Like the rest of us, directors can be in only one place at a time, no matter how many laboratories they oversee. Current CAP Guidelines Mismatch Repair and Microsatellite Instability Testing for Immune Checkpoint Inhibitor Therapy Diagnostic Testing for Diffuse Gliomas Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies Validating Whole Slide Imaging for Diagnostic Purposes in Pathology - Update Laboratory Workup of Lymphoma in Adults 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. About the College of American Pathologists. http://www.businesswire.com/news/home/20200604005016/en, 1985 - 2023 BioSpace.com. And now its taking place with imaging mass spectrometry. 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. z\G832. The Checklists used f or inspection b y the College of Amer ican Pathologists' Accreditation Prog rams have August 2018The CAP and the Centers for Medicare and Medicaid Services reached an understanding earlier this year on how adequacy assessments and rapid on-site evaluations in cytology can be accounted for without causing undue impact on workload limits. !l8FXl'ir^f[3z2}==:$wD>1pq]l }$j4YG stream 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. This is not just another guideline. CAP Laboratory Accreditation helps laboratories: Maintain accuracy of test results and ensure accurate patient diagnosis. 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. Arrow Right. March 2014Like Gypsy Rose Lee, tests and their true nature reveal themselves bit by bit. September 2018Ten years ago, Richard J. Zarbo, MD, was feeling pretty proud of his laboratory. 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. Within weeks, several other cases emerged. To ensure the most secure and best overall experience on our website, we recommend the latest versions of. The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. Just ask Cubs fans who watched their team leap from a 101-loss season in 2012 to a 103-win season in 2016 and a World Series title as the cherry on top. 4 0 obj But now we can take it to the next level by embracing what other industries have doneadopt a quality management system that is robust and livingand continually ask the questions, Are we effective with our improvements and with our corrections? 3 0 obj 2023 College of American Pathologists. The list of requirements, which was a new section in the molecular pathology checklist, focused on constitutive (germline) testing and oncology testing. Now a change to the CAP Laboratory Accreditation Programs checklists will clarify expectations for directors who are in charge of more than one laboratory. 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. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. The checks and balances have to work to improve quality. 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. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. x]Ys7~weA pdWbh0_%qj!$*y_ExO".n? 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. Learn more about the webinar and register. 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. 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. What if patients call the number and no one records their complaints? Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. A two-week open comment period followed; all comments were reviewed and appropriate changes were incorporated into the protocol. "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 CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. 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. 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. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. All Common Checklist . 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. CHM.14200Alternative Control Procedures Revision: Modified the requirement for consistency with other checklists to clarify the Were not adding anything. 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. For more information, visityourpathologist.orgto watch pathologists at work and see the stories of the patients who trust them with their care. GEN.20316 QM Indicators of Quality says a QM program must include monitoring key indicators of quality in the preanalytic, analytic, and postanalytic testing phases by regularly comparing performance against targets defined by the laboratory. 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. They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. endobj 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. 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. endobj The requirement also specifies that it applies to clinical, rather than business/financial issues. It was presented via webinar to the CAP House of Delegates on March 31. 2 0 obj 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. They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. 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. 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. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). These requirements were implicit in the prior edition of the checklist, Dr. Sarewitz says. <> CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. You must enable cookies in your browser to use the Media Cart feature. Fax or email. If the question and answer are published in the column, the only name published will be that of the person who answered the question. What are the CAP Checklists? 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$LYrU.SBw=-eh\yC@2kwd_3q zFr` _0ZSS^aSBRfenk,--o9U@jzH-_j Q^Wl_*V*I q?. LK VQA([}aW The checks and balances have to work to improve quality. @DPfQ.5nUgkiy--]_?kBqjvl>>/#EW>>ryZ/b>Y>3SVEj>>kfdS?K8qz[GEi}7PmqUGP s`qiwly.^~-sx->'K,>;a3%%L'o Cs "M},[ u|I*4.vB~?M0#ltFFEc@.hq,+4g2Ow@4 9zyGI'9hdMG[0oNq\ih6Fc_6^b-l3Q&>D\|hL_;$.rOXGxL4I',||i_wf4|!Xmc The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. 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. Licenses and Certificates. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. "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 aim of others is to improve the preanalytic quality of specimens used for all types of testing. %PDF-1.7 Just ask the architects of an updated document on molecular testing for lung cancer, issued by the CAP, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. 