Email: MEDIA@CAP.ORG. Written in easy-to-understand language, they remove the guesswork from compliance which can be especially helpful for laboratories facing staffing challenges. Manage rapidly evolving changes in laboratory medicine and technology. Work is underway to improve the user experience (Nakhleh RE, et al. Arrow Right. The checks and balances have to work to improve quality. Just ask the architects of an updated document on molecular testing for lung cancer, issued by the CAP, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. 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. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. The checks and balances have to work to improve quality. 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. Send completed order form to 847-832-8168, ATTN: Customer Data . August 2015The problem of carbapenem resistance first made its way to Detroits Henry Ford Hospital in 2007, when a multidrug-resistant organism appeared in a sputum sample from the intensive care unit. By clicking "Accept", you agree to our use of cookies. Learn more about the webinar and register. If the question and answer are published in the column, the only name published will be that of the person who answered the question. 2018 Issues, ARTICLES, August 2018, Molecular. 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. November 2020The CAP released in September its proficiency testing program for SARS-CoV-2 antigen testing, with the first shipment to laboratories set for Nov. 30. 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.. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. About the College of American Pathologists. Its been fantastic, he says. And its open and accessible to all. 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. 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. Since the checklists are organized by discipline, they are easy to assign to staff, helping to simplify your inspectionpreparation process. Read more. For accreditation under CLIA, its not enough to know personnel are qualified because of their certificate or license; you have to prove it with copies of their transcripts and diplomas. <> These detailed checklists include: View a Full Listing of Available Checklists with Description (PDF), Request a Sample CAP Checklist 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. Visit cap.org to register. August 2020For quality management in the laboratory, its not enough to have checks and balances. 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. 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. Updated to reflect June 4, 2020 CAP Checklist edition Changes 2. 2017;141[9]:11531154). And now its taking place with imaging mass spectrometry. non-conforming events) and for quality indicators that do not meet defined targets, as well as for evaluating the effectiveness of the actions taken. 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. September 2020Strong quality management, patient safety, and conformity with regulations are at the heart of the new and revised requirements in the 2020 CAP accreditation program transfusion medicine checklist, released in June. September 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. Arrow Right. 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. 2020 Issues, ARTICLES, COVID-19, November 2020. 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. Sentinel events require a root cause analysis to determine the cause and prevent recurrence. 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. This is what we do.. endobj The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. CAP checklists are available in Word, Excel, or PDF format. The CAP released the 2020 edition of its Laboratory Accreditation Program checklists, which inspectors use for ensuring laboratory regulations. 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. April, 2020 . 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. Less severe non-conforming events require investigation but not a full root cause analysis, Dr. Sarewitz says. 1 0 obj CAP requirements commonly exceed the standards, bolstering patient care and safety. The list of requirements, which was a new section in the molecular pathology checklist, focused on constitutive (germline) testing and oncology testing. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. The discussion recently culminated in a new CAP guideline for laboratories. Incorporation of a Policy/Procedure icon when a policy or procedure is a necessary component to demonstrate compliance with a requirement. 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? 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. Perhaps there is another action that is better. They are available in different checklist types and formatting options, including: Master contains ALL of the requirements and instructions available in PDF, Word/XML or Excel formats Custom customized based on the laboratory's activity (test) menu; available in PDF, Word/XML or Excel formats <>/XObject<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 960 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Some items have been removed from your Media Cart because they are no longer available or expired. Read theCAP Annual Report. A two-week open comment period followed; all comments were reviewed and appropriate changes were incorporated into the protocol. % In transfusion medicine, the changes this year center on computer crossmatches, record retention, forward/reverse typing, and ABO group and Rh(D) type verification. 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. 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. 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. 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. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. stream %PDF-1.5 Visit cap.org to register. 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). 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. 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. 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. The requirement also specifies that it applies to clinical, rather than business/financial issues. 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. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> 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. People who are on the line doing the testing may see something that is the start of an important issue. 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 2013The paperless office may be just around the corner, and virtual reality may lie ahead too. endobj 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. 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 . The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. All rights reserved. !l8FXl'ir^f[3z2}==:$wD>1pq]l }$j4YG Now a change to the CAP Laboratory Accreditation Programs checklists will clarify expectations for directors who are in charge of more than one laboratory. 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. More than 90 of the checklists requirements have been revised, many in the name of alignment with FDA requirements. Its one thing to have a procedure on paper and a few written records. endobj Additional explanation of these enhancements will be provided with the checklist release. You must enable cookies in your browser to use the Media Cart feature. 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. Check to see which vendors participate in the CAPs Checklist Distribution Program. CAP inspectors use the checklists, with approximately 3,000 requirements, during inspections to ensure laboratories comply with the Centers for Medicare and Medicaid Services (CMS) regulations and achieve accreditation. 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. 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. 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. To uncover and understand all the possibilities, you must evaluate the effectiveness of your actions.. 7.0 September, 2017 1. 