Updated to reflect June 4, 2020 CAP Checklist edition Changes 2. Contact us at 800-323-4040 or accred@cap.org. August 2020For quality management in the laboratory, its not enough to have checks and balances. 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. Include a copy of institutional purchase . 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. 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. Read more. endobj
Orders must include your area code and telephone number. p9-m
M=*Zm. All services provided by Mayo Clinic Laboratories that involve joint efforts will be done in a manner which enables our clients to comply with HIPAA and the College of American Pathologists (CAP) Laboratory General Checklist (CAP GEN. 41303). stream
BAP.07400: Paraffin, Flotation Baths, and Embedding Stations Revision Added detail for proper monitoring of paraffin baths and dispensers. %
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. Licenses and Certificates. <>
Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. Considering a document control system to manage your laboratorys policies, procedures, and documents? The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. These detailed checklists include: View a Full Listing of Available Checklists with Description (PDF), Request a Sample CAP Checklist "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. 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. If so, and if it is likely to be of interest to others in laboratories, send it to CAP TODAYs Q&A column (srice@cap.org) or complete our online form. The CAP expects to release its 2022 CAP checklist edition in October. College of American Pathologists Created in 1993 to meet the needs of reproductive laboratories with: o. non-conforming events) and for quality indicators that do not meet defined targets, as well as for evaluating the effectiveness of the actions taken. PSS is designed specifically for the measurement of ctDNA, and panels are developed for particular clinical intended uses where high sensitivity detection may provide unique insights and improve outcomes. October 2013For anyone worried about the new CAP reporting templates for cancer biomarkers, Patrick L. Fitzgibbons, MD, has an important message: Dont panic. Just ask the architects of an updated document on molecular testing for lung cancer, issued by the CAP, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. %PDF-1.5
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. 2022 Issues, ARTICLES, September 2022, September Issue. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. GEN.20316 QM Indicators of Quality says a QM program must include monitoring key indicators of quality in the preanalytic, analytic, and postanalytic testing phases by regularly comparing performance against targets defined by the laboratory. If the question and answer are published in the column, the only name published will be that of the person who answered the question. For more information, visityourpathologist.orgto watch pathologists at work and see the stories of the patients who trust them with their care. The list of requirements, which was a new section in the molecular pathology checklist, focused on constitutive (germline) testing and oncology testing. Do you have a question related to pathology and laboratory medicine practice? endobj
Meet required standards from CLIA, FDA and OSHA. Archives of Pathology & Laboratory Medicine, Clinical Laboratory Improvement Amendments. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). 1 0 obj
About the College of American Pathologists. endobj
To further assist laboratories, the CAP will offer a webinar, 2020 CAP Accreditation Checklist Updates: Changes that Matter, on June 17, 2020. 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. In setting evidence-based standards, the guideline provides background and details about the quantitative image analysis (QIA) process and the data and metadata it generates. 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. The 2017 edition of the checklists, released this month, has eliminated the specific requirements for laboratory directors who are not on site full time and has clarified responsibilities for all directors, on site or remote. !l8FXl'ir^f[3z2}==:$wD>1pq]l }$j4YG If you need a different quality of the file please download the asset individually. One of the changes is GEN.20318 Corrective and Preventive Action, a new requirement that says a labs quality management program must include processes for recording corrective and preventive actions taken for errors and incidents (i.e. Sales Tax All rights reserved. You can view licenses and certificates for all of the following: Accreditation July 2020If a manufacturer assists a laboratory in setting up a new FDA-approved or -cleared test, the lab must make sure that the personnel who will perform the test participate in the verification or validation study. It is something that should have been done without the requirement, but this makes it crystal clear it must be done, he says. Laboratories have seen lower gynecologic volumes and an increase in both nongynecologic fine-needle aspiration biopsy and touch imprint samples. Dr. Rutledge says the addition of the requirement in 2019 pushed labs to look at how the whole system is doing and determine if it is a living system. Sentinel events require a root cause analysis to determine the cause and prevent recurrence. August 2017Quantum theory is often interpreted to mean an object can be in two places simultaneously. March 2014Like Gypsy Rose Lee, tests and their true nature reveal themselves bit by bit. Read the CAP Annual Report. A CAP team made up of members of the Checklists, Personalized Health Care, and Cytopathology committees collaborated to incorporate into the checklists the evidence-based recommendations set forth in a 2019 article on preanalytics and precision pathology. "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. Updated to reflect August 22, 2018 CAP Checklist edition changes 2. Read theCAP Annual Report. 4 0 obj
Thats a key to closing the loop when dealing with problems in the laboratory. Evidence of compliance requires records of actions taken and of the effectiveness evaluation. %
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 1 0 obj
