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. If you need a different quality of the file please download the asset individually. Arrow Right. It brings a little more rigor into the system.. p9-m M=*Zm. Program Benefits. Just today I canceled the third hemoglobin electrophoresis test order on a patient. 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 . To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. stream 3 0 obj 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. 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. %PDF-1.7 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. Personnel is a hot topic for the College, says CAP Checklists Committee chair William W. West, MD. Visit cap.org to register. <>/XObject<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 960 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> 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. They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. These detailed checklists include: Notes, references, and practical examples to further clarify requirements and facilitate compliance 2022 Issues, ARTICLES, Cytopathology, May 2022. 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.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. 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. When labs define the frequency, Dr. Rutledge says, it means they have a plan for revisiting the indicator appropriately. Arch Pathol Lab Med. stream NORTHFIELD, Ill.--(BUSINESS WIRE)--The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. Joe Schramm Read theCAP Annual Report. 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 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. It was an important step for in vivo microscopy. <> The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. 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{ For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. 2018 Issues, ARTICLES, August 2018, Molecular. 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. 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. Well forward it to experts for a reply. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. In many cases, in fact, HPV testing is just what treating clinicians and patients need. "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. Now, with the release of the new checklist edition this month, NGS laboratories will find the NGS section in their customized checklists leaner, more relevant, and easier to read. 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. <>/Metadata 2347 0 R/ViewerPreferences 2348 0 R>> 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. % Please accept marketing cookies to share content. Laboratories have seen lower gynecologic volumes and an increase in both nongynecologic fine-needle aspiration biopsy and touch imprint samples. The Checklists used f or inspection b y the College of Amer ican Pathologists' Accreditation Prog rams have Were not adding anything. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. About the College of American Pathologists. It is something that should have been done without the requirement, but this makes it crystal clear it must be done, he says. Read the CAP Annual Report. Include a copy of institutional purchase . Within weeks, several other cases emerged. Manage rapidly evolving changes in laboratory medicine and technology. 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. CHM.14200Alternative Control Procedures Revision: Modified the requirement for consistency with other checklists to clarify the Work is underway to improve the user experience (Nakhleh RE, et al. @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 The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). August 2017Quantum theory is often interpreted to mean an object can be in two places simultaneously. 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. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. 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. Highest quality files will be downloaded for all the assets. 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. Well forward it to experts for a reply. The templates will look very familiar to users of the CAP cancer protocols. 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. 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. One of the changes is GEN.20318 Corrective and Preventive Action, a new requirement that says a labs quality management program must include processes for recording corrective and preventive actions taken for errors and incidents (i.e. 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. The key question at that point was quotidian: Have new data emerged to warrant changing the original recommendations? <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612.12 792.12] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> 1. 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. Check to see which vendors participate in the CAPs Checklist Distribution Program. 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. 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. 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. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. 2 0 obj The specific checklist used is automatically assigned when a laboratory updates its activity menu in Organization Profile on cap.org. At disease progression on an EGFR TKI, integrating circulating tumor DNA and tissue-based testing may lessen some of the limitations of each form of testing. But some sections of the 2017 edition of the CAP Laboratory Accreditation Program checklist are looking trimmed and toned compared with last years checklists. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. 1 0 obj 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. 7445 2022 Issues, ARTICLES, August 2022, Cytopathology. October 2013For anyone worried about the new CAP reporting templates for cancer biomarkers, Patrick L. Fitzgibbons, MD, has an important message: Dont panic. 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. September 2016For the CAP Laboratory Accreditation Program, inspection checklist requirements covering personnel are a perennial concern. It may be that you chose the wrong action or the action was never implemented. Personnel is also high on the list of questions asked of Laboratory Accreditation Program staff. In transfusion medicine, the changes this year center on computer crossmatches, record retention, forward/reverse typing, and ABO group and Rh(D) type verification. endobj August 2017There was no trip to the spa. 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 . Incorporation of a Policy/Procedure icon when a policy or procedure is a necessary component to demonstrate compliance with a requirement. 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. We dont want any fear of whistleblower blowback in labs. 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. Participants of the CAP accreditation programs may download the checklists from the CAP website (cap.org) by logging into e-LAB Solutions Suite. 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.. 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. Labs need to have a complaint/non-conforming event resolution system. It is a test you only need once. Phone: 800-323-4040, ext. ROSE for patient care has proven value. non-conforming events) and for quality indicators that do not meet defined targets, as well as for evaluating the effectiveness of the actions taken. 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. 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. In many cases, in fact, HPV testing is just what treating and! Specific checklist used is automatically assigned when a policy or procedure is a necessary component to demonstrate compliance with requirement... 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cap laboratory general checklist 2020 pdf