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. Lab General 129 potential pages of fun! There is never a slam dunk ‘this is the right way to do things’ with no downsides,” he says. Microbiology Checklist Cap molecular genetics laboratory detailed requirements for. IQCPF 12.0 FAQs Topic: Individualized Quality Control Plan (IQCP) Frequently Asked Questions Date: May 5, 2015 (last updated 09/16/2019) Click on the links below to go to a specific section of the FAQs. 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. 2018 CAP Deficiencies Based on 2018 CAP Inspection Data CHECKLIST REQUIREMENT CAP-WIDE* GEN.55500 Competency Assessment 1 COM.01200Activity Menu 2 COM.04250 Comparability of … NOTE: It is the responsibility of the laboratory director to determine the extent of confirmatory testing necessary. 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. “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.”. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. 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 … “If they are going into that specimen and taking out an aliquot, are they doing that in a sterile manner? MIC.21835 will be revised further in the 2020 Checklist Edition to more fully clarify the intent. “Mandating it, regulating it, and making it happen could severely impair access. Microbiology Checklist 04.21.2014 ON-LINE CHECKLIST AVAILABILITY Par ticipants of the CAP accreditation prog rams ma y do wnload the chec klists from the CAP Web site (www .cap .org) 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. 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 … Watch Now, Webinar presenters Steve Miller, MD, PhD, University of California San Francisco, and Joseph Yao, MD, Mayo Clinic, Rochester, Minnesota, discuss the need for standardization in post-transplant diagnostics with emphasis on Epstein-Barr virus (EBV) and BK virus (BKV), how this can be achieved and how improvements in laboratory testing can potentially translate into better patient care, and the impact of COVID-19 on transplant diagnostics and laboratory testing and what this means for patients and for the laboratory. 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. The list of analytes for which CAP requires proficiency testing is available on the CAP website or by phoning 800-323-4040, option … 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. In recent microbiology checklist versions, the CAP has incorporated items addressing microscopy quality. The 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.). 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. 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So the labs may be performing testing in areas where one would not expect it to be done. September 2020—Strong quality management, patient safety, and conformity with regulations are at the heart of the new and revised requirements in the 2020 CAP accreditation program transfusion medicine checklist, released in June. 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.”. 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. 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. 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. 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. 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. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. “Some providers and laboratories prefer to use a diagnostic algorithm where a rapid test may be performed initially, and if negative, a second more sensitive test is performed,” Dr. Pritt says. 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 … They could treat the person for flu and send them home when the person has a bacterial pneumonia.” Or a patient with a false-positive result could be treated unnecessarily, with Tamiflu perhaps. “Good laboratory practice is its own discipline,” he says. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. They have to think about the entire process from start to finish.”. 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. Contact us at 800-323-4040 or accred@cap.org. 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 … This on-demand webinar originally broadcast October 21, 2020. “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. This webinar will provide insight into the key changes of the CAP Laboratory Accreditation Program checklist requirements and use CAP resources to identify checklist … But it has served us well.”, Solving problems, restricting orders: Compass on COVID, “We cannot keep up using only our current platforms. Does he view that as a problem? For questions about the use of the Checklists or Checklist interpretation, email accred@cap… 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. The pandemic is providing a perfect example of that in the laboratory world, but with added twists, at least for now. Back to top 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. 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. “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. 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. “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. 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 … 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. They have seen false-positive and -negative results, even with the purportedly low-risk molecular tests. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. “You wouldn’t turn untrained lab people loose on a nursing process. That, he says, needs to change. 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. This on-demand webinar originally broadcast September 22, 2020. This on-demand webinar originally broadcast December 1, 2020. Over 8,000 laboratories globally are accredited by the College of American Pathologists (CAP) (20). Developed with input from more than 500 pathologists and laboratory experts, our 21 discipline … 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. “The CAP has decided to improve patient care by providing additional safeguards that wouldn’t necessarily be performed otherwise,” says Bobbi Pritt, MD, MSc, DTM&H, chair of the CAP Microbiology Committee and professor, Mayo Clinic Alix School of Medicine. Karen Lusky is a writer in Brentwood, Tenn. 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... 