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. July 2018Take the new ASCO/CAP guideline for HER2 testing. <>/XObject<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 960 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> In work led by the CAP Council on Accreditation, the checklists are examined anew and revised yearly, where needed. 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. 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. The list of requirements, which was a new section in the molecular pathology checklist, focused on constitutive (germline) testing and oncology testing. 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. 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. Thats how Stephen J. Sarewitz, MD, vice chair of the CAP Checklists Committee, characterizes the changes to the quality management requirements in the 2020 laboratory general checklist, released in June. They shouldnt be considered a significant burden.. 2 0 obj Detailed standards developed based on broad principles defined in the CAP Standards for Laboratory Accreditation -21 different checklists with about 2,900 requirements Tool for laboratories to prepare for inspection Roadmap guide for inspectors to perform an inspection Customizable based on tests and activities non-conforming events) and for quality indicators that do not meet defined targets, as well as for evaluating the effectiveness of the actions taken. June 2020Best practices for HIV primary diagnostic testing and rapid detection of Mycobacterium tuberculosis complex are clarified and codified in new checklist requirements in the 2020 Laboratory Accreditation Program checklist edition published June 4. Personnel is also high on the list of questions asked of Laboratory Accreditation Program staff. October 2022As the diagnostic uses for next-generation sequencing have grown, so too has the length of the NGS section of the CAP molecular pathology accreditation program checklist. Personnel is a hot topic for the College, says CAP Checklists Committee chair William W. West, MD. %PDF-1.5 It requires that any such concerns be included in laboratory QM records. 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. Setting the bar higher was important because thats the culture here, he says. xKO@F Send completed order form to 847-832-8168, ATTN: Customer Data . For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. CAP checklists are available in Word, Excel, or PDF format. Less severe non-conforming events require investigation but not a full root cause analysis, Dr. Sarewitz says. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. 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. Arrow Right. Updated to reflect June 4, 2020 CAP Checklist edition Changes 2. Its been fantastic, he says. That would be a recipe for big problems. Dr. Rutledge says it is not enough to have a procedure that says employees can talk to the lab director and patients can call a number. October 2018It happened for next-generation sequencing. Email: MEDIA@CAP.ORG. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. And now its taking place with imaging mass spectrometry. 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. 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. The software solutions in our Accreditation Checklist Distribution program have been evaluated by the CAP to ensure functionality to manage ongoing accreditation compliance using . 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.. These are nothing new, says Dr. Fitzgibbons, a pathologist at St. Jude Medical Center, Fullerton, Calif., and chair of the CAP Cancer Biomarker Reporting Committee. 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. 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. 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. If you need a different quality of the file please download the asset individually. The CAP released the 2020 edition of its Laboratory Accreditation Program checklists, which inspectors use for ensuring laboratory regulations. Learn more about the webinar and register. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. August 2020For quality management in the laboratory, its not enough to have checks and balances. Mpox a Cause for Concern in Pregnant Persons, CAP Discusses Actions to Eliminate Health Disparities with Congressional Black Caucus. In transfusion medicine, the changes this year center on computer crossmatches, record retention, forward/reverse typing, and ABO group and Rh(D) type verification. Please accept marketing cookies to share content. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. The 2017 edition of the checklists, released this month, has eliminated the specific requirements for laboratory directors who are not on site full time and has clarified responsibilities for all directors, on site or remote. The assigned checklist is based on the specific 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. Sample adequacy allows for a single visit and avoids having to make multiple attempts to provide material sufficient for all required testing, including flow cytometry, microbiology, cell block preparation for immunohistochemical and histochemical staining, and molecular testing. 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. ROSE for patient care has proven value. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. October 2018Laboratory personnel safety is at the center of two new requirements and a revised requirement in the latest edition of the CAP accreditation program checklists, released in August. Management or email cdm@cap.org. ddB .2c"7Da KhY. 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. 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. Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines. 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. 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? 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. 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. stream When labs define the frequency, Dr. Rutledge says, it means they have a plan for revisiting the indicator appropriately. September 2022A new icon in the accreditation checklist edition to be released next month will make it easier to know if a written policy or procedure is needed for compliance with a requirement, and easier to inspect and be inspected. 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). Well forward it to experts for a reply. 7.0 September, 2017 1. 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? 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. This release will feature several enhancements designed to clarify and simplify the inspection process for inspectors and laboratories. Prior to an inspection, we create a custom checklist specifically for your laboratory based on your exact testing menu, so you and the inspection team both know whats being inspected so there are no surprises. 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.. endobj % 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. May 2022The number of minimally invasive fine-needle aspirations requiring rapid on-site evaluation (ROSE) in the cytopathology laboratory has increased over the past decade. Just today I canceled the third hemoglobin electrophoresis test order on a patient. Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. Contact us at 800-323-4040 or accred@cap.org. If the question and answer are published in the column, the only name published will be that of the person who answered the question. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. <>/Metadata 2347 0 R/ViewerPreferences 2348 0 R>> 2022 Issues, ARTICLES, Cytopathology, May 2022. 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. <> 7445 About the College of American Pathologists. 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. To ensure the most secure and best overall experience on our website, we recommend the latest versions of. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. What if patients call the number and no one records their complaints? The specific checklist used is automatically assigned when a laboratory updates its activity menu in Organization Profile on cap.org. 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. Highlights of the checklist enhancements include: These new features will be available for use starting with the 2022 Checklist edition. Laboratories can register now for our checklist update webinar, 2022 CAP Accreditation Checklist Updates: Changes that Matter, scheduled for Wednesday, October 19, 2022. 2020 Issues, ARTICLES, COVID-19, November 2020. endobj Updated to reflect review of all references 9.0 . "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. You must enable cookies in your browser to use the Media Cart feature. Behind that effort is the undeniable: Structured discrete data, using a controlled vocabulary, can be captured, stored, and reviewed much more readily than data in other formats, says Mary Edgerton, MD, PhD, vice chair of the CAPs Pathology Electronic Reporting (PERT) Committee and associate professor of pathology, University of Texas MD Anderson Cancer Center. About the College of American Pathologists. We dont want any fear of whistleblower blowback in labs. By clicking "Accept", you agree to our use of cookies. 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. Business/financial/contractual issues are certainly important, but they are not within the purview of the CAP program, Dr. Sarewitz says. Check to see which vendors participate in the CAPs Checklist Distribution Program. NORTHFIELD, Ill.--(BUSINESS WIRE)--The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. 2 0 obj 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. 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 CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. 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. April 2021In the continuum of cancer care, diagnostic specialties such as ours play critical roles. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. 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. It brings a little more rigor into the system.. August 2017Quantum theory is often interpreted to mean an object can be in two places simultaneously. Or ask Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup of acute leukemia. 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. 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. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. 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. 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. The new requirement follows the addition in 2019 of GEN.20310 Investigation of Non-conforming Events, which Dr. Goodman calls a significant movement toward the introduction of ISO concepts to the CAP checklists. View source version on businesswire.com: https://www.businesswire.com/news/home/20200604005016/en/, Joe Schramm Recaptcha secret parameter is missing or invalid! Read theCAP Annual Report. 7445 4 0 obj <> On the other hand, not every head and neck case requires it. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. January 2022The CAP has a robust Laboratory Accreditation Program with a commitment to continually improving the programs and providing appropriate resources needed for compliance. 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. 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. Since the checklists are organized by discipline, they are easy to assign to staff, helping to simplify your inspectionpreparation process. 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. 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, Internet Explorer is no longer supported. A two-week open comment period followed; all comments were reviewed and appropriate changes were incorporated into the protocol. Perhaps there is another action that is better. 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. 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 program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. "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. They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. Streamline management and compliance of CAP accreditation checklist requirements through the use of a software solution from one of the program participant vendors. Highlights of the checklist enhancements include: 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. 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. 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. August 2016As the use of in situ hybridization (ISH) expands, laboratories employing this form of testing increasingly rely on the CAP Laboratory Accreditation Program checklist for guidance. 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. But those things dont always accomplish the goal of effective change, he says. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. Phone: 800-323-4040, ext. Sentinel events require a root cause analysis to determine the cause and prevent recurrence. Employees must feel there is no barrier, Dr. Sarewitz says. 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. %PDF-1.7 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. And its open and accessible to all. Work is underway to improve the user experience (Nakhleh RE, et al. 2018 Issues, ARTICLES, August 2018, Molecular. Read theCAP Annual Report. About the College of American Pathologists. 4 0 obj CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. Sales Tax The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. 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. These detailed checklists include: Notes, references, and practical examples to further clarify requirements and facilitate compliance But some sections of the 2017 edition of the CAP Laboratory Accreditation Program checklist are looking trimmed and toned compared with last years checklists. <> 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 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. 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. To staff, helping to simplify your inspectionpreparation process to assess the laboratory General checklist for laboratories only... Compliance using require a root cause analysis to determine the cause and recurrence. Co-Chaired a hefty new guidelinea half decade in the makingon diagnostic workup of leukemia... Question related to pathology and laboratory medicine practice not within the purview of the patients who trust them with care... Dont always accomplish the goal of effective change, he says number and one! 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