About the College of American Pathologists. Visit cap.org to register. It may be that you chose the wrong action or the action was never implemented. 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. August 2018Testing turnaround times can affect whether non-small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated. Fax or email. 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. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. October 2013For anyone worried about the new CAP reporting templates for cancer biomarkers, Patrick L. Fitzgibbons, MD, has an important message: Dont panic. 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. 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. 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? For more information on the ones we use and how to delete or block them please read our policy. 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. Something like sedately stepping onto a moving sidewalk. 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. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. It requires that any such concerns be included in laboratory QM records. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. xKO@F The Checklists used f or inspection b y the College of Amer ican Pathologists' Accreditation Prog rams have 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. 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{ Updated to reflect review of all references 9.0 . Its one thing to have a procedure on paper and a few written records. 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. October 2017The expert and advisory panels for the CAP/IASLC/AMP guideline on molecular testing for lung cancer biomarkers started updating the guideline in 2014, and an important but fairly routine revision process may have seemed to lie ahead. BAP.07400: Paraffin, Flotation Baths, and Embedding Stations Revision Added detail for proper monitoring of paraffin baths and dispensers. For questions about the use of the Checklists or Checklist interpretation, email accred@cap.org or call 800-323-4040 or 847-832-7000 (international customers, use country code 001). The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. The checks and balances have to work to improve quality. In work led by the CAP Council on Accreditation, the checklists are examined anew and revised yearly, where needed. endobj Personnel is also high on the list of questions asked of Laboratory Accreditation Program staff. 1 0 obj The guideline will help facilitate pathologys increasing use of not only digital pathology but also artificial intelligence, says Marilyn Bui, MD, PhD, chair of the CAP expert panel for QIA of HER2 IHC. 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. endobj <> Updated to reflect August 22, 2018 CAP Checklist edition changes 2. 1 0 obj August 2020For quality management in the laboratory, its not enough to have checks and balances. Sentinel events require a root cause analysis to determine the cause and prevent recurrence. 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. 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. 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. This is not just another guideline. 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. We dont want any fear of whistleblower blowback in labs. 4 0 obj Visit cap.org to register. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. 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. 2022 Issues, ARTICLES, August 2022, Cytopathology. Updated to reflect August 21, 2017 CAP Checklist edition changes 8.0 September, 2018 : 1. Now, a newly published CAP guideline should help physicians figure out the right fit in multiple settings. This is what we do.. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. 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 . Additional explanation of these enhancements will be provided with the checklist release. 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. 7445 These detailed checklists include: View a Full Listing of Available Checklists with Description (PDF), Request a Sample CAP Checklist 3 0 obj It was an important step for in vivo microscopy. 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. This requirement was tweaked, Dr. Sarewitz says, to add the phrase non-conforming events to cover errors and incidents that affect patient care. Highlights of the checklist enhancements include: endobj CAP requirements commonly exceed the standards, bolstering patient care and safety. You must enable cookies in your browser to use the Media Cart feature. 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. Learn more about the webinar and register. Learn more about the webinar and register. Arch Pathol Lab Med. 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. Business/financial/contractual issues are certainly important, but they are not within the purview of the CAP program, Dr. Sarewitz says. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. Email: MEDIA@CAP.ORG, View this news release online at: They shouldnt be considered a significant burden.. April 2020The CAP and the American Society of Clinical Oncology released two years ago a focused update of their clinical practice guideline for HER2 testing for breast cancer, following an update in 2013. Include a copy of institutional purchase . <> 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. There are several reasons why it could happen, he says. The requirement also specifies that it applies to clinical, rather than business/financial issues. CAP checklists are available in Word, Excel, or PDF format. 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. 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. 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. 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. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> It brings a little more rigor into the system.. The milestone: development and adoption of a set of specialized checklist requirements for laboratories that want CAP accreditation. This all helps to close gaps in quality management, Dr. Rutledge says. They are available in different checklist types and formatting options, . View source version on businesswire.com: https://www.businesswire.com/news/home/20200604005016/en/, Joe Schramm % 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 @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 You can view licenses and certificates for all of the following: Accreditation CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. 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. 7.0 September, 2017 1. 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.. So its no surprise that QC should be subject to quality checks of its own, as one of the pivotal checklist areas that CAPs Laboratory Accreditation Program focuses on during inspections. 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. : 1 to improve quality Paraffin Baths and dispensers in ctDNA as low as 0.03 % %. And incidents that affect patient care to add the phrase non-conforming events to cover errors incidents. 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