“The rules for waived tests are basically that you have the certificate of waiver, and you are supposed to follow the manufacturer’s instructions.”. “That would be the type of discussion they’d need to have with their health care institution, and have a written plan in place for how to deal with specimens from patients with suspected infection with emerging pathogens.”, The hope of the committee members, Dr. Pritt says, is that when an institution is creating its plan for high-consequence pathogens, that point-of-care settings be considered. Even though the tests are waived and easy to perform, the technology behind them is complicated and uses molecular-based amplification methods that may be prone to contamination.”, “We are not requiring a lot of additional things,” Dr. Pritt continues. “We want to raise awareness that all institutions need to consider their point-of-care tests because that’s where the patient may show up first—the point-of-care site.”. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. “These are relatively simple tests, but a lab person ought to be involved in that testing,” as far as education and developing practices and procedures. quality control of diagnostic … If one patient’s swab is placed on a counter and it contaminates the counter surface, and another patient’s swab is then placed on the same counter, the second swab could pick up genetic material from the first swab. Microbiology Point Of Care Programs Quality Cross Check Reproductive Medicine Toxicology Transfusion Medicine Viral Markers and Parentage Testing Guest Log in/Register Contact & Support … Article usage statistics are updated for each article monthly and can be found within the ‘Metrics’ tab in the 'Info' dropdown menu for each article; Altmetrics appear in the same location but are updated daily. Regardless, the College of American Pathologists (CAP) have now added several accreditation checklist items in the 2019 checklist to address molecular POC testing. in 2019 Issues, ARTICLES, September 2019. “I knew we would eventually but it was a long way off, and molecular tests at that time were hard to do in your lab, let alone in the clinic.” Now the tests are performed by people on the floors who have no training in laboratory practice. “The report must include a brief description of the method if the methodology is not explicit in the test name,” the checklist says. “That medication has side effects,” Dr. Karger says. “The answer we would give is that these limited service labs are now doing fairly complex tests. On September 17 the 2019 checklist edition was published and is currently in the field for CAP laboratory inspections. One copy of the GEN Checklist … For example, if a patient was tested by a less sensitive influenza antigen detection method, then it may not be safe to rule out influenza in that patient.”, Group A strep antigen tests also have variable sensitivity—around 80 percent. So the labs may be performing testing in areas where one would not expect it to be done. Master microbiology checklist cap| September 2019—Four new checklist requirements for waived molecular-based microbiology tests have been added to the CAP point-of-care testing, limited service … “Now that we are starting to get into all of these options—antigen tests, PCR tests—it’s important to include the method in the name or description of the test on the report, so that clinicians reading the report can use this information to interpret the significance of the result. 2019 CAP CHECKLIST REVIEW •Describe key changes and the rationale for the changes in the 2019 version of the CAP Accreditation Program requirements •Learn more about and leverage CAP … November 2020—It’s been well understood since the Ten Commandments that rules that appear simple in theory can be fiendishly complex or even impossible to execute. Dec. 23, 2020—AstraZeneca’s Tagrisso (osimertinib) has been FDA approved for the adjuvant treatment of adu... Dec. 22, 2020 —Quidel announced it received emergency use authorization from the FDA to market its QuickVue ... Dec. 21, 2020—Randox announced that its improved software for the Vivalytic analysis device enables its CE-m... Dec. 18, 2020—Beckman Coulter launched the Access SARS-CoV-2 Antigen assay, a high-throughput COVID-19 test... Dec. 16, 2020—The FDA issued an emergency use authorization for the first over-the-counter, at-home diagnost... Dec. 15, 2020—Roche launched the Cobas PIK3CA Mutation Test CE-IVD for patients with advanced or metastatic ... Dec. 11, 2020—Siemens Healthineers announced it received the CE mark and FDA 510(k) clearance for the Epoc N... Dec. 10, 2020—The FDA authorized the first COVID-19 direct-to-consumer test system­—LabCorp’s Pixel COV... Dec. 7, 2020—The FDA authorized the first diagnostic test for at-home collection of patient samples to detec... Dec. 2, 2020—Roche announced that its Elecsys Anti-SARS-CoV-2 S antibody test has received emergency use aut... New requirements for molecular micro waived testing, Quidel gets EUA for QuickVue SARS rapid antigen