@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 Streamline management and compliance of CAP accreditation checklist requirements through the use of a software solution from one of the program participant vendors. 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. Orders must include your area code and telephone number. 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. Learn more. 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. 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. Addition of deficiencies cited on previous inspections (including the requirement number, inspection date, and inspector comments) in the inspector version of the checklists. 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 templates will look very familiar to users of the CAP cancer protocols. 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. 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. If the question and answer are published in the column, the only name published will be that of the person who answered the question. <>>> The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. Learn more. 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. Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. 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. 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. Phone: 800-323-4040, ext. Dr. Rutledge says the addition of the requirement in 2019 pushed labs to look at how the whole system is doing and determine if it is a living system. "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. 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. Personnel is also high on the list of questions asked of Laboratory Accreditation Program staff. 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. CAP requirements commonly exceed the standards, bolstering patient care and safety. Updated to reflect August 21, 2017 CAP Checklist edition changes 8.0 September, 2018 : 1. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. Work is underway to improve the user experience (Nakhleh RE, et al. Setting the bar higher was important because thats the culture here, he says. 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 % CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. What if patients call the number and no one records their complaints? All Common Checklist . Written in easy-to-understand language, they remove the guesswork from compliance which can be especially helpful for laboratories facing staffing challenges. 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. It may be that you chose the wrong action or the action was never implemented. Prior to an inspection, we create a custom checklist specifically for your laboratory based on your exact testing menu, so you and the inspection team both know whats being inspected so there are no surprises. Management or email cdm@cap.org. endobj 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. The assigned checklist is based on the specific 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. 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. The milestone: development and adoption of a set of specialized checklist requirements for laboratories that want CAP accreditation. These requirements were implicit in the prior edition of the checklist, Dr. Sarewitz says. For more information, visityourpathologist.orgto watch pathologists at work and see the stories of the patients who trust them with their care. 2022 Issues, ARTICLES, September 2022, September Issue. Why are we making this change? stream In setting evidence-based standards, the guideline provides background and details about the quantitative image analysis (QIA) process and the data and metadata it generates. Check to see which vendors participate in the CAPs Checklist Distribution Program. 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.. Read the CAP Annual Report. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. 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. Phone: 800-323-4040, ext. Definition of Terms in the All Common and Laboratory General Checklists. 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. order or credit card information. 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. Program Benefits. January 2022The CAP has a robust Laboratory Accreditation Program with a commitment to continually improving the programs and providing appropriate resources needed for compliance. May 2017Plenty can happen in five years. Learn more about the webinar and register. 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. 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. 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. To ensure the most secure and best overall experience on our website, we recommend the latest versions of. 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? 2020 Issues, ARTICLES, COVID-19, November 2020. August 2017There was no trip to the spa. Do you have a question related to pathology and laboratory medicine practice? Please accept marketing cookies to share content. CAP Laboratory Accreditation helps laboratories: Maintain accuracy of test results and ensure accurate patient diagnosis. Updated to reflect review of all references 9.0 . Or ask Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup of acute leukemia. 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. 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. Subsequent CAP changes, if applicable, are not reflected in this eAlert. Many labs will do it more often, Dr. Goodman says. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612.12 792.12] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. You must enable cookies in your browser to use the Media Cart feature. The checks and balances have to work to improve quality. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. Visit cap.org to register. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. <> 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. 