The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. xKO@F 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 . 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. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. 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. In many cases, in fact, HPV testing is just what treating clinicians and patients need. z\G832. About the College of American Pathologists. The software solutions in our Accreditation Checklist Distribution program have been evaluated by the CAP to ensure functionality to manage ongoing accreditation compliance using . August 2018One new requirement and several modified requirements in the CAP transfusion medicine checklist are part of the new edition of CAP accreditation program checklists released this month. Subsequent CAP changes, if applicable, are not reflected in this eAlert. 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. 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. Internet Explorer presents a security risk. 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. %PDF-1.7 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. So this addition can eventually benefit labs and patients alike. The frequency for evaluation is to be defined by the laboratory. March 2018Among the many never-ending chores that humans undertakepaying bills, filing taxes, flossingwriting medical guidelines can seem like an especially perpetual task. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. Visit cap.org to register. Meet required standards from CLIA, FDA and OSHA. NORTHFIELD, Ill.--(BUSINESS WIRE)--The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. Email: MEDIA@CAP.ORG, View this news release online at: It requires that any such concerns be included in laboratory QM records. The 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. x]Ys7~weA pdWbh0_%qj!$*y_ExO".n? Now, a newly published CAP guideline should help physicians figure out the right fit in multiple settings. ROSE for patient care has proven value. November 2020Its been well understood since the Ten Commandments that rules that appear simple in theory can be fiendishly complex or even impossible to execute. At the start of the project, I think everyone going into it realized it was going to be a time-consuming, long process. <> @DPfQ.5nUgkiy--]_?kBqjvl>>/#EW>>ryZ/b>Y>3SVEj>>kfdS?K8qz[GEi}7PmqUGP s`qiwly.^~-sx->'K,>;a3%%L'o Cs "M},[ u|I*4.vB~?M0#ltFFEc@.hq,+4g2Ow@4 9zyGI'9hdMG[0oNq\ih6Fc_6^b-l3Q&>D\|hL_;$.rOXGxL4I',||i_wf4|!Xmc The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. 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. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. Fax or email. Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines. October 2021By Jan. 1, 2024, laboratories must use current breakpoints to interpret antimicrobial minimum inhibitory concentration and disk diffusion test results, according to a new requirement in the latest edition of the CAP Accreditation Programs microbiology checklist, released Sept. 22. Licenses and Certificates. 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. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. Unfortunately, quantum theory doesnt apply to laboratory directors, at least not on a scheduling level. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. Read theCAP Annual Report. Now a change to the CAP Laboratory Accreditation Programs checklists will clarify expectations for directors who are in charge of more than one laboratory. March 2014Like Gypsy Rose Lee, tests and their true nature reveal themselves bit by bit. Like the rest of us, directors can be in only one place at a time, no matter how many laboratories they oversee. For more information, visityourpathologist.orgto 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. Phone: 800-323-4040, ext. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. When labs define the frequency, Dr. Rutledge says, it means they have a plan for revisiting the indicator appropriately. If you need a different quality of the file please download the asset individually. Were not adding anything. 2023 College of American Pathologists. Additional explanation of these enhancements will be provided with the checklist release. 4 0 obj 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. 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. Well forward it to experts for a reply. 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. Well forward it to experts for a reply. 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. Thats a key to closing the loop when dealing with problems in the laboratory. Evidence of compliance requires records of actions taken and of the effectiveness evaluation. 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. Highest quality files will be downloaded for all the assets. 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. Include a copy of institutional purchase . 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 Mpox a Cause for Concern in Pregnant Persons, CAP Discusses Actions to Eliminate Health Disparities with Congressional Black Caucus. The Checklists used f or inspection b y the College of Amer ican Pathologists' Accreditation Prog rams have 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. 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. 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. The aim of others is to improve the preanalytic quality of specimens used for all types of testing. August 2018Testing turnaround times can affect whether non-small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated. Read the CAP Annual Report. Many labs will do it more often, Dr. Goodman says. stream Business/financial/contractual issues are certainly important, but they are not within the purview of the CAP program, Dr. Sarewitz says. 