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However, if local labs perform minimal microbiology (e.g., … 2021 CAP Accreditation Checklist Updates: Changes That Matter Harris Goodman, MD, FCAP, Stephen Sarewitz, MD, FCAP Click here to register November 17, 2021 12:00-1:00 PM CST Building a Quality … The note says the policies may be part of an institution’s plan but that the plan must address point of care specifically. “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.”. Regardless, the College of American Pathologists (CAP) have now added several accreditation checklist items in the 2019 checklist to address molecular POC testing. If this checklist … 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. There is no additional training. Microbiology Point Of Care Programs Quality Cross Check Reproductive Medicine Toxicology Transfusion Medicine Viral Markers and Parentage Testing Guest Log in/Register Contact & Support … This checklist requirement applies to both waived and nonwaived tests. Ha, ha, ha,’” Dr. Campbell recalls. 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 … Watch Now, Webinar presenters Stephen Freedland, MD, Staff Physician, Durham VA Medical Center Director, Center for Integrated Research in Cancer & Lifestyle; Associate Director, Education and Training, Cedars-Sinai Cancer; Professor of Surgery (Urology), Cedars-Sinai Medical Center, and John Longshore, PhD, FACMG, Director, Molecular Pathology, Carolinas Pathology Group, Atrium Health, discuss the prevalence of HRD in patients with ovarian cancer and the rationale for HRD testing, prevalence of HRRm in patients with prostate cancer and the rationale for HRRm testing, and current guideline recommendations for molecular testing in ovarian and prostate cancer, and sample type options and considerations. Direct antigen tests for influenza have variable sensitivity, Dr. Pritt says, ranging from less than 40 percent to upwards of 95 percent, compared with molecular-based methods, for which the sensitivity is 95 percent or higher. “I do a lot of work with high-consequence pathogen planning at the institutional level. “The rules for waived tests are basically that you have the certificate of waiver, and you are supposed to follow the manufacturer’s instructions.”. 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. 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. “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. Webinar presenters David Hillyard, MD, Medical Director, Molecular Infectious Disease, ARUP Laboratories, and Blake Buchan, PhD, D(ABMM), Associate Professor, Department of Pathology, Medical College of Wisconsin, Associate Director, Clinical Microbiology, Wisconsin Diagnostic Laboratories, discuss diagnostic testing during the initial COVID-19 outbreak, the future direction of SARS-CoV-2 testing, ChromaCode’s development of a high-throughput, single well Flu A / Flu B / RSV / SARS-CoV-2 PCR assay, the evolution of SARS-CoV-2 testing best practices and additional considerations for the upcoming flu season, developing your lab’s updated SARS-CoV-2 testing strategy as we approach flu season, and understanding some of the available testing options for multiplex flu, RSV, and SARS-CoV-2 testing. That said, I do think occasional checks with wipe testing is a good idea.” If a clinic found that it was seeing a much higher rate of positives, Dr. Karger says, then wipe testing would be part of the investigation to identify the source of the contamination. “We are not saying that you need a unidirectional workflow like with a negative pressure room and that sort of thing. laboratory general checklist pathologie online. Watch Now. “That medication has side effects,” Dr. Karger says. This requirement applies only to testing performed for patient care/management, not to infection control or epidemiology testing. **NEW** 09/17/2019MIC.21835 Direct Testing for Organism Identification and Susceptibility Phase II. Such testing may be limited to confirmation that colony growth morphology is consistent with organism identification results obtained from the direct test. November 2020—Five years after putting in place a urine reflex algorithm at Barnes-Jewish Hospital in St. Louis, and many tweaks later, Melanie Yarbrough, PhD, D(ABMM), D(ABCC), has tips to share on how to increase the odds for success in reducing the number of urine cultures. 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 … Watch Now, An Analysis of Initial Testing Strategies and the Role of Multiplex Syndromic Testing as Flu Season Approaches Customized to your lab and lab services so probably more like 50 for RLAP. “The answer we would give is that these limited service labs are now doing fairly complex tests. 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. “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. If a molecular flu test is a false-positive owing to contamination, “providers may not work up other problems. “There’s no enforcement at all in that kind of setting,” he says. 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 … 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… 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.”. “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. Questions? CAP checklists are living blueprints, used by laboratories and inspectors to ensure quality and patient safety. They may not even want to test the specimen there,” she says, referring to the point-of-care setting. Moderated by: Bob McGonnagle, Publisher, CAP TODAY. 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 … On September 17 the 2019 checklist edition was published and is currently in the field for CAP laboratory inspections. A decade ago, there were fewer analytes and no molecular tests at the point of care. “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. Molecular … Tagged with: CAP lab accreditation/checklists/protocols/guidelines Microbiology. How do they prevent someone from contaminating that specimen?” Someone without laboratory training may not think of those things, she notes. quality control of diagnostic … … 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. “Since this is new technology, we have to adapt our checklists to reflect the different risks that come with molecular testing that aren’t seen with immunoassay testing.” Those who perform the testing must be educated about the risks for false-positives, she says. The responsibility of the laboratory director to determine the extent of confirmatory testing.! * * NEW * * 09/17/2019MIC.21835 Direct testing for more targeted assays, such as gonorrhea and chlamydia screening (! 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