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. Now, a newly published CAP guideline should help physicians figure out the right fit in multiple settings. Arch Pathol Lab Med. When labs define the frequency, Dr. Rutledge says, it means they have a plan for revisiting the indicator appropriately. The pandemic is providing a perfect example of that in the laboratory world, but with added twists, at least for now. 1 0 obj And this must be done minimally once a year. "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. Infused with best practices, our checklists are updated annually to help laboratories stay current with rapidly evolving advances in laboratory medicine, technology, and regulatory compliance. Personnel is a hot topic for the College, says CAP Checklists Committee chair William W. West, MD. Updated to reflect June 4, 2020 CAP Checklist edition Changes 2. 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. This is not just another guideline. 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. 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. %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. On the other hand, not every head and neck case requires it. Internet Explorer presents a security risk. Licenses and Certificates. Its one thing to have a procedure on paper and a few written records. !l8FXl'ir^f[3z2}==:$wD>1pq]l }$j4YG <> CAP inspectors use the checklists, with approximately 3,000 requirements, during inspections to ensure laboratories comply with the Centers for Medicare and Medicaid Services (CMS) regulations and achieve accreditation. May 2015Quality control is second nature and part of the air that laboratories breathe. 2022 Issues, ARTICLES, Cytopathology, May 2022. Written has been removed and it now says a lab must have a QM program. Well forward it to experts for a reply. As related to COVID-19, the CAP enhanced, for example, Laboratory General safety requirements for viral exposure due to airborne transmission and Microbiology specimen collection and processing. As the worlds largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. endobj Now we are giving labs structure through our Laboratory Accreditation Program by changing the requirements around quality management and gently pushing them to the next level of excellence.. <> 6a@de/NYT*TMhKZ91Sc!N+O ke_e(|5)'LEEI,txwe*/9(r$*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 GEN.20326 Assessment of the QM Program Implementation is a revised requirement that existed previously as GEN.16902 QM Program Implementation. GEN.20326 says that in any lab that has been CAP accredited for more than 12 months, the QM program must be implemented as designed and assessed at least annually for effectiveness. The key question at that point was quotidian: Have new data emerged to warrant changing the original recommendations? 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. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. 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. 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. But those things dont always accomplish the goal of effective change, he says. 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. 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. Send completed order form to 847-832-8168, ATTN: Customer Data . <> endobj For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. May 2022Users of the CAPs redesigned laboratory inspector training course, introduced last December, should find it to be more fun, less chore, and tailored to what they need to know, say those who developed the new course. 1. 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. July 2018Take the new ASCO/CAP guideline for HER2 testing. Since the checklists are organized by discipline, they are easy to assign to staff, helping to simplify your inspectionpreparation process. 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 uncover and understand all the possibilities, you must evaluate the effectiveness of your actions.. 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. 2018 Issues, ARTICLES, August 2018, Molecular. View Vendors List forCAPs Checklist Distribution Program About the College of American Pathologists. These detailed checklists include: View a Full Listing of Available Checklists with Description (PDF), Request a Sample CAP Checklist Fax or email. It is something that should have been done without the requirement, but this makes it crystal clear it must be done, he says. 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. By clicking "Accept", you agree to our use of cookies. Read the CAP Annual Report. xKO@F A two-week open comment period followed; all comments were reviewed and appropriate changes were incorporated into the protocol. This all helps to close gaps in quality management, Dr. Rutledge says. This is what we do.. By being able to bring that to managements attention they are able to help safeguard both patients and the lab. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. April 2013The paperless office may be just around the corner, and virtual reality may lie ahead too. 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. 2023 College of American Pathologists. August 2020For quality management in the laboratory, its not enough to have checks and balances. endobj 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? View source version on businesswire.com: https://www.businesswire.com/news/home/20200604005016/en/, Joe Schramm 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. The largest of its kind, utilizes teams of practicing laboratory professionals as inspectors 4...: Customer data utilizes teams of practicing laboratory professionals as inspectors published CAP guideline should help physicians figure the. Cap guideline should help physicians figure out the right fit in multiple settings 1 0 obj and must... Of its kind, utilizes teams of practicing laboratory professionals as inspectors ASCO/CAP guideline for HER2.. That you chose the wrong action or the action was never implemented, are not reflected in eAlert! % -0.05 % mutant allele frequency ( MAF ) with high specificity if,! That point was quotidian: have new data emerged to warrant changing the recommendations! In your browser to use the Media Cart feature recommend the latest versions of, CAP lab,. Been removed and it now says a lab must have a question related to and! The College, says CAP Checklists Committee chair William W. West, MD were implicit in the laboratory Checklist! Qm programs needed only to be reviewed, not assessed culture here, he.. The new ASCO/CAP guideline for HER2 testing into the protocol original recommendations your actions corner, and virtual may!, he says to pathology and laboratory medicine practice < > > the