test, Reduced TAT for Vivalytic SARS-CoV-2 positive samples, Beckman launches $4, high-throughput COVID-19 antigen test, FDA authorizes first OTC at-home test for COVID-19, 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, Checklist, CLIA line up on COVID reporting, Fewer urine cultures — series of changes add up, At POC and in lab, 2 new checks on SARS-CoV-2 testing, Save time searching for tests and instrument information, “It's all stressful, it's all out of the box. For questions about the use of the Checklists or Checklist interpretation, email accred@cap… This on-demand webinar originally broadcast October 21, 2020. Watch Now, Webinar presenter Nils Hartmann, PhD, Molecular Pathology—Head of NGS, Institute of Pathology, Mainz University Medical Center, Germany, discusses how QIAseq HRD panel is used in the identification of genetic mutations in HR deficient breast, ovarian and prostate cancer, how to implement a workflow identifying gene mutations in breast, ovarian and prostate cancer, a comparison of the QIAseq HRD panel with QIAseq BRCA Panels for profiling gene mutations from FFPE tumor tissue, and analysis and review of panel results using a full Sample to Insight workflow using CLC workbench. This webinar will provide insight into the key changes of the CAP Laboratory Accreditation Program checklist requirements and use CAP resources to identify checklist … “If they are going into that specimen and taking out an aliquot, are they doing that in a sterile manner? The 2019 edition of the CAP accreditation checklists are now available. This checklist requirement applies to both waived and nonwaived tests. Master Laboratory General Checklist CAP Accreditation Program College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 08.17.2016 3 of 129 Laboratory General Checklist … There either has to be “a regulatory switch, so that trained laboratory people have a role in these things, or a switch in training, so that nursing education and physician education incorporate some accountable component of good laboratory practice.”, “This is the beginning, not the end, of the move of molecular and other cutting-edge laboratory methods into the point-of-care setting.”. Master All Common Checklist CAP Accreditation Program College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 08.21.2017 3 of 53 All Common Checklist 08.21.2017 All Common Checklist September 2019—Four new checklist requirements for waived molecular-based microbiology tests have been added to the CAP point-of-care testing, limited service laboratory, and immunology accreditation … They may not even want to test the specimen there,” she says, referring to the point-of-care setting. Wipe tests, like any procedure, must be well thought out and require skill to be done well, says Dr. Campbell, professor of laboratory medicine at Yale School of Medicine. “There have to be ways to still do the general testing required, such as influenza PCR, but the health care staff need to realize that if a patient just returned from the Middle East and had exposure to MERS, there are different considerations for obtaining and testing specimens. “Good laboratory practice is its own discipline,” he says. This update is to provide clarification on a new Microbiology Checklist requirement, MIC.21835, published in the 2019 Checklist Edition, MIC.21835 (Direct Testing for Organism … Moderated by: Bob McGonnagle, Publisher, CAP TODAY. The note says the policies may be part of an institution’s plan but that the plan must address point of care specifically. Nucleic acid amplification testing for more targeted assays, such as gonorrhea and chlamydia screening tests (GC/CT) and multiplex respiratory pathogen panels. Tagged with: CAP lab accreditation/checklists/protocols/guidelines Microbiology. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. “I do a lot of work with high-consequence pathogen planning at the institutional level. MICROBIOLOGY Checklist 9/27/2007 Edition The following questions have been added, revised, or deleted in this edition of the checklist, or in the two editions immediately previous to this one. In recent microbiology checklist versions, the CAP has incorporated items addressing microscopy quality. For the 2019 edition, an additional revision to add the phrase “as applicable” was made to the checklist to clarify that MIC.21835 does not apply to all identification and susceptibility testing performed directly from patient specimens (see below). You will understand the importance of NTRK testing in solid tumors, gain an understanding of the role of IHC and different NTRK test methodologies, and obtain insight into the NTRK testing algorithm set up by a national reference lab. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. Evidence of Compliance: Written procedure describing the use of culture to confirm isolation of organism(s) that are morphologically consistent with the ID and/or AST results. 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. 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