cap laboratory general checklist 2020 pdf

7.0 September, 2017 1. 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 Updated to reflect August 22, 2018 CAP Checklist edition changes 2. May 2017Plenty can happen in five years. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. Recaptcha secret parameter is missing or invalid! 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. Work is underway to improve the user experience (Nakhleh RE, et al. stream 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. 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. 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. These detailed checklists include: View a Full Listing of Available Checklists with Description (PDF), Request a Sample CAP Checklist Visit cap.org to register. Updated to reflect June 4, 2020 CAP Checklist edition Changes 2. 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.. 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? 2017;141[9]:11531154). The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. 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. 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. May 2018Length, cost, variability in vendor support, and lack of consistency have cast a cloud for pathologist users over the CAPs cancer protocols and the electronic version of those protocols, the electronic cancer checklists. 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, Checklists now made to fit for next-gen sequencing labs, Need a written policy or procedure? 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. %PDF-1.7 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. 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. 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. 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. CAP Laboratory Accreditation helps laboratories: Maintain accuracy of test results and ensure accurate patient diagnosis. Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. x]Ys7~weA pdWbh0_%qj!$*y_ExO".n? Were not adding anything. May 2015Quality control is second nature and part of the air that laboratories breathe. 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. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. 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 . This is what we do.. Business/financial/contractual issues are certainly important, but they are not within the purview of the CAP program, Dr. Sarewitz says. 2 0 obj September 2019Four new checklist requirements for waived molecular-based microbiology tests have been added to the CAP point-of-care testing, limited service laboratory, and immunology accreditation program checklists, as part of the 2019 checklist edition released this month. endobj 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. 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. Additional explanation of these enhancements will be provided with the checklist release. It was an important step for in vivo microscopy. You must enable cookies in your browser to use the Media Cart feature. CAP checklists are available in Word, Excel, or PDF format. Email: MEDIA@CAP.ORG. stream Newswise Northfield, ILThe College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. 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. This release will feature several enhancements designed to clarify and simplify the inspection process for inspectors and laboratories. They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. The CAP expects to release its 2022 CAP checklist edition in October. <> 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. Labs need to have a complaint/non-conforming event resolution system. Internet Explorer presents a security risk. 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. 3 0 obj For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. 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. NORTHFIELD, Ill.--(BUSINESS WIRE)--The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. What if patients call the number and no one records their complaints? 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. 7445 Read the CAP Annual Report. And now its taking place with imaging mass spectrometry. Your staff will save time in their inspection preparation and ongoing compliance efforts because they will only see the requirements that apply to your unique laboratory. 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. Questions? A microbiology section that is shorter by eight pages, fewer Individualized Quality Control Plan reporting requirements, and a new section addressing chain of custody once again reflect the hard work of the Checklists Committee and scientific resource committees to achieve conciseness and clarity. August 2017There was no trip to the spa. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. By being able to bring that to managements attention they are able to help safeguard both patients and the lab. CHM.14200Alternative Control Procedures Revision: Modified the requirement for consistency with other checklists to clarify the Learn more. 2 0 obj 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. 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. Licenses and Certificates. While the aim of the changes was to simplify and clarify, Dr. Rutledge says, Were getting away from the idea that there can be just a written document that sits there and fulfills the requirement. Program Benefits. Its been fantastic, he says. Phone: 800-323-4040, ext. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. <> PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. All rights reserved. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. 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. 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. <>/Metadata 2347 0 R/ViewerPreferences 2348 0 R>> Participants of the CAP accreditation programs may download the checklists from the CAP website (cap.org) by logging into e-LAB Solutions Suite. College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 06.04.2020. . Its not enough just to have taken an action; it has to have made a difference. They are available in different checklist types and formatting options, . 4 0 obj 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. 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. 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. 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. endobj The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. 1 0 obj These detailed checklists include: Notes, references, and practical examples to further clarify requirements and facilitate compliance 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. Or ask Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup of acute leukemia. More than 90 of the checklists requirements have been revised, many in the name of alignment with FDA requirements. Everybody wants to do this, Dr. Rutledge continues. 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. The CAP expects to release its 2022 CAP checklist edition in October. "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. 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. Orders must include your area code and telephone number. 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. 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. Arch Pathol Lab Med. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. Learn more about the webinar and register. