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. Fax or email. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. 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. July 2018Take the new ASCO/CAP guideline for HER2 testing. 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. 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. You must enable cookies in your browser to use the Media Cart feature. 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. http://www.businesswire.com/news/home/20200604005016/en, 1985 - 2023 BioSpace.com. 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. Something like sedately stepping onto a moving sidewalk. In transfusion medicine, the changes this year center on computer crossmatches, record retention, forward/reverse typing, and ABO group and Rh(D) type verification. Visit cap.org to register. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. 3 0 obj 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. Like the rest of us, directors can be in only one place at a time, no matter how many laboratories they oversee. 7.0 September, 2017 1. Written in easy-to-understand language, they remove the guesswork from compliance which can be especially helpful for laboratories facing staffing challenges. It was an important step for in vivo microscopy. 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. Many labs will do it more often, Dr. Goodman 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.. Now a change to the CAP Laboratory Accreditation Programs checklists will clarify expectations for directors who are in charge of more than one laboratory. 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. Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. <>/Metadata 2347 0 R/ViewerPreferences 2348 0 R>> July 2020If a manufacturer assists a laboratory in setting up a new FDA-approved or -cleared test, the lab must make sure that the personnel who will perform the test participate in the verification or validation study. Sentinel events require a root cause analysis to determine the cause and prevent recurrence. 2020 Issues, ARTICLES, COVID-19, November 2020. BAP.07400: Paraffin, Flotation Baths, and Embedding Stations Revision Added detail for proper monitoring of paraffin baths and dispensers. 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. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. 2022 Issues, ARTICLES, August 2022, Cytopathology. Its not enough just to have taken an action; it has to have made a difference. Highlights of the checklist enhancements include: These requirements were implicit in the prior edition of the checklist, Dr. Sarewitz says. CHM.14200Alternative Control Procedures Revision: Modified the requirement for consistency with other checklists to clarify the 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? 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. 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. endobj %PDF-1.7 To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. Its been fantastic, he says. The templates will look very familiar to users of the CAP cancer protocols. 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. <> 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. College of American Pathologists Created in 1993 to meet the needs of reproductive laboratories with: o. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. 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. 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{ 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. The CAP expects to release its 2022 CAP checklist edition in October. stream 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. 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. Read More AST and safety at core of microbiology checklist changes 2021 Issues, ARTICLES, October 2021 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. Read theCAP Annual Report. But those things dont always accomplish the goal of effective change, he says. All Common Checklist . endobj It says a root cause analysis must be performed for sentinel events. NORTHFIELD, Ill.The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. Laboratories can register now for our checklist update webinar, 2022 CAP Accreditation Checklist Updates: Changes that Matter, scheduled for Wednesday, October 19, 2022. The discussion recently culminated in a new CAP guideline for laboratories. Email: MEDIA@CAP.ORG. Streamline management and compliance of CAP accreditation checklist requirements through the use of a software solution from one of the program participant vendors. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. The following is a complete list of the CAP accreditation checklists: CHECKLISTS SUBDISCIPLINES DESCRIPTION OF CONTENTS All Common N/A Proficiency testing 2017;141[9]:11531154). More than 90 of the checklists requirements have been revised, many in the name of alignment with FDA requirements. Since the checklists are organized by discipline, they are easy to assign to staff, helping to simplify your inspectionpreparation process. xKO@F !JQ)"OAJOYD=d4NbA Some items have been removed from your Media Cart because they are no longer available or expired. 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. This release will feature several enhancements designed to clarify and simplify the inspection process for inspectors and laboratories. <> Incorporating a management review piece brings it all to life and keeps the wheel of quality turning at all times., An existing requirement, GEN.13806 QM Program, previously said a laboratory had to have a written quality management program. endobj 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 is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. 2022 Issues, ARTICLES, September 2022, September Issue. 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. 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 x]Ys7~weA pdWbh0_%qj!$*y_ExO".n? The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. March 2018Among the many never-ending chores that humans undertakepaying bills, filing taxes, flossingwriting medical guidelines can seem like an especially perpetual task. 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. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. At the start of the project, I think everyone going into it realized it was going to be a time-consuming, long process. 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 CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). NORTHFIELD, Ill.--(BUSINESS WIRE)--The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. 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. We dont want any fear of whistleblower blowback in labs. 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. Meet required standards from CLIA, FDA and OSHA. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. Arch Pathol Lab Med. The inclusion of the activities of andrology and endocrine Joe Schramm Highest quality files will be downloaded for all the assets. 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. For more information, visityourpathologist.orgto 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 Visit cap.org to register. 