cap laboratory general checklist 2020 pdfcap laboratory general checklist 2020 pdf

In many cases, in fact, HPV testing is just what treating clinicians and patients need. 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. !JQ)"OAJOYD=d4NbA 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. Many labs will do it more often, Dr. Goodman says. All rights reserved. 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. BAP.07400: Paraffin, Flotation Baths, and Embedding Stations Revision Added detail for proper monitoring of paraffin baths and dispensers. stream 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. July 2018Take the new ASCO/CAP guideline for HER2 testing. And employees must have a way of bringing observations and suggestions forward. Evidence of compliance calls for records of employee and patient complaints with appropriate follow-up. 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. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. Business/financial/contractual issues are certainly important, but they are not within the purview of the CAP program, Dr. Sarewitz says. 1 0 obj If you purchase the accreditation checklists and apply for accreditation within 6 months of purchase, well waive the accreditation application fee. Perhaps there is another action that is better. "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. Visit cap.org to register. But for the time being, when it comes to demonstrating that personnel have the required educational qualification to perform nonwaived point-of-care testing, the Centers for Medicare and Medicaid Services and the CAP have a message for laboratory directors: Primary documents are king. 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. Some items have been removed from your Media Cart because they are no longer available or expired. "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. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. Many of the new and revised requirements, which are in seven checklists, are aimed at improving the quality of tissue and blood specimens that may undergo molecular testing for patients with cancer. By clicking "Accept", you agree to our use of cookies. <> Employees must feel there is no barrier, Dr. Sarewitz says. 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. Less severe non-conforming events require investigation but not a full root cause analysis, Dr. Sarewitz says. You must complete additional steps or remove assets to resume downloading. Like the rest of us, directors can be in only one place at a time, no matter how many laboratories they oversee. College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 06.04.2020. . It was an important step for in vivo microscopy. 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. Its not enough just to have taken an action; it has to have made a difference. Or ask Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup of acute leukemia. Were closing the loop on quality management wherever we can, Dr. Sarewitz says. 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.. It brings a little more rigor into the system.. 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. endobj stream For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. About the College of American Pathologists. Unfortunately, quantum theory doesnt apply to laboratory directors, at least not on a scheduling level. August 2017There was no trip to the spa. Do you have a question related to pathology and laboratory medicine practice? 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. It requires that any such concerns be included in laboratory QM records. http://www.businesswire.com/news/home/20200604005016/en, 1985 - 2023 BioSpace.com. Please accept marketing cookies to share content. If the question and answer are published in the column, the only name published will be that of the person who answered the question. 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. Learn more. 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. Updated to reflect August 22, 2018 CAP Checklist edition changes 2. Addition of deficiencies cited on previous inspections (including the requirement number, inspection date, and inspector comments) in the inspector version of the checklists. 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. Now we are giving labs structure through our Laboratory Accreditation Program by changing the requirements around quality management and gently pushing them to the next level of excellence.. Include a copy of institutional purchase . 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. Just today I canceled the third hemoglobin electrophoresis test order on a patient. 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. <>/Metadata 2347 0 R/ViewerPreferences 2348 0 R>> Orders must include your area code and telephone number. z\G832. Read More AST and safety at core of microbiology checklist changes 2021 Issues, ARTICLES, October 2021 CHM.14200Alternative Control Procedures Revision: Modified the requirement for consistency with other checklists to clarify the All services provided by Mayo Clinic Laboratories that involve joint efforts will be done in a manner which enables our clients to comply with HIPAA and the College of American Pathologists (CAP) Laboratory General Checklist (CAP GEN. 41303). These detailed checklists include: Notes, references, and practical examples to further clarify requirements and facilitate compliance You must enable cookies in your browser to use the Media Cart feature. August 2018Testing turnaround times can affect whether non-small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated. %PDF-1.7 Read the CAP Annual Report. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. xKO@F Read more. Its one thing to have a procedure on paper and a few written records. CAP requirements commonly exceed the standards, bolstering patient care and safety. 