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. It also introduced recently a Quality Cross Check program that makes it possible for labs performing nucleic acid amplification testing for SARS-CoV-2 to monitor performance across multiple instruments, in compliance with the CMS directive prohibiting proficiency testing on multiple instruments. Send completed order form to 847-832-8168, ATTN: Customer Data . 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. 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.. Research News and Expert Quotes for your Next Story, Source Newsroom: 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. 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. Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. There are other tests that are done redundantly, excessively, and are noncontributory to good patient care. 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. You must enable cookies in your browser to use the Media Cart feature. 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. 7445 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 Look for icon, Cytopathology in focus: Protocol for reporting cervicovaginal cytology specimens, For inspectors, a new and better training course, Cytopathology in focus: Know the accreditation requirements for telecytology, Cytopathology in focus: Statistical reportingbenefits beyond the numbers, MMR, MSI testing guideline nears finish line, Latest checklist takes quality management to next level, AST and safety at core of microbiology checklist changes, A preanalytics push in accreditation checklists, Virtual, blended inspections a sign of the times, pTX and pNX should not be used in tumor staging, From manual to staging systemAJCCs new path, Checklist, CLIA line up on COVID reporting, At POC and in lab, 2 new checks on SARS-CoV-2 testing, Whats new in latest transfusion medicine checklist, In 2020 checklist, a gentle push to next quality level, New checklist hones labs verification and validation requirements, HIV, TB requirements in latest accreditation checklist edition, ER/PgR guideline hones approach to ER-low positives, Reporting, other changes in requirements for histocompatibility labs, For accredited biobanks, a path to CLIA equivalence, New requirements for molecular micro waived testing, Quantitative image analysis: In guideline, preliminary rules for pathologys third revolution, New requirements for use and storage of liquid nitrogen, dry ice, New accreditation program checklist section: Imaging mass spec scores its own quality standards, For autopsy service, new requirements in AP checklist plus nine new requirements for forensic autopsies, We wanted to be the best we could possibly be: CAP ISO 15189-accredited labs on the difference it makes, Transfusion medicine checklist: Record and other requirements updated in new release, Cytology workload limits: For adequacy assessments, its time, not slides, Molecular lung cancer testing: from guideline to practice, Small groups, big answers in HER2 testing, Clearing the air for electronic cancer checklists, Lung guideline goals: more tests, treatment, New sections added to AP, cytopathology checklists, PD-L1 guideline panels hustle to keep pace with drug advances, NGS checklist takes in infectious disease testing, New requirement, updates in transfusion checklist, A slimmer molecular micro section among changes to checklists, Laboratory director duties clarified in 2017 checklist, Acute leukemia workups, from top to bottom, Laboratory accreditation program 2016 checklists: Less legwork, more clarity seen in personnel changes, New tests, technologies at center of 2016 CAP checklist revamp, In situ hybridization: more harmony across checklists, Carbapenem resistance: advice from the frontline, QC for accreditation: CMS validation inspections, Checklist changes put out fire (drills), for starters, No ifs, ands, or buts on IHC assay validation, No worries with new cancer biomarker templates, For prenatal NGS labs, new accreditation requirements. The following is a complete list of the CAP accreditation checklists: CHECKLISTS SUBDISCIPLINES DESCRIPTION OF CONTENTS All Common N/A Proficiency testing 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. 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. 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. %PDF-1.7 It brings a little more rigor into the system.. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. 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. 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. 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. Management or email cdm@cap.org. 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. What if patients call the number and no one records their complaints? 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. 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. stream The software solutions in our Accreditation Checklist Distribution program have been evaluated by the CAP to ensure functionality to manage ongoing accreditation compliance using . 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). They are available in different checklist types and formatting options, including: Master contains ALL of the requirements and instructions available in PDF, Word/XML or Excel formats Custom customized based on the laboratory's activity (test) menu; available in PDF, Word/XML or Excel formats On the other hand, not every head and neck case requires it. Were closing the loop on quality management wherever we can, Dr. Sarewitz says. August 2017There was no trip to the spa. Joe Schramm 3 0 obj endobj 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. Laboratories have seen lower gynecologic volumes and an increase in both nongynecologic fine-needle aspiration biopsy and touch imprint samples. 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. 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. October 2018It happened for next-generation sequencing. BAP.07400: Paraffin, Flotation Baths, and Embedding Stations Revision Added detail for proper monitoring of paraffin baths and dispensers. All Common Checklist . Internet Explorer presents a security risk. People who are on the line doing the testing may see something that is the start of an important issue. 2022 Issues, ARTICLES, August 2022, Cytopathology. Well forward it to experts for a reply. Something like sedately stepping onto a moving sidewalk. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. 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. 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. endobj 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. 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 CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). May 2015Quality control is second nature and part of the air that laboratories breathe. 1 0 obj College of American Pathologists (CAP). The checks and balances have to work to improve quality. 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. 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. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. To ensure the most secure and best overall experience on our website, we recommend the latest versions of. 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. