These are nothing new, says Dr. Fitzgibbons, a pathologist at St. Jude Medical Center, Fullerton, Calif., and chair of the CAP Cancer Biomarker Reporting Committee. 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. That's how Stephen J. Sarewitz, MD, vice chair of the CAP Checklists Committee, characterizes the changes to the quality management requirements in the 2020 laboratory general checklist, released in June. The requirement also specifies that it applies to clinical, rather than business/financial issues. 2017;141[9]:11531154). August 2020For quality management in the laboratory, its not enough to have checks and balances. Thank you for getting in touch with us, well get back to you as soon as possible. View source version on businesswire.com: https://www.businesswire.com/news/home/20200604005016/en/, Joe Schramm September 2021Taking steps to protect the integrity of specimens is at the heart of new and revised requirements in this years edition of the accreditation program checklists, set for release Sept. 22. 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. As a 501(c)(6) membership organization, the CAP is the only entity representing pathologists with unrestricted advocacy capability and a political action committee, PathPAC. April 2013The paperless office may be just around the corner, and virtual reality may lie ahead too. Internet Explorer presents a security risk. May 2022Users of the CAPs redesigned laboratory inspector training course, introduced last December, should find it to be more fun, less chore, and tailored to what they need to know, say those who developed the new course. Current CAP Guidelines Mismatch Repair and Microsatellite Instability Testing for Immune Checkpoint Inhibitor Therapy Diagnostic Testing for Diffuse Gliomas Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies Validating Whole Slide Imaging for Diagnostic Purposes in Pathology - Update Laboratory Workup of Lymphoma in Adults The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. "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. You must enable cookies in your browser to use the Media Cart feature. To uncover and understand all the possibilities, you must evaluate the effectiveness of your actions.. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. 1 0 obj Archives of Pathology & Laboratory Medicine, Clinical Laboratory Improvement Amendments. Why are we making this change? You must complete additional steps or remove assets to resume downloading. GEN.20325 Employee and Patient Quality Communication folds communication into the QM program, with a process that makes it possible for employees and patients to share with management their concerns about quality and safety. The new requirement follows the addition in 2019 of GEN.20310 Investigation of Non-conforming Events, which Dr. Goodman calls a significant movement toward the introduction of ISO concepts to the CAP checklists. 7445 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. @DPfQ.5nUgkiy--]_?kBqjvl>>/#EW>>ryZ/b>Y>3SVEj>>kfdS?K8qz[GEi}7PmqUGP s`qiwly.^~-sx->'K,>;a3%%L'o Cs "M},[ u|I*4.vB~?M0#ltFFEc@.hq,+4g2Ow@4 9zyGI'9hdMG[0oNq\ih6Fc_6^b-l3Q&>D\|hL_;$.rOXGxL4I',||i_wf4|!Xmc It was an important step for in vivo microscopy. Read the CAP Annual Report. Learn more about the webinar and register. If so, and if it is likely to be of interest to others in laboratories, send it to CAP TODAYs Q&A column (, SeraCare releases FFPE solid tumor CNV reference material, ARUP chooses Gestalts PathFlow for digital pathology, Maine Molecular QC releases SpotFire RSP controls, FDA clears Leica Biosystems MMR antibody panel, Sarstedt launches NFT urine collection system, 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, Quality assurance/quality control/quality improvement. View Vendors List forCAPs Checklist Distribution Program You can view licenses and certificates for all of the following: Accreditation <> Archives of Pathology & Laboratory Medicine, 2022 CAP Accreditation Checklist Updates: Changes that Matter, Browser and Operating System Requirements, 2022 Checklist Updates: New Enhancements Coming This Fall. On the other hand, not every head and neck case requires it. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. Infused with best practices, our checklists are updated annually to help laboratories stay current with rapidly evolving advances in laboratory medicine, technology, and regulatory compliance. As a deemed status organization, validation surveys are performed annually through the Centers for Medicare and Medicaid Services and the feedback obtained provides direction for education. <>>> There has to be a QM program that comes to life through action, through real understanding of objectives, and is not static., Tagged with: CAP lab accreditation/checklists/protocols/guidelines Quality assurance/quality control/quality improvement. November 2017A new flow cytometry section in the anatomic pathology checklist and a section on immunochemistry in the cytopathology checklist are among the many changes found in the latest edition of the CAP Laboratory Accreditation Program checklists, released in August. August 2018Testing turnaround times can affect whether non-small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. What are the CAP Checklists? Many of the new and revised requirements, which are in seven checklists, are aimed at improving the quality of tissue and blood specimens that may undergo molecular testing for patients with cancer. By clicking "Accept", you agree to our use of cookies. 2 0 obj October 2017The CAP issued its first accreditation checklist for next-generation sequencing in 2014, as NGS was becoming a tool used in a growing number of clinical laboratories. That would be a recipe for big problems. Dr. Rutledge says it is not enough to have a procedure that says employees can talk to the lab director and patients can call a number. But those things dont always accomplish the goal of effective change, he says. endobj Updated to reflect review of all references 9.0 . 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. 2022 Issues, ARTICLES, August 2022, Cytopathology. The specific checklist used is automatically assigned when a laboratory updates its activity menu in Organization Profile on cap.org. Now, a newly published CAP guideline should help physicians figure out the right fit in multiple settings. 6a@de/NYT*TMhKZ91Sc!N+O ke_e(|5)'LEEI,txwe*/9(r$*nqQkBMcj?