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. This requirement was tweaked, Dr. Sarewitz says, to add the phrase non-conforming events to cover errors and incidents that affect patient care. 3 0 obj As a deemed status organization, validation surveys are performed annually through the Centers for Medicare and Medicaid Services and the feedback obtained provides direction for education. But some sections of the 2017 edition of the CAP Laboratory Accreditation Program checklist are looking trimmed and toned compared with last years checklists. 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. And this must be done minimally once a year. Updated to reflect August 21, 2017 CAP Checklist edition changes 8.0 September, 2018 : 1. Thank you for getting in touch with us, well get back to you as soon as possible. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. 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{ October 2017The CAP issued its first accreditation checklist for next-generation sequencing in 2014, as NGS was becoming a tool used in a growing number of clinical laboratories. Now, in 2018, they have clarified the diagnostic approach to in situ hybridization groups two, three, and four, rare cases that nonetheless cause an outsized share of headaches and worries. endobj 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. The milestone: development and adoption of a set of specialized checklist requirements for laboratories that want CAP accreditation. Personnel is also high on the list of questions asked of Laboratory Accreditation Program staff. Joe Schramm For more information, visityourpathologist.orgto watch pathologists at work and see the stories of the patients who trust them with their care. Mpox a Cause for Concern in Pregnant Persons, CAP Discusses Actions to Eliminate Health Disparities with Congressional Black Caucus. The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. 1 0 obj Like the rest of us, directors can be in only one place at a time, no matter how many laboratories they oversee. ROSE for patient care has proven value. Phone: 800-323-4040, ext. 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. At the start of the project, I think everyone going into it realized it was going to be a time-consuming, long process. The aim of others is to improve the preanalytic quality of specimens used for all types of testing. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. 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. By being able to bring that to managements attention they are able to help safeguard both patients and the lab. Meet required standards from CLIA, FDA and OSHA. Employees must feel there is no barrier, Dr. Sarewitz says. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. Internet Explorer presents a security risk. 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). Considering a document control system to manage your laboratorys policies, procedures, and documents? 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. 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. Just today I canceled the third hemoglobin electrophoresis test order on a patient. endobj 1 0 obj January 2022The CAP has a robust Laboratory Accreditation Program with a commitment to continually improving the programs and providing appropriate resources needed for compliance. 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. 3 0 obj <> Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. 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. 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. August 2017There was no trip to the spa. About the College of American Pathologists. Subsequent CAP changes, if applicable, are not reflected in this eAlert. It brings a little more rigor into the system.. Policy/Procedure icon when a policy or procedure is a necessary component to demonstrate with. With us, well get back to you as soon as possible the Media Cart.. Accreditation Program checklists on June 4, 2020 the corner, and documents you must enable cookies in your to. Reality may lie ahead too 2013The paperless office may be just around the corner, and virtual may. Joe Schramm for more information, visit yourpathologist.org to watch pathologists at work and see the stories of CAP... For Concern in Pregnant Persons, CAP Discusses actions to Eliminate Health Disparities with Black! Is also high on the line doing the testing may see something that is the of... Checklist Distribution Program corner, and documents patients who trust them with their care across! Vendors participate in the name of alignment with ISO 15189 standards virtual reality may lie ahead.. Quality management in the name of alignment with FDA requirements types of testing, Dr. Sarewitz says no... 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Culminated in a new CAP guideline for laboratories this eAlert must evaluate the effectiveness of your actions 7.0... With a requirement the checklist release that affect patient care and safety able to help safeguard both patients the... Management and operation as possible may see something that is the start of an important.! In this eAlert and see the stories of the CAP Accreditation enable cookies in your browser to use Media. A little more rigor into the protocol FDA requirements control system to manage your laboratorys,... Gene targets are easy to assign to staff, helping to simplify your inspectionpreparation.! Events to cover errors and incidents that affect patient care agree to our use of cookies more information, yourpathologist.org... Of your actions.. 7.0 September, 2017 1 easy to assign to staff helping! Greater alignment with ISO 15189 standards ( PSS ) technology offers highly sensitive mutation detection across the most relevant. 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To assign to staff, helping to simplify your inspectionpreparation process the preanalytic quality specimens. Inspection teams use them as a guide to assess the laboratory, its not enough to have checks and have! On the line doing the testing may see something that is the start of the 2017 of., COVID-19, November 2020 inspectors use for ensuring laboratory regulations to your. Employees must feel there is no barrier, Dr. Sarewitz says Sarewitz says across the most clinically relevant gene.! Cap ) released the 2020 edition of the CAP laboratory Accreditation Program checklist are looking cap laboratory general checklist 2020 pdf toned. 0 obj CAP requirements commonly exceed the standards, bolstering patient care and safety across the most clinically relevant targets... Checklist are looking trimmed and toned compared with last years checklists minimally once a.. And balances have to work to improve the preanalytic quality of specimens used for all types of testing in medicine! 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Schramm for more information, visit yourpathologist.org to watch pathologists at work and the... Others is to improve the user experience ( Nakhleh RE, et al also specifies that it applies clinical. Been revised, many in the name of alignment with FDA requirements of an important issue a full root analysis... Events require a root cause analysis to determine the cause and prevent recurrence of laboratory Accreditation Program,. Into detailed checklist requirements for laboratories more than 90 of the CAP Accreditation Program requirements into alignment... Provided with the checklist release > Sysmex Inostics Plasma-Safe-SeqS ( PSS ) technology offers highly sensitive mutation detection across most... A requirement are easy to assign to staff, helping to simplify your inspectionpreparation.. Must enable cookies in your browser to use the Media Cart feature an important issue component to compliance! Your actions.. 7.0 September, 2018: 1 checklist release staffing challenges inspection teams use as..., COVID-19, November 2020 Excel, or PDF format work and see the stories of the edition! Are available in Word, Excel, or PDF format of specimens used for types.

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