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. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. Mpox a Cause for Concern in Pregnant Persons, CAP Discusses Actions to Eliminate Health Disparities with Congressional Black Caucus. For immunohistochemistry, this unhurried disclosure has meant evolving ideas of whether these tests must indeed be validated and, if so, then how, exactly. Personnel is also high on the list of questions asked of Laboratory Accreditation Program staff. 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. endobj June 2021For the June 2021 release of updates for the CAP cancer protocols and the corresponding electronic cancer checklists used by electronic health record vendors, pTX and pNX will no longer be selectable options for use by pathologists when assigning pathologic staging based on definitive surgical resection (pTNM). <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612.12 792.12] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> August 2020For quality management in the laboratory, its not enough to have checks and balances. April, 2020 . 1 0 obj 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 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. Considering a document control system to manage your laboratorys policies, procedures, and documents? Joe Schramm 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. 2022 Issues, ARTICLES, Cytopathology, May 2022. 4 0 obj October 2018It happened for next-generation sequencing. 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. December 2021No single assay can capture all cancer patients with DNA mismatch repair deficiency, and in determining a patients eligibility for immune checkpoint inhibitor therapy, assays for MMR deficiency, microsatellite instability, and tumor mutation burden should not be considered interchangeable. As a 501(c)(6) membership organization, the CAP is the only entity representing pathologists with unrestricted advocacy capability and a political action committee, PathPAC. 2020 Issues, ARTICLES, COVID-19, November 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. 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. When labs define the frequency, Dr. Rutledge says, it means they have a plan for revisiting the indicator appropriately. 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. 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. 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. And this must be done minimally once a year. 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. In transfusion medicine, the changes this year center on computer crossmatches, record retention, forward/reverse typing, and ABO group and Rh(D) type verification. 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. 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 pandemic is providing a perfect example of that in the laboratory world, but with added twists, at least for now. October 2013For anyone worried about the new CAP reporting templates for cancer biomarkers, Patrick L. Fitzgibbons, MD, has an important message: Dont panic. At the start of the project, I think everyone going into it realized it was going to be a time-consuming, long process. View Vendors List forCAPs Checklist Distribution Program 3 0 obj Labs need to have a complaint/non-conforming event resolution system. 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.. August 2018One new requirement and several modified requirements in the CAP transfusion medicine checklist are part of the new edition of CAP accreditation program checklists released this month. 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. August 2016Maybe laboratory accreditation checklists arent the first reading you reach for when you want to unwind. 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. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). 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. 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. Communication Date: August 1, 2022NOTE: The information below was current at the time of communication. August 2016As the use of in situ hybridization (ISH) expands, laboratories employing this form of testing increasingly rely on the CAP Laboratory Accreditation Program checklist for guidance. %PDF-1.7 Learn more. By being able to bring that to managements attention they are able to help safeguard both patients and the lab. Orders must include your area code and telephone number. 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. Do you have a question related to pathology and laboratory medicine practice? Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines. Email: MEDIA@CAP.ORG, View this news release online at: As system chairman of pathology and laboratory medicine at Detroit-based Henry Ford Health System, over the previous few years hed seen his team rigorously implement Lean practices, practices that had paid off in greater safety and efficiency. 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. 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. Do you have a question related to pathology and laboratory medicine practice? 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{ These detailed checklists include: View a Full Listing of Available Checklists with Description (PDF), Request a Sample CAP Checklist Something like sedately stepping onto a moving sidewalk. August 2017There was no trip to the spa. You must complete additional steps or remove assets to resume downloading. 2022 Issues, ARTICLES, August 2022, Cytopathology. 1 0 obj About the College of American Pathologists. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. 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? D,JeN0k+aaldE(CLb4a2K>1[ W|:vdo&FZ8eJZX1%T{nN3e,35P4ekvrtzLNHHodBY68dZXh6\`)i5H,E+447ad>Z.g`~ 62uz[F-1|)^A,%U+(E?s. 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. 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