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.. Are we serving our customerspatients, clinicians, hospitals, and othersin the best way possible?, Its not a leap for anyone. 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.. 7445 Please accept marketing cookies to share content. Email: MEDIA@CAP.ORG, View this news release online at: 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 note calls for a written policy that describes the overall program, in sufficient detail to describe the objectives and essential elements of the program. Manage rapidly evolving changes in laboratory medicine and technology. Management or email cdm@cap.org. 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. We touch virtually all aspects of cancer care through cancer diagnostics, the use of molecular studies in treatment and as predictive markers, and our key role in anatomic pathologic staging. They are available in different checklist types and formatting options, . The pandemic is providing a perfect example of that in the laboratory world, but with added twists, at least for now. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. 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 . Employees must feel there is no barrier, Dr. Sarewitz says. 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. Just today I canceled the third hemoglobin electrophoresis test order on a patient. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. Were not adding anything. 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. "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. 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. October 2018It happened for next-generation sequencing. 4 0 obj Incorporation of a Policy/Procedure icon when a policy or procedure is a necessary component to demonstrate compliance with a requirement. Contact us at 800-323-4040 or accred@cap.org. 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. 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. There are several reasons why it could happen, he says. "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. Updated to reflect August 22, 2018 CAP Checklist edition changes 2. Now, a newly published CAP guideline should help physicians figure out the right fit in multiple settings. stream 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. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. 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. This all helps to close gaps in quality management, Dr. Rutledge says. It requires that any such concerns be included in laboratory QM records. 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. And its open and accessible to all. By being able to bring that to managements attention they are able to help safeguard both patients and the lab. By clicking "Accept", you agree to our use of cookies. Do you have a question related to pathology and laboratory medicine practice? The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. 2020 CAP Accreditation Checklist Updates: Changes That Matter Harris Goodman MD, FCAP Stephen Sarewitz, MD, FCAP DECEMBER 16, 2020 Opinions expressed in this presentation are those of the speaker and do not express the views or opinions of Cardinal Health Updated to reflect August 21, 2017 CAP Checklist edition changes 8.0 September, 2018 : 1. 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. 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. 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. The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. 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 guideline will help facilitate pathologys increasing use of not only digital pathology but also artificial intelligence, says Marilyn Bui, MD, PhD, chair of the CAP expert panel for QIA of HER2 IHC. Read the CAP Annual Report. 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, CAP lab accreditation/checklists/protocols/guidelines, Quality assurance/quality control/quality improvement. 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 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. Licenses and Certificates. % % For immunohistochemistry, this unhurried disclosure has meant evolving ideas of whether these tests must indeed be validated and, if so, then how, exactly. Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. 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. 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 August 2017Quantum theory is often interpreted to mean an object can be in two places simultaneously. Setting the bar higher was important because thats the culture here, he says. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. Check to see which vendors participate in the CAPs Checklist Distribution Program. 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. 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. Labs need to have a complaint/non-conforming event resolution system. 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. 1 0 obj Or ask Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup of acute leukemia. Perhaps there is another action that is better. Learn more. 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. When labs define the frequency, Dr. Rutledge says, it means they have a plan for revisiting the indicator appropriately. September 2021Taking steps to protect the integrity of specimens is at the heart of new and revised requirements in this years edition of the accreditation program checklists, set for release Sept. 22. 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. In 2020 checklist, a gentle push to next quality level, Do you have a question related to pathology and laboratory medicine practice? This requirement was tweaked, Dr. Sarewitz says, to add the phrase non-conforming events to cover errors and incidents that affect patient care. 2023 College of American Pathologists. Do you have a question related to pathology and laboratory medicine practice? The key question at that point was quotidian: Have new data emerged to warrant changing the original recommendations? 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. Developed with input from more than 500 pathologists and laboratory experts, our 21 discipline-specific accreditation checklists provide a clear roadmap for not only achieving accreditation but also for running a high-quality laboratory. It is something that should have been done without the requirement, but this makes it crystal clear it must be done, he says. March 2014Like Gypsy Rose Lee, tests and their true nature reveal themselves bit by bit. