order or credit card information. %PDF-1.7 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 % <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612.12 792.12] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> 7445 <> April 2021In the continuum of cancer care, diagnostic specialties such as ours play critical roles. 2 0 obj Now, in 2018, they have clarified the diagnostic approach to in situ hybridization groups two, three, and four, rare cases that nonetheless cause an outsized share of headaches and worries. Many labs will do it more often, Dr. Goodman says. Considering a document control system to manage your laboratorys policies, procedures, and documents? About the College of American Pathologists. The requirement also specifies that it applies to clinical, rather than business/financial issues. endobj endobj 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. And this must be done minimally once a year. http://www.businesswire.com/news/home/20200604005016/en, 1985 - 2023 BioSpace.com. This protocol is a collaborative effort, based on input from past and present members of the CAP Cytopathology Committee and prepared in conjunction with the CAP Pathology Electronic Reporting Committee. College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750. This release will feature several enhancements designed to clarify and simplify the inspection process for inspectors and laboratories. CAP requirements commonly exceed the standards, bolstering patient care and safety. CAP checklists are available in Word, Excel, or PDF format. 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. This is not just another guideline. 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 2015Quality control is second nature and part of the air that laboratories breathe. January 2022The CAP has a robust Laboratory Accreditation Program with a commitment to continually improving the programs and providing appropriate resources needed for compliance. November 2020Its been well understood since the Ten Commandments that rules that appear simple in theory can be fiendishly complex or even impossible to execute. For more information, visityourpathologist.orgto watch pathologists at work and see the stories of the patients who trust them with their care. Arrow Right. It was presented via webinar to the CAP House of Delegates on March 31. Communication Date: August 1, 2022NOTE: The information below was current at the time of communication. April, 2020 . August 2017There was no trip to the spa. CAP Laboratory Accreditation helps laboratories: Maintain accuracy of test results and ensure accurate patient diagnosis. 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. Its been fantastic, he says. Highlights of the checklist enhancements include: These new features will be available for use starting with the 2022 Checklist edition. 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. 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. 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. Read More AST and safety at core of microbiology checklist changes 2021 Issues, ARTICLES, October 2021 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. 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. 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 . Streamline management and compliance of CAP accreditation checklist requirements through the use of a software solution from one of the program participant vendors. Like the rest of us, directors can be in only one place at a time, no matter how many laboratories they oversee. Or ask Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup of acute leukemia. ROSE for patient care has proven value. Archives of Pathology & Laboratory Medicine, Clinical Laboratory Improvement Amendments. It says a root cause analysis must be performed for sentinel events. Research News and Expert Quotes for your Next Story, Source Newsroom: Learn more. "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. Less severe non-conforming events require investigation but not a full root cause analysis, Dr. Sarewitz says. If the question and answer are published in the column, the only name published will be that of the person who answered the question. 3 0 obj Include a copy of institutional purchase . 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 . 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. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. 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. 2018 Issues, ARTICLES, August 2018, Molecular. Read the CAP Annual Report. 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. NORTHFIELD, Ill.--(BUSINESS WIRE)--The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. 3 0 obj 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. 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. 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. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). 2022 Issues, ARTICLES, September 2022, September Issue. Something like sedately stepping onto a moving sidewalk. The checks and balances have to work to improve quality. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. 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. August 2018Testing turnaround times can affect whether non-small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated. The key question at that point was quotidian: Have new data emerged to warrant changing the original recommendations? These detailed checklists include: View a Full Listing of Available Checklists with Description (PDF), Request a Sample CAP Checklist July 2018Take the new ASCO/CAP guideline for HER2 testing. 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 Laboratories have seen lower gynecologic volumes and an increase in both nongynecologic fine-needle aspiration biopsy and touch imprint samples. 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. 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. The checks and balances have to work to improve quality. 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. Were closing the loop on quality management wherever we can, Dr. Sarewitz says. <> Recaptcha secret parameter is missing or invalid! And now its taking place with imaging mass spectrometry. Internet Explorer presents a security risk. 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. "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. Manage rapidly evolving changes in laboratory medicine and technology. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. endobj Sentinel events require a root cause analysis to determine the cause and prevent recurrence. 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. But some sections of the 2017 edition of the CAP Laboratory Accreditation Program checklist are looking trimmed and toned compared with last years checklists. