“Good laboratory practice is its own discipline,” he says. A point-of-care coordinator or supervisor who is observing and overseeing the staff’s workflow should determine whether to do wipe testing, Dr. Karger says, though it’s preferable to teach the best practice of not putting exposed samples where they could deposit genetic material. “You wouldn’t turn untrained lab people loose on a nursing process. The Microbiology Committee recognized that if a member of a community traveled recently and has become ill, he or she may go to the local emergency room, which may be performing waived molecular testing, or the person may just visit a local walk-in care clinic and not communicate that they traveled, Dr. Pritt says. 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. The note says, “Examples of this may include review of summary statistics (eg, monitoring percentage of positive results relative to current local and regional rates and increased positive Strep results above historical rate within a run or over multiple runs), performance of wipe (environmental) testing, review and investigation of physician inquiries, and use of process controls to minimize risk of contamination.”, Molecular platforms amplify genetic material from an organism, and because of that amplification step, Dr. Karger says, “you just need a little bit of material to contaminate a sample and create a false-positive.” Environmental contamination is a worry in POC testing, says Sheldon Campbell, MD, PhD, a member of the Checklists Committee, “where neither the staff nor the environment is set up for contamination control.”. The note says the policies may be part of an institution’s plan but that the plan must address point of care specifically. The molecular tests cost more, yes, but you can charge more or bill more for them in environments where that matters, and the performance is markedly better.”, Wielgos notes that supervisors in many labs have been asked to oversee multiple areas. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. “If you have robust procedures in place where something like that wasn’t happening, then perhaps you wouldn’t feel like you needed to do wipe testing as a routine part of the process. This on-demand webinar originally broadcast November 4, 2020. Although the tests are waived, “we feel like there is still quality assurance and quality control that should be performed around them, as a best patient practice, knowing that this will be going beyond what the basic requirements may be,” says Dr. Pritt, who is director of Mayo’s clinical parasitology lab and co-director, vector-borne diseases laboratory services. Testing is often performed in a small area, in which the same counter might be used to prepare vaccines. “Others prefer to use the most sensitive method first, which is generally a nucleic acid amplification method, but this may not always be easily and rapidly available.”, Dr. Campbell says there was an “argument for access” with the antigen tests. If a molecular flu test is a false-positive owing to contamination, “providers may not work up other problems. 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. Questions? This section provides a journal-level summary of these article metrics using 2018 data: full-text download information is based on platform usage statistics, while Altmetric data is from the Altmetric Explorer. 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. 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. However, if local labs perform minimal microbiology (e.g., … •Describe key changes to the 2018 CAP Accreditation Checklist edition •Interpret the rationale for the changes made to the checklist •Use CAP resources to identify and understand key changes … “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. Lab General 129 potential pages of fun! The third new checklist requirement, POC.08715 Safe Specimen Handling/Processing, says there must be written policies for safely handling and processing samples from patients with suspected infection due to avian influenza, SARS, Ebola, or similar emerging pathogens. Watch Now, An Analysis of Initial Testing Strategies and the Role of Multiplex Syndromic Testing as Flu Season Approaches Moderated by: Bob McGonnagle, Publisher, CAP TODAY. You don’t let untrained nursing people loose on a lab process.”, Physician offices that perform CLIA-waived testing are required to have a CLIA certificate of waiver and are not inspected routinely by the CMS. This on-demand webinar originally broadcast December 1, 2020. 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.”. Over 8,000 laboratories globally are accredited by the College of American Pathologists (CAP) (20). 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 … 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… “We are not saying that you need a unidirectional workflow like with a negative pressure room and that sort of thing. If organism identification (ID) and/or antimicrobial susceptibility testing (AST) (phenotypic or genotypic) is performed directly from patient specimens (as applicable) or directly from positive blood culture broths, the specimen/blood culture is inoculated onto solid media to assess for purity, and the growth examined for consistency with the ID and AST. 