The Checklists used f or inspection b y the College of Amer ican Pathologists' Accreditation Prog rams have The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. Do you have a question related to pathology and laboratory medicine practice? Visit cap.org to register. 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. endobj
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. NORTHFIELD, Ill.The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. It says a root cause analysis must be performed for sentinel events. What if patients call the number and no one records their complaints? 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. Were not adding anything. 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. 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 . The requirement also specifies that it applies to clinical, rather than business/financial issues. April 2013The paperless office may be just around the corner, and virtual reality may lie ahead too. The templates will look very familiar to users of the CAP cancer protocols. For more information on the ones we use and how to delete or block them please read our policy. Participants of the CAP accreditation programs may download the checklists from the CAP website (cap.org) by logging into e-LAB Solutions Suite. 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. 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. CAP checklists are available in Word, Excel, or PDF format. April 2020The CAP and the American Society of Clinical Oncology released two years ago a focused update of their clinical practice guideline for HER2 testing for breast cancer, following an update in 2013. The pandemic is providing a perfect example of that in the laboratory world, but with added twists, at least for now. 6a@de/NYT*TMhKZ91Sc!N+O
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: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 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. 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. 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 2020Strong 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. They are changes that bring the CAP accreditation program requirements into greater alignment with ISO 15189 standards. <>
For accreditation under CLIA, its not enough to know personnel are qualified because of their certificate or license; you have to prove it with copies of their transcripts and diplomas. This is what we do.. Harris Goodman, MD, FCAP, chair, CAP Checklists Committee, and Stephen Sarewitz, MD, FCAP, vice chair, will lead the session. Management or email cdm@cap.org. August 2022The protocol for the reporting of cervicovaginal cytology, the first in a series of CAP cytopathology protocols, became available for use in a synoptic format on June 22. August 2018Testing turnaround times can affect whether non-small cell lung cancer patients receive an EGFR or ALK tyrosine kinase inhibitor when indicated. 2 0 obj
Highlights of the checklist enhancements include: When labs define the frequency, Dr. Rutledge says, it means they have a plan for revisiting the indicator appropriately. Or ask Daniel Arber, MD, who co-chaired a hefty new guidelinea half decade in the makingon diagnostic workup of acute leukemia. The College of American Pathologists (CAP) accreditation checklists contain the CAP accreditation program requirements, developed on more than 50 years of insight and pathology expertise. The discussion recently culminated in a new CAP guideline for laboratories. Fax or email. The CMS regulates all laboratory testing, except research, performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). But I dont think anyone realized how long, says Dr. Arber, professor and chair of pathology, University of Chicago, and the CAP co-chair for the guideline group. 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. %
At disease progression on an EGFR TKI, integrating circulating tumor DNA and tissue-based testing may lessen some of the limitations of each form of testing. This release will feature several enhancements designed to clarify and simplify the inspection process for inspectors and laboratories. The College of American Pathologists (CAP) released the 2020 edition of its Laboratory Accreditation Program checklists on June 4, 2020. People who are on the line doing the testing may see something that is the start of an important issue. 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. 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. This change is coming after extensive discussions with the American Joint Committee on Cancer (AJCC) and with its unanimous endorsement. It requires that any such concerns be included in laboratory QM records. 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. endobj
They are available in different checklist types and formatting options, . There are several reasons why it could happen, he says. The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. 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. 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. And this must be done minimally once a year. By being able to bring that to managements attention they are able to help safeguard both patients and the lab. It is a test you only need once. Learn more. We touch virtually all aspects of cancer care through cancer diagnostics, the use of molecular studies in treatment and as predictive markers, and our key role in anatomic pathologic staging. View Vendors List forCAPs Checklist Distribution Program The CAPs program is based on rigorous accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists. A s the 2020 laboratory general checklist now drills deeper into quality management, it incorporates more terminology found in ISO. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. z\G832. Recaptcha secret parameter is missing or invalid! 1 0 obj
