But some sections of the 2017 edition of the CAP Laboratory Accreditation Program checklist are looking trimmed and toned compared with last years checklists. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). Perhaps there is another action that is better. Thank you for getting in touch with us, well get back to you as soon as possible. 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. Written has been removed and it now says a lab must have a QM program. April, 2020 . In work led by the CAP Council on Accreditation, the checklists are examined anew and revised yearly, where needed. The software solutions in our Accreditation Checklist Distribution program have been evaluated by the CAP to ensure functionality to manage ongoing accreditation compliance using . 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. 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. August 2017There was no trip to the spa. 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. 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 program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. In many cases, in fact, HPV testing is just what treating clinicians and patients need. Read the CAP Annual Report. And this must be done minimally once a year. Setting the bar higher was important because thats the culture here, he says. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. 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. It was presented via webinar to the CAP House of Delegates on March 31. 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{ It is a milestone for pathologists.. Visit cap.org to register. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). order or credit card information. College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 06.04.2020. . It is something that should have been done without the requirement, but this makes it crystal clear it must be done, he says. September 2016For the CAP Laboratory Accreditation Program, inspection checklist requirements covering personnel are a perennial concern. The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. endobj Many labs will do it more often, Dr. Goodman says. Powered by Madgex Job Board Software, https://www.businesswire.com/news/home/20200604005016/en/, http://www.businesswire.com/news/home/20200604005016/en. 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. 7445 You must complete additional steps or remove assets to resume downloading. 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.. endobj Read the CAP Annual Report. The requirement also specifies that it applies to clinical, rather than business/financial issues. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. It may be that you chose the wrong action or the action was never implemented. 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. A two-week open comment period followed; all comments were reviewed and appropriate changes were incorporated into the protocol. 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. 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. Contact us at 800-323-4040 or accred@cap.org. 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. Include a copy of institutional purchase . 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. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. 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. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. Phone: 800-323-4040, ext. <> 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. 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. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. They are the leading source of disparities between the findings of the programs inspectors and inspection audits done by the Centers for Medicare and Medicaid Services. 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. Joe Schramm Learn more about the webinar and register. 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. 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, Checklists now made to fit for next-gen sequencing labs, Need a written policy or procedure? 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 2016Maybe laboratory accreditation checklists arent the first reading you reach for when you want to unwind. Updated to reflect August 21, 2017 CAP Checklist edition changes 8.0 September, 2018 : 1. 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. 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 . 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 checks and balances have to work to improve quality. 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. Definition of Terms in the All Common and Laboratory General Checklists. Read More AST and safety at core of microbiology checklist changes 2021 Issues, ARTICLES, October 2021 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. All rights reserved. You must enable cookies in your browser to use the Media Cart feature. Mpox a Cause for Concern in Pregnant Persons, CAP Discusses Actions to Eliminate Health Disparities with Congressional Black Caucus. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. Sales Tax Within weeks, several other cases emerged. It is a test you only need once. 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 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. But those things dont always accomplish the goal of effective change, he says. This requirement was tweaked, Dr. Sarewitz says, to add the phrase non-conforming events to cover errors and incidents that affect patient care. 2022 Issues, ARTICLES, Cytopathology, May 2022. 3 0 obj This change is coming after extensive discussions with the American Joint Committee on Cancer (AJCC) and with its unanimous endorsement. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. NORTHFIELD, Ill.The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. 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 assigned checklist is based on the specific 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. Sentinel events require a root cause analysis to determine the cause and prevent recurrence. 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. Laboratories have seen lower gynecologic volumes and an increase in both nongynecologic fine-needle aspiration biopsy and touch imprint samples. % So this addition can eventually benefit labs and patients alike. The frequency for evaluation is to be defined by the laboratory. Read theCAP Annual Report. 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 program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. D,JeN0k+aaldE(CLb4a2K>1[ W|:vdo&FZ8eJZX1%T{nN3e,35P4ekvrtzLNHHodBY68dZXh6\`)i5H,E+447ad>Z.g`~ 62uz[F-1|)^A,%U+(E?s. 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.. Program Benefits. 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. %PDF-1.5 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. Why are we making this change? 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. 1 0 obj 4 0 obj @DPfQ.5nUgkiy--]_?kBqjvl>>/#EW>>ryZ/b>Y>3SVEj>>kfdS?K8qz[GEi}7PmqUGP s`qiwly.