cancer diagnostics, the use of molecular studies in treatment and as predictive markers, and our key role in anatomic pathologic staging. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. Newswise Northfield, ILThe College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. 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. In setting evidence-based standards, the guideline provides background and details about the quantitative image analysis (QIA) process and the data and metadata it generates. They are available in different checklist types and formatting options, . The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. It brings a little more rigor into the system.. What if patients call the number and no one records their complaints? Do you have a question related to pathology and laboratory medicine practice? "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. 2 0 obj By being able to bring that to managements attention they are able to help safeguard both patients and the lab. 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. If the question and answer are published in the column, the only name published will be that of the person who answered the question. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. 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. 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. Read the CAP Annual Report. Do you have a question related to pathology and laboratory medicine practice? 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. 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. About the College of American Pathologists. May 2017Plenty can happen in five years. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. Personnel is also high on the list of questions asked of Laboratory Accreditation Program staff. Arch Pathol Lab Med. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. endobj By clicking "Accept", you agree to our use of cookies. Program Benefits. What are the CAP Checklists? But those things dont always accomplish the goal of effective change, he says. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. 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{ Learn more about the webinar and register. stream 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. <> Updated to reflect August 22, 2018 CAP Checklist edition changes 2. 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. College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 06.04.2020. . 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. 2020 Issues, ARTICLES, COVID-19, November 2020. Updated to reflect review of all references 9.0 . 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. %PDF-1.7 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. The templates will look very familiar to users of the CAP cancer protocols. More than 90 of the checklists requirements have been revised, many in the name of alignment with FDA requirements. <> 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. Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines. order or credit card information. Perhaps there is another action that is better. October 2017The expert and advisory panels for the CAP/IASLC/AMP guideline on molecular testing for lung cancer biomarkers started updating the guideline in 2014, and an important but fairly routine revision process may have seemed to lie ahead. endobj About the College of American Pathologists. 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). The following is a complete list of the CAP accreditation checklists: CHECKLISTS SUBDISCIPLINES DESCRIPTION OF CONTENTS All Common N/A Proficiency testing 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. z\G832. !l8FXl'ir^f[3z2}==:$wD>1pq]l }$j4YG In GEN.16902, QM programs needed only to be reviewed, not assessed. The focus of what is now an annual assessment has been expanded beyond simply evaluating the performance of the quality indicators to also evaluating other aspects of the QM program, such as follow-up on non-conforming events that require corrective/preventive action and actions taken to address concerns about quality and safety. stream 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. This release will feature several enhancements designed to clarify and simplify the inspection process for inspectors and laboratories. Work is underway to improve the user experience (Nakhleh RE, et al. 2023 College of American Pathologists. That's 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. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. 4 0 obj 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 In work led by the CAP Council on Accreditation, the checklists are examined anew and revised yearly, where needed. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. 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.. This change is coming after extensive discussions with the American Joint Committee on Cancer (AJCC) and with its unanimous endorsement. Less severe non-conforming events require investigation but not a full root cause analysis, Dr. Sarewitz says. 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. Highest quality files will be downloaded for all the assets. %PDF-1.7 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. August 2017There was no trip to the spa. They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. Manage rapidly evolving changes in laboratory medicine and technology. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. endobj 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. Definition of Terms in the All Common and Laboratory General Checklists. 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 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. 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. 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. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. endobj Its been fantastic, he says. 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. Well forward it to experts for a reply. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. 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. Questions? People who are on the line doing the testing may see something that is the start of an important issue. 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. In transfusion medicine, the changes this year center on computer crossmatches, record retention, forward/reverse typing, and ABO group and Rh(D) type verification. Licenses and Certificates. 2022 Issues, ARTICLES, Cytopathology, May 2022. Laboratories have seen lower gynecologic volumes and an increase in both nongynecologic fine-needle aspiration biopsy and touch imprint samples. 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. 1 0 obj The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. 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. Prior to an inspection, we create a custom checklist specifically for your laboratory based on your exact testing menu, so you and the inspection team both know whats being inspected so there are no surprises. At the start of the project, I think everyone going into it realized it was going to be a time-consuming, long process. 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. Now a change to the CAP Laboratory Accreditation Programs checklists will clarify expectations for directors who are in charge of more than one laboratory. December 2021No single assay can capture all cancer patients with DNA mismatch repair deficiency, and in determining a patients eligibility for immune checkpoint inhibitor therapy, assays for MMR deficiency, microsatellite instability, and tumor mutation burden should not be considered interchangeable. These detailed checklists include: View a Full Listing of Available Checklists with Description (PDF), Request a Sample CAP Checklist So its no surprise that QC should be subject to quality checks of its own, as one of the pivotal checklist areas that CAPs Laboratory Accreditation Program focuses on during inspections. Read the CAP Annual Report. Please accept marketing cookies to share content. 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. 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. 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. 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. For immunohistochemistry, this unhurried disclosure has meant evolving ideas of whether these tests must indeed be validated and, if so, then how, exactly. Communication Date: August 1, 2022NOTE: The information below was current at the time of communication. Subsequent CAP changes, if applicable, are not reflected in this eAlert. 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. 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. For more information on the ones we use and how to delete or block them please read our policy. 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