cap laboratory general checklist 2020 pdfcap laboratory general checklist 2020 pdf

GEN.20326 Assessment of the QM Program Implementation is a revised requirement that existed previously as GEN.16902 QM Program Implementation. GEN.20326 says that in any lab that has been CAP accredited for more than 12 months, the QM program must be implemented as designed and assessed at least annually for effectiveness. You can view licenses and certificates for all of the following: Accreditation Visit cap.org to register. August 2020For quality management in the laboratory, its not enough to have checks and balances. 1 0 obj Written in easy-to-understand language, they remove the guesswork from compliance which can be especially helpful for laboratories facing staffing challenges. Learn more. 2020 Issues, ARTICLES, COVID-19, November 2020. <> The assigned checklist is based on the specific The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. October 2018It happened for next-generation sequencing. April 2013The paperless office may be just around the corner, and virtual reality may lie ahead too. About the College of American Pathologists. The templates will look very familiar to users of the CAP cancer protocols. 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. Labs need to have a complaint/non-conforming event resolution system. Streamline management and compliance of CAP accreditation checklist requirements through the use of a software solution from one of the program participant vendors. 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. 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. October 2013For anyone worried about the new CAP reporting templates for cancer biomarkers, Patrick L. Fitzgibbons, MD, has an important message: Dont panic. 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. % These requirements were implicit in the prior edition of the checklist, Dr. Sarewitz says. 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? 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. xKO@F The inclusion of the activities of andrology and endocrine 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. Sales Tax Email: MEDIA@CAP.ORG, View this news release online at: Updated to reflect August 21, 2017 CAP Checklist edition changes 8.0 September, 2018 : 1. 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. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. 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. GEN.20208 QM Patient Care/Client Services says the QM program must include a process to identify and evaluate non-conforming events. 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. Thank you for getting in touch with us, well get back to you as soon as possible. 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. Now a change to the CAP Laboratory Accreditation Programs checklists will clarify expectations for directors who are in charge of more than one laboratory. For questions about the use of the Checklists or Checklist interpretation, email accred@cap.org or call 800-323-4040 or 847-832-7000 (international customers, use country code 001). 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. 2022 Issues, ARTICLES, Cytopathology, May 2022. On the other hand, not every head and neck case requires it. Just today I canceled the third hemoglobin electrophoresis test order on a patient. This change is coming after extensive discussions with the American Joint Committee on Cancer (AJCC) and with its unanimous endorsement. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. But those things dont always accomplish the goal of effective change, he says. Some items have been removed from your Media Cart because they are no longer available or expired. Setting the bar higher was important because thats the culture here, he says. 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. A two-week open comment period followed; all comments were reviewed and appropriate changes were incorporated into the protocol. Participants of the CAP accreditation programs may download the checklists from the CAP website (cap.org) by logging into e-LAB Solutions Suite. 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. Read the CAP Annual Report. 2018 Issues, ARTICLES, August 2018, Molecular. 1. By being able to bring that to managements attention they are able to help safeguard both patients and the lab. Fax or email. 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. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612.12 792.12] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Business/financial/contractual issues are certainly important, but they are not within the purview of the CAP program, Dr. Sarewitz says. p9-m M=*Zm. 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. The aim of others is to improve the preanalytic quality of specimens used for all types of testing. Something like sedately stepping onto a moving sidewalk. And now its taking place with imaging mass spectrometry. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). <> In 2020 checklist, a gentle push to next quality level, Do you have a question related to pathology and laboratory medicine practice? Considering a document control system to manage your laboratorys policies, procedures, and documents? endobj Read theCAP Annual Report. CHM.14200Alternative Control Procedures Revision: Modified the requirement for consistency with other checklists to clarify the endobj May 2015Quality control is second nature and part of the air that laboratories breathe. Management or email cdm@cap.org. College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750. CAP Laboratory Accreditation helps laboratories: Maintain accuracy of test results and ensure accurate patient diagnosis. Thats a key to closing the loop when dealing with problems in the laboratory. Evidence of compliance requires records of actions taken and of the effectiveness evaluation. Like the rest of us, directors can be in only one place at a time, no matter how many laboratories they oversee. 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. Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. 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 changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. 2 0 obj Highlights of the checklist enhancements include: These new features will be available for use starting with the 2022 Checklist edition. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. People who are on the line doing the testing may see something that is the start of an important issue. Research News and Expert Quotes for your Next Story, Source Newsroom: "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 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. September 2018Ten years ago, Richard J. Zarbo, MD, was feeling pretty proud of his laboratory. March 2014Like Gypsy Rose Lee, tests and their true nature reveal themselves bit by bit. Visit cap.org to register. 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 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. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. View source version on businesswire.com: https://www.businesswire.com/news/home/20200604005016/en/, Joe Schramm 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. About the College of American Pathologists. 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. All comments were reviewed and appropriate changes were incorporated into the protocol compliance... Period followed ; all comments were reviewed and appropriate changes were incorporated into the protocol low as 0.03 -0.05... Tests and their true nature reveal themselves bit by bit and with its unanimous endorsement for laboratories facing challenges... Mutations in ctDNA as low as 0.03 % -0.05 % mutant allele (... 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As GEN.16902 QM program Implementation is a revised requirement that existed previously as GEN.16902 QM must... Mutations in ctDNA as low as 0.03 % -0.05 % mutant allele frequency MAF... ( AJCC ) and with its unanimous endorsement Programs may download the from! To users of the CAP website ( cap.org ) by logging into e-LAB Suite... Comments were reviewed and appropriate changes were incorporated into the protocol prior of! Quality management in the laboratory, its not enough to have a complaint/non-conforming event resolution system,. Inostics Plasma-Safe-SeqS ( PSS ) technology offers highly sensitive mutation detection across the most clinically relevant mutations in as. Now a change to the CAP laboratory Accreditation Programs may download the checklists from the CAP protocols... Is coming after extensive discussions with the American Joint Committee on cancer ( )., Richard J. Zarbo, MD, was feeling pretty proud of his laboratory unanimous endorsement to identify evaluate. 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