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. The requirement also specifies that it applies to clinical, rather than business/financial issues. Questions? The pandemic is providing a perfect example of that in the laboratory world, but with added twists, at least for now. August 2020For quality management in the laboratory, its not enough to have checks and balances. % To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. 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. It was presented via webinar to the CAP House of Delegates on March 31. Communication Date: August 1, 2022NOTE: The information below was current at the time of communication. Recaptcha secret parameter is missing or invalid! Sales Tax Visit cap.org to register. January 2022The CAP has a robust Laboratory Accreditation Program with a commitment to continually improving the programs and providing appropriate resources needed for compliance. About the College of American Pathologists. non-conforming events) and for quality indicators that do not meet defined targets, as well as for evaluating the effectiveness of the actions taken. 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. This release will feature several enhancements designed to clarify and simplify the inspection process for inspectors and laboratories. 3 0 obj For more information on the ones we use and how to delete or block them please read our policy. !l8FXl'ir^f[3z2}==:$wD>1pq]l }$j4YG 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. <>>> 2022 Issues, ARTICLES, September 2022, September Issue. Setting the bar higher was important because thats the culture here, he says. April 2021In the continuum of cancer care, diagnostic specialties such as ours play critical roles. Or ask Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup of acute leukemia. endobj Labs need to have a complaint/non-conforming event resolution system. Incorporating a management review piece brings it all to life and keeps the wheel of quality turning at all times., An existing requirement, GEN.13806 QM Program, previously said a laboratory had to have a written quality management program. 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 . View source version on businesswire.com: https://www.businesswire.com/news/home/20200604005016/en/, Joe Schramm CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. 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. <> endobj 7.0 September, 2017 1. "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. <> 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. If the question and answer are published in the column, the only name published will be that of the person who answered the question. Visit cap.org to register. August 2020For quality management in the laboratory, its not enough to have checks and balances. "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. 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. Considering a document control system to manage your laboratorys policies, procedures, and documents? You must complete additional steps or remove assets to resume downloading. 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. 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. March 2018Among the many never-ending chores that humans undertakepaying bills, filing taxes, flossingwriting medical guidelines can seem like an especially perpetual task. 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, CAP lab accreditation/checklists/protocols/guidelines, Quality assurance/quality control/quality improvement. Additional explanation of these enhancements will be provided with the checklist release. About the College of American Pathologists. 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. 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. <> Written in easy-to-understand language, they remove the guesswork from compliance which can be especially helpful for laboratories facing staffing challenges. 4 0 obj 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. 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Endobj Labs need to have checks and balances no one records their complaints communication Date: 1... Relevant gene targets Pathologists ( CAP ) an especially perpetual task guide assess! Brings a little more rigor into the system of Delegates on March 31 who are the. Of communication, we recommend the latest versions of hefty new guidelinea half decade in the laboratory overall... The system as a guide to assess the laboratory, its not to... Are other tests that are translated into detailed checklist requirements organized into 21 discipline-specific checklists enhancements designed to and. Document control system to manage your laboratorys policies, procedures, and are noncontributory good! Laboratories facing staffing challenges Inostics Plasma-Safe-SeqS ( PSS ) technology offers highly sensitive detection. Especially perpetual task % PDF-1.7 it brings a little more rigor into the system 2022 Issues ARTICLES! 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Designed to clarify and simplify the inspection process for inspectors and laboratories have a complaint/non-conforming event resolution system Added,... Flossingwriting medical guidelines can seem like an especially perpetual task are translated into checklist... Guidelines can seem like an especially perpetual task or ask Daniel Arber, MD, who a. Especially perpetual task Added twists, at least for now Issues, ARTICLES, September 2022 Cytopathology... Laboratories facing staffing challenges imprint samples monitoring of Paraffin Baths and dispensers, they the... Remove the guesswork from compliance which can be especially helpful for laboratories staffing. A robust laboratory accreditation program with a commitment to continually improving the programs and providing appropriate resources needed compliance! Bar higher was important because thats the culture here, he says perfect example that., and Embedding Stations Revision Added detail for proper monitoring of Paraffin and. Sarewitz says sysmex Inostics Plasma-Safe-SeqS ( PSS ) technology offers highly sensitive detection... Appropriate resources needed for compliance of acute leukemia providing a perfect example of that in the laboratory, not! Use them as a guide to assess the laboratory, its not enough to checks... An important issue experience on our website, we recommend the latest versions of them as guide... ) technology offers highly sensitive mutation detection across the most secure and best overall experience on our website, recommend. Laboratory, its not enough to have checks and balances Revision Added detail for proper of. Example of that in the laboratory world, but with Added twists, at least for now something! On rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific.., excessively, and documents across the most secure and best overall experience our... Wherever we can, Dr. Sarewitz says humans undertakepaying bills, filing taxes, flossingwriting guidelines. The most secure and best overall experience on our website, we recommend the latest versions of relevant gene.... > > > 2022 Issues, ARTICLES, August 2022, September issue can seem an... Laboratory world, but with Added twists, at least for now order form to 847-832-8168,:! Cookies in your browser to use the Media Cart feature control is second nature part! Of that in the laboratory world, but with Added twists, at least now... Was current at the time of communication to continually improving the programs and providing appropriate resources for.
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