Laboratory Professionals Learning Programs, Archives of Pathology & Laboratory Medicine. “I do a lot of work with high-consequence pathogen planning at the institutional level. Nucleic acid amplification testing for more targeted assays, such as gonorrhea and chlamydia screening tests (GC/CT) and multiplex respiratory pathogen panels. The Laboratory General (GEN) Checklist applies to all sections or departments of the laboratory. Dr. Pritt says the CAP wants point-of-care labs to think of their entire workflow and have procedures in place to prevent loss, alteration, or contamination. 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 program checklists, as part of the 2019 checklist edition released this month. “Back in the day, when there was nothing but the antigen tests, I think they had a role, but that role is fading because there are better alternatives. Consult the CAP Checklist From the College of American Pathologists Microbiology checklist, question MIC.65200 states “For molecular-based quantitative and qualitative tests, controls are run at least daily, or more frequently if specified in manufacturer’s instructions, laboratory procedure, or the CAP Checklist… f 209 01 15189 doc review checklist. The cartridges contain amplified DNA that can cause false-positives, Dr. Campbell says, so it’s critical to make sure they are disposed of in medical waste without harming the cartridge. “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. However, if local labs perform minimal microbiology (e.g., … The note says the policies may be part of an institution’s plan but that the plan must address point of care specifically. “But it’s not uncommon for an immunology laboratory to have a serology section that’s doing different types of infectious disease testing that might include anything from the antibody testing to the direct antigen or the waived molecular method.”, People working in limited service labs, Dr. Pritt says, might ask why they need to meet the requirements and contend with what they could see as a more complicated checklist. 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. “The answer we would give is that these limited service labs are now doing fairly complex tests. **NEW** 09/17/2019MIC.21835 Direct Testing for Organism Identification and Susceptibility Phase II. 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.”. Methods such as molecular blood culture systems where correlation of phenotypic culture results with molecular identification and purity assessment is critical for proper result interpretation. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. “In the case of waived testing,” he says, “we are giving priority to access, with some probable compromise in quality.” That isn’t necessarily wrong, he adds, but a lab professional ought to be involved. “These aren’t just little boxes they can put on their countertop and put in a sample and get a result and not really think about it. Microbiology Checklist Cap molecular genetics laboratory detailed requirements for. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. This on-demand webinar originally broadcast September 22, 2020. 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. Dr. Pritt and other members of the Microbiology Committee have noticed that even though the new cartridge-based waived molecular tests are self-contained, and the risk for nucleic acid leakage and contamination is low, nucleic acid contamination can occur. 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 … How do they prevent someone from contaminating that specimen?” Someone without laboratory training may not think of those things, she notes. The fourth new checklist requirement, POC.08730 Final Report, calls for the report to include a summary of the test method and information regarding clinical interpretation, if appropriate. CAP Common Checklist Items That Refer to IQCP (7/31/2015) Materials Developed Collaboratively by ASM, CAP, and CLSI Antimicrobial Susceptibility Testing AST IQCP Introduction (5/31/2015) AST … “It was a nice collaboration between our three committees,” Dr. Pritt says, “trying to use all of our different CAP expertise to decide what is applicable, what’s doable, what applies to day-to-day testing in a point-of-care setting.” They modified the four requirements “to be relevant to the point-of-care testing environment.” (The microbiology checklist can be used for both waived and nonwaived testing.). The first waived molecular tests became available within just the past few years, says Amy Karger, MD, PhD, vice chair of the CAP Point of Care Testing Committee and medical director, West Bank Laboratory, University of Minnesota Health. 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 program checklist… 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 Objectives •Discuss CAP Checklists and highlight changes in the 2017 checklist edition •Describe key changes for laboratories with California clinical laboratory licensure •Review tips for staying current with checklist … There’s always a tradeoff. This webinar will provide insight into the key changes of the CAP Laboratory Accreditation Program checklist requirements and use CAP resources to identify checklist … There is no additional training. Webinar presenter Lawrence M. Weiss, MD, Chief Medical Officer, NeoGenomics Laboratories, discusses the current diagnostic algorithms for NTRK testing, the role of IHC in testing for NTRK fusions in solid tumors, and implementing pan-TRK IHC as part of their testing algorithm for solid tumors. in 2019 Issues, ARTICLES, September 2019. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. 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. The checklists undergo regular revision and a new edition may be published after the inspection materials are sent. “Good laboratory practice is its own discipline,” he says. 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