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. View Vendors List forCAPs Checklist Distribution Program stream 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. %PDF-1.5 October 2021By Jan. 1, 2024, laboratories must use current breakpoints to interpret antimicrobial minimum inhibitory concentration and disk diffusion test results, according to a new requirement in the latest edition of the CAP Accreditation Programs microbiology checklist, released Sept. 22. The assigned checklist is based on the specific <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> 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. Check to see which vendors participate in the CAPs Checklist Distribution Program. 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.. stream 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. 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. Updated to reflect August 22, 2018 CAP Checklist edition changes 2. 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. So this addition can eventually benefit labs and patients alike. The frequency for evaluation is to be defined by the laboratory. NORTHFIELD, Ill.--(BUSINESS WIRE)-- The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020.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. One of the changes is GEN.20318 Corrective and Preventive Action, a new requirement that says a labs quality management program must include processes for recording corrective and preventive actions taken for errors and incidents (i.e. They include test order accuracy, test turnaround time, critical result reporting, and blood culture contamination, among others. New to the list of suggested indicators is laboratory test utilization, an indicator Dr. Goodman says he focuses on at his hospital. Contact us at 800-323-4040 or accred@cap.org. 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. !JQ)"OAJOYD=d4NbA Within weeks, several other cases emerged. Updated to reflect review of all references 9.0 . Send completed order form to 847-832-8168, ATTN: Customer Data . To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. Arrow Right. 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. <> But those things dont always accomplish the goal of effective change, he says. 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. Questions? CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. As a deemed status organization, validation surveys are performed annually through the Centers for Medicare and Medicaid Services and the feedback obtained provides direction for education. May 2017Plenty can happen in five years. 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. 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. 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. All services provided by Mayo Clinic Laboratories that involve joint efforts will be done in a manner which enables our clients to comply with HIPAA and the College of American Pathologists (CAP) Laboratory General Checklist (CAP GEN. 41303). The aim of others is to improve the preanalytic quality of specimens used for all types of testing. 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. <>/XObject<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 960 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> About the College of American Pathologists. August 2016Maybe laboratory accreditation checklists arent the first reading you reach for when you want to unwind. 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. 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. 2017;141[9]:11531154). 2020 Issues, ARTICLES, COVID-19, November 2020. 4 0 obj September 2018Ten years ago, Richard J. Zarbo, MD, was feeling pretty proud of his laboratory. 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. S 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. August 2022The protocol for the reporting of cervicovaginal cytology, the first in a series of CAP cytopathology protocols, became available for use in a synoptic format on June 22. It is a milestone for pathologists.. The CAP expects to release its 2022 CAP checklist edition in October. Orders must include your area code and telephone number. It is something that should have been done without the requirement, but this makes it crystal clear it must be done, he says. If you need a different quality of the file please download the asset individually. These requirements were implicit in the prior edition of the checklist, Dr. Sarewitz says. xKO@F NORTHFIELD, Ill.The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. And employees must have a way of bringing observations and suggestions forward. Evidence of compliance calls for records of employee and patient complaints with appropriate follow-up. 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. They are available in different checklist types and formatting options, . It was an important step for in vivo microscopy. 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 CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. 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. 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.. 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. There are other tests that are done redundantly, excessively, and are noncontributory to good patient care. This release will feature several enhancements designed to clarify and simplify the inspection process for inspectors and laboratories. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. Archives of Pathology & Laboratory Medicine, View Vendors List forCAPs Checklist Distribution Program, Browser and Operating System Requirements, Notes, references, and practical examples to further clarify requirements and facilitate compliance, Citations to additional resources for further explanation, Built-in references for easy access to specific regulations, Evidence of compliance with integrated best practices. This change is coming after extensive discussions with the American Joint Committee on Cancer (AJCC) and with its unanimous endorsement. When labs define the frequency, Dr. Rutledge says, it means they have a plan for revisiting the indicator appropriately. 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. 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. 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{ Subsequent CAP changes, if applicable, are not reflected in this eAlert. The note calls for a written policy that describes the overall program, in sufficient detail to describe the objectives and essential elements of the program. The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. 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. Updated to reflect August 21, 2017 CAP Checklist edition changes 8.0 September, 2018 : 1. 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. Is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA safety. Root cause analysis, Dr. Sarewitz says so this addition can eventually benefit labs and patients alike specimens... 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