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. 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. They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. Participants of the CAP accreditation programs may download the checklists from the CAP website (cap.org) by logging into e-LAB Solutions Suite. Manage rapidly evolving changes in laboratory medicine and technology. These detailed checklists include: Notes, references, and practical examples to further clarify requirements and facilitate compliance 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. 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. 2 0 obj Thank you for getting in touch with us, well get back to you as soon as possible. Labs need to have a complaint/non-conforming event resolution system. They are available in different checklist types and formatting options, . For immunohistochemistry, this unhurried disclosure has meant evolving ideas of whether these tests must indeed be validated and, if so, then how, exactly. 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. Contact us at 800-323-4040 or accred@cap.org. Use of enhanced NOTE customization for laboratories performing next generation sequencing (NGS) to limit the NGS NOTE content to the testing applications on the laboratorys activity menu. 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. %PDF-1.7 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. 6a@de/NYT*TMhKZ91Sc!N+O ke_e(|5)'LEEI,txwe*/9(r$*nqQkBMcj?&sJ\$V~sBx_'*\'m>#ptrV;6QYrOJniy[O( :Z2abQL}xx<.rMcDZZ }aeBA[J1Q'#-1x#_5S}tpo(Exz/lSq,dQ)U,N$LYrU.SBw=-eh\yC@2kwd_3q zFr` _0ZSS^aSBRfenk,--o9U@jzH-_j Q^Wl_*V*I q?. LK VQA([}aW Were closing the loop on quality management wherever we can, Dr. Sarewitz says. April 2013The paperless office may be just around the corner, and virtual reality may lie ahead too. The discussion recently culminated in a new CAP guideline for laboratories. And its open and accessible to all. They shouldnt be considered a significant burden.. 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. About the College of American Pathologists. 2020 Issues, ARTICLES, COVID-19, November 2020. September 2016For the CAP Laboratory Accreditation Program, inspection checklist requirements covering personnel are a perennial concern. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. 7445 On the other hand, not every head and neck case requires it. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. Learn more about the webinar and register. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. April 2021In the continuum of cancer care, diagnostic specialties such as ours play critical roles. Communication Date: August 1, 2022NOTE: The information below was current at the time of communication. 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. But those things dont always accomplish the goal of effective change, he says. Questions? The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). 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.. 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. Laboratories can register now for our checklist update webinar, 2022 CAP Accreditation Checklist Updates: Changes that Matter, scheduled for Wednesday, October 19, 2022. May 2017Plenty can happen in five years. College of American Pathologists (CAP). The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). <> 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). Personnel is also high on the list of questions asked of Laboratory Accreditation Program staff. 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.. !l8FXl'ir^f[3z2}==:$wD>1pq]l }$j4YG The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. College of American Pathologists Created in 1993 to meet the needs of reproductive laboratories with: o. 3 0 obj 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. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> May 2015Quality control is second nature and part of the air that laboratories breathe. 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{ 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. 4 0 obj <> If the question and answer are published in the column, the only name published will be that of the person who answered the question. stream CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. 2022 Issues, ARTICLES, August 2022, Cytopathology. 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. 3 0 obj Check to see which vendors participate in the CAPs Checklist Distribution Program. The CAP expects to release its 2022 CAP checklist edition in October. Arrow Right. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. 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. % The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. It may be that you chose the wrong action or the action was never implemented. BAP.07400: Paraffin, Flotation Baths, and Embedding Stations Revision Added detail for proper monitoring of paraffin baths and dispensers. 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. 1 0 obj In work led by the CAP Council on Accreditation, the checklists are examined anew and revised yearly, where needed. June 2021As COVID-19 restrictions halted traditional laboratory inspections, virtual and blended inspections became the stand-ins, and early adopters say theres much to like and hold on to post-pandemic. In 2020 checklist, a gentle push to next quality level, Do you have a question related to pathology and laboratory medicine practice? Be in only one place at a time, critical result reporting, and virtual reality may lie ahead.! Head and neck case requires it: Paraffin, Flotation Baths, and reality. 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