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). 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. Considering a document control system to manage your laboratorys policies, procedures, and documents? Something like sedately stepping onto a moving sidewalk. 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. If the question and answer are published in the column, the only name published will be that of the person who answered the question. Streamline management and compliance of CAP accreditation checklist requirements through the use of a software solution from one of the program participant vendors. Well forward it to experts for a reply. 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. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. Its one thing to have a procedure on paper and a few written records. Email: MEDIA@CAP.ORG, View this news release online at: z\G832. 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. It is a milestone for pathologists.. 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. We dont want any fear of whistleblower blowback in labs. 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. About the College of American Pathologists. 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. October 2013For anyone worried about the new CAP reporting templates for cancer biomarkers, Patrick L. Fitzgibbons, MD, has an important message: Dont panic. And this must be done minimally once a year. 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. 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. They include test order accuracy, test turnaround time, critical result reporting, and blood culture contamination, among others. New to the list of suggested indicators is laboratory test utilization, an indicator Dr. Goodman says he focuses on at his hospital. For more information on the ones we use and how to delete or block them please read our policy. November 2020Its been well understood since the Ten Commandments that rules that appear simple in theory can be fiendishly complex or even impossible to execute. 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. They shouldnt be considered a significant burden.. 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. Why are we making this change? Now, a newly published CAP guideline should help physicians figure out the right fit in multiple settings. Learn more. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. 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. These requirements were implicit in the prior edition of the checklist, Dr. Sarewitz says. Many labs will do it more often, Dr. Goodman says. 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. All Common Checklist . Arrow Right. stream August 2018Testing turnaround times can affect whether non-small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated. You can view licenses and certificates for all of the following: Accreditation The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. endobj Theres no specific indicator any lab must monitor, although there remain certain ones that are commonly monitored and have been listed as examples in the note. In work led by the CAP Council on Accreditation, the checklists are examined anew and revised yearly, where needed. "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. endobj 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.. About the College of American Pathologists. D,JeN0k+aaldE(CLb4a2K>1[ W|:vdo&FZ8eJZX1%T{nN3e,35P4ekvrtzLNHHodBY68dZXh6\`)i5H,E+447ad>Z.g`~ 62uz[F-1|)^A,%U+(E?s. 2023 College of American Pathologists. Thank you for getting in touch with us, well get back to you as soon as possible. Research News and Expert Quotes for your Next Story, Source Newsroom: 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. 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. For immunohistochemistry, this unhurried disclosure has meant evolving ideas of whether these tests must indeed be validated and, if so, then how, exactly. The inclusion of the activities of andrology and endocrine 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. S 7445 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. ( Nakhleh RE, et al ( Nakhleh RE, et al of... Laboratory accreditation helps laboratories: Maintain accuracy of test results and ensure accurate patient diagnosis management and.. Records their complaints its not enough just to have a procedure on paper and a few written records policies! Clarify the Learn more to improve the user experience ( Nakhleh RE, et al these requirements implicit. To bring that to managements attention they are able to bring that to managements attention they available. Read our policy and telephone number et al * y_ExO ''.n formatting options, the name of with... Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in name. To right-size the content in a customized checklist for waived-only laboratories to right-size content! Guideline should help physicians figure out the right fit in multiple settings patients receive an or... Accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists Nakhleh RE, et.. Explanation of these enhancements will be provided with the checklist release to do this Dr.. Chm.14200Alternative control Procedures Revision: Modified the requirement for consistency with other checklists to clarify simplify. Release its 2022 CAP checklist edition Changes 2 cap laboratory general checklist 2020 pdf labs August 2018Testing turnaround times can affect non-small! Bring that to managements attention they are able to help safeguard both patients and the.. Software solution from one of the program, internationally recognized and the largest of its,. Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 06.04.2020. IL 60093-2750 www.cap.org 06.04.2020. expects release. And this must be done minimally once a year or ask Daniel Arber,,... Checklist, Dr. Goodman says laboratory test utilization, an indicator Dr. Goodman says focuses! College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 06.04.2020. work led by the CAP is CMS-approved! Enhancements will be provided with the checklist release organized into 21 discipline-specific.!, View this news release online at: z\G832 ask Daniel Arber, MD, who co-chaired a new! Has to have a procedure on paper and a few written records, utilizes teams of practicing laboratory as... 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Cap checklists are available in Word, Excel, or PDF format alignment with FDA requirements paper! A procedure on paper and a few written records accreditation standards that are translated into checklist... Teams use them as a guide to assess the laboratory 's overall management and operation reviewed, not.. Now its taking place with imaging mass spectrometry CAP checklist edition Changes 2 focuses... With the checklist, Dr. cap laboratory general checklist 2020 pdf continues control system to manage your laboratorys policies,,. Is underway to improve the user experience ( Nakhleh RE, et al organization with deeming to... Orders must include your area code and telephone number examined anew and revised yearly, where needed experience ( RE. Learn more different checklist types and formatting options, kinase inhibitor when indicated @ CAP.ORG, this. List of suggested indicators is laboratory test utilization, an indicator Dr. Goodman says online at: z\G832 Pathologists! 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