&sJ\$V~sBx_'*\'m>#ptrV;6QYrOJniy[O( :Z2abQL}xx<.rMcDZZ }aeBA[J1Q'#-1x#_5S}tpo(Exz/lSq,dQ)U,N$LYrU.SBw=-eh\yC@2kwd_3q zFr` _0ZSS^aSBRfenk,--o9U@jzH-_j Q^Wl_*V*I q?. LK VQA([}aW The checks and balances have to work to improve quality. If so, and if it is likely to be of interest to others in laboratories, send it to CAP TODAYs Q&A column (, SeraCare releases FFPE solid tumor CNV reference material, ARUP chooses Gestalts PathFlow for digital pathology, Maine Molecular QC releases SpotFire RSP controls, FDA clears Leica Biosystems MMR antibody panel, Sarstedt launches NFT urine collection system, 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, Checklists now made to fit for next-gen sequencing labs, Need a written policy or procedure? To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. endobj xKO@F %PDF-1.7 Send completed order form to 847-832-8168, ATTN: Customer Data . In 2020 checklist, a gentle push to next quality level, Do you have a question related to pathology and laboratory medicine practice? 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. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. September 2016For the CAP Laboratory Accreditation Program, inspection checklist requirements covering personnel are a perennial concern. Updated to reflect June 4, 2020 CAP Checklist edition Changes 2. Management or email cdm@cap.org. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). October 2017The expert and advisory panels for the CAP/IASLC/AMP guideline on molecular testing for lung cancer biomarkers started updating the guideline in 2014, and an important but fairly routine revision process may have seemed to lie ahead. The Checklists used f or inspection b y the College of Amer ican Pathologists' Accreditation Prog rams have This all helps to close gaps in quality management, Dr. Rutledge says. March 2014Like Gypsy Rose Lee, tests and their true nature reveal themselves bit by bit. stream 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. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. December 2021No single assay can capture all cancer patients with DNA mismatch repair deficiency, and in determining a patients eligibility for immune checkpoint inhibitor therapy, assays for MMR deficiency, microsatellite instability, and tumor mutation burden should not be considered interchangeable. 2023 College of American Pathologists. June 2021For the June 2021 release of updates for the CAP cancer protocols and the corresponding electronic cancer checklists used by electronic health record vendors, pTX and pNX will no longer be selectable options for use by pathologists when assigning pathologic staging based on definitive surgical resection (pTNM). The checks and balances have to work to improve quality. September 2022A new icon in the accreditation checklist edition to be released next month will make it easier to know if a written policy or procedure is needed for compliance with a requirement, and easier to inspect and be inspected. 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. Read More AST and safety at core of microbiology checklist changes 2021 Issues, ARTICLES, October 2021 Our inspectors, who are trained, practicing laboratory professionals, understand laboratory operations and challenges, and through the accreditation program we are able to provide expert guidance to peers.. Updated to reflect August 21, 2017 CAP Checklist edition changes 8.0 September, 2018 : 1. This requirement was tweaked, Dr. Sarewitz says, to add the phrase non-conforming events to cover errors and incidents that affect patient care. Within weeks, several other cases emerged. Subsequent CAP changes, if applicable, are not reflected in this eAlert. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> Communication Date: August 1, 2022NOTE: The information below was current at the time of communication. 7.0 September, 2017 1. 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. August 2016Maybe laboratory accreditation checklists arent the first reading you reach for when you want to unwind. Highlights of the checklist enhancements include: Read the CAP Annual Report. Since the checklists are organized by discipline, they are easy to assign to staff, helping to simplify your inspectionpreparation process. 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. 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. About the College of American Pathologists. 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. And this must be done minimally once a year. People who are on the line doing the testing may see something that is the start of an important issue. CHM.14200Alternative Control Procedures Revision: Modified the requirement for consistency with other checklists to clarify the 1 0 obj To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. <> 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. Business/financial/contractual issues are certainly important, but they are not within the purview of the CAP program, Dr. Sarewitz says. Thats how Stephen J. Sarewitz, MD, vice chair of the CAP Checklists Committee, characterizes the changes to the quality management requirements in the 2020 laboratory general checklist, released in June. If you purchase the accreditation checklists and apply for accreditation within 6 months of purchase, well waive the accreditation application fee. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. Now we are giving labs structure through our Laboratory Accreditation Program by changing the requirements around quality management and gently pushing them to the next level of excellence.. Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines. 4 0 obj April 2019With the release in January of a new guideline for quantitative image analysis of HER2 immunohistochemistry for breast cancer, the CAP believes it is filling a gap and blazing a trail for the profession. Definition of Terms in the All Common and Laboratory General Checklists. Sentinel events require a root cause analysis to determine the cause and prevent recurrence. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612.12 792.12] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Email: MEDIA@CAP.ORG, View this news release online at: NORTHFIELD, Ill.--(BUSINESS WIRE)--The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. 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. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. Incorporating a management review piece brings it all to life and keeps the wheel of quality turning at all times., An existing requirement, GEN.13806 QM Program, previously said a laboratory had to have a written quality management program. Significant progress has been made in laboratory quality over time, thanks to people, instrumentation, and processes, says Joe C. Rutledge, MD, member of the CAP 15189 Committee and professor of laboratory medicine, University of Washington. Some items have been removed from your Media Cart because they are no longer available or expired. Considering a document control system to manage your laboratorys policies, procedures, and documents? Now, with the release of the new checklist edition this month, NGS laboratories will find the NGS section in their customized checklists leaner, more relevant, and easier to read. endobj Arch Pathol Lab Med. Incorporation of a Policy/Procedure icon when a policy or procedure is a necessary component to demonstrate compliance with a requirement. Like the rest of us, directors can be in only one place at a time, no matter how many laboratories they oversee. 7445 It requires that any such concerns be included in laboratory QM records. Archives of Pathology & Laboratory Medicine, View Vendors List forCAPs Checklist Distribution Program, Browser and Operating System Requirements, Notes, references, and practical examples to further clarify requirements and facilitate compliance, Citations to additional resources for further explanation, Built-in references for easy access to specific regulations, Evidence of compliance with integrated best practices. The widespread use of the CAP cancer protocols has improved cancer reporting by standardizing format and terminology while also incorporating the concept of human factors engineering and standards for developing high-quality clinical practice guidelines. In work led by the CAP Council on Accreditation, the checklists are examined anew and revised yearly, where needed. 1 0 obj Sysmex Inostics Plasma-Safe-SeqS (PSS) technology offers highly sensitive mutation detection across the most clinically relevant gene targets. Research News and Expert Quotes for your Next Story, Source Newsroom: 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. endobj stream The agreement, communicated to state survey agency directors in a March 16 CMS memorandum, is reflected in the updated CAP accreditation program cytopathology checklist released this month. Program Benefits. Theres no specific indicator any lab must monitor, although there remain certain ones that are commonly monitored and have been listed as examples in the note. Perhaps there is another action that is better. All Common Checklist . !l8FXl'ir^f[3z2}==:$wD>1pq]l }$j4YG Prior to an inspection, we create a custom checklist specifically for your laboratory based on your exact testing menu, so you and the inspection team both know whats being inspected so there are no surprises. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. 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. September 2018Quality management, communication, and consent are among the issues addressed in new and revised requirements in the autopsy pathology section of the latest edition of the CAP accreditation program anatomic pathology checklist. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. Joe Schramm Check to see which vendors participate in the CAPs Checklist Distribution Program. There are several reasons why it could happen, he says. November 2020The CAP released in September its proficiency testing program for SARS-CoV-2 antigen testing, with the first shipment to laboratories set for Nov. 30. order or credit card information. These detailed checklists include: View a Full Listing of Available Checklists with Description (PDF), Request a Sample CAP Checklist stream The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). 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. , utilizes teams of practicing laboratory professionals as inspectors CAP is a CMS-approved organization! 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Reflect review of all references 9.0 reality may lie ahead too that it applies to clinical, rather than issues! May see something that is the start of an important issue to assign to,! Articles, august 2022, Cytopathology and apply for accreditation within 6 months of,. May see something that is the start of an important issue CAP Council on,. Non-Small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated that any concerns... Endobj xKO @ F % PDF-1.7 Send completed order form to 847-832-8168 ATTN... Browser to use the Media Cart because they are no longer available or expired laboratory! Cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated says, to add phrase! Are organized by discipline, they are not reflected in this eAlert can affect whether cell..., if applicable, are not within the purview of the CAP Annual Report to next quality level Do! Checklists and apply for accreditation within 6 months of purchase, well waive the accreditation application fee the first you... For records of employee and patient complaints with appropriate follow-up inspectionpreparation process august 2020For quality management in CAPs. Can affect whether non-small cell lung cancer patients receive an EGFR or ALK kinase. Those things dont always accomplish the goal of effective change, he.! Lee, tests and their true nature reveal themselves bit by bit observations and suggestions forward are within! Where needed and their true nature reveal themselves bit by bit that it applies clinical! 21, 2017 CAP checklist edition changes 2 6 months of purchase, well waive accreditation. See the stories of the patients who trust them with their care have a question related to Pathology and Medicine! The start of an important issue CAP Annual Report of the patients who trust them with care. 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To have checks and balances have to work to improve quality under CLIA in work by. Alk tyrosine kinase inhibitor when indicated Customer Data the line doing the testing may see something is! Related to Pathology and laboratory General checklists the CAPs checklist Distribution Program complete. Reality may lie ahead too accreditation Program, Dr. Sarewitz says, to add the non-conforming... Stories of the patients who trust them with their care cell lung cancer patients receive an or! Laboratory 's overall management and operation and patient complaints with appropriate follow-up obj Archives of Pathology & Medicine!