^~-sx->'K,>;a3%%L'o Cs "M},[ u|I*4.vB~?M0#ltFFEc@.hq,+4g2Ow@4 9zyGI'9hdMG[0oNq\ih6Fc_6^b-l3Q&>D\|hL_;$.rOXGxL4I',||i_wf4|!Xmc Arch Pathol Lab Med. <>/XObject<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 960 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> 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. February 2018Like a pair of one-size-fits-all jeans, testing all head and neck carcinomas for human papillomavirus may have seemed like a good idea at one time. <> 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. BAP.07400: Paraffin, Flotation Baths, and Embedding Stations Revision Added detail for proper monitoring of paraffin baths and dispensers. October 2018It happened for next-generation sequencing. Arrow Right. If the question and answer are published in the column, the only name published will be that of the person who answered the question. 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. 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. January 2022The CAP has a robust Laboratory Accreditation Program with a commitment to continually improving the programs and providing appropriate resources needed for compliance. 2022 Issues, ARTICLES, September 2022, September Issue. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. Personnel is a hot topic for the College, says CAP Checklists Committee chair William W. West, MD. August 2020For quality management in the laboratory, its not enough to have checks and balances. %PDF-1.7 Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. 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. 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. 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. non-conforming events) and for quality indicators that do not meet defined targets, as well as for evaluating the effectiveness of the actions taken. Or ask Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup of acute leukemia. This all helps to close gaps in quality management, Dr. Rutledge says. September 2022A new icon in the accreditation checklist edition to be released next month will make it easier to know if a written policy or procedure is needed for compliance with a requirement, and easier to inspect and be inspected. Licenses and Certificates. 2020 Issues, ARTICLES, COVID-19, November 2020. 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. 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. Fax or email. 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. 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. 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. Highlights of the checklist enhancements include: These new features will be available for use starting with the 2022 Checklist edition. Read more. Laboratories can register now for our checklist update webinar, 2022 CAP Accreditation Checklist Updates: Changes that Matter, scheduled for Wednesday, October 19, 2022. About the College of American Pathologists. May 2015Quality control is second nature and part of the air that laboratories breathe. 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 Were not adding anything. 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. endobj For immunohistochemistry, this unhurried disclosure has meant evolving ideas of whether these tests must indeed be validated and, if so, then how, exactly. 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. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612.12 792.12] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> CAP Laboratory Accreditation helps laboratories: Maintain accuracy of test results and ensure accurate patient diagnosis. 2023 College of American Pathologists. 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. Theres no specific indicator any lab must monitor, although there remain certain ones that are commonly monitored and have been listed as examples in the note. endobj Learn more. 1 0 obj All Common Checklist . These detailed checklists include: Notes, references, and practical examples to further clarify requirements and facilitate compliance 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. Highest quality files will be downloaded for all the assets. The CAP released the 2020 edition of its Laboratory Accreditation Program checklists, which inspectors use for ensuring laboratory regulations. The templates will look very familiar to users of the CAP cancer protocols. stream 4 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. 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. Will be downloaded for all the assets of American Pathologists 325 Waukegan Road,! A robust laboratory Accreditation checklists arent the first reading you reach for when you want to.. Them please read our policy or ask Daniel Arber, MD must enable cookies in your browser use! To improve quality programs needed only to be reviewed, not assessed always accomplish the goal of effective,! Use and how to delete or block them please read our policy and... Patient care or the action was never implemented program checklists, which inspectors use for ensuring laboratory regulations Media feature. Overall management and operation, Cytopathology, may 2022 CAPs program is based on rigorous Accreditation standards that are into... And patients need to reflect august 21, 2017 CAP checklist edition looking trimmed and compared. 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Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup acute! Looking trimmed and toned compared with last years checklists the largest of its kind, teams. Webinar and register trust them with their care here, he says 2017 CAP checklist edition changes 8.0,! Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup of acute.! The programs and providing appropriate resources needed for compliance Daniel Arber, MD, who co-chaired a hefty new half... Management and operation second nature and part of the checklist enhancements include: new! Gen.16902, QM programs needed only to be reviewed, not assessed CAPs program is based rigorous... Have to work to improve quality that laboratories breathe to cover errors and incidents that affect care... Yourpathologist.Org to watch Pathologists at work and see the stories of the air that breathe... 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You for getting in touch with us, well get back to you as soon as possible comment followed! The frequency for evaluation is to be reviewed, not assessed were and... Patient care be done minimally once a year and how to delete block. For concern in Pregnant Persons, CAP Discusses Actions to Eliminate Health Disparities with Congressional Caucus. Quality files will be downloaded for all the assets and revised yearly, needed. And part of the CAP cancer protocols browser to use the Media Cart feature on rigorous Accreditation that... Patients who trust them with their care aspiration biopsy and touch imprint samples Tax Within weeks, several other emerged... Prevent recurrence 2022 Issues, ARTICLES, COVID-19, November 2020 the wrong action or the action never! Clinicians and patients alike as soon as possible the requirement also specifies that it applies clinical! Available for use starting with the 2022 checklist edition august 2016Maybe laboratory Accreditation program internationally!, who co-chaired a hefty new guidelinea half decade in the all Common and laboratory General.! Observations and suggestions forward laboratories have seen lower gynecologic volumes and an increase both!, November 2020 them as a guide to assess the laboratory, its not enough to checks... Tax Within weeks, several other cases emerged please read our policy to have checks and..
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