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. laboratory general checklist pathologie online. November 2020—The CAP released in September its proficiency testing program for SARS-CoV-2 antigen testing, with the first shipment to laboratories set for Nov. 30. Ha, ha, ha,’” Dr. Campbell recalls. This on-demand webinar originally broadcast November 5, 2020. CAP認定についてはこれからご説明します。 臨床検査における製品はあくまでデータであり、形に残りづらいものです。 当社では検査品質の維持・向上を最重要課題と位置づけ、世界基準の検査室を目指すべく2009年にCAP … They have seen false-positive and -negative results, even with the purportedly low-risk molecular tests. 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. This checklist requirement applies to both waived and nonwaived tests. A test could become contaminated if people are administering influenza immunizations and a vial of influenza vaccine leaks onto the area where influenza PCR testing is performed, Dr. Pritt says. f 209 01 15189 doc review checklist. They may not even want to test the specimen there,” she says, referring to the point-of-care setting. The first new checklist requirement, POC.08675 Quality Monitoring Statistics, calls for written procedures to monitor for the presence of false-positive results (owing to nucleic acid contamination, for example) for all molecular microbiology tests. There is never a slam dunk ‘this is the right way to do things’ with no downsides,” he says. Laboratory Professionals Learning Programs, Archives of Pathology & Laboratory Medicine. On September 17 the 2019 checklist edition was published and is currently in the field for CAP laboratory inspections. 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. The committee was asked what requirements from the microbiology checklist should be made part of the POC testing checklist, and they worked with members of the Checklists and Point of Care Testing committees to make the selection. “I do a lot of work with high-consequence pathogen planning at the institutional level. 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 Identification and Susceptibility), based on inquires that the CAP has received on the applicability of this requirement to different organisms and test systems. For questions about the use of the Checklists or Checklist interpretation, email accred@cap… “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. “We want to raise awareness that those types of activities should be done in separate areas,” she says. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. MIC.21835 will be revised further in the 2020 Checklist Edition to more fully clarify the intent. Microbiology Checklist Cap molecular genetics laboratory detailed requirements for. Measles is one of these pathogens,” she says, “and we realize that people with measles feel relatively well.” Because of this, they may have just a rash and slight fever and go to their local physician’s office or an emergency or walk-in clinic, rather than the main hospital where the specimen will be sent to the microbiology laboratory. The note says that for tests that may be performed by either direct antigen or molecular-based methods, including the test method in the report is important for result interpretation. How do they prevent someone from contaminating that specimen?” Someone without laboratory training may not think of those things, she notes. But we want labs to be aware of the risks and have a procedure for preventing contamination, keeping an eye out for it, and being able to detect it.”, Point-of-care testing in large health systems overseen by pathologists is the right model, says Dr. Campbell. The Laboratory General (GEN) Checklist applies to all sections or departments of the laboratory. 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. “Mandating it, regulating it, and making it happen could severely impair access. Microbiology Point Of Care Programs Quality Cross Check Reproductive Medicine Toxicology Transfusion Medicine Viral Markers and Parentage Testing Guest Log in/Register Contact & Support … 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. Master Molecular Pathology Checklist CAP Accreditation Program College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org 08.21.2017 3 of 74 Molecular Pathology Checklist … “The answer we would give is that these limited service labs are now doing fairly complex tests. “You wipe potentially contaminated surfaces and put the swab into your molecular test to see if you are getting positives from your environment as opposed to from patients.”. Karen Lusky. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. “If they are going into that specimen and taking out an aliquot, are they doing that in a sterile manner? … “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. One copy of the GEN Checklist … “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. Regardless, the College of American Pathologists (CAP) have now added several accreditation checklist items in the 2019 checklist to address molecular POC testing. Watch Now, Webinar presenters Rodrigo Hasbun, MD, MPH, FIDSA, and Joan-Miquel Balada-Llasat, PharmD, PhD, D(ABMM), discuss the financial impact of CNS infections on the health care system, how a comprehensive, rapid multiplexed molecular test can help make better treatment decisions with patients suspected of CNS infections, and a review of the BioFire® ME Panel publications that support shorten time to diagnosis, impact on antimicrobial utilization, and reduced length of stay. 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 … “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. 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