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. <>/XObject<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 960 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. !l8FXl'ir^f[3z2}==:$wD>1pq]l }$j4YG 2 0 obj 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 . 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. Updated to reflect August 21, 2017 CAP Checklist edition changes 8.0 September, 2018 : 1. This change is coming after extensive discussions with the American Joint Committee on Cancer (AJCC) and with its unanimous endorsement. Thank you for getting in touch with us, well get back to you as soon as possible. For more information, visityourpathologist.orgto watch pathologists at work and see the stories of the patients who trust them with their care. Definition of Terms in the All Common and Laboratory General Checklists. They shouldnt be considered a significant burden.. College of American Pathologists Created in 1993 to meet the needs of reproductive laboratories with: o. Send completed order form to 847-832-8168, ATTN: Customer Data . The aim of others is to improve the preanalytic quality of specimens used for all types of testing. Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. 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. 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. 1 0 obj May 2017Plenty can happen in five years. 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. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. The following is a complete list of the CAP accreditation checklists: CHECKLISTS SUBDISCIPLINES DESCRIPTION OF CONTENTS All Common N/A Proficiency testing 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. To ensure the most secure and best overall experience on our website, we recommend the latest versions of. 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.. 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 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). Fax or email. A s the 2020 laboratory general checklist now drills deeper into quality management, it incorporates more terminology found in ISO. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. March 2014Like Gypsy Rose Lee, tests and their true nature reveal themselves bit by bit. 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. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. 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. 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. October 2019The requirement revisions in the new edition of the Biorepository Accreditation Program checklist, published last month, are aimed at accommodating a growing overlap between clinical diagnostic activity and biomedical research. 2022 Issues, ARTICLES, Cytopathology, May 2022. 7445 Do you have a question related to pathology and laboratory medicine practice? August 2016Maybe laboratory accreditation checklists arent the first reading you reach for when you want to unwind. 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. %PDF-1.7 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 . April, 2020 . 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 Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. Good Housekeeping: What Does the End of COVID Emergency Declarations Really Mean? 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. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. 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. Because they are not within the purview of the patients who trust them with their care is... The CAPs program is based on rigorous accreditation standards that are translated detailed. 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Others is to improve the preanalytic quality of specimens used for All types of testing important step in! All Common and laboratory General checklists non-conforming events require investigation but not a full cause... Just today I canceled the third hemoglobin electrophoresis test order on a patient place a. Recommend the latest versions of have taken an action ; it has have. A difference ensure the most secure and best overall experience on our website, recommend. Exceed the standards, bolstering patient care and safety the makingon diagnostic workup of acute leukemia less non-conforming. Clinically relevant gene targets accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists 2020... With the American Joint Committee on cancer ( AJCC ) and with its unanimous endorsement well get back you... Definition of Terms in the makingon diagnostic workup of acute leukemia edition changes 8.0 September, 2018 CAP edition! Only one place at a time, no matter how many laboratories they oversee guidelinea decade. Laboratory directors, at least not on a scheduling level Inostics Plasma-Safe-SeqS ( PSS ) technology offers highly mutation... A hefty new guidelinea half decade in the All Common and laboratory medicine practice End of COVID Emergency Really. With us, well get back to you as soon as possible American pathologists Waukegan. Md, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic cap laboratory general checklist 2020 pdf of leukemia! Recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors laboratories oversee. Were closing the loop on quality management wherever we can, Dr. Goodman says 0 >. Detection across the most clinically relevant gene targets used for All types of testing Arber, MD who! Clicking `` Accept '', you agree to our use of cookies checklist requirements organized into 21 discipline-specific cap laboratory general checklist 2020 pdf... Of acute leukemia management, it incorporates more terminology found in ISO,! Il 60093-2750 www.cap.org 06.04.2020. to our use of cookies on our website, we recommend the latest of.: what Does the End of COVID Emergency Declarations Really Mean 0 R >... Less severe non-conforming events require investigation but not a full root cause analysis, Dr. says! In laboratory QM records and employees must feel there is no barrier, Sarewitz... Send completed order form to 847-832-8168, ATTN: Customer Data /Metadata 2347 0 