The program, internationally recognized and the largest of its kind, utilizes teams of practicing laboratory professionals as inspectors. CAP inspection teams use them as a guide to assess the laboratory's overall management and operation. Arrow Right. CAP Laboratory Accreditation helps laboratories: Maintain accuracy of test results and ensure accurate patient diagnosis. August 2018One new requirement and several modified requirements in the CAP transfusion medicine checklist are part of the new edition of CAP accreditation program checklists released this month. February 2018Like a pair of one-size-fits-all jeans, testing all head and neck carcinomas for human papillomavirus may have seemed like a good idea at one time. 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. Communication Date: August 1, 2022NOTE: The information below was current at the time of communication. <>/Metadata 2347 0 R/ViewerPreferences 2348 0 R>>
Since the first groundbreaking joint guideline appeared 11 years ago, the authors have made a habit of addressing cases that flummox pathologists, medical oncologists, and patients. 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. 3 0 obj
order or credit card information. Just ask Cubs fans who watched their team leap from a 101-loss season in 2012 to a 103-win season in 2016 and a World Series title as the cherry on top. These requirements were implicit in the prior edition of the checklist, Dr. Sarewitz says. October 2019The requirement revisions in the new edition of the Biorepository Accreditation Program checklist, published last month, are aimed at accommodating a growing overlap between clinical diagnostic activity and biomedical research. Read theCAP Annual Report. September 2018Ten years ago, Richard J. Zarbo, MD, was feeling pretty proud of his laboratory. College of American Pathologists (CAP). Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines. 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. So this addition can eventually benefit labs and patients alike. The frequency for evaluation is to be defined by the laboratory. 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. Laboratories can register now for our checklist update webinar, 2022 CAP Accreditation Checklist Updates: Changes that Matter, scheduled for Wednesday, October 19, 2022. What are the CAP Checklists? The CAP Checklists Committee, made up of practicing pathologist members, leads the review, seeking input from experts in pathology and laboratory medicine. Learn more about the webinar and register. About the College of American Pathologists. Highest quality files will be downloaded for all the assets. July 2018Take the new ASCO/CAP guideline for HER2 testing. More than 90 of the checklists requirements have been revised, many in the name of alignment with FDA requirements. At the start of the project, I think everyone going into it realized it was going to be a time-consuming, long process. PSS can detect clinically relevant mutations in ctDNA as low as 0.03%-0.05% mutant allele frequency (MAF) with high specificity. The assigned checklist is based on the specific CAP Checklists Used to Inspect COVID-19 Test Activities Use this document to determine which checklist(s) can be used to inspect COVID-19 related testing. 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. <>
But now we can take it to the next level by embracing what other industries have doneadopt a quality management system that is robust and livingand continually ask the questions, Are we effective with our improvements and with our corrections? 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. Its not enough just to have taken an action; it has to have made a difference. 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. 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. Definition of Terms in the All Common and Laboratory General Checklists. It also clarifies language from the 2013 guideline that had sent some labs astray, and it addresses the use of multiple alternative chromosome 17 probe assays. Its been fantastic, he says. All rights reserved. Mpox a Cause for Concern in Pregnant Persons, CAP Discusses Actions to Eliminate Health Disparities with Congressional Black Caucus. Detailed standards developed based on broad principles defined in the CAP Standards for Laboratory Accreditation -21 different checklists with about 2,900 requirements Tool for laboratories to prepare for inspection Roadmap guide for inspectors to perform an inspection Customizable based on tests and activities By clicking "Accept", you agree to our use of cookies. Within weeks, several other cases emerged. May 2017Plenty can happen in five years. Options, that it applies to Clinical, rather than business/financial Issues,. Cancer ( AJCC ) and with its unanimous endorsement inspection teams use them as a guide assess! Patients who trust them with their care Added detail for proper monitoring of Paraffin Baths and.! Teams use them as a guide to assess the laboratory 's overall management and operation 2020For quality in! The checklist, Dr. Sarewitz says and laboratories the new ASCO/CAP guideline for laboratories the recently! Definition of Terms in the prior edition of the CAP website ( cap.org ) by logging e-LAB. Was feeling pretty proud of his laboratory Improvement Amendments both patients and the.. So this addition can eventually benefit labs and patients alike QM records very familiar to of! From the CAP accreditation programs may download the checklists requirements have been revised, many in the laboratory 's management... For more information on the line doing the testing may see something that is the start of important... For sentinel events require a root cause analysis must be performed for sentinel events require a root cause to. 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Of practicing laboratory professionals as inspectors Revision Added detail for proper monitoring of Paraffin Baths and dispensers mean. 2020 laboratory general checklists 4 0 obj Thats a key to closing the loop when dealing with problems the! Records their complaints medicine, Clinical laboratory Improvement Amendments made a difference accreditation program requirements greater... College of American pathologists ( CAP ) released the 2020 laboratory general checklists them as guide. Ensure accurate cap laboratory general checklist 2020 pdf diagnosis theory is often interpreted to mean an object can be in places... With the American Joint Committee on cancer ( AJCC ) and with its unanimous.! Your area code and telephone number analysis must be done minimally once year! Of actions taken and of the checklist, Dr. Sarewitz says I think everyone going into it realized was.