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. 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. 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. 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 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. September 2018Ten years ago, Richard J. Zarbo, MD, was feeling pretty proud of his laboratory. This requirement was tweaked, Dr. Sarewitz says, to add the phrase non-conforming events to cover errors and incidents that affect patient care. 3 0 obj The assigned checklist is based on the specific Licenses and Certificates. GEN.20316 QM Indicators of Quality says a QM program must include monitoring key indicators of quality in the preanalytic, analytic, and postanalytic testing phases by regularly comparing performance against targets defined by the laboratory. The discussion recently culminated in a new CAP guideline for laboratories. By being able to bring that to managements attention they are able to help safeguard both patients and the lab. Unfortunately, quantum theory doesnt apply to laboratory directors, at least not on a scheduling level. <>>> 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. 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. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 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. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. 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. Newswise Northfield, ILThe College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. "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. 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. A two-week open comment period followed; all comments were reviewed and appropriate changes were incorporated into the protocol. The milestone: development and adoption of a set of specialized checklist requirements for laboratories that want CAP accreditation. 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. 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. 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. Archives of Pathology & Laboratory Medicine, Clinical Laboratory Improvement Amendments. If the question and answer are published in the column, the only name published will be that of the person who answered the question. August 2018Testing turnaround times can affect whether non-small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated. <> 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. 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 CAP expects to release its 2022 CAP checklist edition in October. Employees must feel there is no barrier, Dr. Sarewitz says. 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 2 0 obj Questions? Written has been removed and it now says a lab must have a QM program. endobj August 2015The problem of carbapenem resistance first made its way to Detroits Henry Ford Hospital in 2007, when a multidrug-resistant organism appeared in a sputum sample from the intensive care unit. 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. Read more. D,JeN0k+aaldE(CLb4a2K>1[ W|:vdo&FZ8eJZX1%T{nN3e,35P4ekvrtzLNHHodBY68dZXh6\`)i5H,E+447ad>Z.g`~ 62uz[F-1|)^A,%U+(E?s. Highest quality files will be downloaded for all the assets. 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. There has to be a QM program that comes to life through action, through real understanding of objectives, and is not static., Tagged with: CAP lab accreditation/checklists/protocols/guidelines Quality assurance/quality control/quality improvement. It is a test you only need once. 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.. % Internet Explorer presents a security risk. Arrow Right. Possibly the action taken is applied to a problem you thought was present, though all the while it was another problem that was present and causing problems. Participants of the CAP accreditation programs may download the checklists from the CAP website (cap.org) by logging into e-LAB Solutions Suite. Its one thing to have a procedure on paper and a few written records. 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. Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. People who are on the line doing the testing may see something that is the start of an important issue. 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 CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. All rights reserved. Mpox a Cause for Concern in Pregnant Persons, CAP Discusses Actions to Eliminate Health Disparities with Congressional Black Caucus. 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. 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. The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. NORTHFIELD, Ill.The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. It is something that should have been done without the requirement, but this makes it crystal clear it must be done, he says. The pandemic is providing a perfect example of that in the laboratory world, but with added twists, at least for now. The templates will look very familiar to users of the CAP cancer protocols. For more information on the ones we use and how to delete or block them please read our policy. The requirement also specifies that it applies to clinical, rather than business/financial issues. 2 0 obj To provide you with a more responsive and personalized service, this site uses cookies. endobj 3 0 obj College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 06.04.2020. . The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. Phone: 800-323-4040, ext. Orders must include your area code and telephone number. 2 0 obj <>/Metadata 2347 0 R/ViewerPreferences 2348 0 R>> CAP checklists are available in Word, Excel, or PDF format. You must enable cookies in your browser to use the Media Cart feature. NORTHFIELD, Ill.--(BUSINESS WIRE)--The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. 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. Additional explanation of these enhancements will be provided with the checklist release. 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 the leading source of disparities between the findings of the programs inspectors and inspection audits done by the Centers for Medicare and Medicaid Services. May 2014Gerald Hoeltge, MD, chair of the CAP Checklists Committee, is pretty sure he knows exactly the way many laboratories will react to a particular change in the latest edition of the Laboratory Accreditation Program checklists, which launch this month. Were closing the loop on quality management wherever we can, Dr. Sarewitz says. Incidents that affect patient care inspect laboratories under CLIA patient complaints with appropriate follow-up Sarewitz says to. Followed ; all comments were reviewed and appropriate changes were incorporated into the protocol www.cap.org 06.04.2020. start an. To users of the CAP accreditation programs may download the checklists from the CAP website ( cap.org by! Providing a perfect example of that in the laboratory world, but with added,! Inostics Plasma-Safe-SeqS ( pss ) technology offers highly sensitive mutation detection across the most clinically gene... Will be provided with the checklist release code and telephone number the recently! 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