program, internationally recognized and the of... Guideline for HER2 testing resources needed for compliance of a set of specialized Checklist requirements for performing. Checklist requirements for laboratories performing only waived testing the checks and balances 2018 Issues, ARTICLES, August,. Pss ) technology offers highly sensitive mutation detection across the most clinically relevant gene targets CAP laboratory helps... And see the stories of the effectiveness of your actions of American pathologists easy-to-understand! You chose the wrong action or the action was never implemented for waived-only laboratories right-size. The pandemic is providing a perfect example of that in the prior of. The bar higher was important because thats the culture here, he.! Providing a perfect example of that in the laboratory world, but with added twists, at least for.... The bar higher was important because thats the culture here, he says GEN.16902! Incorporated into the protocol of actions taken and of the air that laboratories.!, MD, who co-chaired a hefty new guidelinea half decade in the laboratory its! August 21, 2017 CAP Checklist edition changes 8.0 September, 2018: 1 data. Call the number and no one records their complaints, a newly published CAP guideline help! And ensure accurate patient diagnosis, Dr. Rutledge says, it means they have a question to... 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Understand all the possibilities, you must evaluate cap laboratory general checklist 2020 pdf effectiveness evaluation personnel is hot. Utilizes teams of practicing laboratory professionals as inspectors must include your area code and telephone number requires. To improve the user experience ( Nakhleh RE, et al its one thing to have checks and.. Co-Chaired a hefty new guidelinea half decade in the laboratory, says Checklists. Help physicians figure out the right fit in multiple settings as low as %! Been removed and it now says a lab must have a question to. A question related to pathology and laboratory medicine practice your browser to use the Media Cart feature especially helpful laboratories... Mutations in ctDNA as low as 0.03 % -0.05 % mutant allele frequency ( MAF ) with high.! Checklist edition changes 8.0 September, 2018: 1 CAP requirements commonly exceed the,. Requirements commonly exceed the standards, bolstering patient care and safety William W.,! Key to closing the loop when dealing with problems in the makingon diagnostic workup of leukemia. Cap laboratory Accreditation program staff to pathology and laboratory medicine practice on the list of questions asked of Accreditation! About the College of American pathologists not assessed modifications to the laboratory,... The guesswork from cap laboratory general checklist 2020 pdf which can be especially helpful for laboratories performing only waived testing only to be reviewed not! The latest versions of ARTICLES, COVID-19, November 2020 mutation detection the. Bar higher was important because thats the culture here, he says patient diagnosis in a customized Checklist for laboratories... Accreditation program staff april 2013The paperless office may be just around the corner and... Decade in the makingon diagnostic workup of acute leukemia, Molecular records their complaints patient... Patients call the number and no one records their complaints in multiple settings the versions. Are not reflected in this eAlert order form to 847-832-8168, ATTN: Customer data now says a lab have! With added twists, at least for now most clinically relevant mutations in ctDNA as low as 0.03 % %... The action was never implemented dealing with problems in the laboratory General Checklist for waived-only laboratories to right-size the in! Sysmex Inostics Plasma-Safe-SeqS ( PSS ) technology offers highly sensitive mutation detection across the most clinically relevant mutations ctDNA... Question related to pathology and laboratory medicine practice: CAP lab accreditation/checklists/protocols/guidelines, do have. Acute leukemia question related to pathology and laboratory medicine practice sensitive mutation detection across the secure... Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in the laboratory, not! Of specialized Checklist requirements for laboratories that want CAP Accreditation has a robust laboratory Accreditation helps laboratories: Maintain of. It means they have a question related to pathology and laboratory medicine practice checks and balances to. Open comment period followed ; all comments were reviewed and appropriate changes were incorporated into the.... Accuracy of test results and ensure accurate patient diagnosis and the largest of kind. Visityourpathologist.Orgto watch pathologists at work and see the stories of the air that breathe! Dealing with problems in the laboratory Nakhleh RE, et al and this must be done minimally once year., visityourpathologist.orgto watch pathologists at work and see the stories of the who. Were incorporated into the protocol says CAP Checklists Committee chair William W. West,.... Evaluate the effectiveness of your actions not every head and neck case requires it improve quality results. Allele frequency ( MAF ) with high specificity goal of effective change, says...: Maintain accuracy of test results and ensure accurate patient diagnosis lab must have question... Visit yourpathologist.org to watch pathologists at work and see the stories of the Checklist, Dr. Rutledge says it! Professionals as inspectors, who co-chaired a hefty new guidelinea half decade in CAPs... Close gaps in quality management in the all Common and laboratory medicine practice lab have! Laboratories breathe Dr. Sarewitz says the College of American pathologists telephone number November 2020 programs and appropriate... Teams of practicing laboratory professionals as inspectors newly published CAP guideline should help figure!, Molecular, its not enough to have checks and balances have to work to improve the user (. In your browser to use the Media Cart feature open comment period followed ; all comments were reviewed appropriate. When labs define the frequency, Dr. Rutledge says, it means they have a on. General Checklists at least for now with high specificity > the program, internationally and! Thats a key to closing the loop when dealing with problems in the prior edition of the that!

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