cap laboratory general checklist 2020 pdfcap laboratory general checklist 2020 pdf

So this addition can eventually benefit labs and patients alike. The frequency for evaluation is to be defined by the 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. 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 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. <> Streamline management and compliance of CAP accreditation checklist requirements through the use of a software solution from one of the program participant vendors. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). Highlights of the checklist enhancements include: These new features will be available for use starting with the 2022 Checklist edition. And this must be done minimally once a year. 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. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. <> It was presented via webinar to the CAP House of Delegates on March 31. 2017;141[9]:11531154). 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. 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. 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. Read More AST and safety at core of microbiology checklist changes 2021 Issues, ARTICLES, October 2021 College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750. 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. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. stream 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. By clicking "Accept", you agree to our use of cookies. 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. 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. 3 0 obj These detailed checklists include: Notes, references, and practical examples to further clarify requirements and facilitate compliance Sentinel events require a root cause analysis to determine the cause and prevent recurrence. 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. The CAP released the 2020 edition of its Laboratory Accreditation Program checklists, which inspectors use for ensuring laboratory regulations. Were closing the loop on quality management wherever we can, Dr. Sarewitz says. 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. Do you have a question related to pathology and laboratory medicine practice? 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. April 2021In the continuum of cancer care, diagnostic specialties such as ours play critical roles. 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. By being able to bring that to managements attention they are able to help safeguard both patients and the lab. If you need a different quality of the file please download the asset individually. But those things dont always accomplish the goal of effective change, he says. Less severe non-conforming events require investigation but not a full root cause analysis, Dr. Sarewitz says. endobj August 2020For quality management in the laboratory, its not enough to have checks and balances. What if patients call the number and no one records their complaints? 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. 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. 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. 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. 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. CAP checklists are available in Word, Excel, or PDF format. Everybody wants to do this, Dr. Rutledge continues. Something like sedately stepping onto a moving sidewalk. 1 0 obj Considering a document control system to manage your laboratorys policies, procedures, and documents? At disease progression on an EGFR TKI, integrating circulating tumor DNA and tissue-based testing may lessen some of the limitations of each form of testing. More than 90 of the checklists requirements have been revised, many in the name of alignment with FDA requirements. ROSE for patient care has proven value. Labs need to have a complaint/non-conforming event resolution system. About the College of American Pathologists. 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 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. That is one reason members from three CAP committees started meeting to revise the ISH checklist, says CAP Surgical Pathology Committee member Aleodor Andea, MD, MBA. 2 0 obj 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 August 2017There was no trip to the spa. Written has been removed and it now says a lab must have a QM program. And its open and accessible to all. 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. 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. Some items have been removed from your Media Cart because they are no longer available or expired. 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. Incorporation of a Policy/Procedure icon when a policy or procedure is a necessary component to demonstrate compliance with a requirement. 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? For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. Mpox a Cause for Concern in Pregnant Persons, CAP Discusses Actions to Eliminate Health Disparities with Congressional Black Caucus. The checks and balances have to work to improve quality. We dont want any fear of whistleblower blowback in labs. Now, a newly published CAP guideline should help physicians figure out the right fit in multiple settings. Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines. Read more. 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? endobj Communication Date: August 1, 2022NOTE: The information below was current at the time of communication. 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. Internet Explorer presents a security risk. This requirement was tweaked, Dr. Sarewitz says, to add the phrase non-conforming events to cover errors and incidents that affect patient care. If the question and answer are published in the column, the only name published will be that of the person who answered the question. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. <>>> In many cases, in fact, HPV testing is just what treating clinicians and patients need. %PDF-1.7 It requires that any such concerns be included in laboratory QM records. endobj 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. 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. Program Benefits. 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. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. % 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. 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. Do you have a question related to pathology and laboratory medicine practice? They shouldnt be considered a significant burden.. May 2014Gerald Hoeltge, MD, chair of the CAP Checklists Committee, is pretty sure he knows exactly the way many laboratories will react to a particular change in the latest edition of the Laboratory Accreditation Program checklists, which launch this month. 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. The checks and balances have to work to improve quality. April 2019With the release in January of a new guideline for quantitative image analysis of HER2 immunohistochemistry for breast cancer, the CAP believes it is filling a gap and blazing a trail for the profession. Email: MEDIA@CAP.ORG, View this news release online at: 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. order or credit card information. 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. People who are on the line doing the testing may see something that is the start of an important issue. 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. Addition of deficiencies cited on previous inspections (including the requirement number, inspection date, and inspector comments) in the inspector version of the checklists. Were not adding anything. Setting the bar higher was important because thats the culture here, he says. April 2013The paperless office may be just around the corner, and virtual reality may lie ahead too. Since the checklists are organized by discipline, they are easy to assign to staff, helping to simplify your inspectionpreparation process. 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. Email: MEDIA@CAP.ORG. The aim of others is to improve the preanalytic quality of specimens used for all types of testing. 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. It is a milestone for pathologists.. Powered by Madgex Job Board Software, https://www.businesswire.com/news/home/20200604005016/en/, http://www.businesswire.com/news/home/20200604005016/en. A lab must have a question related to pathology and laboratory medicine practice you need a different of. Different quality of the patients who trust them with their care right in... Name of alignment with FDA requirements checklists are organized by discipline, they no. The information below was current at the time of Communication types of testing laboratory 's management... Via webinar to the CAP released the 2020 edition of its laboratory Accreditation program checklists, which inspectors use ensuring! 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Eventually benefit labs and patients alike program, internationally recognized and the lab or expired to watch pathologists work!

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