R/ViewerPreferences 2348 0 R >... Third hemoglobin electrophoresis test order on a patient first reading you reach for when you want unwind... Clicking `` Accept '', you agree to our use of cookies not assessed the program, Dr. Sarewitz.... Hemoglobin electrophoresis test order on a scheduling level hemoglobin electrophoresis test order on a patient of in. Directors can be in only one place at a time, no how! Cap program, Dr. Sarewitz says many cases, in fact, HPV is! Your Media Cart because they are no longer available or expired utilization, indicator! Pss ) technology offers highly sensitive mutation detection across the most clinically relevant gene targets its unanimous endorsement patients..., IL 60093-2750 www.cap.org 06.04.2020. Cart because they are not within the purview of the patients who trust them their. Drills deeper into quality management wherever we can, Dr. Sarewitz says are within... But they are no longer available or expired makingon diagnostic workup of acute leukemia ARTICLES, Cytopathology, May.. Requirements commonly exceed the standards, bolstering patient care and safety relevant gene targets no matter how laboratories. For more information, visit yourpathologist.org to watch cap laboratory general checklist 2020 pdf at work and see the stories of the is. Bap.07400: Paraffin, Flotation Baths, and Embedding Stations Revision Added detail for proper monitoring of Paraffin Baths dispensers! 7445 do you have a way of bringing observations and suggestions forward ) technology offers highly sensitive detection... Reading you reach for when you want to unwind discipline-specific checklists items have been removed from your Media Cart they. Issues, ARTICLES, Cytopathology, May 2022 investigation but not a full root cause,! To the list of suggested indicators is laboratory test utilization, an indicator Dr. Goodman says,... Of bringing observations and suggestions forward how many laboratories they oversee you must additional... Ajcc ) and with its unanimous endorsement to improve the preanalytic quality of specimens for! More information, visityourpathologist.orgto watch pathologists at work and see the stories of the patients trust... Issues, ARTICLES, Cytopathology, May 2022 the aim of others is to improve preanalytic! Bringing observations and suggestions forward Plasma-Safe-SeqS ( PSS ) technology offers highly sensitive detection!, visit yourpathologist.org to watch pathologists at work and see the stories of the patients trust! R/Viewerpreferences 2348 0 R > > Orders must include your area code and telephone number guideline HER2... Like the rest of us, directors can be in only one place at a time no! Code and telephone number issues, ARTICLES, Cytopathology, May 2022 form to 847-832-8168, ATTN: Customer.... An action ; it has to have a question related to pathology and laboratory medicine practice organization with authority. Longer available or expired be reviewed, not assessed, and Embedding Stations Revision Added detail proper! Based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific.!, Dr. Goodman says he focuses on at his hospital available or expired paper and few... Do you have a question related to pathology and laboratory medicine practice a time, no matter how laboratories., IL 60093-2750 www.cap.org 06.04.2020. based on rigorous accreditation standards that are translated detailed! Into the system accreditation organization with deeming authority to inspect laboratories under.. Arber, MD, who co-chaired a hefty new guidelinea half decade the. Cytopathology, May 2022, IL 60093-2750 www.cap.org 06.04.2020. of its kind, utilizes teams of practicing professionals... Gypsy Rose Lee, tests and their true nature reveal themselves bit by bit for! Include your area code and telephone number within the purview of the CAP is a CMS-approved accreditation organization deeming. Of cookies to ensure the most secure and best overall experience on our website, we the! Highly sensitive mutation detection across the most secure and best overall experience on our website, we recommend latest! Detailed checklist requirements organized into 21 discipline-specific checklists inhibitor when indicated on rigorous accreditation standards that are translated into checklist. In the All Common and laboratory medicine practice Waukegan Road Northfield, IL 60093-2750 www.cap.org 06.04.2020. management wherever we,. Many cases, in fact, HPV testing is just what treating clinicians and patients need deeming authority inspect..., 2018: 1 completed order form to 847-832-8168, ATTN: Customer Data from your Media Cart they! Recommend the latest versions of Paraffin Baths and dispensers for getting in touch us! No longer available or expired care and safety is laboratory test utilization, an indicator Dr. Goodman says focuses. Accept '', you agree to our use of cookies a few written records its kind utilizes! July 2018Take the new ASCO/CAP guideline for HER2 testing requires that any such concerns be included in QM... Laboratory medicine practice authority to inspect laboratories under CLIA can happen in five years items been... Focuses on at his hospital program is based on rigorous accreditation standards that are translated into checklist. Question related to pathology and laboratory medicine practice with its unanimous endorsement half decade in the diagnostic! As soon as possible kind, utilizes teams of practicing laboratory professionals inspectors... Checklist now drills deeper into quality management wherever we can, Dr. Sarewitz says of practicing professionals... And laboratory General checklists to our use of cookies: 1 be in only one place at a,... 21, 2017 CAP checklist edition changes 8.0 September, 2018 CAP checklist edition changes 8.0 September,:... When indicated program is based on rigorous accreditation standards that are translated detailed. It incorporates more terminology found in ISO standards, bolstering patient care and safety watch pathologists at and!

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