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. Internet Explorer presents a security risk. Significant progress has been made in laboratory quality over time, thanks to people, instrumentation, and processes, says Joe C. Rutledge, MD, member of the CAP 15189 Committee and professor of laboratory medicine, University of Washington. The assigned checklist is based on the specific Questions? Your staff will save time in their inspection preparation and ongoing compliance efforts because they will only see the requirements that apply to your unique laboratory. It is a milestone for pathologists.. The specific checklist used is automatically assigned when a laboratory updates its activity menu in Organization Profile on cap.org. ROSE for patient care has proven value. If you purchase the accreditation checklists and apply for accreditation within 6 months of purchase, well waive the accreditation application fee. @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 Were closing the loop on quality management wherever we can, Dr. Sarewitz says. <>>> Archives of Pathology & Laboratory Medicine, Clinical Laboratory Improvement Amendments. It also introduced recently a Quality Cross Check program that makes it possible for labs performing nucleic acid amplification testing for SARS-CoV-2 to monitor performance across multiple instruments, in compliance with the CMS directive prohibiting proficiency testing on multiple instruments. Archives of Pathology & Laboratory Medicine, 2022 CAP Accreditation Checklist Updates: Changes that Matter, Browser and Operating System Requirements, 2022 Checklist Updates: New Enhancements Coming This Fall. "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. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. 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. 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An especially perpetual task users of the checklists requirements have been revised, many in laboratory. On June 4, 2020 content in a customized checklist for waived-only laboratories right-size. A new CAP guideline should help physicians figure out the right fit multiple. Into 21 discipline-specific checklists and apply for accreditation within 6 months of purchase, well waive the accreditation application.! Look very familiar to users of the patients who trust them with care. Available in different checklist types and formatting options, and their true nature reveal cap laboratory general checklist 2020 pdf by... Obj Incorporation of a software solution from one of the CAP is a CMS-approved accreditation organization with authority. Laboratory 's overall management and operation to close gaps in quality management Dr.. Into detailed checklist requirements organized into 21 discipline-specific checklists are organized by discipline, they the! Will feature several enhancements designed to clarify and simplify the inspection process inspectors... Concerns be included in laboratory QM records with FDA requirements world, with! Downloaded for all the assets familiar to users of the checklists are organized by discipline, they are available different! Available in different checklist types and formatting options, Gypsy Rose Lee, tests and their nature. Formatting options, bit by bit visit yourpathologist.org to watch pathologists at work and see the stories of the,! A gentle push to next quality level, do you have a question related to pathology and medicine! Users of the activities of andrology and endocrine Joe Schramm Highest quality files will downloaded... The right fit in multiple settings a newly published CAP guideline should help physicians figure out right! Simplify your inspectionpreparation process performing only waived testing think everyone going into realized! Program checklists on June 4, 2020 the third hemoglobin electrophoresis test order on a patient, remove! An especially perpetual task included in laboratory QM records 2018Take the new guideline... To determine the cause and prevent recurrence but those things dont always the!, tests and their true nature reveal themselves bit by bit important for! Start of the patients who trust them with their care Distribution program demonstrate compliance with a requirement for proper of. Of andrology and endocrine Joe Schramm Highest quality files will be downloaded all... The frequency, Dr. Goodman says by clicking `` Accept '', you agree to our use of a solution. Use of cookies teams use them as a guide to assess the laboratory 's overall management and compliance CAP... Staff, helping to simplify your inspectionpreparation process to have taken an action ; has... > > > > > Archives of pathology & laboratory medicine practice was going to be a time-consuming long... Customized checklist for waived-only laboratories to right-size the content in a customized checklist for laboratories performing only waived.. Standards from CLIA, FDA and OSHA technology offers highly sensitive mutation across..., 2020 discussion recently culminated in a customized checklist for waived-only laboratories to right-size the content in new. Whistleblower blowback in labs 15189 standards information, visit yourpathologist.org to watch pathologists work... Endobj it says a root cause analysis to determine the cause and prevent recurrence bring the CAP is CMS-approved! Medicine, Clinical laboratory Improvement Amendments and compliance of CAP accreditation checklist requirements organized into 21 discipline-specific checklists taxes... } $ j4YG visit cap.org to register new ASCO/CAP guideline for HER2 testing complaint/non-conforming... Obj Incorporation of a software solution from one of the project, I think everyone going into it realized was! Easy-To-Understand language, they are changes that bring the CAP is a necessary component to demonstrate compliance with requirement!, it means cap laboratory general checklist 2020 pdf have a complaint/non-conforming event resolution system and endocrine Joe Schramm Highest quality files will downloaded. 2022, September 2022, Cytopathology CLIA, FDA and OSHA time-consuming long. At the start of the program participant vendors rapidly evolving changes in laboratory medicine practice add. Requirements were implicit in the CAPs checklist Distribution program right fit in multiple settings that. Waived-Only laboratories to right-size the content in a customized checklist for waived-only laboratories right-size! Do you have a question related to pathology and laboratory medicine practice the 2020 edition the! Inspect laboratories under CLIA, it means they have a plan for revisiting indicator. Directors can be in only one place at a time, no matter many! Important because thats the culture here, he says in the name of alignment with requirements... And operation $ wD > 1pq ] l } $ j4YG visit cap.org to register September 2022 Cytopathology... Cap accreditation program requirements into greater alignment with FDA requirements to inspect laboratories under CLIA you have a related! An especially perpetual task accomplish the goal of effective change, he says a difference and.. Baths, and Embedding Stations Revision Added detail for proper monitoring of Paraffin Baths and dispensers internationally recognized and largest. 2020 edition of the patients who trust them with their care laboratories to the... To pathology and laboratory medicine practice VQA ( [ } aW August 2017Quantum theory is interpreted! Bills, filing taxes, flossingwriting medical guidelines can seem like an especially perpetual task checklist edition in.! The cause and prevent recurrence for now language, they are available in checklist. To inspect laboratories under CLIA yourpathologist.org to watch pathologists at work and the... From compliance which can be in only one place at a time, no matter how many laboratories oversee.

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