The checks and balances have to work to improve quality. % <> z\G832. "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. Learn more. What if patients call the number and no one records their complaints? 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. 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.. <>/Metadata 2347 0 R/ViewerPreferences 2348 0 R>> 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? 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. 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. 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. Questions? 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. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. Something like sedately stepping onto a moving sidewalk. Read theCAP Annual Report. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. 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. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. <> Manage rapidly evolving changes in laboratory medicine and technology. The list of requirements, which was a new section in the molecular pathology checklist, focused on constitutive (germline) testing and oncology testing. This requirement was tweaked, Dr. Sarewitz says, to add the phrase non-conforming events to cover errors and incidents that affect patient care. Read the CAP Annual Report. %PDF-1.7 Read the CAP Annual Report. All rights reserved. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. View source version on businesswire.com: https://www.businesswire.com/news/home/20200604005016/en/, Joe Schramm 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. <> The following is a complete list of the CAP accreditation checklists: CHECKLISTS SUBDISCIPLINES DESCRIPTION OF CONTENTS All Common N/A Proficiency testing Management or email cdm@cap.org. 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 CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. 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. 4 0 obj 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.. Written has been removed and it now says a lab must have a QM program. Fax or email. September 2018Ten years ago, Richard J. Zarbo, MD, was feeling pretty proud of his laboratory. About the College of American Pathologists. 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. Learn more. Unfortunately, quantum theory doesnt apply to laboratory directors, at least not on a scheduling level. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. 2020 Issues, ARTICLES, COVID-19, November 2020. xKO@F The Checklists used f or inspection b y the College of Amer ican Pathologists' Accreditation Prog rams have CHM.14200Alternative Control Procedures Revision: Modified the requirement for consistency with other checklists to clarify the 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. Arch Pathol Lab Med. Personnel is a hot topic for the College, says CAP Checklists Committee chair William W. West, MD. 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 expects to release its 2022 CAP checklist edition in October. 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. August 2020For quality management in the laboratory, its not enough to have checks and balances. stream 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. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. It says a root cause analysis must be performed for sentinel events. endobj 2022 Issues, ARTICLES, September 2022, September Issue. 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. GEN.20326 Assessment of the QM Program Implementation is a revised requirement that existed previously as GEN.16902 QM Program Implementation. GEN.20326 says that in any lab that has been CAP accredited for more than 12 months, the QM program must be implemented as designed and assessed at least annually for effectiveness. 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. Now, a newly published CAP guideline should help physicians figure out the right fit in multiple settings. Sentinel events require a root cause analysis to determine the cause and prevent recurrence. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. October 2017The CAP issued its first accreditation checklist for next-generation sequencing in 2014, as NGS was becoming a tool used in a growing number of clinical laboratories. Orders must include your area code and telephone number. 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. For more information on the ones we use and how to delete or block them please read our policy. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. 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 aim of others is to improve the preanalytic quality of specimens used for all types of testing. The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. %PDF-1.7 Email: MEDIA@CAP.ORG. September 2019Four new checklist requirements for waived molecular-based microbiology tests have been added to the CAP point-of-care testing, limited service laboratory, and immunology accreditation program checklists, as part of the 2019 checklist edition released this month. Just today I canceled the third hemoglobin electrophoresis test order on a patient. Incorporation of a Policy/Procedure icon when a policy or procedure is a necessary component to demonstrate compliance with a requirement. 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. The checks and balances have to work to improve quality. 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. Well forward it to experts for a reply. Less severe non-conforming events require investigation but not a full root cause analysis, Dr. Sarewitz says. Its not enough just to have taken an action; it has to have made a difference. x]Ys7~weA pdWbh0_%qj!$*y_ExO".n? 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 . A microbiology section that is shorter by eight pages, fewer Individualized Quality Control Plan reporting requirements, and a new section addressing chain of custody once again reflect the hard work of the Checklists Committee and scientific resource committees to achieve conciseness and clarity. Updated to reflect June 4, 2020 CAP Checklist edition Changes 2. endobj The CAP released the 2020 edition of its Laboratory Accreditation Program checklists, which inspectors use for ensuring laboratory regulations. Perhaps there is another action that is better. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. <> This all helps to close gaps in quality management, Dr. Rutledge says. 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. By being able to bring that to managements attention they are able to help safeguard both patients and the lab. What are the CAP Checklists? The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. <> 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. non-conforming events) and for quality indicators that do not meet defined targets, as well as for evaluating the effectiveness of the actions taken. The inclusion of the activities of andrology and endocrine 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. The discussion recently culminated in a new CAP guideline for laboratories. Recaptcha secret parameter is missing or invalid! The key question at that point was quotidian: Have new data emerged to warrant changing the original recommendations? Visit cap.org to register. stream In 2020 checklist, a gentle push to next quality level, Do you have a question related to pathology and laboratory medicine practice? 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. April 2019With the release in January of a new guideline for quantitative image analysis of HER2 immunohistochemistry for breast cancer, the CAP believes it is filling a gap and blazing a trail for the profession. July 2018Take the new ASCO/CAP guideline for HER2 testing. endobj August 2016Maybe laboratory accreditation checklists arent the first reading you reach for when you want to unwind. But some sections of the 2017 edition of the CAP Laboratory Accreditation Program checklist are looking trimmed and toned compared with last years checklists. endobj endobj Imaging mass spectrometry, an adjunct methodology to help pathologists analyze areas of interest in tissue specimens, is, at this point, used in a small number of research laboratories in the U.S., says CAP Checklists Committee member Christopher M. Lehman, MD, clinical professor of pathology, University of Utah College of Medicine, and medical director of the University of Utah Hospital Laboratory. Send completed order form to 847-832-8168, ATTN: Customer Data . 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. And this must be done minimally once a year. 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. stream About the College of American Pathologists. Everybody wants to do this, Dr. Rutledge continues. Sales Tax Read More AST and safety at core of microbiology checklist changes 2021 Issues, ARTICLES, October 2021 Learn more about the webinar and register. 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). 1 0 obj A s the 2020 laboratory general checklist now drills deeper into quality management, it incorporates more terminology found in ISO. 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. 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. 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. 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. This release will feature several enhancements designed to clarify and simplify the inspection process for inspectors and laboratories. If the question and answer are published in the column, the only name published will be that of the person who answered the question. 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. It was an important step for in vivo microscopy. Many labs will do it more often, Dr. Goodman says. 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. 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? When labs define the frequency, Dr. Rutledge says, it means they have a plan for revisiting the indicator appropriately. 2022 Issues, ARTICLES, August 2022, Cytopathology. Arrow Right. And now its taking place with imaging mass spectrometry. The software solutions in our Accreditation Checklist Distribution program have been evaluated by the CAP to ensure functionality to manage ongoing accreditation compliance using . 1 0 obj Just ask the architects of an updated document on molecular testing for lung cancer, issued by the CAP, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Were closing the loop on quality management wherever we can, Dr. Sarewitz says. 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. 3 0 obj 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. All Common Checklist . 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. Read theCAP Annual Report. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). Now we are giving labs structure through our Laboratory Accreditation Program by changing the requirements around quality management and gently pushing them to the next level of excellence.. It requires that any such concerns be included in laboratory QM records. 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. "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. p9-m M=*Zm. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. 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. The specific checklist used is automatically assigned when a laboratory updates its activity menu in Organization Profile on cap.org. !JQ)"OAJOYD=d4NbA 2 0 obj Subsequent CAP changes, if applicable, are not reflected in this eAlert. 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. endobj 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. 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. Highlights of the checklist enhancements include: These new features will be available for use starting with the 2022 Checklist edition. 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. They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. 7.0 September, 2017 1. % Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. So this addition can eventually benefit labs and patients alike. The frequency for evaluation is to be defined by the laboratory. Do you have a question related to pathology and laboratory medicine practice? August 2017There was no trip to the spa. 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.. View Vendors List forCAPs Checklist Distribution Program Powered by Madgex Job Board Software, https://www.businesswire.com/news/home/20200604005016/en/, http://www.businesswire.com/news/home/20200604005016/en. Its one thing to have a procedure on paper and a few written records. Highlights of the checklist enhancements include: They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. More than 90 of the checklists requirements have been revised, many in the name of alignment with FDA requirements. College of American Pathologists Created in 1993 to meet the needs of reproductive laboratories with: o. 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 2017Quantum theory is often interpreted to mean an object can be in two places simultaneously. 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.. Have to work to improve the preanalytic quality of specimens used for all types testing... Often interpreted to mean an object can be in two places simultaneously it now a. Just to have a QM program Implementation be defined by the CAP is a necessary component to demonstrate with! Orders must include your area code and telephone number cause analysis to determine the cause and prevent recurrence patients trust... 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